[Federal Register Volume 74, Number 213 (Thursday, November 5, 2009)]
[Rules and Regulations]
[Pages 57248-57251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26524]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2007-C-0044] (formerly Docket No. 2007C-0474)


Listing of Color Additives Exempt From Certification; Astaxanthin 
Dimethyldisuccinate

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the color 
additive regulations to provide for the safe use of astaxanthin 
dimethyldisuccinate as a color additive in the feed of salmonid fish to 
enhance the color of their flesh. This action is in response to a 
petition filed by DSM Nutritional Products, Inc.

DATES: This rule is effective December 8, 2009, except as to any 
provisions that may be stayed by the filing of proper objections. 
Submit electronic or written objections and requests for a hearing by 
December 7, 2009. See section X of this document for information on the 
filing of objections.

[[Page 57249]]


ADDRESSES: You may submit electronic or written objections and requests 
for a hearing, identified by Docket No. FDA-2007-C-0044, by any of the 
following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of objections, FDA is no longer 
accepting objections submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic objections by using the Federal 
eRulemaking Portal, as described previously in the ADDRESSES portion of 
this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No. for this rulemaking. All objections received will be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For detailed instructions on submitting 
objections, see the ``Objections'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Felicia M. Ellison, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of December 4, 2007 
(72 FR 68166), with a correction of the docket number on December 26, 
2007 (72 FR 73028), FDA announced that a color additive petition (CAP 
7C0284) had been filed by DSM Nutritional Products, Inc., 45 Waterview 
Blvd., Parsippany, NJ 07054. The petition proposed to amend the color 
additive regulations in part 73 (21 CFR part 73) to provide for the 
safe use of astaxanthin dimethyldisuccinate (hereinafter referred to as 
astaxanthin DMDS) as a color additive in the feed of salmonid fish to 
enhance the color of their flesh.

II. Identity, Technical Effect, and Specifications

    Astaxanthin DMDS (3,3'-bis(4-methoxy-1,4-dioxobutoxy)-[bgr],[bgr]-
carotene-4,4'-dione) is a synthetic carotenoid with pink or red 
pigmenting properties. Astaxanthin DMDS is derived by esterification of 
astaxanthin, the principal pigment that imparts the characteristic pink 
or orange-red coloring of the flesh of wild salmonids, followed by 
several purification steps. The color additive contains not less than 
96 percent astaxanthin DMDS, including trans, 9-cis, and 13-cis 
isomers, and minor amounts of astaxanthin monomethylsuccinate (MMS) and 
free astaxanthin. Other carotenoids (present at not more than 4 
percent) are the esters of astaxanthin-related substances.
    The stability studies of astaxanthin DMDS submitted by the 
petitioner show that astaxanthin DMDS is unstable on its own. 
Therefore, in order to minimize chemical changes that would result in 
loss of color of astaxanthin, astaxanthin DMDS may be added to fish 
feed only in the form of a stabilized color additive mixture. This 
requirement is reflected in new Sec.  73.37(a)(2), which provides that 
astaxanthin DMDS be added to fish feed only as a component of a 
stabilized color additive mixture.
    In the Federal Register of April 13, 1995 (60 FR 18736), the agency 
published a final rule that listed astaxanthin in Sec.  73.35 for use 
in the feed of salmonid fish. In that final rule, the agency concluded 
that 80 milligrams (mg) of astaxanthin per (/) kilogram (kg) of 
finished feed would result in adequate pigmentation of the flesh of 
salmonids. Therefore, in Sec.  73.35(c)(2), the agency limited the 
astaxanthin content of finished feed to not more than 80 mg/kg. In the 
Federal Register of July 6, 2000 (65 FR 41581 and 41584), the agency 
published final rules that listed haematococcus algae meal (Sec.  
73.185) and phaffia yeast (Sec.  73.355) as additional sources of 
astaxanthin for use in the feed of salmonid fish. Both haematococcus 
algae meal and phaffia yeast may be used alone or in combination with 
other astaxanthin color additive sources, provided that the quantity of 
astaxanthin in the finished feed does not exceed 80 mg/kg.
    Consistent with these other listings, the petitioner proposes that 
the maximum amount of astaxanthin in finished feed from the use of 
astaxanthin DMDS not exceed 110 mg/kg, which corresponds to an 
astaxanthin equivalent of 80 mg/kg (72 grams (g) per ton) in the 
finished feed. Because of the other listed sources of astaxanthin and 
other color additives that are sources of astaxanthin the agency may 
list in the future, new Sec.  73.37(c)(2) requires that the quantity of 
astaxanthin in finished feed, from astaxanthin DMDS when used alone or 
in combination with other astaxanthin color additive sources listed in 
part 73, shall not exceed 80 mg/kg (72 g per ton) of finished feed.

III. Evaluation of Safety

    Data provided by the petitioner demonstrate that the color additive 
is safe for the fish at the proposed use levels, and that astaxanthin 
DMDS is converted to free astaxanthin during digestion and deposited as 
such in the flesh of the fish. There also is no evidence that any 
constituents of the color additive, other than astaxanthin, will 
accumulate in fish maintained on diets supplemented with astaxanthin 
DMDS. Consequently, consumers will not be directly exposed to 
astaxanthin DMDS, but to the astaxanthin in the flesh of the fish that 
have consumed the color additive. The safety of astaxanthin has been 
previously established (see 65 FR 41581 and 41584).
    FDA has determined that the astaxanthin from the subject color 
additive will substitute for the fish feed uses of other approved color 
additive sources of astaxanthin. Additionally, the agency considers the 
intake of astaxanthin from the consumption of wild salmon and the 
intake of astaxanthin from consumption of farm-raised salmonid fish 
that have been fed approved color additive sources of astaxanthin to be 
comparable. Therefore, the agency concludes that the petitioned use of 
the subject color additive will not increase the current cumulative 
estimated daily intake of astaxanthin. Based on this information, as 
well as other relevant material provided by the petitioner, FDA 
concludes that the petitioned use of astaxanthin DMDS is safe.

IV. Labeling Requirements

    All color additives, in accordance with Sec.  70.25 (21 CFR 70.25), 
are required to be labeled with sufficient information to assure their 
safe use and to allow a determination of compliance with any 
limitations imposed by the agency in other applicable regulations. The 
labeling of the color additive,

[[Page 57250]]

astaxanthin DMDS, and any mixture prepared therefrom, is subject to the 
requirements of Sec.  70.25.
    According to Sec.  70.25(a)(4), an expiration date for a color 
additive must be stated on its label if stability data require it. FDA 
finds that because of the instability of astaxanthin DMDS, expiration 
dates must be stated on the label of the sealed and open containers, in 
accordance with Sec.  70.25(a)(4). FDA also finds that declaration of 
the expiration dates constitutes a material fact that must be disclosed 
on the label of the stabilized mixture formulated with astaxanthin DMDS 
because under sections 201(n) and 403(a)(1) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 321(n) and 343(a)(1)), failure to 
do so would constitute a failure to reveal facts material in light of 
the representations made on the label and material with respect to 
consequences which may result from the use of the color additive. The 
use of astaxanthin DMDS requires the declaration of expiration dates 
because the astaxanthin component of astaxanthin DMDS is unstable and 
can decompose, thereby affecting the efficacy of the color.
    In addition to the requirements for labeling the color additive or 
color additive mixture, the ingredient list on fish feed to which 
astaxanthin DMDS is added must identify the presence of the color 
additive under Sec.  501.4 (21 CFR 501.4). New Sec.  73.37(d)(2) 
references Sec.  501.4 to ensure that the presence of astaxanthin DMDS 
as a color additive in the fish feed will be declared on the ingredient 
label. Finally, the presence of the color additive must be declared on 
the label of any food, including salmonid fish given feed containing 
astaxanthin DMDS and food containing such salmonid fish as an 
ingredient. Section 101.22(b) (21 CFR 101.22(b)) requires a food that 
bears or contains artificial coloring, such as salmon artificially 
colored with a source of astaxanthin, to bear labeling even though such 
food is not in package form. Section 101.22(c) requires that label 
statements of artificial coloring be ``likely to be read by the 
ordinary person under customary conditions of purchase and use of such 
food.''
    Furthermore, Sec.  101.22(k)(2) requires, in the statement of 
ingredients for a food to which any coloring has been added, and for 
which the coloring is not subject to certification, a declaration that 
makes it clear that a color additive has been used in the food. In 
addition, the presence of a color additive in a food received in a bulk 
container that is held at a retail establishment must be declared on 
the labeling of the bulk container or on a counter card or other 
similar device under the provisions in Sec.  101.100(a)(2) (21 CFR 
101.100(a)(2)). The ingredient label would alert the consumer that the 
fish is artificially colored. Without such ingredient labeling, food 
containing salmonid fish previously given feed containing astaxanthin 
DMDS would be deemed to be misbranded under section 403(k) of the act, 
which states that a food shall be deemed to be misbranded ``if it bears 
or contains any artificial flavoring, artificial coloring, or chemical 
preservative, unless it bears labeling stating that fact.''
    Therefore, in accordance with Sec. Sec.  101.22(b), (c), and 
(k)(2), and 101.100(a)(2), labeling on any salmonid fish given feed 
containing astaxanthin DMDS is required to declare the presence of the 
color additive. New Sec.  73.37(d)(3) references Sec. Sec.  101.22(b), 
(c), and (k)(2), and 101.100(a)(2) to ensure that, at the retail level, 
the presence of a source of astaxanthin as a color additive in the fish 
will be declared, and that the labeling of the bulk fish container, 
including a list of ingredients, will be displayed on the container or 
on a counter card with similar information.

V. Conclusion

    FDA reviewed data in the petition and other available relevant 
material to evaluate the safety of the use of astaxanthin DMDS as a 
color additive in the feed of salmonid fish to enhance the color of 
their flesh. Based on this information, the agency concludes that the 
proposed use of the additive is safe and the additive will achieve its 
intended technical effect. Therefore, the regulations in part 73 should 
be amended as set forth in this document. In addition, based upon the 
factors listed in 21 CFR 71.20(b), the agency concludes that 
certification of astaxanthin DMDS is not necessary for the protection 
of the public health.

VI. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the 
documents that FDA considered and relied upon in reaching its decision 
to approve the petition will be made available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above (see FOR FURTHER INFORMATION 
CONTACT). As provided in Sec.  71.15, the agency will delete from the 
documents any materials that are not available for public disclosure 
before making the documents available for inspection.

VII. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for CAP 7C0284 (72 FR 
68166 and 72 FR 73028). No new information or comments have been 
received that would affect the agency's previous determination that 
there is no significant impact on the human environment and that an 
environmental impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 721 of the act 
(21 U.S.C. 379e). This final rule is not a statement regarding 
compliance with other sections of the act. For example, the Food and 
Drug Administration Amendments Act of 2007, which was signed into law 
on September 27, 2007, amended the act to, among other things, add 
section 301(ll). Section 301(ll) of the act (21 U.S.C. 331(ll)) 
prohibits the introduction or delivery for introduction into interstate 
commerce of any food that contains a drug approved under section 505 of 
the act (21 U.S.C. 355), a biological product licensed under section 
351 of the Public Health Service Act (42 U.S.C. 262), or a drug or 
biological product for which substantial clinical investigations have 
been instituted and their existence has been made public, unless one of 
the exemptions in section 301(ll)(1)-(4) applies. In our review of this 
petition, FDA did not consider whether section 301(ll) of the act or 
any of its exemptions apply to food products containing this color 
additive. Accordingly, this final rule should not be construed to be a 
statement that a product containing this color additive, if introduced 
or delivered for introduction into interstate commerce, would not 
violate section 301(ll) of the act. Furthermore, this language is 
included in all color additive final rules that pertain to food and 
therefore should not be construed to be a statement of the likelihood 
that section 301(ll) of the act applies.

X. Objections

    This rule is effective as shown in the DATES section of this 
document, except as to any provisions that may be stayed by the filing 
of proper objections. Any

[[Page 57251]]

person who will be adversely affected by this regulation may at any 
time file with the Division of Dockets Management (see ADDRESSES) 
electronic or written objections. Each objection shall be separately 
numbered, and each numbered objection shall specify with particularity 
the provisions of the regulation to which objection is made and the 
grounds for the objection. Each numbered objection on which a hearing 
is requested shall specifically so state. Failure to request a hearing 
for any particular objection shall constitute a waiver of the right to 
a hearing on that objection. Each numbered objection for which a 
hearing is requested shall include a detailed description and analysis 
of the specific factual information intended to be presented in support 
of the objection in the event that a hearing is held. Failure to 
include such a description and analysis for any particular objection 
shall constitute a waiver of the right to a hearing on the objection. 
Three copies of all documents are to be submitted and are to be 
identified with the docket number found in brackets in the heading of 
this document. Any objections received in response to the regulation 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday. FDA will publish notice of the objections 
that the agency has received or lack thereof in the Federal Register.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.

0
2. Section 73.37 is added to subpart A to read as follows:


Sec.  73.37  Astaxanthin dimethyldisuccinate.

    (a) Identity. (1) The color additive astaxanthin 
dimethyldisuccinate is 3,3'-bis(4-methoxy-1,4-dioxobutoxy)-[bgr],[bgr]-
carotene-4,4'-dione.
    (2) Astaxanthin dimethyldisuccinate may be added to the fish feed 
only as a component of a stabilized mixture. Color additive mixtures 
for fish feed use made with astaxanthin dimethyldisuccinate may contain 
only those diluents that are suitable and are listed in this subpart as 
safe for use in color additive mixtures for coloring foods.
    (b) Specifications. Astaxanthin dimethyldisuccinate shall conform 
to the following specifications and shall be free from impurities other 
than those named to the extent that such impurities may be avoided by 
good manufacturing practice:
    (1) Physical state, solid.
    (2) 0.05 percent solution in chloroform, complete and clear.
    (3) Absorption maximum wavelength 484-493 nanometers (in 
chloroform).
    (4) Residue on ignition, not more than 0.1 percent.
    (5) Total carotenoids other than astaxanthin dimethyldisuccinate, 
not more than 4 percent.
    (6) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts 
per million).
    (7) Arsenic, not more than 2 mg/kg (2 parts per million).
    (8) Mercury, not more than 1 mg/kg (1 part per million).
    (9) Heavy metals, not more than 10 mg/kg (10 parts per million).
    (10) Assay including astaxanthin dimethyldisuccinate, astaxanthin 
monomethylsuccinate, and astaxanthin, minimum 96 percent.
    (c) Uses and restrictions. Astaxanthin dimethyldisuccinate may be 
safely used in the feed of salmonid fish in accordance with the 
following prescribed conditions:
    (1) The color additive is used to enhance the pink to orange-red 
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin dimethyldisuccinate in the finished 
feed, when used alone or in combination with other astaxanthin color 
additive sources listed in this part 73, shall not exceed 110 
milligrams per kilogram (mg/kg), which is equivalent to 80 mg/kg 
astaxanthin (72 grams per ton).
    (d) Labeling requirements. (1) The labeling of the color additive 
and any premixes prepared therefrom shall bear expiration dates for the 
sealed and open container (established through generally accepted 
stability testing methods), other information required by Sec.  70.25 
of this chapter, and adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The presence of the color additive in finished fish feed 
prepared according to paragraph (c) of this section shall be declared 
in accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have 
been fed feeds containing astaxanthin dimethyldisuccinate shall be 
declared in accordance with Sec. Sec.  101.22(b), (c), and (k)(2), and 
101.100(a)(2) of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification 
requirements of section 721(c) of the act.

    Dated: October 21, 2009.
Leslye M. Fraser,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. E9-26524 Filed 11-04-09; 8:45 am]
BILLING CODE 4160-01-S