CFR 2021 Title21 Vol3 Part177 PDF

§ 176.320 21 CFR Ch.
I (4–1–21 Edition)
§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer.

177.1050 Acrylonitrile/styrene copolymer
Sodium nitrate-urea complex may be modified with butadiene/styrene elas-
safely used as a component of articles tomer.
intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly-
facturing, packing, processing, pre- mers.
paring, treating, packaging, trans- 177.1200 Cellophane.
porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for
food containers.
provisions of this section. 177.1211 Cross-linked polyacrylate copoly-
(a) Sodium nitrate-urea complex is a mers.
clathrate of approximately two parts 177.1240 1,4-Cyclohexylene dimethylene
urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene
(b) Sodium nitrate-urea complex con- dimethylene isophthalate copolymer.
forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers.
in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly-
used as provided in paragraph (b)(2) of mers.
177.1315 Ethylene-1,4-cyclohexylene
this section. dimethylene terephthalate copolymers.
(1) Limitations. (i) It is used as a plas- 177.1320 Ethylene-ethyl acrylate copoly-
ticizer in glassine and greaseproof mers.
paper. 177.1330 Ionomeric resins.
(ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly-
that required to accomplish its in- mer resins.
tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene
percent by weight of the finished paper. isophthalate/terephthalate copolymer.
177.1350 Ethylene-vinyl acetate copolymers.
(2) Conditions of use. The glassine and 177.1360 Ethylene-vinyl acetate-vinyl alco-
greaseproof papers are used for pack- hol copolymers.
aging dry food or as the food-contact 177.1380 Fluorocarbon resins.
surface for dry food. 177.1390 Laminate structures for use at tem-
peratures of 250 °F and above.
§ 176.350 Tamarind seed kernel pow- 177.1395 Laminate structures for use at tem-
der. peratures between 120 °F and 250 °F.
Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water-
insoluble.
safely used as a component of articles 177.1420 Isobutylene polymers.
intended for use in producing, manu- 177.1430 Isobutylene-butene copolymers.
facturing, packing, processing, pre- 177.1440 4,4′-Isopropylidenediphenol-
paring, treating, packaging, trans- epichlorohydrin resins minimum molec-
porting, or holding food, subject to the ular weight 10,000.
provisions of this section. 177.1460 Melamine-formaldehyde resins in
(a) Tamarind seed kernel powder is molded articles.
177.1480 Nitrile rubber modified acrylo-
the ground kernel of tamarind seed
nitrile-methyl acrylate copolymers.
(Tamarindus indica L.) after removal of 177.1500 Nylon resins.
the seed coat. 177.1520 Olefin polymers.
(b) It is used in the manufacture of 177.1550 Perfluorocarbon resins.
paper and paperboard. 177.1555 Polyarylate resins.
177.1556 Polyaryletherketone resins.
177.1560 Polyarylsulfone resins.
PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/
ADDITIVES: POLYMERS ethylene copolymers.
177.1580 Polycarbonate resins.
Subpart A [Reserved] 177.1585 Polyestercarbonate resins.
177.1590 Polyester elastomers.
Subpart B—Substances for Use as Basic 177.1595 Polyetherimide resin.
Components of Single and Repeated 177.1600 Polyethylene resins, carboxyl modi-
Use Food Contact Surfaces fied.
177.1610 Polyethylene, chlorinated.
Sec. 177.1615 Polyethylene, fluorinated.
177.1010 Acrylic and modified acrylic plas- 177.1620 Polyethylene, oxidized.
tics, semirigid and rigid. 177.1630 Polyethylene phthalate polymers.
177.1020 Acrylonitrile/butadiene/styrene co- 177.1632 Poly(phenyleneterephthalamide)
kpayne on VMOFRWIN702 with $$_JOB
polymer. resins.
177.1030 Acrylonitrile/butadiene/styrene/ 177.1635 Poly(p-methylstyrene) and rubber-
methyl methacrylate copolymer. modified poly(p-methylstyrene).
244
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Food and Drug Administration, HHS § 177.1010
177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers.
ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes.
naphthalenediylcarbonyl) resins.
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.
177.1640 Polystyrene and rubber-modified
polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless
177.1650 Polysulfide polymer-polyepoxy res- otherwise noted.
ins.
177.1655 Polysulfone resins. EDITORIAL NOTE: Nomenclature changes to
177.1660 Poly(tetramethylene part 177 appear at 61 FR 14482, Apr. 2, 1996; 66
terephthalate). FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27,
177.1670 Polyvinyl alcohol film. 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 72074,
177.1680 Polyurethane resins. Dec. 1, 2005; and 81 FR 49896, July 29, 2016.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copoly- Subpart A [Reserved]
mers.
177.1830 Styrene-methyl methacrylate co-
polymers. Subpart B—Substances for Use as
177.1850 Textryls. Basic Components of Single
177.1900 Urea-formaldehyde resins in molded and Repeated Use Food Con-
articles.
177.1950 Vinyl chloride-ethylene copoly-
tact Surfaces
mers.
177.1960 Vinyl chloride-hexene-1 copoly-
§ 177.1010 Acrylic and modified acrylic
mers.
plastics, semirigid and rigid.
177.1970 Vinyl chloride-lauryl vinyl ether Semirigid and rigid acrylic and modi-
copolymers. fied acrylic plastics may be safely used
177.1980 Vinyl chloride-propylene copoly- as articles intended for use in contact
mers. with food, in accordance with the fol-
177.1990 Vinylidene chloride/methyl acry-
late copolymers. lowing prescribed conditions. The
177.2000 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers
late/methyl methacrylate polymers. or plastics described in this section
also may be safely used as components
Subpart C—Substances for Use Only as of articles intended for use in contact
Components of Articles Intended for with food.
Repeated Use (a) The optional substances that may
be used in the formulation of the
177.2210 Ethylene polymer,
chlorosulfonated. semirigid and rigid acrylic and modi-
177.2250 Filters, microporous polymeric. fied acrylic plastics, or in the formula-
177.2260 Filters, resin-bonded. tion of acrylic and modified acrylic
177.2280 4,4′-Isopropylidenediphenol- components of articles, include sub-
epichlorohydrin thermosetting epoxy stances generally recognized as safe in
resins. food, substances used in accordance
177.2355 Mineral reinforced nylon resins. with a prior sanction or approval, sub-
177.2400 Perfluorocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
stances permitted for use in such plas-
177.2415 Poly(aryletherketone) resins. tics by regulations in parts 170 through
177.2420 Polyester resins, cross-linked. 189 of this chapter, and substances
177.2430 Polyether resins, chlorinated. identified in this paragraph. At least 50
177.2440 Polyethersulfone resins. weight-percent of the polymer content
177.2450 Polyamide-imide resins. of the acrylic and modified acrylic ma-
177.2460 Poly(2,6-dimethyl-1,4-phenylene) terials used as finished articles or as
oxide resins.
177.2465 Polymethylmethacrylate/poly(tri
components of articles shall consist of
methoxysilylpropyl) methacrylate copolymer units derived from one or
polymers. more of the acrylic or methacrylic
177.2470 Polyoxymethylene copolymer. monomers listed in paragraph (a)(1) of
177.2480 Polyoxymethylene homopolymer. this section.
177.2490 Polyphenylene sulfide resins. (1) Homopolymers and copolymers of
177.2500 Polyphenylene sulfone resins. the following monomers:
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes. n-Butyl acrylate.
177.2600 Rubber articles intended for re- n-Butyl methacrylate.
peated use. Ethyl acrylate.

177.2710 Styrene-divinylbenzene resins, 2-Ethylhexyl acrylate.
cross-linked. Ethyl methacrylate.
245
§ 177.1010 21 CFR Ch. I (4–1–21 Edition)
Methyl acrylate. Methacryloxyacetamidoethylethylene urea.
Methyl methacrylate. Methacryloxyacetic acid.
n-Propyl methacrylate.
(2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate.
erizing one or more of the monomers
listed in paragraph (a)(1) of this section (4) Polymers identified in paragraphs
with one or more of the following (a)(1), (2), and (3) of this section are
monomers: mixed together and/or with the fol-
lowing polymers, provided that no
Acrylonitrile. chemical reactions, other than addi-
Methacrylonitrile.
a-Methylstyrene.
tion reactions, occur when they are
Styrene. mixed:
Vinyl chloride. Butadiene-acrylonitrile copolymers.
Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers.
(3) Polymers identified in paragraphs Butadiene-acrylonitrile-styrene-methyl
methacrylic copolymers.
(a)(1) and (2) of this section containing
Butadiene-styrene copolymers.
no more than 5 weight-percent of total Butyl rubber.
polymer units derived by copolym- Natural rubber.
erization with one or more of the Polybutadiene.
monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene).
and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of
ed in paragraph (a)(3)(ii) of this section this chapter.
are limited to use only in plastic arti- Polyvinyl chloride.
Vinyl chloride copolymers complying with
cles intended for repeated use in con- § 177.1980.
tact with food. Vinyl chloride-vinyl acetate copolymers.
(i) List of minor monomers:
(5) Antioxidants and stabilizers iden-
Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap-
Acrylic acid
1,3-Butylene glycol dimethacrylate.
ter and the following:
1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol.
Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone.
Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2-
Divinylbenzene. carboxybenzophenone.
Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate.
Itaconic acid. p-Methoxyphenol.
Methacrylic acid. Methyl salicylate.
N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro-
N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For
4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2
Propylene glycol dimethacrylate. percent by weight in semirigid and rigid
Trivinylbenzene. acrylic and modified acrylic plastics,
(ii) List of minor monomers limited where the finished articles contact foods
to use only in plastic articles intended containing not more than 15 percent alco-
hol; and (2) at levels not exceeding 0.01 per-
for repeated use in contact with food: cent by weight in semirigid and rigid
Allyl methacrylate [Chemical Abstracts acrylic and modified acrylic plastics in-
Service Registry No. 96–05–9] tended for repeated food-contact use where
tert-Butyl acrylate. the finished article may be used for foods
tert-Butylaminoethyl methacrylate. containing more than 15 percent alcohol.
sec-Butyl methacrylate. Phenyl salicylate.
tert-Butyl methacrylate.
Cyclohexyl methacrylate.
(6) Release agents: Fatty acids de-
Dimethylaminoethyl methacrylate. rived from animal and vegetable fats
2-Ethylhexyl methacrylate. and oils, and fatty alcohols derived
Hydroxyethyl methacrylate. from such acids.
Hydroxyethyl vinyl sulfide. (7) Surface active agent: Sodium
Hydroxypropyl methacrylate. dodecylbenzenesulfonate.
Isobornyl methacrylate. (8) Miscellaneous materials:
Isobutyl methacrylate.
Isopropyl acrylate. Di(2-ethylhexyl) phthalate, for use only as a
Isopropyl methacrylate. flow promoter at a level not to exceed 3

Methacrylamide. weight-percent based on the monomers.
Methacrylamidoethylene urea. Dimethyl phthalate.
246
Oxalic acid, for use only as a polymerization prepared in a still using a block tin
catalyst aid. condenser. The 8 and 50 percent (by vol-
Tetraethylenepentamine, for use only as a ume) alcohol solvents shall be prepared
catalyst activator at a level not to exceed
0.5 weight-percent based on the monomers.
from ethyl alcohol meeting the speci-
Toluene. fications of the United States Pharma-
Xylene. copeia XX and diluted with double-dis-
tilled water that has been prepared in a
(b) The semirigid and rigid acrylic
still using a tin block condenser. The
and modified acrylic plastics, in the
n-heptane shall be spectrophotometric
finished form in which they are to con-
grade. Adequate precautions must be
tact food, when extracted with the sol-
taken to keep all solvents dust-free.
vent or solvents characterizing the
(4) Blank values on solvents. (i) Dupli-
type of food and under the conditions
cate determinations of residual solids
of time and temperature as determined
shall be run on samples of each solvent
from tables 1 and 2 of § 176.170(c) of this
that have been exposed to the tempera-
chapter, shall yield extractives not to
ture-time conditions of the extraction
exceed the following, when tested by
the methods prescribed in paragraph test without the plastic sample. Sixty
(c) of this section. The acrylic and milliliters of exposed solvent is
modified acrylic polymers or plastics pipetted into a clean, weighed plat-
intended to be used as components of inum dish, evaporated to 2–5 milliliters
articles also shall yield extractives not on a nonsparking, low-temperature hot
to exceed the following limitations plate and dried in 212 °F oven for 30
when prepared as strips as described in minutes. The residue for each solvent
paragraph (c)(2) of this section: shall be determined by weight and the
(1) Total nonvolatile extractives not average residue weight used as the
to exceed 0.3 milligram per square inch blank value in the total solids deter-
of surface tested. mination set out in paragraph (c)(6) of
(2) Potassium permanganate oxidiz- this section. The residue for an accept-
able distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5
cent alcohol extractives not to exceed milligram per 60 milliliters.
an absorbance of 0.15. (ii) For acceptability in the ultra-
(3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each
water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra-
tractives not to exceed an absorbance violet spectrophotometer in 5-centi-
of 0.30. meter silica spectrophotometric ab-
(4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the
extractives not to exceed an absorb- distilled water when measured versus
ance of 0.10. air in the reference cell shall not ex-
(c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave-
extractability conditions. These are to be length region of 245 to 310 mμ. The ab-
chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when
chapter. measured versus distilled water in the
(2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at
samples to allow duplicates of all ap- any point in the wavelength region of
plicable tests shall be cut from the ar- 245 to 310 mμ. The absorbance of the 50
ticles or formed from the plastic com- percent alcohol when measured versus
position under tests, as strips about 2.5 distilled water in the reference cell
inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the
0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mμ. The
face should be 5 square inches ±0.5- absorbance of the heptane when meas-
square inch. The samples, after prepa- ured versus distilled water in the ref-
ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245,
brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any
running hot tapwater (140 °F min- point in the wavelength region of 280 to
imum), rinsed with distilled water, and 310 mμ.
air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de-
iccator. terminations shall be run on samples of
(3) Preparation of solvents. The water each solvent that has been exposed to
used shall be double-distilled water, the temperature-time conditions of the
247
§ 177.1010 21 CFR Ch. I (4–1–21 Edition)
extraction test without the plastic tents to room temperature if nec-

sample. An aliquot of the exposed sol- essary.
vent shall be measured versus the un- (6) Determination of total nonvolatile
exposed solvent in the reference cell. extractives. Remove the plastic strip
The average difference in the from the solvent with a pair of clean
absorbances at any wavelength in the forceps and wash the strip with 5 milli-
region of 245 to 310 mμ shall be used as liters of the appropriate solvent, add-
a blank correction for the ultraviolet ing the washings to the contents of the
absorbers measured at the same wave- test tube. Pour the contents of the test
length according to paragraph (c)(8)(ii) tube into a clean, weighed platinum
of this section. dish. Wash the tube with 5 milliliters
(iv) The acceptability of the solvents of the appropriate solvent and add the
for use in the permanganate test shall solvent to the platinum dish. Evapo-
be determined by preparing duplicate rate the solvent to 2–5 milliliters on a
permanganate test blanks according to nonsparking, low-temperature
paragraph (c)(7)(iv) of this section. For hotplate. Complete the evaporation in
this test, the directions referring to a 212 °F oven for 30 minutes. Cool the
the sample extract shall be dis- dish in a desiccator for 30 minutes and
regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal-
in 5-centimeter silica culate the total nonvolatile extractives
spectrophotometric cells in the spec- as follows:
trophotometer versus the appropriate
Milligrams extractives e − b
solvent as reference. The absorbance in
=
distilled water in the wavelength re- per square inch s
gion of 544 to 552 mμ should be 1.16 but
must not be less than 1.05 nor more
Extractives in parts eb
than 1.25. The absorbance in the 8 and = × 100
50 percent alcohol must not be less per million s
than 0.85 nor more than 1.15. where:
(v) Duplicate permanganate test de- e = Total increase in weight of the dish, in
terminations shall be run on samples of milligrams.
distilled water and 8 and 50 percent al- b = Blank value of the solvent in milligrams,
cohol solvents that have been exposed as determined in paragraph (c)(4)(i) of
to the temperature-time conditions of this section.
the extraction test without the plastic s = Total surface of the plastic sample in
square inches.
sample. The procedure shall be as de-
scribed in paragraph (c)(7)(iv) of this (7) Determination of potassium per-
section, except that the appropriate ex- manganate oxidizable extractives. (i) Pi-
posed solvent shall be substituted pette 25 milliliters of distilled water
where the directions call for sample ex- into a clean 125-milliliter Erlenmeyer
tract. The average difference in the flask that has been rinsed several
absorbances in the region of 544 to 552 times with aliquots of distilled water.
mμ shall be used as a blank correction This is the blank. Prepare a distilled
for the determination of permanganate water solution containing 1.0 part per
oxidizable extractives according to million of p-methoxyphenol (melting
paragraph (c)(7)(iv) of this section. point 54–56 °C, Eastman grade or equiv-
(5) Extraction procedure. For each ex- alent). Pipette 25 milliliters of this p-
traction, place a plastic sample in a methoxyphenol solution into a rinsed
clean 25 millimeters × 200 millimeters Erlenmeyer flask. Pipette exactly 3.0
hard-glass test tube and add solvent milliliters of 154 parts per million
equal to 10 milliliters of solvent per aqueous potassium permanganate solu-
square inch of plastic surface. This tion into the p-methoxyphenol and ex-
amount will be between 45 milliliters actly 3.0 milliliters into the blank, in
and 55 milliliters. The solvent must be that order. Swirl both flasks to mix the
preequilibrated to the temperature of contents and then transfer aliquots
the extraction test. Close the test tube from each flask into matched 5-centi-
with a ground-glass stopper and expose meter spectrophotometric absorption
ER01JA93.393</GPH>
to the specified temperature for the cells. The cells are placed in the spec-
specified time. Cool the tube and con- trophotometer cell compartment with
248
ER01JA93.392</GPH>
the p-methoxyphenol solution in the pose of ascertaining compliance with

reference beam. Spectrophotometric the limitations in paragraph (b)(2) of
measurement is conducted as in para- this section, the absorbance measure-
graph (c)(7)(iv) of this section. The ab- ments obtained on the distilled water
sorbance reading in the region 544–552 extracts according to paragraph
mμ should be 0.24 but must be not less (c)(7)(iv) of this section shall be multi-
than 0.12 nor more than 0.36. This test plied by a correction factor, calculated
shall be run in duplicate. For the pur- as follows:
0.24
= Correction factor for water extracts.
Average of duplicate ρ-methoxyphenol
absorbance determinations according to
this paragraph (c)(7)(i) of this section
(ii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi-
more than 0.39. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.26 Correction factor for aqueous

=
Average of duplicate ρ-methoxyphenol 8 percent alcohol extracts.
absorbance determination according to
this paragraph (c)(7)(ii) of this section
(iii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi-
more than 0.38. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.25 Correction factor for 50 percent

=
Average of duplicate ρ-methoxyphenol aqueous alcohol extracts.
paragraph (c)(7)(ii) of this section
ER01JA93.395</GPH> ER01JA93.396</GPH>
(iv) Water and 8 and 50 percent alcohol the same solvent. This is the blank.
extracts. Pipette 25 milliliters of the ap- Into another similarly rinsed flask, pi-
propriate solvent into a clean, 125-mil- pette 25 milliliters of the sample ex-
liliter Erlenmeyer flask that has been tract that has been exposed under the
rinsed several times with aliquots of conditions specified in paragraph (c)(5)
249
ER01JA93.394</GPH>
§ 177.1010 21 CFR Ch. I (4–1–21 Edition)
of this section. Pipette exactly 3.0 mil- propriate correction factor determined
liliters of 154 parts per million aqueous according to paragraph (c)(7)(i), (ii),
potassium permanganate solution into and (iii) of this section. This test shall
the sample and exactly 3.0 milliliters be run in duplicate and the two results
into the blank, in that order. Before averaged.
use, the potassium permanganate solu- (8) Determination of ultraviolet-absorb-
tion shall be checked as in paragraph ing extractives. (i) A distilled water so-
(c)(7)(i) of this section. Both flasks are lution containing 1.0 part per million
swirled to mix the contents, and then of p-methoxyphenol (melting point 54
aliquots from each flask are trans-
°C–56 °C. Eastman grade or equivalent)
ferred to matched 5-centimeter
shall be scanned in the region 360 to 220
spectrophotometric absorption cells.
Both cells are placed in the spectro- mμ in 5-centimeter silica spectrophoto-
photometer cell compartment with the metric absorption cells versus a dis-
sample solution in the reference beam. tilled water reference. The absorbance
The spectrophotometer is adjusted for at the wavelength of maximum absorb-
0 and 100 percent transmittance at 700 ance (should be about 285 mμ) is about
mμ. The spectrum is scanned on the ab- 0.11 but must be not less than 0.08 nor
sorbance scale from 700 mμ to 500 mμ in more than 0.14. This test shall be run in
such a way that the region 544 mμ to duplicate. For the purpose of
552 mμ is scanned within 5 minutes to ascertaining compliance with the limi-
10 minutes of the time that permanga- tations prescribed in paragraph (b)(3)
nate was added to the solutions. The and (4) of this section, the absorbance
height of the absorbance peak shall be obtained on the extracts according to
measured, corrected for the blank as paragraph (c)(8)(ii) of this section shall
determined in paragraph (c)(4)(v) of be multiplied by a correction factor,
this section, and multiplied by the ap- calculated as follows:
0.11
= Correction factor for ultraviolet
Average of duplicate ρ-methoxyphenol absorbers test.
this paragraph (c)(8)(i) of this section
(ii) An aliquot of the extract that has (e) Acrylonitrile copolymers identi-
been exposed under the conditions fied in this section shall comply with
specified in paragraph (c)(5) of this sec- the provisions of § 180.22 of this chap-
tion is scanned in the wavelength re- ter.
gion 360 to 220 mμ versus the appro- (f) The acrylic and modified acrylic
priate solvent reference in matched 5- polymers identified in and complying
centimeter silica spectrophotometric with this section, when used as compo-
absorption cells. The height of any ab- nents of the food-contact surface of an
sorption peak shall be measured, cor- article that is the subject of a regula-
rected for the blank as determined in tion in this part and in parts 174, 175,
paragraph (c)(4)(iii) of this section, and 176, and 178 of this chapter, shall com-
multiplied by the correction factor de- ply with any specifications and limita-
termined according to paragraph tions prescribed by such regulation for
(c)(8)(i) of this section. the article in the finished form in
(d) In accordance with current good which it is to contact food.
manufacturing practice, finished
semirigid and rigid acrylic and modi- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct.
fied acrylic plastics, and articles con- 28, 1977, as amended at 43 FR 54927, Nov. 24,
1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796,
taining these polymers, intended for
Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR
repeated use in contact with food shall
13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985]

be thoroughly cleansed prior to their
first use in contact with food.
250
ER01JA93.397</GPH>
§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer

rene co-polymer. content of the finished copolymer arti-
Acrylonitrile/butadiene/styrene co- cles is not more than 11 parts per mil-
polymer identified in this section may lion as determined by a gas
be safely used as an article or compo- chromatographic method titled ‘‘De-
nent of articles intended for use with termination of Residual Acrylonitrile
all foods, except those containing alco- and Styrene Monomers-Gas
hol, under conditions of use E, F, and G Chromatographic Internal Standard
described in table 2 of § 176.170(c) of this Method,’’ which is incorporated by ref-
chapter. erence. Copies are available from the
(a) Identity. For the purpose of this Center for Food Safety and Applied Nu-
section, the acrylonitrile/butadiene/ trition (HFS–200), Food and Drug Ad-
styrene copolymer consists of: ministration, 5001 Campus Dr., College
(1) Eighty-four to eighty-nine parts Park, MD 20740, or available for inspec-
by weight of a matrix polymer con- tion at the National Archives and
taining 73 to 78 parts by weight of acry- Records Administration (NARA). For
lonitrile and 22 to 27 parts by weight of information on the availability of this
styrene; and material at NARA, call 202–741–6030, or
(2) Eleven to sixteen parts by weight go to: http://www.archives.gov/fed-
of a grafted rubber consisting of (i) 8 to erallregister/
13 parts of butadiene/styrene elastomer codeloflfederallregulations/
containing 72 to 77 parts by weight of ibrllocations.html.
butadiene and 23 to 28 parts by weight
(d) Extractive limitations. (1) Total
of styrene and (ii) 3 to 8 parts by
weight of a graft polymer having the nonvolatile extractives not to exceed
same composition range as the matrix 0.0005 milligram per square inch sur-
polymer. face area when the finished food con-
(b) Adjuvants. The copolymer identi- tact article is exposed to distilled
fied in paragraph (a) of this section water, 3 percent acetic acid, or n-
may contain adjuvant substances re- heptane for 8 days at 120 °F.
quired in its production. Such adju- (2) The finished food-contact article
vants may include substances gen- shall yield not more than 0.0015 milli-
erally recognized as safe in food, sub- gram per square inch of acrylonitrile
stances used in accordance with prior monomer when exposed to distilled
sanction, substances permitted in this water and 3 percent acetic acid at 150
part, and the following: °F for 15 days when analyzed by a po-
larographic method titled ‘‘Extracted
Substance Limitations
Acrylonitrile by Differential Pulse Po-
2-Mercapto- ethanol The finished copolymer shall contain larography,’’ which is incorporated by
not more than 100 ppm 2- reference. Copies are available from
mercaptoethanol acrylonitrile adduct
as determined by a method titled the Center for Food Safety and Applied
‘‘Analysis of Cycopac Resin for Re- Nutrition (HFS–200), Food and Drug
sidual b-(2-Hydroxyethylmercapto) Administration, 5001 Campus Dr., Col-
propionitrile,’’ which is incorporated
by reference. Copies are available lege Park, MD 20740, or available for in-
from the Bureau of Foods (HFS– spection at the National Archives and
200), Food and Drug Administra- Records Administration (NARA). For
tion, 5001 Campus Dr., College
Park, MD 20740, or available for in- information on the availability of this
spection at the National Archives material at NARA, call 202–741–6030, or
and Records Administration go to: http://www.archives.gov/fed-
(NARA). For information on the
availability of this material at NARA, erallregister/
call 202–741–6030, or go to: http:// codeloflfederallregulations/
www.archives.gov/federallregister/ ibrllocations.html.
codeloflfederallregulations/
ibrllocations.html. (e) Acrylonitrile copolymers identi-
fied in this section shall comply with
(c) Specifications. (1) Nitrogen content the provisions of § 180.22 of this chap-
of the copolymer is in the range of 16 ter.
to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi-

Kjeldahl analysis. fied in this section are not authorized
251
§ 177.1030 21 CFR Ch. I (4–1–21 Edition)
to be used to fabricate beverage con- Substances Limitations

tainers.
2–Mercaptoethanol .. The finished copolymer shall contain
[42 FR 14572, Mar. 15, 1977, as amended at 42 not more than 800 ppm 2–
mercaptoethanol acrylonitrile adduct
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19,
as determined by a method titled
1982; 54 FR 24897, June 12, 1989] ‘‘Analysis of Cycopac Resin for Re-
sidual b–(2–Hydroxyethylmercapto)
§ 177.1030 Acrylonitrile/butadiene/sty- propionitrile,’’ which is incorporated
rene/methyl methacrylate copoly- by reference. Copies are available
from the Bureau of Foods (HFS–
mer. 200), Food and Drug Administra-
Acrylonitrile/butadiene/styrene/ tion, 5001 Campus Dr., College
Park, MD 20740, or available for in-
methyl methacrylate copolymer iden- spection at the National Archives
tified in this section may be safely and Records Administration
used as an article or component of arti- (NARA). For information on the
availability of this material at NARA,
cles intended for use with food identi- call 202–741–6030, or go to: http://
fied in table 1 of § 176.170(c) of this www.archives.gov/federallregister/
chapter as Type I, II, III, IVA, IVB, V, codeloflfederallregulations/
ibrllocations.html.
VIB, (except bottles intended to hold
carbonated beverages), VIIA, VIIB, VIII (c) Specifications. (1) Nitrogen content
and IX, under conditions of use C, D, E, of the copolymer is in the range of 13.0
F, and G described in table 2 of to 16.0 percent as determined by Micro-
§ 176.170(c) of this chapter with a high Kjeldahl analysis.
temperature limitation of 190 °F.
(2) Residual acrylonitrile monomer
(a) Identity. For the purpose of this content of the finished copolymer arti-
section, acrylonitrile/butadiene/sty- cles is not more than 11 parts per mil-
rene/methyl methacrylate copolymer lion as determined by a gas
consists of: (1) 73 to 79 parts by weight chromatographic method titled ‘‘De-
of a matrix polymer containing 64 to 69 termination of Residual Acrylonitrile
parts by weight of acrylonitrile, 25 to and Styrene Monomers-Gas
30 parts by weight of styrene and 4 to Chromatographic Internal Standard
6 parts by weight of methyl methacry- Method,’’ which is incorporated by ref-
late; and (2) 21 to 27 parts by weight of erence. Copies are available from the
a grafted rubber consisting of (i) 16 to Center for Food Safety and Applied Nu-
20 parts of butadiene/styrene/elastomer trition (HFS–200), Food and Drug Ad-
containing 72 to 77 parts by weight of ministration, 5001 Campus Dr., College
butadiene and 23 to 28 parts by weight Park, MD 20740, or available for inspec-
of styrene and (ii) 5 to 10 parts by tion at the National Archives and
weight of a graft polymer having the Records Administration (NARA). For
same composition range as the matrix information on the availability of this
polymer. material at NARA, call 202–741–6030, or
(b) Adjuvants. The copolymer identi- go to: http://www.archives.gov/fed-
fied in paragraph (a) of this section erallregister/
may contain adjuvant substances re- codeloflfederallregulations/
quired in its production. Such adju- ibrllocations.html.
vants may include substances gen- (d) Extractive limitations. (1) Total
erally recognized as safe in food, sub- nonvolatile extractives not to exceed
stances used in accordance with prior 0.0005 milligram per square inch sur-
sanction, substances permitted under face area of the food-contact article
applicable regulations in this part, and when exposed to distilled water, 3 per-
the following: cent acetic acid, 50 percent ethanol,
and n-heptane for 10 days at 120 °F.
(2) The finished food-contact article
shall yield not more than 0.0025 milli-
gram per square inch of acrylonitrile
monomer when exposed to distilled
water, 3 percent acetic acid and n-

heptane at 190 °F for 2 hours, cooled to
252
120 °F (80 to 90 minutes) and main- used as a component of packaging ma-

tained at 120 °F for 10 days when ana- terials subject to the provisions of this
lyzed by a polarographic method titled section.
‘‘Extracted Acrylonitrile by Differen- (a) Identity. For the purposes of this
tial Pulse Polarography,’’ which is in- section acrylonitrile/styrene copoly-
corporated by reference. Copies are mers are basic copolymers meeting the
available from the Center for Food specifications prescribed in paragraph
Safety and Applied Nutrition (HFS– (c) of this section.
200), Food and Drug Administration, (b) Adjuvants. (1) The copolymers
5001 Campus Dr., College Park, MD identified in paragraph (c) of this sec-
20740, or available for inspection at the
tion may contain adjuvant substances
National Archives and Records Admin-
required in their production, with the
istration (NARA). For information on
exception that they shall not contain
the availability of this material at
NARA, call 202–741–6030, or go to: http:// mercaptans or other substances which
www.archives.gov/federallregister/ form reversible complexes with acryl-
codeloflfederallregulations/ onitrile monomer. Permissible adju-
ibrllocations.html. vants may include substances gen-
(e) Acrylonitrile copolymers identi- erally recognized as safe in food, sub-
fied in this section shall comply with stances used in accordance with prior
the provisions of § 180.22 of this chap- sanction, substances permitted under
ter. applicable regulations in this part, and
(f) Acrylonitrile copolymers identi- those authorized in paragraph (b)(2) of
fied in this section are not authorized this section.
to be used to fabricate beverage con- (2) The optional adjuvants for the ac-
tainers. rylonitrile/styrene copolymer identi-
[42 FR 14572, Mar. 15, 1977, as amended at 42 fied in paragraphs (c)(1) and (3) of this
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, section are as follows:
1982; 54 FR 24898, June 12, 1989]
Substances Limitation
§ 177.1040 Acrylonitrile/styrene copoly- Condensation polymer of toluene 0.15 pct maximum.
mer. sulfonamide and formaldehyde.
Acrylonitrile/styrene copolymers
identified in this section may be safely (c) Specifications.
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av-
consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular
duced by polymerization of 66– area of the food contact article weight is 30,000. 1
72 parts by weight of acrylo- when exposed to distilled water
nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at
of styrene; for use with food of 66 °C (150 °F).
Type VI-B identified in table 1 of The extracted copolymer shall not
§ 176.170(c) of this chapter exceed 0.001 mg/in 2 surface
under conditions of use C, D, E, area of the food contact article
F, G described in table 2 of when exposed to distilled water
§ 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at
66 °C (150 °F) 1.
2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu-
consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25
duced by polymerization of 45– heptane extract obtained when °C (77 °F) is
65 parts by weight of acrylo- 100 g sample of the basic co- 10cP. 1
nitrile and 35–55 parts by weigth polymer in the form of particles
of styrene; for use with food of of a size that will pass through a
Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and
bottles), VII, VIII, and IX identi- that will be held on a U.S.
fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex-
this chapter under conditions B tracted with 250 mil of deionized
(not to exceed 93 °C (200 °F)), water or reagent grade n-

C, D, E, F, G described in table heptane at reflux temperature
2 of § 176.170(c) of this chapter. for 2 h.1
253
§ 177.1050 21 CFR Ch. I (4–1–21 Edition)
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di-
consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability
duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for
72 parts by weight of acrylo- basis of when exposed to distilled water the finished article
nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer. 3
of styrene; for use with food of of the ac- 66 °C (150 °F).
Types VI-A and VI-B identified in rylonitrile The extracted copolymer shall not
table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface
chapter under conditions of use resin in the area of the food contact article
C, D, E, F, G described in table finished ar- when exposed to distilled water
2 of § 176.170(c) of this chapter. ticles). 2 and 3 pct acetic acid for 10 d at
66 °C (150 °F). 1.
1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average mo-
lecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas
Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210
Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical
Method for 10% Solution Viscosity of Tyril,’’ which are incorproated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.
2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo-
nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html.
3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction
by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’
which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5001
Campus Dr., College Park, MD 20740, and the American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/fed-
erallregister/ codeloflfederallregulations/ ibrllocations.html.
(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene

polymers identified in this section elastomer consists of a blend of:
shall comply with the provisions of (1) 82–88 parts by weight of a matrix
§ 180.22 of this chapter. copolymer produced by polymerization
(e) Acrylonitrile copolymer identified of 77–82 parts by weight of acrylonitrile
in this section may be used to fabricate and 18–23 parts of styrene; and
beverage containers only if they com- (2) 12–18 parts by weight of a grafted
ply with the specifications of item 3 in rubber consisting of (i) 8–12 parts of bu-
paragraph (c) of this section. tadiene/styrene elastomer containing
[42 FR 14572, Mar. 15, 1977, as amended at 42 77–82 parts by weight of butadiene and
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 18–23 parts by weight of styrene and (ii)
1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 4–6 parts by weight of a graft copoly-
Sept. 8, 1987] mer consisting of 70–77 parts by weight
of acrylonitrile and 23–30 parts by
§ 177.1050 Acrylonitrile/styrene copoly- weight of styrene.
mer modified with butadiene/sty-
rene elastomer. (b) Adjuvants. The modified copoly-
mer identified in paragraph (a) of this
Acrylonitrile/styrene copolymer section may contain adjuvant sub-
modified with butadiene/styrene elas- stances required in its production.
tomer identified in this section may be Such adjuvants may include substances
safely used as a component of bottles generally recognized as safe in food,
intended for use with foods identified substances used in accordance with
in table I of § 176.170(c) of this chapter prior sanction, substances permitted
as Type VI-B under conditions for use
under applicable regulations in this
E, F, or G described in table 2 of
part, and the following:
§ 176.170(c) of this chapter.
(a) Identity. For the purpose of this

section, acrylonitrile/styrene copoly-
254
Substances Limitations go to: http://www.archives.gov/fed-

erallregister/
n-Dodecylmercaptan The finished copolymer shall contain
not more than 500 parts per million codeloflfederallregulations/
(ppm) dodecylmercaptan as ibrllocations.html.
dodecylmercapto-propionitrile as de- (d) Extractives limitations. The fol-
termined by the method titled, ‘‘De-
termination of b-Dodecyl-
lowing extractives limitations are de-
mercaptopropionitrile in NR–16 termined by an infrared spectrophoto-
Polymer,’’ which is incorporated by metric method titled ‘‘Infrared
reference. Copies are available Spectrophotometric Determination of
from the Center for Food Safety
and Applied Nutrition (HFS–200), Polymer Extracted from Borex ® 210
Food and Drug Administration, 5001 Resin Pellets,’’ which is incorporated
Campus Dr., College Park, MD by reference. Copies are available from
20740, or available for inspection at
the National Archives and Records
the Center for Food Safety and Applied
Administration (NARA). For informa- Nutrition (HFS–200), Food and Drug
tion on the availability of this mate- Administration, 5001 Campus Dr., Col-
rial at NARA, call 202–741–6030, or lege Park, MD 20740, or available for in-
go to: http://www.archives.gov/fed-
erallregister/ spection at the National Archives and
codeloflfederallregulations/ Records Administration (NARA). For
ibrllocations.html. information on the availability of this
material at NARA, call 202–741–6030, or
(c) Specifications. (1) Nitrogen content go to: http://www.archives.gov/fed-
of the modified copolymer is in the erallregister/
range of 17.7–19.8 percent. codeloflfederallregulations/
(2) Intrinsic viscosity of the matrix ibrllocations.html. Copies are applica-
copolymer in butyrolactone is not less ble to the modified copolymers in the
than 0.5 deciliter/gram at 35 °C, as de- form of particles of a size that will pass
termined by the method titled ‘‘Molec- through a U.S. Standard Sieve No. 6
ular Weight of Matrix Copolymer by and that will be held on a U.S. Stand-
Solution Viscosity,’’ which is incor- ard Sieve No. 10:
porated by reference. Copies are avail- (1) The extracted copolymer shall not
able from the Center for Food Safety exceed 2.0 ppm in aqueous extract ob-
and Applied Nutrition (HFS–200), Food tained when a 100-gram sample of co-
and Drug Administration, 5001 Campus polymer is extracted with 250 milli-
Dr., College Park, MD 20740, or avail- liters of freshly distilled water at
able for inspection at the National Ar- reflux temperature for 2 hours.
chives and Records Administration (2) The extracted copolymer shall not
(NARA). For information on the avail- exceed 0.5 ppm in n-heptane when a 100-
ability of this material at NARA, call gram sample of the basic copol-ymer is
202–741–6030, or go to: http:// extracted with 250 milliliters spectral
www.archives.gov/federallregister/ grade n-heptane at reflux temperature
codeloflfederallregulations/ for 2 hours.
ibrllocations.html. (e) Accelerated extraction end test. The
(3) Residual acrylonitrile monomer modified copolymer shall yield acrylo-
content of the modified copolymer ar- nitrile monomer not in excess of 0.4
ticles is not more than 11 ppm as deter- ppm when tested as follows:
mined by a gas chromatographic meth- (1) The modified copolymer shall be
od titled ‘‘Determination of Residual in the form of eight strips 1⁄2 inch by 4
Acrylonitrile and Styrene Monomers- inches by .03 inch.
Gas Chromatographic Internal Stand- (2) The modified copolymer strips
ard Method,’’ which is incorporated by shall be immersed in 225 milliliters of 3
reference. Copies are available from percent acetic acid in a Pyrex glass
the Center for Food Safety and Applied pressure bottle.
Nutrition (HFS–200), Food and Drug (3) The pyrex glass pressure bottle is
Administration, 5001 Campus Dr., Col- then sealed and heated to 150 °F in ei-
lege Park, MD 20740, or available for in- ther a circulating air oven or a thermo-
spection at the National Archives and stat controlled bath for a period of 8
Records Administration (NARA). For days.
information on the availability of this (4) The Pyrex glass pressure bottle is
material at NARA, call 202–741–6030, or then removed from the oven or bath
255
§ 177.1060 21 CFR Ch. I (4–1–21 Edition)
and cooled to room temperature. A such use by applicable regulations, as

sample of the extracting solvent is set forth in part 174 of this chapter.
then withdrawn and analyzed for acry- (c) Specifications. Maximum nitrogen
lonitrile monomer by a gas content of the copolymer determined
chromatographic method titled ‘‘Gas- by micro-Kjeldahl analysis, shall not
Solid Chromatographic Procedure for exceed 8 percent.
Determining Acrylonitrile Monomer in (d) Limitations. (1) The n-alkylglutar-
Acrylonitrile-Containing Polymers and imide/acrylic copolymers in the fin-
Food Simulating Solvents,’’ which is ished form in which they shall contact
incorporated by reference. Copies, are food, when extracted with the solvent
available from the Center for Food or solvents characterizing the type of
Safety and Applied Nutrition (HFS– food and under the conditions of time
200), Food and Drug Administration, and temperature described in tables 1
5001 Campus Dr., College Park, MD and 2 of § 176.170(c) of this chapter,
20740, or available for inspection at the shall yield extractives not to exceed
National Archives and Records Admin- the limitations of § 177.1010(b) of this
istration (NARA). For information on chapter, when prepared as strips, as de-
the availability of this material at scribed in § 177.1010(c)(2) of this chapter.
NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic co-
polymers shall not be used as polymer
www.archives.gov/federallregister/
modifiers in vinyl chloride homo- or
copolymers.
ibrllocations.html.
(e) Conditions of use. The n-
(f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers
fied in this section shall comply with are used as articles or components of
the provisions of § 180.22 of this chap- articles (other than articles composed
ter. of vinyl chloride homo- or copolymers)
(g) Acrylonitrile copolymers identi- intended for use in contact with all
fied in this section are not authorized foods except beverages containing
to be used to fabricate beverage con- more than 8 percent alcohol under con-
tainers. ditions of use D, E, F, and G as de-
[42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this
FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter.
1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58
June 12, 1989] FR 17098, Apr. 1, 1993]
§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane.
copolymers.
Cellophane may be safely used for
n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the
mers identified in this section may be following prescribed conditions:
safely used as articles or components (a) Cellophane consists of a base
of articles intended for use in contact sheet made from regenerated cellulose
with food subject to provisions of this to which have been added certain op-
section and part 174 of this chapter. tional substances of a grade of purity
(a) Identity. For the purpose of this suitable for use in food packaging as
section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as
polymers are copolymers obtained by coatings applied to impart desired
reaction of substances permitted by technological properties.
§ 177.1010(a)(1), (2), and (3) with the fol- (b) Subject to any limitations pre-
lowing substance: Monomethylamine scribed in this part, the optional sub-
(CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and
methylglutarimide/acrylic copolymers. coating may include:
(b) Adjuvants. The copolymers identi- (1) Substances generally recognized
fied in paragraph (a) of this section as safe in food.
may contain adjuvant substances re- (2) Substances for which prior ap-
quired in their production. The op- proval or sanctions permit their use in
tional adjuvant substances required in cellophane, under conditions specified
the production of the basic polymer in such sanctions and substances listed
may include substances permitted for in § 181.22 of this chapter.
256
(3) Substances that by any regulation (4) Substances named in this section
promulgated under section 409 of the and further identified as required.
act may be safely used as components (c) List of substances:
of cellophane.
Limitations (residue and limits of addition expressed as percent
List of substances by weight of finished packaging cellophane)
Acrylonitrile-butadiene copolymer resins ..................................... As the basic polymer.

Acrylonitrile-butadiene-styrene copolymer resins ........................ Do.
Acrylonitrile-styrene copolymer resins ......................................... Do.
Acrylonitrile-vinyl chloride copolymer resins ............................... Do.
N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to ex-
ceed a total of 0.3 percent by weight of the finished pack-
aging cellophane.
Alkyl ketene dimers identified in § 176.120 of this chapter.
Aluminum hydroxide.
Aluminum silicate.
Ammonium persulfate.
Ammonium sulfate.
Behenamide.
Butadiene-styrene copolymer ...................................................... As the basic polymer.
1,3-Butanediol.
n-Butyl acetate ............................................................................. 0.1 percent.
n-Butyl alcohol ............................................................................. Do.
Calcium ethyl acetoacetate.
Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Carboxymethyl hydroxyethylcellulose polymer.
Castor oil, hydrogenated.
Castor oil phthalate with adipic acid and fumaric acid-diethyl- As the basic polymer.
ene glycol polyester.
Castor oil phthalate, hydrogenated ............................................. Alone or in combination with other phthalates where total
phthalates do not exceed 5 percent.
Castor oil, sulfonated, sodium salt.
Cellulose acetate butyrate.
Cellulose acetate propionate.
Cetyl alcohol.
Clay, natural.
Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of
fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base
mixture having total alkali (calculated as potassium hydrox- sheet.
ide) of 16–18% and having an acid number of 25–35.
Copal resin, heat processed ....................................................... As basic resin.
Damar resin.
Defoaming agents identified in § 176.200 of this chapter.
Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent.
Dibutylphthalate ........................................................................... Alone or in combination with other phthalates where total
Dicyclohexyl phthalate ................................................................. Do.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Di(2-ethylhexyl) adipate.
Di(2-ethylhexyl) phthalate ............................................................ Alone or in combination with other phthalates where total
Diisobutyl phthalate ..................................................................... Do.
Dimethylcyclohexyl phthalate ...................................................... Do.
Dimethyldialkyl (C8-C18) ammonium chloride .............................. 0.005 percent for use only as a flocculant for slip agents.
Di-n-ocyltin bis (2-ethylhexyl maleate) ........................................ For use only as a stabilizer at a level not to exceed 0.55 per-
cent by weight of the coating solids in vinylidene chloride co-
polymer waterproof coatings prepared from vinylidene chlo-
ride copolymers identified in this paragraph, provided that
such vinylidene chloride copolymers contain not less than 90
percent by weight of polymer units derived from vinylidene
chloride.
257
§ 177.1200 21 CFR Ch. I (4–1–21 Edition)

N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent.

and N-oleoyl-N′linoleoylethylene-diamine mixture produced
when tall oil fatty acids are made to react with ethylene-
diamine such that the finished mixture has a melting point of
212°–228 °F., as determined by ASTM method D127–60
(‘‘Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax’’ (Revised 1960), which is incor-
porated by reference; copies are available from University
Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI
48106, or available for inspection at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federallregister/
codeloflfederallregulations/ ibrllocations.html.), and an
acid value of 10 maximum.
N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide).
Disodium EDTA.
Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent.
monoacetate.
N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide).
Epoxidized polybutadiene ............................................................ For use only as a primer subcoat to anchor surface coatings to
the base sheet.
Erucamide.
Ethyl acetate.
Ethylene-vinyl acetate copolymers complying with § 177.1350.
2-Ethylhexyl alcohol ..................................................................... 0.1 percent for use only as lubricant.
Fatty acids derived from animal and vegetable fats and oils,
and the following salts of such acids, single or mixed: Alu-
minum, ammonium, calcium, magnesium, potassium, sodium.
Ferrous ammonium sulfate.
Fumaric acid.
Glycerin-maleic anhydride ........................................................... As the basic polymer.
Glycerol diacetate.
Glycerol monoacetate.
Hydroxyethyl cellulose, water-insoluble.
Hydroxypropyl cellulose identified in § 172.870 of this chapter.
Isopropyl acetate ......................................................................... Residue limit 0.1 percent
Isopropyl alcohol .......................................................................... Do.
Itaconic acid.
Lanolin.
Lauryl alcohol.
Lauryl sulfate salts: ammonium, magnesium, potassium, so-
dium.
Maleic acid ................................................................................... 1 percent.
Maleic acid adduct of butadienestyrene copolymer.
Melamine formaldehyde .............................................................. As the basic polymer.
Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings
lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate.
ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-eth-
ylamine, imino-bis-propylamine, methyl alcohol, polyamines
made by reacting ethylenediamine or trimethylenediamine
with dichloroethane or dichloropropane, sulfanilic acid,
tetraethylenepentamine, triethanolamine, triethylenetetra-
mine.
Methyl ethyl ketone ..................................................................... Residue limit 0.1 percent
Methyl hydrogen siloxane ............................................................ 0.1 percent as the basic polymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
methylstyrene to 3 vinyltoluene).
Mineral oil, white.
Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6
Reg. No. 62362–49–6). percent by weight of coatings for cellophane.
Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier.
salt.
Nitrocellulose, 10.9 percent–12.2 percent nitrogen.
Nylon resins complying with § 177.1500.
n-Octyl alcohol ............................................................................. For use only as a defoaming agent in the manufacture of cello-
phane base sheet.
Olefin copolymers complying with § 177.1520.
Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16
to C18).
Oleic acid, sulfonated, sodium salt.
Oleyl palmitamide.
258

N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl-
aminoethyl)oleamide).
Paraffin, synthetic, complying with § 175.250 of this chapter.
Pentaerythritol tetrastearate ........................................................ 0.1 percent.
Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem-
(containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature.
ethylenediamine as the basic resin.
Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at
maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that
table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished
omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per
hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface.
10 percent by weight of said polyamide resins).
Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer
bromine number range 210–320). coatings.
Polycarbonate resins complying with § 177.1580.
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 °C–92 °C, and a color of
K or paler.
Polyethylene.
Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent.
aric acid is made to react with equal parts of
diethylenetriamine and triethylenetetramine and the reaction
product is quaternized with diethyl sulfate.
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, oxidized: complying with the identity prescribed
in § 177.1620(a).
Polyethylenimine .......................................................................... As the basic polymer, for use as a resin to anchor coatings to
the substrate and for use as an impregnant in the food-con-
tact surface of regenerated cellulose sheet in an amount not
to exceed that required to improve heat-sealable bonding
between coated and uncoated sides of cellophane.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel-
weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base
sheet.
Polypropylene complying with § 177.1520.
Polystyrene .................................................................................. As the basic polymer.
Polyvinyl acetate .......................................................................... Do.
Polyvinyl alcohol (minimum viscosity of 4 percent aqueous so-
lution at 20 °C of 4 centipoises).
Polyvinyl chloride ......................................................................... As the basic polymer.
Polyvinyl stearate ........................................................................ Do.
n-Propyl acetate .......................................................................... Residue limit 0.1 percent.
n-Propyl alcohol ........................................................................... Do.
Rapeseed oil, blown.
Rosins and rosin derivatives as provided in § 178.3870 of this
chapter.
Rubber, natural (natural latex solids).
Silica.
Silicic acid.
Sodium m-bisulfite.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate.
Sodium lauroyl sarcosinate ......................................................... 0.35 percent; for use only in vinylidene chloride copolymer
coatings.
Sodium oleyl sulfate-sodium cetyl sulfate mixture ...................... For use only as an emulsifier for coatings; limit 0.005 percent
where coating is applied to one side only and 0.01 percent
where coating is applied to both sides.
Sodium silicate.
Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Sodium sulfate.
Sodium sulfite.
Spermaceti wax.
Stannous oleate.
259
§ 177.1210 21 CFR Ch. I (4–1–21 Edition)

2-Stearamido-ethyl stearate.
Stearyl alcohol.
Styrene-maleic anhydride resins ................................................. As the basic polymer.
Terpene resins identified in § 172.615 of this chapter.
Tetrahydrofuran ........................................................................... Residue limit of 0.1 percent.
Titanium dioxide.
Toluene ........................................................................................ Residue limit of 0.1 percent.
Toluene sulfonamide formaldehyde ............................................ 0.6 percent as the basic polymer.
Triethylene glycol.
Triethylene glycol diacetate, prepared from triethylene glycol
containing not more than 0.1 percent of diethylene glycol.
2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ............................. For use only in cellophane coatings and limited to use at a
level not to exceed 10 percent by weight of the coating sol-
ids except when used as provided in § 178.3740 of this
chapter
Urea (carbamide).
Urea formaldehyde ...................................................................... As the basic polymer.
Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings
diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate.
mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-eth-
ylamine, imino-bis-propylamine, imino-bis-butylamine,
diaminopropane, diaminobutane, aminomethylsulfonic acid,
polyamines made by reacting ethylenediamine or
trimethylenediamine with dichlorethane or dichloropropane.
Vinyl acetate-vinyl chloride copolymer resins ............................. As the basic polymer.
Vinyl acetate-vinyl chloride-maleic acid copolymer resins .......... Do.
Vinylidene chloride copolymerized with one or more of the fol- Do.
lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl
methacrylate, ethyl methacrylate, itaconic acid, methacrylic
acid, methyl acrylate, methyl methacrylate, propyl acrylate,
propyl methacrylate, vinyl chloride.
Vinylidene chloride-methacrylate decyloctyl copolymer .............. Do.
Wax, petroleum, complying with § 178.3710 of this chapter.
(d) Any optional component listed in in parts 174, 175, 176, 177, 178 and § 179.45
this section covered by a specific food of this chapter; and closure-sealing
additive regulation must meet any gaskets, as further prescribed in this
specifications in that regulation. section.
(e) Acrylonitrile copolymers identi- (b) Closure-sealing gaskets and over-
fied in this section shall comply with all discs are formulated from sub-
the provisions of § 180.22 of this chap- stances identified in § 175.300(b) of this
ter. chapter, with the exception of para-
graph (b)(3)(v), (xxxi), and (xxxii) of
[42 FR 14572, Mar. 15, 1977, as amended at 47
FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, that section, and from other optional
1999] substances, including the following:
(1) Substances generally recognized
§ 177.1210 Closures with sealing gas- as safe in food.
kets for food containers. (2) Substances used in accordance
Closures with sealing gaskets may be with the provisions of a prior sanction
safely used on containers intended for or approval within the meaning of sec-
use in producing, manufacturing, pack- tion 201(s) of the act.
ing, processing, preparing, treating, (3) Substances that are the subject of
packaging, transporting, or holding regulations in parts 174, 175, 176, 177, 178
food in accordance with the following and § 179.45 of this chapter and used in
prescribed conditions: accordance with the conditions pre-
(a) Closures for food containers are scribed.
manufactured from substances gen- (4) Substances identified in para-
erally recognized as safe for contact graph (b)(5) of this section, used in
with food; substances that are subject amounts not to exceed those required
to the provisions of prior sanctions; to accomplish the intended physical or

substances authorized by regulations technical effect and in conformance
260
with any limitation provided; and fur- conforms with the identity or speci-
ther provided that any substance em- fications prescribed.
ployed in the production of closure- (5) Substances that may be employed
sealing gasket compositions that is the in the manufacture of closure-sealing
subject of a regulation in parts 174, 175, gaskets include:
176, 177, 178 and § 179.45 of this chapter
TABLE 1
Limitations (expressed as percent by weight of closure-sealing
List of substances gasket composition)
Arachidy-l-behenyl amide (C20-C22fatty acid amides) ................. 5 percent.

Azodicarbonamide ....................................................................... 1. 2 percent.
2. 5 percent; for use only in the manufacture of polyethylene
complying with item 2.1 in § 177.1520(c) of this chapter.
Balata rubber.
Benzyl alcohol ............................................................................. 1 percent.
Brominated isobutylene-isoprene copolymers, produced when
isobutylene-isoprene copolymers complying with
§ 177.1420(a)(2) are modified by bromination with not more
than 2.3 weight-percent of bromine and having a Mooney
Viscosity (ML 1 + 8 (125 °C)) of 27 or higher. The viscosity
is determined by the American Society for Testing and Mate-
rials (ASTM) method D 1646–81, ‘‘Standard Test Method for
Rubber—Viscosity and Vulcanization Characteristics (Moon-
ey Viscometer),’’ which is incorporated by reference in ac-
cordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies
are available from the AOAC INTERNATIONAL, 481 North
Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504
and the Center for Food Safety and Applied Nutrition (HFS–
200), Food and Drug Administration, 5001 Campus Dr., Col-
lege Park, MD 20740, or available for inspection at the Na-
tional Archives and Records Administration (NARA). For in-
formation on the availability of this material at NARA, call
202–741–6030, or go to: http://www.archives.gov/fed-
erallregister/ codeloflfederallregulations/
ibrllocations.html..
1,3-Butanediol.
Calcium tin stearate ..................................................................... 2 percent.
Calcium zinc stearate .................................................................. Do.
Carbon, activated ........................................................................ 1 percent.
Castor oil, hydrogenated ............................................................. 2 percent.
Chlorinated isobutylene-isoprene copolymers complying with
§ 177.1420.
Coco amide (coconut oil fatty acids amides) .............................. 2 percent.
Cork (cleaned, granulated).
Diebenzamide phenyl disulfide .................................................... 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Di(C7, C9-alkyl) adipate ............................................................... Complying with § 178.3740 of this chapter; except that, there is
no limitation on polymer thickness.
Di-2-ethylhexyl adipate.
Di-2-ethylhexyl sebacate ............................................................. 2 percent.
Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per
hundred by weight of permitted vinyl chloride homo- and/or
copolymer resins used in contact with food of Types I, II, IV-
B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII-
B, and VIII described in § 176.170(c) of this chapter, table 1,
and under conditions of use A through H described in
§ 176.170 (c) of this chapter, table 2.
Dihexyl ester of sodium sulfosuccinate ....................................... 1 percent.
Diisodecyl phthalate .................................................................... No limitation on amount used but for use only in closure-seal-
ing gasket compositions used in contact with non-fatty foods
containing no more than 8 percent of alcohol.
Di-b-naphthyl-p-phenylenediamine .............................................. 1 percent.
Dipentamethylenethiurametetrasulfide ........................................ 0.4 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
Eicosane (technical grade) (water-white mixture of predomi-
nantly straight-chain paraffin hydrocarbons averaging 20 car-
bon atoms per molecule).
Epoxidized linseed oil.
Epoxidized linseed oil modified with trimellitic anhydride.
Epoxidized safflower oil.

Epoxidized safflower oil modified with trimellitic anhydride.
Epoxidized soybean oil modified with trimellitic anhydride.
261
§ 177.1210 21 CFR Ch. I (4–1–21 Edition)
TABLE 1—Continued
Erucylamide ................................................................................. 5 percent.

Ethylene-propylene copolymer.
Ethylene-propylene modified copolymer elastomers produced
when ethylene and propylene are copolymerized with 5-
methylene-2-norbornene and/or 5-ethylidine-2-norbornene.
The finished copolymer elastomers so produced shall con-
tain not more than 5 weight-percent of total polymer units
derived from 5-methylene-2-norbornene and/or 5-ethylidine-
2-norbornene, and shall have a minimum viscosity average
molecular weight of 120,000 as determined by the method
described in § 177.1520(d)(5), and a minimum Mooney vis-
cosity of 35 as determined by the method described in
§ 177.1520(d)(6).
Ethylene-vinyl acetate copolymer.
Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent.
ricinoleate).
Gutta-percha.
Hexamethylenetetramine ............................................................. 1 percent.
Hexylene glycol ........................................................................... 0.5 percent.
Isobutylene-isoprene copolymers complying with § 177.1420.
Maleic anhydride-polyethylene copolymer .................................. 5 percent.
Maleic anhydride-styrene copolymer ........................................... Do.
2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ..................... 1 percent.
Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated
isobutylene-isoprene copolymers complying with § 177.1420,
and brominated isobutylene-isoprene copolymers complying
with this section.
Naphthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent.
salt.
Natural rubber (crepe, latex, mechanical dispersions).
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent.
octadecenyl group is derived from oleyl alcohol and the poly
(oxyethylene) content averages 20 moles.
Oleyl alcohol ................................................................................ 1 percent.
4,4′-Oxybis (benzene sulfonyl hydrazide) ................................... 0.5 percent.
Paraformaldehyde ....................................................................... 1 percent.
Polybutadiene.
Poly-p-dinitroso benzene (activator for butyl rubber) .................. 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent.
mal and vegetable fats and oils.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent.
wt. 2750–3000.
Polyurethane resins manufactured from diphenylmethane For use only:
diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure
26375–23–5).. gasket compositions used in contact with food types VI-A
and VI-C (up to 15 percent alcohol) under conditions of use
D, E, F, and G, as described in § 176.170(c) of this chapter,
tables 1 and 2, respectively.
Potassium benzoate .................................................................... 1 percent.
Potassium propionate .................................................................. 2 percent.
Potassium and sodium persulfate ............................................... 1 percent.
Resorcinol .................................................................................... 0.24 percent; for use only as a reactive adjuvant substance
employed in the production of gelatin-bonded cord composi-
tions for use in lining crown closures. The gelatin so used
shall be technical grade or better.
Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of
this chapter for use only in resinous and polymeric coatings
on metal substrates; for all other uses as defined in
§ 178.3870 of this chapter.
Sodium cetyl sulfate .................................................................... 1 percent.
Sodium decylbenzenesulfonate ................................................... Do.
Sodium decyl sulfate ................................................................... Do.
Sodium formaldehyde sulfoxylate ............................................... 0.05 percent.
Sodium lauryl sulfate ................................................................... 1 percent.
Sodium lignin sulfonate ............................................................... 0.2 percent.
Sodium myristyl sulfate (sodium tetradecyl sulfate) .................... 0.6 percent.
Sodium nitrite ............................................................................... 0.2 percent; for use only in annular ring gaskets applied in
aqueous dispersions to closures for containers having a ca-
pacity of not less than 5 gallons.
262
TABLE 1—Continued
Sodium o-phenylphenate ............................................................. 0.05 percent.

Sodium polyacrylate .................................................................... 5 percent.
Sodium and potassium pentachlorophenate ............................... 0.05 percent.
Sodium salt of trisopropyl naphthalenesulfonic acid ................... 0.2 percent.
Sodium tridecylsulfate ................................................................. 0.6 percent.
Stearic acid amide ....................................................................... 5 percent.
Sulfur ........................................................................................... For use only as a vulcanizing agent in vulcanized natural or
synthetic rubber gasket compositions at a level not to ex-
ceed 4 percent by weight of the elastomer content of the
rubber gasket composition.
Tallow, sulfated ............................................................................ 1 percent.
Tin-zinc stearate .......................................................................... 2 percent.
Tri(mixed mono- and dinonylphenyl) phosphite .......................... 1 percent.
Vinyl chloride-vinyl stearate copolymer.
Zinc dibutyldithiocarbamate ......................................................... 0.8 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES when extracted on a suitable glass con-

[In parts per million] tainer with a solvent or solvents char-
acterizing the type of foods, and under
Chloro-
Chloro- form Chloro- conditions of time and temperature
form form
Type of closure-sealing gas- fraction fraction fraction characterizing the conditions of its use
of
ket composition of water heptane of alco- as determined from tables 3 and 4 shall
extrac- hol ex-
tives extrac- tractives yield net chloroform-soluble extrac-
tives
tives (corrected for zinc as zinc oleate)
1. Plasticized polymers, in- not to exceed the tolerances specified
cluding unvulcanized or in table 2, calculated on the basis of
vulcanized or otherwise
cured natural and syn-
the water capacity of the container on
thetic rubber formed in which the closure is to be used. Employ
place as overall discs or the analytical method described in
annular rings from a hot § 175.300 of this chapter, adapting the
melt, solution, plastisol,
organisol, mechanical dis- procedural details to make the method
persion, or latex ............... 50 500 50 applicable to closures; such as, for ex-
2. Preformed overall discs ample, placing the closed glass con-
or annular rings of plasti-
cized polymers, including tainer on its side to assure contact of
unvulcanized natural or the closure’s food-contacting surface
synthetic rubber ............... 50 250 50 with the solvent.
3. Preformed overall discs
or annular rings of vulcan- TABLE 3—TYPES OF FOOD
ized plasticized polymers,
including natural or syn- I. Nonacid (pH above 5.0), aqueous products;
thetic rubber ..................... 50 50 50 may contain salt or sugar or both, and in-
4. Preformed overall discs cluding oil-in-water emulsions of low- or
or annular rings of poly- high-fat content.
meric or resinous-coated
paper, paperboard, plas-
II. Acidic (pH 5.0 or below), aqueous prod-
tic, or metal foil substrates 50 250 50 ucts; may contain salt or sugar or both,
5. Closures with sealing and including oil-in-water emulsions of
gaskets or sealing com- low- or high-fat content.
positions as described in III. Aqueous, acid or nonacid products con-
1, 2, 3, and 4, and includ- taining free oil or fat; may contain salt,
ing paper, paperboard,
and including water-in-oil emulsions of
and glassine used for dry
foods only ........................ (1) (1) (1) low- or high-fat content.
IV. Dairy products and modifications:
1 Extractability tests not applicable. A. Water-in-oil emulsions, high- or low-fat.
(c) The closure assembly to include B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oils.
the sealing gasket or sealing com-
VI. Beverages:
pound, together with any polymeric or A. Containing alcohol.
resinous coating, film, foil, natural B. Nonalcoholic.
cork, or glass that forms a part of the
VII. Bakery products.

food-contact surface of the assembly, VIII. Dry solids (no end-test required).
263
§ 177.1211 21 CFR Ch. I (4–1–21 Edition)
TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF

EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS
AND BEVERAGES
Extractant
Types of food
Conditions of use (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol
perature) temperature) (time and temperature)
A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

heat-sterilized (e.g.,
over 212 °F).
III, IV–A, VII ........... do .................................. 150 °F, 2 hr.
B. Boiling water-sterilized II ............................ 212 °F, 30 min .............. .
III, VII ..................... do .................................. 120 °F, 30 min.
C. Hot filled or pasteur- II, IV–B .................. Fill boiling, cool to 100 .
ized above 150 °F. °F.
III, IV–A ................. do .................................. 120 °F, 15 min.
V ............................ ....................................... do.
D. Hot filled or pasteur- II, IV–B, VI–B ........ 150 °F, 2 hr ................... .
ized below 150 °F.
III, IV–A ................. do .................................. 100 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 150 °F, 2 hr.
E. Room temperature II, IV–B, VI–B ........ 120 °F, 24 hr ................. .
filled and stored (no
thermal treatment in
the container).
III, IV–A ................. do .................................. 70 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 120 °F, 24 hr.
F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ................... 70 °F, 30 min.
(no thermal treatment). VI–B,VII.
VI–A ...................... ....................................... ....................................... 70 °F, 48 hr.
G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ................... .
thermal treatment in
the container).
1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982;
49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May
9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011; 78 FR
14665, Mar. 7, 2013; 82 FR 20832, May 4, 2017]
§ 177.1211 Cross-linked polyacrylate propenoate and sodium 2-propenoate

copolymers. (CAS Reg. No. 76774–25–9).
Cross-linked polyacrylate copoly- (b) Adjuvants. The copolymers identi-
mers identified in paragraph (a) of this fied in paragraph (a) of this section
section may be safely used as articles may contain optional adjuvant sub-
or components of articles intended for stances required in the production of
use in contact with food in accordance such copolymers. The optional adju-
with the following prescribed condi- vant substances may include sub-
tions: stances permitted for such use by regu-
(a) Identity. For the purpose of this lations in parts 170 through 179 of this
section, the cross-linked polyacrylate chapter, substances generally recog-
copolymers consist of: nized as safe in food, and substances
(1) The grafted copolymer of cross- used in accordance with a prior sanc-
linked sodium polyacrylate identified tion or approval.
as 2-propenoic acid, polymers with N,N- (c) Extractives limitations. The copoly-
di-2-propenyl-2-propen-1-amine and mers identified in paragraph (a) of this
hydrolyzed polyvinyl acetate, sodium section, in the finished form in which
salts, graft (CAS Reg. No. 166164–74–5); they will contact food, must yield low
or molecular weight (less than 1,000 Dal-
(2) 2-propenoic acid, polymer with 2- tons) extractives of no more than 0.15
ethyl-2-(((1-oxo-2-pro- percent by weight of the total polymer

penyl)oxy)methyl)-1,3-propanediyl di-2- when extracted with 0.2 percent by
264
weight of aqueous sodium chloride so- effect or any limitation further pro-
lution at 20 °C for 24 hours. The low vided.
molecular weight extractives shall be (c) Any substance employed in the
determined using size exclusion chro- production of the copolymer that is the
matography or an equivalent method. subject of a regulation in parts 174, 175,
When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter
the copolymer, with no other absorp- conforms with any specification in
tive media, shall be confined either in such regulation.
a finished absorbent pad or in any suit- (d) Substances employed in the pro-
able flexible porous article, (such as a duction of the copolymer include:
‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized
pressure of 0.15 pounds per square inch as safe in food.
(for example, a 4 × 6 inch square pad is (2) Substances subject to prior sanc-
subjected to a 1.6 kilograms applied tion or approval for use in the copoly-
mass). The solvent used shall be at mer and used in accordance with such
least 60 milliliters aqueous sodium sanction or approval.
chloride solution per gram of copoly- (3) Substances which by regulation in
mer. parts 174, 175, 176, 177, 178 and § 179.45 of
(d) Conditions of use. The copolymers this chapter may be safely used as
identified in paragraph (a)(1) of this components of resinous or polymeric
section are limited to use as a fluid ab- coatings and film used as food-contact
sorbent in food-contact materials used surfaces, subject to the provisions of
in the packaging of frozen or refrig- such regulation.
erated poultry. The copolymers identi- (e) The copolymer conforms with the
fied in paragraph (a)(2) of this section following specifications:
are limited to use as a fluid absorbent (1) The copolymer, when extracted
in food-contact materials used in the with distilled water at reflux tempera-
packaging of frozen or refrigerated ture for 2 hours, yields total extrac-
meat and poultry. tives not to exceed 0.05 percent.
[64 FR 28098, May 25, 1999, as amended at 65 (2) The copolymer, when extracted
FR 16817, Mar. 30, 2000] with ethyl acetate at reflux tempera-
ture for 2 hours, yields total extrac-
§ 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent.
dimethylene terephthalate and 1,4-
cyclohexylene dimethylene (3) The copolymer, when extracted
isophthalate copolymer. with n-hexane at reflux temperature
for 2 hours, yields total extractives not
Copolymer of 1,4-cyclohexylene to exceed 0.05 percent.
dimethylene terephthalate and 1,4-
cyclohexylene dimethylene isophtha- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15,
late may be safely used as an article or 1984, as amended at 55 FR 34555, Aug. 23, 1990]
component of articles used in pro-
ducing, manufacturing, packing, proc- § 177.1310 Ethylene-acrylic acid co-
polymers.
essing, preparing, treating, packaging,
transporting, or holding food, subject The ethylene-acrylic acid copolymers
to the provisions of this section: identified in paragraph (a) of this sec-
(a) The copolymer is a basic poly- tion may be safely used as components
ester produced by the catalytic con- of articles intended for use in contact
densation of dimethyl terephthalate with food subject to the provisions of
and dimethyl isophthalate with 1,4- this section.
cyclohexanedimethanol, to which may (a) The ethylene-acrylic acid copoly-
have been added certain optional sub- mers consist of basic copolymers pro-
stances required in its production or duced by the copolymerization of
added to impart desired physical and ethylene and acrylic acid such that the
technical properties. finished basic copolymers contain no
(b) The quantity of any optional sub- more than:
stance employed in the production of (1) 10 weight-percent of total polymer
the copolymer does not exceed the units derived from acrylic acid when
amount reasonably required to accom- used in accordance with paragraph (b)

plish the intended physical or technical of this section; and
265
§ 177.1312 21 CFR Ch. I (4–1–21 Edition)
(2) 25 weight-percent of total polymer hesives complying with § 175.105 of this

units derived from acrylic acid when chapter.
used in accordance with paragraph (c)
of this section. FR 19060, May 27, 1986; 53 FR 44009, Nov. 1,
(b) The finished food-contact articles 1988]
made with no more than 10 percent
total polymer units derived from acryl- § 177.1312 Ethylene-carbon monoxide
ic acid, when extracted with the sol- copolymers.
vent or solvents characterizing the The ethylene-carbon monoxide co-
type of food and under the conditions polymers identified in paragraph (a) of
of its intended use as determined from this section may be safely used as com-
tables 1 and 2 of § 176.170(c) of this chap- ponents of articles intended for use in
ter, yield net acidified chloroform-solu- contact with food subject to the provi-
ble extractives not to exceed 0.5 milli- sions of this section.
gram per square inch of food-contact (a) Identity. For the purposes of this
surface when tested by the methods section, ethylene-carbon monoxide co-
prescribed in § 177.1330(e)(1), (3)(i) polymers (CAS Reg. No. 25052–62–4) con-
through (iv), (4), (5), and (6), except sist of the basic polymers produced by
that the copolymerization of ethylene and
(1) The total residue method using 3 carbon monoxide such that the copoly-
percent acetic acid, as prescribed in mers contain not more than 30 weight-
§ 177.1330(e)(6)(i)(a), does not apply, and percent of polymer units derived from
carbon monoxide.
(2) The net acidified chloroform-solu-
ble extractives from paper and paper- (b) Conditions of use. (1) The polymers
may be safely used as components of
board complying with § 176.170 of this
the food-contact or interior core layer
chapter may be corrected for wax, pet-
of multilaminate food-contact articles.
rolatum, and mineral oil as provided in
(2) The polymers may be safely used
§ 176.170(d)(5)(iii)(b) of this chapter.
as food-contact materials at tempera-
If the finished food-contact article is tures not to exceed 121 °C (250 °F).
itself the subject of a regulation in (c) Specifications. (1) Food-contact
parts 174, 175, 176, 177, 178, and § 179.45 of layers formed from the basic copoly-
this chapter, it shall also comply with mer identified in paragraph (a) of this
any specifications and limitations pre- section shall be limited to a thickness
scribed for it by that regulation. of not more than 0.01 centimeter (0.004
(c) The finished food-contact layer inch).
made with basic copolymers containing (2) The copolymers identified in para-
more than 10 weight-percent but no graph (a) of this section shall have a
more than 25 weight-percent of total melt index not greater than 500 as de-
polymer units derived from acrylic termined by ASTM method D1238–82,
acid and with a maximum thickness of condition E ‘‘Standard Test Method for
0.0025 inch (2.5 mils) may be used in Flow Rates of Thermoplastics by Ex-
contact with food types I, II, IVB, VIA, trusion Plastometer,’’ which is incor-
VIB, VIIB, and VIII identified in table porated by reference in accordance
1 of § 176.170(c) of the chapter under with 5 U.S.C. 552(a) and 1 CFR part 51.
conditions of use B through H as de- Copies may be obtained from the Amer-
scribed in table 2 of § 176.170(c) of this ican Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken,
chapter, and in contact with food types
Philadelphia, PA 19428-2959, or may be
III, IVA, V, VIIA, and IX identified in
examined at the Center for Food Safety
table 1 of § 176.170(c) of this chapter and Applied Nutrition (HFS–200), Food
under conditions of use E through G as and Drug Administration, 5001 Campus
described in table 2 of § 176.170(c) of this Dr., College Park, MD 20740, or at the
chapter. National Archives and Records Admin-
(d) The provisions of this section are istration (NARA). For information on
not applicable to ethylene-acrylic acid the availability of this material at
copolymers used in food-packaging ad- NARA, call 202–741–6030, or go to: http://

266
codeloflfederallregulations/ may be safely used as articles or com-

ibrllocations.html. ponents of articles intended for use in
(3) The basic copolymer identified in contact with food subject to provisions
paragraph (a) of this section, when ex- of this section and of part 174 of this
tracted with the solvent or solvents chapter.
characterizing the type of food and (a) Identity. For the purposes of this
under the conditions of time and tem- section, ethylene-1,4-cyclohexylene
perature characterizing the conditions dimethylene terephthalate copolymers
of its intended use, as determined from
(1,4-benzene dicarboxylic acid, di-
tables 1 and 2 of § 176.170(c) of this chap-
ter, yields net chloroform-soluble ex- methyl ester, polymerized with 1,4-
tractives in each extracting solvent cyclohexanedimethanol and 1,2-
not to exceed 0.5 milligram per square ethanediol) (CAS Reg. No. 25640–14–6) or
inch of food-contact surface when test- (1,4-benzenedicarboxylic acid, polym-
ed by methods described in § 176.170(d) erized with 1,4-cyclohexanedimethanol
of this chapter. and 1,2-ethanediol) (CAS Reg. No.
(4) The provisions of this section are 25038–91–9) are basic copolymers meet-
not applicable to ethylene-carbon mon- ing the specifications prescribed in
oxide copolymers complying with paragraph (b) of this section, to which
§ 175.105 of this chapter. may have been added certain optional
[57 FR 32422, July 22, 1992] substances required in their production
or added to impart desired physical or
§ 177.1315 Ethylene-1, 4-cyclohexylene technical properties.
dimethylene terephthalate copoly- (b) Specifications:
mers.
Ethylene-1, 4-cyclohexylene
dimethylene terephthalate copolymer
Maximum extractable fractions
of the copolymer in the fin-
Ethylene-1,4- ished form at specified tem-
cyclohexylene peratures and times (ex- Test for
Inherent viscosity Conditions of use
dimethylene pressed in micrograms of the orientability
terephthalate copolymers terephthaloyl moletles/square
centimeter of food-contact sur-
face)
1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in-
ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con-
dimethylene cent solution of per square inch) of food-containing not more than
terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol-
mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol,
product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated
terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer.
ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill
mixture containing 99 not less than ticle. not to exceed 82.2 °C
to 66 mole percent of 0.669 as deter- (180 °F), storage at
ethylene glycol and 1 mined by using temperatures not in
to 34 mole percent of a Wagner vis- excess of 48.9 °C
1,4-cyclo- cometer (or (120 °F). No thermal
hexanedimethanol (70 equivalent) and treatment in the con-
percent trans isomer, calculated from tainer.
30 percent cls isomer). the following
equation: Inher-
ent viscosity =
(Natural loga-
rithm of (Nr)/(c)
where: Nr =
Ratio of flow
time of the poly-
mer solution to
that of the sol-
vent, and c =
concentration of
the test solution
expressed in
grams per 100

milliliters.
267
§ 177.1315 21 CFR Ch. I (4–1–21 Edition)

face)
......do ................... (2) 0.23 microgram per square ......do ................... Do.
centimeter (1.5 micrograms
per square inch) of food-con-
tact surface when extracted
with 3 percent (by volume)
aqueous acetic acid added
at 82.2 °C (180 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
food-contact article.
centimeter (0.5 microgram
for 2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
for 24 hours with 25 percent
(by volume) aqueous ethanol
at 48.9 °C (120 °F).
2. Oriented ethylene-1,4- ......do ................... (1) 0.23 microgram per square When extracted In contact with non-
cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ-
dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev-
terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of
mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding
product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor-
terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures
ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9
mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther-
to 85 mole percent ticle. meter (0.60 mal treatment in the
ethylene glycol and 1 microgram per container.
to 15 mole percent of square inch) of
1,4-cyclohexane-di- food-contact
methanol (70 percent surface.
trans isomer, 30 per-
cent cls isomer).
centimeter (1.5 micrograms
tact surface of oriented co-
polymer when extracted with
3 percent (by volume) aque-
ous acetic acid added at
87.8 °C (190 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
tact surface of oriented co-
polymer when extracted for
2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
268

face)
......do ................... (4) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 20 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of thermal
20 percent (by volume) treatment in the con-
aqueous ethanol heated to tainer not exceeding
65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for
utes and allowed to cool to 20 minutes. Storage at
48.9 °C (120 °F) in contact temperatures not in
with the food-contact article. excess of 48.9 °C
(120 °F).
......do ................... (5) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 50 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of fill and stor-
50 percent (by volume) age not exceeding
aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No
(120 °F) for 24 hours. thermal treatment in
the container.
3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding
cyclohexylene tion of use, must meet speci- specification, may be
dimethylene fications described in used as a base sheet
terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in
mer is the reaction accordance with con-
product of dimethyl ditions of use de-
terephthalate or ter- scribed in
ephthalic acid with a § 177.1630(f), (g), (h),
mixture containing 99 or (j).
to 95 mole percent of
ethylene glycol and 1
to 5 mole percent of
1,4-
cyclohexanedimethan-
ol (70 percent trans
isomer, 30 percent cis
isomer).
(c) Analytical method for determination standards prepared in 95:5 percent (v/v)
of extractability. The total extracted heptane: tetrahydrofuran.
terephthaloyl moieties can be deter-
[45 FR 39252, June 10, 1980, as amended at 47
mined in the extracts, without evapo- FR 24288, June 4, 1982; 49 FR 25629, June 22,
ration of the solvent, by measuring the 1984; 51 FR 22929, June 24, 1986; 60 FR 57926,
ultraviolet (UV) absorbance at 240 Nov. 24, 1995]
nanometers. The spectrophotometer
(Varian 635–D, or equivalent) is zeroed § 177.1320 Ethylene-ethyl acrylate co-
with a sample of the solvent taken polymers.
from the same lot used in the extrac- Ethylene-ethyl acrylate copolymers
tion tests. The concentration of the may be safely used to produce pack-
total terephthaloyl moieties in water, 3 aging materials, containers, and equip-
percent acetic acid, and in 8 percent ment intended for use in producing,
aqueous alcohol is calculated as bis(2- manufacturing, packing, processing,
hydroxyethyl terephthalate) by ref- preparing, treating, packaging, trans-
erence to standards prepared in the ap- porting, or holding food, in accordance
propriate solvent. Concentration of the with the following prescribed condi-
terephthaloyl moieties in heptane is tions:
calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly-

(C6H4CO2C2H4CO2)3, by reference to mers consist of basic resins produced
269
§ 177.1330 21 CFR Ch. I (4–1–21 Edition)
by the catalytic copolymerization of Plastics by the Density-Gradient Tech-

ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref-
may have been added certain optional erence. Copies may be obtained from
substances to impart desired techno- the American Society for Testing Ma-
logical properties to the resin. Subject terials, 100 Barr Harbor Dr., West
to any limitations prescribed in this Conshohocken, Philadelphia, PA 19428-
section, the optional substances may 2959, or may be examined at the Na-
include: tional Archives and Records Adminis-
(1) Substances generally recognized tration (NARA). For information on
as safe in food and food packaging. the availability of this material at
(2) Substances the use of which is NARA, call 202–741–6030, or go to: http://
permitted under applicable regulations www.archives.gov/federallregister/
in parts 170 through 189 of this chapter, codeloflfederallregulations/
prior sanction, or approvals. ibrllocations.html.
(b) The ethyl acrylate content of the (2) Limitations. Ethylene-ethyl acry-
copolymer does not exceed 8 percent by late copolymers or the blend may be
weight unless it is blended with poly- used in contact with food except as a
ethylene or with one or more olefin co- component of articles used for pack-
polymers complying with § 177.1520 or aging or holding food during cooking
with a mixture of polyethylene and one provided they meet the following
or more olefin copolymers, in such pro- extractability limits:
portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3
tent of the blend does not exceed 8 per- percent in xylene after refluxing and
cent by weight, or unless it is used in subsequent cooling to 25 °C.
a coating complying with § 175.300 or (ii) Maximum extractable fraction of
§ 176.170 of this chapter, in such propor- 5.5 percent when extracted with n-
tions that the ethyl acrylate content hexane at 50 °C.
does not exceed 8 percent by weight of (d) The provisions of paragraphs (b)
the finished coating. and (c)(2) of this section are not appli-
(c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co-
mers or the blend shall conform to the polymers used in the formulation of ad-
specifications prescribed in paragraph hesives complying with § 175.105 of this
(c)(1) of this section and shall meet the chapter.
ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49
scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984]
and the extractability limits pre-
scribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins.
tion, when tested by the methods pre- Ionomeric resins manufactured from
scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co-
(1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal-
fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium,
polymers can be identified by their and/or zinc partial salts), ethylene-
characteristic infrared spectra. methacrylic acid-vinyl acetate copoly-
(ii) Quantitative determination of ethyl mers (and/or their ammonium, cal-
acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium,
be determined by the infrared spectra. and/or zinc partial salts,), or meth-
Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene
microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po-
at 11.6 microns and divide by the tassium, sodium and/or zinc partial
plaque thickness to obtain absorbance salts) may be safely used as articles or
per mil. From a previously prepared components of articles intended for use
calibration curve, obtain the amount of in contact with food, in accordance
ethyl acrylate present. with the following prescribed condi-
(iii) Specific gravity. Ethylene-ethyl tions:
acrylate copolymers have a specific (a) For the purpose of this section,
gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly-
than 0.935, as determined by ASTM mers consist of basic copolymers pro-
method D1505–68 (Reapproved 1979), duced by the copolymerization of

‘‘Standard Test Method for Density of ethylene and methacrylic acid such
270
that the copolymers contain no more determined from table I of paragraph

than 20 weight percent of polymer (f) of this section, shall yield net acidi-
units derived from methacrylic acid, fied chloroform-soluble extractives as
and the ethylene-methacrylic acid- follows:
vinyl acetate copolymers consist of (1) For fatty food use. (i) For films of
basic copolymers produced by the co- 2 mil (0.002 inches) thickness or less,
polymerization of ethylene, meth- extractives shall not exceed 0.70 milli-
acrylic acid, and vinyl acetate such gram/square inch 1 (0.109 milligram/
that the copolymers contain no more square centimeter) of food-contact sur-
than 15 weight percent of polymer face (n-heptane extractions) when ex-
units derived from methacrylic acid. tracted by the abbreviated method
(b) For the purpose of this section, cited in paragraph (e)(2)(i) of this sec-
the methacrylic acid copolymers with tion.
ethylene and isobutyl acrylate consist (ii) For films of greater than 2 mils
of basic copolymers produced by the (0.002 inch) thickness, extractives shall
copolymerization of methacrylic acid, not exceed 0.40 milligram/square inch 1
ethylene, and isobutyl acrylate such (0.062 milligram/square centimeter) of
that the copolymers contain no less food-contact surface (n-heptane extrac-
than 70 weight percent of polymer tions) when extracted by the abbre-
units derived from ethylene, no more viated method cited in paragraph
than 15 weight percent of polymer (e)(2)(i) of this section, or
units derived from methacrylic acid, (iii) Alternatively, for films of great-
and no more than 20 weight percent of er than 2 mils thickness, extractives
polymer units derived from isobutyl shall not exceed 0.70 milligram/square
acrylate. From 20 percent to 70 percent inch 1 (0.109 milligram/square centi-
of the carboxylic acid groups may op- meter) of food-contact surface (n-
tionally be neutralized to form sodium heptane extractions) when extracted by
or zinc salts. the equilibrium method cited in para-
(c) The finished food-contact article graph (e)(2)(ii) of this section.
described in paragraph (a) of this sec- (2) For aqueous foods. (i) The net
tion, when extracted with the solvent acidified chloroform-soluble extrac-
or solvents characterizing the type of tives shall not exceed 0.02 milligram/
food and under the conditions of time square inch 2(0.003 milligram/square
and temperature characterizing the centimeter) of food-contact surface
conditions of its intended use as deter- (water, acetic acid, or ethanol/water
mined from tables 1 and 2 of § 176.170(c) extractions) when extracted by the ab-
of this chapter, yields net acidified breviated method cited in paragraph
chloroform-soluble extractives in each (e)(2)(i) of this section.
extracting solvent not to exceed 0.5 (ii) Alternatively, the net acidified
milligram per square inch of food-con- chloroform-soluble extractives shall
tact surface when tested by the meth- not exceed 0.05 milligram/square inch 3
ods described in paragraph (e)(1) of this (0.078 mg/square centimeter) of food-
section, and if the finished food-con- contact surface (water, acetic acid, or
tact article is itself the subject of a ethanol/water extractions) when ex-
regulation in parts 174, 175, 176, 177, 178 tracted by the equilibrium method
and § 179.45 of this chapter, it shall also cited in paragraph (e)(2)(ii) of this sec-
comply with any specifications and tion. If when exposed to n-heptane, a
limitations prescribed for it by that particular film splits along die lines,
regulation. thus permitting exposure of both sides
NOTE: In testing the finished food-contact of the film to the extracting solvent,
article, use a separate test sample for each
required extracting solvent.
1 Average of four separate values, no single
(d) The finished food-contact article
described in paragraph (b) of this sec- value of which differs from the average of
those values by more then ±10 percent.
tion, when extracted according to the 2 Average of four separate values, no single
methods listed in paragraph (e)(2) of value of which differs from the average of
this section and referenced in this those values by more than ±50 percent.
paragraph (d), using the solvent or sol- 3 See footnote 2 to paragraph (d)(2)(i) of
vents characterizing the type of food as this section.
271
§ 177.1330 21 CFR Ch. I (4–1–21 Edition)
the results for that film sample are in- lating solvent is to contact the food-
valid and the test must be repeated for contact film at a temperature of 120 °F
that sample until no splitting by the until equilibrium is demonstrated.
solvent occurs. If the finished food-con-
tact article is itself the subject of a Minimum
extraction
regulation in parts 174, 175, 176, 177, 178 Solvent times
and § 179.45 of this chapter, it shall also (hours)
comply with any specifications and n-Heptane ............................................................ 8, 10, 12
limitations prescribed for it by that Water, 3% acetic acid, or 8%/50% ethanol ........ 72, 96,
regulation. 120
NOTE: In testing the finished food-contact
article, use a separate test sample for each The results from a series of extraction
required extracting solvent. times demonstrate equilibrium when
(e) Analytical methods—(1) Selection of the net chloroform-soluble extractives
extractability conditions for ionomeric res- are unchanging within experimental
ins. First ascertain the type of food error appropriate to the method as de-
(table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d)(1)(i) and (2)(i)
that is being packed or used in contact of this section. Should equilibrium not
with the finished food-contact article be demonstrated over the above time
described in paragraph (a) of this sec-
series, extraction times must be ex-
tion, and also ascertain the normal
tended until three successive unchang-
conditions of thermal treatment used
ing values for extractives are obtained.
in packaging or contacting the type of
In the case where intended uses involve
food involved. Using table 2 of § 176.170
temporary food contact above 120 °F,
(c) of this chapter, select the food-sim-
the food-simulating solvent is to be
ulating solvent or solvents and the
contacted with the food-contact article
time-temperature test conditions that
under conditions of time and tempera-
correspond to the intended use of the
ture that duplicate the actual condi-
finished food-contact article. Having
tions in the intended use. Subsequently
selected the appropriate food-simu-
lating solvent or solvents and time- the extraction is to be continued for
temperature exaggeration over normal the time period and under the condi-
use, follow the applicable extraction tions specified in the above table.
procedure. (3) Reagents—(i) Water. All water used
(2) Selection of extractability conditions in extraction procedures should be
for ionomeric resins. Using table I of freshly demineralized (deionized) dis-
paragraph (f) of this section ascertain tilled water.
the type of food that is being packed or (ii) n-Heptane. Reagent grade, freshly
used in contact with the finished food- redistilled before use, using only mate-
contact article described in paragraph rial boiling at 208 °F (97.8 °C).
(b) of this section, and also ascertain (iii) Alcohol. 8 or 50 percent (by vol-
the food-simulating solvent or solvents ume), prepared from undenatured 95
that correspond to the intended use of percent ethyl alcohol diluted with
the finished food-contact article. demineralized (deionized), distilled
(i) Abbreviated test. For intended use water.
involving food contact at or below 120 (iv) Chloroform. Reagent grade, fresh-
°F (49 °C), the appropriate food-simu- ly redistilled before use, or a grade
lating solvent is to contact the food- having an established, consistently low
contact film for the time and tempera- blank.
tures as follows: (v) Acetic acid. 3 percent (by weight),
Solvent Time Temperature
prepared from glacial acetic acid di-
luted with demineralized (deionized),
n-Heptane ................................. 12 120 °F (49 °C). distilled water.
Water, 3% acetic acid, or 8%/ 1 48 120 °F (49 °C).
50% ethanol.
(4) Selection of test method. The fin-
1 Hours
ished food-contact articles shall be
tested either by the extraction cell de-
(ii) Equilibrium test. For intended use scribed in the Journal of the Association
involving food contact at or below 120 of Official Agricultural Chemists, Vol. 47,
°F (49 °C), the appropriate food-simu- No. 1, p. 177–179 (February 1964), also
272
described in ASTM method F34–76 (Re- where:

approved 1980), ‘‘Standard Test Method e = Milligrams extractives per sample tested.
for Liquid Extraction of Flexible Bar- s = Surface area tested, in square inches.
rier Materials,’’ which are incorporated F = Five, the ratio of the amount of extrac-
by reference, or by adapting the in-con- tives removed by heptane under exagger-
tainer methods described in § 175.300(e) ated time-temperature test conditions
of this chapter. Copies of the material compared to the amount extracted by a
incorporated by reference are available fat or oil under exaggerated conditions of
thermal sterilization and use.
from the Center for Food Safety and
e′ = Acidified chloroform-soluble extractives
Applied Nutrition (HFS–200), Food and residue. e′ is substituted for e in the
Drug Administration, 5001 Campus Dr., above equations when necessary (See
College Park, MD 20740, and the Amer- paragraph (e)(6)(ii) of this section for
ican Society for Testing Materials, 100 method to obtain e′).
Philadelphia, PA 19428-2959, respec- If when calculated by the equations in
tively, or may be examined at the Na- paragraphs (e)(6)(i)(a) and (b) of this
tional Archives and Records Adminis- section, the extractives in milligrams
tration (NARA). For information on per square inch exceed the limitations
the availability of this material at prescribed in paragraphs (c) or (d) of
NARA, call 202–741–6030, or go to: http:// this section, proceed to paragraph
www.archives.gov/federallregister/ (e)(6)(ii) of this section (method for de-
codeloflfederallregulations/ termining the amount of acidified chlo-
ibrllocations.html. roform-soluble extractives residue).
(5) Selection of samples. Quadruplicate (ii) Acidified chloroform-soluble extrac-
samples should be tested, using for tives residue. Add 3 milliliters of 37 per-
each replicate sample the number of cent ACS reagent grade hydrochloric
finished articles with a food-contact acid and 3 milliliters of distilled water
surface nearest to 100 square inches. to the evaporating dish containing the
(6) Determination of amount of extrac- dried and weighed residue, e, obtained
tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section.
the exposure period, remove the test Mix well so every portion of the residue
container or test cell from the oven, if is wetted with the hydrochloric acid
any, and combine the solvent for each solution. Then add 50 milliliters of
replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter
lent) flask or beaker, being sure to through Whatman No. 41 filter paper
rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva-
small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a
rate the food-simulating solvents to clean separatory funnel. Shake for 1
about 100 milliliters in the flask, and minute, then draw off the chloroform
transfer to a clean, tared evaporating layer into a clean tared evaporating
dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the
flask three times with small portions chloroform extraction, washing the
of solvent used in the extraction proce- dish, the filter paper, and the sepa-
dure, and evaporate to a few milliliters ratory funnel with this second portion
on a nonsparking, low-temperature of chloroform. Add this filtrate to the
hotplate. The last few milliliters original filtrate and evaporate the
should be evaporated in an oven main- total down to a few milliliters on a
tained at a temperature of 221 °F (105 low-temperature hotplate. The last few
°C). Cool the evaporating dish in a des- milliliters should be evaporated in an
iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the
residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30
Calculate the extractives in milligrams minutes and weigh to the nearest 0.1
per square inch of the container or ma- milligram to get the acidified chloro-
terial surface. form-soluble extractives residue, e′.
(a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa-
percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i)(a) and (b)
grams extractives per square inch=e/s. of this section.
(b) Heptane. Milligrams extractives (f) The types of food and appropriate
per square inch=(e)/(s)(F) solvents are as follows:
273
§ 177.1340 21 CFR Ch. I (4–1–21 Edition)
TABLE 1 temperature characterizing the condi-

tions of its intended use as determined
Types of food Appropriate solvent
from tables 1 and 2 of § 176.170(c) of this
1. Nonacid (pH above 5.0), aque- Water, n-heptane. chapter, yields net chloroform-soluble
ous products; may contain salt extractives (corrected for zinc extrac-
or sugar or both, and including
oil-in-water emulsions of low- or
tives as zinc oleate) in each extracting
high-fat content. solvent not to exceed 0.5 milligram per
2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% square inch of food-contact surface
ous products; may contain salt acetic acid. when tested by the methods described
or sugar or both, and including
oil-in-water emulsions of low- or
in § 176.170(d) of this chapter. If the fin-
high-fat content. ished food-contact article is itself the
3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% subject of a regulation in parts 174, 175,
ucts containing free oil or fat; acetic acid. 176, 177, 178 and § 179.45 of this chapter,
may contain salt, and including
water-in-oil emulsions of low- or it shall also comply with any specifica-
high-fat content. tions and limitations prescribed for it
4. Dairy products and modifica- by that regulation.
tions:
NOTE: In testing the finished food-contact
Water, n-heptane.
i. Water-in-oil emulsions, high article, use a separate test sample for each
or low fat. required extracting solvent.
ii. Oil-in-water emulsions, high (c) The provisions of this section are
or low fat. not applicable to ethylene-methyl ac-
5. Low moisture fats and oils ........ n-heptane.
6. Beverages: rylate copolymer resins used in food-
i. Containing up to 8% alcohol 8% ethanol/water. packaging adhesives complying with
ii. Nonalcoholic ........................ 3% acetic acid. § 175.105 of this chapter.
iii. Containing more than 8% 50% ethanol/water.
alcohol.
7. Bakery products ........................ Water, n-heptane.
§ 177.1345 Ethylene/1,3-phenylene oxy-
8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/
oil). quired. terephthalate copolymer.
9. Dry solids (with free fat or oil) .. n-heptane.
Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer
(g) The provisions of paragraphs (c) (CAS Reg. No. 87365–98–8) identified in
and (d) of this section are not applica- paragraph (a) of this section may be
ble to the ionomeric resins that are safely used, subject to the provisions of
used in food-packaging adhesives com- this section, as the non-food-contact
plying with § 175.105 of this chapter. layer of laminate structures subject to
[45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in
FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate
1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630.
June 12, 1989] (a) Identity. For the purpose of this
section, ethylene/1,3-phenylene oxy-
§ 177.1340 Ethylene-methyl acrylate co- ethylene isophthalate/terephthalate
polymer resins.
copolymer consists of the basic copoly-
Ethylene-methyl acrylate copolymer mer produced by the catalytic
resins may be safely used as articles or polycondensation of isophthalic acid
components of articles intended for use and terephthalic acid with ethylene
in contact with food, in accordance glycol and 1,3-bis(2-
with the following prescribed condi- hydroxyethoxy)benzene such that the
tions: finished resin contains between 42 and
(a) For the purpose of this section, 48 mole-percent of isophthalic
the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent
mer resins consist of basic copolymers of terephthalic moieties, and not more
produced by the copolymerization of than 10 mole-percent of 1,3-bis(2-
ethylene and methyl acrylate such hydroxyethoxy)benzene moieties.
that the copolymers contain no more (b) Specifications—(1) Density. Ethyl-
than 25 weight percent of polymer ene/1,3-phenylene oxyethylene
units derived from methyl acrylate. isophthalate/terephthalate copolymer
(b) The finished food-contact article, identified in paragraph (a) of this sec-
when extracted with the solvent or sol- tion has a density of 1.33±0.02 grams per
vents characterizing the type of food cubic centimeter measured by ASTM

and under the conditions of time and Method D 1505–85 (Reapproved 1990),
274
‘‘Standard Test Method for Density of of use C at temperatures not to exceed

Plastics by the Density-Gradient Tech- 160 °F (71 °C).
nique,’’ which is incorporated by ref- [57 FR 43399, Sept. 21, 1992, as amended at 59
erence in accordance with 5 U.S.C. FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2,
552(a) and 1 CFR part 51. Copies may be 1996; 62 FR 34628, June 27, 1997; 81 FR 5593,
obtained from the American Society Feb. 3, 2016]
for Testing and Materials, 100 Barr
Harbor Dr., West Conshohocken, Phila- § 177.1350 Ethylene-vinyl acetate co-
delphia, PA 19428-2959, or may be exam- polymers.
ined at the Food and Drug Administra- Ethylene-vinyl acetate copolymers
tion’s Main Library, 10903 New Hamp- may be safely used as articles or com-
shire Ave., Bldg. 2, Third Floor, Silver ponents of articles intended for use in
Spring, MD 20993, 301–796–2039, and at producing, manufacturing, packing,
the National Archives and Records Ad- processing, preparing, treating, pack-
ministration (NARA). For information aging, transporting, or holding food in
on the availability of this material at accordance with the following pre-
NARA, call 202–741–6030, or go to: http:// scribed conditions:
www.archives.gov/federallregister/ (a)(1) Ethylene-vinyl acetate copoly-
codeloflfederallregulations/ mers consist of basic resins produced
ibrllocations.html. by the catalytic copolymerization of
ethylene and vinyl acetate to which
(2) Softening point. Ethylene/1,3–phen-
may have been added certain optional
ylene oxyethylene isophthalate/
substances to impart desired techno-
terephthalate copolymer identified in logical or physical properties to the
paragraph (a) of this section has a soft- resin. Subject to any limitations pre-
ening point of 63±5 °C as measured by scribed in this section, the optional
ASTM Method D 1525–87, ‘‘Standard substances may include:
Test Method for VICAT Softening Tem- (i) Substances generally recognized
perature of Plastics,’’ which is incor- as safe in food and food packaging.
porated by reference in accordance (ii) Substances the use of which is
with 5 U.S.C. 552(a) and 1 CFR part 51. permitted under applicable regulations
The availability of this material is pro- in parts 170 through 189 of this chapter,
vided in paragraph (b)(1) of this sec- prior sanction, or approvals.
tion. (iii) Substances identified in
(c) Optional adjuvant substances. § 175.300(b)(3)(xxv), (xxvii), (xxx), and
Ethylene/1,3–phenylene oxyethylene (xxxiii) of this chapter, and colorants
isophthalate/terephthalate copolymer, used in accordance with § 178.3297 of
identified in paragraph (a) of this sec- this chapter.
tion, may contain optional adjuvant (iv) Erucamide as identified in
substances required in their produc- § 178.3860 of this chapter.
tion. The optional adjuvants may in- (v) Xanthan gum as identified in
clude substances used in accordance § 172.695 for use as a thickening agent
with § 174.5 of this chapter. at a level not to exceed 1 percent by
(d) Limitations. Copolymer blends de- weight of coating solids in aqueous dis-
scribed above shall not exceed 30 per- persions of ethylene-vinyl acetate co-
cent by weight of ethylene/1,3-phen- polymers, where such copolymers are
ylene oxyethylene isophthalate/ used only as coatings or a component
terephthalate copolymer. The finished of coatings.
blend may be used in contact with food (vi) The copolymer of vinylidene flu-
only under conditions of use C through oride and hexafluoropropene (CAS Reg.
G, as described in table 2 of § 176.170(c) No. 9011–17–0), containing 65 to 71 per-
of this chapter, except that with food cent fluorine and having a Mooney Vis-
cosity of at least 28, for use as a proc-
identified as Type III, IV-A, V, VII-A,
essing aid at a level not to exceed 0.2
and IX in § 176.170(c), table 1, the co-
percent by weight of ethylene-vinyl ac-
polymer may be used under condition etate copolymers.
(2) Maleic anhydride-grafted ethyl-

ene-vinyl acetate copolymers (CAS
275
§ 177.1350 21 CFR Ch. I (4–1–21 Edition)
Reg. No. 28064–24–6) consist of basic res- National Archives and Records Admin-
ins produced by the catalytic copolym- istration (NARA). For information on
erization of ethylene and vinyl acetate, the availability of this material at
followed by reaction with maleic anhy- NARA, call 202–741–6030, or go to: http://
dride. Such polymers shall contain not www.archives.gov/federallregister/
more than 11 percent of polymer units codeloflfederallregulations/
derived from vinyl acetate by weight of ibrllocations.html. Compliance of the
total polymer prior to reaction with melt flow index specification shall be
maleic anhydride, and not more than 2 determined using conditions and proce-
percent of grafted maleic anhydride by dures corresponding to those described
weight of the finished polymer. Op- in the method as Condition E, Proce-
tional adjuvant substances that may be dure A). The copolymers shall be used
added to the copolymers include sub- in blends with other polymers at levels
stances generally recognized as safe in not to exceed 17 percent by weight of
food and food packaging, substances total polymer, subject to the limita-
the use of which is permitted under ap- tion that when contacting food of types
plicable regulations in parts 170 III, IV-A, V, VI-C, VII-A, and IX, iden-
through 189 of this chapter, and sub- tified in § 176.170(c) of this chapter,
stances identified in § 175.300(b)(3)(xxv), Table 1, the polymers shall be used
(xxvii), (xxxiii), and (xxx) of this chap- only under conditions of use C, D, E, F,
ter and colorants for polymers used in and G, described in § 176.170(c) of this
accordance with the provisions of chapter, Table 2.
§ 178.3297 of this chapter. (c) The provisions of paragraph (b) of
(b)(1) Ethylene-vinyl acetate copoly- this section are not applicable to ethyl-
mers, with or without the optional sub- ene-vinyl acetate copolymers used in
stances described in paragraph (a) of food-packaging adhesives complying
this section, when extracted with the with § 175.105 of this chapter.
solvent or solvents characterizing the
(d) Ethylene-vinyl acetate copoly-
type of food, and under conditions of
mers may be irradiated under the fol-
time and temperature characterizing
lowing conditions to produce molecular
the conditions of their intended use as
crosslinking of the polymers to impart
determined from tables 1 and 2 of
desired properties such as increased
§ 176.170(c) of this chapter, shall yield
strength and increased ability to
net chloroform-soluble extractives cor-
shrink when exposed to heat:
rected for zinc as zinc oleate not to ex-
ceed 0.5 milligram per square inch of an (1) Electron beam source of ionizing
appropriate sample. radiation at a maximum energy of 3
(2) Maleic anhydride grafted ethyl- million electron volts: Maximum ab-
ene-vinyl acetate copolymers shall sorbed dose not to exceed 150 kiloGray
have a melt flow index not to exceed 2.1 (15 megarads).
grams per 10 minutes as determined by (2) The finished food-contact film
ASTM method D 1238–82, ‘‘Standard shall meet the extractives limitations
Test Method for Flow Rates of Thermo- prescribed in paragraph (e)(2) of this
plastics by Extrusion Plastometer,’’ section.
which is incorporated by reference in (3) The ethylene-vinyl acetate co-
accordance with 5 U.S.C. 552(a). Copies polymer films may be further irradi-
may be obtained from the American ated in accordance with the provisions
Society for Testing Materials, 100 Barr of paragraph (e)(1) of this section: Pro-
Harbor Dr., West Conshohocken, Phila- vided, That the total accumulated radi-
delphia, PA 19428-2959, or at the Office ation dose from both electron beam
of Food Additive Safety (HFS–200), and gamma ray radiation does not ex-
Center for Food Safety and Applied Nu- ceed 150 kiloGray (15 megarads).
trition, Food and Drug Administration, (e) Ethylene-vinyl acetate copolymer
5001 Campus Dr., College Park, MD films intended for contact with food
20740, 240–402–1200, or may be examined may be irradiated to control the
at the Food and Drug Administration’s growth of microorganisms under the
Main Library, 10903 New Hampshire following conditions:
Ave., Bldg. 2, Third Floor, Silver (1) Gamma photons emitted from a
Spring, MD 20993, 301–796–2039, or at the cobalt–60 sealed source in the dose
276
range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard

megarads). Test Method for Liquid Extraction of
(2) The irradiated ethylene-vinyl ace- Flexible Barrier Materials,’’ which is
tate copolymer films, when extracted incorporated by reference. Copies may
with reagent grade n-heptane (freshly be obtained from the American Society
redistilled before use) according to for Testing Materials, 100 Barr Harbor
methods described under § 176.170(d)(3) Dr., West Conshohocken, Philadelphia,
of this chapter, at 75 °F for 30 minutes PA 19428-2959, or may be examined at
shall yield total extractives not to ex- the National Archives and Records Ad-
ceed 4.5 percent by weight of the film. ministration (NARA). For information
on the availability of this material at
FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, NARA, call 202–741–6030, or go to: http://
1989; 55 FR 18595, May 3, 1990; 56 FR 42932, www.archives.gov/federallregister/
Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR codeloflfederallregulations/
14665, Mar. 7, 2013; 81 FR 5593, Feb. 3, 2016] ibrllocations.html.
(1) The film when extracted with dis-
§ 177.1360 Ethylene-vinyl acetate-vinyl tilled water at 21 °C (70 °F) for 48 hours
alcohol copolymers. yields total extractives not to exceed
Ethylene-vinyl acetate-vinyl alcohol 0.0047 milligram per square centimeter
copolymers (CAS Reg. No. 26221–27–2) (0.03 milligram per square inch) of
may be safely used as articles or com- food-contact surface.
ponents of articles intended for use in (2) The film when extracted with 50
contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for
the following prescribed conditions: 48 hours yields total extractives not to
(a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen-
hol copolymers are produced by the timeter (0.04 milligram per square
partial or complete alcoholysis or hy- inch) of food-contact surface.
drolysis of those ethylene-vinyl acetate (c) The finished food-contact article
copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003
(1) Those copolymers containing a inch) thickness and shall contact foods
minimum of 55 percent ethylene and a only of the types identified in table 1 of
maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories
units by weight may be used in contact III, IV-A, VII-A, and IX under condi-
with foods as described in paragraph (b) tions of use F and G described in table
of this section. 2 of § 176.170(c) of this chapter. Film
(2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch)
minimum of 55 percent ethylene and a thickness representing the finished ar-
maximum of 15 percent vinyl alcohol ticles shall meet the following extrac-
units by weight may be used in contact tive limitation when tested by ASTM
with foods as described in paragraph (c) method F34–76 (Reapproved 1980),
of this section. ‘‘Standard Test Method for Liquid Ex-
(3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’
40 percent ethylene and 60 to 83 percent which is incorporated by reference. The
vinyl alcohol units by weight may be availability of this incorporation by
used in contact with foods as described reference is given in paragraph (b) of
in paragraph (d) of this section. this section. The film when extracted
(b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30
shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to
inch) thickness and shall contact foods exceed 0.0078 milligram per square cen-
only of the types identified in table 1 of timeter (0.05 milligram per square
§ 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor-
I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid-
conditions of use D through G de- ing by a factor of five.
scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article
chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007
meter (0.005) inch thickness rep- inch) thickness and may contact all
resenting the finished article shall foods, except those containing more
meet the following extractive limita- than 8 percent alcohol, under condi-
tion when tested by ASTM method tions of use B through H described in
277
§ 177.1380 21 CFR Ch. I (4–1–21 Edition)
table 2 of § 176.170(c) of this chapter. (a) For the purpose of this section,
Film samples of 0.018 centimeter (0.007 fluorocarbon resins consist of basic res-
inch) thickness representing the fin- ins produced as follows:
ished articles shall meet the following (1) Chlorotrifluoroethylene resins
extractive limitation when tested by produced by the homopolymerization
ASTM method F34–76 (Reapproved of chlorotrifluoroethylene.
1980), ‘‘Standard Test Methods for Liq- (2) Chlorotrifluoroethylene-1,1-
uid Extraction of Flexible Barrier Ma- difluoroethylene copolymer resins pro-
terials,’’ which is incorporated by ref- duced by copolymerization of
erence. The availability of this incor- chlorotrifluoroethylene and 1,1-
poration by reference is given in para- difluoroethylene.
graph (b) of this section. The film when (3) Chlorotrifluoroethylene-1,1-
extracted with distilled water at 100 °C difluoroethylene-tetrafluoroethylene
(212 °F) for 30 minutes yields ethylene- co-polymer resins produced by co-
vinyl acetate-vinyl alcohol oligomers polymerization of
not to exceed 0.093 milligram per chlorotrifluoroethylene, 1,1-
square centimeter (0.6 milligram per difluoroethylene, and tetrafluoro-
square inch) of food contact surface as ethylene.
determined by a method entitled ‘‘An- (4) Ethylene-chlorotrifluoroethylene
alytical Method of Determining the copolymer resins produced by copolym-
Amount of EVOH in the Extractives erization of nominally 50 mole percent
Residue of EVOH Film,’’ dated March of ethylene and 50 mole percent of
23, 1987, as developed by the Kuraray chlorotrifluoroethylene. The copoly-
Co., Ltd., which is incorporated by ref- mer shall have a melting point of 239 to
erence in accordance with 5 U.S.C. 243 °C and a melt index of less than or
552(a) and 1 CFR part 51. Copies may be equal to 20 as determined by ASTM
obtained from the Office of Food Addi- Method D 3275–89 ‘‘Standard Specifica-
tive Safety (HFS–200)), Center for Food tion for E-CTFE-Fluoroplastic Mold-
Safety and Applied Nutrition, Food and ing, Extrusion, and Coating Mate-
Drug Administration, 5001 Campus Dr., rials,’’ which is incorporated by ref-
College Park, MD 20740, 240–402–1200, or erence in accordance with 5 U.S.C.
may be examined at the Food and Drug 552(a) and 1 CFR part 51. Copies may be
Administration’s Main Library, 10903 obtained from the American Society
New Hampshire Ave., Bldg. 2, Third for Testing and Materials, 1916 Race
Floor, Silver Spring, MD 20993, 301–796– St., Philadelphia, PA 19013, or may be
2039, or at the National Archives and examined at the National Archives and
Records Administration (NARA). For Records Administration (NARA). For
information on the availability of this information on the availability of this
material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/fed- go to: http://www.archives.gov/fed-
erallregister/ erallregister/
codeloflfederallregulations/ codeloflfederallregulations/
ibrllocations.html. ibrllocations.html.
(e) The provisions of this section are (b) Fluorocarbon resins that are iden-
not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section
tate-vinyl alcohol copolymers used in and that comply with extractive limi-
the food-packaging adhesives com- tations prescribed in paragraph (c) of
plying with § 175.105 of this chapter. this section may be used as articles or
[47 FR 41531, Sept. 21, 1982, as amended at 49 components of articles intended for use
FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, in contact with food as follows:
2000; 78 FR 14665, Mar. 7, 2013; 81 FR 5593, Feb. (1) Fluorocarbon resins that are iden-
3, 2016] tified in paragraphs (a)(1), (a)(2), and
(a)(3) of this section and that comply
§ 177.1380 Fluorocarbon resins. only with the extractive limitations
Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and
used as articles or components of arti- (c)(2) of this section may be used when
cles intended for use in contact with such use is limited to articles or com-
food, in accordance with the following ponents of articles that are intended
prescribed conditions: for repeated use in contact with food or
278
that are intended for one-time use in rated from the exterior layer(s) by a
contact with foods only of the types functional barrier, such as aluminum
identified in § 176.170(c) of this chapter, foil. Upon review of the physical prop-
table 1, under Types I, II, VI, VII-B, erties of a particular construction, the
and VIII. Food and Drug Administration may
(2) Fluorocarbon resins that are iden- consider other layers to serve as func-
tified in paragraph (a)(4) of this section tional barriers. This regulation is not
and that comply with the extractive intended to limit these constructions
limitations prescribed in paragraphs as to shape, degree of flexibility, thick-
(c)(1) and (c)(2) of this section may be ness, or number of layers. These layers
used only when such use is limited to may be laminated, extruded, co-
articles or components of articles that extruded, or fused.
are intended for repeated use in con- (b) When containers subject to this
tact with food. regulation undergo heat sterilization
(3) In accordance with current good to produce shelf-stable foods, certain
manufacturing practice, those food- control measures (in addition to the
contact articles intended for repeated food additive requirements in para-
use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are
to their first use in contact with food. necessary to ensure proper food steri-
(c) Extractives limitations are appli- lization and package integrity. Refer
cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this
pellets that have been ground or cut chapter for details.
into small particles that will pass (c) Subject to the provisions of this
through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro-
and that will be held on a U.S. Stand- duced from high-temperature lami-
ard Sieve No. 10. nates may be safely used to package all
(1) A 100-gram sample of the resin food types except those containing
pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol.
liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay-
perature for 8 hours, shall yield total ers not separated from food by a func-
extractives not to exceed 0.003 percent tional barrier must meet the following
by weight of the resins. requirements:
(2) A 100-gram sample of the resin (i) Films/layers may consist of the
pellets, when extracted with 100 milli- following:
liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with
alcohol in distilled water at reflux item 2.2 or 3.2 of the table in
temperature for 8 hours, shall yield § 177.1520(c).
total extractives not to exceed 0.003 (b) Polymeric resin blends formu-
percent by weight of the resins. lated from a base polymer complying
(3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in
pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than
liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of
ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying
tractives not to exceed 0.01 percent by with § 177.1350.
weight of the resins. (c) Polymeric resin blends formulated
[42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with
FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in
§ 177.1520(c) blended with no more than
§ 177.1390 Laminate structures for use 38 percent by weight of a homopolymer
at temperatures of 250 ≥F and of isobutylene complying with
above. § 177.1420(a)(1).
(a) The high-temperature laminates (d) Polyethylene phthalate resins
identified in this section may be safely complying with § 177.1630(e)(4)(i) and
used for food contact at temperatures (ii).
not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply
erwise specified. These articles are lay- with item 10.3 of the table in
ered constructions that are optionally § 177.1500(b) of this chapter when ex-
bonded with adhesives. The interior tracted with water and heptane under
(food-contact) layer(s) may be sepa- the conditions of time and temperature
279
§ 177.1390 21 CFR Ch. I (4–1–21 Edition)
specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS

forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional
chapter. trimethoxysilane coupling agents con-
(f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or
25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per-
the table in § 177.1500(b), for use as cent by weight of the cured adhesive.
nonfood-contact layers of laminated (b) Urethane cross-linking agent
films and in rigid multilaminate con- comprising not more than 25 percent
structions with polypropylene outer by weight of the cured adhesive and
layers. Laminate structures with au- formulated from 3-isocyanatomethyl-
thorized food-contact materials yield 3,5,5-trimethylcyclohexyl isocyanate
no more than 0.15 milligrams of epsilon- (CAS Reg. No. 4098–71–9) adduct of
caprolactam and 0.04 milligrams of trimethylol propane (Cas Reg. No. 77–
omega-laurolactam per square inch 99–6) and/or 1,3-bis(isocyanatomethyl)
when extracted with 95 percent ethanol benzene (CAS Reg. No. 25854–16–4)
at 121 °C (250 °F) for 2 hours. adduct of trimethylol propane.
(g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe-
with an applicable regulation in this sives formulated from the following:
chapter which permits food type and (a) Polyester resin formed by the re-
time/temperature conditions to which action of polybasic acids and
the container will be exposed, includ- polyhydric alcohols listed in
ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze-
(ii) Adjuvants used in these layers laic acid may also be used as a
must comply with an applicable regu- polybasic acid.
lation that permits food type and time/
(b) Epoxy resin listed in
temperature conditions to which the
§ 175.300(b)(3)(viii)(a) of this chapter and
container will be exposed, including
comprising no more than 30 percent by
sterilization processing.
weight of the cured adhesive.
(2) Adhesives. The use of adhesives in
(c) Urethane cross-linking agent com-
these containers is optional. Adhesives
prising no more than 14 percent weight
may be formulated from the following
of the cured adhesive and formulated
substances, subject to the prescribed
from 3-isocyanatomethyl-3,5.5-
limitations:
trimethylcyclohexyl isocyanate
(i) Any substance suitable for use in
cyanurate (CAS Reg. No. 53880–05–0).
formulating adhesives that complies
with an applicable regulation of this (vi) Polyurethane-polyester resin-
chapter which permits food type and epoxy adhesives formulated from the
time/temperature conditions to which following mixture:
the container will be exposed, includ- (a)(1) Polyester-polyurethanediol res-
ing sterilization processing. ins prepared by the reaction of a mix-
(ii) Substances complying with ture of polybasic acids and polyhydric
§ 175.105 of this chapter may be used in alcohols listed in § 175.300(b)(3)(vii) of
these constructions, provided they are this chapter and 3-isocyanatomethyl-
separated from the interior (food-con- 3,5,5-trimethylcyclohexyl isocyanate
tact) layer(s) by a functional barrier as (CAS Reg. No. 4098–71–9).
discussed under paragraph (a) of this (2) Polyester resin formed by the re-
section. action of polybasic acids and
(iii) Maleic anhydride adduct of poly- polyhydric alcohols listed in
propylene complying with § 175.300 of § 175.300(b)(3)(vii) of this chapter. Addi-
this chapter. tionally, azelaic acid and 1,6-
(iv) Polyester-urethane adhesive for hexanediol may also be used as
use at temperatures not exceeding 121 reactants in lieu of a polyhydric alco-
°C (250 °F) and formulated from the fol- hol.
lowing: (3) Epoxy resin listed in
(a) Polyester-urethanediol resin pre- § 175.300(b)(3)(viii)(a) of this chapter and
pared by the reaction of a mixture of comprising not more than 5 percent by
polybasic acids and polyhydric alcohols weight of the cured adhesive.
listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing

ter, 3-isocyanatomethyl-3,5,5- agents, containing amino, epoxy, ether,
280
or mercapto groups not in excess of 3 (i) Nonvolatile extractives. (a) For use
percent of the cured adhesive. at temperatures not to exceed 121 °C
(b) Urethane cross-linking agent, (250 °F): The container interior (food-
comprising not more than 20 percent contact side) shall be extracted with
by weight of the cured adhesive, and deionized distilled water at 121 °C (250
formulated from trimethylol propane °F) for 2 hours.
(CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of
isocyanatomethyl–3,5,5– the total nonvolatile extractives for
trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in
Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii),
bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section
Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per
(vii) Polyester-polyurethane resin-
square centimeter (0.01 milligram per
acid dianhydride adhesives for use at
square inch) as determined by a meth-
temperatures not to exceed 121 °C (250
od entitled ‘‘Determination of Non-
°F), in contact only with food Types I,
Volatile Chloroform Soluble Residues
II, VIA, VIB, VIIB, and VIII as de-
scribed in Table I of § 176.170 of this in Retort Pouch Water Extracts,’’
chapter, and formulated from the fol- which is incorporated by reference.
lowing mixture: Copies are available from the Center
(a)(1) Polyesterpolyurethanediol res- for Food Safety and Applied Nutrition
ins prepared by the reaction of a mix- (HFS–200), Food and Drug Administra-
ture of polybasic acids and polyhydric tion, 5001 Campus Dr., College Park,
alcohols listed in § 175.300(b)(3)(vii) of MD 20740, and may be examined at the
this chapter and 3-isocyanatomethyl- Food and Drug Administration’s Main
3,5,5-trimethylcyclohexyl isocyanate Library, 10903 New Hampshire Ave.,
(CAS Reg. No. 4098–71–9). Additionally, Bldg. 2, Third Floor, Silver Spring, MD
dimethylol propionic acid and 1,6- 20993, 301–796–2039, or at the National
hexanediol may be used alone or in Archives and Records Administration
combination as reactants in lieu of a (NARA). For information on the avail-
polybasic acid and a polyhydric alco- ability of this material at NARA, call
hol. 202–741–6030, or go to: http://
(2) Acid dianhydride formulated from www.archives.gov/federallregister/
3a,4,5,7a-tetrahydro-7-methyl-5- codeloflfederallregulations/
(tetrahydro-2,5-dioxo-3-furanyl)-1,3- ibrllocations.html.
isobenzofurandione (CAS Reg. No. (2) The chloroform-soluble fraction of
73003–90–4), comprising not more than the total nonvolatile extractives for
one percent of the cured adhesive. containers using adhesives listed in
(b) Urethane cross-linking agent, paragraph (c)(2)(v) of this section shall
comprising not more than twelve per- not exceed 0.016 milligram per square
cent by weight of the cured adhesive, centimeter (0.10 milligram per square
and formulated from trimethylol pro-
inch) as determined by a method titled
pane (CAS Reg. No. 77–99–6) adducts of
‘‘Determination of Non-volatile Chlo-
3-isocyanatomethyl-3,5,5-
roform Soluble Residues in Retort
trimethylcyclohexyl isocyanate (CAS
Pouch Water Extracts,’’ which is incor-
Reg. No. 4098–71–9) and/or 1,3-
bis(isocyanatomethyl)benzene (CAS porated by reference in paragraph
Reg. No. 363–48–31). (c)(3)(i)(a)(1) of this section.
(3) Test specifications. These specifica- (b) For use at temperatures not to ex-
tions apply only to materials on the ceed 135 °C (275 °F): The container inte-
food-contact side of a functional bar- rior (food-contact side) shall be ex-
rier, if present. All tests must be per- tracted with deionized distilled water
formed on containers made under pro- at 135 °C (275 °F) for 1 hour.
duction conditions. Laminated struc- (1) The chloroform-soluble fraction of
tures submitted to extraction proce- the total nonvolatile extractives for
dures must maintain complete struc- containers using no adhesive, or adhe-
tural integrity (particularly with re- sives listed in paragraphs (c)(2)(i), (ii),
gard to delamination) throughout the and (iii) of this section shall not exceed
test. 0.0020 milligram per square centimeter
281
§ 177.1395 21 CFR Ch. I (4–1–21 Edition)
(0.013 milligram per square inch) as de- crons) may be used as the food-contact
termined by a method titled ‘‘Deter- surface of the container.
mination of Non-volatile Chloroform (3) Container test specifications. On
Soluble Residues in Retort Pouch exposure to distilled water at 250 °F
Water Extracts,’’ which is incorporated (121 °C) for 2 hours, extractives from
by reference. The availability of this the food-contact side of the nylon 12
incorporation by reference is given in multilayered construction shall not ex-
paragraph (c)(3)(i)(a)(1) of this section. ceed 0.05 milligram per square inch
(2) The chloroform-soluble fraction of (0.0078 milligram per square centi-
the total nonvolatile extractives for meter) as total nonvolatile extractives.
containers using adhesives listed in
paragraph (c)(2)(v) of this section shall [45 FR 2843, Jan. 15, 1980, as amended at 47
not exceed 0.016 milligram per square FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983;
centimeter (0.10 milligram per square 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22,
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575,
inch) as determined by a method titled
Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR
‘‘Determination of Non-volatile Chlo- 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996;
roform Soluble Residues in Retort 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1,
Pouch Water Extracts,’’ which is incor- 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668,
porated by reference. The availability Mar. 26, 2004; 81 FR 5593, Feb. 3, 2016]
of this incorporation by reference is
given in paragraph (c)(3)(i)(a)(1) of this § 177.1395 Laminate structures for use
section. at temperatures between 120 ≥F and
(3) The chloroform-soluble fraction of 250 ≥F.
the total nonvolatile extractives for (a) The laminates identified in this
containers using adhesives listed in section may be safely used at the speci-
paragraph (c)(2)(vi) of this section shall fied temperatures. These articles are
not exceed 0.008 milligram per square layered structures that are optionally
centimeter (0.05 milligram per square bonded with adhesives. In these arti-
inch) as determined by a method enti- cles, the food-contact layer does not
tled, ‘‘Determination of Non-volatile function as a barrier to migration of
Chloroform Soluble Residues in Retort components from non-food-contact lay-
Pouch Water Extracts,’’ which is incor-
ers. The layers may be laminated, ex-
porated by reference in paragraph
truded, coextruded, or fused.
(c)(3)(i)(a)(1) of this section.
(b) Laminate structures may be man-
(ii) Volatiles. Volatile substances em-
ufactured from:
ployed in the manufacture of high-tem-
perature laminates must be removed to (1) Polymers and adjuvants com-
the greatest extent possible in keeping plying with § 177.1390 of this chapter.
with good manufacturing practice pre- (2) Any polymeric resin listed in
scribed in § 174.5(a) of this chapter. these regulations so long as the use of
(d) Nylon 12/aluminum foil high-tem- the resin in the structure complies
perature laminates: Subject to the pro- with the conditions of use (food type
visions of this paragraph, containers and time/temperature) specified in the
constructed of nylon 12 laminated to regulation for that resin.
aluminum foil may be safely used at (3) Optional adjuvant substances used
temperatures no greater than 250 °F in accordance with § 174.5 of this chap-
(121 °C) in contact with all food types ter.
except those containing more than 8 (4) The following substances in non-
percent alcohol. food-contact layers only:
(1) The container is constructed of
aluminum foil to which nylon 12 film is
fused. Prior to fusing the nylon 12, the
aluminum foil may be optionally
precoated with a coating complying
with § 175.300 of this chapter.
(2) Nylon 12 resin complying with
§ 177.1500 and having an average thick-

ness not to exceed 0.0016 inch (41 mi-
282
Substances Limitations Substances Limitations
Ethylene/1,3–phenylene oxy- For use only with poly- Nylon 6/69 resins complying For use with nonalcoholic
ethylene isophthalate/ ethylene terephthalate as with § 177.1500(b), item 14, foods under conditions of
terephthalate copolymer the food-contact layer, of this chapter (CAS Reg. use B, C, D, E, F, G, and
(CAS Reg. No. 87365–98–8) complying with No. 51995–62–1). H described in table 2 of
complying with § 177.1345. § 177.1630 under condi- § 176.170 of this chapter.
tions of use C through G Laminate structures with
described in table 2 of authorized food-contact
§ 176.170(c) of this chap- materials may contain
ter. Laminate structures, nylon 6/69 resins pro-
when extracted with 8 vided that the nitrogen
percent ethanol at 150 °F content of aqueous ex-
for 2 hours shall not yield tracts of a representative
m-pheny lenedioxy-O,O′- laminate (obtained at 100
diethyl isophthalate or cy- °C (212 °F) for 8 hours)
clic bis(ethylene does not exceed 15
isophthalate) in excess of micrograms per square
7.8 micrograms/square centimeter (100
decimeter (0.5 micrograms per square
microgram/square inch) of inch).
food-contact surface.
Nylon 6/12 resins complying For use with nonalcoholic
with § 177.1500(b), item foods at temperatures not [52 FR 33575, Sept. 4, 1987, as amended at 53
13.2, of this chapter (CAS to exceed 100 °C (212 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21,
Reg. No. 25191–04–2). °F). Laminate structures 1992; 58 FR 32610, June 11, 1993; 62 FR 53957,
with authorized food-con- Oct. 17, 1997]
tact materials yield no
more than 0.15 milligram § 177.1400 Hydroxyethyl cellulose film,
of epsilon-caprolactam water-insoluble.
and 0.04 milligram of
omega-laurolactam per Water-insoluble hydroxyethyl cel-
square inch when ex- lulose film may be safely used for
tracted with water at 100
°C (212 °F) for 5 hours. packaging food in accordance with the
Nylon 6/66 resins complying For use only with: following prescribed conditions:
with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) Water-insoluble hydroxyethyl cel-
of this chapter (CAS Reg. temperatures not to ex- lulose film consists of a base sheet
24993–04–2). ceed 82.2 °C (180 °F).
Laminate structures with manufactured by the ethoxylation of
authorized food-contact cellulose under controlled conditions,
materials yield no more to which may be added certain optional
than 0.15 milligram of ep- substances of a grade of purity suitable
silon-caprolactam per
square inch when ex- for use in food packaging as constitu-
tracted with water at 82.2 ents of the base sheet or as coatings
°C (180 °F) for 5 hours. applied to impart desired technological
2. Nonalcoholic foods at
temperatures not to ex-
properties.
ceed 100 °C (212 °F). (b) Subject to any limitations pre-
Laminate films with au- scribed in parts 170 through 189 of this
thorized food-contact ma- chapter, the optional substances used
terials yield no more than
0.15 milligram of epsilon-
in the base sheet and coating may in-
caprolactam per square clude:
inch when extracted with (1) Substances generally recognized
water at 100 °C (212 °F) as safe in food.
for 5 hours.
(2) Substances permitted to be used
in water-insoluble hydroxyethyl cel-
lulose film by prior sanction or ap-
proval and under conditions specified
in such sanctions or approval, and sub-
stances listed in part 181, subpart B of
this chapter.
(3) Substances that by any regulation
promulgated under section 409 of the
act may be safely used as components
of water-insoluble hydroxyethyl cel-
lulose film.
(4) Substances identified in and used

in compliance with § 177.1200(c).
283
§ 177.1420 21 CFR Ch. I (4–1–21 Edition)
(c) Any substance employed in the (b) The polymers identified in para-
production of the water-insoluble hy- graph (a) of this section may contain
droxyethyl cellulose film described in optional adjuvant substances required
this section that is the subject of a reg- in the production of the polymers. The
ulation in parts 174, 175, 176, 177, 178 optional adjuvant substances required
and § 179.45 of this chapter conforms in the production of the polymers may
with any specification in such regula- include substances generally recog-
tion. nized as safe in food, substances used in
§ 177.1420 Isobutylene polymers. accordance with a prior sanction or ap-
proval, and aluminum chloride.
Isobutylene polymers may be safely
(c) The provisions of this section are
used as components of articles in-
tended for use in producing, manufac- not applicable to polyisobutylene used
turing, packing, processing, preparing, in food-packaging adhesives complying
treating, packaging, transporting, or with § 175.105 of this chapter.
holding food, in accordance with the
following prescribed conditions: § 177.1430 Isobutylene-butene copoly-
mers.
(a) For the purpose of this section,
isobutylene polymers are those pro- Isobutylene-butene copolymers iden-
duced as follows: tified in paragraph (a) of this section
(1) Polyisobutylene produced by the may be safely used as components of
homopolymerization of isobutylene articles intended for use in contact
such that the finished polymers have a with food, subject to the provisions of
molecular weight of 750,000 (Flory) or this section.
higher. (a) For the purpose of this section,
(2) Isobutylene-isoprene copolymers isobutylene-butene copolymers consist
produced by the copolymerization of
of basic copolymers produced by the
isobutylene with not more than 3
copolymerization of isobutylene with
molar percent of isoprene such that the
finished polymers have a molecular mixtures of n-butenes such that the
weight of 300,000 (Flory) or higher. finished basic copolymers contain not
(3) Chlorinated isobutylene-isoprene less than 45 weight percent of polymer
copolymers produced when units derived from isobutylene and
isobutylene-isoprene copolymers (mo- meet the specifications prescribed in
lecular weight 300,000 (Flory) or higher) paragraph (b) of this section when test-
are modified by chlorination with not ed by the methods described in para-
more than 1.3 weight-percent of chlo- graph (c) of this section.
rine. (b) Specifications:
Maximum
Molecular
Isobutylene-butene copolymers Viscosity (range) bromine
weight (range) value
1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§ 178.3710 of this chapter. Saybolt at 200 °F.
2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40
with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F.
3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F.
178.3570 (provided that addition to food does not exceed 10 parts
per million), or § 176.180 of this chapter.
4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90.
(foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F.
chapter.
5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90
sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.
(c) The analytical methods for deter- (1) Molecular weight. Molecular
mining whether isobutylene-butene co- weight shall be determined by Amer-
polymers conform to the specifications ican Society for Testing and Materials
in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard

Test Method for Molecular Weight
284
(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re-

carbons by Thermoelectric Measure- quired in the production of the resins.
ment of Vapor Pressure,’’ which is in- (b) The optional adjuvant substances
corporated by reference. Copies may be required in the production of the resins
obtained from the American Society may include substances generally rec-
for Testing Materials, 100 Barr Harbor ognized as safe in food, substances used
Dr., West Conshohocken, Philadelphia, in accordance with a prior sanction or
PA 19428-2959, or may be examined at approval, and the following:
the National Archives and Records Ad-
List of substances Limitations
ministration (NARA). For information
on the availability of this material at Butyl alcohol ................... Not to exceed 300 p.p.m. as re-
NARA, call 202–741–6030, or go to: http:// sidual solvent in finished resin.
Ethyl alcohol.
www.archives.gov/federallregister/ Toluene ........................... Not to exceed 1,000 p.p.m. as re-
codeloflfederallregulations/ sidual solvent in finished resin.
ibrllocations.html.
(2) Viscosity. Viscosity shall be deter- (c) 4,4′-Isopropylidenediphenol-ep-
mined by ASTM method D445–74, ‘‘Test ichlorohydrin resins shall meet the fol-
for Kinematic Viscosity of Transparent lowing nonvolatile extractives limita-
and Opaque Liquids,’’ which is incor- tions:
porated by reference. The availability (1) Maximum extractable nonvolatile
of this incorporation by reference is fraction of 2 parts per million when ex-
given in paragraph (c)(1) of this sec- tracted with distilled water at 70 °C for
tion. 2 hours, using a volume-to-surface
(3) Maximum bromine value. Maximum ratio of 2 milliliters per square inch.
bromine value shall be determined by (2) Maximum extractable nonvolatile
ASTM method D1492–78, ‘‘Standard fraction of 3 parts per million when ex-
Test Method for Bromine Index of Aro- tracted with n-heptane at 70 °C for 2
matic Hydrocarbons by Coulometric hours, using a volume-to-surface ratio
Titration,’’ which is incorporated by of 2 milliliters per square inch.
reference. The availability of this in- (3) Maximum extractable nonvolatile
corporation by reference is given in fraction of 6 parts per million when ex-
paragraph (c)(1) of this section. tracted with 10 percent (by volume)
(d) The provisions of this section are ethyl alcohol in distilled water at 70 °C
not applicable to isobutylene-butene for 2 hours, using a volume-to-surface
copolymers used as provided under ratio of 2 milliliters per square inch.
§ 175.105 of this chapter. (d) The provisions of this section are
[52 FR 11641, Apr. 10, 1987, as amended at 63 not applicable to 4,4′-isopropylidene-
FR 36175, July 2, 1998] diphenol-epichlorohydrin resins listed
in other sections of subchapter B of
§ 177.1440 4,4′-Isopropylidenediphenol- this chapter.
epichlorohydrin resins minimum
molecular weight 10,000. § 177.1460 Melamine-formaldehyde res-
4,4′-Isopropylidenediphenol-epichlo- ins in molded articles.
rohydrin resins having a minimum mo- Melamine-formaldehyde resins may
lecular weight of 10,000 may be safely be safely used as the food-contact sur-
used as articles or components of arti- face of molded articles intended for use
cles intended for use in producing, in producing, manufacturing, packing,
manufacturing, packing, processing, processing, preparing, treating, pack-
preparing, treating, packaging, trans- aging, transporting, or holding food in
porting, or holding food in accordance accordance with the following pre-
with the following prescribed condi- scribed conditions:
tions: (a) For the purpose of this section,
(a) 4,4′-Isopropylidenediphenol-ep- melamine-formaldehyde resins are
ichlorohydrin resins consist of basic those produced when 1 mole of mel-
resins produced by the condensation of amine is made to react with not more
equimolar amounts of 4,4′- than 3 moles of formaldehyde in water
isopropylidenediphenol and solution.
epichlorohydrin terminated with phe- (b) The resins may be mixed with re-
nol, to which may have been added cer- fined woodpulp and the mixture may
285
§ 177.1480 21 CFR Ch. I (4–1–21 Edition)
contain other optional adjuvant sub- method D1243–79, ‘‘Standard Test Meth-
stances which may include the fol- od for Dilute Solution Viscosity of
lowing: Vinyl Chloride Polymers,’’ which is in-
corporated by reference. Copies may be
obtained from the American Society
Colorants used in accord- for Testing Materials, 100 Barr Harbor
ance with § 178.3297 Dr., West Conshohocken, Philadelphia,
of this chapter.
Dioctyl phthalate ............. For use as lubricant. PA 19428-2959, or may be examined at
Hexamethylenetetramine For use only as polymerization the National Archives and Records Ad-
reaction control agent. ministration (NARA). For information
Phthalic acid anhydride .. Do.
Zinc stearate ................... For use as lubricant. on the availability of this material at
NARA, call 202–741–6030, or go to: http://
(c) The molded melamine-formalde- www.archives.gov/federallregister/
hyde articles in the finished form in codeloflfederallregulations/
which they are to contact food, when ibrllocations.html.
extracted with the solvent or solvents (iii) Residual acrylonitrile monomer
characterizing the type of food and content is not more than 11 parts per
under the conditions of time and tem- million as determined by gas chroma-
perature as determined from tables 1 tography.
and 2 of § 175.300(d) of this chapter, (iv) Acetonitrile-soluble fraction
shall yield net chloroform-soluble ex- after refluxing the base polymer in ace-
tractives not to exceed 0.5 milligram tonitrile for 1 hour is not greater than
per square inch of food-contact surface. 95 percent by weight of the basic co-
[42 FR 14572, Mar. 15, 1977, as amended at 56 polymers.
FR 42933, Aug. 30, 1991] (2) Extractives limitations. The fol-
lowing extractive limitations are de-
§ 177.1480 Nitrile rubber modified ac- termined by an infrared
rylonitrile-methyl acrylate copoly-
mers. spectrophotometric method titled,
‘‘Infrared Spectrophotometric Deter-
Nitrile rubber modified acrylonitrile- mination of Polymer Extracted from
methyl acrylate copolymers identified Borex ® 210 Resin Pellets,’’ which is in-
in this section may be safely used as corporated by reference. Copies are
components of articles intended for available from the Center for Food
food-contact use under conditions of Safety and Applied Nutrition (HFS–
use D, E, F, or G described in table 2 of 200), Food and Drug Administration,
§ 176.170(c) of this chapter, subject to
5001 Campus Dr., College Park, MD
the provisions of this section.
(a) For the purpose of this section,
nitrile rubber modified acrylonitrile-
methyl acrylate copolymers consist of
basic copolymers produced by the graft the availability of this material at
copolymerization of 73–77 parts by NARA, call 202–741–6030, or go to: http://
weight of acrylonitrile and 23–27 parts www.archives.gov/federallregister/
by weight of methyl acrylate in the codeloflfederallregulations/
presence of 8–10 parts by weight of bu- ibrllocations.html.Copies are applicable
tadiene-acrylonitrile copolymers con- to the basic copolymers in the form of
taining approximately 70 percent by particles of a size that will pass
weight of polymer units derived from through a U.S. standard sieve No. 6 and
butadiene. that will be held on a U.S. standard
(b) The nitrile rubber modified acry- sieve No. 10:
lonitrile-methyl acrylate basic copoly- (i) Extracted copolymer not to ex-
mers meet the following specifications ceed 2.0 parts per million in aqueous
and extractives limitations: extract obtained when a 100-gram sam-
(1) Specifications. (i) Nitrogen content ple of the basic copolymers is extracted
is in the range 16.5–19 percent as deter- with 250 milliliters of demineralized
mined by Kjeldahl analysis. (deionized) water at reflux temperature
(ii) Intrinsic viscosity in acetonitrile for 2 hours.
at 25 °C is not less than 0.29 deciliter (ii) Extracted copolymer not to ex-
per gram as determined by ASTM ceed 0.5 part per million in n-heptane
286
extract obtained when a 100-gram sam- adipic acid, and 21.6±1.2 weight percent
ple of the basic copolymers is extracted terephthalic acid.
with 250 milliliters of reagent grade n- (8) Nylon 612 resins are manufactured
heptane at reflux temperature for 2 by the condensation of
hours. hexamethylenediamine and
(c) Acrylonitrile copolymers identi- dodecanedioic acid.
fied in this section shall comply with (9) Nylon 12 resins are manufactured
the provisions of § 180.22 of this chap- by the condensation of omega-
ter. laurolactam.
(d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6
fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu-
to be used to fabricate beverage con- factured by the condensation of adipic
tainers. acid, 1,3-benzenedimethanamine, and
alpha-(3-aminopropyl)-omega-(3-amino-
[42 FR 14572, Mar. 15, 1977, as amended at 42 propoxy)polyoxyethylene under such
FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19,
conditions that the alpha-(3-amino-
1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR propyl)-omega-(3-aminopropoxy)
14481, Apr. 2, 1996] polyoxyethylene monomer content
does not exceed 7 percent by weight of
§ 177.1500 Nylon resins. the finished resin.
(ii) Nylon MXD–6 resins (CAS Reg.
The nylon resins listed in paragraph
No. 25718–70–1) manufactured by the
(a) of this section may be safely used to
condensation of adipic acid and 1,3-
produce articles intended for use in
benzenedimethanamine.
processing, handling, and packaging
(11) Nylon 12T resins are manufac-
food, subject to the provisions of this
tured by the condensation of omega-
section:
laurolactam (CAS Reg. No. 0947–04–6),
(a) The nylon resins are manufac-
isophthalic acid (CAS Reg. No. 0121–91–
tured as described in this paragraph so
5), and bis(4-amino-3-methylcycl-
as to meet the specifications prescribed
ohexyl)methane (CAS Reg. No. 6864–37–
in paragraph (b) of this section when
5) such that the composition in terms
tested by the methods described in
of ingredients is 34.4±1.5 weight percent
paragraph (d) of this section.
omega-laurolactam, 26.8±0.4 weight per-
(1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5
by the condensation of hexamethylene- weight percent bis(4-amino-3-
diamine and adipic acid. methylcyclohexyl)-methane.
(2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No.
by the condensation of hexamethylene- 25750–23–6) are manufactured by the
diamine and sebacic acid. condensation of
(3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic
tured by the condensation of equal- acid, and isophthalic acid such that 65
weight mixtures of nylon 66 salts and to 80 percent of the polymer units are
nylon 610 salts. derived from hexamethylene
(4) Nylon 6/66 resins manufactured by isophthalamide.
the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No.
Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co-
(5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by
by the condensation of 11- weight of epsilon-caprolactam and
aminoundecanoic acid. omega-laurolactam.
(6) Nylon 6 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No.
by the polymerization of epsilon- 25191–04–2) are manufactured by the co-
caprolactam. polymerization of a ratio of at least 80
(7) Nylon 66T resins are manufac- weight percent of epsilon-caprolactam
tured by the condensation of and no more than 20 weight percent of
hexamethyl-enediamine, adipic acid, omega-laurolactam.
and terephthalic acid such that com- (14) Nylon 6/69 resins (CAS Reg. No.
position in terms of ingredients is 51995–62–1) are manufactured by the
43.1±0.2 weight percent hexamethyl- condensation of 49.5 + 0.5 weight per-

enediamine, 35.3±1.2 weight percent cent epsilon-caprolactam, 19.4 + 0.2
287
§ 177.1500 21 CFR Ch. I (4–1–21 Edition)
weight percent hexamethylenediamine by the condensation of 50 mol percent

and 31.2 + 0.3 weight percent azelaic 1,4-benzenedicarboxylic acid, dimethyl
acid. ester and 50 mol percent of an
(15) Nylon 46 resins (CAS Reg. No. equimolar mixture of 2,2,4-trimethyl-
50327–77–0) are manufactured by the 1,6-hexanediamine and 2,4,4-trimethyl-
condensation of 1,4-butanediamine and 1,6-hexanediamine.
adipic acid. (b) Specifications:
(16) Nylon resins PA 6–3–T (CAS Reg-
istry No. 26246–77–5) are manufactured
Maximum extractable fraction
in selected solvents
Melting (expressed in percent
point Solubility by weight of resin)
Specific Viscosity No.
Nylon resins (degrees in boiling
gravity (mL/g)
Fahr- 4.2N HC1 95 Ethyl
enheit) percent Ben-
Water ace-
ethyl zene
tate
alcohol
1. Nylon 66 resins .............. 1.14±.015 475–495 Dissolves in .................................. 1.5 1.5 0.2 0.2
1 h.
2. Nylon 610 resins ............ 1.09±.015 405–425 Insoluble .................................. 1.0 2.0 1.0 1.0
after 1 h.
3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in .................................. 1.5 2.0 1.0 1.0
1 h.
4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ......do ......... .................................. 2.0 2.0 1.5 1.5
silon-caprolactam mon-
omer content not to ex-
ceed 0.7 percent by
weight.
4.2 Nylon 6/66 resins with 1.14±.015 380–425 ......do ......... .................................. 0.8 1.0 0.5 0.5
combined caprolactam
content greater than 60
percent and residual ep-
silon-caprolactam mon-
omer content not to ex-
ceed 0.4 percent by
weight. For use only as
specified in § 177.1395 of
this chapter (CAS Reg.
No. 24993–04–2).
5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble .................................. .30 .35 .25 .3
in articles intended for 1- after 1 h.
time use or repeated use
in contact with food.
5.2 Nylon 11 resins for use 1.04±.015 355–375 ......do ......... .................................. .35 1.60 .35 .40
only:
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
§ 175.300 of this chap-
ter.
6.1 Nylon 6 resins .............. 1.15±.015 392–446 Dissolves in .................................. 1.0 2.0 1.0 1.0
1 h.
6.2 Nylon 6 resins for use 1.15±.015 392–446 ......do ......... .................................. 1.5 2.0 1.0 1.0
only in food-contact films
having an average thick-
ness not to exceed 0.001
in.
7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble .................................. 1.0 1.0 .25 .25
only in food-contact films after 1 h.
having an average thick-
ness not to exceed 0.001
in.
288

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
8. Nylon 612 resins for use 1.06±.015 406–420 ......do ......... .................................. .50 1.50 .50 .50
only in articles intended
for repeated use in con-
tact with food at tempera-
tures not to exceed 212
°F.
9. Nylon 12 resins for use 1.01±.015 335–355 ......do ......... .................................. 1.0 2.0 1.50 1.50
only:.
a. In food-contact films hav-
ing 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 ex-
ceed 250 °F), and B
through H of table 2 of
§ 176.170(c) of this chap-
ter, except as provided in
§ 177.1390(d)
b. In coatings intended for
repeated use in contact
with all food types de-
scribed in table 1 of
ter, except those con-
taining more than 8 per-
cent alcohol, under con-
ditions of use B through
H described in table 2 of
ter.
10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in .................................. 2.0 2.5 1.0 1.0
pact modified Nylon 1h.
MXD–6 film 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 § 176.170(c) of
this chapter under condi-
tions of use C, D, E, F,
G, and H in table 2 of
§ 176.170(C) of this
chapter.
289
§ 177.1500 21 CFR Ch. I (4–1–21 Edition)

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
10.2 Impact modified Nylon 1.21±0.02 437–491 do ............... .................................. 2.0 2.5 1.0 1.0
MXD–6 resins for use as
polymer 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 av-
erage thickness will not
exceed 15 microns (0.6
mils). The finished film is
used for packaging,
transporting, or holding
food, excluding bev-
erages containing more
than 8 percent alcohol
(by volume) at tempera-
tures not to exceed 49
°C (120 °F) (conditions of
use E, F, and G in table
2 of § 176.170(c) of this
chapter).
10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2
for use only as nonfood- 1 h.
contact layers of: (1) Mul-
tilayer films and (2) rigid
plastic containers com-
posed of polypropylene
food-contact and exterior
layers, as defined in
§ 177.1520(c), item 1.1(a)
and 1.1(b), of this chap-
ter. The finished food-
contact laminate, in the
form in which it contacts
food, when extracted with
the food simulating sol-
vent or solvents charac-
terizing the conditions of
the intended use as de-
termined from Table 2 of
ter, shall yield not more
than 0.5 micrograms of
m-xylylenediamine-adipic
acid cyclic monomer per
square inch of food-con-
tact surface, when the
food simulating solvent is
analyzed by any appro-
priate, properly validated
method.
11. Nylon 12T resins for 1.06±0.015 N/A Insoluble .................................. 0.1 ............ 0.5 0.5
use in contact with all after 1
types of food except hour.
those containing more
than 8 percent alcohol.
12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble .................................. 0.2 1.0 0.1 0.1
use in contact with all after 1
types of food except al- hour.
coholic beverages con-
cent alcohol.
290

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ............ 1.5 1.5
use only in food-contact 1 hour.
films having an average
thickness not to exceed
51 microns (0.002 inch).
The finished film is in-
tended to contact all
foods except those con-
cent ethanol under condi-
tions of use B, C, D, E,
F, G, and H listed in
table 2 of § 176.170(c) of
this chapter.
13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.5 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ............................. 1.0 1.5 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.8 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
14. Nylon 6/69 resins for 1.09±0.02 270–277 .................... >140 using the meth- 3.0
use only as specified in od described in
21 CFR 177.1395 of this § 177.1500(c)(5)(ii)
chapter. of this chapter.
15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in .................................. 0.3 0.2 0.2 0.3
only in food-contact 1 h.
membrane filters in-
tended for repeated use.
The finished membrane
filter is intended to con-
tact beverages containing
no more than 13 percent
alcohol, under conditions
of use E, F, and G listed
in table 2 of § 176.170(c)
of this chapter.
16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble >110 ......................... 0.007 0.64 0.003 0
for repeated-use (exclud- after 1 h.
ing bottles) in contact
with food of type VIA and
VIB described in table 1
of § 176.170(c) of this
chapter under conditions
of use D through H de-
scribed in table 2 of
ter with a hot-fill tempera-
ture limitation of 40 °C.
291
§ 177.1500 21 CFR Ch. I (4–1–21 Edition)
(c) Nylon modifier—(1) Identity. Co- of Nylon modifiers listed in paragraph

polyester-graft-acrylate copolymer is (c)(1) of this section may include:
the substance 1,4-benzenedicarboxylic (A) Substances generally recognized
acid, polymer with 1,4-butanediol, (E)- as safe for use in food and food pack-
2-butenedioic acid, 1,2-ethanediol, aging;
ethyl 2-propenoate, hexanedioic acid (B) Substances subject to prior sanc-
and 2-propenoic acid, graft (CAS Reg. tion or approval for use in Nylon resins
No. 175419–23–5), and is derived from and used in accordance with such sanc-
grafting of 25 weight percent of acrylic tions or approval; and
polymer with 75 weight percent of co- (C) Optional substances required in
polyester. The copolyester is polym- the production of the additive identi-
erized terephthalic acid (55 mol%), fied in this paragraph and other op-
adipic acid (40 mol%), and fumaric acid tional substances that may be required
(5 mol%) with ethylene glycol (40 to accomplish the intended physical or
mol%) and 1,4-butanediol (60 mol%). technical effect.
The acrylic polymer is made from (d) Analytical methods—(1) Specific
acrylic acid (70 mol%) and ethyl acry- gravity. Specific gravity shall be deter-
late (30 mol%). mined by weighing a 1-gram to 5-gram
(2) Specifications. The finished copoly- sample first in air and then in freshly
ester-graft-acrylate copolymer shall boiled distilled water at 23 °C±2 °C.
meet the following specifications: (2) Melting point. The melting point
(i) Weight average molecular weight shall be determined as follows: Use a
15,000–35,000, hot-stage apparatus. The use of crossed
nicol prisms with a microscope hot
(ii) pH 7.2 to 8.2, and
stage and reading of the thermometer
(iii) Glass transition temperature when the birefringence disappears in-
¥15 to ¥25 °C. creases the accuracy. If the crossed
(3) Conditions of use. (i) Copolyester- nicol apparatus is not available, use
graft acrylate copolymer described in the lowest temperature at which the
paragraph (c)(1) of this section is in- sample becomes transparent or the
tended to improve the adhesive quali- sharp edges or corners of the sample
ties of film. It is limited for use as a become rounded as the melting point.
modifier of Nylon 6 and Nylon 6 modi- In case of doubt as to the onset of
fied with Nylon MXD–6 at a level not melting, the sample is prodded with a
to exceed 0.17 weight percent of the ad- sharp instrument. If it sticks to the
ditive in the finished film. heating block, it is considered to have
(ii) The finished film is used for pack- melted. If the melting point is low, dry
aging, transporting, or holding all the sample in an oven at 85 °C for 24
types of foods under conditions of use B hours in a nitrogen atmosphere then
through H, described in table 2 of repeat the test.
§ 176.170(c) of this chapter, except that (3) Solubility in boiling 4.2N HCl. The
in the case of Nylon 6 films modified test shall be run on a sample approxi-
with Nylon MXD–6 (complying with mately the size of a 1⁄8-inch cube in at
§ 177.1500, item 10.2), the use complies least 25 milliliters of 4.2 normal hydro-
with the conditions of use specified in chloric acid.
table 2. (4) Maximum extractable fraction in se-
(iii) Extractives. Food contact films lected solvents. The procedure for deter-
described in paragraphs (c)(1) of this mining the maximum extractable frac-
section, when extracted with solvent or tion of the nylon resins in selected sol-
solvents prescribed for the type of food vents is as follows:
and under conditions of time and tem- (i) Film should be cut with ordinary
perature specified for the intended use, scissors into pieces of a convenient size
shall yield total extractives not to ex- such as 1⁄4-inch squares, for the extrac-
ceed 0.5 milligram per inch squared of tion tests described in this section. The
food-contact surface when tested by granules of nylon molding powders are
the methods described in § 176.170(d) of in the proper form for the extraction
this chapter. tests. Samples of fabricated articles
(iv) Optional adjuvant substances. The such as pipe, fittings, and other similar
substances employed in the production articles must be cut to approximately
292
the size of the molding powder. This Copies are available from the Center
can be done conveniently by using a for Food Safety and Applied Nutrition
small-scale commercial plastics (HFS–200), Food and Drug Administra-
granulator and cutting the sample tion, 5001 Campus Dr., College Park,
through a screen having 1⁄4-inch mesh. MD 20740, or available for inspection at
Fine particles should be separated from the National Archives and Records Ad-
the cut resin by screening through a 20- ministration (NARA). For information
mesh screen. The material retained on on the availability of this material at
the screen is suitable for the extraction NARA, call 202–741–6030, or go to: http://
tests. www.archives.gov/federallregister/
(ii) The organic solvents must be of codeloflfederallregulations/
American Chemical Society analytical ibrllocations.html.
reagent grade; distilled water is used. (ii) The viscosity number (VN) for
Approximately 30 grams of the pre- Nylon 6/69 and Nylon PA–6–3–T resins
pared sample is weighed to the nearest in a 99 percent cresol solution (5 milli-
milligram. The weighed resin is trans- grams resin per milliliter) shall be de-
ferred to a 500-milliliter round-bottom termined at 25 °C (77 °F) by method ISO
flask equipped with a reflux condenser. 307–1984(E), ‘‘Plastics-Polyamides-De-
Approximately 300-milliliters of sol- termination of Viscosity Number,’’
vent is added to the flask and the con- which is incorporated by reference. The
tents refluxed gently for 8 hours with a availability of this incorporation by
heating mantle. The solvent is then fil- reference is given in paragraph (d)(5)(i)
tered off immediately while still hot, of this section.
using a Buchner funnel approximately
[42 FR 14572, Mar. 15, 1977]
5 inches in diameter, a suction flask,
and a hardened filter paper (Whatman EDITORIAL NOTE: For FEDERAL REGISTER ci-
No. 50 or equivalent). The paper is wet tations affecting § 177.1500, see the List of
with the solvent and a slight suction CFR Sections Affected, which appears in the
applied just before starting the filtra- Finding Aids section of the printed volume
and at www.govinfo.gov.
tion. The resin is washed twice with
approximately 100-milliliter portions of § 177.1520 Olefin polymers.
solvent and the combined filtrate and
washings are reduced to approximately The olefin polymers listed in para-
25 milliliters by evaporation at reduced graph (a) of this section may be safely
pressure (50 millimeters to 100 millime- used as articles or components of arti-
ters of mercury, absolute), heating as cles intended for use in contact with
necessary. The contents of the flask food, subject to the provisions of this
are transferred to an evaporation dish section.
(which has been held in a vacuum des- (a) For the purpose of this section,
iccator over anhydrous calcium sulfate olefin polymers are basic polymers
until constant weight has been at- manufactured as described in this para-
tained) and carefully evaporated to graph, so as to meet the specifications
dryness. The weight of the solid residue prescribed in paragraph (c) of this sec-
is determined by difference after hold- tion, when tested by the methods de-
ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section.
drous calcium sulfate until constant (1)(i) Polypropylene consists of basic
weight has been attained. The percent polymers manufactured by the cata-
of solids extracted is calculated by di- lytic polymerization of propylene.
viding the weight of the solid residue (ii) Propylene homopolymer consists
by the weight of the sample and multi- of basic polymers manufactured by the
plying by 100. catalytic polymerization of propylene
(5) Viscosity number (VN). (i) The vis- with a metallocene catalyst.
cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic
in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata-
milligrams resin per milliliter) shall be lytic polymerization of ethylene.
determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly-
ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con-
Determination of Viscosity Number,’’ sists of basic polymers manufactured

which is incorporated by reference. by the catalytic polymerization of
293
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)
ethylene followed by reaction with fu- units derived from butene-1 with the
maric acid in the absence of free rad- remainder being propylene.
ical initiators. Such polymers shall (d) Olefin basic terpolymers manufac-
contain grafted fumaric acid at levels tured by the catalytic copolymeriza-
not to exceed 2 percent by weight of tion of ethylene, hexene-1, and either
the finished polymer. propylene or butene-1, shall contain
(3) Olefin basic copolymers consist of not less than 85 weight percent poly-
basic copolymers manufactured by the mer units derived from ethylene.
catalytic copolymerization of: (e) Olefin basic copolymers manufac-
(i) Two or more of the 1-alkenes hav- tured by the catalytic polymerization
ing 2 to 8 carbon atoms. Such olefin of ethylene and octene-1, or ethylene,
basic copolymers contain not less than octene-1, and either hexene-1, butene-1,
96 weight-percent of polymer units de- propylene, or 4-methylpentene-1 shall
rived from ethylene and/or propylene, contain not less than 80 weight percent
except that: of polymer units derived from ethyl-
(a)(1) Olefin basic copolymers manu- ene.
factured by the catalytic copolym- (ii) 4-Methylpentene-1 and 1-alkenes
erization of ethylene and hexene-1 or having from 6 to 18 carbon atoms. Such
ethylene and octene-1 shall contain not olefin basic copolymers shall contain
less than 90 weight-percent of polymer not less than 95 molar percent of poly-
units derived from ethylene; mer units derived from 4-
(2) Olefin basic copolymers manufac- methylpentene-1, except that copoly-
tured by the catalytic copolymeriza- mers manufactured with 1-alkenes hav-
tion of ethylene and hexene-1 shall con- ing from 12 to 18 carbon atoms shall
tain not less than 80 but not more than contain not less than 97 molar percent
90 weight percent of polymer units de-
of polymer units derived from 4-
rived from ethylene.
methylpentene-1; or
(3) Olefin basic copolymers manufac-
(iii) Ethylene and propylene that
tured by the catalytic copolymeriza-
may contain as modifiers not more
tion of ethylene and pentene-1 shall
than 5 weight-percent of total polymer
contain not less than 90 weight-percent
of polymer units derived from ethyl- units derived by copolymerization with
ene. one or more of the following mono-
(4) Olefin basic copolymers manufac- mers:
tured by the catalytic polymerization 5-Ethylidine-2-norbornene.
of ethylene and octene-1 shall contain 5-Methylene-2-norbornene.
not less than 50 weight-percent of poly-
mer units derived from ethylene. (iv) Ethylene and propylene that may
contain as a modifier not more than 4.5
(b) Olefin basic copolymers manufac-
tured by the catalytic copolymeriza- weight percent of total polymer units
tion of ethylene and 4-methylpentene-1 derived by copolymerization with 1,4-
shall contain not less than 89 weight- hexadiene.
percent of polymer units derived from (v) Ethylene and butene-1 copolymers
ethylene; (CAS Reg. No. 25087–34–7) that shall
(c)(1) Olefin basic copolymers manu- contain not less than 80 weight percent
factured by the catalytic copolym- of polymer units derived from ethyl-
erization of two or more of the mono- ene.
mers ethylene, propylene, butene-1, 2- (vi) Olefin basic copolymers (CAS
methylpropene-1, and 2,4,4- Reg. No. 61615–63–2) manufactured by
trimethylpentene-1 shall contain not the catalytic copolymerization of
less than 85 weight-percent of polymer ethylene and propylene with 1,4-
units derived from ethylene and/or pro- hexadiene, followed by reaction with
pylene; fumaric acid in the absence of free rad-
(2) Olefin basic copolymers manufac- ical initiators. Such polymers shall
tured by the catalytic copolymeriza- contain not more than 4.5 percent of
tion of propylene and butene-1 shall polymer units deriving from 1,4-
contain greater than 15 but not greater hexadiene by weight of total polymer
than 35 weight percent of polymer prior to reaction with fumaric acid and
294
not more than 2.2 percent of grafted fu- (6) Ethylene-maleic anhydride co-
maric acid by weight of the finished polymers (CAS Reg. No. 9006–26–2) con-
polymer. taining no more than 2 percent by
(vii) Ethylene and 2-norbornene (CAS weight of copolymer units derived from
Reg. No. 26007–43–2) copolymers that maleic anhydride.
shall contain not less than 30 and not (b) The basic olefin polymers identi-
more than 70 mole percent of polymer fied in paragraph (a) of this section
units derived from 2-norbornene. may contain optional adjuvant sub-
(4) Poly(methylpentene) consists of
stances required in the production of
basic polymers manufactured by the
catalytic polymerization of 4- such basic olefin polymers. The op-
methylpentene-1. tional adjuvant substances required in
(5) Polyethylene graft copolymers the production of the basic olefin poly-
consist of polyethylene complying with mers or finished food-contact articles
item 2.2 of paragraph (c) of this section may include substances permitted for
which subsequently has 3a,4,7,7a- such use by applicable regulations in
tetrahydromethyl-4,7- parts 170 through 189 of this chapter,
methanoisobenzofuran-1,3-dione graft- substances generally recognized as safe
ed onto it at a level not to exceed 1.7 in food and food packaging, substances
percent by weight of the finished co- used in accordance with a prior sanc-
polymer. tion or approval, and the following:
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent
Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para-
erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may
cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through
220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of
of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de-
ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with
mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of
‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D
Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap-
as determined by ASTM Method D 611–82, ‘‘Standard Test ter.
Methods for Aniline Point and Mixed Aniline Point of Petro-
leum Products and Hydrocarbon Solvents,’’ both of which
are incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the
American Society for Testing and Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia, PA 19428-2959, or
from the Center for Food Safety and Applied Nutrition (HFS–
lege Park, MD 20740, or may be examined at the National
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202–
741–6030, or go to: http://www.archives.gov/fed-
Colorants used in accordance with § 178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene
63–7). homopolymer complying with § 177.1520(c), item 1.1 and
olefin copolymers complying with § 177.1520(c), items 3.1
and 3.2 and containing not less than 75 weight percent of
polymer units derived from propylene, provided that the max-
imum concentration of tert-butyl alcohol in the polymer does
not exceed 100 parts per million, as determined by a method
titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’
which is incorporated by reference. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS–
lege Park, MD 20740, or available for inspection at the Na-
tional Archives and Records Administration (NARA). For in-
formation on the availability of this material at NARA, call
202–741–6030, or go to: http://www.archives.gov/fed-
ibrllocations.html.
295
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)
Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of
polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section,
polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com-
acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than
3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene.
14–7), and polypropylene (CAS Reg. No. 9003–07–0), re-
sulting from the reaction of a mixture of methyl methacrylate
and butyl acrylate with polypropylene. The finished product
contains no more than 55 percent by weight of polymer units
derived from methyl methacrylate and butyl acrylate as de-
termined by a method entitled, ‘‘Determination of the Total
Acrylic in PP–MMA/BA Polymers,’’ 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 Food Addi-
tive Safety, Center for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, or may be examined at the
Food and Drug Administration’s Main Library, 10903 New
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National Archives and
Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federallregister/
codeloflfederallregulations/ ibrllocations.html.
Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent
genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with
mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of
codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight
cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item
drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con-
°C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-
approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I,
by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of
3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C
ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap-
parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi-
rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con-
ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of
available from the American Society for Testing and Mate- § 176.170(c) of this chapter.
rials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or from the Center For Food Safety
and Applied Nutrition (HFS–200), Food and Drug Administra-
tion, 5001 Campus Dr., College Park, MD 20740, or may be
examined at the National Archives and Records Administra-
tion (NARA). For information on the availability of this mate-
rial at NARA, call 202–741–6030, or go to: http://
codeloflfederallregulations/ ibrllocations.html..
Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ............ For use only as a surface lubricant or anti-blocking agent in
films.
Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin
79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev-
rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The
Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de-
Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi-
Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H.
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, 5001 Campus Dr., College
Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/federallregister/
Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin
68937–54–2). polymers that comply with § 177.1520(c) at levels not to ex-
ceed 0.3 percent by weight of the polymer. The finished
polymer is used in contact with foods under conditions of
use B through H described in table 2 of § 176.170 of this
chapter.
296
Triisopropanolamine (CAS Reg. No. 122–20–3) ........................ For use as a Zeigler-Natta-type catalyst deactivator and anti-
oxidant in the production of olefin polymers complying with
§ 177.1520(c), items 2.1, 2.2, and 2.3, and having a min-
imum density of 0.94 grams per cubic centimeter, and co-
polymers complying with § 177.1520(c), items 3.1 and 3.2,
for use in contact with all foods under the following condi-
tions of use: (a) films with a maximum thickness of 0.102
millimeter (0.004 inch) may be used under conditions A
through H defined in table 2 of § 176.170(c) of this chapter;
and (b) articles with thickness greater than 0.102 millimeter
(0.004 inch) may be used under conditions C through G de-
fined in table 2 of § 176.170(c) of this chapter.
Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of
by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and
(CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1,
trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad-
27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million
not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers.
more than 6 percent.
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded
No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight
cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only
a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap-
by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H.
available from the Center for Food Safety and Applied Nutri-
tion (HFS–200), Food and Drug Administration, 5001 Cam-
pus Dr., College Park, MD 20740, or may be examined at
the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA,
call 202–741–6030, or go to: http://www.archives.gov/fed-
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin
No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev-
less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The
and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de-
100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi-
3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H.
Rheological Properties of Thermoplastics with a Capillary
Rheometer’’ using a capillary of 15:1 L/D, which is incor-
porated 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, 5001 Campus Dr., College Park, MD
20740, or may be examined at the National Archives and
Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to:
(c) Specifications:
Maximum extract- Maximum soluble
Melting Point able fraction (ex- fraction (ex-
(MP) or softening pressed as per- pressed as per-
Olefin polymers Density point (SP) (De- cent by weight of cent by weight of
grees Centi- the polymer) in N- polymer) in xy-
grade)— hexane at speci- lene at specified
fied temperatures temperatures
1.1a. Polypropylene described in paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
(a)(1)(i) of this section temperature
1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
paragraph (a)(1)(ii) of this section temperature
1.2. Polypropylene, noncrystalline; for use 0.80–0.88
only to plasticize polyethylene described
under items 2.1 and 2.2 of this table, pro-
vided that such plasticized polymers meet
the maximum extractable fraction and max-
imum soluble fraction specifications pre-

scribed for such basic polyethylene
297
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)

1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C.

only: To plasticize polypropylene described
by item 1.1 of this table, provided that such
plasticized polymers meet the maximum ex-
tractable fraction and maximum soluble
fraction specifications prescribed for such
basic polypropylene, and further provided
that such plasticized polypropylene contacts
food only of the types identified in
§ 176.170(c) of this chapter, table 1, under
Types I, II, IV-B, VI-B, VII-B, and VIII; and
for use at levels not to exceed 50 pct by
weight of any mixture employed as a food-
contact coating provided such coatings con-
tact food only of the types identified in
Types I, II, IV-B, VI-B, VII-B, and VIII
2.1. Polyethylene for use in articles that con- 0.85–1.00 ............................. 5.5 pct at 50 °C 11.3 pct at 25 °C
tact food except for articles used for pack-
ing or holding food during cooking
2.2. Polyethylene for use in articles used for 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
packing or holding food during cooking
2.3. Polyethylene for use only as component 0.85–1.00 ............................. 53 pct at 50 °C 75 pct at 25 °C
of food-contact coatings at levels up to and
including 50 percent by weight of any mix-
ture employed as a food-contact coating
2.4. Olefin polymers described in paragraph
(a)(2)(ii) of this section, having a melt flow
index not to exceed 17 grams/per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 20 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX identified in § 176.170(c)
of this chapter, Table 1, the polymers shall
be used only under conditions of use C, D,
E, F, and G, described in § 176.170(c) of
this chapter, Table 2.
3.1a. Olefin copolymers described in para- 0.85–1.00 ............................. 5.5 pct at 50 °C 30 pct at 25 °C
graph (a)(3)(i) of this section for use in arti-
cles that contact food except for articles
used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(a)(3) of this section
and listed in item 3.1c of this table and
olefin copolymers described in paragraph
(a)(3)(i)(e) of this section and listed in item
3.1b of this table
3.1b. Olefin copolymers described in para- 0.9–1.00 ............................. Do Do.
graph (a)(3)(i)(e) of this section for use in
contact with food only under conditions of
use D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2
3.1c. Olefin copolymers described in para- Not less than 0.92
graph (a)(3)(i)(a)(3) of this section for use in
contact with food only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2; except
that such copolymers when used in contact
with food of the types identified in
§ 176.170(c), table 1, under types III, IVA,
V, VIIA, and IX, shall be used only under
conditions of use D, E, F, and G described
in § 176.170(c) of this chapter, table 2
298

3.2a. Olefin copolymers described in para- 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
graph (a)(3)(i) of this section for use in arti-
cles used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(c)(2) of this section
and listed in item 3.2b of this table; except
that olefin copolymers containing 89 to 95
percent ethylene with the remainder being
4-methyl-pentene-1 contacting food Types
III, IVA, V, VIIA, and IX identified in
§ 176.170(c) of this chapter, table 1, shall
not exceed 0.051 millimeter (mm) (0.002
inch (in)) in thickness when used under
conditions of use A and shall not exceed
0.102 mm (0.004 in) in thickness when
used under conditions of use B, C, D, E,
and H described in § 176.170(c) of this
chapter, table 2. Additionally, olefin copoly-
mers described in (a)(3)(i)(a)(2) of this sec-
tion may be used only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2, in con-
tact with all food types identified in
§ 176.170(c) of this chapter, table 1
3.2b. Olefin copolymers described in para- Do.
graph (a)(3)(i)(c)(2) of this section have a
melt flow index no greater than 10 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion, and the thickness of the finished poly-
mer contacting food shall not exceed 0.025
mm (0.001 in). Additionally, optional adju-
vants permitted for use in olefin copolymers
complying with item 3.2a of this table may
be used in the production of this copolymer
3.2c. Olefin copolymers described in para- 0.85–0.92
graph (a)(3)(i)(a)(4) of this section have a
melt flow index no greater than 50 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion. Articles manufactured using these
polymers may be used with all types of food
under conditions of use C through H as de-
scribed in table 2 of § 176.170(c) of this
chapter
3.3a. Olefin copolymers described in para-
graph (a)(3)(ii) of this section and manufac-
tured with 1-alkenes having from 6 to 10
carbon atoms
3.3b. Olefin copolymers described in para-
graph (a)(3)(ii) of this section, provided that
such olefin polymers have a melt tempera-
ture of 220 °C to 250 °C (428 °F to 482 °F)
as determined by the method described in
paragraph (d)(8) of this section and min-
imum intrinsic viscosity of 1.0 as determined
in paragraph (d)(9) of this section.
299
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)

3.4. Olefin copolymers, primarily non-crys- 0.85–0.90

talline, described in par. (a)(3)(iii) of this
section provided that such olefin polymers
have a minimum viscosity average molec-
ular weight of 120,000 as determined by the
method described in par. (d)(5) of this sec-
tion and a minimum Mooney viscosity of 35
as determined by the method described in
par. (d)(6) of this section, and further pro-
vided that such olefin copolymers contact
food only of the types identified in
Types I, II, III, IV-B, VI, VII, VIII, and IX
3.5. Olefin copolymers, primarily non-crys- 0.85–0.90
talline, described in paragraph (a)(3)(iv) of
this section, provided that such olefin poly-
mers have a minimum viscosity average
molecular weight of 95,600 as determined
by the method described in paragraph
(d)(5) of this section, and further provided
that such olefin polymers are used only in
blends with olefin polymers described under
items 1.1, 2.1, and 2.2 of this table at a
maximum level of 25 pct by weight, and
provided that such olefin copolymers con-
tact food only of the types identified in
§ 176.170 (c) of this chapter, table 1, under
Types I, II, IV-B, VI, VII-B, and VIII at tem-
peratures not exceeding 190 °F
3.6. Olefin copolymers described in para- Not less than 0.88
graph (a)(3)(v) of this section for use in
blends with olefin polymer resins have a
melt flow index no greater than 5 grams/10
minutes as determined by the method de-
scribed in paragraph (d)(7) of this section
and the thickness of the finished blends
shall not exceed 0.1 millimeter (0.004 inch).
The ethylene/butene-1 copolymer may be
used subject to the following conditions: (1)
For use at a level not to exceed 20 weight
percent in polypropylene as described
under item 1.1 of this table. (2) For use at a
level not to exceed 40 weight percent in
polyethylene as described under items 2.1
and 2.2 of this table. (3) For use at a level
not to exceed 40 weight percent in olefin
copolymers as described under items 3.1
and 3.2 of this table
300

3.7. Ethylene/propylene copolymers, meeting Not less than 0.86

the identity described in paragraph (a)(3)(i)
of this section, containing not less than 80
mole-percent of polymer units derived from
ethylene and having a minimum viscosity
average molecular weight of 95,000 as de-
termined by the method described in para-
graph (d)(5) of this section, and a minimum
Mooney viscosity of 13 as determined by
the method described in paragraph (d)(6) of
this section. Ethylene/propylene copolymers
described in this item 3.7 are to be used
only in blends with other olefin polymers
complying with this section, at levels not to
exceed 30 percent by weight of the total
polymer blend, and in contact with food only
of types identified in § 176.170(c) of this
chapter, Table 1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX. Additionally, optional
adjuvants permitted for use in olefin copoly-
mers complying with item 3.4 of this table
may be used in the production of this
copolymer
3.8. Olefin polymers described in paragraph
(a)(3)(vi) of this section, having a melt flow
index not to exceed 9.2 grams per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 8 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX, identified in
§ 176.170(c) of this chapter, Table 1, the
polymers shall be used only under condi-
tions of use C, D, E, F, and G, described in
§ 176.170(c) of this chapter, Table 2.
3.9. Olefin copolymers described in paragraph Not less than 1.0
(a)(3)(vii) of this section may only be used
in contact with dry foods, Type VIII, as iden-
tified in § 176.170(c) of this chapter, Table 1
4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C
temperature
5. Polyethylene copolymer described in para- Not less than 0.94 ............................. 0.45 pct at 15 °C 1.8 pct at 25 °C
graph (a)(5) of this section and having a
melt index not to exceed 2, for use, either
alone or in blends with other olefin poly-
mers, subject to the limitation that when
contacting foods of types III, IV-A, V, VI-C,
VII-A, VIII, and IX identified in § 176.170(c)
of this chapter, table 1, the thickness of the
film (in mils) containing the polyethylene
graft copolymer times the concentration of
the polyethylene graft copolymer shall not
exceed a value of 2
6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ........................ 1.36 pct at 50 °C 2.28 pct at 25 °C
scribed in paragraph (a)(6) of this section
for use as the adhesive component in multi-
laminate structures, or as the sealant layer
in flexible packaging, in contact with food at
temperatures not exceeding 49 °C (120 °F)
(d) The analytical methods for deter- this section are as follows, and are ap-
mining whether olefin polymers con- plicable to the basic polymer in film
form to the specifications prescribed in form not exceeding 4 mils in thickness.
301
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)
The film to be tested shall be cut into polypropylene, and poly(methylpentene).

approximately 1-inch squares by any A sample is refluxed in the solvent for
convenient method that avoids con- 2 hours and filtered at the boiling
tamination by dust, dirt, or grease point. The filtrate is evaporated and
(NOTE: Do not touch samples with bare the total residue weighed as a measure
fingers—use forceps to hold or transfer of the solvent extractable fraction.
samples). (a) Apparatus. (1) Erlenmeyer flasks,
(1) Density. Density shall be deter- 250-milliliter, with ground joint.
mined by ASTM method D1505–68 (Re- (2) Condensers, Allihn, 400-millimeter
approved 1979), ‘‘Standard Test Method jacket, with ground joint.
for Density of Plastics by the Density- (3) Funnels, ribbed 75-millimeter di-
Gradient Technique,’’ which is incor- ameter, stem cut to 40 millimeters.
porated by reference. Copies may be (4) Funnels, Buchner type, with
coarse-porosity fritted disc, 60-milli-
for Testing Materials, 100 Barr Harbor
meter diameter.
Dr., West Conshohocken, Philadelphia,
(5) Bell jar for vacuum filtration into
PA 19428-2959, or may be examined at
the National Archives and Records Ad- beaker.
ministration (NARA). For information (b) Reagent. n-Hexane, commercial
on the availability of this material at grade, specific gravity 0.663–0.667 (20 °C/
NARA, call 202–741–6030, or go to: http:// 20 °C), boiling range 66 °C-69 °C, or
www.archives.gov/federallregister/ equivalent.
codeloflfederallregulations/ (c) Procedure. Weigh 1 gram of sample
ibrllocations.html. accurately and place in a 250-milliliter
(2) Melting point or softening point—(i) Erlenmeyer flask containing two or
Melting point. The melting point shall three boiling stones. Add 100 milliliters
be determined by ASTM method D2117– of solvent, attach the flask to the con-
82, ‘‘Standard Test Method for Melting denser (use no grease), and reflux the
Point of Semicrystalline Polymers by mixture for 2 hours. Remove the flask
the Hot Stage Microscopy Method,’’ from the heat, disconnect the con-
which is incorporated by reference. The denser, and filter rapidly, while still
availability of this incorporation by hot, through a small wad of glass wool
reference is given in paragraph (d)(1) of packed in a short-stem funnel into a
this section. tared 150-millimeter beaker. Rinse the
(ii) Softening point. The softening flask and filter with two 10-milliliter
point shall be determined by ASTM portions of the hot solvent, and add the
method E28–67 (Reapproved 1982), rinsings to the filtrate. Evaporate the
‘‘Standard Test Method for Softening filtrate on a stream bath with the aid
Point by Ring-and-Ball Apparatus,’’ of a stream of nitrogen. Dry the res-
which is incorporated by reference. The idue in a vacuum oven at 110 °C for 2
availability of this incorporation by hours, cool in a desiccator, and weigh
reference is given in paragraph (d)(1) of to the nearest 0.0001 gram. Determine
this section. the blank on 120 milliliters of solvent
(3) Maximum extractable fraction in n- evaporated in a tared 150-milliliter
hexane—(i) Olefin copolymers described beaker. Correct the sample residue for
in paragraph (a)(3)(ii) of this section, this blank if significant. Calculation:
Grams of residue
= Percent extractable with n-hexane.
Grams of sample × 100
(ii) Olefin copolymers described in para- residue weighed as a measure of the

graph (a)(3)(i) of this section and poly- solvent extractable fraction. Alter-
ethylene. A preweighed sample is ex- natively, the sample is reweighed after
tracted at 50 °C for 2 hours and filtered.
the extraction period to give a measure

The filtrate is evaporated and the total of the solvent extractable fraction. The
302
ER01JA93.398</GPH>
maximum n-hexane-extractable frac- vent temperature has reached 50 °C,

tion may be determined by the meth- disconnect the heater, remove the resin
ods set forth in paragraphs (d)(3)(ii)(a) kettle from the heating jacket, and de-
through (d)(3)(ii)(i) of this section. cant the solvent, while still warm,
(a) Extraction apparatus. Two-liter, through a coarse filter paper placed on
straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting
resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered
ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity.
ient for this purpose. The cover is Determine the weight of the filtrate re-
fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery
stirrer driven by an air motor or explo- should be at least 90 percent of the
sion-proof electric motor, and a reflux original solvent. Losses due to evapo-
condenser. The kettle is fitted with an ration during heating and filtering
electric heating mantle of appropriate have been found not to exceed 10 per-
size and shape, which is controlled by a cent. Transfer about half of the solvent
variable-voltage transformer. filtrate to a 1-liter beaker placed on an
(b) Evaporating apparatus. Rapid opening in the steam bath and imme-
evaporation of large volumes of solvent diately cover with the special ‘‘gas’’
requires special precautions to prevent cover, the inlet tube of which has been
contamination by dust. This is facili- attached with flexible tetrafluoro-
tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu-
sisting of an inverted flat Pyrex crys-
rity nitrogen in series with a stainless
tallizing dish of an appropriate size (190
steel heating coil immersed directly in
millimeters × 100 millimeters) to fit a
the body of the steam bath. Maintain a
1-liter beaker. Through the center of
positive flow of warm nitrogen gas
the dish are sealed an inlet tube for
throughout the evaporation of the sol-
preheated, oxygen-free nitrogen, and
an outlet tube located 1 inch off center. vent, adding the remainder of the fil-
Nitrogen is fed from the supply source trate from the Erlenmeyer flask as the
through a coil of 1⁄4-inch stainless steel evaporation proceeds. When the volume
tubing immersed in the same steam of the solvent has been reduced to
bath used to supply heat for solvent about 50 milliliters, transfer the con-
evaporation. All connections are made centrated liquid to a previously tared
with flexible tetrafluoroethylene tub- weighing dish of suitable size. Wash the
ing. beaker twice with 20–30 milliliter por-
(c) Reagents—(1) n-Hexane. Spectro- tions of warm solvent, adding the
grade n-hexane. washings to the weighing dish while
(2) Nitrogen. High-purity dry nitrogen continuing to evaporate the remainder
containing less than 10 parts per mil- of the solvent under the gas cover with
lion of oxygen. its flow of warm nitrogen directed to-
(d) Procedure. Transfer 2.5 grams (ac- ward the center of the dish. In the
curately weighed to nearest 0.001 gram) event that an insoluble residue that
of the polymer to the resin kettle. Add cannot be removed with warm solvent
1 liter of solvent and clamp top in posi- remains in the beaker, it may be nec-
tion. Start water flowing through jack- essary to heat with a small amount of
et of the reflux condenser and apply air a higher boiling solvent such as ben-
pressure to the stirring motor to zene or toluene, transferring these
produce vigorous agitation. Turn on washings to the weighing dish before
heating jacket with transformer set at final evaporation to dryness. Transfer
a predetermined voltage to bring the the weighing dish with its residue to a
temperature of the contents to 50 °C vacuum desiccator, and allow it to re-
within 20–25 minutes. As the thermom- main overnight (at least 12 hours),
eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry
duce the voltage to the predetermined residue is determined to the nearest
setting that will just maintain the 0.0001 gram. Correct the result for any
temperature at 50 °C. Do not overshoot solvent blank equivalent to the non-
the prescribed temperature. Should volatile matter determined to be con-
this occur discard the test and start tained in the amount of solvents used
afresh. Exactly 2 hours after the sol- in the test.
303
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)
(e) Extraction apparatus for alternate should be prepared by the same process
method. Two-liter extraction vessel, as will be used with the production
such as a resin kettle or round bottom resin. Using gloves and metal tweezers
flask, fitted with an Allihn condenser to avoid sample contamination, cut
(size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4
sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1-
Water bath maintained at 49.5 °C ±0.5 inch squares using clean sharp scissors.
°C containing a submersible magnetic Proceed with Option 1 or 2.
stirrer motor with power supply. Other Option 1. Using tweezers and noting
suitable means of maintaining tem- the number of film pieces, transfer 2.5
perature control, such as electric heat- grams (accurately weighed to 0.1 milli-
ing mantles, may be used provided that
gram) of polymer to the extraction ves-
the temperature range can be strictly
sel. Extract the film sample for 2
maintained.
hours. Allow the vessel to cool and fil-
(f) Sample basket (Optional). A per-
ter the contents through a fritted por-
forated stainless steel cylindrical bas-
ket that is approximately 1.5 inches in celain funnel. Wash the film pieces
diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry-
forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a
33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to
The basket should pass freely through verify that none were lost during the
the 45/50 female joint of the extraction transfer. Place the beaker in the vacu-
flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After
bolt is attached to the lid for posi- 2 hours, remove and place in a desic-
tioning the basket in the extraction cator to cool to room temperature
vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh
mately 18 inches long and made from the film pieces to the nearest 0.1 milli-
1⁄16 inch outside diameter 316 stainless gram. Calculate the percent hexane-
steel welding rod or equivalent and extractables content from the weight
hooked at both ends, is used to position loss of the original sample. Multiply
the basket in the extraction apparatus. the result by 0.935 and compare with
(g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of
taining 80 °C ±5 °C and a minimum of this section. Repeat the above proce-
635 millimeters of mercury pressure. dure for successive samples.
(h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of
spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a
milligram per liter), minimum 85 per- tared sample basket and accurately
cent n-hexane. This reagent may be reweigh to the nearest 0.1 milligram.
used until it contains a maximum of 1.5 Carefully raise the condenser until the
grams polyolefin extractables or has hook on the positioning rod is above
been used for 12 determinations. the neck of the 2-liter extraction ves-
(i) Procedure. Assemble the extraction
sel. The basket should be totally below
vessel, condenser, and magnetic stir
the level of n-hexane solvent. Extract
bar. Add n-hexane (1 liter) to the ex-
the sample resin film for 2 hours and
traction vessel and clamp the assembly
into a water bath set at 49.5 °C ±0.5 °C. then raise the basket above the solvent
Start the water flowing through the level to drain momentarily. Remove
jacket of the reflux condenser. Adjust the basket and rinse the contents by
the air flow through the stirring motor immersing several times in fresh n-
to give a smooth and uniform stir rate. hexane. Allow the basket to dry be-
Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol-
hour to bring the temperature to 49.5 vent by briefly blowing the basket with
°C±0.5 °C. Temperature is a critical fac- a stream of nitrogen or dry air. Place
tor in this analysis and it must not the basket in the vacuum oven for 2
vary more than 1 °C. If the temperature hours at 80 °C ±5 °C. After 2 hours, re-
exceeds these limits, the test must be move and place in a desiccator to cool
discontinued and restarted. Blown, to room temperature (about 1 hour).
compression molded, or extrusion cast After cooling, reweigh the basket to

films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate
304
the percent hexane extractables con- thylamine in 1 liter of industrial grade

tent from the weight loss of the origi- xylene having specific gravity 0.856–
nal sample. Multiply the result by 0.935 0.867 (20 °C/20 °C) and boiling range 123
and compare with extraction limits in °C–160 °C.
paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of
the above procedure for successive sample to the nearest 0.001 gram and
samples. The same solvent charge place in a 125-milliliter Pyrex reagent
should remain clear and can be used for bottle containing a 1-inch long tetra-
at least 12 determinations. Applica- fluoroethylene-resin-coated stirring
tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set
firmed for each resin type before use. the stopper in lightly, and place the
(4) Maximum soluble fraction in xy- bottle in the heating mantle or alu-
lene—(i) Olefin copolymers described in minum block maintained at a tempera-
paragraph (a)(3)(ii) of this section, poly- ture of 120 °C, and stir with a magnetic
propylene, and poly(methylpen-tene). A stirrer until the sample is completely
sample is dissolved completely in xy- dissolved. Remove the bottle from the
lene by heating and stirring in a bottle heat and allow it to cool 1 hour in the
with little free space. The solution is air, without stirring. Then place the
allowed to cool without stirring, bottle in a water bath maintained at 25
whereupon the insoluble portion pre- °C ±0.5 °C, and allow to stand 1 hour
cipitates and is filtered off; the total without stirring. Next, remove the bot-
solids content of the filtrate is then de- tle from the water bath, shake, and
termined as a measure of the soluble pour part of the contents into the
fraction. coarse-porosity fritted-glass funnel.
(a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli-
lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more
glass-stoppered. slurry to the funnel, and catching the
(2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the
liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of
block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the
scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior
this section. to the filtration.) Pipet a suitable ali-
(3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the
heating mantle (combination magnetic filtrate into a tared aluminum dispos-
stirrer and hotplate may be used if alu- able dish. Place the dish on a steam
minum block is used in place of heat- bath covered with a fresh sheet of alu-
ing mantle). minum foil and invert a short-stemmed
(4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro-
amperes. gen (heated if desired) down through
(5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just
stirring bar, 1-inch long. ripple the surface of the solvent. When
(6) Constant temperature water bath the liquid has evaporated, place the
maintained at 25 °C±0.5 °C. dish in a vacuum oven at 140 °C and
(7) Aluminum dishes, 18 millimeters × less than 50 millimeters mercury pres-
60 millimeters, disposable. sure for 2 hours. Cool in a desiccator
(8) Funnel, Buchner type, with and weigh. (Note: If the residue value
coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven
meter diameter. for one-half hour to ensure complete
(b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula-
Dissolve 0.020 gram of phenyl-b- naph- tion:
Grams of residue 100 milliters

× × 100 = Percent soluble in xylene
Grams of sample volume of aliquot in milliliters
305
ER01JA93.399</GPH>
§ 177.1520 21 CFR Ch. I (4–1–21 Edition)
(ii) Olefin copolymers described in para- reflux condenser and apply full voltage
graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When
ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the
lene at reflux temperature for 2 hours voltage to a level just sufficient to
and filtered. The filtrate is evaporated maintain reflux. After refluxing for at
and the total residue weighed as a least 2 hours, disconnect the power
measure of soluble fraction. source to the mantle, remove the ket-
(a) Apparatus—(1) Extraction appa- tle, and allow to cool in air until the
ratus. Two-liter, straight-walled Pyrex temperature of the contents drops to 50
(or equivalent) resin kettles, fitted °C, after which the kettle may be rap-
with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing
venient for this purpose. The cover is in a cold water bath. Transfer the ket-
equipped with a thermometer and an tle to a constant temperature bath set
efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to
fitted with an electric heating mantle equilibrate for a least 1 hour (may be
of appropriate size and shape which is left overnight if convenient). Break up
controlled by a variable-voltage trans- any precipitated polymers that may
former. have formed, and decant the xylene so-
(2) Constant temperature water bath. It lution successively through a fast filter
must be large enough to permit immer- paper and then through a fritted-glass
sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer
maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil-
(3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any
consisting of a flat Pyrex crystallizing attempt to collect more of the xylene
dish (190 millimeters × 100 millimeters) solution usually results in clogging the
inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the
with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the
through center and an outlet tube 1 weight of the filtrate obtained to the
inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate,
cover is inserted in an electric heating quantitatively, from the Erlenmeyer
mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the
age transformer. The outlet tube is at- beaker in its heating mantle, add a
tached to an efficient condenser glass-coated magnetic stirring bar, and
mounted on a receiving flask for sol- mount the gas cover in place, con-
vent recovery and having an outlet for necting the inlet tube to the nitrogen
connection to an aspirator pump. The source and the outlet to the condenser
heating mantle (with the beaker) is of the receiving flask. Start a flow of
mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into
An infrared heat lamp is mounted the gas cover and connect an aspirator
vertically 3–4 inches above the gas to the receiver using a free-flow rate
cover to prevent condensation of the equivalent to 6–7 liters of air per
solvent inside the cover. Make all con- minute. With the infrared lamp on, ad-
nections with flexible tetrafluoro- just the voltage to the heating mantle
ethylene tubing. to give a distillation rate of 12–13 milli-
(b) Reagents—(1) Xylene. American liters per minute when the magnetic
Chemical Society reagent grade that stirrer is revolving just fast enough to
has been redistilled through a promote good boiling. When the vol-
fractionating column to reduce the ume of solvent in the beaker has been
nonvolatile residue. reduced to 30–50 milliliters, transfer
(2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit-
containing less than 104 parts per mil- able weighing dish that has been pre-
lion oxygen. viously tared (dry). Rinse the beaker
(c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of
gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the
1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain-
and clamp top in position after insert- der of the xylene on an electric
ing a piece of glass rod to prevent hotplate set at low heat under the gas
bumping during reflux. Start water cover with a stream of nitrogen di-
flowing through the jacket of the rected toward the center of the dish.
306
Avoid any charring of the residue. termined at 100 °C. The apparatus con-
Transfer the weighing dish to a vacu- taining the sample is warmed for 1
um desiccator at room temperature minute, run for 8 minutes, and vis-
and allow to remain under reduced cosity measurements are then made.
pressure for at least 12 hours (over- (7) Melt flow index. The melt flow
night), after which determine the net index of olefin polymers described
weight of the residue to the nearest below shall be determined by ASTM
0.0001 gram. Correct the result for non- method D–1238–82, ‘‘Standard Test
volatile solvent blank obtained by Method for Flow Rates of Thermo-
evaporating the equivalent amount of plastics by Extrusion Plastometer,’’
xylene under identical conditions. Cal- which is incorporated by reference in
culate the weight of residue originally accordance with 5 U.S.C. 552(a). The
present in the total weight of solvent availability of this incorporation by
(840 grams), using the appropriate fac- reference is given in paragraph (d)(1) of
tor based on the weight of filtrate this section. The olefin polymers and
evaporated. test conditions and procedures are as
(5) Viscosity average molecular weight follows:
olefin copolymers described in paragraphs List of polymers Conditions/procedures
(a)(3)(iii) and (iv) of this section. The vis-
cosity average molecular weight shall Olefin copolymers described in para- Condition L, proce-
graph (a)(3)(i)(c)(2) of this section. dure A.
be determined from the kinematic vis- Olefin copolymers described in para- Condition E, proce-
cosity (using ASTM method D445–74, graph (a)(3)(v) of this section. dure A.
‘‘Test for Kinematic Viscosity of Olefin polymers described in para- Condition E, proce-
graph (a)(2)(ii) of this section. dure A.
Transparent and Opaque Liquids’’ (Re- Olefin polymers described in para- Condition E, proce-
vised 1974), which is incorporated by graph (a)(3)(vi) of this section. dure A.
reference; copies are available from
American Society for Testing and Ma- (8) Melting peak temperature. The melt
terials (ASTM), 100 Barr Harbor Dr., temperature of the olefin polymers de-
West Conshohocken, Philadelphia, PA scribed in paragraph (a)(3)(ii) of this
19428-2959, or available for inspection at section shall be determined by ASTM
the National Archives and Records Ad- method D 3418–82, ‘‘Standard Test
ministration (NARA). For information Method for Transition Temperatures of
on the availability of this material at Polymers by Thermal Analysis,’’ which
NARA, call 202–741–6030, or go to: http:// is incorporated by reference in accord-
www.archives.gov/federallregister/ ance with 5 U.S.C. 552(a). The avail-
codeloflfederallregulations/ ability of this incorporation by ref-
ibrllocations.html.) of solutions of the erence is given in paragraph (d)(1) of
copolymers in solvents and at tempera- this section.
tures as follows: (9) Intrinsic viscosity. The intrinsic
(i) Olefin polymers described in para- viscosity of the olefin polymers de-
graph (a)(3)(iii) of this section in scribed in paragraph (a)(3)(ii) of this
decahydronaphthalene at 135 °C. section shall be determined by ASTM
(ii) Olefin polymers described in method D 1601–78, ‘‘Standard Test
paragraph (a)(3)(iv) of this section in Method for Dilute Solution Viscosity
tetrachloroethylene at 30 °C. of Ethylene Polymers,’’ which is incor-
(6) Mooney viscosity—olefin copolymers porated by reference in accordance
described in paragraph (a)(3)(iii) of this with 5 U.S.C. 552(a). The availability of
section. Mooney viscosity is determined this incorporation by reference is given
by ASTM method D1646–81, ‘‘Standard in paragraph (d)(1) of this section.
Test Method for Rubber—Viscosity and (e) Olefin copolymers described in
Vulcanization Characteristics (Mooney paragraph (a)(3)(i) of this section and
Viscometer),’’ which is incorporated by polyethylene, alone or in combination,
reference (the availability of this in- may be subjected to irradiation bom-
corporation by reference is given in bardment from a source not to exceed
paragraph (d)(1) of this section), using 2.3 million volts intensity to cause mo-
the large rotor at a temperature of 100 lecular crosslinking of the polymers to
°C, except that a temperature of 127 °C impart desired properties, such as in-
shall be used for those copolymers creased strength and increased ability
whose Mooney viscosity cannot be de- to shrink when exposed to heat.
307
§ 177.1550 21 CFR Ch. I (4–1–21 Edition)
(f) The olefin polymers identified in (3) Substances authorized under ap-
and complying with this section, when plicable regulations in this part and in
used as components of the food-contact parts 175 and 178 of this chapter and
surface of any article that is the sub- subject to any limitations prescribed
ject of a regulation in parts 174, 175, therein.
176, 177, 178, and § 179.45 of this chapter, (4) The following substances, subject
shall comply with any specifications to any limitations prescribed:
and limitations prescribed by such reg-
ulation for the article in the finished List of substances Limitations
form in which it is to contact food.
Lithium polysilicate containing For use only as a compo-
(g) The provisions of this section are not more than 20 weight per- nent of repeated-use
not applicable to olefin polymers iden- cent silica, not more than 2.1 coatings not exceeding
tified in § 175.105(c)(5) of this chapter percent lithium oxide and 0.030 millimeter (0.0012
having a maximum mole inch) in thickness where
and used in food-packaging adhesives ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally
complying with § 175.105 of this chapter. cured at minimum sinter-
ing temperatures of 371
[42 FR 14572, Mar. 15, 1977] °C (700 °F). Lithium ex-
EDITORIAL NOTE: For FEDERAL REGISTER ci- tractives shall not exceed
tations affecting § 177.1520, see the List of 1.55 milligrams per
square decimeter (0.1
CFR Sections Affected, which appears in the milligram per square inch)
Finding Aids section of the printed volume of coating surface when
and at www.govinfo.gov. tested in accordance with
paragraph (e)(2) of this
§ 177.1550 Perfluorocarbon resins. section.
Naphthalene sulfonic acid For use only:
Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re-
this section may be safely used as arti- sodium salt. peated-use coatings,
cles or components of articles intended based on the
to contact food, subject to the provi- perfluorocarbon resin
identified in paragraph
sions of this section: (a)(1) of this section, not
(a) Identity. For the purpose of this to exceed 0.030 milli-
section, perfluorocarbon resins are meter (0.0012 inch) in
thickness, and at a level
those produced by: (1) The not to exceed 0.4 weight
homopolymerization and/or copolym- percent of the coating.
erization of hexafluoropropylene and 2. As a component of re-
tetrafluoroethylene, and (2) the co- peated-use coatings,
based on the
polymerization of perfluorocarbon resin
perfluoropropylvinylether and tetra- identified in paragraph
fluoroethylene (CAS Reg. No. 26655–00– (a)(2) of this section, not
to exceed 0.10 millimeter
5). The resins shall meet the extrac- (0.004 inch) in thickness,
tives limitations in paragraph (d) of and at a level not to ex-
this section. ceed 0.4 weight percent
(b) Optional components. The of the coating.
perfluorocarbon resins identified in
paragraph (a) of this section as well as (c) Optional processing. Poly- tetra-
articles or coating made from these fluoroethylene resins may be irradi-
resins may include the following op- ated by either a cobalt-60 sealed
tional components except that the source, at a maximum dose of gamma
resin identified in paragraph (a)(2) of radiation not to exceed 7.5 megarads,
this section may not be used with the or an electron beam at energy levels
optional component, lithium not to exceed 2.5 million electron volts
polysilicate, mentioned in paragraph with a maximum dosage of 7.5
(b)(4) of this section. megarads, to produce lubricant pow-
(1) Substances generally recognized ders having a particle diameter of not
as safe (GRAS) in food or food pack- more than 20 microns for use only as
aging subject to any limitations cited components of articles intended for re-
on their use. peated use in contact with food.
(2) Substances used in accordance (d) Specifications—(1) Infrared identi-
with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be
ject to any limitations cited in the identified by their characteristic infra-

prior sanction or approval. red spectra.
308
(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741–
carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/
(a)(1) of this section shall have a melt federallregister/
viscosity of not less than 104 poises at codeloflfederallregulations/
380 °C (716 °F) as determined by ASTM ibrllocations.html. The requirements of
method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly-
od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant
Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of
corporated by reference. Copies may be this section.
obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon-
for Testing Materials, 100 Barr Harbor molded articles having a surface area
Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square
PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli-
the National Archives and Records Ad- meters (0.05 inch) thick shall be ex-
ministration (NARA). For information tracted at reflux temperatures for 2
on the availability of this material at hours separately with distilled water,
NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and
www.archives.gov/federallregister/ ethyl acetate.
codeloflfederallregulations/ (2) Perfluorocarbon resins identified
ibrllocations.html. The melt viscosity in paragraphs (a)(1) and (2) of this sec-
of the perfluorocarbon resins identified tion and intended for use as coatings or
in paragraph (a)(1) of this section shall components of coatings shall meet
not vary more than 50 percent within extractability limits prescribed in
one-half hour at 380 °C (716 °F). paragraph (e)(3) of this section when
(ii) Perfluorocarbon resins identified the resins in the form of coatings de-
in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2)(i) and (ii) of
have a melt viscosity of not less than this section are extracted at reflux
104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately
mined by a more detailed method ti- with distilled water, 8 percent ethanol,
tled ‘‘Determination of Melt Viscosity, and n-heptane:
Molecular Weight Distribution Index (i) Perfluorocarbon resin coatings
and Viscosity Stability,’’ which is in- based on resins identified in paragraph
corporated by reference. Copies are (a)(1) of this section shall be applied to
available from the Center for Food both sides of a 0.025-millimeter (0.001
Safety and Applied Nutrition (HFS– inch) thick aluminum foil to a thick-
200), Food and Drug Administration, ness of 0.025 millimeter (0.001 inch)
5001 Campus Dr., College Park, MD after thermal curing at 399 °C (750 °F)
20740, or available for inspection at the for 10 minutes. If a primer is used, the
National Archives and Records Admin- total thickness of the primer plus top-
istration (NARA). For information on coat shall equal 0.025 millimeter (0.001
the availability of this material at inch) after heat curing.
NARA, call 202–741–6030, or go to: http:// (ii) Perfluorocarbon resin coatings
www.archives.gov/federallregister/ based on resins identified in paragraph
codeloflfederallregulations/ (a)(2) of this section shall be applied to
ibrllocations.html. both sides of a 0.025-millimeter (0.001
(3) Thermal instability index. The ther-
mal instability index of the tetra- 1 A more detailed procedure of extraction
fluoroethylene homopolymer shall not conditions is entitled, ‘‘Preparation of Ex-
exceed 50 as determined by ASTM tracts,’’ which is incorporated by reference.
method D1457–56T, ‘‘Test for Thermal Copies are available from the Center for
Instablility index of Tetrafluoro- Food Safety and Applied Nutrition (HFS–
ethylene Homopolymer’’ (Revised 1956), 200), Food and Drug Administration, 5001
which is incorporated by reference. Campus Dr., College Park, MD 20740, or
Copies are available from University available for inspection at the National Ar-
chives and Records Administration (NARA).
Microfilms International, 300 N. Zeeb For information on the availability of this
Rd., Ann Arbor, MI 48106, or available material at NARA, call 202–741–6030, or go to:
for inspection at the National Archives
and Records Administration (NARA). codeloflfederallregulations/
For information on the availability of ibrllocations.html.
309
§ 177.1555 21 CFR Ch. I (4–1–21 Edition)
inch) thick aluminum foil to a thick- (250 °F) for 2 hours, shall yield total
ness of 0.10 millimeter (0.004 inch) after nonvolatile extractives not to exceed
thermal curing at 427 °C (800 °F) for 10 2.33 micrograms per square centimeter
minutes. If a primer is used, the total (15 micrograms per square inch) of the
thickness of the primer plus topcoat exposed resin surface.
shall equal 0.10 millimeter (0.004 inch) (d) Limitations. Polyarylate resin ar-
after heat curing. ticles may be used in contact with all
(3) The extracted surfaces shall meet foods except beverages containing
the following extractability limits: more than 8 volume percent ethanol
(i) Total extractives not to exceed 3.1 under conditions of use A through H,
milligrams per square decimeter (0.2 described in table 2 of § 176.170(c) of this
milligram per square inch). chapter.
(ii) Fluoride extractives calculated as [52 FR 35540, Sept. 22, 1987]
fluorine not to exceed 0.46 milligram
per square decimeter (0.03 milligram § 177.1556 Polyaryletherketone resins.
per square inch). The poly(oxy-1,4-phenylenecarbonyl-
(f) Conditions of use. Perfluorocarbon 1,4-phenyleneoxy-1,4-
resins identified in paragraph (a)(2) of phenylenecarbonyl-1,4-
this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res-
ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS
cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly re-
use. ferred to as polyaryletherketone res-
[43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this
FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles
1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for
Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub-
14481, Apr. 2, 1996] ject to the provisions of this section.
(a) Identity. Polyaryletherketone res-
§ 177.1555 Polyarylate resins.
ins consist of basic resins produced by
Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone
51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a
cles or components of articles intended way that the finished resins have a
for use in contact with food in accord- minimum weight average molecular
ance with the following prescribed con- weight of 20,000 grams per mole, as de-
ditions: termined by light scattering measure-
(a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem-
benzenedicarboxylic acid, diphenyl perature.
ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The
benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden-
methylethylidine) bis(phenol)) are tified in paragraph (a) of this section
formed by melt polycondensation of may contain optional adjuvant sub-
bisphenol-A with diphenylisophthalate stances required in the production of
and diphenylterephthalate. such basic resins. These adjuvants may
(b) Specifications. (1) The finished co- include substances used in accordance
polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol-
weight percent of polymer units de- lowing:
rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro
to 30 weight percent of polymer units ethylene).
derived from diphenylterephthalate. (2) [Reserved]
(2) Polyarylate resins shall have a (c) Extractive limitations. The finished
minimum weight average molecular food-contact article yields net total ex-
weight of 20,000. tractives in each extracting solvent
(3) Polyarylate resins may be identi- not to exceed 0.052 milligram per
fied by their characteristic infrared square inch (corresponding to 0.008 mil-
spectra. ligram per square centimeter) of food-
(c) Extractive limitations. The finished contact surface, when extracted at
polyarylate resins in sheet form at reflux temperature for 2 hours with the
least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50
when extracted with water at 121 °C percent (by volume) ethyl alcohol in
310
distilled water, 3 percent acetic acid paragraph and further identified as re-
(by weight) in distilled water, and n- quired:
heptane.
(d) In testing the finished food-con- Substances Limitations
tact article made of Sulfolane ..... Not to exceed 0.15 percent as residual sol-
polyaryletherketone resin, use a sepa- vent in the finished basic resin.
rate test sample for each required ex-
tracting solvent. (c) Extractive limitations. The finished
[61 FR 42381, Aug. 15, 1996] polyarylsulfone resin when extracted
for 2 hours with the following solvents
§ 177.1560 Polyarylsulfone resins. at the specified temperatures yields
total extractives in each extracting
Polyarylsulfone resins (CAS Reg. No.
79293–56–4) may be safely used as arti- solvent not to exceed 0.008 milligram
cles or components of articles intended per square centimeter of food-contact
for use in contact with food, at tem- surface: distilled water at 121 °C (250
peratures up to and including normal °F), 50 percent (by volume) ethyl alco-
baking temperatures, in accordance hol in distilled water at 71.1 °C (160 °F),
with the following prescribed condi- 3 percent acetic acid in distilled water
tions: at 100 °C (212 °F), and n-heptane at 65.6
(a) Identity. Polyarylsulfone resins °C (150 °F).
are copolymers containing not more NOTE: In testing the finished polyaryl-
than 25 percent of oxy-p-phenylene- sulfone resin use a separate test sample for
oxy-p-phenylenesulfonyl-p-phenylene each required extracting solvent.
polymer units and not less than 75 per- [50 FR 31046, July 24, 1985]
cent of oxy-p-phenylenesulfonyl-p-
phenylene-oxy-p-phenylenesulfonyl-p- § 177.1570 Poly-1-butene resins and
phenylene polymer units. The copoly- butene/ethylene copolymers.
mers have a minimum reduced vis-
The poly-1-butene resins and butene/
cosity of 0.40 deciliter per gram in 1-
ethylene copolymers identified in this
methyl-2-pyrrolidinone in accordance
with ASTM method D2857–70 (Re- section may be safely used as articles
approved 1977), ‘‘Standard Test Method or components of articles intended for
for Dilute Solution Viscosity of Poly- use in contact with food subject to the
mers,’’ which is incorporated by ref- provisions of this section.
erence. Copies may be obtained from (a) Identity. Poly-1-butene resins are
the American Society for Testing and produced by the catalytic polymeriza-
Materials, 100 Barr Harbor Dr., West tion of 1-butene liquid monomer.
Conshohocken, Philadelphia, PA 19428- Butene/ethylene copolymers are pro-
2959, or may be examined at the Na- duced by the catalytic polymerization
tional Archives and Records Adminis- of 1-butene liquid monomer in the pres-
tration (NARA). For information on ence of small amounts of ethylene
the availability of this material at monomer so as to yield no higher than
NARA, call 202–741–6030, or go to: http:// a 6-weight percent concentration of
www.archives.gov/federallregister/ polymer units derived from ethylene in
codeloflfederallregulations/ the copolymer.
ibrllocations.html. (b) Specifications and limitations. Poly-
(b) Optional adjuvant substances. The 1-butene resins and butene/ethylene co-
basic polyarylsulfone resins identified polymers shall conform to the speci-
in paragraph (a) of this section may fications prescribed in paragraph (b)(1)
contain optional adjuvant substances of this section, and shall meet the
required in the production of such extractability limits prescribed in
basic copolymers. These optional adju- paragraph (b)(2) of this section.
vant substances may include sub- (1) Specifications—(i) Infrared identi-
stances permitted for such use by regu- fication. Poly-1-butene resins and
lations in parts 170 through 179 of this butene/ethylene copolymers can be
chapter, substances generally recog- identified by their characteristic infra-
nized as safe in food, substances used in red spectra.
accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and
proval, and substances named in this the butene/ethylene copolymers have
311
§ 177.1580 21 CFR Ch. I (4–1–21 Edition)
an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of
mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in
‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter,
lution Viscosity of Ethylene Poly- subject to the provisions of this section
mers,’’ which is incorporated by ref- and provided that the maximum
erence. Copies may be obtained from extractables from test films 0.1 to 0.2
the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick-
terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by
Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted
2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with
tional Archives and Records Adminis- refluxing 95 percent ethanol.
tration (NARA). For information on (iii) Poly-1-butene resins may be used
the availability of this material at as articles or components of articles
NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food
www.archives.gov/federallregister/ during cooking, provided that the
codeloflfederallregulations/ thickness of such polymers in the form
ibrllocations.html. in which they contact food shall not
(iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and
have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not
and butene/ethylene copolymers have a more than 2.5 percent by weight of the
density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2
termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane.
(Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49
Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2,
Density-Gradient Technique,’’ which is 1985]
incorporated by reference. The avail-
ability of this incorporation by ref- § 177.1580 Polycarbonate resins.
erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely
this section. used as articles or components of arti-
(iv) Melt index. Poly-1-butene resins cles intended for use in producing,
have a melt index of 0.1 to 24 and the manufacturing, packing, processing,
butene/ethylene copolymers have a preparing, treating, packaging, trans-
melt index of 0.1 to 20 as determined by porting, or holding food, in accordance
ASTM method D1238–82, condition E, with the following prescribed condi-
‘‘Standard Test Method for Flow Rates tions:
of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly-
tometer,’’ which is incorporated by ref- esters produced by:
erence. The availability of this incor- (1) The condensation of 4,4′-iso-
poration by reference is given in para- propylidenediphenol and carbonyl chlo-
graph (b)(1)(ii) of this section. ride to which may have been added cer-
(2) Limitations. Poly-1-butene resins tain optional adjuvant substances re-
and butene/ethylene copolymers for use quired in the production of the resins;
in articles that contact food, and for or by
articles used for packing or holding (2) The reaction of molten 4,4′-iso-
food during cooking shall yield no propylidenediphenol with molten di-
more than the following extractables: phenyl carbonate in the presence of the
(i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro-
as articles or components of articles pylidenediphenol.
intended for use in contact with food, (3) The condensation of 4,4′-isopro-
provided that the maximum pylidenediphenol, carbonyl chloride,
extractables do not exceed 2.5 percent and 0.5 percent weight maximum of
by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to
molded samples are tested for 2 hours which may have been added certain op-
at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in
(ii) Butene/ethylene copolymers con- the production of branched
taining no more than 6 percent by polycarbonate resins.
weight of polymer units derived from (b) The optional adjuvant substances
ethylene may be used as articles or required in the production of resins

components of articles intended for produced by the methods described in
312
paragraph (a)(1) and (3) of this section in infant feeding bottles (baby bottles)
may include substances generally rec- and spill-proof cups, including their
ognized as safe in food, substances used closures and lids, designed to help train
in accordance with a prior sanction or babies and toddlers to drink from cups
approval, and the following: (sippy cups).
List of substances Limitations [42 FR 14572, Mar. 15, 1977, as amended at 46
FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6,
p-tert-Butylphenol .................. 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656,
Chloroform .............................
p-Cumylphenol (CAS Reg. For use only as a chain ter-
Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR
No. 599–64–4). minator at a level not to ex- 41902, July 17, 2012]
ceed 5 percent by weight
of the resin. § 177.1585 Polyestercarbonate resins.
Ethylene dichloride.
Heptane. Polyestercarbonate resins may be
Methylene chloride. safely used as articles or components
Monochlorobenzene .............. Not to exceed 500 p.p.m. as of articles intended for use in pro-
residual solvent in finished
resin. ducing, manufacturing, packing, proc-
Pentaerythritol tetrastearate For use only as a mold re- essing, preparing, treating, packaging,
(CAS Reg. No. 115–83–3). lease agent, at a level not or holding food, in accordance with the
to exceed 0.5 percent by
weight of the finished resin.
following prescribed conditions:
Phenol (CAS Reg. No. 108– (a) Polyestercarbonate resins (CAS
95–2). Reg. No. 71519–80–7) are produced by the
Pyridine.
Toluene: (CAS Reg. No. Not to exceed 800 parts per
condensation of 4,4′-
108–88–3). million as residual solvent isopropylidenediphenol, carbonyl chlo-
in finished resin. ride, terephthaloyl chloride, and
Triethylamine. isophthaloyl chloride such that the fin-
ished resins are composed of 45 to 85
(c) Polycarbonate resins shall con- molepercent ester, of which up to 55
form to the specification prescribed in mole-percent is the terephthaloyl iso-
paragraph (c)(1) of this section and mer. The resins are manufactured
shall meet the extractives limitations using a phthaloyl chloride/carbonyl
prescribed in paragraph (c)(2) of this chloride mole ratio of 0.81 to 5.7/1 and
section. isophthaloyl chloride/terephthaloyl
(1) Specification. Polycarbonate resins chloride mole ratio of 0.81/1 or greater.
can be identified by their char- The resins are also properly identified
acteristic infrared spectrum. by CAS Reg. No. 114096–64–9 when pro-
(2) Extractives limitations. The duced with the use of greater than 2
polycarbonate resins to be tested shall but not greater than 5 weight percent
be ground or cut into small particles p-cumylphenol (CAS Reg. No. 599–64–4),
that will pass through a U.S. standard as an optional adjuvant substance in
sieve No. 6 and that will be held on a accordance with paragraph (b)(2) of
U.S. standard sieve No. 10. this section.
(i) Polycarbonate resins, when ex- (b) Optional adjuvants. The optional
tracted with distilled water at reflux adjuvant substances required in the
temperature for 6 hours, shall yield production of resins identified in para-
total extractives not to exceed 0.15 per- graph (a) of this section may include:
cent by weight of the resins.
(1) Substances used in accordance
(ii) Polycarbonate resins, when ex-
with § 174.5 of this chapter.
tracted with 50 percent (by volume)
(2) Substances identified in
ethyl alcohol in distilled water at
§ 177.1580(b).
reflux temperature for 6 hours, shall
(3) Substances regulated in
yield total extractives not to exceed
§ 178.2010(b) of this chapter for use in
0.15 percent by weight of the resins.
polycarbonate resins complying with
(iii) Polycarbonate resins, when ex-
§ 177.1580:
tracted with n-heptane at reflux tem-
perature for 6 hours, shall yield total Provided, That the substances are used
extractives not to exceed 0.15 percent in accordance with any limitation on
by weight of the resins. concentration, conditions of use, and
(d) Polycarbonate resins may be used food types specified in § 178.2010(b) of

in accordance with this section except this chapter.
313
§ 177.1590 21 CFR Ch. I (4–1–21 Edition)
(c) Polyestercarbonate resins shall reflux temperature for 6 hours, shall

conform to the specifications pre- yield total nonvolatile extractives not
scribed in paragraph (c)(1) of this sec- to exceed 0.005 percent by weight of the
tion and shall meet the extractive lim- resins.
itations prescribed in paragraph (c)(2) (iii) Polyestercarbonate resins, when
of this section. extracted with n-heptane at reflux
(1) Specifications. Polyestercarbonate temperature for 6 hours, shall yield
resins identified in paragraph (a) of total nonvolatile extractives not to ex-
this section can be identified by their ceed 0.002 percent by weight of the res-
characteristic infrared spectrum. The ins.
resins shall comply with either or both (3) Residual methylene chloride levels in
of the following specifications: polyestercarbonate resins. Polyester-
(i) The solution intrinsic viscosity of carbonate resin articles in the finished
the polyestercarbonate resins shall be form shall not contain residual meth-
a minimum of 0.44 deciliter per gram, ylene chloride in excess of 5 parts per
as determined by a method entitled
million as determined by a method ti-
‘‘Intrinsic Viscosity (IV) of Lexan ®
tled ‘‘Analytical Method for Deter-
Polyestercarbonate Resin by a Single
mination of Residual Methylene Chlo-
Point Method Using Dichloromethane
ride in Polyestercarbonate Resin,’’ de-
as the Solvent,’’ developed by the Gen-
veloped by the General Electric Co.,
eral Electric Co., September 20, 1985,
which is incorporated by reference in July 23, 1991, which is incorporated by
accordance with 5 U.S.C. 552(a) and 1 reference in accordance with 5 U.S.C.
CFR part 51. Copies are available from 552(a) and 1 CFR part 51. Copies are
the Office of Food Additive Safety, available from the Center for Food
Center for Food Safety and Applied Nu- Safety and Applied Nutrition (HFS–
trition (HFS–215), Food and Drug Ad- 200), Food and Drug Administration,
ministration, 5001 Campus Dr., College 5001 Campus Dr., College Park, MD
Park, MD 20740, or may be examined at 20740, or may be examined at the Na-
the Food and Drug Administration’s tional Archives and Records Adminis-
Main Library, 10903 New Hampshire tration (NARA). For information on
Ave., Bldg. 2, Third Floor, Silver the availability of this material at
Spring, MD 20993, 301–796–2039, or at the NARA, call 202–741–6030, or go to: http://
National Archives and Records Admin- www.archives.gov/federallregister/
istration (NARA). For information on codeloflfederallregulations/
the availability of this material at ibrllocations.html.
NARA, call 202–741–6030, or go to: http:// [57 FR 3940, Feb. 3, 1992, as amended at 64 FR
www.archives.gov/federallregister/ 27178, May 19, 1999; 81 FR 5594, Feb. 3, 2015]
ibrllocations.html. § 177.1590 Polyester elastomers.
(ii) A minimum weight-average mo-
lecular weight of 27,000, as determined The polyester elastomers identified
by gel permeation chromatography in paragraph (a) of this section may be
using polystyrene standards. safely used as the food-contact surface
(2) Extractives limitations. The of articles intended for use in contact
polyestercarbonate resins to be tested with bulk quantities of dry food of the
shall be ground or cut into small par- type identified in § 176.170(c) of this
ticles that will pass through a U.S. chapter, table 1, under Type VIII, in ac-
standard sieve No. 6 and that will be cordance with the following prescribed
held on U.S. standard sieve No. 10. conditions:
(i) Polyestercarbonate resins, when (a) For the purpose of this section,
extracted with distilled water at reflux polyester elastomers are those pro-
temperature for 6 hours, shall yield duced by the ester exchange reaction
total nonvolatile extractives not to ex- when one or more of the following
ceed 0.005 percent by weight of the res- phthalates—dimethyl terephthalate,
ins. dimethyl orthophthalate, and dimethyl
(ii) Polyestercarbonate resins, when isophthalate—is made to react with
extracted with 50 percent (by volume) alpha-hydroomega-hydroxypoly

ethyl alcohol in distilled water at (oxytetramethylene) and/or 1,4-
314
butanediol such that the finished elas- this section may contain optional adju-
tomer has a number average molecular vant substances required in the produc-
weight between 20,000 and 30,000. tion of basic resins or finished food-
(b) Optional adjuvant substances em- contact articles. The optional adjuvant
ployed in the production of the poly- substances required in the production
ester elastomers or added thereto to of the basic polymer may include sub-
impart desired technical or physical stances permitted for such use by ap-
properties may include the following plicable regulations as set forth in part
substances: 174 of this chapter.
(c) Specifications and extractives limita-
List of substances Limitations tions—(1) Specifications. Polyetherimide
4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this
methyl-benzyl) oxidant. section shall have an intrinsic vis-
diphenylamine. cosity in chloroform at 25 °C (77 °F) of
Tetrabutyl titanate .................. For use only as a catalyst.
not less than 0.35 deciliter per gram as
determined by a method titled ‘‘In-
(c) An appropriate sample of the fin- trinsic Viscosity of ULTEM
ished polyester elastomer in the form Polyetherimide Using Chloroform as
in which it contacts food when sub- the Solvent,’’ which is incorporated by
jected to ASTM method D968–81, reference. Copies are available from
‘‘Standard Test Methods for Abrasion the Center for Food Safety and Applied
Resistance of Organic Coatings by the Nutrition (HFS–200), Food and Drug
Falling Abrasive Tester,’’ which is in- Administration, 5001 Campus Dr., Col-
corporated by reference (Copies may be lege Park, MD 20740, or available for in-
obtained from the American Society spection at the National Archives and
for Testing Materials, 100 Barr Harbor Records Administration (NARA). For
Dr., West Conshohocken, Philadelphia, information on the availability of this
PA 19428-2959, or may be examined at material at NARA, call 202–741–6030, or
the National Archives and Records Ad- go to: http://www.archives.gov/fed-
ministration (NARA). For information erallregister/
on the availability of this material at codeloflfederallregulations/
NARA, call 202–741–6030, or go to: http:// ibrllocations.html.
www.archives.gov/federallregister/ (2) Extractive limitations. Extractive
codeloflfederallregulations/ limitations are applicable to the basic
ibrllocations.html.), using No. 50 emery polyetherimide resin in the form of
abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi-
exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when
less than 100 liters per mil of thickness. extracted with distilled water at 121 °C
[42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola-
FR 10109, Mar. 19, 1984] tile extractives of not more than 12.3
micrograms per square centimeter.
§ 177.1595 Polyetherimide resin.
[50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept.
The polyetherimide resin identified 3, 1985]
in this section may be safely used as an
article or component of an article in- § 177.1600 Polyethylene resins,
tended for use in contact with food, carboxyl modified.
subject to the provisions of this sec- Carboxyl-modified polyethylene res-
tion. ins may be safely used as the food-con-
(a) Identity. For the purpose of this tact surface of articles intended for use
section, the polyetherimide resin is 1,3- in contact with food in accordance
isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi-
ethylidene)bis(4,1-phenyleneoxy)] bis- tions:
polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section,
Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins
the condensation reaction of m- consist of basic polymers produced
phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic
dianhydride. copolymers, containing no more than
(b) Optional adjuvants. The basic 25 weight percent of polymer units de-
polymer identified in paragraph (a) of rived from methyl acrylate, are made
315
§ 177.1610 21 CFR Ch. I (4–1–21 Edition)
to react in an aqueous medium with (Copies may be obtained from the

one or more of the following sub- American Society for Testing Mate-
stances: rials, 100 Barr Harbor Dr., West
Ammonium hydroxide. Conshohocken, Philadelphia, PA 19428-
Calcium carbonate. 2959, or may be examined at the Na-
Potassium hydroxide. tional Archives and Records Adminis-
Sodium hydroxide. tration (NARA). For information on
(b) The finished food-contact article, the availability of this material at
when extracted with the solvent or sol- NARA, call 202–741–6030, or go to: http://
vents characterizing the type of food www.archives.gov/federallregister/
and under the conditions of time and codeloflfederallregulations/
temperature characterizing the condi- ibrllocations.html.), and has a 7.0 per-
tions of its intended use as determined cent maximum extractable fraction in
from tables 1 and 2 of § 176.170(c) of this n-hexane at 50 °C, as determined by the
chapter, yields total extractives in method described in § 177.1520(d)(3)(ii).
each extracting solvent not to exceed (b) Chlorinated polyethylene may be
0.5 milligram per square inch of food- used in contact with all types of food,
contact surface as determined by the except that when used in contact with
methods described in § 176.170(d) of this fatty food of Types III, IV-A, V, VII-A,
chapter; and if the finished food-con- and IX described in table 1 of § 176.170(c)
tact article is itself the subject of a of this chapter, chlorinated poly-
regulation in parts 174, 175, 176, 177, 178, ethylene is limited to use only as a
and § 179.45 of this chapter, it shall also modifier admixed at levels not exceed-
comply with any specifications and ing 15 weight percent in plastic articles
limitations prescribed for it by that prepared from polyvinyl chloride and/
regulation. In testing the finished food- or from vinyl chloride copolymers com-
contact articles, a separate test sample plying with § 177.1980.
is to be used for each required extract-
ing solvent. FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29,
(c) The provisions of paragraph (b) of 1994]
this section are not applicable to
carboxyl-modified polyethylene resins § 177.1615 Polyethylene, fluorinated.
used in food-packaging adhesives com-
plying with § 175.105 of this chapter. Fluorinated polyethylene, identified
in paragraph (a) of this section, may be
§ 177.1610 Polyethylene, chlorinated. safely used as food-contact articles in
accordance with the following pre-
Chlorinated polyethylene identified
scribed conditions:
in this section may be safely used as
articles or components of articles that (a) Fluorinated polyethylene food-
contact food, except for articles used contact articles are produced by modi-
for packing or holding food during fying the surface of polyethylene arti-
cooking, subject to the provisions of cles through action of fluorine gas in
this section. combination with gaseous nitrogen as
(a) For the purpose of this section, an inert diluent. Such modification af-
chlorinated polyethylene consists of fects only the surface of the polymer,
basic polymers produced by the direct leaving the interior unchanged.
chlorination of polyethylene con- Fluorinated polyethylene articles are
forming to the density, maximum n- manufactured from basic resins con-
hexane extractable fraction, and max- taining not less than 85 weight-percent
imum xylene soluble fraction specifica- of polymer units derived from ethylene
tions prescribed under item 2.1 of the and identified in § 177.1520 (a)(2) and
table in § 177.1520(c). Such chlorinated (3)(i).
polyethylene contains a maximum of 60 (b) Fluorinated polyethylene articles
percent by weight of total chlorine, as conform to the specifications and use
determined by ASTM 1method D1303–55 limitations of § 177.1520(c), items 2.1 and
(Reapproved 1979), ‘‘Standard Test 3.1.
Method for Total Chlorine in Vinyl (c) The finished food-contact article,
Chloride Polymers and Copolymers,’’ when extracted with the solvent or sol-
which is incorporated by reference vents characterizing the type of food
316
and under conditions of time and tem- used as provided in §§ 175.105 and 176.210
perature characterizing the conditions of this chapter, and § 177.2800. The pro-
of its intended use as determined from visions of paragraph (b) of this section
tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly-
ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125
parts per million calculated on the and 176.170(a)(5) of this chapter and
basis of the volume of food held by the § 177.1200.
§ 177.1630 Polyethylene phthalate
[48 FR 39057, Aug. 29, 1983] polymers.
§ 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers
Oxidized polyethylene identified in identified in this section may be safely
paragraph (a) of this section may be used as, or components of plastics
safely used as a component of food-con- (films, articles, or fabric) intended for
tact articles, in accordance with the use in contact with food in accordance
following prescribed conditions: with the following prescribed condi-
(a) Oxidized polyethylene is the basic tions:
resin produced by the mild air oxida- (a) Polyethylene phthalate films con-
tion of polyethylene conforming to the sist of a base sheet of ethylene
density, maximum n-hexane extract- terephthalate polymer, ethylene
able fraction, and maximum xylene terephthalate-isophthalate copolymer,
soluble fraction specifications pre- or ethylene-1,4-cyclohexylene
scribed under item 2.3 of the table in dimethylene terephthalate copoly-
§ 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to
has a minimum number average molec- which have been added optional sub-
ular weight of 1,200, as determined by stances, either as constituents of the
high temperature vapor pressure os- base sheet or as constituents of coat-
mometry, contains a maximum of 5 ings applied to the base sheet.
percent by weight of total oxygen, and (b) Polyethylene phthalate articles
has an acid value of 9 to 19. consist of a base polymer of ethylene
(b) The finished food-contact article, terephthalate polymer, or ethylene-1,4-
when extracted with the solvent or sol- cyclohexylene dimethylene
vents characterizing the type of food terephthalate copolyesters described in
and under the conditions of time and § 177.1315(b)(3), to which have been
temperature characterizing the condi- added optional substances, either as
tions of its intended use as determined constituents of the base polymer or as
from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the
chapter, yields net acidified chloro- base polymer.
form-soluble extractives not to exceed (c)(1) Polyethylene phthalate
0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of
contact surface when tested by the continuous filaments of ethylene
methods described in § 177.1330(c), ex- terephthalate polymer and ethylene
cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer
ble extractives from paper and paper- to which may have been added optional
board complying with § 176.170 of this adjuvant substances required in their
chapter may be corrected for wax, pet- preparation and finishing.
rolatum, and mineral oil as provided in (2) The ethylene terephthalate-
§ 176.170(d)(5)(iii)(b) of this chapter. If isophthalate copolymer component of
the finished food-contact article is the fabric shall not exceed 25 percent
itself the subject of a regulation in by weight. The filaments may be blend-
parts 174, 175, 176, 177, 178 and § 179.45 of ed with other fibers regulated for the
this chapter, it shall also comply with specific use and the spunbonded fabric
any specifications and limitations pre- may be further bonded by application
scribed for it by such regulations. of heat and/or pressure.
(NOTE: In testing the finished food-con- (3) The fabric shall be used only in
tact article, use a separate test sample accordance with paragraph (i) of this
for each extracting solvent.) section.
(c) The provisions of this section are (d) The quantity of any optional sub-
not applicable to oxidized polyethylene stance employed in the production of
317
§ 177.1630 21 CFR Ch. I (4–1–21 Edition)
polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene

not exceed the amount reasonably re- terephthalate copolyesters described in
quired to accomplish the intended § 177.1315(b)(3).
Ethylene terephthalate polymer: Prepared
physical or technical effect or any lim- by the condensation of dimethyl
itations further provided. Any sub- terephthalate and ethylene glycol.
stance employed in the production of Ethylene terephthalate polymer: Prepared
polyethylene phthalate plastics that is by the condensation of terephthalic acid
the subject of a regulation in parts 174, and ethylene glycol.
175, 176, 177, 178 and 179 of this chapter (iii) Coatings:
conforms with any specification in Acrylic copolymers (CAS Reg. No. 30394–86–
such regulation. 6): Prepared by reaction of ethyl acrylate
(e) Substances employed in the pro- (CAS Reg. No. 140–88–5), methyl methacry-
duction of polyethylene phthalate plas- late (CAS Reg. No. 80–62–6), and
tics include: methacrylamide (CAS Reg. No. 79–39–0)
(1) Substances generally recognized blended with melamine-formaldehyde resin
as safe in food. (CAS Reg. No. 68002–20–0). For use in coat-
(2) Substances subject to prior sanc- ings for polyethylene phthalate films com-
tion or approval for use in poly- plying with paragraph (a) of this section.—
Ethylene azelate-terephthalate copolymer:
ethylene phthalate plastics and used in The copolymer, dissolved in 1,1,2-trichloro-
accordance with such sanction or ap- ethane and/or methylene chloride, may be
proval. used as a heat-activated sealant on poly-
(3) Substances which by regulation in ethylene terephthalate film intended for
parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch-
this chapter may be safely used as es that are used as containers of either
components of resinous or polymeric nonalcoholic beverages or alcoholic bev-
food-contact surfaces subject to the erages containing not more than 15 percent
provisions of such regulation. ethyl alcohol. The copolymer has a
terephthalate/azelate molecular ratio of
(4) Substances identified in this para-
1.25/1.00 and a relative viscosity of not less
graph (e)(4) subject to the limitations than 1.5 as determined by a method title
prescribed: ‘‘General Procedure of Determining the
Relative Viscosity of Resin Polymers,’’
LIST OF SUBSTANCES AND LIMITATIONS which is incorporated by reference. Copies
(i) Base sheet: are available from the Center for Food
Safety and Applied Nutrition (HFS–200),
Ethylene terephthalate copolymers: Pre-
Food and Drug Administration, 5001 Cam-
pared by the condensation of dimethyl
pus Dr., College Park, MD 20740, or avail-
terephthalate or terephthalic acid with
able for inspection, at the National Ar-
ethylene glycol, modified with one or more
chives and Records Administration
of the following: Azelaic acid, dimethyl
(NARA). For information on the avail-
azelate, dimethyl sebacate, sebacic acid.
Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202–
pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/
terephthalate or terephthalic acid with federallregister/
ethylene glycol, modified with one or more codeloflfederallregulations/
of the following: Azelaic acid, dimethyl ibrllocations.html. Total residual copoly-
azelate, dimethyl sebacate, sebacic acid, mer solvent (1,1,2-trichloroethane and/or
pyromellitic dianhydride. The level of methylene chloride) shall not exceed 0.13
pyromellitic dianhydride shall not exceed milligram per square inch of film, and food
0.5 percent by weight of the finished co- contact of the film shall be limited to not
polymer which may be used under condi- more than 1 square inch per 250 grams of
tions of use E through H as described in beverage.
table 2 of § 176.170(c) of this chapter. 2-Ethylhexyl acrylate copolymerized with
Ethylene terephthalate-isophthalate copoly- one or more of the following:
mers: Prepared by the condensation of Acrylonitrile.
dimethyl terephthalate or terephthalic Methacrylonitrile.
acid and dimethyl isophthalate or iso- Methyl acrylate.
phthalic acid with ethylene glycol. The Methyl methacrylate.
finished copolymers contain either: Itaconic acid.
(a) 77 to 83 weight percent or Vinylidene chloride copolymerized with one
(b) At least 97 weight percent of polymer or more of the following:
units derived from ethylene Methacrylic acid and its methyl, ethyl,
terephthalate. propyl, butyl, or octyl esters.

Acrylic acid and its methyl, ethyl, propyl,
(ii) Base sheet and base polymer: butyl, or octyl esters.
318
Acrylonitrile. formation on the availability of this ma-
Methacrylonitrile. terial at NARA, call 202–741–6030, or go
Vinyl chloride. to: http://www.archives.gov/fed-
Itaconic acid. erallregister/
Styrene-maleic anhydride resin, partial 2- codeloflfederallregulations/
butoxyethyl ester, ammonium salt (CAS ibrllocations.html.
Reg. No. 68890–80–2). For use only as a coat- The modifier is used at a level not to ex-
ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene
plying with paragraph (a) of this section, terephthalate film. The average thick-
at levels not to exceed 0.025 gram per ness of the finished film shall not exceed
square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch).
inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3-
types VIII and IX in table 1 of § 176.170(c) of benzenedimethanamine (CAS Reg. No.
this chapter, under use conditions E, F, 25718–70–1) meeting the specifications in
and G in table 2 of § 176.170(c) of this chap- § 177.1500(b), item 10, when tested by the
ter. methods given in § 177.1500(c). The modi-
fier is used in polyethylene terephthalate
(iv) Emulsifiers: at a level not to exceed 30 percent by
Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene
juvant in the application of coatings to the terephthalate.
base sheet or base polymer. Chloroform-soluble extractives shall not
Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5
application of coatings to the base sheet or milligram/inch2) of food-contact surface
base polymer. of the modified polyethylene
2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to
Reg. No. 1804–87–1). For use only in copoly- the following solvents at temperatures
mer coatings on polyethylene phthalate and times indicated:
film under conditions of use E, F, and G de- (a) Distilled water at 49 °C (120 °F) for 24
scribed in table 2 of § 175.300(d) of this chap- hours;
ter, and limited to use at a level not to ex- (b) n-Heptane at 49 °C (120 °F) for 24 hours;
ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 °C (120 °F)
polymer coating. for 24 hours.
For use in contact with all types of foods
(v) Modifier: except (a) those containing more than 8
1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera-
polymer with 1,4-butanediol and a-hydro- tures over 49 °C (120 °F).
omega-hydroxypoly(oxy-1,4-butanediyl)
CAS Reg. No. 9078–71–1) meeting the fol- (f) Polyethylene phthalate plastics
lowing specifications: conforming with the specifications pre-
Melting point: 200° to 215 °C as determined scribed in paragraph (f)(1) of this sec-
by ASTM method D2117–82, ‘‘Standard tion are used as provided in paragraph
Test Method for Melting Point of (f)(2) of this section:
Semicrystalline Polymers by the Hot
(1) Specifications. (i) The food contact
Stage Microscopy Method,’’ which is in-
corporated by reference. Copies may be surface, when exposed to distilled
obtained from the American Society for water at 250 °F for 2 hours, yields chlo-
Testing Materials, 100 Barr Harbor Dr., roform-soluble extractives not to ex-
West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface
19428-2959, or may be examined at the Na- exposed to the solvent; and
tional Archives and Records Administra- (ii) The food contact surface, when
tion (NARA). For information on the exposed to n-heptane at 150 °F for 2
availability of this material at NARA, hours, yields chloroform-soluble ex-
call 202–741–6030, or go to: http://
tractives not to exceed 0.5 mg/in2 of
codeloflfederallregulations/ food contact surface exposed to the sol-
ibrllocations.html. vent.
Density: 1.15 to 1.20 as determined by ASTM (2) Conditions of use. The plastics are
method D1505–68 (Reapproved 1979), used for packaging, transporting, or
‘‘Standard Test Method for Density of holding food, excluding alcoholic bev-
Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed
nique,’’ which is incorporated by ref- 250 °F.
erence. Copies may be obtained from the
(g) Polyethylene phthalate plastics
American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken, conforming with the specifications pre-
scribed in paragraph (g)(1) of this sec-
Philadelphia, PA 19428-2959, or may be

examined at the National Archives and tion are used as provided in paragraph
Records Administration (NARA). For in- (g)(2) of this section.
319
§ 177.1632 21 CFR Ch. I (4–1–21 Edition)
(1) Specifications. (i) The food contact including filtration, at temperatures

surface meets the specifications in not exceeding 212 °F.
paragraph (f)(1) of this section; and (iii) Filtration of bulk alcoholic bev-
(ii) The food contact surface when ex- erages, not exceeding 50 percent alco-
posed to 50 percent ethyl alcohol at 120 hol by volume, at temperatures not ex-
°F for 24 hours, yields chloroform-solu- ceeding 120 °F.
ble extractives not to exceed 0.5 mg/in2 (j) Polyethylene phthalate plastics,
of food contact surface exposed to the composed of ethylene terephthalate-
solvent. isophthalate containing a minimum of
(2) Conditions of use. The plastics are 98 weight percent of polymer units de-
used for packaging, transporting, or rived from ethylene terephthalate, or
holding alcoholic beverages that do not ethylene-1,4-cyclohexylene
exceed 50 percent alcohol by volume. dimethylene terephthalate copoly-
(h) Uncoated polyethylene phthalate esters described in § 177.1315(b)(3), con-
plastics consisting of a base sheet or forming with the specifications pre-
base polymer prepared as prescribed scribed in paragraph (j)(1) of this sec-
from substances identified in para- tion, are used as provided in paragraph
graphs (e)(4)(i) and (ii) of this section (j)(2) of this section.
and conforming with the specifications (1) Specifications. (i) The food contact
prescribed in paragraph (h)(1) of this surface meets the specifications in
section are used as provided in para- paragraph (f)(1) of this section and
graph (h)(2) of this section: (ii)(a) Containers with greater than 500
(1) Specifications. (i) The food contact mL capacity. The food-contact surface
surface, when exposed to distilled when exposed to 95 percent ethanol at
water at 250 °F for 2 hours yields chlo- 120 °F for 24 hours should not yield
roform-soluble extractives not to ex- chloroform-soluble extractives in ex-
ceed 0.02 milligram/inch 2 of food con- cess of 0.005 mg/in 2.
tact surface exposed to the solvent; and (b) Containers with less than or equal to
(ii) The food contact surface, when 500 mL capacity. The food contact sur-
exposed to n-heptane at 150 °F for 2 face when exposed to 95 percent eth-
hours, yields chloroform-soluble ex- anol at 120 °F for 24 hours should not
tractives not to exceed 0.02 milligram/ yield chloroform-soluble extractives in
inch 2 of food contact surface exposed excess of 0.05 mg/in 2.
to the solvent. (2) Conditions of use. The plastics are
(2) Conditions of use. The plastics are used for packaging, transporting, or
used to contain foods during oven bak- holding alcoholic foods that do not ex-
ing or oven cooking at temperatures ceed 95 percent alcohol by volume.
above 250 °F.
(i) Polyethylene phthalate fabric, [42 FR 14572, Mar. 15, 1977, as amended at 42
identified in paragraph (c) of this sec- FR 18611, Apr. 8, 1977; 44 FR 40886, July 13,
tion and conforming with the specifica- 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844,
Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR
tions prescribed in paragraph (i)(1) of
30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984;
this section, is used only as provided in 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30,
paragraph (i)(2) of this section. 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750,
(1) Specifications. Chloroform-soluble Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR
extractives shall not exceed 0.2 milli- 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995;
gram/inch 2 of food-contact surface 61 FR 46718, Sept. 5, 1996]
when exposed to the following solvents
at temperatures and times indicated: § 177.1632
(i) Distilled water at 212 °F for 2 Poly(phenyleneterephthalamide)
resins.
hours.
(ii) n-Heptane at 150 °F for 2 hours. Poly(phenyleneterephthalamide) res-
(iii) 50 percent ethyl alcohol at 120 °F ins identified in paragraph (a) of this
for 24 hours. section may be safely used as articles
(2) Conditions of use. The plastics are or components of articles intended for
intended for: repeated contact with food.
(i) Dry food contact. (a) Identity. For the purpose of this
(ii) Bulk food (excluding alcoholic section, the poly(phenylene-

beverages) repeated use applications, terephthalamide) resins (CAS Reg. No.
320
26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water

erization of terephthalolyl chloride mixture for 24 hours, yields total
with p-phenylenediamine. The extractables not exceeding 0.65 percent
poly(phenyleneterephthalamide) resin by weight of the sample.
fibers and yarns may contain optional (d) Conditions of use. (1)
adjuvant substances required in their Poly(phenyleneterephthalamide) resins
preparation and finishing. in the form of continuous filament
(b) Optional adjuvant substances. The yarns and fibers may be used as compo-
poly(phenyleneterephthalamide) resins nents of articles intended for repeated
identified in paragraph (a) of this sec- use in contact with food at tempera-
tion may contain the following op- tures not to exceed 260 °C (500 °F). All
tional adjuvant substances, subject to items are scoured prior to use by agita-
any limitation on their use: tion in a water bath containing 0.5
(1) Optional adjuvant substances au- gram/liter of tetrasodium
thorized for this use in accordance with pyrophosphate and 0.5 percent deter-
§ 174.5 of this chapter. gent. The items are agitated at 80 °C
(2) Optional finish components, total (180 °F) for 20 minutes, and then sub-
weight not to exceed 1 percent by jected to a cold water rinse.
weight of the base polymer, as follows: (2) Poly(phenyleneterephthalamide)
resins in the form of pulp may be used
as gaskets and packing for food proc-
Diundecylphthalate (CAS essing equipment at temperatures not
Reg. No. 3648–20–2). to exceed 260 °C (500 °F).
Mono- and dipotassium salts
of lauryl phosphate (CAS [57 FR 3125, Jan. 28, 1992, as amended at 69
Reg. No. 39322–78–6). FR 24512, May 4, 2004]
o-Phenylphenol (CAS Reg. For use as a fungicide for fin-
No. 90–43–7). ish coating materials. Not
to exceed 0.01 percent by
§ 177.1635 Poly(p-methylstyrene) and
weight of the base poly- rubber-modified poly(p-methyl-
mer. styrene).
Poly(oxyethylene/
oxypropylen-
Poly(p-methylstyrene) and rubber-
e)monobutylether (CAS modified poly(p-methylstyrene) identi-
Reg. No. 9038–95–3). fied in this section may be safely used
Poly(oxyethylene) as components of articles intended for
mono(nonylphenyl)ether
(CAS Reg. No. 9016–45– use in contact with food, subject to the
9). provisions of this section:
Polyvinyl methylether (CAS (a) Identity. For the purposes of this
Reg. No. 9003–09–2).
Poly(oxyethylene) sorbitol
section, poly(p-methylstyrene) and
monolaurate tetraoleate rubber-modified poly(p-methylstyrene)
(CAS Reg. No. 71243–28– are basic polymers, manufactured as
2). described in this paragraph, meeting
Poly(oxyethylene) sorbitol
hexaoleate (CAS Reg. No. the specifications prescribed in para-
57171–56–9). graph (c) of this section.
4,4′-Butylidenebis (6-tert- For use only as an oxidation (1) Poly(p-methylstyrene) (CAS Reg.
butyl-m-cresol) (CAS Reg. inhibitor for finish coating No. 24936–41–2) polymer produced by the
No. 85–60–9). materials. Not to exceed
0.01 percent by weight of polymerization of p-methylstyrene.
the base polymer. (2) Rubber-modified poly(p-
methylstyrene) (CAS Reg. No. 33520–88–
(c) Specifications. (1) 6) polymer produced by combining sty-
Poly(phenyleneterephthalamide) resins rene-butadiene copolymer and/or
in the form of continuous filament polybutadiene with poly(p-
yarns or fibers that have been scoured methylstyrene), either during or after
in accordance with paragraph (d)(1) of polymerization of the poly(p-
this section, when refluxed in a 50 per- methylstyrene), such that the finished
cent ethanol/water mixture for 24 polymers contain not less than 75
hours, yields total extractables not ex- weight percent of total polymer units
ceeding 0.5 percent by weight of the derived from p-methylstyrene) mon-
sample. omer.
(2) Poly(phenyleneterephthalamide) (b) Optional adjuvants. The basic

resins in the form of pulp, when polymers identified in paragraph (a) of
321
§ 177.1637 21 CFR Ch. I (4–1–21 Edition)
this section may contain optional adju- (a)(1) and (a)(2), respectively, of this
vant substances required in the produc- section shall be used in contact with
tion of such basic polymers. Such op- food only under conditions of use B
tional adjuvant substances may in- through H set forth in table 2 of
clude substances permitted for such § 176.170(c) of this chapter.
use by applicable regulations in this [48 FR 31384, July 8, 1983, as amended at 54
chapter, substances generally recog- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26,
nized as safe in food, substances gen- 1990]
erally recognized as safe in indirect ad-
ditives, and substances used in accord- § 177.1637 Poly(oxy-1,2-
ance with prior sanction or approval. ethanediyloxycarbonyl-2,6-
(c) Specifications. (1) Poly(p- naphthalenediylcarbonyl) resins.
methylstyrene) basic polymers identi- Poly(oxy-1,2-ethanediyloxycarbonyl-
fied in paragraph (a)(1) of this section 2,6-naphthalenediylcarbonyl) resins
shall contain not more than 1 weight identified in paragraph (a) of this sec-
percent of total residual p- tion may be safely used as articles or
methystyrene monomer, as determined components of articles intended for use
by a gas chromatographic method ti- in contact with food in accordance
tled, ‘‘Gas Chromatographic Deter- with the following conditions:
mination of PMS and PET in PPMS (a) Identity. For the purpose of this
Basic Polymers,’’ which is incorporated section, poly(oxy-1,2-
by reference. Copies are available from ethanediyloxycarbonyl-2,6-
the Center for Food Safety and Applied naphthalenediylcarbonyl) resins (CAS
Nutrition (HFS–200), Food and Drug Reg. No. 24968–11–4) are polymers
Administration, 5001 Campus Dr., Col- formed by catalytic transesterification
lege Park, MD 20740, or available for in- of 2,6-dimethylnaphthalene
spection at the National Archives and dicarboxylate with ethylene glycol fol-
Records Administration (NARA). For lowed by catalytic polycondensation.
information on the availability of this (b) Specifications—(1) Density. The
material at NARA, call 202–741–6030, or density of poly(oxy-1,2-
go to: http://www.archives.gov/fed- ethanediyloxycarbonyl-2,6-
erallregister/ naphthalenediylcarbonyl) resins shall
codeloflfederallregulations/ be between 1.33 and 1.40 grams per
ibrllocations.html. cubic centimeter.
(2) Rubber-modified poly(p- (2) Inherent viscosity. The finished
methylstyrene) basic polymers identi- food-contact article shall have a min-
fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci-
shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram
percent of total residual p- of polymer in 100 milliliters of a 25/40/
methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p-
mined by the method identified in chlorophenol/tetrachloroethane/phenol.
paragraph (c)(1) of this section The viscosity is determined by East-
(d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC-
The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So-
modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated
fied in and complying with this sec- May 31, 1988, which is incorporated by
tion, when used as components of the reference in accordance with 5 U.S.C.
food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are
is the subject of a regulation in parts available from the Office of Food Addi-
175, 176, 177, 178 and § 179.45 of this chap- tive Safety (HFS–200), Center for Food
ter, shall comply with any specifica- Safety and Applied Nutrition, Food and
tions and limitations prescribed by Drug Administration, 5001 Campus Dr.,
such regulation for the article in the College Park, MD 20740, 240–402–1200, or
finished form in which it is to contact may be examined at the Food and Drug
food. Administration’s Main Library, 10903
(e) Conditions of use. Poly(p- New Hampshire Ave., Bldg. 2, Third
methylstyrene) basic polymers and Floor, Silver Spring, MD 20993, 301–796–
rubber-modified poly(p-methylstyrene) 2039, or at the National Archives and

basic polymers identified in paragraphs Records Administration (NARA). For
322
information on the availability of this the finished basic polymers contain not
material at NARA, call 202–741–6030, or less than 75 weight percent of total
go to: http://www.archives.gov/fed- polymer units derived from styrene
erallregister/ monomer.
codeloflfederallregulations/ (b) Optional adjuvants. The basic
ibrllocations.html. polymers identified in paragraph (a) of
(c) Extraction limitations. A 0.5 milli- this section may contain optional adju-
meter (0.02 inch) thick sheet of resin vant substances required in the produc-
when extracted with water at 121 °C tion of such basic polymers. Such op-
(250 °F) for 2 hours shall yield total tional adjuvant substances may in-
nonvolatile extractives not exceeding clude substances permitted for such
2.0 micrograms per square inch of ex- use by regulations in parts 170 through
posed resin surface. 189 of this chapter, substances gen-
(d) Conditions of use. The finished erally recognized as safe in food, and
food contact article shall be: substances used in accordance with a
(1) Used in contact only with food of prior sanction or approval.
Types I, II, IVB, VIA, VIB, VIIB, and
(c) Specifications. (1) Polystyrene
VIII identified in table 1 of § 176.170(c)
basic polymers identified in paragraph
of this chapter, under conditions of use
(a)(1) of this section shall contain not
A through H described in table 2 of
more than 1 weight percent of total re-
§ 176.170(c) of this chapter; and with
food of Types III, IVA, V, VIC, VIIA, sidual styrene monomer, as determined
and IX identified in table 1 of by the method described in paragraph
§ 176.170(c) of this chapter, under condi- (d) of this section, except that when
tions of use C through H described in used in contact with fatty foods of
table 2 of § 176.170(c) of this chapter; Types III, IV-A, V, VII-A, and IX de-
and scribed in table 1 of § 176.170(c) of this
(2) Identified in a manner that will chapter, such polystyrene basic poly-
differentiate the article from articles mers shall contain not more than 0.5
made of other polymeric resins to fa- weight percent of total residual sty-
cilitate collection and sorting. rene monomer.
(2) Rubber-modified polystyrene
[61 FR 14965, Apr. 4, 1996, as amended at 78 basic polymers identified in paragraph
FR 14666, Mar. 7, 2013; 81 FR 5594, Feb. 3, 2016]
(a)(2) of this section shall contain not
§ 177.1640 Polystyrene and rubber- more than 0.5 weight percent of total
modified polystyrene. residual styrene monomer, as deter-
Polystyrene and rubber-modified pol- mined by the method described in para-
ystyrene identified in this section may graph (d) of this section.
be safely used as components of arti- (d) Analytical method for determination
cles intended for use in contact with of total residual styrene monomer con-
food, subject to the provisions of this tent—(1) Scope. This method is suitable
section. for the determination of residual sty-
(a) Identity. For the purposes of this rene monomer in all types of styrene
section, polystyrene and rubber-modi- polymers.
fied polystyrene are basic polymers (2) Principle. The sample is dissolved
manufactured as described in this para- in methylene chloride. An aliquot of
graph so as to meet the specifications the solution is injected into a gas chro-
prescribed in paragraph (c) of this sec- matograph. The amount of styrene
tion when tested by the method de- monomer present is determined from
scribed in paragraph (d) of this section. the area of the resulting peak.
(1) Polystyrene consists of basic poly- (3) Apparatus—(i) Gas chromatograph.
mers produced by the polymerization Beckman GC-2A gas chromatograph
of styrene. with hydrogen flame detector or appa-
(2) Rubber-modified polystyrene con- ratus of equivalent sensitivity.
sists of basic polymers produced by (ii) Chromatograph column. One-quar-
combining styrene-butadiene copoly- ter inch outside diameter stainless
mers and/or polybutadiene with poly- steel tubing (0.028 inch wall thickness),
styrene, either during or after polym- 4 feet in length, packed with 20 percent
erization of the polystyrene, such that polyethylene glycol (20,000 molecular
323
§ 177.1650 21 CFR Ch. I (4–1–21 Edition)
weight) on alkaline treated 60–80 mesh polystyrene identified in and com-

firebrick. plying with this section, when used as
(iii) Recorder. Millivolt range of 0–1, components of the food-contact surface
chart speed of 30 inches per hour. of any article that is the subject of a
(4) Reagents. Compressed air, purified; regulation in parts 174, 175, 176, 177, 178
helium gas; hydrogen gas; methylene and § 179.45 of this chapter, shall com-
chloride, redistilled; and styrene mon- ply with any specifications and limita-
omer, redistilled. tions prescribed by such regulation for
(5) Operating conditions for the gas the article in the finished form in
chromatograph. (i) The column is oper- which it is to contact food.
ated at a temperature of 100 °C with a (f) Nonapplicability. The provisions of
helium flow rate of 82 milliliters per this section are not applicable to poly-
minute. styrene and rubber-modified poly-
(ii) The hydrogen burner is operated styrene used in food-packaging adhe-
with 15 pounds per square inch of air sives complying with § 175.105 of this
pressure and 7 pounds per square inch chapter.
of hydrogen pressure.
(iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer-
flame detector is set at 2 × 102. polyepoxy resins.
(6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res-
standard solution by weighing accu- ins may be safely used as the food-con-
rately 15 to 20 milligrams of styrene tact surface of articles intended for
monomer into a 2-ounce bottle con- packaging, transporting, holding, or
taining 25.0 milliliters of methylene otherwise contacting dry food, in ac-
chloride. Cap the bottle tightly and cordance with the following prescribed
shake to thoroughly mix the solution. conditions:
(ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy
inject 1 microliter of the standard solu- resins are the reaction products of liq-
tion into the gas chromatograph. Meas- uid polysulfide polymers and
ure the area of the styrene monomer polyfunctional epoxide resins, cured
peak which emerges after approxi- with the aid of
mately 12 minutes. tri(dimethylaminomethyl) phenol, to
(7) Procedure. (i) Transfer 1 gram of which have been added certain optional
sample (accurately weighed to the substances to impart desired techno-
nearest 0.001 gram to a 2-ounce bottle logical properties to the resins. Subject
and add several glass beads. Pipette to any limitations prescribed in this
25.0 milliliters of methylene chloride section, the optional substances may
into the bottle. Cap the bottle tightly include:
and place on a mechanical shaker. (1) Substances generally recognized
Shake until the polymer is completely as safe in food and food packaging.
dissolved. If any insoluble residue re- (2) Substances the use of which is
mains, allow the bottle to stand (or permitted under applicable regulations
centrifuge at a low speed) until a clear in this part, prior sanctions, or approv-
supernatant layer appears. als.
(ii) By means of a microliter syringe, (3) Substances named in this subpara-
inject 3 microliters of the clear super- graph and further identified as re-
natant liquid into the gas chro- quired:
matograph.
(iii) Measure the area of the resulting List of substances Limitations
styrene monomer peak. Compare the Bis(2-chloroethyl) formal.
sample peak area with the area pro- Bis(dichloropropyl) formal .................. Cross-linking agent.
duced by the standard styrene mon- Butyl alcohol ...................................... Solvent.
Carbon black (channel process).
omer solution. Calculation: Chlorinated paraffins ......................... Cross-linking agent.
Percent residual styrene monomer = Milli- Epoxidized linseed oil.
Epoxidized soybean oil.
grams monomer in standard × peak area of Epoxy resins (as listed in
sample / Peak area of monomer standard × § 175.300(b)(3)(viii)(a) of this chap-
sample weight in grams × 30 ter)..
Ethylene glycol monobutyl ether ....... Solvent.

(e) Other specifications and limitations. Magnesium chloride.
The polystyrene and rubber-modified Methyl isobutyl ketone ....................... Solvent.
324
List of substances Limitations in such a way that the finished resins

have a minimum number average mo-
Naphthalene sulfonic acid-formalde-
hyde condensate, sodium salt. lecular weight of 15,000, as determined
Sodium dibutyl naphthalene Wetting agent. by osmotic pressure in
sulfonate. monochlorobenzene; or
Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene]
Sodium polysulfide.
b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. polymer with 4,4′-(1-
ether. methylethylidene)bis[phenol] (min-
Titanium dioxide. imum 92 percent) and 4,4′-
Toluene .............................................. Solvent.
Trichloroethane .................................. Cross-linking agent.
sulfonylbis[phenol] (maximum 8 per-
1,2,3-Trichloropropane ...................... Do. cent) (CAS Reg. No. 88285–91–0) pro-
Urea-formaldehyde resins. duced when a mixture of 4,4′-
Xylene ................................................ Solvent. isopropylidenediphenol (minimum 92
percent) and 4,4′-sulfonylbis[phenol]
(b) The resins are used as the food- (maximum 8 percent) is made to react
contact surface for dry food. with 4,4′-dichlorodiphenyl sulfone in
(c) An appropriate sample of the fin- such a way that the finished resin has
ished resin in the form in which it con- a minimum number average molecular
tacts food, when subjected to ASTM weight of 26,000, as determined by os-
method D968–81, ‘‘Standard Test Meth- motic pressure in dimethylformamide.
ods for Abrasion Resistance of Organic (b) The basic polysulfone resins iden-
Coatings by the Falling Abrasive Test- tified in paragraph (a) of this section
er,’’ which is incorporated by reference may contain optional adjuvant sub-
(Copies may be obtained from the stances required in the production of
American Society for Testing Mate- such basic resins. The optional adju-
rials, 100 Barr Harbor Dr., West vant substances required in the produc-
Conshohocken, Philadelphia, PA 19428- tion of the basic polysulfone resins
2959, or may be examined at the Na- may include substances described in
tional Archives and Records Adminis- § 174.5(d) of this chapter and the fol-
tration (NARA). For information on lowing:
the availability of this material at
NARA, call 202–741–6030, or go to: http:// List of substances Limitations
www.archives.gov/federallregister/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as
codeloflfederallregulations/ residual solvent in finished basic
ibrllocations.html.), using No. 50 Emery resin in paragraph (a)(1) of this
section.
abrasive in lieu of Ottawa sand, shall Monochlorobenzene .. Not to exceed 500 parts per million
exhibit and abrasion coefficient of not as residual solvent in finished
less than 20 liters per mil of film thick- basic resin in paragraph (a)(1) of
this section.
ness. N-methyl-2- Not to exceed 0.01 percent (100
pyrrolidone. parts per million) as residual sol-
vent in finished basic resin in para-
FR 10110, Mar. 19, 1984] graph (a)(2) of this section.
§ 177.1655 Polysulfone resins. (c) Polysulfone resins, when ex-

Polysulfone resins identified in para- tracted at reflux temperatures for 6
graph (a) of this section may be safely hours with the solvents—distilled
used as articles or components of arti- water, 50 percent (by volume) ethyl al-
cles intended for use in contact with cohol in distilled water, 3 percent ace-
food, in accordance with the following tic acid in distilled water, and n-
prescribed conditions: heptane, yield total extractives in each
(a) For the purpose of this section, extracting solvent not to exceed 0.0078
polysulfone resins are: milligram per square centimeter (0.05
(1) Poly(oxy-p-phenylenesulfonyl-p- milligram per square inch) of resin sur-
phenyleneoxy-p- face. Note: In testing the finished
phenyleneisopropylidene-p-phenylene) polysulfone resins, use a separate resin
resins (CAS Reg. No. 25154–01–2) con- test sample for each required extract-
sisting of basic resins produced when ing solvent.
the disodium salt of 4,4′- (d) Polysulfone resins intended for re-
isopropylidenediphenol is made to peated use in contact with food may be

react with 4,4′-dichlorodiphenyl sulfone used under conditions of use A through
325
§ 177.1660 21 CFR Ch. I (4–1–21 Edition)
H in table 2 of § 176.170(c) of this chap- (2) Poly(tetramethylene

ter. The resins intended for single-serv- terephthalate) in the finished form in
ice food-contact use may be used only which it is to contact food shall yield
under condition of use H described in total extractives as follows:
table 2 of § 176.170(c) of this chapter. (i) Not to exceed 0.08 milligram per
square inch of food contact surface
[51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F
1986; 61 FR 29475, June 11, 1996]
with distilled water.
(ii) Not to exceed 0.02 milligram per
§ 177.1660 Poly (tetramethylene
terephthalate). square inch of food contact surface
when extracted for 2 hours at 150 °F
Poly(tetramethylene terephthalate) with n-heptane.
(poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per
ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface
ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F
in this section may be safely used as with 3 percent aqueous acetic acid.
articles or components of articles in- (iv) Not to exceed 0.02 milligram per
tended to contact food, in accordance square inch of food contact surface
with the following prescribed condi- when extracted for 2 hours at 65.6 °C
tions: (150 °F) with 50 percent ethanol.
(a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50
section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29,
terephthalate) is the reaction product 1987]
of dimethyl terephthalate with 1,4-
butanediol to which may have been § 177.1670 Polyvinyl alcohol film.
added certain optional substances to Polyvinyl alcohol film may be safely
impart desired technological properties used in contact with food of the types
to the polymer. identified in § 176.170(c) of this chapter,
(b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in
Poly(tetramethylene terephthalate) accordance with the following pre-
identified in paragraph (a) of this sec- scribed conditions:
tion may contain optional adjuvant (a) The polyvinyl alcohol film is pro-
substances. The quantity of any op- duced from polyvinyl alcohol having a
tional adjuvant substance employed in minimum viscosity of 4 centipoises
the production of the polymer does not when a 4-percent aqueous solution is
exceed the amount reasonably required tested at 20 °C.
to accomplish the intended technical (b) The finished food-contact film for
or physical effect. Such adjuvants may use in contact with Food Types V or
include substances generally recog- IX, when extracted with the solvent
nized as safe in food, substances used in characterizing the type of food and
accordance with prior sanction, and under the conditions of time and tem-
substances permitted under applicable perature characterizing its intended
regulations in this part. use as determined from tables 1 and 2
(c) Specifications. (1) Inherent vis- of § 176.170(c) of this chapter, yields
cosity of a 0.50 percent solution of the total extractives not to exceed 0.078
polymer in phenol/tetrachloroethane milligram per square centimeter (0.5
(60/40 weight ratio) solvent is not less milligram per square inch) of food-con-
than 0.6 as determined using a Wagner tact surface when tested by ASTM
viscometer (or equivalent) and cal- method F34–76 (Reapproved 1980),
culated from the following equation: ‘‘Standard Test Method for Liquid Ex-
traction of Flexible Barrier Materials,’’
Inherent ( natural logarithm of N r ) which is incorporated by reference.
viscosity = Copies may be obtained from the Amer-
(c) ican Society for Testing Materials, 100
where: Barr Harbor Dr., West Conshohocken,
Nr = Ratio of flow time of the polymer solu- Philadelphia, PA 19428-2959, or may be
examined at the National Archives and
tion to that of the solvent and c = poly-

mer concentration of the test solution in Records Administration (NARA). For
grams per 100 milliliters. information on the availability of this
326
ER01JA93.400</GPH>
material at NARA, call 202–741–6030, or 1,4–Cyclohexane dimethanol (CAS Reg. No.

go to: http://www.archives.gov/fed- 105–08–8).
erallregister/ 2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6–Hexanediol (CAS Reg. No. 629–11–8).a–
ibrllocations.html. Hydro–w–hydroxypoly(oxy–1,4–butanediyl)
(c) The finished food-contact film (CAS Reg. No. 25190–06–1).
shall not be used as a component of a-Hydro-omega-hydroxypoly (oxytetra-
food containers intended for use in con- methylene).
tact with water. a,a′-(Isopropylidenedi-p-phenylene)bis[omega-
hydroxypoly (oxypropylene)(3–4 moles)],
[42 FR 14572, Mar. 15, 1977, as amended at 49 average molecular weight 675.
FR 10110, Mar. 19, 1984] Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS
§ 177.1680 Polyurethane resins. Reg. No. 9003–11–6).
The polyurethane resins identified in Methyl oxirane polymer with oxirane, ether
paragraph (a) of this section may be with 1,2,3–propanetriol (CAS Reg. No. 9082–
00–2).
safely used as the food-contact surface a,a′a″,a″′-Neopentanetetrayltetrakis [omega-
of articles intended for use in contact hydroxypoly (oxypropylene) (1–2 moles)],
with bulk quantities of dry food of the average molecular weight 400.
type identified in § 176.170(c) of this Pentaerythritol-linseed oil alcoholysis prod-
chapter, table 1, under Type VIII, in ac- uct.
cordance with the following prescribed Phthalic anhydride.
conditions: Polybutylene glycol.
(a) For the purpose of this section, Polyethyleneadipate modified with ethanol-
amine with the molar ratio of the amine to
polyurethane resins are those produced the adipic acid less than 0.1 to 1.
when one or more of the isocyanates Poly(oxycarbonylpentamethylene).
listed in paragraph (a)(1) of this section Polyoxypropylene ethers of 4.4′-isopropyl-
is made to react with one or more of idenediphenol (containing an average of 2–
the substances listed in paragraph 4 moles of propylene oxide).
(a)(2) of this section: Polypropylene glycol.
(1) Isocyanates: a,a′,a″-1,2,3-Propanetriyltris [omega-
hydroxypoly (oxypropylene) (15–18 moles)],
Bis(isocyanatomethyl) benzene (CAS Reg. average molecular weight 3,000.
No. 25854–16–4). Propylene glycol.
Bis(isocyanatomethyl) cyclohexane (CAS a,a′,a″-[Propylidynetris (methylene)] tris
Reg. No. 38661–72–2). [omega-hydroxypoly (oxypropylene) (min-
4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- imum 1.5 moles)], minimum molecular
tolylene diisocyanate). weight 400.
Diphenylmethane diisocyanate. a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]-
Hexamethylene diisocyanate. omega-hydroxypoly(oxyethylene) (5 moles),
3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- average molecular weight 425.
hexyl isocyanate. Trimethylol propane.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate. (b) Optional adjuvant substances em-
ployed in the production of the poly-
(2) List of substances: urethane resins or added thereto to im-
Adipic acid. part desired technical or physical prop-
1,4-Butanediol. erties may include the following sub-
1,3-Butylene glycol. stances:
1-[(2-Aminoethyl)amino]2-propanol ............................................. As a curing agent.

1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....... As a preservative.
Colorants used in accordance with § 178.3297 of this chapter..
Dibutyltin diacetate ...................................................................... As a catalyst.
Dibutyltin dichloride ..................................................................... Do.
Dibutyltin dilaurate ....................................................................... Do.
N,N-Dimethyldodecylamine ......................................................... Do.
N-Dodecylmorpholine .................................................................. Do.
a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer.
]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], av-
erage molecular weight 15,000.

4,4′-Methylenedianiline ................................................................ As a curing agent.
1,1′,1″-Nitrilotri-2-propanol ........................................................... Do.
327
§ 177.1810 21 CFR Ch. I (4–1–21 Edition)
2,2′-(p-Phenylenedioxy) diethanol ............................................... Do.

Polyvinyl isobutyl ether.
Polyvinyl methyl ether.
Soyaalkyd resin ........................................................................... Conforming in composition with § 175.300 of this chapter and
containing litharge not to exceed that residual from its use
as the reaction catalyst and creosol not to exceed that re-
quired as an antioxidant.
Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer.
mate)]methane (CAS Reg. No. 6683–19–8).
N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ................. As a curing agent.
Triethanolamine ........................................................................... Do.
Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent.
57609–64–0).
(c) An appropriate sample of the fin- § 177.1810 Styrene block polymers.

ished resin in the form in which it con- The styrene block polymers identi-
tacts food, when subjected to ASTM fied in paragraph (a) of this section
method D968–81, ‘‘Standard Test Meth- may be safely used as articles or as
ods for Abrasion Resistance of Organic components of articles intended for use
Coatings by the Falling Abrasive Test- in contact with food, subject to provi-
er,’’ which is incorporated by reference sions of this section.
(Copies may be obtained from the (a) For the purpose of this section,
American Society for Testing Mate- styrene block polymers are basic poly-
rials, 100 Barr Harbor Dr., West mers manufactured as described in this
Conshohocken, Philadelphia, PA 19428- paragraph, so that the finished poly-
2959, or may be examined at the Na- mers meet the specifications prescribed
tional Archives and Records Adminis- in paragraph (b) of this section, when
tration (NARA). For information on tested by the methods described in
the availability of this material at paragraph (c) of this section.
NARA, call 202–741–6030, or go to: http:// (1) Styrene block polymers with 1,3-
www.archives.gov/federallregister/ butadiene are those produced by the
codeloflfederallregulations/ catalytic solution polymerization of
ibrllocations.html.), using No. 50 Emery styrene and 1,3-butadiene.
abrasive in lieu of Ottawa sand, shall (2) Styrene block polymers with 2-
methyl-1,3-butadiene are those pro-
exhibit an abrasion coefficient of not
duced by the catalytic solution polym-
less than 20 liters per mil of film thick-
erization of styrene and 2-methyl-1,3-
ness.
butadiene.
[42 FR 14572, Mar. 15, 1977, as amended at 46 (3) Styrene block polymers with 1,3-
FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, butadiene, hydrogenated are those pro-
1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, duced by the catalytic solution polym-
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] erization of styrene and 1,3-butadiene,
and subsequently hydrogenated.
(b) Specifications:
Maximum extract- Maximum extract-
able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01
butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur-
components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C
food of Types I, II, IV-B, VI, VII-B, (¥96 °F) temperature for (150 °F) for 2 hr
and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm
§ 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick
conditions of use D, E, F, and G de- 122 °C thick sample. sample.
scribed in table 2 in § 176.170(c) of (252 °F).
this chapter.
328

able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
(ii) Styrene block polymers with 1,3-bu- 29,000 ......do .......... ......do .......... ......do .................... Do.
tadiene; for use as components of
pressure-sensitive adhesives that
contact food of Types I, II, IV-B, VI,
VII-B, and VIII identified in table 1 in
§ 176.170(c) of this chapter under
conditions of use C, D, E, F and G
described in table 2 in § 176.170(c) of
this chapter, provided the pressure-
sensitive adhesives be applied only
to closure tapes for sealing con-
tainers having a capacity of not less
than 160 cc (5.5 fluid ounces) and
that the area of the adhesive ex-
posed to food shall not exceed 4.03
cm2 (0.625 in2). The pressure-sen-
sitive adhesive may contain terpene
resins as identified in § 175.125(b)(2)
of this chapter.
2. Styrene block polymers with 2-meth- 29,000 ......do .......... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur-
or as components of articles that to ¥47 °C face at reflux face at 66 °C
contact food of Types I, II, IV-B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr
VII-B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm
§ 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick
122 °C sample. (Option- sample. (Option-
(252 °F). ally, maximum ally, maximum
net residue solu- net residue solu-
ble in chloroform ble in chloroform
shall not exceed shall not exceed
0.00020 mg/cm2 0.00040 mg/cm2
(0.0013 mg/in2) (0.0025 mg/in2)
of surface.). of surface.)
3. (i) Styrene block polymers with 1,3- 16,000 ......do .......... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur-
No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C
or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr
contact food of Types I, II, IV-B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm
VII-B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick
§ 176.170(c) of this chapter. 98 °C (208 sample. sample.
°F).
(ii) Styrene block polymers with 1,3-bu- 16,000 ......do .......... ......do .......... ......do .................... Do.
tadiene, hydrogenated (CAS Reg.
No. 66070–58–4): for use at levels
not to exceed 42.4 percent by weight
as a component of closures with
sealing gaskets that would contact
food of Types III, IV-A, V, VII-A, VIII,
and IX identified in table 1 in
§ 176.170(c) of this chapter, and in
condition of use D as described
under table 2 in § 176.170(c) of this
chapter.
(c) The analytical methods for deter- (2) Glass transition points. The glass
mining whether styrene block poly- transition points shall be determined
mers conform to the specifications pre- by either of the following methods:
scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand-
and are applicable to the finished poly- ard Method of Test for Dynamic Me-
mer. chanical Properties of Plastics by
(1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which
weight shall be determined by intrinsic is incorporated by reference; copies are
viscosity (or other suitable method). available from American Society for
Testing and Materials (ASTM), 100
329
§ 177.1820 21 CFR Ch. I (4–1–21 Edition)
Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in

Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and
able for inspection at the National Ar- the maximum net residue solubles in chlo-
chives and Records Administration roform. The maximum extractable frac-
(NARA). For information on the avail- tions in distilled water and 50 percent
ability of this material at NARA, call ethanol, and the maximum net residue
202–741–6030, or go to: http:// solubles in chloroform, shall be deter-
www.archives.gov/federallregister/ mined in accordance with § 176.170(d)(3)
codeloflfederallregulations/ of this chapter using a sandwich form
ibrllocations.html.) modified by using a of the finished copolymer of the speci-
forced resonant vibration instead of a fied thickness and for the time and
fixed vibration and by using fre- temperature specified in paragraph (b)
quencies of 25 to 40 cycles per second of this section.
instead of 0.1 to 10 cycles per second.
(d) The provisions of this section are
(ii) Direct reading viscoelastometric
not applicable to butadiene-styrene co-
method titled ‘‘Direct Reading
Viscoelastrometric Method for Deter- polymers listed in other sections of
mining Glass Transition Points of Sty- this subpart.
rene Block Polymers’’ (which is incor- (e) The provisions of this section are
porated by reference; copies are avail- not applicable to styrene block poly-
able from the Center for Food Safety mers with 1,3-butadiene listed in
and Applied Nutrition (HFS–200), Food § 175.105 of this chapter.
and Drug Administration, 5001 Campus [42 FR 14572, Mar. 15, 1977, as amended at 42
Dr., College Park, MD 20740, or avail- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19,
able for inspection at the National Ar- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898,
chives and Records Administration June 12, 1989; 58 FR 65546, Dec. 15, 1993]
(NARA). For information on the avail-
ability of this material at NARA, call § 177.1820 Styrene-maleic anhydride
202–741–6030, or go to: http:// copolymers.
www.archives.gov/federallregister/ Styrene-maleic anhydride copoly-
codeloflfederallregulations/ mers identified in paragraph (a) of this
ibrllocations.html.), by which the glass section may be safely used as articles
transition points are determined in the
or components of articles intended for
tensile mode of deformation at a fre-
use in contact with food, subject to
quency of 35 hertz using a Rheovibron
provisions of this section.
Model DDV-II (or equivalent) Direct
Reading Viscoelastometer. Take maxi- (a) For the purpose of this section,
ma in the out-of-phase component of styrene-maleic anhydride copolymers
the complex modulus as the glass tran- are those produced by the polymeriza-
sition points. For block polymers of tion of styrene and maleic anhydride so
low styrene content or for simple block that the finished polymers meet the
polymers, the polymer may be treated specifications prescribed in paragraph
with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the
oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of
to accentuate the upper transition this section.
point. (b) Specifications:
330

Molecular Residual able fraction in dis- able fraction in n-
weight Residual sty- maleic anhy- tilled water at spec- heptane at speci-
Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures,
number omer omer times, and particle times, and particle
average) size size
1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent
mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr
maleic anhydride units by weight; for temperature for 1 utilizing particles
use as articles or as components of hr utilizing par- of a size that will
articles that contact food of Types I, ticles of a size pass through a
II, III, IV-A, IV-B, V, VI-B (except car- that will pass U.S. standard
bonated beverages), VII-A, VII-B, through a U.S. sieve No. 10 and
VIII, and IX identified in table 1 in standard sieve will be held on a
§ 176.170(c) of this chapter under No. 10 and will U.S. standard
conditions of use B, C, D, E, F, G, be held on a sieve No. 20.
and H described in table 2 in U.S. standard
§ 176.170(c) of this chapter. sieve No. 20.
2. Styrene-maleic anhydride copolymer .................. 0.3 ............... 0.1 ............... 0.015 weight per- 1.0 weight percent
modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F)
No. 27288–99–9) containing not temperature for 1 for 2 hours uti-
more than 15 percent maleic anhy- hour utilizing par- lizing particles of
dride units by weight and not more ticles of a size a size that will
than 20 percent styrene-butadiene that will pass pass through a
and/or butadiene rubber units by through a U.S. U.S. standard
weight; for use (except carbonated standard sieve sieve No. 10 and
beverage bottles) as articles or as No. 10 and will will be held on a
components of articles that contact be held on a U.S. standard
food of Types I, II, III, IV-A, IV-B, V, U.S. standard sieve No. 20.
VI, VII-A, VII-B, VIII, and IX identified sieve No. 20.
in table I in § 176.170(c) of this chap-
ter under conditions of use B, C, D,
E, F, G, and H described in table 2 in
§ 176.170(c) of this chapter.
(c) The analytical methods for deter- codeloflfederallregulations/

mining conformance with specifica- ibrllocations.html.
tions for styrene-maleic anhydride co- (d) The provisions of this section are
polymers prescribed in this section are not applicable to styrene-maleic anhy-
as follows: dride copolymers listed in other sec-
(1) Molecular weight. Molecular tions of this subpart.
weight shall be determined by mem-
brane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47
(2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6,
1982; 54 FR 24898, June 12, 1989]
Residual styrene monomer content
shall be determined by the method de- § 177.1830 Styrene-methyl methacry-
scribed in § 177.1640(d). late copolymers.
(3) Residual maleic anhydride monomer
content. Residual maleic anhydride Styrene-methyl methacrylate co-
monomer content shall be determined polymers identified in this section may
by a gas chromatographic method ti- be safely used as components of plastic
tled ‘‘Determination of Residual Ma- articles intended for use in contact
leic Anhydride in Polymers by Gas with food, subject to the provisions of
Chromatography,’’ which is incor- this section.
porated by reference. Copies are avail- (a) For the purpose of this section,
able from the Center for Food Safety styrene-methyl methacrylate copoly-
and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro-
and Drug Administration, 5001 Campus duced by the copolymerization of sty-
Dr., College Park, MD 20740, or avail- rene and methyl methacrylate such
able for inspection at the National Ar- that the finished basic copolymers con-
chives and Records Administration tain more than 50 weight percent of
(NARA). For information on the avail- polymer units derived from styrene.
ability of this material at NARA, call (b) The finished plastic food-contact
202–741–6030, or go to: http:// article, when extracted with the sol-

www.archives.gov/federallregister/ vent or solvents characterizing the
331
§ 177.1850 21 CFR Ch. I (4–1–21 Edition)
type of food and under the conditions Substances Limitations

of time and temperature characterizing
(3) Adjuvant substance, As a solvent in the prepara-
the conditions of intended use as deter- dimethylformamide. tion of fibryl.
mined from tables 1 and 2 of § 176.170(c)
of this chapter, yields extractives not (d) Textryls meeting the conditions
to exceed the following when tested by of test prescribed in paragraph (d)(1) of
the methods prescribed in § 177.1010(c); this section are used as prescribed in
(1) Total nonvolatile extractives not paragraph (d)(2) of this section.
to exceed 0.3 milligram per square inch (1) Conditions of test. Textryls, when
of surface tested.
extracted with distilled water at reflux
(2) Potassium permanganate oxidiz-
temperature for 1 hour, yield total ex-
able distilled water and 8 and 50 per-
tractives not to exceed 1 percent.
cent alcohol extractives not to exceed
an absorbance of 0.15. (2) Uses. Textryls are used for pack-
(3) Ultraviolet-absorbing distilled aging or holding food at ordinary tem-
water and 8 and 50 percent alcohol ex- peratures and in the brewing of hot
tractives not to exceed an absorbance beverages.
of 0.30.
(4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in
molded articles.
extractives not to exceed an absorb-
ance of 0.40. Urea-formaldehyde resins may be
safely used as the food-contact surface
§ 177.1850 Textryls. of molded articles intended for use in
Textryls identified in this section contact with food, in accordance with
may be safely used as articles or com- the following prescribed conditions:
ponents of articles, intended for use in (a) For the purpose of this section,
producing, manufacturing, packing, urea-formaldehyde resins are those
processing, preparing, treating, pack- produced when 1 mole of urea is made
aging, transporting or holding food, to react with not more than 2 moles of
subject to the provisions of this sec- formaldehyde in water solution.
tion. (b) The resins may be mixed with re-
(a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may
pared from natural or synthetic fibers, contain other optional adjuvant sub-
bonded with fibryl (Fibryl consists of a stances which may include the fol-
polymeric resin in fibrous form com- lowing:
mingled with fiber to facilitate sheet
formation and subsequently heat cured List of substances Limitations
to fuse the fibryl and effect bonding).
Hexamethylenetetramine ....... For use only as polymeriza-
(b) Textryls are prepared from the fi- tion-control agent.
bers, fibryls, and adjuvants identified Tetrachlorophthalic acid an- Do.
in paragraph (c) of this section, and hydride.
subject to limitations prescribed in Zinc stearate .......................... For use as lubricant.
that paragraph, provided that any sub-
stance that is the subject of a regula- (c) The finished food-contact article,
tion in parts 174, 175, 176, 177, 178 and when extracted with the solvent or sol-
§ 179.45 of this chapter conforms with vents characterizing the type of food
any specifications in such regulation and under the conditions of time and
for that substance as a component of temperature characterizing the condi-
polymeric resins used as food contact tions of its intended use as determined
surfaces. from tables 1 and 2 of § 175.300(d) of this
(c) The fibers, fibryls, and adjuvants chapter, yields total extractives in
permitted are as follows: each extracting solvent not to exceed
0.5 milligram per square inch of food-
Substances Limitations
contact surface as determined by the
(1) Fibers prepared from pol- Conforming with § 177.1630. methods described in § 175.300(e) of this
yethylene terephthalate chapter.
resins.
(2) Fibryls prepared from As the basic polymer. NOTE: In testing the finished food-contact
vinyl chloride-vinyl acetate article, use a separate test sample for each
copolymer. required extracting solvent.
332
§ 177.1950 Vinyl chloride-ethylene co- codeloflfederallregulations/

polymers. ibrllocations.html.
The vinyl chloride-ethylene copoly- (2) Extractives limitations. The fol-
mers identified in paragraph (a) of this lowing extractives limitations are de-
section may be safely used as compo- termined by the methods described in
nents of articles intended for contact paragraph (d) of this section:
with food, under conditions of use D, E, (i) Total extractives do not exceed
F, or G described in table 2 of § 176.170 0.10 weight-percent when extracted
(c) of this chapter, subject to the provi- with n-heptane at 150 °F for 2 hours.
sions of this section. (ii) Total extractives do not exceed
(a) For the purpose of this section, 0.03 weight-percent when extracted
vinyl chloride-ethylene copolymers with water at 150 °F for 2 hours.
consist of basic copolymers produced (iii) Total extractives obtained by ex-
by the copolymerization of vinyl chlo- tracting with water at 150 °F for 2
ride and ethylene such that the fin- hours contain no more than 0.5 milli-
ished basic copolymers meet the speci- gram of vinyl chloride-ethylene copol-
fications and extractives limitations ymer per 100 grams of sample tested as
prescribed in paragraph (c) of this sec- determined from the organic chlorine
tion, when tested by the methods de- content. The organic chlorine content
scribed in paragraph (d) of this section. is determined as described in paragraph
(b) The basic vinyl chloride-ethylene (d)(3) of this section.
copolymers identified in paragraph (a) (d) Analytical methods: The analyt-
of this section may contain optional ical methods for determining whether
adjuvant substances required in the vinyl chloride-ethylene basic copoly-
production of such basic copolymers. mers conform to the extractives limi-
The optional adjuvant substances re- tations prescribed in paragraph (c) of
quired in the production of the basic this section are as follows and are ap-
vinyl chloride-ethylene copolymers plicable to the basic copolymers in
may include substances permitted for powder form having a particle size such
such use by regulations in parts 170 that 100 percent will pass through a
through 189 of this chapter, substances U.S. Standard Sieve No. 40 and 80 per-
generally recognized as safe in food, cent will pass through a U.S. Standard
and substances used in accordance with Sieve No. 80:
a prior sanction or approval. (1) Reagents—(i) Water. All water used
(c) The vinyl chloride-ethylene basic in these procedures shall be
copolymers meet the following speci- demineralized (deionized), freshly dis-
fications and extractives limitations: tilled water.
(1) Specifications. (i) Total chlorine (ii) n-Heptane. Reagent grade, freshly
content is in the range of 53 to 56 per- distilled n-heptane shall be used.
cent as determined by any suitable an- (2) Determination of total amount of ex-
alytical procedure of generally accept- tractives. All determinations shall be
ed applicability. done in duplicate using duplicate
(ii) Intrinsic viscosity in blanks. Approximately 400 grams of
cyclohexanone at 30 °C is not less than sample (accurately weighed) shall be
0.50 deciliter per gram as determined placed in a 2-liter Erlenmeyer flask.
by ASTM method D1243–79, ‘‘Standard Add 1,200 milliliters of solvent and
Test Method for Dilute Solution Vis- cover the flask with aluminum foil.
cosity of Vinyl Chloride Polymers,’’ The covered flask and contents are sus-
which is incorporated by reference. pended in a thermostated bath and are
Copies may be obtained from the Amer- kept, with continual shaking at 150 °F
ican Society for Testing Materials, 100 for 2 hours. The solution is then fil-
Barr Harbor Dr., West Conshohocken, tered through a No. 42 Whatman filter
Philadelphia, PA 19428-2959, or may be paper, and the filtrate is collected in a
examined at the National Archives and graduated cylinder. The total amount
Records Administration (NARA). For of filtrate (without washing) is meas-
information on the availability of this ured and called A milliliters. The fil-
material at NARA, call 202–741–6030, or trate is transferred to a Pyrex (or
go to: http://www.archives.gov/fed- equivalent) beaker and evaporated on a

erallregister/ steam bath under a stream of nitrogen
333
§ 177.1950 21 CFR Ch. I (4–1–21 Edition)
to a small volume (approximately 50–60 aqueous extract or to a vacuum oven at

milliliters). The concentrated filtrate 150 °F in the case of the heptane ex-
is then quantitatively transferred to a tract. In the case of the aqueous ex-
tared 100-milliliter Pyrex beaker using tract, the evaporation to constant
small, fresh portions of solvent and a weight is completed in 15 minutes at
rubber policeman to effect the transfer. 230 °F; and in the case of heptane ex-
The concentrated filtrate is evaporated tract, it is overnight under vacuum at
almost to dryness on a hotplate under 150 °F. The residue is weighed and cor-
nitrogen, and is then transferred to a rected for the solvent blank. Calcula-
drying oven at 230 °F in the case of the tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-ethylene copolymer extract and washings are collected in a

content of aqueous extract—(i) Principle. 1,500-milliliter beaker. The solution is
The vinyl chloride-ethylene copolymer evaporated carefully on a steam plate
content of the aqueous extract can be to a volume of approximately 50 milli-
determined by determining the organic liters and then transferred quan-
chlorine content and calculating the titatively, a little at a time, to a clean
amount of copolymer equivalent to the 22-milliliter Parr cup, also on the
organic chlorine content. steam plate. The solution is evaporated
(ii) Total organic chlorine content. A to dryness. Next 0.25 gram of sucrose
weighed sample of approximately 400 and 0.5 gram of benzoic acid are added
grams is extracted with 1,200 milliliters to the cup. One scoop (approximately
of water at 150 °F for 2 hours, filtered, 15 grams) of sodium peroxide is then
and the volume of filtrate is measured added to the cup. The bomb is assem-
(A milliliters) as described in para- bled and ignition is conducted in the
graph (d)(2) of this section. usual fashion.
(a) A slurry of Amberlite IRA–400, or (d) After the bomb has cooled, it is
equivalent, is made with distilled
rinsed thoroughly with distilled water
water in a 150-milliliter beaker. The
and disassembled. The top of the bomb
slurry is added to a chromatographic
is rinsed into a 250-milliliter beaker
column until it is filled to about half
with distilled water. The beaker is
its length. This should give a volume of
placed on the steam plate. The bomb
resin of 15–25 milliliters. The liquid
must not be allowed to drain below the cup is placed in the beaker and care-
top of the packed column. fully tipped over to allow the water to
(b) The column is regenerated to the leach out the combustion mixture.
basic (OH) form by slowly passing After the bubbling has stopped, the cup
through it (10–15 milliliters per minute) is removed from the beaker and rinsed
10 grams of sodium hydroxide dissolved thoroughly. The solution is cooled to
in 200 milliliters of water. The column room temperature and cautiously neu-
is washed with distilled water until the tralized with concentrated nitric acid
effluent is neutral to phenolphthalein. by slowly pouring the acid down a stir-
One drop of methyl red indicator is ring rod until the bubbling ceases. The
added to the A milliliters of filtered solution is cooled and an equal volume
aqueous extract and, if on the basic of acetone is added.
side (yellow), nitric acid is added drop (e) The solution is titrated with 0.005
by drop until the solution turns pink. N silver nitrate using standard poten-
(c) The extract is deionized by pass- tiometric titration techniques with a
ing it through the exchange column at silver electrode as indicator and a po-
a rate of 10–15 milliliters per minute. tassium nitrate modified calomel elec-
The column is washed with 200 milli- trode as a reference electrode. An ex-
liters of distilled water. The deionized panded scale recording titrimeter.
334
ER01JA93.401</GPH>
Metrohm Potentiograph 2336 or equiva- (iii) Calculations.

lent, should be used; a complete blank
must be run in duplicate.
Milligrams of aqueous extracted T × F × 64.3

= × 100
copolymer per 100-gram sample Weight of sample in grams
where: agent, respectively, in their produc-

T = Milliliters of silver nitrate (sample tion.
minus blank) × normality of silver ni- (b) Specifications and limitations. The
trate. vinyl chloride-hexene-1 basic copoly-
F = 1,200 / A (as defined above) mers meet the following specifications
(e) The vinyl chloride-ethylene co- and extractives limitations:
polymers identified in and complying (1) Specifications. (i) Total chlorine
with this section, when used as compo- content is 53 to 56 percent as deter-
nents of the food-contact surface of mined by any suitable analytical pro-
any article that is the subject of a reg- cedure of generally accepted applica-
ulation in parts 174, 175, 176, 177, 178 bility.
and § 179.45 of this chapter, shall com- (ii) Inherent viscosity in
ply with any specifications and limita- cyclohexanone at 30 °C is not less than
tions prescribed by such regulation for 0.59 deciliters per gram as determined
the article in the finished form in by ASTM method D1243–79, ‘‘Standard
which it is to contact food. Test Method for Dilute Solution Vis-
cosity of Vinyl Chloride Polymers,’’
(f) The provisions of this section are
which is incorporated by reference.
not applicable to vinyl chloride-ethyl-
Copies may be obtained from the Amer-
ene copolymers used as provided in
ican Society for Testing Materials, 100
§§ 175.105 and 176.180 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 49 Philadelphia, PA 19428-2959, or may be
FR 10110, Mar. 19, 1984] examined at the National Archives and
Records Administration (NARA). For
§ 177.1960 Vinyl chloride-hexene-1 co- information on the availability of this
polymers. material at NARA, call 202–741–6030, or
The vinyl chloride-hexene-1 copoly- go to: http://www.archives.gov/fed-
mers identified in paragraph (a) of this erallregister/
section or as components of articles in- codeloflfederallregulations/
tended for use in contact with food, ibrllocations.html.
under conditions of use D, E, F, or G (2) Extractives limitations. The fol-
described in table 2 of § 176.170(c) of this lowing extractives limitations are de-
chapter, subject to the provisions of termined by the methods prescribed in
this section. § 177.1970(d).
(a) Identity. For the purposes of this (i) Total extractives do not exceed
section vinyl chloride-hexene-1 copoly- 0.01 weight percent when extracted
mers consist of basic copolymers pro- with water at 150 °F for 2 hours.
duced by the copolymerization of vinyl (ii) Total extractives do not exceed
chloride and hexene-1 such that the fin- 0.30 weight percent when extracted
ished copolymers contain not more with n-heptane at 150 °F for 2 hours.
than 3 mole-percent of polymer units (c) Other specifications and limitations.
derived from hexene-1 and meet the The vinyl chloride-hexene-1 copoly-
specifications and extractives limita- mers identified in and complying with
tions prescribed in paragraph (b) of this this section, when used as components
section. The copolymers may option- of the food-contact surface of any arti-
ally contain hydroxypropyl methyl- cle that is subject to a regulation in
cellulose and trichloroethylene used as parts 174, 175, 176, 177, 178 and § 179.45 of
a suspending agent and chain transfer this chapter, shall comply with any
335
ER01JA93.402</GPH>
§ 177.1970 21 CFR Ch. I (4–1–21 Edition)
specifications and limitations pre- Conshohocken, Philadelphia, PA 19428-

scribed by such regulation for the arti- 2959, or may be examined at the Na-
cle in the finished form in which it is tional Archives and Records Adminis-
to contact food. tration (NARA). For information on
[42 FR 14572, Mar. 15, 1977, as amended at 49 the availability of this material at
FR 10110, Mar. 19, 1984] NARA, call 202–741–6030, or go to: http://
§ 177.1970 Vinyl chloride-lauryl vinyl codeloflfederallregulations/
ether copolymers. ibrllocations.html.
The vinyl chloride-lauryl vinyl ether (2) Extractives limitations. The fol-
copolymers identified in paragraph (a) lowing extractives limitations are de-
of this section may be used as an arti- termined by the method described in
cle or as a component of an article in- paragraph (d) of this section:
tended for use in contact with food sub- (i) Total extractives do not exceed
ject to the provisions of this section. 0.03 weight-percent when extracted
(a) Identity. For the purposes of this with water at 150 °F for 2 hours.
section vinyl chloride-lauryl vinyl (ii) Total extractives do not exceed
ether copolymers consist of basic co- 0.60 weight-percent when extracted
polymers produced by the copolym- with n-heptane at 150 °F for 2 hours.
erization of vinyl chloride and lauryl (d) Analytical methods. The analytical
vinyl ether such that the finished co- methods for determining total extrac-
polymers contain not more than 3 tives are applicable to the basic co-
weight-percent of polymer units de- polymers in powder form having a par-
rived from lauryl vinyl ether and meet ticle size such that 100 percent will
the specifications and extractives limi- pass through a U.S. Standard Sieve No.
tations prescribed in paragraph (c) of 40 and such that not more than 10 per-
this section. cent will pass through a U.S. Standard
(b) Optional adjuvant substances. The Sieve No. 200.
basic vinyl chloride-lauryl vinyl ether (1) Reagents—(i) Water. All water used
copolymers identified in paragraph (a) in these procedures shall be
of this section may contain optional demineralized (deionized), freshly dis-
adjuvant substances required in the tilled water.
production of such basic copolymers. (ii) n-Heptane. Reagent grade, freshly
These optional adjuvant substances distilled n-heptane shall be used.
may include substances permitted for (2) Determination of total amount of ex-
such use by regulations in parts 170 tractives. Place an accurately weighed
through 189 of this chapter, substances sample of suitable size in a clean
generally recognized as safe in food, borosilicate flask, and for each gram of
and substances used in accordance with sample add 3 milliliters of solvent pre-
a prior sanction or approval. viously heated to 150 °F. Maintain the
(c) Specifications and limitations. The temperature of the contents of the
vinyl chloride-lauryl vinyl ether basic flask at 150 °F for 2 hours using a hot
copolymers meet the following speci- plate while also maintaining gentle
fications and extractives limitations: mechanical agitation. Filter the con-
(1) Specifications. (i) Total chlorine tents of the flask rapidly through No.
content is 53 to 56 percent as deter- 42 Whatman filter paper with the aid of
mined by any suitable analytical pro- suction. Transfer the filtrate to flat
cedure of generally accepted applica- glass dishes that are warmed on a hot
bility. plate and evaporate the solvent with
(ii) Inherent viscosity in the aid of a stream of filtered air. When
cylcoHhexanone at 30 °C is not less the volume of the filtrate has been re-
than 0.60 deciliter per gram as deter- duced to 10 to 15 milliliters, transfer
mined by ASTM method D1243–79, the filtrate to tared 50-milliliter
‘‘Standard Test Method for Dilute So- borosilicate glass beakers and com-
lution Viscosity of Vinyl Chloride plete evaporation to a constant weight
Polymers,’’ which is incorporated by in a 140 °F vacuum oven. Carry out a
reference. Copies may be obtained from corresponding blank determination
the American Society for Testing Ma- with each solvent. Determine the
terials, 100 Barr Harbor Dr., West weight of the residue corrected for the
336
solvent blank and calculate the result (ii) Intrinsic viscosity in cyclo-
as percent of the initial weight of the hexanone at 30 °C is not less than 0.50
resin sample taken for analysis. deciliter per gram as determined by
(e) Other specifications and limitations. ASTM method D1243–79, ‘‘Standard
The vinyl chloride-lauryl vinyl ether Test Method for Dilute Solution Vis-
copolymers identified in and complying cosity of Vinyl Chloride Polymers,’’
with this section, when used as compo- which is incorporated by reference.
nents of the food-contact surface of Copies may be obtained from the Amer-
any article that is subject to a regula- ican Society for Testing Materials, 100
tion in parts 174, 175, 176, 177, 178 and Barr Harbor Dr., West Conshohocken,
§ 179.45 of this chapter, shall comply Philadelphia, PA 19428-2959, or may be
with any specifications and limitations examined at the National Archives and
prescribed by such regulation for the Records Administration (NARA). For
article in the finished form in which it information on the availability of this
is to contact food. material at NARA, call 202–741–6030, or
[42 FR 14572, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/fed-
FR 10110, Mar. 19, 1984] erallregister/
§ 177.1980 Vinyl chloride-propylene co- ibrllocations.html.
polymers. (2) Extractives limitations. The fol-
The vinyl chloride-propylene copoly- lowing extractives limitations are de-
mers identified in paragraph (a) of this termined by the methods described in
section may be safely used as compo- paragraph (d) of this section:
nents of articles intended for contact (i) Total extractives do not exceed
with food, subject to the provisions of 0.10 weight-percent when extracted
this section. with n-heptane at 150 °F for 2 hours.
(a) For the purpose of this section, (ii) Total extractives do not exceed
vinyl chloride-propylene copolymers 0.03 weight-percent when extracted
consist of basic copolymers produced with water at 150 °F for 2 hours.
by the copolymezation of vinyl chlo- (iii) Total extractives obtained by ex-
ride and propylene such that the fin- tracting with water at 150 °F for 2
ished basic copolymers meet the speci- hours contain no more than 0.17 milli-
fications and extractives limitations gram of vinyl chloride-propylene co-
prescribed in paragraph (c) of this sec- polymer per 100 grams of sample tested
tion, when tested by the methods de- as determined from the organic chlo-
scribed in paragraph (d) of this section. rine content. For the purpose of this
(b) The basic vinyl chloride-pro- section, the organic chlorine content is
pylene copolymers identified in para- the difference between the total chlo-
graph (a) of this section may contain rine and ionic chlorine contents deter-
optional adjuvant substances required mined as described in paragraph (d) of
in the production of such basic copoly- this section.
mers. The optional adjuvant sub- (d) Analytical methods: The analyt-
stances required in the production of ical methods for determining whether
the basic vinyl chloride-propylene co- vinyl chloride-propylene basic copoly-
polymers may include substances per- mers conform to the extractives limi-
mitted for such use by regulations in tations prescribed in paragraph (c) of
parts 170 through 189 of this chapter, this section are as follows and are ap-
substances generally recognized as safe plicable to the basic copolymers in
in food, and substances used in accord- powder form having a particle size such
ance with a prior sanction or approval. that 100 percent will pass through a
(c) The vinyl chloride-propylene U.S. Standard Sieve No. 40 and 80 per-
basic copolymers meet the following cent will pass through a U.S. Standard
specifications and extractives limita- Sieve No. 80:
tions: (1) Reagents—(i) Water. All water used
(1) Specifications. (i) Total chlorine in these procedures shall be
content is in the range of 53 to 56 per- demineralized (deionized), freshly dis-
cent as determined by any suitable an- tilled water.
alytical procedure of generally accept- (ii) n-Heptane. Reagent grade, freshly

ed applicability. distilled n-heptane shall be used.
337
§ 177.1980 21 CFR Ch. I (4–1–21 Edition)
(2) Determination of total amount of ex- to a small volume (approximately 50–60

tractives. All determinations shall be milliliters). The concentrated filtrate
done in duplicate using duplicate is then quantitatively transferred to a
blanks. Approximately 400 grams of tared 100-milliliter Pyrex beaker using
sample (accurately weighed) shall be small, fresh portions of solvent and a
placed in a 2-liter Erlenmeyer flask. rubber policeman to effect the transfer.
Add 1,200 milliliters of solvent and The concentrated filtrate is evaporated
cover the flask with aluminum foil. almost to dryness on a hotplate under
The covered flask and contents are sus- nitrogen, and is then transferred to a
pended in a thermostated bath and are drying oven at 230 °F in the case of the
kept, with continual shaking, at 150 °F aqueous extract or to a vacuum oven at
for 2 hours. The solution is then fil- 150 °F in the case of the heptane ex-
tered through a No. 42 Whatman filter tract. In the case of the aqueous ex-
paper, and the filtrate is collected in a tract the evaporation to constant
graduated cylinder. The total amount weight is completed in 15 minutes at
of filtrate (without washing) is meas- 230 °F; and in the case of heptane ex-
ured and called A milliliters. The fil- tract, it is overnight under vacuum at
trate is transferred to a Pyrex (or 150 °F. The residue is weighed and cor-
equivalent) beaker and evaporated on a rected for the solvent blank. Calcula-
steam bath under a stream of nitrogen tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-propylene copolymer sembled, water is added to the recess at

content of aqueous extract—(i) Principle. the top of the bomb and ignition is con-
The vinyl chloride-propylene copoly- ducted in the usual fashion using a
mer content of the aqueous extract can Meeker burner. The heating is contin-
be determined by determining the or- ued for 1 minute after the water at the
ganic chlorine content and calculating top has evaporated. The bomb is
the amount of copolymer equivalent to quenched in water, rinsed with distilled
the organic chlorine content. The or- water, and placed in a 400-milliliter
ganic chlorine content is the difference beaker. The bomb cover is rinsed with
between the total chlorine content and water, catching the washings in the
the ionic chlorine content. same 400-milliliter beaker. The bomb is
(ii) Total chlorine content. A weighed covered with distilled water and a
sample is extracted with water at 150 watch glass and heated until the melt
°F for 2 hours, filtered, and the volume has dissolved. The bomb is removed,
of filtrate is measured (A milliliters) as rinsed, catching the rinsings in the
described in paragraph (d)(2) of this beaker, and the solution is acidified
section. Two drops of 50 percent by with concentrated nitric acid using
weight sodium hydroxide solution are methyl purple as an indicator. The
added to prevent loss of chloride from beaker is covered with a watch glass,
ammonium chloride, if present, and the and the contents are boiled gently for
solution is evaporated to approxi- 10–15 minutes. After cooling to room
mately 15 milliliters. The concentrated temperature the solution is made
filtrate is quantitatively transferred to slightly alkaline with 50 percent by
a 22-milliliter Parr bomb fusion cup weight sodium hydroxide solution,
and gently evaporated to dryness. To then acidified with dilute (1:5) nitric
the contents of the cup are added 3.5 acid. Then 1.5 milliliters of 2 N nitric
grams of granular sodium peroxide, 0.1 acid per 100 milliliters of solution is
gram of powdered starch, and 0.02 gram added and the solution is titrated with
potassium nitrate; and the contents 0.005 N silver nitrate to the equivalence
are mixed thoroughly. The bomb is as- potential end point using an expanded
338
ER01JA93.403</GPH>
scale pH meter (Beckman Model 76, or

equivalent). A complete blank must be
run in duplicate. Calculation:
Grams of sample 1,200 milliliters Milliequivalents of total chlorine in

× × 100 =
(B − C) Volume of filtrate aqueous extract of 100 grams of sample
A in milliliters
where: solution is evaporated to approxi-

A = volume of filtrate obtained in extraction. mately 150 milliliters. The solution is
B = milliliters of silver nitrate solution used quantitatively transferred to a 250-mil-
in sample titration × normality of silver
liliter beaker, methyl purple indicator
nitrate solution.
C = milliliters of silver nitrate solution used is added, and the solution is neutral-
in blank titration × normality of silver ized with 0.1 N nitric acid. For each 100
nitrate solution. milliliters of solution is added 1.5 mil-
(iii) Ionic chlorine content. A weighed liliters of 2 N nitric acid. The solution
sample is extracted with water at 150 is titrated with 0.005 N silver nitrate to
°F for 2 hours, filtered, and the volume the equivalence potential end point,
of filtrate is measured (A milliliters) as using the expanded scale pH meter de-
in paragraph (d)(2) of this section. Two scribed in paragraph (d)(3)(ii) of this
drops of 50 percent by weight sodium section. A complete blank must be run
hydroxide solution are added and the in duplicate. Calculation:
D−E 1,200 milliliters Milliequivalents of ionic chlorine in

× × 100 =
Grams of sample Volume of filtrate aqueous extract of 100 grams of sample.
A in milliliters
where: (b) Vinyl chloride-propylene copolymer

A = volume of filtrate obtained in extraction. content. Milligrams of vinyl chloride-
D = milliliters of silver nitrate solution used propylene copolymer in aqueous ex-
in sample titration × normality of silver tract of 100 grams of sample equal
nitrate solution. milliequivalents of organic chlorine in
E = milliliters of silver nitrate solution used aqueous extract of 100 grams of sample
in blank titration × normality of silver
nitrate solution.
(as calculated in paragraph (d)(3)(iv)(a)
of this section) multiplied by 84.5.
(iv) Organic chlorine content and vinyl NOTE: The conversion factor, 84.5, is de-
chloride-propylene copolymer content of rived from the equivalent weight of chlorine
aqueous extract. The organic chlorine divided by the chlorine content of the
content and the vinyl chloride pro- heptane extractable fraction.)
pylene copolymer content of the aque- (e) The vinyl chloride-propylene co-
ous extract is calculated as follows: polymers identified in and complying
(a) Organic chlorine content. Milli- with this section, when used as compo-
equivalents of organic chlorine in nents of the food-contact surface of
aqueous extract of 100 grams of sample any article that is the subject of a reg-
equal milliequivalents of total chlorine ulation in parts 174, 175, 176, 177, 178
in aqueous extract of 100 grams of sam- and § 179.45 of this chapter, shall com-
ple (as calculated in paragraph (d)(3)(ii) ply with any specifications and limita-
of this section) minus milliequivalents tions prescribed by such regulation for
of ionic chlorine in aqueous extract of
the article in the finished form in

ER01JA93.405</GPH>
100 grams of sample (as calculated in which it is to contact food.

paragraph (d)(3)(iii) of this section).
339
ER01JA93.404</GPH>
§ 177.1990 21 CFR Ch. I (4–1–21 Edition)
(f) The provisions of this section are (2) The weight average molecular
not applicable to vinyl chloride-pro- weight of the copolymer is not less
pylene copolymers used in food-pack- than 50,000 when determined by gel per-
aging adhesives complying with meation chromatography using tetra-
§ 175.105 of this chapter. hydrofuran as the solvent. The gel per-
meation chromatograph is calibrated
FR 10111, Mar. 19, 1984] with polystyrene standards. The basic
gel permeation chromatographic meth-
§ 177.1990 Vinylidene chloride/methyl od is described in ANSI/ASTM D3536–76,
acrylate copolymers. ‘‘Standard Test Method for Molecular
The vinylidene chloride/methyl acry- Weight Averages and Molecular Weight
late copolymers (CAS Reg. No. 25038– Distribution of Polystyrene by Liquid
72–6) identified in paragraph (a) of this Exclusion Chromatography (Gel Per-
section may be safely used as an article meation Chromatography-GPC),’’
or as a component of an article in- which is incorporated by reference.
tended for use in contact with food sub- Copies are available from University
ject to the provisions of this section. Microfilms International, 300 North
(a) Identity. For the purposes of this Zeeb Rd., Ann Arbor, MI 48106, or avail-
section vinylidene chloride/methyl ac- able for inspection at the National Ar-
rylate copolymers consist of basic co- chives and Records Administration
polymers produced by the copolym- (NARA). For information on the avail-
erization of vinylidene chloride and ability of this material at NARA, call
methyl acrylate such that the copoly- 202–741–6030, or go to: http://
mers contain not more than 15 weight- www.archives.gov/federallregister/
percent of polymer units derived from codeloflfederallregulations/
methyl acrylate. ibrllocations.html.
(b) Optional adjuvant substances. The (3) Residual vinylidene chloride and
basic vinylidene chloride/methyl acry- residual methyl acrylate in the copoly-
late copolymers identified in paragraph mer in the form in which it will con-
(a) of this section may contain optional tact food (unsupported film, barrier
adjuvant substances required in the layer, or as a copolymer for blending)
production of such basic copolymers. will not exceed 10 parts per million and
These optional adjuvant substances 5 parts per million, respectively, as de-
may include substances permitted for termined by either a gas
such use by regulations in parts 170 chromatographic method titled ‘‘De-
through 179 of this chapter, substances termination of Residual Vinylidene
generally recognized as safe in food, Chloride and Methyl Acrylate in Vinyl-
and substances used in accordance with idene Chloride/Methyl Acrylate Co-
a prior sanction or approval. polymer Resins and Films,’’ or, alter-
(c) Specifications. (1) The methyl acry- natively, ‘‘Residual Methyl Acrylate
late content is determined by an infra- and Vinylidene Chloride Monomers in
red spectrophotometric method titled Saran MA/VDC Resins and Pellets by
‘‘Determination of Copolymer Ratio in Headspace Gas Chromatography,’’
Vinylidene Chloride/Methyl Acrylate dated March 3, 1986, which are incor-
Copolymers,’’ which is incorporated by porated by reference in accordance
reference. Copies are available from with 5 U.S.C. 552(a). Copies are avail-
the Center for Food Safety and Applied able from the Center for Food Safety
Nutrition (HFS–200), Food and Drug and Applied Nutrition (HFS–200), Food
Administration, 5001 Campus Dr., Col- and Drug Administration, 5001 Campus
lege Park, MD 20740, or available for in- Dr., College Park, MD 20740, or avail-
spection at the National Archives and able for inspection at the National Ar-
Records Administration (NARA). For chives and Records Administration
information on the availability of this (NARA). For information on the avail-
material at NARA, call 202–741–6030, or ability of this material at NARA, call
go to: http://www.archives.gov/fed- 202–741–6030, or go to: http://
erallregister/ www.archives.gov/federallregister/
codeloflfederallregulations/ codeloflfederallregulations/
ibrllocations.html. ibrllocations.html.
340
(d) Extractives limitations. The basic the copolymerization of vinylidene

copolymer resin in the form of granules chloride/methyl acrylate/methyl meth-
that will pass through a U.S. Standard acrylate such that the basic polymers
Sieve No. 45 (350 microns) shall meet or the finished food-contact articles
the following extractives limitations: meet the specifications prescribed in
(1) 10-gram samples of the resin, paragraph (d) of this section.
when extracted separately with 100 (b) Optional adjuvant substances. The
milliliters of distilled water at 121 °C basic vinylidene chloride/methyl acry-
(250 °F) for 2 hours, and 100 milliliters late/methyl methacrylate polymers
of n-heptane at 66 °C (150 °F) for 2 identified in paragraph (a) of this sec-
hours, shall yield total nonvolatile ex- tion may contain optional adjuvant
tractives not to exceed 0.5 percent by substances required in the production
weight of the resin. of such basic polymers. These optional
(2) The basic copolymer in the form adjuvant substances may include sub-
of film when extracted separately with stances permitted for such use by regu-
distilled water at 121 °C (250 °F) for 2 lations in parts 170 through 179 of this
hours shall yield total nonvolatile ex- chapter, substances generally recog-
tractives not to exceed 0.047 milligram nized as safe in food, and substances
per square centimeter (0.3 milligram used in accordance with a prior sanc-
per square inch). tion of approval.
(e) Conditions of use. The copolymers (c) Conditions of use. The polymers
may be safely used as articles or com- may be safely used as articles or as
ponents of articles intended for use in components of articles intended for use
producing, manufacturing, processing, in producing, manufacturing, proc-
preparing, treating, packaging, trans- essing, preparing, treating, packaging,
porting, or holding food, including transporting, or holding food, including
processing of packaged food at tem- processing of packaged food at tem-
peratures not to exceed 135 °C (275 °F). peratures up to 121 °C (250 °F).
(f) Other specifications and limitations. (d) Specifications and limitations. The
The vinylidene chloride-methyl acry- vinylidene chloride/methyl acrylate/
late copolymers identified in and com- methyl methacrylate basic polymers
plying with this section, when used as and/or finished food-contact articles
components of the food contact surface meet the following specifications and
of any article that is subject to a regu- limitations:
lation in parts 174 through 178 and (1)(i) The basic vinylidene chloride/
§ 179.45 of this chapter, shall comply methyl acrylate/methyl methacrylate
with any specifications and limitations polymers contain not more than 2
prescribed by such regulation for the weight percent of polymer units de-
article in the finished form in which it rived from methyl acrylate monomer
is to contact food. and not more than 6 weight percent of
[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. polymer units derived from methyl
31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer.
1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to
a thickness of not more than 0.005 cen-
§ 177.2000 Vinylidene chloride/methyl timeter (0.002 inches).
acrylate/methyl methacrylate poly- (2) The weight average molecular
mers. weight of the basic polymer is not less
The vinylidene chloride/methyl acry- than 100,000 when determined by gel
late/methyl methacrylate polymers permeation chromatography using tet-
(CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel
paragraph (a) of this section may be permeation chromatography is cali-
safely used as articles or as a compo- brated with polystyrene standards. The
nent of articles intended for use in con- basic gel permeation chromatographic
tact with food subject to the provisions method is described in ANSI/ASTM
of this section. D3536–76, which is incorporated by ref-
(a) Identity. For the purpose of this erence. Copies are available from the
section, vinylidene chloride/methyl ac- American Society for Testing Mate-
rylate/methyl methacrylate polymers rials, 100 Barr Harbor Dr., West

consist of basic polymers produced by Conshohocken, Philadelphia, PA 19428-
341
§ 177.2210 21 CFR Ch. I (4–1–21 Edition)
2959, or available for inspection at the Methods for the specifications in this
National Archives and Records Admin- paragraph (b), titled ‘‘Chlorine and
istration (NARA). For information on Bromine—Coulometric Titration Meth-
the availability of this material at od by Aminco Chloridometer,’’
NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter-
www.archives.gov/federallregister/ mination of Sulfur by Parr Bomb,’’ and
codeloflfederallregulations/ ASTM method D2857–70 (Reapproved
ibrllocations.html. 1977), ‘‘Standard Test Method for Di-
(3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’
article described in paragraph (a) of are incorporated by reference. Copies
this section, when extracted with the of the ASTM method may be obtained
solvent or solvents characterizing the from the American Society for Testing
type of food and under the conditions Materials, 100 Barr Harbor Dr., West
of time and temperature characterizing Conshohocken, Philadelphia, PA 19428-
the conditions of its intended use as de- 2959. Copies of the other two methods
termined from tables 1 and 2 of are available from the Center for Food
§ 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS–
chloroform-soluble extractives in each 200), Food and Drug Administration,
extracting solvent not to exceed .08 5001 Campus Dr., College Park, MD
milligram per square centimeter (0.5 20740. Copies of all three methods may
milligram per square inch) of food-con- be examined at the National Archives
tact surface when tested by the meth- and Records Administration (NARA).
ods described in § 176.170(d). If the fin- For information on the availability of
ished food-contact article is itself the this material at NARA, call 202–741–
subject of a regulation in parts 174 6030, or go to: http://www.archives.gov/
through 178 and § 179.45 of this chapter, federallregister/
it shall also comply with any specifica- codeloflfederallregulations/
tions and limitations prescribed for it ibrllocations.html.
by the regulation. (c) The additive is used as the article,
or a component of articles, intended for
[49 FR 29578, July 23, 1984]
use as liners and covers for reservoirs
intended for the storage of water for
Subpart C—Substances for Use drinking purposes.
Only as Components of Arti- (d) Substances permitted by § 177.2600
cles Intended for Repeated may be employed in the preparation of
Use ethylene polymers, chlorosulfonated,
subject to any limitations prescribed
§ 177.2210 Ethylene polymer, chloro- therein.
sulfonated. (e) The finished ethylene copolymers,
Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to
as identified in this section may be § 177.2600(e) and (g).
safely used as an article or component [42 FR 14572, Mar. 15, 1977, as amended at 49
of articles intended for use in contact FR 10111, Mar. 19, 1984; 54 FR 24898, June 12,
with food, subject to the provisions of 1989]
this section.
(a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly-
sulfonated is produced by chloro- meric.
sulfonation of a carbon tetrachloride Microporous polymeric filters identi-
solution of polyethylene with chlorine fied in paragraph (a) of this section
and sulfuryl chloride. may be safely used, subject to the pro-
(b) Ethylene polymer, chloro- visions of this section, to remove par-
sulfonated shall meet the following ticles of insoluble matter in producing,
specifications: manufacturing, processing, and pre-
(1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food.
by weight. (a) Microporous polymeric filters
(2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin-
by weight. uous, polymeric matrix of polyvinyl
(3) Molecular weight is in the range chloride, vinyl chloride-propylene, or

of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which
342
finely divided silicon dioxide is embed- (c) Any substance employed in the
ded. Cyclohexanone may be used as a production of resin-bonded filters that
solvent in the production of the filters. is the subject of a regulation in parts
(b) Any substance employed in the 174, 175, 176, 177, 178 and § 179.45 of this
production of microporous polymeric chapter conforms with any specifica-
filters that is the subject of a regulation in such regulation.
tion in parts 170 through 189 of this (d) Substances employed in the pro-
chapter must conform with any speci- duction of resin-bonded filters include
fication in such regulation. the following, subject to any limita-
(c) Cyclohexanone when used as a sol- tions provided:
vent in the production of the filters
shall not exceed 0.35 percent by weight LIST OF SUBSTANCES AND LIMITATIONS
of the microporous polymeric filters. (1) Fibers:
(d) The microporous polymeric filters
may be colored with colorants used in Cellulose pulp.
accordance with § 178.3297 of this chap- Cotton.
ter. Nylon. (From nylon resins complying with
the provisions of applicable regulations in
(e) The temperature of food being subchapter B of this chapter.
processed through the microporous pol- Polyethylene terephthalate complying in
ymeric filters shall not exceed 180 °F. composition with the provisions of
(f) The microporous polymeric filters § 177.1630; for use in inline filtration only as
shall be maintained in a sanitary man- provided for in paragraphs (e) and (f) of
ner in accordance with good manufac- this section.
turing practice so as to prevent poten- Rayon (viscose).
tial microbial adulteration of the food. (2) Substances employed in fiber fin-
(g) To assure safe use of the micro- ishing:
porous polymeric filters, the label or
labeling shall include adequate direc- BHT.
Butyl (or isobutyl) palmitate or stearate.
tions for a pre-use treatment, con- 2,5-Di-tert-butyl hydroquinone for use only in
sisting of washing with a minimum of lubricant formulations for rayon fiber fin-
2 gallons of potable water at a tem- ishing and at a usage level not to exceed
perature of 180 °F for each square foot 0.1 percent by weight of the lubricant for-
of filter, prior to the filter’s first use in mulations.
contact with food. Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sul-
[42 FR 14572, Mar. 15, 1977, as amended at 56 fate for use only as a lubricant in the man-
FR 42933, Aug. 30, 1991] ufacture of polyethylene terephthalate fi-
bers specified in paragraph (d)(1) of this
§ 177.2260 Filters, resin-bonded. section at a level not to exceed 0.03 percent
Resin-bonded filters may be safely by weight of the finished fibers.
used in producing, manufacturing, Fatty acid (C10-C18) diethanolamide conden-
sates.
processing, and preparing food, subject Fatty acids derived from animal or vegetable
to the provisions of this section. fats and oils, and salts of such acids, sin-
(a) Resin-bonded filters are prepared gle or mixed, as follows:
from natural or synthetic fibers to Aluminum.
which have been added substances re- Ammonium.
quired in their preparation and fin- Calcium.
ishing, and which are bonded with res- Magnesium.
Potassium.
ins prepared by condensation or polym- Sodium.
erization of resin-forming materials, Triethanolamine.
together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of
quired in their preparation, applica- polyoxyethylene glycol (molecular weight
tion, and curing. 400–3,000).
(b) The quantity of any substance Methyl esters of fatty acids (C10-C18).
employed in the production of the Mineral oil.
Polybutene, hydrogenated; complying with
resin-bonded filter does not exceed the
the identity prescribed under § 178.3740 (b)
amount reasonably required to accom- of this chapter.
plish the intended physical or technical
Polyoxyethylene (4 mols) ethylenediamine

effect or any limitation further pro- monolauramide for use only in lubricant
vided. formulations for rayon fiber finishing and
343
§ 177.2260 21 CFR Ch. I (4–1–21 Edition)
at a usage level not to exceed 10 percent by (2) Conditions of use. It is used to fil-
weight of the lubricant formulations. ter milk or potable water at operating
Ricebran oil. temperatures not to exceed 100 °F.
Titanium dioxide. (f) Resin-bonded filters conforming
(3) Resins: with the specifications of paragraph
(f)(1) of this section are used as pro-
Acrylic polymers produced by polymerizing vided in paragraph (e)(2) of this sec-
ethyl acrylate alone or with one or more of tion:
the monomers: Acrylic acid, acrylonitrile,
N-methylolacrylamide, and styrene. The (1) Total extractives. The finished fil-
finished copolymers shall contain at least ter, when exposed to distilled water at
70 weight percent of polymer units derived 145 °F for 2 hours, yields total extrac-
from ethyl acrylate, no more than 2 weight tives not to exceed 4 percent by weight
percent of total polymer units derived of the filter.
from acrylic acid, no more than 10 weight (2) Conditions of use. It is used to fil-
percent of total polymer units derived
ter milk or potable water at operating
from acrylonitrile, no more than 2 weight
percent of total polymer units derived temperatures not to exceed 145 °F.
from N-methylolacrylamide, and no more (g) Resin-bonded filters conforming
than 25 weight percent of total polymer with the specifications of paragraph
units derived from styrene. For use only as (g)(1) of this section are used as pro-
provided in paragraph (m) of this section. vided in paragraph (g)(2) of this sec-
Melamine-formaldehyde. tion:
Melamine-formaldehyde chemically modified (1) Total extractives. The finished fil-
with one or more of the amine catalysts
ter, when exposed to n-hexane at reflux
identified in § 175.300(b)(3)(xiii) of this chap-
ter. temperature for 2 hours, yields total
Melamine-formaldehyde chemically modified extractives not to exceed 0.5 percent by
with methyl alcohol. weight of the filter.
Melamine-formaldehyde chemically modified (2) Conditions of use. It is used to fil-
with urea; for use only as provided for in ter edible oils.
paragraphs (e), (f), (g), (h), and (i) of this (h) Resin-bonded filters conforming
section. with the specifications of paragraph
Phenol-formaldehyde resins. (h)(1) of this section are used as pro-
Polyvinyl alcohol. vided in paragraph (h)(2) of this sec-
Polyvinyl alcohol with the copolymer of tion:
acrylic acid-allyl sucrose.
Polyvinyl alcohol with melamine formalde-
(1) Total extractives. The finished fil-
hyde. ter, when exposed to distilled water at
Polyvinyl acetate with melamine formalde- 212 °F for 2 hours, yields total extrac-
hyde. tives not to exceed 4 percent by weight
p--Toluenesulfonamide-formaldehyde chemi- of the filter.
cally modified with one or more of the (2) Conditions of use. It is used to fil-
amine catalysts identified in § 175.300 ter milk, coffee, tea, and potable water
(b)(3)(xiii) of this chapter. at temperatures not to exceed 212 °F.
(4) Adjuvant substances: (i) Resin-bonded filters conforming
with the specifications of paragraph
Dimethyl polysiloxane with methylcellulose (i)(1) of this section are used as pro-
and sorbic acid (as an antifoaming agent).
vided in paragraph (i)(2) of this section:
Phosphoric acid.
(5) Colorants: Colorants used in ac- ter, when exposed to distilled water for
cordance with § 178.3297 of this chapter. 2 hours at a temperature equivalent to,
(e) Resin-bonded filters conforming or higher than, the filtration tempera-
with the specifications of paragraph ture of the aqueous food, yields total
(e)(1) of this section are used as pro- extractives not to exceed 4 percent, by
vided in paragraph (e)(2) of this sec- weight, of the filter.
tion: (2) Conditions of use. It is used in com-
(1) Total extractives. The finished fil- mercial filtration of bulk quantities of
ter, when exposed to distilled water at nonalcoholic, aqueous foods having a
100 °F for 2 hours, yields total extrac- pH above 5.0.
tives not to exceed 2.8 percent by (j) Resin-bonded filters conforming

weight of the filter. with the specifications of paragraph
344
(j)(1) of this section are used as pro- not to exceed 1 percent by weight of
vided in paragraph (j)(2) of this section: the filter.
(1) Total extractives. The finished fil- (2) The finished filter may be used to
ter, when exposed to 5 percent (by filter milk or potable water at oper-
weight) acetic acid for 2 hours at a ating temperatures not to exceed 145
temperature equivalent to, or higher °F, provided that the finished filter
than, the filtration temperature of the when exposed to distilled water at 145
aqueous food, yields total extractives °F for 2 hours yields total extractives
not to exceed 4 percent, by weight, of not to exceed 1.2 percent by weight of
the filter. the filter.
(2) Conditions of use. It is used in com- (n) Acrylonitrile copolymers identi-
mercial filtration of bulk quantities of fied in this section shall comply with
nonalcoholic, aqueous foods having a the provisions of § 180.22 of this chap-
pH of 5.0 or below. ter.
(k) Resin-bonded filters conforming
with the specifications of paragraph FR 42933, Aug. 30, 1991]
(k)(1) of this section are used as pro-
vided in paragraph (k)(2) of this sec- § 177.2280 4,4′-Isopropylidenediphenol-
tion: epichlorohydrin thermosetting
(1) Total extractives. The finished fil- epoxy resins.
ter, when exposed to 8 percent (by vol- 4,4′-Isopropylidenediphenol-epichlo-
ume) ethyl alcohol in distilled water rohydrin thermosetting epoxy resins
for 2 hours at a temperature equivalent may be safely used as articles or com-
to, or higher than, the filtration tem- ponents of articles intended for re-
perature of the alcoholic beverage, peated use in producing, manufac-
yields total extractives not to exceed 4 turing, packing, processing, preparing,
percent, by weight, of the filter. treating, packaging, transporting, or
(2) Conditions of use. It is used in com- holding food, in accordance with the
mercial filtration of bulk quantities of following prescribed conditions:
alcoholic beverages containing not (a) The basic thermosetting epoxy
more than 8 percent alcohol. resin is made by reacting 4,4′-
(l) Resin-bonded filters conforming isopropylidenediphenol with epichloro-
with the specifications of paragraph hydrin.
(l)(1) of this section are used as pro-
(b) The resin may contain one or
vided in paragraph (l)(2) of this section:
more of the following optional sub-
stances provided the quantity used
ter, when exposed to 50 percent (by vol-
does not exceed that reasonably re-
ume) ethyl alcohol in distilled water
quired to accomplish the intended ef-
for 2 hours at a temperature equivalent
fect:
to, or higher than, the filtration tem-
perature of the alcoholic beverage, Allyl glycidyl ether .................. As curing system additive.
yields total extractives not to exceed 4 Di- and tri-glycidyl ester mix- As modifier at levels not to
percent, by weight, of the filter. ture resulting from the re- exceed equal parts by
action of epichlorohydrin weight of the 4,4′-
(2) Conditions of use. It is used in com- with mixed dimers and isopropylidenediphenol-
mercial filtration of bulk quantities of trimers of unsaturated C18 epichlorohydrin basic resin
alcoholic beverages containing more monobasic fatty acids de- and limited to use in con-
rived from animal and veg- tact with alcoholic bev-
than 8 percent alcohol. etable fats and oils. erages containing not more
(m) Resin-bonded filters fabricated than 8 percent of alcohol.
from acrylic polymers as provided in 1,2-Epoxy-3-phenoxypropane As curing system additive.
paragraph (d)(3) of this section to- Glyoxal ................................... Do.
4,4′-Isopropylidenediphenol ... Do.
gether with other substances as pro- 4,4′-Methylenedianiline .......... Do.
vided in paragraph (d), (1), (2), and (4) m-Phenylenediamine ............. Do.
of this section may be used as follows: Tetrahydrophthalic anhydride Do.
(1) The finished filter may be used to
filter milk or potable water at oper- (c) In accordance with good manufac-
ating temperatures not to exceed 100 turing practice, finished articles con-
°F, provided that the finished filter taining the resins shall be thoroughly
when exposed to distilled water at 100 cleansed prior to their first use in con-
°F for 2 hours yields total extractives tact with food.
345
§ 177.2355 21 CFR Ch. I (4–1–21 Edition)
(d) The provisions of this section are prior to their first use in contact with
not applicable to 4,4′-isopropylidenedi- food.
phenol-epichlorohydrin resins listed in
[42 FR 54533, Oct. 7, 1977, as amended at 42 FR
other sections of parts 174, 175, 176, 177,
61594, Dec. 6, 1977]
178 and 179 of this chapter.
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, § 177.2400 Perfluorocarbon cured
1984] elastomers.
§ 177.2355 Mineral reinforced nylon Perfluorocarbon cured elastomers

resins. identified in paragraph (a) of this sec-
tion may be safely used as articles or
Mineral reinforced nylon resins iden-
components of articles intended for re-
tified in paragraph (a) of this section
peated use in contact with nonacid
may be safely used as articles or com-
food (pH above 5.0), subject to the pro-
ponents of articles intended for re-
visions of this section.
peated use in contact with nonacidic
food (pH above 5.0) and at use tempera- (a) Identity. (1) For the purpose of
tures not exceeding 212 °F. in accord- this section, perfluorocarbon cured
ance with the following prescribed con- elastomers are produced by
ditions: terpolymerizing tetrafluorethylene
(a) For the purpose of this section (CAS Reg. No. 116–14–3),
the mineral reinforced nylon resins perfluoromethyl vinyl ether (CAS Reg.
consist of nylon 66, as identified in and No. 1187–93–5), and perfluoro-2-
complying with the specifications of phenoxypropyl vinyl ether (CAS Reg.
§ 177.1500, reinforced with up to 40 No. 24520–19–2) and subsequent curing of
weight percent of calcium silicate and the terpolymer (CAS Reg. No. 26658–70–
up to 0.5 weight percent 3- 8) using the crosslinking agent, phenol,
(triethoxysilyl) propylamine (Chemical 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)
Abstracts Service Registry No. ethylidene] bis-,dipotassium salt (CAS
000919302) based on the weight of the Reg. No. 25088–69–1) and accelerator,
calcium silicate. 1,4,7,10,13,16-hexaoxacyclooctadecane
(b) The mineral reinforced nylon res- (CAS Reg. No. 17455–13–9).
ins may contain up to 0.2 percent by (2) The perfluorocarbon base polymer
weight of titanium dioxide as an op- shall contain no less than 40 weight-
tional adjuvant substance. percent of polymer units derived from
(c) The mineral reinforced nylon res- tetrafluoroethylene, no less than 40
ins with or without the optional sub- weight-percent of polymer units de-
stance described in paragraph (b) of rived from perfluoromethyl vinyl ether
this section, and in the form of 1⁄8-inch and no more than 5 weight-percent
molded test bars, when extracted with polymer units derived from perfluoro-2-
the solvents, i.e., distilled water and 50 phenoxy-propyl vinyl ether.
percent (by volume) ethyl alcohol in (3) The composition limitations of
distilled water, at reflux temperature the cured elastomer, calculated as
for 24 hours using a volume-to-surface parts per 100 parts of terpolymer, are
ratio of 2 milliliters of solvent per as follows:
square inch of surface tested, shall
meet the following extractives limita- Phenol, 4,4′-[2,2,2-trifluoro-1-
(trifluoromethyl)-ethylidene] bis-
tions:
,dipotassium salt—not to exceed 5 parts.
(1) Total extractives not to exceed 5.0
1,4,7,10,13,16-Hexaoxacyclo-octadecane—not
milligrams per square inch of food-con- to exceed 5 parts.
tact surface tested for each solvent.
(2) The ash after ignition of the ex- (b) Optional adjuvant substances. The
tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden-
of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section
gram per square inch of food-contact may contain the following optional ad-
surface tested. juvant substances, subject to any limi-
(d) In accordance with good manufac- tations cited on their use:
turing practice, finished articles con- (1) Substances generally recognized
taining the mineral reinforced nylon as safe (GRAS) in food or food pack-
resins shall be thoroughly cleansed aging.
346
(2) Substances used in accordance shall meet the following extractability

with a prior sanction. limits:
(3) Substances authorized under ap- (1) Total extractives not to exceed 3.1
plicable regulations in this part and in milligrams per square decimeter (0.2
parts 175 and 178 of this chapter and milligrams per square inch).
subject to any limitations prescribed (2) Fluoride extractives calculated as
therein. fluorine not to exceed 0.47 milligram
(4) Substances identified in this para- per square decimeter (0.03 milligram
graph (b)(4) subject to such limitations per square inch).
as are provided: (e) Conditions of use. In accordance
with current good manufacturing prac-
Substances Limitations tice, finished food contact articles con-
Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured
ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned
process) (CAS Reg. No. terpolymer. prior to their first use in contact with
1333–86–4).
Magnesium oxide (CAS Reg. Not to exceed 5 parts per
food.
No. 1309–48–4). 100 parts of the [49 FR 43050, Oct. 26, 1984]
terpolymer.
§ 177.2410 Phenolic resins in molded
(c) Specifications—(1) Infrared identi- articles.
fication. Perfluorocarbon cured Phenolic resins identified in this sec-
elastomers may be identified by the tion may be safely used as the food-
characteristic infrared spectra of the contact surface of molded articles in-
pyrolysate breakdown product that is tended for repeated use in contact with
obtained by heating and decomposing nonacid food (pH above 5.0), in accord-
the elastomer using the method enti- ance with the following prescribed con-
tled ‘‘Qualitative Identification of ditions:
Kalrez ® by Infrared Examination of (a) For the purpose of this section,
Pyrolysate.’’ This method is incor- the phenolic resins are those produced
porated by reference. Copies of the when one or more of the phenols listed
method are available from the Center in paragraph (a)(1) of this section are
for Food Safety and Applied Nutrition made to react with one or more of the
(HFS–200), Food and Drug Administra- aldehydes listed in paragraph (a)(2) of
tion, 5001 Campus Dr., College Park, this section, with or without aniline
MD 20740, or available for inspection at and/or anhydro-formaldehyde aniline
the National Archives and Records Ad- (hexahydro-1, 3,5-triphenyl-s-triazine):
ministration (NARA). For information (1) Phenols:
on the availability of this material at
NARA, call 202–741–6030, or go to: http:// p-tert-Amylphenol.
www.archives.gov/federallregister/ p-tert-Butylphenol.
o-, m-, and p-Cresol.
codeloflfederallregulations/ p-Octylphenol.
ibrllocations.html. Phenol.
(2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro-
cured elastomers have a major decom- duced when phenol is made to react with
position peak occurring at 490° ±15 °C styrene in the presence of sulfuric acid cat-
(914 °F). Less than 1.5 percent of the alyst.
elastomers will volatilize below 400 °C (2) Aldehydes:
(752 °F) when run under nitrogen at a 10
°C or 18 °F per minute heating rate Acetaldehyde.
Formaldehyde.
using a Du Pont Thermal Analyzer Paraldehyde.
Model 1099 with Model 951 TGA unit or
the equivalent. (b) Optional adjuvant substances em-
(d) Extractive limitations. Articles fab- ployed in the production of the phe-
ricated from perfluorocarbon cured nolic resins or added thereto to impart
elastomers having a thickness of at desired technical or physical properties
least 1.0 millimeter (0.039 inch) when include the following:
extracted at reflux temperatures for 2
Asbestos fiber.
hours separately with distilled water, Barium hydroxide ................... For use as catalyst.
50 percent ethanol, and n-heptane, Calcium stearate .................... For use as lubricant.
347
§ 177.2415 21 CFR Ch. I (4–1–21 Edition)
Carbon black (channel proc- scribed in § 174.5(d) of this chapter and
ess).
Diatomaceous earth.
the following:
Glass fiber. Substance Limitations
Hexamethylenetetramine ....... For use as curing agent.
Mica. Diphenyl sulfone .................... Not to exceed 0.2 percent by
Oxalic acid ............................. For use as catalyst. weight as a residual sol-
Zinc stearate .......................... For use as lubricant. vent in the finished basic
resin.
(c) The finished food-contact article,
when extracted with distilled water at (c) Extractive limitations. The finished
reflux temperature for 2 hours, using a food contact article, when extracted at
volume-to-surface ratio of 2 milliliters reflux temperatures for 2 hours with
of distilled water per square inch of the following four solvents, yields in
surface tested, shall meet the following each extracting solvent net chloroform
extractives limitations: soluble extractives not to exceed 0.05
(1) Total extractives not to exceed milligrams per square inch of food con-
0.15 milligram per square inch of food- tact surface: Distilled water, 50 percent
contact surface. (by volume) ethanol in distilled water,
(2) Extracted phenol not to exceed 3 percent acetic acid in distilled water,
0.005 milligram per square inch of food- and n-heptane. In testing the final food
contact surface. contact article, a separate test sample
shall be used for each extracting sol-
(3) No extracted aniline when tested
vent.
by a spectrophotometric method sen-
sitive to 0.006 milligram of aniline per- [63 FR 20315, Apr. 24, 1998]
square inch of food-contact surface.
(d) In accordance with good manufac- § 177.2420 Polyester resins, cross-
linked.
turing practice, finished molded arti-
cles containing the phenolic resins Cross-linked polyester resins may be
shall be thoroughly cleansed prior to safely used as articles or components
their first use in contact with food. of articles intended for repeated use in
contact with food, in accordance with
§ 177.2415 Poly(aryletherketone) res- the following prescribed conditions:
ins. (a) The cross-linked polyester resins
Poly(aryletherketone) resins identi- are produced by the condensation of
fied in paragraph (a) of this section one or more of the acids listed in para-
may be safely used as articles or com- graph (a)(1) of this section with one or
ponents of articles intended for re- more of the alcohols or epoxides listed
peated use in contact with food subject in paragraph (a)(2) of this section, fol-
to the provisions of this section. lowed by copolymerization with one or
(a) Identity. For the purposes of this more of the cross-linking agents listed
section, poly(aryletherketone) resins in paragraph (a)(3) of this section:
are poly(p-oxyphenylene p- (1) Acids:
oxyphenylene p-carboxyphenylene) res- Adipic.
ins (CAS Reg. No. 29658–26–2) produced Fatty acids, and dimers thereof, from nat-
by the polymerization of hydroquinone ural sources.
and 4,4′-difluorobenzophenone, and Fumaric.
Isophthalic.
have a minimum weight-average mo- Maleic.
lecular weight of 12,000, as determined Methacrylic.
by gel permeation chromatography in Orthophthalic.
comparison with polystyrene stand- Sebacic.
ards, and a minimum mid-point glass Terephthalic.
transition temperature of 142 °C, as de- Trimellitic.
termined by differential scanning (2) Polyols and polyepoxides:
calorimetry.
(b) Optional adjuvant substances. The Butylene glycol.
Diethylene glycol.
basic resins identified in paragraph (a) 2,2-Dimethyl-1,3-propanediol.
may contain optional adjuvant sub-
Dipropylene glycol.
stances used in their production. These Ethylene glycol.
adjuvants may include substances de- Glycerol.
348
4,4′-Isopropylidenediphenol-epichlorohydrin. Methyl methacrylate.
Mannitol. Styrene.
a-Methyl glucoside. Triglycidyl isocyanurate (CAS Reg. No. 2451–
Pentaerythritol. 62–9), for use only in coatings contacting
Polyoxypropylene ethers of 4,4′-isopropylide- bulk quantities of dry food of the type
nediphenol (containing an average of 2–7.5 identified in § 176.170(c) of this chapter,
moles of propylene oxide). table 1, under type VIII.
Propylene glycol. Vinyl toluene.
Sorbitol. (b) Optional adjuvant substances em-
Trimethylol ethane.
ployed to facilitate the production of
Trimethylol propane.
2,2,4-Trimethyl-1,3-pentanediol.
the resins or added thereto to impart
desired technical or physical properties
(3) Cross-linking agents: include the following, provided that
Butyl acrylate. the quantity used does not exceed that
Butyl methacrylate. reasonably required to accomplish the
Ethyl acrylate. intended physical or technical effect
Ethylhexyl acrylate. and does not exceed any limitations
Methyl acrylate. prescribed in this section:
Limitations (limits of addition expressed as percent by weight
List of substances of finished resin)
1. Inhibitors: Total not to exceed 0.08 percent.

Benzoquinone ....................................................................... 0.01 percent.
tert-Butyl catechol.
TBHQ.
Di-tert-butyl hydroquinone.
Hydroquinone.
2. Accelerators: Total not to exceed 1.5 percent.
Benzyl trimethyl ammonium chloride ................................... 0.05 percent.
Calcium naphthenate.
Cobalt naphthenate.
Copper naphthenate.
N, N-Diethylaniline ................................................................ 0.4 percent.
N, N-Dimethylaniline ............................................................. Do.
Ethylene guanidine hydrochloride ........................................ 0.05 percent.
3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ke-
tone peroxide may be used as the sole catalyst at levels not
to exceed 2 percent.
Azo-bis-isobutyronitrile.
Benzoyl peroxide.
tert-Butyl perbenzoate.
Chlorbenzoyl peroxide.
Cumene hydroperoxide.
Dibutyltin oxide (CAS Reg. No. 818–08–6) ......................... For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Dicumyl peroxide.
Hydroxybutyltin oxide (CAS Reg. No. 2273–43–0) ............. For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Lauroyl peroxide.
p-Menthane hydroperoxide.
Methyl ethyl ketone peroxide.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850– For use in the polycondensation reaction at levels not to ex-
94–4). ceed 0.2 percent of the polyester resin.
4. Solvents for inhibitors, accelerators, and catalysts:
Butyl benzyl phthalate (containing not more than 1.0 per-
cent by weight of dibenzyl phthalate).
Dibutyl phthalate.
Diethylene glycol .................................................................. As a solvent for benzyl trimethyl ammonium chloride or ethyl-
ene guanidine hydrochloride only.
Dimethyl phthalate.
Methyl alcohol.
Styrene.
Triphenyl phosphate.
5. Reinforcements:
Asbestos.
Glass fiber.
Polyester fiber produced by the condensation of one or
more of the acids listed in paragraph (a)(1) of this sec-

tion with one or more of the alcohols listed in paragraph
(a)(2) of this section.
349
§ 177.2430 21 CFR Ch. I (4–1–21 Edition)
Limitations (limits of addition expressed as percent by weight

List of substances of finished resin)
6. Miscellaneous materials:
Castor oil, hydrogenated.
a-Methylstyrene.
Polyethylene glycol 6000.
Silicon dioxide.
Wax, petroleum .................................................................... Complying with § 178.3710 of this chapter.
(c) The cross-linked polyester resins, (b) In accordance with good manufac-
with or without the optional sub- turing practice, finished articles con-
stances described in paragraph (b) of taining the chlorinated polyether res-
this section, and in the finished form in ins shall be thoroughly cleansed prior
which they are to contact food, when to their first use in contact with food.
extracted with the solvent or solvents
characterizing the type of food and § 177.2440 Polyethersulfone resins.
under the conditions of time and tem- Polyethersulfone resins identified in
perature characterizing the conditions paragraph (a) of this section may be
of their intended use, as determined safely used as articles or components
from tables 1 and 2 of § 176.170(c) of this of articles intended for repeated use in
chapter, shall meet the following ex- contact with food in accordance with
tractives limitations: the following prescribed conditions:
(1) Net chloroform-soluble extrac- (a) For the purpose of this section,
tives not to exceed 0.1 milligram per polyethersulfone resins are:
square inch of food-contact surface (1) Poly(oxy-p-phenylenesulfonyl-p-
tested when the prescribed food-simu- phenylene) resins (CAS Reg. No. 25667–
lating solvent is water or 8 or 50 per- 42–9), which have a minimum number
cent alcohol. average molecular weight of 16,000.
(2) Total nonvolatile extractives not (2) 1,1′-sulfonylbis[4-chlorobenzene]
to exceed 0.1 milligram per square inch polymer with 4,4′-(1-methylethyl-
of food-contact surface tested when the idene)bis[phenol] (maximum 8 percent)
prescribed food-simulating solvent is and 4,4′-sulfonylbis[phenol] (minimum
heptane. 92 percent) (CAS Reg. No. 88285–91–0),
(d) In accordance with good manufac- which have a minimum number aver-
turing practice, finished articles con- age molecular weight of 26,000.
taining the cross-linked polyester res- (3) In paragraphs (a)(1) and (a)(2) of
ins shall be thoroughly cleansed prior this section, the minimum number av-
to their first use in contact with food. erage molecular weight is determined
by reduced viscosity in dimethyl form-
[42 FR 14572, Mar. 15, 1977, as amended at 48 amide in accordance with ASTM meth-
FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, od D2857–70 (Reapproved 1977), ‘‘Stand-
1989]
ard Test Method for Dilute Solution
Viscosity of Polymers,’’ which is incor-
§ 177.2430 Polyether resins,
chlorinated. porated by reference. Copies may be
Chlorinated polyether resins may be for Testing Materials, 100 Barr Harbor
safely used as articles or components Dr., West Conshohocken, Philadelphia,
of articles intended for repeated use in PA 19428-2959, or may be examined at
producing, manufacturing, packing, the Office of Food Additive Safety
processing, preparing, treating, pack- (HFS–200), Center for Food Safety and
aging, transporting, or holding food, in Applied Nutrition, Food and Drug Ad-
accordance with the following pre- ministration, 5001 Campus Dr., College
scribed conditions: Park, MD 20740, 240–402–1200 or at the
(a) The chlorinated polyether resins National Archives and Records Admin-
are produced by the catalytic polym- istration (NARA). For information on
erization of 3,3-bis(chloromethyl)- the availability of this material at
oxetane, and shall contain not more NARA, call 202–741–6030, or go to: http://
than 2 percent residual monomer. www.archives.gov/federallregister/
350
codeloflfederallregulations/ (2) The polyamide-imide resins (CAS

ibrllocations.html. Reg. No. 31957–38–7) derived from the
(b) The basic resins identified in condensation reaction of equimolar
paragraphs (a)(1) and (a)(2) of this sec- parts of benzoyl chloride-3,4-
tion may contain optional adjuvant dicarboxylic anhydride and 4,4′-
substances described in § 174.5(d) of this diphenylmethanediamine.
chapter and the following: (b) Specifications. (1) Polyamide-imide
resins identified in paragraph (a)(1) of
List of substances Limitations this section shall have a nitrogen con-
Diphenylsulfone ................ Not to exceed 0.2 percent as re-
tent of not less than 7.8 weight percent
sidual solvent in the finished and not more than 8.2 weight percent.
basic resin described in para- Polyamide-imide resins identified in
graph (a)(1) of this section. paragraph (a)(2) of this section shall
Dimethyl sulfoxide ............ Not to exceed 0.01 percent as
residual solvent in the finished
have a nitrogen content of not less
basic resin described in para- than 7.5 weight percent and not more
graph (a)(1) of this section. than 7.8 weight percent. Nitrogen con-
N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as tent is determined by the Dumas Nitro-
residual solvent in the finished
basic resin described in para- gen Determination as set forth in the
graph (a)(2) of this section. ‘‘Official Methods of Analysis of the
Association of Official Analytical
(c) The finished food-contact article, Chemists,’’ 13th Ed. (1980), sections
when extracted at reflux temperatures 7.016–7.020, which is incorporated by
for 2 hours with the following four sol- reference in accordance with 5 U.S.C.
vents, yields net chloroform-soluble ex- 552(a). Copies may be obtained from the
tractives in each extracting solvent AOAC INTERNATIONAL, 481 North
not to exceed 0.02 milligram per square Frederick Ave., suite 500, Gaithersburg,
inch of food-contact surface: distilled MD 20877, or may be examined at the
water, 50 percent (by volume) ethyl al- National Archives and Records Admin-
cohol in distilled water, 3 percent ace- istration (NARA). For information on
tic acid in distilled water, and n- the availability of this material at
heptane. (Note: In testing the finished NARA, call 202–741–6030, or go to: http://
food-contact article, use a separate www.archives.gov/federallregister/
test sample for each required extract- codeloflfederallregulations/
ing solvent.) ibrllocations.html.
(d) In accordance with good manufac- (2) Polyamide-imide resins identified
turing practice, finished food-contact in paragraph (a)(1) of this section shall
articles containing the have a solution viscosity of not less
polyethersulfone resins shall be thor- than 1.200. Polyamide-imide resins
oughly cleansed before their first use identified in paragraph (a)(2) of this
in contact with food. section shall have a solution viscosity
of not less than 1.190. Solution vis-
[44 FR 34493, June 15, 1979, as amended at 47 cosity shall be determined by a method
FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, titled ‘‘Solution Viscosity’’ which is in-
1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, corporated by reference in accordance
Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013]
with 5 U.S.C. 552(a). Copies are avail-
able from the Center for Food Safety
§ 177.2450 Polyamide-imide resins.
and Applied Nutrition (HFS–200), Food
Polyamide-imide resins identified in and Drug Administration, 5001 Campus
paragraph (a) of this section may be Dr., College Park, MD 20740, or avail-
safely used as components of articles able for inspection at the National Ar-
intended for repeated use in contact chives and Records Administration
with food, in accordance with the fol- (NARA). For information on the avail-
lowing prescribed conditions: ability of this material at NARA, call
(a) Identity. (1) For the purpose of 202–741–6030, or go to: http://
this section the polyamide-imide resins www.archives.gov/federallregister/
are derived from the condensation re- codeloflfederallregulations/
action of substantially equimolar parts ibrllocations.html.
of trimellitic anhydride and p,p′- (3) The polyamide-imide resins iden-

diphenylmethane diisocyanate. tified in paragraph (a)(1) of this section
351
§ 177.2460 21 CFR Ch. I (4–1–21 Edition)
are heat cured at 600 °F for 15 minutes amide-imide resins identified in para-
when prepared for extraction tests and graph (a) of this section and intended
the residual monomers: p,p- for repeated use shall be thoroughly
diphenylmethane diisocyanate should cleansed prior to their first use in con-
not be present at greater than 100 parts tact with food.
per million and trimellitic anhydride [42 FR 14572, Mar. 15, 1977, as amended at 47
should not be present at greater than FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19,
500 parts per million. Residual mono- 1984; 54 FR 24898, June 12, 1989; 54 FR 43170,
mers are determined by gas chroma- Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR
tography (the gas chromatography 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
method titled ‘‘Amide-Imide Polymer
Analysis—Analysis of Monomer Con- § 177.2460 Poly(2,6-dimethyl-1,4-phen-
tent,’’ is incorporated by reference in ylene) oxide resins.
accordance with 5 U.S.C. 552(a). Copies The poly(2,6-dimethyl-1,4-phenylene)
are available from the Center for Food oxide resins identified in paragraph (a)
Safety and Applied Nutrition (HFS– of this section may be used as an arti-
200), Food and Drug Administration, cle or as a component of an article in-
5001 Campus Dr., College Park, MD tended for use in contact with food sub-
20740, or available for inspection at the ject to the provisions of this section.
National Archives and Records Admin- (a) Identity. For the purposes of this
istration (NARA). For information on section, poly(2,6-dimethyl-1,4-phen-
the availability of this material at ylene) oxide resins consist of basic res-
NARA, call 202–741–6030, or go to: http:// ins produced by the oxidative coupling
www.archives.gov/federallregister/ of 2,6-xylenol such that the finished
codeloflfederallregulations/ basic resins meet the specifications
ibrllocations.html.). and extractives limitations prescribed
(c) Extractive limitations are appli- in paragraph (c) of this section.
cable to the polyamide-imide resins (b) Optional adjuvant substances. The
identified in paragraphs (a)(1) and (2) of basic poly(2,6-dimethyl-1,4-phenylene)
this section in the form of films of 1 oxide resins identified in paragraph (a)
mil uniform thickness after coating of this section may contain optional
and heat curing at 600 °F for 15 minutes adjuvant substances required in the
on stainless steel plates, each having production of such basic resins. The op-
such resin-coated surface area of 100 tional adjuvant substances required in
square inches. The cured-resin film the production of the basic poly(2,6-di-
coatings shall be extracted in accord- methyl-1,4-phenylene) oxide resins may
ance with the method described in include substances permitted for such
§ 176.170(d)(3) of this chapter, using a use by regulations in parts 170 through
plurality of spaced, coated stainless 189 of this chapter, substances gen-
steel plates, exposed to the respective erally recognized as safe in food, sub-
food simulating solvents. The resin stances used in accordance with a prior
shall meet the following extractive sanction or approval, and the fol-
limitations under the corresponding lowing:
extraction conditions: Limitations (expressed as
(1) Distilled water at 250 °F for 2 List of substances percent by weight of finished
hours: Not to exceed 0.01 milligram per basic resin)
square inch. Diethylamine .......................... Not to exceed 0.16 percent
(2) Three percent acetic acid at 212 °F as residual catalyst.
for 2 hours: Not to exceed 0.05 milli- Methyl alcohol ........................ Not to exceed 0.02 percent
as residual solvent.
gram per square inch. Toluene .................................. Not to exceed 0.2 percent as
(3) Fifty percent ethyl alcohol at 160 residual solvent.
°F for 2 hours: Not to exceed 0.03 milli-
gram per square inch. (c) Specifications and extractives limita-
(4) n-Heptane at 150 °F for 2 hours: tions. The poly(2,6-dimethyl-1,4-phen-
Not to exceed 0.05 milligram per square ylene) oxide basic resins meet the fol-
inch. lowing:
(d) In accordance with good manufac- (1) Specifications. Intrinsic viscosity
turing practice, those food contact ar- is not less than 0.30 deciliter per gram
ticles, having as components the poly- as determined by ASTM method D1243–
352
79, ‘‘Standard Test Method for Dilute (d) Other limitations. The poly(2,6-di-
Solution Viscosity of Vinyl Chloride methyl-1,4-phenylene) oxide resins
Polymers,’’ which is incorporated by identified in and complying with this
reference, modified as follows. Copies section, when used as components of
of the incorporation by reference may the food-contact surface of any article
be obtained from the American Society that is the subject of a regulation in
for Testing Materials, 100 Barr Harbor parts 174, 175, 176, 177, 178 and § 179.45 of
Dr., West Conshohocken, Philadelphia, this chapter, shall comply with any
PA 19428-2959, or may be examined at specifications and limitations pre-
the National Archives and Records Ad- scribed by such regulation for the arti-
ministration (NARA). For information cle in the finished form in which it is
on the availability of this material at to contact food.
NARA, call 202–741–6030, or go to: http:// (e) Uses. The poly(2,6-dimethyl-1,4-
www.archives.gov/federallregister/ phenylene) oxide resins identified in
codeloflfederallregulations/ and complying with the limitations in
ibrllocations.html. this section may be used as articles or
(i) Solvent: Chloroform, reagent grade components of articles intended for re-
containing 0.01 percent tert- peated food-contact use or as articles
butylcatechol. or components of articles intended for
(ii) Resin sample: Powdered resin ob- single-service food-contact use only
tained from production prior to mold- under the conditions described in
ing or extrusion. § 176.170(c) of this chapter, table 2, con-
(iii) Viscometer: Cannno-Ubbelohde se- ditions of use H.
ries 25 dilution viscometer (or equiva- [42 FR 14572, Mar. 15, 1977, as amended at 49
lent). FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23,
(iv) Calculation: The calculation 1998]
method used is that described in appen-
dix X.1.3 (ASTM method D1243–79, cited § 177.2465 Polymethylmethacrylate/
and incorporated by reference in para- poly(trimethoxysilylpropyl)meth-
graph (c)(1) of this section) with the re- acrylate copolymers.
duced viscosity determined for three Polymethylmethacrylate/
concentration levels (0.4, 0.2, and 0.1 poly(trimethoxysilylpropyl) methacry-
gram per deciliter) and extrapolated to late copolymers (CAS Reg. No. 26936–
zero concentration for intrinisic vis- 30–1) may be safely used as components
cosity. The following formula is used of surface primers used in conjunction
for determining reduced viscosity: with silicone polymers intended for re-
peated use and complying with § 175.300
Reduced viscosity in terms t − t o of this chapter and § 177.2600, in accord-
of deciliters per gram = t × c ance with the following prescribed con-
ditions.
o
where: (a) Identity. For the purpose of this
t = Solution efflux time. section, polymethylmethacrylate/
to = Solvent efflux time. poly(trimethoxysilylpropyl)methacry-
c = Concentration of solution in terms of late copolymers are produced by the
grams per deciliter. polymerization of methylmethacrylate
(2) Extractives limitations. Total resin and
extracted not to exceed 0.02 weight-per- trimethoxysilylpropylmethacrylate.
cent when extracted with n-heptane at (b) Conditions of use. (1) The
160 °F for 2 hours as determined using polymethylmethacrylate/
200 milliliters of reagent grade n- poly(trimethoxysilylpropyl)methacry-
heptane which has been freshly dis- late copolymers are used at levels not
tilled before use and 25 grams of poly to exceed 6.0 percent by weight of the
(2,-6-dimethyl-1,4-phenylene) oxide primer formulation.
resin. The resin as tested is in pellet (2) The copolymers may be used in
form having a particle size such that food contact applications with all food
100 percent of the pellets will pass types under conditions of use B
through a U.S. Standard Sieve No. 6 through H as described in table 2 of
and 100 percent of the pellets will be § 176.170(c) of this chapter.

held on a U.S. Standard Sieve No. 10. [59 FR 5948, Feb. 9, 1994]
353
ER01JA93.406</GPH>
§ 177.2470 21 CFR Ch. I (4–1–21 Edition)
§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec-

mer. ular weight of the copolymer is 15,000
Polyoxymethylene copolymer identi- as determined by a method titled
fied in this section may be safely used ‘‘Number Average Molecular Weight,’’
as an article or component of articles which is incorporated by reference.
intended for food-contact use in ac- Copies are available from the Center
cordance with the following prescribed for Food Safety and Applied Nutrition
conditions: (HFS–200), Food and Drug Administra-
(a) Identity. For the purpose of this tion, 5001 Campus Dr., College Park,
section, polyoxymethylene copolymers MD 20740, or available for inspection at
are identified as the following: The re- the National Archives and Records Ad-
action product of trioxane (cyclic ministration (NARA). For information
trimer of formaldehyde) and ethylene on the availability of this material at
oxide (CAS Reg. No. 24969–25–3) or the NARA, call 202–741–6030, or go to: http://
reaction product of trioxane (cyclic www.archives.gov/federallregister/
trimer of formaldehyde) and a max- codeloflfederallregulations/
imum of 5 percent by weight of ibrllocations.html.
butanediol formal (CAS Reg. No. 25214
(d) Extractive limitations. (1) Polyoxy-
85–1). Both copolymers may have cer-
methylene copolymer in the finished
tain optional substances added to im-
part desired technological properties to form in which it is to contact food,
the copolymer. when extracted with the solvent or sol-
(b) Optional adjuvant substances. The vents characterizing the type of food
polyoxymethylene copolymer identi- and under conditions of time and tem-
fied in paragraph (a) of this section perature as determined from tables 1
may contain optional adjuvant sub- and 2 of § 175.300(d) of this chapter,
stances required in its production. The shall yield net chloroform-soluble ex-
quantity of any optional adjuvant sub- tractives not to exceed 0.5 milligram
stance employed in the production of per square inch of food-contact surface.
the copolymer does not exceed the (2) Polyoxymethylene copolymer
amount reasonably required to accom- with or without the optional sub-
plish the intended technical or physical stances described in paragraph (b) of
effect. Such adjuvants may include this section, when ground or cut into
substances generally recognized as safe particles that pass through a U.S.A.
in food, substances used in accordance Standard Sieve No. 6 and that are re-
with prior sanction, substances per- tained on a U.S.A. Standard Sieve No.
mitted under applicable regulations in 10, shall yield total extractives as fol-
parts 170 through 189 of this chapter, lows:
and the following:
(i) Not to exceed 0.20 percent by
(1) Stabilizers (total amount of stabi-
weight of the copolymer when ex-
lizers not to exceed 2.0 percent and
amount of any one stabilizer not to extracted for 6 hours with distilled water
ceed 1.0 percent of polymer by weight) at reflux temperature.
(ii) Not to exceed 0.15 percent by
Calcium ricinoleate. weight of the copolymer when ex-
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-
tracted for 6 hours with n-heptane at
hydroxyhydrocinnamate) (CAS Reg. No. reflux temperature.
35074–77–2). (e) Conditions of use. (1) The
Melamine-formaldehyde resin. polyoxymethylene copolymer is for use
2,2′-Methylenebis(4-methyl-6-tert-butyl- as articles or components of articles
phenol).
Nylon 6/66, weight ratio 2/3.
intended for repeated use.
Tetrakis [methylene (3,5-di-tert-butyl-4- (2) Use temperature shall not exceed
hydroxyhydrocinnamate)] methane. 250 °F.
(2) Lubricant: N,N′Distearoylethyl- (3) In accordance with good manufac-
enediamine. turing practice, finished articles con-
(c) Specifications. (1) Polyoxymeth- taining polyoxymethylene copolymer
ylene copolymer can be identified by

its characteristic infrared spectrum.
354
shall be thoroughly cleansed before Substances Limitations

their first use in contact with food.
Nylon 66/610/6 terpolymer, At a maximum level of 1.5
[42 FR 14572, Mar. 15, 1977, as amended at 48 respective proportions of percent by weight of
nylon polymers by weight homopolymer.
FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15,
are: 3/2/4.
1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Nylon 612/6 copolymer (CAS Do.
May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR Reg. No. 51733-10-9),
24898, June 12, 1989] weight ratio 6/1.
Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5
§ 177.2480 Polyoxymethylene butyl-4-hydroxy-hydro- percent by weight of
cinnamate)] methane. homopolymer.
homopolymer.
Polyoxymethylene homopolymer (2) Lubricant. N,N′-Distearoylethyl-
identified in this section may be safely enediamine.
used as articles or components of arti- (3) Molding assistant. Polyethylene
cles intended for food-contact use in glycol 6,000.
accordance with the following pre- (c) Specifications. (1)
scribed conditions: Polyoxymethylene homopolymer can
(a) Identity. For the purpose of this be identified by its characteristic in-
section, polyoxymethylene homopoly- frared spectrum.
mer is polymerized formaldehyde (2) Minimum number average molec-
[Chemical Abstracts Service Registry ular weight of the homopolymer is
No. 9002–81–7]. Certain optional adju- 25,000.
vant substances, described in para- (3) Density of the homopolymer is be-
graph (b) of this section, may be added tween 1.39 and 1.44 as determined by
to impart desired technological prop- ASTM method D1505–68 (Reapproved
erties to the homopolymer. 1979), ‘‘Standard Test Method for Den-
(b) Optional adjuvant substances. The sity of Plastics by the Density-Gra-
polyoxymethylene homopolymer iden- dient Technique,’’ which is incor-
tified in paragraph (a) of this section porated by reference. Copies may be
may contain optional adjuvant sub- obtained from the American Society
stances in its production. The quantity for Testing Materials, 100 Barr Harbor
of any optional adjuvant substance em- Dr., West Conshohocken, Philadelphia,
ployed in the production of the PA 19428-2959, or may be examined at
homopolymer does not exceed the the National Archives and Records Ad-
amount reasonably required to accom- ministration (NARA). For information
plish the intended effect. Such adju- on the availability of this material at
vants may include substances gen- NARA, call 202–741–6030, or go to: http://
erally recognized as safe in food, sub- www.archives.gov/federallregister/
stances used in accordance with prior codeloflfederallregulations/
sanction, substances permitted under ibrllocations.html.
applicable regulations in this part, and (4) Melting point is between 172 °C
the following: and 184 °C as determined by ASTM
method D2133–66, ‘‘Specifications for
(1) Stabilizers. The homopolymer may
Acetal Resin Injection Molding and Ex-
contain one or more of the following
trusion Materials’’ (Revised 1966),
stabilizers. The total amount of stabi-
which is incorporated by reference.
lizers shall not exceed 1.9 percent of
Copies are available from American So-
homopolymer by weight, and the quan-
ciety for Testing and Materials
tity of individual stabilizer used shall
(ASTM), 100 Barr Harbor Dr., West
not exceed the limitations set forth
Conshohocken, Philadelphia, PA 19428-
below:
Substances Limitations National Archives and Records Admin-
Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- the availability of this material at
butyl-4-hydroxy-hydro- cent by weight of
cinnamate) (CAS Reg. No. homopolymer. The finished NARA, call 202–741–6030, or go to: http://
35074–77–2). articles shall not be used www.archives.gov/federallregister/
for foods containing more codeloflfederallregulations/
than 8 percent alcohol.
ibrllocations.html.
2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5

tert-butylphenol). percent by weight of (d) Extractive limitations. (1)
homopolymer. Polyoxymethylene homopolymer, in
355
§ 177.2490 21 CFR Ch. I (4–1–21 Edition)
the finished form which is to contact cleansed prior to first use in contact
food, when extracted with the solvent with food.
or solvents characterizing the type of [42 FR 14572, Mar. 15, 1977, as amended at 43
food and under conditions of time and FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19,
temperature characterizing the condi- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111,
tions of intended use under paragraphs Mar. 19, 1984; 54 FR 24898, June 12, 1989]
(c)(3) and (d) of § 175.300 of this chapter
§ 177.2490 Polyphenylene sulfide res-
and as limited by paragraph (e) of this ins.
section, shall yield net chloroform-
soluble extractives not to exceed 0.5 Polyphenylene sulfide resins
milligram per square inch of food-con- (poly(1,4-phenylene sulfide) resins) may
tact surface. be safely used as coatings or compo-
nents of coatings of articles intended
(2) Polyoxymethylene homopolymer,
for repeated use in contact with food,
with or without the optional adjuvant in accordance with the following pre-
substances described in paragraph (b) scribed conditions.
of this section, when ground or cut into (a) Polyphenylene sulfide resins con-
particles that pass through a U.S.A. sist of basic resins produced by the re-
Standard Sieve No. 6 and that are reaction of equimolar parts of p-
tained on a U.S.A. Standard Sieve No. dichlorobenzene and sodium sulfide,
10, shall yield extractives as follows: such that the finished resins meet the
(i) Formaldehyde not to exceed 0.0050 following specifications as determined
percent by weight of homopolymer as by methods titled ‘‘Oxygen Flask Com-
determined by a method titled ‘‘Form- bustion-Gravimetric Method for Deter-
aldehyde Release and Formaldehyde mination of Sulfur in Organic Com-
Analysis,’’ which is incorporated by pounds,’’ ‘‘Determination of the Inher-
reference. Copies are available from ent Viscosity of Polyphenylene Sul-
Center for Food Safety and Applied Nu- fide,’’ and ‘‘Analysis for
trition (HFS–200) Food and Drug Ad- Dichlorobenzene in Ryton
ministration, 5001 Campus Dr., College Polyphenylene Sulfide,’’ which are in-
Park, MD 20740, or available for inspec- corporated by reference. Copies are
tion at the National Archives and available from the Center for Food
Records Administration (NARA). For Safety and Applied Nutrition (HFS–
200), Food and Drug Administration,
information on the availability of this
5001 Campus Dr., College Park, MD
material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/fed-
erallregister/ istration (NARA). For information on
codeloflfederallregulations/ the availability of this material at
ibrllocations.html. NARA, call 202–741–6030, or go to: http://
(ii) Total extractives not to exceed www.archives.gov/federallregister/
0.20 percent by weight of homopolymer codeloflfederallregulations/
when extracted for 6 hours with dis- ibrllocations.html.
tilled water at reflux temperature and (1) Sulfur content: 28.2–29.1 percent
0.15 percent by weight of homopolymer by weight of finished resin.
when extracted for 6 hours with n- (2) Minimum inherent viscosity: 0.13
heptane at reflux temperature. deciliters per gram.
(e) Conditions of use. (1) Polyoxy- (3) Maximum residual p-
methylene homopolymer is for use as dichlorobenzene: 0.8 ppm.
articles or components of articles in- (b) Subject to any limitations pre-
tended for repeated use. scribed in parts 170 through 189 of this
(2) Use temperature shall not exceed chapter, the following optional sub-
250 °F. stances may be added to the
polyphenylene sulfide basic resins in an
(3) In accordance with good manufac-
amount not to exceed that reasonably
turing practice, finished articles con- required to accomplish the intended
taining polyoxymethylene physical or technical effect.
homopolymer shall be thoroughly (1) Substances generally recognized

as safe in food.
356
(2) Substances used in accordance acetic acid such that the finished res-
with prior sanction or approval. ins meet the specifications set forth in
(3) Substances the use of which is paragraph (c) of this section. The
permitted in coatings under regula- polyphenylene sulfide used to manufac-
tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared
chapter. by the reaction of sodium sulfide and p-
(c) The finished coatings are ther- dichlorobenzene, and has a minimum
mally cured at temperatures of 700 °F weight average molecular weight of
and above. 5,000 Daltons.
(d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The
ings may be used in contact with food basic polyphenylene sulfone resins
at temperatures not to exceed the boil- identified in paragraph (a) of this sec-
ing point of water; provided that the tion may contain optional adjuvant
finished cured coating, when extracted substances required in the production
at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad-
rately with distilled water, 50 percent juvant substances may include sub-
ethanol in water, and 3 percent acetic stances permitted for such use by regu-
acid, yields total extractives in each lations in parts 170 through 189 of this
extracting solvent not to exceed 0.02 chapter, substances generally recog-
milligram per square inch of surface nized as safe in food, or substances
and when extracted at reflux tempera- used in accordance with a prior sanc-
ture for 8 hours with heptane yields tion or approval.
total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition
ligram per square inch of surface. temperature of the polymer is 360±5 °C
(e) Polyphenylene sulfide resin coat- as determined by the use of differential
ings containing perfluorocarbon resins scanning calorimetry.
complying with § 177.1550 may be used
in contact with food at temperatures [65 FR 15058, Mar. 21, 2000]
up to and including normal baking and
frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res-
finished cured coating, when extracted ins.
at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may
rately with distilled water, 50 percent be safely used as articles or compo-
ethanol in water, 3 percent acetic acid nents of articles intended for repeated
and heptane, yields total extractives in use in contact with food, in accordance
each extracting solvent not to exceed with the following prescribed condi-
0.2 milligram per square inch of surface tions:
and when extracted at reflux tempera- (a) For the purpose of this section,
ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con-
yields total extractives not to exceed sist of basic resins produced by the po-
4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride.
face. (b) The finished food-contact article,
[42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures
FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled
1989] water, 50 percent (by volume) ethyl al-
cohol in distilled water, and n-heptane,
§ 177.2500 Polyphenylene sulfone res- yields total extractives in each ex-
ins. tracting solvent not to exceed 0.01 mil-
The polyphenylene sulfone resins ligram per square inch of food-contact
(CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food-
paragraph (a) of this section may be contact article is itself the subject of a
safely used as articles or components regulation in parts 174, 175, 176, 177, 178
of articles intended for repeated use in and § 179.45 of this chapter, it shall also
contact with food, subject to the provi- comply with any specifications and
sions of this section. limitations prescribed for it by that
(a) Identity. For the purpose of this regulation. (NOTE: In testing the fin-
section, polyphenylene sulfone resins ished food-contact article, use a sepa-
consist of basic resin produced by re- rate test sample for each required ex-
acting polyphenylene sulfide with per- tracting solvent.)
357
§ 177.2550 21 CFR Ch. I (4–1–21 Edition)
(c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0).
turing practice, finished food-contact The membrane is the food contact sur-
articles containing the polyvinylidene face and may be applied as a film on a
fluoride resins shall be thoroughly suitable support. Its maximum weight
cleansed prior to their first use in con- is 512 milligrams per square decimeter
tact with food. (33 milligrams per square inch).
(4) A cross-linked high molecular
§ 177.2550 Reverse osmosis mem-
branes. weight polyamide reaction product of
poly(N-vinyl-N-methylamine) (CAS
Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3-
(a) of this section may be safely used as aminopropyl)ethylenediamine (CAS
reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3-
for use in processing bulk quantities of
benzenedicarbonyl dichloride (CAS
liquid food to separate permeate from
Reg. No. 99–63–8) and 1,3,5-
food concentrate or in purifying water
benzenetricarbonyl trichloride (CAS
for food manufacturing under the fol-
Reg. No. 4422–95–1). The membrane is
lowing prescribed conditions:
(a) Identity. For the purpose of this the food-contact surface. Its maximum
section, reverse osmosis membranes weight is 20 milligrams per square deci-
may consist of either of the following meter (1.3 milligrams per square inch)
formulations: as a thin film composite on a suitable
(1) A cross-linked high molecular support.
weight polyamide reaction product of (5) A polyamide reaction product of
1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride
with 1,3-benzenediamine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with
83044–99–9) or piperazine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and
110–85–0). The membrane is on the food- 1,2-diaminoethane (CAS Reg. No. 107–
contact surface, and its maximum 15–3). The membrane is the food-con-
weight is 62 milligrams per square deci- tact layer and may be applied as a film
meter (4 milligrams per square inch) as on a suitable support. Its maximum
a thin film composite on a suitable weight is 15 milligrams per square deci-
support. meter (1 milligram per square inch).
(2) A cross-linked polyetheramine (b) Optional adjuvant substances. The
(CAS Reg. No. 101747–84–6), identified as basic polymer identified in paragraph
the copolymer of epichlorohydrin, 1,2- (a) of this section may contain optional
ethanediamine and 1,2-dichloroethane, adjuvant substances required in the
whose surface is the reaction product production of such basic polymer.
of this copolymer with 2,4- These optional adjuvant substances
toluenediisocyanate (CAS Reg. No. of may include substances permitted for
the final polymer is 99811–80–0) for use such use by regulations in parts 170
as the food-contact surface of reverse
through 186 of this chapter, substances
osmosis membranes used in processing
generally recognized as safe in food,
liquid food. The composite membrane
and substances used in accordance with
is on the food-contact surface and its
maximum weight is 4.7 milligrams per a prior sanction or approval.
square decimeter (0.3 milligrams per (c) Supports. Suitable supports for re-
square inch) as a thin film composite verse osmosis membranes are mate-
on a suitable support. The maximum rials permitted for such use by regula-
weight of the 2,4-toluenediisocyanate tions in parts 170 through 186 of this
component of the thin film composite chapter, substances generally recog-
is 0.47 milligrams per square decimeter nized as safe in food, and substances
(0.03 milligrams per square inch). used in accordance with a prior sanc-
(3) For the purpose of this section, tion or approval.
the reverse osmosis membrane consists (d) Conditions of use. (1) Reverse os-
of a polyaramide identified as 2,4- mosis membranes described in para-
diaminobenzenesulfonic acid, calcium graphs (a)(1), (a)(2), (a)(3), and (a)(5) of
salt (2:1) polymer with 1,3- this section may be used in contact
benzenediamine, 1,3-benzenedicarbonyl with all types of liquid food at tem-

dichloride, and 1,4-benzenedicarbonyl peratures up to 80 °C (176 °F).
358
(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and
scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with
tion may be used in contact with all any specification in such regulation.
types of liquid food, except food con- (i) Elastomers.
taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer.
temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers
(3) Reverse osmosis membranes shall complying with § 177.1210.
be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol
accordance with current good manufac- dimethacrylate copolymers containing not
turing practice so as to prevent micro- more than 5 weight percent of polymer
bial adulteration of food. units derived from ethylene glycol
dimethacrylate.
(4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co-
osmosis membranes and their supports polymer.
shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly-
their first use in accordance with cur- mer.
rent good manufacturing practice. Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride
[49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer.
FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers
1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5
Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units de-
rived from 5-methylene-2-norbornene and/
§ 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene.
repeated use. Ethylene-propylene-dicyclopentadiene co-
Rubber articles intended for repeated polymer.
Ethylene-propylene-1,4-hexadiene copoly-
use may be safely used in producing, mers containing no more than 8 weight
manufacturing, packing, processing, percent of total polymer units derived
preparing, treating, packaging, trans- from 1,4-hexadiene.
porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co-
provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro-
(a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly-
from natural and/or synthetic polymers mers are modified by hydrogenation of the
olefinic unsaturation to leave either: (1)
and adjuvant substances as described Not more than 10 percent trans olefinic
in paragraph (c) of this section. unsaturation and no a, b-olefinic
(b) The quantity of any substance unsaturation as determined by a method
employed in the production of rubber entitled ‘‘Determination of Residual a, b-
articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation
not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1,
quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South
Vidal St., Sarnia, Ontario, Canada N7T
fect in the rubber article and shall not
7MI; or (2) 0.4 percent to 20 percent olefinic
be intended to accomplish any effect in unsaturation and Mooney viscosities great-
food. er than 45 (ML 1 + 4 @ 100 °C), as deter-
(c) Substances employed in the prep- mined by ASTM Standard Method D1646–
aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber—
following, subject to any limitations Viscosity and Vulcanization Characteris-
prescribed: tics (Mooney Viscometer),’’ which are both
(1) Substances generally recognized incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Cop-
as safe for use in food or food pack- ies of these methods may be obtained from
aging. the Office of Food Additive Safety (HFS–
(2) Substances used in accordance 200), Center for Food Safety and Applied
with the provisions of a prior sanction Nutrition, Food and Drug Administration,
or approval. 5001 Campus Dr., College Park, MD 20740,
(3) Substances that by regulation in 240–402–1200, or may be examined at the
parts 170 through 189 of this chapter Food and Drug Administration’s Main Li-
may be safely used in rubber articles, brary, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301–
subject to the provisions of such regu-
796–2039, or at the National Archives and
lation. Records Administration (NARA). For in-
(4) Substances identified in this para-
formation on the availability of this mate-

graph (c)(4), provided that any sub- rial at NARA, call 202–741–6030, or go to:
stance that is the subject of a regula- http://www.archives.gov/federallregister/
359
§ 177.2600 21 CFR Ch. I (4–1–21 Edition)
codeloflfederallregulations/ Silicone (Fsi) elastomers containing meth-
ibrllocations.html. A copy of ASTM Stand- yl and fluorine groups.
ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing
from the American Society for Testing and phenyl, methyl, and vinyl groups.
Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer.
Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co-
Isobutylene-isoprene copolymer. polymers (minimum number average mo-
Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os-
Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone).
copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene-
acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum
col). The polyamide and polyether compo- number average molecular weight 100,000
nents are reacted in ratios such that the as determined by osmotic pressure in
polyamide component constitutes a min- methyl ethyl ketone).
imum of 30 weight-percent of total polymer
units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul-
tact with foods of Types I, II, III, IV, V, VI, canizing agents.
VII, VIII, and IX identified in table 1 of
§ 176.170(c) of this chapter at temperatures 4,4′-Bis(aminocyclohexyl)methane carbamate
not to exceed 150 °F except that those co- for use only as cross-linking agent in the
polymers prepared with less than 50 vulcanization of vinylidene
weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer
use in contact with such foods at tempera- and vinylidene fluoride-
tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene
Polybutadiene. copolymer elastomers identified under
Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim-
tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per-
butanediol, and a-hydro-omega- cent by weight of such copolymers.
hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1
tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio-
used as a reactant. The polyester bis-thioformate, O,O-di(1-
elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate,
with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis-
cent alcohol and limited to use in contact thioformate) for use as a cross linking
with food at temperatures not exceeding agent in the vulcanization of natural rub-
150 °F. ber, styrene-butadiene copolymer, acrylo-
Polyisoprene. nitrile-butadiene copolymer, and ethylene-
Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under
1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim-
diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per-
butanediol and polytetramethylene ether cent by weight of such copolymers.
glycol. Hexamethylenediamine carbamate for use
Polyurethane resins derived from reactions only as cross-linking agent in the vul-
of diphenylmethane diisocyanate with canization of vinylidene fluoride-
adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli-
Rubber, natural. dene fluoride-hexafluoropropylene-tetra-
Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden-
method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec-
Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex-
clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly-
erence. Copies may be obtained from the mers.
American Society for Testing Materials, Sulfur, ground.
100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5
amined at the National Archives and percent by weight of rubber product).
Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul-
formation on the availability of this mate- fide.
rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide.
http://www.archives.gov/federallregister/ 1,3-Bis(2-benzothiazolylmercaptomethyl)
codeloflfederallregulations/ urea.
ibrllocations.html. N-tert-Butyl-2-benzothiazole sulfenamide.
Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number
groups. 670–705).
Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine
yl and phenyl groups. reaction product.

Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate.
yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide.
360
Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per-
Dibenzylamine. cent of weight of rubber product).
Diisopropyl xanthogen polysulfide (a 1:2:1
mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine.
bis-thioformate, O,O-di(1- Phthalic anhydride.
methylethyl)tetrathio-bis-thioformate, Salicylic acid.
and O,O-di(1-methylethyl)pentathio-bis-
thioformate). (d) Activators (total not to exceed 5 per-
Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except
895–85–2) for use only as a crosslinking magnesium oxide may be used at higher
agent in silicone polymers and elastomers levels).
identified under paragraph (c)(4)(i) of this
section at levels not to exceed 1 percent by Diethylamine.
weight of such polymers and elastomers Fatty acid amines, mixed.
where the total of all accelerators does not Fatty acids.
exceed 1.5 percent by weight of rubber Magnesium carbonate.
product. Magnesium oxide, light and heavy.
Di-tert-butyl peroxide. Oleic acid, dibutylamine salt
Dibutyl xanthogen disulfide. (dibutylammonium oleate).
2,4-Dichlorobenzoyl peroxide. Stannous chloride.
Dicumyl peroxide. Tall oil fatty acids.
N,N-Dimethylcyclohexylamine salt of Tetrachloro-p-benzoquinone.
dibutyldithiocarbamic acid. Triethanolamine.
2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids.
Dipentamethylenethiuram hexasulfide (CAS
Reg. No. 971–15–3).
(iii) Antioxidants and antiozonants
Diphenylguanidine. (total not to exceed 5 percent by weight of
Diphenylguanidine phthalate. rubber product).
1,3-Diphenyl-2-thiourea.
Aldol-a-naphthylamine.
2,2′-Dithiobis[benzothiazole].
Alkylated (C4 and/or C8) phenols.
4,4′-Dithiodimorpholine.
BHT (butylated hydroxytoluene).
N,N′-Di-o-tolylguanidine.
4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-
Di-o-tolylguanidine salt of
2,6-di-tert-butylphenol (CAS Reg. No. 991–
pyrocatecholborate.
84–4) for use only as a stabilizer at levels
Ethylenediamine carbamate.
not to exceed 0.5 percent by weight of the
Heptaldehyde-aniline resin (iodine number
finished rubber product.
430–445).
Hexamethylenetetramine. Butylated reaction product of p-cresol and
2-Mercaptobenzothiazole. dicyclopentadiene as identified in
2-Mercaptothiazoline. § 178.2010(b) of this chapter.
N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in
sulfenamide. § 178.2010(b) of this chapter.
Piperidinium pentamethylenedithiocarba- 4,4′-Butylidinebis(6-tert-butyl-m-cresol).
mate. N-Cyclohexyl-N′-phenylphenylenediamine.
Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane.
p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone.
Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl
Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl.
Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol.
erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetrabutylthiuram monosulfide. dodecylquinoline.
Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6-
(1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline.
butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetramethylthiuram monosulfide. phenylquinoline.
Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine.
Triallyl cyanurate. 4,6-Dinonyl-o-cresol.
Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine.
1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin.
(triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin.
Triphenylguanidine. N,N′-Diphenylethylenediamine.
Zinc butyl xanathate. N,N′-Disalicylalpropylenediamine.
Zinc dibenzyl dithiocarbamate. N,N′-Di-o-tolylethylenediamine.
Zinc dibutyldithiocarbamate. Hydroquinone monobenzyl ether.
Zinc diethyldithiocarbamate. Isopropoxydiphenylamine.

Zinc 2-mercaptobenzothiazole. N-Isopropyl-N′-phenyl-p-phenylenediamine.
Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol).
361
§ 177.2600 21 CFR Ch. I (4–1–21 Edition)
2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate.
phenol). Dioctyl adipate.
2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate.
2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate.
octylphenol). Dipentene resin.
Monooctyl- and dioctyldiphenylamine. Fatty acids.
N,N′-Di-b-naphthyl-p-phenylenediamine. Fatty acids, hydrogenated.
Phenyl-a-naphthylamine. Isooctyl ester of tall oil fatty acids.
Phenyl-b-naphthylamine. Lanolin.
Phenyl-b-naphthylamine-acetone aromatic a-Methylstyrene-vinyltoluene copolymer
amine resin (average molecular weight 600; resins (molar ratio 1 a-methylstyrene to 3
nitrogen content 5.3 percent). vinyltoluene).
o- and p-Phenylphenol. Mineral oil; (1) In rubber articles complying
Polybutylated (mixture) 4,4′- with this section, not to exceed 30 percent
isopropylidenediphenol. by weight; (2) Alone or in combination
Sodium pentachlorophenate. with waxes, petroleum, total not to exceed
Styrenated cresols produced when 2 moles of 45 percent by weight of rubber articles that
styrene are made to react with 1 mole of a contain at least 20 percent by weight of
mixture of phenol and o-, m-, and p-cresols ethylene-propylene copolymer elastomer
so that the final product has a Brookfield complying with paragraph (c)(4)(i) of this
viscosity at 25 °C of 1400 to 1700 centipoises. section, in contact with foods of Types I,
Styrenated phenol. II, III, IV, VI, VII, VIII, and IX idenified in
4,4′-Thiobis (6-tert-butyl-m-cresol). table 1 of § 176.170(c) of this chapter.
Toluene-2,4-diamine. Montan wax.
N-o-Tolyl-N′-phenyl-p-phenylenediamine. n-Octyl n-decyl adipate.
p(p-Tolylsufanilamide) diphenylamine. n-Octyl n-decyl phthalate.
Tri(mixed mono- and dinonylphenyl) Petrolatum.
phosphite. Petroleum hydrocarbon resin
Tri(nonylphenyl) phosphite-formaldehyde (cyclopentadiene type), hydrogenated.
resins produced when 1 mole of Petroleum hydrocarbon resin (produced by
tri(nonylphenyl) phosphite is made to the homo- and copolymerization of dienes
react with 1.4 moles of formaldehyde or and olefins of the aliphatic, alicyclic, and
produced when 1 mole of nonylphenol is monobenzenoid arylalkene types from dis-
made to react with 0.36 mole of formalde- tillates of cracked petroleum stocks).
hyde and the reaction product is then fur- Petroleum hydrocarbon resin (produced by
ther reacted with 0.33 mole of phosphorus the catalytic polymerization and subse-
trichloride. The finished resins have a min- quent hydrogenation of styrene,
imum viscosity of 20,000 centipoises at 25 vinyltoluene, and indene types from dis-
°C, as determined by LV-series Brookfield tillates of cracked petroleum stocks).
viscometer (or equivalent) using a No. 4 Petroleum oil, sulfonated.
spindle at 12 r.p.m., and have an organic Phenol-formaldehyde resin.
phosphorus content of 4.05 to 4.15 percent Pine tar.
by weight. Polybutene.
(iv) Plasticizers (total not to exceed 30 Polystyrene.
Propylene glycol.
percent by weight of rubber product un-
n-Propyl ester of tall oil fatty acids.
less otherwise specified). Rapeseed oil vulcanized with rubber maker’s
n-Amyl n-decyl phthalate. sulfur.
Butylacetyl ricinoleate. Rosins and rosin derivatives identified in
n-Butyl ester of tall oil fatty acids. § 175.105(c)(5) of this chapter.
Butyl laurate. Soybean oil vulcanized with rubber maker’s
Butyl oleate. sulfur.
Butyl stearate. Styrene-acrylonitrile copolymer.
Calcium stearate. Terpene resins.
Castor oil. Triethylene glycol dicaprate.
Coumarone-indene resins. Triethylene glycol dicaprylate.
2,2′-Dibenzamidodiphenyl disulfide. Waxes, petroleum.
Dibenzyl adipate. Xylene (or toluene) alkylated with
Dibutoxyethoxyethyl adipate. dicyclopentadiene.
Dibutyl phthalate. Zinc 2-benzamidothiophenate.
Dibutyl sebacate. (v) Fillers.
Didecyl adipate.
Didecyl phthalate. Aluminum hydroxide.
Diisodecyl adipate. Aluminum silicate.

Diisodecyl phthalate. Asbestos fiber, chrysotile or crocidolite.
Diisooctyl adipate. Barium sulfate.
362
Carbon black (channel process or furnace levels not to exceed 0.3 percent by weight
combustion process; total carbon black not of the sealants and caulking materials.
to exceed 50 percent by weight of rubber Dodecyl mercaptan isomers, single or mixed.
product; furnace combustion black content 2-Ethoxyethanol.
not to exceed 10 percent by weight of rub- Iodoform.
ber products intended for use in contact p-Menthane hydroperoxide.
with milk or edible oils). a-(p-Nonylphenyl)-omega-hydroxypoly (oxy-
Cork. ethylene) mixture of dihydrogen phosphate
Cotton (floc, fibers, fabric). and monohydrogen phosphate esters, bar-
Mica. ium salt; the nonyl group is a propylene
Nylon (floc, fibers, fabric). trimer isomer and the poly (oxyethylene)
Silica. content averages 9 moles; for use only as
Titanium dioxide. residual polymerization emulsifier at lev-
Zinc carbonate. els not to exceed 0.7 percent by weight of
Zinc sulfide. ethylene-propylene-1,4-hexadiene copoly-
(vi) Colorants. Colorants used in ac- mers identified under paragraph (c)(4)(i) of
cordance with § 178.3297 of this chapter. this section.
4,4′-Oxybis (benzenesulfonhydrazide) as
(vii) Lubricants (total not to exceed 2
chemical blowing agent.
percent by weight of rubber product). Phenothiazine.
Polyethylene. Potassium persulfate.
Sodium stearate. Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
(viii) Emulsifiers. Sodium nitrite.
Fatty acid salts, sodium or potassium. Sodium salt of ethylenediamine tetraacetic
Naphthalene sulfonic acid-formaldehyde con- acid and glycine.
densate, sodium salt. Sodium sulfide.
Rosins and rosin-derivatives identified in Styrene monomer.
§ 175.105(c)(5) of this chapter. Tall oil.
Sodium decylbenzenesulfonate Thioxylenois as peptizing agents.
Sodium dodecylbenzenesulfonate Tridecyl mercaptan.
Sodium lauryl sulfate. Zinc 4-tert-butylthiophenate as peptizing
Tall oil mixed soap (calcium, potassium, and agent.
sodium).
(d) Rubber articles intended for use
(ix) Miscellaneous (total not to exceed 5 with dry food are so formulated and
percent by weight of rubber product). cured under conditions of good manu-
Animal glue as described in § 178.3120 of this facturing practice as to be suitable for
chapter. repeated use.
Azodicarbonamide as chemical blowing (e) Rubber articles intended for re-
agent. peated use in contact with aqueous
2-Anthraquinone sulfonic acid sodium salt food shall meet the following specifica-
for use only as polymerization inhibitor in tions: The food-contact surface of the
chloroprene polymers and not to exceed rubber article in the finished form in
0.03 percent by weight of the chloroprene
polymers.
which it is to contact food, when ex-
1,2-Benzisothiazolin-3-one (CAS Reg. No. tracted with distilled water at reflux
2634–33–5) for use as a biocide in uncured temperature, shall yield total extrac-
liquid rubber latex not to exceed 0.02 per- tives not to exceed 20 milligrams per
cent by weight of the latex solids, where square inch during the first 7 hours of
the total of all items listed in paragraph extraction, nor to exceed 1 milligram
(c)(4)(ix) of this section does not exceed 5 per square inch during the succeeding 2
percent of the rubber product. hours of extraction.
n-Butyllithium for use only as polymeriza-
tion catalyst for polybutadiene. (f) Rubber articles intended for re-
4-tert-Butyl-o-thiocresol as peptizing agent. peated use in contact with fatty foods
tert-Butyl peracetate. shall meet the following specifications:
p-tert-Butylpyrocatechol. The food-contact surface of the rubber
Dialkyl (C8–C18) dimethylammonium chlo- article in the finished form in which it
ride for use only as a flocculating agent in is to contact food, when extracted with
the manufacture of silica. n-hexane at reflux temperature, shall
Di- and triethanolamine.
Diethyl xanthogen disulfide. yield total extractives not to exceed
175 milligrams per square inch during
4-(Diiodomethylsulfonyl) toluene, Chemical

Abstracts Service Registry No. 20018–09–01, the first 7 hours of extraction, nor to
for use as an antifungal preservative at exceed 4 milligrams per square inch
363
§ 177.2710 21 CFR Ch. I (4–1–21 Edition)
during the succeeding 2 hours of ex- taining the resins shall be thoroughly
traction. cleansed prior to their first use in con-
(g) In accordance with good manufac- tact with food.
turing practice finished rubber articles
intended for repeated use in contact § 177.2800 Textiles and textile fibers.
with food shall be thoroughly cleansed Textiles and textile fibers may safely
prior to their first use in contact with be used as articles or components of ar-
food. ticles intended for use in producing,
(h) The provisions of this section are manufacturing, packing, processing,
not applicable to rubber nursing-bottle preparing, treating, packaging, trans-
nipples. porting, or holding food, subject to the
(i) Acrylonitrile copolymers identi- provisions of this section.
fied in this section shall comply with (a) The textiles and textile fibers are
the provisions of § 180.22 of this chap- prepared from one or more of the fibers
ter. identified in paragraph (d) of this sec-
[42 FR 14572, Mar. 15, 1977] tion and from certain other adjuvant
substances required in the production
EDITORIAL NOTE: For FEDERAL REGISTER ci-
of the textiles or textile fibers or added
tations affecting § 177.2600, see the List of
CFR Sections Affected, which appears in the to impart desired properties.
Finding Aids section of the printed volume (b) The quantity of any adjuvant sub-
and at www.govinfo.gov. stance employed in the production of
textiles or textile fibers does not ex-
§ 177.2710 Styrene-divinylbenzene res- ceed the amount reasonably required
ins, cross-linked. to accomplish the intended physical or
Styrene-divinylbenzene cross-linked technical effect or any limitation fur-
copolymer resins may be safely used as ther provided.
articles or components of articles in- (c) Any substance employed in the
tended for repeated use in producing, production of textiles or textile fibers
manufacturing, packing, processing, that is the subject of a regulation in
preparing, treating, packaging, trans- parts 174, 175, 176, 177, 178 and § 179.45 of
porting, or holding food, in accordance this chapter conforms with any speci-
with the following prescribed condi- fication in such regulation.
tions: (d) Substances employed in the pro-
(a) The resins are produced by the co- duction of or added to textiles and tex-
polymerization of styrene with tile fibers may include:
divinylbenzene. (1) Substances generally recognized
(b) The resins meet the extractives as safe in food.
limitations prescribed in this para- (2) Substances subject to prior sanc-
graph: tion or approval for use in textiles and
(1) The resins to be tested are ground textile fibers and used in accordance
or cut into small particles that will with such sanction or approval.
pass through a U.S. standard sieve No. (3) Substances generally recognized
3 and that will be held on a U.S. stand- as safe for use in cotton and cotton fab-
ard sieve No. 20. rics used in dry-food packaging.
(2) A 100-gram sample of the resins, (4) Substances that by regulation in
when extracted with 100 milliliters of this part may safely be used in the pro-
ethyl acetate at reflux temperature for duction of or as a component of tex-
1 hour, yields total extractives not to tiles or textile fibers and subject to
exceed 1 percent by weight of the res- provisions of such regulation.
ins. (5) Substances identified in this para-
(c) In accordance with good manufac- graph (d)(5), subject to such limitations
turing practice, finished articles con- as are provided:
(i) Fibers:
Cotton.
Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use.
the provisions of § 177.1630(e)(4)(ii).
Rayon.
364
(ii) Adjuvant substances:

Aluminum stearate.
Borax .................................................................................... For use as preservative only.
Butyl-acetyl ricinoleate.
Colorants used in accordance with § 178.3297 of this chapter..
Di-tert-butyl hydroquinone.
Dimethylpolysiloxane.
Ethylenediaminetetraacetic acid, sodium salt.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate .......................... For use only as a lubricant in the manufacture of polyethylene
terephthalate fibers specified in paragraph (d)(5)(i) of this
section at a level not to exceed 0.03 percent by weight of
the finished fibers.
Eugenol.
Fats, oils, fatty acids, and fatty alcohols derived from castor,
coconut, cottonseed, fish, mustardseed, palm, peanut,
rapeseed, ricebran, soybean, sperm, and tall oils and tallow.
Fats, oils, fatty acids, and fatty alcohols described in the pre-
ceding item reacted with one or more of the following sub-
stances:
n-Butyl and isobutyl alcohol.
Diethylene glycol.
Diethanolamine.
Glycerol.
Hexylene glycol (2-methyl-2,4-pentanediol).
Hydrogen.
Isopropyl alcohol.
Methyl alcohol.
Oxygen.
Polyethylene glycol (molecular weight 400–3,000).
Potassium hydroxide.
Propylene glycol.
Sodium hydroxide.
Sulfuric acid.
Formaldehyde .............................................................................. For use as preservative only.
Glyceryl mono-12-hydroxystearate.
2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2-
imidazolinium ethyl sulfate.
Hexylene glycol (2-methyl,-2,4-pentanediol).
Isobutyl alcohol.
Isopropyl alcohol.
Kerosene.
Methyl ester of sulfated ricebran oil.
Mineral oil .................................................................................... For use only at a level not to exceed 0.15 percent by weight of
finished fibers.
Mono- and diisopropylated m- and p-cresols (isothymol deriva-
tive).
N-Oleyl, N′-acetyl, N′-b-hydroxy-ethylenediamine.
Petrolatum.
Petroleum sulfonate.
Pine oil.
Polybutene, hydrogenated; complying with the identity pre-
scribed under 21 CFR 178.3740(b) of this chapter.
Polyethylene, oxidized (air blown).
Polyvinyl acetate.
Polyvinyl alcohol.
Potassium soap of a saponified sulfated castor oil.
Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate.
Sodium dioctyl sulfosuccinate.
Sodium dodecyl benzenesulfonate.
Sodium fluoride ............................................................................ For use as preservative only.
Sodium hydrosulfite.
Sodium hypochlorite.
Sodium lauryl sulfate.
Sodium 2-mercaptobenzothiazole ............................................... Do.
Sodium pentachlorophenate ........................................................ Do.
Styrene-butadiene copolymer.
Sulfated butyl, isobutyl and propyl oleate.
Tallow.
Tallow, sulfonated.
Titanium dioxide.
Triethanolamine.
Ultramarine blue.
Waxes, petroleum.
Zinc hydrosulfite.
365
§ 177.2910 21 CFR Ch. I (4–1–21 Edition)
(e) Textile and textile fibers are used practice so as to prevent potential mi-
as articles or components of articles crobial adulteration of the food.
that contact dry food only. (e) Ultrafiltration membranes identi-
(f) The provisions of this section are fied in paragraph (a)(4) may be used to
not applicable to jute fibers used as filter aqueous or acidic foods con-
prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at
chapter. temperatures not to exceed 21 °C (70
°F).
(f) To assure safe use of the ultra-fil-
FR 37042, July 17, 1981; 49 FR 4372, Feb. 6,
1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, tration membranes, the label or label-
Aug. 30, 1991] ing shall include adequate directions
for a pre-use treatment, consisting of
§ 177.2910 Ultra-filtration membranes. conditioning and washing with a min-
imum of 8 gallons of potable water
Ultra-filtration membranes identi-
prior to their first use in contact with
fied in paragraphs (a)(1), (a)(2), (a)(3),
food.
and (a)(4) of this section may be safely
(g) Acrylonitrile copolymers identi-
used in the processing of food, under
fied in this section shall comply with
the following prescribed conditions;
the provisions of § 180.22 of this chap-
(a)(1) Ultra-filtration membranes
ter.
that consist of paper impregnated with
cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53
which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17,
ed with a vinyl chloride-acrylonitrile 1993; 60 FR 54426, Oct. 24, 1995]
copolymer.
(2) Ultra-filtration membranes that
consist of a sintered carbon support PART 178—INDIRECT FOOD ADDI-
that is coated with zirconium oxide TIVES: ADJUVANTS, PRODUCTION
(CAS Reg. No. 1314–23–4) containing up AIDS, AND SANITIZERS
to 12 percent yttrium oxide (CAS Reg.
No. 1314–36–9). Subpart A [Reserved]
(3) Ultra-filtration membranes that
consist of an aluminum oxide support Subpart B—Substances Utilized To Control
that is coated with zirconium oxide the Growth of Microorganisms
(CAS Reg. No. 1314–23–4) containing up Sec.
to 5 percent yttrium oxide (CAS Reg. 178.1005 Hydrogen peroxide solution.
No. 1314–36–9). 178.1010 Sanitizing solutions.
(4) Ultrafiltration membranes that
consist of a microporous Subpart C—Antioxidants and Stabilizers
poly(vinylidene fluoride) membrane
178.2010 Antioxidants and/or stabilizers for
with a hydrophilic surface modifier polymers.
consisting of hydroxypropyl acrylate/ 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl-
tetraethylene glycol diacrylate copoly- phenol.
mer. 178.2650 Organotin stabilizers in vinyl chlo-
(b) Any substance employed in the ride plastics.
production of ultra-filtration mem-
branes that is the subject of a regula- Subpart D—Certain Adjuvants and
tion in parts 174, 175, 176, 177, 178 and Production Aids
§ 179.45 of this chapter conforms with 178.3010 Adjuvant substances used in the
the specifications of such regulation. manufacture of foamed plastics.
(c) Ultra-filtration membranes are 178.3120 Animal glue.
used in the physical separation of dis- 178.3125 Anticorrosive agents.
solved or colloidally suspended varying 178.3130 Antistatic and/or antifogging
molecular size components of liquids agents in food-packaging materials.
178.3280 Castor oil, hydrogenated.
during the commercial processing of
178.3290 Chromic chloride complexes.
bulk quantities of food. 178.3295 Clarifying agents for polymers.
(d) Ultra-filtration membranes shall
178.3297 Colorants for polymers.

be maintained in a sanitary manner in 178.3300 Corrosion inhibitors used for steel
accordance with good manufacturing or tinplate.
366

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§ 176.320 21 CFR Ch.

§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer.

peated use. Ethyl acrylate.

Isopropyl methacrylate. flow promoter at a level not to exceed 3

extraction test without the plastic tents to room temperature if nec-

the p-methoxyphenol solution in the pose of ascertaining compliance with

(ii) The procedure in paragraph ascertaining compliance with the limi-

0.26 Correction factor for aqueous

(iii) The procedure in paragraph ascertaining compliance with the limi-

0.25 Correction factor for 50 percent

13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985]

§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer

to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi-

to be used to fabricate beverage con- Substances Limitations

water, 3 percent acetic acid and n-

120 °F (80 to 90 minutes) and main- used as a component of packaging ma-

(not to exceed 93 °C (200 °F)), water or reagent grade n-

(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene

(a) Identity. For the purpose of this

Substances Limitations go to: http://www.archives.gov/fed-

and cooled to room temperature. A such use by applicable regulations, as

Acrylonitrile-butadiene copolymer resins ..................................... As the basic polymer.

Limitations (residue and limits of addition expressed as percent

N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent.

Limitations (residue and limits of addition expressed as percent

Limitations (residue and limits of addition expressed as percent

to the provisions of prior sanctions; to accomplish the intended physical or

Arachidy-l-behenyl amide (C20-C22fatty acid amides) ................. 5 percent.

Epoxidized safflower oil.

Erucylamide ................................................................................. 5 percent.

Sodium o-phenylphenate ............................................................. 0.05 percent.

TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES when extracted on a suitable glass con-

VII. Bakery products.

TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF

A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

§ 177.1211 Cross-linked polyacrylate propenoate and sodium 2-propenoate

ethyl-2-(((1-oxo-2-pro- percent by weight of the total polymer

amount reasonably required to accom- used in accordance with paragraph (b)

(2) 25 weight-percent of total polymer hesives complying with § 175.105 of this

copolymers used in food-packaging ad- NARA, call 202–741–6030, or go to: http://

codeloflfederallregulations/ may be safely used as articles or com-

grams per 100

Maximum extractable fractions

Maximum extractable fractions

calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly-

by the catalytic copolymerization of Plastics by the Density-Gradient Tech-

method D1505–68 (Reapproved 1979), duced by the copolymerization of

that the copolymers contain no more determined from table I of paragraph

vents characterizing the type of food as this section.

described in ASTM method F34–76 (Re- where:

TABLE 1 temperature characterizing the condi-

vents characterizing the type of food cubic centimeter measured by ASTM

‘‘Standard Test Method for Density of of use C at temperatures not to exceed

(2) Maleic anhydride-grafted ethyl-

range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard

specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS

listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing

§ 177.1500 and having an average thick-

Substances Limitations Substances Limitations

(4) Substances identified in and used

in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard

(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re-

43.1±0.2 weight percent hexamethyl- condensation of 49.5 + 0.5 weight per-