This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177]
[Page 228-347]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS
Subpart A [Reserved]
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec.
177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.
177.1020 Acrylonitrile/butadiene/styrene co-polymer.
177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.
177.1040 Acrylonitrile/styrene copolymer.
177.1050 Acrylonitrile/styrene copolymer modified with butadiene/
styrene elastomer.
177.1060 n-Alkylglutarimide/acrylic copolymers.
177.1200 Cellophane.
177.1210 Closures with sealing gaskets for food containers.
177.1211 Cross-linked polyacrylate copolymers.
177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-
cyclohexylene dimethylene isophthalate copolymer.
177.1310 Ethylene-acrylic acid copolymers.
177.1312 Ethylene-carbon monoxide copolymers.
177.1315 Ethylene-1,4-cyclohexylene dimethylene terephthalate
copolymers.
177.1320 Ethylene-ethyl acrylate copolymers.
177.1330 Ionomeric resins.
177.1340 Ethylene-methyl acrylate copolymer resins.
177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate
copolymer.
177.1350 Ethylene-vinyl acetate copolymers.
177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.
177.1380 Fluorocarbon resins.
177.1390 Laminate structures for use at temperatures of 250 deg.F and
above.
177.1395 Laminate structures for use at temperatures between 120 deg.F
and 250 deg. F.
177.1400 Hydroxyethyl cellulose film, water-insoluble.
177.1420 Isobutylene polymers.
177.1430 Isobutylene-butene copolymers.
177.1440 4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum
molecular weight 10,000.
177.1460 Melamine-formaldehyde resins in molded articles.
177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate
copolymers.
177.1500 Nylon resins.
177.1520 Olefin polymers.
177.1550 Perfluorocarbon resins.
177.1555 Polyarylate resins.
177.1556 Polyaryletherketone resins.
177.1560 Polyarylsulfone resins.
177.1570 Poly-1-butene resins and butene/ethylene copolymers.
177.1580 Polycarbonate resins.
177.1585 Polyestercarbonate resins.
177.1590 Polyester elastomers.
177.1595 Polyetherimide resin.
177.1600 Polyethylene resins, carboxyl modified.
177.1610 Polyethylene, chlorinated.
177.1615 Polyethylene, fluorinated.
177.1620 Polyethylene, oxidized.
177.1630 Polyethylene phthalate polymers.
177.1632 Poly (phenyleneterephthalamide) resins.
177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-
methylstyrene).
177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-
naphthalenediylcarbonyl) resins.
177.1640 Polystyrene and rubber-modified polystyrene.
177.1650 Polysulfide polymer-polyepoxy resins.
177.1655 Polysulfone resins.
[[Page 229]]
177.1660 Poly (tetramethylene terephthalate).
177.1670 Polyvinyl alcohol film.
177.1680 Polyurethane resins.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copolymers.
177.1830 Styrene-methyl methacrylate copolymers.
177.1850 Textryls.
177.1900 Urea-formaldehyde resins in molded articles.
177.1950 Vinyl chloride-ethylene copolymers.
177.1960 Vinyl chloride-hexene-1 copolymers.
177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
177.1980 Vinyl chloride-propylene copolymers.
177.1990 Vinylidene chloride/methyl acrylate copolymers.
177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate
polymers.
Subpart C--Substances for Use Only as Components of Articles Intended
for Repeated Use
177.2210 Ethylene polymer, chlorosulfonated.
177.2250 Filters, microporous polymeric.
177.2260 Filters, resin-bonded.
177.2280 4,4'-Isopropylidenediphenol-epichlorohydrin thermosetting
epoxy resins.
177.2355 Mineral reinforced nylon resins.
177.2400 Perfluorocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
177.2415 Poly(aryletherketone) resins.
177.2420 Polyester resins, cross-linked.
177.2430 Polyether resins, chlorinated.
177.2440 Polyethersulfone resins.
177.2450 Polyamide-imide resins.
177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
177.2465 Polymethylmethacrylate/poly(tri methoxysilylpropyl)
methacrylate copolymers.
177.2470 Polyoxymethylene copolymer.
177.2480 Polyoxymethylene homopolymer.
177.2490 Polyphenylene sulfide resins.
177.2500 Polyphenylene sulfone resins.
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes.
177.2600 Rubber articles intended for repeated use.
177.2710 Styrene-divinylbenzene resins, cross-linked.
177.2800 Textiles and textile fibers.
177.2910 Ultra-filtration membranes.
Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14572, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 177 appear at 61 FR
14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27,
2001, and 68 FR 15355, Mar. 31, 2003.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1010]
[Page 229-234]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.
Semirigid and rigid acrylic and modified acrylic plastics may be
safely used as articles intended for use in contact with food, in
accordance with the following prescribed conditions. The acrylic and
modified acrylic polymers or plastics described in this section also may
be safely used as components of articles intended for use in contact
with food.
(a) The optional substances that may be used in the formulation of
the semirigid and rigid acrylic and modified acrylic plastics, or in the
formulation of acrylic and modified acrylic components of articles,
include substances generally recognized as safe in food, substances used
in accordance with a prior sanction or approval, substances permitted
for use in such plastics by regulations in parts 170 through 189 of this
chapter, and substances identified in this paragraph. At least 50
weight-percent of the polymer content of the acrylic and modified
acrylic materials used as finished articles or as components of articles
shall consist of polymer units derived from one or more of the acrylic
or methacrylic monomers listed in paragraph (a)(1) of this section.
(1) Homopolymers and copolymers of the following monomers:
n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
2-Ethylhexyl acrylate.
Ethyl methacrylate.
Methyl acrylate.
Methyl methacrylate.
(2) Copolymers produced by copolymerizing one or more of the
monomers listed in paragraph (a)(1) of this section with one or more of
the following monomers:
Acrylonitrile.
[[Page 230]]
Methacrylonitrile.
[alpha]-Methylstyrene.
Styrene.
Vinyl chloride.
Vinylidene chloride.
(3) Polymers identified in paragraphs (a)(1) and (2) of this section
containing no more than 5 weight-percent of total polymer units derived
by copolymerization with one or more of the monomers listed in paragraph
(a)(3)(i) and (ii) of this section. Monomers listed in paragraph
(a)(3)(ii) of this section are limited to use only in plastic articles
intended for repeated use in contact with food.
(i) List of minor monomers:
Acrylamide.
Acrylic acid
1,3-Butylene glycol dimethacrylate.
1,4-Butylene glycol dimethacrylate.
Diethylene glycol dimethacrylate.
Diproplylene glycol dimethacrylate.
Divinylbenzene.
Ethylene glycol dimethacrylate.
Itaconic acid.
Methacrylic acid.
N-Methylolacrylamide.
N-Methylolmethacrylamide.
4-Methyl-1,4-pentanediol dimethacrylate.
Propylene glycol dimethacrylate.
Trivinylbenzene.
(ii) List of minor monomers limited to use only in plastic articles
intended for repeated use in contact with food:
Allyl methacrylate [Chemical Abstracts Service Registry No. 96-05-9]
tert-Butyl acrylate.
tert-Butylaminoethyl methacrylate.
sec-Butyl methacrylate.
tert-Butyl methacrylate.
Cyclohexyl methacrylate.
Dimethylaminoethyl methacrylate.
2-Ethylhexyl methacrylate.
Hydroxyethyl methacrylate.
Hydroxyethyl vinyl sulfide.
Hydroxypropyl methacrylate.
Isobornyl methacrylate.
Isobutyl methacrylate.
Isopropyl acrylate.
Isopropyl methacrylate.
Methacrylamide.
Methacrylamidoethylene urea.
Methacryloxyacetamidoethylethylene urea.
Methacryloxyacetic acid.
n-Propyl methacrylate.
3,5,5-Trimethylcyclohexyl methacrylate.
(4) Polymers identified in paragraphs (a)(1), (2), and (3) of this
section are mixed together and/or with the following polymers, provided
that no chemical reactions, other than addition reactions, occur when
they are mixed:
Butadiene-acrylonitrile copolymers.
Butadiene-acrylonitrile-styrene copolymers.
Butadiene-acrylonitrile-styrene-methyl methacrylic copolymers.
Butadiene-styrene copolymers.
Butyl rubber.
Natural rubber.
Polybutadiene.
Poly (3-chloro-1,3-butadiene).
Polyester identified in Sec. 175.300(b)(3)(vii) of this chapter.
Polyvinyl chloride.
Vinyl chloride copolymers complying with Sec. 177.1980.
Vinyl chloride-vinyl acetate copolymers.
(5) Antioxidants and stabilizers identified in
Sec. 175.300(b)(3)(xxx) of this chapter and the following:
Di-tert-butyl-p-cresol.
2-Hydroxy-4-methoxybenzophenone.
2-Hydroxy-4-methoxy-2-carboxybenzophenone.
3-Hydroxyphenyl benzoate.
p-Methoxyphenol.
Methyl salicylate.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-
79-3): For use only: (1) At levels not exceeding 0.2 percent by weight
in semirigid and rigid acrylic and modified acrylic plastics, where the
finished articles contact foods containing not more than 15 percent
alcohol; and (2) at levels not exceeding 0.01 percent by weight in
semirigid and rigid acrylic and modified acrylic plastics intended for
repeated food-contact use where the finished article may be used for
foods containing more than 15 percent alcohol.
Phenyl salicylate.
(6) Release agents: Fatty acids derived from animal and vegetable
fats and oils, and fatty alcohols derived from such acids.
(7) Surface active agent: Sodium dodecylbenzenesulfonate.
(8) Miscellaneous materials:
Di(2-ethylhexyl) phthalate, for use only as a flow promoter at a level
not to exceed 3 weight-percent based on the monomers.
Dimethyl phthalate.
Oxalic acid, for use only as a polymerization catalyst aid.
Tetraethylenepentamine, for use only as a catalyst activator at a level
not to exceed 0.5 weight-percent based on the monomers.
Toluene.
Xylene.
(b) The semirigid and rigid acrylic and modified acrylic plastics,
in the
[[Page 231]]
finished form in which they are to contact food, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, shall yield extractives not to exceed
the following, when tested by the methods prescribed in paragraph (c) of
this section. The acrylic and modified acrylic polymers or plastics
intended to be used as components of articles also shall yield
extractives not to exceed the following limitations when prepared as
strips as described in paragraph (c)(2) of this section:
(1) Total nonvolatile extractives not to exceed 0.3 milligram per
square inch of surface tested.
(2) Potassium permanganate oxidizable distilled water and 8 and 50
percent alcohol extractives not to exceed an absorbance of 0.15.
(3) Ultraviolet-absorbing distilled water and 8 and 50 percent
alcohol extractives not to exceed an absorbance of 0.30.
(4) Ultraviolet-absorbing n-heptane extractives not to exceed an
absorbance of 0.10.
(c) Analytical methods--(1) Selection of extractability conditions.
These are to be chosen as provided in Sec. 176.170(c) of this chapter.
(2) Preparation of samples. Sufficient samples to allow duplicates
of all applicable tests shall be cut from the articles or formed from
the plastic composition under tests, as strips about 2.5 inches by about
0.85-inch wide by about 0.125-inch thick. The total exposed surface
should be 5 square inches 0.5-square inch. The samples,
after preparation, shall be washed with a clean brush under hot
tapwater, rinsed under running hot tapwater (140 deg.F minimum), rinsed
with distilled water, and air-dried in a dust-free area or in a
desiccator.
(3) Preparation of solvents. The water used shall be double-
distilled water, prepared in a still using a block tin condenser. The 8
and 50 percent (by volume) alcohol solvents shall be prepared from ethyl
alcohol meeting the specifications of the United States Pharmacopeia XX
and diluted with double-distilled water that has been prepared in a
still using a tin block condenser. The n-heptane shall be
spectrophotometric grade. Adequate precautions must be taken to keep all
solvents dust-free.
(4) Blank values on solvents. (i) Duplicate determinations of
residual solids shall be run on samples of each solvent that have been
exposed to the temperature-time conditions of the extraction test
without the plastic sample. Sixty milliliters of exposed solvent is
pipetted into a clean, weighed platinum dish, evaporated to 2-5
milliliters on a nonsparking, low-temperature hot plate and dried in 212
deg.F oven for 30 minutes. The residue for each solvent shall be
determined by weight and the average residue weight used as the blank
value in the total solids determination set out in paragraph (c)(6) of
this section. The residue for an acceptable solvent sample shall not
exceed 0.5 milligram per 60 milliliters.
(ii) For acceptability in the ultraviolet absorbers test, a sample
of each solvent shall be scanned in an ultraviolet spectrophotometer in
5-centimeter silica spectrophotometric absorption cells. The absorbance
of the distilled water when measured versus air in the reference cell
shall not exceed 0.03 at any point in the wavelength region of 245 to
310 m[mu]. The absorbance of the 8 percent alcohol when measured versus
distilled water in the reference cell shall not exceed 0.01 at any point
in the wavelength region of 245 to 310 m[mu]. The absorbance of the 50
percent alcohol when measured versus distilled water in the reference
cell shall not exceed 0.05 at any point in the wavelength region of 245
to 310 m[mu]. The absorbance of the heptane when measured versus
distilled water in the reference cell shall not exceed 0.15 at 245, 0.09
at 260, 0.04 at 270, and 0.02 at any point in the wavelength region of
280 to 310 m[mu].
(iii) Duplicate ultraviolet blank determinations shall be run on
samples of each solvent that has been exposed to the temperature-time
conditions of the extraction test without the plastic sample. An aliquot
of the exposed solvent shall be measured versus the unexposed solvent in
the reference cell. The average difference in the absorbances at any
wavelength in the region of 245 to 310 m[mu] shall be used as a blank
correction for the ultraviolet
[[Page 232]]
absorbers measured at the same wavelength according to paragraph
(c)(8)(ii) of this section.
(iv) The acceptability of the solvents for use in the permanganate
test shall be determined by preparing duplicate permanganate test blanks
according to paragraph (c)(7)(iv) of this section. For this test, the
directions referring to the sample extract shall be disregarded. The
blanks shall be scanned in 5-centimeter silica spectrophotometric cells
in the spectrophotometer versus the appropriate solvent as reference.
The absorbance in distilled water in the wavelength region of 544 to 552
m[mu] should be 1.16 but must not be less than 1.05 nor more than 1.25.
The absorbance in the 8 and 50 percent alcohol must not be less than
0.85 nor more than 1.15.
(v) Duplicate permanganate test determinations shall be run on
samples of distilled water and 8 and 50 percent alcohol solvents that
have been exposed to the temperature-time conditions of the extraction
test without the plastic sample. The procedure shall be as described in
paragraph (c)(7)(iv) of this section, except that the appropriate
exposed solvent shall be substituted where the directions call for
sample extract. The average difference in the absorbances in the region
of 544 to 552 m[mu] shall be used as a blank correction for the
determination of permanganate oxidizable extractives according to
paragraph (c)(7)(iv) of this section.
(5) Extraction procedure. For each extraction, place a plastic
sample in a clean 25 millimeters x 200 millimeters hard-glass test tube
and add solvent equal to 10 milliliters of solvent per square inch of
plastic surface. This amount will be between 45 milliliters and 55
milliliters. The solvent must be preequilibrated to the temperature of
the extraction test. Close the test tube with a ground-glass stopper and
expose to the specified temperature for the specified time. Cool the
tube and contents to room temperature if necessary.
(6) Determination of total nonvolatile extractives. Remove the
plastic strip from the solvent with a pair of clean forceps and wash the
strip with 5 milliliters of the appropriate solvent, adding the washings
to the contents of the test tube. Pour the contents of the test tube
into a clean, weighed platinum dish. Wash the tube with 5 milliliters of
the appropriate solvent and add the solvent to the platinum dish.
Evaporate the solvent to 2-5 milliliters on a nonsparking, low-
temperature hotplate. Complete the evaporation in a 212 deg.F oven for
30 minutes. Cool the dish in a desiccator for 30 minutes and weigh to
the nearest 0.1 milligram. Calculate the total nonvolatile extractives
as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.392
[GRAPHIC] [TIFF OMITTED] TR01JA93.393
where:
e=Total increase in weight of the dish, in milligrams.
b=Blank value of the solvent in milligrams, as determined in paragraph
(c)(4)(i) of this section.
s=Total surface of the plastic sample in square inches.
(7) Determination of potassium permanganate oxidizable extractives.
(i) Pipette 25 milliliters of distilled water into a clean 125-
milliliter Erlenmeyer flask that has been rinsed several times with
aliquots of distilled water. This is the blank. Prepare a distilled
water solution containing 1.0 part per million of p-methoxyphenol
(melting point 54-56 deg.C, Eastman grade or equivalent). Pipette 25
milliliters of this p-methoxyphenol solution into a rinsed Erlenmeyer
flask. Pipette exactly 3.0 milliliters of 154 parts per million aqueous
potassium permanganate solution into the p-methoxyphenol and exactly 3.0
milliliters into the blank, in that order. Swirl both flasks to mix the
contents and then transfer aliquots from each flask into matched 5-
centimeter spectrophotometric absorption cells. The cells are placed in
the spectrophotometer cell compartment with the p-methoxyphenol solution
in the reference beam. Spectrophotometric measurement is conducted as in
paragraph (c)(7)(iv) of this section. The absorbance reading in the
region 544-552 m[mu] should be 0.24 but must be not less than 0.12 nor
more than 0.36. This test
[[Page 233]]
shall be run in duplicate. For the purpose of ascertaining compliance
with the limitations in paragraph (b)(2) of this section, the absorbance
measurements obtained on the distilled water extracts according to
paragraph (c)(7)(iv) of this section shall be multiplied by a correction
factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.394
(ii) The procedure in paragraph (c)(7)(i) of this section is
repeated except that, in this instance, the solvent shall be 8 percent
alcohol. The absorbance in the region 544-552 m[mu] should be 0.26 but
must be not less than 0.13 nor more than 0.39. This test shall be run in
duplicate. For the purpose of ascertaining compliance with the
limitations prescribed in paragraph (b)(2) of this section, the
absorbance measurements obtained on the 8 percent alcohol extracts
according to paragraph (c)(7)(iv) of this section shall be multiplied by
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.395
(iii) The procedure in paragraph (c)(7)(i) of this section is
repeated except that, in this instance, the solvent shall be 50 percent
alcohol. The absorbance in the region 544-552 m[mu] should be 0.25 but
must be not less than 0.12 nor more than 0.38. This test shall be run in
duplicate. For the purpose of ascertaining compliance with the
limitations prescribed in paragraph (b)(2) of this section, the
absorbance measurements obtained on the 50 percent alcohol extracts
according to paragraph (c)(7)(iv) of this section shall be multiplied by
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.396
(iv) Water and 8 and 50 percent alcohol extracts. Pipette 25
milliliters of the appropriate solvent into a clean, 125-milliliter
Erlenmeyer flask that has been rinsed several times with aliquots of the
same solvent. This is the blank. Into another similarly rinsed flask,
pipette 25 milliliters of the sample extract that has been exposed under
the conditions specified in paragraph (c)(5) of this section. Pipette
exactly 3.0 milliliters of 154 parts per million aqueous potassium
permanganate solution into the sample and exactly 3.0 milliliters into
the blank, in that order. Before
[[Page 234]]
use, the potassium permanganate solution shall be checked as in
paragraph (c)(7)(i) of this section. Both flasks are swirled to mix the
contents, and then aliquots from each flask are transferred to matched
5-centimeter spectrophotometric absorption cells. Both cells are placed
in the spectrophotometer cell compartment with the sample solution in
the reference beam. The spectrophotometer is adjusted for 0 and 100
percent transmittance at 700 m[mu]. The spectrum is scanned on the
absorbance scale from 700 m[mu] to 500 m[mu] in such a way that the
region 544 m[mu] to 552 m[mu] is scanned within 5 minutes to 10 minutes
of the time that permanganate was added to the solutions. The height of
the absorbance peak shall be measured, corrected for the blank as
determined in paragraph (c)(4)(v) of this section, and multiplied by the
appropriate correction factor determined according to paragraph (c)(7)
(i), (ii), and (iii) of this section. This test shall be run in
duplicate and the two results averaged.
(8) Determination of ultraviolet-absorbing extractives. (i) A
distilled water solution containing 1.0 part per million of p-
methoxyphenol (melting point 54 deg.C-56 deg.C. Eastman grade or
equivalent) shall be scanned in the region 360 to 220 m[mu] in 5-
centimeter silica spectrophotometric absorption cells versus a distilled
water reference. The absorbance at the wavelength of maximum absorbance
(should be about 285 m[mu]) is about 0.11 but must be not less than 0.08
nor more than 0.14. This test shall be run in duplicate. For the purpose
of ascertaining compliance with the limitations prescribed in paragraph
(b) (3) and (4) of this section, the absorbance obtained on the extracts
according to paragraph (c)(8)(ii) of this section shall be multiplied by
a correction factor, calculated as follows:
[GRAPHIC] [TIFF OMITTED] TR01JA93.397
(ii) An aliquot of the extract that has been exposed under the
conditions specified in paragraph (c)(5) of this section is scanned in
the wavelength region 360 to 220 m[mu] versus the appropriate solvent
reference in matched 5-centimeter silica spectrophotometric absorption
cells. The height of any absorption peak shall be measured, corrected
for the blank as determined in paragraph (c)(4)(iii) of this section,
and multiplied by the correction factor determined according to
paragraph (c)(8)(i) of this section.
(d) In accordance with current good manufacturing practice, finished
semirigid and rigid acrylic and modified acrylic plastics, and articles
containing these polymers, intended for repeated use in contact with
food shall be thoroughly cleansed prior to their first use in contact
with food.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(f) The acrylic and modified acrylic polymers identified in and
complying with this section, when used as components of the food-contact
surface of an article that is the subject of a regulation in this part
and in parts 174, 175, 176, and 178 of this chapter, shall comply with
any specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at
43 FR 54927, Nov. 24, 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796,
Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR 13139, Apr. 3, 1984;
50 FR 31045, July 24, 1985]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1020]
[Page 234-235]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1020 Acrylonitrile/butadiene/styrene co-polymer.
Acrylonitrile/butadiene/styrene copolymer identified in this section
may be safely used as an article or component of articles intended for
use with
[[Page 235]]
all foods, except those containing alcohol, under conditions of use E,
F, and G described in table 2 of Sec. 176.170(c) of this chapter.
(a) Identity. For the purpose of this section, the acrylonitrile/
butadiene/styrene copolymer consists of:
(1) Eighty-four to eighty-nine parts by weight of a matrix polymer
containing 73 to 78 parts by weight of acrylonitrile and 22 to 27 parts
by weight of styrene; and
(2) Eleven to sixteen parts by weight of a grafted rubber consisting
of (i) 8 to 13 parts of butadiene/styrene elastomer containing 72 to 77
parts by weight of butadiene and 23 to 28 parts by weight of styrene and
(ii) 3 to 8 parts by weight of a graft polymer having the same
composition range as the matrix polymer.
(b) Adjuvants. The copolymer identified in paragraph (a) of this
section may contain adjuvant substances required in its production. Such
adjuvants may include substances generally recognized as safe in food,
substances used in accordance with prior sanction, substances permitted
in this part, and the following:
------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
2-Mercapto- ethanol....................... The finished copolymer shall
contain not more than 100
ppm 2-mercaptoethanol
acrylonitrile adduct as
determined by a method
titled "Analysis of
Cycopac Resin for Residual
[beta]-(2-
Hydroxyethylmercapto)
propionitrile," which is
incorporated by reference.
Copies are available from
the Bureau of Foods (HFS-
200), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park,
MD 20740, or available for
inspection at the Office of
the Federal Register, 800
North Capitol Street, NW.,
suite 700, Washington, DC
20408.
------------------------------------------------------------------------
(c) Specifications. (1) Nitrogen content of the copolymer is in the
range of 16 to 18.5 percent as determined by Micro-Kjeldahl analysis.
(2) Residual acrylonitrile monomer content of the finished copolymer
articles is not more than 11 parts per million as determined by a gas
chromatographic method titled "Determination of Residual Acrylonitrile
and Styrene Monomers-Gas Chromatographic Internal Standard Method,"
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(d) Extractive limitations. (1) Total nonvolatile extractives not to
exceed 0.0005 milligram per square inch surface area when the finished
food contact article is exposed to distilled water, 3 percent acetic
acid, or n-heptane for 8 days at 120 deg.F.
(2) The finished food-contact article shall yield not more than
0.0015 milligram per square inch of acrylonitrile monomer when exposed
to distilled water and 3 percent acetic acid at 150 deg.F for 15 days
when analyzed by a polarographic method titled "Extracted Acrylonitrile
by Differential Pulse Polarography," which is incorporated by
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(f) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 54 FR 24897, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1030]
[Page 235-236]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.
Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer
identified in this section may be safely used as an article or component
of articles intended for use with food identified in table 1 of
Sec. 176.170(c) of this chapter as Type I, II, III, IVA, IVB, V,
[[Page 236]]
VIB, (except bottles intended to hold carbonated beverages), VIIA, VIIB,
VIII and IX, under conditions of use C, D, E, F, and G described in
table 2 of Sec. 176.170(c) of this chapter with a high temperature
limitation of 190 deg.F.
(a) Identity. For the purpose of this section, acrylonitrile/
butadiene/styrene/methyl methacrylate copolymer consists of: (1) 73 to
79 parts by weight of a matrix polymer containing 64 to 69 parts by
weight of acrylonitrile, 25 to 30 parts by weight of styrene and 4 to 6
parts by weight of methyl methacrylate; and (2) 21 to 27 parts by weight
of a grafted rubber consisting of (i) 16 to 20 parts of butadiene/
styrene/elastomer containing 72 to 77 parts by weight of butadiene and
23 to 28 parts by weight of styrene and (ii) 5 to 10 parts by weight of
a graft polymer having the same composition range as the matrix polymer.
(b) Adjuvants. The copolymer identified in paragraph (a) of this
section may contain adjuvant substances required in its production. Such
adjuvants may include substances generally recognized as safe in food,
substances used in accordance with prior sanction, substances permitted
under applicable regulations in this part, and the following:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
2-Mercaptoethanol......................... The finished copolymer shall
contain not more than 800
ppm 2-mercaptoethanol
acrylonitrile adduct as
determined by a method
titled "Analysis of
Cycopac Resin for Residual
[beta]-(2-
Hydroxyethylmercapto)
propionitrile," which is
incorporated by reference.
Copies are available from
the Bureau of Foods (HFS-
200), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park,
MD 20740, or available for
inspection at the Office of
the Federal Register, 800
North Capitol Street, NW.,
suite 700, Washington, DC
20408.
------------------------------------------------------------------------
(c) Specifications. (1) Nitrogen content of the copolymer is in the
range of 13.0 to 16.0 percent as determined by Micro-Kjeldahl analysis.
(2) Residual acrylonitrile monomer content of the finished copolymer
articles is not more than 11 parts per million as determined by a gas
chromatographic method titled "Determination of Residual Acrylonitrile
and Styrene Monomers-Gas Chromatographic Internal Standard Method,"
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(d) Extractive limitations. (1) Total nonvolatile extractives not to
exceed 0.0005 milligram per square inch surface area of the food-contact
article when exposed to distilled water, 3 percent acetic acid, 50
percent ethanol, and n-heptane for 10 days at 120 deg.F.
(2) The finished food-contact article shall yield not more than
0.0025 milligram per square inch of acrylonitrile monomer when exposed
to distilled water, 3 percent acetic acid and n-heptane at 190 deg.F
for 2 hours, cooled to 120 deg.F (80 to 90 minutes) and maintained at
120 deg.F for 10 days when analyzed by a polarographic method titled
"Extracted Acrylonitrile by Differential Pulse Polarography," which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(f) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1040]
[Page 236-238]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1040 Acrylonitrile/styrene copoly-mer.
Acrylonitrile/styrene copolymers identified in this section may be
safely
[[Page 237]]
used as a component of packaging materials subject to the provisions of
this section.
(a) Identity. For the purposes of this section acrylonitrile/styrene
copoly-mers are basic copolymers meeting the specifications prescribed
in paragraph (c) of this section.
(b) Adjuvants. (1) The copolymers identified in paragraph (c) of
this section may contain adjuvant substances required in their
production, with the exception that they shall not contain mercaptans or
other substances which form reversible complexes with acryl-onitrile
monomer. Permissible adjuvants may include substances generally
recognized as safe in food, substances used in accordance with prior
sanction, substances permitted under applicable regulations in this
part, and those authorized in paragraph (b)(2) of this section.
(2) The optional adjuvants for the acrylonitrile/styrene copolymer
identified in paragraphs (c) (1) and (3) of this section are as follows:
------------------------------------------------------------------------
Substances Limitation
------------------------------------------------------------------------
Condensation polymer of toluene 0.15 pct maximum.
sulfonamide and formaldehyde.
------------------------------------------------------------------------
(c) Specifications.
----------------------------------------------------------------------------------------------------------------
Maximum
Maximum residual extractable
acrylonitrile Nitrogen fractions at Conformance with
Acrylonitrile/styrene copolymers monomer content content of specified certain specifications
of finished copolymer temperatures and
article times
----------------------------------------------------------------------------------------------------------------
1. Acrylonitrile/styrene 80 ppm\1\....... 17.4 to 19 pct. Total nonvolatile Minimum number average
copolymer consisting of the extractives not molecular weight is
copolymer produced by to exceed 0.01 mg/ 30,000.\1\
polymerization of 66-72 parts in \2\ surface
by weight of acrylonitrile and area of the food
28-34 parts by weight of contact article
styrene; for use with food of when exposed to
Type VI-B identified in table 1 distilled water
of Sec. 176.170(c) of this and 3 pct acetic
chapter under conditions of use acid for 10 d at
C, D, E, F, G described in 66 deg.C (150
table 2 of Sec. 176.170(c) of deg.F).
this chapter. The extracted
copolymer shall
not exceed 0.001
mg/in \2\ surface
area of the food
contact article
when exposed to
distilled water
and 3 pct acetic
acid for 10 d at
66 deg.C (150
deg.F) \1\.
2. Acrylonitrile/styrene 50 ppm\1\....... 12.2 to 17.2 Extracted Minimum 10 pct solution
copolymer consisting of the pct. copolymer not to viscosity at 25 deg.C
copolymer produced by exceed 2.0 ppm in (77 deg.F) is
polymerization of 45-65 parts aqueous extract 10cP.\1\
by weight of acrylonitrile and or n-heptane
35-55 parts by weigth of extract obtained
styrene; for use with food of when 100 g sample
Types, I, II, III, IV, V, VI of the basic
(except bottles), VII, VIII, copolymer in the
and IX identified in table 1 of form of particles
Sec. 176.170(c) of this of a size that
chapter under conditions B (not will pass through
to exceed 93 deg.C (200 a U.S. Standard
deg.F)), C, D, E, F, G Sieve No. 6 and
described in table 2 of Sec. that will be held
176.170(c) of this chapter. on a U.S.
Standard Sieve
No. 10 is
extracted with
250 mil of
deionized water
or reagent grade
n-heptane at
reflux
temperature for 2
h.\1\
3. Acrylonitrile/styrene 0.10 ppm 17.4 to 19 pct. Total nonvolatile Maximum carbon dioxide
copolymer consisting of the (calculated on extractives not permeability at 23
copolymer produced by the basis of to exceed 0.01 mg/ deg.C (73 deg.F) for
polymerization of 66-72 parts the weight of in \2\ surface the finished article
by weight of acrylonitrile and the area of the food is 0.04 barrer.\3\
28-34 parts by weight of acrylonitrile contact article
styrene; for use with food of copolymer resin when exposed to
Types VI-A and VI-B identified in the finished distilled water
in table 1 of Sec. 176.170(c) articles).\2\ and 3 pct acetic
of this chapter under acid for 10 d at
conditions of use C, D, E, F, G 66 deg.C (150
described in table 2 of Sec. deg.F).
176.170(c) of this chapter. The extracted
copolymer shall
not exceed 0.001
mg/in \2\ surface
area of the food
contact article
when exposed to
distilled water
and 3 pct acetic
acid for 10 d at
66 deg.C (150
deg.F).\1\.
----------------------------------------------------------------------------------------------------------------
\1\ Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction,
number average molecular 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), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
[[Page 238]]
\2\ As determined by the method titled "Headspace Sampling and Gas-Solid Chromatographic Determination of
Residual Acrylonitrile in Acrylonitrile Copolyemr Solutions," which is incorporated by reference. Copies are
available from the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College
Park, MD 20740, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
\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), 5100 Paint Branch Pkwy., College Park, MD 20740,
and the American Society for Testing Materials, 1916 Race Street, Philadelphia, PA 19103, or may be examined
at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408.
(d) Interim listing. Acrylonitrile copolymers identified in this
section shall comply with the provisions of Sec. 180.22 of this chapter.
(e) Acrylonitrile copolymer identified in this section may be used
to fabricate beverage containers only if they comply with the
specifications of item 3 in paragraph (c) of this section.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803,
Sept. 8, 1987]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1050]
[Page 238-239]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1050 Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer.
Acrylonitrile/styrene copolymer modified with butadiene/styrene
elastomer identified in this section may be safely used as a component
of bottles intended for use with foods identified in table I of
Sec. 176.170(c) of this chapter as Type VI-B under conditions for use E,
F, or G described in table 2 of Sec. 176.170(c) of this chapter.
(a) Identity. For the purpose of this section, acrylonitrile/styrene
copoly- mer modified with butadiene/styrene elastomer consists of a
blend of:
(1) 82-88 parts by weight of a matrix copolymer produced by
polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts
of styrene; and
(2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12
parts of butadiene/styrene elastomer containing 77-82 parts by weight of
butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by
weight of a graft copolymer consisting of 70-77 parts by weight of
acrylonitrile and 23-30 parts by weight of styrene.
(b) Adjuvants. The modified copoly-mer identified in paragraph (a)
of this section may contain adjuvant substances required in its
production. Such adjuvants may include substances generally recognized
as safe in food, substances used in accordance with prior sanction,
substances permitted under applicable regulations in this part, and the
following:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
n-Dodecylmercaptan........................ The finished copolymer shall
contain not more than 500
parts per million (ppm)
dodecylmercaptan as
dodecylmercapto-
propionitrile as determined
by the method titled,
"Determination of [beta]-
Dodecyl-
mercaptopropionitrile in NR-
16 Polymer," which is
incorporated by reference.
Copies are available from
the Center for Food Safety
and Applied Nutrition (HFS-
200), Food and Drug
Administration, 5100 Paint
Branch Pkwy., College Park,
MD 20740, or available for
inspection at the Office of
the Federal Register, 800
North Capitol Street, NW.,
suite 700, Washington, DC
20408.
------------------------------------------------------------------------
(c) Specifications. (1) Nitrogen content of the modified copolymer
is in the range of 17.7-19.8 percent.
(2) Intrinsic viscosity of the matrix copolymer in butyrolactone is
not less than 0.5 deciliter/gram at 35 deg.C, as determined by the
method titled "Molecular Weight of Matrix Copolymer by Solution
Viscosity," which is incorporated by reference. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(3) Residual acrylonitrile monomer content of the modified copolymer
articles is not more than 11 ppm as determined by a gas chromatographic
method titled "Determination of Residual Acrylonitrile and Styrene
Monomers-Gas Chromatographic Internal Standard Method," which is
incorporated by
[[Page 239]]
reference. Copies are available from the Center for Food Safety and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or available for inspection at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(d) Extractives limitations. The following extractives limitations
are determined by an infrared spectrophotometric method titled
"Infrared Spectrophotometric Determination of Polymer Extracted from
Borex[reg] 210 Resin Pellets," which is incorporated by reference.
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408, and are applicable to the modified copolymers in
the form of particles of a size that will pass through a U.S. Standard
Sieve No. 6 and that will be held on a U.S. Standard Sieve No. 10:
(1) The extracted copolymer shall not exceed 2.0 ppm in aqueous
extract obtained when a 100-gram sample of copolymer is extracted with
250 milliliters of freshly distilled water at reflux temperature for 2
hours.
(2) The extracted copolymer shall not exceed 0.5 ppm in n-heptane
when a 100-gram sample of the basic copol-ymer is extracted with 250
milliliters spectral grade n-heptane at reflux temperature for 2 hours.
(e) Accelerated extraction end test. The modified copolymer shall
yield acrylonitrile monomer not in excess of 0.4 ppm when tested as
follows:
(1) The modified copolymer shall be in the form of eight strips \1/
2\ inch by 4 inches by .03 inch.
(2) The modified copolymer strips shall be immersed in 225
milliliters of 3 percent acetic acid in a Pyrex glass pressure bottle.
(3) The pyrex glass pressure bottle is then sealed and heated to 150
deg.F in either a circulating air oven or a thermostat controlled bath
for a period of 8 days.
(4) The Pyrex glass pressure bottle is then removed from the oven or
bath and cooled to room temperature. A sample of the extracting solvent
is then withdrawn and analyzed for acrylonitrile monomer by a gas
chromatographic method titled "Gas-Solid Chromatographic Procedure for
Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers
and Food Simulating Solvents," which is incorporated by reference.
Copies, are available from the Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(f) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(g) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23, 1977;
47 FR 11841, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898,
June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1060]
[Page 239-240]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1060 n-Alkylglutarimide/acrylic copolymers.
n-Alkylglutarimide/acrylic copolymers identified in this section may
be safely used as articles or components of articles intended for use in
contact with food subject to provisions of this section and part 174 of
this chapter.
(a) Identity. For the purpose of this section, n-alkylglutarimide/
acrylic copolymers are copolymers obtained by reaction of substances
permitted by Sec. 177.1010(a) (1), (2), and (3) with the following
substance: Monomethylamine (CAS Reg. No. 74-89-5), to form n-
methylglutarimide/acrylic copolymers.
(b) Adjuvants. The copolymers identified in paragraph (a) of this
section may contain adjuvant substances required in their production.
The optional adjuvant substances required in the production of the basic
polymer may include substances permitted for such use by applicable
regulations, as set forth in part 174 of this chapter.
(c) Specifications. Maximum nitrogen content of the copolymer
determined
[[Page 240]]
by micro-Kjeldahl analysis, shall not exceed 8 percent.
(d) Limitations. (1) The n-alkylglutarimide/acrylic copolymers in
the finished form in which they shall contact food, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature described in tables 1 and 2 of
Sec. 176.170(c) of this chapter, shall yield extractives not to exceed
the limitations of Sec. 177.1010(b) of this chapter, when prepared as
strips, as described in Sec. 177.1010(c)(2) of this chapter.
(2) The n-alkylglutarimide/acrylic copolymers shall not be used as
polymer modifiers in vinyl chloride homo- or copolymers.
(e) Conditions of use. The n-alkylglutarimide/acrylic copolymers are
used as articles or components of articles (other than articles composed
of vinyl chloride homo- or copolymers) intended for use in contact with
all foods except beverages containing more than 8 percent alcohol under
conditions of use D, E, F, and G as described in table 2 of
Sec. 176.170(c) of this chapter.
[54 FR 20382, May 11, 1989, as amended at 58 FR 17098, Apr. 1, 1993]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1200]
[Page 240-243]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1200 Cellophane.
Cellophane may be safely used for packaging food in accordance with
the following prescribed conditions:
(a) Cellophane consists of a base sheet made from regenerated
cellulose to which have been added certain optional substances of a
grade of purity suitable for use in food packaging as constituents of
the base sheet or as coatings applied to impart desired technological
properties.
(b) Subject to any limitations prescribed in this part, the optional
substances used in the base sheet and coating may include:
(1) Substances generally recognized as safe in food.
(2) Substances for which prior approval or sanctions permit their
use in cellophane, under conditions specified in such sanctions and
substances listed in Sec. 181.22 of this chapter.
(3) Substances that by any regulation promulgated under section 409
of the act may be safely used as components of cellophane.
(4) Substances named in this section and further identified as
required.
(c) List of substances:
------------------------------------------------------------------------
Limitations (residue and limits
of addition expressed as
List of substances percent by weight of finished
packaging cellophane)
------------------------------------------------------------------------
Acrylonitrile-butadiene copolymer As the basic polymer.
resins.
Acrylonitrile-butadiene-styrene Do.
copolymer resins.
Acrylonitrile-styrene copolymer resins. Do.
Acrylonitrile-vinyl chloride copolymer Do.
resins.
N-Acyl sarcosines where the acyl group For use only as release agents
is lauroyl or stearoyl. in coatings at levels not to
exceed a total of 0.3 percent
by weight of the finished
packaging cellophane.
Alkyl ketene dimers identified in Sec.
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 Not to exceed 0.5 percent
in Sec. 172.844 of this chapter. weight of cellophane.
Carboxymethyl hydroxyethylcellulose
polymer.
Castor oil, hydrogenated...............
Castor oil phthalate with adipic acid As the basic polymer.
and fumaric acid-diethylene 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..........................
[[Page 241]]
Coconut oil fatty acid (C12-C18) For use only as an adjuvant
diethanolamide, coconut oil fatty acid employed during the processing
(C12-C18) diethanolamine soap, and of cellulose pulp used in the
diethanolamine mixture having total manufacture of cellophane base
alkali (calculated as potassium sheet.
hydroxide) of 16-18% and having an
acid number of 25-35.
Copal resin, heat processed............ As basic resin.
Damar resin............................
Defoaming agents identified in Sec.
176.200 of this chapter.
Dialkyl ketones where the alkyl groups Not to exceed a total of 0.35
are lauryl or stearyl. percent.
Dibutylphthalate....................... Alone or in combination with
other phthalates where total
phthalates do not exceed 5
percent.
Dicyclohexyl phthalate................. Do.
Diethylene glycol ester of the adduct
of terpene and maleic anhydride.
Di(2-ethylhexyl) adipate...............
Di(2-ethylhexyl) phthalate............. Alone or in combination with
other phthalates where total
phthalates do not exceed 5
percent.
Diisobutyl phthalate................... Do.
Dimethylcyclohexyl phthalate........... Do.
Dimethyldialkyl (C8-C18) ammonium 0.005 percent for use only as a
chloride. 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
percent by weight of the
coating solids in vinylidene
chloride copolymer waterproof
coatings prepared from
vinylidene chloride 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.
N,N'-Dioleoyethylenediamine, N,N'- 0.5 percent.
dilinoleoylethylene-diamine and N-
oleoyl-N'linoleoylethylene-diamine
mixture produced when tall oil fatty
acids are made to react with
ethylenediamine such that the finished
mixture has a melting point of 212
deg.-228 deg.F., as determined by
ASTM method D127-60 ("Standard Method
of Test for Melting Point of
Petrolatum and Microcrystalline Wax"
(Revised 1960), which is incorporated
by reference; copies are available
from University Microfilms
International, 300 N. Zeeb Rd., Ann
Arbor, MI 48106, or available for
inspection at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408), and an acid value of 10
maximum.
N,N'-Dioleoylethylenediamine (N,N'-
ethylenebisoleamide).
Disodium EDTA..........................
Distearic acid ester of 0.06 percent.
di(hydroxyethyl) diethylenetriamine
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 Sec. 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: Aluminum, 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
Sec. 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, sodium.
Maleic acid............................ 1 percent.
Maleic acid adduct of butadienestyrene
copolymer.
Melamine formaldehyde.................. As the basic polymer.
[[Page 242]]
Melamine-formaldehyde modified with one As the basic polymer, and used
or more of the following: Butyl as a resin to anchor coatings
alcohol, diaminopropane, to substrate.
diethylenetriamine, ethyl alcohol,
guanidine, imino-bis-butylamine, imino-
bis-ethylamine, 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.
[alpha]-Methylstyrene-vinyltoluene
copolymer resins (molar ratio 1[alpha]-
methylstyrene to 3 vinyltoluene).
Mineral oil, white.....................
Mono- and bis-(octadecyldiethylene For use only as a release agent
oxide) phosphates (CAS Reg. No. 62362- at a level not to exceed 0.6
49-6). percent by weight of coatings
for cellophane.
Naphthalenesulfonic acid-formaldehyde 0.1 percent, for use only as an
condensate, sodium salt. emulsifier.
Nitrocellulose, 10.9 percent-12.2
percent nitrogen.
Nylon resins complying with Sec.
177.1500.
n-Octyl alcohol........................ For use only as a defoaming
agent in the manufacture of
cellophane base sheet.
Olefin copolymers complying with Sec.
177.1520.
Oleic acid reacted with N-alkyl
trimethylenediamine (alkyl C16 to C18).
Oleic acid, sulfonated, sodium salt....
Oleyl palmitamide......................
N,N'-Oleoyl-stearylethylenediamine (N-
(2-stearoyl-aminoethyl)oleamide).
Paraffin, synthetic, complying with
Sec. 175.250 of this chapter.
Pentaerythritol tetrastearate.......... 0.1 percent.
Polyamide resins derived from dimerized For use only in cellophane
vegetable oil acids (containing not coatings that contact food at
more than 20 percent of monomer acids) temperatures not to exceed
and ethylenediamine as the basic resin. room temperature.
Polyamide resins having a maximum acid As the basic resin, for use
value of 5 and a maximum amine value only in coatings that contact
of 8.5 derived from dimerized food at temperatures not to
vegetable oil acids (containing not exceed room temperature
more than 10 percent monomer acids), provided that the
ethylenediamine, and 4,4-bis(4- concentration of the polyamido
hydroxyphenyl)pentanoic acid (in an resins in the finished food-
amount not to exceed 10 percent by contact coating does not
weight of said polyamide resins). exceed 5 milligrams per square
inch of food-contact surface.
Polybutadiene resin (molecular weight For use only as an adjuvant in
range 2,000-10,200; bromine number vinylidene chloride copolymer
range 210-320). coatings.
Polycarbonate resins complying with
Sec. 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
deg.C-92 deg.C, and a color of K or
paler.
Polyethylene...........................
Polyethyleneaminostearamide ethyl 0.1 percent.
sulfate produced when stearic 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 Sec.
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-
contact 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 Sec.
177.1420.
Polyoxypropylene-polyoxyethylene block For use as an adjuvant employed
polymers (molecular weight 1,900- during the processing of
9,000). cellulose pulp used in the
manufacture of cellophane base
sheet.
Polypropylene complying with Sec.
177.1520.
Polystyrene............................ As the basic polymer.
Polyvinyl acetate...................... Do.
[[Page 243]]
Polyvinyl alcohol (minimum viscosity of
4 percent aqueous solution at 20
deg.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 Sec. 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 For use only as an emulsifier
sulfate mixture. 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 Not to exceed 0.5 percent
in Sec. 172.846 of this chapter. weight of cellophane.
Sodium sulfate.........................
Sodium sulfite.........................
Spermaceti wax.........................
Stannous oleate........................
2-Stearamido-ethyl stearate............
Stearyl alcohol........................
Styrene-maleic anhydride resins........ As the basic polymer.
Terpene resins identified in Sec.
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 For use only in cellophane
diisobutyrate. coatings and limited to use at
a level not to exceed 10
percent by weight of the
coating solids except when
used as provided in Sec.
178.3740 of this chapter
Urea (carbamide).......................
Urea formaldehyde...................... As the basic polymer.
Urea formaldehyde modified with As the basic polymer, and used
methanol, ethanol, butanol as a resin to anchor coatings
diethylenetriamine, to the substrate.
triethylenetetramine,
tetraethylenepenta-mine, guanidine,
sodium sulfite, sulfanilic acid, imino-
bis-ethylamine, 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 As the basic polymer.
resins.
Vinyl acetate-vinyl chloride-maleic Do.
acid copolymer resins.
Vinylidene chloride copolymerized with Do.
one or more of the following: Acrylic
acid, acrylonitrile, butyl acrylate,
butyl methacrylate, 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 Do.
decyloctyl copolymer.
Wax, petroleum, complying with Sec.
178.3710 of this chapter.
------------------------------------------------------------------------
(d) Any optional component listed in this section covered by a
specific food additive regulation must meet any specifications in that
regulation.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982;
64 FR 57978, Oct. 28, 1999]
[[Page 244]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1210]
[Page 244-247]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1210 Closures with sealing gaskets for food containers.
Closures with sealing gaskets may be safely used on containers
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food in
accordance with the following prescribed conditions:
(a) Closures for food containers are manufactured from substances
generally recognized as safe for contact with food; substances that are
subject to the provisions of prior sanctions; substances authorized by
regulations in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter; and closure-sealing gaskets, as further prescribed in this
section.
(b) Closure-sealing gaskets and overall discs are formulated from
substances identified in Sec. 175.300(b) of this chapter, with the
exception of paragraph (b)(3) (v), (xxxi), and (xxxii) of that section,
and from other optional substances, including the following:
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with the provisions of a prior
sanction or approval within the meaning of section 201(s) of the act.
(3) Substances that are the subject of regulations in parts 174,
175, 176, 177, 178 and Sec. 179.45 of this chapter and used in
accordance with the conditions prescribed.
(4) Substances identified in paragraph (b)(5) of this section, used
in amounts not to exceed those required to accomplish the intended
physical or technical effect and in conformance with any limitation
provided; and further provided that any substance employed in the
production of closure-sealing gasket compositions that is the subject of
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 of this
chapter conforms with the identity or specifications prescribed.
(5) Substances that may be employed in the manufacture of closure-
sealing gaskets include:
Table 1
------------------------------------------------------------------------
Limitations (expressed as
List of substances percent by weight of closure-
sealing gasket composition)
------------------------------------------------------------------------
Arachidy-l-behenyl amide (C20-C22fatty 5 percent.
acid amides).
Azodicarbonamide....................... 1. 2 percent.
2. 5 percent; for use only in
the manufacture of
polyethylene complying with
item 2.1 in Sec. 177.1520(c)
of this chapter.
Balata rubber..........................
Benzyl alcohol......................... 1 percent.
Brominated isobutylene-isoprene
copolymers, produced when isobutylene-
isoprene copolymers complying with
Sec. 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 deg.C))
of 27 or higher. The viscosity is
determined by the American Society for
Testing and Materials (ASTM) method D
1646-81, "Standard Test Method for
Rubber--Viscosity and Vulcanization
Characteristics (Mooney Viscometer),"
which is incorporated by reference in
accordance with 5 U.S.C. 522(a) and 1
CFR part 51. Copies are available from
the Association of Official Analytical
Chemists 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, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
available for inspection at the Office
of the Federal Register, 800 North
Capitol Street, NW., suite 700,
Washington, DC.
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 Sec.
177.1420.
Coco amide (coconut oil fatty acids 2 percent.
amides).
Cork (cleaned, granulated).............
Diebenzamide phenyl disulfide.......... 1 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
[[Page 245]]
Di(C7, C9-alkyl) adipate............... Complying with Sec. 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. For use as a plasticizer at
No. 006422-86-2).. 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 Sec. 176.170(c)
of this chapter, table 1, and
under conditions of use A
through H described in Sec.
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-
sealing gasket compositions
used in contact with non-fatty
foods containing no more than
8 percent of alcohol.
Di-[beta]-naphthyl-p-phenylenediamine.. 1 percent.
Dipentamethylenethiurametetrasulfide... 0.4 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
Eicosane (technical grade) (water-white
mixture of predominantly straight-
chain paraffin hydrocarbons averaging
20 carbon 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.
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
contain 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
Sec. 177.1520(d)(5), and a minimum
Mooney viscosity of 35 as determined
by the method described in Sec.
177.1520(d)(6).
Ethylene-vinyl acetate copolymer.......
Glyceryl mono-12-hydroxystearate 2 percent.
(hydrogenated glyceryl ricinoleate).
Gutta-percha...........................
Hexamethylenetetramine................. 1 percent.
Hexylene glycol........................ 0.5 percent.
Isobutylene-isoprene copolymers
complying with Sec. 177.1420.
Maleic anhydride-polyethylene copolymer 5 percent.
Maleic anhydride-styrene copolymer..... Do.
2,2'-Methylenebis[6-(1- 1 percent.
methylcylcohexyl)-p-cresol].
Mixed octylated diphenylamine (CAS Reg. 0.1 percent in isobutylene-
No. 68411-46-1). isoprene and chlorinated
isobutylene-isoprene
copolymers complying with Sec.
177.1420, and brominated
isobutylene-isoprene
copolymers complying with this
section.
Napthalene sulfonic acid-formaldehyde 0.2 percent.
condensate, sodium salt.
Natural rubber (crepe, latex,
mechanical dispersions).
[alpha]-cis-9-Octadecenyl-omega- 0.5 percent.
hydroxypoly (oxyethylene); the
octadecenyl group is derived from
oleyl alcohol and the poly
(oxyethylene) content averages 20
moles.
Oleyl alcohol.......................... 1 percent.
4,4'-Oxybis (benzene sulfonyl 0.5 percent.
hydrazide).
Paraformaldehyde....................... 1 percent.
Polybutadiene..........................
Poly-p-dinitroso benzene (activator for 1 percent; for use only in
butyl rubber). vulcanized natural or
synthetic rubber gasket
compositions.
Polyethylene glycol 400 esters of fatty 1 percent.
acids derived from animal and
vegetable fats and oils.
Polyisobutylene complying with Sec.
177.1420.
Polyoxypropylene-polyoxyethylene 0.05 percent.
condensate, average mol. wt. 2750-3000.
[[Page 246]]
Polyurethane resins manufactured from For use only:
diphenylmethane diisocyanate, 1,4- No limitation on amount used,
butanediol, and adipic acid (CAS Reg. but for use only in closure
No. 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 Sec. 176.170(c)
of this chapter, tables 1 and
2, respectively.
Potassium benzoate..................... 1 percent.
Potassium perchlorate.................. Do.
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
compositions for use in lining
crown closures. The gelatin so
used shall be technical grade
or better.
Rosins and rosin derivatives as defined
in Sec. 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 Sec. 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 0.6 percent.
tetradecyl sulfate).
Sodium nitrite......................... 0.2 percent; for use only in
annular ring gaskets applied
in aqueous dispersions to
closures for containers having
a capacity of not less than 5
gallons.
Sodium o-phenylphenate................. 0.05 percent.
Sodium polyacrylate.................... 5 percent.
Sodium and potassium pentachlorophenate 0.05 percent.
Sodium salt of trisopropyl 0.2 percent.
napthalenesulfonic acid.
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
exceed 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) 1 percent.
phosphite.
Vinyl chloride-vinyl stearate copolymer
Zinc dibutyldithiocarbamate............ 0.8 percent; for use only in
vulcanized natural or
synthetic rubber gasket
compositions.
------------------------------------------------------------------------
Table 2--Maximum Extractives Tolerances
[In parts per million]
----------------------------------------------------------------------------------------------------------------
Chloroform Chloroform Chloroform
fraction of fraction of fraction of
Type of closure-sealing gasket composition water heptane alcohol
extractives extractives extractives
----------------------------------------------------------------------------------------------------------------
1. Plasticized polymers, including unvulcanized or vulcanized or 50 500 50
otherwise cured natural and synthetic rubber formed in place as overall
discs or annular rings from a hot melt, solution, plastisol, organisol,
mechanical dispersion, or latex.........................................
2. Preformed overall discs or annular rings of plasticized polymers, 50 250 50
including unvulcanized natural or synthetic rubber......................
3. Preformed overall discs or annular rings of vulcanized plasticized 50 50 50
polymers, including natural or synthetic rubber.........................
4. Preformed overall discs or annular rings of polymeric or resinous- 50 250 50
coated paper, paperboard, plastic, or metal foil substrates.............
5. Closures with sealing gaskets or sealing compositions as described in (\1\) (\1\) (\1\)
1, 2, 3, and 4, and including paper, paperboard, and glassine used for
dry foods only..........................................................
----------------------------------------------------------------------------------------------------------------
\1\ Extractability tests not applicable.
[[Page 247]]
(c) The closure assembly to include the sealing gasket or sealing
compound, together with any polymeric or resinous coating, film, foil,
natural cork, or glass that forms a part of the food-contact surface of
the assembly, when extracted on a suitable glass container with a
solvent or solvents characterizing the type of foods, and under
conditions of time and temperature characterizing the conditions of its
use as determined from tables 3 and 4 shall yield net chloroform-soluble
extractives (corrected for zinc as zinc oleate) not to exceed the
tolerances specified in table 2, calculated on the basis of the water
capacity of the container on which the closure is to be used. Employ the
analytical method described in Sec. 175.300 of this chapter, adapting
the procedural details to make the method applicable to closures; such
as, for example, placing the closed glass container on its side to
assure contact of the closure's food-contacting surface with the
solvent.
Table 3--Types of Food
I. Nonacid (pH above 5.0), aqueous products; may contain salt or sugar
or both, and including oil-in-water emulsions of low- or high-fat
content.
II. Acidic (pH 5.0 or below), aqueous products; may contain salt or
sugar or both, and including oil-in-water emulsions of low- or high-fat
content.
III. Aqueous, acid or nonacid products containing free oil or fat; may
contain salt, and including water-in-oil emulsions of low- or high-fat
content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oils.
VI. Beverages:
A. Containing alcohol.
B. Nonalcoholic.
VII. Bakery products.
VIII. Dry solids (no end-test required).
Table 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 (see -----------------------------------------------------------
Conditions of use table 3) 8 percent alcohol
Water \2\ Heptane \1 2\ \2\
----------------------------------------------------------------------------------------------------------------
A. High temperature heat- I, IV-B........... 250 deg.F, 2 hr.. ..................
sterilized (e.g., over 212 III, IV-A, VII.... ......do.......... 150 deg.F, 2 hr..
deg.F).
B. Boiling water-sterilized..... II................ 212 deg.F, 30 min ..................
III, VII.......... ......do.......... 120 deg.F, 30 min
C. Hot filled or pasteurized II, IV-B.......... Fill boiling, cool ..................
above 150 deg.F. III, IV-A......... to 100 deg.F. 120 deg.F, 15 min
V................. ......do.......... ......do..........
D. Hot filled or pasteurized II, IV-B, VI-B.... 150 deg.F, 2 hr.. .................. ..................
below 150 deg.F. III, IV-A......... ......do.......... 100 deg.F, 30 min 150 deg.F, 2 hr
V................. .......do.........
VI-A..............
E. Temperature filled and stored II, IV-B, VI-B.... 120 deg.F, 24 hr. .................. ..................
(no thermal treatment in the III, IV-A......... ......do.......... 70 deg.F, 30 min. 120 deg.F, 24 hr.
container). V................. ......do..........
VI-A..............
F. Refrigerated storage (no I, II, III, IV-A, 70 deg.F, 48 hr.. 70 deg.F, 30 min. ..................
thermal treatment). IV-B, VI-B, VII. 70 deg.F, 48 hr.
VI-A..............
G. Frozen storage (no thermal I, II, III, IV-B, 70 deg.F, 24 hr.. ..................
treatment in the container). VII.
----------------------------------------------------------------------------------------------------------------
\1\ Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
\2\ Time and temperature.
[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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1211]
[Page 247-248]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1211 Cross-linked polyacrylate copolymers.
Cross-linked polyacrylate copolymers identified in paragraph (a) of
this section may be safely used as articles or components of articles
intended for use in contact with food in accordance with the following
prescribed conditions:
(a) Identity. For the purpose of this section, the cross-linked
polyacrylate copolymers consist of:
[[Page 248]]
(1) The grafted copolymer of cross-linked sodium polyacrylate
identified as 2-propenoic acid, polymers with N,N-di-2-propenyl-2-
propen-1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft
(CAS Reg. No. 166164-74-5); or
(2) 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2-
propenyl)oxy)methyl)-1,3-propanediyl di-2-propenoate and sodium 2-
propenoate (CAS Reg. No. 76774-25-9).
(b) Adjuvants. The copolymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such copolymers. The optional adjuvant substances may
include substances permitted for such use by regulations in parts 170
through 179 of this chapter, substances generally recognized as safe in
food, and substances used in accordance with a prior sanction or
approval.
(c) Extractives limitations. The copolymers identified in paragraph
(a) of this section, in the finished form in which they will contact
food, must yield low molecular weight (less than 1,000 Daltons)
extractives of no more than 0.15 percent by weight of the total polymer
when extracted with 0.2 percent by weight of aqueous sodium chloride
solution at 20 deg.C for 24 hours. The low molecular weight extractives
shall be determined using size exclusion chromatography or an equivalent
method. When conducting the extraction test, the copolymer, with no
other absorptive media, shall be confined either in a finished absorbent
pad or in any suitable flexible porous article, (such as a "tea bag"
or infuser), under an applied pressure of 0.15 pounds per square inch
(for example, a 4x6 inch square pad is subjected to a 1.6 kilograms
applied mass). The solvent used shall be at least 60 milliliters aqueous
sodium chloride solution per gram of copolymer.
(d) Conditions of use. The copolymers identified in paragraph (a)(1)
of this section are limited to use as a fluid absorbent in food-contact
materials used in the packaging of frozen or refrigerated poultry. The
copolymers identified in paragraph (a)(2) of this section are limited to
use as a fluid absorbent in food-contact materials used in the packaging
of frozen or refrigerated meat and poultry.
[64 FR 28098, May 25, 1999, as amended at 65 FR 16817, Mar. 30, 2000]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1240]
[Page 248-249]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer.
Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-
cyclohexylene dimethylene isophthalate may be safely used as an article
or component of articles used in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section:
(a) The copolymer is a basic polyester produced by the catalytic
condensation of dimethyl terephthalate and dimethyl isophthalate with
1,4-cyclohexanedimethanol, to which may have been added certain optional
substances required in its production or added to impart desired
physical and technical properties.
(b) The quantity of any optional substance employed in the
production of the copolymer does not exceed the amount reasonably
required to accomplish the intended physical or technical effect or any
limitation further provided.
(c) Any substance employed in the production of the copolymer that
is the subject of a regulation in parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the production of the copolymer include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in the
copoly-mer and used in accordance with such sanction or approval.
(3) Substances which by regulation in parts 174, 175, 176, 177, 178
and Sec. 179.45 of this chapter may be safely used as components of
resinous or polymeric coatings and film used as food-contact surfaces,
subject to the provisions of such regulation.
(e) The copolymer conforms with the following specifications:
[[Page 249]]
(1) The copolymer, when extracted with distilled water at reflux
temperature for 2 hours, yields total extractives not to exceed 0.05
percent.
(2) The copolymer, when extracted with ethyl acetate at reflux
temperature for 2 hours, yields total extractives not to exceed 0.7
percent.
(3) The copolymer, when extracted with n-hexane at reflux
temperature for 2 hours, yields total extractives not to exceed 0.05
percent.
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984, as amended at 55
FR 34555, Aug. 23, 1990]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1310]
[Page 249]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1310 Ethylene-acrylic acid copolymers.
The ethylene-acrylic acid copolymers identified in paragraph (a) of
this section may be safely used as components of articles intended for
use in contact with food subject to the provisions of this section.
(a) The ethylene-acrylic acid copolymers consist of basic copolymers
produced by the copolymerization of ethylene and acrylic acid such that
the finished basic copolymers contain no more than:
(1) 10 weight-percent of total polymer units derived from acrylic
acid when used in accordance with paragraph (b) of this section; and
(2) 25 weight-percent of total polymer units derived from acrylic
acid when used in accordance with paragraph (c) of this section.
(b) The finished food-contact articles made with no more than 10
percent total polymer units derived from acrylic acid, when extracted
with the solvent or solvents characterizing the type of food and under
the conditions of its intended use as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, yield net acidified chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of food-contact
surface when tested by the methods prescribed in Sec. 177.1330(e)(1),
(3)(i) through (iv), (4), (5), and (6), except that
(1) The total residue method using 3 percent acetic acid, as
prescribed in Sec. 177.1330(e)(6)(i)(a), does not apply, and
(2) The net acidified chloroform-soluble extractives from paper and
paperboard complying with Sec. 176.170 of this chapter may be corrected
for wax, petrolatum, and mineral oil as provided in
Sec. 176.170(d)(5)(iii)(b) of this chapter.
If the finished food-contact article is itself the subject of a
regulation in parts 174, 175, 176, 177, 178, and Sec. 179.45 of this
chapter, it shall also comply with any specifications and limitations
prescribed for it by that regulation.
(c) The finished food-contact layer made with basic copolymers
containing more than 10 weight-percent but no more than 25 weight-
percent of total polymer units derived from acrylic acid and with a
maximum thickness of 0.0025 inch (2.5 mils) may be used in contact with
food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table 1 of
Sec. 176.170(c) of the chapter under conditions of use B through H as
described in table 2 of Sec. 176.170(c) of this chapter, and in contact
with food types III, IVA, V, VIIA, and IX identified in table 1 of
Sec. 176.170(c) of this chapter under conditions of use E through G as
described in table 2 of Sec. 176.170(c) of this chapter.
(d) The provisions of this section are not applicable to ethylene-
acrylic acid copolymers used in food-packaging adhesives complying with
Sec. 175.105 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986; 53
FR 44009, Nov. 1, 1988]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1312]
[Page 249-250]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1312 Ethylene-carbon monoxide copolymers.
The ethylene-carbon monoxide copolymers identified in paragraph (a)
of this section may be safely used as components of articles intended
for use in contact with food subject to the provisions of this section.
(a) Identity. For the purposes of this section, ethylene-carbon
monoxide copolymers (CAS Reg. No. 25052-62-4) consist of the basic
polymers produced by the copolymerization of ethylene and carbon
monoxide such that the copolymers contain not more than 30 weight-
percent of polymer units derived from carbon monoxide.
(b) Conditions of use. (1) The polymers may be safely used as
components of the food-contact or interior core layer of multilaminate
food-contact articles.
(2) The polymers may be safely used as food-contact materials at
temperatures not to exceed 121 deg.C (250 deg.F).
[[Page 250]]
(c) Specifications. (1) Food-contact layers formed from the basic
copolymer identified in paragraph (a) of this section shall be limited
to a thickness of not more than 0.01 centimeter (0.004 inch).
(2) The copolymers identified in paragraph (a) of this section shall
have a melt index not greater than 500 as determined by ASTM method
D1238-82, condition E "Standard Test Method for Flow Rates of
Thermoplastics by Extrusion Plastometer," which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at the Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at
the Office of the Federal Register, 800 North Capitol St. NW., suite
700, Washington, DC.
(3) The basic copolymer identified in paragraph (a) of this section,
when extracted with the solvent or solvents characterizing the type of
food and under the conditions of time and temperature characterizing the
conditions of its intended use, as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, yields net chloroform-soluble
extractives in each extracting solvent not to exceed 0.5 milligram per
square inch of food-contact surface when tested by methods described in
Sec. 176.170(d) of this chapter.
(4) The provisions of this section are not applicable to ethylene-
carbon monoxide copolymers complying with Sec. 175.105 of this chapter.
[57 FR 32422, July 22, 1992]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1315]
[Page 250-253]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart B--Substances for Use as Basic Components of Single and Repeated
Use Food Contact Surfaces
Sec. 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.
Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may
be safely used as articles or components of articles intended for use in
contact with food subject to provisions of this section and of part 174
of this chapter.
(a) Identity. For the purposes of this section, ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymers (1,4-benzene
dicarboxylic acid, dimethyl ester, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or
(1,4-benzenedicarboxylic acid, polymerized with 1,4-
cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are
basic copolymers meeting the specifications prescribed in paragraph (b)
of this section, to which may have been added certain optional
substances required in their production or added to impart desired
physical or technical properties.
(b) Specifications:
[[Page 251]]
----------------------------------------------------------------------------------------------------------------
Maximum
extractable
fractions of the
copolymer in the
finished form at
Ethylene-1,4-cyclohexylene specified
dimethylene terephthalate Inherent viscosity temperatures and Test for Conditions of use
copolymers times (expressed orientability
in micrograms of
the terephthaloyl
moletles/square
centimeter of food-
contact surface)
----------------------------------------------------------------------------------------------------------------
1. Non-oriented ethylene-1,4- Inherent viscosity (1) 0.23 microgram No test required.. In contact with
cyclohexylene dimethylene of a 0.50 percent per square foods, including
terephthalate copolymer is the solution of the centimeter (1.5 foods containing
reaction product of dimethyl copolymer in micrograms per not more than 25
terephthalate or terephthalic phenol-tet square inch) of percent (by
acid with a mixture containing rachloroethane food-contact volume) aqueous
99 to 66 mole percent of (60:40 ratio wt/ surface when alcohol,
ethylene glycol and 1 to 34 wt) solvent is extracted with excluding
mole percent of 1,4-cyclo- not less than water added at carbonated
hexanedimethanol (70 percent 0.669 as 82.2 deg.C (180 beverages and
trans isomer, 30 percent cls determined by deg.F) and beer. Conditions
isomer). using a Wagner allowed to cool of hot fill not
viscometer (or to 48.9 deg.C to exceed 82.2
equivalent) and (120 deg.F) in deg.C (180
calculated from contact with the deg.F), storage
the following food-contact at temperatures
equation: article. not in excess of
Inherent 48.9 deg.C (120
viscosity = deg.F). No
(Natural thermal treatment
logarithm of (Nr)/ in the container.
(c) where:
NrRatio of flow
time of the
polymer solution
to that of the
solvent, and
c=concentration
of the test
solution
expressed in
grams per 100
milliliters.
......do.......... (2) 0.23 microgram ......do.......... Do.
per square
centimeter (1.5
micrograms per
square inch) of
food-contact
surface when
extracted with 3
percent (by
volume) aqueous
acetic acid added
at 82.2 deg.C
(180 deg.F) and
allowed to cool
to 48.9 deg.C
(120 deg.F) in
contact with the
food-contact
article.
......do.......... (3) 0.08 microgram ......do.......... Do.
per square
centimeter (0.5
microgram per
square inch) of
food-contact
surface when
extracted for 2
hours with n-
heptane at 48.9
deg.C (120
deg.F). The
heptane
extractable
results are to be
divided by a
factor of 5.
......do.......... (4) 0.16 microgram ......do.......... Do.
per square
centimeter (1.0
microgram per
square inch) of
food-contact
surface when
extracted for 24
hours with 25
percent (by
volume) aqueous
ethanol at 48.9
deg.C (120
deg.F).
[[Page 252]]
2. Oriented ethylene-1,4- ......do.......... (1) 0.23 microgram When extracted In contact with
cyclohexylene dimethylene per square with heptane at nonalcoholic
terephthalate copolymer is the centimeter (1.5 65.6 deg.C (150 foods including
reaction product of dimethyl micrograms per deg.F) for 2 carbonated
terephthalate or terephthalic square inch) of hours: beverages.
acid with a mixture containing food-contact terephthaloyl Conditions of hot
99 to 85 mole percent ethylene surface of the moieties do not fill not
glycol and 1 to 15 mole percent oriented exceed 0.09 exceeding 87.8
of 1,4-cyclohexane-di-methanol copolymer when microgram per deg.C (190
(70 percent trans isomer, 30 extracted with square centimeter deg.F), storage
percent cls isomer). water added at (0.60 microgram at temperatures
87.8 deg.C (190 per square inch) not in excess of
deg.F) and of food-contact 48.9 deg.C (120
allowed to cool surface. deg.F). No
to 48.9 deg.C thermal treatment
(120 deg.F) in in the container.
contact with the
food-contact
article.
......do.......... (2) 0.23 microgram ......do.......... Do.
per square
centimeter (1.5
micrograms per
square inch) of
food-contact
surface of
oriented
copolymer when
extracted with 3
percent (by
volume) aqueous
acetic acid added
at 87.8 deg.C
(190 deg.F) and
allowed to cool
to 48.9 deg.C
(120 deg.F) in
contact with the
food-contact
article.
......do.......... (3) 0.08 microgram ......do.......... Do.
per square
centimeter (0.5
micro