[Title 21 CFR 177.1500]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 177 - INDIRECT FOOD ADDITIVES: POLYMERS]
[Subpart B - Substances for Use as Basic Components of Single and Repeated]
[Sec. 177.1500 - Nylon resins.]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS31996-04-011996-04-01falseNylon resins.177.1500Sec. 177.1500FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)FOOD FOR HUMAN CONSUMPTIONINDIRECT FOOD ADDITIVES: POLYMERSSubstances for Use as Basic Components of Single and Repeated
Sec. 177.1500 Nylon resins.
The nylon resins listed in paragraph (a) of this section may be
safely used to produce articles intended for use in processing,
handling, and packaging food, subject to the provisions of this section:
(a) The nylon resins are manufactured as described in this paragraph
so as to meet the specifications prescribed in paragraph (b) of this
section when tested by the methods described in paragraph (c) of this
section.
(1) Nylon 66 resins are manufactured by the condensation of
hexamethylene-diamine and adipic acid.
(2) Nylon 610 resins are manufactured by the condensation of
hexamethylene-diamine and sebacic acid.
(3) Nylon 66/610 resins are manufactured by the condensation of
equal-weight mixtures of nylon 66 salts and nylon 610 salts.
(4) Nylon 6/66 resins manufactured by the condensation and
polymerization of Nylon 66 salts and epsilon-caprolactam.
(5) Nylon 11 resins are manufactured by the condensation of 11-
aminoundecanoic acid.
(6) Nylon 6 resins are manufactured by the polymerization of
epsilon-caprolactam.
(7) Nylon 66T resins are manufactured by the condensation of
hexamethyl-enediamine, adipic acid, and terephthalic acid such that
composition in terms of ingredients is 43.1plus-minus0.2 weight
percent hexamethyl-enediamine, 35.3plus-minus1.2 weight percent
adipic acid, and 21.6plus-minus1.2 weight percent terephthalic
acid.
(8) Nylon 612 resins are manufactured by the condensation of
hexamethylenediamine and dodecanedioic acid.
(9) Nylon 12 resins are manufactured by the condensation of omega-
laurolactam.
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(10)(i) Impact modified Nylon MXD-6 resins (CAS Reg. No. 59655-05-9)
manufactured by the condensation of adipic acid, 1,3-
benzenedimethanamine, and T3alpha-(3-aminopropyl)-omega-(3-amino-
propoxy)poly- oxyethylene under such conditions that the alpha-(3-amino-
propyl)-omega-(3-aminopropoxy) polyoxyethylene monomer content does not
exceed 7 percent by weight of the finished resin.
(ii) Nylon MXD-6 resins (CAS Reg. No. 25718-70-1) manufactured by
the condensation of adipic acid and 1,3-benzenedimethanamine.
(11) Nylon 12T resins are manufactured by the condensation of omega-
laurolactam (CAS Reg. No. 0947-04-6), isophthalic acid (CAS Reg. No.
0121-91-5), and bis(4-amino-3-methylcycl-ohexyl)methane (CAS Reg. No.
6864-37-5) such that the composition in terms of ingredients is 34.4
1.5 weight percent omega-laurolactam, 26.8 0.4
weight percent isophthalic acid, and 38.8 0.5 weight
percent bis(4-amino-3-methylcyclohexyl)-methane.
(12) Nylon 6I/6T resins (CAS Reg. No. 25750-23-6) are manufactured
by the condensation of hexamethylenediamine, terephthalic acid, and
isophthalic acid such that 65 to 80 percent of the polymer units are
derived from hexamethylene isophthalamide.
(13)(i) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured
by the copolymerization of a 1 to 1 ratio by weight of epsilon-
caprolactam and omega-laurolactam.
(ii) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured by
the copolymerization of a ratio of at least 80 weight percent of
epsilon-caprolactam and no more than 20 weight percent of omega-
laurolactam.
(14) Nylon 6/69 resins (CAS Reg. No. 51995-62-1) are manufactured by
the condensation of 49.5+0.5 weight percent epsilon-caprolactam,
19.4+0.2 weight percent hexamethylenediamine and 31.2+0.3 weight percent
azelaic acid.
(b) Specifications:
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Maximum extractable fraction in selected solvents
Melting (expressed in percent by weight of resin)
point Solubility in Viscosity No. (mL/---------------------------------------------------
Nylon resins Specific gravity (degrees boiling 4.2N HC1 g) 95 percent
Fahrenheit) Water ethyl Ethyl Benzene
alcohol acetate
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1. Nylon 66 resins............. 1.14plus-minus.0 475-495 Dissolves in 1 h. ................. 1.5 1.5 0.2 0.2
15
2. Nylon 610 resins............ 1.09plus-minus.0 405-425 Insoluble after 1 ................. 1.0 2.0 1.0 1.0
15 h.
3.1 Nylon 66/610 resins........ 1.10plus-minus.0 375-395 Dissolves in 1 h. ................. 1.5 2.0 1.0 1.0
15
4.1 Nylon 6/66 resins, epsilon- 1.13 440-460 ......do......... ................. 2.0 2.0 1.5 1.5
caprolactam monomer content .015
not to exceed 0.7 percent by
weight.
4.2 Nylon 6/66 resins with 1.14 380-400 ......do......... ................. 0.8 1.0 0.5 0.5
combined caprolactam content .015
greater than 60 percent and
residual epsilon-caprolactam
monomer content not to exceed
0.4 percent by weight. For use
only as specified in Sec.
177.1395 of this chapter (CAS
Reg. No. 24993-04-2).
5.1 Nylon 11 resins for use in 1.04plus-minus.0 355-375 Insoluble after 1 ................. .30 .35 .25 .3
articles intended for 1-time 15 h.
use or repeated use in contact
with food.
5.2 Nylon 11 resins for use 1.04plus-minus.0 355-375 ......do......... ................. .35 1.60 .35 .40
only: 15
a. In articles intended for
repeated use in contact with
food.
b. In side-seam cements for
articles intended for 1-time
use in contact with food and
which are in compliance with
Sec. 175.300 of this
chapter.
6.1 Nylon 6 resins............. 1.15plus-minus.0 392-446 Dissolves in 1 h. ................. 1.0 2.0 1.0 1.0
15
6.2 Nylon 6 resins for use only 1.15plus-minus.0 392-446 ......do......... ................. 1.5 2.0 1.0 1.0
in food-contact films having 15
an average thickness not to
exceed 0.001 in.
7. Nylon 66T resins for use 1.16plus-minus.0 482-518 Insoluble after 1 ................. 1.0 1.0 .25 .25
only in food-contact films 15 h.
having an average thickness
not to exceed 0.001 in.
8. Nylon 612 resins for use 1.06plus-minus.0 406-420 ......do......... ................. .50 1.50 .50 .50
only in articles intended for 15
repeated use in contact with
food at temperatures not to
exceed 212 deg. F..
9. Nylon 12 resins for use 1.01plus-minus.0 335-355 ......do......... ................. 1.0 2.0 1.50 1.50
only:. 15
a. In food-contact films having ................
an average thickness not to
exceed 0.0016 inch intended
for use in contact with
nonalcoholic food under the
conditions of use A
(sterilization not to exceed
30 minutes at a temperature
not to exceed 250 F), and B
through H of Table 2 of Sec.
176.170(c) of this chapter,
except as provided in Sec.
177.1390(d).
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b. In coatings intended for
repeated use in contact with
all food types described in
Table 1 of Sec. 176.170(c) of
this chapter, except those
containing more than 8 percent
alcohol, under conditions of
use B through H described in
Table 2 of Sec. 176.170(c) of
this chapter.
10.1 Nylon MXD-6 and impact 1.21 437-491 Dissolves in 1h.. ................. 2.0 2.5 1.0 1.0
modified Nylon MXD-6 film 0.02
having an average thickness
not to exceed 40 microns
(0.0016 inch) for use in
processing, handling, and
packaging of food of types V
and IX listed in table 1 of
Sec. 176.170(c) of this
chapter under conditions of
use C, D, E, F, G, and H in
table 2 of Sec. 176.170(C) of
this chapter.
10.2 Impact modified Nylon MXD- 1.21 437-491 do............... ................. 2.0 2.5 1.0 1.0
6 resins for use as polymer 0.02
use as polymer modifiers in
Nylon 6 resin films complying
with paragraph (a)(6) of this
section, at levels not to
exceed 13 percent by weight of
films whose average thickness
will not exceed 15 microns
(0.6 mils). The finished film
is used for packaging,
transporting, or holding food,
excluding beverages containing
more than 8 percent alcohol
(by volume) at temperatures
not to exceed 49 C (120 F)
(conditions of use E, F, and G
in table 2 of Sec. 176.170(c)
of this chapter).
11. Nylon 12T resins for use in 1.06plus-minus0. 290-310 Insoluble after 1 ................. 0.1 ........... 0.5 0.5
contact with all types of food 015 hour.
except those containing more
than 8 percent alcohol.
12. Nylon 6I/6T resins for use 1.2070.1 hour.
food except alcoholic
beverages containing more than
8 percent alcohol.
13.1 Nylon 6/12 resins for use 1.06 260-285 Dissolves in 1 Greater than 140. 2.0 ........... 1.5 1.5
only in food-contact films 0.015 hour.
having an average thickness
not to exceed 51 microns
(0.002 inch). The finished
film is intended to contact
all foods except those
containing more than 8 percent
ethanol under conditions of
use B, C, D, E, F, G, and H
listed in table 2 of Sec.
176.170(c) of this chapter.
13.2 Nylon 6/12 resins with 1.10 380-400 Dissolves in 1 h. Greater than 160. 0.8 1.0 0.5 0.5
residual epsilon-caprolactam 0.15
not to exceed 0.5 percent by
weight and residual omega-
laurolactam not to exceed 0.1
percent by weight. For use
only as specified in Sec.
177.1395 of this chapter.
14. Nylon 6/69 resins for use 1.09 140 using the 3.0 ........... ........... ...........
only as specified in 21 CFR minus> 0.02 method described
177.1395 of this chapter. in Sec.
177.1500(c)(5)(i
i) of this
chapter.
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(c) Analytical methods--(1) Specific gravity. Specific gravity shall
be determined by weighing a 1-gram to 5-gram sample first in air and
then in freshly boiled distilled water at 23 deg. Cplus-minus2 deg.
C.
(2) Melting point. The melting point shall be determined as follows:
Use a hot-stage apparatus. The use of crossed nicol prisms with a
microscope hot stage and reading of the thermometer when the
birefringence disappears increases the accuracy. If the crossed nicol
apparatus is not available, use the lowest temperature at which the
sample becomes transparent or the sharp edges or corners of the sample
become rounded as the melting point. In case of doubt as to the onset of
melting, the sample is prodded with a sharp instrument. If it sticks to
the heating block, it is considered to have melted. If the melting point
is low, dry the sample in an oven at 85 deg. C for 24 hours in a
nitrogen atmosphere then repeat the test.
(3) Solubility in boiling 4.2N HCl. The test shall be run on a
sample approximately the size of a \1/8\-inch cube in at least 25
milliliters of 4.2 normal hydrochloric acid.
(4) Maximum extractable fraction in selected solvents. The procedure
for determining the maximum extractable fraction of the nylon resins in
selected solvents is as follows:
(i) Film should be cut with ordinary scissors into pieces of a
convenient size such as \1/4\-inch squares, for the extraction tests
described in this section. The granules of nylon molding powders are in
the proper form for the extraction tests. Samples of fabricated articles
such as pipe, fittings, and other similar articles must be cut to
approximately the size of the molding powder. This can be done
conveniently by using a small-scale commercial plastics granulator and
cutting the sample through a screen having \1/4\-inch mesh. Fine
particles should be separated from the cut resin by screening through a
20-mesh screen. The material retained on the screen is suitable for the
extraction tests.
(ii) The organic solvents must be of American Chemical Society
analytical reagent grade; distilled water is used. Approximately 30
grams of the prepared sample is weighed to the nearest milligram. The
weighed resin is transferred to a 500-milliliter round-bottom flask
equipped with a reflux condenser. Approximately 300-milliliters of
solvent is added to the flask and the contents refluxed gently for 8
hours with a heating mantle. The solvent is then filtered off
immediately while still hot, using a Buchner funnel approximately 5
inches in diameter, a suction flask, and a hardened filter paper
(Whatman No. 50 or equivalent). The paper is wet with the solvent and a
slight suction applied just before starting the filtration. The resin is
washed twice with approximately 100-milliliter portions of solvent and
the combined filtrate and washings are reduced to approximately 25
milliliters by evaporation at reduced pressure (50 millimeters to 100
millimeters of mercury, absolute), heating as necessary. The contents of
the flask are transferred to an evaporation dish (which has been held in
a vacuum desiccator over anhydrous calcium sulfate until constant weight
has been attained) and carefully evaporated to dryness. The weight of
the solid residue is determined by difference after holding in a vacuum
desiccator over anhydrous calcium sulfate until constant weight has been
attained. The percent of solids extracted is calculated by dividing the
weight of the solid residue by the weight of the sample and multiplying
by 100.
(5) Viscosity number (VN). (i) The viscosity number (VN) for Nylon
6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin
per milliliter) shall be determined at 25 deg.C (77 deg.F) by method
ISO 307-1984(E), ``Plastics-Polyamides-Determination of Viscosity
Number,'' which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 200 C St. SW., Washington, DC 20204, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(ii) The viscosity number (VN) for Nylon 6/69 resin in a 99 percent
cresol solution (5 milligrams resin per milliliter) shall be determined
at 25 deg.C (77 deg.F) by method ISO 307-1984(E), ``Plastics-
Polyamides-Determination of Viscosity Number,'' which is incorporated
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by reference. The availability of this incorporation by reference is
given in paragraph (c)(5)(i) of this section.
[42 FR 14572, Mar. 15, 1977, as amended at 45 FR 2844, Jan. 15, 1980; 48
FR 30361, July 1, 1983; 48 FR 33478, July 22, 1983; 48 FR 36099, Aug. 9,
1983; 51 FR 33250, Sept. 19, 1986; 52 FR 26667, July 16, 1987; 52 FR
33575, Sept. 4, 1987; 52 FR 39635, Oct. 23, 1987; 52 FR 42760, Nov. 6,
1987; 53 FR 19773, May 31, 1988; 54 FR 29019, July 11, 1989; 58 FR 2977,
Jan. 7, 1993; 58 FR 32610, June 11, 1993; 61 FR 14481, Apr. 2, 1996]