[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2004 Edition]
[From the U.S. Government Printing Office]



[[Page i]]



          21


          Parts 170 to 199

                         Revised as of April 1, 2004


          Food and Drugs
          
          


________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2004
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

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                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2004



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[[Page iii]]




                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Material Approved for Incorporation by Reference........     583
      Table of CFR Titles and Chapters........................     599
      Alphabetical List of Agencies Appearing in the CFR......     617
      List of CFR Sections Affected...........................     627

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                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 170.3 refers 
                       to title 21, part 170, 
                       section 3.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2004), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 741-6010.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-741-6000 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
fedreg.info@nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
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ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, The United States 
Government Manual, the Federal Register, Public Laws, Public Papers, 
Weekly Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format at www.gpoaccess.gov/
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    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.archives.gov/federal--
register. The NARA site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

April 1, 2004.

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                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2004.

    For this volume, Bonnie Fritts was Chief Editor. The Code of Federal 
Regulations publication program is under the direction of Frances D. 
McDonald, assisted by Alomha S. Morris.

[[Page x]]




[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 170 to 199)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         170

Cross References: Food Safety and Inspection Service, Department of 
  Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.

  Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

  United States Customs Service, Department of the Treasury: See Customs 
Duties, 19 CFR chapter I.

  Internal Revenue Service, Department of the Treasury: See Internal 
Revenue, 26 CFR chapter I.

  Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: 
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.

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CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




                           (Parts 170 to 199)

  --------------------------------------------------------------------


  Editorial Note: The Food and Drug Administration published a document 
at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a uniform 
effective date for compliance for regulations affecting the labeling of 
food products. At 51 FR 34085, Sept. 25, 1986, FDA established January 
1, 1989 as a new uniform effective date for compliance. The new uniform 
effective date will apply only to final FDA food labeling regulations 
published after July 1, 1986, and before January 1, 1988. At 55 FR 276, 
Jan. 4, 1990, FDA established January 1, 1993 as a new uniform effective 
date for compliance. The new uniform effective date will apply only to 
final FDA food labeling regulations published after January 1, 1990 and 
before January 1, 1992.

  Editorial Note: For nomenclature changes to chapter I see 59 FR 14366, 
Mar. 28, 1994.

          SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
Part                                                                Page
170             Food additives..............................           5
171             Food additive petitions.....................          24
172             Food additives permitted for direct addition 
                    to food for human consumption...........          30
173             Secondary direct food additives permitted in 
                    food for human consumption..............         117
174             Indirect food additives: General............         148
175             Indirect food additives: Adhesives and 
                    components of coatings..................         149
176             Indirect food additives: Paper and 
                    paperboard components...................         191
177             Indirect food additives: Polymers...........         229
178             Indirect food additives: Adjuvants, 
                    production aids, and sanitizers.........         348
179             Irradiation in the production, processing 
                    and handling of food....................         440
180             Food additives permitted in food or in 
                    contact with food on an interim basis 
                    pending additional study................         446
181             Prior-sanctioned food ingredients...........         451
182             Substances generally recognized as safe.....         456

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184             Direct food substances affirmed as generally 
                    recognized as safe......................         469
186             Indirect food substances affirmed as 
                    generally recognized as safe............         567
189             Substances prohibited from use in human food         572
190             Dietary supplements.........................         577
191-199         [Reserved]

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           SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION (CONTINUED)





PART 170_FOOD ADDITIVES--Table of Contents




                      Subpart A_General Provisions

Sec.
170.3 Definitions.
170.6 Opinion letters on food additive status.
170.10 Food additives in standardized foods.
170.15 Adoption of regulation on initiative of Commissioner.
170.17 Exemption for investigational use and procedure for obtaining 
          authorization to market edible products from experimental 
          animals.
170.18 Tolerances for related food additives.
170.19 Pesticide chemicals in processed foods.

                     Subpart B_Food Additive Safety

170.20 General principles for evaluating the safety of food additives.
170.22 Safety factors to be considered.
170.30 Eligibility for classification as generally recognized as safe 
          (GRAS).
170.35 Affirmation of generally recognized as safe (GRAS) status.
170.38 Determination of food additive status.
170.39 Threshold of regulation for substances used in food-contact 
          articles.

         Subpart C_Specific Administrative Rulings and Decisions

170.45 Fluorine-containing compounds.
170.50 Glycine (aminoacetic acid) in food for human consumption.
170.60 Nitrites and/or nitrates in curing premixes.

                    Subpart D_Premarket Notifications

170.100 Submission of a premarket notification for a food contact 
          substance (FCN) to the Food and Drug Administration (FDA).
170.101 Information in a premarket notification for a food contact 
          substance (FCN).
170.102 Confidentiality of information in a premarket notification for a 
          food contact substance (FCN).
170.103 Withdrawal without prejudice of a premarket notification for a 
          food contact substance (FCN).
170.104 Action on a premarket notification for a food contact substance 
          (FCN).
170.105 The Food and Drug Administration's (FDA's) determination that a 
          premarket notification for a food contact substance (FCN) is 
          no longer effective.
170.106 Notification for a food contact substance formulation (NFCSF).

    Authority: 21 U.S.C. 321, 341, 342, 346a, 348, 371.

    Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 170 appear at 66 FR 
56035, Nov. 6, 2001 and 69 FR 13717, Mar. 24, 2004.



                      Subpart A_General Provisions



Sec. 170.3  Definitions.

    For the purposes of this subchapter, the following definitions 
apply:
    (a) Secretary means the Secretary of Health and Human Services.
    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) As used in this part, the term act means the Federal Food, Drug, 
and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq., as 
amended (21 U.S.C. 301-392).
    (e)(1) Food additives includes all substances not exempted by 
section 201(s) of the act, the intended use of which results or may 
reasonably be expected to result, directly or indirectly, either in 
their becoming a component of food or otherwise affecting the 
characteristics of food. A material used in the production of containers 
and packages is subject to the definition if it may reasonably be 
expected to become a component, or to affect the characteristics, 
directly or indirectly, of food packed in the container. ``Affecting the 
characteristics of food'' does not include such physical effects, as 
protecting contents of packages, preserving shape, and preventing 
moisture loss. If there is no migration of a packaging component from 
the package to the food, it does not become a component of the food and 
thus is not a food additive. A substance that does not become a 
component of food, but that is used, for example, in preparing an 
ingredient of the food to give a different flavor, texture, or other 
characteristic in the food, may be a food additive.

[[Page 6]]

    (2) Uses of food additives not requiring a listing regulation. Use 
of a substance in a food contact article (e.g., food-packaging or food-
processing equipment) whereby the substance migrates, or may reasonably 
be expected to migrate, into food at such levels that the use has been 
exempted from regulation as a food additive under Sec. 170.39, and food 
contact substances used in accordance with a notification submitted 
under section 409(h) of the act that is effective.
    (3) A food contact substance is any substance that is intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.
    (f) Common use in food means a substantial history of consumption of 
a substance for food use by a significant number of consumers.
    (g) The word substance in the definition of the term ``food 
additive'' includes a food or food component consisting of one or more 
ingredients.
    (h) Scientific procedures include those human, animal, analytical, 
and other scientific studies, whether published or unpublished, 
appropriate to establish the safety of a substance.
    (i) Safe or safety means that there is a reasonable certainty in the 
minds of competent scientists that the substance is not harmful under 
the intended conditions of use. It is impossible in the present state of 
scientific knowledge to establish with complete certainty the absolute 
harmlessness of the use of any substance. Safety may be determined by 
scientific procedures or by general recognition of safety. In 
determining safety, the following factors shall be considered:
    (1) The probable consumption of the substance and of any substance 
formed in or on food because of its use.
    (2) The cumulative effect of the substance in the diet, taking into 
account any chemically or pharmacologically related substance or 
substances in such diet.
    (3) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the safety of food and 
food ingredients, are generally recognized as appropriate.
    (j) The term nonperishable processed food means any processed food 
not subject to rapid decay or deterioration that would render it unfit 
for consumption. Examples are flour, sugar, cereals, packaged cookies, 
and crackers. Not included are hermetically sealed foods or manufactured 
dairy products and other processed foods requiring refrigeration.
    (k) General recognition of safety shall be determined in accordance 
with Sec. 170.30.
    (l) Prior sanction means an explicit approval granted with respect 
to use of a substance in food prior to September 6, 1958, by the Food 
and Drug Administration or the United States Department of Agriculture 
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry 
Products Inspection Act, or the Meat Inspection Act.
    (m) Food includes human food, substances migrating to food from 
food-contact articles, pet food, and animal feed.
    (n) The following general food categories are established to group 
specific related foods together for the purpose of establishing 
tolerances or limitations for the use of direct human food ingredients. 
Individual food products will be included within these categories 
according to the detailed classifications lists contained in Exhibit 33B 
of the report of the National Academy of Sciences/National Research 
Council report, ``A Comprehensive Survey of Industry on the Use of Food 
Chemicals Generally Recognized as Safe'' (September 1972), which is 
incorporated by reference. Copies are available from the National 
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, 
VA 22161, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408:
    (1) Baked goods and baking mixes, including all ready-to-eat and 
ready-to-bake products, flours, and mixes requiring preparation before 
serving.
    (2) Beverages, alcoholic, including malt beverages, wines, distilled 
liquors, and cocktail mix.
    (3) Beverages and beverage bases, nonalcoholic, including only 
special or

[[Page 7]]

spiced teas, soft drinks, coffee substitutes, and fruit and vegetable 
flavored gelatin drinks.
    (4) Breakfast cereals, including ready-to-eat and instant and 
regular hot cereals.
    (5) Cheeses, including curd and whey cheeses, cream, natural, 
grating, processed, spread, dip, and miscellaneous cheeses.
    (6) Chewing gum, including all forms.
    (7) Coffee and tea, including regular, decaffeinated, and instant 
types.
    (8) Condiments and relishes, including plain seasoning sauces and 
spreads, olives, pickles, and relishes, but not spices or herbs.
    (9) Confections and frostings, including candy and flavored 
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple, 
powdered, and raw sugars.
    (10) Dairy product analogs, including nondairy milk, frozen or 
liquid creamers, coffee whiteners, toppings, and other nondairy 
products.
    (11) Egg products, including liquid, frozen, or dried eggs, and egg 
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and 
frozen multicourse egg meals, but not fresh eggs.
    (12) Fats and oils, including margarine, dressings for salads, 
butter, salad oils, shortenings and cooking oils.
    (13) Fish products, including all prepared main dishes, salads, 
appetizers, frozen multicourse meals, and spreads containing fish, 
shellfish, and other aquatic animals, but not fresh fish.
    (14) Fresh eggs, including cooked eggs and egg dishes made only from 
fresh shell eggs.
    (15) Fresh fish, including only fresh and frozen fish, shellfish, 
and other aquatic animals.
    (16) Fresh fruits and fruit juices, including only raw fruits, 
citrus, melons, and berries, and home-prepared ``ades'' and punches made 
therefrom.
    (17) Fresh meats, including only fresh or home-frozen beef or veal, 
pork, lamb or mutton and home-prepared fresh meat-containing dishes, 
salads, appetizers, or sandwich spreads made therefrom.
    (18) Fresh poultry, including only fresh or home-frozen poultry and 
game birds and home-prepared fresh poultry-containing dishes, salads, 
appetizers, or sandwich spreads made therefrom.
    (19) Fresh vegetables, tomatoes, and potatoes, including only fresh 
and home-prepared vegetables.
    (20) Frozen dairy desserts and mixes, including ice cream, ice 
milks, sherbets, and other frozen dairy desserts and specialties.
    (21) Fruit and water ices, including all frozen fruit and water 
ices.
    (22) Gelatins, puddings, and fillings, including flavored gelatin 
desserts, puddings, custards, parfaits, pie fillings, and gelatin base 
salads.
    (23) Grain products and pastas, including macaroni and noodle 
products, rice dishes, and frozen multicourse meals, without meat or 
vegetables.
    (24) Gravies and sauces, including all meat sauces and gravies, and 
tomato, milk, buttery, and specialty sauces.
    (25) Hard candy and cough drops, including all hard type candies.
    (26) Herbs, seeds, spices, seasonings, blends, extracts, and 
flavorings, including all natural and artificial spices, blends, and 
flavors.
    (27) Jams and jellies, home-prepared, including only home-prepared 
jams, jellies, fruit butters, preserves, and sweet spreads.
    (28) Jams and jellies, commercial, including only commercially 
processed jams, jellies, fruit butters, preserves, and sweet spreads.
    (29) Meat products, including all meats and meat containing dishes, 
salads, appetizers, frozen multicourse meat meals, and sandwich 
ingredients prepared by commercial processing or using commercially 
processed meats with home preparation.
    (30) Milk, whole and skim, including only whole, lowfat, and skim 
fluid milks.
    (31) Milk products, including flavored milks and milk drinks, dry 
milks, toppings, snack dips, spreads, weight control milk beverages, and 
other milk origin products.
    (32) Nuts and nut products, including whole or shelled tree nuts, 
peanuts, coconut, and nut and peanut spreads.
    (33) Plant protein products, including the National Academy of 
Sciences/National Research Council ``reconstituted vegetable protein'' 
category, and meat, poultry, and fish substitutes, analogs,

[[Page 8]]

and extender products made from plant proteins.
    (34) Poultry products, including all poultry and poultry-containing 
dishes, salads, appetizers, frozen multicourse poultry meals, and 
sandwich ingredients prepared by commercial processing or using 
commercially processed poultry with home preparation.
    (35) Processed fruits and fruit juices, including all commercially 
processed fruits, citrus, berries, and mixtures; salads, juices and 
juice punches, concentrates, dilutions, ``ades'', and drink substitutes 
made therefrom.
    (36) Processed vegetables and vegetable juices, including all 
commercially processed vegetables, vegetable dishes, frozen multicourse 
vegetable meals, and vegetable juices and blends.
    (37) Snack foods, including chips, pretzels, and other novelty 
snacks.
    (38) Soft candy, including candy bars, chocolates, fudge, mints, and 
other chewy or nougat candies.
    (39) Soups, home-prepared, including meat, fish, poultry, vegetable, 
and combination home-prepared soups.
    (40) Soups and soup mixes, including commercially prepared meat, 
fish, poultry, vegetable, and combination soups and soup mixes.
    (41) Sugar, white, granulated, including only white granulated 
sugar.
    (42) Sugar substitutes, including granulated, liquid, and tablet 
sugar substitutes.
    (43) Sweet sauces, toppings, and syrups, including chocolate, berry, 
fruit, corn syrup, and maple sweet sauces and toppings.
    (o) The following terms describe the physical or technical 
functional effects for which direct human food ingredients may be added 
to foods. They are adopted from the National Academy of Sciences/
National Research Council national survey of food industries, reported 
to the Food and Drug Administration under the contract title ``A 
Comprehensive Survey of Industry on the Use of Food Chemicals Generally 
Recognized as Safe'' (September 1972), which is incorporated by 
reference. Copies are available from the National Technical Information 
Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161, or available 
for inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408:
    (1) ``Anticaking agents and free-flow agents'': Substances added to 
finely powdered or crystalline food products to prevent caking, lumping, 
or agglomeration.
    (2) ``Antimicrobial agents'': Substances used to preserve food by 
preventing growth of microorganisms and subsequent spoilage, including 
fungistats, mold and rope inhibitors, and the effects listed by the 
National Academy of Sciences/National Research Council under 
``preservatives.''
    (3) ``Antioxidants'': Substances used to preserve food by retarding 
deterioration, rancidity, or discoloration due to oxidation.
    (4) ``Colors and coloring adjuncts'': Substances used to impart, 
preserve, or enhance the color or shading of a food, including color 
stabilizers, color fixatives, color-retention agents, etc.
    (5) ``Curing and pickling agents'': Substances imparting a unique 
flavor and/or color to a food, usually producing an increase in shelf 
life stability.
    (6) ``Dough strengtheners'': Substances used to modify starch and 
gluten, thereby producing a more stable dough, including the applicable 
effects listed by the National Academy of Sciences/National Research 
Council under ``dough conditioner.''
    (7) ``Drying agents'': Substances with moisture-absorbing ability, 
used to maintain an environment of low moisture.
    (8) ``Emulsifiers and emulsifier salts'': Substances which modify 
surface tension in the component phase of an emulsion to establish a 
uniform dispersion or emulsion.
    (9) ``Enzymes'': Enzymes used to improve food processing and the 
quality of the finished food.
    (10) ``Firming agents'': Substances added to precipitate residual 
pectin, thus strengthening the supporting tissue and preventing its 
collapse during processing.
    (11) ``Flavor enhancers'': Substances added to supplement, enhance, 
or modify the original taste and/or aroma of a food, without imparting a 
characteristic taste or aroma of its own.

[[Page 9]]

    (12) ``Flavoring agents and adjuvants'': Substances added to impart 
or help impart a taste or aroma in food.
    (13) ``Flour treating agents'': Substances added to milled flour, at 
the mill, to improve its color and/or baking qualities, including 
bleaching and maturing agents.
    (14) ``Formulation aids'': Substances used to promote or produce a 
desired physical state or texture in food, including carriers, binders, 
fillers, plasticizers, film-formers, and tableting aids, etc.
    (15) ``Fumigants'': Volatile substances used for controlling insects 
or pests.
    (16) ``Humectants'': Hygroscopic substances incorporated in food to 
promote retention of moisture, including moisture-retention agents and 
antidusting agents.
    (17) ``Leavening agents'': Substances used to produce or stimulate 
production of carbon dioxide in baked goods to impart a light texture, 
including yeast, yeast foods, and calcium salts listed by the National 
Academy of Sciences/National Research Council under ``dough 
conditioners.''
    (18) ``Lubricants and release agents'': Substances added to food 
contact surfaces to prevent ingredients and finished products from 
sticking to them.
    (19) ``Non-nutritive sweeteners'': Substances having less than 2 
percent of the caloric value of sucrose per equivalent unit of 
sweetening capacity.
    (20) ``Nutrient supplements'': Substances which are necessary for 
the body's nutritional and metabolic processes.
    (21) ``Nutritive sweeteners'': Substances having greater than 2 
percent of the caloric value of sucrose per equivalent unit of 
sweetening capacity.
    (22) ``Oxidizing and reducing agents'': Substances which chemically 
oxidize or reduce another food ingredient, thereby producing a more 
stable product, including the applicable effect listed by the National 
Academy of Sciences/National Research Council under ``dough 
conditioners.''
    (23) ``pH control agents'': Substances added to change or maintain 
active acidity or basicity, including buffers, acids, alkalies, and 
neutralizing agents.
    (24) ``Processing aids'': Substances used as manufacturing aids to 
enhance the appeal or utility of a food or food component, including 
clarifying agents, clouding agents, catalysts, flocculents, filter aids, 
and crystallization inhibitors, etc.
    (25) ``Propellants, aerating agents, and gases'': Gases used to 
supply force to expel a product or used to reduce the amount of oxygen 
in contact with the food in packaging.
    (26) ``Sequestrants'': Substances which combine with polyvalent 
metal ions to form a soluble metal complex, to improve the quality and 
stability of products.
    (27) ``Solvents and vehicles'': Substances used to extract or 
dissolve another substance.
    (28) ``Stabilizers and thickeners'': Substances used to produce 
viscous solutions or dispersions, to impart body, improve consistency, 
or stabilize emulsions, including suspending and bodying agents, setting 
agents, jellying agents, and bulking agents, etc.
    (29) ``Surface-active agents'': Substances used to modify surface 
properties of liquid food components for a variety of effects, other 
than emulsifiers, but including solubilizing agents, dispersants, 
detergents, wetting agents, rehydration enhancers, whipping agents, 
foaming agents, and defoaming agents, etc.
    (30) ``Surface-finishing agents'': Substances used to increase 
palatability, preserve gloss, and inhibit discoloration of foods, 
including glazes, polishes, waxes, and protective coatings.
    (31) ``Synergists'': Substances used to act or react with another 
food ingredient to produce a total effect different or greater than the 
sum of the effects produced by the individual ingredients.
    (32) ``Texturizers'': Substances which affect the appearance or feel 
of the food.

[42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 
53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989; 60 FR 36595, July 
17, 1995; 67 FR 35729, May 21, 2002]



Sec. 170.6  Opinion letters on food additive status.

    (a) Over the years the Food and Drug Administration has given 
informal written opinions to inquiries as to the

[[Page 10]]

safety of articles intended for use as components of, or in contact 
with, food. Prior to the enactment of the Food Additives Amendment of 
1958 (Pub. L. 85-929; Sept. 6, 1958), these opinions were given pursuant 
to section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act, which 
reads in part: ``A food shall be deemed to be adulterated if it bears or 
contains any poisonous or deleterious substance which may render it 
injurious to health''.
    (b) Since enactment of the Food Additives Amendment, the Food and 
Drug Administration has advised such inquirers that an article:
    (1) Is a food additive within the meaning of section 201(s) of the 
act; or
    (2) Is generally recognized as safe (GRAS); or
    (3) Has prior sanction or approval under that amendment; or
    (4) Is not a food additive under the conditions of intended use.
    (c) In the interest of the public health, such articles which have 
been considered in the past by the Food and Drug Administration to be 
safe under the provisions of section 402(a)(1), or to be generally 
recognized as safe for their intended use, or to have prior sanction or 
approval, or not to be food additives under the conditions of intended 
use, must be reexamined in the light of current scientific information 
and current principles for evaluating the safety of food additives if 
their use is to be continued.
    (d) Because of the time span involved, copies of many of the letters 
in which the Food and Drug Administration has expressed an informal 
opinion concerning the status of such articles may no longer be in the 
file of the Food and Drug Administration. In the absence of information 
concerning the names and uses made of all the articles referred to in 
such letters, their safety of use cannot be reexamined. For this reason 
all food additive status opinions of the kind described in paragraph (c) 
of this section given by the Food and Drug Administration are hereby 
revoked.
    (e) The prior opinions of the kind described in paragraph (c) of 
this section will be replaced by qualified and current opinions if the 
recipient of each such letter forwards a copy of each to the Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College 
Park, MD 20740, along with a copy of his letter of inquiry, on or before 
July 23, 1970.
    (f) This section does not apply to food additive status opinion 
letters pertaining to articles that were considered by the Food and Drug 
Administration to be food additives nor to articles included in 
regulations in parts 170 through 189 of this chapter if the articles are 
used in accordance with the requirements of such regulations.

[42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12, 1989]



Sec. 170.10  Food additives in standardized foods.

    (a) The inclusion of food ingredients in parts 170 through 189 of 
this chapter does not imply that these ingredients may be used in 
standardized foods unless they are recognized as optional ingredients in 
applicable food standards. Where a petition is received for the issuance 
or amendment of a regulation establishing a definition and standard of 
identity for a food under section 401 of the Act, which proposes the 
inclusion of a food additive in such definition and standard of 
identity, the provisions of the regulations in this part shall apply 
with respect to the information that must be submitted with respect to 
the food additive. Since section 409(b)(5) of the Act requires that the 
Secretary publish notice of a petition for the establishment of a food-
additive regulation within 30 days after filing, notice of a petition 
relating to a definition and standard of identity shall also be 
published within that time limitation if it includes a request, so 
designated, for the establishment of a regulation pertaining to a food 
additive.
    (b) If a petition for a definition and standard of identity contains 
a proposal for a food-additive regulation, and the petitioner fails to 
designate it as such, the Commissioner, upon determining that the 
petition includes a proposal for a food-additive regulation, shall so 
notify the petitioner and shall

[[Page 11]]

thereafter proceed in accordance with the regulations in this part.
    (c) A regulation will not be issued allowing the use of a food 
additive in a food for which a definition and standard of identity is 
established, unless its issuance is in conformity with section 401 of 
the Act or with the terms of a temporary permit issued under Sec. 
130.17 of this chapter. When the contemplated use of such additive 
complies with the terms of a temporary permit, the food additive 
regulation will be conditioned on such compliance and will expire with 
the expiration of the temporary permit.



Sec. 170.15  Adoption of regulation on initiative of Commissioner.

    (a) The Commissioner upon his own initiative may propose the 
issuance of a regulation prescribing, with respect to any particular use 
of a food additive, the conditions under which such additive may be 
safely used. Notice of such proposal shall be published in the Federal 
Register and shall state the reasons for the proposal.
    (b) Action upon a proposal made by the Commissioner shall proceed as 
provided in part 10 of this chapter.

[42 FR 14486, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



Sec. 170.17  Exemption for investigational use and procedure for obtaining 
authorization to market edible products from experimental animals.

    A food additive or food containing a food additive intended for 
investigational use by qualified experts shall be exempt from the 
requirements of section 409 of the Act under the following conditions:
    (a) If intended for investigational use in vitro or in laboratory 
research animals, it bears a label which states prominently, in addition 
to the other information required by the act, the warning:

    Caution. Contains a new food additive for investigational use only 
in laboratory research animals or for tests in vitro. Not for use in 
humans.

    (b) If intended for use in animals other than laboratory research 
animals and if the edible products of the animals are to be marketed as 
food, permission for the marketing of the edible products as food has 
been requested by the sponsor, and authorization has been granted by the 
Food and Drug Administration in accordance with Sec. 511.1 of this 
chapter or by the Department of Agriculture in accordance with 9 CFR 
309.17, and it bears a label which states prominently, in addition to 
the other information required by the Act, the warning:

    Caution. Contains a new food additive for use only in 
investigational animals. Not for use in humans.
    Edible products of investigational animals are not to be used for 
food unless authorization has been granted by the U.S. Food and Drug 
Administration or by the U.S. Department of Agriculture.

    (c) If intended for nonclinical laboratory studies in food-producing 
animals, the study is conducted in compliance with the regulations set 
forth in part 58 of this chapter.

[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]



Sec. 170.18  Tolerances for related food additives.

    (a) Food additives that cause similar or related pharmacological 
effects will be regarded as a class, and in the absence of evidence to 
the contrary, as having additive toxic effects and will be considered as 
related food additives.
    (b) Tolerances established for such related food additives may limit 
the amount of a common component that may be present, or may limit the 
amount of biological activity (such as cholinesterase inhibition) that 
may be present or may limit the total amount of related food additives 
that may be present.
    (c) Where food additives from two or more chemicals in the same 
class are present in or on a food, the tolerance for the total of such 
additives shall be the same as that for the additive having the lowest 
numerical tolerance in this class, unless there are available methods 
that permit quantitative determination of the amount of each food 
additive present or unless it is shown that a higher tolerance is 
reasonably required for the combined additives to accomplish the 
physical or technical effect for which such combined additives are 
intended and that the higher tolerance will be safe.

[[Page 12]]

    (d) Where residues from two or more additives in the same class are 
present in or on a food and there are available methods that permit 
quantitative determination of each residue, the quantity of combined 
residues that are within the tolerance may be determined as follows:
    (1) Determine the quantity of each residue present.
    (2) Divide the quantity of each residue by the tolerance that would 
apply if it occurred alone, and multiply by 100 to determine the 
percentage of the permitted amount of residue present.
    (3) Add the percentages so obtained for all residues present.
    (4) The sum of the percentage shall not exceed 100 percent.



Sec. 170.19  Pesticide chemicals in processed foods.

    When pesticide chemical residues occur in processed foods due to the 
use of raw agricultural commodities that bore or contained a pesticide 
chemical in conformity with an exemption granted or a tolerance 
prescribed under section 408 of the Act, the processed food will not be 
regarded as adulterated so long as good manufacturing practice has been 
followed in removing any residue from the raw agricultural commodity in 
the processing (such as by peeling or washing) and so long as the 
concentration of the residue in the processed food when ready to eat is 
not greater than the tolerance prescribed for the raw agricultural 
commodity. But when the concentration of residue in the processed food 
when ready to eat is higher than the tolerance prescribed for the raw 
agricultural commodity, the processed food is adulterated unless the 
higher concentration is permitted by a tolerance obtained under section 
409 of the Act. For example, if fruit bearing a residue of 7 parts per 
million of DDT permitted on the raw agricultural commodity is dried and 
a residue in excess of 7 parts per million of DDT results on the dried 
fruit, the dehydrated fruit is adulterated unless the higher tolerance 
for DDT is authorized by the regulations in this part. Food that is 
itself ready to eat, and which contains a higher residue than allowed 
for the raw agricultural commodity, may not be legalized by blending or 
mixing with other foods to reduce the residue in the mixed food below 
the tolerance prescribed for the raw agricultural commodity.



                     Subpart B_Food Additive Safety



Sec. 170.20  General principles for evaluating the safety of food additives.

    (a) In reaching a decision on any petition filed under section 409 
of the Act, the Commissioner will give full consideration to the 
specific biological properties of the compound and the adequacy of the 
methods employed to demonstrate safety for the proposed use, and the 
Commissioner will be guided by the principles and procedures for 
establishing the safety of food additives stated in current publications 
of the National Academy of Sciences-National Research Council. A 
petition will not be denied, however, by reason of the petitioner's 
having followed procedures other than those outlined in the publications 
of the National Academy of Sciences-National Research Council if, from 
available evidence, the Commissioner finds that the procedures used give 
results as reliable as, or more reliable than, those reasonably to be 
expected from the use of the outlined procedures. In reaching a 
decision, the Commissioner will give due weight to the anticipated 
levels and patterns of consumption of the additive specified or 
reasonably inferrable. For the purposes of this section, the principles 
for evaluating safety of additives set forth in the abovementioned 
publications will apply to any substance that may properly be classified 
as a food additive as defined in section 201(s) of the Act.
    (b) Upon written request describing the proposed use of an additive 
and the proposed experiments to determine its safety, the Commissioner 
will advise a person who wishes to establish the safety of a food 
additive whether he believes the experiments planned will yield data 
adequate for an evaluation of the safety of the additive.



Sec. 170.22  Safety factors to be considered.

    In accordance with section 409(c)(5)(C) of the Act, the following

[[Page 13]]

safety factors will be applied in determining whether the proposed use 
of a food additive will be safe: Except where evidence is submitted 
which justifies use of a different safety factor, a safety factor in 
applying animal experimentation data to man of 100 to 1, will be used; 
that is, a food additive for use by man will not be granted a tolerance 
that will exceed \1/100\th of the maximum amount demonstrated to be 
without harm to experimental animals.



Sec. 170.30  Eligibility for classification as generally recognized as safe (GRAS).

    (a) General recognition of safety may be based only on the views of 
experts qualified by scientific training and experience to evaluate the 
safety of substances directly or indirectly added to food. The basis of 
such views may be either (1) scientific procedures or (2) in the case of 
a substance used in food prior to January 1, 1958, through experience 
based on common use in food. General recognition of safety requires 
common knowledge about the substance throughout the scientific community 
knowledgeable about the safety of substances directly or indirectly 
added to food.
    (b) General recognition of safety based upon scientific procedures 
shall require the same quantity and quality of scientific evidence as is 
required to obtain approval of a food additive regulation for the 
ingredient. General recognition of safety through scientific procedures 
shall ordinarily be based upon published studies which may be 
corroborated by unpublished studies and other data and information.
    (c)(1) General recognition of safety through experience based on 
common use in food prior to January 1, 1958, may be determined without 
the quantity or quality of scientific procedures required for approval 
of a food additive regulation. General recognition of safety through 
experience based on common use in food prior to January 1, 1958, shall 
be based solely on food use of the substance prior to January 1, 1958, 
and shall ordinarily be based upon generally available data and 
information. An ingredient not in common use in food prior to January 1, 
1958, may achieve general recognition of safety only through scientific 
procedures.
    (2) A substance used in food prior to January 1, 1958, may be 
generally recognized as safe through experience based on its common use 
in food when that use occurred exclusively or primarily outside of the 
United States if the information about the experience establishes that 
the use of the substance is safe within the meaning of the act (see 
Sec. 170.3(i)). Common use in food prior to January 1, 1958, that 
occurred outside of the United States shall be documented by published 
or other information and shall be corroborated by information from a 
second, independent source that confirms the history and circumstances 
of use of the substance. The information used to document and to 
corroborate the history and circumstances of use of the substance must 
be generally available; that is, it must be widely available in the 
country in which the history of use has occurred and readily available 
to interested qualified experts in this country. Persons claiming GRAS 
status for a substance based on its common use in food outside of the 
United States should obtain FDA concurrence that the use of the 
substance is GRAS.
    (d) The food ingredients listed as GRAS in part 182 of this chapter 
or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter do not 
include all substances that are generally recognized as safe for their 
intended use in food. Because of the large number of substances the 
intended use of which results or may reasonably be expected to result, 
directly or indirectly, in their becoming a component or otherwise 
affecting the characteristics of food, it is impracticable to list all 
such substances that are GRAS. A food ingredient of natural biological 
origin that has been widely consumed for its nutrient properties in the 
United States prior to January 1, 1958, without known detrimental 
effects, which is subject only to conventional processing as practiced 
prior to January 1, 1958, and for which no known safety hazard exists, 
will ordinarily be regarded as GRAS without specific inclusion in part 
182, part 184 or Sec. 186.1 of this chapter.

[[Page 14]]

    (e) Food ingredients were listed as GRAS in part 182 of this chapter 
during 1958-1962 without a detailed scientific review of all available 
data and information relating to their safety. Beginning in 1969, the 
Food and Drug Administration has undertaken a systematic review of the 
status of all ingredients used in food on the determination that they 
are GRAS or subject to a prior sanction. All determinations of GRAS 
status or food additive status or prior sanction status pursuant to this 
review shall be handled pursuant to Sec. Sec. 170.35, 170.38, and 180.1 
of this chapter. Affirmation of GRAS status shall be announced in part 
184 or Sec. 186.1 of this chapter.
    (f) The status of the following food ingredients will be reviewed 
and affirmed as GRAS or determined to be a food additive or subject to a 
prior sanction pursuant to Sec. 170.35, Sec. 170.38, or Sec. 180.1 of 
this chapter:
    (1) Any substance of natural biological origin that has been widely 
consumed for its nutrient properties in the United States prior to 
January 1, 1958, without known detrimental effect, for which no health 
hazard is known, and which has been modified by processes first 
introduced into commercial use after January 1, 1958, which may 
reasonably be expected significantly to alter the composition of the 
substance.
    (2) Any substance of natural biological origin that has been widely 
consumed for its nutrient properties in the United States prior to 
January 1, 1958, without known detrimental effect, for which no health 
hazard is known, that has had significant alteration of composition by 
breeding or selection after January 1, 1958, where the change may be 
reasonably expected to alter the nutritive value or the concentration of 
toxic constituents.
    (3) Distillates, isolates, extracts, and concentration of extracts 
of GRAS substances.
    (4) Reaction products of GRAS substances.
    (5) Substances not of a natural biological origin, including those 
for which evidence is offered that they are identical to a GRAS 
counterpart of natural biological origin.
    (6) Substances of natural biological origin intended for consumption 
for other than their nutrient properties.
    (g) A food ingredient that is not GRAS or subject to a prior 
sanction requires a food additive regulation promulgated under section 
409 of the act before it may be directly or indirectly added to food.
    (h) A food ingredient that is listed as GRAS in part 182 of this 
chapter or affirmed as GRAS in part 184 or Sec. 186.1 of this chapter 
shall be regarded as GRAS only if, in addition to all the requirements 
in the applicable regulation, it also meets all of the following 
requirements:
    (1) It complies with any applicable food grade specifications of the 
Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in 
the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed. 
(1981), which are incorporated by reference, except that any substance 
used as a component of articles that contact food and affirmed as GRAS 
in Sec. 186.1 of this chapter shall comply with the specifications 
therein, or in the absence of such specifications, shall be of a purity 
suitable for its intended use. Copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) It performs an appropriate function in the food or food-contact 
article in which it is used.
    (3) It is used at a level no higher than necessary to achieve its 
intended purpose in that food or, if used as a component of a food-
contact article, at a level no higher than necessary to achieve its 
intended purpose in that article.
    (i) If a substance is affirmed as GRAS in part 184 or Sec. 186.1 of 
this chapter with no limitation other than good manufacturing practice, 
it shall be regarded as GRAS if its conditions of use are not 
significantly different from those reported in the regulation as the 
basis on which the GRAS status of the substance was affirmed. If the 
conditions of use are significantly different, such use of the substance 
may not be GRAS. In such a case a manufacturer may not

[[Page 15]]

rely on the regulation as authorizing the use but must independently 
establish that the use is GRAS or must use the substance in accordance 
with a food additive regulation.
    (j) If an ingredient is affirmed as GRAS in part 184 or Sec. 186.1 
of this chapter with specific limitation(s), it may be used in food only 
within such limitation(s) (including the category of food(s), the 
functional use(s) of the ingredient, and the level(s) of use). Any use 
of such an ingredient not in full compliance with each such established 
limitation shall require a food additive regulation.
    (k) Pursuant to Sec. 170.35, a food ingredient may be affirmed as 
GRAS in part 184 or Sec. 186.1 of this chapter for a specific use(s) 
without a general evaluation of use of the ingredient. In addition to 
the use(s) specified in the regulation, other uses of such an ingredient 
may also be GRAS. Any affirmation of GRAS status for a specific use(s), 
without a general evaluation of use of the ingredient, is subject to 
reconsideration upon such evaluation.
    (l) New information may at any time require reconsideration of the 
GRAS status of a food ingredient. Any change in part 182, part 184, or 
Sec. 186.1 of this chapter shall be accomplished pursuant to Sec. 
170.38.

[42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 53 
FR 16546, May 10, 1988]



Sec. 170.35  Affirmation of generally recognized as safe (GRAS) status.

    (a) The Commissioner, either on his initiative or on the petition of 
an interested person, may affirm the GRAS status of substances that 
directly or indirectly become components of food.
    (b)(1) If the Commissioner proposes on his own initiative that a 
substance is entitled to affirmation as GRAS, he will place all of the 
data and information on which he relies on public file in the office of 
the Division of Dockets Management and will publish in the Federal 
Register a notice giving the name of the substance, its proposed uses, 
and any limitations proposed for purposes other than safety.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Division of Dockets Management. Copies of 
all comments received shall be made available for examination in the 
Division of Dockets Management's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is convincing evidence that the substance is GRAS 
as described in Sec. 170.30, he will publish a notice in the Federal 
Register listing the substance as GRAS in part 182, part 184, or part 
186 of this chapter, as appropriate.
    (4) If, after evaluation of the comments, the Commissioner concludes 
that there is a lack of convincing evidence that the substance is GRAS 
and that it should be considered a food additive subject to section 409 
of the Act, he shall publish a notice thereof in the Federal Register in 
accordance with Sec. 170.38.
    (c)(1) Persons seeking the affirmation of GRAS status of substances 
as provided in Sec. 170.30(e), except those subject to the NAS/NRC GRAS 
list survey (36 FR 20546; October 23, 1971), shall submit a petition for 
GRAS affirmation pursuant to part 10 of this chapter. Such petition 
shall contain information to establish that the GRAS criteria as set 
forth in Sec. 170.30 (b) or (c) have been met, in the following form:
    (i) Description of the substance, including:
    (a) Common or usual name.
    (b) Chemical name.
    (c) Chemical Abstract Service (CAS) registry number.
    (d) Empirical formula.
    (e) Structural formula.
    (f) Specifications for food grade material, including arsenic and 
heavy metals. (Recommendation for any change in the Food Chemicals Codex 
monograph should be included where applicable.)
    (g) Quantitative compositions.
    (h) Manufacturing process (excluding any trade secrets).
    (ii) Use of the substance, including:
    (a) Date when use began.
    (b) Information and reports or other data on past uses in food.
    (c) Foods in which used, and levels of use in such foods, and for 
what purposes.

[[Page 16]]

    (iii) Methods for detecting the substance in food, including:
    (a) References to qualitative and quantitative methods for 
determining the substance(s) in food, including the type of analytical 
procedures used.
    (b) Sensitivity and reproducibility of such method(s).
    (iv) Information to establish the safety and functionality of the 
substance in food. Published scientific literature, evidence that the 
substance is identical to a GRAS counterpart of natural biological 
origin, and other data may be submitted to support safety. Any adverse 
information or consumer complaints shall be included. Complete 
bibliographic references shall be provided where a copy of the article 
is not provided.
    (v) A statement signed by the person responsible for the petition 
that to the best of his knowledge it is a representative and balanced 
submission that includes unfavorable information, as well as favorable 
information, known to him pertinent to the evaluation of the safety and 
functionality of the substance.
    (vi) If nonclinical laboratory studies are involved, additional 
information and data submitted in support of filed petitions shall 
include, with respect to each nonclinical study, either a statement that 
the study was conducted in compliance with the requirements set forth in 
part 58 of this chapter, or, if the study was not conducted in 
compliance with such regulations, a brief statement of the reason for 
the noncompliance.
    (vii) [Reserved]
    (viii) A claim for categorical exclusion under Sec. 25.30 or Sec. 
25.32 of this chapter or an environmental assessment under Sec. 25.40 
of this chapter.
    (2) Within 30 days after the date of filing the petition, the 
Commissioner will place the petition on public file in the office of the 
Division of Dockets Management and will publish a notice of filing in 
the Federal Register giving the name of the petitioner and a brief 
description of the petition including the name of the substance, its 
proposed use, and any limitations proposed for reasons other than 
safety. A copy of the notice will be mailed to the petitioner at the 
time the original is sent to the Federal Register.
    (3)(i) If intended uses of the substance include uses in meat, meat 
food product, or poultry product subject to regulation by the U.S. 
Department of Agriculture (USDA) under the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) or Federal Meat Inspection Act (FMIA) 
(21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward 
a copy of the petition or relevant portions thereof to the Food Safety 
and Inspection Service, USDA, for simultaneous review under the PPIA and 
FMIA.
    (ii) FDA will ask USDA to advise whether the proposed meat and 
poultry uses comply with the FMIA and PPIA or, if not, whether use of 
the substance would be permitted in products under USDA jurisdiction 
under specified conditions or restrictions.
    (4) The notice of filing in the Federal Register will allow a period 
of 60 days during which any interested person may review the petition 
and/or file comments with the Division of Dockets Management. Copies of 
all comments received shall be made available for examination in the 
Division of Dockets Management's office.
    (5) The Commissioner will evaluate the petition and all available 
information including all comments received. If the petition and such 
information provide convincing evidence that the substance is GRAS as 
described in Sec. 170.30 he will publish an order in the Federal 
Register listing the substance as GRAS in part 182, part 184, or part 
186 of this chapter, as appropriate.
    (6) If, after evaluation of the petition and all available 
information, the Commissioner concludes that there is a lack of 
convincing evidence that the substance is GRAS and that it should be 
considered a food additive subject to section 409 of the Act, he shall 
publish a notice thereof in the Federal Register in accordance with 
Sec. 170.38.
    (7) The notice of filing in the Federal Register will request 
submission of proof of any applicable prior sanction for use of the 
ingredient under conditions different from those proposed to be 
determined to be GRAS. The failure of any person to come forward with 
proof of such an applicable

[[Page 17]]

prior sanction in response to the notice of filing will constitute a 
waiver of the right to assert or rely on such sanction at any later 
time. The notice of filing will also constitute a proposal to establish 
a regulation under part 181 of this chapter, incorporating the same 
provisions, in the event that such a regulation is determined to be 
appropriate as a result of submission of proof of such an applicable 
prior sanction in response to the notice of filing.

(Information collection requirements were approved by the Office of 
Management and Budget under control number 0910-0132)

[42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985; 50 
FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988; 62 FR 40599, July 
29, 1997; 65 FR 51762, Aug. 25, 2000]



Sec. 170.38  Determination of food additive status.

    (a) The Commissioner may, in accordance with Sec. 170.35(b)(4) or 
(c)(5), publish a notice in the Federal Register determining that a 
substance is not GRAS and is a food additive subject to section 409 of 
the Act.
    (b)(1) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may issue a 
notice in the Federal Register proposing to determine that a substance 
is not GRAS and is a food additive subject to section 409 of the Act. 
Any petition shall include all relevant data and information of the type 
described in Sec. 171.130(b). The Commissioner will place all of the 
data and information on which he relies on public file in the office of 
the Division of Dockets Management and will include in the Federal 
Register notice the name of the substance, its known uses, and a summary 
of the basis for the determination.
    (2) The Federal Register notice will allow a period of 60 days 
during which any interested person may review the data and information 
and/or file comments with the Division of Dockets Management. Copies of 
all comments shall be made available for examination in the Division of 
Dockets Management's office.
    (3) The Commissioner will evaluate all comments received. If he 
concludes that there is a lack of convincing evidence that the substance 
is GRAS or is otherwise exempt from the definition of a food additive in 
section 201(s) of the Act, he will publish a notice thereof in the 
Federal Register. If he concludes that there is convincing evidence that 
the substance is GRAS, he will publish an order in the Federal Register 
listing the substance as GRAS in part 182, part 184, or part 186 of this 
chapter, as appropriate.
    (c) A Federal Register notice determining that a substance is a food 
additive shall provide for the use of the additive in food or food 
contact surfaces as follows:
    (1) It may promulgate a food additive regulation governing use of 
the additive.
    (2) It may promulgate an interim food additive regulation governing 
use of the additive.
    (3) It may require discontinuation of the use of the additive.
    (4) It may adopt any combination of the above three approaches for 
different uses or levels of use of the additive.
    (d) If the Commissioner of Food and Drugs is aware of any prior 
sanction for use of the substance, he will concurrently propose a 
separate regulation covering such use of the ingredient under part 181 
of this chapter. If the Commissioner is unaware of any such applicable 
prior sanction, the proposed regulation will so state and will require 
any person who intends to assert or rely on such sanction to submit 
proof of its existence. Any regulation promulgated pursuant to this 
section constitutes a determination that excluded uses would result in 
adulteration of the food in violation of section 402 of the Act, and the 
failure of any person to come forward with proof of such an applicable 
prior sanction in response to the proposal will constitute a waiver of 
the right to assert or rely on such sanction at any later time. The 
notice will also constitute a proposal to establish a regulation under 
part 181 of this chapter, incorporating the same provisions, in the 
event that such a regulation is determined to be appropriate as a result 
of submission of proof

[[Page 18]]

of such an applicable prior sanction in response to the proposal.

[42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
54 FR 24896, June 12, 1989]



Sec. 170.39  Threshold of regulation for substances used in food-contact 
articles.

    (a) A substance used in a food-contact article (e.g., food-packaging 
or food-processing equipment) that migrates, or that may be expected to 
migrate, into food will be exempted from regulation as a food additive 
because it becomes a component of food at levels that are below the 
threshold of regulation if:
    (1) The substance has not been shown to be a carcinogen in humans or 
animals, and there is no reason, based on the chemical structure of the 
substance, to suspect that the substance is a carcinogen. The substance 
must also not contain a carcinogenic impurity or, if it does, must not 
contain a carcinogenic impurity with a TD50 value based on 
chronic feeding studies reported in the scientific literature or 
otherwise available to the Food and Drug Administration of less than 
6.25 milligrams per kilogram bodyweight per day (The TD50, 
for the purposes of this section, is the feeding dose that causes cancer 
in 50 percent of the test animals when corrected for tumors found in 
control animals. If more than one TD50 value has been 
reported in the scientific literature for a substance, the Food and Drug 
Administration will use the lowest appropriate TD50 value in its 
review.);
    (2) The substance presents no other health or safety concerns 
because:
    (i) The use in question has been shown to result in or may be 
expected to result in dietary concentrations at or below 0.5 parts per 
billion, corresponding to dietary exposure levels at or below 1.5 
micrograms/person/day (based on a diet of 1,500 grams of solid food and 
1,500 grams of liquid food per person per day); or
    (ii) The substance is currently regulated for direct addition into 
food, and the dietary exposure to the substance resulting from the 
proposed use is at or below 1 percent of the acceptable daily intake as 
determined by safety data in the Food and Drug Administration's files or 
from other appropriate sources;
    (3) The substance has no technical effect in or on the food to which 
it migrates; and
    (4) The substance use has no significant adverse impact on the 
environment.
    (b) Notwithstanding paragraph (a) of this section, the Food and Drug 
Administration reserves the right to decline to grant an exemption in 
those cases in which available information establishes that the proposed 
use may pose a public health risk. The reasons for the agency's decision 
to decline to grant an exemption will be explained in the Food and Drug 
Administration's response to the requestor.
    (c) A request for the Food and Drug Administration to exempt a use 
of a substance from regulation as a food additive shall include three 
copies of the following information (If part of the submitted material 
is in a foreign language, it must be accompanied by an English 
translation verified to be complete and accurate in accordance with 
Sec. 10.20(c)(2) of this chapter):
    (1) The chemical composition of the substance for which the request 
is made, including, whenever possible, the name of the chemical in 
accordance with current Chemical Abstract Service (CAS) nomenclature 
guidelines and a CAS registry number, if available;
    (2) Detailed information on the conditions of use of the substance 
(e.g., temperature, type of food with which the substance will come into 
contact, the duration of the contact, and whether the food-contact 
article will be for repeated or single use applications);
    (3) A clear statement as to whether the request for exemption from 
regulation as a food additive is based on the fact that the use of the 
substance in the food-contact article results in a dietary concentration 
at or below 0.5 parts per billion, or on the fact that it involves the 
use of a regulated direct food additive for which the dietary exposure 
is at or below 1 percent of the acceptable dietary intake (ADI);
    (4) Data that will enable the Food and Drug Administration to 
estimate

[[Page 19]]

the daily dietary concentration resulting from the proposed use of the 
substance. These data should be in the form of:
    (i) Validated migration data obtained under worst-case (time/
temperature) intended use conditions utilizing appropriate food 
simulating solvents;
    (ii) Information on the amount of the substance used in the 
manufacture of the food-contact article; or
    (iii) Information on the residual level of the substance in the 
food-contact article. For repeat-use articles, an estimate of the amount 
of food that contacts a specific unit of surface area over the lifetime 
of the article should also be provided. (In cases where data are 
provided only in the form of manufacturing use levels or residual levels 
of the substance present in the food-contact article, the Food and Drug 
Administration will calculate a worst-case dietary concentration level 
assuming 100 percent migration.) A detailed description of the 
analytical method used to quantify the substance should also be 
submitted along with data used to validate the detection limit.
    (iv) In cases where there is no detectable migration into food or 
food simulants, or when no residual level of a substance is detected in 
the food-contact article by a suitable analytical method, the Food and 
Drug Administration will, for the purposes of estimating the dietary 
concentration, consider the validated detection limit of the method used 
to analyze for the substance.
    (5) The results of an analysis of existing toxicological information 
on the substance and its impurities. This information on the substance 
is needed to show whether an animal carcinogen bioassay has been carried 
out, or whether there is some other basis for suspecting that the 
substance is a carcinogen or potent toxin. This type of information on 
the impurities is needed to show whether any of them are carcinogenic, 
and, if carcinogenic, whether their TD50 values are greater than 6.25 
milligrams per kilogram bodyweight per day in accordance with paragraph 
(a)(1) of this section.
    (6) Information on the environmental impact that would result from 
the proposed use of the substance. The request should contain either a 
claim for categorical exclusion as specified in Sec. 25.32 of this 
chapter or an environmental assessment as specified in Sec. 25.40 of 
this chapter.
    (d) Data to be reviewed under this section shall be submitted to the 
Food and Drug Administration's Office of Premarket Approval (HFS-200), 
5100 Paint Branch Pkwy., College Park, MD 20740.
    (e) The Food and Drug Administration will inform the requestor by 
letter whether the specific food-contact application is exempt from 
regulation as a food additive or not. Although a substance that migrates 
to food at a level that results in a dietary concentration at or below 
the threshold of regulation will not be the subject of a regulation 
published in the Federal Register and will not appear in the Code of 
Federal Regulations, the Food and Drug Administration will maintain a 
list of substances exempted from regulation as food additives under this 
section on display at the Division of Dockets Management. This list will 
include the name of the company that made the request, the chemical name 
of the substance, the specific use for which it has received an 
exemption from regulation as a food additive, and any appropriate 
limitations on its use. The list will not include any trade names. This 
list will enable interested persons to see the types of uses of food-
contact materials being exempted under the regulation. Interested 
persons may also obtain a copy of the list of exempted substances by 
contacting the Food and Drug Administration's Office of Premarket 
Approval (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740. For 
actions requiring an environmental assessment, the agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in the petitioner's environmental assessment, also will be 
available for public inspection at the Division of Dockets Management in 
accordance with Sec. 25.51(b)(2) of this chapter. Requests for copies 
of releasable information contained in submissions requesting exemptions 
from the food additive regulations will be handled in accordance

[[Page 20]]

with the Food and Drug Administration's Freedom of Information Act 
procedures, as described in part 20 of this chapter. In particular, data 
and information that fall within the definitions of a trade secret or 
confidential commercial or financial information are not available for 
public disclosure in accordance with Sec. 20.61(c) of this chapter.
    (f) If the request for an exemption from regulation as a food 
additive is not granted, the requestor may submit a petition to the Food 
and Drug Administration for reconsideration of the decision in 
accordance with the provisions of Sec. 10.33 of this chapter.
    (g) If the Food and Drug Administration receives significant new 
information that raises questions about the dietary concentration or the 
safety of a substance that the agency has exempted from regulation, the 
Food and Drug Administration may reevaluate the substance. If the Food 
and Drug Administration tentatively concludes that the information that 
is available about the substance no longer supports an exemption for the 
use of the food-contact material from the food additive regulations, the 
agency will notify any persons that requested an exemption for the 
substance of its tentative decision. The requestors will be given an 
opportunity to show why the use of the substance should not be regulated 
under the food additive provisions of the act. If the requestors fail to 
adequately respond to the new evidence, the agency will notify them that 
further use of the substance in question for the particular use will 
require a food additive regulation. This notification will be placed on 
public display at the Division of Dockets Management as part of the file 
of uses of substances exempted from regulation as food additives. The 
Food and Drug Administration recognizes that manufacturers other than 
those that actually made a request for exemption may also be using 
exempted substances in food-contact articles under conditions of use 
(e.g., use levels, temperature, type of food contacted, etc.) that are 
similar to those for which the exemption was issued. Because only 
requestors will be notified as part of the revocation process described 
in this section, the Food and Drug Administration plans to notify other 
manufacturers by means of a notice published in the Federal Register of 
its decision to revoke an exemption issued for a specific use of a 
substance in a food contact article.
    (h) Guidance documents to assist requestors in the preparation of 
submissions seeking exemptions from the food additive regulations are 
available from the Food and Drug Administration's Office of Premarket 
Approval (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740. 
Interested persons are encouraged to obtain specific guidance from the 
Food and Drug Administration on the appropriate protocols to be used for 
obtaining migration data, on the validation of the analytical methods 
used to quantify migration levels, on the procedures used to relate 
migration data to dietary exposures, and on any other issue not 
specifically covered in the Food and Drug Administration's guidance 
documents.

[60 FR 36595, July 17, 1995, as amended at 62 FR 40599, July 29, 1997; 
65 FR 56479, Sept. 19, 2000]



         Subpart C_Specific Administrative Rulings and Decisions



Sec. 170.45  Fluorine-containing compounds.

    The Commissioner of Food and Drugs has concluded that it is in the 
interest of the public health to limit the addition of fluorine 
compounds to foods (a) to that resulting from the fluoridation of public 
water supplies as stated in Sec. 250.203 of this chapter, (b) to that 
resulting from the fluoridation of bottled water within the limitation 
established in Sec. 103.35(d) of this chapter, and (c) to that 
authorized by regulations (40 CFR part 180) under section 408 of the 
Act.



Sec. 170.50  Glycine (aminoacetic acid) in food for human consumption.

    (a) Heretofore, the Food and Drug Administration has expressed the 
opinion in trade correspondence that glycine is generally recognized as 
safe for certain technical effects in human food when used in accordance 
with good manufacturing practice; however:
    (1) Reports in scientific literature indicate that adverse effects 
were found in cases where high levels of glycine

[[Page 21]]

were administered in diets of experimental animals.
    (2) Current usage information indicates that the daily dietary 
intake of glycine by humans may be substantially increasing due to 
changing use patterns in food technology.

Therefore, the Food and Drug Administration no longer regards glycine 
and its salts as generally recognized as safe for use in human food and 
all outstanding letters expressing sanction for such use are rescinded.
    (b) The Commissioner of Food and Drugs concludes that by May 8, 
1971, manufacturers:
    (1) Shall reformulate food products for human use to eliminate added 
glycine and its salts; or
    (2) Shall bring such products into compliance with an authorizing 
food additive regulation. A food additive petition supported by toxicity 
data is required to show that any proposed level of glycine or its salts 
added to foods for human consumption will be safe.
    (c) The status of glycine as generally recognized as safe for use in 
animal feed, as prescribed in Sec. 582.5049 of this chapter, remains 
unchanged because the additive is considered an essential nutrient in 
certain animal feeds and is safe for such use under conditions of good 
feeding practice.



Sec. 170.60  Nitrites and/or nitrates in curing premixes.

    (a) Nitrites and/or nitrates are food additives when combined in 
curing premixes with spices and/or other flavoring or seasoning 
ingredients that contain or constitute a source of secondary or tertiary 
amines, including but not limited to essential oils, disodium inosinate, 
disodium guanylate, hydrolysates of animal or plant origin (such as 
hydrolyzed vegetable protein), oleoresins of spices, soy products, and 
spice extractives. Such food additives may be used only after the 
establishment of an authorizing food additive regulation. A food 
additive petition submitted pursuant to Sec. Sec. 171.1 and 171.100 of 
this chapter, supported by data demonstrating that nitrosamines are not 
formed in curing premixes containing such food additives, is required to 
establish safety.
    (b) Nitrites and/or nitrates, when packaged separately from 
flavoring and seasoning in curing premixes, may continue to be used 
under prior sanctions in the commercial curing of meat and meat products 
and poultry products and in accordance with the provisions of Sec. Sec. 
172.170 and 172.175 of this chapter that apply to meat curing 
preparations for the home curing of meat and meat products, including 
poultry and wild game. To assure safe use of such ingredients the 
labeling of the premixes shall bear instructions to the user that such 
separately packaged ingredients are not to be combined until just prior 
to use. Encapsulating or coating some or all of the ingredients does not 
constitute separate packaging.



                    Subpart D_Premarket Notifications

    Source:  67 FR 35729, May 21, 2002, unless otherwise noted.



Sec. 170.100  Submission of a premarket notification for a food contact 
substance (FCN) to the Food and Drug Administration (FDA).

    (a) An FCN is effective for the food contact substance manufactured 
or prepared by the manufacturer or supplier identified in the FCN 
submission. If another manufacturer or supplier wishes to market the 
same food contact substance for the same use, that manufacturer or 
supplier must also submit an FCN to FDA.
    (1) An FCN must contain all of the information described in Sec. 
170.101.
    (2) An FCN may incorporate by reference any information in FDA's 
files provided that the manufacturer or supplier is authorized to 
reference the information. The FCN must include information establishing 
that the manufacturer or supplier is authorized to reference information 
in FDA's files.
    (3) Any material submitted in or referenced by an FCN that is in a 
foreign language must be accompanied by an English translation verified 
to be complete and accurate.
    (b) FDA may choose not to accept an FCN for either of the following:

[[Page 22]]

    (1) A use of a food contact substance that is the subject of a 
regulation in parts 173 through 189 of this chapter; or
    (2) A use of a food contact substance that is the subject of an 
exemption under the threshold of regulation process described in Sec. 
170.39.
    (c) A petition must be submitted under Sec. 171.1 of this chapter 
to authorize the safe use of a food contact substance in either of the 
following circumstances, unless FDA agrees to accept an FCN for the 
proposed use.
    (1) The use of the food contact substance increases the cumulative 
dietary concentration to a certain level. For a substance that is a 
biocide (e.g., it is intended to exert microbial toxicity), this level 
is equal to or greater than 200 parts per billion in the daily diet (0.6 
milligram (mg)/person/day). For a substance that is not a biocide, this 
level is equal to or greater than 1 part per million in the daily diet 
(3 mg/person/day); or
    (2) There exists a bioassay on the food contact substance, FDA has 
not reviewed the bioassay, and the bioassay is not clearly negative for 
carcinogenic effects.
    (d) A manufacturer or supplier for which a notification is effective 
must keep a current address on file with FDA.
    (1) The current address may be either the manufacturer's (or 
supplier's) address or the address of the manufacturer's (or supplier's) 
agent.
    (2) FDA will deliver correspondence to the manufacturer's or 
supplier's current address.



Sec. 170.101  Information in a premarket notification for a food contact 
substance (FCN).

    An FCN must contain the following:
    (a) A comprehensive discussion of the basis for the manufacturer's 
or supplier's determination that the use of the food contact substance 
is safe. This discussion must:
    (1) Discuss all information and data submitted in the notification; 
and
    (2) Address any information and data that may appear to be 
inconsistent with the determination that the proposed use of the food 
contact substance is safe.
    (b) All data and other information that form the basis of the 
determination that the food contact substance is safe under the intended 
conditions of use. Data must include primary biological data and 
chemical data.
    (c) A good laboratory practice statement for each nonclinical 
laboratory study, as defined under Sec. 58.3(d) of this chapter, that 
is submitted as part of the FCN, in the form of either:
    (1) A signed statement that the study was conducted in compliance 
with the good laboratory practice regulations under part 58 of this 
chapter; or
    (2) A brief signed statement listing the reason(s) that the study 
was not conducted in compliance with part 58 of this chapter.
    (3) Data from any study conducted after 1978 but not conducted in 
compliance with part 58 of this chapter must be validated by an 
independent third party prior to submission to the Food and Drug 
Administration (FDA), and the report and signed certification of the 
validating party must be submitted as part of the notification.
    (d) Information to address FDA's responsibility under the National 
Environmental Policy Act, in the form of either:
    (1) A claim of categorical exclusion under Sec. 25.30 or Sec. 
25.32 of this chapter; or
    (2) An environmental assessment complying with Sec. 25.40 of this 
chapter.
    (e) A completed and signed FDA Form No. 3480.



Sec. 170.102  Confidentiality of information in a premarket notification 
for a food contact substance (FCN).

    (a) During the 120-day period of the Food and Drug Administration 
(FDA) review of an FCN, FDA will not disclose publicly any information 
in that FCN.
    (b) FDA will not disclose publicly the information in an FCN that is 
withdrawn prior to the completion of FDA's review.
    (c) Once FDA completes its review of an FCN, the agency will make 
its conclusion about the FCN publicly available. For example, if FDA 
objects to a notification 90 days after the date of receipt, the agency 
would make available its objection at that time.

[[Page 23]]

    (d) By submitting an FCN to FDA, the manufacturer or supplier waives 
any claim to confidentiality of the information required to adequately 
describe the food contact substance and the intended conditions of use 
that are the subject of that FCN.
    (e) The following data and information in an FCN are available for 
public disclosure, unless extraordinary circumstances are shown, on the 
121st day after receipt of the notification by FDA, except that no data 
or information are available for public disclosure if the FCN is 
withdrawn under Sec. 170.103.
    (1) All safety and functionality data and information submitted with 
or incorporated by reference into the notification. Safety and 
functionality data include all studies and tests of a food contact 
substance on animals and humans and all studies and tests on a food 
contact substance for establishing identity, stability, purity, potency, 
performance, and usefulness.
    (2) A protocol for a test or study, unless it is exempt from 
disclosure under Sec. 20.61 of this chapter.
    (3) A list of all ingredients contained in a food contact substance, 
excluding information that is exempt from disclosure under Sec. 20.61 
of this chapter. Where applicable, an ingredient list will be identified 
as incomplete.
    (4) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is exempt from disclosure under 
Sec. 20.61 of this chapter.
    (5) All correspondence and written summaries of oral discussions 
relating to the notification, except information that is exempt for 
disclosure under Sec. 20.61 of this chapter.
    (6) All other information not subject to an exemption from 
disclosure under subpart D of part 20 of this chapter.



Sec. 170.103  Withdrawal without prejudice of a premarket notification 
for a food contact substance (FCN).

    A manufacturer or supplier may withdraw an FCN without prejudice to 
a future submission to the Food and Drug Administration (FDA) if FDA has 
not completed review of the FCN. For the purpose of this section, FDA's 
review is completed when FDA has allowed 120 days to pass without 
objecting to the FCN or FDA has issued an objection letter.



Sec. 170.104  Action on a premarket notification for a food contact substance (FCN).

    (a) If the Food and Drug Administration (FDA) does not object to an 
FCN within the 120-day period for FDA review, the FCN becomes effective.
    (b) If an FCN is complete when received, the 120-day review period 
begins on the date FDA receives the FCN.
    (1) If any element required under Sec. 170.101 is missing from an 
FCN, then FDA will not accept that FCN and FDA will send an FCN 
nonacceptance letter to the manufacturer or supplier. If the 
manufacturer or supplier submits the missing information before FDA 
sends an FCN nonacceptance letter, the 120-day review period begins on 
the date of receipt of the missing information.
    (2) If FDA accepts an FCN, then FDA will acknowledge in writing its 
receipt of that FCN.
    (c) Objection to an FCN:
    (1) If FDA objects to an FCN, then FDA will send an FCN objection 
letter. The date of the letter will be the date of FDA's objection for 
purposes of section 409(h)(2)(A) of the act.
    (2) If FDA objects to an FCN within the 120-day period for FDA 
review, the FCN will not become effective.
    (3) FDA may object to an FCN if any part of FDA's 120-day review 
occurs during a period when this program is not funded as required in 
section 409(h)(5) of the act.
    (d) If FDA and a manufacturer or supplier agree that the notifier 
may submit a food additive petition proposing the approval of the food 
contact substance for the use in the manufacturer's or supplier's FCN, 
FDA will consider that FCN to be withdrawn by the manufacturer or 
supplier on the date the petition is received by FDA.



Sec. 170.105  The Food and Drug Administration's (FDA's) determination 

that a premarket notification for a food contact substance (FCN) is no 
longer effective.

    (a) If data or other information available to FDA, including data 
not submitted by the manufacturer or supplier, demonstrate that the 
intended use of the food contact substance is no

[[Page 24]]

longer safe, FDA may determine that the authorizing FCN is no longer 
effective.
    (b) If FDA determines that an FCN is no longer effective, FDA will 
inform the manufacturer or supplier in writing of the basis for that 
determination. FDA will give the manufacturer or supplier an opportunity 
to show why the FCN should continue to be effective and will specify the 
time that the manufacturer or supplier will have to respond.
    (c) If the manufacturer or supplier fails to respond adequately to 
the safety concerns regarding the notified use, FDA will publish a 
notice of its determination that the FCN is no longer effective. FDA 
will publish this notice in the Federal Register, stating that a 
detailed summary of the basis for FDA's determination that the FCN is no 
longer effective has been placed on public display and that copies are 
available upon request. The date that the notice publishes in the 
Federal Register is the date on which the notification is no longer 
effective.
    (d) FDA's determination that an FCN is no longer effective is final 
agency action subject to judicial review.



Sec. 170.106  Notification for a food contact substance formulation (NFCSF).

    (a) In order for the Food and Drug Administration (FDA) to accept an 
NFCSF, any food additive that is a component of the formulation must be 
authorized for its intended use in that NFCSF.
    (b) FDA may publish a notice in the Federal Register stating that 
the agency has insufficient resources to review NFCSFs. From the date 
that this notice publishes in the Federal Register, FDA will no longer 
accept NFCSFs.
    (c) An NFCSF must contain the following:
    (1) A completed and signed FDA Form No. 3479; and
    (2) Any additional documentation required to establish that each 
component of the formulation already may be marketed legally for its 
intended use.



PART 171_FOOD ADDITIVE PETITIONS--Table of Contents




                      Subpart A_General Provisions

Sec.
171.1 Petitions.
171.6 Amendment of petition.
171.7 Withdrawal of petition without prejudice.
171.8 Threshold of regulation for substances used in food-contact 
          articles.

            Subpart B_Administrative Actions on Applications

171.100 Regulation based on petition.
171.102 Effective date of regulation.
171.110 Procedure for objections and hearings.
171.130 Procedure for amending and repealing tolerances or exemptions 
          from tolerances.

    Authority: 21 U.S.C. 321, 342, 348, 371.

    Source: 42 FR 14489, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 171.1  Petitions.

    (a) Petitions to be filed with the Commissioner under the provisions 
of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) 
shall be submitted in triplicate (quadruplicate, if intended uses 
include use in meat, meat food product, or poultry product). If any part 
of the material submitted is in a foreign language, it shall be 
accompanied by an accurate and complete English translation. The 
petition shall state petitioner's post office address to which published 
notices or orders issued or objections filed pursuant to section 409 of 
the Act may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of the Food and 
Drug Administration. However, any reference to unpublished information 
furnished by a person other than the applicant will not be considered 
unless use of such information is authorized in a written statement 
signed by the person who submitted it. Any reference to published 
information offered in support of a food

[[Page 25]]

additive petition should be accompanied by reprints or photostatic 
copies of such references.
    (c) Petitions shall include the following data and be submitted in 
the following form:

                                                                  (Date)
Name of petitioner______________________________________________________
Post-office address_____________________________________________________
Date____________________________________________________________________
Name of food additive and proposed use__________________________________
________________________________________________________________________

Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.

Dear Sirs:
    The undersigned, ---------- submits this petition pursuant to 
section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with 
respect to ----------

(Name of the food additive and proposed use)

    Attached hereto, in triplicate (quadruplicate, if intended uses 
include use in meat, meat food product, or poultry product), and 
constituting a part of this petition are the following:
    A. The name and all pertinent information concerning the food 
additive, including chemical identity and composition of the food 
additive, its physical, chemical, and biological properties, and 
specifications prescribing the minimum content of the desired 
component(s) and identifying and limiting the reaction byproducts and 
other impurities. Where such information is not available, a statement 
as to the reasons why it is not should be submitted.
    When the chemical identity and composition of the food additive is 
not known, the petition shall contain information in sufficient detail 
to permit evaluation regarding the method of manufacture and the 
analytical controls used during the various stages of manufacturing, 
processing, or packing of the food additive which are relied upon to 
establish that it is a substance of reproducible composition. 
Alternative methods and controls and variations in methods and controls 
within reasonable limits that do not affect the characteristics of the 
substance or the reliability of the controls may be specified.
    If the food additive is a mixture of chemicals, the petition shall 
supply a list of all substances used in the synthesis, extraction, or 
other method of preparation, regardless of whether they undergo chemical 
change in the process. Each substance should be identified by its common 
English name and complete chemical name, using structural formulas when 
necessary for specific identification. If any proprietary preparation is 
used as a component, the proprietary name should be followed by a 
complete quantitative statement of composition. Reasonable alternatives 
for any listed substance may be specified.
    If the petitioner does not himself perform all the manufacturing, 
processing, and packing operations for a food additive, the petition 
shall identify each person who will perform a part of such operations 
and designate the part.
    The petition shall include stability data, and, if the data indicate 
that it is needed to insure the identity, strength, quality, or purity 
of the additive, the expiration date that will be employed.
    B. The amount of the food additive proposed for use and the purposes 
for which it is proposed, together with all directions, recommendations, 
and suggestions regarding the proposed use, as well as specimens of the 
labeling proposed for the food additive and any labeling that will be 
required by applicable provisions of the Federal Food, Drug, and 
Cosmetic Act on the finished food by reason of the use of the food 
additive. If the additive results or may reasonably be expected to 
result from the use of packaging material, the petitioner shall show how 
this may occur and what residues may reasonably be anticipated.
    (Typewritten or other draft-labeling copy will be accepted for 
consideration of the petition, provided a statement is made that final 
printed labeling identical in content to the draft copy will be 
submitted as soon as available and prior to the marketing of the food 
additive.)
    (If the food additive is one for which a tolerance limitation is 
required to assure its safety, the level of use proposed should be no 
higher than the amount reasonably required to accomplish the intended 
physical or other technical effect, even though the safety data may 
support a higher tolerance.)
    C. Data establishing that the food additive will have the intended 
physical or other technical effect or that it may reasonably be expected 
to become a component, or to affect the characteristics, directly or 
indirectly, of food and the amount necessary to accomplish this. These 
data should include information in sufficient detail to permit 
evaluation with control data.
    D. A description of practicable methods to determine the amount of 
the food additive in the raw, processed, and/or finished food and of any 
substance formed in or on such food because of its use. The test 
proposed shall be one that can be used for food-control purposes and 
that can be applied with consistent results by any properly equipped and 
trained laboratory personnel.
    E. Full reports of investigations made with respect to the safety of 
the food additive.
    (A petition may be regarded as incomplete unless it includes full 
reports of adequate tests reasonably applicable to show whether

[[Page 26]]

or not the food additive will be safe for its intended use. The reports 
ordinarily should include detailed data derived from appropriate animal 
and other biological experiments in which the methods used and the 
results obtained are clearly set forth. The petition shall not omit 
without explanation any reports of investigations that would bias an 
evaluation of the safety of the food additive.)
    F. Proposed tolerances for the food additive, if tolerances are 
required in order to insure its safety. A petitioner may include a 
proposed regulation.
    G. If submitting petition to modify an existing regulation issued 
pursuant to section 409(c)(1)(A) of the Act, full information on each 
proposed change that is to be made in the original regulation must be 
submitted. The petition may omit statements made in the original 
petition concerning which no change is proposed. A supplemental petition 
must be submitted for any change beyond the variations provided for in 
the original petition and the regulation issued on the basis of the 
original petition.
    H. The petitioner is required to submit either a claim for 
categorical exclusion under Sec. 25.30 or 25.32 of this chapter or an 
environmental assessment under Sec. 25.40 of this chapter.

Yours very truly,
Petitioner______________________________________________________________
By______________________________________________________________________
                                                    (Indicate authority)

    (d) The petitioner will be notified of the date on which his 
petition is filed; and an incomplete petition, or one that has not been 
submitted in triplicate, will usually be retained but not filed as a 
petition under section 409 of the Act. The petitioner will be notified 
in what respects his petition is incomplete.
    (e) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (f) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application, the 
present petition may incorporate it by specific reference to the 
earlier. If part of the data have been submitted by the manufacturer of 
the food additive as a master file, the petitioner may refer to the 
master file if and to the extent he obtains the manufacturer's written 
permission to do so. The manufacturer may authorize specific reference 
to the data without disclosure to the petitioner. Nothing herein shall 
prevent reference to published data.
    (g) A petition shall be retained but shall not be filed if any of 
the data prescribed by section 409(b) of the Act are lacking or are not 
set forth so as to be readily understood.
    (h)(1) The following data and information in a food additive 
petition are available for public disclosure, unless extraordinary 
circumstances are shown, after the notice of filing of the petition is 
published in the Federal Register or, if the petition is not promptly 
filed because of deficiencies in it, after the petitioner is informed 
that it will not be filed because of the deficiencies involved:
    (i) All safety and functionality data and information submitted with 
or incorporated by reference in the petition.
    (ii) A protocol for a test or study, unless it is shown to fall 
within the exemption established for trade secrets and confidential 
commercial information in Sec. 20.61 of this chapter.
    (iii) Adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information, after deletion of:
    (a) Names and any information that would identify the person using 
the product.
    (b) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (iv) A list of all ingredients contained in a food additive, whether 
or not it is in descending order of predominance. A particular 
ingredient or group of ingredients shall be deleted from any such list 
prior to public disclosure if it is shown to fall within the exemption 
established in Sec. 20.61 of this chapter, and a notation shall be made 
that any such ingredient list is incomplete.
    (v) An assay method or other analytical method, unless it serves no 
regulatory or compliance purpose and is shown to fall within the 
exemption established in Sec. 20.61 of this chapter.
    (2) The following data and information in a food additive petition 
are not available for public disclosure unless they have been previously 
disclosed to the public as defined in Sec. 20.81 of this chapter or 
they relate to a product or ingredient that has been abandoned

[[Page 27]]

and they no longer represent a trade secret or confidential commercial 
or financial information as defined in Sec. 20.61 of this chapter:
    (i) Manufacturing methods or processes, including quality control 
procedures.
    (ii) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this 
provision is available for public disclosure.
    (iii) Quantitative or semi quan ti ta tive formulas.
    (3) All correspondence and written summaries of oral discussions 
relating to a food additive petition are available for public disclosure 
in accordance with the provisions of part 20 of this chapter when the 
food additive regulation is published in the Federal Register.
    (4) For purposes of this regulation, safety and functionality data 
include all studies and tests of a food additive on animals and humans 
and all studies and tests on a food additive for identity, stability, 
purity, potency, performance, and usefulness.
    (i)(1)(i) Within 15 days after receipt, the Food and Drug 
Administration will notify the petitioner of the acceptance or 
nonacceptance of a petition, and if not accepted, the reasons therefor. 
If accepted, the petitioner will be sent a letter stating this and the 
date of the letter shall become the date of filing for the purposes of 
section 409(b)(5) of the act. In cases in which the Food and Drug 
Administration agrees that a premarket notification for a food contact 
substance (Food Contact Notification (FCN)) submitted under section 
409(h) of the act may be converted to a petition, the withdrawal date 
for the FCN will be deemed the date of receipt for the petition.
    (ii) If the petitioner desires, he may supplement a deficient 
petition after being notified regarding deficiencies. If the 
supplementary material or explanation of the petition is deemed 
acceptable, the petitioner shall be notified. The date of such 
notification becomes the date of filing. If the petitioner does not wish 
to supplement or explain the petition and requests in writing that it be 
filed as submitted, the petition shall be filed and the petitioner so 
notified.
    (iii) Notwithstanding paragraph (i)(1)(ii) of this section, the 
petition shall not be filed if the Food and Drug Administration 
determines that the use identified in the petition should be the subject 
of an FCN under section 409(h) of the act rather than a petition.
    (2) The Commissioner will publish in the Federal Register within 30 
days from the date of filing of such petition, a notice of the filing, 
the name of the petitioner, and a brief description of the proposal in 
general terms. In the case of a food additive which becomes a component 
of food by migration from packaging material, the notice shall include 
the name of the migratory substance, and where it is different from that 
of one of the original components, the name of the parent component, the 
maximum quantity of the migratory substance that is proposed for use in 
food, and the physical or other technical effect which the migratory 
substance or its parent component is intended to have in the packaging 
material. A copy of the notice will be mailed to the petitioner when the 
original is forwarded to the Federal Register for publication.
    (j) The Commissioner may request a full description of the methods 
used in, and the facilities and controls used for, the production of the 
food additive, or a sample of the food additive, articles used as 
components thereof, or of the food in which the additive is proposed to 
be used, at any time while a petition is under consideration. The 
Commissioner shall specify in the request for a sample of the food 
additive, or articles used as components thereof, or of the food in or 
on which the additive is proposed to be used, a quantity deemed adequate 
to permit tests of analytical methods to determine quantities of the 
food additive present in foods for which it is intended to be used or 
adequate for any study or investigation reasonably required with respect 
to the safety of the food additive or the physical or technical effect 
it produces. The date used for computing the 90-day limit for the 
purposes of section 409(c)(2) of the

[[Page 28]]

Act shall be moved forward 1 day for each day after the mailing date of 
the request taken by the petitioner to submit the sample. If the 
information or sample is requested a reasonable time in advance of the 
180 days, but is not submitted within such 180 days after filing of the 
petition, the petition will be considered withdrawn without prejudice.
    (k) If nonclinical laboratory studies are involved, petitions filed 
with the Commissioner under section 409(b) of the act shall include, 
with respect to each nonclinical study contained in the petition, either 
a statement that the study has been, or will be, conducted in compliance 
with the good laboratory practice regulations as set forth in part 58 of 
this chapter, or, if any such study was not conducted in compliance with 
such regulations, a brief statement of the reason for the noncompliance.
    (l) [Reserved]
    (m) If clinical investigations involving human subjects are 
involved, petitions filed with the Commissioner under section 409(b) of 
the Act shall include statements regarding each such clinical 
investigation relied upon in the petition that it either was conducted 
in compliance with the requirements for institutional review set forth 
in part 56 of this chapter, or was not subject to such requirements in 
accordance with Sec. 56.104 or Sec. 56.105, and that it was conducted 
in compliance with the requirements for informed consent set forth in 
part 50 of this chapter.
    (n)(1) If intended uses of the food additive include uses in meat, 
meat food product, or poultry product subject to regulation by the U.S. 
Department of Agriculture (USDA) under the Poultry Products Inspection 
Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act 
(FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, 
forward a copy of the petition or relevant portions thereof to the Food 
Safety and Inspection Service, USDA, for simultaneous review under the 
PPIA and FMIA.
    (2) FDA will ask USDA to advise whether the proposed meat and 
poultry uses comply with the FMIA and PPIA, or if not, whether use of 
the substance would be permitted in products under USDA jurisdiction 
under specified conditions or restrictions.

[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 
46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, 
1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR 
35731, May 21, 2002]

    Effective Date Note: At 65 FR 51763, Aug. 25, 2000, Sec. 171.1 was 
amended in paragraph (a) by revising the first sentence, in paragraph 
(c) in the petition by revising the introductory paragraph preceding 
paragraph A., and by adding paragraph (n). The revised and added text 
contains information collection and recordkeeping requirements and will 
not become effective until approval has been given by the Office of 
Management and Budget.



Sec. 171.6  Amendment of petition.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof. In such cases, if the 
Commissioner determines that the additional information or data amount 
to a substantive amendment, the petition as amended will be given a new 
filing date, and the time limitation will begin to run anew. If 
nonclinical laboratory studies are involved, additional information and 
data submitted in support of filed petitions shall include, with respect 
to each nonclinical study, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.

[50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985]



Sec. 171.7  Withdrawal of petition without prejudice.

    (a) In some cases the Commissioner will notify the petitioner that 
the petition, while technically complete, is inadequate to justify the 
establishment of a regulation or the regulation requested by petitioner. 
This may be due to the fact that the data are not sufficiently clear or 
complete. In such cases, the petitioner may withdraw the petition 
pending its clarification or the obtaining of additional data. This 
withdrawal will be without prejudice to a future filing. Upon refiling, 
the time

[[Page 29]]

limitation will begin to run anew from the date of refiling.
    (b) At any time before the order provided for in Sec. 171.100(a) 
has been forwarded to the Federal Register for publication, the 
petitioner may withdraw the petition without prejudice to a future 
filing. Upon refiling the time limitation will begin to run anew.
    (c) Any petitioner who has a food additive petition pending before 
the agency and who subsequently submits a premarket notification for a 
food contact substance (FCN) for a use or uses described in such 
petition shall be deemed to have withdrawn the petition for such use or 
uses without prejudice to a future filing on the date the FCN is 
received by the Food and Drug Administration.

[42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]



Sec. 171.8  Threshold of regulation for substances used in food-contact articles.

    Substances used in food-contact articles (e.g., food-packaging or 
food-processing equipment) that migrate or that may be expected to 
migrate into food at negligible levels may be reviewed under Sec. 
170.39 of this chapter. The Food and Drug Administration will exempt 
substances whose uses it determines meet the criteria in Sec. 170.39 of 
this chapter from regulation as food additives and, therefore, a food 
additive petition will not be required for the exempted use.

[60 FR 36596, July 17, 1995]



            Subpart B_Administrative Actions on Applications



Sec. 171.100  Regulation based on petition.

    (a) The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the petition (or within 180 
days if the time is extended as provided for in section 409(c)(2) of the 
Act), a regulation prescribing the conditions under which the food 
additive may be safely used (including, but not limited to, 
specifications as to the particular food or classes of food in or on 
which such additive may be used, the maximum quantity that may be used 
or permitted to remain in or on such food, the manner in which such 
additive may be added to or used in or on such food, and any directions 
or other labeling or packaging requirements for such additive deemed 
necessary by him to assure the safety of such use), and prior to the 
forwarding of the order to the Federal Register for publication shall 
notify the petitioner of such order and the reasons for such action; or 
by order deny the petition, and shall notify the petitioner of such 
order and of the reasons for such action.
    (b) The regulation shall describe the conditions under which the 
substance may be safely used in any meat product, meat food product, or 
poultry product subject to the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.).
    (c) If the Commissioner determines that additional time is needed to 
study and investigate the petition, he shall by written notice to the 
petitioner extend the 90-day period for not more than 180 days after the 
filing of the petition.

[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]



Sec. 171.102  Effective date of regulation.

    A regulation published in accordance with Sec. 171.100(a) shall 
become effective upon publication in the Federal Register.



Sec. 171.110  Procedure for objections and hearings.

    Objections and hearings relating to food additive regulations under 
section 409 (c), (d), or (h) of the Act shall be governed by part 12 of 
this chapter.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]



Sec. 171.130  Procedure for amending and repealing tolerances or exemptions 
from tolerances.

    (a) The Commissioner, on his own initiative or on the petition of 
any interested person, pursuant to part 10 of this chapter, may propose 
the issuance of a regulation amending or repealing a regulation 
pertaining to a food additive or granting or repealing an exception for 
such additive.

[[Page 30]]

    (b) Any such petition shall include an assertion of facts, supported 
by data, showing that new information exists with respect to the food 
additive or that new uses have been developed or old uses abandoned, 
that new data are available as to toxicity of the chemical, or that 
experience with the existing regulation or exemption may justify its 
amendment or repeal. New data shall be furnished in the form specified 
in Sec. Sec. 171.1 and 171.100 for submitting petitions.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]



PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN 
CONSUMPTION--Table of Contents




                      Subpart A_General Provisions

Sec.
172.5 General provisions for direct food additives.

                      Subpart B_Food Preservatives

172.105 Anoxomer.
172.110 BHA.
172.115 BHT.
172.120 Calcium disodium EDTA.
172.130 Dehydroacetic acid.
172.133 Dimethyl dicarbonate.
172.135 Disodium EDTA.
172.140 Ethoxyquin.
172.145 Heptylparaben.
172.150 4-Hydroxymethyl-2,6-di-tert-butyl-phenol.
172.155 Natamycin (pimaricin).
172.160 Potassium nitrate.
172.165 Quaternary ammonium chloride combination.
172.170 Sodium nitrate.
172.175 Sodium nitrite.
172.177 Sodium nitrite used in processing smoked chub.
172.180 Stannous chloride.
172.185 TBHQ.
172.190 THBP.

            Subpart C_Coatings, Films and Related Substances

172.210 Coatings on fresh citrus fruit.
172.215 Coumarone-indene resin.
172.225 Methyl and ethyl esters of fatty acids produced from edible fats 
          and oils.
172.230 Microcapsules for flavoring substances.
172.235 Morpholine.
172.250 Petroleum naphtha.
172.255 Polyacrylamide.
172.260 Oxidized polyethylene.
172.270 Sulfated butyl oleate.
172.275 Synthetic paraffin and succinic derivatives.
172.280 Terpene resin.

           Subpart D_Special Dietary and Nutritional Additives

172.310 Aluminum nicotinate.
172.315 Nicotinamide-ascorbic acid complex.
172.320 Amino acids.
172.325 Bakers yeast protein.
172.330 Calcium pantothenate, calcium chloride double salt.
172.335 D-Pantothenamide.
172.340 Fish protein isolate.
172.345 Folic acid (folacin).
172.350 Fumaric acid and salts of fumaric acid.
172.365 Kelp.
172.370 Iron-choline citrate complex.
172.372 N-Acetyl-L-methionine.
172.375 Potassium iodide.
172.380 Vitamin D3.
172.385 Whole fish protein concentrate.
172.395 Xylitol.
172.399 Zinc methionine sulfate.

                       Subpart E_Anticaking Agents

172.410 Calcium silicate.
172.430 Iron ammonium citrate.
172.480 Silicon dioxide.
172.490 Yellow prussiate of soda.

            Subpart F_Flavoring Agents and Related Substances

172.510 Natural flavoring substances and natural substances used in 
          conjunction with flavors.
172.515 Synthetic flavoring substances and adjuvants.
172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
172.530 Disodium guanylate.
172.535 Disodium inosinate.
172.540 DL-Alanine.
172.560 Modified hop extract.
172.575 Quinine.
172.580 Safrole-free extract of sassafras.
172.585 Sugar beet extract flavor base.
172.590 Yeast-malt sprout extract.

        Subpart G_Gums, Chewing Gum Bases and Related Substances

172.610 Arabinogalactan.
172.615 Chewing gum base.
172.620 Carrageenan.
172.623 Carrageenan with polysorbate 80.
172.626 Salts of carrageenan.
172.655 Furcelleran.
172.660 Salts of furcelleran.
172.665 Gellan gum.
172.695 Xanthan gum.

[[Page 31]]

                Subpart H_Other Specific Usage Additives

172.710 Adjuvants for pesticide use dilutions.
172.712 1,3-Butylene glycol.
172.715 Calcium lignosulfonate.
172.720 Calcium lactobionate.
172.723 Epoxidized soybean oil.
172.725 Gibberellic acid and its potassium salt.
172.730 Potassium bromate.
172.735 Glycerol ester of wood rosin.
172.755 Stearyl monoglyceridyl citrate.
172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770 Ethylene oxide polymer.
172.775 Methacrylic acid-divinylbenzene copolymer.

                    Subpart I_Multipurpose Additives

172.800 Acesulfame potassium.
172.802 Acetone peroxides.
172.804 Aspartame.
172.806 Azodicarbonamide.
172.808 Copolymer condensates of ethylene oxide and propylene oxide.
172.809 Curdlan.
172.810 Dioctyl sodium sulfosuccinate.
172.811 Glyceryl tristearate.
172.812 Glycine.
172.814 Hydroxylated lecithin.
172.816 Methyl glucoside-coconut oil ester.
172.818 Oxystearin.
172.820 Polyethylene gylcol (mean molecular weight 200-9,500).
172.822 Sodium lauryl sulfate.
172.824 Sodium mono- and dimethyl naphthalene sulfonates.
172.826 Sodium stearyl fumarate.
172.828 Acetylated monoglycerides.
172.829 Neotame.
172.830 Succinylated monoglycerides.
172.831 Sucralose.
172.832 Monoglyceride citrate.
172.833 Sucrose acetate isobutyrate (SAIB).
172.834 Ethoxylated mono- and diglycerides.
172.836 Polysorbate 60.
172.838 Polysorbate 65.
172.840 Polysorbate 80.
172.841 Polydextrose.
172.842 Sorbitan monostearate.
172.844 Calcium stearoyl-2-lactylate.
172.846 Sodium stearoyl lactylate.
172.848 Lactylic esters of fatty acids.
172.850 Lactylated fatty acid esters of glycerol and propylene glycol.
172.852 Glyceryl-lacto esters of fatty acids.
172.854 Polyglycerol esters of fatty acids.
172.856 Propylene glycol mono- and diesters of fats and fatty acids.
172.858 Propylene glycol alginate.
172.859 Sucrose fatty acid esters.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or 
          both oils.
172.862 Oleic acid derived from tall oil fatty acids.
172.863 Salts of fatty acids.
172.864 Synthetic fatty alcohols.
172.866 Synthetic glycerin produced by the hydrogenolysis of 
          carbohydrates.
172.867 Olestra.
172.868 Ethyl cellulose.
172.869 Sucrose oligoesters.
172.870 Hydroxypropyl cellulose.
172.872 Methyl ethyl cellulose.
172.874 Hydroxypropyl methylcellulose.
172.876 Castor oil.
172.878 White mineral oil.
172.880 Petrolatum.
172.882 Synthetic isoparaffinic petroleum hydrocarbons.
172.884 Odorless light petroleum hydrocarbons.
172.886 Petroleum wax.
172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.892 Food starch-modified.
172.894 Modified cottonseed products intended for human consumption.
172.896 Dried yeasts.
172.898 Bakers yeast glycan.

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

    Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 172 appear at 61 FR 
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 
2001, and 68 FR 15355, Mar. 31, 2003.



                      Subpart A_General Provisions



Sec. 172.5  General provisions for direct food additives.

    (a) Regulations prescribing conditions under which food additive 
substances may be safely used predicate usage under conditions of good 
manufacturing practice. For the purposes of this part, good 
manufacturing practice shall be defined to include the following 
restrictions.
    (1) The quantity of the substance added to food does not exceed the 
amount reasonably required to accomplish its intended physical, 
nutritive, or other technical effect in food.
    (2) Any substance intended for use in or on food is of appropriate 
food grade and is prepared and handled as a food ingredient.
    (b) The existence of a regulation prescribing safe conditions of use 
for a food additive shall not be construed to relieve the use of the 
substance from compliance with any other provision of the Act.

[[Page 32]]

    (c) The existence of any regulation prescribing safe conditions of 
use for a nutrient substance does not constitute a finding that the 
substance is useful or required as a supplement to the diet of humans.



                      Subpart B_Food Preservatives



Sec. 172.105  Anoxomer.

    Anoxomer as identified in this section may be safely used in 
accordance with the following conditions:
    (a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with 
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-
(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-
57-2) prepared by condensation polymerization of divinylbenzene (m- and 
p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-
cresol and 4,4'-isopropylidenediphenol.
    (b) The polymeric antioxidant meets the following specifications:
    (1) Polymer, not less than 98.0 percent as determined by an 
ultraviolet method entitled ``Ultraviolet Assay, ``1982, which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Molecular weight: Total monomers, dimers and trimers below 500 
not more than 1 percent as determined by a method entitled ``Low 
Molecular Weight Anoxomer Analysis,'' 1982, which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (3) Phenol content: Not less than 3.2 milliequivalent/gram and not 
more than 3.8 milliequivalent/gram as determined by a method entitled 
``Total Phenols,'' 1982, which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (4) Heavy metals as lead (as Pb), not more than 10 parts per 
million. Arsenic (as As), not more than 3 parts per million. Mercury (as 
Hg), not more than 1 part per million.
    (c) Anoxomer may be safely used as an antioxidant in food at a level 
of not more than 5,000 parts per million based on fat and oil content of 
the food.

[48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989]



Sec. 172.110  BHA.

    The food additive BHA (butylated hydroxyanisole) alone or in 
combination with other antioxidants permitted in food for human 
consumption in this subpart B may be safely used in or on specified 
foods, as follows:
    (a) The BHA meets the following specification:

Assay (total BHA), 98.5 percent minimum. Melting point 48 [deg]C 
minimum.

    (b) The BHA is used alone or in combination with BHT, as an 
antioxidant in foods, as follows:

------------------------------------------------------------------------
                                                             Limitations
                                                              (total BHA
                            Food                               and BHT)
                                                              parts per
                                                               million
------------------------------------------------------------------------
Dehydrated potato shreds...................................           50
Active dry yeast...........................................    \1\ 1,000
Beverages and desserts prepared from dry mixes.............        \1\ 2
Dry breakfast cereals......................................           50
Dry diced glazed fruit.....................................       \1\ 32
Dry mixes for beverages and desserts.......................       \1\ 90
Emulsion stabilizers for shortenings.......................          200
Potato flakes..............................................           50
Potato granules............................................           10
Sweet potato flakes........................................           50
------------------------------------------------------------------------
\1\ BHA only.

    (c) To assure safe use of the additive:
    (1) The label of any market package of the additive shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) When the additive is marketed in a suitable carrier, in addition 
to meeting the requirement of paragraph (c)(1) of this section, the 
label shall declare

[[Page 33]]

the percentage of the additive in the mixture.
    (3) The label or labeling of dry mixes for beverages and desserts 
shall bear adequate directions for use to provide that beverages and 
desserts prepared from the dry mixes contain no more than 2 parts per 
million BHA.



Sec. 172.115  BHT.

    The food additive BHT (butylated hydroxytoluene), alone or in 
combination with other antioxidants permitted in this subpart B may be 
safely used in or on specified foods, as follows:
    (a) The BHT meets the following specification: Assay (total BHT) 99 
percent minimum.
    (b) The BHT is used alone or in combination with BHA, as an 
antioxidant in foods, as follows:

------------------------------------------------------------------------
                                                             Limitations
                                                              (total BHA
                            Food                               and BHT)
                                                              parts per
                                                               million
------------------------------------------------------------------------
Dehydrated potato shreds...................................           50
Dry breakfast cereals......................................           50
Emulsion stabilizers for shortenings.......................          200
Potato flakes..............................................           50
Potato granules............................................           10
Sweetpotato flakes.........................................           50
------------------------------------------------------------------------

    (c) To assure safe use of the additive:
    (1) The label of any market package of the additive shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) When the additive is marketed in a suitable carrier, in addition 
to meeting the requirement of paragraph (c)(1) of this section, the 
label shall declare the percentage of the additive in the mixture.



Sec. 172.120  Calcium disodium EDTA.

    The food additive calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate) may be safely used in designated foods for the 
purposes and in accordance with the conditions prescribed, as follows:
    (a) The additive contains a minimum of 99 percent by weight of 
either the dihydrate 
C10H12O8N2CaNa2[mi
ddot]2H2O or the trihydrate 
C10H12O8N2CaNa2[mi
ddot]3H2O, or any mixture of the two.
    (b) It is used or intended for use as follows:
    (1) Alone, in the following foods at not to exceed the levels 
prescribed, calculated as the anhydrous compound:

------------------------------------------------------------------------
                                      Limitation
                Food                  (parts per            Use
                                       million)
------------------------------------------------------------------------
Cabbage, pickled....................        220   Promote color, flavor,
                                                   and texture
                                                   retention.
Canned carbonated soft drinks.......         33   Promote flavor
                                                   retention.
Canned white potatoes...............        110   Promote color
                                                   retention.
Clams (cooked canned)...............        340   Promote color
                                                   retention.
Crabmeat (cooked canned)............        275   Retard struvite
                                                   formation; promote
                                                   color retention.
Cucumbers pickled...................        220   Promote color, flavor,
                                                   and texture
                                                   retention.
Distilled alcoholic beverages.......         25   Promote stability of
                                                   color, flavor, and/or
                                                   product clarity.
Dressings, nonstandardized..........         75   Preservative.
Dried lima beans (cooked canned)....        310   Promote color
                                                   retention.
Egg product that is hard-cooked and     \1\ 200   Preservative.
 consists, in a cylindrical shape,
 of egg white with an inner core of
 egg yolk.
Fermented malt beverages............         25   Antigushing agent.
French dressing.....................         75   Preservative.
Legumes (all cooked canned, other           365   Promote color
 than dried lima beans, pink beans,                retention.
 and red beans).
Mayonnaise..........................         75    Do.
Mushrooms (cooked canned)...........        200   Promote color
                                                   retention.
Oleomargarine.......................         75   Preservative.
Pecan pie filling...................        100   Promote color
                                                   retention.
Pink beans (cooked canned)..........        165   Promote color
                                                   retention.
Potato salad........................        100   Preservative.
Processed dry pinto beans...........        800   Promote color
                                                   retention.
Red beans (cooked canned)...........        165   Promote color
                                                   retention.
Salad dressing......................         75   Preservative.
Sandwich spread.....................        100    Do.
Sauces..............................         75    Do.
Shrimp (cooked canned)..............        250   Retard struvite
                                                   formation; promote
                                                   color retention.
Spice extractives in soluble                 60   Promote color and
 carriers.                                         flavor retention.
Spreads, artificially colored and           100   Promote color
 lemon-flavored or orange-flavored.                retention.
------------------------------------------------------------------------
\1\ By weight of egg yolk portion.

    (2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the 
following foods at not to exceed, in combination, the levels prescribed, 
calculated as anhydrous 
C10H12O8N2CaNa2:

[[Page 34]]



------------------------------------------------------------------------
                                      Limitation
                Food                  (parts per            Use
                                       million)
------------------------------------------------------------------------
Dressings, nonstandardized..........         75   Preservative.
French dressing.....................         75    Do.
Mayonnaise..........................         75    Do.
Salad dressing......................         75    Do.
Sandwich spread.....................        100    Do.
Sauces..............................         75    Do.
------------------------------------------------------------------------

    (c) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the Act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to provide a final food product that complies 
with the limitations provided in paragraph (b) of this section.
    (d) In the standardized foods listed in paragraph (b) of this 
section, the additives are used only in compliance with the applicable 
standards of identity for such foods.

[42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15, 1983; 
58 FR 52222, Oct. 7, 1993; 60 FR 33710, June 29, 1995; 65 FR 48379, Aug. 
8, 2000]



Sec. 172.130  Dehydroacetic acid.

    The food additive dehydroacetic acid and/or its sodium salt may be 
safely used in accordance with the following prescribed conditions:
    (a) The food additive meets the following specifications:

Dehydroacetic acid: Melting point, 109 [deg]C-111 [deg]C; assay, minimum 
98 percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry 
basis).

    (b) It is used or intended for use as a preservative for cut or 
peeled squash, and is so used that no more than 65 parts per million 
expressed as dehydroacetic acid remains in or on the prepared squash.
    (c) The label or labeling of any package of the additive intended 
for use in food shall bear adequate directions for use to insure 
compliance with this section.



Sec. 172.133  Dimethyl dicarbonate.

    Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive meets the following specifications:
    (1) The additive has a purity of not less than 99.8 percent as 
determined by the following titration method:

                          principles of method

    Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine 
with which it reacts quantitatively. The excess amine is backtitrated 
with acid.

                                apparatus

250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, eg., Metrohm burette)
Stirrer
Device for potentiometric titration
Reference electrode
Glass electrode

                                reagents

Acetone, analytical-grade
Solution of 1 N diisobutylamine in chlorobenzene, distilled
1 N Acetic Acid

                                procedure

    Accurately weigh in about 2 grams of the sample (W) and dissolve in 
100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine solution 
by pipette and allow to stand for 5 minutes. Subsequently, titrate the 
reaction mixture potentiometrically with 1 N hydrochloric acid 
(consumption=a mL) while stirring. For determining the blank 
consumption, carry out the analysis without a sample (consumption=b mL).

                               calculation
[GRAPHIC] [TIFF OMITTED] TR10MR99.023

    Note: For adding the diisobutylamine solution, always use the same 
pipette and wait for a further three drops to fall when the flow has 
stopped.
    (2) The additive contains not more than 2,000 ppm (0.2 percent) 
dimethyl carbonate as determined by a method entitled ``Gas 
Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl 
Dicarbonate,'' whichis incorporated by reference in accordance with 5 
U.S.C. 552(a). Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD

[[Page 35]]

20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (b) The additive is used or intended for use as a microbial control 
agent in the following beverages under normal circumstances of bottling, 
canning, or other forms of final packaging, where the viable microbial 
load has been reduced to 500 microorganisms per milliliter or less by 
current good manufacturing practices such as heat treatment, filtration, 
or other technologies prior to the use of dimethyl dicarbonate:
    (1) In wine, dealcoholized wine, and low alcohol wine in an amount 
not to exceed 200 parts per million.
    (2) In ready-to-drink teas in an amount not to exceed 250 parts per 
million.
    (3) In carbonated or noncarbonated, nonjuice-containing (less than 
or equal to 1 percent juice), flavored or unflavored beverages 
containing added electrolytes (5-20 milliequivalents/liter sodium ion 
(Na+) and 3-7 milliequivalents/liter potassium ion (K+)) in an amount 
not to exceed 250 parts per million.
    (4) In carbonated, dilute beverages containing juice, fruit flavor, 
or both, with juice content not to exceed 50 percent, in an amount not 
to exceed 250 parts per million.
    (c) To ensure the safe use of the food additive, the label of the 
package containing the additive shall bear, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The name of the additive ``dimethyl dicarbonate.''
    (2) The intended use of the additive.
    (3) Adequate directions for use to ensure compliance with this 
section.

[53 FR 41329, Oct. 21, 1988, as amended at 58 FR 6091, Jan. 26, 1993; 59 
FR 5319, Feb. 4, 1994; 61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, 
1996; 66 FR 13653, Mar. 7, 2001]



Sec. 172.135  Disodium EDTA.

    The food additive disodium EDTA (disodium ethylenediaminetetraace 
tate) may be safely used in designated foods for the purposes and in 
accordance with the following prescribed conditions:
    (a) The additive contains a minimum of 99 percent disodium 
ethylenedia-minetetraacetate dihydrate 
(C10H14O8N2Na2[mid
dot]2H2O).
    (b) It is used or intended for use as follows:
    (1) Alone, in the following foods at not to exceed the levels 
prescribed, calculated as anhydrous calcium disodium EDTA:

------------------------------------------------------------------------
                                      Limitation
                Food                  (parts per            Use
                                       million)
------------------------------------------------------------------------
Aqueous multivitamin preparations...        150   With iron salts as a
                                                   stabilizer for
                                                   vitamin B \12\ in
                                                   liquid multivitamin
                                                   preparations.
Canned black-eyed peas..............        145   Promote color
                                                   retention.
Canned kidney beans.................        165   Preservative.
Canned strawberry pie filling.......        500   Promote color
                                                   retention.
Cooked sausage......................         36   As a cure accelerator
                                                   with sodium ascorbate
                                                   or ascorbic acid.
Dressings, nonstandardized..........         75   Preservative.
French dressing.....................         75    Do.
Frozen white potatoes including cut         100   Promote color
 potatoes.                                         retention.
Gefilte fish balls or patties in         \1\ 50   Inhibit discoloration.
 packing medium.
Legumes (all cooked canned, other           165   Promote color
 than black-eyed peas).                            retention.
Mayonnaise..........................         75   Preservative.
Ready-to-eat cereal products            \2\ 315   Promote color
 containing dried bananas.                         retention.
Salad dressing......................         75   Preservative.
Sandwich spread.....................        100    Do.
Sauces..............................         75    Do.
------------------------------------------------------------------------
\1\ Based on total weight of finished product including packing medium.
\2\ In dried banana component of cereal product.

    (2) With calcium disodium EDTA (calcium disodium ethylenediamine 
tetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the 
following foods at not to exceed, in combination, the levels prescribed, 
calculated as anhydrous 
C10H12O8N2CaNa2:

------------------------------------------------------------------------
                                      Limitation
                Food                  (parts per            Use
                                       million)
------------------------------------------------------------------------
Dressings, nonstandardized..........         75   Preservative.
French dressing.....................         75    Do.
Mayonnaise..........................         75    Do.
Salad dressing......................         75    Do.
Sandwich spread.....................        100    Do.
Sauces..............................         75    Do.
------------------------------------------------------------------------


[[Page 36]]

    (3) Alone, as a sequestrant in the nonnutritive sweeteners that are 
listed in Sec. 180.37 of this chapter and that, in addition, are 
designed for aqueous solution: Provided, That the amount of the 
additive, calculated as anhydrous calcium disodium EDTA, does not exceed 
0.1 percent by weight of the dry nonnutritive sweetener.
    (c) To assure the safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the act, the name of the 
additive.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to provide a final food product that complies 
with the limitations provided in paragraph (b) of this section.
    (d) In the standardized foods listed in paragraphs (b) (1) and (2) 
of this section the additives are used only in compliance with the 
applicable standards of identity for such foods.

[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]



Sec. 172.140  Ethoxyquin.

    (a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may 
be safely used as an antioxidant for preservation of color in the 
production of chili powder, paprika, and ground chili at levels not in 
excess of 100 parts per million.
    (b) In order to provide for the safe use of the additive in feed 
prepared in accordance with Sec. Sec. 573.380 and 573.400 of this 
chapter, tolerances are established for residues of ethoxyquin in or on 
edible products of animals as follows:

5 parts per million in or on the uncooked fat of meat from animals 
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.



Sec. 172.145  Heptylparaben.

    (a) The food additive heptylparaben is the chemical n-heptyl p-
hydroxybenzoate.
    (b) It may be safely used to inhibit microbiological spoilage in 
accordance with the following prescribed conditions:
    (1) In fermented malt beverages in amounts not to exceed 12 parts 
per million.
    (2) In noncarbonated soft drinks and fruit-based beverages in 
amounts not to exceed 20 parts per million, when standards of identity 
established under section 401 of the Act (21 U.S.C. 341) do not preclude 
such use.



Sec. 172.150  4-Hydroxymethyl-2,6-di-tert-butylphenol.

    The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The additive has a solidification point of 140 [deg]C-141 
[deg]C.
    (b) The additive is used as an antioxidant alone or in combination 
with other permitted antioxidants.
    (c) The total amount of all antioxidants added to such food shall 
not exceed 0.02 percent of the oil or fat content of the food, including 
the essential (volatile) oil content of the food.



Sec. 172.155  Natamycin (pimaricin).

    (a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is 
a polyene macrolide antimycotic substance possessing an empirical 
formula of C33H47NO13 and a molecular 
weight of 665.7.
    (b) The additive shall conform to the following specifications:

Purity: 97 percent 2 percent on an anhydrous 
basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.

    (c) The additive may be applied on cheese, as an antimycotic, in 
amounts not to exceed 20 milligrams per kilogram (20 parts per million) 
in the finished product as determined by International Dairy Federation 
(IDF) Standard 140A:1992, ``Cheese and Cheese Rind-Determination of 
Natamycin Content-Method by Molecular Absorption Spectrometry and by 
High-Performance Liquid Chromatography,'' which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the Division of Product

[[Page 37]]

Policy (HFS-206), Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.

[47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985; 63 
FR 66015, Dec. 1, 1998; 66 FR 13847, Mar. 8, 2001]



Sec. 172.160  Potassium nitrate.

    The food additive potassium nitrate may be safely used as a curing 
agent in the processing of cod roe, in an amount not to exceed 200 parts 
per million of the finished roe.



Sec. 172.165  Quaternary ammonium chloride combination.

    The food additive, quaternary ammonium chloride combination, may be 
safely used in food in accordance with the following conditions:
    (a) The additive contains the following compounds: n-dodecyl 
dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl 
dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3); n-
hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9); n-
octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0); n-
tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2); n-
tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-
29-4).
    (b) The additive meets the following specifications: pH (5 percent 
active solution) 7.0-8.0; total amines, maximum 1 percent as combined 
free amines and amine hydrochlorides.
    (c) The additive is used as an antimicrobial agent, as defined in 
Sec. 170.3(o)(2) of this chapter, in raw sugar cane juice. It is added 
prior to clarification when further processing of the sugar cane juice 
must be delayed.
    (d) The additive is applied to the sugar juice in the following 
quantities, based on the weight of the raw cane:

------------------------------------------------------------------------
                                                              Parts per
                         Component                             million
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride................     0.25-1.0
n-Dodecyl dimethyl ethylbenzyl ammonium chloride...........     3.4-13.5
n-Hexadecyl dimethyl benzyl ammonium chloride..............      1.5-6.0
n-Octadecyl dimethyl benzyl ammonium chloride..............     0.25-1.0
n-Tetradecyl dimethyl benzyl ammonium chloride.............     3.0-12.0
n-Tetradecyl dimethyl ethylbenzyl ammonium chloride........      1.6-6.5
------------------------------------------------------------------------


[50 FR 3890, Jan. 29, 1985]



Sec. 172.170  Sodium nitrate.

    The food additive sodium nitrate may be safely used in or on 
specified foods in accordance with the following prescribed conditions:
    (a) It is used or intended for use as follows:
    (1) As a preservative and color fixative, with or without sodium 
nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked, 
cured shad, so that the level of sodium nitrate does not exceed 500 
parts per million and the level of sodium nitrite does not exceed 200 
parts per million in the finished product.
    (2) As a preservative and color fixative, with or without sodium 
nitrite, in meat-curing preparations for the home curing of meat and 
meat products (including poultry and wild game), with directions for use 
which limit the amount of sodium nitrate to not more than 500 parts per 
million in the finished meat product and the amount of sodium nitrite to 
not more than 200 parts per million in the finished meat product.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive or of a mixture containing the 
additive shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive in any 
mixture.
    (2) If in a retail package intended for household use, the label and 
labeling of the additive, or of a mixture containing the additive, shall 
bear adequate directions for use to provide a final food product that 
complies with the limitations prescribed in paragraph (a) of this 
section.

[[Page 38]]

    (3) If in a retail package intended for household use, the label of 
the additive or of a mixture containing the additive, shall bear the 
statement ``Keep out of the reach of children''.



Sec. 172.175  Sodium nitrite.

    The food additive sodium nitrite may be safely used in or on 
specified foods in accordance with the following prescribed conditions:
    (a) It is used or intended for use as follows:
    (1) As a color fixative in smoked cured tunafish products so that 
the level of sodium nitrite does not exceed 10 parts per million (0.001 
percent) in the finished product.
    (2) As a preservative and color fixative, with or without sodium 
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked, 
cured shad so that the level of sodium nitrite does not exceed 200 parts 
per million and the level of sodium nitrate does not exceed 500 parts 
per million in the finished product.
    (3) As a preservative and color fixative, with sodium nitrate, in 
meat-curing preparations for the home curing of meat and meat products 
(including poultry and wild game), with directions for use which limit 
the amount of sodium nitrite to not more than 200 parts per million in 
the finished meat product, and the amount of sodium nitrate to not more 
than 500 parts per million in the finished meat product.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive or of a mixture containing the 
additive shall bear:
    (i) The name of the additive.
    (ii) A statement of the concentration of the additive in any 
mixture.
    (2) If in a retail package intended for household use, the label and 
labeling of the additive, or of a mixture containing the additive, shall 
bear adequate directions for use to provide a final food product which 
complies with the limitations prescribed in paragraph (a) of this 
section.
    (3) If in a retail package intended for household use, the label of 
the additive, or of a mixture containing the additive, shall bear the 
statement ``Keep out of the reach of children''.



Sec. 172.177  Sodium nitrite used in processing smoked chub.

    The food additive sodium nitrite may be safely used in combination 
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation 
from Clostridium botulinum type E in the commercial processing of smoked 
chub in accordance with the following prescribed conditions:
    (a) All fish in smoking establishments shall be clean and wholesome 
and shall be expeditiously processed, packed, and stored under adequate 
sanitary conditions in accordance with good manufacturing practice.
    (b) The brining procedure is controlled in such a manner that the 
water phase portion of the edible portion of the finished smoked product 
has a salt (NaCl) content of not less than 3.5 percent, as measured in 
the loin muscle, and the sodium nitrite content of the edible portion of 
the finished smoked product is not less than 100 parts per million and 
not greater than 200 parts per million, as measured in the loin muscle.
    (c) Smoked chub shall be heated by a controlled heat process which 
provides a monitoring system positioned in as many strategic locations 
in the smokehouse as necessary to assure a continuous temperature 
throughout each fish of at least 160 [deg]F for a minimum of 30 minutes.
    (d) The finished product shall be cooled to a temperature of 50 
[deg]F or below within 3 hours after smoking and further cooled to a 
temperature of 38 [deg]F or below within 12 hours after smoking. A 
temperature of 38 [deg]F or below shall be maintained during all 
subsequent storage and distribution. All shipping containers, retail 
packages, and shipping records shall indicate with appropriate notice 
the perishable nature of the product and specify that the product shall 
be held under refrigeration (38 [deg]F or below) until consumed.
    (e) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the Act, the name of the 
additive.

[[Page 39]]

    (2) The label or labeling of the additive container shall bear 
adequate directions to assure use in compliance with the provisions of 
this section.



Sec. 172.180  Stannous chloride.

    The food additive stannous chloride may be safely used for color 
retention in asparagus packed in glass, with lids lined with an inert 
material, in an amount not to exceed 20 parts per million calculated as 
tin (Sn).



Sec. 172.185  TBHQ.

    The food additive TBHQ, which is the chemical 2-(1,1-dimethylethyl)-
1,4-benzenediol (Chemical Abstracts Service Registry Number 1948-33-0), 
also known as tertiary butylhydroquinone, may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive has a melting point of 126.5 [deg]C-128.5 
[deg]C.
    (b) It is used as an antioxidant alone or in combination with BHA 
and/or BHT.
    (c) The total antioxidant content of a food containing the additive 
will not exceed 0.02 percent of the oil or fat content of the food, 
including the essential (volatile) oil content of the food.



Sec. 172.190  THBP.

    The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely 
used in food in accordance with the following prescribed conditions:
    (a) The food additive has a melting point of 149 [deg]C-153 [deg]C.
    (b) It is used as an antioxidant alone or in combination with other 
permitted antioxidants.
    (c) The total antioxidant content of a food containing the additive 
will not exceed 0.02 percent of the oil or fat content of the food, 
including the essential (volatile) oil content of the food.



            Subpart C_Coatings, Films and Related Substances



Sec. 172.210  Coatings on fresh citrus fruit.

    Coatings may be applied to fresh citrus fruit for protection of the 
fruit in accordance with the following conditions:
    (a) The coating is applied in the minimum amount required to 
accomplish the intended effect.
    (b) The coating may be formulated from the following components, 
each used in the minimum quantity required to accomplish the intended 
effect:
    (1) Substances generally recognized as safe for the purpose or 
previously sanctioned for the purpose.
    (2) One or more of the following:

------------------------------------------------------------------------
           Component                           Limitations
------------------------------------------------------------------------
Fatty acids....................  Complying with Sec.  172.860.
Oleic acid derived from tall     Complying with Sec.  172.862.
 oil fatty acids.
Partially hydrogenated rosin...  Catalytically hydrogenated to a maximum
                                  refractive index of 1.5012 at 100
                                  [deg]C. Color of WG or paler.
Pentaerythritol ester of maleic  Acid number of 134-145; drop-softening
 anhydride-modified wood rosin.   point of 127 [deg]C-173 [deg]C;
                                  saponification number of less than
                                  280; and a color of M or paler.
 Do............................  Acid number of 176-186; drop-softening
                                  point of 110 [deg]C-118 [deg]C;
                                  saponification number of less than
                                  280; and a color of M or paler.
Polyethylene glycol............  Complying with Sec.  172.820. As a
                                  defoamer and dispersing adjuvant.
Polyhydric alcohol diesters of   Complying with Sec.  178.3770 of this
 oxidatively refined              chapter and having a dropping point of
 (Gersthofen process) montan      77 to 83 [deg]C (170.6 to 181.4
 wax acids.                       [deg]F), as determined by ASTM Method
                                  D566-76 (Reapproved 1982), ``Standard
                                  Test Method for Dropping Point of
                                  Lubricating Grease,'' which is
                                  incorporated by reference (copies are
                                  available from the American Society
                                  for Testing and Materials, 1916 Race
                                  St., Philadelphia, PA 19103, or
                                  available for inspection at the Office
                                  of the Federal Register, 800 North
                                  Capitol Street, NW., suite 700,
                                  Washington, DC 20408) using as a
                                  solvent xylene-ethyl alcohol in a 2:1
                                  ratio instead of toluene-ethyl alcohol
                                  in a 2:1 ratio.
Sodium lauryl sulfate..........  Complying with Sec.  172.822. As a
                                  film former.
Wood rosin.....................  Color of K or paler.
------------------------------------------------------------------------

    (3) In lieu of the components listed in paragraph (b) (2) and (4) of 
this section, the following copolymer and one or more of the listed 
adjuvants.

[[Page 40]]



------------------------------------------------------------------------
           Component                           Limitations
------------------------------------------------------------------------
Vinyl chloride-vinylidene        As an aqueous dispersion containing a
 chloride copolymer.              minimum of 75 percent water when
                                  applied.
Polyethylene glycol............  Complying with Sec.  172.820. As a
                                  defoamer and dispersing adjuvant.
Polyvinylpyrrolidone...........  As an adjuvant.
Potassium persulfate...........   Do.
Propylene glycol alginate......   Do.
Sodium decylbenzenesulfonate...   Do.
------------------------------------------------------------------------

    (4) In lieu of the components listed in paragraph (b) (2) and (3) of 
this section, the following rosin derivative and either or both of the 
listed adjuvants:

------------------------------------------------------------------------
           Component                           Limitations
------------------------------------------------------------------------
Calcium salt of partially        Having a maximum drop-softening point
 dimerized rosin.                 of 197 [deg]C and a color of H or
                                  paler. It is prepared by reaction with
                                  not more than 7 parts hydrated lime
                                  per 100 parts of partially dimerized
                                  rosin. The partially dimerized rosin
                                  is rosin that has been dimerized by
                                  sulfuric acid catalyst to a drop-
                                  softening point of 95 [deg]C to 105
                                  [deg]C and a color of WG or paler.
Petroleum naphtha..............  As adjuvant. Complying with Sec.
                                  172.250.
Sperm oil......................  As adjuvant.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 
FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 
1996]



Sec. 172.215  Coumarone-indene resin.

    The food additive coumarone-indene resin may be safely used on 
grapefruit, lemons, limes, oranges, tangelos, and tangerines in 
accordance with the following prescribed conditions:
    (a) The food additive is manufactured by the polymerization of a 
crude, heavy coal-tar solvent naphtha meeting the following 
specifications:
    (1) It is a mixture of indene, indan (hydrindene), substituted 
benzenes, and related compounds.
    (2) It contains no more than 0.25 percent tar bases.
    (3) 95 percent distills in the range 167 [deg]C-184 [deg]C.
    (b) The food additive meets the following specifications:
    (1) Softening point, ring and ball: 126 [deg]C minimum as determined 
by ASTM method E28-67 (Reapproved 1982), ``Standard Test Method for 
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Refractive index (n\25\/D) 1.63-1.64.
    (c) It is used or intended for use as a protective coating for 
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the 
maximum amount of the resin remaining on the fruit does not exceed 200 
parts per million on a fresh-weight basis.
    (d) To assure safe use of the additive:
    (1) The label of the market package or any intermediate premix of 
the additive shall bear, in addition to the other information required 
by the act:
    (i) The name of the additive, coumarone-indene resin.
    (ii) A statement of the concentration of the additive therein.
    (2) The label or accompanying labeling shall bear adequate 
directions that, if followed, will result in a finished food not in 
conflict with the requirements of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19, 1984]



Sec. 172.225  Methyl and ethyl esters of fatty acids produced from 
edible fats and oils.

    Methyl esters and ethyl esters of fatty acids produced from edible 
fats and oils may be safely used in food, subject to the following 
prescribed conditions:
    (a) The additive consists of a mixture of either methyl or ethyl 
esters of

[[Page 41]]

fatty acids produced from edible fats and oils and meets the following 
specifications:
    (1) Not less than 90 percent methyl or ethyl esters of fatty acids.
    (2) Not more than 1.5 percent unsaponifiable matter.
    (b) The additive is used or intended for use at the level not to 
exceed 3 percent by weight in an aqueous emulsion in dehydrating grapes 
to produce raisins, whereby the residue of the additive on the raisins 
does not exceed 200 parts per million.

[57 FR 12711, Apr. 13, 1992]



Sec. 172.230  Microcapsules for flavoring substances.

    Microcapsules may be safely used for encapsulating discrete 
particles of flavoring substances that are generally recognized as safe 
for their intended use or are regulated under this part, in accordance 
with the following conditions:
    (a) The microcapsules may be formulated from the following 
components, each used in the minimum quantity required to accomplish the 
intended effect:
    (1) Substances generally recognized as safe for the purpose.
    (2) One or more of the following components:

                        component and limitations

Succinylated gelatin--Not to exceed 15 percent by combined weight of the 
microcapsule and flavoring oil. Succinic acid content of the gelatin is 
4.5 to 5.5 percent.
Arabinogalactan--Complying with Sec. 172.610; as adjuvant.
Silicon dioxide--Complying with Sec. 172.480; as adjuvant.

    (3) In lieu of the components listed in paragraph (a)(2) of this 
section, the following components:

                        component and limitations

Glutaraldehyde--As cross-linking agent for insolubilizing a coacervate 
of gum arabic and gelatin.
n-Octyl alcohol--As a defoamer.

    (4) In lieu of the components listed in paragraphs (a)(2) and (3) of 
this section, the following component:

                        component and limitations

Petroleum wax--Complying with Sec. 172.886. Not to exceed 50 percent by 
combined weight of the microcapsule and spice-flavoring substance.

    (b) The microcapsules produced from the components listed in 
paragraphs (a) (1), (2), and (3) of this section may be used for 
encapsulating authorized flavoring oils for use, in accordance with good 
manufacturing practice, in foods for which standards of identity 
established under section 401 of the Act do not preclude such use, 
except that microcapsules formulated from components listed in paragraph 
(a)(2) of this section may be used only for encapsulating lemon oil, 
distilled lime oil, orange oil, peppermint oil, and spearmint oil for 
use in dry mixes for puddings and gelatin desserts.
    (c) The microcapsules produced from the components listed in 
paragraphs (a) (1) and (4) of this section may be used only for 
encapsulating authorized spice-flavoring substances for use, in 
accordance with good manufacturing practice, in frozen pizzas which are 
to be further processed by heat. Such pizzas shall bear labels or 
labeling including adequate directions for use to ensure heating to 
temperatures which will melt the wax to release the spice-flavoring 
substances.

[45 FR 48123, July 18, 1980]



Sec. 172.235  Morpholine.

    Morpholine may be safely used as a component of food, subject to the 
following restrictions.
    (a) It is used as the salt(s) of one or more of the fatty acids 
meeting the requirements of Sec. 172.860, as a component of protective 
coatings applied to fresh fruits and vegetables.
    (b) It is used at a level not in excess of that reasonably required 
to produce its intended effect.



Sec. 172.250  Petroleum naphtha.

    Petroleum naphtha may be safely used in food in accordance with the 
following conditions:
    (a) The additive is a mixture of liquid hydrocarbons, essentially 
paraffinic and naphthenic in nature obtained from petroleum,

[[Page 42]]

    (b) The additive is refined to meet the following specifications 
when subjected to the procedures described in this paragraph.
    (1) Boiling-point range: 175 [deg]F-300 [deg]F.
    (2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.
    (3) Ultraviolet absorbance limits, as follows:

------------------------------------------------------------------------
                                                                Maximum
                                                              absorbance
                                                                  per
                 Wavelength (milli-microns)                   centimeter
                                                                optical
                                                              pathlength
------------------------------------------------------------------------
280-289.....................................................        0.15
290-299.....................................................         .13
300-359.....................................................         .08
360-400.....................................................         .02
------------------------------------------------------------------------

             Analytical Specification for Petroleum Naphtha

                          general instructions

    All glassware should be scrupulously cleaned to remove all organic 
matter such as oil, grease, detergent residues, etc. Examine all 
glassware, including stoppers and stopcocks, under ultraviolet light to 
detect any residual fluorescent contamination. As a precautionary 
measure, it is recommended practice to rinse all glassware with purified 
isooctane immediately before use. No grease is to be used on stopcocks 
or joints. Great care to avoid contamination of petroleum naphtha 
samples in handling and to assure absence of any extraneous material 
arising from inadequate packaging is essential. Because some of the 
polynuclear hydrocarbons sought in this test are very susceptible to 
photo-oxidation, the entire procedure is to be carried out under subdued 
light.

                                apparatus

    Separatory funnels. 250-milliliter, and 2,000-milliliter capacity, 
equipped with tetrafluoroethylene polymer stopcocks.
    Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.
    Evaporation flask. 250-milliliter capacity all-glass flask equipped 
with 24/40 standard taper stopper having inlet and outlet tubes to 
permit passage of nitrogen across the surface of the container liquid to 
be evaporated.
    Condenser. 24/40 joints, fitted with drying tube, length optional.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5,000 centimeters 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1,000 centimeter 0.005 
centimeter. With distilled water in the cells, determine any absorbance 
difference.
    Spectrophotometer. Spectral range 250-400 m[mu] with spectral slit 
width of 2 m[mu] or less; under instrument operating conditions for 
these absorbance measurements, the spectrophotometer shall also meet the 
following performance requirements:

Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy, \1\ 0.05 at 0.4 absorbance.
---------------------------------------------------------------------------

    \1\ As determined by procedure using potassium chromate for 
reference standard and described in National Bureau of Standards 
Circular 484, Spectrophotometry, U.S. Department of Commerce, (1949). 
The accuracy is to be determined by comparison with the standard values 
at 290, 345, and 400 millimicrons. The procedure is incorporated by 
reference. Copies of the material incorporated by reference are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.

    Ultraviolet lamp. Long wavelength (3400-3800A[deg]).

                                reagents

    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a 250-
milliliter Erlenmeyer flask, add 1 milliliter of purified n-hexadecane, 
insert the head assembly, allow nitrogen gas to flow into the inlet tube 
and connect the outlet tube to a solvent trap and vacuum line in such a 
way as to prevent any back flow of condensate into the flask. The 
contents of the flask are evaporated on a steam bath until 1 milliliter 
of residue remains. Dissolve the 1 milliliter of hexadecane residue in 
isooctane and make up to 25 milliliters. Determine the absorbance in a 
5-centimeter path length cell compared to isooctane as reference. The 
absorbance should not exceed 0.01 per centimeter path length between 
280-400 m[mu]. If necessary, isooctane may be purified by passage 
through a column of activated silica gel (Grade 12, Davidson Chemical 
Co., Baltimore, Md., or equivalent) or by distillation.
    Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed 
as with isooctane. The absorbance per centimeter of path length should 
be 0.00 between 280-400 m[mu]. Methyl alcohol may be purified by simple 
distillation or by refluxing in the presence of potassium hydroxide (10 
grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours followed 
by distillation.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance

[[Page 43]]

in a 5-centimeter cell compared to isooctane as reference between 280-
400 m[mu]. The absorbance per centimeter path length shall not exceed 
0.00 in this range. Purify, if necessary, by percolation through 
activated silica gel or by distillation.
    Sodium borohydride. 98 percent.
    Water. All distilled water must be extracted with isooctane before 
use. A series of three successive extracts of 1.5 liters of distilled 
water with 100-milliliter portions of isooctane is satisfactory.

                                procedure

    Determination of ultraviolet absorbance. Add a 25-milliliter aliquot 
of the hydrocarbon solvent together with 1 milliliter of hexadecane to 
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen, 
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through 
a 81-milliliter outer-diameter tube, drawn out 
into a 21-centimeter long and 10.5-millimeter inner-diameter capillary tip. This is 
positioned so that the capillary tip extends 4 centimeters into the 
flask. The nitrogen flow rate is such that the surface of the liquid is 
barely disturbed. After the volume is reduced to that of the 1 
milliliter of hexadecane, the flask is left on the steam bath for 10 
more minutes before removing. Add 10 milliliters of purified isooctane 
to the flask and reevaporate the solution to a 1-milliliter volume in 
the same manner as described above, except do not heat for an added 10 
minutes. Repeat this operation twice more. Let the flask cool.
    Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium 
borohydride. (Minimize exposure of the borohydride to the atmosphere; a 
measuring dipper may be used.) Immediately fit a water-cooled condenser 
equipped with a 24/40 joint and with a drying tube into the flask, mix 
until the sodium borohydride is dissolved, and allow to stand for 30 
minutes at room temperature, with intermittent swirling. At the end of 
this time, disconnect the flask and evaporate the methyl alcohol on the 
steam bath under nitrogen until sodium borohydride begins to drop out of 
solution. Remove the flask and let it cool.
    Add 6 milliliters of isooctane to the flask and swirl to wash the 
crystalline slurry. Carefully transfer the isooctane extract to a 250-
milliliter separatory funnel. Dissolve the crystals in the flask with 
about 25 milliliters of distilled water and pour this also into the 
separatory funnel. Adjust the water volume in the separatory funnel to 
about 100 milliliters and shake for 1 minute. After separation of the 
layers, draw off the aqueous layer into a second 250-milliliter 
separatory funnel. Transfer the hydrocarbon layer in the first funnel to 
a 25-milliliter volumetric flask.
    Carefully wash the Erlenmeyer flask with an additional 6 milliliters 
of isooctane, swirl, and transfer to the second separatory funnel. Shake 
the funnel for 1 minute. After separation of the layers, draw off the 
aqueous layer into the first separatory funnel. Transfer the isooctane 
in the second funnel to the volumetric flask. Again wash the Erlenmeyer 
flask with an additional 6 milliliters of isooctane, swirl, and transfer 
to the first separatory funnel. Shake the funnel for 1 minute. After 
separation of the layers, draw off the aqueous layer and discard. 
Transfer the isooctane layer to the volumetric flask and adjust the 
volume to 25 milliliters of isooctane. Mix the contents well, then 
transfer to the first separatory funnel and wash twice with 50-
milliliter portions of distilled water. Discard the aqueous layers after 
each wash.
    Determine the ultraviolet absorbance of the isooctane extract in 5-
centimeter path length cells compared to isooctane as reference between 
280-400 m[mu]. Determine a reagent blank concurrently with the sample, 
using 25 milliliters of purified isooctane instead of a solvent sample 
and measuring the ultraviolet absorbance of the blank between 280-
400m[mu].
    The reagent blank absorbance should not exceed 0.04 per centimeter 
path length between 280-289 m[mu]; 0.020 between 290-359 m[mu]; and 
0.010 between 360-400 m[mu].
    Determination of boiling-point range. Use ASTM method D86-82, 
``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    Determination of nonvolatile residue. For hydrocarbons boiling below 
121 [deg]C, determine the nonvolatile residue by ASTM method D1353-78, 
``Standard Test Method for Nonvolatile Matter in Volatile Solvents for 
Use in Paint, Varnish, Lacquer, and Related Products;'' for those 
boiling above 121 [deg]C, use ASTM method D381-80, ``Standard Test 
Method for Existent Gum in Fuels by Jet Evaporation,'' which methods are 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

    (c) Petroleum naphtha containing antioxidants shall meet the 
specified ultraviolet absorbance limits after correction for any 
absorbance due to the antioxidants. Petroleum naphtha may contain 
antioxidants authorized for use in food in an amount not to exceed that 
reasonably required to accomplish

[[Page 44]]

the intended effect or to exceed any prescribed limitations.
    (d) Petroleum naphtha is used or intended for use as a solvent in 
protective coatings on fresh citrus fruit in compliance with Sec. 
172.210.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19, 1982; 
49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989]



Sec. 172.255  Polyacrylamide.

    Polyacrylamide containing not more than 0.2 percent of acrylamide 
monomer may be safely used as a film former in the imprinting of soft-
shell gelatin capsules when the amount used is not in excess of the 
minimum required to produce the intended effect.



Sec. 172.260  Oxidized polyethylene.

    Oxidized polyethylene may be safely used as a component of food, 
subject to the following restrictions:
    (a) Oxidized polyethylene is the basic resin produced by the mild 
air oxidation of polyethylene. The polyethylene used in the oxidation 
process conforms to the density, maximum n-hexane extractable fraction, 
and maximum xylene soluble fraction specifications prescribed in item 
2.3 of the table in Sec. 177.1520(c) of this chapter. The oxidized 
polyethylene has a minimum number average molecular weight of 1,200, as 
determined by high temperature vapor pressure osmometry; contains a 
maximum of 5 percent by weight of total oxygen; and has an acid value of 
9 to 19.
    (b) The additive is used or intended for use as a protective coating 
or component of protective coatings for fresh avocados, bananas, beets, 
coconuts, eggplant, garlic, grapefruit, lemons, limes, mango, 
muskmelons, onions, oranges, papaya, peas (in pods), pineapple, 
plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines, 
turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts, 
pecans, and walnuts (all nuts in shells).
    (c) The additive is used in accordance with good manufacturing 
practice and in an amount not to exceed that required to produce the 
intended effect.



Sec. 172.270  Sulfated butyl oleate.

    Sulfate butyl oleate may be safely used in food, subject to the 
following prescribed conditions:
    (a) The additive is prepared by sulfation, using concentrated 
sulfuric acid, of a mixture of butyl esters produced by 
transesterification of an edible vegetable oil using 1-butanol. 
Following sulfation, the reaction mixture is washed with water and 
neutralized with aqueous sodium or potassium hydroxide. Prior to 
sulfation, the butyl oleate reaction mixture meets the following 
specifications:
    (1) Not less than 90 percent butyl oleate.
    (2) Not more than 1.5 percent unsaponifiable matter.
    (b) The additive is used or intended for use at a level not to 
exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes 
to produce raisins, whereby the residue of the additive on the raisins 
does not exceed 100 parts per million.

[57 FR 12711, Apr. 13, 1992]



Sec. 172.275  Synthetic paraffin and succinic derivatives.

    Synthetic paraffin and succinic derivatives identified in this 
section may be safely used as a component of food, subject to the 
following restrictions:
    (a) The additive is prepared with 50 percent Fischer-Tropsch process 
synthetic paraffin, meeting the definition and specifications of Sec. 
172.615, and 50 percent of such synthetic paraffin to which is bonded 
succinic anhydride and succinic acid derivatives of isopropyl alcohol, 
polyethylene glycol, and polypropylene glycol. It consists of a mixture 
of the Fischer-Tropsch process paraffin (alkane), alkyl succinic 
anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl 
succinic anhydride polyethylene glycol half ester, and dialkyl succinic 
anhydride polypropylene glycol half ester, where the alkane (alkyl) has 
a chain length of 30-70 carbon atoms and the polyethylene and 
polypropylene glycols have molecular weights of 600 and 260, 
respectively.
    (b) The additive meets the following specifications: Molecular 
weight, 880-930; melting point, 215[deg]-217 [deg]F; acid

[[Page 45]]

number, 43-47; and saponification number, 75-78.
    (c) It is used or intended for use as a protective coating or 
component of protective coatings for fresh grapefruit, lemons, limes, 
muskmelons, oranges, sweetpotatoes, and tangerines.
    (d) It is used in an amount not to exceed that required to produce 
the intended effect.



Sec. 172.280  Terpene resin.

    The food additive terpene resin may be safely used in accordance 
with the following prescribed conditions:
    (a) The food additive is the betapinene polymer obtained by 
polymerizing terpene hydrocarbons derived from wood. It has a softening 
point of 112 [deg]C-118 [deg]C, as determined by ASTM method E28-67 
(Reapproved 1982), ``Standard Test Method for Softening Point By Ring-
and-Ball Apparatus,'' which is incorporated by reference. Copies may be 
obtained from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (b) It is used or intended for use as follows:
    (1) As a moisture barrier on soft gelatin capsules in an amount not 
to exceed 0.07 percent of the weight of the capsule.
    (2) As a moisture barrier on powders of ascorbic acid or its salts 
in an amount not to exceed 7 percent of the weight of the powder.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984]



           Subpart D_Special Dietary and Nutritional Additives



Sec. 172.310  Aluminum nicotinate.

    Aluminum nicotinate may be safely used as a source of niacin in 
foods for special dietary use. A statement of the concentration of the 
additive, expressed as niacin, shall appear on the label of the food 
additive container or on that of any intermediate premix prepared 
therefrom.



Sec. 172.315  Nicotinamide-ascorbic acid complex.

    Nicotinamide-ascorbic acid complex may be safely used in accordance 
with the following prescribed conditions:
    (a) The additive is the product of the controlled reaction between 
ascorbic acid and nicotinamide, melting in the range 141 [deg]C to 145 
[deg]C.
    (b) It is used as a source of ascorbic acid and nicotinamide in 
multivitamin preparations.



Sec. 172.320  Amino acids.

    The food additive amino acids may be safely used as nutrients added 
to foods in accordance with the following conditions:
    (a) The food additive consists of one or more of the following 
individual amino acids in the free, hydrated or anhydrous form or as the 
hydrochloride, sodium or potassium salts:

L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine

    (b) The food additive meets the following specifications:
    (1) As found in ``Food Chemicals Codex,'' National Academy of 
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), which is 
incorporated by reference (copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408) for the following:

L-Alanine
L-Arginine

[[Page 46]]

L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
DL-Methionine
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine

    (2) As found in ``Specifications and Criteria for Biochemical 
Compounds,'' NAS/NRC Publication, 3rd Ed. (1972), which is incorporated 
by reference (copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408) for the following:

L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine

    (c) The additive(s) is used or intended for use to significantly 
improve the biological quality of the total protein in a food containing 
naturally occurring primarily-intact protein that is considered a 
significant dietary protein source, provided that:
    (1) A reasonable daily adult intake of the finished food furnishes 
at least 6.5 grams of naturally occurring primarily intact protein 
(based upon 10 percent of the daily allowance for the ``reference'' 
adult male recommended by the National Academy of Sciences in 
``Recommended Dietary Allowances,'' NAS Publication No. 1694, 7th Ed. 
(1968), which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (2) The additive(s) results in a protein efficiency ratio (PER) of 
protein in the finished ready-to-eat food equivalent to casein as 
determined by the method specified in paragraph (d) of this section.
    (3) Each amino acid (or combination of the minimum number necessary 
to achieve a statistically significant increase) added results in a 
statistically significant increase in the PER as determined by the 
method described in paragraph (d) of this section. The minimum amount of 
the amino acid(s) to achieve the desired effect must be used and the 
increase in PER over the primarily-intact naturally occurring protein in 
the food must be substantiated as a statistically significant difference 
with at least a probability (P) value of less than 0.05.
    (4) The amount of the additive added for nutritive purposes plus the 
amount naturally present in free and combined (as protein) form does not 
exceed the following levels of amino acids expressed as percent by 
weight of the total protein of the finished food:

------------------------------------------------------------------------
                                                              Percent by
                                                               weight of
                                                                 total
                                                                protein
                                                              (expressed
                                                                as free
                                                                 amino
                                                                 acid)
------------------------------------------------------------------------
L-Alanine...................................................         6.1
L-Arginine..................................................         6.6
L-Aspartic acid (including L-asparagine)....................         7.0
L-Cystine (including L-cysteine)............................         2.3
L-Glutamic acid (including L-glutamine).....................        12.4
Aminoacetic acid (glycine)..................................         3.5
L-Histidine.................................................         2.4
L-Isoleucine................................................         6.6
L-Leucine...................................................         8.8
L-Lysine....................................................         6.4
L- and DL-Methionine........................................         3.1
L-Phenylalanine.............................................         5.8
L-Proline...................................................         4.2
L-Serine....................................................         8.4
L-Threonine.................................................         5.0
L-Tryptophan................................................         1.6
L-Tyrosine..................................................         4.3
L-Valine....................................................         7.4
------------------------------------------------------------------------

    (d) Compliance with the limitations concerning PER under paragraph 
(c) of this section shall be determined by the method described in 
sections 43.212-43.216, ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International,

[[Page 47]]

481 North Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408. Each manufacturer or 
person employing the additive(s) under the provisions of this section 
shall keep and maintain throughout the period of his use of the 
additive(s) and for a minimum of 3 years thereafter, records of the 
tests required by this paragraph and other records required to assure 
effectiveness and compliance with this regulation and shall make such 
records available upon request at all reasonable hours by any officer or 
employee of the Food and Drug Administration, or any other officer or 
employee acting on behalf of the Secretary of Health and Human Services 
and shall permit such officer or employee to conduct such inventories of 
raw and finished materials on hand as he deems necessary and otherwise 
to check the correctness of such records.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The name of the amino acid(s) contained therein including the 
specific optical and chemical form.
    (2) The amounts of each amino acid contained in any mixture.
    (3) Adequate directions for use to provide a finished food meeting 
the limitations prescribed by paragraph (c) of this section.
    (f) The food additive amino acids added as nutrients to special 
dietary foods that are intended for use solely under medical supervision 
to meet nutritional requirements in specific medical conditions and 
comply with the requirements of part 105 of this chapter are exempt from 
the limitations in paragraphs (c) and (d) of this section and may be 
used in such foods at levels not to exceed good manufacturing practices.

[42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
47 FR 11836, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, 
June 12, 1989; 59 FR 14550, Mar. 29, 1994; 61 FR 14480, Apr. 2, 1996]



Sec. 172.325  Bakers yeast protein.

    Bakers yeast protein may be safely used in food in accordance with 
the following conditions:
    (a) Bakers yeast protein is the insoluble proteinaceous material 
remaining after the mechanical rupture of yeast cells of Saccharomyces 
cerevisiae and removal of whole cell walls by centrifugation and 
separation of soluble cellular materials.
    (b) The additive meets the following specifications on a dry weight 
basis:
    (1) Zinc salts less than 500 parts per million (ppm) as zinc.
    (2) Nucleic acid less than 2 percent.
    (3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05 
ppm mercury, and 0.3 ppm selenium.
    (c) The viable microbial content of the finished ingredient is:
    (1) Less than 10,000 organisms/gram by aerobic plate count.
    (2) Less than 10 yeasts and molds/gram.
    (3) Negative for Salmonella, E. coli, coagulase positive 
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any 
other recognized microbial pathogen or any harmful microbial toxin.
    (d) The ingredient is used in food as a nutrient supplement as 
defined in Sec. 170.3(o)(20) of this chapter.



Sec. 172.330  Calcium pantothenate, calcium chloride double salt.

    The food additive calcium chloride double salt of calcium 
pantothenate may be safely used in foods for special dietary uses in 
accordance with good manufacturing practice and under the following 
prescribed conditions:
    (a) The food additive is of the d (dextrorotatory) or the dl 
(racemic) form.
    (b) To assure safe use of the additive, the label and labeling of 
the food additive container, or that of any intermediate premixes 
prepared therefrom, shall bear, in addition to the other information 
required by the Act, the following:
    (1) The name of the additive ``calcium chloride double salt of d-
calcium pantothenate'' or ``calcium chloride double salt of dl-calcium 
pantothenate'', whichever is appropriate.

[[Page 48]]

    (2) A statement of the appropriate concentration of the additive, 
expressed as pantothenic acid.



Sec. 172.335  D-Pantothenamide.

    The food additive D-pantothenamide as a source of pantothenic acid 
activity, may be safely used in foods for special dietary use in an 
amount not in excess of that reasonably required to produce its intended 
effect.



Sec. 172.340  Fish protein isolate.

    (a) The food additive fish protein isolate may be safely used as a 
food supplement in accordance with the following prescribed conditions:
    (1) The additive shall consist principally of dried fish protein 
prepared from the edible portions of fish after removal of the heads, 
fins, tails, bones, scales, viscera, and intestinal contents.
    (2) The additive shall be derived only from species of bony fish 
that are generally recognized by qualified scientists as safe for human 
consumption and that can be processed as prescribed to meet the required 
specifications.
    (3) Only wholesome fresh fish otherwise suitable for human 
consumption may be used. The fish shall be handled expeditiously under 
sanitary conditions. These conditions shall be in accordance with 
recognized good manufacturing practice for fish to be used as human 
food.
    (4) The additive shall be prepared by extraction with hexane and 
food-grade ethanol to remove fat and moisture. Solvent residues shall be 
reduced by drying.
    (b) The food additive meets the following specifications: (Where 
methods of determination are specified, they are Association of Official 
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by 
reference). \1\
---------------------------------------------------------------------------

    \1\ Copies are available from: Association of Official Analytical 
Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

    (1) Protein content, as N x 6.25, shall not be less than 90 percent 
by weight of the final product, as determined by the method described in 
section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20)--
Official Final Action.
    (2) Moisture content shall not be more than 10 percent by weight of 
the final product, as determined by the method described in section 
24.003, Air Drying (1)--Official First Action.
    (3) Fat content shall not be more than 0.5 percent by weight of the 
final product, as determined by the method described in section 24.005, 
Crude Fat or Ether Extract--Official Final Action.
    (4) Solvent residues in the final product shall not be more than 5 
parts per million of hexane and 3.5 percent ethanol by weight.

[46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26, 1982; 
54 FR 24897, June 12, 1989]



Sec. 172.345  Folic acid (folacin).

    Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, 
may be safely used in food as a nutrient in accordance with the 
following prescribed conditions:
    (a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
    (b) Folic acid meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 157-158, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, Box 285, 2101 Constitution 
Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.
    (c) Folic acid may be added to foods subject to a standard of 
identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act (the act) when the standard of identity specifically 
provides for the addition of folic acid.
    (d) Folic acid may be added, at levels not to exceed 400 micrograms 
([mu]g) per serving, to breakfast cereals, as defined under Sec. 
170.3(n)(4) of this chapter, and to corn grits at a level such that each

[[Page 49]]

pound of corn grits contains not more than 1.0 milligram of folic acid.
    (e) Folic acid may be added to infant formula in accordance with 
section 412(i)(1) of the act or with regulations issued under section 
412(i)(2) of the act which are codified in Sec. 107.100 of this 
chapter.
    (f) Folic acid may be added to a medical food, as defined in section 
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to 
exceed the amount necessary to meet the distinctive nutritional 
requirements of the disease or condition for which the food is 
formulated.
    (g) Folic acid may be added to food for special dietary use at 
levels not to exceed the amount necessary to meet the special dietary 
needs for which the food is formulated.
    (h) Folic acid may be added to foods represented as meal-replacement 
products, in amounts not to exceed:
    (1) Four hundred [mu]g per serving if the food is a meal-replacement 
that is represented for use once per day; or
    (2) Two hundred [mu]g per serving if the food is a meal-replacement 
that is represented for use more than once per day.

[61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 
FR 1758, Jan. 12, 1999]



Sec. 172.350  Fumaric acid and salts of fumaric acid.

    Fumaric acid and its calcium, ferrous, magnesium, potassium, and 
sodium salts may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additives meet the following specifications:
    (1) Fumaric acid contains a minimum of 99.5 percent by weight of 
fumaric acid, calculated on the anhydrous basis.
    (2) The calcium, magnesium, potassium, and sodium salts contain a 
minimum of 99 percent by weight of the respective salt, calculated on 
the anhydrous basis. Ferrous fumarate contains a minimum of 31.3 percent 
total iron and not more than 2 percent ferric iron.
    (b) With the exception of ferrous fumarate, fumaric acid and the 
named salts are used singly or in combination in food at a level not in 
excess of the amount reasonably required to accomplish the intended 
effect.
    (c) Ferrous fumarate is used as a source of iron in foods for 
special dietary use, when the use is consistent with good nutrition 
practice.



Sec. 172.365  Kelp.

    Kelp may be safely added to a food as a source of the essential 
mineral iodine, provided the maximum intake of the food as may be 
consumed during a period of one day, or as directed for use in the case 
of a dietary supplement, will not result in daily ingestion of the 
additive so as to provide a total amount of iodine in excess of 225 
micrograms for foods labeled without reference to age or physiological 
state; and when age or the conditions of pregnancy or lactation are 
specified, in excess of 45 micrograms for infants, 105 micrograms for 
children under 4 years of age, 225 micrograms for adults and children 4 
or more years of age, and 300 micrograms for pregnant or lactating 
women. The food additive kelp is the dehydrated, ground product prepared 
from Macrocystis pyrifera, Laminaria digitata, Laminaria saccharina, and 
Laminaria cloustoni.



Sec. 172.370  Iron-choline citrate complex.

    Iron-choline citrate complex made by reacting approximately 
equimolecular quantities of ferric hydroxide, choline, and citric acid 
may be safely used as a source of iron in foods for special dietary use.



Sec. 172.372  N-Acetyl-L-methionine.

    The food additive N-acetyl-L-methionine may be safely added to food 
(except infant foods and foods containing added nitrites/nitrates) as a 
source of L-methionine for use as a nutrient in accordance with the 
following conditions:
    (a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No. 
65-82-7) is the derivative of the amino acid methionine formed by 
addition of an acetyl group to the alpha-amino group of methionine. It 
may be in the free, hydrated or anhydrous form, or as the sodium or 
potassium salts.
    (b) The additive meets the following specifications:

[[Page 50]]

    (1) Purity assay, on a dry basis: Minimum 99 percent.
    (2) Residue on ignition: Maximum 0.1 percent.
    (3) Specific optical rotation [alpha]\20\D: Between -
19[deg] and -23[deg].
    (4) The additive may contain residues of not more than 500 ppm ethyl 
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm 
acetone, when used as processing solvents.
    (c) The additive is used or intended for use as a source of L-
methionine to improve significantly the biological quality of the total 
protein in a food containing naturally occurring primarily intact 
vegetable protein that is considered a significant dietary protein 
source, provided that:
    (1) A reasonable daily adult intake of the finished food furnishes 
at least 6.5 grams of naturally occurring primarily intact vegetable 
protein.
    (2) The additive results in a protein efficiency ratio (PER) of 
protein in the finished ready-to-eat food equivalent to casein as 
determined by the method specified in paragraph (d) of this section.
    (3) The use of the additive results in a statistically significant 
increase in the PER as determined by the method described in paragraph 
(d) of this section. The minimum amount of the additive to achieve the 
desired effect must be used, and the increase in PER over the primarily 
intact naturally occurring vegetable protein in the food must be 
substantiated as a statistically significant difference with at least a 
probability (P) value of less than 0.05.
    (4) The amount of the additive added for nutritive purpose shall not 
exceed the level that will provide a total of 3.1 percent L- and DL-
methionine (expressed as the free amino acid) by weight of the total 
protein of the finished food, including the amount naturally present in 
free and combined (as protein) form.
    (5) The additive shall not be added to infant foods or to foods 
containing added nitrites/nitrates.
    (d) Compliance with the limitations concerning PER under paragraph 
(c) of the section shall be determined by the method described in 
sections 43.212-43.216, ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 13th Ed. (1980), which is 
incorporated by reference. Copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408. Each manufacturer or person employing the additive 
under the provisions of this section shall keep and maintain throughout 
the period of use of the additive and for a minimum of 3 years 
thereafter, records of the tests required by this paragraph and other 
records required to assure effectiveness and compliance with this 
regulation. Those records shall be made available upon request at all 
reasonable hours by any officer or employee acting on behalf of the 
Secretary of Health and Human Services. Those officers or employees 
shall be permitted to conduct inventories of raw and finished materials 
on hand as are deemed necessary to verify the records.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The name of the additive contained therein.
    (2) The amounts of additive and each amino acid contained in any 
mixture.
    (3) Adequate directions for use to provide a finished food meeting 
the limitations prescribed by paragraph (c) of this section.
    (f) When the food additive is added as a nutrient to special dietary 
foods that are intended for use solely under medical supervision to meet 
nutritional requirements in specific medical conditions and these foods 
comply with the requirements of part 105 of this chapter, the food 
additive is exempt from the limitations in paragraphs (c)(1) through (4) 
and (d) of this section and may be used in those foods at levels not to 
exceed good manufacturing practices.

[43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981; 49 
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

[[Page 51]]



Sec. 172.375  Potassium iodide.

    The food additive potassium iodide may be safely used in accordance 
with the following prescribed conditions:
    (a) Potassium iodide may be safely added to a food as a source of 
the essential mineral iodine, provided the maximum intake of the food as 
may be consumed during a period of one day, or as directed for use in 
the case of a dietary supplement, will not result in daily ingestion of 
the additive so as to provide a total amount of iodine in excess of 225 
micrograms for foods labeled without reference to age or physiological 
state; and when age or the conditions of pregnancy or lactation are 
specified, in excess of 45 micrograms for infants, 105 micrograms for 
children under 4 years of age, 225 micrograms for adults and children 4 
or more years of age, and 300 micrograms for pregnant or lactating 
women.
    (b) To assure safe use of the additive, in addition to the other 
information required by the Act, the label of the additive shall bear:
    (1) The name of the additive.
    (2) A statement of the concentration of the additive in any mixture.



Sec. 172.380  Vitamin D3.

    The food additive may be used safely in foods as a nutrient 
supplement defined under Sec. 170.3(o)(20) of this chapter in 
accordance with the following prescribed conditions:
    (a) Vitamin D3, also known as cholecalciferol, is the 
chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Vitamin 
D3 occurs in and is isolated from fish liver oils. It also is 
manufactured by ultraviolet irradiation of 7-dehydrocholesterol produced 
from cholesterol and is purified by crystallization.
    (b) Vitamin D3 meets the specifications of the Food 
Chemicals Codex, 4\th\ ed. (1996), p. 434, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. You may obtain copies from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418 (Internet address http://
www.nap.edu. Copies may be examined at the Center for Food Safety and 
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) Vitamin D3 may be added, at levels not to exceed 100 
International Units (IU) per serving, to 100 percent fruit juices, as 
defined under Sec. 170.3(n)(35) of this chapter, excluding fruit juices 
that are specially formulated or processed for infants, that are 
fortified with greater than 33 percent of the Recommended Daily Intake 
(RDI) of calcium per Reference Amount Customarily Consumed (RACC).
    (d) Vitamin D3 may be added, at levels not to exceed 100 
IU per serving, to fruit drinks, as defined under Sec. 170.3(n)(35) of 
this chapter, excluding fruit drinks that are specially formulated or 
processed for infants, that are fortified with greater than 10 percent 
of the RDI of calcium per RACC.

[68 FR 9003, Feb. 27, 2003]



Sec. 172.385  Whole fish protein concentrate.

    The food additive whole fish protein concentrate may be safely used 
as a food supplement in accordance with the following prescribed 
conditions:
    (a) The additive is derived from whole, wholesome hake and hakelike 
fish, herring of the genera Clupea, menhaden, and anchovy of the species 
Engraulis mordax, handled expeditiously and under sanitary conditions in 
accordance with good manufacturing practices recognized as proper for 
fish that are used in other forms for human food.
    (b) The additive consists essentially of a dried fish protein 
processed from the whole fish without removal of heads, fins, tails, 
viscera, or intestinal contents. It is prepared by solvent extraction of 
fat and moisture with isopropyl alcohol or with ethylene dichloride 
followed by isopropyl alcohol, except that the additive derived from 
herring, menhaden and anchovy is prepared by solvent extraction with 
isopropyl alcohol alone. Solvent residues are reduced by conventional 
heat drying and/or microwave radiation and there is a partial removal of 
bone.
    (c) The food additive meets the following specifications:

[[Page 52]]

    (1) Protein content (N x 6.25) shall not be less than 75 percent by 
weight of the final product, as determined by the method described in 
section 2.057 in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists'' (AOAC), 13th Ed. (1980). Protein quality 
shall not be less than 100, as determined by the method described in 
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by 
reference, and copies may be obtained from the Association of Official 
Analytical Chemists International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2504, or may be examined at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.
    (2) Moisture content shall not exceed 10 percent by weight of the 
final product, as determined by the method described in section 24.003 
of the AOAC. See paragraph (c)(1) of this section for availability of 
the material incorporated by reference.
    (3) Fat content shall not exceed 0.5 percent by weight of the final 
product, as determined by the method described in section 24.005 of the 
AOAC. See paragraph (c)(1) of the this section for availability of the 
material incorporated by reference.
    (4) The additive may contain residues of isopropyl alcohol and 
ethylene dichloride not in excess of 250 parts per million and 5 parts 
per million, respectively, when used as solvents in the extraction 
process.
    (5) Microwave radiation meeting the requirements of Sec. 179.30 of 
this chapter may be used to reduce residues of the solvents used in the 
extraction process.
    (6) The additive shall contain not in excess of 100 parts per 
million fluorides (expressed as F).
    (7) The additive shall be free of Escherichia coli and pathogenic 
organisms, including Salmonella, and shall have a total bacterial plate 
count of not more than 10,000 per gram.
    (8) The additive shall have no more than a faint characteristic fish 
odor and taste.
    (d) When the additive is used or intended for use in the household 
as a protein supplement in food for regular consumption by children up 
to 8 years of age, the amount of the additive from this source shall not 
exceed 20 grams per day (about one heaping tablespoon).
    (e) When the additive is used as a protein supplement in 
manufactured food, the total fluoride content (expressed as F) of the 
finished food shall not exceed 8 ppm based on the dry weight of the food 
product.
    (f) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of consumer-sized or bulk containers of the additive 
shall bear the name ``whole fish protein concentrate''.
    (2) The label or labeling of containers of the additive shall bear 
adequate directions for use to comply with the limitations prescribed by 
paragraphs (d) and (e) of this section.
    (3) Labels of manufactured foods containing the additive shall bear, 
in the ingredient statement, the name of the additive, ``whole fish 
protein concentrate'' in the proper order of decreasing predominance in 
the finished food.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19, 1984; 
54 FR 24897, June 12, 1989]



Sec. 172.395  Xylitol.

    Xylitol may be safely used in foods for special dietary uses, 
provided the amount used is not greater than that required to produce 
its intended effect.



Sec. 172.399  Zinc methionine sulfate.

    Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used 
in accordance with the following prescribed conditions:
    (a) The additive is the product of the reaction between equimolar 
amounts of zinc sulfate and DL-methionine in purified water.
    (b) The additive meets the following specifications:

Zinc content--19 to 22 percent.
C5H11NO2S ``DL-methionine''--46 to 50 
percent.
Cadmium--not more than 0.05 part per million.

    (c) The additive is used in tablet form as a source of dietary zinc.

[46 FR 58297, Dec. 1, 1981]

[[Page 53]]



                       Subpart E_Anticaking Agents



Sec. 172.410  Calcium silicate.

    Calcium silicate, including synthetic calcium silicate, may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) It is used as an anticaking agent in food in an amount not in 
excess of that reasonably required to produce its intended effect.
    (b) It will not exceed 2 percent by weight of the food, except that 
it may be present up to 5 percent by weight of baking powder.



Sec. 172.430  Iron ammonium citrate.

    Iron ammonium citrate may be safely used in food in accordance with 
the following prescribed conditions:
    (a) The additive is the chemical green ferric ammonium citrate.
    (b) The additive is used, or intended for use as an anticaking agent 
in salt for human consumption so that the level of iron ammonium citrate 
does not exceed 25 parts per million (0.0025 percent) in the finished 
salt.
    (c) To assure safe use of the additive the label or labeling of the 
additive shall bear, in addition to the other information required by 
the Act:
    (1) The name of the additive.
    (2) Adequate directions to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.



Sec. 172.480  Silicon dioxide.

    The food additive silicon dioxide may be safely used in food in 
accordance with the following conditions:
    (a) The food additive is manufactured by vapor phase hydrolysis or 
by other means whereby the particle size is such as to accomplish the 
intended effect.
    (b) It is used as an anticaking agent, subject to the following 
conditions:
    (1) It is used in only those foods in which the additive has been 
demonstrated to have an anticaking effect.
    (2) It is used in an amount not in excess of that reasonably 
required to produce its intended effect.
    (3) [Reserved]
    (4) It is used in an amount not to exceed 2 percent by weight of the 
food.
    (c) It is used or intended for use as a stabilizer in the production 
of beer, and is removed from the beer by filtration prior to final 
processing.
    (d) It is used or intended for use as an adsorbent for dl-a-
tocopheryl acetate and pantothenyl alcohol in tableted foods for special 
dietary use, in an amount not greater than that required to accomplish 
the intended physical or technical effect.



Sec. 172.490  Yellow prussiate of soda.

    (a) The food additive yellow prussiate of soda (sodium ferrocyanide 
decahydrate; Na4Fe(CN)6[middot]10H2O 
contains a minimum of 99 percent by weight of sodium ferrocyanide 
decahydrate.
    (b) The additive is used or intended for use as an anticaking agent 
in salt and as an adjuvant in the production of dendritic crystals of 
salt in an amount needed to produce its intended effect but not in 
excess of 13 parts per million calculated as anhydrous sodium 
ferrocyanide.

[42 FR 14491, Mar. 15, 1977, as amended at 58 FR 17098, Apr. 1, 1993]



            Subpart F_Flavoring Agents and Related Substances



Sec. 172.510  Natural flavoring substances and natural substances 
used in conjunction with flavors.

    Natural flavoring substances and natural adjuvants may be safely 
used in food in accordance with the following conditions.
    (a) They are used in the minimum quantity required to produce their 
intended physical or technical effect and in accordance with all the 
principles of good manufacturing practice.
    (b) In the appropriate forms (plant parts, fluid and solid extracts, 
concretes, absolutes, oils, gums, balsams, resins, oleoresins, waxes, 
and distillates) they consist of one or more of the following, used 
alone or in combination with flavoring substances and adjuvants 
generally recognized as safe in food, previously sanctioned for such 
use, or regulated in any section of this part.

[[Page 54]]



----------------------------------------------------------------------------------------------------------------
                   Common name                            Scientific name                  Limitations
----------------------------------------------------------------------------------------------------------------
Aloe.............................................  Aloe perryi Baker, A.
                                                    barbadensis Mill., A. ferox
                                                    Mill., and hybrids of this
                                                    sp. with A. africana Mill.
                                                    and A. spicata Baker.
Althea root and flowers..........................  Althea officinalis L........
Amyris (West Indian sandalwood)..................  Amyris balsamifera L........
Angola weed......................................  Roccella fuciformis Ach.....  In alcoholic beverages only
Arnica flowers...................................  Arnica montana L., A.          Do.
                                                    fulgens Pursh, A. sororia
                                                    Greene, or A. cordifolia
                                                    Hooker.
Artemisia (wormwood).............................  Artemisia spp...............  Finished food thujone free\1\
Artichoke leaves.................................  Cynara scolymus L...........  In alcoholic beverages only
Benzoin resin....................................  Styrax benzoin Dryander, S.
                                                    paralleloneurus Perkins, S.
                                                    tonkinensis (Pierre) Craib
                                                    ex Hartwich, or other spp.
                                                    of the Section Anthostyrax
                                                    of the genus Styrax.
Blackberry bark..................................  Rubus, Section Eubatus......
Boldus (boldo) leaves............................  Peumus boldus Mol...........   Do.
Boronia flowers..................................  Boronia megastigma Nees.....
Bryonia root.....................................  Bryonia alba L., or B.         Do.
                                                    diocia Jacq.
Buchu leaves.....................................  Barosma betulina Bartl. et
                                                    Wendl., B. crenulata (L.)
                                                    Hook. or B. serratifolia
                                                    Willd.
Buckbean leaves..................................  Menyanthes trifoliata L.....   Do.
Cajeput..........................................  Melaleuca leucadendron L.
                                                    and other Melaleuca spp.
Calumba root.....................................  Jateorhiza palmata (Lam.)      Do.
                                                    Miers.
Camphor tree.....................................  Cinnamomum camphora (L.)      Safrole free
                                                    Nees et Eberm.
Cascara sagrada..................................  Rhamnus purshiana DC........
Cassie flowers...................................  Acacia farnesiana (L.) Willd
Castor oil.......................................  Ricinus communis L..........
Catechu, black...................................  Acacia catechu Willd........
Cedar, white (aborvitae), leaves and twigs.......  Thuja occidentalis L........  Finished food thujone free\1\
Centuary.........................................  Centaurium umbellatum Gilib.  In alcoholic beverages only
Cherry pits......................................  Prunus avium L. or P.         Not to exceed 25 p.p.m. prussic
                                                    cerasus L.                    acid
Cherry-laurel leaves.............................  Prunus laurocerasus L.......   Do.
Chestnut leaves..................................  Castanea dentata (Marsh.)
                                                    Borkh.
Chirata..........................................  Swertia chirata Buch.-Ham...  In alcoholic beverages only
Cinchona, red, bark..............................  Cinchona succirubra Pav. or   In beverages only; not more
                                                    its hybrids.                  than 83 p.p.m. total cinchona
                                                                                  alkaloids in finished beverage
Cinchona, yellow, bark...........................  Cinchona ledgeriana Moens,     Do.
                                                    C. calisaya Wedd., or
                                                    hybrids of these with other
                                                    spp. of Cinchona..
Copaiba..........................................  South American spp. of
                                                    Copaifera L.
Cork, oak........................................  Quercus suber L., or Q.       In alcoholic beverages only
                                                    occidentalis F. Gay.
Costmary.........................................  Chrysanthemum balsamita L...   Do.
Costus root......................................  Saussurea lappa Clarke......
Cubeb............................................  Piper cubeba L. f...........
Currant, black, buds and leaves..................  Ribes nigrum L..............
Damiana leaves...................................  Turnera diffusa Willd.......
Davana...........................................  Artemisia pallens Wall......
Dill, Indian.....................................  Anethum sowa Roxb.
                                                    (Peucedanum graveolens
                                                    Benth et Hook., Anethum
                                                    graveolens L.).
Dittany (fraxinella) roots.......................  Dictamnus albus L...........   Do.
Dittany of Crete.................................  Origanum dictamnus L........
Dragon's blood (dracorubin)......................  Daemonorops spp.............
Elder tree leaves................................  Sambucus nigra L............  In alcoholic beverages only;
                                                                                  not to exceed 25 p.p.m.
                                                                                  prussic acid in the flavor
Elecampane rhizome and roots.....................  Inula helenium L............  In alcoholic beverages only
Elemi............................................  Canarium commune L. or C.
                                                    luzonicum Miq.
Erigeron.........................................  Erigeron canadensis L.......
Eucalyptus globulus leaves.......................  Eucalyptus globulus Labill..
Fir (``pine'') needles and twigs.................  Abies sibirica Ledeb., A.
                                                    alba Mill., A. sachalinesis
                                                    Masters or A. mayriana
                                                    Miyabe et Kudo.
Fir, balsam, needles and twigs...................  Abies balsamea (L.) Mill....
Galanga, greater.................................  Alpinia galanga Willd.......   Do.

[[Page 55]]

 
Galbanum.........................................  Ferula galbaniflua Boiss. et
                                                    Buhse and other Ferula spp.
Gambir (catechu, pale)...........................  Uncaria gambir Roxb.........
Genet flowers....................................  Spartium junceum L..........
Gentian rhizome and roots........................  Gentiana lutea L............
Gentian, stemless................................  Gentiana acaulis L..........   Do.
Germander, chamaedrys............................  Teucrium chamaedrys L.......   Do.
Germander, golden................................  Teucrium polium L...........   Do.
Guaiac...........................................  Guaiacum officinale L., G.
                                                    santum L., Bulnesia
                                                    sarmienti Lor.
Guarana..........................................  Paullinia cupana HBK........
Haw, black, bark.................................  Viburnum prunifolium L......
Hemlock needles and twigs........................  Tsuga canadensis (L.) Carr.
                                                    or T. heterophylla (Raf.)
                                                    Sarg.
Hyacinth flowers.................................  Hyacinthus orientalis L.....
Iceland moss.....................................  Cetraria islandica Ach......   Do.
Imperatoria......................................  Peucedanum ostruthium (L.).
                                                    Koch (Imperatoria
                                                    ostruthium L.).
Iva..............................................  Achillea moschata Jacq......   Do.
Labdanum.........................................  Cistus spp..................
Lemon-verbena....................................  Lippia citriodora HBK.......   Do.
Linaloe wood.....................................  Bursera delpechiana Poiss.
                                                    and other Bursera spp.
Linden leaves....................................  Tillia spp..................   Do.
Lovage...........................................  Levisticum officinale Koch..
Lungmoss (lungwort)..............................  Sticta pulmonacea Ach.......
Maidenhair fern..................................  Adiantum capillus-veneris L.   Do.
Maple, mountain..................................  Acer spicatum Lam...........
Mimosa (black wattle) flowers....................  Acacia decurrens Willd. var.
                                                    dealbata.
Mullein flowers..................................  Verbascum phlomoides L. or     Do.
                                                    V. thapsiforme Schrad.
Myrrh............................................  Commiphora molmol Engl., C.
                                                    abyssinica (Berg) Engl., or
                                                    other Commiphora spp.
Myrtle leaves....................................  Myrtus communis L...........   Do.
Oak, English, wood...............................  Quercus robur L.............   Do.
Oak, white, chips................................  Quercus alba L..............
Oak moss.........................................  Evernia prunastri (L.) Ach.,  Finished food thujone
                                                    E. furfuracea (L.) Mann,
                                                    and other lichens.
Olibanum.........................................  Boswellia carteri Birdw. and
                                                    other Boswellia spp.
Opopanax (bisabolmyrrh)..........................  Opopanax chironium Koch
                                                    (true opopanax) of
                                                    Commiphora erythraea Engl.
                                                    var. Llabrescens.
Orris root.......................................  Iris germanica L. (including
                                                    its variety florentina
                                                    Dykes) and I. pallida Lam.
Pansy............................................  Viola tricolor L............  In alcoholic beverages only
Passion flower...................................  Passiflora incarnata L......
Patchouly........................................  Pogostemon cablin Benth. and
                                                    P. heyneanus Benth.
Peach leaves.....................................  Prunus persica (L.) Batsch..  In alcoholic beverages only;
                                                                                  not to exceed 25 p.p.m.
                                                                                  prussic acid in the flavor
Pennyroyal, American.............................  Hedeoma pulegioides (L.)
                                                    Pers.
Pennyroyal, European.............................  Mentha pulegium L...........
Pine, dwarf, needles and twigs...................  Pinus mugo Turra var.
                                                    pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs..................  Pinus sylvestris L..........
Pine, white, bark................................  Pinus strobus L.............  In alcoholic beverages only
Pine, white oil..................................  Pinus palustris Mill., and
                                                    other Pinus spp.
Poplar buds......................................  Populus balsamifera L. (P.     Do.
                                                    tacamahacca Mill.), P.
                                                    candicans Ait., or P. nigra
                                                    L.
Quassia..........................................  Picrasma excelsa (Sw.)
                                                    Planch, or Quassia amara L.
Quebracho bark...................................  Aspidosperma quebracho-       Schinopsis lorentzii (Griseb.)
                                                    blanco Schlecht, or           Engl.
                                                    (Quebrachia lorentzii
                                                    (Griseb)).
Quillaia (soapbark)..............................  Quillaja saponaria Mol......
Red saunders (red sandalwood)....................  Pterocarpus san alinus L....  In alcoholic beverages only
Rhatany root.....................................  Krameria triandra Ruiz et
                                                    Pav. or K. argentea Mart.
Rhubarb, garden root.............................  Rheum rhaponticum L.........   Do.
Rhubarb root.....................................  Rheum officinale Baill., R.
                                                    palmatum L., or other spp.
                                                    (excepting R. rhaponticum
                                                    L.) or hybrids of Rheum
                                                    grown in China.
Roselle..........................................  Hibiscus sabdariffa L.......   Do.
Rosin (colophony)................................  Pinus palustris Mill., and     Do.
                                                    other Pinus spp.
St. Johnswort leaves, flowers, and caulis........  Hypericum perforatum L......  Hypericin-free alcohol
                                                                                  distillate form only; in
                                                                                  alcoholic beverages only

[[Page 56]]

 
Sandalwood, white (yellow, or East Indian).......  Santalum album L............
Sandarac.........................................  Tetraclinis articulata        In alcoholic beverages only
                                                    (Vahl.), Mast.
Sarsaparilla.....................................  Smilax aristolochiaefolia
                                                    Mill., (Mexican
                                                    sarsaparilla), S. regelii
                                                    Killip et Morton (Honduras
                                                    sarsaparilla), S. febrifuga
                                                    Kunth (Ecuadorean
                                                    sarsaparilla), or
                                                    undetermined Smilax spp.
                                                    (Ecuadorean or Central
                                                    American sarsaparilla).
Sassafras leaves.................................  Sassafras albidum (Nutt.)     Safrole free
                                                    Nees.
Senna, Alexandria................................  Cassia acutifolia Delile....
Serpentaria (Virginia snakeroot).................  Aristolochia serpentaria L..  In alcoholic beverages only
Simaruba bark....................................  Simaruba amara Aubl.........   Do.
Snakeroot, Canadian (wild ginger)................  Asarum canadense L..........
Spruce needles and twigs.........................  Picea glauca (Moench) Voss
                                                    or P. mariana (Mill.) BSP.
Storax (styrax)..................................  Liquidambar orientalis Mill.
                                                    or L. styraciflua L.
Tagetes (marigold)...............................  Tagetes patula L., T. erecta  As oil only
                                                    L., or T. minuta L. (T.
                                                    glandulifera Schrank).
Tansy............................................  Tanacetum vulgare L.........  In alcoholic beverages only;
                                                                                  finished alcoholic beverage
                                                                                  thujone free\1\
Thistle, blessed (holy thistle)..................  Onicus benedictus L.........  In alcoholic beverages only
Thymus capitatus (Spanish ``origanum'')..........  Thymus capitatus Hoffmg. et
                                                    Link.
Tolu.............................................  Myroxylon balsamum (L.)
                                                    Harms.
Turpentine.......................................  Pinus palustris Mill. and
                                                    other Pinus spp. which
                                                    yield terpene oils
                                                    exclusively.
Valerian rhizome and roots.......................  Valeriana officinalis L.....
Veronica.........................................  Veronica officinalis L......   Do.
Vervain, European................................  Verbena officinalis L.......   Do.
Vetiver..........................................  Vetiveria zizanioides Stapf.   Do.
Violet, Swiss....................................  Viola calcarata L...........
Walnut husks (hulls), leaves, and green nuts.....  Juglans nigra L. or J. regia
                                                    L.
Woodruff, sweet..................................  Asperula odorata L..........  In alcoholic beverages only
Yarrow...........................................  Achillea millefolium L......  In beverages only; finished
                                                                                  beverage thujone free\1\
Yerba santa......................................  Eriodictyon californicum
                                                    (Hook, et Arn.) Torr.
Yucca, Joshua-tree...............................  Yucca brevifolia Engelm.....
Yucca, Mohave....................................  Yucca schidigera Roezl ex
                                                    Ortgies (Y. mohavensis
                                                    Sarg.).
----------------------------------------------------------------------------------------------------------------
\1\ As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in
  section 9.129 of the ``Official Methods of Analysis of the Association of Official Analytical Chemists,'' 13th
  Ed. (1980), which is incorporated by reference. Copies may be obtained from the Association of Official
  Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
  examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408


[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.515  Synthetic flavoring substances and adjuvants.

    Synthetic flavoring substances and adjuvants may be safely used in 
food in accordance with the following conditions.
    (a) They are used in the minimum quantity required to produce their 
intended effect, and otherwise in accordance with all the principles of 
good manufacturing practice.
    (b) They consist of one or more of the following, used alone or in 
combination with flavoring substances and adjuvants generally recognized 
as safe in food, prior-sanctioned for such use, or regulated by an 
appropriate section in this part.

Acetal; acetaldehyde diethyl acetal.
Acetaldehyde phenethyl propyl acetal.
Acetanisole; 4'-methoxyacetophenone.
Acetophenone; methyl phenyl ketone.
Allyl anthranilate.
Allyl butyrate.
Allyl cinnamate.
Allyl cyclohexaneacetate.
Allyl cyclohexanebutyrate.
Allyl cyclohexanehexanoate.
Allyl cyclohexaneproprionate.
Allyl cyclohexanevalerate.
Allyl disulfide.

[[Page 57]]

Allyl 2-ethylbutyrate.
Allyl hexanoate; allyl caproate.
Allyl [alpha]-ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-1,6-
heptadiene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
[alpha]-Amylcinnamaldehyde.
[alpha]-Amylcinnamaldehyde dimethyl acetal.
[alpha]-Amylcinnamyl acetate.
[alpha]-Amylcinnamyl alcohol.
[alpha]-Amylcinnamyl formate.
[alpha]-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzophenone; diphenylketone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; [alpha]-toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl [beta]-methoxyethyl 
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
[beta]-Bourbonene; 1,2,3,3a,3b[beta],4,5,6,6a[beta],6b[alpha]-deca-
hydro-l[alpha]-isopropyl-3aa-methyl-6-methylene-cyclobuta 
[1,2:3,4] dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
[alpha]-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
[beta]-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
[beta]-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-oxatricylo 
[8.2.0.04, 6] dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.

[[Page 58]]

Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit ronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
[gamma]-Decalactone; 4-hydroxy-decanoic acid, [gamma]-lactone.
[gamma]-Decalactone; 5-hydroxy-decanoic acid, [delta]-lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl-[gamma]-butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid, 
[gamma]-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
[alpha],[alpha]-Dimethylbenzyl isobutyrate; phenyldi methylcarbinyl 
isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
[alpha],[alpha]-Dimethylphenethyl acetate; benzylpropyl acetate; 
benzyldimethylcarbinyl acetate.
[alpha],[alpha]-Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
[alpha],[alpha]-Dimethylphenethyl butyrate; benzyldimethylcarbinyl 
butyrate.
[alpha],[alpha]-Dimethylphenethyl formate; benzyldi methylcarbinyl 
formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
[gamma]-Dodecalactone; 4-hydroxydodecanoic acid [gamma]-lactone.
2-Dodecenal.
Estragole.
[rho]-Ethoxybenzaldehyde.
Ethyl acetoacetate.
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl [rho]-anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
[alpha]-Ethylbenzyl butyrate; [alpha]-phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol diester; 
cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.
Ethyl heptanoate.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein.
Ethyl hexanoate.
Ethyl isobutyrate.
Ethyl isovalerate.
Ethyl lactate.
Ethyl laurate.
Ethyl levulinate.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4-one.
Ethyl 2-methylbutyrate.
Ethyl myristate.
Ethyl nitrite.
Ethyl nonanoate.
Ethyl 2-nonynoate; ethyl octyne carbonate.
Ethyl octanoate.
Ethyl oleate.
Ethyl phenylacetate.
Ethyl 4-phenylbutyrate.

[[Page 59]]

Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Eugenyl methyl ether; 4-allylveratrole; methyl eugenol.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl 
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; [mu]-methoxyphenol.
Guaiacyl acetate; [mu]-methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl-[Delta]9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-([alpha]-hydroxy-isopropyl)-[delta]9,10-
octahydroazulene acetate.
[gamma]-Heptalactone; 4-hydroxyheptanoic acid, [gamma]-lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
[omega]-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, [omega]-
lactone; ambrettolide.
[gamma]-Hexalactone; 4-hydroxyhexanoic acid, [gamma]-lactone; tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
[alpha]-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellal; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hy dro xy ben zyl acetone.
Indole.
[alpha]-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
[beta]-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
[alpha]-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-yl)-3-buten-2-one; 
6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; [alpha]-isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; [alpha]-isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.

[[Page 60]]

Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
[alpha]-Isobutylphenethyl alcohol; isobutyl benzyl carbinol; 4-methyl-1-
phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and 2-hexyl-2-
cyclopenten-1-one.
[alpha]-Isomethylionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-methyl-
3-buten-2-one; methyl [gamma]-ionone.
Isopropyl acetate.
[rho]-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
[rho]-Isopropylbenzyl alcohol; cuminic alcohol; [rho]-cymen-7-ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
[rho]-Isopropylphenylacetaldehyde; [rho]-cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-([rho]-Isopropylphenyl)-propionaldehyde; [rho]-
isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-
methylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.
Menthadienol; p-mentha-1,8(10)-dien-9-ol.
p-Mentha-1,8-dien-7-ol; perillyl alcohol.
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p-menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p-Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl 
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; [alpha]-methylanisylidene acetone; 
ethone.
1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
[alpha]-Methylbenzyl acetate; styralyl acetate.
[alpha]-Methylbenzyl alcohol; styralyl alcohol.
[alpha]-Methylbenzyl butyrate; styralyl butyrate.
[alpha]-Methylbenzyl isobutyrate; styralyl isobutyrate.
[alpha]-Methylbenzyl formate; styralyl formate.

[[Page 61]]

[alpha]-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
[alpha]-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methyl cy clo pen tane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in Sec. 
172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl [alpha]-ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [beta]-ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-penten-3-
one.
Methyl [Delta]-ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-penten-
3-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde; [alpha]-methyl-p-
isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl-3-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl [beta]-naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
[beta]-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl 
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; [alpha]-isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myrcene; 7-methyl-3-methylene-1,6-octadiene.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
[gamma]-Nonalactone; 4-hydroxynonanoic acid, [gamma]-lactone; aldehyde 
C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.
Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo[4,4,0]-dec-1-en-3-one.
Ocimene; trans-[beta]-ocimene; 3,7-dimethyl-1,3,6-octatriene.
[gamma]-Octalactone; 4-hydroxyoctanoic acid, [gamma]-lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.

[[Page 62]]

Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
[omega]-Pentadecalactone; 15-hydroxypentadeca-noic acid, [omega]-
lactone; pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;p-mentha-
1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
[alpha]-Phellandrene; [rho]-mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; [beta]-phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; [alpha]-toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; [alpha]-toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde dimethyl 
acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
[alpha]-Pinene; 2-pinene.
[beta]-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
[alpha]-Propylphenethyl alcohol.
Propyl phenylacetate.
Propyl propionate.
Pulegone; p-menth-4(8)-en-3-one.
Pyridine.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol, [alpha] and [beta].
Santalyl acetate.
Santalyl phenylacetate.

[[Page 63]]

Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
[alpha]-Terpinene.
[gamma]-Terpinene.
[alpha]-Terpineol; p-menth-1-en-8-ol.
[beta]-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of 5-ethyl-2,3,4,5-tetramethyl-
2-cyclohexen-1-one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methyl benzy la ce tone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methyl hy dra tro pic al de hyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
[gamma]-Undecalactone; 4-hydroxyundecanoic acid [gamma]-lactone; peach 
aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.

    (c) [Delta]-Decalactone and [Delta]-dodecalactone when used 
separately or in combination in oleomargarine are used at levels not to 
exceed 10 parts per million and 20 parts per million, respectively, in 
accordance with Sec. 166.110 of this chapter.
    (d) BHA (butylated hydroxyanisole) may be used as an antioxidant in 
flavoring substances whereby the additive does not exceed 0.5 percent of 
the essential (volatile) oil content of the flavoring substance.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977; 43 
FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June 25, 
1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49 FR 
5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, 
1989; 61 FR 14245, Apr. 1, 1996]



Sec. 172.520  Cocoa with dioctyl sodium sulfosuccinate for manufacturing.

    The food additive ``cocoa with dioctyl sodium sulfosuccinate for 
manufacturing,'' conforming to Sec. 163.117 of this chapter and Sec. 
172.810, is used or intended for use as a flavoring substance in dry 
beverage mixes whereby the amount of dioctyl sodium sulfosuccinate does 
not exceed 75 parts per million of the finished beverage. The labeling 
of the dry beverage mix shall bear adequate directions to assure use in 
compliance with this section.



Sec. 172.530  Disodium guanylate.

    Disodium guanylate may be safely used as a flavor enhancer in foods, 
at a level not in excess of that reasonably required to produce the 
intended effect.



Sec. 172.535  Disodium inosinate.

    The food additive disodium inosinate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the disodium salt of inosinic acid, 
manufactured and purified so as to contain no more than 150 parts per 
million of soluble barium in the compound disodium inosinate with seven 
and one-half molecules of water of crystallization.
    (b) The food additive is used as a flavoring adjuvant in food.



Sec. 172.540  DL-Alanine.

    DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-
72-7) may be safely used as a flavor enhancer for sweeteners in pickling 
mixtures at a level not to exceed 1 percent of the

[[Page 64]]

pickling spice that is added to the pickling brine.

[56 FR 6968, Feb. 21, 1991]



Sec. 172.560  Modified hop extract.

    The food additive modified hop extract may be safely used in beer in 
accordance with the following prescribed conditions:
    (a) The food additive is used or intended for use as a flavoring 
agent in the brewing of beer.
    (b) The food additive is manufactured by one of the following 
processes:
    (1) The additive is manufactured from a hexane extract of hops by 
simultaneous isomerization and selective reduction in an alkaline 
aqueous medium with sodium borohydride, whereby the additive meets the 
following specifications:
    (i) A solution of the food additive solids is made up in 
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n 
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show 
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This 
absorbance is obtained by approximately 0.03 milligram solids 
permilliliter.) The ultraviolet absorption spectrum of this solution 
exhibits the following characteristics: An absorption peak at 253 
millimicrons; no absorption peak at 325 to 330 millimicrons; the 
absorbance at 268 millimicrons does not exceed the absorbance at 272 
millimicrons.
    (ii) The boron content of the food additive does not exceed 310 
parts per million (0.0310 percent), calculated as boron.
    (2) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using benzene, light petroleum spirits, 
and methyl alcohol as solvents, followed by isomerization by potassium 
carbonate treatment. Residues of solvents in the modified hop extract 
shall not exceed 1.0 part per million of benzene, 1.0 part per million 
of light petroleum spirits, and 250 parts per million of methyl alcohol. 
The light petroleum spirits and benzene solvents shall comply with the 
specifications in Sec. 172.250 except that the boiling point range for 
light petroleum spirits is 150 [deg]F-300 [deg]F.
    (3) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using methylene chloride, hexane, and 
methyl alcohol as solvents, followed by isomerization by sodium 
hydroxide treatment. Residues of the solvents in the modified hop 
extract shall not exceed 5 parts per million of methylene chloride, 25 
parts per million of hexane, and 100 parts per million of methyl 
alcohol.
    (4) The additive is manufactured from hops by a sequence of 
extractions and fractionations, using benzene, light petroleum spirits, 
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed 
by isomerization by potassium carbonate treatment. Residues of solvents 
in the modified hop extract shall not exceed 1.0 part per million of 
benzene, 1.0 part per million of light petroleum spirits, 50 parts per 
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and 
1 part per million of ethyl acetate. The light petroleum spirits and 
benzene solvents shall comply with the specifications in Sec. 172.250 
except that the boiling point range for light petroleum spirits is 150 
[deg]F to 300 [deg]F.
    (5) The additive is manufactured from hops by an initial extraction 
and fractionation using one or more of the following solvents: Ethylene 
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene 
chloride, trichloroethylene, and water; followed by isomerization by 
calcium chloride or magnesium chloride treatment in ethylene dichloride, 
methylene chloride, or trichloroethylene and a further sequence of 
extractions and fractionations using one or more of the solvents set 
forth in this paragraph. Residues of the solvents in the modified hop 
extract shall not exceed 125 parts per million of hexane; 150 parts per 
million of ethylene dichloride, methylene chloride, or 
trichloroethylene; or 250 parts per million of isopropyl alcohol or 
methyl alcohol.
    (6) The additive is manufactured from hops by an initial extraction 
and fractionation using one or more of the solvents listed in paragraph 
(b)(5) of this section followed by: Hydrogenation using palladium as a 
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol 
acidified with hydrochloric or sulfuric acid; oxidation with

[[Page 65]]

peracetic acid; isomerization by calcium chloride or magnesium chloride 
treatment in ethylene dichloride, methylene chloride, or 
trichloroethylene (alternatively, the hydrogenation and isomerization 
steps may be performed in reverse order); and a further sequence of 
extractions and fractionations using one or more of the solvents listed 
in paragraph (b)(5) of this section. The additive shall meet the residue 
limitations as prescribed in paragraph (b)(5) of this section.
    (7) The additive is manufactured from hops as set forth in paragraph 
(b)(6) of this section followed by reduction with sodium borohydride in 
aqueous alkaline methyl alcohol, and a sequence of extractions and 
fractionations using one or more of the solvents listed in paragraph 
(b)(5) of this section. The additive shall meet the residue limitations 
as prescribed in paragraph (b)(5) of this section, and a boron content 
level not in excess of 300 parts per million (0.0300 percent), 
calculated as boron.
    (8) The additive is manufactured from hops as a nonisomerizable 
nonvolatile hop resin by an initial extraction and fractionation using 
one or more of the solvents listed in paragraph (b)(5) of this section 
followed by a sequence of aqueous extractions and removal of nonaqueous 
solvents to less than 0.5 percent. The additive is added to the wort 
before or during cooking in the manufacture of beer.



Sec. 172.575  Quinine.

    Quinine, as the hydrochloride salt or sulfate salt, may be safely 
used in food in accordance with the following conditions:

------------------------------------------------------------------------
                  Uses                              Limitations
------------------------------------------------------------------------
In carbonated beverages as a flavor.....  Not to exceed 83 parts per
                                           million, as quinine. Label
                                           shall bear a prominent
                                           declaration of the presence
                                           of quinine either by the use
                                           of the word ``quinine'' in
                                           the name of the article or
                                           through a separate
                                           declaration.
------------------------------------------------------------------------



Sec. 172.580  Safrole-free extract of sassafras.

    The food additive safrole-free extract of sassafras may be safely 
used in accordance with the following prescribed conditions:
    (a) The additive is the aqueous extract obtained from the root bark 
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
    (b) It is obtained by extracting the bark with dilute alcohol, first 
concentrating the alcoholic solution by vacuum distillation, then 
diluting the concentrate with water and discarding the oily fraction.
    (c) The purified aqueous extract is safrole-free.
    (d) It is used as a flavoring in food.



Sec. 172.585  Sugar beet extract flavor base.

    Sugar beet extract flavor base may be safely used in food in 
accordance with the provisions of this section.
    (a) Sugar beet extract flavor base is the concentrated residue of 
soluble sugar beet extractives from which sugar and glutamic acid have 
been recovered, and which has been subjected to ion exchange to minimize 
the concentration of naturally occurring trace minerals.
    (b) It is used as a flavor in food.



Sec. 172.590  Yeast-malt sprout extract.

    Yeast-malt sprout extract, as described in this section, may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The additive is produced by partial hydrolysis of yeast extract 
(derived from Saccharomyces cereviseae, Saccharomyces fragilis, or 
Candida utilis) using the sprout portion of malt barley as the source of 
enzymes. The additive contains a maximum of 6 percent 5' nucleotides by 
weight.
    (b) The additive may be used as a flavor enhancer in food at a level 
not in excess of that reasonably required to produce the intended 
effect.



        Subpart G_Gums, Chewing Gum Bases and Related Substances



Sec. 172.610  Arabinogalactan.

    Arabinogalactan may be safely used in food in accordance with the 
following conditions:
    (a) Arabinogalactan is a polysaccharide extracted by water from 
Western larch wood, having galactose units and arabinose units in the 
approximate ratio of six to one.

[[Page 66]]

    (b) It is used in the following foods in the minimum quantity 
required to produce its intended effect as an emulsifier, stabilizer, 
binder, or bodying agent: Essential oils, nonnutritive sweeteners, 
flavor bases, nonstandardized dressings, and pudding mixes.



Sec. 172.615  Chewing gum base.

    The food additive chewing gum base may be safely used in the 
manufacture of chewing gum in accordance with the following prescribed 
conditions:
    (a) The food additive consists of one or more of the following 
substances that meet the specifications and limitations prescribed in 
this paragraph, used in amounts not to exceed those required to produce 
the intended physical or other technical effect.

                         Masticatory Substances
    natural (coagulated or concentrated latices) of vegetable origin
------------------------------------------------------------------------
             Family                         Genus and species
------------------------------------------------------------------------
Sapotaceae:
  Chicle.......................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.
  Chiquibul....................  Manilkara zapotilla Gilly.
  Crown gum....................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.
  Gutta hang kang..............  Palaquium leiocarpum Boerl. and
                                  Palaquium oblongifolium Burck.
  Massaranduba balata (and the   Manilkara huberi (Ducke) Chevalier.
   solvent-free resin extract
   of Massaranduba balata).
  Massaranduba chocolate.......  Manilkara solimoesensis Gilly.
  Nispero......................  Manilkara zapotilla Gilly and Manilkara
                                  chicle Gilly.
  Rosidinha (rosadinha)........  Micropholis (also known as Sideroxylon)
                                  spp.
  Venezuelan chicle............  Manilkara williamsii Standley and
                                  related spp.
Apocynaceae:
  Jelutong.....................  Dyera costulata Hook, F. and Dyera
                                  lowii Hook, F.
  Leche caspi (sorva)..........  Couma macrocarpa Barb. Rodr.
  Pendare......................  Couma macrocarpa Barb. Rodr. and Couma
                                  utilis (Mart.) Muell. Arg.
  Perillo......................  Couma macrocarpa Barb. Rodr. and Couma
                                  utilis (Mart.) Muell. Arg.
Moraceae:
  Leche de vaca................  Brosimum utile (H.B.K.) Pittier and
                                  Poulsenia spp.; also Lacmellea
                                  standleyi (Woodson), Monachino
                                  (Apocynaceae).
  Niger gutta..................  Ficus platyphylla Del.
  Tunu (tuno)..................  Castilla fallax Cook.
Euphorbiaceae:
  Chilte.......................  Cnidoscolus (also known as Jatropha)
                                  elasticus Lundell and Cnidoscolus
                                  tepiquensis (Cost. and Gall.) McVaugh.
  Natural rubber (smoked sheet   Hevea brasiliensis.
   and latex solids).
--------------------------------
                        Synthetic Specifications
------------------------------------------------------------------------
  Butadiene-styrene rubber.....  Basic polymer.
  Isobutylene-isoprene            Do.
   copolymer (butyl rubber).
Paraffin.......................  Synthesized by Fischer-Tropsch process
                                  from carbon monoxide and hydrogen
                                  which are catalytically converted to a
                                  mixture of paraffin hydrocarbon. Lower
                                  molecular weight fractions are removed
                                  by distillation. The residue is
                                  hydrogenated and further treated by
                                  percolation through activated
                                  charcoal. The product has a congealing
                                  point of 93[deg]-99 [deg]C as
                                  determined by ASTM method D938-71
                                  (Reapproved 1981), ``Standard Test
                                  Method for Congealing Point of
                                  Petroleum Waxes, Including
                                  Petrolatum,'' a maximum oil content of
                                  0.5 percent as determined by ASTM
                                  method D721-56T, ``Tentative Method of
                                  Test for Oil Content of Petroleum
                                  Waxes,'' and an absorptivity of less
                                  than 0.01 at 290 millimicrons in
                                  decahydronaphthalene at 88 [deg]C as
                                  determined by ASTM method D2008-80,
                                  ``Standard Test Method for Ultraviolet
                                  Absorbance and Absorptivity of
                                  Petroleum Products,'' which are
                                  incorporated by reference. Copies may
                                  be obtained from the American Society
                                  for Testing Materials, 1916 Race St.,
                                  Philadelphia, PA 19103, or may be
                                  examined at the Office of the Federal
                                  Register, 800 North Capitol Street,
                                  NW., suite 700, Washington, DC 20408.
  Petroleum wax................  Complying with Sec.  172.886.
  Petroleum wax synthetic......  Complying with Sec.  172.888.
  Polyethylene.................  Molecular weight 2,000-21,000.
  Polyisobutylene..............  Minimum molecular weight 37,000
                                  (Flory).
  Polyvinyl acetate............  Molecular weight, minimum 2,000.
--------------------------------

[[Page 67]]

 
                   Plasticizing Materials (Softeners)
------------------------------------------------------------------------
Glycerol ester of partially      Having an acid number of 3-8, a minimum
 dimerized rosin.                 drop-softening point of 109 [deg]C,
                                  and a color of M or paler.
Glycerol ester of partially      Having an acid number of 3-10, a
 hydrogenated gum or wood rosin.  minimum drop-softening point of 79
                                  [deg]C, and a color of N or paler.
Glycerol ester of polymerized    Having an acid number of 3-12, a
 rosin.                           minimum melting-point of 80 [deg]C,
                                  and a color of M or paler.
Glycerol ester of gum rosin....  Having an acid number of 5-9, a minimum
                                  drop-softening point of 88 [deg]C, and
                                  a color of N or paler. The ester is
                                  purified by steam stripping.
Glycerol ester of tall oil       Having an acid number of 2-12, a
 rosin.                           softening point (ring and ball) of
                                  80[deg]-88 [deg]C, and a color of N or
                                  paler. The ester is purified by steam
                                  stripping.
Glycerol ester of wood rosin...  Having an acid number of 3-9, a drop-
                                  softening point of 88 [deg]C-96
                                  [deg]C, and a color of N or paler. The
                                  ester is purified by steam stripping.
Lanolin........................  .......................................
Methyl ester of rosin,           Having an acid number of 4-8, a
 partially hydrogenated.          refractive index of 1.5170-1.5205 at
                                  20 [deg]C, and a viscosity of 23-66
                                  poises at 25 [deg]C. The ester is
                                  purified by steam stripping.
Pentaerythritol ester of         Having an acid number of 7-18, a
 partially hydrogenated gum or    minimum drop-softening point of 102
 wood rosin.                      [deg]C, and a color of K or paler.
Pentaerythritol ester of gum or  Having an acid number of 6-16, a
 wood rosin.                      minimum drop-softening point of 109
                                  [deg]C, and a color of M or paler.
Rice bran wax..................  Complying with Sec.  172.890.
Stearic acid...................  Complying with Sec.  172.860.
Sodium and potassium stearates.  Complying with Sec.  172.863.
--------------------------------
                             Terpene Resins
------------------------------------------------------------------------
Synthetic resin................  Consisting of polymers of
                                  [alpha]pinene, [beta]pinene, and/or
                                  dipentene; acid value less than 5,
                                  saponification number less than 5, and
                                  color less than 4 on the Gardner scale
                                  as measured in 50 percent mineral
                                  spirit solution.
Natural resin..................  Consisting of polymers of [alpha]-
                                  pinene; softening point minimum 155
                                  [deg]C, determined by U.S.P. closed-
                                  capillary method, United States
                                  Pharmacopeia XX (1980) (page 961).
--------------------------------
                              Antioxidants
------------------------------------------------------------------------
Butylated hydroxyanisole.......  Not to exceed antioxidant content of
                                  0.1% when used alone or in any
                                  combination.
Butylated hydroxytoluene.......   Do.
Propyl gallate.................   Do.
--------------------------------
                              Miscellaneous
------------------------------------------------------------------------
Sodium sulfate.................  .......................................
Sodium sulfide.................  Reaction-control agent in synthetic
                                  polymer production.
------------------------------------------------------------------------

    (b) In addition to the substances listed in paragraph (a) of this 
section, chewing gum base may also include substances generally 
recognized as safe in food.
    (c) To assure safe use of the additive, in addition to the other 
information required by the act, the label and labeling of the food 
additive shall bear the name of the additive, ``chewing gum base.'' As 
used in this paragraph, the term ``chewing gum base'' means the 
manufactured or partially manufactured nonnutritive masticatory 
substance comprised of one or more of the ingredients named and so 
defined in paragraph (a) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980; 
49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July 
23, 2001; 66 FR 53711, Oct. 24, 2001]



Sec. 172.620  Carrageenan.

    The food additive carrageenan may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the refined hydrocolloid prepared by 
aqueous extraction from the following members of

[[Page 68]]

the families Gigartinaceae and Solieriaceae of the class Rodophyceae 
(red seaweed):

Chondrus crispus.
Chondrus ocellatus.
Eucheuma cottonii.
Eucheuma spinosum.
Gigartina acicularis.
Gigartina pistillata.
Gigartina radula.
Gigartina stellata.

    (b) The food additive conforms to the following conditions:
    (1) It is a sulfated polysaccharide the dominant hexose units of 
which are galactose and anhydrogalactose.
    (2) Range of sulfate content: 20 percent to 40 percent on a dry-
weight basis.
    (c) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the additive, carrageenan.



Sec. 172.623  Carrageenan with polysorbate 80.

    Carrageenan otherwise meeting the definition and specifications of 
Sec. 172.620 (a) and (b) and salts of carrageenan otherwise meeting the 
definition of Sec. 172.626(a) may be safely produced with the use of 
polysorbate 80 meeting the specifications and requirements of Sec. 
172.840 (a) and (b) in accordance with the following prescribed 
conditions:
    (a) The polysorbate 80 is used only to facilitate separation of 
sheeted carrageenan and salts of carrageenan from drying rolls.
    (b) The carrageenan and salts of carrageenan contain not more than 5 
percent by weight of polysorbate 80, and the final food containing the 
additives contains polysorbate 80 in an amount not to exceed 500 parts 
per million.
    (c) The carrageenan and salts of carrageenan so produced are used 
only in producing foods in gel form and only for the purposes defined in 
Sec. Sec. 172.620(c) and 172.626(b), respectively.
    (d) The carrageenan and salts of carrageenan so produced are not 
used in foods for which standards of identity exist unless the standards 
provide for the use of carrageenan, or salts of carrageenan, combined 
with polysorbate 80.
    (e) The carrageenan and salts of carrageenan produced in accordance 
with this section, and foods containing the same, in addition to the 
other requirements of the Act, are labeled to show the presence of 
polysorbate 80, and the label or labeling of the carrageenan and salts 
of carrageenan so produced bear adequate directions for use.



Sec. 172.626  Salts of carrageenan.

    The food additive salts of carrageenan may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive consists of carrageenan, meeting the 
provisions of Sec. 172.620, modified by increasing the concentration of 
one of the naturally occurring salts (ammonium, calcium, potassium, or 
sodium) of carrageenan to the level that it is the dominant salt in the 
additive.
    (b) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the salt of carrageenan that 
dominates the mixture by reason of the modification, e.g., ``sodium 
carrageenan'', ``potassium carrageenan'', etc.



Sec. 172.655  Furcelleran.

    The food additive furcelleran may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the refined hydrocolloid prepared by 
aqueous extraction of furcellaria fastigiata of the class Rodophyceae 
(red seaweed).
    (b) The food additive conforms to the following:
    (1) It is a sulfated polysaccharide the dominant hexose units of 
which are galactose and anhydrogalactose.
    (2) Range of sulfate content: 8 percent to 19 percent, on a dry-
weight basis.
    (c) The food additive is used or intended for use in the amount 
necessary

[[Page 69]]

for an emulsifier, stabilizer, or thickener in foods, except for those 
standardized foods that do not provide for such use.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the additive, furcelleran.



Sec. 172.660  Salts of furcelleran.

    The food additive salts of furcelleran may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive consists of furcelleran, meeting the 
provisions of Sec. 172.655, modified by increasing the concentration of 
one of the naturally occurring salts (ammonium, calcium, potassium, or 
sodium) of furcelleran to the level that it is the dominant salt in the 
additive.
    (b) The food additive is used or intended for use in the amount 
necessary for an emulsifier, stabilizer, or thickener in foods, except 
for those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label and labeling of 
the additive shall bear the name of the salt of furcelleran that 
dominates the mixture by reason of the modification, e.g., ``sodium 
furcelleran'', ``potassium furcelleran'', etc.



Sec. 172.665  Gellan gum.

    The food additive gellan gum may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The additive is a high molecular weight polysaccharide gum 
produced from Pseudomonas elodea by a pure culture fermentation process 
and purified by recovery with isopropyl alcohol. It is composed of 
tetrasaccharide repeat units, each containing one molecule of rhamnose 
and glucuronic acid, and two molecules of glucose. The glucuronic acid 
is neutralized to a mixed potassium, sodium, calcium, and magnesium 
salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups 
as the O-glycosidically linked esters.
    (b) The strain of P. elodea is nonpathogenic and nontoxic in man and 
animals.
    (c) The additive is produced by a process that renders it free of 
viable cells of P. elodea.
    (d) The additive meets the following specifications:
    (1) Positive for gellan gum when subjected to the following 
identification tests:
    (i) A 1-percent solution is made by hydrating 1 gram of gellan gum 
in 99 milliliters of distilled water. The mixture is stirred for about 2 
hours, using a motorized stirrer and a propeller-type stirring blade. A 
small amount of the above solution is drawn into a wide bore pipet and 
transferred into a solution of 10-percent calcium chloride. A tough 
worm-like gel will form instantly.
    (ii) To the 1-percent distilled water solution prepared for 
identification test (i), 0.50 gram of sodium chloride is added. The 
solution is heated to 80 [deg]C with stirring, held at 80 [deg]C for 1 
minute, and allowed to cool to room temperature without stirring. A firm 
gel will form.
    (2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as 
determined by the procedure described in the Xanthan Gum monograph, the 
``Food Chemicals Codex,'' 4th ed. (1996), pp. 437-438, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the National Academy Press, Box 285, 
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address 
http://www.nap.edu), or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (e) The additive is used or intended for use in accordance with 
current good manufacturing practice as a stabilizer and thickener as 
defined in Sec. 170.3(o)(28) of this chapter. The additive may be used 
in foods where standards of identity established under section 401 of 
the Federal Food, Drug, and Cosmetic Act do not preclude such use.
    (f) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to other 
information required by the Federal Food, Drug,

[[Page 70]]

and Cosmetic Act, the name of the additive and the designation ``food 
grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.

[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992; 
64 FR 1758, Jan. 12, 1999]



Sec. 172.695  Xanthan gum.

    The food additive xanthan gum may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The additive is a polysaccharide gum derived from Xanthomonas 
campestris by a pure-culture fermentation process and purified by 
recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and 
D-glucuronic acid as the dominant hexose units and is manufactured as 
the sodium, potassium, or calcium salt.
    (b) The strain of Xanthomonas campestris is nonpathogenic and 
nontoxic in man or other animals.
    (c) The additive is produced by a process that renders it free of 
viable cells of Xanthomonas campestris.
    (d) The additive meets the following specifications:
    (1) Residual isopropyl alcohol not to exceed 750 parts per million.
    (2) An aqueous solution containing 1 percent of the additive and 1 
percent of potassium chloride stirred for 2 hours has a minimum 
viscosity of 600 centipoises at 75 [deg]F, as determined by Brookfield 
Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60 
r.p.m., and the ratio of viscosities at 75 [deg]F and 150 [deg]F is in 
the range of 1.02 to 1.45.
    (3) Positive for xanthan gum when subjected to the following 
procedure:

                        Locust Bean Gum Gel Test

    Blend on a weighing paper or in a weighing pan 1.0 gram of powdered 
locust bean gum with 1.0 gram of the powdered polysaccharide to be 
tested. Add the blend slowly (approximately \1/2\ minute) at the point 
of maximum agitation to a stirred solution of 200 milliliters of 
distilled water previously heated to 80 [deg]C in a 400-milliliter 
beaker. Continue mechanical stirring until the mixture is in solution, 
but stir for a minimum time of 30 minutes. Do not allow the water 
temperature to drop below 60 [deg]C.
    Set the beaker and its contents aside to cool in the absence of 
agitation. Allow a minimum time of 2 hours for cooling. Examine the 
cooled beaker contents for a firm rubbery gel formation after the 
temperature drops below 40 [deg]C.
    In the event that a gel is obtained, make up a 1 percent solution of 
the polysaccharide to be tested in 200 milliliters of distilled water 
previously heated to 80 [deg]C (omit the locust bean gum). Allow the 
solution to cool without agitation as before. Formation of a gel on 
cooling indicates that the sample is a gelling polysaccharide and not 
xanthan gum.
    Record the sample as ``positive'' for xanthan gum if a firm, rubbery 
gel forms in the presence of locust bean gum but not in its absence. 
Record the sample as ``negative'' for xanthan gum if no gel forms or if 
a soft or brittle gel forms both with locust bean gum and in a 1 percent 
solution of the sample (containing no locust bean gum).

    (4) Positive for xanthan gum when subjected to the following 
procedure:

                            Pyruvic Acid Test

    Pipet 10 milliliters of an 0.6 percent solution of the 
polysaccharide in distilled water (60 milligrams of water-soluble gum) 
into a 50-milliliter flask equipped with a standard taper glass joint. 
Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux 
the mixture for 3 hours. Take precautions to avoid loss of vapor during 
the refluxing. Cool the solution to room temperature. Add distilled 
water to make up any weight loss from the flask contents.
    Pipet 1 milliliter of a 2,4-dinitro phenyl hydrazine reagent (0.5 
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel 
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum) 
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to 
stand at room temperature for 5 minutes. Extract the mixture with 5 
milliliters of ethyl acetate. Discard the aqueous layer.
    Extract the hydrazone from the ethyl acetate with three 5 milliliter 
portions of 10 percent sodium carbonate solution. Dilute the combined 
sodium carbonate extracts to 100 milliliters with additional 10 percent 
sodium carbonate in a 10-milliliter volumetric flask. Measure the 
optical density of the sodium carbonate solution at 375 millimicrons.
    Compare the results with a curve of the optical density versus 
concentration of an authentic sample of pyruvic acid that has been run 
through the procedure starting with the preparation of the hydrazone.
    Record the percent by weight of pyruvic acid in the test 
polysaccharide. Note ``positive'' for xanthan gum if the sample contains 
more than 1.5 percent of pyruvic acid and ``negative'' for xanthan gum 
if the sample

[[Page 71]]

contains less than 1.5 percent of pyruvic acid by weight.

    (e) The additive is used or intended for use in accordance with good 
manufacturing practice as a stabilizer, emulsifier, thickener, 
suspending agent, bodying agent, or foam enhancer in foods for which 
standards of identity established under section 401 of the Act do not 
preclude such use.
    (f) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to other 
information required by the Act, the name of the additive and the 
designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



                Subpart H_Other Specific Usage Additives



Sec. 172.710  Adjuvants for pesticide use dilutions.

    The following surfactants and related adjuvants may be safely added 
to pesticide use dilutions by a grower or applicant prior to application 
to the growing crop:

    n-Alkyl (C8-C18) amine acetate, where the 
alkyl groups (C8-C18) are derived from coconut 
oil, as a surfactant in emulsifier blends at levels not in excess of 5 
percent by weight of the emulsifier blends that are added to herbicides 
for application to corn and sorghum.
    Di-n-alkyl (C8-C18) dimethyl ammonium 
chloride, where the alkyl groups (C8-C18) are 
derived from coconut oil, as surfactants in emulsifier blends at levels 
not in excess of 5 percent by weight of emulsifier blends that are added 
to herbicides for application to corn or sorghum.
    Diethanolamide condensate based on a mixture of saturated and 
unsaturated soybean oil fatty acids (C16-C18) as a 
surfactant in emulsifier blends that are added to the herbicide atrazine 
for application to corn.
    Diethanolamide condensate based on stripped coconut fatty acids 
(C10 C18) as a surfactant in emulsifier blends 
that are added to the herbicide atrazine for application to corn.
    [alpha]-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced 
by the condensation of 1 mole of dodecylphenol (dodecyl group is a 
proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of 
ethylene oxide; if a blend of products is used, the average number of 
moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70.
    Ethylene dichloride.
    Polyglyceryl phthalate ester of coconut oil fatty acids.
    [alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles 
of ethylene oxide; if a blend of products is used, the average number of 
moles of ethylene oxide reacted to produce any product that is a 
component of the blend shall be in the range of 4-14 or 30-70.
    [alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene oxide.
    Sodium acrylate and acrylamide copolymer with a minimum average 
molecular weight of 10,000,000 in which 30 percent of the polymer is 
comprised of acrylate units and 70 percent acrylamide units, for use as 
a drift control agent in herbicide formulations applied to crops at a 
level not to exceed 0.5 ounces of the additive per acre.



Sec. 172.712  1,3-Butylene glycol.

    The food additive 1,3-butylene glycol (CAS Reg. No. 107-88-0) may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) It is prepared by the aldol condensation of acetaldehyde 
followed by catalytic hydrogenation.
    (b) The food additive shall conform to the identity and 
specifications listed in the monograph entitled ``1,3-Butylene Glycol'' 
in the Food Chemicals Codex, 4th ed. (1996), p. 52, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Office of Premarket Approval, 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) It is used in the manufacture of sausage casings as a 
formulation aid as defined in Sec. 170.3(o)(14) of this chapter and as 
a processing aid as defined in Sec. 170.3(o)(24) of this chapter.

[62 FR 26228, May 13, 1997]

[[Page 72]]



Sec. 172.715  Calcium lignosulfonate.

    Calcium lignosulfonate may be safely used in or on food, subject to 
the provisions of this section.
    (a) Calcium lignosulfonate consists of sulfonated lignin, primarily 
as calcium and sodium salts.
    (b) It is used in an amount not to exceed that reasonably required 
to accomplish the intended physical or technical effect when added as a 
dispersing agent and stabilizer in pesticides for preharvest or 
postharvest application to bananas.



Sec. 172.720  Calcium lactobionate.

    The food additive calcium lactobionate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is the calcium salt of lactobionic acid (4-
([beta],D-galactosido)-D-gluconic acid) produced by the oxidation of 
lactose.
    (b) It is used or intended for use as a firming agent in dry pudding 
mixes at a level not greater than that required to accomplish the 
intended effect.



Sec. 172.723  Epoxidized soybean oil.

    Epoxidized soybean oil may be safely used in accordance with the 
following prescribed conditions:
    (a) The additive is prepared by reacting soybean oil in toluene with 
hydrogen peroxide and formic acid.
    (b) It meets the following specifications:
    (1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 
8.0 percent, as determined by the American Oil Chemists' Society 
(A.O.C.S.) method Cd 9-57, ``Oxirane Oxygen,'' reapproved 1989, which is 
incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR 
part 51. Copies are available from the American Oil Chemists' Society, 
P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the 
Division of Petition Control (HFS-215), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., 
suite 1200, Washington, DC, or at the Office of the Federal Register, 
800 North Capitol St. NW., suite 700, Washington, DC.
    (2) The maximum iodine value is 3.0, as determined by A.O.C.S. 
method Cd 1-25, ``Iodine Value of Fats and Oils Wijs Method,'' revised 
1993, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in paragraph (b)(1) of this section.
    (3) The heavy metals (as Pb) content cannot be more than 10 parts 
per million, as determined by the ``Heavy Metals Test,'' of the ``Food 
Chemicals Codex,'' 4th ed. (1996), pp. 760-761, Method II (with a 2-gram 
sample and 20 microgram of lead ion in the control), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the National Academy Press, Box 285, 
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address 
http://www.nap.edu), or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) The additive is used as a halogen stabilizer in brominated 
soybean oil at a level not to exceed 1 percent.

[60 FR 32903, June 26, 1995, as amended at 64 FR 1759, Jan. 12, 1999]



Sec. 172.725  Gibberellic acid and its potassium salt.

    The food additives gibberellic acid and its potassium salt may be 
used in the malting of barley in accordance with the following 
prescribed conditions:
    (a) The additives meet the following specifications:
    (1) The gibberellic acid is produced by deep-culture fermentation of 
a suitable nutrient medium by a strain of Fusarium moniliforme or a 
selection of this culture.
    (2) The gibberellic acid produced is of 80 percent purity or better.
    (3) The empirical formula of gibberellic acid is represented by 
C19H22O6.
    (4) Potassium gibberellate is the potassium salt of the specified 
gibberellic acid.
    (5) The potassium gibberellate is of 80 percent purity or better.

[[Page 73]]

    (6) The gibberellic acid or potassium gibberellate may be diluted 
with substances generally recognized as safe in foods or with salts of 
fatty acids conforming to Sec. 172.863.
    (b) They are used or intended for use in the malting of barley under 
conditions whereby the amount of either or both additives present in the 
malt is not in excess of 2 parts per million expressed as gibberellic 
acid, and the treated malt is to be used in the production of fermented 
malt beverages or distilled spirits only, whereby the finished distilled 
spirits contain none and the finished malt beverage contains not more 
than 0.5 part per million of gibberellic acid.
    (c) To insure the safe use of the food additives the label of the 
package shall bear, in addition to the other information required by the 
Act:
    (1) The name of the additive, ``gibberellic acid'' or ``potassium 
gibberellate'', whichever is appropriate.
    (2) An accurate statement of the concentration of the additive 
contained in the package.
    (3) Adequate use directions to provide not more than 2 parts per 
million of gibberellic acid in the finished malt.
    (4) Adequate labeling directions to provide that the final malt is 
properly labeled as described in paragraph (d) of this section.
    (d) To insure the safe use of the additive the label of the treated 
malt shall bear, in addition to the other information required by the 
Act, the statements:
    (1) ``Contains not more than 2 parts per million ------'', the blank 
being filled in with the words ``gibberellic acid'' or ``potassium 
gibberellate'', whichever is appropriate; and
    (2) ``Brewer's malt--To be used in the production of fermented malt 
beverages only'' or ``Distiller's malt--To be used in the production of 
distilled spirits only'', whichever is appropriate.



Sec. 172.730  Potassium bromate.

    The food additive potassium bromate may be safely used in the 
malting of barley under the following prescribed conditions:
    (a)(1) It is used or intended for use in the malting of barley under 
conditions whereby the amount of the additive present in the malt from 
the treatment does not exceed 75 parts per million of bromate 
(calculated as Br), and the treated malt is used only in the production 
of fermented malt beverages or distilled spirits.
    (2) The total residue of inorganic bromides in fermented malt 
beverages, resulting from the use of the treated malt plus additional 
residues of inorganic bromides that may be present from uses in 
accordance with other regulations in this chapter promulgated under 
sections 408 and/or 409 of the act, does not exceed 25 parts per million 
of bromide (calculated as Br). No tolerance is established for bromide 
in distilled spirits because there is evidence that inorganic bromides 
do not pass over in the distillation process.
    (b) To assure safe use of the additive, the label or labeling of the 
food additive shall bear, in addition to the other information required 
by the Act, the following:
    (1) The name of the additive.
    (2) Adequate directions for use.
    (c) To assure safe use of the additive, the label or labeling of the 
treated malt shall bear, in addition to other information required by 
the Act, the statement, ``Brewer's Malt--To be used in the production of 
fermented malt beverages only'', or ``Distiller's Malt--To be used in 
the production of distilled spirits only'', whichever is the case.



Sec. 172.735  Glycerol ester of wood rosin.

    Glycerol ester of wood rosin may be safely used in food in 
accordance with the following prescribed conditions:
    (a) It has an acid number of 3 to 9, a drop-softening point of 88 
[deg]C-96 [deg]C; and a color of N or paler as determined in accordance 
with Official Naval Stores Standards of the United States. It is 
purified by countercurrent steam distillation.
    (b) It is used to adjust the density of citrus oils used in the 
preparation of beverages whereby the amount of the additive does not 
exceed 100 parts per million of the finished beverage.

[[Page 74]]



Sec. 172.755  Stearyl monoglyceridyl citrate.

    The food additive stearyl monoglyceridyl citrate may be safely used 
in food in accordance with the following provisions:
    (a) The additive is prepared by controlled chemical reaction of the 
following:

------------------------------------------------------------------------
                 Reactant                           Limitations
------------------------------------------------------------------------
Citric acid..............................  .............................
Monoglycerides of fatty acids............  Prepared by the glycerolysis
                                            of edible fats and oils or
                                            derived from fatty acids
                                            conforming with Sec.
                                            172.860.
Stearyl alcohol..........................  Derived from fatty acids
                                            conforming with Sec.
                                            172.860, or derived
                                            synthetically in conformity
                                            with Sec.  172.864.
------------------------------------------------------------------------

    (b) The additive stearyl monoglyceridyl citrate, produced as 
described under paragraph (a) of this section, meets the following 
specifications:

Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Saponification number 215-255.

    (c) The additive is used or intended for use as an emulsion 
stabilizer in or with shortenings containing emulsifiers.



Sec. 172.765  Succistearin (stearoyl propylene glycol hydrogen succinate).

    The food additive succistearin (stearoyl propylene glycol hydrogen 
succinate) may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additive is the reaction product of succinic anhydride, 
fully hydrogenated vegetable oil (predominantly C16 or 
C18 fatty acid chain length), and propylene glycol.
    (b) The additive meets the following specifications:

Acid number 50-150.
Hydroxyl number 15-50.
Succinated ester content 45-75 percent.

    (c) The additive is used or intended for use as an emulsifier in or 
with shortenings and edible oils intended for use in cakes, cake mixes, 
fillings, icings, pastries, and toppings, in accordance with good 
manufacturing practice.



Sec. 172.770  Ethylene oxide polymer.

    The polymer of ethylene oxide may be safely used as a foam 
stabilizer in fermented malt beverages in accordance with the following 
conditions.
    (a) It is the polymer of ethylene oxide having a minimum viscosity 
of 1,500 centipoises in a 1 percent aqueous solution at 25 [deg]C.
    (b) It is used at a level not to exceed 300 parts per million by 
weight of the fermented malt beverage.
    (c) The label of the additive bears directions for use to insure 
compliance with paragraph (b) of this section.



Sec. 172.775  Methacrylic acid-divinylbenzene copolymer.

    Methacrylic acid-divinylbenzene copolymer may be safely used in food 
in accordance with the following prescribed conditions:
    (a) The additive is produced by the polymerization of methacrylic 
acid and divinylbenzene. The divinylbenzene functions as a cross-linking 
agent and constitutes a minimum of 4 percent of the polymer.
    (b) Aqueous extractives from the additive do not exceed 2 percent 
(dry basis) after 24 hours at 25 [deg]C.
    (c) The additive is used as a carrier of vitamin B12 in 
foods for special dietary use.



                    Subpart I_Multipurpose Additives



Sec. 172.800  Acesulfame potassium.

    Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as 
acesulfame K, may be safely used as a general-purpose sweetener and 
flavor enhancer in foods generally, except in meat and poultry, in 
accordance with current good manufacturing practice and in an amount not 
to exceed that reasonably required to accomplish the intended technical 
effect in foods for which standards of identity established under 
section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude 
such use, under the following conditions:
    (a) Acesulfame potassium is the potassium salt of 6-methyl-1,2,3-
oxathiazine-4(3H)-one-2,2-dioxide.
    (b) The additive meets the following specifications:

[[Page 75]]

    (1) Purity is not less than 99 percent on a dry basis. The purity 
shall be determined by a method titled ``Acesulfame Potassium Assay,'' 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (2) Fluoride content is not more than 30 parts per million, as 
determined by method III of the Fluoride Limit Test of the Food 
Chemicals Codex, 3d Ed. (1981), p. 511, which is incorporated by 
reference. Copies are available from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or available for inspection 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC 20408.
    (c) If the food containing the additive is represented to be for 
special dietary uses, it shall be labeled in compliance with part 105 of 
this chapter.

[53 FR 28382, July 28, 1988, as amended at 57 FR 57961, Dec. 8, 1992; 59 
FR 61540, 61543, 61545, Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR 
36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003]



Sec. 172.802  Acetone peroxides.

    The food additive acetone peroxides may be safely used in flour, and 
in bread and rolls where standards of identity do not preclude its use, 
in accordance with the following prescribed conditions:
    (a) The additive is a mixture of monomeric and linear dimeric 
acetone peroxide, with minor proportions of higher polymers, 
manufactured by reaction of hydrogen peroxide and acetone.
    (b) The additive may be mixed with an edible carrier to give a 
concentration of: (1) 3 grams to 10 grams of hydrogen peroxide 
equivalent per 100 grams of the additive, plus carrier, for use in flour 
maturing and bleaching; or (2) approximately 0.75 gram of hydrogen 
peroxide equivalent per 100 grams of the additive, plus carrier, for use 
in dough conditioning.
    (c) It is used or intended for use: (1) In maturing and bleaching of 
flour in a quantity not more than sufficient for such effect; and (2) as 
a dough-conditioning agent in bread and roll production at not to exceed 
the quantity of hydrogen peroxide equivalent necessary for the 
artificial maturing effect.
    (d) To insure safe use of the additive, the label of the food 
additive container and any intermediate premix thereof shall bear, in 
addition to the other information required by the act:
    (1) The name of the additive, ``acetone peroxides''.
    (2) The concentration of the additive expressed in hydrogen peroxide 
equivalents per 100 grams.
    (3) Adequate use directions to provide a final product that complies 
with the limitations prescribed in paragraph (c) of this section.



Sec. 172.804  Aspartame.

    The food additive aspartame may be safely used in food in accordance 
with good manufacturing practice as a sweetening agent and a flavor 
enhancer in foods for which standards of identity established under 
section 401 of the act do not preclude such use under the following 
conditions:
    (a) Aspartame is the chemical 1-methyl N-l-[alpha]-aspartyl-l-
phenylalanine (C14H18N2O5).
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981) pp. 28-29 and First Supplement p. 5, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food And Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c)(1) When aspartame is used as a sugar substitute tablet for 
sweetening hot beverages, including coffee and tea, L-leucine may be 
used as a lubricant in the manufacture of such tablets at a level not to 
exceed 3.5 percent of the weight of the tablet.
    (2) When aspartame is used in baked goods and baking mixes, the 
amount of the additive is not to exceed 0.5 percent

[[Page 76]]

by weight of ready-to-bake products or of finished formulations prior to 
baking. Generally recognized as safe (GRAS) ingredients or food 
additives approved for use in baked goods shall be used in combination 
with aspartame to ensure its functionality as a sweetener in the final 
baked product. The level of aspartame used in these products is 
determined by an analytical method entitled ``Analytical Method for the 
Determination of Aspartame and Diketopiperazine in Baked Goods and 
Baking Mixes,'' October 8, 1992, which was developed by the Nutrasweet 
Co. Copies are available from the Office of Premarket Approval (HFS-
200), Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or are available for inspection at the 
Center for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 20204, 
and the Office of the Federal Register, 800 North Capitol St. NW., suite 
700, Washington, DC.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The principal display panel of any intermediate mix of the 
additive for manufacturing purposes shall bear a statement of the 
concentration of the additive contained therein;
    (2) The label of any food containing the additive shall bear, either 
on the principal display panel or on the information panel, the 
following statement:


PHENYLKETONURICS: CONTAINS PHENYLALANINE


The statement shall appear in the labeling prominently and conspicuously 
as compared to other words, statements, designs or devices and in bold 
type and on clear contrasting background in order to render it likely to 
be read and understood by the ordinary individual under customary 
conditions of purchase and use.
    (3) When the additive is used in a sugar substitute for table use, 
its label shall bear instructions not to use in cooking or baking.
    (4) Packages of the dry, free-flowing additive shall prominently 
display the sweetening equivalence in teaspoons of sugar.
    (e) If the food containing the additive purports to be or is 
represented for special dietary uses, it shall be labeled in compliance 
with part 105 of this chapter.

[39 FR 27319, July 26, 1974]

    Editorial Note: For Federal Register citations affecting Sec. 
172.804, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 172.806  Azodicarbonamide.

    The food additive azodicarbonamide may be safely used in food in 
accordance with the following prescribed conditions:
    (a) It is used or intended for use:
    (1) As an aging and bleaching ingredient in cereal flour in an 
amount not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent; 
45 parts per million).
    (2) As a dough conditioner in bread baking in a total amount not to 
exceed 0.0045 percent (45 parts per million) by weight of the flour 
used, including any quantity of azodicarbonamide added to flour in 
accordance with paragraph (a)(1) of this section.
    (b) To assure safe use of the additive:
    (1) The label and labeling of the additive and any intermediate 
premix prepared therefrom shall bear, in addition to the other 
information required by the Act, the following:
    (i) The name of the additive.
    (ii) A statement of the concentration or the strength of the 
additive in any intermediate premixes.
    (2) The label or labeling of the food additive shall also bear 
adequate directions for use.



Sec. 172.808  Copolymer condensates of ethylene oxide and propylene oxide.

    Copolymer condensates of ethylene oxide and propylene oxide may be 
safely used in food under the following prescribed conditions:
    (a) The additive consists of one of the following:
    (1) [alpha]-Hydro-omega-hydroxy-poly (oxyethylene) 
poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer, 
having a molecular weight range of 9,760-13,200 and a cloud point above 
100 [deg]C in 1 percent aqueous solution.

[[Page 77]]

    (2) [alpha]-Hydro-omega-hydroxy-poly (oxy 
ethylene)poly(oxypropylene)-(53-59 moles)poly(oxyethylene)(14-16 moles) 
block copolymer, having a molecular weight range of 3,500-4,125 and a 
cloud point of 9 [deg]C-12 [deg]C in 10 percent aqueous solution.
    (3) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene)/
poly(oxypropylene) (minimum 15 moles)/poly(oxyethylene) block copolymer, 
having a minimum average molecular weight of 1900 and a minimum cloud 
point of 9 [deg]C-12 [deg]C in 10 percent aqueous solution.
    (4) [alpha]-Hydro-omega-hydroxy-poly(ox-yethylene) poly 
(oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having 
an average molecular weight of 14,000 and a cloud point above 100 [deg]C 
in 1 percent aqueous solution.
    (b) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a)(1) of this section is 
used in practice as a solubilizing and stabilizing agent in flavor 
concentrates (containing authorized flavoring oils) for use in foods for 
which standards of identity established under section 401 of the Act do 
not preclude such use, provided that the weight of the additive does not 
exceed the weight of the flavoring oils in the flavor concentrate.
    (2) The additive identified in paragraph (a)(2) of this section is 
used as a processing aid and wetting agent in combination with dioctyl 
sodium sulfosuccinate for fumaric acid as prescribed in Sec. 172.810.
    (3) The additive identified in paragraph (a)(3) of this section is 
used:
    (i) As a surfactant and defoaming agent, at levels not to exceed 
0.05 percent by weight, in scald baths for poultry defeathering, 
followed by potable water rinse. The temperatures of the scald baths 
shall be not less than 125 [deg]F.
    (ii) As a foam control and rinse adjuvant in hog dehairing machines 
at a use level of not more than 5 grams per hog.
    (4) The additive identified in paragraph (a)(4) of this section is 
used as a dough conditioner in yeast-leavened bakery products for which 
standards of identity established under section 401 of the Act do not 
preclude such use, provided that the amount of the additive dose not 
exceed 0.5 percent by weight of the flour used.

[42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24, 1981]



Sec. 172.809  Curdlan.

    Curdlan may be safely used in accordance with the following 
conditions:
    (a) Curdlan is a high molecular weight polymer of glucose ([beta]-
1,3-glucan; CAS Reg. No. 54724-00-4) produced by pure culture 
fermentation from the nonpathogenic and nontoxicogenic bacterium 
Alcaligenes faecalis var. myxogenes.
    (b) Curdlan meets the following specifications when it is tested 
according to the methods described or referenced in the document 
entitled ``Analytical Methods for Specification Tests for Curdlan,'' by 
Takeda Chemical Industries, Ltd., 12-10 Nihonbashi, 2-Chome, Chuo-ku, 
Tokyo, 103, Japan, 1996, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Division of Petition Control (HFS-215), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (1) Positive for curdlan.
    (2) Assay for curdlan (calculated as anhydrous glucose), not less 
than 80 percent.
    (3) pH of 1 percent aqueous suspension, 6.0-7.5.
    (4) Lead, not more than 0.5 mg/kg.
    (5) Heavy metals (as Pb), not more than 0.002 percent.
    (6) Total nitrogen, not more than 0.2 percent.
    (7) Loss on drying, not more than 10 percent.
    (8) Residue on ignition, not more than 6 percent.
    (9) Gel strength of 2 percent aqueous suspension, not less than 
600x10\3\ dyne per square centimeter.
    (10) Aerobic plate count, not more than 10\3\ per gram.
    (11) Coliform bacteria, not more than 3 per gram.

[[Page 78]]

    (c) Curdlan is used or intended for use in accordance with good 
manufacturing practice as a formulation aid, processing aid, stabilizer 
and thickener, and texturizer in foods for which standards of identity 
established under section 401 of the act do not preclude such use.

[61 FR 65941, Dec. 16, 1996]



Sec. 172.810  Dioctyl sodium sulfo suc cinate.

    The food additive dioctyl sodium sulfosuccinate, which meets the 
specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 102-104, 
which is incorporated by reference (copies may be obtained from the 
National Academy Press, 2101 Constitution Ave. NW., Washington, DC 
20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408), may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) As a wetting agent in the following fumaric acid-acidulated 
foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks, 
when standards of identity do not preclude such use. The labeling of the 
dry gelatin dessert and dry beverage base shall bear adequate directions 
for use, and the additive shall be used in such an amount that the 
finished gelatin dessert will contain not in excess of 15 parts per 
million of the additive and the finished beverage or fruit juice drink 
will contain not in excess of 10 parts per million of the additive.
    (b) As a processing aid in sugar factories in the production of 
unrefined cane sugar, in an amount not in excess of 0.5 part per million 
of the additive per percentage point of sucrose in the juice, syrup, or 
massecuite being processed, and so used that the final molasses will 
contain no more than 25 parts per million of the additive.
    (c) As a solubilizing agent on gums and hydrophilic colloids to be 
used in food as stabilizing and thickening agents, when standards of 
identity do not preclude such use. The additive is used in an amount not 
to exceed 0.5 percent by weight of the gums or hydrophilic colloids.
    (d) As an emulsifying agent for cocoa fat in noncarbonated beverages 
containing cocoa, whereby the amount of the additive does not exceed 25 
parts per million of the finished beverage.
    (e) As a dispersing agent in ``cocoa with dioctyl sodium 
sulfosuccinate for manufacturing'' that conforms to the provisions of 
Sec. 163.117 of this chapter and the use limitations prescribed in 
Sec. 172.520, in an amount not to exceed 0.4 percent by weight thereof.
    (f) As a processing aid and wetting agent in combination with 
[alpha]-hydro-omega -hydroxy - poly(oxyethylene) - poly-(oxypropylene) 
(53-59 moles) poly(oxyethylene) (14-16 moles) block copolymer, having a 
molecular weight range of 3,500-4,125 and a cloud point of 9 [deg]C-12 
[deg]C in 10 percent aqueous solution, for fumaric acid used in fumaric 
acid-acidulated dry beverage base and in fumaric acid-acidulated fruit 
juice drinks, when standards of identity do not preclude such use. The 
labeling of the dry beverage base shall bear adequate directions for 
use, and the additives shall be used in such an amount that the finished 
beverage or fruit juice drink will contain not in excess of a total of 
10 parts per million of the dioctyl sodium sulfosuccinate-block 
copolymer combination.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.811  Glyceryl tristearate.

    The food additive glyceryl tristearate may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive (CAS Reg. No. 555-43-1) is prepared by 
reacting stearic acid with glycerol in the presence of a suitable 
catalyst.
    (b) The food additive meets the following specifications:

Acid number: Not to exceed 1.0.
Iodine number: Not to exceed 1.0.
Saponification number: 186-192.
Hydroxyl number: Not to exceed 5.0.
Free glycerol content: Not to exceed 0.5 percent.
Unsaponifiable matter: Not to exceed 0.5 percent.
Melting point (Class II): 69 [deg]C-73 [deg]C.

    (c) The additive is used or intended for use as follows when 
standards of

[[Page 79]]

identity established under section 401 of the Act do not preclude such 
use:

------------------------------------------------------------------------
                 Uses                             Limitations
------------------------------------------------------------------------
1. As a crystallization accelerator    Not to exceed 1 percent of the
 in cocoa products, in imitation        combined weight of the
 chocolate, and in compound coatings.   formulation.
2. As a formulation aid as defined in  Not to exceed 0.5 percent.
 Sec.  170.3(o)(14) of this chapter,
 lubricant and release agent as
 defined in Sec.  170.3(o)(18) of
 this chapter, and surface-finishing
 agent as defined in Sec.
 170.3(o)(30) of this chapter in food.
3. As a formulation aid as defined in  Not to exceed 3.0 percent of the
 Sec.  170.3(o)(14) of this chapter    combined weight of the
 in confections.                        formulation.
4. As a formulation aid as defined in  Not to exceed 1.0 percent of the
 Sec.  170.3(o)(14) of this chapter    combined weight of the
 in fats and oils as defined in Sec.   formulation.
  170.3 (n)(12) of this chapter.
5. As a winterization and              Not to exceed 0.5 percent by
 fractionation aid in fat and oil       weight of the processed fat or
 processing.                            oil.
------------------------------------------------------------------------

    (d) To assure safe use of the additive:
    (1) In addition to the other information required by the act, the 
label or labeling of the additive shall bear the name of the additive.
    (2) The label of the additive shall bear adequate directions to 
provide a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[53 FR 21632, June 9, 1988, as amended at 59 FR 24924, May 13, 1994]



Sec. 172.812  Glycine.

    The food additive glycine may be safely used for technological 
purposes in food in accordance with the following prescribed conditions:
    (a) The additive complies with the specifications of the ``Food 
Chemicals Codex,'' 3d Ed. (1981), p. 140, which is incorporated by 
reference. Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (b) The additive is used or intended for use as follows:

------------------------------------------------------------------------
                   Uses                              Limitations
------------------------------------------------------------------------
As a masking agent for the bitter           Not to exceed 0.2 percent in
 aftertaste of saccharin used in             the finished beverage.
 manufactured beverages and beverage bases.
As a stabilizer in mono- and diglycerides   Not to exceed 0.02 percent
 prepared by the glycerolysis of edible      of the mono- and
 fats or oils.                               diglycerides.
------------------------------------------------------------------------

    (c) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The labeling of the additive shall bear adequate directions for 
use of the additive in compliance with the provisions of this section.
    (2) The labeling of beverage bases containing the additive shall 
bear adequate directions for use to provide that beverages prepared 
therefrom shall contain no more than 0.2 percent glycine.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.814  Hydroxylated lecithin.

    The food additive hydroxylated lecithin may be safely used as an 
emulsifier in foods in accordance with the following conditions:
    (a) The additive is obtained by the treatment of lecithin in one of 
the following ways, under controlled conditions whereby the separated 
fatty acid fraction of the resultant product has an acetyl value of 30 
to 38:
    (1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and 
sodium hydroxide.
    (2) With hydrogen peroxide, acetic acid, and sodium hydroxide.
    (b) It is used or intended for use, in accordance with good 
manufacturing practice, as an emulsifier in foods, except for those 
standardized foods that do not provide for such use.
    (c) To assure safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive, ``hydroxylated lecithin''.
    (2) Adequate directions for its use.

[[Page 80]]



Sec. 172.816  Methyl glucoside-coconut oil ester.

    Methyl glucoside-coconut oil ester may be safely used in food in 
accordance with the following conditions:
    (a) It is the methyl glucoside-coconut oil ester having the 
following specifications:

Acid number: 10-20
Hydroxyl number: 200-300
pH (5% aqueous): 4.8-5.0
Saponification number: 178-190

    (b) It is used or intended for use as follows:
    (1) As an aid in crystallization of sucrose and dextrose at a level 
not to exceed the minimum quantity required to produce its intended 
effect.
    (2) As a surfactant in molasses at a level not to exceed 320 parts 
per million in the molasses.



Sec. 172.818  Oxystearin.

    The food additive oxystearin may be safely used in foods, when such 
use is not precluded by standards of identity in accordance with the 
following conditions:
    (a) The additive is a mixture of the glycerides of partially 
oxidized stearic and other fatty acids obtained by heating hydrogenated 
cottonseed or soybean oil under controlled conditions, in the presence 
of air and a suitable catalyst which is not a food additive as so 
defined. The resultant product meets the following specifications:

Acid number: Maximum 15.
Iodine number: Maximum 15.
Saponification number: 225-240.
Hydroxyl number: 30-45.
Unsaponifiable material: Maximum 0.8 percent.
Refractive index (butyro): 601 at 48 [deg]C.

    (b) It is used or intended for use as a crystallization inhibitor in 
vegetable oils and as a release agent in vegetable oils and vegetable 
shortenings, whereby the additive does not exceed 0.125 percent of the 
combined weight of the oil or shortening.
    (c) To insure safe use of the additive, the label and labeling of 
the additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive.
    (2) Adequate directions to provide an oil or shortening that 
complies with the limitations prescribed in paragraph (b) of this 
section.



Sec. 172.820  Polyethylene glycol (mean molecular weight 200-9,500).

    Polyethylene glycol identified in this section may be safely used in 
food in accordance with the following prescribed conditions:
    (a) Identity. (1) The additive is an addition polymer of ethylene 
oxide and water with a mean molecular weight of 200 to 9,500.
    (2) It contains no more than 0.2 percent total by weight of ethylene 
and diethylene glycols when tested by the analytical methods prescribed 
in paragraph (b) of this section.
    (b) Analytical method. (1) The analytical method prescribed in the 
National Formulary XV (1980), page 1244, for polyethylene glycol 400 
shall be used to determine the total ethylene and diethylene glycol 
content of polyethylene glycols having mean molecular weights of 450 or 
higher.
    (2) The following analytical method shall be used to determine the 
total ethylene and diethylene glycol content of polyethylene glycols 
having mean molecular weights below 450.

                            Analytical Method

  ethylene glycol and diethylene glycol content of polyethylene glycols

    The analytical method for determining ethylene glycol and diethylene 
glycol is as follows:

                                apparatus

    Gas chromatograph with hydrogen flame ionization detector (Varian 
Aerograph 600 D or equivalent). The following conditions shall be 
employed with the Varian Aerograph 600 D gas chromatograph:
    Column temperature: 165 [deg]C.
    Inlet temperature: 260 [deg]C.
    Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
    Hydrogen and air flow to burner: Optimize to give maximum 
sensitivity.
    Sample size: 2 microliters.
    Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5 
minutes.
    Recorder: -0.5 to +1.05 millivolt, full span, 1 second full response 
time.
    Syringe: 10-microliter (Hamilton 710 N or equivalent).
    Chromatograph column: 5 feet x \1/8\ inch. I.D. stainless steel tube 
packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol

[[Page 81]]

SX850, or equivalent) 12 percent in H2O by weight on 60-80 
mesh nonacid washed diatomaceous earth (Chromosorb W. Johns-Manville, or 
equivalent).

                         reagents and materials

    Carrier gas, nitrogen: Commercial grade in cylinder equipped with 
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
    Ethylene glycol: Commercial grade. Purify if necessary, by 
distillation.
    Diethylene glycol: Commercial grade. Purify, if necessary, by 
distillation.
    Glycol standards: Prepare chromatographic standards by dissolving 
known amounts of ethylene glycol and diethylene glycol in water. 
Suitable concentrations for standardization range from 1 to 6 milligrams 
of each component per milliliter (for example 10 milligrams diluted to 
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram 
per milliliter).

                             standardization

    Inject a 2-microliter aliquot of the glycol standard into the gas 
chromatograph employing the conditions described above. Measure the net 
peak heights for the ethylene glycol and for the diethylene glycol. 
Record the values as follows:
    A=Peak height in millimeters of the ethylene glycol peak.
    B=milligrams of ethylene glycol per milliliter of standard solution.
    C=Peak height in millimeters of the diethylene glycol peak.
    D=Milligrams of diethylene glycol per milliliter of standard 
solution.

                                procedure

    Weigh approximately 4 grams of polyethylene glycol sample accurately 
into a 10-milliliter volumetric flask. Dilute to volume with water. Mix 
the solution thoroughly and inject a 2-microliter aliquot into the gas 
chromatograph. Measure the heights, in millimeters, of the ethylene 
glycol peak and of the diethylene glycol peak and record as E and F, 
respectively.

Percent ethylene glycol=(ExB)/(Axsample weight in grams)

Percent diethylene glycol=(FxD)/(Cxsample weight in grams)

    (c) Uses. It may be used, except in milk or preparations intended 
for addition to milk, as follows:
    (1) As a coating, binder, plasticizing agent, and/or lubricant in 
tablets used for food.
    (2) As an adjuvant to improve flavor and as a bodying agent in 
nonnutritive sweeteners identified in Sec. 180.37 of this chapter.
    (3) As an adjuvant in dispersing vitamin and/or mineral 
preparations.
    (4) As a coating on sodium nitrite to inhibit hygroscopic 
properties.
    (d) Limitations. (1) It is used in an amount not greater than that 
required to produce the intended physical or technical effect.
    (2) A tolerance of zero is established for residues of polyethylene 
glycol in milk.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.822  Sodium lauryl sulfate.

    The food additive sodium lauryl sulfate may be safely used in food 
in accordance with the following conditions:
    (a) The additive meets the following specifications:
    (1) It is a mixture of sodium alkyl sulfates consisting chiefly of 
sodium lauryl sulfate 
[CH2(CH2)10CH2OSO2
Na].
    (2) It has a minimum content of 90 percent sodium alkyl sulfates.
    (b) It is used or intended for use:
    (1) As an emulsifier in or with egg whites whereby the additive does 
not exceed the following limits:

Egg white solids, 1,000 parts per million.
Frozen egg whites, 125 parts per million.
Liquid egg whites, 125 parts per million.

    (2) As a whipping agent at a level not to exceed 0.5 percent by 
weight of gelatine used in the preparation of marshmallows.
    (3) As a surfactant in:
    (i) Fumaric acid-acidulated dry beverage base whereby the additive 
does not exceed 25 parts per million of the finished beverage and such 
beverage base is not for use in a food for which a standard of identity 
established under section 401 of the Act precludes such use.
    (ii) Fumaric acid-acidulated fruit juice drinks whereby the additive 
does not exceed 25 parts per million of the finished fruit juice drink 
and it is not used in a fruit juice drink for which a standard of 
identity established under section 401 of the Act precludes such use.
    (4) As a wetting agent at a level not to exceed 10 parts per million 
in the partition of high and low melting fractions of crude vegetable 
oils and animal fats, provided that the partition

[[Page 82]]

step is followed by a conventional refining process that includes alkali 
neutralization and deodorization of the fats and oils.
    (c) To insure the safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the Act:
    (1) The name of the additive, sodium lauryl sulfate.
    (2) Adequate use directions to provide a final product that complies 
with the limitations prescribed in paragraph (b) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978]



Sec. 172.824  Sodium mono- and dimethyl naphthalene sulfonates.

    The food additive sodium mono- and dimethyl naphthalene sulfonates 
may be safely used in accordance with the following prescribed 
conditions:
    (a) The additive has a molecular weight range of 245-260.
    (b) The additive is used or intended for use:
    (1) In the crystallization of sodium carbonate in an amount not to 
exceed 250 parts per million of the sodium carbonate. Such sodium 
carbonate is used or intended for use in potable water systems to reduce 
hardness and aid in sedimentation and coagulation by raising the pH for 
the efficient utilization of other coagulation materials.
    (2) As an anticaking agent in sodium nitrite at a level not in 
excess of 0.1 percent by weight thereof for authorized uses in cured 
fish and meat.
    (c) In addition to the general labeling requirements of the Act:
    (1) Sodium carbonate produced in accordance with paragraph (b)(1) of 
this section shall be labeled to show the presence of the additive and 
its label or labeling shall bear adequate directions for use.
    (2) Sodium nitrite produced in accordance with paragraph (b)(2) of 
this section shall bear the labeling required by Sec. 172.175 and a 
statement declaring the presence of sodium mono- and dimethyl 
naphthalene sulfonates.

[42 FR 14491, Mar. 15, 1977, as amended at 63 FR 7069, Feb. 12, 1998]



Sec. 172.826  Sodium stearyl fumarate.

    Sodium stearyl fumarate may be safely used in food in accordance 
with the following conditions:
    (a) It contains not less than 99 percent sodium stearyl fumarate 
calculated on the anhydrous basis, and not more than 0.25 percent sodium 
stearyl maleate.
    (b) The additive is used or intended for use:
    (1) As a dough conditioner in yeast-leavened bakery products in an 
amount not to exceed 0.5 percent by weight of the flour used.
    (2) As a conditioning agent in dehydrated potatoes in an amount not 
to exceed 1 percent by weight thereof.
    (3) As a stabilizing agent in nonyeast-leavened bakery products in 
an amount not to exceed 1 percent by weight of the flour used.
    (4) As a conditioning agent in processed cereals for cooking in an 
amount not to exceed 1 percent by weight of the dry cereal, except for 
foods for which standards of identity preclude such use.
    (5) As a conditioning agent in starch-thickened or flour-thickened 
foods in an amount not to exceed 0.2 percent by weight of the food.



Sec. 172.828  Acetylated monoglycerides.

    The food additive acetylated monoglycerides may be safely used in or 
on food in accordance with the following prescribed conditions:
    (a) The additive is manufactured by:
    (1) The interesterification of edible fats with triacetin and in the 
presence of catalytic agents that are not food additives or are 
authorized by regulation, followed by a molecular distillation or by 
steam stripping; or
    (2) The direct acetylation of edible monoglycerides with acetic 
anhydride without the use of catalyst or molecular distillation, and 
with the removal by vacuum distillation, if necessary, of the acetic 
acid, acetic anhydride, and triacetin.
    (b) The food additive has a Reichert-Meissl value of 75-200 and an 
acid value of less than 6.

[[Page 83]]

    (c) The food additive is used at a level not in excess of the amount 
reasonably required to produce its intended effect in food, or in food-
processing, food-packing, or food-storage equipment.

[42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985]



Sec. 172.829  Neotame.

    (a) Neotame is the chemical N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine-1-methyl ester (CAS Reg. No. 165450-17-9).
    (b) Neotame meets the following specifications when it is tested 
according to the methods described or referenced in the document 
entitled ``Specifications and Analytical Methods for Neotame'' dated 
April 3, 2001, by the NutraSweet Co., 699 North Wheeling Rd., Mount 
Prospect, IL 60056. The Director of the Office of the Federal Register 
has approved the incorporation by reference of this material in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Office of Food Additive Safety (HFS-200), Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 
20740. Copies may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., rm. 1C-100, College Park, 
MD 20740, or at the Office of the Federal Register, 800 North Capitol 
St. NW., suite 700, Washington, DC 20001.
    (1) Assay for neotame, not less than 97.0 percent and not more than 
102.0 percent on a dry basis.
    (2) Free dipeptide acid (N-[N-(3,3-dimethylbutyl)-L-[alpha]-
aspartyl]-L-phenylalanine), not more than 1.5 percent.
    (3) Other related substances, not more than 2.0 percent.
    (4) Lead, not more than 2.0 milligrams per kilogram.
    (5) Water, not more than 5.0 percent.
    (6) Residue on ignition, not more than 0.2 percent
    (7) Specific rotation, determined at 20 [deg]C 
[[alpha]]D: -40.0[deg] to 43.4[deg] calculated on a dry 
basis.
    (c) The food additive neotame may be safely used as a sweetening 
agent and flavor enhancer in foods generally, except in meat and 
poultry, in accordance with current good manufacturing practice, in an 
amount not to exceed that reasonably required to accomplish the intended 
technical effect, in foods for which standards of identity established 
under section 401 of the Federal Food, Drug, and Cosmetic Act do not 
preclude such use.
    (d) When neotame is used as a sugar substitute tablet, L-leucine may 
be used as a lubricant in the manufacture of tablets at a level not to 
exceed 3.5 percent of the weight of the tablet.
    (e) If the food containing the additive purports to be or is 
represented to be for special dietary use, it shall be labeled in 
compliance with part 105 of this chapter.

[67 FR 45310, July 9, 2002]



Sec. 172.830  Succinylated monoglycerides.

    The food additive succinylated monoglycerides may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is a mixture of semi-and neutral succinic acid 
esters of mono- and diglycerides produced by the succinylation of a 
product obtained by the glycerolysis of edible fats and oils, or by the 
direct esterification of glycerol with edible fat-forming fatty acids.
    (b) The additive meets the following specifications:

Succinic acid content: 14.8%-25.6%
Melting point: 50 [deg]C-60 [deg]C.
Acid number: 70-120

    (c) The additive is used or intended for use in the following foods:
    (1) As an emulsifier in liquid and plastic shortenings at a level 
not to exceed 3 percent by weight of the shortening.
    (2) As a dough conditioner in bread baking, when such use is 
permitted by an appropriate food standard, at a level not to exceed 0.5 
percent by weight of the flour used.



Sec. 172.831  Sucralose.

    (a) Sucralose is the chemical 1,6-dichloro-1,6-dideoxy-[beta]-D-
fructofuranosyl-4-chloro-4-deoxy-[alpha]-D-galactopyranoside (CAS Reg. 
No. 56038-13-2).
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,''

[[Page 84]]

4th ed. (1996), pp. 398-400, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the the Division of Product Policy (HFS-206), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be examined at the Center 
for Food Safety and Applied Nutrition's Library, 5100 Paint Branch 
Pkwy., College Park, MD 20740 20204-0001, or the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) The additive may be used as a sweetener in foods generally, in 
accordance with current good manufacturing practice in an amount not to 
exceed that reasonably required to accomplish the intended effect.
    (d) If the food containing the additive purports to be or is 
represented to be for special dietary use, it shall be labeled in 
compliance with part 105 of this chapter.

[63 FR 16433, Apr. 3, 1998, as amended at 64 FR 43909, Aug. 12, 1999]



Sec. 172.832  Monoglyceride citrate.

    A food additive that is a mixture of glyceryl monooleate and its 
citric acid monoester manufactured by the reaction of glyceryl 
monooleate with citric acid under controlled conditions may be safely 
used as a synergist and solubilizer for antioxidants in oils and fats, 
when used in accordance with the conditions prescribed in this section.
    (a) The food additive meets the following specifications:

Acid number, 70-100.
Total citric acid (free and combined), 14 percent-17 percent.

    (b) It is used, or intended for use, in antioxidant formulations for 
addition to oils and fats whereby the additive does not exceed 200 parts 
per million of the combined weight of the oil or fat and the additive.
    (c) To assure safe use of the additive:
    (1) The container label shall bear, in addition to the other 
information required by the Act, the name of the additive.
    (2) The label or accompanying labeling shall bear adequate 
directions for the use of the additive which, if followed, will result 
in a food that complies with the requirements of this section.



Sec. 172.833  Sucrose acetate isobutyrate (SAIB).

    Sucrose acetate isobutyrate may be safely used in foods in 
accordance with the following prescribed conditions:
    (a) Sucrose acetate isobutyrate (CAS Reg. No. 27216-37-1), or SAIB, 
is the chemical alpha-D-glucopyranoside, O-acetyl-tris-O-(2-methyl-1-
oxopropyl)-beta-D-fructofuranosyl, acetate tris(2-methyl propanoate).
    (b) SAIB, a pale, straw-colored liquid, meets the following 
specifications: (1) Assay: Not less than 98.8 percent and not more than 
101.9 percent, based on the following formula:
Assay = ((SV 0.10586) / 56.1) x 100
Where SV = Saponification value
    (2) Saponification value: 524-540 determined using 1 gram of sample 
by the ``Guide to Specifications for General Notices, General Analytical 
Techniques, Identification Tests, Test Solutions, and Other Reference 
Materials,'' in the ``Compendium of Food Additive Specifications, 
Addendum 4, Food and Agriculture Organization of the United Nations 
(FAO), Food and Nutrition Paper 5, Revision 2'' (1991), pp. 203 and 204, 
which is incorporated by reference, in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the Office of the Federal Register, 800 North Capitol St. NW., suite 
700, Washington, DC.
    (3) Acid value: Not to exceed 0.20 determined using 50 grams of 
sample by the ``Guide to Specifications for General Notices, General 
Analytical Techniques, Identification Tests, Test Solutions, and Other 
Reference Materials,'' in the ``Compendium of Food Additive 
Specifications, Addendum 4, FAO Food and Nutrition Paper 5, Revision 
2,'' p.

[[Page 85]]

189 (1991), which is incorporated by reference; see paragraph (b)(2) of 
this section for availability of the incorporation by reference.
    (4) Lead: Not to exceed 1.0 milligrams/kilogram determined by the 
``Atomic Absorption Spectrophotometric Graphite Furnace Method, Method 
I,'' in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 763 and 764, 
with an attached modification to the sample digestion section in 
Appendix III.B (July 1996), which is incorporated by reference. Copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Box 285, Washington, DC 20055 (Internet http://www.nap.edu), or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (5) Triacetin: Not to exceed 0.10 percent determined by gas 
chromatography as described in the ``Guide to Specifications for General 
Notices, General Analytical Techniques, Identification Tests, Test 
Solutions, and Other Reference Materials,'' in the ``Compendium of Food 
Additive Specifications, Addendum 4, FAO Food and Nutrition Paper 5, 
Revision 2,'' (1991), pp. 13-26, which is incorporated by reference; see 
paragraph (b)(2) of this section for availability of the incorporation 
by reference.
    (c) The food additive is used as a stabilizer (as defined in Sec. 
170.3(o)(28) of this chapter) of emulsions of flavoring oils in 
nonalcoholic beverages.
    (d) The total SAIB content of a beverage containing the additive 
does not exceed 300 milligrams/kilogram of the finished beverage.

[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, 1999]



Sec. 172.834  Ethoxylated mono- and diglycerides.

    The food additive ethoxylated mono-and diglycerides (polyoxyethylene 
(20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by:
    (1) Glycerolysis of edible fats primarily composed of stearic, 
palmitic, and myristic acids; or
    (2) Direct esterification of glycerol with a mixture of primarily 
stearic, palmitic, and myristic acids;


to yield a product with less than 0.3 acid number and less than 0.2 
percent water, which is then reacted with ethylene oxide.
    (b) The additive meets the following specifications:

Saponification number, 65-75.
Acid number, 0-2.
Hydroxyl number, 65-80.
Oxyethylene content, 60.5-65.0 percent.

    (c) The additive is used or intended for use in the following foods 
when standards of identity established under section 401 of the Act do 
not preclude such use:

------------------------------------------------------------------------
                    Use                              Limitations
------------------------------------------------------------------------
1. As an emulsifier in pan-release agents   Not to exceed levels
 for and as a dough conditioner in yeast-    required to produce the
 leavened bakery products.                   intended effects, total not
                                             to exceed 0.5 percent by
                                             weight of the flour used.
2. As an emulsifier in cakes and cake       Not to exceed 0.5 percent by
 mixes.                                      weight of the dry
                                             ingredients.
3. As an emulsifier in whipped vegetable    Not to exceed 0.45 percent
 oil toppings and topping mixes.             by weight of the finished
                                             whipped vegetable oil
                                             toppings.
4. As an emulsifier in icings and icing     Not to exceed 0.5 percent by
 mixes.                                      weight of the finished
                                             icings.
5. As an emulsifier in frozen desserts....  Not to exceed 0.2 percent by
                                             weight of the finished
                                             frozen desserts.
6. As an emulsifier in edible vegetable     Not to exceed 0.4 percent by
 fat-water emulsions intended for use as     weight of the finished
 substitutes for milk or cream in beverage   vegetable fat-water
 coffee.                                     emulsions.
------------------------------------------------------------------------

    (d) When the name ``polyglycerate 60'' is used in labeling it shall 
be followed by either ``polyoxyethylene (20) mono-and diglycerides of 
fatty acids'' or ``ethoxylated mono- and diglycerides'' in parentheses.

[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26, 1977; 
50 FR 49536, Dec. 3, 1985]



Sec. 172.836  Polysorbate 60.

    The food additive polysorbate 60 (polyoxyethylene (20) sorbitan 
monostearate) which is a mixture of polyoxyethylene ethers of mixed 
partial stearic and palmitic acid esters of

[[Page 86]]

sorbitol anhydrides and related compounds, may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield a product with a maximum acid number of 10 and a 
maximum water content of 0.2 percent, which is then reacted with 
ethylene oxide.
    (b) The food additive meets the following specifications:

Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.

    (c) It is used or intended for use as follows:
    (1) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 65;
    (iii) Polysorbate 80;


whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping; except that a combination of the additive with sorbitan 
monostearate may be used in excess of 0.4 percent, provided that the 
amount of the additive does not exceed 0.77 percent and the amount of 
sorbitan monostearate does not exceed 0.27 percent of the weight of the 
finished whipped edible oil topping.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.


When used alone, the maximum amount of polysorbate 60 shall not exceed 
0.46 percent of the cake or cake mix, on a dry-weight basis. When used 
with polysorbate 65 and/or sorbitan monostearate, it shall not exceed 
0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
sorbitan monostearate exceed 0.61 percent, and no combination of these 
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all 
calculated on a dry-weight basis.
    (3) As an emulsifier, alone or in combination with sorbitan 
monostearate, in nonstandardized confectionery coatings and standardized 
cacao products specified in Sec. Sec. 163.123, 163.130, 163.135, 
163.140, 163.145, and 163.150 of this chapter, as follows:
    (i) It is used alone in an amount not to exceed 0.5 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (ii) It is used with sorbitan monostearate in any combination of up 
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan 
monostearate: Provided, That the total combination does not exceed 1 
percent of the weight of the finished nonstandardized confectionery 
coating or standardized cacao product.
    (4) [Reserved]
    (5) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.


When used alone, the maximum amount of polysorbate 60 shall not exceed 
0.46 percent of the weight of the cake icings and cake fillings. When 
used with polysorbate 65 and/or sorbitan monostearate, it shall not 
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or 
the sorbitan monostearate exceed 0.7 percent, and no combination of 
these emulsifiers shall exceed 1 percent of the weight of the cake icing 
or cake filling.
    (6) To impart greater opacity to sugar-type confection coatings 
whereby the maximum amount of the additive does not exceed 0.2 percent 
of the weight of the finished sugar coating.
    (7) As an emulsifier in nonstandardized dressings whereby the 
maximum amount of the additive does not exceed 0.3 percent of the weight 
of the finished dressings.
    (8) As an emulsifier, alone or in combination with polysorbate 80, 
in shortenings and edible oils intended for use in foods as follows, 
when standards of identity established under section 401 of the act do 
not preclude such use:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished shortening or oil.
    (ii) It is used with polysorbate 80 in any combination providing no 
more than 1 percent of polysorbate 60 and no

[[Page 87]]

more than 1 percent of polysorbate 80, provided that the total 
combination does not exceed 1 percent of the finished shortening or oil.
    (iii) The 1-percent limitation specified in paragraph (c)(8) (i) and 
(ii) of this section may be exceeded in premix concentrates of 
shortening or edible oil if the labeling complies with the requirements 
of paragraph (d) of this section.
    (9) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Sorbitan monostearate.


The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (10) As a foaming agent in nonalcoholic mixes, to be added to 
alcoholic beverages in the preparation of mixed alcoholic drinks, at a 
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
    (11) As a dough conditioner in yeast-leavened bakery products in an 
amount not to exceed 0.5 percent by weight of the flour used.
    (12) As an emulsifier, alone or in combination with sorbitan 
monostearate, in the minimum quantity required to accomplish the 
intended effect, in formulations of white mineral oil conforming with 
Sec. 172.878 and/or petroleum wax conforming with Sec. 172.886 for use 
as protective coatings on raw fruits and vegetables.
    (13) As a dispersing agent in artificially sweetened gelatin 
desserts and in artificially sweetened gelatin dessert mixes, whereby 
the amount of the additive does not exceed 0.5 percent on a dry-weight 
basis.
    (14) As an emulsifier in chocolate flavored syrups, whereby the 
maximum amount of the additive does not exceed 0.05 percent in the 
finished product.
    (15) As a surfactant and wetting agent for natural and artificial 
colors in food as follows:
    (i) In powdered soft drink mixes in an amount not to exceed 4.5 
percent by weight of the mix.
    (ii) In sugar-based gelatin dessert mixes in an amount not to exceed 
0.5 percent by weight of the mix.
    (iii) In artificially sweetened gelatin dessert mixes in an amount 
not to exceed 3.6 percent by weight of the mix.
    (iv) In sugar-based pudding mixes in an amount not to exceed 0.5 
percent by weight of the mix.
    (v) In artificially sweetened pudding mixes in an amount not to 
exceed 0.5 percent by weight of the mix.
    (16) As an emulsifier in ice cream, frozen custard, fruit sherbet, 
and nonstandardized frozen desserts when used alone or in combination 
with polysorbate 65 and/or polysorbate 80, whereby the maximum amount of 
the additives, alone or in combination, does not exceed 0.1 percent of 
the finished frozen dessert.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978; 45 
FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976, Oct. 
28, 1999]



Sec. 172.838  Polysorbate 65.

    The food additive polysorbate 65 (polyoxyethylene (20) sorbitan 
tristearate), which is a mixture of polyoxyethylene ethers of mixed 
stearic acid esters of sorbitol anhydrides and related compounds, may be 
safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield a product with a maximum acid number of 15 and a 
maximum water content of 0.2 percent, which is then reacted with 
ethylene oxide.
    (b) The food additive meets the following specifications:


[[Page 88]]


Saponification number 88-98.
Acid number 0-2.
Hydroxyl number 44-60.
Oxyethylene content 46 percent-50 percent.

    (c) The additive is used, or intended for use, as follows:
    (1) As an emulsifier in ice cream, frozen custard, ice milk, fruit 
sherbet and nonstandardized frozen desserts when used alone or in 
combination with polysorbate 80, whereby the maximum amount of the 
additives, alone or in combination, does not exceed 0.1 percent of the 
finished frozen dessert.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.


When used alone, the maximum amount of polysorbate 65 shall not exceed 
0.32 percent of the cake or cake mix, on a dry-weight basis. When used 
with sorbitan monostearate and/or polysorbate 60, it shall not exceed 
0.32 percent, nor shall the sorbitan monostearate exceed 0.61 percent or 
the polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 0.66 percent of the cake or cake mix, all 
calculated on a dry-weight basis.
    (3) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 60;
    (iii) Polysorbate 80;


whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping.
    (4) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.


The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (5) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Sorbitan monostearate.
    (ii) Polysorbate 60.


When used alone, the maximum amount of polysorbate 65 shall not exceed 
0.32 percent of the weight of the cake icing or cake filling. When used 
with sorbitan monostearate and/or polysorbate 60, it shall not exceed 
0.32 percent, nor shall the sorbitan monostearate exceed 0.7 percent or 
the polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 1 percent of the weight of the cake icing or 
cake filling.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]



Sec. 172.840  Polysorbate 80.

    The food additive polysorbate 80 (polyoxyethylene (20) sorbitan 
monooleate), which is a mixture of polyoxyethylene ethers of mixed 
partial oleic acid esters of sorbitol anhydrides and related compounds, 
may be safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting oleic acid 
(usually containing associated fatty acids) with sorbitol to yield a 
product with a maximum acid number of 7.5 and a maximum water content of 
0.5 percent, which is then reacted with ethylene oxide.
    (b) The food additive meets the following specifications:

Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.

    (c) The additive is used or intended for use as follows:
    (1) An emulsifier in ice cream, frozen custard, ice milk, fruit 
sherbet, and nonstandardized frozen desserts, when

[[Page 89]]

used alone or in combination with polysorbate 65 whereby the maximum 
amount of the additives, alone or in combination, does not exceed 0.1 
percent of the finished frozen dessert.
    (2) In yeast-defoamer formulations whereby the maximum amount of the 
additive does not exceed 4 percent of the finished yeast defoamer and 
the maximum amount of the additive in the yeast from such use does not 
exceed 4 parts per million.
    (3) As a solubilizing and dispersing agent in pickles and pickle 
products, whereby the maximum amount of the additive does not exceed 500 
parts per million.
    (4) As a solubilizing and dispersing agent in:
    (i) Vitamin-mineral preparations containing calcium caseinate in the 
absence of fat-soluble vitamins, whereby the maximum intake of 
polysorbate 80 shall not exceed 175 milligrams from the recommended 
daily dose of the preparations.
    (ii) Fat-soluble vitamins in vitamin and vitamin-mineral 
preparations containing no calcium caseinate, whereby the maximum intake 
of polysorbate 80 shall not exceed 300 milligrams from the recommended 
daily dose of the preparations.
    (iii) In vitamin-mineral preparations containing both calcium 
caseinate and fat-soluble vitamins, whereby the maximum intake of 
polysorbate 80 shall not exceed 475 milligrams from the recommended 
daily dose of the preparations.
    (5) As a surfactant in the production of coarse crystal sodium 
chloride whereby the maximum amount of the additive in the finished 
sodium chloride does not exceed 10 parts per million.
    (6) In special dietary foods, as an emulsifier for edible fats and 
oils, with directions for use which provide for the ingestion of not 
more than 360 milligrams of polysorbate 80 per day.
    (7) As a solubilizing and dispersing agent for dill oil in canned 
spiced green beans, not to exceed 30 parts per million.
    (8) As an emulsifier, alone or in combination with polysorbate 60, 
in shortenings and edible oils intended for use in foods as follows, 
when standards of identity established under section 401 of the act do 
not preclude such use:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished shortening or oil.
    (ii) It is used with polysorbate 60 in any combination providing no 
more than 1 percent of polysorbate 80 and no more than 1 percent of 
polysorbate 60, provided that the total combination does not exceed 1 
percent of the finished shortening or oil.
    (iii) The 1-percent limitation specified in paragraph (c)(8) (i) and 
(ii) of this section may be exceeded in premix concentrates of 
shortening or edible oil if the labeling complies with the requirements 
of paragraph (d) of this section.
    (9) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Sorbitan monostearate;
    (ii) Polysorbate 60;
    (iii) Polysorbate 65;


whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping.
    (10) It is used as a wetting agent in scald water for poultry 
defeathering, followed by potable water rinse. The concentration of the 
additive in the scald water does not exceed 0.0175 percent.
    (11) As a dispersing agent in gelatin desserts and in gelatin 
dessert mixes, whereby the amount of the additive does not exceed 0.082 
percent on a dry-weight basis.
    (12) As an adjuvant added to herbicide use and plant-growth 
regulator use dilutions by a grower or applicator prior to application 
of such dilutions to the growing crop. Residues resulting from such use 
are exempt from the requirement of a tolerance. When so used or intended 
for use, the additive shall be exempt from the requirements of paragraph 
(d)(1) of this section.
    (13) As a defoaming agent in the preparation of the creaming mixture 
for cottage cheese and lowfat cottage cheese, as identified in 
Sec. Sec. 133.128 and 133.131 of this chapter, respectively, whereby 
the amount of the additive does not exceed .008 percent by weight of the 
finished products.

[[Page 90]]

    (14) As a surfactant and wetting agent for natural and artificial 
colors for use in barbecue sauce where the level of the additive does 
not exceed 0.005 percent by weight of the barbecue sauce.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final product that complies with the limitations prescribed in 
paragraph (c) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978; 45 
FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981]



Sec. 172.841  Polydextrose.

    Polydextrose as identified in this section may be safely used in 
food in accordance with the following prescribed conditions:
    (a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially 
metabolizable water-soluble polymer prepared by the condensation of a 
melt which consists either of approximately 89 percent D-glucose, 10 
percent sorbitol, and 1 percent citric acid or of approximately 90 
percent D-glucose, 10 percent sorbitol, and 0.1 percent phosphoric acid, 
on a weight basis.
    (2) Polydextrose may be partially neutralized with potassium 
hydroxide, or partially reduced by transition metal catalytic 
hydrogenation in aqueous solution.
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 297-300, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) Polydextrose is used in accordance with current good 
manufacturing practices as a bulking agent, formulation aid, humectant, 
and texturizer in the following foods when standards of identity 
established under section 401 of the act do not preclude such use:
    (1) Baked goods and baking mixes (restricted to fruit, custard, and 
pudding-filled pies, cakes, cookies, and similar baked products);
    (2) Chewing gum;
    (3) Confections and frostings;
    (4) Dressings for salads;
    (5) Film coatings on single and multiple vitamin and mineral 
supplement tablets;
    (6) Frozen dairy desserts and mixes;
    (7) Fruit and water ices;
    (8) Fruit spreads;
    (9) Gelatins, puddings and fillings;
    (10) Hard and soft candy;
    (11) Peanut spread;
    (12) Sweet sauces, toppings, and syrups;
    (13) Tablespreads.
    (d) If the food containing the additive purports to be or is 
represented for special dietary uses, it shall be labeled in compliance 
with part 105 of this chapter.
    (e) The label and labeling of food a single serving of which would 
be expected to exceed 15 grams of the additive shall bear the statement: 
``Sensitive individuals may experience a laxative effect from excessive 
consumption of this product''.

[46 FR 30081, June 5, 1981, as amended at 59 FR 37421, July 22, 1994; 60 
FR 54425, Oct. 24, 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985, June 6, 
1997; 63 FR 57597, Oct. 28, 1998; 65 FR 64605, Oct. 30, 2000; 65 FR 
79719, Dec. 20, 2000]



Sec. 172.842  Sorbitan monostearate.

    The food additive sorbitan monostearate, which is a mixture of 
partial stearic and palmitic acid esters of sorbitol anhydrides, may be 
safely used in or on food in accordance with the following prescribed 
conditions:
    (a) The food additive is manufactured by reacting stearic acid 
(usually containing associated fatty acids, chiefly palmitic) with 
sorbitol to yield essentially a mixture of esters.
    (b) The food additive meets the following specifications:

Saponification number, 147-157

[[Page 91]]

Acid number, 5-10
Hydroxyl number, 235-260

    (c) It is used or intended for use, alone or in combination with 
polysorbate 60 as follows:
    (1) As an emulsifier in whipped edible oil topping with or without 
one or a combination of the following:
    (i) Polysorbate 60;
    (ii) Polysorbate 65;
    (iii) Polysorbate 80;


whereby the maximum amount of the additive or additives used does not 
exceed 0.4 percent of the weight of the finished whipped edible oil 
topping; except that a combination of the additive with polysorbate 60 
may be used in excess of 0.4 percent: Provided, That the amount of the 
additive does not exceed 0.27 percent and the amount of polysorbate 60 
does not exceed 0.77 percent of the weight of the finished whipped 
edible oil topping.
    (2) As an emulsifier in cakes and cake mixes, with or without one or 
a combination of the following:
    (i) Polysorbate 65.
    (ii) Polysorbate 60.


When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.61 percent of the cake or cake mix, on a dry-weight basis. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.61 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of the 
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake 
mix, calculated on a dry-weight basis.
    (3) As an emulsifier, alone or in combination with polysorbate 60 in 
nonstandardized confectionery coatings and standardized cacao products 
specified in Sec. Sec. 163.123, 163.130, 163.135, 163.140, 163.145, and 
163.150 of this chapter, as follows:
    (i) It is used alone in an amount not to exceed 1 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (ii) It is used with polysorbate 60 in any combination of up to 1 
percent sorbitan monostearate and up to 0.5 percent polysorbate 60 
provided that the total combination does not exceed 1 percent of the 
weight of the finished nonstandardized confectionery coating or 
standardized cacao product.
    (4) As an emulsifier in cake icings and cake fillings, with or 
without one or a combination of the following:
    (i) Polysorbate 65.
    (ii) Polysorbate 60.


When used alone, the maximum amount of sorbitan monostearate shall not 
exceed 0.7 percent of the weight of the cake icing or cake filling. When 
used with polysorbate 65 and/or polysorbate 60, it shall not exceed 0.7 
percent, nor shall the polysorbate 65 exceed 0.32 percent or the 
polysorbate 60 exceed 0.46 percent, and no combination of these 
emulsifiers shall exceed 1 percent of the weight of the cake icing or 
cake filling.
    (5) As an emulsifier in solid-state, edible vegetable fat-water 
emulsions intended for use as substitutes for milk or cream in beverage 
coffee, with or without one or a combination of the following:
    (i) Polysorbate 60.
    (ii) Polysorbate 65.


The maximum amount of the additive or additives shall not exceed 0.4 
percent by weight of the finished edible vegetable fat-water emulsion.
    (6) It is used alone as a rehydration aid in the production of 
active dry yeast in an amount not to exceed 1 percent by weight of the 
dry yeast.
    (7) As an emulsifier, alone or in combination with polysorbate 60, 
in the minimum quantity required to accomplish the intended effect, in 
formulations of white mineral oil conforming with Sec. 172.878 and/or 
petroleum wax conforming with Sec. 172.886 for use as protective 
coatings on raw fruits and vegetables.
    (d) To assure safe use of the additive, in addition to the other 
information required by the Act:
    (1) The label of the additive and any intermediate premixes shall 
bear:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling shall bear adequate directions to provide 
a final

[[Page 92]]

product that complies with the limitations prescribed in paragraph (c) 
of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978]



Sec. 172.844  Calcium stearoyl-2-lactylate.

    The food additive calcium stearoyl-2-lactylate may be safely used in 
or on food in accordance with the following prescribed conditions:
    (a) The additive, which is a mixture of calcium salts of stearoyl 
lactylic acids and minor proportions of other calcium salts of related 
acids, is manufactured by the reaction of stearic acid and lactic acid 
and conversion to the calcium salts.
    (b) The additive meets the following specifications:

Acid number, 50-86.
Calcium content, 4.2-5.2 percent.
Lactic acid content, 32-38 percent.
Ester number, 125-164.

    (c) It is used or intended for use as follows:
    (1) As a dough conditioner in yeast-leavened bakery products and 
prepared mixes for yeast-leavened bakery products in an amount not to 
exceed 0.5 part for each 100 parts by weight of flour used.
    (2) As a whipping agent in:
    (i) Liquid and frozen egg white at a level not to exceed 0.05 
percent.
    (ii) Dried egg white at a level not to exceed 0.5 percent.
    (iii) Whipped vegetable oil topping at a level not to exceed 0.3 
percent of the weight of the finished whipped vegetable oil topping.
    (3) As a conditioning agent in dehydrated potatoes in an amount not 
to exceed 0.5 percent by weight thereof.
    (d) To assure safe use of the additive:
    (1) The label and labeling of the food additive and any intermediate 
premix prepared therefrom shall bear, in addition to the other 
information required by the act, the following:
    (i) The name of the additive.
    (ii) A statement of the concentration or strength of the additive in 
any intermediate premixes.
    (2) The label or labeling of the food additive shall also bear 
adequate directions of use to provide a finished food that complies with 
the limitations prescribed in paragraph (c) of this section.



Sec. 172.846  Sodium stearoyl lactylate.

    The food additive sodium stearoyl lactylate (CAS Reg. No. 25-383-
997) may be safely used in food in accordance with the following 
prescribed conditions:
    (a) The additive, which is a mixture of sodium salts of stearoyl 
lactylic acids and minor proportions of sodium salts of related acids, 
is manufactured by the reaction of stearic acid and lactic acid and 
conversion to the sodium salts.
    (b) The additive meets the specifications of the ``Food Chemicals 
Codex,'' 3d Ed. (1981), pp. 300-301, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) It is used or intended for use as follows when standards of 
identity established under section 401 of the Act do not preclude such 
use:
    (1) As a dough strengthener, emulsifier, or processing aid in baked 
products, pancakes, and waffles, in an amount not to exceed 0.5 part for 
each 100 parts by weight of flour used.
    (2) As a surface-active agent, emulsifier, or stabilizer in icings, 
fillings, puddings, and toppings, at a level not to exceed 0.2 percent 
by weight of the finished food.
    (3) As an emulsifier or stabilizer in liquid and solid edible fat-
water emulsions intended for use as substitutes for milk or cream in 
beverage coffee, at a level not to exceed 0.3 percent by weight of the 
finished edible fat-water emulsion.
    (4) As a formulation aid, processing aid, or surface-active agent in 
dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry 
weight of the food.
    (5) As an emulsifier, stabilizer, or texturizer in snack dips, at a 
level not to exceed 0.2 percent by weight of the finished product.
    (6) As an emulsifier, stabilizer, or texturizer in cheese 
substitutes and

[[Page 93]]

imitations and cheese product substitutes and imitations, at a level not 
to exceed 0.2 percent by weight of the finished food.
    (7) As an emulsifier, stabilizer, or texturizer in sauces or 
gravies, and the products containing the same, in an amount not to 
exceed 0.25 percent by weight of the finished food.
    (8) In prepared mixes for each of the foods listed in paragraphs (c) 
(1) through (7) of this section, provided the additive is used only as 
specified in each of those paragraphs.
    (9) As an emulsifier, stabilizer, or texturizer in cream liqueur 
drinks, at a level not to exceed 0.5 percent by weight of the finished 
product.

[45 FR 51767, Aug. 5, 1980, as amended at 49 FR 10105, Mar. 19, 1984; 50 
FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. 27, 
1986; 65 FR 60859, Oct. 13, 2000]



Sec. 172.848  Lactylic esters of fatty acids.

    Lactylic esters of fatty acids may be safely used in food in 
accordance with the following prescribed conditions:
    (a) They are prepared from lactic acid and fatty acids meeting the 
requirements of Sec. 172.860(b) and/or oleic acid derived from tall oil 
fatty acids meeting the requirements of Sec. 172.862.
    (b) They are used as emulsifiers, plasticizers, or surface-active 
agents in the following foods, when standards of identity do not 
preclude their use:

------------------------------------------------------------------------
                   Foods                             Limitations
------------------------------------------------------------------------
Bakery mixes..............................  ............................
Baked products............................  ............................
Cake icings, fillings, and toppings.......  ............................
Dehydrated fruits and vegetables..........  ............................
Dehydrated fruit and vegetable juices.....  ............................
Edible vegetable fat-water emulsions......  As substitutes for milk or
                                             cream in beverage coffee.
Frozen desserts...........................  ............................
Liquid shortening.........................  For household use.
Pancake mixes.............................  ............................
Precooked instant rice....................  ............................
Pudding mixes.............................  ............................
------------------------------------------------------------------------

    (c) They are used in an amount not greater than required to produce 
the intended physical or technical effect, and they may be used with 
shortening and edible fats and oils when such are required in the foods 
identified in paragraph (b) of this section.



Sec. 172.850  Lactylated fatty acid esters of glycerol and propylene 
glycol.

    The food additive lactylated fatty acid esters of glycerol and 
propylene glycol may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additive is a mixture of esters produced by the lactylation 
of a product obtained by reacting edible fats or oils with propylene 
glycol.
    (b) The additive meets the following specifications: Water insoluble 
combined lactic acid, 14-18 percent; and acid number, 12 maximum.
    (c) It is used in amounts not in excess of that reasonably required 
to produce the intended physical effect as an emulsifier, plasticizer, 
or surface-active agent in food.



Sec. 172.852  Glyceryl-lacto esters of fatty acids.

    Glyceryl-lacto esters of fatty acids (the lactic acid esters of 
mono- and diglycerides) may be safely used in food in accordance with 
the following prescribed conditions:
    (a) They are manufactured from glycerin, lactic acid, and fatty 
acids conforming with Sec. 172.860 and/or oleic acid derived from tall 
oil fatty acids conforming with Sec. 172.862 and/or edible fats and 
oils.
    (b) They are used in amounts not in excess of those reasonably 
required to accomplish their intended physical or technical effect as 
emulsifiers and plasticizers in food.



Sec. 172.854  Polyglycerol esters of fatty acids.

    Polyglycerol esters of fatty acids, up to and including the 
decaglycerol esters, may be safely used in food in accordance with the 
following prescribed conditions:
    (a) They are prepared from corn oil, cottonseed oil, lard, palm oil 
from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and 
tallow and the fatty acids derived from these substances (hydrogenated 
and nonhydrogenated) meeting the requirements of Sec. 172.860(b) and/or 
oleic acid derived from tall oil fatty acids meeting the requirements of 
Sec. 172.862.
    (b) They are used as emulsifiers in food, in amounts not greater 
than that

[[Page 94]]

required to produce the intended physical or technical effect.
    (c) Polyglycerol esters of a mixture of stearic, oleic, and coconut 
fatty acids are used as a cloud inhibitor in vegetable and salad oils 
when use is not precluded by standards of identity. The fatty acids used 
in the production of the polyglycerol esters meet the requirements of 
Sec. 172.860(b), and the polyglycerol esters are used at a level not in 
excess of the amount required to perform its cloud-inhibiting effect. 
Oleic acid derived from tall oil fatty acids conforming with Sec. 
172.862 may be used as a substitute for or together with the oleic acid 
permitted by this paragraph.
    (d) Polyglycerol esters of butter oil fatty acids are used as 
emulsifiers in combination with other approved emulsifiers in dry, 
whipped topping base. The fatty acids used in the production of the 
polyglycerol esters meet the requirements of Sec. 172.860(b), and the 
polyglycerol esters are used at a level not in excess of the amount 
required to perform their emulsifying effect.



Sec. 172.856  Propylene glycol mono- and diesters of fats and fatty acids.

    Propylene glycol mono- and diesters of fats and fatty acids may be 
safely used in food, subject to the following prescribed conditions:
    (a) They are produced from edible fats and/or fatty acids in 
compliance with Sec. 172.860 and/or oleic acid derived from tall oil 
fatty acids in compliance with Sec. 172.862.
    (b) They are used in food in amounts not in excess of that 
reasonably required to produce their intended effect.



Sec. 172.858  Propylene glycol alginate.

    The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2) 
may be used as an emulsifier, flavoring adjuvant, formulation aid, 
stabilizer, surfactant, or thickener in foods in accordance with the 
following prescribed conditions:
    (a) The additive meets the specifications of the Food Chemicals 
Codex, 3d Ed. (1981), p. 256, which is incorporated by reference (copies 
are available from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20418, or available for inspection at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408), and the additional specification that it shall 
have up to 85 percent of the carboxylic acid groups esterified with the 
remaining groups either free or neutralized.
    (b) The additive is used or intended for use in the following foods 
as defined in Sec. 170.3(n) of this chapter, when standards of identity 
established under section 401 of the act do not preclude such use:
    (1) As a stabilizer in frozen dairy desserts, in fruit and water 
ices, and in confections and frostings at a level not to exceed 0.5 
percent by weight of the finished product.
    (2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener 
in baked goods at a level not to exceed 0.5 percent by weight of the 
finished product.
    (3) As an emulsifier, stabilizer, or thickener in cheeses at a level 
not to exceed 0.9 percent by weight of the finished product.
    (4) As an emulsifier, stabilizer, or thickener in fats and oils at a 
level not to exceed 1.1 percent by weight of the finished product.
    (5) As an emulsifier, stabilizer, or thickener in gelatins and 
puddings at a level not to exceed 0.6 percent by weight of the finished 
product.
    (6) As a stabilizer or thickener in gravies and in sweet sauces at a 
level not to exceed 0.5 percent by weight of the finished product.
    (7) As a stabilizer in jams and jellies at a level not to exceed 0.4 
percent by weight of the finished product.
    (8) As an emulsifier, stabilizer, or thickener in condiments and 
relishes at a level not to exceed 0.6 percent by weight of the finished 
product.
    (9) As a flavoring adjunct or adjuvant in seasonings and flavors at 
a level not to exceed 1.7 percent by weight of the finished product.
    (10) As an emulsifier, flavoring adjuvant, formulation aid, 
stabilizer or thickener, or surface active agent in other foods, where 
applicable, at a level not to exceed 0.3 percent by weight of the 
finished product.
    (c) To ensure safe use of the additive, the label of the food 
additive container shall bear, in addition to the other information 
required by the act:

[[Page 95]]

    (1) The name of the additive, ``propylene glycol alginate'' or 
``propylene glycol ester of alginic acid''.
    (2) Adequate directions for use.

[47 FR 29950, July 9, 1982]



Sec. 172.859  Sucrose fatty acid esters.

    Sucrose fatty acid esters identified in this section may be safely 
used in accordance with the following prescribed conditions:
    (a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of 
sucrose with fatty acids and are derived from sucrose and edible tallow 
or hydrogenated edible tallow or edible vegetable oils. The only 
solvents which may be used in the preparation of sucrose fatty acid 
esters are those generally recognized as safe in food or regulated for 
such use by an appropriate section in this part. Ethyl acetate or methyl 
ethyl ketone or dimethyl sulfoxide and isobutyl alcohol (2-methyl-1-
propanol) may be used in the preparation of sucrose fatty acid esters.
    (b) Sucrose fatty acid esters meet the following specifications:
    (1) The total content of mono-, di-, and tri-esters is not less than 
80 percent as determined by a method title ``Sucrose Fatty Acid Esters, 
Method of Assay,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (2) The free sucrose content is not more than 5 percent as 
determined by Test S.2 in the method titled ``Sucrose Fatty Acid Esters, 
Method of Assay,'' which is incorporated by reference. The availability 
of this incorporation by reference is given in paragraph (b)(1) of this 
section.
    (3) The acid value is not more than 6.
    (4) The residue on ignition (sulfated ash) is not more than 2 
percent.
    (5) The total ethyl acetate content is not more than 350 parts per 
million as determined by a method titled ``Determination of Ethyl 
Acetate,'' which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (6) Arsenic is not more than 3 parts per million.
    (7) Total heavy metal content (as Pb) is not more than 50 parts per 
million.
    (8) Lead is not more than 10 parts per million.
    (9) The total content of methyl ethyl ketone or of methanol shall 
not be more than 10 parts per million as determined by a method titled 
``Methyl Ethyl Ketone Test; Methyl Alcohol Test,'' which is incorporated 
by reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (10) The total dimethyl sulfoxide content is not more than 2 parts 
per million as determined by a method entitled ``Determination of 
Dimethyl Sulfoxide,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (11) The total isobuytl alcohol (2-methyl-1-propanol) content is not 
more than 10 parts per million as determined by a method entitled 
``Determination of Isobutyl Alcohol,'' which is incorporated by 
reference. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (c) Sucrose fatty acid esters may be used as follows when standards 
of identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act do not preclude such use:

[[Page 96]]

    (1) As emulsifiers as defined in Sec. 170.3(o)(8) of this chapter, 
or as stabilizers as defined in Sec. 170.3(o)(28) of this chapter, in 
baked goods and baking mixes as defined in Sec. 170.3(n)(1) of this 
chapter, in chewing gum as defined in Sec. 170.3(n)(6) of this chapter, 
in coffee and tea beverages with added dairy ingredients and/or dairy 
product analogues, in confections and frostings as defined in Sec. 
170.3(n)(9) of this chapter, in dairy product analogues as defined in 
Sec. 170.3(n)(10) of this chapter, in frozen dairy desserts and mixes 
as defined in Sec. 170.3(n)(20) of this chapter, and in whipped milk 
products.
    (2) As texturizers as defined in Sec. 170.3(o)(32) of this chapter 
in biscuit mixes, in chewing gum as defined in Sec. 170.3(n)(6) of this 
chapter, in confections and frostings as defined in Sec. 170.3(n)(9) of 
this chapter, and in surimi-based fabricated seafood products.
    (3) As components of protective coatings applied to fresh apples, 
avocados, bananas, banana plantains, limes, melons (honeydew and 
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard 
ripening and spoiling.
    (d) Sucrose fatty acid esters are used in accordance with current 
good manufacturing practice and in an amount not to exceed that 
reasonably required to accomplish the intended effect.

[47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23, 1983; 
52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988; 54 FR 
24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995]



Sec. 172.860  Fatty acids.

    The food additive fatty acids may be safely used in food and in the 
manufacture of food components in accordance with the following 
prescribed conditions:
    (a) The food additive consists of one or any mixture of the 
following straight-chain monobasic carboxylic acids and their associated 
fatty acids manufactured from fats and oils derived from edible sources: 
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid, 
palmitic acid, and stearic acid.
    (b) The food additive meets the following specifications:
    (1) Unsaponifiable matter does not exceed 2 percent.
    (2) It is free of chick-edema factor:
    (i) As evidenced during the bioassay method for determining the 
chick-edema factor as prescribed in paragraph (c)(2) of this section; or
    (ii) As evidenced by the absence of chromatographic peaks with a 
retention time relative to aldrin (RA) between 10 and 25, using the gas 
chromatographic-electron capture method prescribed in paragraph (c)(3) 
of this section. If chromatographic peaks are found with RA values 
between 10 and 25, the food additive shall meet the requirements of the 
bioassay method prescribed in paragraph (c)(2) of this section for 
determining chick-edema factor.
    (c) For the purposes of this section:
    (1) Unsaponifiable matter shall be determined by the method 
described in the 13th Ed. (1980) of the ``Official Methods of Analysis 
of the Association of Official Analytical Chemists,'' which is 
incorporated by reference. Copies are available from the Association of 
Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or available for inspection at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.
    (2) Chick-edema factor shall be determined by the bioassay method 
described in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' 13th Ed. (1980), sections 28.127-28.130, 
which is incorporated by reference. Copies may be obtained from the 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (3) The gas chromatographic-electron capture method for testing 
fatty acids for chick-edema shall be the method described in the 
``Journal of the Association of Official Analytical Chemists,'' Volume 
50 (No. 1), pages 216-218 (1967), or the modified method using a 
sulfuric acid clean-up procedure, as described in the ``Journal of the 
Association of the Offical Analytical Chemists,'' Volume 51 (No. 2), 
pages 489-490

[[Page 97]]

(1968), which are incorporated by reference. See paragraph (c)(2) of 
this section for availability of these references.
    (d) It is used or intended for use as follows:
    (1) In foods as a lubricant, binder, and as a defoaming agent in 
accordance with good manufacturing practice.
    (2) As a component in the manufacture of other food-grade additives.
    (e) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the act, the following:
    (1) The common or usual name of the acid or acids contained therein.
    (2) The words ``food grade,'' in juxtaposition with and equally as 
prominent as the name of the acid.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.861  Cocoa butter substitute from coconut oil, palm kernel oil, 
or both oils.

    The food additive, cocoa butter substitute from coconut oil, palm 
kernel oil, or both oils, may be safely used in food in accordance with 
the following conditions:
    (a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS 
Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is 
manufactured by esterification of glycerol with food-grade fatty acids 
(complying with Sec. 172.860) derived from edible coconut oil, edible 
palm kernel oil, or both oils.
    (b) The ingredient meets the following specifications:

Acid number: Not to exceed 0.5.
Saponification number: 220 to 260.
Iodine number: Not to exceed 3.
Melting range: 30 to 44 [deg]C.

    (c) The ingredient is used or intended for use as follows:
    (1) As coating material for sugar, table salt, vitamins, citric 
acid, succinic acid, and spices; and
    (2) In compound coatings, cocoa creams, cocoa-based sweets, toffees, 
caramel masses, and chewing sweets as defined in Sec. 170.3 (n)(9) and 
(n)(38) of this chapter, except that the ingredient may not be used in a 
standardized food unless permitted by the standard of identity.
    (d) The ingredient is used in accordance with current good 
manufacturing practice and in an amount not to exceed that reasonably 
required to accomplish the intended effect.

[56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992]



Sec. 172.862  Oleic acid derived from tall oil fatty acids.

    The food additive oleic acid derived from tall oil fatty acids may 
be safely used in food and as a component in the manufacture of food-
grade additives in accordance with the following prescribed conditions:
    (a) The additive consists of purified oleic acid separated from 
refined tall oil fatty acids.
    (b) The additive meets the following specifications:
    (1) Specifications for oleic acid prescribed in the ``Food Chemicals 
Codex.'' 3d Ed. (1981), pp. 207-208, which is incorporated by reference, 
except that titer (solidification point) shall not exceed 13.5 [deg]C 
and unsaponifiable matter shall not exceed 0.5 percent. Copies of the 
material incorporated by reference may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) The resin acid content does not exceed 0.01 as determined by 
ASTM method D1240-82, ``Standard Test Method for Rosin Acids in Fatty 
Acids,'' which is incorporated by reference. Copies may be obtained from 
the American Society for Testing Materials, 1916 Race St., Philadelphia, 
PA 19103, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (3) The requirements for absence of chick-edema factor as prescribed 
in Sec. 172.860.
    (c) It is used or intended for use as follows:
    (1) In foods as a lubricant, binder, and defoaming agent in 
accordance with good manufacturing practice.

[[Page 98]]

    (2) As a component in the manufacture of other food-grade additives.
    (d) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The common or usual name of the acid.
    (2) The words ``food grade'' in juxtaposition with and equally as 
prominent as the name of the acid.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.863  Salts of fatty acids.

    The food additive salts of fatty acids may be safely used in food 
and in the manufacture of food components in accordance with the 
following prescribed conditions:
    (a) The additive consists of one or any mixture of two or more of 
the aluminum, calcium, magnesium, potassium, and sodium salts of the 
fatty acids conforming with Sec. 172.860 and/or oleic acid derived from 
tall oil fatty acids conforming with Sec. 172.862.
    (b) The food additive is used or intended for use as a binder, 
emulsifier, and anticaking agent in food in accordance with good 
manufacturing practice.
    (c) To assure safe use of the additive, the label and labeling of 
the additive and any premix thereof shall bear, in addition to the other 
information required by the Act, the following:
    (1) The common or usual name of the fatty acid salt or salts 
contained therein.
    (2) The words ``food grade,'' in juxtaposition with and equally as 
prominent as the name of the salt.



Sec. 172.864  Synthetic fatty alcohols.

    Synthetic fatty alcohols may be safely used in food and in the 
synthesis of food components in accordance with the following prescribed 
conditions:
    (a) The food additive consists of any one of the following fatty 
alcohols:
    (1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl; 
manufactured by fractional distillation of alcohols obtained by a 
sequence of oxidation and hydrolysis of organo-aluminums generated by 
the controlled reaction of low molecular weight trialkylaluminum with 
purified ethylene (minimum 99 percent by volume 
C2H4), and utilizing the hydrocarbon solvent as 
defined in paragraph (b) of this section, such that:
    (i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not 
less than 99 percent of total alcohols and not less than 96 percent of 
straight chain alcohols. Any nonalcoholic impurities are primarily 
paraffins.
    (ii) Cetyl and stearyl alcohols contain not less than 98 percent of 
total alcohols and not less than 94 percent of straight chain alcohols. 
Any nonalcoholic impurities are primarily paraffins.
    (iii) The synthetic fatty alcohols contain no more than 0.1 weight 
percent of total diols as determined by a method available upon request 
from the Commissioner of Food and Drugs.
    (2) Hexyl, octyl, and decyl; manufactured by fractional distillation 
of alcohols obtained by a sequence of oxidation, hydrolysis, and 
catalytic hydrogenation (catalyst consists of copper, chromium, and 
nickel) of organo-aluminums generated by the controlled reaction of low 
molecular weight trialkylaluminum with purified ethylene (minimum 99 
percent by volume C2H4), and utilizing an external 
coolant such that these alcohols meet the specifications prescribed in 
paragraph (a)(1) (i) and (iii) of this section.
    (b) The hydrocarbon solvent used in the process described in 
paragraph (a)(1) of this section is a mixture of liquid hydrocarbons 
essentially paraffinic in nature, derived from petroleum and refined to 
meet the specifications described in paragraph (b)(1) of this section 
when subjected to the procedures described in paragraph (b) (2) and (3) 
of this section.
    (1) The hydrocarbon solvent meets the following specifications:
    (i) Boiling-point range: 175 [deg]C-275 [deg]C.
    (ii) Ultraviolet absorbance limits as follows:

------------------------------------------------------------------------
                                                                Maximum
                                                              absorbance
                                                                  per
                   Wavelength (millicrons)                    centimeter
                                                                optical
                                                                 path
                                                                length
------------------------------------------------------------------------
280-289.....................................................        0.15
290-299.....................................................         .12
300-359.....................................................         .05

[[Page 99]]

 
360-400.....................................................         .02
------------------------------------------------------------------------

    (2) Use ASTM method D86-82, ``Standard Method for Distillation of 
Petroleum Products,'' which is incorporated by reference, to determine 
boiling point range. Copies of the material incorporated by reference 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (3) The analytical method for determining ultraviolet absorbance 
limits is as follows:

                          General Instructions

    All glassware should be scrupulously cleaned to remove all organic 
matter such as oil, grease, detergent residues, etc. Examine all 
glassware, including stoppers and stopcocks, under ultraviolet light to 
detect any residual fluorescent contamination. As a precautionary 
measure, it is recommended practice to rinse all glassware with purified 
isooctane immediately before use. No grease is to be used on stopcocks 
or joints. Great care to avoid contamination of hydrocarbon solvent 
samples in handling and to assure absence of any extraneous material 
arising from inadequate packaging is essential. Because some of the 
polynuclear hydrocarbons sought in this test are very susceptible to 
photo-oxidation, the entire procedure is to be carried out under subdued 
light.

                                Apparatus

    Chromatographic tube. 450 millimeters in length (packing section), 
inside diameter 19 millimeters 1 millimeter, 
equipped with a wad of clean Pyrex brand filtering wool (Corning Glass 
Works Catalog No. 3950 or equivalent). The tube shall contain a 250-
milliliter reservoir and a 2-millimeter tetrafluoroethylene polymer 
stopcock at the opposite end. Overall length of the tube is 670 
millimeters.
    Stainless steel rod. 2 feet in length, 2 to 4 millimeters in 
diameter.
    Vacuum oven. Similar to Labline No. 3610 but modified as follows: A 
copper tube one-fourth inch in diameter and 13 inches in length is bent 
to a right angle at the 4-inch point and plugged at the opposite end; 
eight copper tubes one-eighth inch in diameter and 5 inches in length 
are silver soldered in drilled holes (one-eighth inch in diameter) to 
the one-fourth-inch tube, one on each side at the 5-, 7.5-, 10- and 
12.5-inch points; the one-eighth-inch copper tubes are bent to conform 
with the inner periphery of the oven.
    Beakers. 250-milliliter and 500-milliliter capacity.
    Graduated cylinders. 25-milliliter, 50-milliliter, and 150-
milliliter capacity.
    Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge 
needle.
    Volumetric flask. 5-milliliter capacity.
    Spectrophotometric cells. Fused quartz ground glass stoppered cells, 
optical path length in the range of 1.000 centimeter 0.005 centimeter. With distilled water in the cells, 
determine any absorbance difference.
    Spectrophotometer. Spectral range 250 millimicrons--400 millimicrons 
with spectral slit width of 2 millimicrons or less: under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, 0.01 at 0.4 
absorbance.
    Absorbance accuracy,\1\ 0.05 at 0.4 
absorbance.
---------------------------------------------------------------------------

    \1\ As determined by using potassium chromate for reference standard 
and described in National Bureau of Standards Circular 484, 
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is 
to be determined by comparison with the standard values at 290, 345, and 
400 millimicrons. Circular 484 is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 millimicron.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         Reagents and Materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane, benzene, hexane, and 1,2-dichloroethane designated in the 
list following this paragraph shall pass the following test:
    To the specified quantity of solvent in a 250-milliliter beaker, add 
1 milliliter of purified n-hexadecane and evaporate in the vacuum oven 
under a stream of nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. (To the residue from

[[Page 100]]

benzene add a 5-milliliter portion of purified isooctane, reevaporate, 
and repeat once to insure complete removal of benzene.)
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 5 milliliters volume. Determine the absorbance in the 1-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue shall not exceed 0.02 
per centimeter path length between 280 and 300 m[mu] and shall not 
exceed 0.01 per centimeter path length between 300 and 400 m[mu].
    Isooctane (2,2,4-trimethylpentane). Use 10 milliliters for the test 
described in the preceding paragraph. If necessary, isooctane may be 
purified by passage through a column of activated silica gel (Grade 12, 
Davison Chemical Co., Baltimore, Md., or equivalent).
    Benzene, spectro grade (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If 
necessary, benzene may be purified by distillation or otherwise.
    Hexane, spectro grade (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 650 milliliters for the test. If 
necessary, hexane may be purified by distillation or otherwise.
    1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East 
Rutherford, N.J., or equivalent). Use 20 milliliters for test. If 
necessary, 1,2-dichloroethane may be purified by distillation.
    Eluting mixtures:
    1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of 
1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and 
adjust to volume with hexane, with mixing.
    2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene 
into a 1-liter glass-stoppered volumetric flask and adjust to volume 
with hexane, with mixing.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 5 milliliters with isooctane and determine the absorbance 
in a 1-centimeter cell compared to isooctane as reference between 280 
m[mu]-400m[mu]. The absorbance per centimeter path length shall not 
exceed 0.00 in this range. If necessary, n-hexadecane may be purified by 
percolation through activated silica gel or by distillation.
    Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore, 
Md., or equivalent). Activate as follows: Weigh about 900 grams into a 
1-gallon bottle, add 100 milliliters of de-ionized water, seal the 
bottle and shake and roll at intervals for 1 hour. Allow to equilibrate 
overnight in the sealed bottle. Activate the gel at 150 [deg]C for 16 
hours, in a 2-inch x 7-inch x 12-inch porcelain pan loosely covered with 
aluminum foil, cool in a dessicator, transfer to a bottle and seal.

                                Procedure

    Determination of ultraviolet absorbance. Before proceeding with the 
analysis of a sample determine the absorbance in a 1-centimeter path 
cell for the reagent blank by carrying out the procedure without a 
sample. Record the absorbance in the wavelength range of 280 to 400 
millimicrons. Typical reagent blank absorbance in this range should not 
exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359 
millimicron range, and 0.01 in the 360 to 400 millimicron range. If the 
characteristic benzene peaks in the 250 to 260 millimicron region are 
present, remove the benzene by the procedure described above under 
``Reagents and Materials,'' ``Organic Solvents,'' and record absorbance 
again.
    Transfer 50 grams of silica gel to the chromatographic tube for 
sample analysis. Raise and drop the column on a semisoft, clean surface 
for about 1 minute to settle the gel. Pour 100 milliliters of hexane 
into the column with the stopcock open and allow to drain to about one-
half inch above the gel. Turn off the stopcock and allow the column to 
cool for 30 minutes. After cooling, vibrate the column to eliminate air 
and stir the top 1 to 2 inches with a small diameter stainless steel 
rod. Take care not to get the gel above the liquid and onto the sides of 
the column.
    Weigh out 40 grams 0.1 gram of the hydrocarbon 
solvent sample into a 250-milliliter beaker, add 50 milliliters of 
hexane, and pour the solution into the column. Rinse the beaker with 50 
milliliters of hexane and add this to the column. Allow the hexane 
sample solution to elute into a 500-milliliter beaker until the solution 
is about one-half inch above the gel. Rinse the column three times with 
50-milliliter portions of hexane. Allow each hexane rinse to separately 
elute to about one-half inch above the gel. Replace the eluate beaker 
(discard the hexane eluate) with a 250-milliliter beaker. Add two 
separate 25-milliliter portions of 10 percent 1,2-dichloroethane and 
allow each to separately elute as before. Finally, add 150 milliliters 
of 10 percent 1,2-dichloroethane for a total of 200 milliliters. When 
the final 10 percent 1,2-dichloroethane fraction is about one-half inch 
above the top of the gel bed, replace the receiving beaker (discard the 
1,2-dichloroethane eluate) with a 250-milliliter beaker containing 1 
milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters 
per minute, add two 25-milliliter portions of 40 percent benzene and 
allow each to separately elute as before to within about one-half inch 
of the gel bed. Finally, add 150 milliliters of 40 percent benzene for a 
total of 200 milliliters. Evaporate the benzene in the oven with vacuum 
and sufficient nitrogen

[[Page 101]]

flow to just ripple the top of the benzene solution. When the benzene is 
removed (as determined by a constant volume of hexadecane) add 5 
milliliters of isooctane and evaporate. Repeat once to insure complete 
removal of benzene. Remove the beaker and cover with aluminum foil 
(previously rinsed with hexane) until cool.
    Quantitatively transfer the hexadecane residue to a 5-milliliter 
volumetric flask and dilute to volume with isooctane. Determine the 
absorbance of the solution in 1-centimeter path length cells between 280 
and 400 millimicrons using isooctane as a reference. Correct the 
absorbance values for any absorbance derived from reagents as determined 
by carrying out the procedure without a sample. If the corrected 
absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii) 
of this section, the sample meets the ultraviolet absorbance 
specifications for hydrocarbon solvent.

    (c) Synthetic fatty alcohols may be used as follows:
    (1) As substitutes for the corresponding naturally derived fatty 
alcohols permitted in food by existing regulations in this part or part 
173 of this chapter provided that the use is in compliance with any 
prescribed limitations.
    (2) As substitutes for the corresponding naturally derived fatty 
alcohols used as intermediates in the synthesis of food additives and 
other substances permitted in food.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19, 1982; 
49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.866  Synthetic glycerin produced by the hydrogenolysis of carbohydrates.

    Synthetic glycerin produced by the hydrogenolysis of carbohydrates 
may be safely used in food, subject to the provisions of this section:
    (a) It shall contain not in excess of 0.2 percent by weight of a 
mixture of butanetriols.
    (b) It is used or intended for use in an amount not to exceed that 
reasonably required to produce its intended effect.



Sec. 172.867  Olestra.

    Olestra, as identified in this section, may be safely used in 
accordance with the following conditions:
    (a) Olestra is a mixture of octa-, hepta-, and hexa-esters of 
sucrose with fatty acids derived from edible fats and oils or fatty acid 
sources that are generally recognized as safe or approved for use as 
food ingredients. The chain lengths of the fatty acids are no less than 
12 carbon atoms.
    (b) Olestra meets the following specifications:
    (1) The total content of octa-, hepta-, and hexa-esters is not less 
than 97 percent as determined by a method entitled ``Determination of 
Olestra by Size Exclusion Chromatography,'' dated December 19, 1995, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the Office of Premarket 
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.
    (2) The content of octa-ester is not less than 70 percent as 
determined by a method entitled ``Measurement of the Relative Ester 
Distribution of Olestra Test Material'' dated December 19, 1995, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the Office of Premarket Approval, 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC.
    (3) The content of hexa-ester is not more than 1 percent as 
determined by the method listed in paragraph (b)(2) of this section.
    (4) The content of penta-ester is not more than 0.5 percent as 
determined by the method listed in paragraph (b)(2) of this section.
    (5) The unsaturated fatty acid content is not less than 25 percent 
(thus not more than 75 percent saturated

[[Page 102]]

fatty acid) and not more than 83 percent as determined by a method 
entitled ``Measurement of the Fatty Acid Composition of Olestra Test 
Material,'' dated December 19, 1995, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the Office of Premarket Approval, Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (6) The content of C12 and C14 fatty acids is each not more than 1 
percent, and total C20 and longer fatty acids is not more than 20 
percent. C16 and C18 fatty acids make up the remainder with total 
content not less than 78 percent as determined by the method listed in 
paragraph (b)(5) of this section.
    (7) The free fatty acid content is not more than 0.5 percent as 
determined by a method entitled ``Free Fatty Acids'' published in the 
Official Methods and Recommended Practices of the American Oil Chemists' 
Society, 3d Ed. (1985) vol. 1, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the American Oil Chemists Society, 1608 Broadmoor Dr., Champaign, 
IL 61821, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the Office of the Federal Register, 800 North Capitol Street, NW., 
suite 700, Washington, DC.
    (8) The residue on ignition (sulfated ash) is not more than 0.5 
percent.
    (9) Total methanol content is not more than 300 parts per million as 
determined by the ``Total Available Methanol Method,'' dated December 
19, 1995, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the Office of 
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740 or may be examined at the Center for Food Safety and 
Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC.
    (10) The total heavy metal content (as Pb) is not more than 10 parts 
per million.
    (11) Lead is not more than 0.1 part per million, as determined by a 
method entitled ``Atomic Absorption Spectrophotometric Graphite Furnace 
Method,'' Food Chemicals Codex, 3d Ed. 3d Supp. p. 168 (1992), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the National Research Council Press, 
2101 Constitution Ave. NW., Washington, DC, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (12) Water is not more than 0.1 percent, as determined by a method 
entitled ``Moisture,'' Official Methods and Recommended Practices of the 
American Oil Chemists' Society, 4th Ed. (1989), vol. 1, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the American Oil Chemists Society, 
1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (13) Peroxide value is not more than 10 meq/kg as determined by a 
method entitled ``Peroxide Value,'' Official Methods and Recommended 
Practices of the American Oil Chemists' Society, 4th Ed. (1989) vol. 1, 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies are available from the American Oil Chemists 
Society, 1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register,

[[Page 103]]

800 North Capitol Street, NW., suite 700, Washington, DC.
    (14) The stiffness is not less than 50 kiloPascals/second, as 
determined by a method entitled ``Method for Measurement of the 
Stiffness of Olestra,'' dated December 19, 1995, which is incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies are available from the Office of Premarket Approval, Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (c) Olestra may be used in place of fats and oils in prepackaged 
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks. In 
such foods, the additive may be used in place of fats and oils for 
frying or baking, in dough conditioners, in sprays, in filling 
ingredients, or in flavors.
    (d) To compensate for any interference with absorption of fat 
soluble vitamins, the following vitamins shall be added to foods 
containing olestra: 1.9 milligrams alpha-tocopherol equivalents per gram 
olestra; 51 retinol equivalents per gram olestra (as retinyl acetate or 
retinyl palmitate); 12 IU vitamin D per gram olestra; and 8 [mu]g 
vitamin K1 per gram olestra.
    (e)(1) Vitamins A, D, E, and K present in foods as a result of the 
requirement in paragraph (d) of this section shall be declared in the 
listing of ingredients. Such vitamins shall not be considered in 
determining nutrient content for the nutritional label or for any 
nutrient claims, express or implied.
    (i) An asterisk shall follow vitamins A, D, E, and K in the listing 
of ingredients;
    (ii) The asterisk shall appear as a superscript following each 
vitamin;
    (iii) Immediately following the ingredient list an asterisk and 
statement, ``Dietarily insignificant'' shall appear prominently and 
conspicuously as specified in Sec. 101.2(c) of this chapter;
    (2) Olestra shall not be considered as a source of fat or calories 
for purposes of Sec. Sec. 101.9 and 101.13 of this chapter.
    (f) Consistent with its obligation to monitor the safety of all 
additives in the food supply, including olestra, the Food and Drug 
Administration will review and evaluate all data and information bearing 
on the safety of olestra received by the agency after the effective date 
of this regulation, and will present such data, information, and 
evaluation to the agency's Food Advisory Committee within 30 months of 
the effective date of this regulation. The purpose of such presentation 
will be to receive advice from the Committee on whether there continues 
to be reasonable certainty that use of olestra in compliance with this 
regulation is not harmful. The agency will hold such additional Food 
Advisory Committee meetings on olestra as the agency determines, in its 
discretion, to be necessary. Based upon the results of this entire 
process, the FDA will initiate any appropriate regulatory proceedings.

[61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21, 1996, as amended at 68 
FR 46402, Aug. 5, 2003]



Sec. 172.868  Ethyl cellulose.

    The food additive ethyl cellulose may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is a cellulose ether containing ethoxy 
(OC2H5) groups attached by an ether linkage and 
containing on an anhydrous basis not more than 2.6 ethoxy groups per 
anhydroglucose unit.
    (b) It is used or intended for use as follows:
    (1) As a binder and filler in dry vitamin preparations.
    (2) As a component of protective coatings for vitamin and mineral 
tablets.
    (3) As a fixative in flavoring compounds.



Sec. 172.869  Sucrose oligoesters.

    Sucrose oligoesters, as identified in this section, may be safely 
used in accordance with the following conditions:
    (a) Sucrose oligoesters consist of mixtures of sucrose fatty acid 
esters with an average degree of

[[Page 104]]

esterification ranging from four to seven. It is produced by 
interesterification of sucrose with methyl esters of fatty acids derived 
from edible fats and oils (including hydrogenated fats and oils). The 
only solvents which may be used in the preparation of sucrose 
oligoesters are dimethyl sulfoxide, isobutyl alcohol, and those solvents 
generally recognized as safe in food.
    (b) Sucrose oligoesters meet the specifications in the methods 
listed in the table in this paragraph. The methods cited for determining 
compliance with each specification are incorporated by reference, in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the methods 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, room 1C-100, 5100 Paint Branch Pkwy., College Park, MD 20740, 
or at the Office of the Federal Register, 800 North Capitol St. NW., 
suite 700, Washington, DC. Copies of the methods are available from the 
sources listed in the table in this paragraph:

----------------------------------------------------------------------------------------------------------------
                                                                                           Source for Obtaining
            Specification                      Limit                  Method Cited                Method
----------------------------------------------------------------------------------------------------------------
(1) Sucrose esters..................  Not less than 90%......  ``Method for Analyzing     Office of Food
                                                                the Purity of Sucrose      Additive Safety,
                                                                Fatty Acid Esters,''       Center for Food
                                                                issued by Mitsubishi       Safety and Applied
                                                                Chemical Corp., June 17,   Nutrition (HFS-200),
                                                                1998.                      Food and Drug
                                                                                           Administration, 5100
                                                                                           Paint Branch Pkwy.,
                                                                                           College Park, MD
                                                                                           20740.
----------------------------------------------------------------------------------------------------------------
(2) Mono-, di-, and tri-esters......  Not more than 45%......  ``Method for Measuring     Do.
                                                                the Ester Distribution
                                                                of Sucrose
                                                                Oligoesters,'' issued by
                                                                Mitsubishi Chemical
                                                                Corp., June 17, 1998.
----------------------------------------------------------------------------------------------------------------
(3) Tetra-, penta-, hexa-, and hepta- Not less than 50%......  Do.                        Do.
 esters.
----------------------------------------------------------------------------------------------------------------
(4) Octa-esters.....................  Not more than 40%......  Do.                        Do.
----------------------------------------------------------------------------------------------------------------
(5) Free Sucrose....................  Not more than 0.5%.....  ``Free Sucrose Method,''   Do.
                                                                issued by Mitsubishi
                                                                Chemical Corp., June 17,
                                                                1998.
----------------------------------------------------------------------------------------------------------------
(6) Acid Value......................  Not more than 4.0......  ``Acid Value,'' Appendix   National Academy
                                                                VII, Method I              Press, 2101
                                                                (Commercial Fatty          Constitution Ave. NW,
                                                                Acids), in the Food        Washington, DC 20418
                                                                Chemicals Codex, 4th ed.   (Internet: http://
                                                                (1996), p. 820.            www.nap.edu).
----------------------------------------------------------------------------------------------------------------
(7) Residue on Ignition.............  Not more than 0.7%.....  ``Residue on Ignition,     Do.
                                                                Appendix IIC, Method I,
                                                                in the Food Chemicals
                                                                Codex, 4th ed. (1996),
                                                                pp. 751-752, (using a 1-
                                                                gram sample).
----------------------------------------------------------------------------------------------------------------
(8) Residual Methanol...............  Not more than 10         Method listed in the       Do.
                                       milligrams/kilogram.     monograph for ``Sucrose
                                                                Fatty Acid Esters'' in
                                                                the First Supplement to
                                                                the 4th ed. of the Food
                                                                Chemicals Codex (1997),
                                                                pp. 44-45.
----------------------------------------------------------------------------------------------------------------
(9) Residual Dimethyl Sulfoxide.....  Not more than 2.0        Do.                        Do.
                                       milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(10) Residual Isobutyl Alcohol......  Not more than 10         Do.                        Do.
                                       milligrams/kilogram.
----------------------------------------------------------------------------------------------------------------
(11) Lead...........................  Not more than 1.0        ``Atomic Absorption        Do.
                                       milligram/kilogram.      Spectrophotometric
                                                                Graphite Furnace
                                                                Method,'' Method I, in
                                                                the Food Chemicals
                                                                Codex, 4th ed. (1996),
                                                                pp. 763-765.
----------------------------------------------------------------------------------------------------------------


[[Page 105]]

    (c) The additive is used as an emulsifier (as defined in Sec. 
170.3(o)(8) of this chapter) or stabilizer (as defined in Sec. 
170.3(o)(28) of this chapter) in chocolate and in butter-substitute 
spreads, at a level not to exceed 2.0 percent; except that the additive 
may not be used in a standardized food unless permitted by the standard 
of identity.

[68 FR 50072, Aug. 20, 2003]



Sec. 172.870  Hydroxypropyl cellulose.

    The food additive hydroxypropyl cellulose may be safely used in 
food, except standardized foods that do not provide for such use, in 
accordance with the following prescribed conditions:
    (a) The additive consists of one of the following:
    (1) A cellulose ether containing propylene glycol groups attached by 
an ether linkage which contains, on an anhydrous basis, not more than 
4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a 
minimum viscosity of 145 centipoises for 10 percent by weight aqueous 
solution at 25 [deg]C.
    (2) A cellulose ether containing propylene glycol groups attached by 
an ether linkage having a hydroxypropoxy (OC3H6OH) 
content of 5 to 16 percent weight in weight (w/w) on an anhydrous basis, 
i.e., 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit. The 
common name for this form of the additive is low substituted 
hydroxypropyl cellulose.
    (b) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a)(1) of this section is 
used or intended for use as an emulsifier, film former, protective 
colloid, stabilizer, suspending agent, or thickener, in accordance with 
good manufacturing practice.
    (2) The additive identified in paragraph (a)(2) of this section is 
used or intended for use as a binder and disintegrator in tablets or 
wafers containing dietary supplements of vitamins and/or minerals. The 
additive is used in accordance with good manufacturing practice.

[46 FR 50065, Oct. 9, 1981]



Sec. 172.872  Methyl ethyl cellulose.

    The food additive methyl ethyl cellulose may be safely used in food 
in accordance with the following prescribed conditions.
    (a) The additive is a cellulose ether having the general formula 
[C6H(10	x	
y)O5(CH3)x(C2H5)y]n, where x 
is the number of methyl groups and y is the number of ethyl groups. The 
average value of x is 0.3 and the average value of y is 0.7.
    (b) The additive meets the following specifications:
    (1) The methoxy content shall be not less than 3.5 percent and not 
more than 6.5 percent, calculated as OCH3, and the ethoxy 
content shall be not less than 14.5 percent and not more than 19 
percent, calculated as OC2H5, both measured on the 
dry sample.
    (2) The viscosity of an aqueous solution, 2.5 grams of the material 
in 100 milliliters of water, at 20 [deg]C, is 20 to 60 centipoises.
    (3) The ash content on a dry basis has a maximum of 0.6 percent.
    (c) The food additive is used as an aerating, emulsifying, and 
foaming agent, in an amount not in excess of that reasonably required to 
produce its intended effect.



Sec. 172.874  Hydroxypropyl methylcellulose.

    The food additive hydroxypropyl methylcellulose (CAS Reg. No. 9004-
65-3) may be safely used in food, except in standardized foods which do 
not provide for such use if:
    (a) The additive complies with the definition and specifications 
prescribed in the National Formulary, 12th edition.
    (b) It is used or intended for use as an emulsifier, film former, 
protective colloid, stabilizer, suspending agent, or thickener, in 
accordance with good manufacturing practice.
    (c) To insure safe use of the additive, the container of the 
additive, in addition to being labeled as required by the general 
provisions of the act, shall be accompanied by labeling which contains 
adequate directions for use to provide a final product that complies

[[Page 106]]

with the limitations prescribed in paragraph (b) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 38273, Aug. 31, 1982]



Sec. 172.876  Castor oil.

    The food additive castor oil may be safely used in accordance with 
the following conditions:
    (a) The additive meets the specifications of the United States 
Pharmacopeia XX (1980).
    (b) The additive is used or intended for use as follows:

                           Use and Limitations

    Hard candy production--As a release agent and antisticking agent, 
not to exceed 500 parts per million in hard candy.
    Vitamin and mineral tablets--As a component of protective coatings.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.878  White mineral oil.

    White mineral oil may be safely used in food in accordance with the 
following conditions:
    (a) White mineral oil is a mixture of liquid hydrocarbons, 
essentially paraffinic and naphthenic in nature obtained from petroleum. 
It is refined to meet the following specifications:
    (1) It meets the test requirements of the United States Pharmacopeia 
XX (1980) for readily carbonizable substances (page 532).
    (2) It meets the test requirements of U.S.P. XVII for sulfur 
compounds (page 400).
    (3) It meets the specifications prescribed in the ``Journal of the 
Association of Official Analytical Chemists,'' Volume 45, page 66 
(1962), which is incorporated by reference, after correction of the 
ultraviolet absorbance for any absorbance due to added antioxidants. 
Copies of the material incorporated by reference are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (b) White mineral oil may contain any antioxidant permitted in food 
by regulations issued in accordance with section 409 of the Act, in an 
amount not greater than that required to produce its intended effect.
    (c) White mineral oil is used or intended for use as follows:

------------------------------------------------------------------------
                                               Limitation (inclusive of
                                              all petroleum hydrocarbons
                     Use                          that may be used in
                                                combination with white
                                                     mineral oil)
------------------------------------------------------------------------
1. As a release agent, binder, and lubricant  Not to exceed 0.6% of the
 in or on capsules and tablets containing      capsule or tablet.
 concentrates of flavoring, spices,
 condiments, and nutrients intended for
 addition to food, excluding confectionery.
2. As a release agent, binder, and lubricant  Not to exceed 0.6% of the
 in or on capsules and tablets containing      capsule or tablet.
 food for special dietary use.
3. As a float on fermentation fluids in the   In an amount not to exceed
 manufacture of vinegar and wine to prevent    good manufacturing
 or retard access of air, evaporation, and     practice.
 wild yeast contamination during
 fermentation.
4. As a defoamer in food....................  In accordance with Sec.
                                               173.340 of this chapter.
5. In bakery products, as a release agent     Not to exceed 0.15% of
 and lubricant.                                bakery products.
6. In dehydrated fruits and vegetables, as a  Not to exceed 0.02% of
 release agent.                                dehydrated fruits and
                                               vegetables.
7. In egg white solids, as a release agent..  Not to exceed 0.1% of egg
                                               white solids.
8. On raw fruits and vegetables, as a         In an amount not to exceed
 protective coating.                           good manufacturing
                                               practice.
9. In frozen meat, as a component of hot-     Not to exceed 0.095% of
 melt coating.                                 meat.
10. As a protective float on brine used in    In an amount not to exceed
 the curing of pickles.                        good manufacturing
                                               practice.
11. In molding starch used in the             Not to exceed 0.3 percent
 manufacture of confectionery.                 in the molding starch.
12. As a release agent, binder, and           Not to exceed 0.15 percent
 lubricant in the manufacture of yeast.        of yeast.
13. As an antidusting agent in sorbic acid    Not to exceed 0.25 percent
 for food use.                                 in the sorbic acid.
14. As release agent and as sealing and       Not to exceed 0.2 percent
 polishing agent in the manufacture of         of confectionery.
 confectionery.
15. As a dust control agent for wheat, corn,  Applied at a level of no
 soybean, barley, rice, rye, oats, and         more than 0.02 percent by
 sorghum.                                      weight of grain.

[[Page 107]]

 
16. As a dust control agent for rice........  ISO 100 oil viscosity (100
                                               centistokes (cSt) at
                                               100[deg]F) applied at a
                                               level of no more than
                                               0.08 percent by weight of
                                               the rice grain.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 
FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 
19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014, Dec. 1, 1998]



Sec. 172.880  Petrolatum.

    Petrolatum may be safely used in food, subject to the provisions of 
this section.
    (a) Petrolatum complies with the specifications set forth in the 
United States Pharmacopeia XX (1980) for white petrolatum or in the 
National Formulary XV (1980) for petrolatum.
    (b) Petrolatum meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in Sec. 
172.886(b):

    Ultraviolet absorbance per centimeter path length:

------------------------------------------------------------------------
                        Millimicrons                            Maximum
------------------------------------------------------------------------
280-289.....................................................        0.25
290-299.....................................................         .20
300-359.....................................................         .14
360-400.....................................................         .04
------------------------------------------------------------------------

    (c) Petrolatum is used or intended for use as follows:

------------------------------------------------------------------------
                                           Limitation (inclusive of all
                                         petroleum hydrocarbons that may
                  Use                      be used in combination with
                                                   petrolatum)
------------------------------------------------------------------------
In bakery products; as release agent     With white mineral oil, not to
 and lubricant.                           exceed 0.15 percent of bakery
                                          product.
In confectionery; as release agent and   Not to exceed 0.2 percent of
 as sealing and polishing agent.          confectionery.
In dehydrated fruits and vegetables; as  Not to exceed 0.02 percent of
 release agent.                           dehydrated fruits and
                                          vegetables.
In egg white solids; as release agent..  Not to exceed 0.1 percent of
                                          egg white solids.
On raw fruits and vegetables; as         In an amount not to exceed good
 protective coating.                      manufacturing practice.
In beet sugar and yeast; as defoaming    As prescribed in Sec.  173.340
 agent.                                   of this chapter.
------------------------------------------------------------------------

    (d) Petrolatum may contain any antioxidant permitted in food by 
regulations issued in accordance with section 409 of the Act, in an 
amount not greater than that required to produce its intended effect.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19, 1984]



Sec. 172.882  Synthetic isoparaffinic petroleum hydrocarbons.

    Synthetic isoparaffinic petroleum hydrocarbons may be safely used in 
food, in accordance with the following conditions:
    (a) They are produced by synthesis from petroleum gases and consist 
of a mixture of liquid hydrocarbons meeting the following 
specifications:

    Boiling point 93-260 [deg]C as determined by ASTM method D86-82, 
``Standard Method for Distillation of Petroleum Products,'' which is 
incorporated by reference. Copies may be obtained from the American 
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or 
may be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    Ultraviolet absorbance:
    260-319 millimicrons--1.5 maximum.
    320-329 millimicrons--0.08 maximum.
    330-350 millimicrons--0.05 maximum.
    Nonvolatile residual: 0.002 gram per 100 milliliters maximum.
    Synthetic isoparaffinic petroleum hydrocarbons containing 
antioxidants shall meet the specified ultraviolet absorbance limits 
after correction for any absorbance due to the antioxidants. The 
ultraviolet absorbance shall be determined by the procedure described 
for application of mineral oil, disregarding the last sentence of the 
procedure, under ``Specifications'' on page 66 of the ``Journal of the 
Association of Official Analytical Chemists,'' Volume 45 (February

[[Page 108]]

1962), which is incorporated by reference. Copies are available from the 
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408. For 
hydrocarbons boiling below 250 [deg]F, the nonvolatile residue shall be 
determined by ASTM method D1353-78, ``Standard Test Method for 
Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, 
Lacquer, and Related Products;'' for those boiling above 121 [deg]C, 
ASTM method D381-80, ``Standard Test Method for Existent Gum in Fuels by 
Jet Evaporation'' shall be used. These methods are incorporated by 
reference. Copies may be obtained from the American Society for Testing 
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at 
the Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.

    (b) Isoparaffinic petroleum hydrocarbons may contain antioxidants 
authorized for use in food in an amount not to exceed that reasonably 
required to accomplish the intended technical effect nor to exceed any 
prescribed limitations.
    (c) Synthetic isoparaffinic petroleum hydrocarbons are used or 
intended for use as follows:

------------------------------------------------------------------------
                   Uses                              Limitations
------------------------------------------------------------------------
1. In the froth-flotation cleaning of       In an amount not to exceed
 vegetables.                                 good manufacturing
                                             practice.
2. As a component of insecticide             Do.
 formulations for use on processed foods.
3. As a component of coatings on fruits      Do.
 and vegetables.
4. As a coating on shell eggs.............   Do.
5. As a float on fermentation fluids in      Do.
 the manufacture of vinegar and wine and
 on brine used in curing pickles, to
 prevent or retard access of air,
 evaporation, and contamination with wild
 organisms during fermentation.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 172.884  Odorless light petroleum hydrocarbons.

    Odorless light petroleum hydrocarbons may be safely used in food, in 
accordance with the following prescribed conditions:
    (a) The additive is a mixture of liquid hydrocarbons derived from 
petroleum or synthesized from petroleum gases. The additive is chiefly 
paraffinic, isoparaffinic, or naphthenic in nature.
    (b) The additive meets the following specifications:
    (1) Odor is faint and not kerosenic.
    (2) Initial boiling point is 300 [deg]F minimum.
    (3) Final boiling point is 650 [deg]F maximum.
    (4) Ultraviolet absorbance limits determined by method specified in 
Sec. 178.3620(b)(1)(ii) of this chapter, as follows:

------------------------------------------------------------------------
                                                                Maximum
                                                              absorbance
                                                                  per
                      Wavelength m[mu]                        centimeter
                                                                optical
                                                              pathlength
------------------------------------------------------------------------
280-289.....................................................         4.0
290-299.....................................................         3.3
300-329.....................................................         2.3
330-360.....................................................          .8
------------------------------------------------------------------------

    (c) The additive is used as follows:

------------------------------------------------------------------------
                    Use                              Limitations
------------------------------------------------------------------------
As a coating on shell eggs................  In an amount not to exceed
                                             good manufacturing
                                             practice.
As a defoamer in processing beet sugar and  Complying with Sec.
 yeast.                                      173.340 of this chapter.
As a float on fermentation fluids in the    In an amount not to exceed
 manufacture of vinegar and wine to          good manufacturing
 prevent or retard access of air,            practice.
 evaporation, and wild yeast contamination
 during fermentation.
In the froth-flotation cleaning of           Do.
 vegetables.
As a component of insecticide formulations   Do.
 used in compliance with regulations
 issued in parts 170 through 189 of this
 chapter.
------------------------------------------------------------------------



Sec. 172.886  Petroleum wax.

    Petroleum wax may be safely used in or on food, in accordance with 
the following conditions:
    (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in 
nature, derived from petroleum, and refined to meet the specifications 
prescribed by this section.
    (b) Petroleum wax meets the following ultraviolet absorbance limits 
when subjected to the analytical procedure described in this paragraph.

[[Page 109]]



------------------------------------------------------------------------
                                                               Maximum
                                                             ultraviolet
                                                              absorbance
                                                                 per
                                                              centimeter
                                                             path length
------------------------------------------------------------------------
280-289 millimicrons.......................................         0.15
290-299 millimicrons.......................................         0.12
300-359 millimicrons.......................................         0.08
360-400 millimicrons.......................................         0.02
------------------------------------------------------------------------

               Analytical Specification for Petroleum Wax

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware, 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of wax samples in handling and to 
assure absence of any extraneous material arising from inadequate 
packaging is essential. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                apparatus

    Separatory funnels. 250-milliliter, 500-milliliter, 1,000-
milliliter, and preferably 2,000-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    Reservoir. 500-milliliter capacity, equipped with a 24/40 standard 
taper male fitting at the bottom and a suitable ball-joint at the top 
for connecting to the nitrogen supply. The male fitting should be 
equipped with glass hooks.
    Chromatographic tube. 180 millimeters in length, inside diameter to 
be 15.7 millimeters 0.1 millimeter, equipped with 
a coarse, fritted-glass disc, a tetrafluoroethylene polymer stopcock, 
and a female 24/40 standard tapered fitting at the opposite end. 
(Overall length of the column with the female joint is 235 millimeters.) 
The female fitting should be equipped with glass hooks.
    Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately 
\3/16\-inch thick with a hole bored in the center to closely fit the 
stem of the chromatographic tube.
    Heating jacket. Conical, for 500-milliliter separatory funnel. (Used 
with variable transformer heat control.)
    Suction flask. 250-milliliter or 500-milliliter filter flask.
    Condenser. 24/40 joints, fitted with a drying tube, length optional.
    Evaporation flask (optional). 250-milliliter or 500-milliliter 
capacity all-glass flask equipped with standard taper stopper having 
inlet and outlet tubes to permit passage of nitrogen across the surface 
of contained liquid to be evaporated.
    Vacuum distillation assembly. All glass (for purification of 
dimethyl sulfoxide); 2-liter distillation flask with heating mantle; 
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters 
in length and distilling head with separable cold finger condenser. Use 
of tetrafluoroethylene polymer sleeves on the glass joints will prevent 
freezing. Do not use grease on stopcocks or joints.
    Spectrophotometric cells. Fused quartz cells, optical path length in 
the range of 5.000 centimeters 0.005 centimeter; 
also for checking spectrophotometer performance only, optical path 
length in the range 1.000 centimeter 0.005 
centimeter. With distilled water in the cells, determine any absorbance 
differences.
    Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons 
with spectral slit width of 2 millimicrons or less, under instrument 
operating conditions for these absorbance measurements, the 
spectrophotometer shall also meet the following performance 
requirements:
    Absorbance repeatability, 0.01 at 0.4 
absorbance.
    Absorbance accuracy, \1\ 0.05 at 0.4 
absorbance.
---------------------------------------------------------------------------

    \1\ As determined by using potassium chromate for reference standard 
and described in National Bureau of Standards Circular 484, 
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is 
to be determined by comparison with the standard values at 290, 345, and 
400 millimicrons. Circular 484 is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
---------------------------------------------------------------------------

    Wavelength repeatability, 0.2 millimicron.
    Wavelength accuracy, 1.0 millimicron.
    Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in 
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
isooctane, benzene, acetone, and

[[Page 110]]

methyl alcohol designated in the list following this paragraph shall 
pass the following test:
    To the specified quantity of solvent in a 250-milliliter Erlenmeyer 
flask, add 1 milliliter of purified n-hexadecane and evaporate on the 
steam bath under a stream of nitrogen (a) loose aluminum foil jacket 
around the flask will speed evaporation). Discontinue evaporation when 
not over 1 milliliter of residue remains. (To the residue from benzene 
add a 10-milliliter portion of purified isooctane, reevaporate, and 
repeat once to insure complete removal of benzene.)
    Alternatively, the evaporation time can be reduced by using the 
optional evaporation flask. In this case the solvent and n-hexadecane 
are placed in the flask on the steam bath, the tube assembly is 
inserted, and a stream of nitrogen is fed through the inlet tube while 
the outlet tube is connected to a solvent trap and vacuum line in such a 
way as to prevent any flow-back of condensate into the flask.
    Dissolve the 1 milliliter of hexadecane residue in isooctane and 
make to 25 milliliters volume. Determine the absorbance in the 5-
centimeter path length cells compared to isooctane as reference. The 
absorbance of the solution of the solvent residue (except for methyl 
alcohol) shall not exceed 0.01 per centimeter path length between 280 
and 400 m[mu]. For methyl alcohol this absorbance value shall be 0.00.
    Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test 
described in the preceding paragraph. Purify, if necessary, by passage 
through a column of activated silica gel (Grade 12, Davison Chemical 
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in 
length and 5 centimeters to 8 centimeters in diameter.
    Benzene, A.C.S. reagent grade. Use 150 milliliters for the test. 
Purify, if necessary, by distillation or otherwise.
    Acetone, A.C.S. reagent grade. Use 200 milliliters for the test. 
Purify, if necessary, by distillation.
    Eluting mixtures:
    1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 500-milliliter glass-stoppered volumetric flask and adjust to 
volume with isooctane, with mixing.
    2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene 
into a 250-milliliter glass-stoppered volumetric flask, and adjust to 
volume with isooctane, with mixing.
    3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380 
milliliters of acetone and 200 milliliters of benzene, and mix.
    n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of n-
hexadecane to 25 milliliters with isooctane and determine the absorbance 
in a 5-centimeter cell compared to isooctane as reference point between 
280 m[mu]-400 m[mu]. The absorbance per centimeter path length shall not 
exceed 0.00 in this range. Purify, if necessary, by percolation through 
activated silica gel or by distillation.
    Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl 
alcohol. Purify, if necessary, by distillation.
    Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18[deg] 
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240 
milliliters of distilled water in a 500-milliliter separatory funnel, 
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane 
to the solution and extract by shaking the funnel vigorously for 2 
minutes. Draw off the lower aqueous layer into a second 500-milliliter 
separatory funnel and repeat the extraction with 40 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 40-
milliliter extractives three times with 50-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium sulfate under ``Reagents 
and Materials'' for preparation of filter), into a 250-milliliter 
Erlenmeyer flask, or optionally into the evaporating flask. Wash the 
first separatory funnel with the second 40-milliliter isooctane 
extractive, and pass through the sodium sulfate into the flask. Then 
wash the second and first separatory funnels successively with a 10-
milliliter portion of isooctane, and pass the solvent through the sodium 
sulfate into the flask. Add 1 milliliter of n-hexadecane and evaporate 
the isooctane on the steam bath under nitrogen. Discontinue evaporation 
when not over 1 milliliter of residue remains. To the residue, add a 10-
milliliter portion of isooctane and reevaporate to 1 milliliter of 
hexadecane. Again, add 10 milliliters of isooctane to the residue and 
evaporate to 1 milliliter of hexadecane to insure complete removal of 
all volatile materials. Dissolve the 1 milliliter of hexadecane in 
isooctane and make to 25-milliliter volume. Determine the reference. The 
absorbance of the solution should not exceed 0.02 per centimeter path 
length in the 280 m[mu]-400 m[mu] range. (Note.--Difficulty in meeting 
this absorbance specification may be due to organic impurities in the 
distilled water. Repetition of the test omitting the dimethyl sulfoxide 
will disclose their presence. If necessary to meet the specification, 
purify the water by redistillation, passage through an ion-exchange 
resin, or otherwise.)
    Purify, if necessary, by the following procedure: To 1,500 
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask, 
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A 
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and 
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated 
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide 
through four thicknesses of fluted

[[Page 111]]

paper (18.5 centimeters, Schleicher & Schuell, No. 597, or equivalent). 
If the initial filtrate contains carbon fines, refilter through the same 
filter until a clear filtrate is obtained. Protect the sulfoxide from 
air and moisture during this operation by covering the solvent in the 
funnel and collection flask with a layer of isooctane. Transfer the 
filtrate to a 2-liter separatory funnel and draw off the dimethyl 
sulfoxide into the 2-liter distillation flask of the vacuum distillation 
assembly and distill at approximately 3-millimeter Hg pressure or less. 
Discard the first 200-milliliter fraction of the distillate and replace 
the distillate collection flask with a clean one. Continue the 
distillation until approximately 1 liter of the sulfoxide has been 
collected.
    At completion of the distillation, the reagent should be stored in 
glass-stoppered bottles since it is very hygroscopic and will react with 
some metal containers in the presence of air.
    Phosphoric acid. 85 percent A.C.S. reagent grade.
    Sodium borohydride. 98 percent.
    Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco 
Division, distributed by chemical supply firms, or equivalent). Place 
100 grams of the magnesium oxide in a large beaker, add 700 milliliters 
of distilled water to make a thin slurry, and heat on a steam bath for 
30 minutes with intermittent stirring. Stir well initially to insure 
that all the absorbent is completely wetted. Using a Buchner funnel and 
a filter paper (Schleicher & Schuell No. 597, or equivalent) of suitable 
diameter, filter with suction. Continue suction until water no longer 
drips from the funnel. Transfer the absorbent to a glass trough lined 
with aluminum foil (free from rolling oil). Break up the magnesia with a 
clean spatula and spread out the absorbent on the aluminum foil in a 
layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours at 160 
[deg]C 1 [deg]C. Pulverize the magnesia with 
mortar and pestle. Sieve the pulverized absorbent between 60-180 mesh. 
Use the magnesia retained on the 180-mesh sieve.
    Celite 545. Johns-Manville Company, diatomaceous earth, or 
equivalent.
    Magnesium oxide-Celite 545 mixture (2+ 1) by weight. Place the 
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions, 
respectively, by weight in a glass-stoppered flask large enough for 
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture 
to a glass trough lined with aluminum foil (free from rolling oil) and 
spread it out on a layer about 1 centimeter to 2 centimeters thick. 
Reheat the mixture at 160 [deg]C 1 [deg]C for 2 
hours, and store in a tightly closed flask.
    Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in 
granular form. For each bottle of sodium sulfate reagent used, establish 
as follows the necessary sodium sulfate prewash to provide such filters 
required in the method: Place approximately 35 grams of anhydrous sodium 
sulfate in a 30-milliliter coarse, fritted-glass funnel or in a 65-
millimeter filter funnel with glass wool plug; wash with successive 15-
milliliter portions of the indicated solvent until a 15-milliliter 
portion of the wash shows 0.00 absorbance per centimeter path length 
between 280 m[mu] and 400 m[mu] when tested as prescribed under 
``Organic solvents.'' Usually three portions of wash solvent are 
sufficient.
    Before proceeding with analysis of a sample, determine the 
absorbance in a 5-centimeter path cell between 250 m[mu] and 400 m[mu] 
for the reagent blank by carrying out the procedure, without a wax 
sample, at room temperature, recording the spectra after the extraction 
stage and after the complete procedure as prescribed. The absorbance per 
centimeter path length following the extraction stage should not exceed 
0.040 in the wavelength range from 280 m[mu] to 400 m[mu]; the 
absorbance per centimeter path length following the complete procedure 
should not exceed 0.070 in the wavelength range from 280 m[mu] to 299 
m[mu], inclusive, nor 0.045 in the wavelength range from 300 m[mu] to 
400 m[mu]. If in either spectrum the characteristic benzene peaks in the 
250 m[mu]-260 m[mu] region are present, remove the benzene by the 
procedure under ``Organic solvents'' and record absorbance again.
    Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory 
funnel and add 75 milliliters of phosphoric acid. Mix the contents of 
the funnel and allow to stand for 10 minutes. (The reaction between the 
sulfoxide and the acid is exothermic. Release pressure after mixing, 
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake 
to preequilibrate the solvents. Draw off the individual layers and store 
in glass-stoppered flasks.
    Place a representative 1-kilogram sample of wax, or if this amount 
is not available, the entire sample, in a beaker of a capacity about 
three times the volume of the sample and heat with occasional stirring 
on a steam bath until the wax is completely melted and homogeneous. 
Weigh four 25-gram 0.2 gram portions of the melted 
wax in separate 100-milliliter beakers. Reserve three of the portions 
for later replicate analyses as necessary. Pour one weighed portion 
immediately after remelting (on the steam bath) into a 500-milliliter 
separatory funnel containing 100 milliliters of the preequilibrated 
sulfoxide-phosphoric acid mixture that has been heated in the heating 
jacket at a temperature just high enough to keep the wax melted. (Note: 
In preheating the sulfoxide-acid mixture, remove the stopper of the 
separatory funnel at intervals to release the pressure.)

[[Page 112]]

    Promptly complete the transfer of the sample to the funnel in the 
jacket with portions of the preequilibrated isooctane, warming the 
beaker, if necessary, and using a total volume of just 50 milliliters of 
the solvent. If the wax comes out of solution during these operations, 
let the stoppered funnel remain in the jacket until the wax redissolves. 
(Remove stopper from the funnel at intervals to release pressure.) When 
the wax is in solution, remove the funnel from the jacket and shake it 
vigorously for 2 minutes. Set up three 250-milliliter separatory funnels 
with each containing 30 milliliters of preequilibrated isooctane. After 
separation of the liquid phases, allow to cool until the main portion of 
the wax-isooctane solution begins to show a precipitate. Gently swirl 
the funnel when precipitation first occurs on the inside surface of the 
funnel to accelerate this process. Carefully draw off the lower layer, 
filter it slowly through a thin layer of glass wool fitted loosely in a 
filter funnel into the first 250-milliliter separatory funnel, and wash 
in tandem with the 30-milliliter portions of isooctane contained in the 
250-milliliter separatory funnels. Shaking time for each wash is 1 
minute. Repeat the extraction operation with two additional portions of 
the sulfoxide-acid mixture, replacing the funnel in the jacket after 
each extraction to keep the wax in solution and washing each extractive 
in tandem through the same three portions of isooctane.
    Collect the successive extractives (300 milliliters total) in a 
separatory funnel (preferably 2-liter), containing 480 milliliters of 
distilled water, mix, and allow to cool for a few minutes after the last 
extractive has been added. Add 80 milliliters of isooctane to the 
solution and extract by shaking the funnel vigorously for 2 minutes. 
Draw off the lower aqueous layer into a second separatory funnel 
(preferably 2-liter) and repeat the extraction with 80 milliliters of 
isooctane. Draw off and discard the aqueous layer. Wash each of the 80-
milliliter extractives three times with 100-milliliter portions of 
distilled water. Shaking time for each wash is 1 minute. Discard the 
aqueous layers. Filter the first extractive through anhydrous sodium 
sulfate prewashed with isooctane (see Sodium Sulfate under ``Reagents 
and Materials'' for preparation of filter) into a 250-milliliter 
Erlenmeyer flask (or optionally into the evaporation flask). Wash the 
first separatory funnel with the second 80-milliliter isooctane 
extractive and pass through the sodium sulfate. Then wash the second and 
first separatory funnels successively with a 20-milliliter portion of 
isooctane and pass the solvent through the sodium sulfate into the 
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on 
the steam bath under nitrogen. Discontinue evaporation when not over 1 
milliliter of residue remains. To the residue, add a 10-milliliter 
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and 
repeat this operation once.
    Quantitatively transfer the residue with isooctane to a 25-
milliliter volumetric flask, make to volume, and mix. Determine the 
absorbance of the solution in the 5-centimeter path length cells 
compared to isooctane as reference between 280 m[mu]-400 m[mu] (take 
care to lose none of the solution in filling the sample cell). Correct 
the absorbance values for any absorbance derived from reagents as 
determined by carrying out the procedure without a wax sample. If the 
corrected absorbance does not exceed the limits prescribed in this 
paragraph (b), the wax meets the ultraviolet absorbance specifications. 
If the corrected absorbance per centimeter path length exceeds the 
limits prescribed in this paragraph (b), proceed as follows:
    Quantitatively transfer the isooctane solution to a 125-milliliter 
flask equipped with 24/40 joint and evaporate the isooctane on the steam 
bath under a stream of nitrogen to a volume of 1 milliliter of 
hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3 
gram of sodium borohydride. (Minimize exposure of the borohydride to the 
atmosphere. A measuring dipper may be used.) Immediately fit a water-
cooled condenser equipped with a 24/40 joint and with a drying tube into 
the flask, mix until the borohydride is dissolved, and allow to stand 
for 30 minutes at room temperature, with intermittent swirling. At the 
end of this period, disconnect the flask and evaporate the methyl 
alcohol on the steam bath under nitrogen until the sodium borohydride 
begins to come out of the solution. Then add 10 milliliters of isooctane 
and evaporate to a volume of about 2-3 milliliters. Again, add 10 
milliliters of isooctane and concentrate to a volume of approximately 5 
milliliters. Swirl the flask repeatedly to assure adequate washing of 
the sodium borohydride residues.
    Fit the tetrafluoroethylene polymer disc on the upper part of the 
stem of the chromatographic tube, then place the tube with the disc on 
the suction flask and apply the vacuum (approximately 135 millimeters Hg 
pressure). Weight out 14 grams of the 2:1 magnesium oxide-Celite 545 
mixture and pour the adsorbent mixture into the chromatographic tube in 
approximately 3-centimeter layers. After the addition of each layer, 
level off the top of the adsorbent with a flat glass rod or metal 
plunger by pressing down firmly until the adsorbent is well packed. 
Loosen the topmost few millimeters of each adsorbent layer with the end 
of a metal rod before the addition ofthe next layer. Continue packing in 
this manner until all the 14 grams of the adsorbent is added to the 
tube. Level off the top of the adsorbent by pressing down firmly with a 
flat glass rod or metal plunger to make the depth of the

[[Page 113]]

adsorbent bed approximately 12.5 centimeters in depth. Turn off the 
vacuum and remove the suction flask. Fit the 500-milliliter reservoir 
onto the top of the chromatographic column and prewet the column by 
passing 100 milliliters of isooctane through the column. Adjust the 
nitrogen pressure so that the rate of descent of the isooctane coming 
off of the column is between 2-3 milliliters per minute. Discontinue 
pressure just before the last of the isooctane reaches the level of the 
adsorbent. (Caution: Do not allow the liquid level to recede below the 
adsorbent level at any time.) Remove the reservoir and decant the 5-
milliliter isooctane concentrate solution onto the column and with 
slight pressure again allow the liquid level to recede to barely above 
the adsorbent level. Rapidly complete the transfer similarly with two 5-
milliliter portions of isooctane, swirling the flask repeatedly each 
time to assure adequate washing of the residue. Just before the final 5-
milliliter wash reaches the top of the adsorbent, add 100 milliliters of 
isooctane to the reservoir and continue the percolation at the 2-3 
milliliter per minute rate. Just before the last of the isooctane 
reaches the adsorbent level, add 100 milliliters of 10 percent benzene 
in isooctane to the reservoir and continue the percolation at the 
aforementioned rate. Just before the solvent mixture reaches adsorbent 
level, add 25 milliliters of 20 percent benzene in isooctane to the 
reservoir and continue the percolation at 2-3 milliliters per minute 
until all this solvent mixture has been removed from the column. Discard 
all the elution solvents collected up to this point. Add 300 milliliters 
of the acetone-benzene-water mixture to the reservoir and percolate 
through the column to elute the polynuclear compounds. Collect the 
eluate in a clean 1-liter separatory funnel. Allow the column to drain 
until most of the solvent mixture is removed. Wash the eluate three 
times with 300-milliliter portions of distilled water, shaking well for 
each wash. (The addition of small amounts of sodium chloride facilitates 
separation.) Discard the aqueous layer after each wash. After the final 
separation, filter the residual benzene through anhydrous sodium sulfate 
prewashed with benzene (see Sodium sulfate under ``Reagents and 
Materials'' for preparation of filter) into a 250-milliliter Erlenmeyer 
flask (or optionally into the evaporation flask). Wash the separatory 
funnel with two additional 20-milliliter portions of benzene which are 
also filtered through the sodium sulfate. Add 1 milliliter of n-
hexadecane and completely remove the benzene by evaporation under 
nitrogen, using the special procedure to eliminate benzene as previously 
described under ``Organic Solvents.'' Quantitatively transfer the 
residue with isooctane to a 25-milliliter volumetric flask and adjust to 
volume. Determine the absorbance of the solution in the 5-centimeter 
path length cells compared to isooctane as reference between 250 m[mu]-
400 m[mu]. Correct for any absorbance derived from the reagents as 
determined by carrying out the procedure without a wax sample. If either 
spectrum shows the characteristic benzene peaks in the 250 m[mu]-260 
m[mu] region, evaporate the solution to remove benzene by the procedure 
under ``Organic Solvents.'' Dissolve the residue, transfer 
quantitatively, and adjust to volume in isooctane in a 25-milliliter 
volumetric flask. Record the absorbance again. If the corrected 
absorbance does not exceed the limits prescribed in this paragraph (b), 
the wax meets the ultraviolet absorbance specifications.

    (c) Petroleum wax may contain one or more of the following adjuvants 
in amounts not greater than that required to produce their intended 
effect:
    (1) Antioxidants permitted in food by regulations issued in 
accordance with section 409 of the act.
    (2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long 
chain (C16-C22) alcohols and acrylic acid, or 
poly(alkylmethacrylate) (CAS Reg. No. 179529-36-3), made from long chain 
(C18-C22) methacrylate esters, having:
    (i) A number average molecular weight between 40,000 and 100,000;
    (ii) A weight average molecular weight (MWw) to number 
average molecular weight (MWn) ratio (MWw/
MWn) of not less than 3; and
    (iii) Unreacted alkylacrylate or alkylmethacrylate monomer content 
not in excess of 14 percent, as determined by a method entitled ``Method 
for Determining Weight-Average and Number-Average Molecular Weight and 
for Determining Alkylacrylate Monomer Content of Poly(alkylacrylate) 
used as Processing Aid in Manufacture of Petroleum Wax,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Office of Premarket Approval 
(HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may 
be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740 or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC. Petroleum wax shall contain 
not more than 1,050 parts per million of

[[Page 114]]

poly(alkylacrylate) or poly(alkylmethacrylate) residues as determined by 
a method entitled ``Method for Determining Residual Level of 
Poly(alkylacrylate) in Petroleum Wax,'' which is incorporated by 
reference. Copies are available from the addresses cited in this 
paragraph.
    (d) Petroleum wax is used or intended for use as follows:

------------------------------------------------------------------------
                    Use                              Limitations
------------------------------------------------------------------------
In chewing gum base, as a masticatory       In an amount not to exceed
 substance.                                  good manufacturing
                                             practice.
On cheese and raw fruits and vegetables as   Do.
 a protective coating.
As a defoamer in food.....................  In accordance with Sec.
                                             173.340 of this chapter.
As a component of microcapsules for spice-  In accordance with Sec.
 flavoring substances.                       172.230 of this chapter.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 48123, July 18, 1980; 
47 FR 11838, Mar. 19, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544, May 
30, 1986; 54 FR 24897, June 12, 1989; 64 FR 44122, Aug. 13, 1999]



Sec. 172.888  Synthetic petroleum wax.

    Synthetic petroleum wax may be safely used in or on foods in 
accordance with the following conditions:
    (a) Synthetic petroleum wax is a mixture of solid hydrocarbons, 
paraffinic in nature, prepared by either catalytic polymerization of 
ethylene or copolymerization of ethylene with linear (C3 to 
C12) alpha-olefins, and refined to meet the specifications 
prescribed in this section.
    (b) Synthetic petroleum wax meets the ultraviolet absorbance limits 
of Sec. 172.886(b) when subjected to the analytical procedure described 
therein.
    (c) Synthetic petroleum wax has a number average molecular weight of 
not less than 500 nor greater than 1,200 as determined by vapor pressure 
osmometry.
    (d) Synthetic petroleum wax may contain any antioxidant permitted in 
food by regulations issued in accordance with section 409 of the act, in 
an amount not greater than that required to produce its intended effect.
    (e) Synthetic petroleum wax is used or intended for use as follows:

------------------------------------------------------------------------
                    Use                              Limitations
------------------------------------------------------------------------
In chewing gum base, as a masticatory       In accordance with Sec.
 substance.                                  172.615 in an amount not to
                                             exceed good manufacturing
                                             practice.
On cheese and raw fruits and vegetables as  In an amount not to exceed
 a protective coating.                       good manufacturing
                                             practice.
As a defoamer in food.....................  In accordance with Sec.
                                             173.340 of this chapter.
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 59 FR 10986, Mar. 9, 1994]



Sec. 172.890  Rice bran wax.

    Rice bran wax may be safely used in food in accordance with the 
following conditions:
    (a) It is the refined wax obtained from rice bran and meets the 
following specifications:

Melting point 75 [deg]C to 80 [deg]C.
Free fatty acids, maximum 10 percent.
Iodine number, maximum 20.
Saponification number 75 to 120.

    (b) It is used or intended for use as follows:

------------------------------------------------------------------------
              Food                Limitation in food          Use
------------------------------------------------------------------------
Candy...........................  50 p.p.m..........  Coating.
Fresh fruits and fresh            ......do..........   Do.
 vegetables.
Chewing gum.....................  2\1/2\ pct........  Plasticizing
                                                       material.
------------------------------------------------------------------------



Sec. 172.892  Food starch-modified.

    Food starch-modified as described in this section may be safely used 
in food. The quantity of any substance employed to effect such 
modification shall not exceed the amount reasonably required to 
accomplish the intended physical or technical effect, nor exceed any 
limitation prescribed. To insure safe use of the food starch-modified, 
the label of the food additive container shall bear the name of the 
additive ``food starch-modified'' in addition to other information 
required by the Act. Food starch may be modified by treatment prescribed 
as follows:
    (a) Food starch may be acid-modified by treatment with hydrochloric 
acid or sulfuric acid or both.
    (b) Food starch may be bleached by treatment with one or more of the 
following:

[[Page 115]]



------------------------------------------------------------------------
                                                     Limitations
------------------------------------------------------------------------
Active oxygen obtained from hydrogen        ............................
 peroxide and/or peracetic acid, not to
 exceed 0.45 percent of active oxygen.
Ammonium persulfate, not to exceed 0.075    ............................
 percent and sulfur dioxide, not to exceed
 0.05 percent.
Chlorine, as calcium hypochlorite, not to   The finished food starch-
 exceed 0.036 percent of dry starch.         modified is limited to use
                                             only as a component of
                                             batter for commercially
                                             processed foods.
Chlorine, as sodium hypochlorite, not to    ............................
 exceed 0.0082 pound of chlorine per pound
 of dry starch.
Potassium permanganate, not to exceed 0.2   Residual manganese
 percent.                                    (calculated as Mn), not to
                                             exceed 50 parts per million
                                             in food starch-modified.
Sodium chlorite, not to exceed 0.5 percent  ............................
------------------------------------------------------------------------

    (c) Food starch may be oxidized by treatment with chlorine, as 
sodium hypochlorite, not to exceed 0.055 pound of chlorine per pound of 
dry starch.
    (d) Food starch may be esterified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations
------------------------------------------------------------------------
Acetic anhydride..........................  Acetyl groups in food starch-
                                             modified not to exceed 2.5
                                             percent.
Adipic anhydride, not to exceed 0.12         Do.
 percent, and acetic anhydride.
Monosodium orthophosphate.................  Residual phosphate in food
                                             starch-modified not to
                                             exceed 0.4 percent
                                             calculated as phosphorus.
1-Octenyl succinic anhydride, not to        ............................
 exceed 3 percent.
1-Octenyl succinic anhydride, not to        ............................
 exceed 2 percent, and aluminum sulfate,
 not to exceed 2 percent.
1-Octenyl succinic anhydride, not to        Limited to use as a
 exceed 3 percent, followed by treatment     stabilizer or emulsifier in
 with a beta-amylase enzyme that is either   beverages and beverage
 an approved food additive of is generally   bases as defined in Sec.
 recognized as safe.                         170.3(n)(3) of this
                                             chapter.
Phosphorus oxychloride, not to exceed 0.1   ............................
 percent.
Phosphorus oxychloride, not to exceed 0.1   Acetyl groups in food starch-
 percent, followed by either acetic          modified not to exceed 2.5
 anhydride, not to exceed 8 percent, or      percent.
 vinyl acetate, not to exceed 7.5 percent.
Sodium trimetaphosphate...................  Residual phosphate in food
                                             starch-modified not to
                                             exceed 0.04 percent,
                                             calculated as phosphorus.
Sodium tripolyphosphate and sodium          Residual phosphate in food
 trimetaphosphate.                           starch-modified not to
                                             exceed 0.4 percent
                                             calculated as phosphorus.
Succinic anhydride, not to exceed 4         ............................
 percent.
Vinyl acetate.............................  Acetyl groups in food starch-
                                             modified not to exceed 2.5
                                             percent.
------------------------------------------------------------------------

    (e) Food starch may be etherified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent.......  ............................
Epichlorohydrin, not to exceed 0.3 percent  ............................
Epichlorohydrin, not to exceed 0.1          Residual propylene
 percent, and propylene oxide, not to        chlorohydrin not more than
 exceed 10 percent, added in combination     5 parts per million in food
 or in any sequence.                         starch-modified.
Epichlorohydrin, not to exceed 0.1           Do.
 percent, followed by propylene oxide, not
 to exceed 25 percent.
Propylene oxide, not to exceed 25 percent.   Do.
------------------------------------------------------------------------

    (f) Food starch may be esterified and etherified by treatment with 
one of the following:

------------------------------------------------------------------------
                                                     Limitations
------------------------------------------------------------------------
Acrolein, not to exceed 0.6 percent and     Acetyl groups in food starch-
 vinyl acetate, not to exceed 7.5 percent.   modified not to exceed 2.5
                                             percent.
Epichlorohydrin, not to exceed 0.3          Acetyl groups in food starch-
 percent, and acetic anhydride.              modified not to exceed 2.5
                                             percent.
Epichlorohydrin, not to exceed 0.3          ............................
 percent, and succinic anhydride, not to
 exceed 4 percent.
Phosphorus oxychloride, not to exceed 0.1   Residual propylene
 percent, and propylene oxide, not to        chlorohydrin not more than
 exceed 10 percent.                          5 parts per million in food
                                             starch-modified.
------------------------------------------------------------------------

    (g) Food starch may be modified by treatment with one of the 
following:

------------------------------------------------------------------------
                                                     Limitations
------------------------------------------------------------------------
Chlorine, as sodium hypochlorite, not to    Residual propylene
 exceed 0.055 pound of chlorine per pound    chlorohydrin not more than
 of dry starch; 0.45 percent of active       5 parts per million in food
 oxygen obtained from hydrogen peroxide;     starch-modified.
 and propylene oxide, not to exceed 25
 percent.
Sodium hydroxide, not to exceed 1 percent.  ............................
------------------------------------------------------------------------


[[Page 116]]

    (h) Food starch may be modified by a combination of the treatments 
prescribed by paragraphs (a), (b), and/or (i) of this section and any 
one of the treatments prescribed by paragraph (c), (d), (e), (f), or (g) 
of this section, subject to any limitations prescribed by the paragraphs 
named.
    (i) Food starch may be modified by treatment with the following 
enzymes:

------------------------------------------------------------------------
                  Enzyme                             Limitations
------------------------------------------------------------------------
Alpha-amylase (E.C. 3.2.1.1)..............  The enzyme must be generally
                                             recognized as safe or
                                             approved as a food additive
                                             for this purpose. The
                                             resulting nonsweet
                                             nutritive saccharide
                                             polymer has a dextrose
                                             equivalent of less than 20.
Beta-amylase (E.C. 3.2.1.2)...............  ............................
Glucoamylase (E.C. 3.2.1.3)...............  ............................
Isoamylase (E.C. 3.2.1.68)................  ............................
Pullulanase (E.C. 3.2.1.41)...............  ............................
------------------------------------------------------------------------


[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 11697, Mar. 21, 1978; 
46 FR 32015, June 19, 1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100, 
Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001]



Sec. 172.894  Modified cottonseed products intended for human consumption.

    The food additive modified cottonseed products may be used for human 
consumption in accordance with the following prescribed conditions:
    (a) The additive is derived from:
    (1) Decorticated, partially defatted, cooked, ground cottonseed 
kernels; or
    (2) Decorticated, ground cottonseed kernels, in a process that 
utilizes n-hexane as an extracting solvent in such a way that no more 
than 60 parts per million of n-hexane residues and less than 1 percent 
fat by weight remain in the finished product; or
    (3) Glandless cottonseed kernels roasted to attain a temperature of 
not less than 250 [deg]F in the kernel for not less than 5 minutes for 
use as a snack food, or in baked goods, or in soft candy; or
    (4) Raw glandless cottonseed kernels may be used in hard candy where 
the kernel temperature during cooking will exceed 250 [deg]F for not 
less than 5 minutes.
    (b) The additive is prepared to meet the following specifications:
    (1) Free gossypol content not to exceed 450 parts per million.
    (2) It contains no added arsenic compound and therefore may not 
exceed a maximum natural background level of 0.2 part per million total 
arsenic, calculated as As.
    (c) To assure safe use of the additive, the label of the food 
additive container shall bear, in addition to other information required 
by the act, the name of the additive as follows:
    (1) The additive identified in paragraph (a)(1) of this section as 
``partially defatted, cooked cottonseed flour''.
    (2) The additive identified in paragraph (a)(2) of this section as 
``defatted cottonseed flour''.
    (3) The additive identified in paragraph (a)(3) of this section as 
``roasted glandless cottonseed kernels''.
    (4) The additive identified in paragraph (a)(4) of this section as 
``raw glandless cottonseed kernels for use in cooked hard candy''.
    (d) The Food and Drug Administration and the Environmental 
Protection Agency have determined that glandless cottonseed kernels 
permitted for use by this section are a distinct commodity from glanded 
cottonseed.



Sec. 172.896  Dried yeasts.

    Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis) 
and dried torula yeast (Candida utilis) may be safely used in food 
provided the total folic acid content of the yeast does not exceed 0.04 
milligram per gram of yeast (approximately 0.008 milligram of 
pteroyglutamic acid per gram of yeast).



Sec. 172.898  Bakers yeast glycan.

    Bakers yeast glycan may be safely used in food in accordance with 
the following conditions:
    (a) Bakers yeast glycan is the comminuted, washed, pasteurized, and 
dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed 
principally of long chain carbohydrates, not less than 85 percent on a 
dry solids basis. The carbohydrate is composed of glycan and mannan 
units in approximately a 2:1 ratio.
    (b) The additive meets the following specifications on a dry weight 
basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium, 
0.2 ppm lead,

[[Page 117]]

0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
    (c) The viable microbial content of the finished ingredient is:
    (1) Less than 10,000 organisms/gram by aerobic plate count.
    (2) Less than 10 yeasts and molds/gram.
    (3) Negative for Salmonella, E. coli, coagulase positive 
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any 
other recognized microbial pathogen or any harmful microbial toxin.
    (d) The additive is used or intended for use in the following foods 
when standards of identity established under section 401 of the Act do 
not preclude such use:

------------------------------------------------------------------------
                    Use                              Limitations
------------------------------------------------------------------------
(1) In salad dressings as an emulsifier     Not to exceed a
 and emulsifier salt as defined in Sec.     concentration of 5 percent
 170.3(o)(8) of this chapter, stabilizer     of the finished salad
 and thickener as defined in Sec.           dressing.
 170.3(o)(28) of this chapter, or
 texturizer as defined in Sec.
 170.3(o)(32) of this chapter.
(2) In frozen dessert analogs as a          In an amount not to exceed
 stabilizer and thickener as defined in      good manufacturing
 Sec.  170.3(o)(28) of this chapter, or     practice.
 texturizer as defined in Sec.
 170.3(o)(32) of this chapter.
(3) In sour cream analogs as a stabilizer    Do.
 and thickener as defined in Sec.
 170.3(o)(28) of this chapter, or
 texturizer as defined in Sec.
 170.3(o)(32) of this chapter.
(4) In cheese spread analogs as a            Do.
 stabilizer and thickener as defined in
 Sec.  170.3(o)(28) of this chapter, or
 texturizer as defined in Sec.
 170.3(o)(32) of this chapter.
(5) In cheese-flavored and sour cream-       Do.
 flavored snack dips as a stabilizer and
 thickener as defined in Sec.
 170.3(o)(28) of this chapter, or
 texturizer as defined in Sec.
 170.3(o)(32) of this chapter.
------------------------------------------------------------------------

    (e) The label and labeling of the ingredient shall bear adequate 
directions to assure that use of the ingredient complies with this 
regulation.

[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5, 1980]



PART 173_SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN 
CONSUMPTION--Table of Contents




  Subpart A_Polymer Substances and Polymer Adjuvants for Food Treatment

Sec.
173.5 Acrylate-acrylamide resins.
173.10 Modified polyacrylamide resin.
173.20 Ion-exchange membranes.
173.21 Perfluorinated ion exchange membranes.
173.25 Ion-exchange resins.
173.40 Molecular sieve resins.
173.45 Polymaleic acid and its sodium salt.
173.50 Polyvinylpolypyrrolidone.
173.55 Polyvinylpyrrolidone.
173.60 Dimethylamine-epichlorohydrin copolymer.
173.65 Divinylbenzene copolymer.
173.70 Chloromethylated aminated styrene-divinylbenzene resin.
173.73 Sodium polyacrylate.
173.75 Sorbitan monooleate.

            Subpart B_Enzyme Preparations and Microorganisms

173.110 Amyloglucosidase derived from Rhizopus niveus.
173.115 Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme 
          preparation derived from a recombinant Bacillus subtilis.
173.120 Carbohydrase and cellulase derived from Aspergillus niger.
173.130 Carbohydrase derived from Rhizopus oryzae.
173.135 Catalase derived from Microccocus lysodeikticus.
173.140 Esterase-lipase derived from Mucor miehei.
173.145 Alpha-Galactosidase derived from Mortierella vinaceae var. 
          raffinoseutilizer.
173.150 Milk-clotting enzymes, microbial.
173.160 Candida guilliermondii.
173.165 Candida lipolytica.
173.170 Aminoglycoside 3'-phosphotransferase II.

  Subpart C_Solvents, Lubricants, Release Agents and Related Substances

173.210 Acetone.
173.220 1,3-Butylene glycol.
173.228 Ethyl acetate.
173.230 Ethylene dichloride.
173.240 Isopropyl alcohol.
173.250 Methyl alcohol residues.
173.255 Methylene chloride.
173.270 Hexane.
173.275 Hydrogenated sperm oil.
173.280 Solvent extraction process for citric acid.
173.290 Trichloroethylene.

[[Page 118]]

                   Subpart D_Specific Usage Additives

173.300 Chlorine dioxide.
173.310 Boiler water additives.
173.315 Chemicals used in washing or to assist in the peeling of fruits 
          and vegetables.
173.320 Chemicals for controlling microorganisms in cane-sugar and beet-
          sugar mills.
173.322 Chemicals used in delinting cottonseed.
173.325 Acidified sodium chlorite solutions.
173.340 Defoaming agents.
173.342 Chlorofluorocarbon 113 and perfluorohexane.
173.345 Chloropentafluoroethane.
173.350 Combustion product gas.
173.355 Dichlorodifluoromethane.
173.357 Materials used as fixing agents in the immobilization of enzyme 
          preparations.
173.360 Octafluorocyclobutane.
173.368 Ozone.
173.370 Peroxyacids.
173.385 Sodium methyl sulfate.
173.395 Trifluoromethane sulfonic acid.
173.400 Dimethyldialkylammonium chloride.

    Authority: 21 U.S.C. 321, 342, 348.

    Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 173 appear at 61 FR 
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 
27, 2001.



  Subpart A_Polymer Substances and Polymer Adjuvants for Food Treatment



Sec. 173.5  Acrylate-acrylamide resins.

    Acrylate-acrylamide resins may be safely used in food under the 
following prescribed conditions:
    (a) The additive consists of one of the following:
    (1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is 
produced by the polymerization of acrylamide with partial hydrolysis, or 
by copolymerization of acrylamide and acrylic acid, with the greater 
part of the polymer being composed of acrylamide units.
    (2) Sodium polyacrylate-acrylamide resin is produced by the 
polymerization and subsequent hydrolysis of acrylonitrile in a sodium 
silicate-sodium hydroxide aqueous solution, with the greater part of the 
polymer being composed of acrylate units.
    (b) The additive contains not more than 0.05 percent of residual 
monomer calculated as acrylamide.
    (c) The additive is used or intended for use as follows:
    (1) The additive identified in paragraph (a) (1) of this section is 
used as a flocculent in the clarification of beet sugar juice and liquor 
or cane sugar juice and liquor or corn starch hydrolyzate in an amount 
not to exceed 5 parts per million by weight of the juice or 10 parts per 
million by weight of the liquor or the corn starch hydrolyzate.
    (2) The additive identified in paragraph (a)(2) of this section is 
used to control organic and mineral scale in beet sugar juice and liquor 
or cane sugar juice and liquor in an amount not to exceed 2.5 parts per 
million by weight of the juice or liquor.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981]



Sec. 173.10  Modified polyacrylamide resin.

    Modified polyacrylamide resin may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The modified polyacrylamide resin is produced by the 
copolymerization of acrylamide with not more than 5-mole percent [beta]-
methacrylyloxyethy-ltrimethylammonium methyl sulfate.
    (b) The modified polyacrylamide resin contains not more than 0.05 
percent residual acrylamide.
    (c) The modified polyacrylamide resin is used as a flocculent in the 
clarification of beet or cane sugar juice in an amount not exceeding 5 
parts per million by weight of the juice.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to the other information required 
by the act, adequate directions to assure use in compliance with 
paragraph (c) of this section.



Sec. 173.20  Ion-exchange membranes.

    Ion-exchange membranes may be safely used in the processing of food 
under the following prescribed conditions:
    (a) The ion-exchange membrane is prepared by subjecting a 
polyethylene

[[Page 119]]

base conforming to Sec. 177.1520 of this chapter to polymerization with 
styrene until the polystyrene phase of the base is not less than 16 
percent nor more than 30 percent by weight. The base is then modified by 
reaction with chloromethyl methyl ether, and by subsequent amination 
with tri methyl amine, di methyl amine, di ethyl ene triamine, or di 
methyl ethanol amine.
    (b) The ion-exchange membrane is manufactured so as to comply with 
the following extraction limitations when subjected to the described 
procedure: Separate square-foot samples of membrane weighing 
approximately 14 grams each are cut into small pieces and refluxed for 4 
hours in 150 cubic centimeters of the following solvents: Distilled 
water, 5 percent acetic acid, and 50 percent alcohol. Extraction from 
each sample will not exceed 0.4 percent by weight of sample.
    (c) The ion-exchange membrane will be used in the production of 
grapefruit juice to adjust the ratio of citric acid to total solids of 
the grapefruit juice produced.



Sec. 173.21  Perfluorinated ion exchange membranes.

    Substances identified in paragraph (a) of this section may be safely 
used as ion exchange membranes intended for use in the treatment of bulk 
quantities of liquid food under the following prescribed conditions:
    (a) Identity. The membrane is a copolymer of ethanesulfonyl 
fluoride, 2-[1-[difluoro-[(tri fluoro ethenyl) oxy] methyl]-1,2,2,2-
tetra fluoro ethoxy]-1,1,2,2,-tetra fluoro-, with tetra fluoro ethylene 
that has been subsequently treated to hydrolyze the sulfonyl fluoride 
group to the sulfonic acid. The Chemical Abstracts Service name of this 
polymer is ethane sulfonic acid, 2-[1-[difluoro-[(tri fluoro 
ethenyl)oxy] methyl]-1,2,2,2-tetra fluoro ethoxy]-1,1,2,2,-tetra fluoro-
, polymer with tetra fluoro ethane (CAS Reg. No. 31175-20-9).
    (b) Optional adjuvant substances. The basic polymer identified in 
paragraph (a) of this section may contain optional adjuvant substances 
required in the production of such basic polymer. These optional 
adjuvant substances may include substances used in accordance with Sec. 
174.5 of this chapter.
    (c) Conditions of use. (1) Perfluorinated ion exchange membranes 
described in paragraph (a) of this section may be used in contact with 
all types of liquid foods at temperatures not exceeding 70[deg] (158 
[deg]F).
    (2) Maximum thickness of the copolymer membrane is 0.007 inch (0.017 
centimeter).
    (3) Perfluorinated ion exchange membranes shall be maintained in a 
sanitary manner in accordance with current good manufacturing practice 
so as to prevent microbial adulteration of food.
    (4) To assure their safe use, perfluorinated ionomer membranes shall 
be thoroughly cleaned prior to their first use in accordance with 
current good manufacturing practice.

[59 FR 15623, Apr. 4, 1994]



Sec. 173.25  Ion-exchange resins.

    Ion-exchange resins may be safely used in the treatment of food 
under the following prescribed conditions:
    (a) The ion-exchange resins are prepared in appropriate physical 
form, and consist of one or more of the following:
    (1) Sulfonated copolymer of styrene and divinylbenzene.
    (2) Sulfonated anthracite coal meeting the requirements of ASTM 
method D388-38, Class I, Group 2, ``Standard Specifications for 
Classification of Coal by Rank,'' which is incorporated by reference. 
Copies are available from University Microfilms International, 300 N. 
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (3) Sulfite-modified cross-linked phenol-formaldehyde, with 
modification resulting in sulfonic acid groups on side chains.
    (4) Methacrylic acid-divinylbenzene copolymer.
    (5) Cross-linked polystyrene, first chloromethylated then aminated 
with trimethylamine, dimethylamine, di-ethylenetriamine, or 
dimethylethanol-amine.
    (6) Diethylenetriamine, triethylene-tetramine, or 
tetraethylenepentamine cross-linked with epichlorohydrin.

[[Page 120]]

    (7) Cross-linked phenol-formaldehyde activated with one or both of 
the following: Triethylene tetramine and tetraethylenepentamine.
    (8) Reaction resin of formaldehyde, acetone, and 
tetraethylenepentamine.
    (9) Completely hydrolyzed copolymers of methyl acrylate and 
divinylbenzene.
    (10) Completely hydrolyzed terpolymers of methyl acrylate, 
divinylbenzene, and acrylonitrile.
    (11) Sulfonated terpolymers of styrene, divinylbenzene, and 
acrylonitrile or methyl acrylate.
    (12) Methyl acrylate-divinylbenzene copolymer containing not less 
than 2 percent by weight of divinylbenzene, aminolyzed with 
dimethylaminopro-pylamine.
    (13) Methyl acrylate-divinylbenzene copolymer containing not less 
than 3.5 percent by weight of divinylbenzene, aminolyzed with 
dimethylaminopro-pylamine.
    (14) Epichlorohydrin cross-linked with ammonia.
    (15) Sulfonated tetrapolymer of styrene, divinylbenzene, 
acrylonitrile, and methyl acrylate derived from a mixture of monomers 
containing not more than a total of 2 percent by weight of acrylonitrile 
and methyl acrylate.
    (16) Methyl acrylate-divinyl benzene di ethylene glycol divinyl 
ether terpolymer containing not less than 3.5 percent by weight of di 
vinyl benzene and not more than 0.6 percent by weight of di ethylene 
glycol divinyl ether, aminolyzed with di methyl amino propyl amine.
    (17) Styrene-divinylbenzene cross-linked copolymer, first 
chloromethylated then aminated with dimethylamine and oxidized with 
hydrogen peroxide whereby the resin contains not more than 15 percent by 
weight of vinyl N,N-di methyl benzyl amine-N-oxide and not more than 6.5 
percent by weight of nitrogen.
    (18) Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether 
terpolymer containing not less than 7 percent by weight of 
divinylbenzene and not more than 2.3 percent by weight of diethylene 
glycol divinyl ether, aminolyzed with di methyl amino propyl amine and 
quaternized with methyl chloride.
    (19) Epichlorohydrin cross-linked with ammonia and then quaternized 
with methyl chloride to contain not more than 18 percent strong base 
capacity by weight of total exchange capacity [Chemical Abstracts 
Service name: Oxirane (chloromethyl)-, polymer with ammonia, reaction 
product with chloromethane; CAS Reg. No. 68036-99-7].
    (20) Regenerated cellulose, cross-linked and alkylated with epi 
chloro hydrin and propylene oxide, then sulfonated whereby the amount of 
epi chloro hydrin plus propylene oxide employed does not exceed 250 
percent by weight of the starting quantity of cellulose.
    (b) Ion-exchange resins are used in the purification of foods, 
including potable water, to remove undesirable ions or to replace less 
desirable ions with one or more of the following: bicarbonate, calcium, 
carbonate, chloride, hydrogen, hydroxyl, magnesium, potassium, sodium, 
and sulfate except that: The ion-exchange resin identified in paragraph 
(a)(12) of this section is used only in accordance with paragraph (b)(1) 
of this section, the ion-exchange resin identified in paragraph (a)(13) 
of this section is used only in accordance with paragraph (b)(2) of this 
section, the resin identified in paragraph (a)(16) of this section is 
used only in accordance with paragraph (b)(1) or (b)(2) of this section, 
the ion-exchange resin identified in paragraph (a)(17) of this section 
is used only in accordance with paragraph (b)(3) of this section, the 
ion-exchange resin identified in paragraph (a)(18) of this section is 
used only in accordance with paragraph (b)(4) of this section, and the 
ion-exchange resin identified in paragraph (a)(20) of this section is 
used only in accordance with paragraphs (b)(5) and (d) of this section.
    (1) The ion-exchange resins identified in paragraphs (a) (12) and 
(16) of this section are used to treat water for use in the manufacture 
of distilled alcoholic beverages, subject to the following conditions:
    (i) The water is subjected to treatment through a mixed bed 
consisting of one of the resins identified in paragraph (a) (12) or (16) 
of this section and

[[Page 121]]

one of the strongly acidic cation-exchange resins in the hydrogen form 
identified in paragraphs (a) (1), (2), and (11) of this section; or
    (ii) The water is first subjected to one of the resins identified in 
paragraph (a) (12) or (16) of this section and is subsequently subjected 
to treatment through a bed of activated carbon or one of the strongly 
acidic cation-exchange resins in the hydrogen form identified in 
paragraphs (a) (1), (2), and (11) of this section.
    (iii) The temperature of the water passing through the resin beds 
identified in paragraphs (b)(1) (i) and (ii) of this section is 
maintained at 30 [deg]C or less, and the flow rate of the water passing 
through the beds is not less than 2 gallons per cubic foot per minute.
    (iv) The ion-exchange resins identified in paragraph (a) (12) or 
(16) of this section are exempted from the requirements of paragraph 
(c)(4) of this section, but the strongly acidic cation-exchange resins 
referred to in paragraphs (b)(1) (i) and (ii) of this section used in 
the process meet the requirements of paragraph (c)(4) of this section, 
except for the exemption described in paragraph (d) of this section.
    (2) The ion-exchange resins identified in paragraphs (a) (13) and 
(16) of this section are used to treat water and aqueous food only of 
the types identified under Categories I, II, and VI-B in table 1 of 
Sec. 176.170(c) of this chapter: Provided, That the temperature of the 
water or food passing through the resin beds is maintained at 50 [deg]C 
or less and the flow rate of the water or food passing through the beds 
is not less than 0.5 gallon per cubic foot per minute.
    (i) The ion-exchange resin identified in paragraph (a)(13) of this 
section is used to treat water and aqueous food only of the types 
identified under categories I, II, and VI-B in Table 1 of Sec. 
176.170(c) of this chapter: Provided, That the temperature of the water 
or food passing through the resin bed is maintained at 50 [deg]C or less 
and the flow rate of the water or food passing through the bed is not 
less than 0.5 gallon per cubic foot per minute.
    (ii) The ion-exchange resin identified in paragraph (a)(16) of this 
section is used to treat water and aqueous food only of the types 
identified under categories I, II, and VI-B in Table 1 of Sec. 
176.170(c) of this chapter, Provided, that either:
    (A) The temperature of the water or food passing through the resin 
bed is maintained at 50 [deg]C or less and the flow rate of the water or 
food passing through the bed is not less than 0.5 gallon per cubic foot 
per minute; or
    (B) Extracts of the resin will be found to contain no more than 1 
milligram/kilogram dimethylaminopropylamine in each of the food 
simulants, distilled water and 10 percent ethanol, when, following 
washing and pretreatment of the resin in accordance with Sec. 
173.25(c)(1), the resin is subjected to the following test under 
conditions simulating the actual temperature and flow rate of use: ``The 
Determination of 3-Dimethylaminopropylamine in Food Simulating Extracts 
of Ion Exchange Resins,'' February 4, 1998, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
are available from the Division of Petition Control (HFS-215), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (3) The ion-exchange resin identified in paragraph (a)(17) of this 
section is used only for industrial application to treat bulk quantities 
of aqueous food, including potable water, or for treatment of municipal 
water supplies, subject to the condition that the temperature of the 
food or water passing through the resin bed is maintained at 25 [deg]C 
or less and the flow rate of the food or water passing through the bed 
is not less than 2 gallons per cubic foot per minute.
    (4) The ion-exchange resin identified in paragraph (a)(18) of this 
section is used to treat aqueous sugar solutions subject to the 
condition that the temperature of the sugar solution passing through the 
resin bed is maintained at 82 [deg]C (179.6 [deg]F) or less and the flow 
rate of the sugar solution passing through

[[Page 122]]

the bed is not less than 46.8 liters per cubic meter (0.35 gallon per 
cubic foot) of resin bed volume per minute.
    (5) The ion-exchange resin identified in paragraph (a)(20) of this 
section is limited to use in aqueous process streams for the isolation 
and purification of protein concentrates and isolates under the 
following conditions:
    (i) For resins that comply with the requirements in paragraph 
(d)(2)(i) of this section, the pH range for the resin shall be no less 
than 3.5 and no more than 9, and the temperatures of water and food 
passing through the resin bed shall not exceed 25 [deg]C.
    (ii) For resins that comply with the requirements in paragraph 
(d)(2)(ii) of this section, the pH range for the resin shall be no less 
than 2 and no more than 10, and the temperatures of water and food 
passing through the resin shall not exceed 50 [deg]C.
    (c) To insure safe use of ion-exchange resins, each ion-exchange 
resin will be:
    (1) Subjected to pre-use treatment by the manufacturer and/or the 
user in accordance with the manufacturer's directions prescribed on the 
label or labeling accompanying the resins, to guarantee a food-grade 
purity of ion-exchange resins, in accordance with good manufacturing 
practice.
    (2) Accompanied by label or labeling to include directions for use 
consistent with the intended functional purpose of the resin.
    (3) Used in compliance with the label or labeling required by 
paragraph (c)(2) of this section.
    (4) Found to result in no more than 1 part per million of organic 
extractives obtained with each of the named solvents, distilled water, 
15 percent alcohol, and 5 percent acetic acid when, having been washed 
and otherwise treated in accordance with the manufacturer's directions 
for preparing them for use with food, the ion-exchange resin is 
subjected to the following test: Using a separate ion-exchange column 
for each solvent, prepare columns using 50 milliliters of the ready to 
use ion-exchange resin that is to be tested. While maintaining the 
highest temperature that will be encountered in use pass through these 
beds at the rate of 350-450 milliliters per hour the three test solvents 
distilled water, 15 percent (by volume) ethyl alcohol, and 5 percent (by 
weight) acetic acid. The first liter of effluent from each solvent is 
discarded, then the next 2 liters are used to determine organic 
extractives. The 2-liter sample is carefully evaporated to constant 
weight at 105 [deg]C; this is total extractives. This residue is fired 
in a muffle furnace at 850 [deg]C to constant weight; this is ash. Total 
extractives, minus ash equals the organic extractives. If the organic 
extractives are greater than 1 part per million of the solvent used, a 
blank should be run on the solvent and a correction should be made by 
subtracting the total extractives obtained with the blank from the total 
extractives obtained in the resin test. The solvents used are to be made 
as follows:

Distilled water (de-ionized water is distilled).
15 percent ethyl alcohol made by mixing 15 volumes of absolute ethyl 
alcohol A.C.S. reagent grade, with 85 volumes of distilled de-ionized 
water.
5 percent acetic acid made by mixing 5 parts by weight of A.C.S. reagent 
grade glacial acetic acid with 95 parts by weight of distilled de-
ionized water.


In addition to the organic extractives limitation prescribed in this 
paragraph, the ion-exchange resin identified in paragraph (a)(17) of 
this section, when extracted with each of the named solvents, distilled 
water, 50 percent alcohol, and 5 percent acetic acid, will be found to 
result in not more than 7 parts per million of nitrogen extractives 
(calculated as nitrogen) when the resin in the free-base form is 
subjected to the following test immediately before each use: Using a 
separate 1-inch diameter glass ion-exchange column for each solvent, 
prepare each column using 100 milliliters of ready to use ion-exchange 
resin that is to be tested. With the bottom outlet closed, fill each 
ion-exchange column with one of the three solvents at a temperature of 
25 [deg]C until the solvent level is even with the top of the resin bed. 
Seal each column at the top and bottom and store in a vertical position 
at a temperature of 25 [deg]C. After 96 hours, open the top of each 
column, drain the solvent into a collection vessel, and analyze each 
drained

[[Page 123]]

solvent and a solvent blank for nitrogen by a standard micro-Kjeldahl 
method.
    (d)(1) The ion-exchange resins identified in paragraphs (a)(1), 
(a)(2), (a)(11), and (a)(15) of this section are exempted from the 
acetic acid extraction requirement of paragraph (c)(4) of this section.
    (2) The ion-exchange resin identified in paragraph (a)(20) of this 
section shall comply either with:
    (i) The extraction requirement in paragraph (c)(4) of this section 
by using dilute sulfuric acid, pH 3.5 as a substitute for acetic acid; 
or
    (ii) The extraction requirement in paragraph (c)(4) of this section 
by using reagent grade hydrochloric acid, diluted to pH 2, as a 
substitute for acetic acid. The resin shall be found to result in no 
more than 25 parts per million of organic extractives obtained with each 
of the following solvents: Distilled water; 15 percent alcohol; and 
hydrochloric acid, pH 2. Blanks should be run for each of the solvents, 
and corrections should be made by subtracting the total extractives 
obtained with the blank from the total extractives obtained in the resin 
test.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981; 46 
FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Apr. 
22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR 14609, Mar. 26, 1999; 64 FR 
56173, Oct. 18, 1999]



Sec. 173.40  Molecular sieve resins.

    Molecular sieve resins may be safely used in the processing of food 
under the following prescribed conditions:
    (a) The molecular sieve resins consist of purified dextran having an 
average molecular weight of 40,000, cross-linked with epichlorohydrin in 
a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a 
stable three dimensional structure. The resins have a pore size of 2.0 
to 3.0 milliliters per gram of dry resin (expressed in terms of water 
regain), and a particle size of 10 to 300 microns.
    (b) The molecular sieve resins are thoroughly washed with potable 
water prior to their first use in contact with food.
    (c) Molecular sieve resins are used as the gel filtration media in 
the final purification of partially delactosed whey. The gel bed shall 
be maintained in a sanitary manner in accordance with good manufacturing 
practice so as to prevent microbial build-up on the bed and adulteration 
of the product.



Sec. 173.45  Polymaleic acid and its sodium salt.

    Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS 
Reg. No. 70247-90-4) may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additives have a weight-average molecular weight in the 
range of 540 to 850 and a number-average molecular weight in the range 
of 520 to 650, calculated as the acid. Molecular weights shall be 
determined by a method entitled ``Determination of Molecular Weight 
Distribution of Poly(Maleic) Acid,'' March 17, 1992, produced by Ciba-
Geigy, Inc., Seven Skyline Dr., Hawthorne, NY 10532-2188, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Division of Product Policy, 
Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or are 
available for inspection at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the Office of the Federal Register, 800 North Capitol St. NW., suite 
700, Washington, DC.
    (b) The additives may be used, individually or together, in the 
processing of beet sugar juice and liquor or of cane sugar juice and 
liquor to control mineral scale.
    (c) The additives are to be used so that the amount of either or 
both additives does not exceed 4 parts per million (calculated as the 
acid) by weight of the beet or cane sugar juice or liquor process 
stream.

[51 FR 5315, Feb. 13, 1986, as amended at 61 FR 386, Jan. 5, 1996]

[[Page 124]]



Sec. 173.50  Polyvinylpolypyrrolidone.

    The food additive polyvinylpoly pyrrolidone may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive is a homopolymer of purified vinylpyrrolidone 
catalytically produced under conditions producing polymerization and 
cross-linking such that an insoluble polymer is produced.
    (b) The food additive is so processed that when the finished polymer 
is refluxed for 3 hours with water, 5 percent acetic acid, and 50 
percent alcohol, no more than 50 parts per million of extractables is 
obtained with each solvent.
    (c) It is used or intended for use as a clarifying agent in 
beverages and vinegar, followed by removal with filtration.



Sec. 173.55  Polyvinylpyrrolidone.

    The food additive polyvinylpyrroli-done may be safely used in 
accordance with the following prescribed conditions:
    (a) The additive is a polymer of purified vinylpyrrolidone 
catalytically produced, having an average molecular weight of 40,000 and 
a maximum unsaturation of 1 percent, calculated as the monomer, except 
that the polyvinylpyrrolidone used in beer is that having an average 
molecular weight of 360,000 and a maximum unsaturation of 1 percent, 
calculated as the monomer.
    (b) The additive is used or intended for use in foods as follows:

------------------------------------------------------------------------
              Food                              Limitations
------------------------------------------------------------------------
Beer............................  As a clarifying agent, at a residual
                                   level not to exceed 10 parts per
                                   million.
Flavor concentrates in tablet     As a tableting adjuvent in an amount
 form.                             not to exceed good manufacturing
                                   practice.
Nonnutritive sweeteners in        As a stabilizer, bodying agent, and
 concentrated liquid form.         dispersant, in an amount not to
                                   exceed good manufacturing practice.
Nonnutritive sweeteners in        As a tableting adjuvant in an amount
 tablet form.                      not to exceed good manufacturing
                                   practice.
Vitamin and mineral concentrates  As a stabilizer, bodying agent, and
 in liquid form.                   dispersant, in an amount not to
                                   exceed good manufacturing practice.
Vitamin and mineral concentrates  As a tableting adjuvant in an amount
 in tablet form.                   not to exceed good manufacturing
                                   practice.
Vinegar.........................  As a clarifying agent, at a residual
                                   level not to exceed 40 parts per
                                   million.
Wine............................  As a clarifying agent, at a residual
                                   level not to exceed 60 parts per
                                   million.
------------------------------------------------------------------------



Sec. 173.60  Dimethylamine-epichlorohydrin copolymer.

    Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) 
may be safely used in food in accordance with the following prescribed 
conditions:
    (a) The food additive is produced by copolymerization of 
dimethylamine and epichlorohydrin in which not more than 5 mole-percent 
of dimethylamine may be replaced by an equimolar amount of 
ethylenediamine, and in which the mole ratio of total amine to 
epichlorohydrin is approximately 1:1.
    (b) The additive meets the following specifications:
    (1) The nitrogen content of the copolymer is 9.4 to 10.8 weight 
percent on a dry basis.
    (2) A 50-percent-by-weight aqueous solution of the copolymer has a 
minimum viscosity of 175 centipoises at 25 [deg]C as determined by LVT-
series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by 
another equivalent method).
    (3) The additive contains not more than 1,000 parts per million of 
1,3-dichloro-2-propanol and not more than 10 parts per million 
epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol content 
is determined by an analytical method entitled ``The Determination of 
Epichlorohydrin and 1,3-Dichloro-2-Propanol in Dimethylamine-
Epichlorohydrin Copolymer,'' which is incorporated by reference. Copies 
are available from the Center for Food Safety and Applied Nutrition 
(HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College

[[Page 125]]

Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (4) Heavy metals (as Pb), 2 parts per million maximum.
    (5) Arsenic (as As), 2 parts per million maximum.
    (c) The food additive is used as a decolorizing agent and/or 
flocculant in the clarification of refinery sugar liquors and juices. It 
is added only at the defecation/clarification stage of sugar liquor 
refining at a concentration not to exceed 150 parts per million of 
copolymer by weight of sugar solids.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to other information required by 
the Act, adequate directions to assure use in compliance with paragraph 
(c) of this section.

[48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12, 1989]



Sec. 173.65  Divinylbenzene copolymer.

    Divinylbenzene copolymer may be used for the removal of organic 
substances from aqueous foods under the following prescribed conditions:
    (a) The copolymer is prepared in appropriate physical form and is 
derived by the polymerization of a grade of divinylbenzene which 
comprises at least 79 weight-percent divinylbenzene, 15 to 20 weight-
percent ethyl vinyl benzene, and no more than 4 weight-percent 
nonpolymerizable impurities.
    (b) In accordance with the manufacturer's directions, the copolymer 
described in paragraph (a) of this section is subjected to pre-use 
extraction with a water soluble alcohol until the level of 
divinylbenzene in the extract is less than 50 parts per billion as 
determined by a method titled, ``The Determination of Divinylbenzene in 
Alcohol Extracts of Amberlite XAD-4,'' which is incorporated by 
reference. Copies of this method are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408. The copolymer is then 
treated with water according to the manufacturer's recommendation to 
remove the extraction solvent to guarantee a food-grade purity of the 
resin at the time of use, in accordance with current good manufacturing 
practice.
    (c) The temperature of the aqueous food stream contacting the 
polymer is maintained at 79.4 [deg]C (175 [deg]F) or less.
    (d) The copolymer may be used in contact with food only of Types I, 
II, and VI-B (excluding carbonated beverages) described in table 1 of 
paragraph (c) of Sec. 176.170 of this chapter.

[50 FR 61, Jan. 2, 1985]



Sec. 173.70  Chloromethylated aminated styrene-divinylbenzene resin.

    Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg. 
No. 60177-39-1) may be safely used in food in accordance with the 
following prescribed conditions:
    (a) The additive is an aqueous dispersion of styrene-divinylbenzene 
copolymers, first chloromethylated then aminated with trimethylamine, 
having an average particle size of not more than 2.0 microns.
    (b) The additive shall contain no more than 3.0 percent nonvolatile, 
soluble extractives when tested as follows: One hundred grams of the 
additive is centrifuged at 17,000 r/min for 2 hours. The resulting clear 
supernatant is removed from the compacted solids and concentrated to 
approximately 10 grams on a steam bath. The 10-gram sample is again 
centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble 
material. The supernatant from the second centrifugation is then removed 
from any compacted solids and dried to constant residual weight using a 
steam bath. The percent nonvolatile solubles is obtained by dividing the 
weight of the dried residue by the weight of the solids in the original 
resin dispersion.
    (c) The additive is used as a decolorizing and clarification agent 
for treatment of refinery sugar liquors and juices at levels not to 
exceed 500 parts of additive solids per million parts of sugar solids.

[50 FR 29209, July 18, 1985]

[[Page 126]]



Sec. 173.73  Sodium polyacrylate.

    Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is produced by the polymerization of acrylic acid 
and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium 
hydroxide solution. As determined by a method entitled ``Determination 
of Weight Average and Number Average Molecular Weight of Sodium 
Polyacrylate,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a), the additive has--
    (1) A weight average molecular weight of 2,000 to 2,300; and
    (2) A weight average molecular weight to number average molecular 
weight ratio of not more than 1.3. Copies of the method are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.
    (b) The additive is used to control mineral scale during the 
evaporation of beet sugar juice or cane sugar juice in the production of 
sugar in an amount not to exceed 3.6 parts per million by weight of the 
raw juice.

[53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988]



Sec. 173.75  Sorbitan monooleate.

    Sorbitan monooleate may be safely used in accordance with the 
following prescribed conditions:
    (a) The additive is produced by the esterification of sorbitol with 
commercial oleic acid.
    (b) It meets the following specifications:
    (1) Saponification number, 145-160.
    (2) Hydroxyl number, 193-210.
    (c) The additive is used or intended for use as follows:
    (1) As an emulsifier in polymer dispersions that are used in the 
clarification of cane or beet sugar juice or liquor in an amount not to 
exceed 7.5 percent by weight in the final polymer dispersion.
    (2) The additive is used in an amount not to exceed 0.70 part per 
million in sugar juice and 1.4 parts per million in sugar liquor.

[51 FR 11720, Apr. 7, 1986]



            Subpart B_Enzyme Preparations and Microorganisms



Sec. 173.110  Amyloglucosidase derived from Rhizopus niveus.

    Amyloglucosidase enzyme product, consisting of enzyme derived from 
Rhizopus niveus, and diatomaceous silica as a carrier, may be safely 
used in food in accordance with the following conditions:
    (a) Rhizopus niveus is classified as follows: Class, Phycomycetes; 
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, niveus.
    (b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in 
man or other animals.
    (c) The enzyme is produced by a process which completely removes the 
organism Rhizopus niveus from the amyloglucosidase.
    (d) The additive is used or intended for use for degrading 
gelatinized starch into constituent sugars, in the production of 
distilled spirits and vinegar.
    (e) The additive is used at a level not to exceed 0.1 percent by 
weight of the gelatinized starch.



Sec. 173.115  Alpha-acetolactate decarboxylase ([alpha]-ALDC) enzyme 
preparation derived from a recombinant Bacillus subtilis.

    The food additive alpha-acetolactate decarboxylase ([alpha]-ALDC) 
enzyme preparation, may be safely used in accordance with the following 
conditions:
    (a) The food additive is the enzyme preparation derived from a 
modified Bacillus subtilis strain that contains the gene coding for 
[alpha]-ALDC from Bacillus brevis.
    (b)(1) The manufacturer produces the additive from a pure culture 
fermentation of a strain of Bacillus subtilis that is nonpathogenic and 
nontoxigenic in man or other animals.
    (2) The manufacturer may stabilize the enzyme preparation with 
glutaraldehyde or with other suitable approved food additives or 
generally recognized as safe substances.

[[Page 127]]

    (3) The enzyme preparation must meet the general and additional 
requirements for enzyme preparations in the Food Chemicals Codex, 4th 
ed., 1996, pp. 133-134, which is incorporated by reference. The Director 
of the Office of the Federal Register approves this incorporation by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
may be obtained from the National Academy Press, 2101 Constitution Ave. 
NW., Washington, DC 20055, or may be examined at the Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 
20740, or at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect as a processing aid in the 
production of alcoholic malt beverages and distilled liquors.

[66 FR 27022, May 16, 2001]



Sec. 173.120  Carbohydrase and cellulase derived from Aspergillus niger.

    Carbohydrase and cellulase enzyme preparation derived from 
Aspergillus niger may be safely used in food in accordance with the 
following prescribed conditions:
    (a) Aspergillus niger is classified as follows: Class, 
Deuteromycetes; order, Moniliales; family, Moniliaceae; genus, 
Aspergillus; species, niger.
    (b) The strain of Aspergillus niger is nonpathogenic and nontoxic in 
man or other animals.
    (c) The additive is produced by a process that completely removes 
the organism Aspergillus niger from the carbohydrase and cellulase 
enzyme product.
    (d) The additive is used or intended for use as follows:
    (1) For removal of visceral mass (bellies) in clam processing.
    (2) As an aid in the removal of the shell from the edible tissue in 
shrimp processing.
    (e) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect.



Sec. 173.130  Carbohydrase derived from Rhizopus oryzae.

    Carbohydrase from Rhizopus oryzae may be safely used in the 
production of dextrose from starch in accordance with the following 
prescribed conditions:
    (a) Rhizopus oryzae is classified as follows: Class, Phycomycetes; 
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species, Rhizopus 
oryzae.
    (b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.
    (c) The carbohydrase is produced under controlled conditions to 
maintain nonpathogenicity and nontoxicity, including the absence of 
aflatoxin.
    (d) The carbohydrase is produced by a process which completely 
removes the organism Rhizopus oryzae from the carbohydrase product.
    (e) The carbohydrase is maintained under refrigeration from 
production to use and is labeled to include the necessity of 
refrigerated storage.



Sec. 173.135  Catalase derived from Micrococcus lysodeikticus.

    Bacterial catalase derived from Micrococcus lysodeikticus by a pure 
culture fermentation process may be safely used in destroying and 
removing hydrogen peroxide used in the manufacture of cheese, in 
accordance with the following conditions.
    (a) The organism Micrococcus lysodeikticus from which the bacterial 
catalase is to be derived is demonstrated to be nontoxic and 
nonpathogenic.
    (b) The organism Micrococcus lysodeikticus is removed from the 
bacterial catalase prior to use of the bacterial catalase.
    (c) The bacterial catalase is used in an amount not in excess of the 
minimum required to produce its intended effect.



Sec. 173.140  Esterase-lipase derived from Mucor miehei.

    Esterase-lipase enzyme, consisting of enzyme derived from Mucor 
miehei var. Cooney et Emerson by a pure culture fermentation process, 
with maltodextrin or sweet whey as a carrier, may be safely used in food 
in accordance with the following conditions:

[[Page 128]]

    (a) Mucor miehei var. Cooney et Emerson is classified as follows: 
Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, 
Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson.
    (b) The strain of Mucor miehei var. Cooney et Emerson is 
nonpathogenic and nontoxic in man or other animals.
    (c) The enzyme is produced by a process which completely removes the 
organism Mucor miehei var. Cooney et Emerson from the esterase-lipase.
    (d) The enzyme is used as a flavor enhancer as defined in Sec. 
170.3(o)(12).
    (e) The enzyme is used at levels not to exceed current good 
manufacturing practice in the following food categories: cheeses as 
defined in Sec. 170.3(n)(5) of this chapter; fat and oils as defined in 
Sec. 170.(3)(n)(12) of this chapter; and milk products as defined in 
Sec. 170.(3)(n)(31) of this chapter. Use of this food ingredient is 
limited to nonstandarized foods and those foods for which the relevant 
standards of identity permit such use.
    (f) The enzyme is used in the minimum amount required to produce its 
limited technical effect.

[47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983]



Sec. 173.145  Alpha-Galactosidase derived from Mortierella vinaceae var. 
raffinoseutilizer.

    The food additive alpha-galactosidase and parent mycelial 
microorganism Mortierella vinaceae var. raffinoseutilizer may be safely 
used in food in accordance with the following conditions:
    (a) The food additive is the enzyme alpha-galactosidase and the 
mycelia of the microorganism Mortierella vinaceae var. raffinoseutilizer 
which produces the enzyme.
    (b) The nonpathogenic microorganism matches American Type Culture 
Collection (ATCC) No. 20034, \1\ and is classified as follows:
---------------------------------------------------------------------------

    \1\ Available from: American Type Culture Collection, 12301 Parklawn 
Drive, Rockville, MD 20852.

Class: Phycomycetes.
Order: Mucorales.
Family: Mortierellaceae.
Genus: Mortierella.
Species: vinaceae.
Variety: raffinoseutilizer.

    (c) The additive is used or intended for use in the production of 
sugar (sucrose) from sugar beets by addition as mycelial pellets to the 
molasses to increase the yield of sucrose, followed by removal of the 
spent mycelial pellets by filtration.
    (d) The enzyme removal is such that there are no enzyme or mycelial 
residues remaining in the finished sucrose.

[42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12, 1989]



Sec. 173.150  Milk-clotting enzymes, microbial.

    Milk-clotting enzyme produced by pure-culture fermentation process 
may be safely used in the production of cheese in accordance with the 
following prescribed conditions:
    (a) Milk-clotting enzyme is derived from one of the following 
organisms by a pure-culture fermentation process:
    (1) Endothia parasitica classified as follows: Class, Ascomycetes; 
order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species, 
parasitica.
    (2) Bacillus cereus classified as follows: Class, Schizomycetes; 
order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species, 
cereus (Frankland and Frankland).
    (3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes; 
subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus, 
Mucor; species, pusillus; variety, Lindt.
    (4) Mucor miehei Cooney et Emerson classified as follows: Class, 
Phycomycetes; subclass, Zygomycetes; order, Mucorales; family, 
Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et Emerson.
    (5) Aspergillus oryzae modified by recombinant deoxyribonucleic 
(DNA) techniques to contain the gene coding for aspartic proteinase from 
Rhizomucor miehei var. Cooney et Emerson as defined in paragraph (a)(4) 
of this section, and classified as follows: Class, Blastodeuteromycetes 
(Hyphomycetes); order, Phialidales (Moniliales); genus, Aspergillus; 
species oryzae.
    (b) The strains of organism identified in paragraph (a) of this 
section are nonpathogenic and nontoxic in man or other animals.

[[Page 129]]

    (c) The additive is produced by a process that completely removes 
the generating organism from the milk-clotting enzyme product.
    (d) The additive is used in an amount not in excess of the minimum 
required to produce its intended effect in the production of those 
cheeses for which it is permitted by standards of identity established 
pursuant to section 401 of the Act.

[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 
62 FR 59284, Nov. 3, 1997]



Sec. 173.160  Candida guilliermondii.

    The food additive Candida guilliermondii may be safely used as the 
organism for fermentation production of citric acid in accordance with 
the following conditions:
    (a) The food additive is the enzyme system of the viable organism 
Candida guilliermondii and its concomitant metabolites produced during 
the fermentation process.
    (b)(1) The nonpathogenic and nontoxicogenic organism descending from 
strain, American Type Culture Collection (ATCC) No. 20474,\1\ is 
classified as follows:
---------------------------------------------------------------------------

    \1\ Available from: American Type Culture Collection, 12301 Parklawn 
Drive, Rockville, MD 20852.

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: guilliermondii.
Variety: guilliermondii.

    (2) The toxonomic characteristics of the reference culture strain 
ATCC No. 20474 agree in the essentials with the standard description for 
Candida guilliermondii variety guilliermondii listed in ``The Yeasts--A 
Toxonomic Study;'' 2d Ed. (1970), by Jacomina Lodder, which is 
incorporated by reference. Copies are available from the Center for Food 
Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, or available for 
inspection at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (c)(1) The additive is used or intended for use as a pure culture in 
the fermentation process for the production of citric acid using an 
acceptable aqueous carbohydrate substrate.
    (2) The organism Candida quilliermondii is made nonviable and is 
completely removed from the citric acid during the recovery and 
purification process.
    (d) The additive is so used that the citric acid produced conforms 
to the specifications of the ``Food Chemicals Codex,'' 3d Ed. (1981), 
under ``Citric acid,'' pp. 86-87, which is incorporated by reference. 
Copies may be obtained from the National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418, or may be examined at the 
Office of the Federal Register., 800 North Capitol Street, NW., suite 
700, Washington, DC 20408.

[42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 173.165  Candida lipolytica.

    The food additive Candida lipolytica may be safely used as the 
organism for fermentation production of citric acid in accordance with 
the following conditions:
    (a) The food additive is the enzyme system of the organism Candida 
lipolytica and its concimitant metabolites produced during the 
fermentation process.
    (b)(1) The nonpathogenic organism is classified as follows:

Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: lipolytica.

    (2) The taxonomic characteristics of the culture agree in essential 
with the standard description for Candida lipolytica variety lipolytica 
listed in ``The Yeasts--A Toxonomic Study,'' 2d Ed. (1970), by Jacomina 
Lodder, which is incorporated by reference. Copies are available from 
the Center for Food Safety and Applied Nutrition (HFS-200), Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.

[[Page 130]]

    (c) The additive is used or intended for use as a pure culture in 
the fermentation process for the production of citric acid from purified 
normal alkanes.
    (d) The additive is so used that the citric acid produced conforms 
to the specifications of the ``Food Chemicals Codex,'' 3d Ed. (1981), 
pp. 86-87, which is incorporated by reference. Copies may be obtained 
from the National Academy Press, 2101 Constitution Ave. NW., Washington, 
DC 20418, or may be examined at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Wasington, DC 20408. The additive 
meets the following ultraviolet absorbance limits when subjected to the 
analytical procedure described in this paragraph:

------------------------------------------------------------------------
      Ultraviolet absorbance per centimeter path length         Maximum
------------------------------------------------------------------------
280 to 289 millimicrons.....................................        0.25
290 to 299 millimicrons.....................................        0.20
300 to 359 millimicrons.....................................        0.13
360 to 400 millimicrons.....................................        0.03
------------------------------------------------------------------------

                  Analytical Procedure for Citric Acid

                          general instructions

    Because of the sensitivity of the test, the possibility of errors 
arising from contamination is great. It is of the greatest importance 
that all glassware be scrupulously cleaned to remove all organic matter 
such as oil, grease, detergent residues, etc. Examine all glassware 
including stoppers and stopcocks, under ultraviolet light to detect any 
residual fluorescent contamination. As a precautionary measure it is 
recommended practice to rinse all glassware with purified isooctane 
immediately before use. No grease is to be used on stopcocks or joints. 
Great care to avoid contamination of citric acid samples in handling is 
essential to assure absence of any extraneous material arising from 
inadequate packaging. Because some of the polynuclear hydrocarbons 
sought in this test are very susceptible to photo-oxidation, the entire 
procedure is to be carried out under subdued light.

                                apparatus

    1. Aluminum foil, oil free.
    2. Separatory funnels, 500-milliliter capacity, equipped with 
tetrafluoroethylene polymer stopcocks.
    3. Chromatographic tubes: (a) 80-millimeter ID x 900-millimeter 
length equipped with tetrafluoroethylene polymer stopcock and course 
fritted disk; (b) 18-millimeter ID x 300-millimeter length equipped with 
tetrafluoroethylene polymer stopcock.
    4. Rotary vacuum evaporator, Buchi or equivalent.
    5. Spectrophotometer--Spectral range 250-400 nanometers with 
spectral slit width of 2 nanometers or less; under instrument operating 
conditions for these absorbance measurements, the spectrophotometer 
shall also meet the following performance requirements:
    Absorbance repeatability, 0.01 at 0.4 
absorbance.
    Wavelength repeatability, 0.2 nanometer.
    Wavelength accuracy, 1.0 nanometer.
    The spectrophotometer is equipped with matched 1 centimeter path 
length quartz microcuvettes with 0.5-milliliter volume capacity.
    6. Vacuum oven, minimum inside dimensions: 200 mm x 200 mm x 300 mm 
deep.

                         reagents and materials

    Organic solvents. All solvents used throughout the procedure shall 
meet the specifications and tests described in this specification. The 
methyl alcohol, isooctane, benzene, hexane and 1,2-dichloroethane 
designated in the list following this paragraph shall pass the following 
test:
    The specified quantity of solvent is added to a 250-milliliter round 
bottom flask containing 0.5 milliliter of purified n-hexadecane and 
evaporated on the rotary evaporator at 45 [deg]C to constant volume. Six 
milliliters of purified isooctane are added to this residue and 
evaporated under the same conditions as above for 5 minutes. Determine 
the absorbance of the residue compared to purified n-hexadecane as 
reference. The absorbance of the solution of the solvent residue shall 
not exceed 0.03 per centimeter path length between 280 and 299 
nanometers and 0.01 per centimeter path length between 300 and 400 
nanometers.
    Methyl alcohol, A.C.S. reagent grade. Use 100 milliliters for the 
test described in the preceding paragraph. If necessary, methyl alcohol 
may be purified by distillation through a Virgreaux column discarding 
the first and last ten percent of the distillate or otherwise.
    Benzene, spectrograde (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If 
necessary, benzene may be purified by distillation or otherwise.
    Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the 
test. If necessary, isooctane may be purified by passage through a 
column of activated silica gel, distillation or otherwise.
    Hexane, spectrograde (Burdick and Jackson Laboratories, Inc., 
Muskegon, Mich., or equivalent). Use 100 milliliters for the test. If 
necessary, hexane may be purified by distillation or otherwise.
    1,2-Dichloroethane, spectrograde (Matheson, Coleman and Bell, East 
Rutherford, N.J., or

[[Page 131]]

equivalent). Use 100 milliliters for the test. If necessary, 1,2-
dichloroethane may be purified by distillation or otherwise.

                            eluting mixtures

    1. 10 percent 1,2-dichloroethane in hexane. Prepare by mixing the 
purified solvents in the volume ratio of 1 part of 1,2-dichloroethane to 
9 parts of hexane.
    2. 40 percent benzene in hexane. Prepare by mixing the purified 
solvents in the volume ratio of 4 parts of benzene to 6 parts of hexane.
    n-Hexadecane, 99 percent olefin-free. Determine the absorbance 
compared to isooctane as reference. The absorbance per centimeter path 
length shall not exceed 0.00 in the range of 280-400 nanometers. If 
necessary, n-hexadecane may be purified by percolation through activated 
silica gel, distillation or otherwise.
    Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore, 
MD, or equivalent). Activate as follows: Slurry 900 grams of silica gel 
reagent with 2 liters of purified water in a 3-liter beaker. Cool the 
mixture and pour into a 80 x 900 chromatographic column with coarse 
fritted disc. Drain the water, wash with an additional 6 liters of 
purified water and wash with 3,600 milliliters of purified methyl 
alcohol at a relatively slow rate. Drain all of the solvents and 
transfer the silica gel to an aluminum foil-lined drying dish. Place 
foil over the top of the dish. Activate in a vacuum oven at low vacuum 
(approximately 750 millimeters Mercury or 27 inches of Mercury below 
atmospheric pressure) at 173[deg] to 177 [deg]C for at least 20 hours. 
Cool under vacuum and store in an amber bottle.
    Sodium sulfate, anhydrous, A.C.S. reagent grade. This reagent should 
be washed with purified isooctane. Check the purity of this reagent as 
described in Sec. 172.886 of this chapter.
    Water, purified. All water used must meet the specifications of the 
following test:
    Extract 600 milliliters of water with 50 milliliters of purified 
isooctane. Add 1 milliliter of purified n-hexadecane to the isooctane 
extract and evaporate the resulting solution to 1 milliliter. The 
absorbance of this residue shall not exceed 0.02 per centimeter path 
length between 300-400 nanometers and 0.03 per centimeter path length 
between 280-299 nanometers. If necessary, water may be purified by 
distillation, extraction with purified organic solvents, treatment with 
an absorbent (e.g., activated carbon) followed by filtration of the 
absorbent or otherwise.

                                procedure

    Separate portions of 200 milliliters of purified water are taken 
through the procedure for use as control blanks. Each citric acid sample 
is processed as follows: Weigh 200 grams of anhydrous citric acid into a 
500 milliliter flask and dissolve in 200 milliliters of pure water. Heat 
the solution to 60 [deg]C and transfer to a 500 milliliter separatory 
funnel. Rinse the flask with 50 milliliters of isooctane and add the 
isooctane to the separatory funnel. Gently shake the mixture 90 times 
(caution: vigorous shaking will cause emulsions) with periodic release 
of the pressure caused by shaking.
    Allow the phases to separate for at least 5 minutes. Draw off the 
lower aqueous layer into a second 500-milliliter separatory funnel and 
repeat the extraction with a second aliquot of 50 milliliters of 
isooctane. After separation of the layers, draw off and discard the 
water layer. Combine both isooctane extracts in the funnel containing 
the first extract. Rinse the funnel which contained the second extract 
with 10 milliliters of isooctane and add this portion to the combined 
isooctane extract.
    A chromatographic column containing 5.5 grams of silica gel and 3 
grams of anhydrous sodium sulfate is prepared for each citric acid 
sample as follows: Fit 18 x 300 column with a small glass wool plug. 
Rinse the inside of the column with 10 milliliters of purified 
isooctane. Drain the isooctane from the column. Pour 5.5 grams of 
activated silica gel into the column. Tap the column approximately 20 
times on a semisoft, clean surface to settle the silica gel. Carefully 
pour 3 grams of anhydrous sodium sulfate onto the top of the silica gel 
in the column.
    Carefully drain the isooctane extract of the citric acid solution 
into the column in a series of additions while the isooctane is draining 
from the column at an elution rate of approximately 3 milliliters per 
minute. Rinse the separatory funnel with 10 milliliters of isooctane 
after the last portion of the extract has been applied to the column and 
add this rinse to the column. After all of the extract has been applied 
to the column and the solvent layer reaches the top of the sulfate bed, 
rinse the column with 25 milliliters of isooctane followed by 10 
milliliters of a 10-percent dichloroethane in hexane solution. For each 
rinse solution, drain the column until the solvent layer reaches the top 
of the sodium sulfate bed. Discard the rinse solvents. Place a 250-
milliliter round bottom flask containing 0.5 milliliter of purified n-
hexadecane under the column. Elute the polynuclear aromatic hydrocarbons 
from the column with 30 milliliters of 40-percent benzene in hexane 
solution. Drain the eluate until the 40-percent benzene in the hexane 
solvent reaches the top of the sodium sulfate bed.
    Evaporate the 40-percent benzene in hexane eluate on the rotary 
vacuum evaporator at 45 [deg]C until only the n-hexadecane residue of 
0.5 milliliter remains. Treat the n-hexadecane residue twice with the 
following

[[Page 132]]

wash step: Add 6 milliliters of purified isooctane and remove the 
solvents by vacuum evaporation at 45 [deg]C to constant volume, i.e., 
0.5 milliliter. Cool the n-hexadecane residue and transfer the solution 
to an 0.5-milliliter microcuvette. Determine the absorbance of this 
solution compared to purified n-hexadecane as reference. Correct the 
absorbance values for any absorbance derived from the control reagent 
blank. If the corrected absorbance does not exceed the limits 
prescribed, the samples meet the ultraviolet absorbance specifications.
    The reagent blank is prepared by using 200 milliliters of purified 
water in place of the citric acid solution and carrying the water sample 
through the procedure. The typical control reagent blank should not 
exceed 0.03 absorbance per centimeter path length between 280 and 299 
nanometers, 0.02 absorbance per centimeter path length between 300 and 
359 nanometers, and 0.01 absorbance per centimeter path length between 
360 and 400 nanometers.

[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]



Sec. 173.170  Aminoglycoside 3'-phospho trans ferase II.

    The food additive aminoglycoside 3'-phosphotransferase II may be 
safely used in the development of genetically modified cotton, oilseed 
rape, and tomatoes in accordance with the following prescribed 
conditions:
    (a) The food additive is the enzyme aminoglycoside 3'-
phosphotransferase II (CAS Reg. No. 58943-39-8) which catalyzes the 
phosphorylation of certain aminoglycoside antibiotics, including 
kanamycin, neomycin, and gentamicin.
    (b) Aminoglycoside 3'-phos pho trans ferase II is encoded by the 
kanr gene originally isolated from transposon Tn5 of the 
bacterium Escherichia coli.
    (c) The level of the additive does not exceed the amount reasonably 
required for selection of plant cells carrying the kanr gene 
along with the genetic material of interest.

[59 FR 26711, May 23, 1994]



  Subpart C_Solvents, Lubricants, Release Agents and Related Substances



Sec. 173.210  Acetone.

    A tolerance of 30 parts per million is established for acetone in 
spice oleoresins when present therein as a residue from the extraction 
of spice.



Sec. 173.220  1,3-Butylene glycol.

    1,3-Butylene glycol (1,3-butanediol) may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The substance meets the following specifications:
    (1) 1,3-Butylene glycol content: Not less than 99 percent.
    (2) Specific gravity at 20/20 [deg]C: 1.004 to 1.006.
    (3) Distillation range: 200[deg]-215 [deg]C.
    (b) It is used in the minimum amount required to perform its 
intended effect.
    (c) It is used as a solvent for natural and synthetic flavoring 
substances except where standards of identity issued under section 401 
of the act preclude such use.



Sec. 173.228  Ethyl acetate.

    Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in 
accordance with the following conditions:
    (a) The additive meets the specifications of the Food Chemicals 
Codex, \1\ (Ethyl Acetate; p. 372, 3d Ed., 1981), which are incorporated 
by reference.
---------------------------------------------------------------------------

    \1\ Copies may be obtained from: National Academy Press, 2101 
Constitution Ave. NW., Washington, DC 20418 or examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
---------------------------------------------------------------------------

    (b) The additive is used in accordance with current good 
manufacturing practice as a solvent in the decaffeination of coffee and 
tea.

[47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984]



Sec. 173.230  Ethylene dichloride.

    A tolerance of 30 parts per million is established for ethylene 
dichloride in spice oleoresins when present therein as a residue from 
the extraction of spice; Provided, however, That if residues of other 
chlorinated solvents are also present the total of all residues of such 
solvents shall not exceed 30 parts per million.

[[Page 133]]



Sec. 173.240  Isopropyl alcohol.

    Isopropyl alcohol may be present in the following foods under the 
conditions specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 50 parts per million.
    (b) In lemon oil as a residue in production of the oil, at a level 
not to exceed 6 parts per million.
    (c) In hops extract as a residue from the extraction of hops at a 
level not to exceed 2.0 percent by weight: Provided, That,
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of the 
isopropyl alcohol and provides for the use of the hops extract only as 
prescribed by paragraph (c)(1) of this section.



Sec. 173.250  Methyl alcohol residues.

    Methyl alcohol may be present in the following foods under the 
conditions specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 50 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent by weight; Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of methyl 
alcohol and provides for the use of the hops extract only as prescribed 
by paragraph (b)(1) of this section.



Sec. 173.255  Methylene chloride.

    Methylene chloride may be present in food under the following 
conditions:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 30 parts per million; Provided, That, if 
residues of other chlorinated solvents are also present, the total of 
all residues of such solvents shall not exceed 30 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent, Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract identifies the presence of the 
methylene chloride and provides for the use of the hops extract only as 
prescribed by paragraph (b)(1) of this section.
    (c) In coffee as a residue from its use as a solvent in the 
extraction of caffeine from green coffee beans, at a level not to exceed 
10 parts per million (0.001 percent) in decaffeinated roasted coffee and 
in decaffeinated soluble coffee extract (instant coffee).



Sec. 173.270  Hexane.

    Hexane may be present in the following foods under the conditions 
specified:
    (a) In spice oleoresins as a residue from the extraction of spice, 
at a level not to exceed 25 parts per million.
    (b) In hops extract as a residue from the extraction of hops, at a 
level not to exceed 2.2 percent by weight; Provided, That:
    (1) The hops extract is added to the wort before or during cooking 
in the manufacture of beer.
    (2) The label of the hops extract specifies the presence of the 
hexane and provides for the use of the hops extract only as prescribed 
by paragraph (b)(1) of this section.



Sec. 173.275  Hydrogenated sperm oil.

    The food additive hydrogenated sperm oil may be safely used in 
accordance with the following prescribed conditions:
    (a) The sperm oil is derived from rendering the fatty tissue of the 
sperm whale or is prepared by synthesis of fatty acids and fatty 
alcohols derived from the sperm whale. The sperm oil obtained by 
rendering is refined. The oil is hydrogenated.
    (b) It is used alone or as a component of a release agent or 
lubricant in bakery pans.
    (c) The amount used does not exceed that reasonably required to 
accomplish the intended lubricating effect.



Sec. 173.280  Solvent extraction process for citric acid.

    A solvent extraction process for recovery of citric acid from 
conventional

[[Page 134]]

Aspergillus niger fermentation liquor may be safely used to produce 
food-grade citric acid in accordance with the following conditions:
    (a) The solvent used in the process consists of a mixture of n-octyl 
alcohol meeting the requirements of Sec. 172.864 of this chapter, 
synthetic isoparaffinic petroleum hydrocarbons meeting the requirements 
of Sec. 172.882 of this chapter, and tridodecyl amine.
    (b) The component substances are used solely as a solvent mixture 
and in a manner that does not result in formation of products not 
present in conventionally produced citric acid.
    (c) The citric acid so produced meets the specifications of the 
``Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, which is 
incorporated by reference (copies may be obtained from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may 
be examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408), and the polynuclear 
aromatic hydrocarbon specifications of Sec. 173.165.
    (d) Residues of n-octyl alcohol and synthetic isoparaffinic 
petroleum hydrocarbons are removed in accordance with good manufacturing 
practice. Current good manufacturing practice results in residues not 
exceeding 16 parts per million (ppm) n-octyl alcohol and 0.47 ppm 
synthetic isoparaffinic petroleum hydrocarbons in citric acid.
    (e) Tridodecyl amine may be present as a residue in citric acid at a 
level not to exceed 100 parts per billion.

[42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19, 1984]



Sec. 173.290  Trichloroethylene.

    Tolerances are established for residues of trichloroethylene 
resulting from its use as a solvent in the manufacture of foods as 
follows:

Decaffeinated ground coffee...............  25 parts per million.
Decaffeinated soluble (instant) coffee      10 parts per million.
 extract.
Spice oleoresins..........................  30 parts per million
                                             (provided that if residues
                                             of other chlorinated
                                             solvents are also present,
                                             the total of all residues
                                             of such solvents in spice
                                             oleoresins shall not exceed
                                             30 parts per million).
 



                   Subpart D_Specific Usage Additives



Sec. 173.300  Chlorine dioxide.

    Chlorine dioxide (CAS Reg. No. 10049-04-4) may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive is generated by one of the following methods: 
Treating an aqueous solution of sodium chlorite with either chlorine gas 
or a mixture of sodium hypochlorite and hydrochloric acid, or treating 
an aqueous solution of sodium chlorate with hydrogen peroxide in the 
presence of sulfuric acid. In either case, the generator effluent 
contains at least 90 percent (by weight) of chlorine dioxide with 
respect to all chlorine species as determined by Method 4500-
ClO2 E in the ``Standard Methods for the Examination of Water 
and Wastewater,'' 18th ed., 1992, or an equivalent method. Method 4500-
ClO2 E is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and the 
American Public Health Association, 1015 Fifteenth St. NW., Washington, 
DC 20005, or may be examined at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
    (b)(1) The additive may be used as an antimicrobial agent in water 
used in poultry processing in an amount not to exceed 3 parts per 
million (ppm) residual chlorine dioxide as determined by Method 4500-
ClO2 E, referenced in paragraph (a) of this section, or an 
equivalent method.
    (2) The additive may be used as an antimicrobial agent in water used 
to wash fruits and vegetables that are not raw agricultural commodities 
in an amount not to exceed 3 ppm residual chlorine dioxide as determined 
by Method 4500-ClO2 E, referenced in paragraph (a) of this 
section, or an equivalent method. Treatment of the fruits and vegetables 
with chlorine dioxide shall be followed by a potable water

[[Page 135]]

rinse or by blanching, cooking, or canning.

[60 FR 11900, Mar. 3, 1995. Redesignated at 61 FR 14245, Apr. 1, 1996, 
as amended at 61 FR 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998; 65 
FR 34587, May 31, 2000]



Sec. 173.310  Boiler water additives.

    Boiler water additives may be safely used in the preparation of 
steam that will contact food, under the following conditions:
    (a) The amount of additive is not in excess of that required for its 
functional purpose, and the amount of steam in contact with food does 
not exceed that required to produce the intended effect in or on the 
food.
    (b) The compounds are prepared from substances identified in 
paragraphs (c) and (d) of this section, and are subject to the 
limitations, if any, prescribed:
    (c) List of substances:

------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
Acrylamide-sodium acrylate resin...  Contains not more than 0.05 percent
                                      by weight of acrylamide monomer.
Acrylic acid/2-acrylamido-2-methyl   Total not to exceed 20 parts per
 propane sulfonic acid copolymer      million (active) in boiler
 having a minimum weight average      feedwater.
 molecular weight of 9,900 and a
 minimum number average molecular
 weight of 5,700 as determined by a
 method entitled ``Determination of
 Weight Average and Number Average
 Molecular Weight of 60/40 AA/
 AMPS'' (October 23, 1987), which
 is incorporated by reference in
 accordance with 5 U.S.C. 552(a).
 Copies may be obtained from the
 Center for Food Safety and Applied
 Nutrition (HFS-200), Food and Drug
 Administration, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 may be examined at the Office of
 the Federal Register, 800 North
 Capitol Street, NW., suite 700,
 Washington, DC.
Ammonium alginate..................
Cobalt sulfate (as catalyst).......
1-hydroxyethylidene-1,1-
 diphosphonic acid (CAS Reg. No.
 2809-21-4) and its sodium and
 potassium salts.
Lignosulfonic acid.................
Monobutyl ethers of polyethylene-    Minimum mol. wt. 1,500.
 polypropylene glycol produced by
 random condensation of a 1:1
 mixture by weight of ethylene
 oxide and propylene oxide with
 butanol.
Poly(acrylic acid-co-                Total not to exceed 1.5 parts per
 hypophosphite), sodium salt (CAS     million in boiler feed water.
 Reg. No. 71050-62-9), produced       Copolymer contains not more than
 from a 4:1 to a 16:1 mixture by      0.5 percent by weight of acrylic
 weight of acrylic acid and sodium    acid monomer (dry weight basis).
 hypophosphite.
Polyethylene glycol................  As defined in Sec.  172.820 of
                                      this chapter.
Polymaleic acid [CAS Reg. No. 26099- Total not to exceed 1 part per
 09-2], and/or its sodium salt.       million in boiler feed water
 [CAS Reg. No. 30915-61-8 or CAS      (calculated as the acid).
 Reg. No. 70247-90-4].
Polyoxypropylene glycol............  Minimum mol. wt. 1,000.
Potassium carbonate................
Potassium tripolyphosphate.........
Sodium acetate.....................
Sodium alginate....................
Sodium aluminate...................
Sodium carbonate...................
Sodium carboxymethylcellulose......  Contains not less than 95 percent
                                      sodium carboxymethylcellulose on a
                                      dry-weight basis, with maximum
                                      substitution of 0.9
                                      carboxymethylcellulose groups per
                                      anhydroglucose unit, and with a
                                      minimum viscosity of 15
                                      centipoises for 2 percent by
                                      weight aqueous solution at 25
                                      [deg]C; by the method prescribed
                                      in the ``Food Chemicals Codex,''
                                      4th ed. (1996), pp. 744-745, which
                                      is incorporated by reference in
                                      accordance with 5 U.S.C. 552(a)
                                      and 1 CFR part 51. Copies are
                                      available from the National
                                      Academy Press, Box 285, 2101
                                      Constitution Ave. NW., Washington,
                                      DC 20055 (Internet address http://
                                      www.nap.edu), or may be examined
                                      at the Center for Food Safety and
                                      Applied Nutrition's Library, Food
                                      and Drug Administration, 5100
                                      Paint Branch Pkwy., College Park,
                                      MD 20740, or at the Office of the
                                      Federal Register, 800 North
                                      Capitol St. NW., suite 700,
                                      Washington, DC.
Sodium glucoheptonate..............  Less than 1 part per million
                                      cyanide in the sodium
                                      glucoheptonate.
Sodium hexametaphosphate...........
Sodium humate......................
Sodium hydroxide...................

[[Page 136]]

 
Sodium lignosulfonate..............
Sodium metabisulfite...............
Sodium metasilicate................
Sodium nitrate.....................
Sodium phosphate (mono-, di-, tri-)
Sodium polyacrylate................
Sodium polymethacrylate............
Sodium silicate....................
Sodium sulfate.....................
Sodium sulfite (neutral or
 alkaline).
Sodium tripolyphosphate............
Sorbitol anhydride esters: a         The mixture is used as an
 mixture consisting of sorbitan       anticorrosive agent in steam
 monostearate as defined in Sec.     boiler distribution systems, with
 172.842 of this chapter;             each component not to exceed 15
 polysorbate 60 ((polyoxyethylene     parts per million in the steam.
 (20) sorbitan monostearate)) as
 defined in Sec.  172.836 of this
 chapter; and polysorbate 20
 ((polyoxyethylene (20) sorbitan
 monolaurate)), meeting the
 specifications of the Food
 Chemicals Codex, 4th ed. (1996),
 pp. 306-307, which is incorporated
 by reference in accordance with 5
 U.S.C. 552(a) and 1 CFR part 51.
 Copies are available from the
 National Academy Press, 2101
 Constitution Ave. NW., Box 285,
 Washington, DC 20055 (Internet
 http://www.nap.edu), or may be
 examined at the Center for Food
 Safety and Applied Nutrition's
 Library, Food and Drug
 Administration, 5100 Paint Branch
 Pkwy., College Park, MD 20740, or
 at the Office of the Federal
 Register, 800 North Capitol St.
 NW., suite 700, Washington, DC.
Tannin (including quebracho
 extract).
Tetrasodium EDTA...................
Tetrasodium pyrophosphate..........
------------------------------------------------------------------------

    (d) Substances used alone or in combination with substances in 
paragraph (c) of this section:

------------------------------------------------------------------------
               Substances                           Limitations
------------------------------------------------------------------------
Cyclohexylamine.........................  Not to exceed 10 parts per
                                           million in steam, and
                                           excluding use of such steam
                                           in contact with milk and milk
                                           products.
Diethylaminoethanol.....................  Not to exceed 15 parts per
                                           million in steam, and
                                           excluding use of such steam
                                           in contact with milk and milk
                                           products.
Hydrazine...............................  Zero in steam.
Morpholine..............................  Not to exceed 10 parts per
                                           million in steam, and
                                           excluding use of such steam
                                           in contact with milk and milk
                                           products.
Octadecylamine..........................  Not to exceed 3 parts per
                                           million in steam, and
                                           excluding use of such steam
                                           in contact with milk and milk
                                           products.
Trisodium nitrilotriacetate.............  Not to exceed 5 parts per
                                           million in boiler feedwater;
                                           not to be used where steam
                                           will be in contact with milk
                                           and milk products.
------------------------------------------------------------------------

    (e) To assure safe use of the additive, in addition to the other 
information required by the Act, the label or labeling shall bear:
    (1) The common or chemical name or names of the additive or 
additives.
    (2) Adequate directions for use to assure compliance with all the 
provisions of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980; 45 
FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb. 15, 
1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985; 53 FR 
15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172, Apr. 2, 
1990; 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12, 1999; 64 FR 29227, 
June 1, 1999]

[[Page 137]]



Sec. 173.315  Chemicals used in washing or to assist in the peeling of 
fruits and vegetables.

    Chemicals may be safely used to wash or to assist in the peeling of 
fruits and vegetables in accordance with the following conditions:
    (a) The chemicals consist of one or more of the following:
    (1) Substances generally recognized as safe in food or covered by 
prior sanctions for use in washing fruits and vegetables.
    (2) Substances identified in this subparagraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
A mixture of alkylene oxide adducts of   May be used at a level not to
 alkyl alcohols and phosphate esters of   exceed 0.2 percent in lye-
 alkylene oxide adducts of alkyl          peeling solution to assist in
 alcohols consisting of: [alpha]-alkyl    the lye peeling of fruit and
 (C12-C18)-omega-hydroxy-poly             vegetables.
 (oxyethylene) (7.5-8.5 moles)/poly
 (oxypropylene) block copolymer having
 an average molecular weight of 810;
 [alpha]-alkyl (C12-C18)-omega-hydroxy-
 poly (oxyethylene) (3.3-3.7 moles)
 polymer having an average molecular
 weight of 380, and subsequently
 esterified with 1.25 moles phosphoric
 anhydride; and [alpha]-alkyl (C10-C12)-
 omega-hydroxypoly (oxyethylene) (11.9-
 12.9 moles)/poly (oxypropylene)
 copolymer, having an average molecular
 weight of 810, and subsequently
 esterified with 1.25 moles phosphoric
 anhydride.
Aliphatic acid mixture consisting of     May be used at a level not to
 valeric, caproic, enanthic, caprylic,    exceed 1 percent in lye
 and pelargonic acids.                    peeling solution to assist in
                                          the lye peeling of fruits and
                                          vegetables.
Polyacrylamide.........................  Not to exceed 10 parts per
                                          million in wash water.
                                          Contains not more than 0.2
                                          percent acrylamide monomer.
                                          May be used in the washing of
                                          fruits and vegetables.
Potassium bromide......................  May be used in the washing or
                                          to assist in the lye peeling
                                          of fruits and vegetables.
Sodium n-alkylbenzene-sulfonate (alkyl   Not to exceed 0.2 percent in
 group predominantly C12 and C13 and      wash water. May be used in
 not less than 95 percent C10 to C16).    washing or to assist in the
                                          lye peeling of fruits and
                                          vegetables.
Sodium dodecylbenzene-sulfonate (alkyl    Do.
 group predominantly C12 and not less
 than 95% C10 to C16).
Sodium 2 ethyl-hexyl sulfate...........   Do.
Sodium hypochlorite....................  May be used in the washing or
                                          to assist in the lye peeling
                                          of fruits and vegetables.
Sodium mono- and dimethyl naphthalene    Not to exceed 0.2 percent in
 sulfonates (mol. wt. 245-260).           wash water. May be used in the
                                          washing or to assist in the
                                          lye peeling of fruits and
                                          vegetables.
------------------------------------------------------------------------

    (3) Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245-
260) may be used in the steam/scald vacuum peeling of tomatoes at a 
level not to exceed 0.2 percent in the condensate or scald water.
    (4) Substances identified in this paragraph (a)(4) for use in flume 
water for washing sugar beets prior to the slicing operation and subject 
to the limitations as are provided for the level of the substances in 
the flume water:

------------------------------------------------------------------------
                 Substance                           Limitations
------------------------------------------------------------------------
[alpha]-Alkyl-omega-hydroxypoly-            Not to exceed 3 ppm.
 (oxyethylene) produced by condensation of
 1 mole of C11-C486315 straight chain
 randomly substituted secondary alcohols
 with an average of 9 moles of ethylene
 oxide.
Linear undecylbenzenesulfonic acid........   Do.
Dialkanolamide produced by condensing 1     Not to exceed 2 ppm.
 mole of methyl laurate with 1.05 moles of
 diethanolamine.
Triethanolamine...........................   Do.
Ethylene glycol monobutyl ether...........  Not to exceed 1 ppm.
Oleic acid conforming with Sec.  172.860    Do.
 of this chapter.
Tetrapotassium pyrophosphate..............  Not to exceed 0.3 ppm.
Monoethanolamine..........................   Do.
Ethylene dichloride.......................  Not to exceed 0.2 ppm.
Tetrasodium ethylenediaminetetraacetate...  Not to exceed 0.1 ppm.
------------------------------------------------------------------------

    (5) Substances identified in this paragraph (a)(5) for use on fruits 
and vegetables that are not raw agricultural commodities and subject to 
the limitations provided:

[[Page 138]]



------------------------------------------------------------------------
                Substances                          Limitations
------------------------------------------------------------------------
Hydrogen peroxide........................  Used in combination with
                                            acetic acid to form
                                            peroxyacetic acid. Not to
                                            exceed 59 ppm in wash water.
1-Hydroxyethylidene-1,1-diphosphonic acid  May be used only with
                                            peroxyacetic acid. Not to
                                            exceed 4.8 ppm in wash
                                            water.
Peroxyacetic acid........................  Prepared by reacting acetic
                                            acid with hydrogen peroxide.
                                            Not to exceed 80 ppm in wash
                                            water.
------------------------------------------------------------------------

    (b) The chemicals are used in amounts not in excess of the minimum 
required to accomplish their intended effect.
    (c) The use of the chemicals listed under paragraphs (a)(1), (a)(2), 
and (a)(4) is followed by rinsing with potable water to remove, to the 
extent possible, residues of the chemicals.
    (d) To assure safe use of the additive:
    (1) The label and labeling of the additive container shall bear, in 
addition to the other information required by the act, the name of the 
additive or a statement of its composition.
    (2) The label or labeling of the additive container shall bear 
adequate use directions to assure use in compliance with all provisions 
of this section.

[42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10, 1977; 
42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376, 
46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998; 64 FR 38564, July 19, 
1999]



Sec. 173.320  Chemicals for controlling microorganisms in cane-sugar 
and beet-sugar mills.

    Agents for controlling microorganisms in cane-sugar and beet-sugar 
mills may be safely used in accordance with the following conditions:
    (a) They are used in the control of microorganisms in cane-sugar 
and/or beet-sugar mills as specified in paragraph (b) of this section.
    (b) They are applied to the sugar mill grinding, crusher, and/or 
diffuser systems in one of the combinations listed in paragraph (b) (1), 
(2), (3), or (5) of this section or as a single agent listed in 
paragraph (b) (4) or (6) of this section. Quantities of the individual 
additives in parts per million are expressed in terms of the weight of 
the raw cane or raw beets.
    (1) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                                  Parts
                                                                   per
                                                                 million
------------------------------------------------------------------------
Disodium cyanodithioimidocarbonate.............................      2.5
Ethylenediamine................................................      1.0
Potassium N-methyldithiocarbamate..............................      3.5
------------------------------------------------------------------------

    (2) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                                  Parts
                                                                   per
                                                                 million
------------------------------------------------------------------------
Disodium ethylenebisdithiocarbamate............................      3.0
Sodium dimethyldithiocarbamate.................................      3.0
------------------------------------------------------------------------

    (3) Combinations for cane-sugar mills and beet-sugar mills:

------------------------------------------------------------------------
                                                                  Parts
                                                                   per
                                                                 million
------------------------------------------------------------------------
(i) Disodium ethylenebisdithiocarbamate........................      3.0
Ethylenediamine................................................      2.0
Sodium dimethyldithiocarbamate.................................      3.0
(ii) Disodium cyanodithioimidocarbonate........................      2.9
Potassium N-methyldithiocarbamate..............................      4.1
------------------------------------------------------------------------

    (4) Single additive for cane-sugar mills and beet-sugar mills.

------------------------------------------------------------------------
                                                 Parts per million
------------------------------------------------------------------------
2,2-Dibromo-3-nitrilopropionamide (CAS     Not more than 10.0 and not
 Reg. No. 10222-01-2). Limitations:         less than 2.0.
 Byproduct molasses, bagasse, and pulp
 containing residues of 2,2-dibromo-3-
 nitrilopropionamide are not authorized
 for use in animal feed.
------------------------------------------------------------------------

    (5) Combination for cane-sugar mills:

------------------------------------------------------------------------
                                                             Parts per
                                                              million
------------------------------------------------------------------------
n-Dodecyl dimethyl benzyl ammonium chloride.............      0.05
Sec. 173.322  Chemicals used in delinting cottonseed.

    Chemicals may be safely used to assist in the delinting of 
cottonseed in accordance with the following conditions:
    (a) The chemicals consist of one or more of the following:
    (1) Substances generally recognized as safe for direct addition to 
food.
    (2) Substances identified in this paragraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
alpha-Alkyl-omega-hydroxypoly-              May be used at an
 (oxyethylene) produced by condensation of   application rate not to
 a linear primary alcohol containing an      exceed 0.3 percent by
 average chain length of 10 carbons with     weight of cottonseeds to
 poly(oxyethylene) having an average of 5    enhance delinting of
 ethylene oxide units.                       cottonseeds intended for
                                             the production of
                                             cottonseed oil. Byproducts
                                             including lint, hulls, and
                                             meal may be used in animal
                                             feed.
An alkanomide produced by condensation of   May be used at an
 coconut oil fatty acids and dietha          application rate not to
 nolamine, CAS Reg. No. 068603-42-9.         exceed 0.2 percent by
                                             weight of cottonseeds to
                                             enhance delinting of
                                             cottonseeds intended for
                                             the production of
                                             cottonseed oil. Byproducts
                                             including lint, hulls, and
                                             meal may be used in animal
                                             feed.
------------------------------------------------------------------------


[47 FR 8346, Feb. 26, 1982]



Sec. 173.325  Acidified sodium chlorite solutions.

    Acidified sodium chlorite solutions may be safely used in accordance 
with the following prescribed conditions:
    (a) The additive is produced by mixing an aqueous solution of sodium 
chlorite (CAS Reg. No. 7758-19-2) with any generally recognized as safe 
(GRAS) acid.
    (b)(1) The additive is used as an antimicrobial agent in poultry 
processing water in accordance with current industry practice under the 
following conditions:
    (i) As a component of a carcass spray or dip solution prior to 
immersion of the intact carcass in a prechiller or chiller tank;
    (ii) In a prechiller or chiller solution for application to the 
intact carcass;
    (iii) As a component of a spray or dip solution for application to 
poultry carcass parts;
    (iv) In a prechiller or chiller solution for application to poultry 
carcass parts; or
    (v) As a component of a post-chill carcass spray or dip solution 
when applied to poultry meat, organs, or related parts or trim.
    (2) When used in a spray or dip solution, the additive is used at 
levels that result in sodium chlorite concentrations between 500 and 
1,200 parts per million (ppm), in combination with any GRAS acid at a 
level sufficient to achieve a solution pH of 2.3 to 2.9.
    (3) When used in a prechiller or chiller solution, the additive is 
used at levels that result in sodium chlorite concentrations between 50 
and 150 ppm, in combination with any GRAS acid at levels sufficient to 
achieve a solution pH of 2.8 to 3.2.
    (c) The additive is used as an antimicrobial agent in accordance 
with current industry practice in the processing of red meat, red meat 
parts, and organs as a component of a spray or in the processing of red 
meat parts and organs as a component of a dip. Applied as a dip or 
spray, the additive is used at levels that result in sodium chlorite 
concentrations between 500 and 1,200 ppm in combination with any GRAS 
acid at levels sufficient to achieve a solution pH of 2.5 to 2.9.
    (d) The additive is used as an antimicrobial agent in water and ice 
that are used to rinse, wash, thaw, transport, or store seafood in 
accordance with current industry standards of good manufacturing 
practice. The additive is produced by mixing an aqueous solution of 
sodium chlorite with any GRAS acid to achieve a pH in the range of 2.5 
to 2.9 and diluting this solution with water to achieve an actual use 
concentration of 40 to 50 parts per million (ppm) sodium chlorite. Any 
seafood that is intended to be consumed raw shall be subjected to a 
potable water rinse prior to consumption.
    (e) The additive is used as an antimicrobial agent on raw 
agricultural

[[Page 140]]

commodities in the preparing, packing, or holding of the food for 
commercial purposes, consistent with section 201(q)(1)(B)(i) of the act, 
and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act, in accordance with 
current industry standards of good manufacturing practice. Applied as a 
dip or a spray, the additive is used at levels that result in chlorite 
concentrations of 500 to 1200 parts per million (ppm), in combination 
with any GRAS acid at levels sufficient to achieve a pH of 2.3 to 2.9. 
Treatment of the raw agricultural commodities with acidified sodium 
chlorite solutions shall be followed by a potable water rinse, or by 
blanching, cooking, or canning.
    (f) The additive is used as an antimicrobial agent on processed, 
comminuted or formed meat food products (unless precluded by standards 
of identity in 9 CFR part 319) prior to packaging of the food for 
commercial purposes, in accordance with current industry standards of 
good manufacturing practice. Applied as a dip or spray, the additive is 
used at levels that result in sodium chlorite concentrations of 500 to 
1200 ppm, in combination with any GRAS acid at levels sufficient to 
achieve a pH of 2.5 to 2.9.
    (g) The additive is used as an antimicrobial agent in the water 
applied to processed fruits and processed root, tuber, bulb, legume, 
fruiting (i.e., eggplant, groundcherry, pepino, pepper, tomatillo, and 
tomato), and cucurbit vegetables in accordance with current industry 
standards of good manufacturing practices, as a component of a spray or 
dip solution, provided that such application be followed by a potable 
water rinse and a 24-hour holding period prior to consumption. However, 
for processed leafy vegetables (i.e., vegetables other than root, tuber, 
bulb, legume, fruiting, and cucurbit vegetables) and vegetables in the 
Brassica [Cole] family, application must be by dip treatment only, and 
must be preceded by a potable water rinse and followed by a potable 
water rinse and a 24-hour holding period prior to consumption. When used 
in a spray or dip solution, the additive is used at levels that result 
in sodium chlorite concentrations between 500 and 1,200 ppm, in 
combination with any GRAS acid at a level sufficient to achieve a 
solution pH of 2.3 to 2.9.
    (h) The concentration of sodium chlorite is determined by a method 
entitled ``Determination of Sodium Chlorite: 50 ppm to 1500 ppm 
Concentration,'' September 13, 1995, developed by Alcide Corp., Redmond, 
WA, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. Copies are available from the Division of 
Petition Control (HFS-215), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, 
MD 20740 20204-0001, or the Office of the Federal Register, 800 North 
Capitol St. NW., Suite 700, Washington, DC.

[61 FR 17829, Apr. 23, 1996, as amended at 63 FR 11119, Mar. 6, 1998; 64 
FR 44123, Aug. 13, 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776, Jan. 
12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR 22922, May 7, 2001; 66 FR 
31841, June 13, 2001; 67 FR 15720, Apr. 3, 2002]



Sec. 173.340  Defoaming agents.

    Defoaming agents may be safely used in processing foods, in 
accordance with the following conditions:
    (a) They consist of one or more of the following:
    (1) Substances generally recognized by qualified experts as safe in 
food or covered by prior sanctions for the use prescribed by this 
section.
    (2) Substances listed in this paragraph (a)(2) of this section, 
subject to any limitations imposed:

[[Page 141]]



------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
Dimethylpolysiloxane (substantially  10 parts per million in food, or at
 free from hydrolyzable chloride      such level in a concentrated food
 and alkoxy groups; no more than 18   that when prepared as directed on
 percent loss in weight after         the labels, the food in its ready-
 heating 4 hours at 200 [deg]C;       for-consumption state will have
 viscosity 300 to 1,050 centistokes   not more than 10 parts per million
 at 25 [deg]C; refractive index       except as follows: Zero in milk;
 1.400-1.404 at 25 [deg]C).           110 parts per million in dry
                                      gelatin dessert mixes labeled for
                                      use whereby no more than 16 parts
                                      per million is present in the
                                      ready-to-serve dessert; 250 parts
                                      per million in salt labeled for
                                      cooking purposes, whereby no more
                                      than 10 parts per million is
                                      present in the cooked food.
Formaldehyde.......................  As a preservative in defoaming
                                      agents containing
                                      dimethylpolysiloxane, in an amount
                                      not exceeding 1.0 percent of the
                                      dimethylpolysiloxane content.
[alpha]-Hydro-omega-hydroxy-poly     For use as prescribed in Sec.
 (oxyethylene)/poly(oxypropylene)     172.808(b)(3) of this chapter.
 (minimum 15 moles)/
 poly(oxyethylene) block copolymer
 (CAS Reg. No. 9003-11-6) as
 defined in Sec.  172.808(a)(3) of
 this chapter.
Polyacrylic acid, sodium salt......  As a stabilizer and thickener in
                                      defoaming agents containing
                                      dimethylpolysiloxane in an amount
                                      reasonably required to accomplish
                                      the intended effect.
Polyethylene glycol................  As defined in Sec.  172.820 of
                                      this chapter.
Polyoxyethylene 40 monostearate....  As defined in U.S.P. XVI.
Polysorbate 60.....................  As defined in Sec.  172.836 of
                                      this chapter.
Polysorbate 65.....................  As defined in Sec.  172.838 of
                                      this chapter.
Propylene glycol alginate..........  As defined in Sec.  172.858 of
                                      this chapter.
Silicon dioxide....................  As defined in Sec.  172.480 of
                                      this chapter.
Sorbitan monostearate..............  As defined in Sec.  172.842 of
                                      this chapter.
White mineral oil: Conforming with   As a component of defoaming agents
 Sec.  172.878 of this chapter.      for use in wash water for sliced
                                      potatoes at a level not to exceed
                                      0.008 percent of the wash water.
------------------------------------------------------------------------

    (3) Substances listed in this paragraph (a)(3), provided they are 
components of defoaming agents limited to use in processing beet sugar 
and yeast, and subject to any limitations imposed:

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Aluminum stearate......................  As defined in Sec.  172.863 of
                                          this chapter.
Butyl stearate.........................
BHA....................................  As an antioxidant, not to
                                          exceed 0.1 percent by weight
                                          of defoamer.
BHT....................................   Do.
Calcium stearate.......................  As defined in Sec.  172.863 of
                                          this chapter.
Fatty acids............................  As defined in Sec.  172.860 of
                                          this chapter.
Formaldehyde...........................  As a preservative.
Hydroxylated lecithin..................  As defined in Sec.  172.814 of
                                          this chapter.
Isopropyl alcohol......................
Magnesium stearate.....................  As defined in Sec.  172.863 of
                                          this chapter.
Mineral oil: Conforming with Sec.       Not more than 150 p.p.m. in
 172.878 of this chapter.                 yeast, measured as
                                          hydrocarbons.
Odorless light petroleum hydrocarbons:   ...............................
 Conforming with Sec.  172.884 of this
 chapter.
Petrolatum: Conforming with Sec.        ...............................
 172.880 of this chapter.
Petroleum wax: Conforming with Sec.
 172.886 of this chapter.
Petroleum wax, synthetic...............
Polyethylene glycol (400)dioleate:       As an emulsifier not to exceed
 Conforming with Sec.  172.820(a)(2)     10 percent by weight of
 of this chapter and providing the        defoamer formulation.
 oleic acid used in the production of
 this substance complies with Sec.
 172.860 or Sec.  172.862 of this
 chapter.
Synthetic isoparaffinic petroleum
 hydrocarbons: Conforming with Sec.
 172.882 of this chapter.
Oleic acid derived from tall oil fatty   Complying with Sec.  172.862
 acids.                                   of this chapter.
Oxystearin.............................  As defined in Sec.  172.818 of
                                          this chapter.
Polyoxyethylene (600) dioleate.........
Polyoxyethylene (600) monoricinoleate..
Polypropylene glycol...................  Molecular weight range, 1,200-
                                          3,000.
Polysorbate 80.........................  As defined in Sec.  172.840 of
                                          this chapter.
Potassium stearate.....................  As defined in Sec.  172.863 of
                                          this chapter.
Propylene glycol mono- and diesters of   As defined in Sec.  172.856 of
 fats and fatty acids.                    this chapter.
Soybean oil fatty acids, hydroxylated..
Tallow, hydrogenated, oxidized or
 sulfated.
Tallow alcohol, hydrogenated...........
------------------------------------------------------------------------


[[Page 142]]

    (4) The substances listed in this paragraph (a)(4), provided they 
are components of defoaming agents limited to use in processing beet 
sugar only, and subject to the limitations imposed:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
n-Butoxypoly(oxyethylene)-                  Viscosity range, 4,850-5,350
 poly(oxypropylene)glycol.                   Saybolt Universal Seconds
                                             (SUS) at 37.8 [deg]C (100
                                             [deg]F). The viscosity
                                             range is determined by the
                                             method ``Viscosity
                                             Determination of n-
                                             butoxypoly(oxyethylene)-
                                             poly(oxypropylene) glycol''
                                             dated April 26, 1995,
                                             developed by Union Carbide
                                             Corp., P.O. Box 670, Bound
                                             Brook, NJ 08805, which is
                                             incorporated by reference
                                             in accordance with 5 U.S.C.
                                             552(a) and 1 CFR part 51.
                                             Copies of the material
                                             incorporated by reference
                                             are available from the
                                             Division of Petition
                                             Control, Center for Food
                                             Safety and Applied
                                             Nutrition (HFS-215), Food
                                             and Drug Administration,
                                             5100 Paint Branch Pkwy.,
                                             College Park, MD 20740, and
                                             may be examined at the
                                             Center for Food Safety and
                                             Applied Nutrition's
                                             Library, 5100 Paint Branch
                                             Pkwy., College Park, MD
                                             20740, or at the Office of
                                             the Federal Register, 800
                                             North Capitol St. NW.,
                                             suite 700, Washington, DC.
Monoester of alpha-hydro-omega-hydroxy-     ............................
 poly(oxyethylene) poly(oxypropylene)
 poly(oxyethylene) (15 mole minimum)
 blocked copolymer derived from low erucic
 acid rapeseed oil.
------------------------------------------------------------------------

    (b) They are added in an amount not in excess of that reasonably 
required to inhibit foaming.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978; 46 
FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, Oct. 
19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR 29134, May 28, 1998]



Sec. 173.342  Chlorofluorocarbon 113 and perfluorohexane.

    A mixture of 99 percent chlorofluorocarbon 113 (1,1,2-trichloro-
1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also known as fluorocarbon 
113, CFC 113 and FC 113) and 1 percent perfluorohexane (CAS Reg. No. 
355-42-0) may be safely used in accordance with the following prescribed 
conditions:
    (a) The additive chlorofluorocarbon 113 has a purity of not less 
than 99.99 percent.
    (b) The additive mixture is intended for use to quickly cool or 
crust-freeze chickens sealed in intact bags composed of substances 
regulated in parts 174, 175, 177, 178, and Sec. 179.45 of this chapter 
and conforming to any limitations or specifications in such regulations.

[55 FR 8913, Mar. 9, 1990]



Sec. 173.345  Chloropentafluoroethane.

    The food additive chloropentafluoroethane may be safely used in food 
in accordance with the following prescribed conditions:
    (a) The food additive has a purity of not less than 99.97 percent, 
and contains not more than 200 parts per million saturated fluoro 
compounds and 10 parts per million unsaturated fluoro compounds as 
impurities.
    (b) The additive is used or intended for use alone or with one or 
more of the following substances: Carbon dioxide, nitrous oxide, 
propane, and octafluorocyclobutane complying with Sec. 173.360, as an 
aerating agent for foamed or sprayed food products, with any propellant 
effect being incidental and no more than is minimally necessary to 
achieve the aerating function, except that use is not permitted for 
those standardized foods that do not provide for such use.
    (c) To assure safe use of the additive
    (1) The label of the food additive container shall bear, in addition 
to the other information required by the act, the following:
    (i) The name of the additive, chloropentafluoroethane.
    (ii) The percentage of the additive present in the case of a 
mixture.
    (iii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.

[42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17, 1978; 
43 FR 14644, Apr. 7, 1978]

[[Page 143]]



Sec. 173.350  Combustion product gas.

    The food additive combustion product gas may be safely used in the 
processing and packaging of the foods designated in paragraph (c) of 
this section for the purpose of removing and displacing oxygen in 
accordance with the following prescribed conditions:
    (a) The food additive is manufactured by the controlled combustion 
in air of butane, propane, or natural gas. The combustion equipment 
shall be provided with an absorption-type filter capable of removing 
possible toxic impurities, through which all gas used in the treatment 
of food shall pass; and with suitable controls to insure that any 
combustion products failing to meet the specifications provided in this 
section will be prevented from reaching the food being treated.
    (b) The food additive meets the following specifications:
    (1) Carbon monoxide content not to exceed 4.5 percent by volume.
    (2) The ultraviolet absorbance in isooctane solution in the range 
255 millimicrons to 310 millimicrons not to exceed one-third of the 
standard reference absorbance when tested as described in paragraph (e) 
of this section.
    (c) It is used or intended for use to displace or remove oxygen in 
the processing, storage, or packaging of beverage products and other 
food, except fresh meats.
    (d) To assure safe use of the additive in addition to the other 
information required by the act, the label or labeling of the combustion 
device shall bear adequate directions for use to provide a combustion 
product gas that complies with the limitations prescribed in paragraph 
(b) of this section, including instructions to assure proper filtration.
    (e) The food additive is tested for compliance with paragraph (b)(2) 
by the following empirical method:

    Spectrophotometric measurements. All measurements are made in an 
ultraviolet spectrophotometer in optical cells of 5 centimeters in 
length, and in the range of 255 millimicrons to 310 millimicrons, under 
the same instrumental conditions. The standard reference absorbance is 
the absorbance at 275 millimicrons of a standard reference solution of 
naphthalene (National Bureau of Standards Material No. 577 or equivalent 
in purity) containing a concentration of 1.4 milligrams per liter in 
purified isooctane, measured against isooctane of the same spectral 
purity in 5-centimeter cells. (This absorbance will be approximately 
0.30.)
    Solvent. The solvent used is pure grade isooctane having an 
ultraviolet absorbance not to exceed 0.05 measured against distilled 
water as a reference. Upon passage of purified inert gas through some 
isooctane under the identical conditions of the test, a lowering of the 
absorbance value has been observed. The absorbance of isooctane to be 
used in this procedure shall not be more than 0.02 lower in the range 
255 millimicrons to 310 millimicrons, inclusive, than that of the 
untreated solvent as measured in a 5-centimeter cell. If necessary to 
obtain the prescribed purities, the isooctane may be passed through 
activated silica gel.
    Apparatus. To assure reproducible results, the additive is passed 
into the isooctane solution through a gas-absorption train consisting of 
the following components and necessary connections:
    1. A gas flow meter with a range up to 30 liters per hour provided 
with a constant differential relay or other device to maintain a 
constant flow rate independent of the input pressure.
    2. An absorption apparatus consisting of an inlet gas dispersion 
tube inserted to the bottom of a covered cylindrical vessel with a 
suitable outlet on the vessel for effluent gas. The dimensions and 
arrangement of tube and vessel are such that the inlet tube introduces 
the gas at a point not above 5\1/4\ inches below the surface of the 
solvent through a sintered glass outlet. The dimensions of the vessel 
are such, and both inlet and vessel are so designed, that the gas can be 
bubbled through 60 milliliters of isooctane solvent at a rate up to 30 
liters per hour without mechanical loss of solvent. The level 
corresponding to 60 milliliters should be marked on the vessel.
    3. A cooling bath containing crushed ice and water to permit 
immersion of the absorption vessel at least to the solvent level mark.
    Caution. The various parts of the absorption train must be connected 
by gas-tight tubing and joints composed of materials which will neither 
remove components from nor add components to the gas stream. The gas 
source is connected in series to the flow-rate device, the flow meter, 
and the absorption apparatus in that order. Ventilation should be 
provided for the effluent gases which may contain carbon monoxide.
    Sampling procedure. Immerse the gas-absorption apparatus containing 
60 milliliters of isooctane in the coolant bath so that the solvent is 
completely immersed. Cool for at least 15 minutes and then pass 120 
liters of the test gas through the absorption train at a rate of 30 
liters per hour or less. Maintain the coolant bath at 0 [deg]C 
throughout. Remove the absorption vessel from the bath, disconnect, and 
warm to room temperature.

[[Page 144]]

Add isooctane to bring the contents of the absorption vessel to 60 
milliliters, and mix. Determine the absorbance of the solution in the 5-
centimeter cell in the range 255 millimicrons to 310 millimicrons, 
inclusive, compared to isooctane. The absorbance of the solution of 
combustion product gas shall not exceed that of the isooctane solvent at 
any wavelength in the specified range by more than one-third of the 
standard reference absorbance.



Sec. 173.355  Dichlorodifluoromethane.

    The food additive dichlorodi fluoromethane may be safely used in 
food in accordance with the following prescribed conditions:
    (a) The additive has a purity of not less than 99.97 percent.
    (b) It is used or intended for use, in accordance with good 
manufacturing practice, as a direct-contact freezing agent for foods.
    (c) To assure safe use of the additive:
    (1) The label of its container shall bear, in addition to the other 
information required by the act, the following:
    (i) The name of the additive, dichlorodifluoromethane, with or 
without the parenthetical name ``Food Freezant 12''.
    (ii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



Sec. 173.357  Materials used as fixing agents in the immobilization of 
enzyme preparations.

    Fixing agents may be safely used in the immobilization of enzyme 
preparations in accordance with the following conditions:
    (a) The materials consist of one or more of the following:
    (1) Substances generally recognized as safe in food.
    (2) Substances identified in this subparagraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
              Substances                          Limitations
------------------------------------------------------------------------
Acrylamide-acrylic acid resin:         May be used as a fixing material
 Complying with Sec.  173.5(a)(1)      in the immobilization of glucose
 and (b) of this chapter.               isomerase enzyme preparations
                                        for use in the manufacture of
                                        high fructose corn syrup, in
                                        accordance with Sec.  184.1372
                                        of this chapter.
Cellulose triacetate.................  May be used as a fixing material
                                        in the immobilization of lactase
                                        for use in reducing the lactose
                                        content of milk.
Diethylaminoethyl-cellulose..........  May be used as a fixing material
                                        in the immobilization of glucose
                                        isomerase enzyme preparations
                                        for use in the manufacture of
                                        high fructose corn syrup, in
                                        accordance with Sec.  184.1372
                                        of this chapter.
Dimethylamine-epichlorohydrin resin:   May be used as a fixing material
 Complying with Sec.  173.60(a) and    in the immobilization of glucose
 (b) of this chapter.                   isomerase enzyme preparations
                                        for use in the manufacture of
                                        high fructose corn syrup, in
                                        accordance with Sec.  184.1372
                                        of this chapter.
Glutaraldehyde.......................   Do.
Periodic acid (CAS Reg. No. 10450-60-
 9)..

[[Page 145]]

 
Polyethylenimine reaction product      May be used as a fixing material
 with 1,2-dichloroethane (CAS Reg.No.   in the immobilization of
 68130-97-2) is the reaction product    glucoamylase enzyme preparations
 of homopolymerization of               from Aspergillus niger for use
 ethylenimine in aqueous hydrochloric   in the manufacture of beer.
 acid at 100 [deg]C and of cross-      May be used as a fixing material
 linking with 1,2-dichloroethane. The   in the immobilization of:
 finished polymer has an average       1. Glucose isomerase enzyme
 molecular weight of 50,000 to 70,000   preparations for use in the
 as determined by gel permeation        manufacture of high fructose
 chromatography. The analytical         corn syrup, in accordance with
 method is entitled ``Methodology for   Sec.  184.1372 of this chapter.
 Molecular Weight Detection of         2. Glucoamylase enzyme
 Polyethylenimine,'' which is           preparations from Aspergillus
 incorporated by reference in           niger for use in the manufacture
 accordance with 5 U.S.C. 552(a) and    of beer. Residual ethylenimine
 1 CFR part 51. Copies may be           in the finished polyethylenimine
 obtained from the Division of          polymer will be less than 1 part
 Petition Control, Center for Food      per million as determined by gas
 Safety and Applied Nutrition (HFS-     chromatography-mass
 200), 5100 Paint Branch Pkwy.,         spectrometry. The residual
 College Park, MD 20740, and may be     ethylenimine is determined by an
 examined at the Center for Food        analytical method entitled
 Safety and Applied Nutrition's         ``Methodology for Ethylenimine
 Library, 5100 Paint Branch Pkwy.,      Detection in Polyethylenimine,''
 College Park, MD 20740, or at the      which is incorporated by
 Office of the Federal Register, 800    reference in accordance with 5
 North Capitol St. NW., suite 700,      U.S.C. 552(a) and 1 CFR part 51.
 Washington, DC.                        Residual 1,2-dichloroethane in
                                        the finished polyethylenimine
                                        polymer will be less than 1 part
                                        per million as determined by gas
                                        chromatography. The residual 1,2-
                                        dichloroethane is determined by
                                        an analytical method entitled,
                                        ``Methodology for
                                        Ethylenedichloride Detection in
                                        Polyethylenimine,'' which is
                                        incorporated by reference in
                                        accordance with 5 U.S.C. 552(a)
                                        and 1 CFR part 51. Copies may be
                                        obtained from the Division of
                                        Petition Control, Center for
                                        Food Safety and Applied
                                        Nutrition (HFS-215), 5100 Paint
                                        Branch Pkwy., College Park, MD
                                        20740, or may be examined at the
                                        Center for Food Safety and
                                        Applied Nutrition's Library,
                                        5100 Paint Branch Pkwy., College
                                        Park, MD 20740, or the Office of
                                        the Federal Register, 800 North
                                        Capitol St. NW., suite 700,
                                        Washington, DC.
------------------------------------------------------------------------

    (b) The fixed enzyme preparation is washed to remove residues of the 
fixing materials.

[48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987; 55 
FR 12172, Apr. 2, 1990; 59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, 
1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, June 25, 2002]



Sec. 173.360  Octafluorocyclobutane.

    The food additive octafluorocyclo-butane may be safely used as a 
propellant and aerating agent in foamed or sprayed food products in 
accordance with the following conditions:
    (a) The food additive meets the following specifications:

99.99 percent octafluorocyclobutane.
Less than 0.1 part per million fluoroolefins, calculated as 
perfluoroisobutylene.

    (b) The additive is used or intended for use alone or with one or 
more of the following substances: Carbon dioxide, nitrous oxide, and 
propane, as a propellant and aerating agent for foamed or sprayed food 
products, except for those standardized foods that do not provide for 
such use.
    (c) To assure safe use of the additive:
    (1) The label of the food additive container shall bear, in addition 
to the other information required by the act, the following:
    (i) The name of the additive, octafluorocyclobutane.
    (ii) The percentage of the additive present in the case of a 
mixture.
    (iii) The designation ``food grade''.
    (2) The label or labeling of the food additive container shall bear 
adequate directions for use.



Sec. 173.368  Ozone.

    Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, 
storage, and processing of foods, including meat and poultry (unless 
such use is precluded by standards of identity in 9 CFR part 319), in 
accordance with the following prescribed conditions:
    (a) The additive is an unstable, colorless gas with a pungent, 
characteristic odor, which occurs freely in nature. It is produced 
commercially by passing electrical discharges or ionizing radiation 
through air or oxygen.
    (b) The additive is used as an antimicrobial agent as defined in 
Sec. 170.3(o)(2) of this chapter.
    (c) The additive meets the specifications for ozone in the Food 
Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the National Academy

[[Page 146]]

Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be 
examined at the Office of Premarket Approval (HFS-200), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and the Office of the Federal 
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (d) The additive is used in contact with food, including meat and 
poultry (unless such use is precluded by standards of identity in 9 CFR 
part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase 
in accordance with current industry standards of good manufacturing 
practice.
    (e) When used on raw agricultural commodities, the use is consistent 
with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act 
(the act) and not applied for use under section 201(q)(1)(B)(i)(I), 
(q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]



Sec. 173.370  Peroxyacids.

    Peroxyacids may be safely used in accordance with the following 
prescribed conditions:
    (a) The additive is a mixture of peroxyacetic acid, octanoic acid, 
acetic acid, hydrogen peroxide, peroxyoctanoic acid, and 1-
hydroxyethylidene-1,1-diphosphonic acid.
    (b)(1) The additive is used as an antimicrobial agent on meat 
carcasses, parts, trim, and organs in accordance with current industry 
practice where the maximum concentration of peroxyacids is 220 parts per 
million (ppm) as peroxyacetic acid, and the maximum concentration of 
hydrogen peroxide is 75 ppm.
    (2) The additive is used as an antimicrobial agent on poultry 
carcasses, poultry parts, and organs in accordance with current industry 
standards of good manufacturing practice (unless precluded by the U.S. 
Department of Agriculture's standards of identity in 9 CFR part 381, 
subpart P) where the maximum concentration of peroxyacids is 220 parts 
per million (ppm) as peroxyacetic acid, the maximum concentration of 
hydrogen peroxide is 110 ppm, and the maximum concentration of 1-
hydroxyethylidene-1,1-diphosphonic acid (HEDP) is 13 ppm.
    (c) The concentrations of peroxyacids and hydrogen peroxide in the 
additive are determined by a method entitled ``Hydrogen Peroxide and 
Peracid (as Peracetic Acid) Content,'' July 26, 2000, developed by 
Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The 
concentration of 1-hydroxyethylidene-1,1-diphosphonic acid is determined 
by a method entitled ``Determination of 1-hydroxyethylidene-1,1-
diphosphonic acid (HEDP) Peroxyacid/Peroxide-Containing Solutions,'' 
August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is 
incorporated by reference. The Director of the Office of the Federal 
Register approves these incorporations by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods 
from the Division of Petition Review, Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or you may examine a copy at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC.

[65 FR 70660, Nov. 27, 2000, as amended at 66 FR 48208, Sept. 19, 2001; 
67 FR 61784, Oct. 2, 2002]



Sec. 173.385  Sodium methyl sulfate.

    Sodium methyl sulfate may be present in pectin in accordance with 
the following conditions.
    (a) It is present as the result of methylation of pectin by sulfuric 
acid and methyl alcohol and subsequent treatment with sodium 
bicarbonate.
    (b) It does not exceed 0.1 percent by weight of the pectin.



Sec. 173.395  Trifluoromethane sulfonic acid.

    Trifluoromethane sulfonic acid has the empirical formula 
CF3SO3H (CAS Reg. No. 1493-13-6). The catalyst 
(Trifluoromethane sulfonic acid) may safely be used in the production of 
cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) 
(see

[[Page 147]]

Sec. 184.1259 of this chapter) in accordance with the following 
conditions:
    (a) The catalyst meets the following specifications:

Appearance, Clear liquid.
Color, Colorless to amber.
Neutralization equivalent, 147-151.
Water, 1 percent maximum.
Fluoride ion, 0.03 percent maximum.
Heavy metals (as Pb), 30 parts per million maximum.
Arsenic (as As), 3 parts per million maximum.

    (b) It is used at levels not to exceed 0.2 percent of the reaction 
mixture to catalyze the directed esterification.
    (c) The esterification reaction is quenched with steam and water and 
the catalyst is removed with the aqueous phase. Final traces of catalyst 
are removed by washing batches of the product three times with an 
aqueous solution of 0.5 percent sodium bicarbonate.
    (d) No residual catalyst may remain in the product at a detection 
limit of 0.2 part per million fluoride as determined by the method 
described in ``Official Methods of Analysis of the Association of 
Official Analytical Chemists,'' sections 25.049-25.055, 13th Ed. (1980), 
which is incorporated by reference. Copies may be obtained from the 
Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 
54 FR 24897, June 12, 1989]



Sec. 173.400  Dimethyldialkylammonium chloride.

    Dimethyldialkylammonium chloride may be safely used in food in 
accordance with the following prescribed conditions:
    (a) The food additive is produced by one of the following methods:
    (1) Ammonolysis of natural tallow fatty acids to form amines that 
are subsequently reacted with methyl chloride to form the quaternary 
ammonium compounds consisting primarily of dimethyldioctadecylammonium 
chloride and di methyl dihexa decyl ammonium chloride. The additive may 
contain residues of isopropyl alcohol not in excess of 18 percent by 
weight when used as a processing solvent.
    (2) Ammonolysis of natural tallow fatty acids to form amines that 
are then reacted with 2-ethylhexanal, reduced, methylated, and 
subsequently reacted with methyl chloride to form the quaternary 
ammonium compound known as dimethyl(2-ethylhexyl) hydrogenated tallow 
ammonium chloride and consisting primarily of dimethyl (2-ethyl hexyl) 
octa decyl ammonium chloride and dimethyl (2-ethyl hexyl) hexa decyl 
ammonium chloride.
    (b) The food additive described in paragraph (a)(1) of this section 
contains not more than a total of 2 percent by weight of free amine and 
amine hydrochloride. The food additive described in paragraph (a)(2) of 
this section contains not more than 3 percent by weight, each, of free 
amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, 
``Acid Value and Free Amine Value of Fatty Quaternary Ammonium 
Chlorides,'' 2d printing including additions and revisions 1990, which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and from the American Oil 
Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC.
    (c) The food additive is used as a decolorizing agent in the 
clarification of refinery sugar liquors under the following limitations:
    (1) The food additive described in paragraph (a)(1) of this section 
is added only at the defecation/clarification stage of sugar liquor 
refining in an amount not to exceed 700 parts per million by weight of 
sugar solids.
    (2) The food additive described in paragraph (a)(2) of this section 
is used under the following conditions:
    (i) The additive is adsorbed onto a support column composed of 
suitable

[[Page 148]]

polymers that are regulated for contact with aqueous food. Excess 
nonadsorbed additive shall be rinsed away with potable water prior to 
passage of sugar liquor through the column.
    (ii) The residue of the additive in the decolorized sugar liquor 
prior to crystallization shall not exceed 1 part per million of sugar as 
determined by a method entitled ``Colorimetric Determination of Residual 
Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar 
Solutions,'' June 13, 1990, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the Center for Food Safety and Applied Nutrition (HFS-200), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
    (d) To assure safe use of the additive, the label and labeling of 
the additive shall bear, in addition to other information required by 
the Federal Food, Drug, and Cosmetic Act, adequate directions to assure 
use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]



PART 174_INDIRECT FOOD ADDITIVES: GENERAL--Table of Contents




Sec.
174.5 General provisions applicable to indirect food additives.
174.6 Threshold of regulation for substances used in food-contact 
          articles.

    Authority: 21 U.S.C. 321, 342, 348, 371.



Sec. 174.5  General provisions applicable to indirect food additives.

    (a) Regulations prescribing conditions under which food additive 
substances may be safely used predicate usage under conditions of good 
manufacturing practice. For the purpose of this part and parts 175, 176, 
and 177 of this chapter, good manufacturing practice shall be defined to 
include the following restrictions:
    (1) The quantity of any food additive substance that may be added to 
food as a result of use in articles that contact food shall not exceed, 
where no limits are specified, that which results from use of the 
substance in an amount not more than reasonably required to accomplish 
the intended physical or technical effect in the food-contact article; 
shall not exceed any prescribed limitations; and shall not be intended 
to accomplish any physical or technical effect in the food itself, 
except as such may be permitted by regulations in parts 170 through 189 
of this chapter.
    (2) Any substance used as a component of articles that contact food 
shall be of a purity suitable for its intended use.
    (b) The existence in the subchapter B of a regulation prescribing 
safe conditions for the use of a substance as an article or component of 
articles that contact food shall not be construed to relieve such use of 
the substance or article from compliance with any other provision of the 
Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-
packaging material were found on appropriate test to impart odor or 
taste to a specific food product such as to render it unfit within the 
meaning of section 402(a)(3) of the Act, the regulation would not be 
construed to relieve such use from compliance with section 402(a)(3).
    (c) The existence in this subchapter B of a regulation prescribing 
safe conditions for the use of a substance as an article or component of 
articles that contact food shall not be construed as implying that such 
substance may be safely used as a direct additive in food.
    (d) Substances that under conditions of good manufacturing practice 
may be safely used as components of articles that contact food include 
the following, subject to any prescribed limitations:
    (1) Substances generally recognized as safe in or on food.
    (2) Substances generally recognized as safe for their intended use 
in food packaging.
    (3) Substances used in accordance with a prior sanction or approval.
    (4) Substances permitted for use by regulations in this part and 
parts 175, 176, 177, 178 and Sec. 179.45 of this chapter.
    (5) Food contact substances used in accordance with an effective 
premarket notification for a food contact

[[Page 149]]

substance (FCN) submitted under section 409(h) of the act.

[42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]



Sec. 174.6  Threshold of regulation for substances used in food-contact 
articles.

    Substances used in food-contact articles (e.g., food-packaging or 
food-processing equipment) that migrate, or that may be expected to 
migrate, into food at negligible levels may be reviewed under Sec. 
170.39 of this chapter. The Food and Drug Administration will exempt 
substances whose uses it determines meet the criteria in Sec. 170.39 of 
this chapter from regulation as food additives and, therefore, a food 
additive petition will not be required for the exempted use.

[60 FR 36596, July 17, 1995]



PART 175_INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF 
COATINGS--Table of Contents




Subpart A [Reserved]

      Subpart B_Substances for Use Only as Components of Adhesives

Sec.
175.105 Adhesives.
175.125 Pressure-sensitive adhesives.

         Subpart C_Substances for Use as Components of Coatings

175.210 Acrylate ester copolymer coating.
175.230 Hot-melt strippable food coatings.
175.250 Paraffin (synthetic).
175.260 Partial phosphoric acid esters of polyester resins.
175.270 Poly(vinyl fluoride) resins.
175.300 Resinous and polymeric coatings.
175.320 Resinous and polymeric coatings for polyolefin films.
175.350 Vinyl acetate/crotonic acid copolymer.
175.360 Vinylidene chloride copolymer coatings for nylon film.
175.365 Vinylidene chloride copolymer coatings for polycarbonate film.
175.380 Xylene-formaldehyde resins condensed with 4,4'-
          isopropylidenediphenol-epichlorohydrin epoxy resins.
175.390 Zinc-silicon dioxide matrix coatings.

    Authority: 21 U.S.C. 321, 342, 348, 379e.

    Source: 42 FR 14534, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 175 appear at 61 FR 
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.

Subpart A [Reserved]



      Subpart B_Substances for Use Only as Components of Adhesives



Sec. 175.105  Adhesives.

    (a) Adhesives may be safely used as components of articles intended 
for use in packaging, transporting, or holding food in accordance with 
the following prescribed conditions:
    (1) The adhesive is prepared from one or more of the optional 
substances named in paragraph (c) of this section, subject to any 
prescribed limitations.
    (2) The adhesive is either separated from the food by a functional 
barrier or used subject to the following additional limitations:
    (i) In dry foods. The quantity of adhesive that contacts packaged 
dry food shall not exceed the limits of good manufacturing practice.
    (ii) In fatty and aqueous foods. (a) The quantity of adhesive that 
contacts packaged fatty and aqueous foods shall not exceed the trace 
amount at seams and at the edge exposure between packaging laminates 
that may occur within the limits of good manufacturing practice.
    (b) Under normal conditions of use the packaging seams or laminates 
will remain firmly bonded without visible separation.
    (b) To assure safe usage of adhesives, the label of the finished 
adhesive container shall bear the statement ``food-packaging adhesive''.
    (c) Subject to any limitation prescribed in this section and in any 
other regulation promulgated under section 409 of the Act which 
prescribes safe conditions of use for substances that may be employed as 
constituents of adhesives, the optional substances used in the 
formulation of adhesives may include the following:
    (1) Substances generally recognized as safe for use in food or food 
packaging.
    (2) Substances permitted for use in adhesives by prior sanction or 
approval

[[Page 150]]

and employed under the specific conditions of use prescribed by such 
sanction or approval.
    (3) Flavoring substances permitted for use in food by regulations in 
this part, provided that such flavoring substances are volatilized from 
the adhesives during the packaging fabrication process.
    (4) Color additives approved for use in food.
    (5) Substances permitted for use in adhesives by other regulations 
in this subchapter and substances named in this subparagraph: Provided, 
however, That any substance named in this paragraph and covered by a 
specific regulation in this subchapter, must meet any specifications in 
such regulation.

------------------------------------------------------------------------
               Substances                          Limitations
------------------------------------------------------------------------
Abietic acid...........................
Acetone................................
Acetone-formaldehyde condensate (CAS
 Reg. No. 25619-09-4).
Acetone-urea-formaldehyde resin........
N-Acetyl ethanolamine..................
Acetyl tributyl citrate................
Acetyl triethyl citrate................
2-Acrylamido-2-methyl-propanesulfonic
 acid, homopolymer, sodium salt (CAS
 Reg. No. 35641-59-9).
Albumin, blood.........................
(2-Alkenyl) succinic anhydrides in
 which the alkenyl groups are derived
 from olefins which contain not less
 than 78 percent C30 and higher groups
 (CAS Reg. No. 70983-55-0).
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy)
 ethoxy]ethyl] disodium sulfosuccinate.
1-Alkyl (C6-C18) amino-3-amino-propane
 monoacetate.
Alkylated (C4 and/or C8) phenols.......
Alkyl (C7-C12) benzene.................
Alkyl (C10-C20) dimethylbenzyl ammonium
 chloride.
n-Alkyl(C12, C14, C16, or C18) dimethyl  For use as preservative only.
 (ethylbenzyl) ammonium
 cyclohexylsulfamate.
Alkyl ketene dimers as described in
 Sec.  176.120 of this chapter.
Alkyl (C7-C12) naphthalene.............
alpha Olefin sulfonate [alkyl group is
 in the range of C10-C18 with not less
 than 50 percent C14-C16], ammonium,
 calcium, magnesium, potassium, and
 sodium salts.
2-[(2-aminoethyl)amino]ethanol (CAS
 Reg. No. 111-41-1).
3-Aminopropanediol.....................  For use only in the preparation
                                          of polyurethane resins.
Aluminum...............................
Aluminum acetate.......................
Aluminum di(2-ethylhexoate)............
Aluminum potassium silicate............
N-[beta]-Aminoethyl-gamma-aminopropyl
 trimethoxysilane.
3-(Aminomethyl)-3,5,5-
 trimethylcyclohexylamine.
Aminomethylpropanol....................
Ammonium benzoate......................  For use as preservative only.
Ammonium bifluoride....................  For use only as bonding agent
                                          for aluminum foil, stabilizer
                                          or preservative. Total
                                          fluoride from all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesive.
Ammonium borate........................
Ammonium citrate.......................
Ammonium persulfate....................
Ammonium polyacrylate..................
Ammonium potassium hydrogen phosphate..
Ammonium silico-fluoride...............  For use only as bonding agent
                                          for aluminum foil, stabilizer,
                                          or preservative. Total
                                          fluoride from all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesive.
Ammonium sulfamate.....................
Ammonium thiocyanate...................
Ammonium thiosulfate...................
Amyl acetate...........................
Anhydroenneaheptitol...................
Animal glue as described in Sec.
 178.3120 of this chapter.
2-Anthraquinone sulfonic acid, sodium    For use only as polymerization-
 salt.                                    control agent.
Antimony oxide.........................
Asbestos...............................
Asphalt, paraffinic and naphthenic.....

[[Page 151]]

 
Azelaic acid...........................
Azo-bis-isobutyronitrile...............
Balata rubber..........................
Barium acetate.........................
Barium peroxide........................
Barium sulfate.........................
Bentonite..............................
Benzene (benzol).......................
1,4-Benzenedicarboxylic acid, bis[2-     For use as a stabilizer.
 (1,1-dimethylethyl)-6-[[3-(1,1-
 dimethylethyl)-2-hydroxy-5-
 methylphenyl]methyl]-4-methyl-
 phenyl]ester (CAS Reg. No. 57569-40-1).
1,2-Benzisothiazolin-3-one (CAS          For use as preservative only.
 Registry No. 2634-33-5).
Benzothiazyldisulfide..................
p-Benzoxyphenol........................  For use as preservative only.
Benzoyl peroxide.......................
Benzyl alcohol.........................
Benzyl benzoate........................
Benzyl bromoacetate....................  For use as preservative only.
p-Benzyloxyphenol......................   Do.
BHA (butylated hydroxyanisole).........
BHT (butylated hydroxytoluene).........
Bicyclo[2.2.1]hept-2-ene-6-methyl
 acrylate.
2-Biphenyl diphenyl phosphate..........
Bis(benzoate-O)(2-propanolato)aluminum   For use only as a reactant in
 (CAS Reg. No. 105442-85-1).              the preparation of polyester
                                          resins.
1,2-Bis(3,5-di-tert-butyl-4-             For use at a level not to
 hydroxyhydrocinnamoyl)hy-drazine (CAS    exceed 2 percent by weight of
 Reg. No. 32687-78-8).                    the adhesive.
1,3-Bis(2-benzothiazolylmercaptomethyl)
 urea.
4,4'-Bis([alpha],[alpha]-
 dimethylbenzyl)diphenylamine.
2,6-Bis(1,1-dimethylethyl)-4-(1-         For use as an antioxidant and/
 methylpropyl)phenol (CAS Reg. No.        or stabilizer only.
 17540-75-9).
2,6-Bis (1-methylheptadecyl)-p-cresol..
4-[[4, 6-Bis(octylthio)6-
 Bis(octylthio)6-Bis(octylthio)-s-
 triazin-2-yl]amino]-2,6-di-tert-
 butylphenol (CAS Reg. No. 991-84-4).
Bis(tri-n-butyltin) oxide..............  For use as preservative only.
Bis(trichloromethyl)sulfone C.A.          Do.
 Registry No. 3064-70-8.
Borax..................................
Boric acid.............................
2-Bromo-2-nitro-1, 3-propanediol (CAS    For use only as an
 Reg. No. 52-51-7).                       antibacterial preservative.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in adhesives.
 known as butanedioic acid, sulfo-1,4-
 diisodecyl ester, ammonium salt [CAS
 Reg. No. 144093-88-9])..
1,3-Butanediol.........................
1,4-Butanediol.........................
1,4-Butanediol modified with adipic
 acid.
Butoxy polyethylene polyproplyene
 glycol (molecular weight 900-4,200).
Butyl acetate..........................
Butyl acetyl ricinoleate...............
Butyl alcohol..........................
Butylated reaction product of p-cresol   As identified in Sec.
 and dicyclopentadiene.                   178.2010(b) of this chapter.
Butylated, styrenated cresols
 identified in Sec.  178.2010(b) of
 this chapter.
Butyl benzoate.........................
Butyl benzyl phthalate.................
Butyldecyl phthalate...................  ...............................
1,3-Butylene glycoldiglycolic acid
 copolymer.
tert-Butyl hydroperoxide...............
4,4'-Butylidenebis(6-tert-butyl-m-
 cresol).
Butyl lactate..........................
Butyloctyl phthalate...................
p-tert-Butylphenyl salicylate..........
Butyl phthalate butyl glycolate........
p-tert-Butylpyrocatechol...............  For use only as polymerization-
                                          control agent.
Butyl ricinoleate......................
Butyl rubber polymer...................
Butyl stearate.........................
Butyl titanate, polymerized............
Butyraldehyde..........................
Calcium ethyl acetoacetate.............
Calcium nitrate........................
Calcium metasilicate...................
Camphor................................
Camphor fatty acid esters..............
Candelilla wax.........................
epsilon-Caprolactam-(ethylene-ethyl
 acrylate) graft polymer.

[[Page 152]]

 
Carbon black, channel process..........
Carbon disulfide-1,1'-
 methylenedipiperidine reaction product.
Carbon tetrachloride...................
Carboxymethylcellulose.................
Castor oil, polyoxyethylated (4-84
 moles ethylene oxide).
Cellulose acetate butyrate.............
Cellulose acetate propionate...........
Ceresin wax (ozocerite)................
Cetyl alcohol..........................
Chloracetamide.........................
Chloral hydrate........................
Chlorinated liquid n-paraffins with
 chain lengths of C10-C17, containing
 40-70 percent chlorine by weight.
Chlorinated pyridine mixture with        For use as preservative only.
 active ingredients consisting of
 2,3,5,6-tetrachloro-4-(methylsulfonyl)
 pyridine, 2,3,5,6-tetrachloro-4-
 (methylsulfinyl) pyridine and
 pentachloropyridine.
Chlorinated rubber polymer (natural
 rubber polymer containing
 approximately 67 percent chlorine).
1-(3-Chloroallyl)-3,5,7-triaza-1-        For use as preservative only.
 azoniaadamantane chloride.
Chlorobenzene..........................
4-Chloro-3,5-dimethylphenol (p-chloro-m- For use as preservative only.
 xylenol).
4-Chloro-3-methylphenol................   Do.
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only as an
 (CAS Reg. No. 26172-55-4) and 2-methyl-  antimicrobial agent in polymer
 4-isothiazolin-3-one (CAS Reg. No.       latex emulsions.
 2682-20-4) mixture at a ratio of 3
 parts to 1 part, manufactured from
 methyl-3-mercaptopropionate (CAS Reg.
 No. 2935-90-2). The mixture may
 contain magnesium nitrate (CAS Reg.
 No. 10377-60-3) at a concentration
 equivalent to the isothiazolone active
 ingredients (weight/weight).
Chloroform.............................
Chloroprene............................
Chromium caseinate.....................
Chromium nitrate.......................
Chromium potassium sulfate.............
Cobaltous acetate......................
Coconut fatty acid amine salt of         For use as preservative only.
 tetrachlorophenol.
Copal..................................
Copper 8-quinolinolate.................  For use as preservative only.
Coumarone-indene resin.................
Cresyl diphenyl phosphate..............
Cumene hydroperoxide...................
Cyanoguanidine.........................
Cyclized rubber as identified in Sec.
 176.170(b)(2) of this chapter.
Cyclohexane............................
1,4-Cyclohexanedimethanoldibenzoate
 (CAS Reg. No. 35541-81-2).
Cyclohexanol...........................
Cyclohexanone resin....................
Cyclohexanone-formaldehyde condensate..
N-Cyclohexyl p-toluene sulfonamide.....
([eta]\5\-Cyclopentadienyl)-([eta]\6\-   For use only as a
 isopropylbenzene)iron(II)                photoinitiator.
 hexafluorophosphate (CAS Reg. No.
 32760-80-8).
Damar..................................
Defoaming agents as described in Sec.
 176.210 of this chapter.
Dehydroacetic acid.....................  ...............................
Diacetone alcohol......................
Diacetyl peroxide......................
N,N'-Dialkoyl-4,4'-
 diaminodiphenylmethane mixtures where;
 the alkoyl groups are derived from
 marine fatty acids (C12-C24).
2,5-Di-tert-amylhydroquinone...........
Diamines derived from dimerized
 vegetable oil acids.
Diaryl-p-phenylenediamine, where the
 aryl group may be phenyl, tolyl, or
 xylyl.
1,2-Dibromo-2,4-dicyanobutane (CAS       For use as a preservative only.
 Registry No. 3569-65-7).
2,2-Dibromo-3-nitrilopropionamide (CAS   For use as a preservative only.
 Reg. No. 10222-01-2)..
Di(butoxyethyl) phthalate..............
2,5-Di-tert-butylhydroquinone..........
Dibutyl maleate........................
2,6-Di-tert-butyl-4-methylphenol.......  For use as preservative only.
Di(C7, C9-alkyl)adipate................
Dibutyl phthalate......................
Dibutyl sebacate.......................
Dibutyltin dilaurate for use only as a
 catalyst for polyurethane resins.
1,2-Dichloroethylene (mixed isomers)...
Dicumyl peroxide.......................

[[Page 153]]

 
Dicyclohexyl phthalate.................
Diethanolamine.........................
Diethanolamine condensed with animal or
 vegetable fatty acids.
Diethylamine...........................
Diethylene glycol......................
Diethylene glycol adipic acid copolymer
Diethylene glycol dibenzoate...........
Diethylene glycol hydrogenated
 tallowate monoester.
Diethylene glycol laurate..............
Diethylene glycol monobutyl ether......
Diethylene glycol monobutyl ether
 acetate.
Diethylene glycol monoethyl ether......
Diethylene glycol monoethyl ether
 acetate.
Diethylene glycol monomethyl ether.....
Diethylene glycol monooleate...........
Diethylene glycol monophenyl ether.....
Diethylene glycol copolymer of adipic
 acid and phthalic anhydride.
Di(2-ethylhexyl) adipate...............
Di(2-ethylhexyl)hexahydrophthalate.....
Di(2-ethylhexyl)phthalate..............
Diethyl oxalate........................
Diethyl phthalate......................
Dihexyl phthalate......................
Dihydroabietylphthalate................
Di(2-hydroxy-5-tert-butylphenyl)
 sulfide.
2,2'-Dihydroxy-5,5'-
 dichlorodiphenylmethane
 (dichlorophene).
4,5-Dihydroxy-2-imidazolidinone........
4-(Diiodomethylsulfonyl) toluene CA      For use as an antifungal
 Registry No.: 20018-09-01.               preservative only.
Diisobutyl adipate.....................
Diisobutyl ketone......................
Diisobutylphenoxyethoxyethyl dimethyl
 benzyl ammonium chloride.
Diisobutyl phthalate...................
Diisodecyl adipate.....................
Diisodecyl phthalate...................
Diisooctyl phthalate...................
Diisopropylbenzene hydroperoxide.......
N,N-Dimethylcyclohexylamine
 dibutyldithiocarbamate.
Dimethyl formamide.....................
Dimethyl hexynol.......................
2,2-Dimethyl-1,3-propanediol dibenzoate
Dimethyl octynediol....................
N-(1,1-dimethyl-3-oxobutyl) acrylamide.
Dimethyl phthalate.....................
3,5-Dimethyl-1,3,5,2H-                   For use as preservative only.
 tetrahydrothiadiazine-2-thione.
Di-[beta]-naphthyl-p-phenylenediamine..
4,6-Dinonyl-o-cresol...................
Dinonylphenol..........................
Di-n-octyldecyl adipate................
Dioctyldiphenylamine...................
Dioctylphthalate.......................
Dioctylsebacate........................
Dioxane................................
Dipentaerythritol pentastearate........
Dipentamethylene-thiuram-tetrasulfide..
Dipentene..............................  ...............................
Dipentene resins.......................
Dipentene-beta-pinene-styrene resins...  ...............................
Dipentene-styrene resin (CAS Registry
 No. 64536-06-7).
Diphenyl-2-ethylhexyl phosphate........
Diphenyl, hydrogen ated................
N,N'-Diphenyl-p-phenylenediamine.......
Diphenyl phthalate.....................
1,3-Diphenyl-2-thiourea................
Dipropylene glycol.....................
Dipropylene glycol dibenzoate..........
Dipropylene glycol monomethyl ether....
Dipropylene glycol copolymer of adipic
 acid and phthalic anhydride.
Disodium cyanodithioimidocarbonate.....
Disodium 4-isodecyl sulfosuccinate (CAS
 Reg. No. 37294-49-8).
N,N'-Distearoylethylenediamine.........
Distearyl thiodipropionate.............
3,5-Di-tert-butyl-4-                     For use as antioxidant only.
 hydroxyhydrocinnamic acid triester
 with 1,3,5-tris(2-hydroxyethyl)-s-
 triazine-2,4,6(1H, 3H, 5H)-trione.
4,4'-Dithiodimorpholine................

[[Page 154]]

 
n-Dodecylmercaptan.....................
tert-Dodecylmercaptan..................
Dodecylphenoxybenzene-disulfonic acid
 and/or its calcium, magnesium, and
 sodium salts.
Elemi gum..............................
Epichlorohydrin-4,4'-
 isopropylidenediphenol resin.
Epichlorohydrin-4,4'-sec-
 butylidenediphenol resin.
Epichlorohydrin-4,4'-isopropylidene-di-
 o-cresol resin.
Epichlorohydrin-phenolformaldehyde
 resin.
Erucamide (erucylamide)................
Ethanolamine...........................
Ethoxylated primary linear alcohols of
 greater than 10 percent ethylene oxide
 by weight having molecular weights of
 390 to 7,000 (CAS Reg. No. 97953-22-5).
Ethoxypropanol butyl ether.............
Ethyl alcohol (ethanol)................
5-Ethyl-1,3-diglycidyl-5-
 methylhydantoin (CAS Reg. No. 15336-82-
 0).
Ethylene-acrylic acid-carbon monoxide
 copolymer (CAS Reg. No. 97756-27-9).
Ethylene-acrylic acid copolymer,
 partial sodium salt containing no more
 than 20 percent acrylic acid by
 weight, and no more than 16 percent of
 the acrylic acid as the sodium salt
 (CAS Reg. No. 25750-82-7).
Ethylenediamine........................
Ethylenediaminetetra-acetic acid,
 calcium, ferric, potassium, or sodium
 salts, single or mixed.
Ethylene dichloride....................
Ethylene glycol........................
Ethylene glycol monobutyl ether........
Ethylene glycol monobutyl ether acetate
Ethylene glycol monoethyl ether........
Ethylene glycol monoethyl ether acetate
Ethylene glycol monoethyl ether
 ricinoleate.
Ethylene glycol monomethyl ether.......
Ethylene glycol monophenyl ether.......
Ethylene-carbon monoxide copolymer (CAS
 Reg. No. 25052-62-4) containing not
 more than 30 weight percent of the
 units derived from carbon monoxide.
Ethylene-maleic anhydride copolymer,
 ammonium or potassium salt.
Ethylene-methacrylic acid copolymer
 partial salts: Ammonium, calcium,
 magnesium, sodium, and/or zinc.
Ethylene-methacrylic acid-vinyl acetate
 copolymer partial salts: Ammonium,
 calcium, magnesium, sodium, and/or
 zinc.
Ethylene-octene-1 copolymers containing
 not less than 70 weight percent
 ethylene (CAS Reg. No. 26221-73-8).
Ethylene-propylene-dicyclopentadiene
 copolymer rubber.
Ethylene, propylene, 1,4-hexadiene and
 2,5-norbornadiene tetrapolymer.
Ethylene-vinyl acetate carbon monoxide
 terpolymer (CAS Registry No. 26337-35-
 9) containing not more than 15 weight
 percent of units derived from carbon
 monoxide.
2,2'-Ethylidenebis (4,6-di-tert-
 butylphenol) (CAS Reg. No. 35958-30-6).
Ethyl-p-hydroxybenzoate................  For use as preservative only.
Ethyl hydroxyethylcellulose............
Ethyl lactate..........................
2,2'-Ethylidenebis(4,6-di-tert-          For use as an antioxidant and/
 butylphenyl)fluorophosphonite (CAS       or stabilizer only.
 Reg. No. 118337-09-0).
Ethyl phthalyl ethyl glycolate.........
Ethyl-p-toluene sulfonamide............  ...............................
Fats and oils derived from animal or
 vegetable sources, and the
 hydrogenated, sulfated, or sulfonated
 forms of such fats and oils.
Fatty acids derived from animal or
 vegetable fats and oils; and salts of
 such acids, single or mixed, as
 follows:
  Aluminum.............................
  Ammonium.............................
  Calcium..............................
  Magnesium............................
  Potassium............................
  Sodium...............................
  Zinc.................................
Ferric chloride........................
Fluosilicic acid (hydrofluosilicic       For use only as bonding agent
 acid).                                   for aluminum foil, stabilizer,
                                          or preservative. Total
                                          fluoride from all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesive.
Formaldehyde...........................

[[Page 155]]

 
Formaldehyde o- and p-toluene
 sulfonamide.
Formamide..............................
Fumaratochromium (III) nitrate.........
Furfural...............................
Furfuryl alcohol.......................
Fumaric acid...........................
gamma-Aminopropyltrimethoxysilane (CAS
 Reg. No. 13822-56-5).
Glutaraldehyde.........................
Glycerides, di- and monoesters.........
Glycerol polyoxypropylene triol,         For use only in the preparation
 minimum average molecular weight 250     of polyester and polyurethane
 (CAS Reg. No. 25791-96-2).               resins in adhesives.
Glyceryl borate (glycol boriborate
 resin).
Glyceryl ester of damar, copal, elemi,
 and sandarac.
Glyceryl monobutyl ricinoleate.........
Glyceryl monohydroxy stearate..........
Glyceryl monohydroxy tallowate.........
Glyceryl polyoxypropylene triol
 (average molecular weight 1,000).
Glyceryl tribenzoate...................
Glycol diacetate.......................
Glyoxal................................
Heptane................................
Hexamethylenetetramine.................
Hexane.................................
Hexanetriols...........................
Hexylene glycol........................
Hydroabietyl alcohol...................
Hydrocarbon resins (produced by
 polymerization of mixtures of mono-
 and di-unsaturated hydrocarbons of the
 aliphatic, alicyclic, and
 monobenzenoid type derived both from
 cracked petroleum and terpene stocks)
 (CAS Reg. No. 68239-99-6).
Hydrocarbon resins (produced by the
 polymerization of styrene and alpha-
 methyl styrene), hydrogenated (CAS
 Reg. No. 68441-37-2).
Hydrofluoric acid......................  For use only as bonding agent
                                          for aluminum foil, stabilizer,
                                          or preservative. Total
                                          fluoride from all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesive.
Hydrogen peroxide......................
Hydrogenated dipentene resin (CAS Reg.
 No. 106168-39-2).
Hydrogenated dipentene-styrene
 copolymer resin (CAS Reg. No. 106168-
 36-9).
Hydrogenated-beta-pinene-alpha-pinene-
 dipentene copolymer resin (CAS Reg.
 No. 106168-37-0).
a-Hydro-omega-hydroxypoly-               For use only in the preparation
 (oxytetramethylene).                     of polyurethane resins.
Hydroquinone...........................
Hydroquinone monobenzyl ether..........
Hydroquinone monoethyl ether...........
2(2'-Hydroxy-3',5' di-tert-amylphenyl)
 benzotriazole.
Hydroxyacetic acid.....................
7-Hydroxycoumarin......................
Hydroxyethylcellulose..................
2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]- For use only as a
 2-methyl-1-propanone(CAS Reg. No.        photoinitiator at a level not
 106797-53-9).                            to exceed 5 percent by weight
                                          of the adhesive.
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2
 alkyl (C6-C17) imidazolinium chloride.
Hydroxyethyldiethylenetriamine.........
[beta]-Hydroxyethyl pyridinium 2-
 mercaptobenzothiazol.
Hydroxyethyl starch....................
Hydroxyethylurea.......................  ...............................
Hydroxylamine sulfate..................
5-Hydroxymethoxymethyl-1-aza-3,7-        For use only as an
 dioxabicyclo[3.3.0]octane, 5-            antibacterial preservative.
 hydroxymethyl-1-aza-3,7-
 dioxabicyclo[3.3.0]octane, and 5-
 hydroxypoly-[methyleneoxy]methyl-1-aza-
 3,7-dioxabicyclo[3.3.0] octane mixture.
Hydroxypropyl methylcellulose..........
2-(Hydroxymethyl)-2-methyl-1,3-
 propanediol tribenzoate.
2-Imidazolidinone......................
3-Iodo-2-propynyl-N-butyl carbamate       For use only as an antifungal
 (CAS Reg. No. 55406-53-6).               preservative.
Iodoform...............................  For use only as polymerization-
                                          control agent.
Isoascorbic acid.......................
Isobutyl alcohol (isobutanol)..........
Isobutylene-isoprene copolymer.........
Isodecyl benzoate (CAS Reg. No. 131298-
 44-77).
Isophorone.............................
Isopropanolamine (mono-, di-, tri-)....

[[Page 156]]

 
Isopropyl acetate......................
Isopropyl alcohol (isopropanol)........
Isopropyl-m- and p-cresol (thymol
 derived).
4,4'-Isopropylidenediphenol............
4,4'-Isopropylidenediphenol,             For use as preservative only.
 polybutylated mixture.
Isopropyl peroxydicarbonate............
p-Isopropoxy diphenylamine.............
4,4'-Isopropylidene-bis(p-phenyleneoxy)-
 di-2-propanol.
Itaconic acid..........................
Japan wax..............................
Kerosene...............................
Lauroyl peroxide.......................
Lauroyl sulfate salts:
  Ammonium.............................
  Magnesium............................
  Potassium............................
  Sodium...............................
Lauryl alcohol.........................
Lauryl pyridinium 5-chloro-2-
 mercaptobenzothiazole.
Lignin calcium sulfonate...............
Lignin sodium sulfonate................
Linoleamide (linoleic acid amide)......
Magnesium fluoride.....................  For use only as bonding agent
                                          for aluminum foil, stabilizer,
                                          or preservative. Total
                                          fluoride from all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesives.
Magnesium glycerophosphate.............
Maleic acid............................
Maleic anhydride-diisobutylene
 copolymer, ammonium or sodium salt.
Manganese acetate......................
Marine oil fatty acid soaps,
 hydrogenated.
Melamine...............................
Melamine-formaldehyde copolymer........
2-Mercaptobenzothiazole................
2-Mercaptobenzothiazole and dimethyl     For use as preservative only.
 dithiocarbamic acid mixture, sodium
 salt.
2-Mercaptobenzothiazole, sodium or zinc  For use as preservative only.
 salt.
Methacrylate-chromic chloride complex,
 ethyl or methyl ester.
p-Menthane hydroperoxide...............
Methyl acetate.........................
Methyl acetyl ricinoleate..............
Methyl alcohol (methanol)..............
Methylcellulose........................
Methylene chloride.....................
4,4'-Methylenebis(2,6-di-tert-
 butylphenol).
2,2-Methylenebis (4-ethyl-6-tert-
 butylphenol).
2,2-Methylenebis (4-methyl-6-
 nonylphenol).
2,2-Methylenebis (4-methyl-6-tert-
 butylphenol).
Methyl ethyl ketone....................
Methyl ethyl ketone-formaldehyde
 condensate.
2-Methylhexane.........................
1-Methyl-2-hydroxy-4-isopropyl benzene.
Methyl isobutyl ketone.................
Methyl oleate..........................
Methyl oleate-palmitate mixture........
Methyl phthalyl ethyl glycolate........
Methyl ricinoleate.....................
Methyl salicylate......................
a-Methylstyrene-vinyltoluene copolymer   ...............................
 resins (molar ratio 1 a methylstyrene
 to 3 vinyltoluene).
Methyl tallowate.......................
Mineral oil............................
Monochloracetic acid...................
Monooctyldiphenylamine.................
Montan wax.............................
Morpholine.............................
Myristic acid-chromic chloride complex.
Myristyl alcohol.......................
Naphtha................................
Naphthalene, monosulfonated............
Naphthalene sulfonic acid-formaldehyde
 condensate, sodium salt.
[alpha]-Naphthylamine..................
[alpha],[alpha]',[alpha][dprime],[alpha
 ][dprime]'-Neopentane tetrayltetrakis
 [omega-hydroxypoly (oxypropylene) (1-2
 moles)], average molecular weight 400.

[[Page 157]]

 
Nitric acid............................
[mu]-Nitrobiphenyl.....................
Nitrocellulose.........................
2-Nitropropane.........................
[alpha]-(p-Nonylphenyl)-omega-
 hydroxypoly (oxyethylene) mixture of
 dihydrogen phosphate and monohydrogen
 phosphate esters; the nonyl group is a
 propylene trimer isomer and the poly
 (oxyethylene) content averages 6-9
 moles or 50 moles.
[alpha](p-Nonylphenyl)-omega-
 hydroxypoly (oxyethylene) produced by
 the condensation of 1 mole of p-
 nonylphenol (nonyl group is a
 propylene trimer isomer) with an
 average of 1-40 moles of ethylene
 oxide.
[alpha]-(p-Nonylphenyl)-omega-
 hydroxypoly (oxyethylene) sulfate,
 ammonium salt: the nonyl group is a
 propylene trimer isomer and the poly
 (oxyethylene) content averages 9 or 30
 moles.
endo-cis-5-Norbornene-2,3-dicarboxylic
 anhydride.
[alpha]-cis-9-Octadecenyl-omega-
 hydroxypoly (oxyethylene); the
 octadecenyl group is derived from
 oleyl alcohol and the poly
 (oxyethylene) content averages 20
 moles.
Octadecyl 3,5-di-tert-butyl-4-
 hydroxyhydrocinnamate.
Octyl alcohol..........................
Octyldecyl phthalate...................
Octylphenol............................
Octylphenoxyethanols...................
Octylphenoxypolyethoxy-
 polypropoxyethanol (13 moles of
 ethylene oxide and propylene oxide).
Odorless light petroleum hydrocarbons..
Oleamide (oleic acid amide)............
Oleic acid, sulfated...................
2,2'-Oxamidobis[ethyl 3-(3,5-di-tert-
 butyl-4-hydroxyphenyl)propionate] (CAS
 Reg. No. 70331-94-1).
Oxazoline..............................
[alpha]-(oxiranylmethyl)-[omega]-        For use as a reactant in the
 (oxiranylmethoxy)poly[oxy(methyl-1,2-    preparation of epoxy-based
 ethanediyl)], (alternative name:         resins.
 epichlorohydrin-polypropylene glycol)
 (CAS Reg. No. 26142-30-3).
2,2'-[oxybis[(methyl-2,1-ethanediyl)-    For use as a reactant in the
 oxymethylene]]bisoxirane, (alternative   preparation of epoxy-based
 name: epichlorohydrin-dipropylene        resins.
 glycol) (CAS Reg. No. 41638-13-5).
n-Oxydiethylene-benzothiazole..........
Palmitamide (palmitic acid amide)......
Paraffin (C12-C20) sulfonate...........
Paraformaldehyde.......................
Pentachlorophenol......................
Pentaerythritol ester of maleic
 anhydride.
Pentaerythritol monostearate...........  For use as preservative only.
Pentaerythritol tetrabenzoate [CAS
 Registry No. 4196-86-5].
Pentaerythritol tetrastearate..........
2,4-Pentanedione.......................
Pentasodium
 diethylenetriaminepentaacetate (CAS
 Reg. No. 140-01-2).
Perchloroethylene......................
Petrolatum.............................
Petroleum hydrocarbon resin
 (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced
 by the catalytic polymerization and
 subsequent hydrogenation of styrene,
 vinyltoluene, and indene types from
 distillates of cracked petroleum
 stocks).
Petroleum hydrocarbon resins (produced
 by the homo-and copolymerization of
 dienes and olefins of the aliphatic,
 alicyclic, and monobenzenoid
 arylalkene types from distillates of
 cracked petroleum stocks).
Phenol.................................  For use as preservative only.
Phenol-coumarone-indene resin..........
Phenolic resins as described in Sec.
 175.300(b)(3)(vi).
Phenothiazine..........................  For use only as polymerization-
                                          control agent.
Phenyl-[beta]-naphthylamine (free of
 [beta]-naphthylamine).
o-Phenylphenol.........................  For use as preservative only.
o-Phthalic acid........................
Pimaric acid...........................  ...............................
Pine oil...............................
Piperazine.............................
Piperidinium
 pentamethylenedithiocarbamate.
Poly(acrylamide-[2-acrylamide-2-
 methylpropylsulfonate]-
 dimethylidiallyl ammonium chloride)
 sodium salt (CAS Reg. No. 72275-68-4).
Polyamides derived from reaction of one
 or more of the following acids with
 one or more of the following amines:
    Acids:
        Azelaic acid...................

[[Page 158]]

 
        Dimerized vegetable oil acids..
    Amines:
        Bis(hexamethylene) triamine and
         higher homologues.
        Diethylenetriamine.............
        Diphenylamine..................
        Ethylenediamine................
        Hexamethylenediamine...........
        Poly(oxypropylene)diamine
         (weight average molecular
         weight 2010) (CAS Reg. No.
         9046-10-0).
        Poly(oxypropylene)diamine
         (weight average molecular
         weight 440) (CAS Reg. No. 9046-
         10-0).
        Tetraethylenepentamine.........
        Triethylenetetramine...........
Polybutene, hydrogenated...............
Polybutylene glycol (molecular weight
 1,000).
Poly [2(diethylamino) ethyl
 methacrylate] phosphate.
Polyester of adipic acid, phthalic
 acid, and propylene glycol, terminated
 with butyl alcohol.
Polyester of diglycolic acid and
 propylene glycol containing ethylene
 glycol monobutyl ether as a chain
 stopper.
Polyester resins (including alkyd
 type), as the basic polymer, formed as
 esters when one or more of the
 following acids are made to react with
 one or more of the following alcohols:
    Acids:
        Azelaic acid...................
        Dimethyl 1,4-
         cyclohexanedicarboxylate (CAS
         Reg. No. 94-60-0).
        Dimethyl-5-sulfoisophthalic
         acid (CAS Reg. No. 50975-82-1)
         and/or its sodium salt (CAS
         Reg. No. 3965-55-7).
        Polybasic and monobasic acids
         identified in Sec.
         175.300(b)(3)(vii)(a) and (b).
        5-sulfo-1,3-benzenedicarboxylic
         acid, monosodium salt (CAS
         Reg. No. 6362-79-4).
        Tetrahydrophthalic acid........
    Alcohols:
        1,4-Cyclohexanedimethanol......
        2,2-Dimethyl-1,3-propanediol...
        1,6-Hexanediol (CAS Reg. No.
         629-11-8).
        Polyhydric and monohydric
         alcohols identified in Sec.
         175.300(b)(3)(vii)(c) and (d).
Polyethyleneadipate modified with        For use only in the preparation
 ethanolamine with the molar ratio of     of polyurethan resins.
 the amine to the adipic acid less than
 0.1 to 1.
Polyethylene glycol (molecular weight
 200-6,000).
Polyethylene glycol mono-isotridecyl     ...............................
 ether sulfate, sodium salt (CAS Reg.
 No. 150413-26-6).
Polyethyleneglycol alkyl(C10-C12) ether  ...............................
 sulfosuccinate, disodium salt (CAS
 Reg. No. 68954-91-6).
Polyethylene, oxidized.................
Polyethylene resins, carboxyl modified,
 identified in Sec.  177.1600 of this
 chapter.
Polyethylenimine.......................
Polyethylenimine-epichlorohydrin resins
Poly(ethyloxazoline) (CAS Reg. No.
 25805-17-8).
Polyisoprene...........................
Polymeric esters of polyhydric alcohols
 and polycarboxylic acids prepared from
 glycerin and phthalic anhydride and
 modified with benzoic acid, castor
 oil, coconut oil, linseed oil, rosin,
 soybean oil, styrene, and vinyl
 toluene.
Polymers: Homopolymers and copolymers
 of the following monomers:.
  Acrylamide...........................
  Acrylic acid.........................
  Acrylonitrile........................
  Allylmethacrylate (CAS Reg. No. 00096-
   05-09).
  Butadiene............................
  Butene...............................
  N-tert-Butylacrylamide...............
  Butyl acrylate.......................
  1,3-Butylene glycol dimethacrylate...
  Butyl methacrylate...................
  Crotonic acid........................
  Decyl acrylate.......................
  Diallyl fumarate.....................
  Diallyl maleate......................

[[Page 159]]

 
  Diallyl phthalate....................
  Dibutyl fumarate.....................
  Dibutyl itaconate....................
  Dibutyl maleate......................
  Di(2-ethylhexyl) maleate.............
  Dimethyl-[alpha]-methylstyrene.......
  Dioctyl fumarate.....................
  Dioctyl maleate......................
  Divinylbenzene.......................
  Ethyl acrylate.......................
  Ethylene.............................
  Ethylene cyanohydrin.................
  2-Ethylhexyl acrylate................
  Ethyl methacrylate...................
  Fatty acids, C10-13-branched, vinyl
   esters (CAS Reg. No. 184785-38-4).
  Fumaric acid and/or its methyl,
   ethyl, propyl, butyl, amyl hexyl,
   heptyl and octyl esters.
  Glycidyl methacrylate................
  1-Hexene (CAS Reg. No. 592-41-6).....
  2-Hydroxyethyl acrylate..............
  2-Hydroxyethyl methacrylate..........
  2-Hydroxypropyl methacrylate.........
  Isobutyl acrylate....................
  Isobutylene..........................
  Itaconic acid........................
  Maleic acid, diester with 2-
   hydroxyethanesulfonic acid, sodium
   salt.
  Maleic anhydride.....................
  Methacrylic acid.....................
  Methyl acrylate......................
  N,N'-Methylenebisacrylamide..........
  Methyl methacrylate..................
  N-Methylolacrylamide.................
  Methyl styrene.......................
  -Methyl styrene......................
  Monoethyl maleate....................
  Monomethyl maleate...................
  Mono (2-ethylhexyl) maleate..........
  5-Norbornene-2 3-dicarboxylic acid,
   mono-n-butyl ester.
  1-Octene (CAS Reg. No. 111-66-0).....
  Propyl acrylate......................
  Propylene............................
  Styrene..............................
  Triallyl cyanurate...................
  Vinyl acetate........................
  Vinyl alcohol (from alcoholysis or
   hydrolysis of vinyl acetate units).
  Vinyl butyrate.......................
  Vinyl chloride.......................
  Vinyl crotonate......................
  Vinyl ethyl ether....................
  Vinyl hexoate........................
  Vinylidene chloride..................
  Vinyl methyl ether...................
  Vinyl pelargonate....................
  Vinyl propionate.....................
  Vinyl pyrrolidone....................
  Vinyl stearate.......................
Polyoxyalkylated-phenolic resin
 (phenolic resin obtained from
 formaldehyde plus butyl- and/or
 amylphenols, oxyalkylated with
 ethylene oxide and/or propylene oxide).
Poly(oxycaproyl) diols and triols
 (minimum molecular weight 500).
Polyoxyethylated (40 moles) tallow
 alcohol sulfate, sodium salt.
Polyoxyethylene (20 mol)--anhydrous
 lanolin adduct.
Polyoxyethylene (molecular weight 200)
 dibenzoate.
Polyoxyethylene (molecular weight 200-
 600) esters of fatty acids derived
 from animal or vegetable fats and oils
 (including tall oil).
Polyoxyethylene (15 moles) ester of
 rosin.
Polyoxyethylene (4-5 moles) ether of
 phenol.
Polyoxyethylene (25 moles)--glycerol
 adduct.
Polyoxyethylene (40 moles) stearate....
Polyoxyethylene (5-15 moles) tridecyl
 alcohol.
Polyoxypropylene (3 moles) tridecyl
 alcohol sulfate.
Polyoxypropylene (20 moles) butyl ether
Polyoxypropylene (40 moles) butyl ether

[[Page 160]]

 
Polyoxypropylene (20 moles) oleate
 butyl ether.
Polyoxypropylene-polyoxyethylene
 condensate (minimum molecular weight
 1,900).
Polypropylene glycol (minimum molecular
 weight 150).
Polypropylene glycol (3-4 moles)
 triether with 2-ethyl-2-
 (hydroxymethyl)-1,3-propane-diol,
 average molecular weight 730.
Polypropylene glycol dibenzoate (CAS     For use as a plasticizer at
 Reg. No. 72245-46-6).                    levels not to exceed 20
                                          percent by weight of the
                                          finished adhesive.
Polypropylene, noncrystalline..........
Polysiloxanes:
  Diethyl polysiloxane.................
  Dihydrogen polysiloxane..............
  Dimethyl polysiloxane................
  Diphenyl polysiloxane................
  Ethyl hydrogen polysiloxane..........
  Ethyl phenyl polysiloxane............
  Methyl ethyl polysiloxane............
  Methyl hydrogen polysiloxane.........
  Methyl phenyl polysiloxane...........
  Phenyl hydrogen polysiloxane.........
Polysorbate 60.........................
Polysorbate 80.........................
Polysorbate 20 (polyoxyethylene (20)
 sorbitan monolaurate).
Polysorbate 40 (polyoxyethylene (20)
 sorbitan monopalmitate).
Poly[styrene-co-disodium maleate-co-
 [alpha]-(p-nonyl-phenyl)-omega-(p-
 vinyl-benzyl)poly(oxyethylene)]
 terpolymer.
Polytretrafluoroethylene...............
Polyurethane resins produced by: (1)
 reacting diisocyanates with one or
 more of the polyols or polyesters
 named in this paragraph, or (2)
 reacting the chloroformate derivatives
 of one or more of the polyols or
 polyesters named in this paragraph
 with one or more of the polyamines
 named in this paragraph, or (3)
 reacting toluene diisocyanate or 4,4'
 methylenebis(cyclohexylisocyanate)
 (CAS Reg. No. 5124-30-1) with: (i) one
 or more of the polyols or polyesters
 named in this paragraph and with
 either N-methyldiethanolamine (CAS
 Reg. No. 105-59-9) and dimethyl
 sulfate (CAS Reg. No. 77-78-1) or
 dimethylolpropionic acid (CAS Reg. No.
 4767-03-7) and triethylamine (CAS Reg.
 No. 121-44-8), or (ii) a fumaric acid-
 modified polypropylene glycol or
 fumaric acid-modified tripropylene
 glycol), triethylamine (CAS Reg. No.
 107-15-3), and ethylenediamine (CAS
 Reg. No. 121-44-8), or (4) reacting
 meta-tetramethylxylene diisocyanate
 (CAS Reg. No. 2778-42-9) with one or
 more of the polyols and polyesters
 listed in this paragraph and with
 dimethylolpropionic acid (CAS Reg. No.
 4767-03-7) and triethylamine (CAS Reg.
 No. 121-44-8), N-methyldiethanolamine
 (CAS Reg. No. 105-59-9), 2-
 dimethylaminoethanol (CAS Reg. No. 108-
 01-0), 2-dimethylamino-2-methyl-1-
 propanol (CAS Reg. No. 7005-47-2), and/
 or 2-amino-2-methyl-1-propanol (CAS
 Reg. No. 124-68-5).
Polyvinyl alcohol modified so as to
 contain not more than 3 weight percent
 of comonomer units derived from 1-
 alkenes having 12 to 20 carbon atoms.
Polyvinyl butyral......................
Polyvinyl formal.......................
Potassium ferricyanide.................  For use only as polymerization-
                                          control agent.
Potassium N-methyldithiocarbamate......
Potassium pentachlorophenate...........  For use as preservative only.
Potassium permanganate.................
Potassium persulfate...................
Potassium phosphates (mono-, di-,
 tribasic).
Potassium tripolyphosphate.............
[alpha], [alpha]', [alpha][dprime]-
 1,2,3-Propanetriyltris [omega-(2,3-
 epoxypropoxy) poly (oxypropylene) (24
 moles)].
[beta]-Propiolactone...................
Propyl alcohol (propanol)..............
Propylene carbonate....................
Propylene glycol and p-p'-
 isopropylidenediphenol diether.
Propylene glycol dibenzoate (CAS Reg.    For use as a plasticizer at
 No. 19224-26-1).                         levels not to exceed 20
                                          percent by weight of the
                                          finished adhesive.
Propylene glycol esters of coconut
 fatty acids.
Propylene glycol monolaurate...........
Propylene glycol monomethyl ether......
Propylene glycol monostearate..........
[alpha], [alpha]', [alpha][dprime]-
 [Propylidynetris (methylene)] tris
 [omega-hydroxypoly (oxypropylene) (1.5
 moles minimum)], minimum molecular
 weight 400.

[[Page 161]]

 
Quaternary ammonium chloride             For use as preservative only.
 (hexadecyl, octadecyl derivative).
Rosin (wood, gum, and tall oil rosin),
 rosin dimers, decarboxylated rosin
 (including rosin oil,
 disproportionated rosin, and these
 substances as modified by one or more
 of the following reactants:.
  Alkyl (C1-C9) phenolformaldehyde.....
  Ammonia..............................
  Ammonium caseinate-p-
   Cyclohexylphenolformaldehyde.
  Diethylene glycol....................
  Dipentaerythritol....................
  Ethylene glycol......................
  Formaldehyde.........................
  Fumaric acid.........................
  Glycerin.............................
  Hydrogen.............................
  Isophthalic acid.....................
  4,4'-Isopropylidenediphenol-
   epichlorohydrin (epoxy).
  4,4'-Isopropylidenediphenol-
   formaldehyde.
  Maleic anhydride.....................
  Methyl alcohol.......................
  Pentaerythritol......................
  Phthalic anhydride...................
  Polyethylene glycol..................
  Phenol-formaldehyde..................
  Phenyl [mu]-cresol-formaldehyde......
  p-Phenylphenol-formaldehyde..........
  Sulfuric acid........................
  Triethylene glycol...................
  Xylenol-formaldehyde.................
Rosin salts (salts of wood, gum, and
 tall oil rosin, and the dimers
 thereof, decarboxylated rosin
 disproportionated rosin, hydrogenated
 rosin):
  Aluminum.............................
  Ammonium.............................
  Calcium..............................
  Magnesium............................
  Potassium............................
  Sodium...............................
  Zinc.................................
Rosin, gasoline-insoluble fraction.....
Rubber hydrochloride polymer...........
Rubber latex, natural..................
Salicylic acid.........................  For use as preservative only.
Sandarac...............................
Sebacic acid...........................
Shellac................................
Silicon dioxide as defined in Sec.
 172.480(a) of this chapter.
Sodium alkyl (C2-C13.5 aliphatic)
 benezenesulfonate.
Sodium aluminum pyrophosphate..........
Sodium aluminum sulfate................
Sodium bisulfate.......................
Sodium calcium silicate................
Sodium capryl polyphosphate............
Sodium carboxymethylcellulose..........
Sodium chlorate........................
Sodium chlorite........................
Sodium chromate........................
Sodium decylsulfate....................
Sodium dehydroacetate..................  For use as preservative only.
Sodium di-(2-ethylhexoate).............
Sodium di-(2-ethylhexyl) pyrophosphate.
Sodium dihexylsulfosuccinate...........
Sodium dissobutylphenoxydiethoxyethyl
 sulfonate.
Sodium diisobutylphenoxymonoethoxyethyl
 sulfonate.
Sodium diisopropyl- and
 triisopropylnaphthalenesulfonate.
Sodium dimethyldithiocarbamate.........
Sodium dioctylsulfosuccinate...........
Sodium n-dodecylpolyethoxy (50 moles)
 sulfate.
Sodium ethylene ether of nonylphenol
 sulfate.
Sodium 2-ethylhexyl sulfate............
Sodium fluoride........................  For use only as bonding agent
                                          for aluminum foil, stabilizer,
                                          or preservative. Total
                                          fluoride for all sources not
                                          to exceed 1 percent by weight
                                          of the finished adhesive.
Sodium formaldehyde sulfoxylate........
Sodium formate.........................

[[Page 162]]

 
Sodium heptadecylsulfate...............
Sodium hypochlorite....................
Sodium isododecylphenoxypolyethoxy (40
 moles) sulfate.
Sodium N-lauroyl sarcosinate...........
Sodium metaborate......................
Sodium [alpha]-naphthalene sulfonate...
Sodium nitrate.........................
Sodium nitrite.........................
Sodium oleoyl isopropanolamide
 sulfosuccinate.
Sodium pentachlorophenate..............  For use as preservative only.
Sodium perborate.......................
Sodium persulfate......................
Sodium [mu]-phenylphenate..............  For use as preservative only.
Sodium polyacrylate....................
Sodium polymethacrylate................
Sodium polystyrene sulfonate...........
Sodium salicylate......................  For use as preservative only.
Sodium salt of 1-hydroxy 2(1H)-pyridine   Do.
 thione.
Sodium tetradecylsulfate...............
Sodium thiocyanate.....................
Sodium bis-tridecylsulfosuccinate......
Sodium xylene sulfonate................
Sorbitan monooleate....................
Sorbitan monostearate..................
Soybean oil, epoxidized................
Spermaceti wax.........................
Sperm oil wax..........................
Stannous 2-ethylhexanoate..............  For use only as a catalyst for
                                          polyurethane resins.
Stannous stearate......................
Starch hydrolysates....................
Starch or starch modified by one or
 more of the treatments described in
 Sec. Sec.  172.892 and 178.3520 of
 this chapter.
Starch, reacted with a urea-
 formaldehyde resin.
Starch, reacted with formaldehyde......
Stearamide (stearic acid amide)........
Stearic acid...........................
Stearic acid-chromic chloride complex..
Stearyl-cetyl alcohol, technical grade,
 approximately 65 percent-80 percent
 stearyl and 20 percent-35 percent
 cetyl.
Strontium salicylate...................
Styrenated phenol......................
Styrene block polymers with 1,3-
 butadiene.
Styrene-maleic anhydride copolymer,
 ammonium or potassium salt.
Styrene-maleic anhydride copolymer
 (partially methylated) sodium salt.
Styrene-methacrylic acid copolymer,
 potassium salt.
Sucrose acetate isobutyrate............
Sucrose benzoate.......................
Sucrose octaacetate....................
2-sulfoethyl methacrylate (CAS Registry  For use at levels not to exceed
 No. 10595-80-9).                         2 percent by weight of the dry
                                          adhesive.
[alpha]-Sulfo-omega-(dodecyloxy)poly
 (oxyethylene), ammonium salt.
Sulfonated octadecylene (sodium form)..
Sulfosuccinic acid 4-ester with
 polyethylene glycol dodecyl ether
 disodium salt (alcohol moiety produced
 by condensation of 1 mole of n-dodecyl
 alcohol and an average of 5-6 moles of
 ethylene oxide, Chemical Abstracts
 Service Registry No. 039354-45-5).
Sulfosuccinic acid 4-ester with
 polyethylene glycol nonylphenyl ether,
 disodium salt (alcohol moiety produced
 by condensation of 1 mole of
 nonylphenol and an average of 9-10
 moles of ethylene oxide) (CAS Reg. No.
 9040-38-4).
Sulfur.................................
Synthetic primary linear aliphatic
 alcohols whose weight average
 molecular weight is greater than 400
 (CAS Reg. No. 71750-71-5).
Synthetic wax polymer as described in
 Sec.  176.170(a)(5) of this chapter.
Tall oil...............................
Tall oil fatty acids, linoleic and
 oleic.
Tall oil fatty acid methyl ester.......
Tall oil, methyl ester.................
Tall oil pitch.........................
Tall oil soaps.........................
Tallow alcohol (hydrogenated)..........
Tallow amine, secondary (hexadecyl,
 octadecyl), of hard tallow.
Tallow, blown (oxidized)...............
Tallow, propylene glycol ester.........

[[Page 163]]

 
Terpene resins ([alpha]-and [beta]-      ...............................
 pinene) homopolymers, copolymers, and
 condensates with phenol, formaldehyde,
 coumarone, and/or indene.
Terphenyl..............................
Terphenyl, hydrogenated................
Terpineol..............................
Tetraethylene pentamine................
Tetraethylthiuram disulfide............
Tetrahydrofuran........................
Tetrahydrofurfuryl alcohol.............
Tetra-isopropyl titanate...............
Tetrakis[methylene (3,5-di-tert-butyl-4-
 hydroxy-hydro-cinnamate)] methane.
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
 omega-hydroxypoly-(oxyethylene)
 produced by the condensation of 1 mole
 of p-(1,1,3,3-tetramethylbutyl) phenol
 with an average of 1-40 moles of
 ethylene oxide.
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
 omega-hydroxy-poly(oxyethylene)
 mixture of dihydrogen phosphate and
 monohydrogen phosphate esters and
 their sodium, potassium, and ammonium
 salts having a poly(oxyethylene)
 content averaging 6-9 or 40 moles.
Tetramethyl decanediol.................
Tetramethyl decynediol.................
Tetramethyl decynediol plus 1-30 moles
 of ethylene oxide.
Tetramethylthiuram monosulfide.........
Tetrasodium N-(1,2-dicarboxyethyl)N-
 octadecylsulfosuccinamate.
4,4'-Thiobis-6-tert-butyl-m-cresol.....
Thiodiethylene-bis(3,5-di-tert-butyl-4-
 hydroxyhydrocinnamate).
2,2'-(2,5-Thiophenediyl) bis[5-tert-
 butylbenzoxazole].
Thiram.................................
Thymol.................................  For use as preservative only.
Titanium dioxide.......................
Titanium dioxide-barium sulfate........
Titanium dioxide-calcium sulfate.......
Titanium dioxide-magnesium silicate....
Toluene................................
Toluene 2,4-diisocyanate...............
Toluene 2,6-diisocyanate...............
o- and p-Toluene ethyl sulfonamide.....
o- and p-Toluene sulfonamide...........
p-Toluene sulfonic acid................
p-(p'-Toluene-sulfonylamide)-
 diphenylamide.
Triazine-formaldehyde resins as
 described in Sec.
 175.300(b)(3)(xiii).
Tributoxyethyl phosphate...............
Tributylcitrate........................
Tri-tert-butyl-p-phenyl phenol.........  For use as preservative only.
Tributyl phosphate.....................
Tributyltin chloride complex of          For use as preservative only.
 ethylene oxide condensate of
 dehydroabietylamine.
Tri-n-butyltin acetate.................  For use as preservative only.
Tri-n-butyltin neodecanoate............   Do.
1,1,1-Trichloroethane..................
1,1,2-Trichloroethane..................
Trichloroethylene......................
Tri-[beta]-chloroethylphosphate........
Tridecyl alcohol.......................
Triethanolamine........................
3-(Triethoxysilyl) propylamine.........
Triethylene glycol.....................
Triethylene glycol dibenzoate..........
Triethylene glycol di(2-ethylhexoate)..
Triethylene glycol polyester of benzoic
 acid and phthalic acid.
Triethylhexyl phosphate................
Triethylphosphate......................
2,4,5-Trihydroxy butyrophenone.........
Triisopropanolamine....................
Trimethylol propane....................
2,2,4-Trimethylpentanediol-1,3-
 diisobutyrate.
Trimeric aromatic amine resin from
 diphenylamine and acetone of molecular
 weight approximately 500.
Tri(nonylphenyl) phosphite-formaldehyde  As identified in Sec.
 resins.                                  177.2600(c)(4)(iii) of this
                                          chapter. For use only as a
                                          stabilizer.
Triphenylphosphate.....................
Tripropylene glycol monomethyl ether...
1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-
 benzyl)-triazine-2,4,6 (1H,3H,5H)-
 trione.

[[Page 164]]

 
Tris (p-tertiary butyl phenyl)
 phosphate.
Tris(2-methyl-4-hydroxy-5-tert-butyl-
 phenyl)butane.
Trisodium N-
 hydroxyethylethylenediaminetriacetate
 (CAS Reg. No. 139-89-9).
Turpentine.............................
Urea-formaldehyde resins as described
 in Sec.  175.300(b)(3)(xii).
Vegetable oil, sulfonated or sulfated,
 potassium salt.
Vinyl acetate-maleic anhydride
 copolymer, sodium salt.
Waxes, petroleum.......................
Wax, petroleum, chlorinated (40% to 70%
 chlorine).
Waxes, synthetic paraffin (Fischer-
 Tropsch process).
3-(2-Xenolyl)-1,2-epoxypropane.........
Xylene.................................
Xylene (or toluene) alkylated with
 dicyclopentadiene.
Zein...................................
Zinc acetate...........................
Zinc ammonium chloride.................
Zinc dibenzyl dithiocarbamate..........
Zinc dibutyldithiocarbamate............
Zinc diethyldithiocarbamate............
Zinc di(2-ethylhexoate)................
Zinc formaldehyde sulfoxylate..........
Zinc naphthenate and
 dehydroabietylamine mixture.
Zinc nitrate...........................
Zinc orthophosphate....................
Zinc resinate..........................
Zinc sulfide...........................
Zineb (zinc ethylenebis-
 dithiocarbamate).
Ziram (zinc dimethyldithiocarbamate)...
------------------------------------------------------------------------


[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
175.105, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 175.125  Pressure-sensitive adhesives.

    Pressure-sensitive adhesives may be safely used as the food-contact 
surface of labels and/or tapes applied to food, in accordance with the 
following prescribed conditions:
    (a) Pressure-sensitive adhesives prepared from one or a mixture of 
two or more of the substances listed in this paragraph may be used as 
the food-contact surface of labels and/or tapes applied to poultry, dry 
food, and processed, frozen, dried, or partially dehydrated fruits or 
vegetables.
    (1) Substances generally recognized as safe in food.
    (2) Substances used in accordance with a prior sanction or approval.
    (3) Color additives listed for use in or on food in parts 73 and 74 
of this chapter.
    (4) Substances identified in Sec. 172.615 of this chapter other 
than substances used in accordance with paragraph (a)(2) of this 
section.
    (5) Polyethylene, oxidized; complying with the identity prescribed 
in Sec. 177.1620(a) of this chapter.
    (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-
butylphenol (CAS Reg. No. 991-84-4) as an antioxidant/stabilizer at a 
level not to exceed 1.5 percent by weight of the finished pressure-
sensitive adhesive.
    (7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. 
No. 7128-64-5) as an optical brightener at a level not to exceed 0.05 
percent by weight of the finished pressure-sensitive adhesive.
    (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy) phenyl]-2-methyl-1-propanone 
(CAS Reg. No. 106797-53-9) as a photoinitiator at a level not to exceed 
5 percent by weight of the pressure-sensitive adhesive.
    (9) Butanedioic acid, sulfo-1,4-di-(C9-C11 
alkyl) ester, ammonium salt (also known as butanedioic acid sulfo-1, 4-
diisodecyl ester, ammonium salt [CAS Reg. No. 144093-88-9]) as a surface 
active agent at a level not to exceed 3.0

[[Page 165]]

percent by weight of the finished pressure-sensitive adhesive.
    (b) Pressure-sensitive adhesives prepared from one or a mixture of 
two or more of the substances listed in this paragraph may be used as 
the food-contact surface of labels and/or tapes applied to raw fruit and 
raw vegetables.
    (1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5), 
(a)(6), (a)(7), (a)(8), and (a)(9) of this section, and those substances 
prescribed by paragraph (a)(4) of this section that are not identified 
in paragraph (b)(2) of this section.
    (2) Substances identified in this subparagraph and subject to the 
limitations provided:

BHA.
BHT.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Butylated reaction product of p-cresol and dicyclopentadiene produced by 
reacting p-cresol and dicyclopentadiene in an approximate mole ratio of 
1.5 to 1.0, respectively, followed by alkylation with isobutylene so 
that the butyl content of the final product is not less than 18 percent, 
for use at levels not to exceed 1.0 percent by weight of the adhesive 
formulation.
Chlorinated natural rubber.
Isobutylene-styrene copolymer.
Petrolatum.
Polybutene-1.
Polybutene, hydrogenated; complying with the identity prescribed under 
Sec. 178.3740(b) of this chapter.
Polyisobutylene.
cis-1,4-Polyisoprene.
Polystyrene.
Propyl gallate.
Rapeseed oil, vulcanized.
Rosins and rosin derivatives as provided in Sec. 178.3870 of this 
chapter.
Rubber hydrochloride.
Rubber (natural latex solids or crepe, smoked or unsmoked).
Terpene resins ([alpha]- and [beta]-pinene), homopolymers, copolymers, 
and condensates with phenol, formaldehyde, coumarone, and/or indene.
Tetrasodium ethylenediaminetetraacetate.
Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not more 
than 1 percent by weight of triisopropanolamine).

    (c) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 
48 FR 15617, Apr. 12, 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528, 
Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]



         Subpart C_Substances for Use as Components of Coatings



Sec. 175.210  Acrylate ester copolymer coating.

    Acrylate ester copolymer coating may safely be used as a food-
contact surface of articles intended for packaging and holding food, 
including heating of prepared food, subject to the provisions of this 
section:
    (a) The acrylate ester copolymer is a fully polymerized copolymer of 
ethyl acrylate, methyl methacrylate, and methacrylic acid applied in 
emulsion form to molded virgin fiber and heat-cured to an insoluble 
resin.
    (b) Optional substances used in the preparation of the polymer and 
in the preparation and application of the emulsion may include 
substances named in this paragraph, in an amount not to exceed that 
required to accomplish the desired technical effect and subject to any 
limitation prescribed: Provided, however, That any substance named in 
this paragraph and covered by a specific regulation in subchapter B of 
this chapter must meet any specifications in such regulation.

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Aluminum stearate.........................
Ammonium lauryl sulfate...................
Borax.....................................  Not to exceed the amount
                                             required as a preservative
                                             in emulsion defoamer.
Disodium hydrogen phosphate...............   Do.
Formaldehyde..............................
Glyceryl monostearate.....................
Methyl cellulose..........................
Mineral oil...............................
Paraffin wax..............................
Potassium hydroxide.......................
Potassium persulfate......................
Tallow....................................
Tetrasodium pyrophosphate.................
Titanium dioxide..........................
------------------------------------------------------------------------

    (c) The coating in the form in which it contacts food meets the 
following tests:
    (1) An appropriate sample when exposed to distilled water at 212 
[deg]F for 30

[[Page 166]]

minutes shall yield total chloroform-soluble extractables not to exceed 
0.5 milligram per square inch.
    (2) An appropriate sample when exposed to n-heptane at 120 [deg]F 
for 30 minutes shall yield total chloroform-soluble extractables not to 
exceed 0.5 milligram per square inch.



Sec. 175.230  Hot-melt strippable food coatings.

    Hot-melt strippable food coatings may be safely applied to food, 
subject to the provisions of this section.
    (a) The coatings are applied to and used as removable coatings for 
food.
    (b) The coatings may be prepared, as mixtures, from the following 
substances:
    (1) Substances generally recognized as safe in food.
    (2) Substances identified in this subparagraph.

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Acetylated monoglycerides.................  Complying with 172.828 of
                                             this chapter.
Cellulose acetate butyrate................
Cellulose acetate propionate..............
Mineral oil, white........................  For use only as a component
                                             of hot-melt strippable food
                                             coatings applied to frozen
                                             meats and complying with
                                             Sec.  172.878 of this
                                             chapter.
------------------------------------------------------------------------



Sec. 175.250  Paraffin (synthetic).

    Synthetic paraffin may be safely used as an impregnant in, coating 
on, or component of coatings on articles used in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food in accordance with the following 
prescribed conditions:
    (a) The additive is synthesized by the Fischer-Tropsch process from 
carbon monoxide and hydrogen, which are catalytically converted to a 
mixture of paraffin hydrocarbons. Lower molecular-weight fractions are 
removed by distillation. The residue is hydrogenated and may be further 
treated by percolation through activated charcoal. This mixture can be 
fractionated into its components by a solvent separation method, using 
synthetic isoparaffinic petroleum hydrocarbons complying with Sec. 
178.3530 of this chapter.
    (b) Synthetic paraffin shall conform to the following 
specifications:
    (1) Congealing point. There is no specification for the congealing 
point of synthetic paraffin components, except those components that 
have a congealing point below 50 [deg]C when used in contact with food 
Types III, IVA, V, VIIA, and IX identified in table 1 of Sec. 
176.170(c) of this chapter and under conditions of use E, F, and G 
described in table 2 of Sec. 176.170(c) of this chapter shall be 
limited to a concentration not exceeding 15 percent by weight of the 
finished coating. The congealing point shall be determined by ASTM 
method D938-71 (Reapproved 1981), ``Standard Test Method for Congealing 
Point of Petroleum Waxes, Including Petrolatum,'' which is incorporated 
by reference. Copies may be obtained from the American Society for 
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.
    (2) Oil content. The substance has an oil content not exceeding 2.5 
percent as determined by ASTM method D721-56T, ``Tentative Method of 
Test for Oil Content of Petroleum Waxes'' (Revised 1956), which is 
incorporated by reference. See paragraph (b)(1) of this section for 
availability of the incorporation by reference.
    (3) Absorptivity. The substance has an absorptivity at 290 
millimicrons in decahydronaphthalene at 88 [deg]C not exceeding 0.01 as 
determined by ASTM method E131-81a, ``Standard Definitions of Terms and 
Symbols Relating to Molecular-Spectroscopy,'' which is incorporated by 
reference. See paragraph (b)(1) of this section for availability of the 
incorporation by reference.
    (c) The provisions of this section are not applicable to synthetic 
paraffin used in food-packaging adhesives complying with Sec. 175.105.

[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 
49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, 
Aug. 3, 1995]

[[Page 167]]



Sec. 175.260  Partial phosphoric acid esters of polyester resins.

    Partial phosphoric acid esters of polyester resins identified in 
this section and applied on aluminum may be safely used as food-contact 
coatings, in accordance with the following prescribed conditions:
    (a) For the purpose of this section, partial phosphoric acid esters 
of polyester resins are prepared by the reaction of trimellitic 
anhydride with 2,2-dimethyl-1,3-propanediol followed by reaction of the 
resin thus produced with phosphoric acid anhydride to produce a resin 
having an acid number of 81 to 98 and a phosphorus content of 4.05 to 
4.65 percent by weight.
    (b) The coating is chemically bonded to the metal and cured at 
temperatures exceeding 450 [deg]F.
    (c) The finished food-contact coating, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of its 
intended use, as determined from tables 1 and 2 of Sec. 175.300(d), 
yields total extractives in each extracting solvent not to exceed 0.3 
milligrams per square inch of food-contact surface, as determined by the 
methods described in Sec. 175.300(e), and the coating yields 2,2-
dimethyl-1,3-propanediol in each extracting solvent not to exceed 0.3 
micrograms per square inch of food-contact surface. In testing the 
finished food-contact articles, a separate test sample is to be used for 
each required extracting solvent.



Sec. 175.270  Poly(vinyl fluoride) resins.

    Poly(vinyl fluoride) resins identified in this section may be safely 
used as components of food-contact coatings for containers having a 
capacity of not less than 5 gallons, subject to the provisions of this 
section.
    (a) For the purpose of this section, poly(vinyl fluoride) resins 
consist of basic resins produced by the polymerization of vinyl 
fluoride.
    (b) The poly(vinyl fluoride) basic resins have an intrinsic 
viscosity of not less than 0.75 deciliter per gram as determined by ASTM 
method D1243-79, ``Standard Test Method for Dilute Solution Viscosity of 
Vinyl Chloride Polymers,'' which is incorporated by reference. Copies 
may be obtained from the American Society for Testing Materials, 1916 
Race St., Philadelphia, PA 19103, or may be examined at the Office of 
the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408.
    (1) Solvent. N,N-Dimethylacetamide, technical grade.
    (2) Solution. Powdered resin and solvent are heated at 120 [deg]C 
until the resin is dissolved.
    (3) Temperature. Flow times of the solvent and solution are 
determined at 110 [deg]C.
    (4) Viscometer. Cannon-Ubbelohde size 50 semimicro dilution 
viscometer (or equivalent).
    (5) Calculation. The calculation method used is that described in 
appendix X 1.3 (ASTM method D1243-79, ``Standard Test Method for Dilute 
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated 
by reference; see paragraph (b) of this section for availability of the 
incorporation by reference) with the reduced viscosity determined for 
three concentration levels not greater than 0.5 gram per deciliter and 
extrapolated to zero concentration for intrinsic viscosity. The 
following formula is used for determining reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.387

where:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.

[42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19, 1982; 
49 FR 10107, Mar. 19, 1984]



Sec. 175.300  Resinous and polymeric coatings.

    Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The coating is applied as a continuous film or enamel over a 
metal substrate, or the coating is intended for

[[Page 168]]

repeated food-contact use and is applied to any suitable substrate as a 
continuous film or enamel that serves as a functional barrier between 
the food and the substrate. The coating is characterized by one or more 
of the following descriptions:
    (1) Coatings cured by oxidation.
    (2) Coatings cured by polymerization, condensation, and/or cross-
linking without oxidation.
    (3) Coatings prepared from pre poly merized substances.
    (b) The coatings are formulated from optional substances that may 
include:
    (1) Substances generally recognized as safe in food.
    (2) Substances the use of which is permitted by regulations in this 
part or which are permitted by prior sanction or approval and employed 
under the specific conditions, if any, of the prior sanction or 
approval.
    (3) Any substance employed in the production of resinous and 
polymeric coatings that is the subject of a regulation in subchapter B 
of this chapter and conforms with any specification in such regulation. 
Substances named in this paragraph (b)(3) and further identified as 
required:
    (i) Drying oils, including the triglycerides or fatty acids derived 
therefrom:

Beechnut.
Candlenut.
Castor (including dehydrated).
Chinawood (tung).
Coconut.
Corn.
Cottonseed.
Fish (refined).
Hempseed.
Linseed.
Oiticica.
Perilla.
Poppyseed.
Pumpkinseed.
Safflower.
Sesame.
Soybean.
Sunflower.
Tall oil.
Walnut.


The oils may be raw, heat-bodied, or blown. They may be refined by 
filtration, degumming, acid or alkali washing, bleaching, distillation, 
partial dehydration, partial polymerization, or solvent extraction, or 
modified by combination with maleic anhydride.
    (ii) Reconstituted oils from triglycerides or fatty acids derived 
from the oils listed in paragraph (b)(3)(i) of this section to form 
esters with:

Butylene glycol.
Ethylene glycol.
Pentaerythritol.
Polyethylene glycol.
Polypropylene glycol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.

    (iii) Synthetic drying oils, as the basic polymer:

Butadiene and methylstyrene copolymer.
Butadiene and styrene copolymer, blown or unblown.
Maleic anhydride adduct of butadiene styrene.
Polybutadiene.

    (iv) Natural fossil resins, as the basic resin:

Copal.
Damar.
Elemi.
Gilsonite.
Glycerol ester of damar, copal, elemi, and sandarac.
Sandarac.
Shellac.
Utah coal resin.

    (v) Rosins and rosin derivatives, with or without modification by 
polymerization, isomerization, incidental decarboxylation, and/or 
hydrogenation, as follows:
    (a) Rosins, refined to color grade of K or paler:

Gum rosin.
Tall oil rosin.
Wood rosin.

    (b) Rosin esters formed by reacting rosin (paragraph (b)(3)(v)(a) of 
this section) with:

4,4'-sec-Butylidenediphenol-epichlorohydrin (epoxy).
Diethylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epichlorohydrin (epoxy).
Methyl alcohol.
Pentaerythritol.


[[Page 169]]


    (c) Rosin esters (paragraph (b)(3) (v)(b) of this section) modified 
by reaction with:

Maleic anhydride.
o-, m-, and p-substituted phenol-form alde hydes listed in paragraph 
(b)(3)(vi) of this section.
Phenol-formaldehyde.

    (d) Rosin salts:

Calcium resinate (limed rosin).
Zinc resinate.

    (vi) Phenolic resins as the basic polymer formed by reaction of 
phenols with formaldehyde:
    (a) Phenolic resins formed by reaction of formaldehyde with:

Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols.
p-tert-Amylphenol.
4,4'-sec-Butylidenediphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Cyclohexylphenol.
4,4'-Isopropylidenediphenol.
p-Nonylphenol.
p-Octylphenol.
3-Pentadecyl phenol mixture obtained from cashew nut shell liquid.
Phenol.
Phenyl o-cresol.
p-Phenylphenol.
Xylenol.

    (b) Adjunct for phenolic resins: Aluminum butylate.
    (vii) Polyester resins (including alkyd-type), as the basic 
polymers, formed as esters of acids listed in paragraph (b)(3)(vii) (a) 
and (b) of this section by reaction with alcohols in paragraph 
(b)(3)(vii) (c) and (d) of this section.
    (a) Polybasic acids:

Adipic.
1,4-cyclohexanedicarboxylic (CAS Reg. No. 1076-97-7).
Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i) of 
this section.
Fumaric.
Isophthalic.
Maleic.
2,6-Naphthalenedicarboxylic.
2,6-Naphthalenedicarboxylic, dimethyl ester.
Orthophthalic.
Sebacic.
Terephthalic.
Terpene-maleic acid adduct.
Trimellitic.

    (b) Monobasic acids:

Benzoic acid.
4,4-Bis(4'-hydroxyphenyl)-pentanoic acid.
tert-Butyl benzoic acid.
Fatty acids derived from oils listed in paragraph (b)(3)(i) of this 
section.
Rosins listed in paragraph (b)(3)(v)(a) of this section, for use only as 
reactants in oil-based or fatty acid-based alkyd resins.

    (c) Polyhydric alcohols:

Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins 
for coatings intended for use in contact with non-alcoholic foods.
Ethylene glycol.
Glycerol.
Mannitol.
[alpha]-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Triethylene glycol, for use as a component in polyester resins for 
coatings not exceeding a coating weight of 4 milligrams per square inch 
and that are intended for contact under conditions of use D, E, F or G 
described in table 2 of paragraph (d) of this section with alcoholic 
beverages containing less than 8 percent alcohol.
Trimethylol ethane.
Trimethylol propane.

    (d) Monohydric alcohols:

Cetyl alcohol.
Decyl alcohol.
Lauryl alcohol.
Myristyl alcohol.
Octyl alcohol.
Stearyl alcohol.

    (e) Catalysts:

Dibutyltin oxide (CAS Reg. No. 818-08-6), not to exceed 0.2 percent of 
the polyester resin.
Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0), not to exceed 0.2 
percent of the polyester resin.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4), not to 
exceed 0.2 percent of the polyester resin.

    (viii) Epoxy resins, catalysts, and adjuncts:
    (a) Epoxy resins, as the basic polymer:

(Alkoxy C10-C16)-2,3-epoxypropane, in which the 
alkyl groups are even numbered and consist of a maximum of 1 percent 
C10 carbon atoms and a minimum of 48 percent C12 
carbon atoms and a minimum of 18 percent C14 carbon atoms, 
for use only in coatings that are intended for contact with dry bulk 
foods at room temperature.
4,4'-sec-Butylidenediphenol-epichlorohydrin.
4,4'-sec-Butylidenediphenol-epichlorohydrin reacted with one or more of 
the drying oils

[[Page 170]]

or fatty acids listed in paragraph (b)(3)(i) of this section.
4,4'-sec-Butylidenediphenol-epichlorohydrin chemically treated with one 
          or more of the following substances:
    Allyl ether of mono-, di-, or trimethylol phenol.
    4,4'-sec-Butylidenediphenol-formaldehyde.
    4,4'-Isopropylidenediphenol-formaldehyde.
    Melamine-formaldehyde.
    Phenol-formaldehyde.
    Urea-formaldehyde.
Epoxidized polybutadiene.
Glycidyl ethers formed by reacting phenolnovolak resins with 
epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin reacted with one or more of 
the drying oils or fatty acids listed in paragraph (b)(3)(i) of this 
section.
4,4'-Isopropylidenediphenol-epichlorohydrin chemically treated with one 
          or more of the following substances:
    Allyl ether of mono-, di-, or trimethylol phenol.
    4,4'-sec-Butylidenediphenol-formaldehyde.
    4,4'-Isopropylidenediphenol-formaldehyde.
    Melamine-formaldehyde.
    2,2'-[(1-methylethylidene)bis[4,1-phenyleneoxy[1-(butoxymethyl)-2,1-
ethanediyl]oxymethylene]]bisoxirane, CAS Reg. No. 71033-08-4, for use 
only in coatings intended for contact with bulk dry foods at 
temperatures below 100 [deg]F.
    Phenol-formaldehyde.
    Urea-formaldehyde.

    (b) Catalysts and cross-linking agents for epoxy resins:

3-(Aminomethyl)-3,5,5-trimethyl cyclo hexyl amine reacted with phenol 
and formaldehyde in a ratio of 2.6:1.0:2.0, for use only in coatings 
intended for repeated use in contact with foods only of the types 
identified in paragraph (d) of this section, table 1, under Category I 
and Category VIII, at temperatures not exceeding 88 [deg]C (190 [deg]F).
N-Beta-(aminoethyl)-gamma-amino propyl tri meth oxysilane (CAS Reg. No. 
1760-24-3), for use only in coatings at a level not to exceed 1.3 
percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of this section, table 1, under Types I, II, and III, 
under conditions of use C, D, E, or F as described in table 2 of 
paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons.
Benzyl alcohol (CAS Reg. No. 100-51-6), for use only in coatings at a 
level not to exceed 4 percent by weight of the resin when such coatings 
are intended for repeated use in contact with foods only of the types 
identified in paragraph (d) of this section, table 1, under Types I, II, 
and III, under conditions of use C, D, E, or F as described in table 2 
of paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons.
Catalysts and cross-linking agents for epoxy resins:
    3-Aminomethyl-3,5,5-trimethylcyclohexylamine (CAS Reg. No. 2855-
0913-092).
Cyanoguanidine.
Dibutyl phthalate, for use only in coatings for containers having a 
capacity of 1,000 gallons or more when such containers are intended for 
repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
3-Diethylaminopropylamine (CAS Reg. No. 104-78-9), for use in coatings 
at a level not to exceed 6 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, table 1, under Types 
I, II, and III, under conditions of use C, D, E, or F as described in 
table 2 of paragraph (d) of this section; or when such coatings are 
intended for repeated use in contact with foods of the types identified 
in paragraph (d) of this section, table 1, under Types V, VI, VII, and 
VIII, under conditions of use E or F as described in table 2 of 
paragraph (d) of this section. Use shall be limited to coatings for 
tanks of capacity greater than 530,000 gallons.
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Isophthalyl dihydrazide for use only in coatings subject to the 
provisions of paragraph (c) (3) or (4) of this section.
4,4'-Methylenedianiline, for use only in coatings for containers having 
a capacity of 1,000 gallons or more when such containers are intended 
for repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
N-Oleyl-1,3-propanediamine with not more than 10 percent by weight of 
diethylaminoethanol.
3-Pentadecenyl phenol mixture (obtained from cashew nutshell liquid) 
reacted with formaldehyde and ethylenediamine in a ratio of 1:2:2 (CAS 
Reg. No. 68413-28-5).

[[Page 171]]

Polyamine produced when 1 mole of the chlorohydrin diether of 
polyethylene glycol 400 is made to react under dehydrohalogenating 
conditions with 2 moles of N-octadecyltrimethylenediamine for use only 
in coatings that are subject to the provisions of paragraph (c) (3) or 
(4) of this section and that contact food at temperatures not to exceed 
room temperature.
Polyethylenepolyamine (CAS Reg. No. 68131-73-7), for use only in 
coatings intended for repeated use in contact with food, at temperatures 
not to exceed 180 [deg]F (82 [deg]C).
Salicylic acid, for use only in coatings for containers having a 
capacity of 1,000 gallons or more when such containers are intended for 
repeated use in contact with alcoholic beverages containing up to 8 
percent of alcohol by volume.
Salicylic acid (CAS Reg. No. 69-72-7), for use only in coatings at a 
level not to exceed 0.35 percent by weight of the resin when such 
coatings are intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, table 1, under Types 
I, II, and III, under conditions of use C, D, E, or F as described in 
table 2 of paragraph (d) of this section; or when such coatings are 
intended for repeated use in contact with foods of the types identified 
in paragraph (d) of this section, table 1, under Types V, VI, VII, and 
VIII, under conditions of use E or F as described in table 2 of 
paragraph (d) of this section. Use shall be limited to coatings for 
tanks of capacity greater than 530,000 gallons.
Stannous 2-ethylhexanoate for use only as a catalyst at a level not to 
exceed 1 percent by weight of the resin used in coatings that are 
intended for contact with food under conditions of use D, E, F, and G 
described in table 2 of paragraph (d) of this section.
Styrene oxide, for use only in coatings for containers having a capacity 
of 1,000 gallons or more when such containers are intended for repeated 
use in contact with alcoholic beverages containing up to 8 percent of 
alcohol by volume.
Tetraethylenepentamine.
Tetraethylenepentamine reacted with equimolar quantities of fatty acids.
Tri(dimethylaminomethyl) phenol and its salts prepared from the fatty 
acid moieties of the salts listed in paragraph (b)(3)(xxii)(b) of this 
section, for use only in coatings subject to the provisions of paragraph 
(c) (3) or (4) of this section.
Triethylenetetramine.
Trimellitic anhydride (CAS Reg. No. 552-30-7) for use only as a cross-
linking agent at a level not to exceed 15 percent by weight of the resin 
in contact with food under all conditions of use, except that resins 
intended for use with foods containing more than 8 percent alcohol must 
contact such food only under conditions of use D, E, F, and G described 
in table 2 of paragraph (d) of this section.
Trimellitic anhydride adducts of ethylene glycol and glycerol, prepared 
by the reaction of 1 mole of trimellitic anhydride with 0.4-0.6 mole of 
ethylene glycol and 0.04-0.12 mole of glycerol, for use only as a cross-
linking agent at a level not to exceed 10 percent by weight of the cured 
coating, provided that the cured coating only contacts food containing 
not more than 8 percent alcohol.
Meta-Xylylenediamine (1,3-benzene di methan amine, CAS Reg. No. 1477-55-
0), for use only in coatings at a level not to exceed 3 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of this 
section, table 1, under Types I, II, and III, under conditions of use C, 
D, E or F as described in table 2 of paragraph (d) of this section; or 
when such coatings are intended for repeated use in contact with foods 
of the types identified in paragraph (d) of this section, table 1, under 
Types V, VI, VII, and VIII, under conditions of use E or F as described 
in table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.
Para-Xylylenediamine (1,4 benzene di methan amine, CAS Reg. No. 539-48-
0), for use only in coatings at a level not to exceed 0.6 percent by 
weight of the resin when such coatings are intended for repeated use in 
contact with foods only of the types identified in paragraph (d) of this 
section, table 1, under Types I, II, III, under conditions of use C, D, 
E, or F as described in table 2 of paragraph (d) of this section; or 
when such coatings are intended for repeated use in contact with foods 
of the types identified in paragraph (d) of this section, table 1, under 
Types V, VI, VII, and VIII, under conditions of use E and F as described 
in table 2 of paragraph (d) of this section. Use shall be limited to 
coatings for tanks of capacity greater than 530,000 gallons.

    (c) Adjuncts for epoxy resins:

Aluminum butylate.
Benzoic acid, for use as a component in epoxy resins for coatings not 
exceeding a coating weight of 4 milligrams per square inch and that are 
intended for contact under conditions of use D, E, F or G described in 
table 2 of paragraph (d) of this section with alcoholic beverages 
containing less than 8 percent alcohol.
Polyamides from dimerized vegetable oils and the amine catalysts listed 
in paragraph (b)(3)(viii)(b) of this section, as the basic polymer.
Silane coupled silica, prepared from the reaction of microcrystalline 
quartz with N-beta-(N-vinylbenzylamino) ethyl-gamma-

[[Page 172]]

aminopropyltrimethoxy silane, mono hydro gen chloride, for use only in 
coatings intended for repeated use in contact with foods only of the 
types identified in paragraph (d) of this section, table 1, under 
Category I and Category VIII, at temperatures not exceeding 88 [deg]C 
(190 [deg]F).
Succinic anhydride, for use as a component in epoxy resins for coatings 
not exceeding a coating weight of 4 milligrams per square inch, and that 
are intended for contact under conditions of use D, E, F or G described 
in table 2 of paragraph (d) of this section with alcoholic beverages 
containing less than 8 percent alcohol.

    (ix) Coumarone-indene resin, as the basic polymer.
    (x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic 
polymer.
    (xi) Terpene resins, as the basic polymer, from one or more of the 
following:

Dipentene.
Hydrogenated dipentene resin (CAS Reg. No. 106168-39-2). For use only 
with coatings in contact with acidic and aqueous foods.
Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin (CAS 
Reg. No. 106168-37-0). For use only with coatings in contact with acidic 
and aqueous foods.
[alpha]-Pinene.
[beta]-Pinene.

    (xii) Urea-formaldehyde, resins and their curing catalyst:
    (a) Urea-formaldehyde resins, as the basic polymer:

Urea-formaldehyde.
Urea-formaldehyde chemically modified with methyl, ethyl, propyl, 
isopropyl, butyl, or isobutyl alcohol.
Urea-formaldehyde chemically modified with one or more of the amine 
catalysts listed in paragraph (b)(3)(viii)(b) of this section.

    (b) Curing (cross-linking) catalyst for urea-formaldehyde resins:

Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).

    (xiii) Triazine-formaldehyde resins and their curing catalyst:
    (a) Triazine-formaldehyde resins, as the basic polymer:

Benzoguanamine-formaldehyde.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the 
following amine catalysts:
    Amine catalysts listed in paragraph (b)(3)(viii)(b) of this section.
    Dimethylamine-2-methyl-1-propanol.
    Methylpropanolamine.
    Triethanolamine.
Melamine-formaldehyde chemically modified with methyl, ethyl, propyl, 
isopropyl, butyl, or isobutyl alcohol.

    (b) Curing (cross-linking) catalyst for triazine-formaldehyde 
resins:

Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).

    (xiv) Modifiers (for oils and alkyds, including polyesters), as the 
basic polymer:

Butyl methacrylate.
Cyclopentadiene.
Methyl, ethyl, butyl, or octyl esters of acrylic acid.
Methyl methacrylate.
Styrene.
Vinyl toluene.

    (xv) Vinyl resinous substance, as the basic polymers:

Polyvinyl acetate.
Polyvinyl alcohol.
Polyvinyl butyral.
Polyvinyl chloride.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Vinyl chloride-acetate-2,3-epoxypropyl methacrylate copolymers 
containing not more than 10 weight percent of total polymer units 
derived from 2,3-epoxypropyl methacrylate and not more than 0.1 weight 
percent of unreacted 2,3-epoxypropyl methacrylate monomer for use in 
coatings for containers.
Vinyl chloride-acetate, hydroxyl-modified copolymer.
Vinyl chloride-acetate, hydroxyl-modified copolymer, reacted with 
trimellitic anhydride.
Vinyl chloride copolymerized with acrylamide and ethylene in such a 
manner that the finished copolymers have a minimum weight average 
molecular weight of 30,000 and contain not more than 3.5 weight percent 
of total polymer units derived from acrylamide; the acrylamide portion 
may or may not be subsequently partially hydrolyzed.
Vinyl chloride copolymerized with one or more of the following 
substances:
Acrylonitrile.
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, 
heptyl, or octyl esters.
Maleic acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl, 
heptyl, or octyl esters.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester; for use such 
that the finished vinyl chloride copolymers contain not more than 4 
weight percent of total polymer units derived from this comonomer.

[[Page 173]]

Vinyl acetate.
Vinylidene chloride.
Vinyl chloride-vinylidene chloride-2,3-epoxypropyl methacrylate 
copolymers containing not more than 10 weight percent of total polymer 
units derived from 2,3-epoxypropyl methacrylate and not more than 0.05 
weight percent of unreacted 2,3-epoxypropyl methacrylate monomer based 
on polymer solids for use only in coatings for containers intended for 
contact with foods under conditions B, C, D, E, F, G, or H described in 
table 2 of paragraph (d) of this section.

    (xvi) Cellulosics, as the basic polymer:

Carboxymethylcellulose.
Cellulose acetate.
Cellulose acetate-butyrate.
Cellulose acetate-propionate.
Ethylcellulose.
Ethyl hydroxyethylcellulose.
Hydroxyethylcellulose.
Hydroxypropyl methylcellulose.
Methylcellulose.
Nitrocellulose.

    (xvii) Styrene polymers, as the basic polymer:

Polystyrene.
[alpha]-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
    Acrylonitrile.
    [alpha]-Methylstyrene.

    (xviii) Polyethylene and its copolymers as the basic polymer:

Ethylene-ethyl acrylate copolymer.
Ethylene-isobutyl acrylate copolymers containing no more than 35 weight 
percent of total polymer units derived from isobutyl acrylate.
Ethylene-vinyl acetate copolymer.
Polyethylene.

    (xix) Polypropylene as the basic polymer:

Polypropylene.
Maleic anhydride adduct of polypropylene The polypropylene used in the 
manufacture of the adduct complies with Sec. 177.1520(c), item 1.1; and 
the adduct has a maximum combined maleic anhydride content of 0.8 
percent and a minimum intrinsic viscosity of 0.9, determined at 135 
[deg]C on a 0.1 percent solution of the modified polypropylene in 
decahydronaphthalene as determined by a method titled ``Method for 
Determination of Intrinsic Viscosity of Maleic Anhydride Adduct of 
Polypropylene,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408.

    (xx) Acrylics and their copolymers, as the basic polymer:

Acrylamide with ethylacrylate and/or styrene and/or methacrylic acid, 
subsequently reacted with formaldehyde and butanol.
Acrylic acid and the following esters thereof:
 Ethyl.
 Methyl.
Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate 
copolymers containing no more than 20 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 7 weight 
percent of total polymer units derived from hydroxyethyl methacrylate; 
for use only in coatings that are applied by electrodeposition to metal 
substrates.
Butyl acrylate-styrene-methacrylic acid-hydroxypropyl methacrylate 
copolymers containing no more than 20 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 7 weight 
percent of total polymer units derived from hydroxypropyl methacrylate; 
for use only in coatings that are applied by electrodeposition to metal 
substrates and that are intended for contact, under condition of use D, 
E, F, or G described in table 2 of paragraph (d) of this section, with 
food containing no more than 8 percent of alcohol.
Ethyl acrylate-styrene-methacrylic acid copolymers for use only as 
modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this 
section.
Ethyl acrylate-methyl methacrylate-styrene-methacrylic acid copolymers 
for use only as modifiers for epoxy resins listed in paragraph 
(b)(3)(viii)(a) of this section.
2-Ethylhexyl acrylate-ethyl acrylate copolymers prepared by 
copolymerization of 2-ethylhexyl acrylate and ethyl acrylate in a 7/3 
weight ratio and having a number average molecular weight range of 5,800 
to 6,500 and a refractive index, nD25[deg] (40 percent in 2,2,4-
trimethyl pentane) of 1.4130-1.4190; for use as a modifier for nylon 
resins complying with Sec. 177.1500 of this chapter and for phenolic 
and epoxy resins listed in paragraph (b)(3) (vi) and (viii) of this 
section, respectively, at a level not to exceed 1.5 percent of the 
coating.
2-Ethylhexyl acrylate-methyl methacrylate-acrylic acid copolymers for 
use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii) 
of this section.
Methacrylic acid and the following esters thereof:
    Butyl.

[[Page 174]]

    Ethyl.
    Methyl.
Methacrylic acid or its ethyl and methyl esters copolymerized with one 
          or more of the following:
    Acrylic acid.
    Ethyl acrylate.
    Methyl acrylate.
n-Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate 
copolymers containing no more than 2 weight percent of total polymer 
units derived from methacrylic acid and containing no more than 9.5 
weight percent of total polymer units derived from hydroxyethyl 
methacrylate; for use only in coatings in contact with dry food (food 
type VIII in table 1 of paragraph (d) of this section). 2-
(Dimethylamino) ethanol (C.A.S. Registry No. 108-01-0) may be employed 
as an optional adjuvant substance limited to no more than 2 weight 
percent based on polymer solids in the coating emulsion.
Styrene polymers made by the polymerization of any combination of 
styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-
ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The 
styrene and alpha methyl styrene, individually, may constitute from 0 to 
80 weight percent of the polymer. The other monomers, individually, may 
be from 0 to 40 weight percent of the polymer. The polymer number 
average molecular weight (Mn) shall be at least 2,000 (as 
determined by gel permeation chromatography). The acid number of the 
polymer shall be less than 250. The monomer content shall be less than 
0.5 percent. The polymers are for use only in contact with food of Types 
IV-A, V, VII in table 1 of paragraph (d) of this section, under use 
conditions E through G in table 2 of paragraph (d), and with food of 
Type VIII without use temperature restriction.

    (xxi) Elastomers, as the basic polymer:

Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated rubber.
2-Chloro-1,3-butadiene (neoprene).
Natural rubber (natural latex or natural latex solids, smoked or 
unsmoked).
Polyisobutylene.
Rubber hydrochloride.
Styrene-isobutylene copolymer.

    (xxii) Driers made by reaction of a metal from paragraph 
(b)(3)(xxii)(a) of this section with acid, to form the salt listed in 
paragraph (b)(3)(xxii)(b) of this section:
    (a) Metals:

Aluminum.
Calcium.
Cerium.
Cobalt.
Iron.
Lithium.
Magnesium.
Manganese.
Zinc.
Zirconium.

    (b) Salts:

Caprate.
Caprylate.
Isodecanoate.
Linoleate.
Naphthenate.
Neodecanoate.
Octoate (2-ethylhexoate).
Oleate.
Palmitate.
Resinate.
Ricinoleate.
Soyate.
Stearate.
Tallate.

    (xxiii) Waxes:

Paraffin, Type I.
Paraffin, Type II.
Polyethylene.
Sperm oil.
Spermaceti.

    (xxiv) Plasticizers:

Acetyl tributyl citrate.
Acetyl triethyl citrate.
Butyl phthalyl butyl glycolate.
Butyl stearate.
p-tert-Butyl phenyl salicylate.
Dibutyl sebacate.
Diethyl phthalate.
Diisobutyl adipate.
Diisooctyl phthalate.
Epoxidized soybean oil (iodine number maximum 14; oxirane oxygen content 
6% minimum), as the basic polymer.
Ethyl phthalyl ethyl glycolate.
2-Ethylhexyl diphenyl phosphate.
di-2-Ethylhexyl phthalate.
Glycerol.
Glyceryl monooleate.
Glyceryl triacetate.
Monoisopropyl citrate.
Propylene glycol.
Sorbitol.
Mono-, di-, and tristearyl citrate.
Triethyl citrate.
Triethylene glycol.
3-(2-Xenolyl)-1,2-epoxypropane.

    (xxv) Release agents, as the basic polymer, when applicable:

N,N'-Dioleoylethylenediamine (CAS Reg. No. 110-31-6) for use only in 
ionomeric resins complying with Sec. 177.1330 of this chapter

[[Page 175]]

and in ethylene vinyl acetate copolymers complying with Sec. 177.1350 
of this chapter at a level not to exceed 0.0085 milligram per square 
centimeter (0.055 milligram per square inch) in the finished food-
contact article.
N,N'-Distearoyl ethylenediamine.
Linoleic acid amide.
Oleic acid amide.
Palmitic acid amide.
Petrolatum.
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene 
glycol moiety greater than 300).
Polytetrafluoroethylene.
Silicones (not less than 300 centistokes viscosity): 
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The methyl-
phenylpolysiloxanes contain not more than 2.0 percent by weight of 
cyclosiloxanes having up to and including 4 siloxy units.
Silicones (not less than 100 centistokes viscosity): 
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use 
only on metal substrates. The methylphenylpolysiloxanes contain not more 
than 2.0 percent by weight of cyclosiloxanes having up to and including 
4 siloxy units.

    (xxvi) Colorants used in accordance with Sec. 178.3297 of this 
chapter.
    (xxvii) Surface lubricants:

Cottonseed oil and other edible oils.
Dibutyl sebacate.
Dioctyl sebacate.
Glyceryl monostearate.
Lanolin.
Mineral oil, white.
Palm oil.
Paraffin, Type I.
Paraffin, Type II.
Petrolatum.
Stearic acid.

    (xxviii) Silicones and their curing catalysts:
    (a) Silicones as the basic polymer:

Siloxane resins originating from methyl hydrogen polysiloxane, dimethyl 
polysiloxane, and methylphenyl polysiloxane.
Siloxane resins originating from the platinum-catalyzed reaction product 
of vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083-18-1 and 
CAS Reg. No. 68083-19-2) with methylhydrogen polysiloxane (CAS Reg. No. 
63148-57-2) and dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037-
59-2), where the platinum content does not exceed 150 parts per million. 
The following substances may be used as optional polymerization 
inhibitors:
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107-54-0), at a level not to 
exceed 0.53 weight-percent;
1-Ethynylcyclohexene (CAS Reg. No. 931-49-7), at a level not to exceed 
0.64 weight-percent;
Bis(methoxymethyl)ethyl maleate (CAS Reg. No. 102054-10-4), at a level 
not to exceed 1.0 weight-percent;
Methylvinyl cyclosiloxane (CAS Reg. No. 68082-23-5); and
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554-06-5).

    (b) Curing (cross-linking) catalysts for silicones (the maximum 
amount of tin catalyst used shall be that required to effect optimum 
cure but shall not exceed 1 part of tin per 100 parts of siloxane resins 
solids):

Dibutyltin dilaurate.
Stannous oleate.
Tetrabutyl titanate.

    (xxix) Surface active agents:

Ethylene oxide adduct of 2,4,7,9-tetramethyl-5-decyn-4,7-diol (CAS Reg. 
No. 9014-85-1).
Poly[2-(diethylamino) ethyl methacrylate] phosphate (minimum intrinsic 
viscosity in water at 25 [deg]C is not less than 9.0 deciliters per gram 
as determined by ASTM method D1243-79, ``Standard Test Method for Dilute 
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated 
by reference (copies may be obtained from the American Society for 
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408), for use only as a 
suspending agent in the manufacture of vinyl chloride copolymers and 
limited to use at levels not to exceed 0.1 percent by weight of the 
copolymers.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. Reg. No. 126-86-3), for use 
only in can coatings which are subsequently dried and cured at 
temperatures of at least 193 [deg]C (380 [deg]F) for 4 minutes.

    (xxx) Antioxidants:

Butylated hydroxyanisole.
Butylated hydroxytoluene.
Gum guaiac.
Dilauryl thiodipropionate.
Nordihydroguaiaretic acid.
Propyl gallate.
Distearyl thiodipropionate.
Thiodipropionic acid.
2,4,5-Trihydroxybutyrophenone.

    (xxxi) Can end cements (sealing compounds used for sealing can ends 
only):

[[Page 176]]

In addition to the substances listed in paragraph (b) of this section 
and those listed in Sec. 177.1210(b)(5) of this chapter, the following 
may be used:

Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 26471-45-4) for 
use only at levels not to exceed 23.8 percent by weight of the cement 
solids in can end cements.
Butadiene-styrene-fumaric acid copolymer.
4,4'-Butylidenebis (6-tert-butyl-m-cresol).
Dibenzamido phenyl disulfide.
Di-[beta]-naphthyl phenylenediamine.
Dipentamethylene thiuram tetrasulfide.
Isobutylene-isoprene-divinylbenzene copolymers for use only at levels 
not to exceed 15 percent by weight of the dry cement composition.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt, for use 
only at levels not to exceed 0.6 percent by weight of the cement solids 
in can end cements for containers having a capacity of not less than 5 
gallons.
Sodium decylbenzene sulfonate.
Sodium nitrite for use only at levels not to exceed 0.3 percent by 
weight of the cement solids in can end cements for containers having a 
capacity of not less than 5 gallons.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by 
weight in can-sealing compounds on containers having a capacity of 5 
gallons or more.
Sodium phenylphenate.
Styrene-maleic anhydride resin, partial methyl and butyl (sec- or iso-) 
esters, for use only at levels not in excess of 3 percent of the cement 
solids in can end cement formulations.
Tetrasodium EDTA (tetrasodium ethylene-diaminetetraacetate).
Tri (mixed mono- and dinonylphenyl) phosphite.
Zinc dibutyldithiocarbamate.

    (xxxii) Side seam cements: In addition to the substances listed in 
paragraph (b)(3) (i) to (xxx), inclusive, of this section, the following 
may be used.

p-tert-Butyl perbenzoate as a catalyst for epoxy resin.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Dicumyl peroxide for use only as polymerization catalyst.
4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018-09-1) for use as a 
preservative at a level not to exceed 0.3 percent by weight in can-
sealing cements.
Diisodecyl phthalate for use only as plasticizer in side seam cements 
for containers intended for use in contact with food only of the types 
identified in paragraph (d) of this section, table 1, under Categories 
I, II, and VI.
4,4'-Bis(alpha,alpha-dimethylbenzyl)diphenylamine, CAS Reg. No. 10081-
67-1.
Ethyl toluene sulfonamide.
N,N'-Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamide), CAS 
Reg. No. 23128-74-7.
Polyamides consisting of the following:
    Copolymer of omega-laurolactam and espilon-caprolactam, CAS Reg. No. 
25191-04-2 (Nylon 12/6).
    Homopolymer of omega-aminododecanoic acid, CAS Reg. No. 24937-16-4.
    Homopolymer of omega-laurolactam, CAS Reg. No. 25038-74-8 (Nylon 
12).
Polyamides derived from the following acids and amines:
    Acids:
Adipic.
Azelaic.
Sebacic.
Vegetable oil acids (with or without dimerization).
    Amines:
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Tetraethylenepentamine.
Triethylenetetramine.
Polypropylene glycol CAS Reg. No. 25322-69-4.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by 
weight in can-sealing compounds on containers having a capacity of 5 
gallons or more.
Tetrakis [methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]methane, 
CAS Reg. No. 6683-19-8.
Toluene sulfonamide formaldehyde resin (basic polymer).
Triethylene glycol methacrylate for use only as polymerization cross-
linking agent in side seam cements for containers intended for use in 
contact with food only of the types identified in paragraph (d) of this 
section, table 1, under Categories I, II, and VI.
Urea.

    (xxxiii) Miscellaneous materials:

Ammonium citrate.
Ammonium potassium phosphate.
Bentonite, modified by reaction with benzyl dimethyl alkyl ammonium 
chloride, where the alkyl groups are derived from hydrogenated tallow 
(CAS Reg. No. 71011-24-0). For use only as a rheological agent in 
coatings intended to contact food under repeated use conditions.
Bentonite, modified by reaction with sodium stearate and benzyl dimethyl 
alkyl ammonium chloride, where the alkyl groups are derived from 
hydrogenated tallow (CAS Reg. No. 121888-68-4). For use as a

[[Page 177]]

rheological agent only in coatings intended to contact dry food under 
repeated-use conditions.
Calcium acetate.
Calcium ethyl acetoacetate.
Calcium glycerophosphate.
Calcium, sodium, and potassium oleates.
Calcium, sodium, and potassium ricinoleates.
Calcium, sodium, and potassium stearates.
Castor oil, hydrogenated.
Castor oil, hydrogenated polymer with ethylenediamine, 12-
hydroxyoctadecanoic acid and sebacic acid (CAS Reg. No. 68604-06-8). The 
condensation product formed by the reaction of hydrogenated castor oil 
with polyamide derived from ethylenediamine, sebacic acid and 12-
hydroxystearic acid, for use only in coatings at a level not to exceed 
3.2 percent by weight of the resin when such coatings are intended for 
repeated use in contact with foods only of the types identified in 
paragraph (d) of this section, table 1, under Types I, II, and III, 
under conditions of use C, D, E, or F as described in table 2 of 
paragraph (d) of this section; or when such coatings are intended for 
repeated use in contact with foods of the types identified in paragraph 
(d) of this section, table 1, under Types V, VI, VII, and VIII, under 
conditions of use E or F as described in table 2 of paragraph (d) of 
this section. Use shall be limited to coatings for tanks of capacity 
greater than 530,000 gallons.
Castor oil, sulfated, sodium salt (CAS Reg. No. 68187-76-8), for use 
only in coatings for containers intended for repeated use.
Cetyl alcohol.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-
methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) mixture, at a ratio 
of 3 parts to 1 part, respectively, manufactured from methyl-3-
mercaptopropionate (CAS Reg. No. 2935-90-2) and optionally containing 
magnesium nitrate (CAS Reg. No. 10377-60-3) at a concentration 
equivalent to the isothiazolone active ingredients (weight/weight). For 
use only as an antimicrobial agent in emulsion-based silicone coatings 
at a level not to exceed 50 milligrams per kilogram (based on 
isothiazolone active ingredient) in the coating formulations.
Cyclohexanone-formaldehyde resin produced when 1 mole of cyclohexanone 
is made to react with 1.65 moles of formaldehyde such that the finished 
resin has an average molecular weight of 600-610 as determined by ASTM 
method D2503-82, ``Standard Test Method for Molecular Weight (Relative 
Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor 
Pressure,'' which is incorporated by reference. Copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408. For use only in contact with nonalcoholic and nonfatty foods 
under conditions of use E, F, and G, described in table 2 of paragraph 
(d) this section.
Decyl alcohol.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg No. 35691-65-7). For use as an 
antimicrobial agent at levels not to exceed 500 milligrams per kilogram 
in emulsion-based silicone coatings.
Disodium hydrogen phosphate.
Ethyl acetoacetate.
Hectorite, modified by reaction with a mixture of benzyl methyl dialkyl 
ammonium chloride and dimethyl dialkyl ammonium chloride, where the 
alkyl groups are derived from hydrogenated tallow (CAS Reg. No. 121888-
67-3). For use as a rheological agent only in coatings intended to 
contact dry food under repeated-use conditions.
Lauryl alcohol.
Lecithin.
Magnesium, sodium, and potassium citrate.
Magnesium glycerophosphate.
Magnesium stearate.
Mono-, di-, and tricalcium phosphate.
Monodibutylamine pyrophosphate as sequestrant for iron.
Mono-, di-, and trimagnesium phosphate.
Myristyl alcohol.
Octyl alcohol.
Phosphoric acid.
Polybutene, hydrogenated; complying with the identity and limitations 
prescribed by Sec. 178.3740 of this chapter.
Poly(ethylene oxide).
Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated, 
diesters with poly(2-oxepanone), diacetates (CAS Reg. No. 116810-47-0) 
at a level not to exceed 0.025 weight percent of the finished coating 
having no greater than a 0.5 mil thickness for use as a component of 
polyester, epoxy, and acrylic coatings complying with paragraphs 
(b)(3)(vii), (viii), and (xx) of this section, respectively.
Silver chloride-coated titanium dioxide for use only as a preservative 
in latex emulsions at a level not to exceed 2.2 parts per million (based 
on silver ion concentration) in the dry coating.
Sodium pyrophosphate.
Stannous chloride.
Stannous stearate.
Stannous sulfate.
Stearyl alcohol.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For use 
only in copolymer coatings on metal under conditions of use E, F, and G 
described in table 2 of paragraph (d) of this section, and limited to 
use at a level not to exceed 2.0 percent by weight of the dry copolymer 
coating.
Tetrasodium pyrophosphate.

[[Page 178]]

Tridecyl alcohol produced from tetrapropylene by the oxo process, for 
use only as a processing aid in polyvinyl chloride resins.
Trimethylolpropane (CAS Reg. No. 77-99-6). For use as a pigment 
dispersant at levels not to exceed 0.45 percent by weight of the 
pigment.
Vinyl acetate-dibutyl maleate copolymers produced when vinyl acetate and 
dibutyl maleate are copolymerized with or without one of the monomers: 
Acrylic acid or glycidyl methacrylate. For use only in coatings for 
metal foil used in contact with foods that are dry solids with the 
surface containing no free fat or oil. The finished copolymers shall 
contain at least 50 weight-percent of polymer units derived from vinyl 
acetate and shall contain no more than 5 weight-percent of total polymer 
units derived from acrylic acid or glycidyl methacrylate.

    (xxxiv) Polyamide resins derived from dimerized vegetable oil acids 
(containing not more than 20 percent of monomer acids) and 
ethylenediamine, as the basic resin, for use only in coatings that 
contact food at temperatures not to exceed room temperature.
    (xxxv) Polyamide resins having a maximum acid value of 5 and a 
maximum amine value of 8.5 derived from dimerized vegetable oil acids 
(containing not more than 10 percent of monomer acids), ethylenediamine, 
and 4,4-bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed 
10 percent by weight of said polyamide resins); as the basic resin, for 
use only in coatings that contact food at temperatures not to exceed 
room temperature provided that the concentration of the polyamide resins 
in the finished food-contact coating does not exceed 5 milligrams per 
square inch of food-contact surface.
    (xxxvi) Methacrylonitrile grafted polybutadiene copolymers 
containing no more than 41 weight percent of total polymer units derived 
from methacrylonitrile; for use only in coatings that are intended for 
contact, under conditions of use D, E, F, or G described in table 2 of 
paragraph (d) of this section, with food containing no more than 8 
percent of alcohol.
    (xxxvii) Polymeric resin as a coating component prepared from 
terephthalic acid, isophthalic acid, succinic anhydride, ethylene 
glycol, diethylene glycol, and 2,2-dimethyl-1,3-propanediol for use in 
contact with aqueous foods and alcoholic foods containing not more than 
20 percent (by volume) of alcohol under conditions of use D, E, F, and G 
described in table 2 of Sec. 176.170 of this chapter. The resin shall 
contain no more than 30 weight percent of 2,2-dimethyl-1,3-propanediol.
    (c) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from tables 1 and 2 of 
paragraph (d) of this section, shall yield chloroform-soluble 
extractives, corrected for zinc extractives as zinc oleate, not to 
exceed the following:
    (1) From a coating intended for or employed as a component of a 
container not to exceed 1 gallon and intended for one-time use, not to 
exceed 0.5 milligram per square inch nor to exceed that amount as 
milligrams per square inch that would equal 0.005 percent of the water 
capacity of the container, in milligrams, divided by the area of the 
food-contact surface of the container in square inches. From a 
fabricated container conforming with the description in this paragraph 
(c)(1), the extractives shall not exceed 0.5 milligram per square inch 
of food-contact surface nor exceed 50 parts per million of the water 
capacity of the container as determined by the methods provided in 
paragraph (e) of this section.
    (2) From a coating intended for or employed as a component of a 
container having a capacity in excess of 1 gallon and intended for one-
time use, not to exceed 1.8 milligrams per square inch nor to exceed 
that amount as milligrams per square inch that would equal 0.005 percent 
of the water capacity of the container in milligrams, divided by the 
area of the food-contact surface of the container in square inches.
    (3) From a coating intended for or employed as a component of a 
container for repeated use, not to exceed 18 milligrams per square inch 
nor to exceed that amount as milligrams per square inch that would equal 
0.005 percent of the water capacity of the container in milligrams, 
divided by the

[[Page 179]]

area of the food-contact surface of the container in square inches.
    (4) From coating intended for repeated use, and employed other than 
as a component of a container, not to exceed 18 milligrams per square 
inch of coated surface.
    (d) Tables:

                         Table 1--Types of Food
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar
 or both, and including oil-in-water emulsions of low- or high-fat
 content.
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or
 sugar or both, and including oil-in-water emulsions of low- or high-fat
 content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
 contain salt, and including water-in-oil emulsions of low- or high-fat
 content.
IV. Dairy products and modifications:
  A. Water-in-oil emulsion, high- or low-fat.
  B. Oil-in-water emulsion, high- or low-fat.
V. Low moisture fats and oils.
VI. Beverages:
  A. Containing alcohol.
  B. Nonalcoholic.
VII. Bakery products.
VIII. Dry solids (no end test required).
 


  Table 2--Test Procedures for Determining the Amount of Extractives From Resinous or Polymeric Coatings, Using
                                Solvents Simulating Types of Foods and Beverages
----------------------------------------------------------------------------------------------------------------
                                                                              Extractant
                                                     -----------------------------------------------------------
        Condition of use          Types of food (see                        Heptane \1\ \2\    8 percent alcohol
                                       table 1)         Water (time and        (time and           (time and
                                                         temperature)        temperature)        temperature)
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-         I, IV-B...........  250 [deg]F, 2 hr..  ..................
 sterilized (e.g., over 212       III, IV-A, VII....  ......do..........  150 [deg]F, 2 hr..
 [deg]F).
B. Boiling water sterilized.....  II................  212 [deg]F, 30 min  ..................
                                  III, VII..........  ......do..........  120 [deg]F, 30 min
C. Hot filled or pasteurized      II, IV-B..........  Fill boiling, cool  ..................
 above 150 [deg]F.                                     to 100 [deg]F.
                                  III, IV-A.........  ......do..........  ..................
                                  V.................                      120 [deg]F, 15 min
                                                                          ......do..........
D. Hot filled or pasteurized      II, IV-B, VI-B....  150 [deg]F, 2 hr..  ..................  ..................
 below 150 [deg]F.                III, IV-A.........  ......do..........  100 [deg]F, 30 min  150 [deg]F, 2 hr
                                  V.................                      ......do..........
                                  VI-A..............
E. Room temperature filled and    I, II, IV-B, VI-B.  120 [deg]F, 24 hr.  ..................  ..................
 stored (no thermal treatment in  III, IV-A.........  ......do..........  70 [deg]F, 30 min.  120 [deg]F, 24 hr
 the container).                  V, VII............                      ......do..........
                                  VI-A..............
F. Refrigerated storage, no       I, II, III, IV-A,   70 [deg]F, 48 hr..  ..................  ..................
 thermal treatment in the          IV-B, VI-B, VII.                                           70 [deg]F, 48 hr
 container).                      VI-A..............
G. Frozen storage (no thermal     I, II, III, IV-B,   70 [deg]F, 24 hr..  ..................
 treatment in the container).      VII.
H. Frozen storage: Ready-
 prepared foods intended to be
 reheated in container at time
 of use:.
  1. Aqueous or oil in water      I, II, IV-B.......  212 [deg]F, 30 min
   emulsion of high or low fat.
  2. Aqueous, high or low free    III, IV-A, VII....  ......do..........  120 [deg]F, 30 min
   oil or fat.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractant not to be used on wax-lined containers.
\2\ Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food
  product.

    (e) Analytical methods--(1) Selection of extractability conditions. 
First ascertain the type of food product (table 1, paragraph (d) of this 
section) that is being packed commercially in the test container and the 
normal conditions of thermal treatment used in packaging the type of 
food involved. Using table 2 (paragraph (d) of this section), select the 
food-simulating solvent or solvents (demineralized distilled water, 
heptane, and/or 8 percent ethyl alcohol) and the time-temperature 
exaggerations of the container-use conditions. Aqueous products (Types 
I, II, IV-B, and VI-B) require only a water-extractability test at the 
temperature and time conditions shown for the most severe ``conditions 
of use.'' Aqueous products with free oil or fat, and water-oil emulsions 
(types III, IV-A, and VII) will require determinations of both water 
extractability and heptane extractability. Low-moisture fats and

[[Page 180]]

oils (type V with no free water) require only the heptane 
extractability. Alcoholic beverages (type VI-A) require only the 8 
percent alcohol extractant. Having selected the appropriate extractant 
or extractants simulating various types of foods and beverages and the 
time-temperature exaggerations over normal use, follow the applicable 
extraction procedure. Adapt the procedure, when necessary, for 
containers having a capacity of over 1 gallon.
    (2) Selection of coated-container samples. For consumer-sized 
containers up to 1 gallon, quadruplicate samples of representative 
containers (using for each replicate sample the number of containers 
nearest to an area of 180 square inches) should be selected from the lot 
to be examined.
    (3) Cleaning procedure preliminary to determining the amount of 
extractables from coated containers. Quadruplicate samples of 
representative containers should be selected from the lot to be examined 
and must be carefully rinsed to remove extraneous material prior to the 
actual extraction procedure. Soda fountain pressure-type hot water 
rinsing equipment, consisting in its simplest form of a \1/8\-inch-\1/
4\-inch internal diameter metal tube attached to a hot water line and 
bent so as to direct a stream of water upward, may be used. Be sure hot 
water has reached a temperature of 190 [deg]F-200 [deg]F before starting 
to rinse the container. Invert the container over the top of the 
fountain and direct a strong stream of hot water against the bottom and 
all sides for 1 minute, drain, and allow to dry.
    (4) Exposure conditions--(i) Water (250 [deg]F for 2 hours), 
simulating high-temperature heat sterilization. Fill the container 
within \1/4\-inch of the top with a measured volume of demineralized 
distilled water. Cover the container with clean aluminum foil and place 
the container on a rack in a pressure cooker. Add a small amount of 
demineralized distilled water to the pressure cooker, but do not allow 
the water to touch the bottom of the container. Close the cooker 
securely and start to heat over a suitable burner. When a steady stream 
of steam emerges from the vent, close the vent and allow the pressure to 
rise to 15 pounds per square inch (250 [deg]F) and continue to maintain 
this pressure for 2 hours. Slowly release the pressure, open the 
pressure cooker when the pressure reads zero, and composite the water of 
each replicate immediately in a clean Pyrex flask or beaker. Proceed 
with the determination of the amount of extractives by the method 
described in paragraph (e)(5) of this section.
    (ii) Water (212 [deg]F for 30 minutes), simulating boiling water 
sterilization. Fill the container within \1/4\-inch of the top with a 
measured volume of boiling, demineralized distilled water. Cover the 
container with clean aluminum foil and place the container on a rack in 
a pressure cooker in which a small amount of demineralized distilled 
water is boiling. Do not close the pressure vent, but operate at 
atmospheric pressure so that there is a continuous escape of a small 
amount of steam. Continue to heat for 30 minutes, then remove the test 
container and composite the contents of each replicate immediately in a 
clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (iii) Water (from boiling to 100 [deg]F), simulating hot fill or 
pasteurization above 150 [deg]F. Fill the container within \1/4\-inch of 
the top with a measured volume of boiling, demineralized distilled 
water. Insert a thermometer in the water and allow the uncovered 
container to stand in a room at 70 [deg]F-85 [deg]F. When the 
temperature reads 100 [deg]F, composite the water from each replicate 
immediately in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (iv) Water (150[deg] for 2 hours), simulating hot fill or 
pasteurization below 150 [deg]F. Preheat demineralized distilled water 
to 150 [deg]F in a clean Pyrex flask. Fill the container within \1/4\-
inch of the top with a measured volume of the 150 [deg]F water and cover 
with clean aluminum foil. Place the test container in an oven maintained 
at 150 [deg]F. After 2 hours, remove the test container from the oven 
and immediately composite the water of each replicate in a clean Pyrex 
flask or beaker. Proceed with

[[Page 181]]

the determination of the amount of extractives by the method described 
in paragraph (e)(5) of this section.
    (v) Water (120 [deg]F for 24 hours), simulating room temperature 
filling and storage. Preheat demineralized distilled water to 120 [deg]F 
in a clean Pyrex flask. Fill the container within \1/4\-inch of the top 
with a measured volume of the 120 [deg]F water and cover with clean 
aluminum foil. Place the test container in an incubator or oven 
maintained at 120 [deg]F. After 24 hours, remove the test container from 
the incubator and immediately composite the water of each replicate in a 
clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (vi) Water (70 [deg]F for 48 hours), simulating refrigerated 
storage. Bring demineralized distilled water to 70 [deg]F in a clean 
Pyrex flask. Fill the container within \1/4\-inch of the top with a 
measured volume of the 70 [deg]F water, and cover with clean aluminum 
foil. Place the test container in a suitable room maintained at 70 
[deg]F. After 48 hours, immediately composite the water of each 
replicate in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (vii) Water (70 [deg]F for 24 hours), simulating frozen storage. 
Bring demineralized distilled water to 70 [deg]F in a clean Pyrex flask. 
Fill the container within \1/4\-inch of the top with a measured volume 
of the 70 [deg]F water and cover with clean aluminum foil. Place the 
container in a suitable room maintained at 70 [deg]F. After 24 hours, 
immediately composite the water of each replicate in a clean Pyrex flask 
or beaker. Proceed with the determination of the amount of extractives 
by the method described in paragraph (e)(5) of this section.
    (viii) Water (212 [deg]F for 30 minutes), simulating frozen foods 
reheated in the container. Fill the container to within \1/4\-inch of 
the top with a measured volume of boiling, demineralized distilled 
water. Cover the container with clean aluminum foil and place the 
container on a rack in a pressure cooker in which a small amount of 
demineralized distilled water is boiling. Do not close the pressure 
vent, but operate at atmospheric pressure so that there is a continuous 
escape of a small amount of steam. Continue to heat for 30 minutes, then 
remove the test container and composite the contents of each replicate 
immediately in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (ix) Heptane (150 [deg]F for 2 hours) simulating high-temperature 
heat sterilization for fatty foods only. Preheat redistilled reagent-
grade heptane (boiling point 208 [deg]F) carefully in a clean Pyrex 
flask on a water bath or nonsparking hot plate in a well-ventilated hood 
to 150 [deg]F. At the same time preheat a pressure cooker or equivalent 
to 150 [deg]F in an incubator. This pressure cooker is to serve only as 
a container for the heptane-containing test package inside the incubator 
in order to minimize the danger of explosion. Fill the test container 
within \1/4\-inch of the top with a measured volume of the 150 [deg]F 
heptane and cover with clean aluminum foil. Place the test container in 
the preheated pressure cooker and then put the assembly into a 150 
[deg]F incubator. After 2 hours, remove the pressure cooker from the 
incubator, open the assembly, and immediately composite the heptane of 
each replicate in a clean Pyrex flask or beaker. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (x) Heptane (120 [deg]F for 30 minutes), simulating boiling water 
sterilization of fatty foods only. Preheat redistilled reagent-grade 
heptane (boiling point 208 [deg]F) carefully in a clean Pyrex flask on a 
water bath or nonsparking hot plate in a well-ventilated hood to 120 
[deg]F. At the same time, preheat a pressure cooker or equivalent to 120 
[deg]F in an incubator. This pressure cooker is to serve only as a 
vented container for the heptane-containing test package inside the 
incubator in order to minimize the danger of explosion. Fill the test 
container within \1/4\-inch of the top with a measured volume of the 120 
[deg]F heptane and cover with clean aluminum foil. Place the test 
container in the preheated

[[Page 182]]

pressure cooker and then put the assembly into a 120 [deg]F incubator. 
After 30 minutes, remove the pressure cooker from the incubator, open 
the assembly, and immediately composite the heptane of each replicate in 
a clean Pyrex flask or beaker. Proceed with the determination of the 
amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (xi) Heptane (120 [deg]F for 15 minutes), simulating hot fill or 
pasteurization above 150 [deg]F for fatty foods only. Preheat 
redistilled reagent-grade heptane (boiling point 208 [deg]F) carefully 
in a clean Pyrex flask on a water bath or nonsparking hot plate in a 
well-ventilated hood to 120 [deg]F. At the same time, preheat a pressure 
cooker or equivalent to 120 [deg]F in an incubator. This pressure cooker 
is to serve only as a container for the heptane-containing test package 
inside the incubator in order to minimize the danger of explosion. Fill 
the test container within \1/4\-inch of the top with a measured volume 
of the 120 [deg]F heptane and cover with clean aluminum foil. Place the 
test container in the preheated pressure cooker and then put the 
assembly into a 120 [deg]F incubator. After 15 minutes, remove the 
pressure cooker from the incubator, open the assembly, and immediately 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xii) Heptane (100 [deg]F for 30 minutes), simulating hot fill or 
pasteurization below 150 [deg]F for fatty foods only. Preheat 
redistilled reagent-grade heptane (boiling point 208 [deg]F) carefully 
in a clean Pyrex flask on a water bath or nonsparking hot plate in a 
well-ventilated hood to 100 [deg]F. At the same time, preheat a pressure 
cooker or equivalent to 100 [deg]F in an incubator. This pressure cooker 
is to serve only as a container for the heptane-containing test package 
inside the incubator in order to minimize the danger of explosion. Fill 
the test container within \1/4\-inch of the top with a measured volume 
of the 100 [deg]F heptane and cover with clean aluminum foil. Place the 
test container in the preheated pressure cooker and then put the 
assembly into a 100 [deg]F incubator. After 30 minutes, remove the 
pressure cooker from the incubator, open the assembly and immediately 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xiii) Heptane (70 [deg]F for 30 minutes), simulating room 
temperature filling and storage of fatty foods only. Fill the test 
container within \1/4\-inch of the top with a measured volume of the 70 
[deg]F heptane and cover with clean aluminum foil. Place the test 
container in a suitable room maintained at 70 [deg]F. After 30 minutes, 
composite the heptane of each replicate in a clean Pyrex flask or 
beaker. Proceed with the determination of the amount of extractives by 
the method described in paragraph (e)(5) of this section.
    (xiv) Heptane (120 [deg]F for 30 minutes), simulating frozen fatty 
foods reheated in the container. Preheat redistilled reagent-grade 
heptane (boiling point 208 [deg]F) carefully in a clean Pyrex flask on a 
water bath or hot plate in a well-ventilated hood to 120 [deg]F. At the 
same time, preheat a pressure cooker to 120 [deg]F in an incubator. This 
pressure cooker is to serve only as a container for the heptane-
containing test package inside the incubator in order to minimize the 
danger of explosion. Fill the test container within \1/4\-inch of the 
top with a measured volume of the 120 [deg]F heptane and cover with 
clean aluminum foil. Place the test container in the preheated pressure 
cooker and then put the assembly into a 120 [deg]F incubator. After 30 
minutes, remove the pressure cooker from the incubator, open the 
assembly and immediately composite the heptane from each replicate into 
a clean Pyrex flask. Proceed with the determination of the amount of 
extractives by the method described in paragraph (e)(5) of this section.
    (xv) Alcohol--8 percent (150 [deg]F for 2 hours), simulating 
alcoholic beverages hot filled or pasteurized below 150 [deg]F. Preheat 
8 percent (by volume) ethyl alcohol in demineralized distilled water to 
150 [deg]F in a clean Pyrex flask. Fill the test container with within 
\1/4\-inch of the top with a measured volume of the 8 percent alcohol. 
Cover the container with clean aluminum foil and place in an oven 
maintained at 150 [deg]F. After 2

[[Page 183]]

hours, remove the container from the oven and immediately composite the 
alcohol from each replicate in a clean Pyrex flask. Proceed with the 
determination of the amount of extractives by the method described in 
paragraph (e)(5) of this section.
    (xvi) Alcohol--8 percent (120 [deg]F for 24 hours), simulating 
alcoholic beverages room-temperature filled and stored. Preheat 8 
percent (by volume) ethyl alcohol in demineralized distilled water to 
120 [deg]F in a clean Pyrex flask. Fill the test container within \1/4\-
inch of the top with a measured volume of the 8 percent alcohol, cover 
the container with clean aluminum foil and place in an oven or incubator 
maintained at 120 [deg]F. After 24 hours, remove the container from the 
oven or incubator and immediately composite the alcohol from each 
replicate into a clean Pyrex flask. Proceed with the determination of 
the amount of extractives by the method described in paragraph (e)(5) of 
this section.
    (xvii) Alcohol--8 percent (70 [deg]F for 48 hours), simulating 
alcoholic beverages in refrigerated storage. Bring 8 percent (by volume) 
ethyl alcohol in demineralized distilled water to 70 [deg]F in a clean 
Pyrex flask. Fill the test container within \1/4\-inch of the top with a 
measured volume of the 8 percent alcohol. Cover the container with clean 
aluminum foil. Place the test container in a suitable room maintained at 
70 [deg]F. After 48 hours, immediately composite the alcohol from each 
replicate into a clean Pyrex flask. Proceed with the determination of 
the amount of extractives by the method described in paragraph (e)(5) of 
this section.

    Note: The tests specified in paragraph (e)(4) (i) through (xvii) of 
this section are applicable to flexible packages consisting of coated 
metal contacting food, in which case the closure end is double-folded 
and clamped with metal spring clips by which the package can be 
suspended.

    (5) Determination of amount of extractives--(i) Total residues. 
Evaporate the food-simulating solvents from paragraph (e)(4) (i) to 
(xvii), inclusive, of this section to about 100 milliliters in the Pyrex 
flask and transfer to a clean, tared platinum dish, washing the flask 
three times with the solvent used in the extraction procedure, and 
evaporate to a few milliliters on a nonsparking low-temperature 
hotplate. The last few milliliters should be evaporated in an oven 
maintained at a temperature of 212 [deg]F. Cool the platinum dish in a 
desiccator for 30 minutes and weigh the residue to the nearest 0.1 
milligram (e). Calculate the extractives in milligrams per square inch 
and in parts per million for the particular size of container being 
tested and for the specific food-simulating solvent used.
    (a) Water and 8-percent alcohol.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.388
    
    [GRAPHIC] [TIFF OMITTED] TR01JA93.389
    
    (b) Heptane.
    [GRAPHIC] [TIFF OMITTED] TR01JA93.390
    
    [GRAPHIC] [TIFF OMITTED] TR01JA93.391
    
where:

Ex=Extractives residue in ppm for any container size.
e=Milligrams extractives per sample tested.
a=Total coated area, including closure in square inches.
c=Water capacity of container, in grams.
s=Surface of coated area tested, in square inches.
F=Five, the ratio of the amount of extractives removed from a coated 
container by heptane under exaggerated time-temperature test conditions 
compared to the amount extracted by a fat or oil from a container tested 
under exaggerated conditions of thermal sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Zinc corrected chloroform-soluble extractive residue.
e' or ee' is substituted for e in the above equations when necessary.


If when calculated by the equations in paragraph (e)(5)(i) (a) and (b) 
of this section, the concentration of extractives residue (Ex) exceeds 
50 parts per million or the extractives in milligrams per square inch 
exceed the limitations prescribed in paragraph (c) of this section for 
the particular container size, proceed to paragraph

[[Page 184]]

(e)(5)(ii) of this section (method for determining the amount of 
chloroform-soluble extractives residue).
    (ii) Chloroform-soluble extractives residue. Add 50 milliliters of 
chloroform (freshly distilled reagent grade or a grade having an 
established consistently low blank) to the dried and weighed residue, 
(e), in the platinum dish, obtained in paragraph (e)(5)(i) of this 
section. Warm carefully, and filter through Whatman No. 41 filter paper 
in a Pyrex funnel, collecting the filtrate in a clean, tared platinum 
dish. Repeat the chloroform extraction, washing the filter paper with 
this second portion of chloroform. Add this filtrate to the original 
filtrate and evaporate the total down to a few milliliters on a low-
temperature hotplate. The last few milliliters should be evaporated in 
an oven maintained at 212 [deg]F. Cool the platinum dish in a desiccator 
for 30 minutes and weigh to the nearest 0.1 milligram to get the 
chloroform-soluble extractives residue (e'). This e' is substituted for 
e in the equations in paragraph (e)(5)(i) (a) and (b) of this section. 
If the concentration of extractives (Ex) still exceeds 50 parts per 
million or the extractives in milligrams per square inch exceed the 
limitations prescribed in paragraph (c) of this section for the 
particular container size, proceed as follows to correct for zinc 
extractives (``C'' enamels only): Ash the residue in the platinum dish 
by heating gently over a Meeker-type burner to destroy organic matter 
and hold at red heat for about 1 minute. Cool in the air for 3 minutes, 
and place the platinum dish in the desiccator for 30 minutes and weigh 
to the nearest 0.1 milligram. Analyze this ash for zinc by standard 
Association of Official Agricultural Chemists methods or equivalent. 
Calculate the zinc in the ash as zinc oleate, and subtract from the 
weight of chloroform-soluble extractives residue (e') to obtain the 
zinc-corrected chloroform-soluble extractives residue (ee'). This ee' is 
substituted for e in the formulas in paragraph (e)(5)(i) (a) and (b) of 
this section. To comply with the limitations in paragraph (c) of this 
section, the chloroform-soluble extractives residue (but after 
correction for the zinc extractives in case of ``C'' enamels) must not 
exceed 50 parts per million and must not exceed in milligrams per square 
inch the limitations for the particular article as prescribed in 
paragraph (c) of this section.
    (f) Equipment and reagent requirements--(1) Equipment.

    Rinsing equipment, soda fountain pressure-type hot water, consisting 
in simplest form of a \1/8\-inch-\1/4\-inch inside diameter metal tube 
attached to a hot water line delivering 190 [deg]F-200 [deg]F water and 
bent so as to direct a stream of water upward.
    Pressure cooker, 21-quart capacity with pressure gage, safety 
release, and removable rack, 12.5 inches inside diameter x 11 inches 
inside height, 20 pounds per square inch safe operating pressure.
    Oven, mechanical convection, range to include 120 [deg]F-212 [deg]F 
explosion-proof, inside dimensions (minimum), 19 x 
19 x 19, constant temperature to 2 [deg]F (water bath may be substituted).
    Incubator, inside dimensions (minimum) 19 x 19 
x 19 for use at 100 [deg]F2 [deg]F 
explosion proof (water bath may be substituted).
    Constant-temperature room or chamber 70 [deg]F2 [deg]F minimum inside dimensions 19 x 
19 x 19.
    Hot plate, nonsparking (explosion proof), top 12 x 
20, 2,500 watts, with temperature control.
    Platinum dish, 100-milliliter capacity minimum.
    All glass, Pyrex or equivalent.

    (2) Reagents.

    Water, all water used in extraction procedure should be freshly 
demineralized (deionized) distilled water.
    Heptane, reagent grade, freshly redistilled before use, using only 
material boiling at 208 [deg]F.
    Alcohol, 8 percent (by volume), prepared from undenatured 95 percent 
ethyl alcohol diluted with demineralized or distilled water.
    Chloroform, reagent grade, freshly redistilled before use, or a 
grade having an established, consistently low blank.
    Filter paper, Whatman No. 41 or equivalent.

    (g) In accordance with good manufacturing practice, finished 
coatings intended for repeated food-contact use shall be thoroughly 
cleansed prior to their first use in contact with food.
    (h) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
175.300, see the List of CFR

[[Page 185]]

Sections Affected, which appears in the Finding Aids section of the 
printed volume and on GPO Access.



Sec. 175.320  Resinous and polymeric coatings for polyolefin films.

    Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from one or more of the basic olefin 
polymers complying with Sec. 177.1520 of this chapter. The base 
polyolefin film may contain optional adjuvant substances permitted for 
use in polyolefin film by applicable regulations in parts 170 through 
189 of this chapter.
    (b) The coatings are formulated from optional substances which are:
    (1) Substances generally recognized as safe for use in or on food.
    (2) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, by prior 
sanctions, or approvals.
    (3) Substances identified in this paragraph (b)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
(i) Resins and polymers:
  Acrylic acid polymer and its ethyl or
   methyl esters.
  Acrylamide copolymerized with ethyl
   acrylate and/or styrene and/or
   methacrylic acid, and the copolymer
   subsequently reacted with
   formaldehyde and butanol.
  Butadiene-acrylonitrile copolymer....
  Butadiene-acrylonitrile-styrene
   terpolymer.
  Butyl rubber.........................
  N,N'-Diphenyl-p-phenylenediamine.....  For use only as a
                                          polymerization inhibitor in 2-
                                          sulfoethyl methacrylate,
                                          sodium salt.
  2-Ethylhexyl acrylate copolymerized
   with one or more of the following:
    Acrylonitrile......................
    Itaconic acid......................
    Methacrylonitrile..................
    Methyl acrylate....................
    Methyl methacrylate................
  4,4'-
   Isopropylidenediphenolepichlorohydri
   n average molecular weight 900.
  Melamine-formaldehyde as the basic
   polymer or chemically modified with
   methyl alcohol.
  Methacrylic acid and its ethyl or
   methyl esters copolymerized with one
   or more of the following:
    Acrylic acid.......................
    Ethyl acrylate.....................
    Methyl acrylate....................
  [alpha]-Methyl styrene polymer.......
  [alpha]-Methylstyrene-vinyltoluene     For use only in coatings that
   copolymer resins (molar ratio 1        contact food under conditions
   [alpha]-methylstyrene to 3             of use D, E, F, or G described
   vinyltoluene).                         in table 2 of Sec.
                                          176.170(c) of this chapter,
                                          provided that the
                                          concentration of [alpha]-
                                          methylstyrene-vinyltoluene
                                          copolymer resins in the
                                          finished food-contact coating
                                          does not exceed 1.0 milligram
                                          per square inch of food-
                                          contact surface.
  Petroleum alicyclic hydrocarbon        As defined in Sec.  176.170 of
   resins.                                this chapter. Blended with
                                          butyl rubber for use as a
                                          component of coatings on
                                          polyolefin fabric for bulk
                                          packaging of raw fruits and
                                          vegetables and used at a level
                                          not to exceed 30 percent by
                                          weight of the total coating
                                          solids.
  Polyamide resins (CAS Reg. No. 68139-  For use only in coatings for
   70-8), as the basic resin, derived     polypropylene films that
   from:                                  contact food at temperatures
                                          not to exceed room
                                          temperature.
    Dimerized vegetable oil or tall oil
     acids containing not more than 20
     percent of monomer acids.
    Azelaic acid (CAS Reg. No. 123-99-
     9) in an amount not to exceed 3.7
     percent by weight of the polyamide
     resin.
    Ethylenediamine (CAS Reg. No. 107-
     15-3).
    Piperazine (CAS Reg. No. 110-85-0)
     in an amount not to exceed 6.4
     percent by weight of the polyamide
     resin.

[[Page 186]]

 
  Polyamide resins, derived from         For use only in coatings for
   dimerized vegetable oil acids          polyolefin films that contact
   (containing not more than 20% of       food at temperatures not to
   monomer acids) and ethylenediamine,    exceed room temperature.
   as the basic resin.
  Polyamide resins having a maximum      For use only in coatings that
   acid value of 5 and a maximum amine    contact food at temperatures
   value of 8.5 derived from dimerized    not to exceed room temperature
   vegetable oil acids (containing not    provided that the
   more than 10 percent of monomer        concentration of the polyamide
   acids), ethylenediamine, and 4,4-bis   resins in the finished food-
   (4-hydroxyphenyl) pentanoic acids      contact coating does not
   (in an amount not to exceed 10         exceed 5 milligrams per square
   percent by weight of said polyamide    inch of food-contact surface.
   resins); as the basic resin.
  Polyester resins formed by reaction
   of one or more of the following
   polybasic acids and monobasic acids
   with one or more of the following
   polyhydric alcohols:
    Polybasic acids:
      Adipic...........................
      Azelaic..........................  For use in forming polyester
                                          resins intended for use in
                                          coatings that contact food
                                          only of the type identified in
                                          Sec.  176.170(c) of this
                                          chapter, table 1, under
                                          Category VIII, and under
                                          conditions of use E, F, or G,
                                          described in table 2 of Sec.
                                          176.170(c) of this chapter.
      Dimerized fatty acids derived
       from:
        Animal, marine or vegetable
         fats and oils.
        Tall oil.......................
      Fumaric..........................
      Isophthalic......................
      Maleic...........................
      o-Phthalic.......................
      Sebacic..........................
      Terephthalic.....................
      Trimellitic......................
    Monobasic acids:
      Fatty acids derived from:
        Animal, marine, or vegetable
         fats and oils.
        Gum rosin......................  As defined in Sec.  178.3870
                                          of this chapter. For use in
                                          forming polyester resins
                                          intended for use in coatings
                                          that contact food only of the
                                          type identified in Sec.
                                          176.170(c) of this chapter,
                                          table 1, under Category VIII,
                                          and under conditions of use E,
                                          F, or G described in table 2
                                          of Sec.  176.170(c) of this
                                          chapter.
    Polyhydric alcohols:
      1,3-Butylene glycol..............
      Diethylene glycol................
      2,2-Dimethyl-1,3-propanediol.....
      Dipropylene glycol...............
      Ethylene glycol..................
      Glycerol.........................
      Mannitol.........................
      [alpha]-Methyl glucoside.........
      Pentaerythritol..................
      Propylene glycol.................
      Sorbitol.........................
      Trimethylol ethane...............
      Trimethylol propane..............
  Polyethylenimine.....................  For use only as a primer
                                          subcoat to anchor epoxy
                                          surface coatings to the base
                                          sheet.
  Polystyrene..........................
  Polyvinyl acetate....................
  Polyvinyl chloride...................  ...............................
Siloxanes and silicones: platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     150 parts per million.
 containing dimethylpolysiloxane (CAS
 Reg. No. 68083-18-1 and CAS Reg. No.
 68083-19-2) with methylhydrogen
 polysiloxane (CAS Reg. No. 63148-57-2)
 and dimethylmethylhydrogen
 polysiloxane (CAS Reg. No. 68037-59-
 2). The following substances may be
 used as optional polymerization
 inhibitors:.
  3,5-Dimethyl-1-hexyne-3-ol (CAS Reg.   ...............................
   No. 107-54-0), at a level not to
   exceed 0.53 weight percent;.
  1-Ethynylcyclohexene (CAS Reg. No.     ...............................
   931-49-7), at a level not to exceed
   0.64 weight percent;.
    Bis(methoxymethyl)ethyl maleate      ...............................
     (CAS Reg. No. 102054-10-4), at a
     level not to exceed 1.0 weight
     percent;.
  Methylvinyl cyclosiloxane (CAS Reg.    ...............................
   No. 68082-23-5); and.

[[Page 187]]

 
  Tetramethyltetravinylcyclotetrasiloxa
   ne (CAS Reg. No. 2554-06-5)..
Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a surface coating
 Reg. Nos. 68083-19-2 and 68083-18-1),    under the following
 with methyl hydrogen polysiloxane (CAS   conditions:
 Reg. No. 63148-57-2). Dimethyl maleate  1. In coatings for olefin
 (CAS Reg. No. 624-48-6) and vinyl        polymers provided the coating
 acetate (CAS Reg. No. 108-05-4) may be   contacts food only of the
 used as optional polymerization          types identified in Sec.
 inhibitors.                              176.170(c) of this chapter,
                                          table 1, under Types I, II,
                                          VI, and VII-B when used under
                                          conditions of use E, F, and G
                                          described in table 2 in Sec.
                                          176.170(c) of this chapter.
                                         2. In coatings for olefin
                                          polymers provided the coating
                                          contacts food only of the
                                          types identified in Sec.
                                          176.170(c) of this chapter,
                                          table 1, under Types III, IV,
                                          V, VII-A, VIII, and IX when
                                          used under conditions of use A
                                          through H described in table 2
                                          in Sec.  176.170(c) of this
                                          chapter.
Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives.
 with methyl hydrogen polysiloxane (CAS
 Reg. No. 63148-57-2). Dimethyl maleate
 (CAS Reg. No. 624-48-6), vinyl acetate
 (CAS Reg. No. 108-05-4), dibutyl
 maleate (CAS Reg. No. 105-76-0) and
 diallyl maleate (CAS Reg. No. 999-21-
 3) may be used as optional
 polymerization inhibitors. The polymer
 may also contain C16-C18 olefins (CAS
 Reg. No. 68855-60-7) as a control
 release agent.
  Styrene copolymerized with one or
   more of the following:
    Acrylonitrile......................
    [alpha]-Methyl styrene.............
  Styrene polymers made by the           For use only in contact with
   polymerization of any combination of   foods of Types IV-A, V, and
   styrene or alpha methyl styrene with   VII in table 1 of Sec.
   acrylic acid, methacrylic acid, 2-     176.170(c) of this chapter,
   ethyl hexyl acrylate, methyl           under use conditions E through
   methacrylate, and butyl acrylate.      G in table 2 of Sec.
   The styrene and alpha methyl           176.170(c), and with foods of
   styrene, individually, may             Types VIII and IX without use
   constitute from 0 to 80 weight         temperature restriction.
   percent of the polymer. The other
   monomers, individually, may be from
   0 to 40 weight percent of the
   polymer. The polymer number average
   molecular weight (Mn) shall be at
   least 2,000 (as determined by gel
   permeation chromatography). The acid
   number of the polymer shall be less
   than 250. The monomer content shall
   be less than 0.5 percent.
  Styrene-isobutylene copolymer........
  Terpene resins consisting of polymers
   of [alpha]-pinene, [beta]-pinene,
   and/or dipentene; acid value less
   than 5, saponification number less
   than 5, and color less than 4 on the
   Gardner scale as measured in 50
   percent mineral spirits solution.
  2-Sulfoethyl methacrylate, sodium      For use only in copolymer
   salt Chemical Abstracts Service No.    coatings under conditions of
   1804-87-1].                            use E, F, and G described in
                                          table 2 of Sec.  176.170(c)
                                          of this chapter and limited to
                                          use at a level not to exceed
                                          2.0 percent by weight of the
                                          dry copolymer coating.
  Vinyl chloride-acetate, hydroxyl-
   modified copolymer or maleic acid-
   modified copolymer.
  Vinyl chloride copolymerized with one
   or more of the following:
    Acrvlonitrile......................
    Vinyl acetate......................
    Vinylidene chloride................
  Vinylidene chloride copolymerized
   with one or more of the following:
    Acrylic acid and its methyl, ethyl,
     propyl, butyl, or octyl esters.
    Acrylonitrile......................
    Itaconic acid......................
    Methacrylic acid and its methyl,
     ethyl, propyl, butyl, or octyl
     esters.
    Methacrylonitrile..................
    Vinyl chloride.....................
(ii) Plasticizers:
  Acetyl tributyl citrate..............
  Acetyl triethyl citrate..............
  Butyl phthalyl butyl glycolate.......
  Butyl stearate.......................
  Dibutyl sebacate.....................
  Diethyl phthalate....................
  2-Ethylhexyl diphenyl phosphate......

[[Page 188]]

 
  Ethyl phthalyl ethyl glycolate.......
  Glycerol monooleate..................  ...............................
  Glycerol triacetate..................
  Triethyl citrate.....................
(iii) Adjuvants (release agents, waxes,
 and dispersants):
  Acetone..............................
  Amides (unsubstituted) of fatty acids
   from vegetable or animal oils.
  n-Butyl acetate......................
  n-Butyl alcohol......................
  Candelilla wax.......................
  Carnauba wax.........................
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only as an
 (CAS Reg. No. 26172-55-4) and 2-methyl-  antimicrobial agent in
 4-isothiazolin-3-one (CAS Reg. No.       emulsion-based silicone
 2682-20-4) mixture, at a ratio of 3      coatings at a level not to
 parts to 1 part, respectively,           exceed 50 milligrams per
 manufactured from methyl-3-              kilogram (based on
 mercaptopropionate (CAS Reg. No. 2935-   isothiazolone active
 90-2) and optionally containing          ingredient) in the coating
 magnesium nitrate (CAS Reg. No. 10377-   formulation.
 60-3) at a concentration equivalent to
 the isothiazolone active ingredients
 (weight/weight)..
  1,2-Dibromo-2,4-dicyanobutane (CAS     For use as an antimicrobial
   Reg. No. 35691-65-7).                  agent at levels not to exceed
                                          500 milligrams per kilogram in
                                          emulsion-based silicone
                                          coating.
  Ethyl acetate........................
  Fatty acids from vegetable or animal
   oils and their aluminum, ammonium,
   calcium, magnesium, and sodium salts.
  Hexane...............................
  Methyl ethyl ketone..................
  N,N'-Dioleoylethylenediamine (CAS      For use only in ionomeric
   Reg. No. 110-31-6).                    resins complying with Sec.
                                          177.1330 of this chapter and
                                          in ethylene vinyl acetate
                                          copolymers complying with Sec.
                                            177.1350 of this chapter at
                                          a level not to exceed 0.0085
                                          milligram per square
                                          centimeter (0.055 milligram
                                          per square inch) in the
                                          finished food-contact article.
  Petroleum waxes conforming to
   specifications included in a
   regulation in subchapter B of this
   chapter.
  Polyvinyl alcohol, minimum viscosity   For use only as a dispersing
   of 4% aqueous solution at 20 [deg]C    agent at levels not to exceed
   of 4 centipoises and percent           6% of total coating weight in
   alcoholysis of 87-100.                 coatings for pol-yolefin films
                                          provided the finished
                                          polyolefin films contact food
                                          only of the types identified
                                          in Sec.  176.170(c) of this
                                          chapter, table 1, under Types
                                          V, VIII, and IX.
  Sodium dioctyl sulfosuccinate........
  Sodium dodecylbenzenesulfonate.......
  Sodium lauryl sulfate................
  Sorbitan and sorbitol esters of fatty
   acids from vegetable or animal oils.
  Spermaceti wax.......................
  Tetrahydrofuran......................
  Toluene..............................
(iv) Preservatives:                      ...............................
  Silver chloride-coated titanium        For use only as a preservative
   dioxide.                               in latex emulsions at a level
                                          not to exceed 2.2 parts per
                                          million (based on silver ion
                                          concentration) in the dry
                                          coating.
------------------------------------------------------------------------

    (c) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from tables 1 and 2 of 
Sec. 176.17(c) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of coated 
surface.
    (d) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 
FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept. 
18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR 
14246, Apr. 1, 1996; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000]

[[Page 189]]



Sec. 175.350  Vinyl acetate/crotonic acid copolymer.

    A copolymer of vinyl acetate and crotonic acid may be safely used as 
a coating or as a component of a coating which is the food-contact 
surface of polyolefin films intended for packaging food, subject to the 
provisions of this section.
    (a) The copolymer may contain added optional substances to impart 
desired properties.
    (b) The quantity of any optional substance does not exceed the 
amount reasonably required to accomplish the intended physical or 
technical effect nor any limitations further provided.
    (c) Any optional substance that is the subject of a regulation in 
parts 174, 175, 176, 177, 178, and Sec. 179.45 of this chapter conforms 
with any specifications in such regulation.
    (d) Optional substances as provided in paragraph (a) of this section 
include:
    (1) Substances generally recognized as safe in food.
    (2) Substances subject to prior sanction or approval for uses with a 
copolymer of vinyl acetate and crotonic acid and used in accordance with 
such sanction or approval.
    (3) Substances identified in this subparagraph and subject to such 
limitations as are provided:

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Silica....................................
Japan wax.................................
------------------------------------------------------------------------

    (e) Copolymer of vinyl acetate and crotonic acid used as a coating 
or as a component of a coating conforming with the specifications of 
paragraph (e)(1) of this section are used as provided in paragraph 
(e)(2) of this section.
    (1) Specifications. (i) The chloroform-soluble portion of the water 
extractives of the coated film obtained with distilled water at 120 
[deg]F for 24 hours does not exceed 0.5 milligram per square inch of 
coated surface.
    (ii) The chloroform-soluble portion of the n-heptane extractives of 
the coated film obtained with n-heptane at 70 [deg]F for 30 minutes does 
not exceed 0.5 milligram per square inch of coated surface.
    (2) Conditions of use. The copolymer of vinyl acetate and crotonic 
acid is used as a coating or as a component of a coating for polyolefin 
films for packaging bakery products and confectionery.



Sec. 175.360  Vinylidene chloride copolymer coatings for nylon film.

    Vinylidene chloride copolymer coatings identified in this section 
and applied on nylon film may be safely used as food-contact surfaces, 
in accordance with the following prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from nylon resins complying with Sec. 
177.1500 of this chapter.
    (b) The coatings are prepared from vinylidene chloride copolymers 
produced by copolymerizing vinylidene chloride with one or more of the 
monomers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid, 
methyl acrylate, methyl methacrylate (CAS Reg. No. 80-62-6; maximum use 
level 6 weight percent) and 2-sulfoethyl methacrylate (CAS Reg. No. 
10595-80-9; maximum use level 1 weight percent). The finished copolymers 
contain at least 50 weight percent of polymer units derived from 
vinylidene chloride. The finished coating produced from vinylidene 
chloride copolymers produced by copolymerizing vinylidene chloride with 
methyl methacrylate and/or 2-sulfoethyl methacrylate, or with methyl 
methacrylate and/or 2-sulfoethyl methacrylate together with one or more 
of the other monomers from this section, is restricted to use at or 
below room temperature.
    (c) Optional adjuvant substances employed in the production of the 
coatings or added thereto to impart desired properties may include 
sodium dodecylbenzenesulfonate.
    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of coated 
surface when

[[Page 190]]

tested by the methods described in Sec. 176.170(d) of this chapter.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 
FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982]



Sec. 175.365  Vinylidene chloride copolymer coatings for polycarbonate film.

    Vinylidene chloride copolymer coatings identified in this section 
and applied on polycarbonate film may be safely used as food-contact 
surfaces, in accordance with the following prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from polycarbonate resins complying with 
Sec. 177.1580 of this chapter.
    (b) The coatings are prepared from vinylidene chloride copolymers 
produced by copolymerizing vinylidene chloride with acrylonitrile, 
methyl acrylate, and acrylic acid. The finished copolymers contain at 
least 50 weight-percent of polymer units derived from vinyldene 
chloride.
    (c) Optional adjuvant substances employed in the production of the 
coatings or added thereto to impart desired properties may include 
sodium dodecylbenzenesulfonate in addition to substances described in 
Sec. 174.5(d) of this chapter.
    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under the conditions of time and temperature characterizing 
the conditions of its intended use as determined from tables 1 and 2 of 
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble 
extractives in each extracting solvent not to exceed 0.5 milligram per 
square inch of coated surface as determined by the methods described in 
Sec. 176.170(d) of this chapter. In testing the finished food-contact 
articles, a separate test sample is to be used for each required 
extracting solvent.
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisons of Sec. 180.22 of this chapter.



Sec. 175.380  Xylene-formaldehyde resins condensed with 
4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins.

    The resins identified in paragraph (a) of this section may be safely 
used as a food-contact coating for articles intended for use in contact 
with food, in accordance with the following prescribed conditions.
    (a) The resins are produced by the condensation of xylene-
formaldehyde resin and 4,4'-isopropylidenediphenol-epichlorohydrin epoxy 
resins, to which may have been added certain optional adjuvant 
substances required in the production of the resins or added to impart 
desired physical and technical properties. The optional adjuvant 
substances may include resins produced by the condensation of allyl 
ether of mono-, di-, or trimethylol phenol and capryl alcohol and also 
may include substances identified in Sec. 175.300(b)(3), with the 
exception of paragraph (b)(3) (xxxi) and (xxxii) of that section.
    (b) The resins identified in paragraph (a) of this section may be 
used as a food-contact coating for articles intended for contact at 
temperatures not to exceed 160 [deg]F with food of Types I, II, VI-A and 
B, and VIII described in table 1 of Sec. 176.170(c) of this chapter 
provided that the coating in the finished form in which it is to contact 
food meets the following extractives limitations when tested by the 
methods provided in Sec. 175.300(e):
    (1) The coating when extracted with distilled water at 180 [deg]F 
for 24 hours yields total extractives not to exceed 0.05 milligram per 
square inch of food-contact surface.
    (2) The coating when extracted with 8 percent (by volume) ethyl 
alcohol in distilled water at 160 [deg]F for 4 hours yields total 
extractives not to exceed 0.05 milligram per square inch of food-contact 
surface.
    (c) The resins identified in paragraph (a) of this section may be 
used as a food-contact coating for articles intended for contact at 
temperatures not to exceed room temperature with food of Type VI-C 
described in table 1 of Sec. 176.170(c) of this chapter provided the 
coating in the finished form in which it is to contact food meets the 
following

[[Page 191]]

extractives limitations when tested by the methods provided in Sec. 
175.300(e):
    (1) The coating when extracted with distilled water at 180 [deg]F 
for 24 hours yields total extractives not to exceed 0.05 milligram per 
square inch of food-contact surface.
    (2) The coating when extracted with 50 percent (by volume) ethyl 
alcohol in distilled water at 180 [deg]F for 24 hours yields total 
extractives not to exceed 0.05 milligram per square inch.



Sec. 175.390  Zinc-silicon dioxide matrix coatings.

    Zinc-silicon dioxide matrix coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, subject to the provisions of this 
section;
    (a) The coating is applied to a metal surface, cured, and washed 
with water to remove soluble substances.
    (b) The coatings are formulated from optional substances which 
include:
    (1) Substances generally recognized as safe.
    (2) Substances for which safe conditions of use have been prescribed 
in Sec. 175.300.
    (3) Substances identified in paragraph (c) of this section, subject 
to the limitations prescribed.
    (c) The optional substances permitted are as follows:

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Ethylene glycol...........................  As a solvent removed by
                                             water washing.
Iron oxide................................
Lithium hydroxide.........................  Removed by water washing.
Methyl orange.............................  As an acid-base indicator.
Potassium dichromate......................  Removed by water washing.
Silica gel................................
Sodium silicate...........................
Zinc, as particulate metal................
------------------------------------------------------------------------

    (d) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under the conditions of its intended use as shown in table 1 
and 2 of Sec. 175.300(d) (using 20 percent alcohol as the solvent when 
the type of food contains approximately 20 percent alcohol) shall yield 
total extractives not to exceed those prescribed in Sec. 175.300(c)(3); 
lithium extractives not to exceed 0.025 milligram per square inch of 
surface; and chromium extractives not to exceed 0.05 microgram per 
square inch of surface.
    (e) The coatings are used as food-contact surfaces for bulk reusable 
containers intended for storing, handling, and transporting food.



PART 176_INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD 
COMPONENTS--Table of Contents




Subpart A [Reserved]

 Subpart B_Substances for Use Only as Components of Paper and Paperboard

Sec.
176.110 Acrylamide-acrylic acid resins.
176.120 Alkyl ketene dimers.
176.130 Anti-offset substances.
176.150 Chelating agents used in the manufacture of paper and 
          paperboard.
176.160 Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane 
          sulfonyl glycine.
176.170 Components of paper and paperboard in contact with aqueous and 
          fatty foods.
176.180 Components of paper and paperboard in contact with dry food.
176.200 Defoaming agents used in coatings.
176.210 Defoaming agents used in the manufacture of paper and 
          paperboard.
176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
176.260 Pulp from reclaimed fiber.
176.300 Slimicides.
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.

    Authority: 21 U.S.C. 321, 342, 346, 348, 379e.

    Source: 42 FR 14554, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 176 appear at 61 FR 
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.

Subpart A [Reserved]



 Subpart B_Substances for Use Only as Components of Paper and Paperboard



Sec. 176.110  Acrylamide-acrylic acid resins.

    Acrylamide-acrylic acid resins may be safely used as components of 
articles intended for use in producing, manufacturing, packing, 
processing,

[[Page 192]]

preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of this section.
    (a) Acrylamide-acrylic acid resins are produced by the 
polymerization of acrylamide with partial hydrolysis or by the 
copolymerization of acrylamide and acrylic acid.
    (b) The acrylamide-acrylic acid resins contain less than 0.2 percent 
residual monomer.
    (c) The resins are used as adjuvants in the manufacture of paper and 
paperboard in amounts not to exceed that necessary to accomplish the 
technical effect and not to exceed 2 percent by weight of the paper or 
paperboard.



Sec. 176.120  Alkyl ketene dimers.

    Alkyl ketene dimers may be safely used as a component of articles 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food, subject 
to the provisions of this section.
    (a) The alkyl ketene dimers are manufactured by the 
dehydrohalogenation of the acyl halides derived from the fatty acids of 
animal or vegetable fats and oils.
    (b) The alkyl ketene dimers are used as an adjuvant in the 
manufacture of paper and paperboard under such conditions that the alkyl 
ketene dimers and their hydrolysis products dialkyl ketones do not 
exceed 0.4 percent by weight of the paper or paperboard.
    (c) The alkyl ketene dimers may be used in the form of an aqueous 
emulsion which may contain sodium lignosulfonate as a dispersant.



Sec. 176.130  Anti-offset substances.

    Substances named in paragraphs (b) and (c) of this section may be 
safely used to prevent the transfer of inks employed in printing and 
decorating paper and paperboard used for food packaging in accordance 
with the provisions of this section:
    (a) The substances are applied to the nonfood contact, printed side 
of the paper or paperboard in an amount not greater than that required 
to accomplish the technical effect nor greater than any specific 
limitations, where such are provided.
    (b) Anti-offset powders are prepared from substances that are 
generally recognized as safe in food, substances for which prior 
sanctions or approvals were granted and which are used in accordance 
with the specific provisions of such sanction or approval, and 
substances named in paragraph (c) of this section.
    (c) The substances permitted are as follows:

------------------------------------------------------------------------
                Substances                           Limitations
------------------------------------------------------------------------
Carbon tetrachloride......................
Methyl hydrogen polysiloxanes.............
Industrial starch--modified...............  Complying with Sec.
                                             178.3520 of this chapter.
Stannous oleate...........................
Zinc-2-ethyl hexoate......................
------------------------------------------------------------------------



Sec. 176.150  Chelating agents used in the manufacture of paper and paperboard.

    The substances named in paragraph (a) of this section may be safely 
used in the manufacture of paper and paperboard, in accordance with the 
conditions prescribed in paragraphs (b) and (c) of this section:
    (a) Chelating agents:

------------------------------------------------------------------------
            List of substances                       Limitations
------------------------------------------------------------------------
Ammonium fructoheptonate..................
Ammonium glucoheptonate...................
Disodium ethylenediamine tetraacetate.....
Pentasodium salt of diethylenetriamine
 pentaacetate.
Sodium fructoheptonate....................
Sodium glucoheptonate.....................
Tetrasodium ethylenediamine tetra acetate.
Trisodium N-hydroxyethyl ethylenediamine
 triacetate.
------------------------------------------------------------------------

    (b) Any one or any combination of the substances named is used or 
intended for use as chelating agents.
    (c) The substances are added in an amount not greater than that 
required to accomplish the intended technical effect nor greater than 
any specific limitation, where such is provided.



Sec. 176.160  Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane 
sulfonyl glycine.

    The chromium (Cr III) complex of N-ethyl - N -heptadecylfluoro-
octane sulfonyl glycine containing up to 20 percent by weight of the 
chromium (Cr III) complex of heptadecylfluoro-octane sulfonic acid may 
be safely used as a

[[Page 193]]

component of paper for packaging dry food when used in accordance with 
the following prescribed conditions.
    (a) The food additive is used as a component of paper in an amount 
not to exceed 0.5 percent by weight of the paper.
    (b)(1) The food-contact surface of the paper is overcoated with a 
polymeric or resinous coating at least \1/3\-mil in thickness, that 
meets the provision of Sec. 176.170; or
    (2) The treated paper forms one or more plies of a paper in a 
multiwall bag and is separated from the food by at least one ply of 
packaging films or grease-resistant papers which serves as a functional 
barrier between the food additive and the food. Such packaging films or 
grease-resistant papers conform with appropriate food additive 
regulations.
    (c) The labeling of the food additive shall contain adequate 
directions for its use to insure compliance with the requirements of 
paragraphs (a) and (b) of this section.



Sec. 176.170  Components of paper and paperboard in contact with aqueous 
and fatty foods.

    Substances identified in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packaging, 
processing, preparing, treating, packing, transporting, or holding 
aqueous and fatty foods, subject to the provisions of this section. 
Components of paper and paperboard in contact with dry food of the type 
identified under Type VIII of table 1 in paragraph (c) of this section 
are subject to the provisions of Sec. 176.180.
    (a) Substances identified in paragraph (a) (1) through (5) of this 
section may be used as components of the food-contact surface of paper 
and paperboard. Paper and paperboard products shall be exempted from 
compliance with the extractives limitations prescribed in paragraph (c) 
of this section: Provided, That the components of the food-contact 
surface consist entirely of one or more of the substances identified in 
this paragraph: And provided further, That if the paper or paperboard 
when extracted under the conditions prescribed in paragraph (c) of this 
section exceeds the limitations on extractives contained in paragraph 
(c) of this section, information shall be available from manufacturing 
records from which it is possible to determine that only substances 
identified in this paragraph (a) are present in the food-contact surface 
of such paper or paperboard.
    (1) Substances generally recognized as safe in food.
    (2) Substances generally recognized as safe for their intended use 
in paper and paperboard products used in food packaging.
    (3) Substances used in accordance with a prior sanction or approval.
    (4) Substances that by regulation in parts 170 through 189 of this 
chapter may be safely used without extractives limitations as components 
of the uncoated or coated food-contact surface of paper and paperboard 
in contact with aqueous or fatty food, subject to the provisions of such 
regulation.
    (5) Substances identified in this paragraph, as follows:

------------------------------------------------------------------------
           List of Substances                      Limitations
------------------------------------------------------------------------
Acetyl peroxide........................  For use only as polymerization
                                          catalyst.
Acrylamide-methacrylic acid-maleic       For use only as a retention aid
 anhydride copolymers containing not      employed prior to the sheet-
 more than 0.2 percent of residual        forming operation in the
 acrylamide monomer and having an         manufacture of paper and
 average nitrogen content of 14.9         paperboard in such an amount
 percent such that a 1 percent by         that the finished paper and
 weight aqueous solution has a minimum    paperboard will contain the
 viscosity of 600 centipoises at 75       additive at a level not in
 [deg]F, as determined by LVG-series      excess of 0.05 percent by
 Brookfield viscometer (or equivalent)    weight of dry fibers in the
 using a No. 2 spindle at 30 r.p.m.       finished paper and paperboard.
Acrylamide-[beta]-                       For use only as a retention aid
 methacrylyloxyethyltrimethylammonium     and flocculant employed prior
 methyl sulfate copolymer resins          to the sheet-forming operation
 containing not more than 10 molar        in the manufacture of paper
 percent of [beta]-                       and paperboard.
 methacrylyloxyethyltrimethylammonium
 methyl sulfate and containing less
 than 0.2% of residual acrylamide
 monomer.
Acrylic acid, sodium salt copolymer      For use only in paper mill
 with polyethyleneglycol allyl ether      boilers.
 (CAS Reg. No. 86830-15-1).

[[Page 194]]

 
Acrylic acid copolymer with 2-           For use only as a scale
 acrylamido-2-methylpropane-sulfonic      inhibitor prior to the sheet-
 acid (CAS Reg. No. 40623-75-4) and/or    forming operation in the
 its ammonium/alkali metal mixed salts.   manufacture of paper and
 The copolymer is produced by poly-       paperboard and used at a level
 merization of acrylic acid and 2-        not to exceed 1.0 kilogram
 acrylamido-2-methylpropane-sulfonic      (2.2 pounds) of copolymer per
 acid in a weight ratio of 60/40, such    907 kilograms (1 ton) of dry
 that a 28 percent by weight aqueous      paper and paperboard fibers.
 solution of the polymer has a
 viscosity of 75-150 centipoises at 25
 [deg]C as determined by LV-series
 Brookfield viscometer (or equivalent)
 using a No. 2 spindle at 60 r.p.m.
Acrylonitrile polymer, reaction product  For use only as a size promoter
 with ethylenediamine sulfate having a    and retention aid at a level
 nitrogen content of 22.5-25.0 percent    not to exceed 0.5 percent by
 (Kjeldahl dry basis) and containing no   weight of the dry paper and
 more than 0.075 percent monomer as       paperboard.
 ethylenediamine. The finished resin in
 a 24 percent by weight aqueous
 solution has a viscosity of 1,000-
 2,000 centipoises at 25 [deg]C as
 determined by LVT-series Brookfield
 viscometer using a No. 4 spindle at 50
 r.p.m. (or by other equivalent method).
Acrylonitrile polymer with styrene,      1. For use only as a sizing
 reaction product with ethylenediamine    material applied after the
 acetate, having a nitrogen content of    sheet-forming operation in the
 7.4-8.3 percent (Kjeldahl dry basis)     manufacture of paper and
 and containing no more than 0.25         paperboard in such amount that
 percent monomer as ethylenediamine.      the paper and paperboard will
                                          contain the additive at a
                                          level not in excess of 0.25
                                          percent by weight of the dry
                                          paper and paperboard.
                                         2. For use only as a sizing
                                          material applied prior to the
                                          sheet-forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the paper and paperboard will
                                          contain the additive at a
                                          level not in excess of 1.0
                                          percent by weight of the dry
                                          paper and paperboard.
1-Alkenyl olefins, containing not less   For use only under the
 than 72 percent of C30 and higher        following conditions:
 olefins.                                1. In coatings for paper and
                                          paperboard with food of Types
                                          I, II, IV-B, and VII-B
                                          described in table 1 of
                                          paragraph (c) of this section
                                          under conditions of use E, F,
                                          and G described in table 2 of
                                          paragraph (c) of this section.
                                         2. In coatings for paper and
                                          paperboard with food of Type
                                          VIII described in table I of
                                          paragraph (c) of this section
                                          under conditions of use A
                                          through H described in table 2
                                          of paragraph (c) of this
                                          section.
(2-Alkenyl) succinic anhydrides          For use only as a sizing agent
 mixture, in which the alkenyl groups     employed prior to the sheet-
 are derived from olefins which contain   forming operation in the
 not less than 95 percent of C15-C21      manufacture of paper and
 groups.                                  paperboard and limited to use
                                          at a level not to exceed 1
                                          percent by weight of the
                                          finished dry paper and
                                          paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic    For use only as stabilizers
 acid copolymers (CAS Reg. No. 27401-06-  employed prior to the sheet-
 5).                                      forming operation in the
                                          manufacture of paper and
                                          paperboard.
tert-Alkyl(C8-C16)mercaptans...........  For use only as polymerization-
                                          control agent.
Aluminum acetate.......................
2-Amino-2-methyl-1-propanol (CAS Reg.    For use as a dispersant for
 No. 124-68-5).                           pigment suspension at a level
                                          not to exceed 0.25 percent by
                                          weight of pigment. The
                                          suspension is used as a
                                          component of coatings for
                                          paper and paperboard under
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use E
                                          through G.
Ammonium bis(N-ethyl-2-                  For use only as an oil and
 perfluoroalkylsulfonamido ethyl)         water repellant at a level not
 phosphates, containing not more than     to exceed 0.17 pound (0.09
 15% ammonium mono (N-ethyl-2-            pound of fluorine) per 1,000
 perfluoroalkylsulfonamido ethyl)         square feet of treated paper
 phosphates, where the alkyl group is     or paperboard of a sheet basis
 more than 95% C8 and the salts have a    weight of 100 pounds or less
 fluorine content of 50.2% to 52.8% as    per 3,000 square feet of paper
 determined on a solids basis.            or paperboard, and at a level
                                          not to exceed 0.5 pound (0.26
                                          pound of fluorine) per 1,000
                                          square feet of treated paper
                                          or paperboard having a sheet
                                          basis weight greater than 100
                                          lb. per 3,000 square feet as
                                          determined by analysis for
                                          total fluorine in the treated
                                          paper or paperboard without
                                          correction for any fluorine
                                          that might be present in the
                                          untreated paper or paperboard,
                                          when such paper or paperboard
                                          is used as follows:
                                         1. In contact, under conditions
                                          of use C, D, E, F, G, or H
                                          described in table 2 of
                                          paragraph (c) of this section,
                                          with nonalcoholic food.
                                         2. In contact with bakery
                                          products of Type VII, VIII,
                                          and IX described in table I of
                                          paragraph (c) of this section
                                          under good manufacturing
                                          practices of commercial and
                                          institutional baking.
Ammonium persulfate....................
Ammonium thiosulfate...................
Ammonium zirconium carbonate (CAS Reg.   For use only as an
 No. 32535-84-5) and its tartaric acid    insolubilizer for binders used
 adduct.                                  in coatings for paper and
                                          paperboard, and limited to use
                                          at a level not to exceed 2.5
                                          percent by weight of coating
                                          solids.

[[Page 195]]

 
Ammonium zirconium citrate (CAS Reg.     For use as insolubilizers with
 No. 149564-62-5), ammonium zirconium     protein binders in coatings
 lactate-citrate (CAS Reg. No. 149564-    for paper and paperboard, at a
 64-7), ammonium zirconium lactate (CAS   level not to exceed 1.4
 Reg. No. 149564-63-6).                   percent by weight of coating
                                          solids.
Anionic polyurethane, produced by        For use only as a surface
 reacting the preliminary adduct formed   sizing agent at a level not to
 from the reaction of glyceryl            exceed 0.1 percent by weight
 monostearate and 2,4-                    of dry paper and paperboard.
 toluenediisocyanate with not more than
 10 mole percent N-methyldiethanolamine
 and not less than 90 mole percent
 dimethylolpropionic acid. The final
 product is a 15 to 20 percent by
 weight aqueous solution, having a
 Brookfield viscosity of 25 to 100
 centipoises at 24 [deg]C (75 [deg]F).
9,10-Anthraquinone (Chemical Abstracts   For use only as a pulping aid
 Service Registry No. 84-65-1) which      in the alkaline pulping of
 has a purity of not less than 98         lignocellulosic material at
 percent.                                 levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic material.
Aromatic petroleum hydrocarbon resin,    For use only as modifiers in
 hydrogenated (CAS Reg. No. 88526-47-     wax polymer blend coatings for
 0), produced by the catalytic            paper and paperboard at a
 polymerization of aromatic substituted   level not to exceed 50 weight-
 olefins from low boiling distillates     percent of the coating solids
 of cracked petroleum stocks with a       under conditions of use E, F,
 boiling point no greater than 220        and G identified in table 2 of
 [deg]C (428 [deg]F), and the             paragraph (c) of this section.
 subsequent catalytic reduction of the
 resulting aromatic petroleum
 hydrocarbon resin. The resin meets the
 following specifications: softening
 point 85 [deg]C (185 [deg]F) minimum,
 as determined by ASTM Method E 28-67
 (Reapproved 1982), ``Standard Test
 Method for Softening Point by Ring-and-
 Ball Apparatus,'' and aniline point 70
 [deg]C (158 [deg]F) minimum, as
 determined by ASTM Method D 611-82,
 ``Standard Test Methods for Aniline
 Point and Mixed Aniline Point of
 Petroleum Products and Hydrocarbon
 Solvents,'' which are incorporated by
 reference in accordance with 5 U.S.C.
 552(a) and 1 CFR part 51. Copies may
 be obtained from the American Society
 for Testing and Materials, 1916 Race
 St., Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC.
Azo-bisisobutyronitrile................  For use only as polymerization
                                          catalyst.
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative
 Registry No. 2634-33-5).                 in paper coating compositions
                                          and limited to use at a level
                                          not to exceed 0.01 mg/in\2\
                                          (0.0016 mg/cm\2\) of the
                                          finished paper and paperboard.
Benzoyl peroxide.......................   Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12-       For use only as an adjuvant to
 C18)amide.                               control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet
                                          forming operation.
Bis(methoxymethyl)tetrakis-              For use only under the
 [(octadecyloxy)-methyl]melamine resins   following conditions:
 having a 5.8-6.5 percent nitrogen       1. As a water repellant
 content (CAS Reg. No. 68412-27-1).       employed prior to the sheet-
                                          forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the finished paper and
                                          paperboard will contain the
                                          additive at a level not in
                                          excess of 1.6 percent by
                                          weight of the finished dry
                                          paper and paperboard fibers.
                                         2. The finished paper and
                                          paperboard will be used in
                                          contact with nonalcoholic
                                          foods only.
                                         3. As a water repellant
                                          employed after the sheet-
                                          forming operation in the
                                          manufacture of paper and
                                          paperboard in such amount that
                                          the finished paper and
                                          paperboard will contain the
                                          additive at a level not to
                                          exceed 1.6 percent by weight
                                          of the finished dry paper and
                                          paperboard fibers. The
                                          finished paper and paperboard
                                          will be used only in contact
                                          with food of Types I, II, IV-
                                          B, VI, VII-B, and VIII
                                          described in table 1 of
                                          paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS     For use only as an
 Reg. No. 52-51-7).                       antimicrobial/preservative in
                                          fillers, pigment slurries,
                                          starch sizing solutions, and
                                          latex coatings at levels not
                                          to exceed 0.01 percent by
                                          weight of those components.
Butanedioic acid, sulfo-1,4-di-(C9-C11   For use as a surface active
 alkyl) ester, ammonium salt (also        agent in package coating inks
 known as butanedioic acid, sulfo-1,4-    at levels not to exceed 3
 diisodecyl ester, ammonium salt [CAS     percent by weight of the
 Reg. No. 144093-88-9])..                 coating ink.
tert-Butyl hydroperoxide...............  For use only as polymerization
                                          catalyst.
tert-Butyl peroxide....................   Do.
Calcium isostearate....................  For use only with n-decyl
                                          alcohol as a stabilizing
                                          material for aqueous calcium
                                          stearate dispersions intended
                                          for use as components of
                                          coatings for paper and
                                          paperboard.
Carrageenan and salts of carrageenan as
 described in Sec. Sec.  172.620 and
 172.626 of this chapter.
Castor oil, hydrogenated...............
Castor oil, sulfated, ammonium,
 potassium, or sodium salt.
Cellulose, regenerated.................
Chloracetamide.........................  For use only as polymerization-
                                          control agent.

[[Page 196]]

 
Cobaltous acetate......................  For use only as polymerization
                                          catalyst.
Cumene hydroperoxide...................   Do.
Cyanoguanidine.........................  For use only:
                                         1. As a modifier for amino
                                          resins.
                                         2. As a fluidizing agent in
                                          starch and protein coatings
                                          for paper and paperboard.
n-Decyl alcohol........................  For use only with calcium
                                          isostearate as a stabilizing
                                          material for aqueous calcium
                                          stearate dispersions intended
                                          for use as components of
                                          coatings for paper and
                                          paperboard.
Dialdehyde guar gum....................  For use only as a wet-strength
                                          agent employed prior to the
                                          sheet-forming operation in the
                                          manufacture of paper and
                                          paperboard and used at a level
                                          not to exceed 1% by weight of
                                          the finished dry paper and
                                          paperboard fibers.
Dialdehyde locust bean gum.............   Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS  For use as a sizing agent at a
 Reg. No. 41319-54-4) manufactured by     level not to exceed 0.2
 the reaction of secondary amines         percent by weight of the dry
 derived from fatty acids of animal or    fiber.
 vegetable sources with phosgene.
Diallyldimethyl ammonium chloride        For use only as a retention and/
 polymer with acrylamide and potassium    or drainage aid employed prior
 acrylate, produced by copolymerizing     to the sheet-forming
 either (1) diallyldimethyl ammonium      operations in the manufacture
 chloride and acrylamide in a weight      of paper and paperboard and
 ratio of 50/50, with 4.4 percent of      limited to use at a level not
 the acrylamide subsequently hydrolyzed   to exceed 0.05 percent by
 to potassium acrylate or (2)             weight of the finished paper
 polymerized diallyldimethyl ammonium     and paperboard.
 chloride, acrylamide and potassium
 acrylate (as acrylic acid) in a weight
 ratio of 50/47.8/2.2, respectively, so
 that the finished resin in a 1 percent
 by weight aqueous solution (active
 polymer) has a viscosity of more than
 22 centipoises at 22 [deg]C (72
 [deg]F) as determined by LVF series,
 Brookfield Viscometer using No. 1
 spindle at 60 RPM (or by other
 equivalent method) (CAS Reg. No. 25136-
 75-8).
Diallyldimethylammonium chloride with    For use only as a drainage and/
 acrylamide (CAS Reg. No. 26590-05-6).    or retention aid employed
 The copolymer is produced by             prior to the sheet-forming
 copolymerizing diallyldimethylammonium   operation in the manufacture
 chloride with acrylamide in a weight     of paper and paperboard and
 ratio of 50-50 so that the finished      limited to use at a level not
 resin in a 1 percent by weight aqueous   to exceed 0.05 percent by
 solution (active polymer) has a          weight of the finished paper
 viscosity of more than 22 centipoises    and paperboard.
 at 22 [deg]C (71.6 [deg]F), as
 determined by LVF-series Brookfield
 viscometer using a No. 1 spindle at 60
 r.p.m. (or by other equivalent method).
Diallyldiethylammonium chloride polymer
 with acrylamide, and
 diallyldimethylammonium chloride,
 produced by copolymerizing acrylamide,
 diallyldiethylammonium chloride, and
 diallyldimethylammonium chloride,
 respectively, in the following weight
 ratios and having viscosities
 determined at 22 [deg]C, by LVF-series
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method), as follows:.
  1. Weight ratio: 50-2.5-47.5. The      For use only as a retention aid
   finished resin in a 1 percent by       employed prior to the sheet-
   weight aqueous solution has a          forming operation in the
   minimum viscosity of 22 centipoises.   manufacture of paper and
                                          paperboard and limited to use
                                          at a level not to exceed 0.05
                                          percent by weight of the
                                          finished paper and paperboard.
  2. Weight ratio: 25-2.5-72.5. The      For use only as a drainage and/
   finished resin in a 0.20 percent by    or retention aid employed
   weight aqueous solution has a          prior to the sheet-forming
   minimum viscosity of 20 centipoises.   operation in the manufacture
                                          of paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.075 percent by
                                          weight of the finished paper
                                          and paperboard.
  3. Weight ratio: 80-2.5-17.5. The      For use only as a drainage and/
   finished resin in a 0.30 percent by    or retention aid employed
   weight aqueous solution has a          prior to the sheet-forming
   minimum viscosity of 50 centipoises.   operation in the manufacture
                                          of paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.075 percent by
                                          weight of the finished paper
                                          and paperboard.

[[Page 197]]

 
Diallyldiethylammonium chloride polymer  For use only as a retention aid
 with acrylamide, potassium acrylate,     employed prior to the sheet-
 and diallyldimethylammonium chloride.    forming operation in the
 The polymer is produced by               manufacture of paper and
 copolymerizing either: (1) acrylamide,   paperboard and limited to use
 diallyldiethylammonium chloride, and     at a level not to exceed 0.05
 diallyldimethylammonium chloride in a    percent by weight of the
 weight ratio of 50-2.5-47.5,             finished paper and paperboard.
 respectively, with 4.4 percent of the
 acrylamide subsequently hydrolyzed to
 potassium acrylate, or (2) acrylamide,
 potassium acrylate (as acrylic acid),
 diallyldiethylammonium chloride, and
 diallyldimethylammonium chloride in a
 weight ratio of 47.8-2.2-2.5-47.5, so
 that the finished resin in a 1 percent
 by weight aqueous solution has a
 minimum viscosity of 22 centipoises at
 22 [deg]C, as determined by LVF-series
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method).
Diallyldimethylammonium chloride         For use only as a dry and wet
 polymer with acrylamide, reaction        strength agent employed prior
 product with glyoxal, produced by        to the sheet-forming operation
 copolymerizing not less than 90 weight   in the manufacture of paper
 percent of acrylamide and not more       and paperboard in such an
 than 10 weight percent of                amount that the finished paper
 diallyldimethylammonium chloride,        and paperboard will contain
 which is then cross-linked with not      the additive at a level not in
 more than 30 weight percent of           excess of 2 percent by weight
 glyoxal, such that a 10 percent          of the dry fibers in the
 aqueous solution has a minimum           finished paper and paperboard.
 viscosity of 25 centipoises at 25
 [deg]C as determined by Brookfield
 viscometer Model RVF, using a No. 1
 spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS   For use as a preservative at a
 Reg. No.10222-01-2)..                    level not to exceed 100 parts
                                          per million in coating
                                          formulations and in component
                                          slurries and emulsions, used
                                          in the production of paper and
                                          paperboard and coatings for
                                          paper and paperboard.
2,5-Di-tert-butyl hydroquinone.........  For use only as an antioxidant
                                          for fatty based coating
                                          adjuvants provided it is used
                                          at a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Diethanolamine.........................  For use only:
                                         1. As an adjuvant to control
                                          pulp absorbency and pitch
                                          content in the manufacture of
                                          paper and paperboard prior to
                                          the sheet-forming operation.
                                         2.In paper mill boilers.
Diethanolamine salts of mono- and bis    For use only as an oil and
 (1H,1H,2H,2H-perfluo roalkyl)            water repellant at a level not
 phosphates where the alkyl group is      to exceed 0.17 pound (0.09
 even-numbered in the range C8-C18 and    pound of fluorine) per 1,000
 the salts have a fluorine content of     square feet of treated paper
 52.4% to 54.4% as determined on a        or paperboard, as determined
 solids basis.                            by analysis for total fluorine
                                          in the treated paper or
                                          paperboard without correction
                                          for any fluorine which might
                                          be present in the untreated
                                          paper or paperboard, when such
                                          paper or paperboard is used in
                                          contact with nonalcoholic
                                          foods under the conditions of
                                          use described in paragraph (c)
                                          of this section, table 2,
                                          conditions of use (B) through
                                          (H).
Diethyl(2-hydroxyethyl) methylammonium   For use only as a retention aid
 methyl sulfate, acrylate, polymer with   and drainage aid employed
 acrylamide, chemical abstract service    prior to the sheet-forming
 registry No. [26796-75-8] having 90-95   operation in the manufacture
 mole pct. acrylamide, a nitrogen         of paper and paperboard at a
 content of not more than 19.7 pct.       level not to exceed 0.15 pct.
 (Kjeldahl, dry basis), and a residual    by weight of finished dry
 acrylamide monomer content of not more   paper and paperboard fibers.
 than 0.1 pct. The finished polymer in
 a 1 pct. by weight aqueous solution
 has a minimum viscosity of 900
 centipoises at 25 [deg]C as determined
 by LVT-series Brookfield viscometer
 using a No. 2 spindle at 12 r.p.m. (or
 by equivalent method).
Diethylenetriamine.....................  For use only as a modifier for
                                          amino resins.
N,N-Diisopropanolamide of tallow fatty   For use only as an adjuvant to
 acids.                                   control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Dimethylamine-epichlorohydrin copolymer  For use only:
 in which not more than 5 mole-percent   1. As a retention aid employed
 of dimethylamine may be replaced by an   before the sheet-forming
 equimolar amount of ethylenediamine      operation in the manufacture
 and in which the ratio of total amine    of paper and paperboard and
 to epichlorohydrin does not exceed       limited to use at a level not
 1:1. The nitrogen content of the         to exceed 1 percent by weight
 copolymer shall be 9.4 to 10.8 weight    of the finished paper and
 percent on a dry basis and a 10          paperboard.
 percent by weight aqueous solution of   2. At the size press at a level
 the final product has a minimum          not to exceed 0.017 percent by
 viscosity of 5.0 centipoises at 25       weight of the finished paper
 [deg]C, as determined by LVT-series      and paperboard.
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m. (or by other
 equivalent method).
N-[(Dimethylamino)methyl]-acrylamide     For use only as a dry-strength
 polymer with acrylamide and styrene      agent employed prior to the
 having a nitrogen content of not more    sheet-forming operation in the
 than 16.9 percent and a residual         manufacture of paper and
 acrylamide monomer content of not more   paperboard and used at a level
 than 0.2 percent on a dry basis.         not to exceed 1 percent by
                                          weight of finished dry paper
                                          or paperboard fibers.
N,N'-Dioleoylethylenediamine...........

[[Page 198]]

 
Diphenylamine..........................  For use only as an antioxidant
                                          for fatty based coating
                                          adjuvants provided it is used
                                          at a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Dipropylene glycol.....................
Disodium salt of 1,4-dihydro-9,10-       For use only as a catalyst in
 dihydroxyanthracene (CAS Reg. No.        the alkaline pulping of
 73347-80-5).                             lignocellulosic materials at
                                          levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic materials.
N,N'-Distearoylethylenediamine.........
n-Dodecylguanidine acetate.............  For use only as an
                                          antimicrobial agent in paper
                                          and paperboard under the
                                          following conditions:
 
1. For contact only with nonalcoholic
 food having a pH above 5 and provided
 it is used at a level not to exceed
 0.4 percent by weight of the paper and
 paperboard.
2. For use in the outer ply of
 multiwall paper bags for contact with
 dry food of Type VIII described in
 table I of paragraph (c) of this
 section and provided it is used at a
 level of 0.8 percent by weight of the
 paper.
n-Dodecylguanidine hydrochloride.......  For use only as an
                                          antimicrobial agent in paper
                                          and paperboard under the
                                          following conditions:
                                         1. For contact only with
                                          nonalcoholic food having a pH
                                          above 5 and provided it is
                                          used at a level not to exceed
                                          0.4 percent by weight of the
                                          paper and paperboard.
                                         2. For use in the outer ply of
                                          multiwall paper bags for
                                          contact with dry food of Type
                                          VIII described in table I of
                                          paragraph (c) of this section
                                          and provided it is used at a
                                          level of 0.8 percent by weight
                                          of the paper.
Fatty acids derived from animal and
 vegetable fats and oils and salts of
 such acids, single or mixed, as
 follows:
 Aluminum.
 Ammonium.
 Calcium.
 Magnesium.
 Potassium.
 Sodium.
 Zinc.
Ferric chloride........................
Ferrous ammonium sulfate...............
Fish oil, hydrogenated.................
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as
 described in Sec. Sec.  172.655 and
 172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111-30-8).  For use only as an
                                          antimicrobial agent in pigment
                                          and filler slurries used in
                                          the manufacture of paper and
                                          paperboard at levels not to
                                          exceed 300 parts per million
                                          by weight of the slurry
                                          solids.
Glyceryl lactostearate.................
Glyceryl mono-1,2-hydroxystearate......
Glyceryl monoricinoleate...............
Guar gum modified by treatment with      For use only as a retention aid
 [beta]-diethylamino- ethyl chloride      and/or drainage aid employed
 hydrochloride.                           prior to the sheet-forming
                                          operation in the manufacture
                                          of paper and paperboard.
Guar gum modified by treatment with not  For use only as a retention aid
 more than 25 weight percent of 2,3-      and/or internal size employed
 epoxypropyltri-methylammonium chloride   prior to the sheet-forming
 such that the finished product has a     operation in the manufacture
 maximum chlorine content of 4.5          of paper and paperboard, and
 percent, a maximum nitrogen content of   limited to use at a level: (1)
 3.0 percent, and a minimum viscosity     Not to exceed 0.15 percent by
 in 1-percent-by-weight aqueous           weight of the finished dry
 solution of 1,000 centipoises at 77      paper and paperboard fibers
 [deg]F, as determined by RV-series       intended for use in contact
 Brookfield viscometer (or equivalent)    with all types of foods,
 using a No. 3 spindle at 20 r.p.m.       except (2) not to exceed 0.30
                                          pct. by weight of the finished
                                          dried paper and paperboard
                                          fibers for use with
                                          nonalcoholic and nonfatty food
                                          of types identified under
                                          Types I, II, IV-B, VI-B, VII-
                                          B, and VIII of table I in par.
                                          (c) of this section.
N, N, N', N', N[dprime], N[dprime]-      For use only as a water-
 Hexakis (methoxymethyl)-1,3,5-triazine-  repellent applied to the
 2,4,6-triamine polymer with stearyl      surface of paper and
 alcohol, [alpha]-octadecenyl-omega-      paperboard at levels not to
 hydroxypoly(oxy-1,2-ethanediyl), and     exceed 1 percent by weight of
 alkyl (C20+) alcohols (CAS Reg. No.      the finished dry paperboard
 130328-24-4).                            fibers. The finished paper and
                                          paperboard will be used in
                                          contact with aqueous foods
                                          under conditions of use B
                                          through G as described in
                                          table 2 of paragraph (c) of
                                          this section.
Hexamethylenetetramine.................  For use only as polymerization
                                          cross-linking agent for
                                          protein, including casein.
Hydroquinone and the monomethyl or       For use only as an inhibitor
 monoethyl ethers of hydroquinone.        for monomers.

[[Page 199]]

 
Hydroxymethyl-5,5-dimethylhydantoin      For use only as a preservative
 (CAS Reg. No. 27636-82-4), mixture       in clay-type fillers at a
 with 1,3-bis(hydroxymethyl)-5,5-         level not to exceed a combined
 dimethylhydantoin (CAS Reg. No. 6440-    total of 1,200 milligrams/
 58-0).                                   kilograms hydroxymethyl-5,5-
                                          dimethylhydantoin and 1,3-
                                          bis(hydroxymethyl)-5,5-
                                          dimethylhydantoin in the
                                          filler.
Hydroxypropyl guar gum having a minimum  For use only as a dry strength
 viscosity of 5,000 centipoises at 25     and formation aid agent
 [deg]C., as determined by RV-series      employed prior to the sheet-
 Brookfield viscometer using a No. 4      forming operation in the
 spindle at 20 r.p.m. (or other           manufacture of paper and
 suitable method) and using a test        paperboard and used at a level
 sample prepared by dissolving 5 grams    not to exceed 1.5 percent by
 of moisture-free hydroxypropyl guar      weight of finished dry paper
 gum in 495 milliliters of a 70 percent   or paperboard fibers.
 by weight aqueous propylene glycol
 solution.
12-Hydroxystearic acid-polyethylene      For use only as a surfactant
 glycol block copolymers (CAS Reg. No.    for dispersions of
 70142-34-6) produced by the reaction     polyacrylamide retention and
 of polyethylene glycol (minimum          drainage aids employed prior
 molecular weight 200) with 12-           to the sheet forming operation
 hydroxystearic acid.                     in the manufacture of paper
                                          and paperboard.
Imidazolium compounds, 2-(C17 and C17-   For use only at a level not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
Isopropyl m- and p-cresols (thymol       For use only as an antioxidant
 derived).                                for fatty based coating
                                          adjuvants provided it is used
                                          as a level not to exceed
                                          0.005% by weight of coating
                                          solids.
Isopropyl peroxydicarbonate............  For use only as polymerization
                                          catalyst.
Japan wax..............................
Lanolin................................
Lauryl peroxide........................  For use only as polymerization
                                          catalyst.
Lauryl sulfate salts:
 Ammonium.
 Magnesium.
 Potassium.
 Sodium.
Lecithin, hydroxylated.................
Lignin sulfonate and its calcium,
 potassium, and sodium salts.
Maleic anhydride, polymer with ethyl     For use only as a deposit
 acrylate and vinyl acetate, hydrolyzed   control additive prior to the
 (CAS Reg. No. 113221-69-5) and/or its    sheet forming operation to
 ammonium, potassium, and sodium salts.   prevent scale buildup in the
                                          manufacture of paper and
                                          paperboard in contact with
                                          food, at a level not to exceed
                                          0.075 percent (as the acid) by
                                          weight of the dry paper and
                                          paperboard.
Methacrylic acid-acrylic acid copolymer  For use only as a boiler water
 (CAS Reg. No. 25751-21-7).               additive at a level not to
                                          exceed 50 parts per million in
                                          the boiler water.
N-methyldiallylamine hydrochloride       For use only as a retention
 polymer with epichlorohydrin having a    aid, flocculating agent, and
 nitrogen content of 4.8 to 5.9 percent   wet-strength agent employed in
 (Kjeldahl dry basis) such that a 20      the manufacture of paper and
 percent by weight aqueous solution has   paperboard prior to the sheet-
 a minimum viscosity of 30 centipoises    forming operation and limited
 and maximum viscosity of 100             to use at a level not to
 centipoises at 25 [deg]C, as             exceed 1.5 percent by weight
 determined by LVF Model Brookfield       of the dry paper and
 viscometer using a No. 1 spindle at 60   paperboard.
 r.p.m. (or equivalent method).
Methyl naphthalene sulfonic acid-        For use only as an adjuvant to
 formaldehyde condensate, sodium salt.    control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
N-methyl-N-(tall oil acyl) taurine,      For use only to control scale
 sodium salt (CAS Reg. No. 61791-41-1).   formation in the manufacture
                                          of paper and paperboard prior
                                          to the sheetforming operation
                                          at a level not to exceed 0.015
                                          percent by weight of the dry
                                          paper and paperboard.
Mineral oil, white.....................
Mono-, di-, tri-(1-methyl-1-             For use only as an emulsifier
 phenylethyl)-phenol, ethoxylated,        for rosin based sizing at a
 sulfated, ammonium salt with an          level not to exceed 0.03
 average of 12 to 16 moles of ethylene    percent by weight of the
 oxide (CAS Reg. No. 68130-71-2).         finished dry paper and
                                          paperboard.
Monoglyceride citrate..................
Monoisopropanolamine (CAS Reg. No. 78-   For use as a dispersant for
 96-6).                                   titanium dioxide suspensions
                                          at a level not to exceed 0.68
                                          percent by weight of titanium
                                          dioxide. The finished paper
                                          and paperboard will be used in
                                          contact with all food types
                                          under conditions of use E
                                          through G described in table 2
                                          of paragraph (c) of this
                                          section.
Mustardseed oil, sulfated, ammonium,
 potassium, or sodium salt.
Naphthalene sulfonic acid-formaldehyde   For use only as an adjuvant to
 condensate, sodium salt.                 control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Nitrocellulose, 10.9-12.2% nitrogen....
Oleic acid, sulfated, ammonium,
 potassium, or sodium salt.
N-Oleoyl-N'-stearoylethylenediamine....
Oxystearin.............................
Paraformaldehyde.......................  For use only as setting agent
                                          for protein.

[[Page 200]]

 
Pentanoic acid, 4,4-bis [(gamma-omega-   For use only as an oil and
 perfluoro-C8	20-alkyl)thio]              water repellent and used at a
 derivatives, compounds with              level not to exceed 8 pounds
 diethanolamine (CAS Reg. No. 71608-61-   per ton of the finished paper
 2).                                      or paperboard when such paper
                                          or paperboard is used in
                                          contact with nonalcoholic
                                          foods under conditions of use
                                          E through H described in table
                                          2 of paragraph (c) of this
                                          section.
Perfluoroalkyl acrylate copolymer (CAS   For use only as an oil and
 Reg. No. 92265-81-1) containing 35 to    water repellent at a level not
 40 weight percent fluorine, produced     to exceed 0.5 percent by
 by the copolymerization of               weight of the finished paper
 ethanaminium, N,N,N-trimethyl-2-[(2-     and paperboard in contact with
 methyl-1-oxo-2-propenyl)-oxy]-,          nonalcoholic foods under
 chloride; 2-propenoic acid, 2-methyl-,   conditions of use C, D, E, F,
 oxiranylmethyl ester; 2-propenoic        G, or H described in table 2
 acid, 2-ethoxyethyl ester; and 2-        of paragraph (c) of this
 propenoic acid, 2[[(heptadecafluoro-     section.
 octyl)sulfonyl] methyl amino]ethyl
 ester.
Perfluoroalkyl substituted phosphate     For use only as an oil and
 ester acids, ammonium salts formed by    water repellant at a level not
 the reaction of 2,2-bis[                 to exceed 0.44 percent
 ([gamma],[omega]-perfluoroC4-20          perfluoroalkyl actives by
 alkylthio) methyl]-1,3-propanediol,      weight of the finished paper
 polyphosphoric acid and ammonium         and paperboard in contact with
 hydroxide.                               non-alcoholic foods under
                                          condition of use H as
                                          described in table 2 of
                                          paragraph (c) of this section;
                                          and in contact with food of
                                          types III, IV-A, V, VII-A, and
                                          IX described in table 1 of
                                          paragraph (c) of this section
                                          under conditions of use C
                                          through G as described in
                                          table 2 of paragraph (c) of
                                          this section..
Petrolatum.............................  Complying with Sec.  178.3700
                                          of this chapter.
Petroleum asphalt, steam and vacuum      For use only as a component of
 refined to meet the following            internal sizing of paper and
 specifications: Softening point          paperboard intended for use in
 88[deg] C to 93[deg] C, as determined    contact only with raw fruits,
 by ASTM method D36-76, ``Standard Test   raw vegetables, and dry food
 Method for Softening Point of Bitumen    of the type identified under
 (Ring-and-Ball Apparatus);''             Type VIII of table 1 in
 penetration at 25[deg] C not to exceed   paragraph (c) of this section,
 0.3 mm, as determined by ASTM method     and provided that the asphalt
 D5-73 (Reapproved 1978), ``Standard      is used at a level not to
 Test Method for Penetration of           exceed 5% by weight of the
 Bituminous Materials,'' which are        finished dry paper and
 incorporated by reference (copies may    paperboard fibers.
 be obtained from the American Society
 for Testing Materials, 1916 Race St.,
 Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC 20408);
 and maximum weight loss not to exceed
 3% when distilled to 371[deg] C, nor
 to exceed an additional 1.1% when
 further distilled between 371[deg] C
 and thermal decomposition.
Petroleum wax, synthetic...............  Complying with Sec.  178.3720
                                          of this chapter.
Phenothiazine..........................  For use only as antioxidant in
                                          dry rosin size.
Phenyl acid phosphate..................  For use only as polymerization
                                          catalyst in melamine-
                                          formaldehyde modified alkyd
                                          coatings and limited to use at
                                          a level not to exceed 2% by
                                          weight of the coating solids.
Phenyl-[beta]-naphthylamine............  For use only as antioxidant in
                                          dry rosin size and limited to
                                          use at a level not to exceed
                                          0.4% by weight of the dry
                                          rosin size.
Phosphoric acid esters and polyesters    For use as an adjuvant prior to
 (and their sodium salts) of              the sheet forming operation to
 triethanolamine formed by the reaction   control pitch and scale
 of triethanolamine with polyphosphoric   formation in the manufacture
 acid to produce a mixture of esters      of paper and paperboard
 having an average nitrogen content of    intended for use in contact
 1.5 percent and an average phosphorus    with food only of the types
 content of 32 percent (as PO4).          identified in paragraph (c) of
                                          this section, table 1, under
                                          Types I, IV, V, VII, VIII, and
                                          IX, and used at a level not to
                                          exceed 0.075 percent by weight
                                          of dry paper or paperboard
                                          fibers.
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid
 (dimethyl-aminomethyl)acryl- amide],     and retention aid employed
 produced by reacting 2.40 to 3.12        prior to the sheet-forming
 parts by weight of polyacrylamide with   operation in the manufacture
 1.55 parts dimethylamine and 1 part      of paper and paperboard for
 formaldehyde, and containing no more     use in contact with fatty
 than 0.2 percent monomer as acrylamide.  foods under conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2- For use only as a retention and
 hydroxypropyl acrylate) produced when    drainage aid employed prior to
 one mole of hydroxypropyl acrylate and   the sheet-forming operation in
 three moles of acrylic acid are          the manufacture of paper and
 reacted with three moles of              paperboard at a level not to
 ethylenimine and three moles of nitric   exceed 0.2 percent by weight
 acid, such that a 35 percent by weight   of dry paper or paperboard
 aqueous solution has a minimum           fiber.
 viscosity of 150 centipoises at 72
 [deg]F., as determined by RVF-series
 Brookfield viscometer (or equivalent)
 using a No. 2 spindle at 20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite  For use only as an agent in
 (0.7 part) adduct, containing excess     modifying starches and starch
 bisulfite (ratio of excess bisulfite     gums used in the production of
 to adduct not to exceed 1.5 to 1).       paper and paperboard and
                                          limited to use at a level not
                                          to exceed 0.09 mg/in\2\ of the
                                          finished paper and paperboard.

[[Page 201]]

 
Poly[acrylamide-acrylic acid-N-          For use only as a drainage aid,
 (dimethylaminomethyl) acrylamide]        retention aid, or dry-strength
 (C.A. Registry No. 53800-41-2),          agent employed prior to the
 produced by reacting 9.6-16.4 parts by   sheet-forming operation in the
 weight of polyacrylamide with 1.6        manufacture of paper and
 parts dimethylamine and 1 part           paperboard at a level not to
 formaldehyde, and containing no more     exceed 0.25 percent by weight
 than 0.2% monomer as acrylamide, such    of finished dry paper and
 that a 20% aqueous solution has a        paperboard fibers, when such
 minimum viscosity of 4,000 cP at 25      paper or paperboard is used in
 [deg]C., as determined by Brookfield     contact with fatty foods under
 viscometer model RVT, using a No. 5      conditions of use described in
 spindle at 20 r/min (or equivalent       paragraph (c) of this section,
 method).                                 table 2, conditions of use E,
                                          F, and G.
Polyamide-epichlorohydrin modified       For use only as a retention aid
 resin produced by reacting adipic acid   and flocculant employed prior
 with diethylene triamine to produce a    to the sheet-forming operation
 basic polyamide which is modified by     in the manufacture of paper
 reaction with formic acid and            and paperboard and used at a
 formaldehyde and further reacted with    level not to exceed 0.2
 epichlorohydrin in the presence of       percent dry resin by weight of
 ammonium hydroxide to form a water-      finished dry paper or
 soluble cationic resin having a          paperboard fibers.
 nitrogen content of 13-16 percent
 (Kjeldahl, dry basis) such that a 35
 percent by weight aqueous solution has
 a minimum viscosity of 75 centipoises
 at 25 [deg]C, as determined by
 Brookfield viscom eter using a No. 1
 spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble  For use only under the
 thermosetting resins [CAS Reg. No.       following conditions:
 68583-79-9] prepared by reacting        1. As a retention aid employed
 adipic acid with diethylenetriamine to   prior to the sheet-forming
 form a basic polyamide and further       operation in the manufacture
 reacting the polyamide with an           of paper and paperboard and
 epichlorohydrin and dimethylamine        limited to use at a level not
 mixture such that the finished resins    to exceed 0.12 percent by
 have a nitrogen content of 17.0 to       weight of dry paper or
 18.0 percent of a dry basis, and that    paperboard.
 a 30-percent-by-weight aqueous          2. The finished paper or
 solution has a minimum viscosity of      paperboard will be used in
 350 centipoises at 20 [deg]C, as         contact with food only of the
 determined by a Brookfield viscometer    types identified in paragraph
 using a No. 3 spindle at 30 r.p.m. (or   (c) of this section, table 1,
 equivalent method).                      under types I and IV-B and
                                          under conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use F and G.
Polyamide-epichlorohydrin water-soluble  For use only as a wet strength
 thermosetting resin (CAS Reg. No.        agent and/or retention aid
 96387-48-3) prepared by reacting N-      employed prior to the sheet-
 methyl-bis(3-aminopropyl) amine with     forming operation in the
 oxalic acid and urea to form a basic     manufacture of paper and
 polyamide and further reacting the       paperboard and used at a level
 polyamide with epichlorohydrin.          not to exceed 1.5 percent by
                                          weight of dry paper and
                                          paperboard fibers.
Polyamide-epichlorohydrin water-soluble  For use only in the manufacture
 thermosetting resins prepared by         of paper and paperboard under
 reacting adipic acid, isophthalic        conditions such that the
 acid, itaconic acid or dimethyl          resins do not exceed 1.5
 glutarate with diethylenetriamine to     percent by weight of the paper
 form a basic polyamide and further       or paperboard.
 reacting the polyamide with one of the
 following:
  Epichlorohydrin.
  Epichlorohydrin and ammonia mixture.
  Epichlorohydrin and sodium
   hydrosulfite mixture.
Polyamidoamine-ethyleneimine-            For use only as a retention aid
 epichlorohydrin resin prepared by        employed prior to the sheet-
 reacting hexanedioic acid, N-(2-         forming operation in the
 aminoethyl)-1,2-ethanediamine,           manufacture of paper and
 (chloromethyl)oxirane, ethyleneimine     paperboard at a level not to
 (aziridine), and polyethylene glycol,    exceed 0.12 percent resin by
 partly neutralized with sulfuric acid    weight of the finished dry
 (CAS Reg. No. 167678-45-7).              paper or paperboard.
Polyamidol-epichlorohydrin modified      For use only as a wet strength
 resin produced by reacting glutaric      agent employed prior to the
 acid dimethyl ester with diethylene-     sheet-forming operation in the
 triamine to produce a basic polyamide    manufacture of paper and
 which is modified by reaction with       paperboard, and used at a
 formaldehyde and further reacted with    level not to exceed 2.5
 epicholorohydrin to form a water         percent by weight of dry paper
 soluble cationic resin having a          and paperboard fibers when
 nitrogen content of 10.9-11.9 percent    such paper or paperboard is
 and a chlorine content of 13.8-14.8      used in contact with food
 percent, on a dry basis, and a minimum   under conditions of use E
 viscosity, in 12.5 percent by weight     through G described in table 2
 aqueous solution, of 10 centipoises at   of paragraph (c) of this
 25 [deg]C, as determined by a            section.
 Brookfield Model LVF viscometer using
 a No. 1 spindle at 60 r.p.m. (or
 equivalent method).
Polyamine-epichlorohydrin resin          For use only as a flocculant,
 produced by the reaction of              drainage aid, formation aid,
 epichlorohydrin with monomethylamine     retention aid, or strength
 to form a prepoly mer and further        additive employed prior to the
 reaction of this prepolymer with         sheet-forming operation in the
 N,N,N',N'-tetramethylethylenediamine     manufacture of paper and
 such that the finished resin having a    paperboard, and used at a
 nitrogen content of 11.6 to 14.8         level not to exceed 0.12
 percent and a chlorine content of 20.8   percent by weight of dry paper
 to 26.4 percent and a minimum            and paperboard fibers.
 viscosity, in 25 percent by weight
 aqueous solution, of 500 centipoises
 at 25 [deg]C, as determined by LV-
 series Brookfield viscometer using a
 No. 2 spindle at 12 r.p.m. (or by
 other equivalent method).

[[Page 202]]

 
Polyamine-epichlorohydrin resin          For use only as a clarifier in
 produced by the reaction of N,N-         the treatment of influent
 dimethyl-1,3-propanediamine with         water to be used in the
 epichlorohydrin and further reacted      manufacture of paper and
 with sulfuric acid, Chemical Abstracts   paperboard, and used at a
 Service Registry Number [27029-41-0],    level not to exceed 20 parts
 such that the finished resin has a       per million of the influent
 maximum nitrogen content of 14.4         water.
 percent (dry basis) and a minimum
 viscosity in 30 percent by weight
 aqueous solution (pH 4-6) of 50
 centipoises at 25 [deg]C, as
 determined by Brookfield LVT model
 viscometer, using a No. 1 spindle at
 12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble  For use only as a wetstrength
 thermosetting resin produced by          agent and/or retention aid
 reacting epichlorohydrin with: (i)       employed prior to the sheet-
 polyamines comprising at least 95        forming operation in the
 percent by weight C4 to C6 aliphatic     manufacture of paper and
 diamines and/or their self-              paperboard, and used at a
 condensation products, and/or (ii)       level not to exceed 1 percent
 prepolymers produced by reacting 1,2-    by weight of dry paper and
 dichloroethane with the polyamines in    paperboard fibers.
 (i). The finished resin has a nitrogen
 content of 5.0 to 9.0 percent, a
 chlorine content of 18.0 to 35.0
 percent on a dry basis, and a minimum
 viscosity, in a 25 percent by weight
 aqueous solution, of 50 centipoises at
 20 [deg]C (68 [deg]F), as determined
 by Brookfield HAT model viscometer
 using a No. 1H spindle at 50 r.p.m.
 (or equivlent method).
Polyamine-epichlorohydrin water-soluble  For use only as a wet-strength
 thermosetting resin produced by          agent and/or retention aid
 reacting epichlorohydrin with: (i)       employed prior to the sheet-
 polyamines comprising at least 95        forming operation in the
 percent by weight C4 to C6 aliphatic     manufacture of paper and
 diamines and/or their seIf-              paperboard, and used at a
 condensation products and/or (ii)        level not to exceed 1 percent
 hexamethylenediamine, and/or (iii)       by weight of dry paper and
 bis(hexamethylene) triamine and higher   paperboard fibers.
 homologues, and/or (iv) prepolymers
 produced by reacting 1,2-
 dichloroethane with the polyamines in
 (i) and/or (ii) and/or (iii). The
 finished resin has a nitrogen content
 of 5.0 to 9.0 percent, a chlorine
 content of 18.0 to 35.0 percent on a
 dry basis, and a minimum viscosity, in
 a 25 percent by weight aqueous
 solution, of 50 centipoises at 20
 [deg]C (68 [deg]F), as determined by
 Brookfield HAT model viscometer using
 a No. 1H spindle at 50 r.p.m. (or
 equivalent method).
Polyamine-epichlorohydrin water soluble  For use only as a wet-strength
 thermosetting resin prepared by          agent and/or retention aid
 reacting hexamethylenediamine with 1,2-  employed prior to the sheet-
 di chloroethane to form a prepolymer     forming operation in the
 and further reacting this prepolymer     manufacture of paper and
 with epichlorohydrin. This resin is      paperboard, and used at a
 then reacted with nitrilotris            level not to exceed 1 percent
 (methylene-phosphonic acid),             by weight of dry paper and
 pentasodium salt, such that the          paperboard fibers.
 finished resin has a nitrogen content
 of 5.0-5.3 percent; a chlorine content
 of 29.7-31.3 percent; and a phosphorus
 content of 2.0-2.2 percent, on a dry
 basis, and a minimum viscosity, in 25
 percent by weight aqueous solution, of
 50 centipoises at 25 [deg]C., as
 determined on a Brookfield HAT model
 viscometer using a No. 1H spindle at
 50 r.p.m. (or equivalent method).
Polyamine resin produced by the          For use only as a retention aid
 reaction of 1,2-dichloroethane with      and/or flocculent employed
 bis(hexamethylene)triamine and higher    prior to the sheet-forming
 homologues such that the finished        operation in the manufacture
 resin has a nitrogen content of 13.0-    of paper and paperboard and
 15.0 percent on a dry basis, and a       used at a level not to exceed
 minimum viscosity in 25-percent-by-      0.1 percent by weight of dry
 weight aqueous solution of 75            paper or paperboard fibers.
 centipoises at 25 [deg]C., as
 determined by Brookfield HAT model
 viscometer using a No. 1 spindle at 50
 r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified  For use only as a wet-strength
 resin produced by reacting adipic acid   agent and/or retention aid
 with diethylenetriamine to produce a     employed prior to the sheet-
 polyamide which is modified by           forming operation in the
 reaction with diethylaminopropylamine    manufacture of paper and
 and further reacted with dichlor         paperboard, and used at a
 oethyl ether to form a polyamide         level not to exceed 0.5
 intermediate. This polyamide             percent by weight of the
 intermediate is then reacted with        finished dry paper and
 epichlorohydrin such that the finished   paperboard.
 resins have a nitrogen content of 10.9-
 12.4 percent (Kjeldahl, dry basis) and
 a minimum viscosity in 40 percent-by-
 weight aqueous solution of 250
 centipoises at 22 [deg]C, as
 determined by a Brookfield Model LVT
 viscometer using a No. 2 spindle at 30
 r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying      For use only as provided in
 with the identity prescribed under       Sec. Sec.  175.300, 178.3740
 Sec.  178.3740(b) of this chapter.      and 178.3860 of this chapter.

[[Page 203]]

 
Poly(diallyldimethylammonium chloride)   For use only:
 (CAS Reg. No. 26062-79-3) produced by   1. As a pigment dispersant and/
 the polymerization of                    or retention aid prior to the
 (diallyldimethylammonium chloride) so    sheet-forming operation in the
 that the finished resin has a nitrogen   manufacture of paper and
 content of 8.660.4 percent on a dry weight basis     level not to exceed 10 pounds
 and a minimum viscosity in a 40          of active polymer per ton of
 percent by weight aqueous solution of    finished paper and paperboard.
 1,000 centipoises at 25 [deg]C (77      2. As a pigment dispersant in
 [deg]F), determined by LVF Model         coatings at a level not to
 Brookfield Viscometer using a No. 3      exceed 3.5 pounds of active
 spindle at 30 r.p.m. (or equivalent      polymer per ton of finished
 method). The level of residual monomer   paper and paperboard.
 is not to exceed 1 percent by weight
 of the polymer (dry basis).
Poly (diallyldimethylammonium chloride)  For use only as a flocculant
 (CAS Reg. No. 26062-79-3) produced by    employed prior to the sheet-
 the polymerization of                    forming operation in the
 diallyldimethylammonium chloride so      manufacture of paper and
 that the finished resin has a nitrogen   paperboard, and used at a
 content of 8.660.4 percent on a dry basis and a      (10 parts per million) of
 minimum viscosity in a 15 weight-        influent water.
 percent aqueous solution of 10
 centipoises at 25 [deg]C (77 [deg]F),
 as determined by LVF Model Brookfield
 viscometer using a No. 1 spindle at 60
 r/min (or equivalent method). The
 level of residual monomer is not to
 exceed 1 weight-percent of the polymer
 (dry basis).
Poly(1,2-dimethyl-5-vinylpyridinium      For use only as an adjuvant
 methyl sulfate) having a nitrogen        employed in the manufacture of
 content of 5.7 to 7.3 percent and a      paper and paperboard prior to
 sulfur content of 11.7 to 13.3 percent   the sheet-forming operation.
 by weight on a dry basis and having a
 minimum viscosity in 30-percent-by-
 weight aqueous solution of 2,000
 centipoises at 25 [deg]C., as
 determined by LV-series Brookfield
 viscometer (or equivalent) using a No.
 4 spindle at 60 r.p.m.
Polyester resin produced by reacting     For use only as a surface-
 dimethylolpropionic acid (CAS Registry   sizing compound applied after
 No. 4767-03-7) as a comonomer, at no     the sheet-forming operation in
 more than 30 percent by weight of        the manufacture of paper and
 total polymer solids in reaction with    paperboard and limited to use
 2,2-dimethyl-1,3-propanediol, phthalic   at levels not to exceed 0.1
 anhydride and isophthalic acid, such     percent by weight of finished
 that the polyester resin has a           dry paper or paperboard.
 viscosity of 200-600 centipoises at 80
 [deg]F as determined by a Brookfield
 RVT viscometer using a number 3
 spindle at 50 rpm (or equivalent
 method).
Polyethylene, oxidized; complying with   For use only as component of
 the identity prescribed in Sec.         coatings that contact food
 177.1620(a) of this chapter.             only of the type identified
                                          under Type VII-B of table 1 in
                                          paragraph (c) of this section,
                                          and limited to use at a level
                                          not to exceed 50 percent by
                                          weight of the coating solids.
Polyethyleneamine mixture produced when  For use only as a retention aid
 1 mole of ethylene dichloride, 1.05      employed prior to the sheet-
 moles of ammonia, and 2 moles of         forming operation in the
 sodium hydroxide are made to react so    manufacture of paper and
 that a 10 percent aqueous solution has   paperboard.
 a minimum viscosity of 40 centipoises
 at 77 [deg]F, as determined by
 Brookfield viscometer using a No. 1
 spindle at 60 r.p.m.
Polyethylene glycol (200) dilaurate....  For use only as an adjuvant
                                          employed in the manufacture of
                                          paper and paperboard prior to
                                          the sheet-forming operation.
Polyethylene glycol (400) dioleate.....
Polyethylene glycol (400) esters of
 coconut oil fatty acids.
Polyethylene glycol (600) esters of
 tall oil fatty acids.
Polyethylene glycol (400) monolaurate..
Polyethylene glycol (600) monolaurate..
Polyethylene glycol (400) monooleate...
Polyethylene glycol (600) monooleate...
Polyethylene glycol (400) monostearate.
Polyethylene glycol (600) monostearate.
Polyethylene glycol (3,000)
 monostearate.
Polyethylenimine, produced by the        For use only as an adjuvant
 polymerization of ethylenimine.          employed prior to sheet
                                          formation in paper-making
                                          systems operated at a pH of
                                          4.5 or higher, and limited to
                                          use at a level not to exceed
                                          5% by weight of finished dry
                                          paper or paperboard fibers.
Poly(isobutene)/maleic anhydride         For use only as a surfactant
 adduct, diethanolamine reaction          for dispersions of
 product. The mole ratio of               polyacrylamide retention and
 poly(isobutene)/maleic anydride adduct   drainage aids employed prior
 to diethanolamine is 1:1.                to the sheet formation
                                          operation in the manufacture
                                          of paper and paperboard.
Polymethacrylic acid, sodium salt,       For use only as a coating
 having a viscosity in 30-percent-by-     adjuvant for controlling
 weight aqueous solution of 125-325       viscosity when used at a level
 centipoises at 25 [deg]C as determined   not to exceed 0.3% by weight
 by LV-series Brookfield viscometer (or   of coating solids.
 equivalent) using a No. 2 spindle at
 60 r.p.m.
Polymethacrylic acid, sodium salt,       For use only as a coating
 having a viscosity in 40-percent-by-     adjuvant for controlling
 weight aqueous solution of 400-700       viscosity when used at a level
 centipoises at 25 [deg]C, as             not to exceed 0.1% by weight
 determined by LV-series Brookfield       of coating solids.
 viscometer (or equivalent) using a No.
 2 spindle at 30 r.p.m.

[[Page 204]]

 
Poly[(methylimino)(2-                    For use only as a retention aid
 hydroxytrimethylene)hydrochlo ride]      employed prior to the sheet-
 produced by reaction of 1:1 molar        forming operation in such an
 ratio of methylamine and                 amount that finished paper and
 epichlorohydrin so that a 31-percent     paperboard will contain the
 aqueous solution at 25[deg] C has a      additive at a level not in
 Stokes viscosity range of 2.5-4.0 as     excess of 1 percent by weight
 determined by ASTM method D1545-76       of the dry paper and
 (Reapproved; 1981), ``Standard Test      paperboard.
 Method for Viscosity of Transparent
 Liquids by Bubble Time Method,'' which
 is incorporated by reference. Copies
 may be obtained from the American
 Society for Testing Materials, 1916
 Race St., Philadelphia, PA 19103, or
 may be examined at the Office of the
 Federal Register, 800 North Capitol
 Street, NW., suite 700, Washington, DC
 20408.
Poly[oxyethylene (dimethyliminio)        For use only to improve dry-
 ethylene (dimethyliminio) ethylene       strength of paper and
 dichloride] produced by reacting         paperboard and as a retention
 equimolar quantities of N,N,N,N-         and drainage aid employed
 tetramethylethylene-diamine and          prior to the sheet-forming
 dichlorethyl ether to yield a solution   operation in the manufacture
 of the solid polymer in distilled        of paper and paperboard and
 water at 25[deg] C with a reduced        limited to use at a level not
 viscosity of not less than 0.15          to exceed 0.1 percent by
 deciliter per gram as determined by      weight of the finished dry
 ASTM method D1243-79, ``Standard Test    paper and paperboard fibers.
 Method for -Dilute Solution Viscosity
 of Vinyl Chloride Polymers,'' which is
 incorporated by reference. Copies may
 be obtained from the American Society
 for Testing Materials, 1916 Race St.,
 Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC 20408).
 The following formula is used for
 determining reduced viscosity:.
  Reduced viscosity in terms of
   deciliters per gram=(t-t0)/(t-C),
  where:
  t=Solution efflux time
  to=Water efflux time
  C=Concentration of solution in terms
   of grams per deciliter
Polypropylene glycol (minimum molecular
 weight 1,000).
Potassium persulfate...................
2-Propenoic acid, telomer with sodium 2- For use only as a deposit
 methyl-2-[(1-oxo-2-propenyl)amino]-1-    control additive employed
 propane sulfonate and sodium             prior to the sheet forming
 phosphinate (CAS Reg. No. 110224-99-2).  operation in the manufacture
                                          of paper and paperboard and at
                                          a level not to exceed 0.15
                                          percent by weight of the dry
                                          paper and paperboard.
Propylene glycol alginate..............
Protein hydrolysate from animal hides
 or soybean protein condensed with
 oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium,
 potassium, or sodium salt.
Ricebran oil, sulfated ammonium,
 potassium, or sodium salt.
Rosin and rosin derivatives............  As provided in Sec.  178.3870
                                          of this chapter.
Siloxanes (silicones), dimethyl,          For use only as a component of
 isopropyl methyl, methyl 1-methyl-C9-    polyolefin coatings with Sec.
 49-alkyl (CAS Reg. No. 144635-08-5).      177.1520 of this chapter at a
                                          level not to exceed 3 percent
                                          by weight. The finished
                                          coating will be used only for
                                          paper and paperboard that
                                          contact food of types VI-A and
                                          VI-B of table 1 in paragraph
                                          (c) of this section, and under
                                          conditions of use C, D, and E,
                                          as described in table 2 in
                                          paragraph (c) of this section,
                                          with a maximum hot fill
                                          temperature of 200 [deg]F (94
                                          [deg]C).
Silver chloride-coated titanium dioxide  For use only as a preservative
                                          in polymer latex emulsions at
                                          a level not to exceed 2.2
                                          parts per million (based on
                                          silver ion concentration) in
                                          the dry coating.
Sodium carboxymethyl guar gum having a   For use only as a dry-strength
 minimum viscosity of 2,700 centipoises   and formation-aid agent
 at 25 [deg]C after 24 hours as           employed prior to the sheet-
 determined by RV-series Brookfield       forming operation in the
 viscometer (or equivalent) using a No.   manufacture of paper and
 4 spindle at 20 r.p.m. and using a       paperboard and used at a level
 test sample prepared by dissolving 8     not to exceed 1% by weight of
 grams of sodium carboxymethyl guar gum   finished dry paper or
 in 392 milliliters of 0.2-percent-by-    paperboard fibers.
 weight aqueous sodium o-phenylphenate
 solution.
Sodium dioctyl sulfosuccinate..........
Sodium formaldehyde sulfoxylate........  For use only as polymerization
                                          catalyst.
Sodium hypochlorite....................
Sodium N-methyl-N-oleyltaurate.........  For use only as an adjuvant to
                                          control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.

[[Page 205]]

 
Sodium nitrite.........................  For use only:
                                         1. At levels not to exceed 0.2%
                                          by weight of lubricants or
                                          release agents applied at
                                          levels not to exceed 1 lb. per
                                          ton of finished paper or
                                          paperboard.
                                         2. As an anticorrosion agent at
                                          levels not to exceed 0.2% by
                                          weight of wax emulsions used
                                          as internal sizing in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Sodium persulfate......................
Sodium polyacrylate....................  For use only:
                                         1. As a thickening agent for
                                          natural rubber latex coatings,
                                          provided it is used at a level
                                          not to exceed 2 percent by
                                          weight of coating solids.
                                         2. As a pigment dispersant in
                                          coatings at a level not to
                                          exceed 0.25 percent by weight
                                          of pigment.
Sodium poly(isopropenylphosphonate)      For use only in paper mill
 (CAS Reg. No. 118632-18-1).              boilers.
Sodium zinc potassium polyphosphate      For use only as a pigment
 (CAS Reg. No. 65997-17-3).               dispersant in coatings at a
                                          level not to exceed 1 percent
                                          by weight of pigment.
Sperm oil, sulfated, ammonium,
 potassium, or sodium salt.
Stannous oleate........................
Stearyl-2-lactylic acid and its calcium
 salt.
Styrene-butadiene copolymers produced
 by copolymerizing styrene-butadiene
 with one or more of the monomers:
 acrylamide, acrylic acid, fumaric
 acid, 2-hydroxyethyl acrylate,
 itaconic acid, methacrylic acid, and N-
 methylolacrylamide (CAS Reg. No. 53504-
 31-7). The finished copolymers shall
 contain not more than 10 weight
 percent of total polymer units derived
 from acrylic acid, fumaric acid, 2-
 hydroxyethyl acrylate, itaconic acid,
 and methacrylic acid, and shall
 contain not more than 3 weight percent
 of total polymer units derived from N-
 methylolacrylamide, and shall contain
 not more than 2 weight percent of
 polymer units derived from acrylamide..
Styrene-maleic anhydride copolymer,      For use only as a surface size
 amidated, ammonium sodium salt;          at a level not to exceed 1
 having, in a 25 percent by weight        percent by weight of paper or
 aqueous solution at pH 8.8, a minimum    paperboard substrate.
 viscosity of 600 centipoises at 25
 [deg]C as determined by Brookfield
 model LVT viscometer using a No. 3
 spindle at 60 r.p.m. (or equivalent
 method).
Styrene-maleic anhydride copolymer,      For use only:
 sodium salt (minimum molecular weight   1. As a coating thickening
 30,000).                                 agent at a level not to exceed
                                          1% by weight of coating
                                          solids.
                                         2. As surface size at a level
                                          not to exceed 1% by weight of
                                          paper or paperboard substrate.
Styrene-methacrylic acid copolymer,      For use only as a coating
 potassium salt (minimum molecular        thickening agent at a level
 weight 30,000).                          not to exceed 1% by weight of
                                          coating solids.
Synthetic wax polymer prepared by the    For use only as a component of
 catalytic po lymerization of alpha       petroleum wax and/or synthetic
 olefins such that the polymer has a      petroleum wax complying with
 maximum iodine number of 18 and a        Sec.  178.3710 or Sec.
 minimum number average molecular         178.3720 of this chapter at
 weight of 2,400.                         levels not to exceed 5 percent
                                          by weight of the wax:
                                         1. Under conditions of use F
                                          and G described in table 2 of
                                          paragraph (c) of this section
                                          for all foods.
                                         2. Under conditions of use E
                                          described in table 2 of
                                          paragraph (c) of this section
                                          for food Types I, II, IV-B,
                                          VI, VII-B and VIII as
                                          described in table 1 of
                                          paragraph (c) of this section.
Tallow.................................
Tallow alcohol.........................
Tallow alcohol, hydrogenated...........
Tallow fatty acid, hydrogenated........
Tallow hydrogenated....................
Tallow sulfated, ammonium, potassium,
 or sodium salt.
Tetraethylenepentamine.................  For use only as a modifier for
                                          amino resins.
1,4,4a,9a-Tetrahydro-9, 10-              For use only as a catalyst in
 anthracenedione (CAS Reg. No. 56136-14-  the alkaline pulping of
 2).                                      lignocellulosic materials at
                                          levels not to exceed 0.1
                                          percent by weight of the raw
                                          lignocellulosic materials.
N,N,N', N'-Tetramethylethylenediamine    For use only as a flocculent,
 polymer with bis-(2-chloroethyl)         drainage aid or retention aid
 ether, first reacted with not more       employed prior to the sheet
 than 5 percent by weight 1-chloro-2,3-   forming operation in the
 epoxypropane and then reacted with not   manufacture of paper and
 more than 5 percent by weight poly       paperboard and limited to use
 (acrylic acid) such that a 50 percent    at a level not to exceed 0.2
 by weight aqueous solution of the        percent by weight of the
 product has a nitrogen content of 4.7-   finished dry paper and
 4.9 percent and viscosity of 350-700     paperboard fibers.
 centipoises at 25 [deg]C as determined
 by LV series Brookfield viscometer
 using a No. 2 spindle at 60 r.p.m. (or
 by other equivalent method).

[[Page 206]]

 
Tetrasodium N- (1,2-dicarboxyethyl) - N  For use only as an emulsifier
 - octadecylsulfo-succinamate.            in aqueous dispersions of
                                          rosin sizes complying with
                                          Sec.  178.3870(a)(4) of this
                                          chapter and limited to use
                                          prior to the sheet-forming
                                          operation in the manufacture
                                          of paper and paperboard at a
                                          level not to exceed 0.02 pct
                                          by weight of finished paper
                                          and paperboard.
Triethanolamine........................  For use only to adjust pH
                                          during the manufacture of
                                          amino resins permitted for use
                                          as components of paper and
                                          paperboard.
Triethylene glycol adipic acid           For use only as a curl-control
 monoester produced by reacting           agent at a level not to exceed
 equimolar quantities of triethylene      2% by weight of coated or
 glycol and adipic acid.                  uncoated paper and paperboard.
Triethylenetetramine...................  For use only as a modifier for
                                          amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine   For use only as an
 (CAS Registry No. 7779-27-3).            antimicrobial agent for
                                          coating, binder, pigment,
                                          filler, sizing, and similar
                                          formulations added prior to
                                          the heat drying step in the
                                          manufacture of paper and
                                          paperboard and limited to use
                                          at a level between 0.05 and
                                          0.15 percent by weight of the
                                          formulation.
Undecafluorocyclohexanemethanol ester    For use only as an oil
 mixture of dihydrogen phosphate,         repellent at a level not to
 compound with 2,2' iminodiethanol        exceed 0.087 lb (0.046 lb of
 (1:1); hydrogen phosphate, compound      fluorine) per 1,000 ft\2\ of
 with 2,2'-iminodiethanol (1:1); and      treated paper or paperboard,
 P,P'-dihydrogen pyrophosphate,           as determined by analysis for
 compound with 2,2'-iminodiethanol        total fluorine in the treated
 (1:2); where the ester mixture has a     paper or paperboard without
 fluorine content of 48.3 pct to 53.1     correction for any fluorine
 pct as determined on a solids basis.     which might be present in the
                                          untreated paper or paperboard,
                                          when such paper or paperboard
                                          is used in contact with food
                                          only of the types identified
                                          in paragraph (c) of this
                                          section, table 1, under Types
                                          IVA, V, VIIA, VIII, and IX,
                                          and under the conditions of
                                          use B through G described in
                                          table 2 of paragraph (c) of
                                          this section.
Viscose rayon fibers...................
Wax, petroleum.........................  Complying with Sec.  178.3710
                                          of this chapter.
Xanthan gum, conforming to the identity  For use only at a maximum level
 and specifications prescribed in Sec.   of 0.125 percent by weight of
  172.695 of this chapter, except that    finished paper as a suspension
 the residual isopropyl alcohol shall     aid or stabilizer for aqueous
 not exceed 6,000 parts per million.      pigment slurries employed in
                                          the manufacture of paper and
                                          paperboard.
Xylene sulfonic acid-formaldehyde        For use only as an adjuvant to
 condensate, sodium salt.                 control pulp absorbency and
                                          pitch content in the
                                          manufacture of paper and
                                          paperboard prior to the sheet-
                                          forming operation.
Zeolite Na-A (CAS Reg. No. 68989-22-0).  For use as a pigment extender
                                          at levels not to exceed 5.4
                                          percent by weight of the
                                          finished paper and paperboard.
Zinc formaldehyde sulfoxylate..........  For use only as polymerization
                                          catalyst.
Zinc octoate...........................
Zirconium oxide........................  For use only as a component of
                                          waterproof coatings where the
                                          zirconium oxide is present at
                                          a level not to exceed 1
                                          percent by weight of the dry
                                          paper or paperboard fiber and
                                          where the zirconium oxide is
                                          produced by hydrolysis of
                                          zirconium acetate.
------------------------------------------------------------------------

    (b) Substances identified in paragraphs (b) (1) and (2) of this 
section may be used as components of the food-contact surface of paper 
and paperboard, provided that the food-contact surface of the paper or 
paperboard complies with the extractives limitations prescribed in 
paragraph (c) of this section.
    (1) Substances identified in Sec. 175.300(b)(3) of this chapter 
with the exception of those identified in paragraphs (b)(3) (v), (xv), 
(xx), (xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of 
this section.
    (2) Substances identified in this paragraph (b)(2) follow:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
Acrylamide copolymerized with ethyl
 acrylate and/or stryene and/or
 methacrylic acid, subsequently reacted
 with formaldehyde and butyl alcohol.
Acrylamide copolymerized with ethylene   For use only as coatings or
 and vinyl chloride in such a manner      components of coatings.
 that the finished copolymers have a
 minimum weight average molecular
 weight of 30,000 and contain not more
 than 3.5 weight percent of total
 polymer units derived from acrylamide,
 and in such a manner that the
 acrylamide portion may or may not be
 subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic    For use only in coatings at a
 acid, homopolymer, sodium salt (CAS      level not to exceed 0.01 mg/
 Reg. No. 35641-59-9).                    in2
Acrylic and modified acrylic polymers..  Complying with Sec.  177.1010
                                          of this chapter.

[[Page 207]]

 
Acrylic copolymers produced by
 copolymerizing 2 or more of the
 acrylate monomers butyl acrylate,
 ethyl acrylate, ethyl methacrylate,
 methyl acrylate, methyl methacrylate,
 and n-propyl methacrylate, or produced
 by copolymerizing one or more of such
 acrylate monomers together with one or
 more of the monomers acrylic acid,
 acrylonitrile, butadiene, 2-ethyl-
 hexyl acrylate, fumaric acid, glycidyl
 methacrylate, n-hexyl-methacrylate,
 itaconic acid, methacrylic acid,
 styrene, vinyl acetate, vinyl
 chloride, and vinylidene chloride. The
 finished copolymers shall contain at
 least 50 weight percent of polymer
 units derived from one or more of the
 monomers butyl acrylate, ethyl
 acrylate, ethyl methacrylate, methyl
 acrylate, methyl methacrylate, and n-
 propyl methacrylate; and shall contain
 not more than 5 weight percent of
 total polymer units derived from
 acrylic acid, fumaric acid, glycidyl
 methacrylate, n-hexyl methacrylate,
 itaconic acid, and methacrylic acid.
 The provision limiting the finished
 acrylic copolymers to not more than 5
 units derived from acrylic acid,
 fumaric acid, glycidyl methacrylate, n-
 hexyl methacrylate, itaconic acid, and
 methacrylic acid is not applicable to
 finished acrylic copolymers used as
 coating adjuvants at a level not
 exceeding 2 weight percent of total
 coating solids.
Alkyl mono- and disulfonic acids,        For use only:
 sodium salts (produced from n-alkanes   1. As emulsifiers for
 in the range of C10-C18 with not less    vinylidene chloride copolymer
 than 50 percent C14-C16)..               coatings and limited to use at
                                          levels not to exceed 2 percent
                                          by weight of the coating
                                          solids.
                                         2. As emulsifiers for
                                          vinylidene chloride copolymer
                                          or homopolymer coatings at
                                          levels not to exceed a total
                                          of 2.6 percent by weight of
                                          coating solids. The finished
                                          polymer contacts food only of
                                          types identified in paragraph
                                          (c) of this section, table 1,
                                          under Types I, II, III, IV, V,
                                          VIA, VIB, VII, VIII, and IX
                                          and under conditions of use E,
                                          F, and G described in table 2
                                          of paragraph (c) of this
                                          section.
2-Bromo-4'-hydroxyacetophenone.........  For use only as a preservative
                                          for coating formulations,
                                          binders, pigment slurries, and
                                          sizing solutions at a level
                                          not to exceed 0.006 percent by
                                          weight of the coating,
                                          solution, slurry or emulsion.
Butylbenzyl phthalate..................  Complying with Sec.  178.3740
                                          of this chapter.
Butyl oleate, sulfated, ammonium,
 potassium, or sodium salt.
Butyraldehyde..........................
Captan (N-trichloromethylmercapto-4-     For use only as a mold- and
 cyclohexene-1, 2-dicarboximide).         mildew-proofing agent in
                                          coatings intended for use in
                                          contact with food only of the
                                          types identified in paragraph
                                          (c) of this section, table 1,
                                          under Type I, II, VI-B, and
                                          VIII.
Castor Oil, polyoxyethylated (42 moles   For use only as an emulsifier
 ethylene oxide).                         in nitrocellulose coatings for
                                          paper and paperboard intended
                                          for use in contact with food
                                          only of the types identified
                                          in paragraph (c) of this
                                          section, table 1, under Types
                                          IV A, V, VII A, VIII, and IX;
                                          and limited to use at a level
                                          not to exceed 8 percent by
                                          weight of the coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1-        For use only:
 azoniaadamantane chloride (CAS Reg.     1. As a preservative at a level
 No. 4080-31-3).                          of 0.3 weight percent in
                                          latexes used as pigment
                                          binders in paper and
                                          paperboard intended for use in
                                          contact with nonacidic,
                                          nonalcoholic food and under
                                          the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. As a preservative at a level
                                          not to exceed 0.07 weight
                                          percent in latexes and 0.05
                                          weight percent in pigment
                                          slurries used as components of
                                          coatings for paper and
                                          paperboard intended for use in
                                          contact with food.
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only:
 (CAS Reg. No. 26172-55-4) and 2-methyl- 1. As an antimicrobial agent
 4-isothiazolin-3-one (CAS Reg. No.       for polymer latex emulsions in
 2682-20-4) mixture at a ratio of 3       paper coatings at a level not
 parts to 1 part, manufactured from       to exceed 50 parts per million
 methyl-3-mercaptopropionate (CAS Reg.    (based on isothiazolone active
 No. 2935-90-2). The mixture may          ingredients) in the coating
 contain magnesium nitrate (CAS Reg.      formulation.
 No. 10377-60-3) at a concentration      2. As an antimicrobial agent
 equivalent to the isothiazolone active   for finished coating
 ingredients (weight/weight).             formulations and for additives
                                          used in the manufacture of
                                          paper and paperboard including
                                          fillers, binders, pigment
                                          slurries, and sizing solutions
                                          at a level not to exceed 25
                                          parts per million (based on
                                          isothiazolone active
                                          ingredients) in the coating
                                          formulations and additives.
Copper 8-quinolinolate.................  For use only as preservative
                                          for coating formulations.

[[Page 208]]

 
Cyclized rubber produced when natural    For use only in coatings for
 pale crepe rubber dissolved in phenol    paper and paperboard intended
 is catalytically cyclized so that the    for use in contact with food
 finished cyclized rubber has a melting   only of the types identified
 point of 145 [deg]C to 155 [deg]C as     in paragraph (c) of this
 determined by ASTM method E28-67         section, table 1, under Types
 (Reapproved 1982), ``Standard Test       VIII and IX.
 Method for Softening Point by Ring-and-
 Ball Apparatus,'' which is
 incorporated by reference (copies may
 be obtained from the American Society
 for Testing Materials, 1916 Race St.,
 Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC 20408),
 and contains no more than 4000 ppm of
 residual-free phenol as determined by
 a gas liquid chromatographic procedure
 titled ``Determination of Free Phenol
 in Cyclized Rubber Resin,'' which is
 incorporated by reference. Copies are
 available from the Center for Food
 Safety and Applied Nutrition (HFS-
 200), Food and Drug Administration,
 5100 Paint Branch Pkwy., College Park,
 MD 20740, or available for inspection
 at the Office of the Federal Register,
 800 North Capitol Street, NW., suite
 700, Washington, DC 20408.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg.  For use only as a preservative
 No. 35691-65-7).                         at levels not more than 0.05
                                          weight percent and not less
                                          than 0.01 weight percent: in
                                          latexes used as pigment
                                          binders in coatings; in
                                          pigment slurries used in
                                          coatings; and/or in coatings
                                          themselves. The total level of
                                          the preservative in the
                                          finished coating shall not
                                          exceed 0.04 weight percent of
                                          the finished coating solids.
Dibutyl phthalate......................
Dibutyl sebacate.......................
Di(C7,C9-alkyl) adipate................  Complying with Sec.  178.3740
                                          of this chapter.
Dicyclohexyl phthalate.................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer
 No. 120-55-8).                           for polyvinyl acetate coatings
                                          at a level not to exceed 5
                                          percent by weight of the
                                          coating solids under
                                          conditions described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use E,
                                          F, and G.
Diethylene glycol ester of the adduct
 of terpene and maleic anhydride.
Dihydroxy dichlorodiphenyl methane.....  For use only as preservative
                                          for coating formulations.
Dimethylpolysiloxane, 100 centistokes
 viscosity.
Dimethylpolysiloxane-beta-phenylethyl
 methyl polysiloxane copolymer (2:1),
 200 to 400 centistokes viscosity.
N,N'-Diphenyl-p-phenylenediamine.......  For use only as polymerization
                                          inhibitor in 2-sulfoethyl
                                          methacrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg.  1. For use only as a
 No. 27138-31-4).                         plasticizer for polyvinyl
                                          acetate coatings at a level
                                          not to exceed 5 percent by
                                          weight of the coating solids
                                          under conditions described in
                                          paragraph (c) of this section,
                                          table 2, condition of use E.
                                         2. For use only as a
                                          plasticizer for polyvinyl
                                          acetate coatings at a level
                                          not to exceed 10 percent by
                                          weight of the coating solids
                                          under conditions described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use F
                                          and G.
Disodium N-octadecylsulfosuccinamate...  For use only as an emulsifier
                                          in resin latex coatings and
                                          limited to use at a level not
                                          to exceed 0.05% by weight of
                                          the coating solids.
EDTA (ethylenediaminetetraacetic acid)
 and its sodium and/or calcium salts.
Ethanedial, polymer with tetrahydro-4-   For use only as an
 hydroxy-5-methyl-2(1H)pyrimidinone,      insolubilizer for starch-based
 propoxylated (CAS Reg. No. 118299-90-    coatings and limited to use at
 4).                                      a level not to exceed 5.0
                                          percent by weight of the
                                          coating.
Ethylene-acrylic acid copolymers
 produced by the copolymerization of
 ethylene and acrylic acid and/or their
 partial ammonium salts. The finished
 copolymer shall contain no more than
 25 weight percent of polymer units
 derived from acrylic acid and no more
 than 0.35 weight percent of residual
 monomeric acrylic acid, and have a
 melt index not to exceed 350 as
 determined by ASTM method D1238-82,
 ``Standard Test Method for Flow Rates
 of Thermoplastics by Extrusion
 Plastometer,'' which is incorporated
 by reference. Copies may be obtained
 from the American Society for Testing
 Materials, 1916 Race St.,
 Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC 20408.
Formaldehyde...........................  For use only as preservative
                                          for coating formulations.

[[Page 209]]

 
Glyoxal................................  For use only as an
                                          insolubilizing agent in starch-
                                           and protein-based coatings
                                          that contact nonalcoholic
                                          foods, and limited to use at a
                                          level not to exceed 6 percent
                                          by weight of the starch or
                                          protein fraction of the
                                          coating solids.
Glyceryl monobutyl ricinoleate.........
Hydroxymethyl derivatives (mixture of    For use only as a comonomer in
 mono and poly) of [N-(1, 1-dimethyl-3-   polyvinyl acetate latex
 oxobutyl) acrylamide] produced by        coatings and limited to use at
 reacting 1 mole of the [N-(1,1-          a level not to exceed 1
 dimethyl-3-oxobutyl) acrylamide] with    percent by weight of dry
 3 moles of formaldehyde such that the    polymer solids.
 finished product has a maximum
 nitrogen content of 6.2 percent and a
 maximum hydroxyl content of 15 percent
 by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium,
 potassium, or sodium salt.
Maleic anhydride adduct of butadiene-
 styrene copolymer.
[alpha]-Methylstyrene-vinyltoluene
 copolymer resins (molar ratio 1[alpha]-
 methylstyrene to 3 vinyltoluene).
Modified kaolin clay (CAS Reg. No. 1344- For use only as a component of
 00-9) is produced by the reaction of     coatings in paper and
 sodium silicate (CAS Reg. No. 1344-09-   paperboard products at a level
 8) and kaolinite clay (CAS Reg. No.      not to exceed 9 percent by
 1332-58-7) under hydrothermal            weight of the coating intended
 conditions. The reaction product has a   for use in contact with food
 molecular weight between 246 and 365     of Types I through IX
 and consists of 46 to 55 percent         described in table 1 of
 silicon dioxide (Si02), 28 to 42         paragraph (c) of this section
 percent aluminum oxide (A1203), and 2    under conditions of use C
 to 7 percent of sodium oxide (Na20).     through H described in table 2
 The reaction product will not consist    of paragraph (c) of this
 of more than 70 percent modified         section.
 kaolin clay.
Naphthalene sulfonic acid-formaldehyde
 condensate, sodium salt.
Oleyl alcohol..........................
Oxazolidinylethylmethacrylate (CAS       For use only as a binder for
 Registry No. 46236-15-1) copolymer       pigment coatings as a binder
 with ethyl acrylate and methyl           level not to exceed 4.0
 methacrylate, and containing not more    percent by weight of dry paper
 than 6 percent by weight of              or paperboard.
 oxazolidinylethylmethacrylate. Maximum
 nitrogen content shall be 0.5 percent
 and number average molecular weight of
 that portion of the copolymer soluble
 in tetrahydrofuran shall be not less
 than 50,000.
Pentaerythritol tetrastearate..........
Petroleum alicyclic hydrocarbon resins,  For use only as modifiers in
 or the hydrogenated product thereof,     waxpolymer blend coatings for
 meeting the following specifications:    corrugated paperboard intended
 Softening point 97 [deg]C minimum, as    for use in bulk packaging or
 determined by ASTM method E28-67         raw fruits, raw vegetables,
 (Reapproved 1982), ``Standard Test       iced meat, iced fish, and iced
 Method for Softening Point by Ring and   poultry; and limited to use at
 Ball Apparatus;'' aniline point 120      a level not to exceed 30
 [deg]C minimum, as determined by ASTM    weight-percent of the coating
 method D611-82, ``Standard Test          solids.
 Methods for Aniline Point and Mixed
 Aniline Point of Petroleum Products
 and Hydrocarbon Solvents,'' which are
 incorporated by reference (copies may
 be obtained from the American Society
 for Testing Materials, 1916 Race St.,
 Philadelphia, PA 19103, or may be
 examined at the Office of the Federal
 Register, 800 North Capitol Street,
 NW., suite 700, Washington, DC 20408).
 Specific gravity 0.96-0.99 (20 [deg]C/
 20 [deg]C). Such petroleum hydrocarbon
 resins are produced by the catalytic
 polymerization of dienes and olefins
 from low-boiling distillates of
 cracked petroleum stocks that contain
 no material boiling over 200 [deg]C
 and that meet the ultraviolet
 absorbance limits prescribed in Sec.
 172.880(b) of this chapter when
 subjected to the analytical procedure
 described in Sec.  172.886(b) of this
 chapter, modified as follows: Treat
 the product as in the first paragraph
 under ``Procedure'' in Sec.
 172.250(b)(3) of this chapter. Then
 proceed with Sec.  172.886(b) of this
 chapter, starting with the paragraph
 commencing with ``Promptly complete
 transfer of the sample * * *''.
Polyester resin formed by the reaction
 of the methyl ester of rosin, phthalic
 anhydride, maleic anhydride and
 ethylene glycol, such that the
 polyester resin has an acid number of
 4 to 11, a drop-softening point of 70
 [deg]C-92 [deg]C., and a color of K or
 paler.
Polyester resin produced by reacting
 the acid groups in montan wax with
 ethylene glycol.
Polyethylene, oxidized.................  Complying with Sec.  177.1620
                                          of this chapter.
Polyethylene reacted with maleic
 anhydride such that the modified
 polyethylene has a saponification
 number not in excess of 6 after
 Soxhlet extraction for 24 hours with
 anhydrous ethyl alcohol.
Polyoxyethylated (40 moles) tallow       Not to exceed 300 p.p.m. in
 alcohol sulfate, sodium salt.            finished coated paper or
                                          paperboard.

[[Page 210]]

 
Polyoxypropylene-polyoxyethylene block
 polymers (minimum molecular weight
 6,800).
Polyvinyl acetate......................
Polyvinyl alcohol (minimum viscosity of
 4% aqueous solution at 20 [deg]C. of 4
 centipoises).
Polyvinyl butyral......................
Polyvinyl formal.......................
Polyvinylidene chloride................
Polyvinyl pyrrolidone..................
Polyvinyl stearate.....................
Propylene glycol mono- and diesters of
 fats and fatty acids.
Siloxanes and silicones; platinum-       For use only as a surface
 catalyzed reaction product of vinyl-     coating. Platinum content not
 containing dimethyl polysiloxane (CAS    to exceed 200 parts per
 Reg. Nos. 68083-19-2 and 68083-18-1)     million.
 with methyl hydrogen polysiloxane (CAS  1. In coatings for paper and
 Reg. No. 63148-57-2) or dimethyl         paperboard provided the
 (methyl hydrogen) polysiloxane (CAS      coating contacts food only of
 Reg. No. 68037-59-2). Diallyl maleate    the types identified in
 (CAS Reg No. 999-21-3), dimethyl         paragraph (c) of this section,
 maleate (CAS Reg. No. 624-48-6), 1-      table 1, under Types I, II,
 ethynyl-1-cyclohexanol (CAS Reg. No.     VI, and VII-B when used under
 78-27-3) and vinyl acetate (CAS Reg.     conditions of use E, F, and G
 No. 108-05-4) may be used as optional    described in table 2 of
 polymerization inhibitors.               paragraph (c) of this section.
                                         2. In coatings for paper and
                                          paperboard provided the
                                          coating contacts food only of
                                          the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types III, IV,
                                          V, VII-A, VIII, and IX when
                                          used under conditions of use A
                                          through H described in table 2
                                          of paragraph (c) of this
                                          section.
Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives.
 with methyl hydrogen polysiloxane (CAS
 Reg. No. 63148-57-2). Dimethyl maleate
 (CAS Reg. No. 624-48-6), vinyl acetate
 (CAS Reg. No. 108-05-4), dibutyl
 maleate (CAS Reg. No. 105-76-0) and
 diallyl maleate (CAS Reg. No. 999-21-
 3) may be used as optional
 polymerization inhibitors. The polymer
 may also contain C16-C18 olefins (CAS
 Reg. No. 68855-60-7) as a control
 release agent.
Sodium decylbenzenesulfonate...........
Sodium dihexyl sulfosuccinate..........
Sodium n-dodecylpolyethoxy (50 moles)    For use only as an emulsifier
 sulfate-sodium                           in coatings that contact food
 isododecylphenoxypolyethoxy (40 moles)   only of the types identified
 sulfate mixtures.                        in paragraph (c) of this
                                          section, table 1, under Types
                                          IV-A, V, VII, VIII, and IX;
                                          and limited to use at levels
                                          not to exceed 0.75 percent by
                                          weight of the coating solids.
Sodium 2-ethylhexyl sulfate............
Sodium oleoyl isopropanolamide
 sulfosuccinate.
Sodium pentachlorophenate..............  For use only as preservative
                                          for coating formulations.
Sodium o-phenylphenate.................   Do.
Sodium vinyl sulfonate polymerized.....
Sodium xylenesulfonate (CAS Reg. No.     For use only in paper and
 1300-72-7).                              paperboard coatings at levels
                                          not to exceed 0.01 percent by
                                          weight of the finished paper
                                          and paperboard.
Styrene copolymers produced by           For use only as a coating or
 copolymerizing styrene with maleic       component of coatings and
 anhydride and its methyl and butyl       limited to use at a level not
 (sec- or iso-) esters. Such copolymers   to exceed 1% by weight of
 may contain [beta]-nitrostyrene as a     paper or paperboard substrate.
 polymerization chain terminator.
Styrene polymers made by the             For use only in contact with
 polymerization of any combination of     foods of Types IV-A, V, and
 styrene or alpha methyl styrene with     VII in table 1 of paragraph
 acrylic acid, methacrylic acid, 2-       (c) of this section, under use
 ethyl hexyl acrylate, methyl             conditions E through G in
 methacrylate, and butyl acrylate. The    table 2 of paragraph (c), and
 styrene and alpha methyl styrene,        with foods of Types VIII and
 individually, may constitute from 0 to   IX without use temperature
 80 weight percent of the polymer. The    restriction.
 other monomers, individually, may be
 from 0 to 40 weight percent of the
 polymer. The polymer number average
 molecular weight (Mn) shall be at
 least 2,000 (as determined by gel
 permeation chromatography). The acid
 number of the polymer shall be less
 than 250. The monomer content shall be
 less than 0.5 percent.
Styrene-acrylic copolymers (CAS Reg.     For use only as a component of
 No. 25950-40-7 produced by               coatings and limited to use at
 polymerizing 77 to 83 parts by weight    a level not to exceed 20
 of styrene with 13 to 17 parts of        percent by weight of the
 methyl methacrylate, 3 to 4 parts of     coating solids.
 butyl methacrylate, 0.5 to 2.5 parts
 of methacrylic acid, and 0.1 to 0.3
 part of butyl acrylate such that the
 finished copolymers have a minimum
 number average molecular weight
 greater than 100,000 and a level of
 residual styrene monomer in the
 polymer not to exceed 0.1 percent by
 weight.

[[Page 211]]

 
Styrene-butadiene copolymers produced
 by copolymerizing styrene-butadiene
 with one or more of the monomer:
 acrylamide, acrylic acid, fumaric
 acid, 2-hydroxyethyl acrylate,
 itaconic acid, and methacrylic acid.
 The finished copolymers shall contain
 not more than 10 weight percent of
 total polymer units derived from
 acrylic acid, fumaric acid, 2-
 hydroxyethyl acrylate, itaconic acid
 and methacrylic acid, and shall
 contain not more than 2 weight percent
 of polymer units derived from
 acrylamide.
Styrene-butadiene copolymers with 2-
 hydroxyethyl acrylate and acrylic acid
 containing not more than 15 weight
 percent acrylic acid and no more than
 20 weight percent of a combination of
 2-hydroxyethyl acrylate and acrylic
 acid.
Styrene-butadiene-vinylidene chloride    For use only as coatings or
 copolymers containing not more than 40   components of coatings.
 weight percent of vinylidene chloride
 in the finished copol ymers. The
 finished copolymers may contain not
 more than 10 weight percent of total
 polymer units derived from acrylic
 acid, fumaric acid, 2-hydroxyethyl
 acrylate, itaconic acid, and/or
 methacrylic acid.
Styrene-dimethylstyrene-[alpha]-         For use only in coatings for
 methylstyrene copolymers produced by     paper and paperboard intended
 polymerizing equimolar ratios of the     for use in contact with
 three comonomers such that the           nonfatty food and limited to
 finished copol ymers have a minimum      use at a level not to exceed
 average molecular weight of 835 as       50% by weight of the coating
 determined by ASTM method D2503-82,      solids.
 ``Standard Test Method for Molecular
 Weight (Relative Molecular Mass) of
 Hydrocarbons by Thermoelectric
 Measurement of Vapor Pressure,'' which
 is incorporated by reference. Copies
 may be obtained from the American
 Society for Testing Materials, 1916
 Race St., Philadelphia, PA 19103, or
 may be examined at the Office of the
 Federal Register, 800 North Capitol
 Street, NW., suite 700, Washington, DC
 20408.
Styrene-isobutylene copolymers (weight   For use only in coatings for
 average molecular weight not less than   paper and paperboard intended
 6,300).                                  for use in contact under
                                          conditions of use D G
                                          described in table 2 of
                                          paragraph (c) of this section,
                                          with food of Types I, II, IV-
                                          B, VI-B, VII-B, and VIII
                                          described in table 1 of
                                          paragraph (c) of this section;
                                          and limited to use at a level
                                          not to exceed 40 percent by
                                          weight of the coating solids.
Styrene-maleic anhydride copolymers....  For use only as a coating or
                                          component of coatings and
                                          limited for use at a level not
                                          to exceed 2 percent by weight
                                          of paper or paperboard
                                          substrate.
Styrene-methacrylic acid copolymers
 containing no more than 5 weight
 percent of polymer units derived from
 methacrylic acid.
Styrene-vinylidene chloride copol ymers  For use only as coatings or
 containing not more than 40 weight       components of coatings.
 percent of vinylidene chloride in the
 finished copol ymers. The finished
 copolymers may contain not more than 5
 weight percent of total polymer units
 derived from acrylic acid, fumaric
 acid, itaconic acid, and/or
 methacrylic acid.
2-Sulfoethyl methacrylate, sodium salt   For use only in copolymer
 [Chemical Abstracts Service No. 1804-    coatings under conditions of
 87-1].                                   use E, F, and G described in
                                          paragraph (c) of this section,
                                          table 2, and limited to use at
                                          a level not to exceed 2.0
                                          percent by weight of the dry
                                          copolymer coating.
[alpha][p-(1,1,3,3-Tetramethylbutyl)     For use only as a surface-
 phenyl]-omega-hydroxypoly                active agent at levels not to
 (oxyethylene) hydrogen sulfate, sodium   exceed 3 percent by weight of
 salt mixture with [alpha]-[p-(1,1,3,3-   vinyl acetate polymer with
 tetramethylbutyl)-phenyl]-omega-         ethylene and N-(hydroxymethyl)
 hydroxypoly (oxyethylene) with both      acrylamide intended for use in
 substances having a poly(oxyethylene)    coatings for paper and
 content averaging 3 moles.               paperboard intended for use in
                                          contact with foods:
                                         1. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types I, II,
                                          III, IV, VI-B, and VII, and
                                          under the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types V, VIII
                                          and IX and under the
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use C,
                                          D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N-    For use only as an emulsifier
 octadecylsulfo-succinamate.              in resin latex coatings, and
                                          limited to use at a level not
                                          to exceed 0.05% by weight of
                                          the coating solids.
Toluenesulfonamide-formaldehyde resins.

[[Page 212]]

 
Vinyl acetate copolymers produced by
 copolymerizing vinyl acetate with one
 or more of the monomers acrylamide,
 acrylic acid, acrylonitrile, bicyclo-
 [2.2.1]hept-2-ene-6-methylacrylate,
 butyl acrylate, crotonic acid, decyl
 acrylate, diallyl fumarate, diallyl
 maleate, diallyl phthalate, dibutyl
 fumarate, dibutyl itaconate,
 dibutylmaleate, di(2-ethylhexyl)
 maleate, divinyl benzene, ethyl
 acrylate, 2-ethyl-hexyl acrylate,
 fumaric acid, itaconic acid, maleic
 acid, methacrylic acid, methyl
 acrylate, methyl methacrylate, mono(2-
 ethylhexyl) maleate, monoethyl
 maleate, styrene, vinyl butyrate,
 vinyl crotonate, vinyl hexoate,
 vinylidene chloride, vinyl
 pelargonate, vinyl propionate, vinyl
 pyrrolidone, vinyl stearate, and vinyl
 sulfonic acid. The finished copolymers
 shall contain at least 50 weight
 percent of polymer units derived from
 vinyl acetate and shall contain no
 more than 5 weight percent of total
 polymer units derived from acrylamide,
 acrylic acid, crotonic acid, decyl
 acrylate, dibutyl itaconate, di(2-
 ethylhexyl) maleate, fumaric acid,
 itaconic acid, maleic acid,
 methacrylic acid, mono(2-ethylhexyl)
 maleate, monoethyl maleate, vinyl
 butyrate, vinyl hexoate, vinyl
 pelargonate, vinyl propionate, vinyl
 stearate, and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and  For use only in coatings for
 N-(hydroxymethyl) acrylamide             paper and paperboard intended
 containing not more than 6 weight        for use in contact with foods:
 percent of total polymer units derived  1. Of the types identified in
 from N-(hydroxymethyl) acrylamide.       paragraph (c) of this section,
                                          table 1, under Types I, II,
                                          III, IV, VI B, and VII and
                                          under the conditions of use
                                          described in paragraph (c) of
                                          this section, table 2,
                                          conditions of use E, F, and G.
                                         2. Of the types identified in
                                          paragraph (c) of this section,
                                          table 1, under Types V, VIII,
                                          and IX and under the
                                          conditions of use described in
                                          paragraph (c) of this section,
                                          table 2, conditions of use C,
                                          D, E, F, and G.
Vinyl chloride copolymers produced by
 copolymerizing vinyl chloride with one
 or more of the monomers acrylonitrile;
 fumaric acid and its methyl, ethyl,
 propyl, butyl, amyl, hexyl, heptyl, or
 octyl esters; maleic acid and its
 methyl, ethyl, propyl, butyl, amyl,
 hexyl, heptyl, or octyl esters; maleic
 anhydride; 5-norbornene-2, 3-
 dicarboxylic acid, mono-n-butyl ester;
 vinyl acetate-and vinylidene chloride.
 The finished copolymers shall contain
 at least 50 weight percent of polymer
 units derived from vinyl chloride:
 shall contain no more than 5 weight
 percent of total polymer units derived
 from fumaric and/or maleic acid and/or
 their methyl, ethyl, propyl, butyl,
 amyl, heptyl, or octyl monoesters or
 from maleic anhydride or from mono-n-
 butyl ester of 5-norbornene-2, 3-
 dicarboxylic acid (however, in any
 case the finished copolymers shall
 contain no more than 4 weight percent
 of total polymer units derived from
 mono-n-butyl ester of 5-norbornene-2,3-
 dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-
 modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-
 modified copolymers reacted with
 trimellitic anhydride.
Vinylidene chloride copolymers produced
 by copolymerizing vinylidene chloride
 with one or more of the monomers
 acrylamide acrylic acid,
 acrylonitrile, butyl acrylate, butyl
 methacrylate ethyl acrylate, ethyl
 methacrylate, fumaric acid, itaconic
 acid, methacrylic acid, methyl
 acrylate, methyl methacrylate,
 octadecyl methacrylate, propyl
 acrylate, propyl methacrylate, vinyl
 chloride and vinyl sulfonic acid. The
 finished copolymers shall contain at
 least 50 weight percent of polymer
 units derived from vinylidene
 chloride; and shall contain no more
 than 5 weight percent of total polymer
 units derived from acrylamide, acrylic
 acid, fumaric acid, itaconic acid,
 methacrylic acid, octadecyl
 methacrylate, and vinyl sulfonic acid.
Colorants:.............................
  Aluminum.............................  For use as a colorant only.
  Aluminum hydrate.....................   Do.
  Aluminum and potassium silicate         Do.
   (mica).
  Aluminum mono-, di-, and tri stearate   Do.
  Aluminum silicate (China clay).......   Do.
  Barium sulfate.......................   Do.
  Bentonite............................   Do.
  Bentonite, modified with                Do.
   dimethyldioctadecylammonium ion.
  Burnt umber..........................   Do.

[[Page 213]]

 
  Calcium carbonate....................   Do.
  Calcium silicate.....................   Do.
  Calcium sulfate......................   Do.
  Carbon black (channel process).......   Do.
  Cobalt aluminate.....................   Do.
  Diatomaceous earth...................   Do.
  Iron oxides..........................   Do.
  Magnesium oxide......................   Do.
  Magnesium silicate (talc)............   Do.
  Phthalocyanine blue (C.I. pigment       Do.
   blue 15, 15:1, 15:2, 15:3, and 15:4;
   C.I. No. 74160; CAS Reg. No. 147-14-
   8).
  Raw sienna...........................   Do.
  Silica...............................   Do.
  Tartrazine lake (certified FD&C         Do.
   Yellow No. 5 only).
  Titanium dioxide.....................   Do.
  Titanium dioxide-barium sulfate......   Do.
  Titanium dioxide-magnesium...........   Do.
   silicate............................
  Zinc carbonate.......................   Do.
  Zinc oxide...........................   Do.
------------------------------------------------------------------------

    (c) The food-contact surface of the paper and paperboard in the 
finished form in which it is to contact food, when extracted with the 
solvent or solvents characterizing the type of food, and under 
conditions of time and temperature characterizing the conditions of its 
intended use as determined from tables 1 and 2 of this paragraph, shall 
yield net chloroform-soluble extractives (corrected for wax, petrolatum, 
mineral oil and zinc extractives as zinc oleate) not to exceed 0.5 
milligram per square inch of food-contact surface as determined by the 
methods described in paragraph (d) of this section.

                Table 1--Types of Raw and Processed Foods
I. Nonacid, aqueous products; may contain salt or sugar or both (pH
 above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and
 including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
 contain salt, and including water-in-oil emulsions of low- or high-fat
 content.
IV. Dairy products and modifications:
  A. Water-in-oil emulsions, high- or low-fat.
  B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
  A. Containing up to 8 percent of alcohol.
  B. Nonalcoholic.
  C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX of
 this table:
  A. Moist bakery products with surface containing free fat or oil.
  B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no end
 test required).
IX. Dry solids with the surface containing free fat or oil.
 


 Table 2--Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food-
    Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and
                                                    Beverages
----------------------------------------------------------------------------------------------------------------
                                                                    Food-simulating solvents
                                              ------------------------------------------------------------------
                                                    Water         Heptane \1\       8 percent       50 percent
      Condition of use         Types of food  ----------------------------------     alcohol          alcohol
                               (see table 1)                                    --------------------------------
                                                   Time and         Time and         Time and        Time and
                                                 temperature      temperature      temperature      temperature
----------------------------------------------------------------------------------------------------------------
A. High temperature heat-     I, IV-B, VII-B.  250 [deg]F, 2    ...............  ...............  ..............
 sterilized (e.g., over 212                     hr.
 [deg]F).
                              III, IV-A, VII-  ......do.......  150 [deg]F, 2    ...............  ..............
                               A.                                hr.
B. Boiling water sterilized.  II, VII-B......  212 [deg]F, 30   ...............  ...............  ..............
                                                min.
                              III, VII-A.....  ......do.......  120 [deg]F, 30   ...............  ..............
                                                                 min.
C. Hot filled or pasteurized  II, IV-B, VII-B  Fill boiling,    ...............  ...............  ..............
 above 150 [deg]F.                              cool to 100
                                                [deg]F.

[[Page 214]]

 
                              III, IV-A, VII-  ......do.......  120 [deg]F, 15   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
D. Hot filled or pasteurized  II, IV-B, VI-B,  ...............  ...............  ...............  ..............
 below 150 [deg]F.
                              VII-B..........  150 [deg]F, 2    ...............  ...............  ..............
                                                hr.
                              III, IV-A, VII-  ......do.......  100 [deg]F, 30   ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  150 [deg]F, 2    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   150 [deg]F, 2
                                                                                                             hr.
E. Room temperature filled    I, II, IV-B, VI- 120 [deg]F, 24   ...............  ...............  ..............
 and stored (no thermal        B, VII-B.        hr.
 treatment in the container).
                              III, IV-A, VII-  ......do.......  70 [deg]F, 30    ...............  ..............
                               A.                                min.
                              V, IX..........  ...............  ......do.......  ...............  ..............
                              VI-A...........  ...............  ...............  120 [deg]F, 24   ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............  120 [deg]F, 24
                                                                                                             hr.
F. Refrigerated storage (no   III, IV-A, VII-  70 [deg]F, 48    70 [deg]F, 30    ...............  ..............
 thermal treatment in the      A.               hr.              min.
 container).
                              I, II, IV-B, VI- ......do.......  ...............  ...............  ..............
                               B, VII-B.
                              VI-A...........  ...............  ...............  70 [deg]F, 48    ..............
                                                                                  hr.
                              VI-C...........  ...............  ...............  ...............   70 [deg]F, 48
                                                                                                             hr.
G. Frozen storage (no         I, II, IV-B,     70 [deg]F, 24    ...............  ...............  ..............
 thermal treatment in the      VII-B.           hr.
 container).
                              III, VII-A.....  ......do.......  70 [deg]F, 30    ...............  ..............
                                                                 min.
H. Frozen or refrigerated
 storage: Ready-prepared
 foods intended to be
 reheated in container at
 time of use:
  1. Aqueous or oil-in-water  I, II, IV-B,     212 [deg]F, 30   ...............  ...............  ..............
   emulsion of high- or low-   VII-B.           min.
   fat.
  2. Aqueous, high- or low-   III, IV-A, VII-  ......do.......  120 [deg]F, 30   ...............  ..............
   free oil or fat.            A, IX.                            min.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractability results must be divided by a factor of five in arriving at the extractability for a
  food product having water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required
  in the case of wax-polymer blend coatings for corrugated paperboard containers intended for use in bulk
  packaging of iced meat, iced fish, and iced poultry.

    (d) Analytical methods--(1) Selection of extractability conditions. 
First ascertain the type of food product (table 1, paragraph (c) of this 
section) that is being packed commercially in the paper or paperboard 
and the normal conditions of thermal treatment used in packaging the 
type of food involved. Using table 2, paragraph (c) of this section, 
select the food-simulating solvent or solvents and the time-temperature 
exaggerations of the paper or paperboard use conditions. Having selected 
the appropriate food-simulating solvent or solvents and the time-
temperature exaggeration over normal use, follow the applicable 
extraction procedure.
    (2) Reagents--(i) Water. All water used in extraction procedures 
should be freshly demineralized (deionized) distilled water.
    (ii) n-Heptane. Reagent grade, freshly redistilled before use, using 
only material boiling at 208 [deg]F.
    (iii) Alcohol. 8 or 50 percent (by volume), prepared from 
undenatured 95 percent ethyl alcohol diluted with demineralized 
(deionized) distilled water.
    (iv) Chloroform. Reagent grade, freshly redistilled before use, or a 
grade having an established consistently low blank.
    (3) Selection of test method. Paper or paperboard ready for use in 
packaging shall be tested by use of the extraction cell described in 
``Official Methods of Analysis of the Association of Official

[[Page 215]]

Analytical Chemists,'' 13th Ed. (1980), sections 21.010-21.015, under 
``Exposing Flexible Barrier Materials for Extraction,'' which is 
incorporated by reference (copies may be obtained from the Association 
of Official Analytical Chemists International, 481 North Frederick Ave., 
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office 
of the Federal Register, 800 North Capitol Street, NW., suite 700, 
Washington, DC 20408); also described in ASTM method F34-76 (Reapproved 
1980), ``Standard Test Method for Liquid Extraction of Flexible Barrier 
Materials,'' which is incorporated by reference (copies may be obtained 
from the American Society for Testing Materials, 1916 Race St., 
Philadelphia, PA 19103, or may be examined at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408), except that formed paper and paperboard products may be tested 
in the container by adapting the in-container methods described in Sec. 
175.300(e) of this chapter. Formed paper and paperboard products such as 
containers and lids, that cannot be tested satisfactorily by any of the 
above methods may be tested in specially designed extraction equipment, 
usually consisting of clamping devices that fit the closure or container 
so that the food-contact surface can be tested, or, if flat samples can 
be cut from the formed paper or paperboard products without destroying 
the integrity of the food-contact surface, they may be tested by 
adapting the following ``sandwich'' method:
    (i) Apparatus. (a) Thermostated (1.0 [deg]F) 
water bath, variable between 70 [deg]F and 120 [deg]F water bath cover 
capable of holding at least one 800-milliliter beaker partially 
submersed in bath.
    (b) Analytical balance sensitive to 0.1 milligram with an 
approximate capacity of 100 grams.
    (c) Tongs.
    (d) Hood and hot-plate facilities.
    (e) Forced draft oven.


For each extraction, the following additional apparatus is necessary:
    (f) One No. 2 paper clip.
    (g) One 800-milliliter beaker with watch-glass cover.
    (h) One 250-milliliter beaker.
    (i) Five 2\1/2\-inch-square aluminum screens (standard aluminum 
window screening is acceptable).
    (j) One wire capable of supporting sample stack.
    (ii) Procedure. (a) For each extraction, accurately cut eight 2\1/
2\-inch-square samples from the formed paper or paperboard product to be 
tested.
    (b) Carefully stack the eight 2\1/2\-inch-square samples and the 
five 2\1/2\-inch-square aluminum screens in sandwich form such that the 
food-contact side of each sample is always next to an aluminum screen, 
as follows: Screen, sample, sample, screen, sample, sample, screen, etc. 
Clip the sandwich together carefully with a No. 2 paper clip, leaving 
just enough space at the top to slip a wire through.
    (c) Place an 800-milliliter beaker containing 100-milliliters of the 
appropriate food-simulating solvent into the constant temperature bath, 
cover with a watch glass and condition at the desired temperature.
    (d) After conditioning, carefully lower the sample sandwich with 
tongs into the beaker.
    (e) At the end of the extraction period, using the tongs, carefully 
lift out the sample sandwich and hang it over the beaker with the wire.
    (f) After draining, pour the food-simulating solvent solution into a 
tared 250-milliliter beaker. Rinse the 800-milliliter beaker three 
times, using a total of not more than 50 milliliters of the required 
solvent.
    (g) Determine total nonvolatile extractives in accordance with 
paragraph (d)(5) of this section.
    (4) Selection of samples. Quadruplicate samples should be tested, 
using for each replicate sample the number of cups, containers, or 
preformed or converted products nearest to an area of 100 square inches.
    (5) Determination of amount of extractives--(i) Total residues. At 
the end of the exposure period, remove the test container or test cell 
from the oven and combine the solvent for each replicate in a clean 
Pyrex (or equivalent) flask or beaker being sure to rinse the test 
container or cell with a small quantity of clean solvent. Evaporate the 
food-simulating solvents to about 100 milliliters in the flask or 
beaker,

[[Page 216]]

and transfer to a clean, tared evaporating dish (platinum or Pyrex), 
washing the flask three times with small portions of solvent used in the 
extraction procedure, and evaporate to a few milliliters on a 
nonsparking, low-temperature hotplate. The last few milliliters should 
be evaporated in an oven maintained at a temperature of approximately 
221 [deg]F. Cool the evaporating dish in a desiccator for 30 minutes and 
weigh the residue to the nearest 0.1 milligram, (e). Calculate the 
extractives in milligrams per square inch of the container or sheeted 
paper or paperboard surface.
    (a) Water and 8- and 50-percent alcohol. Milligrams extractives per 
square inch=(e)/(s).
    (b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)

where:

e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane under 
exaggerated time-temperature test conditions compared to the amount 
extracted by a fat or oil under exaggerated conditions of thermal 
sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Corrected chloroform-soluble extractives residue.
e' or ee' is substituted for e in the above equations when necessary.


If when calculated by the equations in paragraph (d)(5)(i) (a) and (b) 
of this section, the extractives in milligrams per square inch exceeds 
the limitations prescribed in paragraph (c) of this section, proceed to 
paragraph (d)(5)(ii) of this section (method for determining the amount 
of chloroform-soluble extractives residues).
    (ii) Chloroform-soluble extractives residue. Add 50 milliliters of 
chloroform (freshly distilled reagent grade or a grade having an 
established consistently low blank) to the dried and weighed residue, 
(e), in the evaporating dish obtained in paragraph (d)(5)(i) of this 
section. Warm carefully, and filter through Whatman No. 41 filter paper 
(or equivalent) in a Pyrex (or equivalent) funnel, collecting the 
filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat 
the chloroform extraction, washing the filter paper with this second 
portion of chloroform. Add this filtrate to the original filtrate and 
evaporate the total down to a few milliliters on a low-temperature 
hotplate. The last few milliliters should be evaporated in an oven 
maintained at approximately 221 [deg]F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get 
the chloroform-soluble extractives residue ('). This ' is substituted 
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this 
section. If the chloroform-soluble extractives in milligrams per square 
inch still exceeds the limitation prescribed in paragraph (c) of this 
section, proceed to paragraph (d)(5)(iii) of this section (method for 
determining corrected chloroform-soluble extractives residue).
    (iii) Corrected chloroform-soluble extractives residue--(a) 
Correction for zinc extractives. Ash the residue in the evaporating dish 
by heating gently over a Meker-type burner to destroy organic matter and 
hold at red heat for about 1 minute. Cool in the air for 3 minutes, and 
place the evaporating dish in the desiccator for 30 minutes and weigh to 
the nearest 0.1 milligram. Analyze this ash for zinc by standard 
Association of Official Agricultural Chemists methods or equivalent. 
Calculate the zinc in the ash as zinc oleate, and subtract from the 
weight of chloroform-soluble extractives residue (') to obtain the zinc-
corrected chloroform-soluble extractives residue (e'). This e' is 
substituted for e in the equations in paragraph (d)(5)(i) (a) and (b) of 
this section.
    (b) Correction for wax, petrolatum, and mineral oil--(1) Apparatus. 
Standard 10 millimeter inside diameter x 60 centimeter chromatographic 
column (or standard 50-milliliter buret with an inside diameter of 10-11 
millimeters) with a stopcock of glass, perfluorocarbon resin, or 
equivalent material. The column (or buret) may be optionally equipped 
with an integral coarse, fritted glass disc and the top of the column 
(or buret) may be optionally fitted with a 100-millimeter solvent 
reservoir.
    (2) Preparation of column. Place a snug pledget of fine glass wool 
in the bottom of the column (or buret) if the column (or buret) is not 
equipped with

[[Page 217]]

integral coarse, fritted glass disc. Overlay the glass wool pledget (or 
fritted glass disc) with a 15-20 millimeter deep layer of fine sand. 
Measure in a graduated cylinder 15 milliliters of chromatographic grade 
aluminum oxide (80-200 mesh) that has been tightly settled by tapping 
the cylinder. Transfer the aluminum oxide to the chromatographic tube, 
tapping the tube during and after the transfer so as to tightly settle 
the aluminum oxide. Overlay the layer of aluminum oxide with a 1.0-1.5 
centimeter deep layer of anhydrous sodium sulfate and on top of this 
place an 8-10 millimeter thick plug of fine glass wool. Next carefully 
add about 25 milliliters of heptane to the column with stopcock open, 
and allow the heptane to pass through the column until the top level of 
the liquid just passes into the top glass wool plug in the column, and 
close stopcock.
    (3) Chromatographing of sample extract--(i) For chloroform residues 
weighing 0.5 gram or less. To the dried and weighed chloroform-soluble 
extract residue in the evaporating dish, obtained in paragraph 
(d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If 
necessary, heat carefully to dissolve the residue. Additional heptane 
not to exceed a total volume of 50 milliliters may be used if necessary 
to complete dissolving. Cool to room temperature. (If solution becomes 
cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this 
section to obtain an aliquot of heptane solution calculated to contain 
0.1-0.5 gram of chloroform-soluble extract residue.) Transfer the clear 
liquid solution to the column (or buret). Rinse the dish with 10 
millimeters of additional heptane and add to column. Allow the liquid to 
pass through the column into a clean, tared evaporating dish (platinum 
or Pyrex) at a dropwise rate of about 2 milliliters per minute until the 
liquid surface reaches the top glass wool plug; then close the stopcock 
temporarily. Rinse the Pyrex flask which contained the filtrate with an 
additional 10-15 milliliters of heptane and add to the column. Wash 
(elute) the column with more heptane collecting about 100 milliliters of 
total eluate including that already collected in the evaporating dish. 
Evaporate the combined eluate in the evaporating dish to dryness on a 
steam bath. Dry the residue for 15 minutes in an oven maintained at a 
temperature of approximately 221 [deg]F. Cool the evaporating dish in a 
desiccator for 30 minutes and weigh the residue to the nearest 0.1 
milligram. Subtract the weight of the residue from the weight of 
chloroform-soluble extractives residue (') to obtain the wax-, 
petrolatum-, and mineral oil-corrected chloroform-soluble extractives 
residue (e'). This e' is substituted for e in the equations in paragraph 
(d)(5)(i) (a) and (b) of this section.
    (ii) For chloroform residues weighing more than 0.5 gram. Redissolve 
the dried and weighed chloroform-soluble extract residue as described in 
paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately 
larger quantities of heptane. Transfer the heptane solution to an 
appropriate-sized volumetric flask (i.e., a 250-milliliter flask for 
about 2.5 grams of residue) and adjust to volume with additional 
heptane. Pipette out an aliquot (about 50 milliliters) calculated to 
contain 0.1-0.5 gram of the chloroform-soluble extract residue and 
analyze chromatographically as described in paragraph 
(d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the 
dried residue from the heptane eluate must be multiplied by the dilution 
factor to obtain the weight of wax, petrolatum, and mineral oil residue 
to be subtracted from the weight of chloroform-soluble extractives 
residue (') to obtain the wax-, petrolatum-, and mineral oil-corrected 
chloroform-soluble extractives residue (e'). This e' is substituted for 
e in the equations in paragraph (d)(5)(i) (a) and (b) of this section. 
(Note: In the case of chloroform-soluble extracts which contain high 
melting waxes (melting point greater than 170 [deg]F), it may be 
necessary to dilute the heptane solution further so that a 50-milliliter 
aliquot will contain only 0.1-0.2 gram of the chloroform-soluble extract 
residue.)
    (e) Acrylonitrile copolymers identified in this section shall comply 
with the provisions of Sec. 180.22 of this chapter, except where the 
copolymers are restricted to use in contact with food

[[Page 218]]

only of the type identified in paragraph (c), table 1 under Category 
VIII.

[42 FR 14554, Mar. 15, 1977]

    Editorial Note: For Federal Register citations affecting Sec. 
176.170, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec. 176.180  Components of paper and paperboard in contact with dry food.

    The substances listed in this section may be safely used as 
components of the uncoated or coated food-contact surface of paper and 
paperboard intended for use in producing, manufacturing, packing, 
processing, preparing, treating, packaging, transporting, or holding dry 
food of the type identified in Sec. 176.170(c), table 1, under Type 
VIII, subject to the provisions of this section.
    (a) The substances are used in amounts not to exceed that required 
to accomplish their intended physical or technical effect, and are so 
used as to accomplish no effect in food other than that ordinarily 
accomplished by packaging.
    (b) The substances permitted to be used include the following:
    (1) Substances that by Sec. 176.170 and other applicable 
regulations in parts 170 through 189 of this chapter may be safely used 
as components of the uncoated or coated food-contact surface of paper 
and paperboard, subject to the provisions of such regulation.
    (2) Substances identified in the following list:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
Acrylamide polymer with sodium 2-        For use at a level not to
 acrylamido-2-methylpropane-sulfonate     exceed 0.015 weight percent of
 (CAS Reg. No. 38193-60-1).               dry fiber.
(2-Alkenyl) succinic anhydrides in
 which the alkenyl groups are derived
 from olefins which contain not less
 than 78 percent C30 and higher groups
 (CAS Reg. No. 70983-55-0)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy)       For use as a polymerization
 ethoxy]ethyl]disodium sulfosuccinate.    emulsifier and latex emulsion
                                          stabilizer at levels not to
                                          exceed 5 percent by weight of
                                          total emulsion solids.
Alkyl mono- and disulfonic acids,
 sodium salts (produced from n-alkanes
 in the range of C10-C18 with not less
 than 50 percent C14-C16)..
Aluminum and calcium salts of FD & C     Colorant.
 dyes on a substrate of alumina.
Ammonium nitrate.......................
Amylose................................
Barium metaborate......................  For use as preservative in
                                          coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS          For use only as a preservative
 Registry No. 2634-33-5).                 in paper coating compositions
                                          and limited to use at a level
                                          not to exceed 0.02 mg/in\2\
                                          (0.0031 mg/cm\2\) of finished
                                          paper and paperboard.
N,N'-Bis(hydroxyethyl)lauramide........
Bis(trichloromethyl) sulfone C.A.        For use only as a preservative
 Registry No. 3064-70-8.                  in coatings.
Borax..................................  For use as preservative in
                                          coatings.
Boric acid.............................   Do.
sec-Butyl alcohol......................
Butyl benzyl phthalate.................
Candelilla wax.........................
Carbon tetrachloride...................
Castor oil, polyoxyethylated (42 moles
 ethylene oxide)..
Cationic soy protein hydrolyzed          For use only as a coating
 (hydrolyzed soy protein isolate          adhesive, pigment structuring
 modified by treatment with 3-chloro-2-   agent, and fiber retention
 hydroxypropyl-trimethylammonium          aid.
 chloride).
Cationic soy protein (soy protein        For use only as a coating
 isolate modified by treatment with 3-    adhesive, pigment structuring
 chloro-2-hydroxypropyltrimethyl-         agent, and fiber retention
 ammonium chloride).                      aid.
Chloral hydrate........................  Polymerization reaction-control
                                          agent.
N-Cyclohexyl-p-toluene sulfonamide.....
2,5-Di-tert-butyl hydroquinone.........
Diethanolamine.........................
Diethylene glycol dibenzoate (CAS Reg.   For use only as a plasticizer
 No. 120-55-8).                           in polymeric substances.
Diethylene glycol monobutyl ether......
Diethylene glycol monoethyl ether......
Diethylenetriamine.....................
N,N-Diisopropanolamide of tallow fatty
 acids..
N-[(dimethylamino)methyl]acrylamide
 polymer with acrylamide and styrene..

[[Page 219]]

 
N,N-Dioleoylethylenediamine, N,N-
 dilinoeoyl- ethylenediamine, and N-
 oleoyl-N-linoleoyl-ethylenediamine
 mixture produced when tall oil fatty
 acids are made to react with
 ethylenediamine such that the finished
 mixture has a melting point of
 212[deg]-228 [deg]F, as determined by
 ASTM method D127-60, and an acid value
 of 10 maximum. ASTM Method D127-60
 ``Standard Method of Test for Melting
 Point of Petrolatum and
 Microcrystalline Wax'' (Revised 1960)
 is incorporated by reference. Copies
 are available from University
 Microfilms International, 300 N. Zeeb
 Rd., Ann Arbor, MI 48106, or available
 for inspection at the Office of the
 Federal Register, 800 North Capitol
 Street, NW., suite 700, Washington, DC
 20408..
Diphenylamine..........................
Dipropylene glycol dibenzoate (CAS Reg.  For use only as plasticizer in
 No. 27138-31-4).                         polymeric substances.
Disodium N-octadecylsulfosuccinamate...
tert-Dodecyl thioether of polyethylene
 glycol..
Erucamide (erucylamide)................
Ethanedial, polymer with tetrahydro-4-
 hydroxy-5-methyl-2(1H)pyrimidinone,
 propoxylated..
Ethylene oxide.........................  Fumigant in sizing.
Ethylene oxide adduct of mono-(2-
 ethylhexyl) o-phosphate..
Fatty acid (C12-C18) diethanolamide....
Fish oil fatty acids, hydrogenated,
 potassium salt..
Formaldehyde...........................
Glyceryl monocaprate...................
Glyceryl tribenzoate (CAS Reg. No. 614-  For use only as a plasticizer
 33-5).                                   in polymeric coatings.
Glyoxal................................
Glyoxal-urea-formaldehyde condensate     For use as an insolubilizer for
 (CAS Reg. No. 27013-01-0) formed by      starch in coatings.
 reaction in the molar ratio of
 approximately 47:33:15, respectively.
 The reaction product has a number
 average molecular weight of 27814 as determined by a
 suitable method.
Glyoxal-urea polymer (CAS Reg. No.       For use as an insolubilizer for
 53037-34-6).                             starch.
Hexamethylenetetramine.................  Polymerization crosslinking
                                          agent for protein, including
                                          casein. As neutralizing agent
                                          with myristochromic chloride
                                          complex and stearato-chromic
                                          chloride complex.
Hexylene glycol (2-methyl-2,4-
 pentanediol)..
Hydroabietyl alcohol...................
5-Hydroxymethoxymethyl-1-aza-3,7-        For use only as an
 dioxabicyclo[3.3.0] octane, 5-           antibacterial preservative.
 hydroxymethyl-1-aza-3,7-
 dioxabicyclo[3.3.0]octane, and 5-
 hydroxypoly-[methyleneoxy]methyl-1-aza-
 3,7-dioxabicyclo[3.3.0] octane mixture.
Imidazolium compounds, 2-(C17 and C17-   For use only at levels not to
 unsaturated alkyl)-1-[2-(C18 and C18-    exceed 0.5 percent by weight
 unsaturated amido)ethyl]-4,5-dihydro-1-  of the dry paper and
 methyl, methyl sulfates (CAS Reg. No.    paperboard.
 72749-55-4)..
Isopropanolamine hydrochloride.........
Isopropyl m- and p-cresol (thymol
 derived)..
Itaconic acid..........................
Maleic anhydride-diisobutylene
 copolymer, ammonium or sodium salt..
Melamine-formaldehyde modified with:     Basic polymer.
 Alcohols (ethyl, butyl, isobutyl,
 propyl, or isopropyl).
 Diethylenetriamine.
 Imino-bis-butylamine.
 Imino-bis-ethyleneimine.
 Imino-bis-propylamine.
 Polyamines made by reacting
 ethylenediamine or trimethylenediamine
 with dichloroethane or
 dichloropropane.
 Sulfanilic acid.
 Tetraethylenepentamine.
 Triethylenetetramine.
Methyl alcohol.........................
Methyl esters of mono-, di-, and
 tripropylene glycol..
Methyl napthalene sulfonic acid-
 formaldehyde condensate, sodium salt..
Methylated poly(N-1,2-dihydroxyethylene- For use only only as an in
 1,3-imidazolidin-2-one).                 solubilizer for starch.

[[Page 220]]

 
Modified polyacrylamide resulting from   For use only as a dry strength
 an epichlorohydrin addition to a         and pigment retention aid
 condensate of formaldehyde-              agent employed prior to the
 dicyandiamide-diethylene triamine and    sheetforming operation in the
 which product is then reacted with       manufacture of paper and
 polyacrylamide and urea to produce a     paperboard and used at a level
 resin having a nitrogen content of 5.6   not to exceed 1 percent by
 to 6.3 percent and having a minimum      weight of dry fibers.
 viscosity in 56 percent-by-weight
 aqueous solution of 200 centipoises at
 25 [deg]C, as determined by LVT-series
 Brookfield viscometer using a No. 4
 spindle at 60 r.p.m. (or equivalent
 method).
Mono- and di(2-alkenyl)succinyl esters   For use only as an emulsifier.
 of polyethylene glycol containing not
 less than 90 percent of the diester
 product and in which the alkenyl
 groups are derived from olefins that
 contain not less than 95 percent of
 C15-C21 groups.
Monoglyceride citrate..................
Myristo chromic chloride complex.......
Napthalene sulfonic acid-formaldehyde
 condensate, sodium salt..
Nickel.................................
[beta]-Nitrostyrene....................  Basic polymer.
Octadecanoic acid, reaction products     For use prior to sheet forming
 with 2-[(2-aminoethyl)amino]ethanol      at levels not to exceed 12
 and urea (CAS Reg. No. 68412-14-6),      pounds per ton of paper.
 and the acetate salts thereof (CAS
 Reg. No. 68784-21-4), which may be
 emulsified with ethoxylated tallow
 alkyl amines (CAS Reg. No. 61791-26-2).
[alpha]-cis-9-Octadecenyl-omega-
 hydroxypoly (oxyethylene); the
 octadecenyl group is derived from
 oleyl alcohol and the
 poly(oxyethylene) content averages not
 less than 20 moles..
[alpha]-(p-Nonylphenyl)-omega-
 hydroxypoly (oxyethylene) sulfate,
 ammonium salt; the nonyl group is a
 propylene trimer isomer and the poly
 (oxyethylene) content averages 9 or 30
 moles..
Oleic acid reacted with N-alkyl-(C16-
 C18) trimethylenediamine..
Oxidized soy isolate having 50 to 70     For use as a binder adhesive
 percent of its cystine residues          component of coatings.
 oxidized to cysteic acid.
Petroleum alicyclic hydrocarbon resins,  For use as modifiers at levels
 or the hydrogenated product thereof,     up to 30 weight-percent of the
 complying with the identity prescribed   solids content of wax-polymer
 in Sec.  176.170(b)(2).                 blend coatings.
Petroleum hydrocarbon resins (produced
 by the catalytic polymerization and
 subsequent hydrogenation of styrene,
 vinyltoluene, and indene types from
 distillates of cracked petroleum
 stocks)..
Petroleum hydrocarbons, light and
 odorless..
o-Phthalic acid modified hydrolyzed soy
 protein isolate..
Pine oil...............................
Poly(2-aminoethyl acrylate nitrate-co-2-
 hydroxypropyl acrylate) complying with
 the identity described in Sec.
 176.170(a)..
Polyamide-epichloro hydrin modified
 resins resulting from the reaction of
 the initial caprolactam-itaconic acid
 product with diethylenetriamine and
 then condensing this prepolymer with
 epichlorohydrin to form a cationic
 resin having a nitrogen content of 11-
 15 percent and chlorine level of 20-23
 percent on a dry basis..
Polyamide-ethyleneimine-epichlorohydrin
 resin is prepared by reacting
 equimolar amounts of adipic acid and
 three amines (21 mole percent of 1,2-
 ethanediamine, 51 mole percent of N-(2-
 aminoethyl)-1,3-propanediamine, and 28
 mole percent of N, N'-1,2-
 ethanediylbis(1,3-propanediamine)) to
 form a basic polyamidoamine which is
 modified by reaction with
 ethyleneimine (5.5:1.0
 ethyleneimine:polyamidoamine). The
 modified polyamidoamine is reacted
 with a crosslinking agent made by
 condensing approximately 34 ethylene
 glycol units with
 (chloromethyl)oxirane, followed by pH
 adjustment with formic acid or
 sulfuric acid to provide a finished
 product as a formate (CAS Reg. No.
 114133-44-7) or a sulfate (CAS Reg.
 No. 167678-43-5), having a weight-
 average molecular weight of 1,300,000
 and a number-average molecular weight
 of 16,000..
Polyamide-ethyleneimine-epichlorohydrin
 resin (CAS Reg. No. 115340-77-7),
 prepared by reacting equimolar amounts
 of adipic acid and N-(2-aminoethyl)-
 1,2-ethanediamine to form a basic
 polyamidoamine which is modified by
 reaction with ethyleneimine, and
 further reacted with formic acid and
 (chloromethyl)oxirane-[alpha]-hydro-
 omega-hydroxypoly(oxy-1,2-ethanediyl)..

[[Page 221]]

 
Polybutene, hydrogenated; complying
 with the identity prescribed under
 Sec.  178.3740(b) of this chapter..
Poly [2-(diethylamino) ethyl
 methacrylate] phosphate..
Polyethylene glycol (200) dilaurate....
Polyethylene glycol monoisotridecyl      For use only as a surfactant at
 ether sulfate, sodium salt (CAS Reg.     levels not to exceed 3 percent
 No. 150413-26-6).                        in latex formulations used in
                                          pigment binders for paper and
                                          paperboard.
Polymers: Homopolymers and copolymers    Basic polymer.
 of the following monomers:
 Acrylamide.
 Acrylic acid and its methyl, ethyl,
 butyl, propyl, or octyl esters.
 Acrylonitrile.
 Butadiene.
 Crotonic acid.
 Cyclol acrylate.
 Decyl acrylate.
 Diallyl fumarate.
 Diallyl maleate.
 Diallyl phthalate.
 Dibutyl fumarate.
 Dibutyl itaconate.
 Dibutyl maleate.
 Di(2-ethylhexyl) maleate.
 Dioctyl fumarate.
 Dioctyl maleate.
 Divinylbenzene.
 Ethylene.
 2-Ethylhexyl acrylate.
 Fumaric acid.
 Glycidyl methacrylate.
 2-Hydroxyethyl acrylate.
 N-(Hydroxymethyl) acrylamide.
 Isobutyl acrylate.
 Isobutylene.
 Isoprene.
 Itaconic acid.
 Maleic anhydride and its methyl or
 butyl esters.
 Methacrylic acid and its methyl,
 ethyl, butyl, or propyl esters.
 Methylstyrene.
 Mono(2-ethylhexyl) maleate.
 Monoethyl maleate.
 5-Norbornene-2,3-dicarboxylic acid,
 mono-n-butyl ester.
 Styrene.
 Vinyl acetate.
 Vinyl butyrate.
 Vinyl chloride.
 Vinyl crotonate.
 Vinyl hexoate.
 Vinylidene chloride.
 Vinyl pelargonate.
 Vinyl propionate.
 Vinyl pyrrolidone.
 Vinyl stearate.
 Vinyl sulfonic acid.
Polymer prepared from urea, ethanedial,  For use only as a starch and
 formaldehyde, and propionaldehyde (CAS   protein reactant in paper and
 Reg. No. 106569 -82-8).                  paperboard coatings.
Polyoxyethylene (minimum 12 moles)
 ester of tall oil (30%-40% rosin
 acids)..
Polyoxypropylene-polyoxyethylene glycol
 (minimum molecular weight 1,900)..
Polyvinyl alcohol......................
Potassium titanate fibers produced by
 calcining titanium dioxide, potassium
 chloride, and potassium carbonate,
 such that the finished crystalline
 fibers have a nominal diameter of 0.20-
 0.25 micron, a length-to-diameter
 ratio of approximately 25:1 or
 greater, and consist principally of
 K2Ti4O9 and K2Ti 6O13..
Sodium diisobutylphenoxy diethoxyethyl
 sulfonate..
Sodium diisobutylphenoxy monoethoxy
 ethylsulfonate..
Sodium n-dodecylpolyethoxy (50 moles)
 sulfate..
Sodium isododecylphenoxypolyethoxy (40
 moles) sulfate..
Sodium N-methyl-N-oleyl taurate........
Sodium methyl siliconate...............

[[Page 222]]

 
Sodium nitrite.........................
Sodium polyacrylate....................
Sodium bis-tridecylsulfosuccinate......
Sodium xylene sulfonate................
Stearato chromic chloride complex......
Styrene-allyl alcohol copolymers.......
Styrene-methacrylic acid copolymer,
 potassium salt..
Tetraethylenepentamine.................  Polymerization cross-linking
                                          agent.
[alpha]-[p-(1,1,3,3-
 Tetramethylbutyl)phenyl]-omega
 hydroxypoly(oxyethylene) mixture of
 dihydrogen phosphate and monohydrogen
 phosphate esters and their sodium,
 potassium, and ammonium salts having a
 poly(oxyethylene) content averaging 6-
 9 or 40 moles..
[alpha]-[p-(1,1,3,3-
 Tetramethylbutyl)phenyl or p-
 nonylphenyl]-omega-hydroxypoly
 (oxyethylene) where nonyl group is a
 propylene trimer isomer..
Tetrasodium N-(1,2-dicarboxyethyl)-N-
 octadecyl sulfosuccinamate..
Toluene................................
Triethanolamine........................
Triethylenetetramine...................  Polymerization cross-linking
                                          agent.
Triethylenetetramine monoacetate,
 partially stearoylated..
Urea-formaldehyde chemically modified
 with:
 Alcohol (methyl, ethyl, butyl,
 isobutyl, propyl, or isopropyl).
 Aminomethylsulfonic acid.
 Diaminobutane.
 Diaminopropane.
 Diethylenetriamine.
 N,N'-Dioleoylethylenediamine.
 Diphenylamine.
 N,N'-Distearoylethylenediamine.
 Ethylenediamine.
 Guanidine.
 Imino-bis-butylamine.
 Imino-bis-ethylamine.
 Imino-bis-propylamine.
 N-Oleoyl-N'-stearoylethylenediamine.
 Polyamines made by reacting
 ethylenediamine or triethylenediamine
 with dichloroethane or
 dichloropropane.
 Tetraethylenepentamine.
 Triethylenetetramine.
Xylene.................................
Xylene sulfonic acid-formaldehyde
 condensate, sodium salt..
Zinc stearate..........................
------------------------------------------------------------------------


[42 FR 14554, Mar. 15, 1977]

    Editorial Note: For additional Federal Register citations affecting 
Sec. 176.180, see the List of CFR Sections Affected, which appears in 
the Finding Aids section of the printed volume and on GPO Access.



Sec. 176.200  Defoaming agents used in coatings.

    The defoaming agents described in this section may be safely used as 
components of articles intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, transporting, or 
holding food, subject to the provisions of this section.
    (a) The defoaming agents are prepared as mixtures of substances 
described in paragraph (d) of this section.
    (b) The quantity of any substance employed in the formulation of 
defoaming agents does not exceed the amount reasonably required to 
accomplish the intended physical or technical effect in the defoaming 
agents or any limitation further provided.
    (c) Any substance employed in the production of defoaming agents and 
which is the subject of a regulation in parts 174, 175, 176, 177, 178 
and Sec. 179.45 of this chapter conforms with any specification in such 
regulation.
    (d) Substances employed in the formulation of defoaming agents 
include:
    (1) Substances generally recognized as safe in food.

[[Page 223]]

    (2) Substances subject to prior sanction or approval for use in 
defoaming agents and used in accordance with such sanction or approval.
    (3) Substances identified in this paragraph (d)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
n-Butyl alcohol........................
tert-Butyl alcohol.....................
Butyl stearate.........................
Castor oil, sulfated, ammonium,
 potassium, or sodium salt.
Cetyl alcohol..........................
Cyclohexane............................
Cyclohexanol...........................
Diethylene glycol monolaurate..........
Diethylene glycol monostearate.........
Dimers and trimers of unsaturated C18    For use only at levels not to
 fatty acids derived from:                exceed 0.1% by weight of total
                                          coating solids.
  Animal and vegetable fats and oils.
  Tall oil.
Dimethylpolysiloxane...................
[alpha]-(Dinonylphenyl)-[omega]-hydroxy- For use only in defoaming
 poly(oxy-1,2-ethanediyl), containing 7   agents for the production of
 to 24 moles of ethylene oxide per mole   styrene-butadiene coatings at
 of dinonylphenol (CAS Reg. No. 9014-93-  a level not to exceed 0.05
 1).                                      percent by weight of the
                                          finished coating.
Dipropylene glycol.....................
Ethyl alcohol..........................
Fats and oils derived from animal,
 marine, or vegetable sources:
    Fatty acids derived from animal,
     marine, or vegetable fats and
     oils, and salts of such acids,
     single or mixed, as follows:
        Aluminum.......................
        Ammonium.......................
        Calcium........................
        Magnesium......................
        Potassium......................
        Sodium.........................
        Zinc...........................
Formaldehyde...........................  For use as preservative of
                                          defoamer only.
Glyceryl mono-12-hydroxystearate.......
Glyceryl monostearate..................
Hexane.................................
Hexylene glycol (2-methyl-2,4-
 penta