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
microgram per
square inch) of
food-contact
surface of
oriented
copolymer 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) 0.23 microgram ......do.......... In contact with
per square foods and
centimeter (1.5 beverages
micrograms per containing up to
square inch) of 20 percent (by
food-contact volume) alcohol.
surface of Conditions of
oriented thermal treatment
copolymer when in the container
extracted with 20 not exceeding
percent (by 65.6 deg.C (150
volume) aqueous deg.F) for 20
ethanol heated to minutes. Storage
65.6 deg.C (150 at temperatures
deg.F) for 20 not in excess of
minutes and 48.9 deg.C (120
allowed to cool deg.F).
to 48.9 deg.C
(120 deg.F) in
contact with the
food-contact
article.
......do.......... (5) 0.23 microgram ......do.......... In contact with
per square foods and
centimeter (1.5 beverages
micrograms per containing up to
square inch) of 50 percent (by
food-contact volume) alcohol.
surface of Conditions of
oriented fill and storage
copolymer when not exceeding
extracted with 50 48.9 deg.C (120
percent (by deg.F). No
volume) aqueous thermal treatment
ethanol at 48.9 in the container.
deg.C (120
deg.F) for 24
hours.
[[Page 253]]
3. Ethylene-1,4-cyclohexylene No test required.. For each No test required.. For each
dimethylene terephthalate corresponding corresponding
copolymer is the reaction condition of use, specification,
product of dimethyl must meet may be used as a
terephthalate or terephthalic specifications base sheet and
acid with a mixture containing described in Sec. base polymer in
99 to 95 mole percent of 177.1630(f), accordance with
ethylene glycol and 1 to 5 mole (g), (h), or (j). conditions of use
percent of 1,4- described in Sec.
cyclohexanedimethanol (70 177.1630(f),
percent trans isomer, 30 (g), (h), or (j).
percent cis isomer).
----------------------------------------------------------------------------------------------------------------
(c) Analytical method for determination of extractability. The total
extracted terephthaloyl moieties can be determined in the extracts,
without evaporation of the solvent, by measuring the ultraviolet (UV)
absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or
equivalent) is zeroed with a sample of the solvent taken from the same
lot used in the extraction tests. The concentration of the total
terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent
aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by
reference to standards prepared in the appropriate solvent.
Concentration of the terephthaloyl moieties in heptane is calculated as
cyclic trimer
(C6H4CO2C2H4CO2
)3, by reference to standards prepared in 95:5 percent (v/v)
heptane: tetrahydrofuran.
[45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982; 49
FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, Nov.
24, 1995]
[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: 21CFR177.1320]
[Page 253-254]
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. 177.1320 Ethylene-ethyl acrylate copolymers.
Ethylene-ethyl acrylate copolymers may be safely used to produce
packaging materials, containers, and equipment intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
following prescribed conditions:
(a) Ethylene-ethyl acrylate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and ethyl
acrylate, to which may have been added certain optional substances to
impart desired technological properties to the resin. Subject to any
limitations prescribed in this section, the optional substances may
include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(b) The ethyl acrylate content of the copolymer does not exceed 8
percent by weight unless it is blended with polyethylene or with one or
more olefin copolymers complying with Sec. 177.1520 or with a mixture of
polyethylene and one or more olefin copolymers, in such proportions that
the ethyl acrylate content of the blend does not exceed 8 percent by
weight, or unless it is used in a coating complying with Sec. 175.300 or
Sec. 176.170 of this chapter, in such proportions that the ethyl
acrylate content does not exceed 8 percent by weight of the finished
coating.
(c) Ethylene-ethyl acrylate copolymers or the blend shall conform to
the specifications prescribed in paragraph (c)(1) of this section and
shall meet the
[[Page 254]]
ethyl acrylate content limits prescribed in paragraph (b) of this
section, and the extractability limits prescribed in paragraph (c)(2) of
this section, when tested by the methods prescribed for polyethylene in
Sec. 177.1520.
(1) Specifications--(i) Infrared identification. Ethylene-ethyl
acrylate copolymers can be identified by their characteristic infrared
spectra.
(ii) Quantitative determination of ethyl acrylate content. The ethyl
acrylate can be determined by the infrared spectra. Prepare a scan from
10.5 microns to 12.5 microns. Obtain a baseline absorbance at 11.6
microns and divide by the plaque thickness to obtain absorbance per mil.
From a previously prepared calibration curve, obtain the amount of ethyl
acrylate present.
(iii) Specific gravity. Ethylene-ethyl acrylate copolymers have a
specific gravity of not less than 0.920 nor more than 0.935, as
determined by ASTM method D1505-68 (Reapproved 1979), "Standard Test
Method for Density of Plastics by the Density-Gradient Technique,"
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may
be used in contact with food except as a component of articles used for
packaging or holding food during cooking provided they meet the
following extractability limits:
(i) Maximum soluble fraction of 11.3 percent in xylene after
refluxing and subsequent cooling to 25 deg.C.
(ii) Maximum extractable fraction of 5.5 percent when extracted with
n-hexane at 50 deg.C.
(d) The provisions of paragraphs (b) and (c)(2) of this section are
not applicable to ethylene-ethyl acrylate copolymers used in the
formulation of adhesives complying with Sec. 175.105 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19, 1984]
[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: 21CFR177.1330]
[Page 254-257]
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. 177.1330 Ionomeric resins.
Ionomeric resins manufactured from either ethylene-methacrylic acid
copolymers (and/or their ammonium, calcium, magnesium, potassium,
sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl
acetate copolymers (and/or their ammonium, calcium, magnesium,
potassium, sodium, and/or zinc partial salts,), or methacrylic acid
polymers with ethylene and isobutyl acrylate (and/or their potassium,
sodium and/or zinc partial salts) 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) For the purpose of this section, the ethylene-methacrylic acid
copolymers consist of basic copolymers produced by the copolymerization
of ethylene and methacrylic acid such that the copolymers contain no
more than 20 weight percent of polymer units derived from methacrylic
acid, and the ethylene-methacrylic acid-vinyl acetate copolymers consist
of basic copolymers produced by the copolymerization of ethylene,
methacrylic acid, and vinyl acetate such that the copolymers contain no
more than 15 weight percent of polymer units derived from methacrylic
acid.
(b) For the purpose of this section, the methacrylic acid copolymers
with ethylene and isobutyl acrylate consist of basic copolymers produced
by the copolymerization of methacrylic acid, ethylene, and isobutyl
acrylate such that the copolymers contain no less than 70 weight percent
of polymer units derived from ethylene, no more than 15 weight percent
of polymer units derived from methacrylic acid, and no more than 20
weight percent of polymer units derived from isobutyl acrylate. From 20
percent to 70 percent of the carboxylic acid groups may optionally be
neutralized to form sodium or zinc salts.
(c) The finished food-contact article described 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)
[[Page 255]]
of this chapter, yields net acidified chloroform-soluble extractives in
each extracting solvent not to exceed 0.5 milligram per square inch of
food-contact surface when tested by the methods described in paragraph
(e)(1) of this section, and 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.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(d) The finished food-contact article described in paragraph (b) of
this section, when extracted according to the methods listed in
paragraph (e)(2) of this section and referenced in this paragraph (d),
using the solvent or solvents characterizing the type of food as
determined from table I of paragraph (f) of this section, shall yield
net acidified chloroform-soluble extractives as follows:
(1) For fatty food use. (i) For films of 2 mil (0.002 inches)
thickness or less, extractives shall not exceed 0.70 milligram/square
inch \1\ (0.109 milligram/square centimeter) of food-contact surface (n-
heptane extractions) when extracted by the abbreviated method cited in
paragraph (e)(2)(i) of this section.
---------------------------------------------------------------------------
\1\ Average of four separate values, no single value of which
differs from the average of those values by more then 10
percent.
---------------------------------------------------------------------------
(ii) For films of greater than 2 mils (0.002 inch) thickness,
extractives shall not exceed 0.40 milligram/square inch \1\ (0.062
milligram/square centimeter) of food-contact surface (n-heptane
extractions) when extracted by the abbreviated method cited in paragraph
(e)(2)(i) of this section, or
(iii) Alternatively, for films of greater than 2 mils thickness,
extractives shall not exceed 0.70 milligram/square inch \1\ (0.109
milligram/square centimeter) of food-contact surface (n-heptane
extractions) when extracted by the equilibrium method cited in paragraph
(e)(2)(ii) of this section.
(2) For aqueous foods. (i) The net acidified chloroform-soluble
extractives shall not exceed 0.02 milligram/square inch \2\(0.003
milligram/square centimeter) of food-contact surface (water, acetic
acid, or ethanol/water extractions) when extracted by the abbreviated
method cited in paragraph (e)(2)(i) of this section.
---------------------------------------------------------------------------
\2\ Average of four separate values, no single value of which
differs from the average of those values by more than 50
percent.
---------------------------------------------------------------------------
(ii) Alternatively, the net acidified chloroform-soluble extractives
shall not exceed 0.05 milligram/square inch \3\ (0.078 mg/square
centimeter) of food-contact surface (water, acetic acid, or ethanol/
water extractions) when extracted by the equilibrium method cited in
paragraph (e)(2)(ii) of this section. If when exposed to n-heptane, a
particular film splits along die lines, thus permitting exposure of both
sides of the film to the extracting solvent, the results for that film
sample are invalid and the test must be repeated for that sample until
no splitting by the solvent occurs. 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.
---------------------------------------------------------------------------
\3\See footnote 2 to paragraph (d)(2)(i) of this section.
---------------------------------------------------------------------------
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(e) Analytical methods--(1) Selection of extractability conditions
for ionomeric resins. First ascertain the type of food (table 1 of
Sec. 176.170(c) of this chapter) that is being packed or used in contact
with the finished food-contact article described in paragraph (a) of
this section, and also ascertain the normal conditions of thermal
treatment used in packaging or contacting the type of food involved.
Using table 2 of Sec. 176.170 (c) of this chapter, select the food-
simulating solvent or solvents and the time-temperature test conditions
that correspond to the intended use of the finished food-contact
article. Having selected the appropriate food-simulating solvent or
solvents and time-temperature exaggeration over normal use, follow the
applicable extraction procedure.
(2) Selection of extractability conditions for ionomeric resins.
Using table I of
[[Page 256]]
paragraph (f) of this section ascertain the type of food that is being
packed or used in contact with the finished food-contact article
described in paragraph (b) of this section, and also ascertain the food-
simulating solvent or solvents that correspond to the intended use of
the finished food-contact article.
(i) Abbreviated test. For intended use involving food contact at or
below 120 deg.F (49 deg.C), the appropriate food-simulating solvent is
to contact the food-contact film for the time and temperatures as
follows:
------------------------------------------------------------------------
Solvent Time Temperature
------------------------------------------------------------------------
n-Heptane............................ \1\ 2 120 deg.F (49 deg.C).
Water, 3% acetic acid, or 8%/50% \1\ 48 120 deg.F (49 deg.C).
ethanol.
------------------------------------------------------------------------
\1\ Hours
(ii) Equilibrium test. For intended use involving food contact at or
below 120 deg.F (49 deg.C), the appropriate food-simulating solvent is
to contact the food-contact film at a temperature of 120 deg.F until
equilibrium is demonstrated.
------------------------------------------------------------------------
Minimum
extraction
Solvent times
(hours)
------------------------------------------------------------------------
n-Heptane................................................... 8, 10, 12
Water, 3% acetic acid, or 8%/50% ethanol.................... 72, 96,
120
------------------------------------------------------------------------
The results from a series of extraction times demonstrate equilibrium
when the net chloroform-soluble extractives are unchanging within
experimental error appropriate to the method as described in paragraphs
(d) (1)(i) and (2)(i) of this section. Should equilibrium not be
demonstrated over the above time series, extraction times must be
extended until three successive unchanging values for extractives are
obtained. In the case where intended uses involve temporary food contact
above 120 deg.F, the food-simulating solvent is to be contacted with
the food-contact article under conditions of time and temperature that
duplicate the actual conditions in the intended use. Subsequently the
extraction is to be continued for the time period and under the
conditions specified in the above table.
(3) Reagents--(i) Water. All water used in extraction procedures
should be freshly demineralized (deionized) distilled water.
(ii) n-Heptane. Reagent grade, freshly redistilled before use, using
only material boiling at 208 deg.F (97.8 deg.C).
(iii) Alcohol. 8 or 50 percent (by volume), prepared from
undenatured 95 percent ethyl alcohol diluted with demineralized
(deionized), distilled water.
(iv) Chloroform. Reagent grade, freshly redistilled before use, or a
grade having an established, consistently low blank.
(v) Acetic acid. 3 percent (by weight), prepared from glacial acetic
acid diluted with demineralized (deionized), distilled water.
(4) Selection of test method. The finished food-contact articles
shall be tested either by the extraction cell described in the Journal
of the Association of Official Agricultural Chemists, Vol. 47, No. 1, p.
177-179 (February 1964), also described in ASTM method F34-76
(Reapproved 1980), "Standard Test Method for Liquid Extraction of
Flexible Barrier Materials," which are incorporated by reference, or by
adapting the in-container methods described in Sec. 175.300(e) of this
chapter. Copies of the material incorporated by reference are available
from the Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, and the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, respectively, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(5) Selection of samples. Quadruplicate samples should be tested,
using for each replicate sample the number of finished articles with a
food-contact surface nearest to 100 square inches.
(6) Determination of amount of extractives--(i) Total residues. At
the end of the exposure period, remove the test container or test cell
from the oven, if any, and combine the solvent for each replicate in a
clean Pyrex (or equivalent) flask or beaker, being sure to rinse the
test container or cell with a small quantity of clean solvent. Evaporate
the food-simulating solvents to about 100 milliliters in the flask, and
transfer to a clean, tared evaporating dish (platinum or Pyrex), washing
the flask three times with small portions
[[Page 257]]
of solvent used in the extraction procedure, and evaporate to a few
milliliters on a nonsparking, low-temperature hotplate. The last few
milliliters should be evaporated in an oven maintained at a temperature
of 221 deg.F (105 deg.C). Cool the evaporating dish in a desiccator
for 30 minutes and weigh the residues to the nearest 0.1 milligram, e.
Calculate the extractives in milligrams per square inch of the container
or material surface.
(a) Water, 3 percent acetic acid, and 8 percent and 50 percent
alcohol. Milligrams extractives per square inch=e/s.
(b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)
where:
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane under
exaggerated time-temperature test conditions compared to the amount
extracted by a fat or oil under exaggerated conditions of thermal
sterilization and use.
e'=Acidified chloroform-soluble extractives residue. e' is substituted
for e in the above equations when necessary (See paragraph (e)(6)(ii) of
this section for method to obtain e').
If when calculated by the equations in paragraphs (e)(6)(i) (a) and (b)
of this section, the extractives in milligrams per square inch exceed
the limitations prescribed in paragraphs (c) or (d) of this section,
proceed to paragraph (e)(6)(ii) of this section (method for determining
the amount of acidified chloroform-soluble extractives residue).
(ii) Acidified chloroform-soluble extractives residue. Add 3
milliliters of 37 percent ACS reagent grade hydrochloric acid and 3
milliliters of distilled water to the evaporating dish containing the
dried and weighed residue, e, obtained in paragraph (e)(6)(i) of this
section. Mix well so every portion of the residue is wetted with the
hydrochloric acid solution. Then add 50 milliliters of chloroform. Warm
carefully, and filter through Whatman No. 41 filter paper (or
equivalent) in a Pyrex (or equivalent) funnel, collecting the filtrate
in a clean separatory funnel. Shake for 1 minute, then draw off the
chloroform layer into a clean tared evaporating dish (platinum or
Pyrex). Repeat the chloroform extraction, washing the dish, the filter
paper, and the separatory funnel with this second portion of chloroform.
Add this filtrate to the original filtrate and evaporate the total down
to a few milliliters on a low-temperature hotplate. The last few
milliliters should be evaporated in an oven maintained at 221 deg.F.
Cool the evaporating dish in a desiccator for 30 minutes and weigh to
the nearest 0.1 milligram to get the acidified chloroform-soluble
extractives residue, e'. This e' is substituted for e in the equations
in paragraphs (e)(6)(i) (a) and (b) of this section.
(f) The types of food and appropriate solvents are as follows:
Table 1
------------------------------------------------------------------------
Types of food Appropriate solvent
------------------------------------------------------------------------
1. Nonacid (pH above 5.0), aqueous Water, n-heptane.
products; may contain salt or sugar
or both, and including oil-in-water
emulsions of low- or high-fat content.
2. Acidic (pH 5.0 or below), aqueous n-heptane, water, 3% acetic
products; may contain salt or sugar acid.
or both, and including oil-in-water
emulsions of low- or high-fat content.
3. Aqueous, acid or nonacid products Water, n-heptane, 3% acetic
containing free oil or fat; may acid.
contain salt, and including water-in-
oil emulsions of low- or high-fat
content.
4. Dairy products and modifications:
Water, n-heptane....................
i. Water-in-oil emulsions, high or
low fat.
ii. Oil-in-water emulsions, high or
low fat.
5. Low moisture fats and oils......... n-heptane.
6. Beverages:
i. Containing up to 8% alcohol...... 8% ethanol/water.
ii. Nonalcoholic.................... 3% acetic acid.
iii. Containing more than 8% alcohol 50% ethanol/water.
7. Bakery products.................... Water, n-heptane.
8. Dry solids (without free fat or No extraction test required.
oil).
9. Dry solids (with free fat or oil).. n-heptane.
------------------------------------------------------------------------
(g) The provisions of paragraphs (c) and (d) of this section are not
applicable to the ionomeric resins that are used in food-packaging
adhesives complying with Sec. 175.105 of this chapter.
[45 FR 22916, Apr. 4, 1980, as amended at 49 FR 10108, Mar. 19, 1984; 49
FR 37747, Sept. 26, 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, June
12, 1989]
[[Page 258]]
[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: 21CFR177.1340]
[Page 258]
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. 177.1340 Ethylene-methyl acrylate copolymer resins.
Ethylene-methyl acrylate copolymer resins 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) For the purpose of this section, the ethylene-methyl acrylate
copolymer resins consist of basic copolymers produced by the
copolymerization of ethylene and methyl acrylate such that the
copolymers contain no more than 25 weight percent of polymer units
derived from methyl acrylate.
(b) The finished food-contact article, 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 (corrected for
zinc extractives as zinc oleate) in each extracting solvent not to
exceed 0.5 milligram per square inch of food-contact surface when tested
by the methods described in Sec. 176.170(d) 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.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(c) The provisions of this section are not applicable to ethylene-
methyl acrylate copolymer resins used in food-packaging adhesives
complying with Sec. 175.105 of this chapter.
[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: 21CFR177.1345]
[Page 258-259]
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. 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer.
Ethylene/1, 3-phenylene oxyethylene isophthalate/terephthalate
copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this
section may be safely used, subject to the provisions of this section,
as the non-food-contact layer of laminate structures subject to the
provisions of Sec. 177.1395, and in blends with polyethylene
terephthalate polymers complying with Sec. 177.1630.
(a) Identity. For the purpose of this section, ethylene/1,3-
phenylene oxyethylene isophthalate/terephthalate copolymer consists of
the basic copolymer produced by the catalytic polycondensation of
isophthalic acid and terephthalic acid with ethylene glycol and 1,3-
bis(2-hydroxyethoxy)benzene such that the finished resin contains
between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8
mole-percent of terephthalic moieties, and not more than 10 mole-percent
of 1,3-bis(2-hydroxyethoxy)benzene moieties.
(b) Specifications--(1) Density. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer identified in paragraph (a) of this
section has a density of 1.330.02 grams per cubic centimeter
measured by ASTM Method D 1505-85 (Reapproved 1990), "Standard Test
Method for Density of Plastics by the Density-Gradient Technique,"
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 and Materials, 1916 Race St., Philadelphia, PA 19103, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740, and the Office of the Federal Register, 800 North Capitol St.
NW., suite 700, Washington, DC.
(2) Softening point. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer identified in paragraph (a) of this
section has a softening point of 635 deg.C as measured by
ASTM Method D 1525-87, "Standard Test Method for VICAT Softening
Temperature of Plastics," which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of
this material is provided in paragraph (b)(1) of this section.
(c) Optional adjuvant substances. Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer, identified in paragraph (a) of
this section, may contain optional adjuvant substances required in their
production. The optional adjuvants may include substances used in
accordance with Sec. 174.5 of this chapter.
[[Page 259]]
(d) Limitations. Copolymer blends described above shall not exceed
30 percent by weight of ethylene/1, 3-phenylene oxyethylene
isophthalate/terephthalate copolymer. The finished blend may be used in
contact with food only under conditions of use C through G, as described
in table 2 of Sec. 176.170(c) of this chapter, except that with food
identified as Type III, IV-A, V, VII-A, and IX in Sec. 176.170(c), table
1, the copolymer may be used under condition of use C at temperatures
not to exceed 160 deg.F (71 deg.C).
[57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994;
61 FR 14481, Apr. 2, 1996; 62 FR 34628, June 27, 1997]
[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: 21CFR177.1350]
[Page 259-260]
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. 177.1350 Ethylene-vinyl acetate copolymers.
Ethylene-vinyl acetate copolymers may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food in accordance with the following prescribed conditions:
(a)(1) Ethylene-vinyl acetate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and vinyl acetate
to which may have been added certain optional substances to impart
desired technological or physical properties to the resin. Subject to
any limitations prescribed in this section, the optional substances may
include:
(i) Substances generally recognized as safe in food and food
packaging.
(ii) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(iii) Substances identified in Sec. 175.300(b)(3) (xxv), (xxvii),
(xxx), and (xxxiii) of this chapter, and colorants used in accordance
with Sec. 178.3297 of this chapter.
(iv) Erucamide as identified in Sec. 178.3860 of this chapter.
(v) Xanthan gum as identified in Sec. 172.695 for use as a
thickening agent at a level not to exceed 1 percent by weight of coating
solids in aqueous dispersions of ethylene-vinyl acetate copolymers,
where such copolymers are used only as coatings or a component of
coatings.
(vi) The copolymer of vinylidene fluoride and hexafluoropropene (CAS
Reg. No. 9011-17-0), containing 65 to 71 percent fluorine and having a
Mooney Viscosity of at least 28, for use as a processing aid at a level
not to exceed 0.2 percent by weight of ethylene-vinyl acetate
copolymers.
(2) Maleic anhydride-grafted ethylene-vinyl acetate copolymers (CAS
Reg. No. 28064-24-6) consist of basic resins produced by the catalytic
copolymerization of ethylene and vinyl acetate, followed by reaction
with maleic anhydride. Such polymers shall contain not more than 11
percent of polymer units derived from vinyl acetate by weight of total
polymer prior to reaction with maleic anhydride, and not more than 2
percent of grafted maleic anhydride by weight of the finished polymer.
Optional adjuvant substances that may be added to the copolymers include
substances generally recognized as safe in food and food packaging,
substances the use of which is permitted under applicable regulations in
parts 170 through 189 of this chapter, and substances identified in
Sec. 175.300(b)(3)(xxv), (xxvii), (xxxiii), and (xxx) of this chapter
and colorants for polymers used in accordance with the provisions of
Sec. 178.3297 of this chapter.
(b)(1) Ethylene-vinyl acetate copolymers, with or without the
optional substances described in paragraph (a) of this section, when
extracted with the solvent or solvents characterizing the type of food,
and under conditions of time and temperature characterizing the
conditions of their intended use as determined from tables 1 and 2 of
Sec. 176.170(c) of this chapter, shall yield net chloroform-soluble
extractives corrected for zinc as zinc oleate not to exceed 0.5
milligram per square inch of an appropriate sample.
(2) Maleic anhydride grafted ethylene-vinyl acetate copolymers shall
have a melt flow index not to exceed 2.1 grams per 10 minutes as
determined by ASTM method D 1238-82, "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). Copies may
be obtained from the American Society for Testing Materials, 1916 Race
St., Philadelphia, PA 19103, or at
[[Page 260]]
the Division of Petition Control (HFS-215), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC. Compliance of the melt flow
index specification shall be determined using conditions and procedures
corresponding to those described in the method as Condition E, Procedure
A). The copolymers shall be used in blends with other polymers at levels
not to exceed 17 percent by weight of total polymer, subject to the
limitation that when contacting food of types III, IV-A, V, VI-C, VII-A,
and IX, identified in Sec. 176.170(c) of this chapter, Table 1, the
polymers shall be used only under conditions of use C, D, E, F, and G,
described in Sec. 176.170(c) of this chapter, Table 2.
(c) The provisions of paragraph (b) of this section are not
applicable to ethylene-vinyl acetate copolymers used in food-packaging
adhesives complying with Sec. 175.105 of this chapter.
(d) Ethylene-vinyl acetate copolymers may be irradiated under the
following conditions to produce molecular crosslinking of the polymers
to impart desired properties such as increased strength and increased
ability to shrink when exposed to heat:
(1) Electron beam source of ionizing radiation at a maximum energy
of 3 million electron volts: Maximum absorbed dose not to exceed 150
kiloGray (15 megarads).
(2) The finished food-contact film shall meet the extractives
limitations prescribed in paragraph (e)(2) of this section.
(3) The ethylene-vinyl acetate copolymer films may be further
irradiated in accordance with the provisions of paragraph (e)(1) of this
section: Provided, That the total accumulated radiation dose from both
electron beam and gamma ray radiation does not exceed 150 kiloGray (15
megarads).
(e) Ethylene-vinyl acetate copolymer films intended for contact with
food may be irradiated to control the growth of microorganisms under the
following conditions:
(1) Gamma photons emitted from a cobalt-60 sealed source in the dose
range of 5-50 kiloGray (0.5-5.0 megarads).
(2) The irradiated ethylene-vinyl acetate copolymer films, when
extracted with reagent grade n-heptane (freshly redistilled before use)
according to methods described under Sec. 176.170(d)(3) of this chapter,
at 75 deg.F for 30 minutes shall yield total extractives not to exceed
4.5 percent by weight of the film.
[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54
FR 35874, Aug. 30, 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, Aug. 30,
1991; 64 FR 47108, Aug. 30, 1999]
[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: 21CFR177.1360]
[Page 260-261]
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. 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.
Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221-
27-2) 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) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by
the partial or complete alcoholysis or hydrolysis of those ethylene-
vinyl acetate copolymers complying with Sec. 177.1350.
(1) Those copolymers containing a minimum of 55 percent ethylene and
a maximum of 30 percent vinyl alcohol units by weight may be used in
contact with foods as described in paragraph (b) of this section.
(2) Those copolymers containing a minimum of 55 percent ethylene and
a maximum of 15 percent vinyl alcohol units by weight may be used in
contact with foods as described in paragraph (c) of this section.
(3) Those copolymers containing 17 to 40 percent ethylene and 60 to
83 percent vinyl alcohol units by weight may be used in contact with
foods as described in paragraph (d) of this section.
(b) The finished food-contact article shall not exceed 0.013
centimeter (0.005 inch) thickness and shall contact foods only of the
types identified in table 1 of Sec. 176.170(c) of this chapter in
Categories I, II, IV-B, VI, VII-B, and VIII under conditions of use D
through G described in table 2 of Sec. 176.170(c) of this
[[Page 261]]
chapter. Film samples of 0.013 centimeter (0.005) inch thickness
representing the finished article shall meet the following extractive
limitation when tested by ASTM method F34-76 (Reapproved 1980),
"Standard Test Method for Liquid Extraction of Flexible Barrier
Materials," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(1) The film when extracted with distilled water at 21 deg.C (70
deg.F) for 48 hours yields total extractives not to exceed 0.0047
milligram per square centimeter (0.03 milligram per square inch) of
food-contact surface.
(2) The film when extracted with 50 percent ethyl alcohol at 21
deg.C (70 deg.F) for 48 hours yields total extractives not to exceed
0.0062 milligram per square centimeter (0.04 milligram per square inch)
of food-contact surface.
(c) The finished food-contact article shall not exceed 0.0076
centimeter (0.003 inch) thickness and shall contact foods only of the
types identified in table 1 of Sec. 176.170(c) of this chapter in
Categories III, IV-A, VII-A, and IX under conditions of use F and G
described in table 2 of Sec. 176.170(c) of this chapter. Film samples of
0.0076 centimeter (0.003 inch) thickness representing the finished
articles shall meet the following extractive limitation when tested by
ASTM method F34-76 (Reapproved 1980), "Standard Test Method for Liquid
Extraction of Flexible Barrier Materials," which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (b) of this section. The film when extracted with n-heptane
at 38 deg.C (100 deg.F) for 30 minutes yields total extractives not to
exceed 0.0078 milligram per square centimeter (0.05 milligram per square
inch) of food-contact surface, after correcting the total extractives by
dividing by a factor of five.
(d) The finished food-contact article shall not exceed 0.018
centimeter (0.007 inch) thickness and may contact all foods, except
those containing more than 8 percent alcohol, under conditions of use B
through H described in table 2 of Sec. 176.170(c) of this chapter. Film
samples of 0.018 centimeter (0.007 inch) thickness representing the
finished articles shall meet the following extractive limitation when
tested by ASTM method F34-76 (Reapproved 1980), "Standard Test Methods
for Liquid Extraction of Flexible Barrier Materials," which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b) of this section. The film when
extracted with distilled water at 100 deg.C (212 deg.F) for 30 minutes
yields ethylene-vinyl acetate-vinyl alcohol oligomers not to exceed
0.093 milligram per square centimeter (0.6 milligram per square inch) of
food contact surface as determined by a method entitled "Analytical
Method of Determining the Amount of EVOH in the Extractives Residue of
EVOH Film," dated March 23, 1987, as developed by the Kuraray Co.,
Ltd., 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 Office of
Premarket Approval (HFS-200), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or may be examined at the Center for Food Safety
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park,
MD 20740, or at the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
(e) The provisions of this section are not applicable to ethylene-
vinyl acetate-vinyl alcohol copolymers used in the food-packaging
adhesives complying with Sec. 175.105 of this chapter.
[47 FR 41531, Sept. 21, 1982, as amended at 49 FR 10108, Mar. 19, 1984;
65 FR 17135, Mar. 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: 21CFR177.1380]
[Page 261-262]
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. 177.1380 Fluorocarbon resins.
Fluorocarbon resins 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) For the purpose of this section, fluorocarbon resins consist of
basic resins produced as follows:
(1) Chlorotrifluoroethylene resins produced by the
homopolymerization of chlorotrifluoroethylene.
[[Page 262]]
(2) Chlorotrifluoroethylene-1,1-difluoroethylene copolymer resins
produced by copolymerization of chlorotrifluoroethylene and 1,1-
difluoroethylene.
(3) Chlorotrifluoroethylene-1,1-difluoroethylene-tetrafluoroethylene
co-polymer resins produced by copolymerization of
chlorotrifluoroethylene, 1,1-difluoroethylene, and tetrafluoroethylene.
(4) Ethylene-chlorotrifluoroethylene copolymer resins produced by
copolymerization of nominally 50 mole percent of ethylene and 50 mole
percent of chlorotrifluoroethylene. The copolymer shall have a melting
point of 239 to 243 deg.C and a melt index of less than or equal to 20
as determined by ASTM Method D 3275-89 "Standard Specification for E-
CTFE-Fluoroplastic Molding, Extrusion, and Coating Materials," 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
and Materials, 1916 Race St., Philadelphia, PA 19013, or may be examined
at the Office of the Federal Register, 800 North Capitol Street, NW.,
suite 700, Washington, DC.
(b) Fluorocarbon resins that are identified in paragraph (a) of this
section and that comply with extractive limitations prescribed in
paragraph (c) of this section may be used as articles or components of
articles intended for use in contact with food as follows:
(1) Fluorocarbon resins that are identified in paragraphs (a)(1),
(a)(2), and (a)(3) of this section and that comply only with the
extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of
this section may be used when such use is limited to articles or
components of articles that are intended for repeated use in contact
with food or that are intended for one-time use in contact with foods
only of the types identified in Sec. 176.170(c) of this chapter, table
1, under Types I, II, VI, VII-B, and VIII.
(2) Fluorocarbon resins that are identified in paragraph (a)(4) of
this section and that comply with the extractive limitations prescribed
in paragraphs (c)(1) and (c)(2) of this section may be used only when
such use is limited to articles or components of articles that are
intended for repeated use in contact with food.
(3) In accordance with current good manufacturing practice, those
food-contact articles intended for repeated use shall be thoroughly
cleansed prior to their first use in contact with food.
(c) Extractives limitations are applicable to the basic resins in
the form of pellets that have been ground or cut into small particles
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) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of distilled water at reflux temperature for 8 hours, shall
yield total extractives not to exceed 0.003 percent by weight of the
resins.
(2) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of 50 percent (by volume) ethyl alcohol in distilled water
at reflux temperature for 8 hours, shall yield total extractives not to
exceed 0.003 percent by weight of the resins.
(3) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of n-heptane at reflux temperature for 8 hours, shall yield
total extractives not to exceed 0.01 percent by weight of the resins.
[42 FR 14572, Mar. 15, 1977, as amended at 57 FR 185, Jan. 3, 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: 21CFR177.1390]
[Page 262-265]
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. 177.1390 Laminate structures for use at temperatures of 250 deg.F and above.
(a) The high-temperature laminates identified in this section may be
safely used for food contact at temperatures not exceeding 135 deg.C
(275 deg.F) unless otherwise specified. These articles are layered
constructions that are optionally bonded with adhesives. The interior
(food-contact) layer(s) may be separated from the exterior layer(s) by a
functional barrier, such as aluminum foil. Upon review of the physical
properties of a particular construction, the Food and Drug
Administration may consider other layers to serve as functional
barriers. This regulation is not intended to limit these constructions
as to shape, degree of flexibility, thickness, or number of layers.
These layers
[[Page 263]]
may be laminated, extruded, coextruded, or fused.
(b) When containers subject to this regulation undergo heat
sterilization to produce shelf-stable foods, certain control measures
(in addition to the food additive requirements in paragraphs (c) and (d)
of this section) are necessary to ensure proper food sterilization and
package integrity. Refer to parts 108, 110, 113, and 114 of this chapter
for details.
(c) Subject to the provisions of this paragraph, food-contact
articles produced from high-temperature laminates may be safely used to
package all food types except those containing more than 8 percent ethyl
alcohol.
(1) Polymeric films/layers. Films or layers not separated from food
by a functional barrier must meet the following requirements:
(i) Films/layers may consist of the following:
(a) Polyolefin resins complying with item 2.2 or 3.2 of the table in
Sec. 177.1520(c).
(b) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no
more than 10 percent by weight of a copolymer of ethylene and vinyl
acetate complying with Sec. 177.1350.
(c) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in Sec. 177.1520(c) blended with no
more than 38 percent by weight of a homopolymer of isobutylene complying
with Sec. 177.1420(a)(1).
(d) Polyethylene phthalate resins complying with Sec. 177.1630(e)(4)
(i) and (ii).
(e) Nylon MXD-6 resins that comply with item 10.3 of the table in
Sec. 177.1500(b) of this chapter when extracted with water and heptane
under the conditions of time and temperature specified for condition of
use A, as set forth in Table 2 of Sec. 176.170(c) of this chapter.
(f) Nylon \6/12\ resins (CAS Reg. No. 25191-04-2) complying with
item 13.3 of the table in Sec. 177.1500(b), for use as nonfood-contact
layers of laminated films and in rigid multilaminate constructions with
polypropylene outer layers. Laminate structures with authorized food-
contact materials yield no more than 0.15 milligrams of epsilon-
caprolactam and 0.04 milligrams of omega-laurolactam per square inch
when extracted with 95 percent ethanol at 121 deg.C (250 deg.F) for 2
hours.
(ii) Adjuvants used in these layers must comply with an applicable
regulation that permits food type and time/temperature conditions to
which the container will be exposed, including sterilization processing.
(2) Adhesives. The use of adhesives in these containers is optional.
Adhesives may be formulated from the following substances, subject to
the prescribed limitations:
(i) Any substance suitable for use in formulating adhesives that
complies with an applicable regulation of this chapter which permits
food type and time/temperature conditions to which the container will be
exposed, including sterilization processing.
(ii) Substances complying with Sec. 175.105 of this chapter may be
used in these constructions, provided they are separated from the
interior (food-contact) layer(s) by a functional barrier as discussed
under paragraph (a) of this section.
(iii) Maleic anhydride adduct of polypropylene complying with
Sec. 175.300 of this chapter.
(iv) Polyester-urethane adhesive for use at temperatures not
exceeding 121 deg.C (250 deg.F) and formulated from the following:
(a) Polyester-urethanediol resin prepared by the reaction of a
mixture of polybasic acids and polyhydric alcohols listed in
Sec. 175.300(b)(3)(vii) of this chapter, 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) and optional
trimethoxysilane coupling agents containing amino, epoxy, ether, and/or
mercapto groups not to exceed 3 percent by weight of the cured adhesive.
(b) Urethane cross-linking agent comprising not more than 25 percent
by weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) adduct of
trimethylol propane (Cas Reg. No. 77-99-6) and/or 1,3-
bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4) adduct of
trimethylol propane.
[[Page 264]]
(v) Polyester-epoxy-urethane adhesives formulated from the
following:
(a) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter.
Azelaic acid may also be used as a polybasic acid.
(b) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this
chapter and comprising no more than 30 percent by weight of the cured
adhesive.
(c) Urethane cross-linking agent comprising no more than 14 percent
weight of the cured adhesive and formulated from 3-isocyanatomethyl-
3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-
0).
(vi) Polyurethane-polyester resin-epoxy adhesives formulated from
the following mixture:
(a)(1) Polyester-polyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in
Sec. 175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9).
(2) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in Sec. 175.300(b)(3)(vii) of this chapter.
Additionally, azelaic acid and 1,6-hexanediol may also be used as
reactants in lieu of a polyhydric alcohol.
(3) Epoxy resin listed in Sec. 175.300(b)(3)(viii)(a) of this
chapter and comprising not more than 5 percent by weight of the cured
adhesive.
(4) Optional trimethoxy silane curing agents, containing amino,
epoxy, ether, or mercapto groups not in excess of 3 percent of the cured
adhesive.
(b) Urethane cross-linking agent, comprising not more than 20
percent by weight of the cured adhesive, and formulated from trimethylol
propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4).
(vii) Polyester-polyurethane resin-acid dianhydride adhesives for
use at temperatures not to exceed 121 deg.C (250 deg.F), in contact
only with food Types I, II, VIA, VIB, VIIB, and VIII as described in
Table I of Sec. 176.170 of this chapter, and formulated from the
following mixture:
(a)(1) Polyesterpolyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in
Sec. 175.300(b)(3)(vii) of this chapter and 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9). Additionally,
dimethylol propionic acid and 1,6-hexanediol may be used alone or in
combination as reactants in lieu of a polybasic acid and a polyhydric
alcohol.
(2) Acid dianhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-
5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No.
73003-90-4), comprising not more than one percent of the cured adhesive.
(b) Urethane cross-linking agent, comprising not more than twelve
percent by weight of the cured adhesive, and formulated from trimethylol
propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-
trimethylcyclohexyl isocyanate (CAS Reg. No. 4098-71-9) and/or 1,3-
bis(isocyanatomethyl)benzene (CAS Reg. No. 363-48-31).
(3) Test specifications. These specifications apply only to
materials on the food-contact side of a functional barrier, if present.
All tests must be performed on containers made under production
conditions. Laminated structures submitted to extraction procedures must
maintain complete structural integrity (particularly with regard to
delamination) throughout the test.
(i) Nonvolatile extractives. (a) For use at temperatures not to
exceed 121 deg.C (250 deg.F): The container interior (food-contact
side) shall be extracted with deionized distilled water at 121 deg.C
(250 deg.F) for 2 hours.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraphs
(c)(2)(i), (c)(2)(ii), (c)(2)(iii), (c)(2)(iv), and (c)(2)(vii) of this
section shall not exceed 0.0016 milligram per square centimeter (0.01
milligram per square inch) as determined by a method entitled
"Determination of Non-Volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,"
[[Page 265]]
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, and may
be examined at the Center for Food Safety and Applied Nutrition's
Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the
Office of the Federal Register, 800 North Capitol St. NW., suite 700,
Washington, DC 20408.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
"Determination of Non-volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts," which is incorporated by reference in paragraph
(c)(3)(i)(a)(1) of this section.
(b) For use at temperatures not to exceed 135 deg.C (275 deg.F):
The container interior (food-contact side) shall be extracted with
deionized distilled water at 135 deg.C (275 deg.F) for 1 hour.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using no adhesive, or adhesives listed in
paragraphs (c)(2) (i), (ii), and (iii) of this section shall not exceed
0.0020 milligram per square centimeter (0.013 milligram per square inch)
as determined by a method titled "Determination of Non-volatile
Chloroform Soluble Residues in Retort Pouch Water Extracts," which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (c)(3)(i)(a)(1) of this section.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
"Determination of Non-volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(3)(i)(a)(1) of this section.
(3) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph
(c)(2)(vi) of this section shall not exceed 0.008 milligram per square
centimeter (0.05 milligram per square inch) as determined by a method
entitled, "Determination of Non-volatile Chloroform Soluble Residues in
Retort Pouch Water Extracts," which is incorporated by reference in
paragraph (c)(3)(i)(a)(1) of this section.
(ii) Volatiles. Volatile substances employed in the manufacture of
high-temperature laminates must be removed to the greatest extent
possible in keeping with good manufacturing practice prescribed in
Sec. 174.5(a) of this chapter.
(d) Nylon 12/aluminum foil high-temperature laminates: Subject to
the provisions of this paragraph, containers constructed of nylon 12
laminated to aluminum foil may be safely used at temperatures no greater
than 250 deg.F (121 deg.C) in contact with all food types except those
containing more than 8 percent alcohol.
(1) The container is constructed of aluminum foil to which nylon 12
film is fused. Prior to fusing the nylon 12, the aluminum foil may be
optionally precoated with a coating complying with Sec. 175.300 of this
chapter.
(2) Nylon 12 resin complying with Sec. 177.1500 and having an
average thickness not to exceed 0.0016 inch (41 microns) may be used as
the food-contact surface of the container.
(3) Container test specifications. On exposure to distilled water at
250 deg.F (121 deg.C) for 2 hours, extractives from the food-contact
side of the nylon 12 multilayered construction shall not exceed 0.05
milligram per square inch (0.0078 milligram per square centimeter) as
total nonvolatile extractives.
[45 FR 2843, Jan. 15, 1980, as amended at 47 FR 49639, Nov. 2, 1982; 48
FR 236, Jan. 4, 1983; 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22,
1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084,
Oct. 5, 1988; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; 63
FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, 1999; 64 FR 46272, Aug. 25,
1999]
[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: 21CFR177.1395]
[Page 265-266]
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. 177.1395 Laminate structures for use at temperatures between 120 deg.F and 250 deg.F.
(a) The laminates identified in this section may be safely used at
the specified temperatures. These articles are layered structures that
are optionally
[[Page 266]]
bonded with adhesives. In these articles, the food-contact layer does
not function as a barrier to migration of components from non-food-
contact layers. The layers may be laminated, extruded, coextruded, or
fused.
(b) Laminate structures may be manufactured from:
(1) Polymers and adjuvants complying with Sec. 177.1390 of this
chapter.
(2) Any polymeric resin listed in these regulations so long as the
use of the resin in the structure complies with the conditions of use
(food type and time/temperature) specified in the regulation for that
resin.
(3) Optional adjuvant substances used in accordance with Sec. 174.5
of this chapter.
(4) The following substances in non-food-contact layers only:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Ethylene/1,3-phenylene oxyethylene For use only with
isophthalate/terephthalate copolymer (CAS polyethylene terephthalate
Reg. No. 87365-98-8) complying with Sec. as the food-contact layer,
177.1345. complying with Sec.
177.1630 under conditions
of use C through G
described in table 2 of
Sec. 176.170(c) of this
chapter. Laminate
structures, when extracted
with 8 percent ethanol at
150 deg.F for 2 hours
shall not yield m-pheny
lenedioxy-O,O'-diethyl
isophthalate or cyclic
bis(ethylene isophthalate)
in excess of 7.8 micrograms/
square decimeter (0.5
microgram/square inch) of
food-contact surface.
Nylon 6/12 resins complying with Sec. For use with nonalcoholic
177.1500(b), item 13.2, of this chapter foods at temperatures not
(CAS Reg. No. 25191-04-2). to exceed 100 deg.C (212
deg.F). Laminate structures
with authorized food-
contact materials yield no
more than 0.15 milligram of
epsilon-caprolactam and
0.04 milligram of omega-
laurolactam per square inch
when extracted with water
at 100 deg.C (212 deg.F)
for 5 hours.
Nylon 6/66 resins complying with Sec. For use only with:
177.1500(b), item 4.2 of this chapter 1. Nonalcoholic foods at
(CAS Reg. 24993-04-2). temperatures not to exceed
82.2 deg.C (180 deg.F).
Laminate structures with
authorized food-contact
materials yield no more
than 0.15 milligram of
epsilon-caprolactam per
square inch when extracted
with water at 82.2 deg.C
(180 deg.F) for 5 hours.
2. Nonalcoholic foods at
temperatures not to exceed
100 deg.C (212 deg.F).
Laminate films with
authorized food-contact
materials yield no more
than 0.15 milligram of
epsilon-caprolactam per
square inch when extracted
with water at 100 deg.C
(212 deg.F) for 5 hours.
Nylon 6/69 resins complying with Sec. For use with nonalcoholic
177.1500(b), item 14, of this chapter foods under conditions of
(CAS Reg. No. 51995-62-1). use B, C, D, E, F, G, and H
described in table 2 of
Sec. 176.170 of this
chapter. Laminate
structures with authorized
food-contact materials may
contain nylon 6/69 resins
provided that the nitrogen
content of aqueous extracts
of a representative
laminate (obtained at 100
deg.C (212 deg.F) for 8
hours) does not exceed 15
micrograms per square
centimeter (100 micrograms
per square inch).
------------------------------------------------------------------------
[52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988; 57
FR 43399, Sept. 21, 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, Oct.
17, 1997]
[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: 21CFR177.1400]
[Page 266-267]
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. 177.1400 Hydroxyethyl cellulose film, water-insoluble.
Water-insoluble hydroxyethyl cellulose film may be safely used for
packaging food in accordance with the following prescribed conditions:
(a) Water-insoluble hydroxyethyl cellulose film consists of a base
sheet manufactured by the ethoxylation of cellulose under controlled
conditions, to which may be 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 parts 170 through 189
of this chapter, the optional substances used
[[Page 267]]
in the base sheet and coating may include:
(1) Substances generally recognized as safe in food.
(2) Substances permitted to be used in water-insoluble hydroxyethyl
cellulose film by prior sanction or approval and under conditions
specified in such sanctions or approval, and substances listed in part
181, subpart B of this chapter.
(3) Substances that by any regulation promulgated under section 409
of the act may be safely used as components of water-insoluble
hydroxyethyl cellulose film.
(4) Substances identified in and used in compliance with
Sec. 177.1200(c).
(c) Any substance employed in the production of the water-insoluble
hydroxyethyl cellulose film described in this section 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.
[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: 21CFR177.1420]
[Page 267]
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. 177.1420 Isobutylene polymers.
Isobutylene polymers may be safely used as components of articles
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, isobutylene polymers are those
produced as follows:
(1) Polyisobutylene produced by the homopolymerization of
isobutylene such that the finished polymers have a molecular weight of
750,000 (Flory) or higher.
(2) Isobutylene-isoprene copolymers produced by the copolymerization
of isobutylene with not more than 3 molar percent of isoprene such that
the finished polymers have a molecular weight of 300,000 (Flory) or
higher.
(3) Chlorinated isobutylene-isoprene copolymers produced when
isobutylene-isoprene copolymers (molecular weight 300,000 (Flory) or
higher) are modified by chlorination with not more than 1.3 weight-
percent of chlorine.
(b) The polymers identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of the
polymers. The optional adjuvant substances required in the production of
the polymers may include substances generally recognized as safe in
food, substances used in accordance with a prior sanction or approval,
and aluminum chloride.
(c) The provisions of this section are not applicable to
polyisobutylene used in food-packaging adhesives complying with
Sec. 175.105 of this chapter.
[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: 21CFR177.1430]
[Page 267-268]
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. 177.1430 Isobutylene-butene copolymers.
Isobutylene-butene 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) For the purpose of this section, isobutylene-butene copolymers
consist of basic copolymers produced by the copolymerization of
isobutylene with mixtures of n-butenes such that the finished basic
copolymers contain not less than 45 weight percent of polymer units
derived from isobutylene and meet the specifications prescribed in
paragraph (b) of this section when tested by the methods described in
paragraph (c) of this section.
(b) Specifications:
----------------------------------------------------------------------------------------------------------------
Maximum
Isobutylene-butene copolymers Molecular weight (range) Viscosity (range) bromine
value
----------------------------------------------------------------------------------------------------------------
1. Used as release agents in petroleum 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
wax complying with Sec. 178.3710 of deg.F.
this chapter.
2. Used as plasticizers in 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
polyethylene or polypropylene deg.F.
complying with Sec. 177.1520, and in
polystyrene complying with Sec.
177.1640.
3. Used as components of nonfood 300 to 5,000............ 40 to 20,000 seconds Saybolt at 200 40
articles complying with Secs. deg.F.
175.300, 176.170, 176.210,
177.2260(d)(2), 177.2800, and
178.3570 (provided that addition to
food does not exceed 10 parts per
million), or Sec. 176.180 of this
chapter.
4. Used as production aids in the 150 to 5,000............ Less than 20,000 seconds Saybolt at 90.
manufacture of expanded (foamed) 200 deg.F.
polystyrene articles complying with
Sec. 177.1640 of this chapter.
[[Page 268]]
5. Used in release coatings on 150 to 5,000............ Less than 20,000 seconds Saybolt at 90
backings or linings for pressure- 200 deg.F.
sensitive adhesive labels complying
with Sec. 175.125 of this chapter.
----------------------------------------------------------------------------------------------------------------
(c) The analytical methods for determining whether isobutylene-
butene copolymers conform to the specifications in paragraph (b) are as
follows:
(1) Molecular weight. Molecular weight shall be determined by
American Society for Testing and Materials (ASTM) method D2503-82,
"Standard Test Method for Molecular Weight (Relative Molecular Mass) of
Hydrocarbons by Thermoelectric Measurement of Vapor Pressure," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) Viscosity. Viscosity shall be determined by ASTM method D445-74,
"Test for Kinematic Viscosity of Transparent and Opaque Liquids,"
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (c)(1) of this section.
(3) Maximum bromine value. Maximum bromine value shall be determined
by ASTM method D1492-78, "Standard Test Method for Bromine Index of
Aromatic Hydrocarbons by Coulometric Titration," which is incorporated
by reference. The availability of this incorporation by reference is
given in paragraph (c)(1) of this section.
(d) The provisions of this section are not applicable to
isobutylene-butene copolymers used as provided under Sec. 175.105 of
this chapter.
[52 FR 11641, Apr. 10, 1987, as amended at 63 FR 36175, July 2, 1998]
[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: 21CFR177.1440]
[Page 268]
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. 177.1440 4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000.
4,4'-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum
molecular weight of 10,000 may be safely used as articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food in accordance with the following prescribed conditions:
(a) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins consist of
basic resins produced by the condensation of equimolar amounts of 4,4'-
isopropylidenediphenol and epichlorohydrin terminated with phenol, to
which may have been added certain optional adjuvant substances required
in the production of the resins.
(b) The optional adjuvant substances required in the production of
the resins may include substances generally recognized as safe in food,
substances used in accordance with a prior sanction or approval, and the
following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Butyl alcohol............................ Not to exceed 300 p.p.m. as
residual solvent in finished
resin.
Ethyl alcohol............................
Toluene.................................. Not to exceed 1,000 p.p.m. as
residual solvent in finished
resin.
------------------------------------------------------------------------
(c) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet
the following nonvolatile extractives limitations:
(1) Maximum extractable nonvolatile fraction of 2 parts per million
when extracted with distilled water at 70 deg.C for 2 hours, using a
volume-to-surface ratio of 2 milliliters per square inch.
(2) Maximum extractable nonvolatile fraction of 3 parts per million
when extracted with n-heptane at 70 deg.C for 2 hours, using a volume-
to-surface ratio of 2 milliliters per square inch.
(3) Maximum extractable nonvolatile fraction of 6 parts per million
when extracted with 10 percent (by volume) ethyl alcohol in distilled
water at 70 deg.C for 2 hours, using a volume-to-surface ratio of 2
milliliters per square inch.
(d) The provisions of this section are not applicable to 4,4'-
isopropylidene-diphenol-epichlorohydrin resins listed in other sections
of subchapter B of this chapter.
[[Page 269]]
[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: 21CFR177.1460]
[Page 269]
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. 177.1460 Melamine-formaldehyde resins in molded articles.
Melamine-formaldehyde resins may be safely used as the food-contact
surface of molded articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food in accordance with the following prescribed conditions:
(a) For the purpose of this section, melamine-formaldehyde resins
are those produced when 1 mole of melamine is made to react with not
more than 3 moles of formaldehyde in water solution.
(b) The resins may be mixed with refined woodpulp and the mixture
may contain other optional adjuvant substances which may include the
following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Colorants used in accordance with Sec.
178.3297 of this chapter.
Dioctyl phthalate........................ For use as lubricant.
Hexamethylenetetramine................... For use only as
polymerization reaction
control agent.
Phthalic acid anhydride.................. Do.
Zinc stearate............................ For use as lubricant.
------------------------------------------------------------------------
(c) The molded melamine-formaldehyde articles in the 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. 175.300(d) of this chapter, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of food-contact
surface.
[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]
[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: 21CFR177.1480]
[Page 269-270]
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. 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers.
Nitrile rubber modified acrylonitrile-methyl acrylate copolymers
identified in this section may be safely used as components of articles
intended for food-contact use under conditions of use D, E, F, or G
described in table 2 of Sec. 176.170(c) of this chapter, subject to the
provisions of this section.
(a) For the purpose of this section, nitrile rubber modified
acrylonitrile-methyl acrylate copolymers consist of basic copolymers
produced by the graft copolymerization of 73-77 parts by weight of
acrylonitrile and 23-27 parts by weight of methyl acrylate in the
presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers
containing approximately 70 percent by weight of polymer units derived
from butadiene.
(b) The nitrile rubber modified acrylonitrile-methyl acrylate basic
copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Nitrogen content is in the range 16.5-19
percent as determined by Kjeldahl analysis.
(ii) Intrinsic viscosity in acetonitrile at 25 deg.C is not less
than 0.29 deciliter per gram as determined by ASTM method D1243-79,
"Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(iii) Residual acrylonitrile monomer content is not more than 11
parts per million as determined by gas chromatography.
(iv) Acetonitrile-soluble fraction after refluxing the base polymer
in acetonitrile for 1 hour is not greater than 95 percent by weight of
the basic copolymers.
(2) Extractives limitations. The following extractive limitations
are determined by an infrared spectrophotometric method titled,
"Infrared Spectrophotometric Determination of Polymer Extracted from
Borex
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 basic 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:
[[Page 270]]
(i) Extracted copolymer not to exceed 2.0 parts per million in
aqueous extract obtained when a 100-gram sample of the basic copolymers
is extracted with 250 milliliters of demineralized (deionized) water at
reflux temperature for 2 hours.
(ii) Extracted copolymer not to exceed 0.5 part per million in n-
heptane extract obtained when a 100-gram sample of the basic copolymers
is extracted with 250 milliliters of reagent grade n-heptane at reflux
temperature for 2 hours.
(c) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
(d) 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 11843, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]
[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: 21CFR177.1500]
[Page 270-276]
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. 177.1500 Nylon resins.
The nylon resins listed in paragraph (a) of this section may be
safely used to produce articles intended for use in processing,
handling, and packaging food, subject to the provisions of this section:
(a) The nylon resins are manufactured as described in this paragraph
so as to meet the specifications prescribed in paragraph (b) of this
section when tested by the methods described in paragraph (c) of this
section.
(1) Nylon 66 resins are manufactured by the condensation of
hexamethylene-diamine and adipic acid.
(2) Nylon 610 resins are manufactured by the condensation of
hexamethylene-diamine and sebacic acid.
(3) Nylon 66/610 resins are manufactured by the condensation of
equal-weight mixtures of nylon 66 salts and nylon 610 salts.
(4) Nylon 6/66 resins manufactured by the condensation and
polymerization of Nylon 66 salts and epsilon-caprolactam.
(5) Nylon 11 resins are manufactured by the condensation of 11-
aminoundecanoic acid.
(6) Nylon 6 resins are manufactured by the polymerization of
epsilon-caprolactam.
(7) Nylon 66T resins are manufactured by the condensation of
hexamethyl-enediamine, adipic acid, and terephthalic acid such that
composition in terms of ingredients is 43.10.2 weight
percent hexamethyl-enediamine, 35.31.2 weight percent adipic
acid, and 21.61.2 weight percent terephthalic acid.
(8) Nylon 612 resins are manufactured by the condensation of
hexamethylenediamine and dodecanedioic acid.
(9) Nylon 12 resins are manufactured by the condensation of omega-
laurolactam.
(10)(i) Impact modified Nylon MXD-6 resins (CAS Reg. No. 59655-05-9)
manufactured by the condensation of adipic acid, 1,3-
benzenedimethanamine, and T3alpha-(3-aminopropyl)-omega-(3-amino-
propoxy)poly- oxyethylene under such conditions that the alpha-(3-amino-
propyl)-omega-(3-aminopropoxy) polyoxyethylene monomer content does not
exceed 7 percent by weight of the finished resin.
(ii) Nylon MXD-6 resins (CAS Reg. No. 25718-70-1) manufactured by
the condensation of adipic acid and 1,3-benzenedimethanamine.
(11) Nylon 12T resins are manufactured by the condensation of omega-
laurolactam (CAS Reg. No. 0947-04-6), isophthalic acid (CAS Reg. No.
0121-91-5), and bis(4-amino-3-methylcycl-ohexyl)methane (CAS Reg. No.
6864-37-5) such that the composition in terms of ingredients is
34.41.5 weight percent omega-laurolactam,
26.80.4 weight percent isophthalic acid, and
38.80.5 weight percent bis(4-amino-3-methylcyclohexyl)-
methane.
(12) Nylon 6I/6T resins (CAS Reg. No. 25750-23-6) are manufactured
by the condensation of hexamethylenediamine, terephthalic acid, and
isophthalic acid such that 65 to 80 percent of the polymer units are
derived from hexamethylene isophthalamide.
(13)(i) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured
by the copolymerization of a 1 to 1 ratio by weight of epsilon-
caprolactam and omega-laurolactam.
[[Page 271]]
(ii) Nylon 6/12 resins (CAS Reg. No. 25191-04-2) are manufactured by
the copolymerization of a ratio of at least 80 weight percent of
epsilon-caprolactam and no more than 20 weight percent of omega-
laurolactam.
(14) Nylon 6/69 resins (CAS Reg. No. 51995-62-1) are manufactured by
the condensation of 49.5+0.5 weight percent epsilon-caprolactam,
19.4+0.2 weight percent hexamethylenediamine and 31.2+0.3 weight percent
azelaic acid.
(15) Nylon 46 resins (CAS Reg. No. 50327-77-0) are manufactured by
the condensation of 1,4-butanediamine and adipic acid.
(16) Nylon resins PA 6-3-T (CAS Registry No. 26246-77-5) are
manufactured by the condensation of 50 mol percent 1,4-
benzenedicarboxylic acid, dimethyl ester and 50 mol percent of an
equimolar mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-
trimethyl-1,6-hexanediamine.
(b) Specifications:
[[Page 272]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maximum extractable fraction in selected solvents
Melting (expressed in percent by weight of resin)
point Solubility in Viscosity No. (mL/---------------------------------------------------
Nylon resins Specific gravity (degrees boiling 4.2N HC1 g) 95 percent
Fahrenheit) Water ethyl Ethyl Benzene
alcohol acetate
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Nylon 66 resins............. 1.14 475-495 Dissolves in 1 h. ................. 1.5 1.5 0.2 0.2
.015
2. Nylon 610 resins............ 1.09 405-425 Insoluble after 1 ................. 1.0 2.0 1.0 1.0
.015 h.
3.1 Nylon 66/610 resins........ 1.10 375-395 Dissolves in 1 h. ................. 1.5 2.0 1.0 1.0
.015
4.1 Nylon 6/66 resins, epsilon- 1.13 440-460 ......do......... ................. 2.0 2.0 1.5 1.5
caprolactam monomer content .015
not to exceed 0.7 percent by
weight.
4.2 Nylon 6/66 resins with 1.14 380-425 ......do......... ................. 0.8 1.0 0.5 0.5
combined caprolactam content .015
greater than 60 percent and
residual epsilon-caprolactam
monomer content not to exceed
0.4 percent by weight. For use
only as specified in Sec.
177.1395 of this chapter (CAS
Reg. No. 24993-04-2).
5.1 Nylon 11 resins for use in 1.04 355-375 Insoluble after 1 ................. .30 .35 .25 .3
articles intended for 1-time .015 h.
use or repeated use in contact
with food.
5.2 Nylon 11 resins for use 1.04 355-375 ......do......... ................. .35 1.60 .35 .40
only: .015
a. In articles intended for
repeated use in contact with
food.
b. In side-seam cements for
articles intended for 1-time
use in contact with food and
which are in compliance with
Sec. 175.300 of this
chapter.
6.1 Nylon 6 resins............. 1.15 392-446 Dissolves in 1 h. ................. 1.0 2.0 1.0 1.0
.015
6.2 Nylon 6 resins for use only 1.15 392-446 ......do......... ................. 1.5 2.0 1.0 1.0
in food-contact films having .015
an average thickness not to
exceed 0.001 in.
7. Nylon 66T resins for use 1.16 482-518 Insoluble after 1 ................. 1.0 1.0 .25 .25
only in food-contact films .015 h.
having an average thickness
not to exceed 0.001 in.
8. Nylon 612 resins for use 1.06 406-420 ......do......... ................. .50 1.50 .50 .50
only in articles intended for .015
repeated use in contact with
food at temperatures not to
exceed 212 deg.F.
9. Nylon 12 resins for use 1.01 335-355 ......do......... ................. 1.0 2.0 1.50 1.50
only:. .015
a. In food-contact films having ................
an average thickness not to
exceed 0.0016 inch intended
for use in contact with
nonalcoholic food under the
conditions of use A
(sterilization not to exceed
30 minutes at a temperature
not to exceed 250 deg.F), and
B through H of table 2 of Sec.
176.170(c) of this chapter,
except as provided in Sec.
177.1390(d)
[[Page 273]]
b. In coatings intended for
repeated use in contact with
all food types described in
table 1 of Sec. 176.170(c) of
this chapter, except those
containing more than 8 percent
alcohol, under conditions of
use B through H described in
table 2 of Sec. 176.170(c) of
this chapter.
10.1 Nylon MXD-6 and impact 1.21 437-491 Dissolves in 1h.. ................. 2.0 2.5 1.0 1.0
modified Nylon MXD-6 film 0.02
having an average thickness
not to exceed 40 microns
(0.0016 inch) for use in
processing, handling, and
packaging of food of types V
and IX listed in table 1 of
Sec. 176.170(c) of this
chapter under conditions of
use C, D, E, F, G, and H in
table 2 of Sec. 176.170(C) of
this chapter.
10.2 Impact modified Nylon MXD- 1.21 437-491 do............... ................. 2.0 2.5 1.0 1.0
6 resins for use as polymer 0.02
use as polymer modifiers in
Nylon 6 resin films complying
with paragraph (a)(6) of this
section, at levels not to
exceed 13 percent by weight of
films whose average thickness
will not exceed 15 microns
(0.6 mils). The finished film
is used for packaging,
transporting, or holding food,
excluding beverages containing
more than 8 percent alcohol
(by volume) at temperatures
not to exceed 49 deg.C (120
deg.F) (conditions of use E,
F, and G in table 2 of Sec.
176.170(c) of this chapter).
10.3 Nylon MXD-6 resins for use 1.22 455-470 Dissolves in 1 h. 1.0 1.5 0.2 0.2
only as nonfood-contact layers 0.02
of: (1) Multilayer films and
(2) rigid plastic containers
composed of polypropylene food-
contact and exterior layers,
as defined in Sec.
177.1520(c), item 1.1(a) and
1.1(b), of this chapter. The
finished food-contact
laminate, in the form in which
it contacts food, when
extracted with the food
simulating solvent or solvents
characterizing the conditions
of the intended use as
determined from Table 2 of
Sec. 176.170(c) of this
chapter, shall yield not more
than 0.5 micrograms of m-
xylylenediamine-adipic acid
cyclic monomer per square inch
of food-contact surface, when
the food simulating solvent is
analyzed by any appropriate,
properly validated method.
11. Nylon 12T resins for use in 1.06 290-310 Insoluble after 1 ................. 0.1 ........... 0.5 0.5
contact with all types of food 0.015 hour.
except those containing more
than 8 percent alcohol.
12. Nylon 6I/6T resins for use 1.207 N/A Insoluble after 1 ................. 0.2 1.0 0.1 0.1
in contact with all types of 0.1 hour.
food except alcoholic
beverages containing more than
8 percent alcohol.
[[Page 274]]
13.1 Nylon 6/12 resins for use 1.06 260-285 Dissolves in 1 Greater than 140. 2.0 ........... 1.5 1.5
only in food-contact films 0.015 hour.
having an average thickness
not to exceed 51 microns
(0.002 inch). The finished
film is intended to contact
all foods except those
containing more than 8 percent
ethanol under conditions of
use B, C, D, E, F, G, and H
listed in table 2 of Sec.
176.170(c) of this chapter.
13.2 Nylon 6/12 resins with 1.10 380-400 Dissolves in 1 h. Greater than 160. 0.8 1.0 0.5 0.5
residual epsilon-caprolactam 0.15
not to exceed 0.5 percent by
weight and residual omega-
laurolactam not to exceed 0.1
percent by weight. For use
only as specified in Sec.
177.1395 of this chapter.
13.3 Nylon 6/12 resins with 1.13 400-420 Dissolves in 1 h. ............... 1.0 1.5 0.5 0.5
residual epsilon-caprolactam 0.15
not to exceed 0.8 percent by
weight and residual omega-
laurolactam not to exceed 0.1
percent by weight. For use
only as specified in Sec.
177.1390 of this chapter.
14. Nylon 6/69 resins for use 1.09 270-277 ................. 140 3.0 ........... ........... ...........
only as specified in 21 CFR 0.02 using the method
177.1395 of this chapter. described in
Sec. 177.1500(c
)(5)(ii) of this
chapter.
15. Nylon 46 resins for use 1.18 551-09592 Dissolves in 1 h. ................. 0.3 0.2 0.2 0.3
only in food-contact membrane 0.015
filters intended for repeated
use. The finished membrane
filter is intended to contact
beverages containing no more
than 13 percent alcohol, under
conditions of use E, F, and G
listed in table 2 of Sec.
176.170(c) of this chapter.
16. Nylon resins PA 6-3-T for 1.12 NA Insoluble after 1 110.. 0.007 0.64 0.003 0
repeated-use (excluding 0.03 h.
bottles) in contact with food
of type VIA and VIB described
in table 1 of Sec. 176.170(c)
of this chapter under
conditions of use D through H
described in table 2 of Sec.
176.170(c) of this chapter
with a hot-fill temperature
limitation of 40 deg.C.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 275]]
(c) Nylon modifier--(1) Identity. Copolyester-graft-acrylate
copolymer is the substance 1,4-benzenedicarboxylic acid, polymer with
1,4-butanediol, (E)-2-butenedioic acid, 1,2-ethanediol, ethyl 2-
propenoate, hexanedioic acid and 2-propenoic acid, graft (CAS Reg. No.
175419-23-5), and is derived from grafting of 25 weight percent of
acrylic polymer with 75 weight percent of copolyester. The copolyester
is polymerized terephthalic acid (55 mol%), adipic acid (40 mol%), and
fumaric acid (5 mol%) with ethylene glycol (40 mol%) and 1,4-butanediol
(60 mol%). The acrylic polymer is made from acrylic acid (70 mol%) and
ethyl acrylate (30 mol%).
(2) Specifications. The finished copolyester-graft-acrylate
copolymer shall meet the following specifications:
(i) Weight average molecular weight 15,000-35,000,
(ii) pH 7.2 to 8.2, and
(iii) Glass transition temperature -15 to -25 deg.C.
(3) Conditions of use. (i) Copolyester-graft acrylate copolymer
described in paragraph (c)(1) of this section is intended to improve the
adhesive qualities of film. It is limited for use as a modifier of Nylon
6 and Nylon 6 modified with Nylon MXD-6 at a level not to exceed 0.17
weight percent of the additive in the finished film.
(ii) The finished film is used for packaging, transporting, or
holding all types of foods under conditions of use B through H,
described in table 2 of Sec. 176.170(c) of this chapter, except that in
the case of Nylon 6 films modified with Nylon MXD-6 (complying with
Sec. 177.1500, item 10.2), the use complies with the conditions of use
specified in table 2.
(iii) Extractives. Food contact films described in paragraphs (c)(1)
of this section, when extracted with solvent or solvents prescribed for
the type of food and under conditions of time and temperature specified
for the intended use, shall yield total extractives not to exceed 0.5
milligram per inch squared of food-contact surface when tested by the
methods described in Sec. 176.170(d) of this chapter.
(iv) Optional adjuvant substances. The substances employed in the
production of Nylon modifiers listed in paragraph (c)(1) of this section
may include:
(A) Substances generally recognized as safe for use in food and food
packaging;
(B) Substances subject to prior sanction or approval for use in
Nylon resins and used in accordance with such sanctions or approval; and
(C) Optional substances required in the production of the additive
identified in this paragraph and other optional substances that may be
required to accomplish the intended physical or technical effect.
(d) Analytical methods--(1) Specific gravity. Specific gravity shall
be determined by weighing a 1-gram to 5-gram sample first in air and
then in freshly boiled distilled water at 23 deg.C2 deg.C.
(2) Melting point. The melting point shall be determined as follows:
Use a hot-stage apparatus. The use of crossed nicol prisms with a
microscope hot stage and reading of the thermometer when the
birefringence disappears increases the accuracy. If the crossed nicol
apparatus is not available, use the lowest temperature at which the
sample becomes transparent or the sharp edges or corners of the sample
become rounded as the melting point. In case of doubt as to the onset of
melting, the sample is prodded with a sharp instrument. If it sticks to
the heating block, it is considered to have melted. If the melting point
is low, dry the sample in an oven at 85 deg.C for 24 hours in a
nitrogen atmosphere then repeat the test.
(3) Solubility in boiling 4.2N HCl. The test shall be run on a
sample approximately the size of a \1/8\-inch cube in at least 25
milliliters of 4.2 normal hydrochloric acid.
(4) Maximum extractable fraction in selected solvents. The procedure
for determining the maximum extractable fraction of the nylon resins in
selected solvents is as follows:
(i) Film should be cut with ordinary scissors into pieces of a
convenient size such as \1/4\-inch squares, for the extraction tests
described in this section. The granules of nylon molding powders are in
the proper form for the extraction tests. Samples of fabricated articles
such as pipe, fittings, and other similar articles must be cut to
approximately
[[Page 276]]
the size of the molding powder. This can be done conveniently by using a
small-scale commercial plastics granulator and cutting the sample
through a screen having \1/4\-inch mesh. Fine particles should be
separated from the cut resin by screening through a 20-mesh screen. The
material retained on the screen is suitable for the extraction tests.
(ii) The organic solvents must be of American Chemical Society
analytical reagent grade; distilled water is used. Approximately 30
grams of the prepared sample is weighed to the nearest milligram. The
weighed resin is transferred to a 500-milliliter round-bottom flask
equipped with a reflux condenser. Approximately 300-milliliters of
solvent is added to the flask and the contents refluxed gently for 8
hours with a heating mantle. The solvent is then filtered off
immediately while still hot, using a Buchner funnel approximately 5
inches in diameter, a suction flask, and a hardened filter paper
(Whatman No. 50 or equivalent). The paper is wet with the solvent and a
slight suction applied just before starting the filtration. The resin is
washed twice with approximately 100-milliliter portions of solvent and
the combined filtrate and washings are reduced to approximately 25
milliliters by evaporation at reduced pressure (50 millimeters to 100
millimeters of mercury, absolute), heating as necessary. The contents of
the flask are transferred to an evaporation dish (which has been held in
a vacuum desiccator over anhydrous calcium sulfate until constant weight
has been attained) and carefully evaporated to dryness. The weight of
the solid residue is determined by difference after holding in a vacuum
desiccator over anhydrous calcium sulfate until constant weight has been
attained. The percent of solids extracted is calculated by dividing the
weight of the solid residue by the weight of the sample and multiplying
by 100.
(5) Viscosity number (VN). (i) The viscosity number (VN) for Nylon
6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin
per milliliter) shall be determined at 25 deg.C (77 deg.F) by method
ISO 307-1984(E), "Plastics-Polyamides-Determination of Viscosity
Number," which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 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.
(ii) The viscosity number (VN) for Nylon 6/69 and Nylon PA-6-3-T
resins in a 99 percent cresol solution (5 milligrams resin per
milliliter) shall be determined at 25 deg.C (77 deg.F) by method ISO
307-1984(E), "Plastics-Polyamides-Determination of Viscosity Number,"
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (d)(5)(i) of this
section.
[42 FR 14572, Mar. 15, 1977]
Editorial Note: ForFederal Register citations affecting
Sec. 177.1500, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[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: 21CFR177.1520]
[Page 276-291]
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. 177.1520 Olefin polymers.
The olefin polymers listed in paragraph (a) of this section may be
safely used as articles or components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, olefin polymers are basic
polymers manufactured as described in this paragraph, so as to meet the
specifications prescribed in paragraph (c) of this section, when tested
by the methods described in paragraph (d) of this section.
(1)(i) Polypropylene consists of basic polymers manufactured by the
catalytic polymerization of propylene.
(ii) Propylene homopolymer consists of basic polymers manufactured
by the catalytic polymerization of propylene with a metallocene
catalyst.
(2)(i) Polyethylene consists of basic polymers manufactured by the
catalytic polymerization of ethylene.
(ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6)
consists of basic polymers manufactured by the catalytic polymerization
of ethylene followed by reaction with fumaric acid in the absence of
free radical initiators. Such polymers shall contain grafted fumaric
acid at levels
[[Page 277]]
not to exceed 2 percent by weight of the finished polymer.
(3) Olefin basic copolymers consist of basic copolymers manufactured
by the catalytic copolymerization of:
(i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such
olefin basic copolymers contain not less than 96 weight-percent of
polymer units derived from ethylene and/or propylene, except that:
(a)(1) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall
contain not less than 90 weight-percent of polymer units derived from
ethylene;
(2) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and hexene-1 shall contain not less than 80
but not more than 90 weight percent of polymer units derived from
ethylene.
(3) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and pentene-1 shall contain not less than
90 weight-percent of polymer units derived from ethylene.
(4) Olefin basic copolymers manufactured by the catalytic
polymerization of ethylene and octene-1 shall contain not less than 50
weight-percent of polymer units derived from ethylene.
(b) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and 4-methylpentene-1 shall contain not
less than 89 weight-percent of polymer units derived from ethylene;
(c)(1) Olefin basic copolymers manufactured by the catalytic
copolymerization of two or more of the monomers ethylene, propylene,
butene-1, 2-methylpropene-1, and 2,4,4-trimethylpentene-1 shall contain
not less than 85 weight-percent of polymer units derived from ethylene
and/or propylene;
(2) Olefin basic copolymers manufactured by the catalytic
copolymerization of propylene and butene-1 shall contain greater than 15
but not greater than 35 weight percent of polymer units derived from
butene-1 with the remainder being propylene.
(d) Olefin basic terpolymers manufactured by the catalytic
copolymerization of ethylene, hexene-1, and either propylene or butene-
1, shall contain not less than 85 weight percent polymer units derived
from ethylene.
(e) Olefin basic copolymers manufactured by the catalytic
polymerization of ethylene and octene-1, or ethylene, octene-1, and
either hexene-1, butene-1, propylene, or 4-methylpentene-1 shall contain
not less than 80 weight percent of polymer units derived from ethylene.
(ii) 4-Methylpentene-1 and 1-alkenes having from 6 to 18 carbon
atoms. Such olefin basic copolymers shall contain not less than 95 molar
percent of polymer units derived from 4-methylpentene-1, except that
copolymers manufactured with 1-alkenes having from 12 to 18 carbon atoms
shall contain not less than 97 molar percent of polymer units derived
from 4-methylpentene-1; or
(iii) Ethylene and propylene that may contain as modifiers not more
than 5 weight-percent of total polymer units derived by copolymerization
with one or more of the following monomers:
5-Ethylidine-2-norbornene.
5-Methylene-2-norbornene.
(iv) Ethylene and propylene that may contain as a modifier not more
than 4.5 weight percent of total polymer units derived by
copolymerization with 1,4-hexadiene.
(v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087-34-7) that
shall contain not less than 80 weight percent of polymer units derived
from ethylene.
(vi) Olefin basic copolymers (CAS Reg. No. 61615-63-2) manufactured
by the catalytic copolymerization of ethylene and propylene with 1,4-
hexadiene, followed by reaction with fumaric acid in the absence of free
radical initiators. Such polymers shall contain not more than 4.5
percent of polymer units deriving from 1,4-hexadiene by weight of total
polymer prior to reaction with fumaric acid and not more than 2.2
percent of grafted fumaric acid by weight of the finished polymer.
(vii) Ethylene and 2-norbornene (CAS Reg. No. 26007-43-2) copolymers
that shall contain not less than 30 and not
[[Page 278]]
more than 70 mole percent of polymer units derived from 2-norbornene.
(4) Poly(methylpentene) consists of basic polymers manufactured by
the catalytic polymerization of 4-methylpentene-1.
(5) Polyethylene graft copolymers consist of polyethylene complying
with item 2.2 of paragraph (c) of this section which subsequently has
3a,4,7,7a-tetrahydromethyl-4,7-methanoisobenzofuran-1,3-dione grafted
onto it at a level not to exceed 1.7 percent by weight of the finished
copolymer.
(6) Ethylene-maleic anhydride copolymers (CAS Reg. No. 9006-26-2)
containing no more than 2 percent by weight of copolymer units derived
from maleic anhydride.
(b) The basic olefin polymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic olefin polymers. The optional adjuvant
substances required in the production of the basic olefin polymers or
finished food-contact articles may include substances permitted for such
use by applicable regulations in parts 170 through 189 of this chapter,
substances generally recognized as safe in food and food packaging,
substances used in accordance with a prior sanction or approval, and the
following:
------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
Aromatic petroleum hydrocarbon resin, For use only as an adjuvant at
hydrogenated (CAS Reg. No. 88526-47- levels not to exceed 25
0), produced by the catalytic percent by weight in blends
polymerization of aromatic-substituted with polypropylene complying
olefins from distillates of cracked with paragraph (c), item 1.1
petroleum stocks with a boiling point of this section. The finished
no greater than 220 deg.C (428 polymer may be used in contact
deg.F), and the subsequent catalytic with food Types I, II, IV-B,
hydrogenation of the resulting VI-A through VI-C, VII-B, and
aromatic petroleum hydrocarbon resin, VIII identified in table 1 of
having a minimum softening point of Sec. 176.170(c) of this
110 deg.C (230 deg.F), as determined chapter and under conditions
by ASTM Method E 28-67 (Reapproved of use B through H described
1982), "Standard Test Method for in table 2 of Sec. 176.170(c)
Softening Point by Ring-and-Ball of this chapter; and with food
Apparatus," and a minimum aniline Types III, IV-A, V, VII-A, and
point of 107 deg.C (225 deg.F), as IX identified in table 1 of
determined by ASTM Method D 611-82, Sec. 176.170(c) of this
"Standard Test Methods for Aniline chapter and under conditions
Point and Mixed Aniline Point of of use D through G described
Petroleum Products and Hydrocarbon in table 2 of Sec. 176.170(c)
Solvents," both of which are of this chapter.
incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from
the American Society for Testing and
Materials, 1916 Race St.,
Philadelphia, PA 19103, or from the
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or may
be examined at the Office of the
Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC.
Colorants used in accordance with Sec.
178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert- For use as an initiator in the
butylperoxy)hexane (CAS Reg. No. 78-63- production of propylene
7). homopolymer complying with
Sec. 177.1520(c), item 1.1
and olefin copolymers
complying with Sec.
177.1520(c), items 3.1 and 3.2
and containing not less than
75 weight percent of polymer
units derived from propylene,
provided that the maximum
concentration of tert-butyl
alcohol in the polymer does
not exceed 100 parts per
million, as determined by a
method titled "Determination
of tert-Butyl Alcohol in
Polypropylene," which is
incorporated by reference.
Copies are available from the
Center for Food Safety and
Applied Nutrition (HFS-200),
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740, or
available for inspection at
the Office of the Federal
Register, 800 North Capitol
Street, NW., suite 700,
Washington, DC 20408.
[[Page 279]]
Methyl methacrylate/butyl acrylate- For use only at levels not to
grafted polypropylene copolymer exceed 6 percent by weight of
containing methyl methacrylate/butyl olefin polymers complying with
acrylate-grafted polypropylene (CAS paragraph (c) of this section,
Reg. No. 121510-09-6), methyl items 1.1, 3.1a, 3.2a, and
methacrylate/butyl acrylate copolymer 3.2b, where the copolymers
(CAS Reg. No. 25852-37-3), methyl complying with items 3.1a,
methacrylate homopolymer (CAS Reg. No. 3.2a, and 3.2b contain not
9011-14-7), and polypropylene (CAS less than 85 weight-percent of
Reg. No. 9003-07-0), resulting from polymer units derived from
the reaction of a mixture of methyl propylene.
methacrylate and butyl acrylate with
polypropylene. The finished product
contains no more than 55 percent by
weight of polymer units derived from
methyl methacrylate and butyl acrylate
as determined by a method entitled,
"Determination of the Total Acrylic
in PP-MMA/BA Polymers," which is
incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from
the Office of Premarket Approval,
Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or may
be examined at the Center for Food
Safety and Applied Nutrition's
Library, 200 C. St. SW., Washington,
DC, or at the Office of the Federal
Register, 800 North Capitol St. NW.,
suite 700, Washington, DC.
Petroleum hydrocarbon resins For use only as an adjuvant at
(cyclopentadiene-type), hydrogenated levels not to exceed 30
(CAS Reg. No. 68132-00-3) produced by percent by weight in blends
the thermal polymerization of with: (1) Polypropylene
dicyclopentadiene and cyclodiene complying with paragraph (c),
codimers (consisting of a mixture of item 1.1 of this section, or
cyclopentadiene, methyl (2) a copolymer of propylene
cyclopentadiene, and C4-C5 acyclic and ethylene containing not
dienes), followed by hydrogenation and less than 94 weight percent
having a ring-and-ball softening point propylene and complying with
of 119 deg.C minimum as determined by paragraph (c), item 3.2 of
ASTM Method E 28-67 (Reapproved 1982), this section. The average
"Standard Test Method for Softening thickness of the food-contact
Point by Ring-and-Ball Apparatus," film is not to exceed 0.1
and a minimum viscosity of 3,000 millimeter (0.004 inch). The
centipoise, measured at 160 deg.C, as finished polymer may be used
determined by ASTM Method D 3236-88, in contact with (1) Food types
"Standard Test Method for Apparent I, II, IV-B, VI-A, VI-B, VII-
Viscosity of Hot Melt Adhesives and B, and VIII identified in
Coating Materials," both of which are table 1 of Sec. 176.170(c) of
incorporated by reference in this chapter and under
accordance with 5 U.S.C. 552(a) and 1 conditions of use C through G
CFR part 51. Copies are available from described in table 2 of Sec.
the American Society for Testing and 176.170(c) of this chapter;
Materials, 1916 Race St., and (2) food types III, IV-A,
Philadelphia, PA 19103, or from the V, VI-C, VII-A, and IX
Center For Food Safety and Applied identified in table 1 of Sec.
Nutrition (HFS-200), Food and Drug 176.170(c) of this chapter and
Administration, 5100 Paint Branch under conditions of use D
Pkwy., College Park, MD 20740, or may through G described in table 2
be examined at the Office of the of Sec. 176.170(c) of this
Federal Register, 800 North Capitol chapter.
St. NW., suite 700, Washington, DC.
Polymethylsilsesquioxane (CAS Reg. No. For use only as a surface
68554-70-1). lubricant or anti-blocking
agent in films.
Poly(vinylidene fluoride) homopolymer For use only as a processing
(CAS Reg. No. 24937-79-9), having a aid in the production of
melt viscosity of 6 to 37 kilopoise at olefin polymers complying with
a shear rate of 100-1 seconds at 232 paragraph (c) of this section
deg.C as determined by ASTM Method D at levels not to exceed 1.0
3835-79 (Reapproved 1983), "Standard percent by weight of the
Test Method for Rheological Properties polymer. The finished polymers
of Thermoplastics with a Capillary may be used only under the
Rheometer" using a capillary of 15:1 conditions described in Sec.
L/D, which is incorporated by 176.170(c) of this chapter,
reference in accordance with 5 U.S.C. table 2, under conditions of
552(a) and 1 CFR part 51. Copies are use B though H.
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 may be examined at the
Office of the Federal Register, 800
North Capitol Street, NW., suite 700,
Washington, DC.
Polyoxyethylene-grafted For use as an extrusion aid in
polydimethylsiloxane (CAS Reg. No. the production of extruded
68937-54-2). olefin polymers that comply
with Sec. 177.1520(c) at
levels not to exceed 0.3
percent by weight of the
polymer. The finished polymer
is used in contact with foods
under conditions of use B
through H described in table 2
of Sec. 176.170 of this
chapter.
[[Page 280]]
Triisopropanolamine (CAS Reg. No. 122- For use as a Zeigler-Natta-type
20-3). catalyst deactivator and
antioxidant in the production
of olefin polymers complying
with Sec. 177.1520(c), items
2.1, 2.2, and 2.3, and having
a minimum density of 0.94
grams per cubic centimeter,
and copolymers complying with
Sec. 177.1520(c), items 3.1
and 3.2, for use in contact
with all foods under the
following conditions of use:
(a) films with a maximum
thickness of 0.102 millimeter
(0.004 inch) may be used under
conditions A through H defined
in table 2 of Sec. 176.170(c)
of this chapter; and (b)
articles with thickness
greater than 0.102 millimeter
(0.004 inch) may be used under
conditions C through G defined
in table 2 of Sec. 176.170(c)
of this chapter.
Trimethylpyridine and dimethylpyridine For use only as an adjuvant
mixture having percent by weight substance in the production of
composition as follows: 2,4,6- propylene homopolymers
trimethylpyridine (CAS Reg. No. 108-75- complying with items 1.1, 1.2,
8), not less than 60 percent; 2,3,6- and 1.3, and propylene
trimethylpyridine (CAS Reg. No. 1462- copolymers complying with
84-6), not more than 27 percent; 3,5- items 3.1, and 3.2 of
dimethylpyridine (CAS Reg. No. 591-22- paragraph (c) of this section
0), not more than 12 percent; and provided that the adjuvant is
other dimethylpyridines, not more than used at a level not to exceed
6 percent. 20 parts per million by weight
of the olefin polymers.
Vinylidene fluoride-hexafluoropropene For use only as an extrusion
copolymer (CAS Reg. No. 9011-17-0) aid in the production of
having a fluorine content of 65 to 71 extruded olefin polymers at
percent and a Mooney viscosity of at levels not to exceed 0.2
least 28, as determined by a method percent by weight of the
entitled "Mooney Viscosity," which polymer. The finished polymers
is incorporated by reference in may be used only under the
accordance with 5 U.S.C. 552(a). conditions described in Sec.
Copies are available from the Center 176.170(c) of this chapter,
for Food Safety and Applied Nutrition table 2, under conditions of
(HFS-200), Food and Drug use B through H.
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or may
be examined at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
Vinylidene fluoride-hexafluoropropene For use only as a processing
copolymer (CAS Reg. No. 9011-17-0), aid in the production of
having a vinylidene fluoride content olefin polymers complying with
of not less than 87 percent but less paragraph (c) of this section
than 100 percent by weight and a melt at levels not to exceed 1.0
viscosity of 12 to 27 kilopoise at a percent by weight of the
shear rate of 100-1 seconds at 232 polymer. The finished polymers
deg.C as determined by ASTM Method D may be used only under the
3835-79 (Reapproved 1983), "Standard conditions described in Sec.
Test Method for Rheological Properties 176.170(c) of this chapter,
of Thermoplastics with a Capillary table 2, under conditions of
Rheometer" using a capillary of 15:1 use B though H.
L/D, which is incorporated by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are
available from the Center for Food
Safety and Applied Nutrition (HFS-
200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740, or may be examined at the
Office of the Federal Register, 800
North Capitol Street, NW., suite 700,
Washington, DC 20408.
------------------------------------------------------------------------
(c) Specifications:
----------------------------------------------------------------------------------------------------------------
Maximum
extractable Maximum soluble
fraction fraction
Melting Point (MP) (expressed as (expressed as
or softening point percent by percent by weight
Olefin polymers Density (SP) (Degrees weight of the of polymer) in
Centigrade)- polymer) in N- xylene at
hexane at specified
specified temperatures
temperatures
----------------------------------------------------------------------------------------------------------------
1.1a. Polypropylene described in 0.880-0.913 MP: 160 deg.-180 6.4 pct at 9.8 pct at 25
paragraph (a)(1)(i) of this deg.C. reflux deg.C
section temperature
1.1b. Propylene homopolymer 0.880-0.913- MP: 150 deg.-180 6.4 pct at 9.8 pct at 25
described in paragraph (a)(1)(ii) deg.C. reflux deg.C
of this section temperature
1.2. Polypropylene, noncrystalline; 0.80-0.88
for use only to plasticize
polyethylene described under items
2.1 and 2.2 of this table, provided
that such plasticized polymers meet
the maximum extractable fraction
and maximum soluble fraction
specifications prescribed for such
basic polyethylene
[[Page 281]]
1.3. Polypropylene, noncrystalline, 0.80-0.88 SP:115 deg.-138
for use only: To plasticize deg.C.
polypropylene described by item 1.1
of this table, provided that such
plasticized polymers meet the
maximum extractable fraction and
maximum soluble fraction
specifications prescribed for such
basic polypropylene, and further
provided that such plasticized
polypropylene contacts food only of
the types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, IV-B, VI-B,
VII-B, and VIII; and for use at
levels not to exceed 50 pct by
weight of any mixture employed as a
food-contact coating provided such
coatings contact food only of the
types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, IV-B, VI-B,
VII-B, and VIII
2.1. Polyethylene for use in 0.85-1.00 .................. 5.5 pct at 50 11.3 pct at 25
articles that contact food except deg.C deg.C
for articles used for packing or
holding food during cooking
2.2. Polyethylene for use in 0.85-1.00 .................. 2.6 pct at 50 Do.
articles used for packing or deg.C
holding food during cooking
2.3. Polyethylene for use only as 0.85-1.00 .................. 53 pct at 50 75 pct at 25
component of food-contact coatings deg.C deg.C
at levels up to and including 50
percent by weight of any mixture
employed as a food-contact coating
2.4. Olefin polymers described in
paragraph (a)(2)(ii) of this
section, having a melt flow index
not to exceed 17 grams/per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, for use in blends
with other polymers at levels not
to exceed 20 percent by weight of
total polymer, subject to the
limitation that when contacting
food of types III, IV-A, V, VI-C,
VII-A, and IX identified in Sec.
176.170(c) of this chapter, Table
1, the polymers shall be used only
under conditions of use C, D, E, F,
and G, described in Sec.
176.170(c) of this chapter, Table
2.
3.1a. Olefin copolymers described in 0.85-1.00 .................. 5.5 pct at 50 30 pct at 25
paragraph (a)(3)(i) of this section deg.C deg.C
for use in articles that contact
food except for articles used for
packing or holding food during
cooking; except olefin copolymers
described in paragraph
(a)(3)(i)(a)(3) of this section and
listed in item 3.1c of this table
and olefin copolymers described in
paragraph (a)(3)(i)(e) of this
section and listed in item 3.1b of
this table
3.1b. Olefin copolymers described in 0.9-1.00 .................. Do Do.
paragraph (a)(3)(i)(e) of this
section for use in contact with
food only under conditions of use
D, E, F, G, and H described in Sec.
176.170(c) of this chapter, table
2
3.1c. Olefin copolymers described in Not less than
paragraph (a)(3)(i)(a)(3) of this 0.92
section for use in contact with
food only under conditions of use
B, C, D, E, F, G, and H described
in Sec. 176.170(c) of this
chapter, table 2; except that such
copolymers when used in contact
with food of the types identified
in Sec. 176.170(c), table 1, under
types III, IVA, V, VIIA, and IX,
shall be used only under conditions
of use D, E, F, and G described in
Sec. 176.170(c) of this chapter,
table 2
[[Page 282]]
3.2a. Olefin copolymers described in 0.85-1.00 .................. 2.6 pct at 50 Do.
paragraph (a)(3)(i) of this section deg.C
for use in articles used for
packing or holding food during
cooking; except olefin copolymers
described in paragraph
(a)(3)(i)(c)(2) of this section and
listed in item 3.2b of this table;
except that olefin copolymers
containing 89 to 95 percent
ethylene with the remainder being 4-
methyl-pentene-1 contacting food
Types III, IVA, V, VIIA, and IX
identified in Sec. 176.170(c) of
this chapter, table 1, shall not
exceed 0.051 millimeter (mm) (0.002
inch (in)) in thickness when used
under conditions of use A and shall
not exceed 0.102 mm (0.004 in) in
thickness when used under
conditions of use B, C, D, E, and H
described in Sec. 176.170(c) of
this chapter, table 2.
Additionally, olefin copolymers
described in (a)(3)(i)(a)(2) of
this section may be used only under
conditions of use B, C, D, E, F, G,
and H described in Sec. 176.170(c)
of this chapter, table 2, in
contact with all food types
identified in Sec. 176.170(c) of
this chapter, table 1
3.2b. Olefin copolymers described in Do.
paragraph (a)(3)(i)(c)(2) of this
section have a melt flow index no
greater than 10 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, and the thickness of
the finished polymer contacting
food shall not exceed 0.025 mm
(0.001 in). Additionally, optional
adjuvants permitted for use in
olefin copolymers complying with
item 3.2a of this table may be used
in the production of this copolymer
3.2c. Olefin copolymers described in 0.85-0.92 ................
paragraph (a)(3)(i)(a)(4) of this
section have a melt flow index no
greater than 50 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section. Articles manufactured
using these polymers may be used
with all types of food under
conditions of use C through H as
described in table 2 of Sec.
176.170(c) of this chapter
3.3a. Olefin copolymers described ..............
in paragraph (a)(3)(ii) of this
section and manufactured with 1-
alkenes having from 6 to 10 carbon
atoms
3.3b. Olefin copolymers described
in paragraph (a)(3)(ii) of this
section, provided that such olefin
polymers have a melt temperature of
220 deg.C to 250 deg.C (428
deg.F to 482 deg.F) as determined
by the method described in
paragraph (d)(8) of this section
and minimum intrinsic viscosity of
1.0 as determined in paragraph
(d)(9) of this section.
[[Page 283]]
3.4. Olefin copolymers, primarily 0.85-0.90
non-crystalline, described in par.
(a)(3) (iii) of this section
provided that such olefin polymers
have a minimum viscosity average
molecular weight of 120,000 as
determined by the method described
in par. (d)(5) of this section and
a minimum Mooney viscosity of 35 as
determined by the method described
in par. (d)(6) of this section, and
further provided that such olefin
copolymers contact food only of the
types identified in Sec.
176.170(c) of this chapter, table
1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX
3.5. Olefin copolymers, primarily 0.85-0.90
non-crystalline, described in
paragraph (a)(3)(iv) of this
section, provided that such olefin
polymers have a minimum viscosity
average molecular weight of 95,600
as determined by the method
described in paragraph (d)(5) of
this section, and further provided
that such olefin polymers are used
only in blends with olefin polymers
described under items 1.1, 2.1, and
2.2 of this table at a maximum
level of 25 pct by weight, and
provided that such olefin
copolymers contact food only of the
types identified in Sec. 176.170
(c) of this chapter, table 1, under
Types I, II, IV-B, VI, VII-B, and
VIII at temperatures not exceeding
190 deg.F
3.6. Olefin copolymers described in Not less than
paragraph (a)(3)(v) of this section 0.88
for use in blends with olefin
polymer resins have a melt flow
index no greater than 5 grams/10
minutes as determined by the method
described in paragraph (d)(7) of
this section and the thickness of
the finished blends shall not
exceed 0.1 millimeter (0.004 inch).
The ethylene/butene-1 copolymer may
be used subject to the following
conditions: (1) For use at a level
not to exceed 20 weight percent in
polypropylene as described under
item 1.1 of this table. (2) For use
at a level not to exceed 40 weight
percent in polyethylene as
described under items 2.1 and 2.2
of this table. (3) For use at a
level not to exceed 40 weight
percent in olefin copolymers as
described under items 3.1 and 3.2
of this table
[[Page 284]]
3.7. Ethylene/propylene copolymers, Not less than
meeting the identity described in 0.86
paragraph (a)(3)(i) of this
section, containing not less than
80 mole-percent of polymer units
derived from ethylene and having a
minimum viscosity average molecular
weight of 95,000 as determined by
the method described in paragraph
(d)(5) of this section, and a
minimum Mooney viscosity of 13 as
determined by the method described
in paragraph (d)(6) of this
section. Ethylene/propylene
copolymers described in this item
3.7 are to be used only in blends
with other olefin polymers
complying with this section, at
levels not to exceed 30 percent by
weight of the total polymer blend,
and in contact with food only of
types identified in Sec.
176.170(c) of this chapter, Table
1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX.
Additionally, optional adjuvants
permitted for use in olefin
copolymers complying with item 3.4
of this table may be used in the
production of this copolymer
3.8. Olefin polymers described in
paragraph (a)(3)(vi) of this
section, having a melt flow index
not to exceed 9.2 grams per 10
minutes as determined by the method
described in paragraph (d)(7) of
this section, for use in blends
with other polymers at levels not
to exceed 8 percent by weight of
total polymer, subject to the
limitation that when contacting
food of types III, IV-A, V, VI-C,
VII-A, and IX, identified in Sec.
176.170(c) of this chapter, Table
1, the polymers shall be used only
under conditions of use C, D, E, F,
and G, described in Sec.
176.170(c) of this chapter, Table
2.
3.9. Olefin copolymers described in Not less than ................
paragraph (a)(3)(vii) of this 1.0
section may only be used in contact
with dry foods, Type VIII, as
identified in Sec. 176.170(c) of
this chapter, Table 1
4. Poly(methylpentene) 0.82-0.85 MP: 235 deg.-250 6.6 pct at 7.5 pct at 25
deg.C. reflux deg.C
temperature
5. Polyethylene copolymer described Not less than .................. 0.45 pct at 15 1.8 pct at 25
in paragraph (a)(5) of this section 0.94 deg.C deg.C
and having a melt index not to
exceed 2, for use, either alone or
in blends with other olefin
polymers, subject to the limitation
that when contacting foods of types
III, IV-A, V, VI-C, VII-A, VIII,
and IX identified in Sec.
176.170(c) of this chapter, table
1, the thickness of the film (in
mils) containing the polyethylene
graft copolymer times the
concentration of the polyethylene
graft copolymer shall not exceed a
value of 2
6. Ethylene-maleic anhydride 0.92 or greater ................ 1.36 pct at 50 2.28 pct at 25
copolymers described in paragraph deg.C deg.C
(a)(6) of this section for use as
the adhesive component in
multilaminate structures, or as the
sealant layer in flexible
packaging, in contact with food at
temperatures not exceeding 49
deg.C (120 deg.F)
----------------------------------------------------------------------------------------------------------------
(d) The analytical methods for determining whether olefin polymers
conform to the specifications prescribed in this section are as follows,
and are applicable to the basic polymer in film form not exceeding 4
mils in thickness.
[[Page 285]]
The film to be tested shall be cut into approximately 1-inch squares by
any convenient method that avoids contamination by dust, dirt, or grease
(Note: Do not touch samples with bare fingers--use forceps to hold or
transfer samples).
(1) Density. Density shall be determined by ASTM method D1505-68
(Reapproved 1979), "Standard Test Method for Density of Plastics by the
Density-Gradient Technique," which is incorporated by reference. Copies
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(2) Melting point or softening point--(i) Melting point. The melting
point shall be determined by ASTM method D2117-82, "Standard Test
Method for Melting Point of Semicrystalline Polymers by the Hot Stage
Microscopy Method," which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(ii) Softening point. The softening point shall be determined by
ASTM method E28-67 (Reapproved 1982), "Standard Test Method for
Softening Point by Ring-and-Ball Apparatus," which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (d)(1) of this section.
(3) Maximum extractable fraction in n-hexane--(i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpentene). A sample is refluxed in the solvent for 2 hours and
filtered at the boiling point. The filtrate is evaporated and the total
residue weighed as a measure of the solvent extractable fraction.
(a) Apparatus. (1) Erlenmeyer flasks, 250-milliliter, with ground
joint.
(2) Condensers, Allihn, 400-millimeter jacket, with ground joint.
(3) Funnels, ribbed 75-millimeter diameter, stem cut to 40
millimeters.
(4) Funnels, Buchner type, with coarse-porosity fritted disc, 60-
millimeter diameter.
(5) Bell jar for vacuum filtration into beaker.
(b) Reagent. n-Hexane, commercial grade, specific gravity 0.663-
0.667 (20 deg.C/20 deg.C), boiling range 66 deg.C-69 deg.C, or
equivalent.
(c) Procedure. Weigh 1 gram of sample accurately and place in a 250-
milliliter Erlenmeyer flask containing two or three boiling stones. Add
100 milliliters of solvent, attach the flask to the condenser (use no
grease), and reflux the mixture for 2 hours. Remove the flask from the
heat, disconnect the condenser, and filter rapidly, while still hot,
through a small wad of glass wool packed in a short-stem funnel into a
tared 150-millimeter beaker. Rinse the flask and filter with two 10-
milliliter portions of the hot solvent, and add the rinsings to the
filtrate. Evaporate the filtrate on a stream bath with the aid of a
stream of nitrogen. Dry the residue in a vacuum oven at 110 deg.C for 2
hours, cool in a desiccator, and weigh to the nearest 0.0001 gram.
Determine the blank on 120 milliliters of solvent evaporated in a tared
150-milliliter beaker. Correct the sample residue for this blank if
significant. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.398
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A preweighed sample is extracted at 50 deg.C
for 2 hours and filtered. The filtrate is evaporated and the total
residue weighed as a measure of the solvent extractable fraction.
Alternatively, the sample is reweighed after the extraction period to
give a measure of the solvent extractable fraction. The maximum n-
hexane-extractable fraction may be determined by the methods set forth
in paragraphs (d)(3)(ii)(a) through (d)(3)(ii)(i) of this section.
(a) Extraction apparatus. Two-liter, straight-walled, Pyrex (or
equivalent)
[[Page 286]]
resin kettles, fitted with three-hole ground-glass covers are most
convenient for this purpose. The cover is fitted with a thermometer, a
gas-tight stirrer driven by an air motor or explosion-proof electric
motor, and a reflux condenser. The kettle is fitted with an electric
heating mantle of appropriate size and shape, which is controlled by a
variable-voltage transformer.
(b) Evaporating apparatus. Rapid evaporation of large volumes of
solvent requires special precautions to prevent contamination by dust.
This is facilitated by a special "gas" cover consisting of an inverted
flat Pyrex crystallizing dish of an appropriate size (190 millimeters x
100 millimeters) to fit a 1-liter beaker. Through the center of the dish
are sealed an inlet tube for preheated, oxygen-free nitrogen, and an
outlet tube located 1 inch off center. Nitrogen is fed from the supply
source through a coil of \1/4\-inch stainless steel tubing immersed in
the same steam bath used to supply heat for solvent evaporation. All
connections are made with flexible tetrafluoroethylene tubing.
(c) Reagents--(1) n-Hexane. Spectrograde n-hexane.
(2) Nitrogen. High-purity dry nitrogen containing less than 10 parts
per million of oxygen.
(d) Procedure. Transfer 2.5 grams (accurately weighed to nearest
0.001 gram) of the polymer to the resin kettle. Add 1 liter of solvent
and clamp top in position. Start water flowing through jacket of the
reflux condenser and apply air pressure to the stirring motor to produce
vigorous agitation. Turn on heating jacket with transformer set at a
predetermined voltage to bring the temperature of the contents to 50
deg.C within 20-25 minutes. As the thermometer reading approaches 45
deg.C-47 deg.C, reduce the voltage to the predetermined setting that
will just maintain the temperature at 50 deg.C. Do not overshoot the
prescribed temperature. Should this occur discard the test and start
afresh. Exactly 2 hours after the solvent temperature has reached 50
deg.C, disconnect the heater, remove the resin kettle from the heating
jacket, and decant the solvent, while still warm, through a coarse
filter paper placed on top of a fritted-glass funnel, collecting the
filtrate in a tared, glass-stoppered Erlenmeyer flask of 1-liter
capacity. Determine the weight of the filtrate recovered to the nearest
gram. Recovery should be at least 90 percent of the original solvent.
Losses due to evaporation during heating and filtering have been found
not to exceed 10 percent. Transfer about half of the solvent filtrate to
a 1-liter beaker placed on an opening in the steam bath and immediately
cover with the special "gas" cover, the inlet tube of which has been
attached with flexible tetrafluoroethylene tubing to a source of high-
purity nitrogen in series with a stainless steel heating coil immersed
directly in the body of the steam bath. Maintain a positive flow of warm
nitrogen gas throughout the evaporation of the solvent, adding the
remainder of the filtrate from the Erlenmeyer flask as the evaporation
proceeds. When the volume of the solvent has been reduced to about 50
milliliters, transfer the concentrated liquid to a previously tared
weighing dish of suitable size. Wash the beaker twice with 20-30
milliliter portions of warm solvent, adding the washings to the weighing
dish while continuing to evaporate the remainder of the solvent under
the gas cover with its flow of warm nitrogen directed toward the center
of the dish. In the event that an insoluble residue that cannot be
removed with warm solvent remains in the beaker, it may be necessary to
heat with a small amount of a higher boiling solvent such as benzene or
toluene, transferring these washings to the weighing dish before final
evaporation to dryness. Transfer the weighing dish with its residue to a
vacuum desiccator, and allow it to remain overnight (at least 12 hours),
after which the net weight of the dry residue is determined to the
nearest 0.0001 gram. Correct the result for any solvent blank equivalent
to the nonvolatile matter determined to be contained in the amount of
solvents used in the test.
(e) Extraction apparatus for alternate method. Two-liter extraction
vessel, such as a resin kettle or round bottom flask, fitted with an
Allihn condenser (size C), a 45/50 male joint with a Teflon sleeve, and
a Teflon coated stir bar. Water bath maintained at 49.5 deg.C
0.5
[[Page 287]]
deg.C containing a submersible magnetic stirrer motor with power
supply. Other suitable means of maintaining temperature control, such as
electric heating mantles, may be used provided that the temperature
range can be strictly maintained.
(f) Sample basket (Optional). A perforated stainless steel
cylindrical basket that is approximately 1.5 inches in diameter, 1.6
inches high, and has perforations of 0.125 inches in diameter for 33
holes/in2, or 40 percent open area. The basket should pass
freely through the 45/50 female joint of the extraction flask. A No. 6-
32 stainless steel eye-bolt is attached to the lid for positioning the
basket in the extraction vessel. The positioning rod, approximately 18
inches long and made from 1/16 inch outside diameter 316 stainless steel
welding rod or equivalent and hooked at both ends, is used to position
the basket in the extraction apparatus.
(g) Vacuum oven. Capable of maintaining 80 deg.C 5
deg.C and a minimum of 635 millimeters of mercury pressure.
(h) Reagents. n-Hexane, reagent or spectrograde, aromatic free (less
than 1 milligram per liter), minimum 85 percent n-hexane. This reagent
may be reused until it contains a maximum of 1.5 grams polyolefin
extractables or has been used for 12 determinations.
(i) Procedure. Assemble the extraction vessel, condenser, and
magnetic stir bar. Add n-hexane (1 liter) to the extraction vessel and
clamp the assembly into a water bath set at 49.5 deg.C 0.5
deg.C. Start the water flowing through the jacket of the reflux
condenser. Adjust the air flow through the stirring motor to give a
smooth and uniform stir rate. Allow the n-hexane to preheat for 1 hour
to bring the temperature to 49.5 deg.C0.5 deg.C.
Temperature is a critical factor in this analysis and it must not vary
more than 1 deg.C. If the temperature exceeds these limits, the test
must be discontinued and restarted. Blown, compression molded, or
extrusion cast films can be tested. Ideally, the film should be prepared
by the same process as will be used with the production resin. Using
gloves and metal tweezers to avoid sample contamination, cut about 2.7
grams of the prepared film (4 mils or less in thickness) into about 1-
inch squares using clean sharp scissors. Proceed with Option 1 or 2.
Option 1. Using tweezers and noting the number of film pieces,
transfer 2.5 grams (accurately weighed to 0.1 milligram) of polymer to
the extraction vessel. Extract the film sample for 2 hours. Allow the
vessel to cool and filter the contents through a fritted porcelain
funnel. Wash the film pieces with fresh n-hexane, aspirate to dryness,
and transfer, using tweezers, to a beaker. Recount the film pieces to
verify that none were lost during the transfer. Place the beaker in the
vacuum oven for 2 hours at 80 deg.C 5 deg.C. After 2
hours, remove and place in a desiccator to cool to room temperature
(about 1 hour). After cooling, reweigh the film pieces to the nearest
0.1 milligram. Calculate the percent hexane-extractables content from
the weight loss of the original sample. Multiply the result by 0.935 and
compare with extraction limits in paragraph (c) of this section. Repeat
the above procedure for successive samples.
Option 2. Transfer 2.50.05 grams of the prepared 1-inch
film sections into a tared sample basket and accurately weigh to the
nearest 0.1 milligram. Carefully raise the condenser until the hook on
the positioning rod is above the neck of the 2-liter extraction vessel.
The basket should be totally below the level of n-hexane solvent.
Extract the sample resin film for 2 hours and then raise the basket
above the solvent level to drain momentarily. Remove the basket and
rinse the contents by immersing several times in fresh n-hexane. Allow
the basket to dry between rinsings. Remove the excess solvent by briefly
blowing the basket with a stream of nitrogen or dry air. Place the
basket in the vacuum oven for 2 hours at 80 deg.C 5 deg.C.
After 2 hours, remove and place in a desiccator to cool to room
temperature (about 1 hour). After cooling, reweigh the basket to the
nearest 0.1 milligram. Calculate the percent hexane extractables content
from the weight loss of the original sample. Multiply the result by
0.935 and compare with extraction limits in paragraph (c) of this
section. Repeat the above procedure for successive samples. The same
solvent charge should remain clear and can be used for
[[Page 288]]
at least 12 determinations. Applications of solvent reuse should be
confirmed for each resin type before use.
(4) Maximum soluble fraction in xylene--(i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpen-tene). A sample is dissolved completely in xylene by
heating and stirring in a bottle with little free space. The solution is
allowed to cool without stirring, whereupon the insoluble portion
precipitates and is filtered off; the total solids content of the
filtrate is then determined as a measure of the soluble fraction.
(a) Apparatus. (1) Pyrex (or equivalent) reagent bottle, 125-
milliliter, glass-stoppered.
(2) Heating mantle of size for 150-milliliter beaker (or suitable
aluminum block to fit the 125-milliter bottle described in paragraph
(d)(4)(i)(a)(1) of this section.
(3) Magnetic stirrer for use under the heating mantle (combination
magnetic stirrer and hotplate may be used if aluminum block is used in
place of heating mantle).
(4) Variable-voltage transformer, 7.5 amperes.
(5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.
(6) Constant temperature water bath maintained at 25
deg.C0.5 deg.C.
(7) Aluminum dishes, 18 millimeters x 60 millimeters, disposable.
(8) Funnel, Buchner type, with coarse-porosity fritted disc, 30-60
millimeter diameter.
(b) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of phenyl-
[beta]- naphthylamine in 1 liter of industrial grade xylene having
specific gravity 0.856-0.867 (20 deg.C/20 deg.C) and boiling range 123
deg.C-160 deg.C.
(c) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001
gram and place in a 125-milliliter Pyrex reagent bottle containing a 1-
inch long tetrafluoroethylene-resin-coated stirring bar. Add 100
milliliters of solvent, set the stopper in lightly, and place the bottle
in the heating mantle or aluminum block maintained at a temperature of
120 deg.C, and stir with a magnetic stirrer until the sample is
completely dissolved. Remove the bottle from the heat and allow it to
cool 1 hour in the air, without stirring. Then place the bottle in a
water bath maintained at 25 deg.C 0.5 deg.C, and allow to
stand 1 hour without stirring. Next, remove the bottle from the water
bath, shake, and pour part of the contents into the coarse-porosity
fritted-glass funnel. Apply suction, and draw 30-40 milliliters of
filtrate through, adding more slurry to the funnel, and catching the
filtrate in a large test tube. (If the slurry is hard to filter, add 10
grams of diatomaceous earth filter aid to the bottle and shake
vigorously just prior to the filtration.) Pipet a suitable aliquot
(preferably 20 milliliters) of the filtrate into a tared aluminum
disposable dish. Place the dish on a steam bath covered with a fresh
sheet of aluminum foil and invert a short-stemmed 4-inch funnel over the
dish. Pass nitrogen (heated if desired) down through the funnel at a
rate sufficient to just ripple the surface of the solvent. When the
liquid has evaporated, place the dish in a vacuum oven at 140 deg.C and
less than 50 millimeters mercury pressure for 2 hours. Cool in a
desiccator and weigh. (Note: If the residue value seems high, redry in
the vacuum oven for one-half hour to ensure complete removal of all
xylene solvent.) Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.399
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A sample is extracted in xylene at reflux
temperature for 2 hours and filtered. The filtrate is evaporated and the
total residue weighed as a measure of soluble fraction.
(a) Apparatus--(1) Extraction apparatus. Two-liter, straight-walled
Pyrex (or equivalent) resin kettles, fitted
[[Page 289]]
with ground-glass covers, are most convenient for this purpose. The
cover is equipped with a thermometer and an efficient reflux condenser.
The kettle is fitted with an electric heating mantle of appropriate size
and shape which is controlled by a variable-voltage transformer.
(2) Constant temperature water bath. It must be large enough to
permit immersion of the extraction kettle and set to maintain 25 deg.C
0.1 deg.C.
(3) Evaporating apparatus. Gas cover consisting of a flat Pyrex
crystallizing dish (190 millimeters x 100 millimeters) inverted to fit
over a 1-liter beaker with 8-millimeter gas inlet tube sealed through
center and an outlet tube 1 inch off center. The beaker with gas cover
is inserted in an electric heating mantle equipped with a variable-
voltage transformer. The outlet tube is attached to an efficient
condenser mounted on a receiving flask for solvent recovery and having
an outlet for connection to an aspirator pump. The heating mantle (with
the beaker) is mounted on a magnetic stirring device. An infrared heat
lamp is mounted vertically 3-4 inches above the gas cover to prevent
condensation of the solvent inside the cover. Make all connections with
flexible tetrafluoroethylene tubing.
(b) Reagents--(1) Xylene. American Chemical Society reagent grade
that has been redistilled through a fractionating column to reduce the
nonvolatile residue.
(2) Nitrogen. High-purity dry nitrogen containing less than 10\4\
parts per million oxygen.
(c) Procedure. Transfer 5 grams 0.001 gram of sample to
the resin kettle, add 1,000 milliliters (840 grams) of xylene, and clamp
top in position after inserting a piece of glass rod to prevent bumping
during reflux. Start water flowing through the jacket of the reflux
condenser and apply full voltage (115 volts) to the heating mantle. When
the xylene starts to boil, reduce the voltage to a level just sufficient
to maintain reflux. After refluxing for at least 2 hours, disconnect the
power source to the mantle, remove the kettle, and allow to cool in air
until the temperature of the contents drops to 50 deg.C, after which
the kettle may be rapidly cooled to 25 deg.C-30 deg.C by immersing in
a cold water bath. Transfer the kettle to a constant temperature bath
set to maintain 25 deg.C 0.1 deg.C, and allow to
equilibrate for a least 1 hour (may be left overnight if convenient).
Break up any precipitated polymers that may have formed, and decant the
xylene solution successively through a fast filter paper and then
through a fritted-glass filter into a tared 1-liter Erlenmeyer flask,
collecting only the first 450 milliliters--500 milliliters of filtrate
(any attempt to collect more of the xylene solution usually results in
clogging the filter and risking losses). Reweigh the Erlenmeyer flask
and calculate the weight of the filtrate obtained to the nearest 0.1
gram. Transfer the filtrate, quantitatively, from the Erlenmeyer flask
to the 1-liter beaker, insert the beaker in its heating mantle, add a
glass-coated magnetic stirring bar, and mount the gas cover in place,
connecting the inlet tube to the nitrogen source and the outlet to the
condenser of the receiving flask. Start a flow of nitrogen (2 to 3
liters per minute) into the gas cover and connect an aspirator to the
receiver using a free-flow rate equivalent to 6-7 liters of air per
minute. With the infrared lamp on, adjust the voltage to the heating
mantle to give a distillation rate of 12-13 milliliters per minute when
the magnetic stirrer is revolving just fast enough to promote good
boiling. When the volume of solvent in the beaker has been reduced to
30-50 milliliters, transfer the concentrated extractive to a suitable
weighing dish that has been previously tared (dry). Rinse the beaker
twice with 10-20 milliliter portions of fresh xylene, adding the
rinsings to the weighing dish. Evaporate the remainder of the xylene on
an electric hotplate set at low heat under the gas cover with a stream
of nitrogen directed toward the center of the dish. Avoid any charring
of the residue. Transfer the weighing dish to a vacuum desiccator at
room temperature and allow to remain under reduced pressure for at least
12 hours (overnight), after which determine the net weight of the
residue to the nearest 0.0001 gram. Correct the result for nonvolatile
solvent blank obtained by evaporating the equivalent amount of
[[Page 290]]
xylene under identical conditions. Calculate the weight of residue
originally present in the total weight of solvent (840 grams), using the
appropriate factor based on the weight of filtrate evaporated.
(5) Viscosity average molecular weight olefin copolymers described
in paragraphs (a)(3) (iii) and (iv) of this section. The viscosity
average molecular weight shall be determined from the kinematic
viscosity (using ASTM method D445-74, "Test for Kinematic Viscosity of
Transparent and Opaque Liquids" (Revised 1974), which is incorporated
by reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408) of solutions of the
copolymers in solvents and at temperatures as follows:
(i) Olefin polymers described in paragraph (a)(3)(iii) of this
section in decahydronaphthalene at 135 deg.C.
(ii) Olefin polymers described in paragraph (a)(3)(iv) of this
section in tetrachloroethylene at 30 deg.C.
(6) Mooney viscosity--olefin copolymers described in paragraph
(a)(3)(iii) of this section. Mooney viscosity is determined by ASTM
method D1646-81, "Standard Test Method for Rubber--Viscosity and
Vulcanization Characteristics (Mooney Viscometer)," which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (d)(1) of this section), using the large
rotor at a temperature of 100 deg.C, except that a temperature of 127
deg.C shall be used for those copolymers whose Mooney viscosity cannot
be determined at 100 deg.C. The apparatus containing the sample is
warmed for 1 minute, run for 8 minutes, and viscosity measurements are
then made.
(7) Melt flow index. The melt flow index of olefin polymers
described below shall be determined by ASTM method D-1238-82, "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).
The availability of this incorporation by reference is given in
paragraph (d)(1) of this section. The olefin polymers and test
conditions and procedures are as follows:
------------------------------------------------------------------------
List of polymers Conditions/procedures
------------------------------------------------------------------------
Olefin copolymers described in Condition L, procedure A.
paragraph (a)(3)(i)(c)(2) of this
section.
Olefin copolymers described in Condition E, procedure A.
paragraph (a)(3)(v) of this section.
Olefin polymers described in paragraph Condition E, procedure A.
(a)(2)(ii) of this section.
Olefin polymers described in paragraph Condition E, procedure A.
(a)(3)(vi) of this section.
------------------------------------------------------------------------
(8) Melting peak temperature. The melt temperature of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 3418-82, "Standard Test Method for
Transition Temperatures of Polymers by Thermal Analysis," which is
incorporated by reference in accordance with 5 U.S.C. 552(a). The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(9) Intrinsic viscosity. The intrinsic viscosity of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 1601-78, "Standard Test Method for Dilute
Solution Viscosity of Ethylene Polymers," which is incorporated by
reference in accordance with 5 U.S.C. 552(a). The availability of this
incorporation by reference is given in paragraph (d)(1) of this section.
(e) Olefin copolymers described in paragraph (a)(3) (i) of this
section and polyethylene, alone or in combination, may be subjected to
irradiation bombardment from a source not to exceed 2.3 million volts
intensity to cause molecular crosslinking of the polymers to impart
desired properties, such as increased strength and increased ability to
shrink when exposed to heat.
(f) The olefin polymers identified in and complying with this
section, when used as components of the food-contact surface of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178, and Sec. 179.45 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.
(g) The provisions of this section are not applicable to olefin
polymers identified in Sec. 175.105(c) (5) of this chapter
[[Page 291]]
and used in food-packaging adhesives complying with Sec. 175.105 of this
chapter.
[42 FR 14572, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 177.1520, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[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: 21CFR177.1550]
[Page 291-293]
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. 177.1550 Perfluorocarbon resins.
Perfluorocarbon resins identified in this section may be safely used
as articles or components of articles intended to contact food, subject
to the provisions of this section:
(a) Identity. For the purpose of this section, perfluorocarbon
resins are those produced by: (1) The homopolymerization and/or
copolymerization of hexafluoropropylene and tetrafluoroethylene, and (2)
the copolymerization of perfluoropropylvinylether and
tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the
extractives limitations in paragraph (d) of this section.
(b) Optional components. The perfluorocarbon resins identified in
paragraph (a) of this section as well as articles or coating made from
these resins may include the following optional components except that
the resin identified in paragraph (a)(2) of this section may not be used
with the optional component, lithium polysilicate, mentioned in
paragraph (b)(4) of this section.
(1) Substances generally recognized as safe (GRAS) in food or food
packaging subject to any limitations cited on their use.
(2) Substances used in accordance with a prior sanction or approval,
subject to any limitations cited in the prior sanction or approval.
(3) Substances authorized under applicable regulations in this part
and in parts 175 and 178 of this chapter and subject to any limitations
prescribed therein.
(4) The following substances, subject to any limitations prescribed:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Lithium polysilicate containing not more For use only as a component
than 20 weight percent silica, not more of repeated-use coatings
than 2.1 percent lithium oxide and having not exceeding 0.030
a maximum mole ratio of Si02/Li20 of 8.5 millimeter (0.0012 inch) in
to 1. thickness where the
coatings are thermally
cured at minimum sintering
temperatures of 371 deg.C
(700 deg.F). Lithium
extractives shall not
exceed 1.55 milligrams per
square decimeter (0.1
milligram per square inch)
of coating surface when
tested in accordance with
paragraph (e)(2) of this
section.
Naphthalene sulfonic acid formaldehyde For use only:
condensate, sodium salt. 1. As a component of
repeated-use coatings,
based on the
perfluorocarbon resin
identified in paragraph
(a)(1) of this section, not
to exceed 0.030 millimeter
(0.0012 inch) in thickness,
and at a level not to
exceed 0.4 weight percent
of the coating.
2. As a component of
repeated-use coatings,
based on the
perfluorocarbon resin
identified in paragraph
(a)(2) of this section, not
to exceed 0.10 millimeter
(0.004 inch) in thickness,
and at a level not to
exceed 0.4 weight percent
of the coating.
------------------------------------------------------------------------
(c) Optional processing. Poly- tetrafluoroethylene resins may be
irradiated by either a cobalt-60 sealed source, at a maximum dose of
gamma radiation not to exceed 7.5 megarads, or an electron beam at
energy levels not to exceed 2.5 million electron volts with a maximum
dosage of 7.5 megarads, to produce lubricant powders having a particle
diameter of not more than 20 microns for use only as components of
articles intended for repeated use in contact with food.
(d) Specifications--(1) Infrared identification. Perfluorocarbon
resins can be identified by their characteristic infrared spectra.
(2) Melt-viscosity. (i) The perfluorocarbon resins identified in
paragraph (a)(1) of this section shall have a melt viscosity of not less
than 10\4\ poises at 380 deg.C (716 deg.F) as determined by ASTM
method D1238-82, "Standard Test Method for Flow Rates of Thermoplastics
by
[[Page 292]]
Extrusion Plastometer," which is incorporated by reference. Copies may
be obtained from the American Society for Testing Materials, 1916 Race
St., Philadelphia, PA 19103, or may be examined at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408. The melt viscosity of the perfluorocarbon resins identified in
paragraph (a)(1) of this section shall not vary more than 50 percent
within one-half hour at 380 deg.C (716 deg.F).
(ii) Perfluorocarbon resins identified in paragraph (a)(2) of this
section shall have a melt viscosity of not less than 10\4\ poises at 372
deg.C (702 deg.F) as determined by a more detailed method titled
"Determination of Melt Viscosity, Molecular Weight Distribution Index
and Viscosity Stability," 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) Thermal instability index. The thermal instability index of the
tetrafluoroethylene homopolymer shall not exceed 50 as determined by
ASTM method D1457-56T, "Test for Thermal Instablility index of
Tetrafluoroethylene Homopolymer" (Revised 1956), 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. The requirements of this
paragraph do not apply to polytetrafluoroethylene resin lubricant
powders described in paragraph (c) of this section.
(e) Limitations. \1\ (1) Perfluorocarbon-molded articles having a
surface area of 6.45 square decimeters (100 square inches) or more and
at least 1.27 millimeters (0.05 inch) thick shall be extracted at reflux
temperatures for 2 hours separately with distilled water, 50 percent
ethanol, n-heptane, and ethyl acetate.
---------------------------------------------------------------------------
\1\ A more detailed procedure of extraction conditions is entitled,
"Preparation of Extracts," which is incorporated by reference. Copies
are available from the Center for Food Safety and Applied Nutrition
(HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408.
---------------------------------------------------------------------------
(2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2)
of this section and intended for use as coatings or components of
coatings shall meet extractability limits prescribed in paragraph (e)(3)
of this section when the resins in the form of coatings described in
paragraphs (e)(2) (i) and (ii) of this section are extracted at reflux
temperatures for 2 hours separately with distilled water, 8 percent
ethanol, and n-heptane:
(i) Perfluorocarbon resin coatings based on resins identified in
paragraph (a)(1) of this section shall be applied to both sides of a
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of
0.025 millimeter (0.001 inch) after thermal curing at 399 deg.C (750
deg.F) for 10 minutes. If a primer is used, the total thickness of the
primer plus topcoat shall equal 0.025 millimeter (0.001 inch) after heat
curing.
(ii) Perfluorocarbon resin coatings based on resins identified in
paragraph (a)(2) of this section shall be applied to both sides of a
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of 0.10
millimeter (0.004 inch) after thermal curing at 427 deg.C (800 deg.F)
for 10 minutes. If a primer is used, the total thickness of the primer
plus topcoat shall equal 0.10 millimeter (0.004 inch) after heat curing.
(3) The extracted surfaces shall meet the following extractability
limits:
(i) Total extractives not to exceed 3.1 milligrams per square
decimeter (0.2 milligram per square inch).
(ii) Fluoride extractives calculated as fluorine not to exceed 0.46
milligram per square decimeter (0.03 milligram per square inch).
(f) Conditions of use. Perfluorocarbon resins identified in
paragraph (a)(2) of
[[Page 293]]
this section are limited to use as coatings or components of coatings
for articles intended for repeated food-contact use.
[43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19, 1982;
47 FR 14699, Apr. 6, 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, Jan.
11, 1985; 54 FR 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996]
[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: 21CFR177.1555]
[Page 293]
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. 177.1555 Polyarylate resins.
Polyarylate resins (CAS Reg. No. 51706-10-6) 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. Polyarylate resins (1, 3-benzenedicarboxylic acid,
diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4'-
(1-methylethylidine) bis(phenol)) are formed by melt polycondensation of
bisphenol-A with diphenylisophthalate and diphenylterephthalate.
(b) Specifications. (1) The finished copolymers shall contain from
70 to 80 weight percent of polymer units derived from
diphenylisophthalate and 20 to 30 weight percent of polymer units
derived from diphenylterephthalate.
(2) Polyarylate resins shall have a minimum weight average molecular
weight of 20,000.
(3) Polyarylate resins may be identified by their characteristic
infrared spectra.
(c) Extractive limitations. The finished polyarylate resins in sheet
form at least 0.5 millimeter (0.020 inch) thick, when extracted with
water at 121 deg.C (250 deg.F) for 2 hours, shall yield total
nonvolatile extractives not to exceed 2.33 micrograms per square
centimeter (15 micrograms per square inch) of the exposed resin surface.
(d) Limitations. Polyarylate resin articles may be used in contact
with all foods except beverages containing more than 8 volume percent
ethanol under conditions of use A through H, described in table 2 of
Sec. 176.170(c) of this chapter.
[52 FR 35540, Sept. 22, 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: 21CFR177.1556]
[Page 293]
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. 177.1556 Polyaryletherketone resins.
The poly(oxy-1,4-phenylenecarbonyl-1,4-phenyleneoxy-1,4-
phenylenecarbonyl-1,4-phenylenecarbonyl-1,4-phenylene) resins (CAS Reg.
No. 55088-54-5 and CAS Reg. No. 60015-05-6 and commonly referred to as
polyaryletherketone resins) identified in paragraph (a) of this section
may be safely used as articles or components of articles intended for
repeated use in contact with food, subject to the provisions of this
section.
(a) Identity. Polyaryletherketone resins consist of basic resins
produced by reacting 4,4'-diphenoxy benzophenone and terephthaloyl
dichloride in such a way that the finished resins have a minimum weight
average molecular weight of 20,000 grams per mole, as determined by
light scattering measurements in sulfuric acid at room temperature.
(b) Optional adjuvant substances. The basic polyaryletherketone
resins identified in paragraph (a) of this section may contain optional
adjuvant substances required in the production of such basic resins.
These adjuvants may include substances used in accordance with
Sec. 174.5 of this chapter and the following:
(1) Benzoyl chloride, poly(tetrafluoro ethylene).
(2) [Reserved]
(c) Extractive limitations. The finished food-contact article yields
net total extractives in each extracting solvent not to exceed 0.052
milligram per square inch (corresponding to 0.008 milligram per square
centimeter) of food-contact surface, when extracted at reflux
temperature for 2 hours with the following solvents: Distilled water, 50
percent (by volume) ethyl alcohol in distilled water, 3 percent acetic
acid (by weight) in distilled water, and n-heptane.
(d) In testing the finished food-contact article made of
polyaryletherketone resin, use a separate test sample for each required
extracting solvent.
[61 FR 42381, Aug. 15, 1996]
[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: 21CFR177.1560]
[Page 293-294]
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. 177.1560 Polyarylsulfone resins.
Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used
as articles or components of articles intended for use in contact with
food, at temperatures up to and including normal baking temperatures, in
accordance
[[Page 294]]
with the following prescribed conditions:
(a) Identity. Polyarylsulfone resins are copolymers containing not
more than 25 percent of oxy-p-phenylene-oxy-p-phenylenesulfonyl-p-
phenylene polymer units and not less than 75 percent of oxy-p-
phenylenesulfonyl-p-phenylene-oxy-p-phenylenesulfonyl-p-phenylene
polymer units. The copolymers have a minimum reduced viscosity of 0.40
deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM
method D2857-70 (Reapproved 1977), "Standard Test Method for Dilute
Solution Viscosity of Polymers," which is incorporated by reference.
Copies may be obtained from the American Society for Testing and
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(b) Optional adjuvant substances. The basic polyarylsulfone resins
identified in paragraph (a) of this section may contain optional
adjuvant substances required in the production of such basic copolymers.
These 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, substances used in
accordance with a prior sanction of approval, and substances named in
this paragraph and further identified as required:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Sulfolane......................... Not to exceed 0.15 percent as
residual solvent in the finished
basic resin.
------------------------------------------------------------------------
(c) Extractive limitations. The finished polyarylsulfone resin when
extracted for 2 hours with the following solvents at the specified
temperatures yields total extractives in each extracting solvent not to
exceed 0.008 milligram per square centimeter of food-contact surface:
distilled water at 121 deg.C (250 deg.F), 50 percent (by volume) ethyl
alcohol in distilled water at 71.1 deg.C (160 deg.F), 3 percent acetic
acid in distilled water at 100 deg.C (212 deg.F), and n-heptane at
65.6 deg.C (150 deg.F).
Note: In testing the finished polyarylsulfone resin use a separate
test sample for each required extracting solvent.
[50 FR 31046, 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: 21CFR177.1570]
[Page 294-295]
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. 177.1570 Poly-1-butene resins and butene/ethylene copolymers.
The poly-1-butene resins and butene/ethylene copolymers identified
in this section may be safely used as articles or components of articles
intended for use in contact with food subject to the provisions of this
section.
(a) Identity. Poly-1-butene resins are produced by the catalytic
polymerization of 1-butene liquid monomer. Butene/ethylene copolymers
are produced by the catalytic polymerization of 1-butene liquid monomer
in the presence of small amounts of ethylene monomer so as to yield no
higher than a 6-weight percent concentration of polymer units derived
from ethylene in the copolymer.
(b) Specifications and limitations. Poly-1-butene resins and butene/
ethylene copolymers shall conform to the specifications prescribed in
paragraph (b)(1) of this section, and shall meet the extractability
limits prescribed in paragraph (b)(2) of this section.
(1) Specifications--(i) Infrared identification. Poly-1-butene
resins and butene/ethylene copolymers can be identified by their
characteristic infrared spectra.
(ii) Viscosity. Poly-1-butene resins and the butene/ethylene
copolymers have an intrinsic viscosity 1.0 to 3.2 as determined by ASTM
method D1601-78, "Standard Test Method for Dilute Solution Viscosity of
Ethylene Polymers," which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(iii) Density. Poly-1-butene resins have a density of 0.904 to 0.920
gms/cm\3\, and butene/ethylene copolymers have a density of 0.890 to
0.916 gms/cm\3\ as determined by ASTM method D1505-68 (Reapproved 1979),
"Standard Test Method for Density of Plastics by the Density-Gradient
Technique," which is
[[Page 295]]
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b)(1)(ii) of this section.
(iv) Melt index. Poly-1-butene resins have a melt index of 0.1 to 24
and the butene/ethylene copolymers have a melt index of 0.1 to 20 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. The availability of this incorporation by
reference is given in paragraph (b)(1)(ii) of this section.
(2) Limitations. Poly-1-butene resins and butene/ethylene copolymers
for use in articles that contact food, and for articles used for packing
or holding food during cooking shall yield no more than the following
extractables:
(i) Poly-1-butene resins may be used as articles or components of
articles intended for use in contact with food, provided that the
maximum extractables do not exceed 2.5 percent by weight of the polymer
when film or molded samples are tested for 2 hours at 50 deg.C (122
deg.F) in n-heptane.
(ii) Butene/ethylene copolymers containing no more than 6 percent by
weight of polymer units derived from ethylene may be used as articles or
components of articles intended for contact with food under conditions
of use B, C, D, E, F, G, or H described in table 2 of Sec. 176.170(c) of
this chapter, subject to the provisions of this section and provided
that the maximum extractables from test films 0.1 to 0.2 millimeter
(0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by weight
of the polymer when extracted in a soxhlet extractor for 6 hours with
refluxing 95 percent ethanol.
(iii) Poly-1-butene resins may be used as articles or components of
articles intended for packaging or holding food during cooking, provided
that the thickness of such polymers in the form in which they contact
food shall not exceed 0.1 millimeter (0.004 inch) and yield maximum
extractables of not more than 2.5 percent by weight of the polymer when
films are extracted for 2 hours at 50 deg.C (122 deg.F) in n-heptane.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984;
50 FR 31349, Aug. 2, 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: 21CFR177.1580]
[Page 295-296]
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. 177.1580 Polycarbonate resins.
Polycarbonate resins may be safely used as articles or components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, in accordance with the following prescribed conditions:
(a) Polycarbonate resins are polyesters produced by:
(1) The condensation of 4,4'-iso-propylidenediphenol and carbonyl
chloride to which may have been added certain optional adjuvant
substances required in the production of the resins; or by
(2) The reaction of molten 4,4'-iso-propylidenediphenol with molten
diphenyl carbonate in the presence of the disodium salt of 4,4'-
isopropylidenediphenol.
(3) The condensation of 4,4'-isopro- pylidenediphenol, carbonyl
chloride, and 0.5 percent weight maximum of a2,a6-bis (6-hydroxy-m-
tolyl) mesitol to which may have been added certain optional adjuvant
substances required in the production of branched polycarbonate resins.
(b) The optional adjuvant substances required in the production of
resins produced by the methods described in paragraph (a)(1) and (3) of
this section may include substances generally recognized as safe in
food, substances used in accordance with a prior sanction or approval,
and the following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
p-tert-Butylphenol........................ ............................
Chloroform................................ ............................
p-Cumylphenol (CAS Reg. No. 599-64-4)..... For use only as a chain
terminator at a level not
to exceed 5 percent by
weight of the resin.
Ethylene dichloride.......................
Heptane...................................
Methylene chloride........................
Monochlorobenzene......................... Not to exceed 500 p.p.m. as
residual solvent in
finished resin.
Pentaerythritol tetrastearate (CAS Reg. For use only as a mold
No. 115-83-3). release agent, at a level
not to exceed 0.5 percent
by weight of the finished
resin.
Phenol (CAS Reg. No. 108-95-2)............
Pyridine..................................
Toluene: (CAS Reg. No. 108-88-3).......... Not to exceed 800 parts per
million as residual solvent
in finished resin.
Triethylamine.............................
------------------------------------------------------------------------
[[Page 296]]
(c) Polycarbonate resins shall conform to the specification
prescribed in paragraph (c)(1) of this section and shall meet the
extractives limitations prescribed in paragraph (c)(2) of this section.
(1) Specification. Polycarbonate resins can be identified by their
characteristic infrared spectrum.
(2) Extractives limitations. The polycarbonate resins to be tested
shall be ground or cut into small particles that will pass through a
U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve
No. 10.
(i) Polycarbonate resins, when extracted with distilled water at
reflux temperature for 6 hours, shall yield total extractives not to
exceed 0.15 percent by weight of the resins.
(ii) Polycarbonate resins, when extracted with 50 percent (by
volume) ethyl alcohol in distilled water at reflux temperature for 6
hours, shall yield total extractives not to exceed 0.15 percent by
weight of the resins.
(iii) Polycarbonate resins, when extracted with n-heptane at reflux
temperature for 6 hours, shall yield total extractives not to exceed
0.15 percent by weight of the resins.
[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981;
49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug.
8, 1988; 59 FR 43731, Aug. 25, 1994]
[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: 21CFR177.1585]
[Page 296-297]
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. 177.1585 Polyestercarbonate resins.
Polyestercarbonate resins may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, or holding food, in
accordance with the following prescribed conditions:
(a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced
by the condensation of 4,4'-isopropylidenediphenol, carbonyl chloride,
terephthaloyl chloride, and isophthaloyl chloride such that the finished
resins are composed of 45 to 85 molepercent ester, of which up to 55
mole-percent is the terephthaloyl isomer. The resins are manufactured
using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1
and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or
greater. The resins are also properly identified by CAS Reg. No. 114096-
64-9 when produced with the use of greater than 2 but not greater than 5
weight percent p-cumylphenol (CAS Reg. No. 599-64-4), as an optional
adjuvant substance in accordance with paragraph (b)(2) of this section.
(b) Optional adjuvants. The optional adjuvant substances required in
the production of resins identified in paragraph (a) of this section may
include:
(1) Substances used in accordance with Sec. 174.5 of this chapter.
(2) Substances identified in Sec. 177.1580(b).
(3) Substances regulated in Sec. 178.2010(b) of this chapter for use
in polycarbonate resins complying with Sec. 177.1580:
Provided, That the substances are used in accordance with any limitation
on concentration, conditions of use, and food types specified in
Sec. 178.2010(b) of this chapter.
(c) Polyestercarbonate resins shall conform to the specifications
prescribed in paragraph (c)(1) of this section and shall meet the
extractive limitations prescribed in paragraph (c)(2) of this section.
(1) Specifications. Polyestercarbonate resins identified in
paragraph (a) of this section can be identified by their characteristic
infrared spectrum. The resins shall comply with either or both of the
following specifications:
(i) The solution intrinsic viscosity of the polyestercarbonate
resins shall be a minimum of 0.44 deciliter per gram, as determined by a
method entitled "Intrinsic Viscosity (IV) of Lexan[reg]
Polyestercarbonate Resin by a Single Point Method Using Dichloromethane
as the Solvent," developed by the General Electric Co., September 20,
1985, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the Office of
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register,
[[Page 297]]
800 North Capitol St. NW., suite 700, Washington, DC; or
(ii) A minimum weight-average molecular weight of 27,000, as
determined by gel permeation chromatography using polystyrene standards.
(2) Extractives limitations. The polyestercarbonate resins to be
tested shall be ground or cut into small particles that will pass
through a U.S. standard sieve No. 6 and that will be held on U.S.
standard sieve No. 10.
(i) Polyestercarbonate resins, when extracted with distilled water
at reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.005 percent by weight of the resins.
(ii) Polyestercarbonate resins, when extracted with 50 percent (by
volume) ethyl alcohol in distilled water at reflux temperature for 6
hours, shall yield total nonvolatile extractives not to exceed 0.005
percent by weight of the resins.
(iii) Polyestercarbonate resins, when extracted with n-heptane at
reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.002 percent by weight of the resins.
(3) Residual methylene chloride levels in polyestercarbonate resins.
Polyestercarbonate resin articles in the finished form shall not contain
residual methylene chloride in excess of 5 parts per million as
determined by a method titled "Analytical Method for Determination of
Residual Methylene Chloride in Polyestercarbonate Resin," developed by
the General Electric Co., July 23, 1991, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the Center for Food Safety and Applied Nutrition
(HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
[57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999]
[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: 21CFR177.1590]
[Page 297]
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. 177.1590 Polyester elastomers.
The polyester elastomers identified in paragraph (a) of this section
may be safely used as the food-contact surface of articles intended for
use in contact with bulk quantities of dry food of the type identified
in Sec. 176.170(c) of this chapter, table 1, under Type VIII, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, polyester elastomers are those
produced by the ester exchange reaction when one or more of the
following phthalates--dimethyl terephthalate, dimethyl orthophthalate,
and dimethyl isophthalate--is made to react with alpha-hydroomega-
hydroxypoly (oxytetramethylene) and/or 1,4-butanediol such that the
finished elastomer has a number average molecular weight between 20,000
and 30,000.
(b) Optional adjuvant substances employed in the production of the
polyester elastomers or added thereto to impart desired technical or
physical properties may include the following substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
4,4' - Bis (alpha, alpha-dimethyl-benzyl) For use only as an
diphenylamine. antioxidant.
Tetrabutyl titanate....................... For use only as a catalyst.
------------------------------------------------------------------------
(c) An appropriate sample of the finished polyester elastomer in the
form in which it contacts food when subjected to ASTM method D968-81,
"Standard Test Methods for Abrasion Resistance of Organic Coatings by
the Falling Abrasive Tester," which is incorporated by reference
(copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408), using No. 50 emery abrasive in lieu of Ottawa
sand, shall exhibit an abrasion coefficient of not less than 100 liters
per mil of thickness.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984]
[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: 21CFR177.1595]
[Page 297-298]
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. 177.1595 Polyetherimide resin.
The polyetherimide resin identified in this section may be safely
used as an article or component of an article intended for use in
contact with food, subject to the provisions of this section.
[[Page 298]]
(a) Identity. For the purpose of this section, the polyetherimide
resin is 1,3-isobenzofurandione, 5,5'[(1-methyl-ethylidene)bis(4,1-
phenyleneoxy)] bis-polymer with 1,3-benzenediamine (CAS Reg. No. 61128-
46-9), and is derived from the condensation reaction of m-
phenylenediamine and bisphenol A-dianhydride.
(b) Optional adjuvants. The basic polymer identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of basic resins or finished food-contact articles. 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 and extractives limitations--(1) Specifications.
Polyetherimide resin identified in paragraph (a) of this section shall
have an intrinsic viscosity in chloroform at 25 deg.C (77 deg.F) of
not less than 0.35 deciliter per gram as determined by a method titled
"Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as the
Solvent," which is incorporated by reference. Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) Extractive limitations. Extractive limitations are applicable to
the basic polyetherimide resin in the form of molded discs of thickness
0.16 centimeter (0.063 inch). The resin discs when extracted with
distilled water at 121 deg.C (250 deg.F) for 2 hours yield total
nonvolatile extractives of not more than 12.3 micrograms per square
centimeter.
[50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. 3, 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: 21CFR177.1600]
[Page 298]
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. 177.1600 Polyethylene resins, carboxyl modified.
Carboxyl-modified polyethylene resins may be safely used as the
food-contact surface of articles intended for use in contact with food
in accordance with the following prescribed conditions:
(a) For the purpose of this section, carboxyl-modified polyethylene
resins consist of basic polymers produced when ethylene-methyl acrylate
basic copolymers, containing no more than 25 weight percent of polymer
units derived from methyl acrylate, are made to react in an aqueous
medium with one or more of the following substances:
Ammonium hydroxide.
Calcium carbonate.
Potassium hydroxide.
Sodium hydroxide.
(b) The finished food-contact article, 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 total extractives in each extracting solvent not to
exceed 0.5 milligram per square inch of food-contact surface as
determined by the methods described in Sec. 176.170(d) of this chapter;
and 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. In testing the finished food-
contact articles, a separate test sample is to be used for each required
extracting solvent.
(c) The provisions of paragraph (b) of this section are not
applicable to carboxyl-modified polyethylene resins used in food-
packaging adhesives complying with Sec. 175.105 of this chapter.
[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: 21CFR177.1610]
[Page 298-299]
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. 177.1610 Polyethylene, chlorinated.
Chlorinated polyethylene identified in this section may be safely
used as articles or components of articles that contact food, except for
articles used for packing or holding food during cooking, subject to the
provisions of this section.
(a) For the purpose of this section, chlorinated polyethylene
consists of basic polymers produced by the direct chlorination of
polyethylene conforming to the density, maximum n-hexane extractable
fraction, and maximum xylene soluble fraction specifications prescribed
under item 2.1 of the table in Sec. 177.1520(c). Such chlorinated
[[Page 299]]
polyethylene contains a maximum of 60 percent by weight of total
chlorine, as determined by ASTM 1method D1303-55 (Reapproved 1979),
"Standard Test Method for Total Chlorine in Vinyl Chloride Polymers and
Copolymers," which is incorporated by reference (copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408), and has a 7.0 percent maximum extractable fraction in n-hexane
at 50 deg.C, as determined by the method described in
Sec. 177.1520(d)(3)(ii).
(b) Chlorinated polyethylene may be used in contact with all types
of food, except that when used in contact with fatty food of Types III,
IV-A, V, VII-A, and IX described in table 1 of Sec. 176.170(c) of this
chapter, chlorinated polyethylene is limited to use only as a modifier
admixed at levels not exceeding 15 weight percent in plastic articles
prepared from polyvinyl chloride and/or from vinyl chloride copolymers
complying with Sec. 177.1980.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19, 1984;
59 FR 14550, Mar. 29, 1994]
[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: 21CFR177.1615]
[Page 299]
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. 177.1615 Polyethylene, fluorinated.
Fluorinated polyethylene, identified in paragraph (a) of this
section, may be safely used as food-contact articles in accordance with
the following prescribed conditions:
(a) Fluorinated polyethylene food-contact articles are produced by
modifying the surface of polyethylene articles through action of
fluorine gas in combination with gaseous nitrogen as an inert diluent.
Such modification affects only the surface of the polymer, leaving the
interior unchanged. Fluorinated polyethylene articles are manufactured
from basic resins containing not less than 85 weight-percent of polymer
units derived from ethylene and identified in Sec. 177.1520 (a)(2) and
(3)(i).
(b) Fluorinated polyethylene articles conform to the specifications
and use limitations of Sec. 177.1520(c), items 2.1 and 3.1.
(c) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under conditions
of time and temperature characterizing the conditions of its intended
use as determined from tables 1 and 2 of Sec. 176.170(c) of this
chapter, yields fluoride ion not to exceed 5 parts per million
calculated on the basis of the volume of food held by the food-contact
article.
[48 FR 39057, Aug. 29, 1983]
[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: 21CFR177.1620]
[Page 299-300]
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. 177.1620 Polyethylene, oxidized.
Oxidized polyethylene identified in paragraph (a) of this section
may be safely used as a component of food-contact articles, in
accordance with the following prescribed conditions:
(a) Oxidized polyethylene is the basic resin produced by the mild
air oxidation of polyethylene conforming to the density, maximum n-
hexane extractable fraction, and maximum xylene soluble fraction
specifications prescribed under item 2.3 of the table in
Sec. 177.1520(c). Such oxidized polyethylene has a minimum number
average molecular weight of 1,200, as determined by high temperature
vapor pressure osmometry, contains a maximum of 5 percent by weight of
total oxygen, and has an acid value of 9 to 19.
(b) The finished food-contact article, 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 acidified chloroform-soluble extractives not to
exceed 0.5 milligram per square inch of food-contact surface when tested
by the methods described in Sec. 177.1330(c), except that 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 such regulations. (Note: In testing the finished
food-contact article, use a separate test sample for each extracting
solvent.)
[[Page 300]]
(c) The provisions of this section are not applicable to oxidized
polyethylene used as provided in Secs. 175.105 and 176.210 of this
chapter, and Sec. 177.2800. The provisions of paragraph (b) of this
section are not applicable to oxidized polyethylene used as provided in
Secs. 175.125 and 176.170(a)(5) of this chapter and Sec. 177.1200.
[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: 21CFR177.1630]
[Page 300-303]
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. 177.1630 Polyethylene phthalate polymers.
Polyethylene phthalate polymers identified in this section may be
safely used as, or components of plastics (films, articles, or fabric)
intended for use in contact with food in accordance with the following
prescribed conditions:
(a) Polyethylene phthalate films consist of a base sheet of ethylene
terephthalate polymer, ethylene terephthalate-isophthalate copolymer, or
ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters
described in Sec. 177.1315(b)(3), to which have been added optional
substances, either as constituents of the base sheet or as constituents
of coatings applied to the base sheet.
(b) Polyethylene phthalate articles consist of a base polymer of
ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene
dimethylene terephthalate copolyesters described in Sec. 177.1315(b)(3),
to which have been added optional substances, either as constituents of
the base polymer or as constituents of coatings applied to the base
polymer.
(c)(1) Polyethylene phthalate spunbonded nonwoven fabric consist of
continuous filaments of ethylene terephthalate polymer and ethylene
terephthalate-isophthalate copolymer to which may have been added
optional adjuvant substances required in their preparation and
finishing.
(2) The ethylene terephthalate-isophthalate copolymer component of
the fabric shall not exceed 25 percent by weight. The filaments may be
blended with other fibers regulated for the specific use and the
spunbonded fabric may be further bonded by application of heat and/or
pressure.
(3) The fabric shall be used only in accordance with paragraph (i)
of this section.
(d) The quantity of any optional substance employed in the
production of polyethylene phthalate plastics does not exceed the amount
reasonably required to accomplish the intended physical or technical
effect or any limitations further provided. Any substance employed in
the production of polyethylene phthalate plastics that is the subject of
a regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter
conforms with any specification in such regulation.
(e) Substances employed in the production of polyethylene phthalate
plastics include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
polyethylene phthalate plastics 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 food-contact surfaces subject to the provisions of
such regulation.
(4) Substances identified in this paragraph (e)(4) subject to the
limitations prescribed:
List of Substances and Limitations
(i) Base sheet:
Ethylene terephthalate copolymers: Prepared by the condensation of
dimethyl terephthalate or terephthalic acid with ethylene glycol,
modified with one or more of the following: Azelaic acid, dimethyl
azelate, dimethyl sebacate, sebacic acid.
Ethylene terephthalate copolymers: Prepared by the condensation of
dimethyl terephthalate or terephthalic acid with ethylene glycol,
modified with one or more of the following: Azelaic acid, dimethyl
azelate, dimethyl sebacate, sebacic acid, pyromellitic dianhydride. The
level of pyromellitic dianhydride shall not exceed 0.5 percent by weight
of the finished copolymer which may be used under conditions of use E
through H as described in table 2 of Sec. 176.170(c) of this chapter.
Ethylene terephthalate-isophthalate copolymers: Prepared by the
condensation of dimethyl terephthalate or terephthalic acid
and dimethyl isophthalate or isophthalic acid with ethylene
glycol. The finished copolymers contain either:
(a) 77 to 83 weight percent or
[[Page 301]]
(b) At least 97 weight percent of polymer units derived from
ethylene terephthalate.
(ii) Base sheet and base polymer:
Ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters
described in Sec. 177.1315(b)(3).
Ethylene terephthalate polymer: Prepared by the condensation of dimethyl
terephthalate and ethylene glycol.
Ethylene terephthalate polymer: Prepared by the condensation of
terephthalic acid and ethylene glycol.
(iii) Coatings:
Acrylic copolymers (CAS Reg. No. 30394-86-6): Prepared by reaction of
ethyl acrylate (CAS Reg. No. 140-88-5), methyl methacrylate (CAS Reg.
No. 80-62-6), and methacrylamide (CAS Reg. No. 79-39-0) blended with
melamine-formaldehyde resin (CAS Reg. No. 68002-20-0). For use in
coatings for polyethylene phthalate films complying with paragraph (a)
of this section.-
Ethylene azelate-terephthalate copolymer: The copolymer, dissolved in
1,1,2-trichloroethane and/or methylene chloride, may be used as a heat-
activated sealant on polyethylene terephthalate film intended for
sealing polyethylene terephthalate pouches that are used as containers
of either nonalcoholic beverages or alcoholic beverages containing not
more than 15 percent ethyl alcohol. The copolymer has a terephthalate/
azelate molecular ratio of 1.25/1.00 and a relative viscosity of not
less than 1.5 as determined by a method title "General Procedure of
Determining the Relative Viscosity of Resin Polymers," 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. Total residual copolymer
solvent (1,1,2-trichloroethane and/or methylene chloride) shall not
exceed 0.13 milligram per square inch of film, and food contact of the
film shall be limited to not more than 1 square inch per 250 grams of
beverage.
2-Ethylhexyl acrylate copolymerized with one or more of the following:
Acrylonitrile.
Methacrylonitrile.
Methyl acrylate.
Methyl methacrylate.
Itaconic acid.
Vinylidene chloride copolymerized with one or more of the following:
Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl
esters.
Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters.
Acrylonitrile.
Methacrylonitrile.
Vinyl chloride.
Itaconic acid.
Styrene-maleic anhydride resin, partial 2-butoxyethyl ester, ammonium
salt (CAS Reg. No. 68890-80-2). For use only as a coating for
polyethylene phthalate films complying with paragraph (a) of this
section, at levels not to exceed 0.025 gram per square meter (0.016
milligram per square inch) of the film, in contact with food of types
VIII and IX in table 1 of Sec. 176.170(c) of this chapter, under use
conditions E, F, and G in table 2 of Sec. 176.170(c) of this chapter.
(iv) Emulsifiers:
Sodium dodecylbenzenesulfonate: As an adjuvant in the application of
coatings to the base sheet or base polymer.
Sodium lauryl sulfate: As an adjuvant in the application of coatings to
the base sheet or base polymer.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For use
only in copolymer coatings on polyethylene phthalate film under
conditions of use E, F, and G described in table 2 of Sec. 175.300(d) of
this chapter, and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
(v) Modifier:
1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-
butanediol and [alpha]-hydro-omega-hydroxypoly(oxy-1,4-butanediyl) CAS
Reg. No. 9078-71-1) meeting the following specifications:
Melting point: 200 deg. to 215 deg.C as determined by ASTM method
D2117-82, "Standard Test Method for Melting Point of Semicrystalline
Polymers by the Hot Stage Microscopy Method," which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
Density: 1.15 to 1.20 as determined by ASTM method D1505-68
(Reapproved 1979), "Standard Test Method for Density of Plastics by the
Density-Gradient Technique," which is incorporated by reference. Copies
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
The modifier is used at a level not to exceed 5 percent by weight of
polyethylene
[[Page 302]]
terephthalate film. The average thickness of the finished film shall not
exceed 0.016 millimeter (0.0006 inch).
Hexanedioic acid polymer with 1,3-benzenedimethanamine (CAS Reg. No.
25718-70-1) meeting the specifications in Sec. 177.1500(b), item 10,
when tested by the methods given in Sec. 177.1500(c). The modifier is
used in polyethylene terephthalate at a level not to exceed 30 percent
by weight of the polyethylene terephthalate.
Chloroform-soluble extractives shall not exceed 0.08 milligram/
centimeter 2 (0.5 milligram/inch 2) of food-
contact surface of the modified polyethylene terephthalate article when
exposed to the following solvents at temperatures and times indicated:
(a) Distilled water at 49 deg.C (120 deg.F) for 24 hours;
(b) n-Heptane at 49 deg.C (120 deg.F) for 24 hours;
(c) 8 percent ethyl alcohol at 49 deg.C (120 deg.F) for 24 hours.
For use in contact with all types of foods except (a) those
containing more than 8 percent alcohol, or (b) those at temperatures
over 49 deg.C (120 deg.F).
(f) Polyethylene phthalate plastics conforming with the
specifications prescribed in paragraph (f)(1) of this section are used
as provided in paragraph (f)(2) of this section:
(1) Specifications. (i) The food contact surface, when exposed to
distilled water at 250 deg.F for 2 hours, yields chloroform-soluble
extractives not to exceed 0.5 mg/in\2\ of food contact surface exposed
to the solvent; and
(ii) The food contact surface, when exposed to n-heptane at 150
deg.F for 2 hours, yields chloroform-soluble extractives not to exceed
0.5 mg/in\2\ of food contact surface exposed to the solvent.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding food, excluding alcoholic beverages, at
temperatures not to exceed 250 deg.F.
(g) Polyethylene phthalate plastics conforming with the
specifications prescribed in paragraph (g)(1) of this section are used
as provided in paragraph (g)(2) of this section.
(1) Specifications. (i) The food contact surface meets the
specifications in paragraph (f)(1) of this section; and
(ii) The food contact surface when exposed to 50 percent ethyl
alcohol at 120 deg.F for 24 hours, yields chloroform-soluble
extractives not to exceed 0.5 mg/in\2\ of food contact surface exposed
to the solvent.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding alcoholic beverages that do not exceed 50
percent alcohol by volume.
(h) Uncoated polyethylene phthalate plastics consisting of a base
sheet or base polymer prepared as prescribed from substances identified
in paragraphs (e)(4)(i) and (ii) of this section and conforming with the
specifications prescribed in paragraph (h)(1) of this section are used
as provided in paragraph (h)(2) of this section:
(1) Specifications. (i) The food contact surface, when exposed to
distilled water at 250 deg.F for 2 hours yields chloroform-soluble
extractives not to exceed 0.02 milligram/inch \2\ of food contact
surface exposed to the solvent; and
(ii) The food contact surface, when exposed to n-heptane at 150
deg.F for 2 hours, yields chloroform-soluble extractives not to exceed
0.02 milligram/inch \2\ of food contact surface exposed to the solvent.
(2) Conditions of use. The plastics are used to contain foods during
oven baking or oven cooking at temperatures above 250 deg.F.
(i) Polyethylene phthalate fabric, identified in paragraph (c) of
this section and conforming with the specifications prescribed in
paragraph (i)(1) of this section, is used only as provided in paragraph
(i)(2) of this section.
(1) Specifications. Chloroform-soluble extractives shall not exceed
0.2 milligram/inch \2\ of food-contact surface when exposed to the
following solvents at temperatures and times indicated:
(i) Distilled water at 212 deg.F for 2 hours.
(ii) n-Heptane at 150 deg.F for 2 hours.
(iii) 50 percent ethyl alcohol at 120 deg.F for 24 hours.
(2) Conditions of use. The plastics are intended for:
(i) Dry food contact.
(ii) Bulk food (excluding alcoholic beverages) repeated use
applications, including filtration, at temperatures not exceeding 212
deg.F.
(iii) Filtration of bulk alcoholic beverages, not exceeding 50
percent alcohol by volume, at temperatures not exceeding 120 deg.F.
[[Page 303]]
(j) Polyethylene phthalate plastics, composed of ethylene
terephthalate-isophthalate containing a minimum of 98 weight percent of
polymer units derived from ethylene terephthalate, or ethylene-1,4-
cyclohexylene dimethylene terephthalate copolyesters described in
Sec. 177.1315(b)(3), conforming with the specifications prescribed in
paragraph (j)(1) of this section, are used as provided in paragraph
(j)(2) of this section.
(1) Specifications. (i) The food contact surface meets the
specifications in paragraph (f)(1) of this section and
(ii)(a) Containers with greater than 500 mL capacity. The food-
contact surface when exposed to 95 percent ethanol at 120 deg.F for 24
hours should not yield chloroform-soluble extractives in excess of 0.005
mg/in \2\.
(b) Containers with less than or equal to 500 mL capacity. The food
contact surface when exposed to 95 percent ethanol at 120 deg.F for 24
hours should not yield chloroform-soluble extractives in excess of 0.05
mg/in \2\.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding alcoholic foods that do not exceed 95 percent
alcohol by volume.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 18611, Apr. 8, 1977; 44
FR 40886, July 13, 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, Mar.
19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 30361, July 1, 1983; 49 FR
10110, Mar. 19, 1984; 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30,
1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, Apr. 19, 1989; 54 FR
24898, June 12, 1989; 60 FR 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1,
1995; 61 FR 46718, Sept. 5, 1996]
[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: 21CFR177.1632]
[Page 303-304]
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. 177.1632 Poly (phenyleneterephthalamide) resins.
Poly(phenyleneterephthalamide) resins identified in paragraph (a) of
this section may be safely used as articles or components of articles
intended for repeated contact with food.
(a) Identity. For the purpose of this section, the poly(phenylene-
terephthalamide) resins (CAS Reg. No. 26125-61-1) are produced by the
polymerization of terephthalolyl chloride with p-phenylenediamine. The
poly(phenyleneterephthalamide) resin fibers and yarns may contain
optional adjuvant substances required in their preparation and
finishing.
(b) Optional adjuvant substances. The poly(phenyleneterephthalamide)
resins identified in paragraph (a) of this section may contain the
following optional adjuvant substances, subject to any limitation on
their use:
(1) Optional adjuvant substances authorized for this use in
accordance with Sec. 174.5 of this chapter.
(2) Optional finish components, total weight not to exceed 1 percent
by weight of the base polymer, as follows:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Diundecylphthalate (CAS Reg. No. 3648-20-
2).
Mono- and dipotassium salts of lauryl
phosphate (CAS Reg. No. 39322-78-6).
o-Phenylphenol (CAS Reg. No. 90-43-7)..... For use as a fungicide for
finish coating materials.
Not to exceed 0.01 percent
by weight of the base
polymer.
Poly(oxyethylene/
oxypropylene)monobutylether (CAS Reg. No.
9038-95-3).
Poly(oxyethylene) mono(nonylphenyl)ether
(CAS Reg. No. 9019-45-9).
Polyvinyl methylether (CAS Reg. No. 9003-
09-2).
Poly(oxyethylene) sorbitol monolaurate
tetraoleate (CAS Reg. No. 71243-28-2).
Poly(oxyethylene) sorbitol hexaoleate (CAS
Reg. No. 57171-56-9).
4,4'-Butylidenebis (6-tert-butyl-m-cresol) For use only as an oxidation
(CAS Reg. No. 85-60-9). inhibitor for finish
coating materials. Not to
exceed 0.01 percent by
weight of the base polymer.
------------------------------------------------------------------------
(c) Specifications. (1) Poly(phenyleneterephthalamide) resins in the
form of continuous filament yarns or fibers that have been scoured in
accordance with paragraph (d)(1) of this section, when refluxed in a 50
percent ethanol/water mixture for 24 hours, yields total extractables
not exceeding 0.5 percent by weight of the sample.
(2) Poly(phenyleneterephthalamide) resins in the form of pulp, when
refluxed in a 50 percent ethanol/water mixture for 24 hours, yields
total extractables not exceeding 0.65 percent by weight of the sample.
(d) Conditions of use. (1) Poly(phenyleneterephthalamide) resins in
the form of continuous filament
[[Page 304]]
yarns and fibers may be used as components of articles intended for
repeated use in contact with food at temperatures not to exceed 260
deg.C (500 deg.F). All items are scoured prior to use by agitation in a
water bath containing 0.5 gram/liter of tetrasodium pyrophosphate and
0.5 percent detergent. The items are agitated at 80 deg.C (180 deg.F)
for 20 minutes, and then subjected to a cold water rinse.
(2) Poly(phenyleneterephthalamide) resins in the form of pulp may be
used as gaskets and packing for food processing equipment at
temperatures not to exceed 260 deg.C (500 deg.F).
[57 FR 3125, Jan. 28, 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: 21CFR177.1635]
[Page 304]
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. 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).
Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene)
identified in 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, poly(p-
methylstyrene) and rubber-modified poly(p-methylstyrene) are basic
polymers, manufactured as described in this paragraph, meeting the
specifications prescribed in paragraph (c) of this section.
(1) Poly(p-methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced
by the polymerization of p-methylstyrene.
(2) Rubber-modified poly(p-methylstyrene) (CAS Reg. No. 33520-88-6)
polymer produced by combining styrene-butadiene copolymer and/or
polybutadiene with poly(p-methylstyrene), either during or after
polymerization of the poly(p-methylstyrene), such that the finished
polymers contain not less than 75 weight percent of total polymer units
derived from p-methylstyrene) monomer.
(b) Optional adjuvants. The basic polymers identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of such basic polymers. Such optional adjuvant substances
may include substances permitted for such use by applicable regulations
in this chapter, substances generally recognized as safe in food,
substances generally recognized as safe in indirect additives, and
substances used in accordance with prior sanction or approval.
(c) Specifications. (1) Poly(p-methylstyrene) basic polymers
identified in paragraph (a)(1) of this section shall contain not more
than 1 weight percent of total residual p-methystyrene monomer, as
determined by a gas chromatographic method titled, "Gas Chromatographic
Determination of PMS and PET in PPMS Basic Polymers," which is
incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, or available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(2) Rubber-modified poly(p-methylstyrene) basic polymers identified
in paragraph (a)(2) of this section shall contain not more than 0.5
weight percent of total residual p-methylstyrene monomer, as determined
by the method identified in paragraph (c)(1) of this section
(d) Other specifications and limitations. The poly(p-methylstyrene)
and rubber-modified poly(p-methylstyrene) identified in and complying
with this section, when used as components of the food-contact surface
of any article that is the subject of a regulation in parts 175, 176,
177, 178 and Sec. 179.45 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.
(e) Conditions of use. Poly(p-methylstyrene) basic polymers and
rubber-modified poly(p-methylstyrene) basic polymers identified in
paragraphs (a)(1) and (a)(2), respectively, of this section shall be
used in contact with food only under conditions of use B through H set
forth in table 2 of Sec. 176.170(c) of this chapter.
[48 FR 31384, July 8, 1983, as amended at 54 FR 24898, June 12, 1989; 55
FR 52989, Dec. 26, 1990]
[[Page 305]]
[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: 21CFR177.1637]
[Page 305]
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. 177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.
Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl)
resins 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 conditions:
(a) Identity. For the purpose of this section, poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No.
24968-11-4) are polymers formed by catalytic transesterification of 2,6-
dimethylnaphthalene dicarboxylate with ethylene glycol followed by
catalytic polycondensation.
(b) Specifications--(1) Density. The density of poly(oxy-1,2-
ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be
between 1.33 and 1.40 grams per cubic centimeter.
(2) Inherent viscosity. The finished food-contact article shall have
a minimum inherent viscosity of 0.55 deciliter per gram in a solution of
0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/
weight) solution of p-chlorophenol/tetrachloroethane/phenol. The
viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-
5, "Determination of Dilute Solution Viscosity of Polyesters," dated
May 31, 1988, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
215), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, or at the Office of the Federal
Register, 800 North Capitol St. NW., Washington, DC.
(c) Extraction limitations. A 0.5 millimeter (0.02 inch) thick sheet
of resin when extracted with water at 121 deg.C (250 deg.F) for 2
hours shall yield total nonvolatile extractives not exceeding 2.0
micrograms per square inch of exposed resin surface.
(d) Conditions of use. The finished food contact article shall be:
(1) Used in contact only with food of Types I, II, IVB, VIA, VIB,
VIIB, and VIII identified in table 1 of Sec. 176.170(c) of this chapter,
under conditions of use A through H described in table 2 of
Sec. 176.170(c) of this chapter; and with food of Types III, IVA, V,
VIC, VIIA, and IX identified in table 1 of Sec. 176.170(c) of this
chapter, under conditions of use C through H described in table 2 of
Sec. 176.170(c) of this chapter; and
(2) Identified in a manner that will differentiate the article from
articles made of other polymeric resins to facilitate collection and
sorting.
[61 FR 14965, Apr. 4, 1996]
[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: 21CFR177.1640]
[Page 305-307]
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. 177.1640 Polystyrene and rubber-modified polystyrene.
Polystyrene and rubber-modified polystyrene identified in 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, polystyrene and
rubber-modified polystyrene are basic polymers manufactured as described
in this paragraph so as to meet the specifications prescribed in
paragraph (c) of this section when tested by the method described in
paragraph (d) of this section.
(1) Polystyrene consists of basic polymers produced by the
polymerization of styrene.
(2) Rubber-modified polystyrene consists of basic polymers produced
by combining styrene-butadiene copolymers and/or polybutadiene with
polystyrene, either during or after polymerization of the polystyrene,
such that the finished basic polymers contain not less than 75 weight
percent of total polymer units derived from styrene monomer.
(b) Optional adjuvants. The basic polymers identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of such basic polymers. Such optional adjuvant substances
may include substances permitted for such use by regulations in parts
170 through 189 of this chapter, substances generally recognized as safe
in food, and
[[Page 306]]
substances used in accordance with a prior sanction or approval.
(c) Specifications. (1) Polystyrene basic polymers identified in
paragraph (a)(1) of this section shall contain not more than 1 weight
percent of total residual styrene monomer, as determined by the method
described in paragraph (d) of this section, except that when used in
contact with fatty foods of Types III, IV-A, V, VII-A, and IX described
in table 1 of Sec. 176.170(c) of this chapter, such polystyrene basic
polymers shall contain not more than 0.5 weight percent of total
residual styrene monomer.
(2) Rubber-modified polystyrene basic polymers identified in
paragraph (a)(2) of this section shall contain not more than 0.5 weight
percent of total residual styrene monomer, as determined by the method
described in paragraph (d) of this section.
(d) Analytical method for determination of total residual styrene
monomer content--(1) Scope. This method is suitable for the
determination of residual styrene monomer in all types of styrene
polymers.
(2) Principle. The sample is dissolved in methylene chloride. An
aliquot of the solution is injected into a gas chromatograph. The amount
of styrene monomer present is determined from the area of the resulting
peak.
(3) Apparatus--(i) Gas chromatograph. Beckman GC-2A gas
chromatograph with hydrogen flame detector or apparatus of equivalent
sensitivity.
(ii) Chromatograph column. One-quarter inch outside diameter
stainless steel tubing (0.028 inch wall thickness), 4 feet in length,
packed with 20 percent polyethylene glycol (20,000 molecular weight) on
alkaline treated 60-80 mesh firebrick.
(iii) Recorder. Millivolt range of 0-1, chart speed of 30 inches per
hour.
(4) Reagents. Compressed air, purified; helium gas; hydrogen gas;
methylene chloride, redistilled; and styrene monomer, redistilled.
(5) Operating conditions for the gas chromatograph. (i) The column
is operated at a temperature of 100 deg.C with a helium flow rate of 82
milliliters per minute.
(ii) The hydrogen burner is operated with 15 pounds per square inch
of air pressure and 7 pounds per square inch of hydrogen pressure.
(iii) The attenuation of the hydrogen flame detector is set at
2x10\2\.
(6) Standardization. (i) Prepare a standard solution by weighing
accurately 15 to 20 milligrams of styrene monomer into a 2-ounce bottle
containing 25.0 milliliters of methylene chloride. Cap the bottle
tightly and shake to thoroughly mix the solution.
(ii) By means of a microliter syringe, inject 1 microliter of the
standard solution into the gas chromatograph. Measure the area of the
styrene monomer peak which emerges after approximately 12 minutes.
(7) Procedure. (i) Transfer 1 gram of sample (accurately weighed to
the nearest 0.001 gram to a 2-ounce bottle and add several glass beads.
Pipette 25.0 milliliters of methylene chloride into the bottle. Cap the
bottle tightly and place on a mechanical shaker. Shake until the polymer
is completely dissolved. If any insoluble residue remains, allow the
bottle to stand (or centrifuge at a low speed) until a clear supernatant
layer appears.
(ii) By means of a microliter syringe, inject 3 microliters of the
clear supernatant liquid into the gas chromatograph.
(iii) Measure the area of the resulting styrene monomer peak.
Compare the sample peak area with the area produced by the standard
styrene monomer solution. Calculation:
Percent residual styrene monomer=Milligrams monomer in standardxpeak
area of sample/Peak area of monomer standardxsample weight in gramsx30
(e) Other specifications and limitations. The polystyrene and
rubber-modified polystyrene identified in and complying with this
section, when used as components of the food-contact surface of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178 and Sec. 179.45 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.
[[Page 307]]
(f) Nonapplicability. The provisions of this section are not
applicable to polystyrene and rubber-modified polystyrene used in food-
packaging adhesives complying with Sec. 175.105 of this chapter.
[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: 21CFR177.1650]
[Page 307]
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. 177.1650 Polysulfide polymer-polyepoxy resins.
Polysulfide polymer-polyepoxy res- ins may be safely used as the
food-contact surface of articles intended for packaging, transporting,
holding, or otherwise contacting dry food, in accordance with the
following prescribed conditions:
(a) Polysulfide polymer-polyepoxy resins are the reaction products
of liquid polysulfide polymers and polyfunctional epoxide resins, cured
with the aid of tri(dimethylaminomethyl) phenol, to which have been
added certain optional substances to impart desired technological
properties to the resins. Subject to any limitations prescribed in this
section, the optional substances may include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in this part, prior sanctions, or approvals.
(3) Substances named in this subparagraph and further identified as
required:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Bis(2-chloroethyl) formal..............
Bis(dichloropropyl) formal............. Cross-linking agent.
Butyl alcohol.......................... Solvent.
Carbon black (channel process).........
Chlorinated paraffins.................. Cross-linking agent.
Epoxidized linseed oil.................
Epoxidized soybean oil.................
Epoxy resins (as listed in Sec.
175.300(b)(3)(viii)(a) of this
chapter)..
Ethylene glycol monobutyl ether........ Solvent.
Magnesium chloride.....................
Methyl isobutyl ketone................. Solvent.
Naphthalene sulfonic acid-formaldehyde
condensate, sodium salt.
Sodium dibutyl naphthalene sulfonate... Wetting agent.
Sodium hydrosulfide....................
Sodium polysulfide.....................
[beta],[beta]',[gamma],[gamma]'- Cross-linking agent.
Tetrachloro normal propyl ether.
Titanium dioxide.......................
Toluene................................ Solvent.
Trichloroethane........................ Cross-linking agent.
1,2,3-Trichloropropane................. Do.
Urea-formaldehyde resins...............
Xylene................................. Solvent.
------------------------------------------------------------------------
(b) The resins are used as the food-contact surface for dry food.
(c) An appropriate sample of the finished resin in the form in which
it contacts food, when subjected to ASTM method D968-81, "Standard Test
Methods for Abrasion Resistance of Organic Coatings by the Falling
Abrasive Tester," which is incorporated by reference (copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408), using No. 50 Emery abrasive in lieu of Ottawa sand, shall
exhibit and abrasion coefficient of not less than 20 liters per mil of
film thickness.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]
[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: 21CFR177.1655]
[Page 307-308]
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. 177.1655 Polysulfone resins.
Polysulfone resins 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) For the purpose of this section, polysulfone resins are:
(1) Poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-
phenyleneisopropylidene-p-phenylene) resins (CAS Reg. No. 25154-01-2)
consisting of basic resins produced when the disodium salt of 4,4'-
isopropylidenediphenol is made to react with 4,4'-dichlorodiphenyl
sulfone in such a way that the finished resins have a minimum number
average molecular weight of 15,000, as determined by osmotic pressure in
monochlorobenzene; or
(2) 1,1'-Sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (minimum 92 percent) and 4,4'-
sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0)
produced when a mixture of 4,4'-isopropylidenediphenol (minimum 92
percent) and 4,4'-sulfonylbis[phenol] (maximum 8 percent) is made to
react with 4,4'-dichlorodiphenyl sulfone in
[[Page 308]]
such a way that the finished resin has a minimum number average
molecular weight of 26,000, as determined by osmotic pressure in
dimethylformamide.
(b) The basic polysulfone resins identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic resins. The optional adjuvant substances
required in the production of the basic polysulfone resins may include
substances described in Sec. 174.5(d) of this chapter and the following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Dimethyl sulfoxide.................... Not to exceed 50 parts per
million as residual solvent in
finished basic resin in
paragraph (a)(1) of this
section.
Monochlorobenzene..................... Not to exceed 500 parts per
million as residual solvent in
finished basic resin in
paragraph (a)(1) of this
section.
N-methyl-2-pyrrolidone................ Not to exceed 0.01 percent (100
parts per million) as residual
solvent in finished basic resin
in paragraph (a)(2) of this
section.
------------------------------------------------------------------------
(c) Polysulfone resins, when extracted at reflux temperatures for 6
hours with the solvents--distilled water, 50 percent (by volume) ethyl
alcohol in distilled water, 3 percent acetic acid in distilled water,
and n-heptane, yield total extractives in each extracting solvent not to
exceed 0.0078 milligram per square centimeter (0.05 milligram per square
inch) of resin surface. Note: In testing the finished polysulfone
resins, use a separate resin test sample for each required extracting
solvent.
(d) Polysulfone resins intended for repeated use in contact with
food may be used under conditions of use A through H in table 2 of
Sec. 176.170(c) of this chapter. The resins intended for single-service
food-contact use may be used only under condition of use H described in
table 2 of Sec. 176.170(c) of this chapter.
[51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 1986; 61 FR 29475, June
11, 1996]
[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: 21CFR177.1660]
[Page 308-309]
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. 177.1660 Poly (tetramethylene terephthalate).
Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter-
ephthaloyl)) [Chemical Abstracts Service Registry No. 24968-12-5]
identified in this section may be safely used as articles or components
of articles intended to contact food, in accordance with the following
prescribed conditions:
(a) Identity. For the purpose of this section, poly (tetramethylene
terephthalate) is the reaction product of dimethyl terephthalate with
1,4-butanediol to which may have been added certain optional substances
to impart desired technological properties to the polymer.
(b) Optional adjuvant substances. Poly(tetramethylene terephthalate)
identified in paragraph (a) of this section may contain optional
adjuvant substances. The quantity of any optional adjuvant substance
employed in the production of the polymer does not exceed the amount
reasonably required to accomplish the intended technical or physical
effect. Such adjuvants may include substances generally recognized as
safe in food, substances used in accordance with prior sanction, and
substances permitted under applicable regulations in this part.
(c) Specifications. (1) Inherent viscosity of a 0.50 percent
solution of the polymer in phenol/tetrachloroethane (60/40 weight ratio)
solvent is not less than 0.6 as determined using a Wagner viscometer (or
equivalent) and calculated from the following equation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.400
where:
NrRatio of flow time of the polymer solution to that of the
solvent and c=polymer concentration of the test solution in grams per
100 milliliters.
(2) Poly(tetramethylene terephthalate) in the finished form in which
it is to contact food shall yield total extractives as follows:
(i) Not to exceed 0.08 milligram per square inch of food contact
surface when extracted for 2 hours at 250 deg.F with distilled water.
(ii) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 150 deg.F with n-heptane.
(iii) Not to exceed 0.04 milligram per square inch of food contact
surface when extracted for 2 hours at 212 deg.F with 3 percent aqueous
acetic acid.
[[Page 309]]
(iv) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 65.6 deg.C (150 deg.F) with 50
percent ethanol.
[42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985; 52
FR 20069, May 29, 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: 21CFR177.1670]
[Page 309]
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. 177.1670 Polyvinyl alcohol film.
Polyvinyl alcohol film may be safely used in contact with food of
the types identified in Sec. 176.170(c) of this chapter, table 1, under
Types V, VIII, and IX, in accordance with the following prescribed
conditions:
(a) The polyvinyl alcohol film is produced from polyvinyl alcohol
having a minimum viscosity of 4 centipoises when a 4-percent aqueous
solution is tested at 20 deg.C.
(b) The finished food-contact film for use in contact with Food
Types V or IX, when extracted with the solvent characterizing the type
of food and under the conditions of time and temperature characterizing
its intended use as determined from tables 1 and 2 of Sec. 176.170(c) of
this chapter, yields total extractives not to exceed 0.078 milligram per
square centimeter (0.5 milligram per square inch) of food-contact
surface when tested by ASTM method F34-76 (Reapproved 1980), "Standard
Test Method for Liquid Extraction of Flexible Barrier Materials," which
is incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) The finished food-contact film shall not be used as a component
of food containers intended for use in contact with water.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]
[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: 21CFR177.1680]
[Page 309-310]
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. 177.1680 Polyurethane resins.
The polyurethane resins identified in paragraph (a) of this section
may be safely used as the food-contact surface of articles intended for
use in contact with bulk quantities of dry food of the type identified
in Sec. 176.170(c) of this chapter, table 1, under Type VIII, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, polyurethane resins are those
produced when one or more of the isocyanates listed in paragraph (a)(1)
of this section is made to react with one or more of the substances
listed in paragraph (a)(2) of this section:
(1) Isocyanates:
Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4).
Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2).
4,4'-Diisocyanato-3,3'-dimethylbiphenyl (bi-tolylene diisocyanate).
Diphenylmethane diisocyanate.
Hexamethylene diisocyanate.
3-Isocyanatomethyl - 3,5,5 - trimethylcyclohexyl isocyanate.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate.
(2) List of substances:
Adipic acid.
1,4-Butanediol.
1,3-Butylene glycol.
1,4-Cyclohexane dimethanol (CAS Reg. No. 105-08-8).
2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6-Hexanediol (CAS Reg. No. 629-11-8).[alpha]-Hydro-[omega]-
hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1).
[alpha]-Hydro-omega-hydroxypoly (oxytetramethylene).
[alpha],[alpha]'-(Isopropylidenedi-p-phenylene)bis[omega-hydroxypoly
(oxypropylene)(3-4 moles)], average molecular weight 675.
Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS Reg. No. 9003-11-6).
Methyl oxirane polymer with oxirane, ether with 1,2,3-propanetriol (CAS
Reg. No. 9082-00-2).
[alpha],[alpha]'[alpha][dprime],[alpha][dprime]'-
Neopentanetetrayltetrakis [omega-hydroxypoly (oxypropylene) (1-2
moles)], average molecular weight 400.
Pentaerythritol-linseed oil alcoholysis product.
Phthalic anhydride.
Polybutylene glycol.
Polyethyleneadipate modified with ethanolamine with the molar ratio of
the amine to the adipic acid less than 0.1 to 1.
Poly(oxycarbonylpentamethylene).
Polyoxypropylene ethers of 4.4'-isopropyl-idenediphenol (containing an
average of 2-4 moles of propylene oxide).
Polypropylene glycol.
[alpha],[alpha]',[alpha][dprime]-1,2,3-Propanetriyltris [omega-
hydroxypoly (oxypropylene) (15-18 moles)], average molecular weight
3,000.
Propylene glycol.
[[Page 310]]
[alpha],[alpha]',[alpha][dprime]-[Propylidynetris (methylene)] tris
[omega-hydroxypoly (oxypropylene) (minimum 1.5 moles)], minimum
molecular weight 400.
[alpha]-[[rho](1,1,3,3-Tetramethylbutyl) - phenyl]-omega-
hydroxypoly(oxyethylene) (5 moles), average molecular weight 425.
Trimethylol propane.
(b) Optional adjuvant substances employed in the production of the
polyurethane resins or added thereto to impart desired technical or
physical properties may include the following substances:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
1-[(2-Aminoethyl)amino]2-propanol...... As a curing agent.
1-(3-Chloroallyl)-3,5,7-triaza-1- As a preservative.
azoniaadamantane chloride.
Colorants used in accordance with Sec.
178.3297 of this chapter..
Dibutyltin diacetate................... As a catalyst.
Dibutyltin dichloride.................. Do.
Dibutyltin dilaurate................... Do.
N,N-Dimethyldodecylamine............... Do.
N-Dodecylmorpholine.................... Do.
a,a'-[Isopropylidenebis[p- As a stabilizer.
phenyleneoxy(2-hydroxytrimethylene)
]]bis[omega-hydroxypoly-(oxyethylene)
(136-170 moles)], average molecular
weight 15,000.
4,4'-Methylenedianiline................ As a curing agent.
1,1',1[dprime]-Nitrilotri-2-propanol... Do.
2,2'-(p-Phenylenedioxy) diethanol...... Do.
Polyvinyl isobutyl ether...............
Polyvinyl methyl ether.................
Soyaalkyd resin........................ Conforming in composition with
Sec. 175.300 of this chapter
and containing litharge not to
exceed that residual from its
use as the reaction catalyst
and creosol not to exceed that
required as an antioxidant.
Tetrakis [methylene-(2,5-di-tert-butyl- Stabilizer.
4-hydroxyhydrocinnamate)]methane (CAS
Reg. No. 6683-19-8).
N,N,N'N'-Tetrakis (2- As a curing agent.
hydroxypropyl)ethylenediamine.
Triethanolamine........................ Do.
Trimethyleneglycol di (p-aminobenzoate) As a curing agent.
(CAS Reg. No. 57609-64-0).
------------------------------------------------------------------------
(c) An appropriate sample of the finished resin in the form in which
it contacts food, when subjected to ASTM method D968-81, "Standard Test
Methods for Abrasion Resistance of Organic Coatings by the Falling
Abrasive Tester," which is incorporated by reference (copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408), using No. 50 Emery abrasive in lieu of Ottawa sand, shall
exhibit an abrasion coefficient of not less than 20 liters per mil of
film thickness.
[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 57033, Nov. 20, 1981;
49 FR 10110, Mar. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278,
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991]
[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: 21CFR177.1810]
[Page 310-312]
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. 177.1810 Styrene block polymers.
The styrene block polymers identified in paragraph (a) of this
section may be safely used as articles or as components of articles
intended for use in contact with food, subject to provisions of this
section.
(a) For the purpose of this section, styrene block polymers are
basic polymers manufactured as described in this paragraph, so that the
finished polymers meet the specifications prescribed in paragraph (b) of
this section, when tested by the methods described in paragraph (c) of
this section.
(1) Styrene block polymers with 1,3-butadiene are those produced by
the catalytic solution polymerization of styrene and 1,3-butadiene.
(2) Styrene block polymers with 2-methyl-1,3-butadiene are those
produced by the catalytic solution polymerization of styrene and 2-
methyl-1,3-butadiene.
(3) Styrene block polymers with 1,3-butadiene, hydrogenated are
those produced by the catalytic solution polymerization of styrene and
1,3-butadiene, and subsequently hydrogenated.
(b) Specifications:
[[Page 311]]
----------------------------------------------------------------------------------------------------------------
Maximum Maximum
extractable extractable
fraction in fraction in 50
Molecular Glass distilled water percent ethanol
Styrene block polymers weight Solubility transition at specified at specified
(minimum) points temperatures, temperatures,
times, and times, and
thicknesses thicknesses
----------------------------------------------------------------------------------------------------------------
1. (i) Styrene block polymers 29,000 Completely -98 deg.C (- 0.0039 mg/cm\2\ 0.002 mg/cm\2\
with 1,3-butadiene; for use as soluble in 144 deg.F) (0.025 mg/in\2\) (0.01 mg/in\2\)
articles or as components of toluene. to -71 of surface at of surface at 66
articles that contact food of deg.C (-96 reflux deg.C (150
Types I, II, IV-B, VI, VII-B, deg.F) and temperature for deg.F) for 2 hr
and VIII identified in table 1 86 deg.C 30 min on a 0.19 on a 0.19 cm
in Sec. 176.170(c) of this (187 deg.F) cm (0.075 in) (0.075 in) thick
chapter under conditions of to 122 thick sample. sample.
use D, E, F, and G described deg.C (252
in table 2 in Sec. 176.170(c) deg.F).
of this chapter.
(ii) Styrene block polymers 29,000 ......do...... ......do..... ......do......... Do.
with 1,3-butadiene; for use as
components of pressure-
sensitive adhesives that
contact food of Types I, II,
IV-B, VI, VII-B, and VIII
identified in table 1 in Sec.
176.170(c) of this chapter
under conditions of use C, D,
E, F and G described in table
2 in Sec. 176.170(c) of this
chapter, provided the pressure-
sensitive adhesives be applied
only to closure tapes for
sealing containers having a
capacity of not less than 160
cc (5.5 fluid ounces) and that
the area of the adhesive
exposed to food shall not
exceed 4.03 cm\2\ (0.625
in\2\). The pressure-sensitive
adhesive may contain terpene
resins as identified in Sec.
175.125(b)(2) of this chapter.
2. Styrene block polymers with 29,000 ......do...... -65 deg.C (- 0.002 mg/cm\2\ 0.002 mg/cm\2\
2-methyl-1,3-butadiene; for 85 deg.F) (0.01 mg/in\2\) (0.01 mg/in\2\)
use as articles or as to -47 of surface at of surface at 66
components of articles that deg.C (-53 reflux deg.C (150
contact food of Types I, II, deg.F) and temperature for deg.F) for 2 hr
IV-B, VI, VII-B, and VIII 86 deg.C 2 hr on a 0.071 on a 0.071 cm
identified in table 1 in Sec. (187 deg.F) cm (0.028 in) (0.028 in) thick
176.170(c) of this chapter. to 122 thick sample. sample.
deg.C (252 (Optionally, (Optionally,
deg.F). maximum net maximum net
residue soluble residue soluble
in chloroform in chloroform
shall not exceed shall not exceed
0.00020 mg/cm\2\ 0.00040 mg/cm\2\
(0.0013 mg/ (0.0025 mg/
in\2\) of in\2\) of
surface.). surface.)
3. (i) Styrene block polymers 16,000 ......do...... -50 deg.C (- 0.002 mg/cm\2\ 0.002 mg/cm\2\
with 1,3-butadiene, 58 deg.F) (0.01 mg/in\2\) (0.01 mg/in\2\)
hydrogenated (CAS Reg. No. to -30 of surface at of surface at 66
66070-58-4): for use as deg.C (-22 reflux deg.C (150
articles or as components of deg.F) and temperature for deg.F) for 2 hr
articles that contact food of 92 deg.C 2 hr on a 0.071 on a 0.071 cm
Types I, II, IV-B, VI, VII-B, (198 deg.F) cm (0.028 in) (0.028 in) thick
and VIII identified in table 1 to 98 deg.C thick sample. sample.
in Sec. 176.170(c) of this (208 deg.F).
chapter.
(ii) Styrene block polymers 16,000 ......do...... ......do..... ......do......... Do.
with 1,3-butadiene,
hydrogenated (CAS Reg. No.
66070-58-4): for use at levels
not to exceed 42.4 percent by
weight as a component of
closures with sealing gaskets
that would contact food of
Types III, IV-A, V, VII-A,
VIII, and IX identified in
table 1 in Sec. 176.170(c) of
this chapter, and in condition
of use D as described under
table 2 in Sec. 176.170(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
(c) The analytical methods for determining whether styrene block
polymers conform to the specifications prescribed in this section are as
follows and are applicable to the finished polymer.
[[Page 312]]
(1) Molecular weight. Molecular weight shall be determined by
intrinsic viscosity (or other suitable method).
(2) Glass transition points. The glass transition points shall be
determined by either of the following methods:
(i) ASTM method D2236-70 ("Standard Method of Test for Dynamic
Mechanical Properties of Plastics by Means of Torsional Pendulum,"
which is incorporated by reference; copies are available from American
Society for Testing and Materials (ASTM), 1916 Race Street,
Philadelphia, PA 19103, or available for inspection at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC 20408) modified by using a forced resonant vibration instead of a
fixed vibration and by using frequencies of 25 to 40 cycles per second
instead of 0.1 to 10 cycles per second.
(ii) Direct reading viscoelastometric method titled "Direct Reading
Viscoelastrometric Method for Determining Glass Transition Points of
Styrene Block Polymers" (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), by which the glass transition points are determined in the
tensile mode of deformation at a frequency of 35 hertz using a
Rheovibron Model DDV-II (or equivalent) Direct Reading Viscoelastometer.
Take maxima in the out-of-phase component of the complex modulus as the
glass transition points. For block polymers of low styrene content or
for simple block polymers, the polymer may be treated with 0.3 part per
hundred dicumyl peroxide and cured for 30 minutes at 153 deg.C to
accentuate the upper transition point.
(3) Maximum extractable fractions in distilled water and 50 percent
ethanol and the maximum net residue solubles in chloroform. The maximum
extractable fractions in distilled water and 50 percent ethanol, and the
maximum net residue solubles in chloroform, shall be determined in
accordance with Sec. 176.170(d)(3) of this chapter using a sandwich form
of the finished copolymer of the specified thickness and for the time
and temperature specified in paragraph (b) of this section.
(d) The provisions of this section are not applicable to butadiene-
styrene copolymers listed in other sections of this subpart.
(e) The provisions of this section are not applicable to styrene
block polymers with 1,3-butadiene listed in Sec. 175.105 of this
chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 42 FR 43621, Aug. 30, 1977;
47 FR 11844, Mar. 19, 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, June
12, 1989; 58 FR 65546, Dec. 15, 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: 21CFR177.1820]
[Page 312-313]
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. 177.1820 Styrene-maleic anhydride copolymers.
Styrene-maleic anhydride 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, subject to provisions of this
section.
(a) For the purpose of this section, styrene-maleic anhydride
copolymers are those produced by the polymerization of styrene and
maleic anhydride so that the finished polymers meet the specifications
prescribed in paragraph (b) of this section, when tested by the methods
described in paragraph (c) of this section.
(b) Specifications:
[[Page 313]]
----------------------------------------------------------------------------------------------------------------
Maximum Maximum
extractable extractable
Molecular Residual fraction in fraction in n-
weight Residual maleic distilled water heptane at
Styrene-maleic copolymers (minimum styrene anhydride at specified specified
number monomer monomer temperatures, temperatures,
average) times, and times, and
particle size particle size
----------------------------------------------------------------------------------------------------------------
1. Styrene-maleic anhydride 70,000 0.3 weight 0.1 weight 0.006 weight 0.02 weight
copolymers containing not more percent. percent. percent at percent at 73
than 15 pct maleic anhydride reflux deg.F for 2 hr
units by weight; for use as temperature for utilizing
articles or as components of 1 hr utilizing particles of a
articles that contact food of particles of a size that will
Types I, II, III, IV-A, IV-B, size that will pass through a
V, VI-B (except carbonated pass through a U.S. standard
beverages), VII-A, VII-B, U.S. standard sieve No. 10 and
VIII, and IX identified in sieve No. 10 and will be held on
table 1 in Sec. 176.170(c) of will be held on a U.S. standard
this chapter under conditions a U.S. standard sieve No. 20.
of use B, C, D, E, F, G, and H sieve No. 20.
described in table 2 in Sec.
176.170(c) of this chapter.
2. Styrene-maleic anhydride .......... 0.3........... 0.1.......... 0.015 weight 1.0 weight
copolymer modified with percent at percent at 23
butadiene, (CAS Reg. No. 27288- reflux deg.C (73
99-9) containing not more than temperature for deg.F) for 2
15 percent maleic anhydride 1 hour utilizing hours utilizing
units by weight and not more particles of a particles of a
than 20 percent styrene- size that will size that will
butadiene and/or butadiene pass through a pass through a
rubber units by weight; for U.S. standard U.S. standard
use (except carbonated sieve No. 10 and sieve No. 10 and
beverage bottles) as articles will be held on will be held on
or as components of articles a U.S. standard a U.S. standard
that contact food of Types I, sieve No. 20. sieve No. 20.
II, III, IV-A, IV-B, V, VI,
VII-A, VII-B, VIII, and IX
identified in table I in Sec.
176.170(c) of this chapter
under conditions of use B, C,
D, E, F, G, and H described in
table 2 in Sec. 176.170(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
(c) The analytical methods for determining conformance with
specifications for styrene-maleic anhydride copolymers prescribed in
this section are as follows:
(1) Molecular weight. Molecular weight shall be determined by
membrane osmometry.
(2) Residual styrene monomer content. Residual styrene monomer
content shall be determined by the method described in Sec. 177.1640(d).
(3) Residual maleic anhydride monomer content. Residual maleic
anhydride monomer content shall be determined by a gas chromatographic
method titled "Determination of Residual Maleic Anhydride in Polymers
by Gas Chromatography," 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) The provisions of this section are not applicable to styrene-
maleic anhydride copolymers listed in other sections of this subpart.
[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982;
47 FR 14698, Apr. 6, 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: 21CFR177.1830]
[Page 313-314]
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. 177.1830 Styrene-methyl methacrylate copolymers.
Styrene-methyl methacrylate copolymers identified in this section
may be safely used as components of plastic articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, styrene-methyl methacrylate
copolymers consist of basic copolymers produced by the copolymerization
of styrene and methyl methacrylate such that the finished basic
copolymers contain more than 50 weight percent of polymer units derived
from styrene.
(b) The finished plastic food-contact article, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of
intended use as determined from tables 1 and 2 of Sec. 176.170(c)
[[Page 314]]
of this chapter, yields extractives not to exceed the following when
tested by the methods prescribed in Sec. 177.1010(c);
(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 0.40.
[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: 21CFR177.1850]
[Page 314]
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. 177.1850 Textryls.
Textryls identified in this section may be safely used as articles
or components of articles, intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting or
holding food, subject to the provisions of this section.
(a) Textryls are nonwoven sheets prepared from natural or synthetic
fibers, bonded with fibryl (Fibryl consists of a polymeric resin in
fibrous form commingled with fiber to facilitate sheet formation and
subsequently heat cured to fuse the fibryl and effect bonding).
(b) Textryls are prepared from the fibers, fibryls, and adjuvants
identified in paragraph (c) of this section, and subject to limitations
prescribed in that paragraph, provided that any substance that is the
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45
of this chapter conforms with any specifications in such regulation for
that substance as a component of polymeric resins used as food contact
surfaces.
(c) The fibers, fibryls, and adjuvants permitted are as follows:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
(1) Fibers prepared from polyethylene Conforming with Sec.
terephthalate resins. 177.1630.
(2) Fibryls prepared from vinyl chloride- As the basic polymer.
vinyl acetate copolymer.
(3) Adjuvant substance, dimethylformamide. As a solvent in the
preparation of fibryl.
------------------------------------------------------------------------
(d) Textryls meeting the conditions of test prescribed in paragraph
(d)(1) of this section are used as prescribed in paragraph (d)(2) of
this section.
(1) Conditions of test. Textryls, when extracted with distilled
water at reflux temperature for 1 hour, yield total extractives not to
exceed 1 percent.
(2) Uses. Textryls are used for packaging or holding food at
ordinary temperatures and in the brewing of hot beverages.
[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: 21CFR177.1900]
[Page 314]
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. 177.1900 Urea-formaldehyde resins in molded articles.
Urea-formaldehyde resins may be safely used as the food-contact
surface of molded articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, urea-formaldehyde resins are
those produced when 1 mole of urea is made to react with not more than 2
moles of formaldehyde in water solution.
(b) The resins may be mixed with refined wood pulp and the mixture
may contain other optional adjuvant substances which may include the
following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Hexamethylenetetramine.................... For use only as
polymerization-control
agent.
Tetrachlorophthalic acid anhydride........ Do.
Zinc stearate............................. For use as lubricant.
------------------------------------------------------------------------
(c) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from tables 1 and 2 of Sec. 175.300(d) of
this chapter, yields total extractives in each extracting solvent not to
exceed 0.5 milligram per square inch of food-contact surface as
determined by the methods described in Sec. 175.300(e) of this chapter.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
[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: 21CFR177.1950]
[Page 314-317]
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. 177.1950 Vinyl chloride-ethylene copolymers.
The vinyl chloride-ethylene copolymers identified in paragraph (a)
of this section may be safely used as components of articles intended
for contact with food, under conditions of use D, E,
[[Page 315]]
F, or G described in table 2 of Sec. 176.170 (c) of this chapter,
subject to the provisions of this section.
(a) For the purpose of this section, vinyl chloride-ethylene
copolymers consist of basic copolymers produced by the copolymerization
of vinyl chloride and ethylene such that the finished basic copolymers
meet the specifications and extractives limitations prescribed in
paragraph (c) of this section, when tested by the methods described in
paragraph (d) of this section.
(b) The basic vinyl chloride-ethylene copolymers identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic copolymers. The optional
adjuvant substances required in the production of the basic vinyl
chloride-ethylene copolymers may include substances permitted for such
use by regulations in parts 170 through 189 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) The vinyl chloride-ethylene basic copolymers meet the following
specifications and extractives limitations:
(1) Specifications. (i) Total chlorine content is in the range of 53
to 56 percent as determined by any suitable analytical procedure of
generally accepted applicability.
(ii) Intrinsic viscosity in cyclohexanone at 30 deg.C is not less
than 0.50 deciliter per gram as determined by ASTM method D1243-79,
"Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods described in paragraph (d) of this
section:
(i) Total extractives do not exceed 0.10 weight-percent when
extracted with n-heptane at 150 deg.F for 2 hours.
(ii) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 deg.F for 2 hours.
(iii) Total extractives obtained by extracting with water at 150
deg.F for 2 hours contain no more than 0.5 milligram of vinyl chloride-
ethylene copol-ymer per 100 grams of sample tested as determined from
the organic chlorine content. The organic chlorine content is determined
as described in paragraph (d)(3) of this section.
(d) Analytical methods: The analytical methods for determining
whether vinyl chloride-ethylene basic copolymers conform to the
extractives limitations prescribed in paragraph (c) of this section are
as follows and are applicable to the basic copolymers in powder form
having a particle size such that 100 percent will pass through a U.S.
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard
Sieve No. 80:
(1) Reagents--(i) Water. All water used in these procedures shall be
demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. All determinations
shall be done in duplicate using duplicate blanks. Approximately 400
grams of sample (accurately weighed) shall be placed in a 2-liter
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask
with aluminum foil. The covered flask and contents are suspended in a
thermostated bath and are kept, with continual shaking at 150 deg.F for
2 hours. The solution is then filtered through a No. 42 Whatman filter
paper, and the filtrate is collected in a graduated cylinder. The total
amount of filtrate (without washing) is measured and called A
milliliters. The filtrate is transferred to a Pyrex (or equivalent)
beaker and evaporated on a steam bath under a stream of nitrogen to a
small volume (approximately 50-60 milliliters). The concentrated
filtrate is then quantitatively transferred to a tared 100-milliliter
Pyrex beaker using small, fresh portions of solvent and a rubber
policeman to effect the transfer. The concentrated filtrate is
evaporated almost to dryness on a hotplate under nitrogen, and is then
transferred to a drying oven at 230 deg.F in the case of the aqueous
extract or to a vacuum oven at
[[Page 316]]
150 deg.F in the case of the heptane extract. In the case of the
aqueous extract, the evaporation to constant weight is completed in 15
minutes at 230 deg.F; and in the case of heptane extract, it is
overnight under vacuum at 150 deg.F. The residue is weighed and
corrected for the solvent blank. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.401
(3) Vinyl chloride-ethylene copolymer content of aqueous extract--
(i) Principle. The vinyl chloride-ethylene copolymer content of the
aqueous extract can be determined by determining the organic chlorine
content and calculating the amount of copolymer equivalent to the
organic chlorine content.
(ii) Total organic chlorine content. A weighed sample of
approximately 400 grams is extracted with 1,200 milliliters of water at
150 deg.F for 2 hours, filtered, and the volume of filtrate is measured
(A milliliters) as described in paragraph (d)(2) of this section.
(a) A slurry of Amberlite IRA-400, or equivalent, is made with
distilled water in a 150-milliliter beaker. The slurry is added to a
chromatographic column until it is filled to about half its length. This
should give a volume of resin of 15-25 milliliters. The liquid must not
be allowed to drain below the top of the packed column.
(b) The column is regenerated to the basic (OH) form by slowly
passing through it (10-15 milliliters per minute) 10 grams of sodium
hydroxide dissolved in 200 milliliters of water. The column is washed
with distilled water until the effluent is neutral to phenolphthalein.
One drop of methyl red indicator is added to the A milliliters of
filtered aqueous extract and, if on the basic side (yellow), nitric acid
is added drop by drop until the solution turns pink.
(c) The extract is deionized by passing it through the exchange
column at a rate of 10-15 milliliters per minute. The column is washed
with 200 milliliters of distilled water. The deionized extract and
washings are collected in a 1,500-milliliter beaker. The solution is
evaporated carefully on a steam plate to a volume of approximately 50
milliliters and then transferred quantitatively, a little at a time, to
a clean 22-milliliter Parr cup, also on the steam plate. The solution is
evaporated to dryness. Next 0.25 gram of sucrose and 0.5 gram of benzoic
acid are added to the cup. One scoop (approximately 15 grams) of sodium
peroxide is then added to the cup. The bomb is assembled and ignition is
conducted in the usual fashion.
(d) After the bomb has cooled, it is rinsed thoroughly with
distilled water and disassembled. The top of the bomb is rinsed into a
250-milliliter beaker with distilled water. The beaker is placed on the
steam plate. The bomb cup is placed in the beaker and carefully tipped
over to allow the water to leach out the combustion mixture. After the
bubbling has stopped, the cup is removed from the beaker and rinsed
thoroughly. The solution is cooled to room temperature and cautiously
neutralized with concentrated nitric acid by slowly pouring the acid
down a stirring rod until the bubbling ceases. The solution is cooled
and an equal volume of acetone is added.
(e) The solution is titrated with 0.005 N silver nitrate using
standard potentiometric titration techniques with a silver electrode as
indicator and a potassium nitrate modified calomel electrode as a
reference electrode. An expanded scale recording titrimeter. Metrohm
Potentiograph 2336 or equivalent, should be used; a complete blank must
be run in duplicate.
(iii) Calculations.
[[Page 317]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.402
where:
T=Milliliters of silver nitrate (sample minus blank)xnormality of silver
nitrate.
F=1,200/A (as defined above)
(e) The vinyl chloride-ethylene copolymers identified in and
complying with this section, when used as components of the food-contact
surface of any article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and Sec. 179.45 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.
(f) The provisions of this section are not applicable to vinyl
chloride-ethylene copolymers used as provided in Secs. 175.105 and
176.180 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19, 1984]
[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: 21CFR177.1960]
[Page 317]
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. 177.1960 Vinyl chloride-hexene-1 copolymers.
The vinyl chloride-hexene-1 copolymers identified in paragraph (a)
of this section or as components of articles intended for use in contact
with food, under conditions of use D, E, F, or G described in table 2 of
Sec. 176.170(c) of this chapter, subject to the provisions of this
section.
(a) Identity. For the purposes of this section vinyl chloride-
hexene-1 copolymers consist of basic copolymers produced by the
copolymerization of vinyl chloride and hexene-1 such that the finished
copolymers contain not more than 3 mole-percent of polymer units derived
from hexene-1 and meet the specifications and extractives limitations
prescribed in paragraph (b) of this section. The copolymers may
optionally contain hydroxypropyl methylcellulose and trichloroethylene
used as a suspending agent and chain transfer agent, respectively, in
their production.
(b) Specifications and limitations. The vinyl chloride-hexene-1
basic copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Total chlorine content is 53 to 56 percent
as determined by any suitable analytical procedure of generally accepted
applicability.
(ii) Inherent viscosity in cyclohexanone at 30 deg.C is not less
than 0.59 deciliters per gram as determined by ASTM method D1243-79,
"Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods prescribed in Sec. 177.1970(d).
(i) Total extractives do not exceed 0.01 weight percent when
extracted with water at 150 deg.F for 2 hours.
(ii) Total extractives do not exceed 0.30 weight percent when
extracted with n-heptane at 150 deg.F for 2 hours.
(c) Other specifications and limitations. The vinyl chloride-hexene-
1 copolymers identified in and complying with this section, when used as
components of the food-contact surface of any article that is subject to
a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45 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, as amended at 49 FR 10110, Mar. 19, 1984]
[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: 21CFR177.1970]
[Page 317-318]
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. 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
The vinyl chloride-lauryl vinyl ether copolymers identified in
paragraph (a) of this section may be used as an article or as a
component of an article intended for use in contact with food subject to
the provisions of this section.
[[Page 318]]
(a) Identity. For the purposes of this section vinyl chloride-lauryl
vinyl ether copolymers consist of basic copolymers produced by the
copolymerization of vinyl chloride and lauryl vinyl ether such that the
finished copolymers contain not more than 3 weight-percent of polymer
units derived from lauryl vinyl ether and meet the specifications and
extractives limitations prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. The basic vinyl chloride-lauryl
vinyl ether copolymers identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of such
basic copolymers. These optional adjuvant substances may include
substances permitted for such use by regulations in parts 170 through
189 of this chapter, substances generally recognized as safe in food,
and substances used in accordance with a prior sanction or approval.
(c) Specifications and limitations. The vinyl chloride-lauryl vinyl
ether basic copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Total chlorine content is 53 to 56 percent
as determined by any suitable analytical procedure of generally accepted
applicability.
(ii) Inherent viscosity in cylcoHhexanone at 30 deg.C is not less
than 0.60 deciliter per gram as determined by ASTM method D1243-79,
"Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Extractives limitations. The following extractives limitations
are determined by the method described in paragraph (d) of this section:
(i) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 deg.F for 2 hours.
(ii) Total extractives do not exceed 0.60 weight-percent when
extracted with n-heptane at 150 deg.F for 2 hours.
(d) Analytical methods. The analytical methods for determining total
extractives are applicable to the basic copolymers in powder form having
a particle size such that 100 percent will pass through a U.S. Standard
Sieve No. 40 and such that not more than 10 percent will pass through a
U.S. Standard Sieve No. 200.
(1) Reagents--(i) Water. All water used in these procedures shall be
demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. Place an
accurately weighed sample of suitable size in a clean borosilicate
flask, and for each gram of sample add 3 milliliters of solvent
previously heated to 150 deg.F. Maintain the temperature of the
contents of the flask at 150 deg.F for 2 hours using a hot plate while
also maintaining gentle mechanical agitation. Filter the contents of the
flask rapidly through No. 42 Whatman filter paper with the aid of
suction. Transfer the filtrate to flat glass dishes that are warmed on a
hot plate and evaporate the solvent with the aid of a stream of filtered
air. When the volume of the filtrate has been reduced to 10 to 15
milliliters, transfer the filtrate to tared 50-milliliter borosilicate
glass beakers and complete evaporation to a constant weight in a 140
deg.F vacuum oven. Carry out a corresponding blank determination with
each solvent. Determine the weight of the residue corrected for the
solvent blank and calculate the result as percent of the initial weight
of the resin sample taken for analysis.
(e) Other specifications and limitations. The vinyl chloride-lauryl
vinyl ether copolymers identified in and complying with this section,
when used as components of the food-contact surface of any article that
is subject to a regulation in parts 174, 175, 176, 177, 178 and
Sec. 179.45 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, as amended at 49 FR 10110, Mar. 19, 1984]
[[Page 319]]
[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: 21CFR177.1980]
[Page 319-321]
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. 177.1980 Vinyl chloride-propylene copolymers.
The vinyl chloride-propylene copolymers identified in paragraph (a)
of this section may be safely used as components of articles intended
for contact with food, subject to the provisions of this section.
(a) For the purpose of this section, vinyl chloride-propylene
copolymers consist of basic copolymers produced by the copolymezation of
vinyl chloride and propylene such that the finished basic copolymers
meet the specifications and extractives limitations prescribed in
paragraph (c) of this section, when tested by the methods described in
paragraph (d) of this section.
(b) The basic vinyl chloride-propylene copolymers identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic copolymers. The optional
adjuvant substances required in the production of the basic vinyl
chloride-propylene copolymers may include substances permitted for such
use by regulations in parts 170 through 189 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) The vinyl chloride-propylene basic copolymers meet the following
specifications and extractives limitations:
(1) Specifications. (i) Total chlorine content is in the range of 53
to 56 percent as determined by any suitable analytical procedure of
generally accepted applicability.
(ii) Intrinsic viscosity in cyclohexanone at 30 deg.C is not less
than 0.50 deciliter per gram as determined by ASTM method D1243-79,
"Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods described in paragraph (d) of this
section:
(i) Total extractives do not exceed 0.10 weight-percent when
extracted with n-heptane at 150 deg.F for 2 hours.
(ii) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 deg.F for 2 hours.
(iii) Total extractives obtained by extracting with water at 150
deg.F for 2 hours contain no more than 0.17 milligram of vinyl chloride-
propylene copolymer per 100 grams of sample tested as determined from
the organic chlorine content. For the purpose of this section, the
organic chlorine content is the difference between the total chlorine
and ionic chlorine contents determined as described in paragraph (d) of
this section.
(d) Analytical methods: The analytical methods for determining
whether vinyl chloride-propylene basic copolymers conform to the
extractives limitations prescribed in paragraph (c) of this section are
as follows and are applicable to the basic copolymers in powder form
having a particle size such that 100 percent will pass through a U.S.
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard
Sieve No. 80:
(1) Reagents--(i) Water. All water used in these procedures shall be
demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. All determinations
shall be done in duplicate using duplicate blanks. Approximately 400
grams of sample (accurately weighed) shall be placed in a 2-liter
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask
with aluminum foil. The covered flask and contents are suspended in a
thermostated bath and are kept, with continual shaking, at 150 deg.F
for 2 hours. The solution is then filtered through a No. 42 Whatman
filter paper, and the filtrate is collected in a graduated cylinder. The
total amount of filtrate (without washing) is measured and called A
milliliters. The filtrate is transferred to a Pyrex (or equivalent)
beaker and evaporated on a steam bath under a stream of nitrogen to a
small volume (approximately 50-60 milliliters). The concentrated
filtrate is then quantitatively transferred to a
[[Page 320]]
tared 100-milliliter Pyrex beaker using small, fresh portions of solvent
and a rubber policeman to effect the transfer. The concentrated filtrate
is evaporated almost to dryness on a hotplate under nitrogen, and is
then transferred to a drying oven at 230 deg.F in the case of the
aqueous extract or to a vacuum oven at 150 deg.F in the case of the
heptane extract. In the case of the aqueous extract the evaporation to
constant weight is completed in 15 minutes at 230 deg.F; and in the
case of heptane extract, it is overnight under vacuum at 150 deg.F. The
residue is weighed and corrected for the solvent blank. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.403
(3) Vinyl chloride-propylene copolymer content of aqueous extract--
(i) Principle. The vinyl chloride-propylene copolymer content of the
aqueous extract can be determined by determining the organic chlorine
content and calculating the amount of copolymer equivalent to the
organic chlorine content. The organic chlorine content is the difference
between the total chlorine content and the ionic chlorine content.
(ii) Total chlorine content. A weighed sample is extracted with
water at 150 deg.F for 2 hours, filtered, and the volume of filtrate is
measured (A milliliters) as described in paragraph (d)(2) of this
section. Two drops of 50 percent by weight sodium hydroxide solution are
added to prevent loss of chloride from ammonium chloride, if present,
and the solution is evaporated to approximately 15 milliliters. The
concentrated filtrate is quantitatively transferred to a 22-milliliter
Parr bomb fusion cup and gently evaporated to dryness. To the contents
of the cup are added 3.5 grams of granular sodium peroxide, 0.1 gram of
powdered starch, and 0.02 gram potassium nitrate; and the contents are
mixed thoroughly. The bomb is assembled, water is added to the recess at
the top of the bomb and ignition is conducted in the usual fashion using
a Meeker burner. The heating is continued for 1 minute after the water
at the top has evaporated. The bomb is quenched in water, rinsed with
distilled water, and placed in a 400-milliliter beaker. The bomb cover
is rinsed with water, catching the washings in the same 400-milliliter
beaker. The bomb is covered with distilled water and a watch glass and
heated until the melt has dissolved. The bomb is removed, rinsed,
catching the rinsings in the beaker, and the solution is acidified with
concentrated nitric acid using methyl purple as an indicator. The beaker
is covered with a watch glass, and the contents are boiled gently for
10-15 minutes. After cooling to room temperature the solution is made
slightly alkaline with 50 percent by weight sodium hydroxide solution,
then acidified with dilute (1:5) nitric acid. Then 1.5 milliliters of 2
N nitric acid per 100 milliliters of solution is added and the solution
is titrated with 0.005 N silver nitrate to the equivalence potential end
point using an expanded scale pH meter (Beckman Model 76, or
equivalent). A complete blank must be run in duplicate. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.404
where:
A=volume of filtrate obtained in extraction.
[[Page 321]]
B=milliliters of silver nitrate solution used in sample
titrationxnormality of silver nitrate solution.
C=milliliters of silver nitrate solution used in blank
titrationxnormality of silver nitrate solution.
(iii) Ionic chlorine content. A weighed sample is extracted with
water at 150 deg.F for 2 hours, filtered, and the volume of filtrate is
measured (A milliliters) as in paragraph (d)(2) of this section. Two
drops of 50 percent by weight sodium hydroxide solution are added and
the solution is evaporated to approximately 150 milliliters. The
solution is quantitatively transferred to a 250-milliliter beaker,
methyl purple indicator is added, and the solution is neutralized with
0.1 N nitric acid. For each 100 milliliters of solution is added 1.5
milliliters of 2 N nitric acid. The solution is titrated with 0.005 N
silver nitrate to the equivalence potential end point, using the
expanded scale pH meter described in paragraph (d)(3)(ii) of this
section. A complete blank must be run in duplicate. Calculation:
[GRAPHIC] [TIFF OMITTED] TR01JA93.405
where:
A=volume of filtrate obtained in extraction.
D=milliliters of silver nitrate solution used in sample
titrationxnormality of silver nitrate solution.
E=milliliters of silver nitrate solution used in blank
titrationxnormality of silver nitrate solution.
(iv) Organic chlorine content and vinyl chloride-propylene copolymer
content of aqueous extract. The organic chlorine content and the vinyl
chloride propylene copolymer content of the aqueous extract is
calculated as follows:
(a) Organic chlorine content. Milliequivalents of organic chlorine
in aqueous extract of 100 grams of sample equal milliequivalents of
total chlorine in aqueous extract of 100 grams of sample (as calculated
in paragraph (d)(3)(ii) of this section) minus milliequivalents of ionic
chlorine in aqueous extract of 100 grams of sample (as calculated in
paragraph (d)(3)(iii) of this section).
(b) Vinyl chloride-propylene copolymer content. Milligrams of vinyl
chloride-propylene copolymer in aqueous extract of 100 grams of sample
equal milliequivalents of organic chlorine in aqueous extract of 100
grams of sample (as calculated in paragraph (d)(3)(iv) (a) of this
section) multiplied by 84.5.
Note: The conversion factor, 84.5, is derived from the equivalent
weight of chlorine divided by the chlorine content of the heptane
extractable fraction.)
(e) The vinyl chloride-propylene copolymers identified in and
complying with this section, when used as components of the food-contact
surface of any article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and Sec. 179.45 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.
(f) The provisions of this section are not applicable to vinyl
chloride-propylene copolymers used in food-packaging adhesives complying
with Sec. 175.105 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984]
[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: 21CFR177.1990]
[Page 321-323]
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. 177.1990 Vinylidene chloride/methyl acrylate copolymers.
The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No.
25038-72-6) identified in paragraph (a) of this section may be safely
used as an article or as a component of an article intended for use in
contact with food subject to the provisions of this section.
(a) Identity. For the purposes of this section vinylidene chloride/
methyl acrylate copolymers consist of basic copolymers produced by the
copolymerization of vinylidene chloride and methyl acrylate such that
the copolymers contain not more than 15 weight-percent of polymer units
derived from methyl acrylate.
[[Page 322]]
(b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate copolymers identified in paragraph (a) of this section
may contain optional adjuvant substances required in the production of
such basic copolymers. These 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) Specifications. (1) The methyl acrylate content is determined by
an infrared spectrophotometric method titled "Determination of
Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate Copolymers,"
which is incorporated by reference. Copies are available from the Center
for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(2) The weight average molecular weight of the copolymer is not less
than 50,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatograph is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, "Standard
Test Method for Molecular Weight Averages and Molecular Weight
Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel
Permeation Chromatography-GPC)," which is incorporated by reference.
Copies are available from University Microfilms International, 300 North
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(3) Residual vinylidene chloride and residual methyl acrylate in the
copolymer in the form in which it will contact food (unsupported film,
barrier layer, or as a copolymer for blending) will not exceed 10 parts
per million and 5 parts per million, respectively, as determined by
either a gas chromatographic method titled "Determination of Residual
Vinylidene Chloride and Methyl Acrylate in Vinylidene Chloride/Methyl
Acrylate Copolymer Resins and Films," or, alternatively, "Residual
Methyl Acrylate and Vinylidene Chloride Monomers in Saran MA/VDC Resins
and Pellets by Headspace Gas Chromatography," dated March 3, 1986,
which are incorporated by reference in accordance with 5 U.S.C. 552(a).
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-200), 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 basic copolymer resin in the form
of granules that will pass through a U.S. Standard Sieve No. 45 (350
microns) shall meet the following extractives limitations:
(1) 10-gram samples of the resin, when extracted separately with 100
milliliters of distilled water at 121 deg.C (250 deg.F) for 2 hours,
and 100 milliliters of n-heptane at 66 deg.C (150 deg.F) for 2 hours,
shall yield total nonvolatile extractives not to exceed 0.5 percent by
weight of the resin.
(2) The basic copolymer in the form of film when extracted
separately with distilled water at 121 deg.C (250 deg.F) for 2 hours
shall yield total nonvolatile extractives not to exceed 0.047 milligram
per square centimeter (0.3 milligram per square inch).
(e) Conditions of use. The copolymers may be safely used as articles
or components of articles intended for use in producing, manufacturing,
processing, preparing, treating, packaging, transporting, or holding
food, including processing of packaged food at temperatures not to
exceed 135 deg.C (275 deg.F).
(f) Other specifications and limitations. The vinylidene chloride-
methyl acrylate copolymers identified in and complying with this
section, when used as components of the food contact surface of any
article that is subject to a regulation in parts 174 through 178 and
Sec. 179.45 of this chapter, shall comply with any specifications and
limitations prescribed by such regulation for the
[[Page 323]]
article in the finished form in which it is to contact food.
[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended at
53 FR 47185, Nov. 22, 1988; 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: 21CFR177.2000]
[Page 323]
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. 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers.
The vinylidene chloride/methyl acrylate/methyl methacrylate polymers
(CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section
may be safely used as articles or as a component of articles intended
for use in contact with food subject to the provisions of this section.
(a) Identity. For the purpose of this section, vinylidene chloride/
methyl acrylate/methyl methacrylate polymers consist of basic polymers
produced by the copolymerization of vinylidene chloride/methyl acrylate/
methyl methacrylate such that the basic polymers or the finished food-
contact articles meet the specifications prescribed in paragraph (d) of
this section.
(b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate/methyl methacrylate polymers identified in paragraph (a)
of this section may contain optional adjuvant substances required in the
production of such basic polymers. These 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 of
approval.
(c) Conditions of use. The polymers may be safely used as articles
or as components of articles intended for use in producing,
manufacturing, processing, preparing, treating, packaging, transporting,
or holding food, including processing of packaged food at temperatures
up to 121 deg.C (250 deg.F).
(d) Specifications and limitations. The vinylidene chloride/methyl
acrylate/methyl methacrylate basic polymers and/or finished food-contact
articles meet the following specifications and limitations:
(1)(i) The basic vinylidene chloride/methyl acrylate/methyl
methacrylate polymers contain not more than 2 weight percent of polymer
units derived from methyl acrylate monomer and not more than 6 weight
percent of polymer units derived from methyl methacrylate monomer.
(ii) The basic polymers are limited to a thickness of not more than
0.005 centimeter (0.002 inches).
(2) The weight average molecular weight of the basic polymer is not
less than 100,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatography is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, which is
incorporated by reference. Copies are available from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(3) The basic polymer or food-contact article described 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 .08 milligram per square centimeter (0.5 milligram per square
inch) of food-contact surface when tested by the methods described in
Sec. 176.170(d). If the finished food-contact article is itself the
subject of a regulation in parts 174 through 178 and Sec. 179.45 of this
chapter, it shall also comply with any specifications and limitations
prescribed for it by the regulation.
[49 FR 29578, July 23, 1984]
[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: 21CFR177.2210]
[Page 323-324]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2210 Ethylene polymer, chlorosulfonated.
Ethylene polymer, chlorosulfonated as identified in this section may
be safely used as an article or component of articles intended for use
in contact
[[Page 324]]
with food, subject to the provisions of this section.
(a) Ethylene polymer, chlorosulfonated is produced by
chlorosulfonation of a carbon tetrachloride solution of polyethylene
with chlorine and sulfuryl chloride.
(b) Ethylene polymer, chlorosulfonated shall meet the following
specifications:
(1) Chlorine not to exceed 25 percent by weight.
(2) Sulfur not to exceed 1.15 percent by weight.
(3) Molecular weight is in the range of 95,000 to 125,000.
Methods for the specifications in this paragraph (b), titled "Chlorine
and Bromine--Coulometric Titration Method by Aminco Chloridometer,"
"Hypolon[reg] Synthetic Rubber--Determination of Sulfur by Parr Bomb,"
and ASTM method D2857-70 (Reapproved 1977), "Standard Test Method for
Dilute Solution Viscosity of Polymers," are incorporated by reference.
Copies of the ASTM method may be obtained from the American Society for
Testing Materials, 1916 Race St., Philadelphia, PA 19103. Copies of the
other two methods 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. Copies of all three methods may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(c) The additive is used as the article, or a component of articles,
intended for use as liners and covers for reservoirs intended for the
storage of water for drinking purposes.
(d) Substances permitted by Sec. 177.2600 may be employed in the
preparation of ethylene polymers, chlorosulfonated, subject to any
limitations prescribed therein.
(e) The finished ethylene copolymers, chlorosulfonated shall conform
to Sec. 177.2600(e) and (g).
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984;
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: 21CFR177.2250]
[Page 324]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2250 Filters, microporous polymeric.
Microporous polymeric filters identified in paragraph (a) of this
section may be safely used, subject to the provisions of this section,
to remove particles of insoluble matter in producing, manufacturing,
processing, and preparing bulk quantities of liquid food.
(a) Microporous polymeric filters consist of a suitably permeable,
continuous, polymeric matrix of polyvinyl chloride, vinyl chloride-
propylene, or vinyl chloride-vinyl acetate, in which finely divided
silicon dioxide is embedded. Cyclohexanone may be used as a solvent in
the production of the filters.
(b) Any substance employed in the production of microporous
polymeric filters that is the subject of a regulation in parts 170
through 189 of this chapter must conform with any specification in such
regulation.
(c) Cyclohexanone when used as a solvent in the production of the
filters shall not exceed 0.35 percent by weight of the microporous
polymeric filters.
(d) The microporous polymeric filters may be colored with colorants
used in accordance with Sec. 178.3297 of this chapter.
(e) The temperature of food being processed through the microporous
polymeric filters shall not exceed 180 deg.F.
(f) The microporous polymeric filters shall be maintained in a
sanitary manner in accordance with good manufacturing practice so as to
prevent potential microbial adulteration of the food.
(g) To assure safe use of the microporous polymeric filters, the
label or labeling shall include adequate directions for a pre-use
treatment, consisting of washing with a minimum of 2 gallons of potable
water at a temperature of 180 deg.F for each square foot of filter,
prior to the filter's first use in contact with food.
[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]
[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: 21CFR177.2260]
[Page 324-327]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2260 Filters, resin-bonded.
Resin-bonded filters may be safely used in producing, manufacturing,
processing, and preparing food, subject to the provisions of this
section.
(a) Resin-bonded filters are prepared from natural or synthetic
fibers to
[[Page 325]]
which have been added substances required in their preparation and
finishing, and which are bonded with resins prepared by condensation or
polymerization of resin-forming materials, together with adjuvant
substances required in their preparation, application, and curing.
(b) The quantity of any substance employed in the production of the
resin-bonded filter 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 resin-bonded filters
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 resin-bonded filters
include the following, subject to any limitations provided:
List of Substances and Limitations
(1) Fibers:
Cellulose pulp.
Cotton.
Nylon. (From nylon resins complying with the provisions of applicable
regulations in subchapter B of this chapter.
Polyethylene terephthalate complying in composition with the provisions
of Sec. 177.1630; for use in inline filtration only as provided for in
paragraphs (e) and (f) of this section.
Rayon (viscose).
(2) Substances employed in fiber finishing:
BHT.
Butyl (or isobutyl) palmitate or stearate.
2,5-Di-tert-butyl hydroquinone for use only in lubricant formulations
for rayon fiber finishing and at a usage level not to exceed 0.1 percent
by weight of the lubricant formulations.
Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate for use only as a
lubricant in the manufacture of polyethylene terephthalate fibers
specified in paragraph (d)(1) of this section at a level not to exceed
0.03 percent by weight of the finished fibers.
Fatty acid (C10-C18) diethanolamide condensates.
Fatty acids derived from animal or vegetable fats and oils, and salts of
such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Triethanolamine.
Fatty acid (C10-C18) mono- and diesters of
polyoxyethylene glycol (molecular weight 400-3,000).
Methyl esters of fatty acids (C10-C18).
Mineral oil.
Polybutene, hydrogenated; complying with the identity prescribed under
Sec. 178.3740 (b) of this chapter.
Polyoxyethylene (4 mols) ethylenediamine monolauramide for use only in
lubricant formulations for rayon fiber finishing and at a usage level
not to exceed 10 percent by weight of the lubricant formulations.
Ricebran oil.
Titanium dioxide.
(3) Resins:
Acrylic polymers produced by polymerizing ethyl acrylate alone or with
one or more of the monomers: Acrylic acid, acrylonitrile, N-
methylolacrylamide, and styrene. The finished copolymers shall contain
at least 70 weight percent of polymer units derived from ethyl acrylate,
no more than 2 weight percent of total polymer units derived from
acrylic acid, no more than 10 weight percent of total polymer units
derived from acrylonitrile, no more than 2 weight percent of total
polymer units derived from N-methylolacrylamide, and no more than 25
weight percent of total polymer units derived from styrene. For use only
as provided in paragraph (m) of this section.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the amine
catalysts identified in Sec. 175.300(b)(3)(xiii) of this chapter.
Melamine-formaldehyde chemically modified with methyl alcohol.
Melamine-formaldehyde chemically modified with urea; for use only as
provided for in paragraphs (e), (f), (g), (h), and (i) of this section.
Phenol-formaldehyde resins.
Polyvinyl alcohol.
Polyvinyl alcohol with the copolymer of acrylic acid-allyl sucrose.
Polyvinyl alcohol with melamine formaldehyde.
Polyvinyl acetate with melamine formaldehyde.
p--Toluenesulfonamide-formaldehyde chemically modified with
one or more of the amine catalysts identified in Sec. 175.300
(b)(3)(xiii) of this chapter.
(4) Adjuvant substances:
Dimethyl polysiloxane with methylcellulose and sorbic acid (as an
antifoaming agent).
[[Page 326]]
Phosphoric acid.
(5) Colorants: Colorants used in accordance with Sec. 178.3297 of
this chapter.
(e) Resin-bonded filters conforming with the specifications of
paragraph (e) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 100 deg.F for 2 hours, yields total extractives not
to exceed 2.8 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 100 deg.F.
(f) Resin-bonded filters conforming with the specifications of
paragraph (f) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 145 deg.F for 2 hours, yields total extractives not
to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 145 deg.F.
(g) Resin-bonded filters conforming with the specifications of
paragraph (g) (1) of this section are used as provided in paragraph
(g)(2) of this section:
(1) Total extractives. The finished filter, when exposed to n-hexane
at reflux temperature for 2 hours, yields total extractives not to
exceed 0.5 percent by weight of the filter.
(2) Conditions of use. It is used to filter edible oils.
(h) Resin-bonded filters conforming with the specifications of
paragraph (h) (1) of this section are used as provided in paragraph
(h)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 212 deg.F for 2 hours, yields total extractives not
to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk, coffee, tea, and
potable water at temperatures not to exceed 212 deg.F.
(i) Resin-bonded filters conforming with the specifications of
paragraph (i) (1) of this section are used as provided in paragraph
(i)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water for 2 hours at a temperature equivalent to, or higher
than, the filtration temperature of the aqueous food, yields total
extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH above 5.0.
(j) Resin-bonded filters conforming with the specifications of
paragraph (j) (1) of this section are used as provided in paragraph
(j)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 5
percent (by weight) acetic acid for 2 hours at a temperature equivalent
to, or higher than, the filtration temperature of the aqueous food,
yields total extractives not to exceed 4 percent, by weight, of the
filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH of 5.0 or below.
(k) Resin-bonded filters conforming with the specifications of
paragraph (k) (1) of this section are used as provided in paragraph
(k)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 8
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing not more than 8 percent
alcohol.
(l) Resin-bonded filters conforming with the specifications of
paragraph (l) (1) of this section are used as provided in paragraph
(l)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 50
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing more than 8 percent
alcohol.
(m) Resin-bonded filters fabricated from acrylic polymers as
provided in
[[Page 327]]
paragraph (d)(3) of this section together with other substances as
provided in paragraph (d), (1), (2), and (4) of this section may be used
as follows:
(1) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 100 deg.F, provided that the
finished filter when exposed to distilled water at 100 deg.F for 2
hours yields total extractives not to exceed 1 percent by weight of the
filter.
(2) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 145 deg.F, provided that the
finished filter when exposed to distilled water at 145 deg.F for 2
hours yields total extractives not to exceed 1.2 percent by weight of
the filter.
(n) 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 56 FR 42933, Aug. 30, 1991]
[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: 21CFR177.2280]
[Page 327]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2280 4,4'-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins.
4,4'-Isopropylidenediphenol-epichlo-rohydrin thermosetting epoxy
resins may be safely used as articles or components of articles intended
for repeated use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, in
accordance with the following prescribed conditions:
(a) The basic thermosetting epoxy resin is made by reacting 4,4'-
isopropylidenediphenol with epichlorohydrin.
(b) The resin may contain one or more of the following optional
substances provided the quantity used does not exceed that reasonably
required to accomplish the intended effect:
------------------------------------------------------------------------
------------------------------------------------------------------------
Allyl glycidyl ether...................... As curing system additive.
Di- and tri-glycidyl ester mixture As modifier at levels not to
resulting from the reaction of exceed equal parts by
epichlorohydrin with mixed dimers and weight of the 4,4'-
trimers of unsaturated C18 monobasic isopropylidenediphenol-
fatty acids derived from animal and epichlorohydrin basic resin
vegetable fats and oils. and limited to use in
contact with alcoholic
beverages containing not
more than 8 percent of
alcohol.
1,2-Epoxy-3-phenoxypropane................ As curing system additive.
Glyoxal................................... Do.
4,4'-Isopropylidenediphenol............... Do.
4,4'-Methylenedianiline................... Do.
m-Phenylenediamine........................ Do.
Tetrahydrophthalic anhydride.............. Do.
------------------------------------------------------------------------
(c) In accordance with good manufacturing practice, finished
articles containing the resins shall be thoroughly cleansed prior to
their first use in contact with food.
(d) The provisions of this section are not applicable to 4,4'-
isopropylidenedi-phenol-epichlorohydrin resins listed in other sections
of parts 174, 175, 176, 177, 178 and 179 of this chapter.
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984]
[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: 21CFR177.2355]
[Page 327-328]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2355 Mineral reinforced nylon resins.
Mineral reinforced nylon resins identified in paragraph (a) of this
section may be safely used as articles or components of articles
intended for repeated use in contact with nonacidic food (pH above 5.0)
and at use temperatures not exceeding 212 deg.F. in accordance with the
following prescribed conditions:
(a) For the purpose of this section the mineral reinforced nylon
resins consist of nylon 66, as identified in and complying with the
specifications of Sec. 177.1500, reinforced with up to 40 weight percent
of calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl)
propylamine (Chemical Abstracts Service Registry No. 000919302) based on
the weight of the calcium silicate.
(b) The mineral reinforced nylon resins may contain up to 0.2
percent by weight of titanium dioxide as an optional adjuvant substance.
(c) The mineral reinforced nylon resins with or without the optional
substance described in paragraph (b) of this section, and in the form of
\1/8\-inch molded test bars, when extracted with the solvents, i.e.,
distilled water and 50 percent (by volume) ethyl alcohol in distilled
water, at reflux temperature for 24 hours using a volume-to-surface
ratio of 2 milliliters of solvent per square inch of surface tested,
shall meet the following extractives limitations:
(1) Total extractives not to exceed 5.0 milligrams per square inch
of food-contact surface tested for each solvent.
[[Page 328]]
(2) The ash after ignition of the extractives described in paragraph
(c)(1) of this section, not to exceed 0.5 milligram per square inch of
food-contact surface tested.
(d) In accordance with good manufacturing practice, finished
articles containing the mineral reinforced nylon resins shall be
thoroughly cleansed prior to their first use in contact with food.
[42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]
[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: 21CFR177.2400]
[Page 328-329]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2400 Perfluorocarbon cured elastomers.
Perfluorocarbon cured elastomers identified in paragraph (a) of this
section may be safely used as articles or components of articles
intended for repeated use in contact with nonacid food (pH above 5.0),
subject to the provisions of this section.
(a) Identity. (1) For the purpose of this section, perfluorocarbon
cured elastomers are produced by terpolymerizing tetrafluorethylene (CAS
Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-
5), and perfluoro-2-phenoxypropyl vinyl ether (CAS Reg. No. 24520-19-2)
and subsequent curing of the terpolymer (CAS Reg. No. 26658-70-8) using
the crosslinking agent, phenol, 4,4'-[2,2,2-trifluoro-1-
(trifluoromethyl) ethylidene] bis-,dipotassium salt (CAS Reg. No. 25088-
69-1) and accelerator, 1,4,7,10,13,16-hexaoxacyclooctadecane (CAS Reg.
No. 17455-13-9).
(2) The perfluorocarbon base polymer shall contain no less than 40
weight-percent of polymer units derived from tetrafluoroethylene, no
less than 40 weight-percent of polymer units derived from
perfluoromethyl vinyl ether and no more than 5 weight-percent polymer
units derived from perfluoro-2-phenoxy-propyl vinyl ether.
(3) The composition limitations of the cured elastomer, calculated
as parts per 100 parts of terpolymer, are as follows:
Phenol, 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene] bis-
,dipotassium salt--not to exceed 5 parts.
1,4,7,10,13,16-Hexaoxacyclo-octadecane--not to exceed 5 parts.
(b) Optional adjuvant substances. The perfluorocarbon cured
elastomer identified in paragraph (a) of this section may contain the
following optional adjuvant substances, subject to any limitations cited
on their use:
(1) Substances generally recognized as safe (GRAS) in food or food
packaging.
(2) Substances used in accordance with a prior sanction.
(3) Substances authorized under applicable regulations in this part
and in parts 175 and 178 of this chapter and subject to any limitations
prescribed therein.
(4) Substances identified in this paragraph (b)(4) subject to such
limitations as are provided:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Carbon black (channel process of furnace Not to exceed 15 parts per
combustion process) (CAS Reg. No. 1333-86- 100 parts of the
4). terpolymer.
Magnesium oxide (CAS Reg. No. 1309-48-4).. Not to exceed 5 parts per
100 parts of the
terpolymer.
------------------------------------------------------------------------
(c) Specifications--(1) Infrared identification. Perfluorocarbon
cured elastomers may be identified by the characteristic infrared
spectra of the pyrolysate breakdown product that is obtained by heating
and decomposing the elastomer using the method entitled "Qualitative
Identification of Kalrez
by Infrared Examination of
Pyrolysate." This method is incorporated by reference. Copies of the
method are available from the Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
(2) Thermogravimetry. Perfluorocarbon cured elastomers have a major
decomposition peak occurring at 490 deg. 15 deg.C (914
deg.F). Less than 1.5 percent of the elastomers will volatilize below
400 deg.C (752 deg.F) when run under nitrogen at a 10 deg.C or 18
deg.F per minute heating rate using a Du Pont Thermal Analyzer Model
1099 with Model 951 TGA unit or the equivalent.
(d) Extractive limitations. Articles fabricated from perfluorocarbon
cured elastomers having a thickness of at
[[Page 329]]
least 1.0 millimeter (0.039 inch) when extracted at reflux temperatures
for 2 hours separately with distilled water, 50 percent ethanol, and n-
heptane, shall meet the following extractability limits:
(1) Total extractives not to exceed 3.1 milligrams per square
decimeter (0.2 milligrams per square inch).
(2) Fluoride extractives calculated as fluorine not to exceed 0.47
milligram per square decimeter (0.03 milligram per square inch).
(e) Conditions of use. In accordance with current good manufacturing
practice, finished food contact articles containing the perfluorocarbon
cured elastomers shall be thoroughly cleaned prior to their first use in
contact with food.
[49 FR 43050, Oct. 26, 1984]
[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: 21CFR177.2410]
[Page 329]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2410 Phenolic resins in molded articles.
Phenolic resins identified in this section may be safely used as the
food-contact surface of molded articles intended for repeated use in
contact with nonacid food (pH above 5.0), in accordance with the
following prescribed conditions:
(a) For the purpose of this section, the phenolic resins are those
produced when one or more of the phenols listed in paragraph (a)(1) of
this section are made to react with one or more of the aldehydes listed
in paragraph (a)(2) of this section, with or without aniline and/or
anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine):
(1) Phenols:
p-tert-Amylphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Octylphenol.
Phenol.
o- and p-Phenylethylphenol mixture produced when phenol is made to react
with styrene in the presence of sulfuric acid catalyst.
(2) Aldehydes:
Acetaldehyde.
Formaldehyde.
Paraldehyde.
(b) Optional adjuvant substances employed in the production of the
phenolic resins or added thereto to impart desired technical or physical
properties include the following:
------------------------------------------------------------------------
------------------------------------------------------------------------
Asbestos fiber............................
Barium hydroxide.......................... For use as catalyst.
Calcium stearate.......................... For use as lubricant.
Carbon black (channel process)............
Diatomaceous earth........................
Glass fiber...............................
Hexamethylenetetramine.................... For use as curing agent.
Mica......................................
Oxalic acid............................... For use as catalyst.
Zinc stearate............................. For use as lubricant.
------------------------------------------------------------------------
(c) The finished food-contact article, when extracted with distilled
water at reflux temperature for 2 hours, using a volume-to-surface ratio
of 2 milliliters of distilled water per square inch of surface tested,
shall meet the following extractives limitations:
(1) Total extractives not to exceed 0.15 milligram per square inch
of food-contact surface.
(2) Extracted phenol not to exceed 0.005 milligram per square inch
of food-contact surface.
(3) No extracted aniline when tested by a spectrophotometric method
sensitive to 0.006 milligram of aniline per-square inch of food-contact
surface.
(d) In accordance with good manufacturing practice, finished molded
articles containing the phenolic resins shall be thoroughly cleansed
prior to their first use in contact with food.
[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: 21CFR177.2415]
[Page 329-330]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2415 Poly(aryletherketone) resins.
Poly(aryletherketone) resins identified in paragraph (a) of this
section may be safely used as articles or components of articles
intended for repeated use in contact with food subject to the provisions
of this section.
(a) Identity. For the purposes of this section,
poly(aryletherketone) resins are poly(p-oxyphenylene p-oxyphenylene p-
carboxyphenylene) resins (CAS Reg. No. 29658-26-2) produced by the
polymerization of hydroquinone and 4,4'-difluorobenzophenone, and have a
minimum weight-average molecular weight of 12,000, as determined by gel
permeation chromatography in comparison with polystyrene standards, and
a minimum mid-point glass transition temperature of 142 deg.C, as
determined by differential scanning calorimetry.
[[Page 330]]
(b) Optional adjuvant substances. The basic resins identified in
paragraph (a) may contain optional adjuvant substances used in their
production. These adjuvants may include substances described in
Sec. 174.5(d) of this chapter and the following:
------------------------------------------------------------------------
Substance Limitations
------------------------------------------------------------------------
Diphenyl sulfone.......................... Not to exceed 0.2 percent by
weight as a residual
solvent in the finished
basic resin.
------------------------------------------------------------------------
(c) Extractive limitations. The finished food contact article, when
extracted at reflux temperatures for 2 hours with the following four
solvents, yields in each extracting solvent net chloroform soluble
extractives not to exceed 0.05 milligrams per square inch of food
contact surface: Distilled water, 50 percent (by volume) ethanol in
distilled water, 3 percent acetic acid in distilled water, and n-
heptane. In testing the final food contact article, a separate test
sample shall be used for each extracting solvent.
[63 FR 20315, Apr. 24, 1998]
[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: 21CFR177.2420]
[Page 330-331]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2420 Polyester resins, cross-linked.
Cross-linked polyester resins may be safely used as articles or
components of articles intended for repeated use in contact with food,
in accordance with the following prescribed conditions:
(a) The cross-linked polyester resins are produced by the
condensation of one or more of the acids listed in paragraph (a)(1) of
this section with one or more of the alcohols or epoxides listed in
paragraph (a)(2) of this section, followed by copolymerization with one
or more of the cross-linking agents listed in paragraph (a)(3) of this
section:
(1) Acids:
Adipic.
Fatty acids, and dimers thereof, from natural sources.
Fumaric.
Isophthalic.
Maleic.
Methacrylic.
Orthophthalic.
Sebacic.
Terephthalic.
Trimellitic.
(2) Polyols and polyepoxides:
Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epichlorohydrin.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Polyoxypropylene ethers of 4,4'-isopropylide-nediphenol (containing an
average of 2-7.5 moles of propylene oxide).
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
2,2,4-Trimethyl-1,3-pentanediol.
(3) Cross-linking agents:
Butyl acrylate.
Butyl methacrylate.
Ethyl acrylate.
Ethylhexyl acrylate.
Methyl acrylate.
Methyl methacrylate.
Styrene.
Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in
coatings contacting bulk quantities of dry food of the type identified
in Sec. 176.170(c) of this chapter, table 1, under type VIII.
Vinyl toluene.
(b) Optional adjuvant substances employed to facilitate the
production of the resins or added thereto to impart desired technical or
physical properties include the following, provided that the quantity
used does not exceed that reasonably required to accomplish the intended
physical or technical effect and does not exceed any limitations
prescribed in this section:
------------------------------------------------------------------------
Limitations (limits of addition
List of substances expressed as percent by weight
of finished resin)
------------------------------------------------------------------------
1. Inhibitors: Total not to exceed 0.08
percent.
Benzoquinone......................... 0.01 percent.
tert-Butyl catechol..................
TBHQ.................................
Di-tert-butyl hydroquinone...........
Hydroquinone.........................
[[Page 331]]
2. Accelerators: Total not to exceed 1.5
percent.
Benzyl trimethyl ammonium chloride... 0.05 percent.
Calcium naphthenate..................
Cobalt naphthenate...................
Copper naphthenate...................
N, N-Diethylaniline.................. 0.4 percent.
N, N-Dimethylaniline................. Do.
Ethylene guanidine hydrochloride..... 0.05 percent.
3. Catalysts: Total not to exceed 1.5
percent, except that methyl
ethyl ketone peroxide may be
used as the sole catalyst at
levels not to exceed 2
percent.
Azo-bis-isobutyronitrile.............
Benzoyl peroxide.....................
tert-Butyl perbenzoate...............
Chlorbenzoyl peroxide................
Cumene hydroperoxide.................
Dibutyltin oxide (CAS Reg. No. 818-08- For use in the polycondensation
6). reaction at levels not to
exceed 0.2 percent of the
polyester resin.
Dicumyl peroxide.....................
Hydroxybutyltin oxide (CAS Reg. No. For use in the polycondensation
2273-43-0). reaction at levels not to
exceed 0.2 percent of the
polyester resin.
Lauroyl peroxide.....................
p-Menthane hydroperoxide.............
Methyl ethyl ketone peroxide.........
Monobutyltin tris(2-ethylhexoate) For use in the polycondensation
(CAS Reg. No. 23850-94-4). reaction at levels not to
exceed 0.2 percent of the
polyester resin.
4. Solvents for inhibitors,
accelerators, and catalysts:
Butyl benzyl phthalate (containing
not more than 1.0 percent by weight
of dibenzyl phthalate).
Dibutyl phthalate....................
Diethylene glycol.................... As a solvent for benzyl
trimethyl ammonium chloride or
ethylene guanidine
hydrochloride only.
Dimethyl phthalate...................
Methyl alcohol.......................
Styrene..............................
Triphenyl phosphate..................
5. Reinforcements:
Asbestos.............................
Glass fiber..........................
Polyester fiber produced by the
condensation of one or more of the
acids listed in paragraph (a)(1) of
this section with one or more of the
alcohols listed in paragraph (a)(2)
of this section.
6. Miscellaneous materials:
Castor oil, hydrogenated.............
[alpha]-Methylstyrene................
Polyethylene glycol 6000.............
Silicon dioxide......................
Wax, petroleum....................... Complying with Sec. 178.3710
of this chapter.
------------------------------------------------------------------------
(c) The cross-linked polyester resins, with or without the optional
substances described in paragraph (b) of this section, and in the
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 characterizing the conditions of
their intended use, as determined from tables 1 and 2 of Sec. 176.170(c)
of this chapter, shall meet the following extractives limitations:
(1) Net chloroform-soluble extractives not to exceed 0.1 milligram
per square inch of food-contact surface tested when the prescribed food-
simulating solvent is water or 8 or 50 percent alcohol.
(2) Total nonvolatile extractives not to exceed 0.1 milligram per
square inch of food-contact surface tested when the prescribed food-
simulating solvent is heptane.
(d) In accordance with good manufacturing practice, finished
articles containing the cross-linked polyester resins shall be
thoroughly cleansed prior to their first use in contact with food.
[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983;
54 FR 48858, Nov. 28, 1989]
[[Page 332]]
[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: 21CFR177.2430]
[Page 332]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2430 Polyether resins, chlorinated.
Chlorinated polyether resins may be safely used as articles or
components of articles intended for repeated use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, in accordance with the following
prescribed conditions:
(a) The chlorinated polyether resins are produced by the catalytic
polymerization of 3,3-bis(chloromethyl)-oxetane, and shall contain not
more than 2 percent residual monomer.
(b) In accordance with good manufacturing practice, finished
articles containing the chlorinated polyether resins shall be thoroughly
cleansed prior to their first use in contact with food.
[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: 21CFR177.2440]
[Page 332]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2440 Polyethersulfone resins.
Polyethersulfone resins identified in paragraph (a) of this section
may be safely used as articles or components of articles intended for
repeated use in contact with food in accordance with the following
prescribed conditions:
(a) For the purpose of this section, polyethersulfone resins are:
(1) Poly(oxy-p-phenylenesulfonyl-p-phenylene) resins (CAS Reg. No.
25667-42-9), which have a minimum number average molecular weight of
16,000.
(2) 1,1'-sulfonylbis[4-chlorobenzene] polymer with 4,4'-(1-
methylethylidene)bis[phenol] (maximum 8 percent) and 4,4'-
sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0),
which have a minimum number average molecular weight of 26,000.
(3) In paragraphs (a)(1) and (a)(2) of this section, the minimum
number average molecular weight is determined by reduced viscosity in
dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved
1977), "Standard Test Method for Dilute Solution Viscosity of
Polymers," which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Division of Petition
Control (HFS-215), Center for Food Safety and Applied Nutrition, 1110
Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(b) The basic resins identified in paragraphs (a)(1) and (a)(2) of
this section may contain optional adjuvant substances described in
Sec. 174.5(d) of this chapter and the following:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
Diphenylsulfone........................... Not to exceed 0.2 percent as
residual solvent in the
finished basic resin
described in paragraph
(a)(1) of this section.
Dimethyl sulfoxide........................ Not to exceed 0.01 percent
as residual solvent in the
finished basic resin
described in paragraph
(a)(1) of this section.
N-methyl-2-pyrrolidone.................... Not to exceed 0.01 percent
as residual solvent in the
finished basic resin
described in paragraph
(a)(2) of this section.
------------------------------------------------------------------------
(c) The finished food-contact article, when extracted at reflux
temperatures for 2 hours with the following four solvents, yields net
chloroform-soluble extractives in each extracting solvent not to exceed
0.02 milligram per square inch of food-contact surface: distilled water,
50 percent (by volume) ethyl alcohol in distilled water, 3 percent
acetic acid in distilled water, and n-heptane. (Note: In testing the
finished food-contact article, use a separate test sample for each
required extracting solvent.)
(d) In accordance with good manufacturing practice, finished food-
contact articles containing the polyethersulfone resins shall be
thoroughly cleansed before their first use in contact with food.
[44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982;
49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648,
Sept. 20, 1995]
[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: 21CFR177.2450]
[Page 332-333]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2450 Polyamide-imide resins.
Polyamide-imide resins identified in paragraph (a) of this section
may be safely used as components of articles intended for repeated use
in contact with food, in accordance with the following prescribed
conditions:
(a) Identity. (1) For the purpose of this section the polyamide-
imide resins are derived from the condensation reaction of substantially
equimolar parts of trimellitic anhydride and p,p'-diphenylmethane
diisocyanate.
[[Page 333]]
(2) The polyamide-imide resins (CAS Reg. No. 31957-38-7) derived
from the condensation reaction of equimolar parts of benzoyl chloride-
3,4-dicarboxylic anhydride and 4,4'-diphenylmethanediamine.
(b) Specifications. (1) Polyamide-imide resins identified in
paragraph (a)(1) of this section shall have a nitrogen content of not
less than 7.8 weight percent and not more than 8.2 weight percent.
Polyamide-imide resins identified in paragraph (a)(2) of this section
shall have a nitrogen content of not less than 7.5 weight percent and
not more than 7.8 weight percent. Nitrogen content is determined by the
Dumas Nitrogen Determination as set forth in the "Official Methods of
Analysis of the Association of Official Analytical Chemists," 13th Ed.
(1980), sections 7.016-7.020, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies may be obtained from the
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC.
(2) Polyamide-imide resins identified in paragraph (a)(1) of this
section shall have a solution viscosity of not less than 1.200.
Polyamide-imide resins identified in paragraph (a)(2) of this section
shall have a solution viscosity of not less than 1.190. Solution
viscosity shall be determined by a method titled "Solution Viscosity"
which is incorporated by reference in accordance with 5 U.S.C. 552(a).
Copies are available from the Center for Food Safety and Applied
Nutrition (HFS-200), 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.
(3) The polyamide-imide resins identified in paragraph (a)(1) of
this section are heat cured at 600 deg.F for 15 minutes when prepared
for extraction tests and the residual monomers: p,p-diphenylmethane
diisocyanate should not be present at greater than 100 parts per million
and trimellitic anhydride should not be present at greater than 500
parts per million. Residual monomers are determined by gas
chromatography (the gas chromatography method titled "Amide-Imide
Polymer Analysis--Analysis of Monomer Content," is incorporated by
reference in accordance with 5 U.S.C. 552(a). Copies are available from
the Center for Food Safety and Applied Nutrition (HFS-200), 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).
(c) Extractive limitations are applicable to the polyamide-imide
resins identified in paragraphs (a) (1) and (2) of this section in the
form of films of 1 mil uniform thickness after coating and heat curing
at 600 deg.F for 15 minutes on stainless steel plates, each having such
resin-coated surface area of 100 square inches. The cured-resin film
coatings shall be extracted in accordance with the method described in
Sec. 176.170(d)(3) of this chapter, using a plurality of spaced, coated
stainless steel plates, exposed to the respective food simulating
solvents. The resin shall meet the following extractive limitations
under the corresponding extraction conditions:
(1) Distilled water at 250 deg.F for 2 hours: Not to exceed 0.01
milligram per square inch.
(2) Three percent acetic acid at 212 deg.F for 2 hours: Not to
exceed 0.05 milligram per square inch.
(3) Fifty percent ethyl alcohol at 160 deg.F for 2 hours: Not to
exceed 0.03 milligram per square inch.
(4) n-Heptane at 150 deg.F for 2 hours: Not to exceed 0.05
milligram per square inch.
(d) In accordance with good manufacturing practice, those food
contact articles, having as components the polyamide-imide resins
identified in paragraph (a) of this section and intended for repeated
use shall be thoroughly cleansed prior to their first use in contact
with food.
[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11845, Mar. 19, 1982;
49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 54 FR 43170,
Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996]
[[Page 334]]
[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: 21CFR177.2460]
[Page 334-335]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in
paragraph (a) of this section may be used as an article or as a
component of an article intended for use in contact with food subject to
the provisions of this section.
(a) Identity. For the purposes of this section, poly(2,6-dimethyl-
1,4-phenylene) oxide resins consist of basic resins produced by the
oxidative coupling of 2,6-xylenol such that the finished basic resins
meet the specifications and extractives limitations prescribed in
paragraph (c) of this section.
(b) Optional adjuvant substances. The basic poly(2,6-dimethyl-1,4-
phenylene) oxide resins identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of such
basic resins. The optional adjuvant substances required in the
production of the basic poly(2,6-dimethyl-1,4-phenylene) oxide resins
may include substances permitted for such use by regulations in parts
170 through 189 of this chapter, substances generally recognized as safe
in food, substances used in accordance with a prior sanction or
approval, and the following:
------------------------------------------------------------------------
Limitations (expressed as
List of substances percent by weight of
finished basic resin)
------------------------------------------------------------------------
Diethylamine.............................. Not to exceed 0.16 percent
as residual catalyst.
Methyl alcohol............................ Not to exceed 0.02 percent
as residual solvent.
Toluene................................... Not to exceed 0.2 percent as
residual solvent.
------------------------------------------------------------------------
(c) Specifications and extractives limitations. The poly(2,6-
dimethyl-1,4-phenylene) oxide basic resins meet the following:
(1) Specifications. Intrinsic viscosity is not less than 0.30
deciliter per gram as determined by ASTM method D1243-79, "Standard
Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,"
which is incorporated by reference, modified as follows. Copies of the
incorporation by reference may be obtained from the American Society for
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
(i) Solvent: Chloroform, reagent grade containing 0.01 percent tert-
butylcatechol.
(ii) Resin sample: Powdered resin obtained from production prior to
molding or extrusion.
(iii) Viscometer: Cannno-Ubbelohde series 25 dilution viscometer (or
equivalent).
(iv) Calculation: The calculation method used is that described in
appendix X.1.3 (ASTM method D1243-79, cited and incorporated by
reference in paragraph (c)(1) of this section) with the reduced
viscosity determined for three concentration levels (0.4, 0.2, and 0.1
gram per deciliter) and extrapolated to zero concentration for
intrinisic viscosity. The following formula is used for determining
reduced viscosity:
[GRAPHIC] [TIFF OMITTED] TR01JA93.406
where:
t=Solution efflux time.
toSolvent efflux time.
c=Concentration of solution in terms of grams per deciliter.
(2) Extractives limitations. Total resin extracted not to exceed
0.02 weight-percent when extracted with n-heptane at 160 deg.F for 2
hours as determined using 200 milliliters of reagent grade n-heptane
which has been freshly distilled before use and 25 grams of poly (2,-6-
dimethyl-1,4-phenylene) oxide resin. The resin as tested is in pellet
form having a particle size such that 100 percent of the pellets will
pass through a U.S. Standard Sieve No. 6 and 100 percent of the pellets
will be held on a U.S. Standard Sieve No. 10.
(d) Other limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide
resins identified in and complying with this section, when used as
components of the food-contact surface of any article that is the
subject of a regulation in parts 174, 175, 176, 177, 178 and Sec. 179.45
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.
(e) Uses. The poly(2,6-dimethyl-1,4-phenylene) oxide resins
identified in and complying with the limitations in this section may be
used as articles or
[[Page 335]]
components of articles intended for repeated food-contact use or as
articles or components of articles intended for single-service food-
contact use only under the conditions described in Sec. 176.170(c) of
this chapter, table 2, conditions of use H.
[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984;
63 FR 8852, Feb. 23, 1998]
[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: 21CFR177.2465]
[Page 335]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers.
Polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate
copolymers (CAS Reg. No. 26936-30-1) may be safely used as components of
surface primers used in conjunction with silicone polymers intended for
repeated use and complying with Sec. 175.300 of this chapter and
Sec. 177.2600, in accordance with the following prescribed conditions.
(a) Identity. For the purpose of this section,
polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate
copolymers are produced by the polymerization of methylmethacrylate and
trimethoxysilylpropylmethacrylate.
(b) Conditions of use. (1) The polymethylmethacrylate/
poly(trimethoxysilylpropyl)methacrylate copolymers are used at levels
not to exceed 6.0 percent by weight of the primer formulation.
(2) The copolymers may be used in food contact applications with all
food types under conditions of use B through H as described in table 2
of Sec. 176.170(c) of this chapter.
[59 FR 5948, Feb. 9, 1994]
[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: 21CFR177.2470]
[Page 335-336]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2470 Polyoxymethylene copolymer.
Polyoxymethylene copolymer identified in this section may be safely
used as an article or component of articles intended for food-contact
use in accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, polyoxymethylene
copolymers are identified as the following: The reaction product of
trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg.
No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of
formaldehyde) and a maximum of 5 percent by weight of butanediol formal
(CAS Reg. No. 25214 85-1). Both copolymers may have certain optional
substances added to impart desired technological properties to the
copolymer.
(b) Optional adjuvant substances. The polyoxymethylene copolymer
identified in paragraph (a) of this section may contain optional
adjuvant substances required in its production. The quantity of any
optional adjuvant substance employed in the production of the copolymer
does not exceed the amount reasonably required to accomplish the
intended technical or physical effect. Such adjuvants may include
substances generally recognized as safe in food, substances used in
accordance with prior sanction, substances permitted under applicable
regulations in parts 170 through 189 of this chapter, and the following:
(1) Stabilizers (total amount of stabilizers not to exceed 2.0
percent and amount of any one stabilizer not to exceed 1.0 percent of
polymer by weight)
Calcium ricinoleate.
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) (CAS Reg.
No. 35074-77-2).
Melamine-formaldehyde resin.
2,2'-Methylenebis(4-methyl-6-tert-butylphenol).
Nylon 6/66, weight ratio 2/3.
Tetrakis [methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]
methane.
(2) Lubricant: N,N'Distearoylethyl-enediamine.
(c) Specifications. (1) Polyoxymethylene copolymer can be identified
by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the copolymer is
15,000 as determined by a method titled "Number Average Molecular
Weight," 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) Polyoxymethylene copolymer in the
finished form in which it is to contact food,
[[Page 336]]
when extracted with the solvent or solvents characterizing the type of
food and under conditions of time and temperature as determined from
tables 1 and 2 of Sec. 175.300(d) of this chapter, shall yield net
chloroform-soluble extractives not to exceed 0.5 milligram per square
inch of food-contact surface.
(2) Polyoxymethylene copolymer with or without the optional
substances described in paragraph (b) of this section, when ground or
cut into particles that pass through a U.S.A. Standard Sieve No. 6 and
that are retained on a U.S.A. Standard Sieve No. 10, shall yield total
extractives as follows:
(i) Not to exceed 0.20 percent by weight of the copolymer when
extracted for 6 hours with distilled water at reflux temperature.
(ii) Not to exceed 0.15 percent by weight of the copolymer when
extracted for 6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) The polyoxymethylene copolymer is for use
as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 deg.F.
(3) In accordance with good manufacturing practice, finished
articles containing polyoxymethylene copolymer shall be thoroughly
cleansed before their first use in contact with food.
[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20, 1983;
49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, May
17, 1985; 52 FR 4493, Feb. 12, 1987, 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: 21CFR177.2480]
[Page 336-337]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2480 Polyoxymethylene homopolymer.
Polyoxymethylene homopolymer identified in this section may be
safely used as articles or components of articles intended for food-
contact use in accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, polyoxymethylene
homopolymer is polymerized formaldehyde [Chemical Abstracts Service
Registry No. 9002-81-7]. Certain optional adjuvant substances, described
in paragraph (b) of this section, may be added to impart desired
technological properties to the homopolymer.
(b) Optional adjuvant substances. The polyoxymethylene homopolymer
identified in paragraph (a) of this section may contain optional
adjuvant substances in its production. The quantity of any optional
adjuvant substance employed in the production of the homopolymer does
not exceed the amount reasonably required to accomplish the intended
effect. 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:
(1) Stabilizers. The homopolymer may contain one or more of the
following stabilizers. The total amount of stabilizers shall not exceed
1.9 percent of homopolymer by weight, and the quantity of individual
stabilizer used shall not exceed the limitations set forth below:
------------------------------------------------------------------------
Substances Limitations
------------------------------------------------------------------------
Hexamethylenebis(3,5-di-tert-butyl-4- At a maximum level of 1
hydroxy-hydrocinnamate) (CAS Reg. No. percent by weight of
35074-77-2). homopolymer. The finished
articles shall not be used
for foods containing more
than 8 percent alcohol.
2,2'-Methylenebis(4-methyl-6-tert- At a maximum level of 0.5
butylphenol). percent by weight of
homopolymer.
Nylon 66/610/6 terpolymer, respective At a maximum level of 1.5
proportions of nylon polymers by weight percent by weight of
are: 3/2/4. homopolymer.
Nylon 612/6 copolymer (CAS Reg. No. 51733- Do.
10-9), weight ratio 6/1.
Tetrakis[methylene(3,5-di-tert-butyl-4- At a maximum level of 0.5
hydroxy-hydrocinnamate)] methane. percent by weight of
homopolymer.
------------------------------------------------------------------------
(2) Lubricant. N,N'-Distearoylethyl-enediamine.
(3) Molding assistant. Polyethylene glycol 6,000.
(c) Specifications. (1) Polyoxymethylene homopolymer can be
identified by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the homopolymer is
25,000.
(3) Density of the homopolymer is between 1.39 and 1.44 as
determined by ASTM method D1505-68 (Reapproved
[[Page 337]]
1979), "Standard Test Method for Density of Plastics by the Density-
Gradient Technique," which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC
20408.
(4) Melting point is between 172 deg.C and 184 deg.C as determined
by ASTM method D2133-66, "Specifications for Acetal Resin Injection
Molding and Extrusion Materials" (Revised 1966), which is incorporated
by reference. Copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, 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) Polyoxymethylene homopolymer, in the
finished form which is to contact food, when extracted with the solvent
or solvents characterizing the type of food and under conditions of time
and temperature characterizing the conditions of intended use under
paragraphs (c)(3) and (d) of Sec. 175.300 of this chapter and as limited
by paragraph (e) of this section, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of food-contact
surface.
(2) Polyoxymethylene homopolymer, with or without the optional
adjuvant substances described in paragraph (b) of this section, when
ground or cut into particles that pass through a U.S.A. Standard Sieve
No. 6 and that are retained on a U.S.A. Standard Sieve No. 10, shall
yield extractives as follows:
(i) Formaldehyde not to exceed 0.0050 percent by weight of
homopolymer as determined by a method titled "Formaldehyde Release and
Formaldehyde Analysis," which is incorporated by reference. Copies are
available from 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.
(ii) Total extractives not to exceed 0.20 percent by weight of
homopolymer when extracted for 6 hours with distilled water at reflux
temperature and 0.15 percent by weight of homopolymer when extracted for
6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) Polyoxymethylene homopolymer is for use
as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 deg.F.
(3) In accordance with good manufacturing practice, finished
articles containing polyoxymethylene homopolymer shall be thoroughly
cleansed prior to first use in contact with food.
[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978;
47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111,
Mar. 19, 1984; 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: 21CFR177.2490]
[Page 337-338]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2490 Polyphenylene sulfide resins.
Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins)
may be safely used as coatings or components of coatings of articles
intended for repeated use in contact with food, in accordance with the
following prescribed conditions.
(a) Polyphenylene sulfide resins consist of basic resins produced by
the reaction of equimolar parts of p-dichlorobenzene and sodium sulfide,
such that the finished resins meet the following specifications as
determined by methods titled "Oxygen Flask Combustion-Gravimetric
Method for Determination of Sulfur in Organic Compounds,"
"Determination of the Inherent Viscosity of Polyphenylene Sulfide,"
and "Analysis for Dichlorobenzene in Ryton Polyphenylene Sulfide,"
which are incorporated by reference. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC 20408.
(1) Sulfur content: 28.2-29.1 percent by weight of finished resin.
[[Page 338]]
(2) Minimum inherent viscosity: 0.13 deciliters per gram.
(3) Maximum residual p-dichlorobenzene: 0.8 ppm.
(b) Subject to any limitations prescribed in parts 170 through 189
of this chapter, the following optional substances may be added to the
polyphenylene sulfide basic resins in an amount not to exceed that
reasonably required to accomplish the intended physical or technical
effect.
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with prior sanction or approval.
(3) Substances the use of which is permitted in coatings under
regulations in parts 170 through 189 of this chapter.
(c) The finished coatings are thermally cured at temperatures of 700
deg.F and above.
(d) Polyphenylene sulfide resin coatings may be used in contact with
food at temperatures not to exceed the boiling point of water; provided
that the finished cured coating, when extracted at reflux temperatures
for 8 hours separately with distilled water, 50 percent ethanol in
water, and 3 percent acetic acid, yields total extractives in each
extracting solvent not to exceed 0.02 milligram per square inch of
surface and when extracted at reflux temperature for 8 hours with
heptane yields total extractives not to exceed 0.1 milligram per square
inch of surface.
(e) Polyphenylene sulfide resin coatings containing perfluorocarbon
resins complying with Sec. 177.1550 may be used in contact with food at
temperatures up to and including normal baking and frying temperatures;
provided that the finished cured coating, when extracted at reflux
temperatures for 2 hours separately with distilled water, 50 percent
ethanol in water, 3 percent acetic acid and heptane, yields total
extractives in each extracting solvent not to exceed 0.2 milligram per
square inch of surface and when extracted at reflux temperature for 1
hour with diphenyl ether yields total extractives not to exceed 4.5
milligrams per square inch of surface.
[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11846, 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: 21CFR177.2500]
[Page 338]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2500 Polyphenylene sulfone resins.
The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1)
identified in paragraph (a) of this section may be safely used as
articles or components of articles intended for repeated use in contact
with food, subject to the provisions of this section.
(a) Identity. For the purpose of this section, polyphenylene sulfone
resins consist of basic resin produced by reacting polyphenylene sulfide
with peracetic acid such that the finished resins meet the
specifications set forth in paragraph (c) of this section. The
polyphenylene sulfide used to manufacture polyphenylene sulfone is
prepared by the reaction of sodium sulfide and p-dichlorobenzene, and
has a minimum weight average molecular weight of 5,000 Daltons.
(b) Optional adjuvant substances. The basic polyphenylene sulfone
resins identified in paragraph (a) of this section may contain optional
adjuvant substances required in the production of such basic resins.
These optional adjuvant substances may include substances permitted for
such use by regulations in parts 170 through 189 of this chapter,
substances generally recognized as safe in food, or substances used in
accordance with a prior sanction or approval.
(c) Specifications. The glass transition temperature of the polymer
is 3605 deg.C as determined by the use of differential
scanning calorimetry.
[65 FR 15058, Mar. 21, 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: 21CFR177.2510]
[Page 338-339]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2510 Polyvinylidene fluoride resins.
Polyvinylidene fluoride resins may be safely used as articles or
components of articles intended for repeated use in contact with food,
in accordance with the following prescribed conditions:
(a) For the purpose of this section, the polyvinylidene fluoride
resins consist of basic resins produced by the polymerization of
vinylidene fluoride.
(b) The finished food-contact article, when extracted at reflux
temperatures for 2 hours with the solvents distilled water, 50 percent
(by volume) ethyl alcohol in distilled water, and n-heptane,
[[Page 339]]
yields total extractives in each extracting solvent not to exceed 0.01
milligram per square inch of food-contact surface tested; and 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. (Note: In testing the finished food-contact article,
use a separate test sample for each required extracting solvent.)
(c) In accordance with good manufacturing practice, finished food-
contact articles containing the polyvinylidene fluoride resins shall be
thoroughly cleansed prior to their first use in contact with food.
[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: 21CFR177.2550]
[Page 339-340]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2550 Reverse osmosis membranes.
Substances identified in paragraph (a) of this section may be safely
used as reverse osmosis membranes intended for use in processing bulk
quantities of liquid food to separate permeate from food concentrate or
in purifying water for food manufacturing under the following prescribed
conditions:
(a) Identity. For the purpose of this section, reverse osmosis
membranes may consist of either of the following formulations:
(1) A cross-linked high molecular weight polyamide reaction product
of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS
Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The membrane
is on the food-contact surface, and its maximum weight is 62 milligrams
per square decimeter (4 milligrams per square inch) as a thin film
composite on a suitable support.
(2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6),
identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and
1,2-dichloroethane, whose surface is the reaction product of this
copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final
polymer is 99811-80-0) for use as the food-contact surface of reverse
osmosis membranes used in processing liquid food. The composite membrane
is on the food-contact surface and its maximum weight is 4.7 milligrams
per square decimeter (0.3 milligrams per square inch) as a thin film
composite on a suitable support. The maximum weight of the 2,4-
toluenediisocyanate component of the thin film composite is 0.47
milligrams per square decimeter (0.03 milligrams per square inch).
(3) For the purpose of this section, the reverse osmosis membrane
consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid,
calcium salt (2:1) polymer with 1,3-benzenediamine, 1,3-
benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride (CAS
Reg. No. 39443-76-0). The membrane is the food contact surface and may
be applied as a film on a suitable support. Its maximum weight is 512
milligrams per square decimeter (33 milligrams per square inch).
(4) A cross-linked high molecular weight polyamide reaction product
of poly(N-vinyl-N-methylamine) (CAS Reg. No. 31245-56-4), N,N'-bis(3-
aminopropyl)ethylenediamine (CAS Reg. No. 10563-26-5), 1,3-
benzenedicarbonyl dichloride (CAS Reg. No. 99-63-8) and 1,3,5-
benzenetricarbonyl trichloride (CAS Reg. No. 4422-95-1). The membrane is
the food-contact surface. Its maximum weight is 20 milligrams per square
decimeter (1.3 milligrams per square inch) as a thin film composite on a
suitable support.
(5) A polyamide reaction product of 1,3,5-benzenetricarbonyl
trichloride polymer (CAS Reg. No. 4422-95-1) with piperazine (CAS Reg.
No. 110-85-0) and 1,2-diaminoethane (CAS Reg. No. 107-15-3). The
membrane is the food-contact layer and may be applied as a film on a
suitable support. Its maximum weight is 15 milligrams per square
decimeter (1 milligram per square inch).
(b) Optional adjuvant substances. The basic polymer identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymer. These optional
adjuvant substances may include substances permitted for such use by
regulations in parts 170 through 186 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
[[Page 340]]
(c) Supports. Suitable supports for reverse osmosis membranes are
materials permitted for such use by regulations in parts 170 through 186
of this chapter, substances generally recognized as safe in food, and
substances used in accordance with a prior sanction or approval.
(d) Conditions of use. (1) Reverse osmosis membranes described in
paragraphs (a)(1), (a)(2), (a)(3), and (a)(5) of this section may be
used in contact with all types of liquid food at temperatures up to 80
deg.C (176 deg.F).
(2) Reverse osmosis membranes described in paragraph (a)(4) of this
section may be used in contact with all types of liquid food, except
food containing more than 8 percent alcohol, at temperatures up to 80
deg.C (176 deg.F).
(3) Reverse osmosis membranes shall be maintained in a sanitary
manner in accordance with current good manufacturing practice so as to
prevent microbial adulteration of food.
(4) To assure their safe use, reverse osmosis membranes and their
supports shall be thoroughly cleaned prior to their first use in
accordance with current good manufacturing practice.
[49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11, 1987;
53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Mar.
7, 1990; 59 FR 9925, Mar. 2, 1994]
[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: 21CFR177.2600]
[Page 340-345]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2600 Rubber articles intended for repeated use.
Rubber articles intended for repeated use may be safely used in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, subject to the provisions of
this section.
(a) The rubber articles are prepared from natural and/or synthetic
polymers and adjuvant substances as described in paragraph (c) of this
section.
(b) The quantity of any substance employed in the production of
rubber articles intended for repeated use shall not exceed the amount
reasonably required to accomplish the intended effect in the rubber
article and shall not be intended to accomplish any effect in food.
(c) Substances employed in the preparation of rubber articles
include the following, subject to any limitations prescribed:
(1) Substances generally recognized as safe for use in food or food
packaging.
(2) Substances used in accordance with the provisions of a prior
sanction or approval.
(3) Substances that by regulation in parts 170 through 189 of this
chapter may be safely used in rubber articles, subject to the provisions
of such regulation.
(4) Substances identified in this paragraph (c)(4), provided that
any substance that is the subject of a regulation in parts 174, 175,
176, 177, 178 and Sec. 179.45 of this chapter conforms with any
specification in such regulation.
(i) Elastomers.
Acrylonitrile-butadiene copolymer.
Brominated isobutylene-isoprene copolymers complying with Sec. 177.1210.
Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers
containing not more than 5 weight percent of polymer units derived from
ethylene glycol dimethacrylate.
Butadiene-acrylonitrile-methacrylic acid copolymer.
Butadiene-styrene-methacrylic acid copolymer.
Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride copolymer.
Ethylene-propylene copolymer elastomers which may contain not more than
5 weight-percent of total polymer units derived from 5-methylene-2-
norbornene and/or 5-ethylidine-2-norbornene.
Ethylene-propylene-dicyclopentadiene copolymer.
Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8
weight percent of total polymer units derived from 1,4-hexadiene.
Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No. 88254-10-
8) produced when acrylonitrile/butadiene copolymers are modified by
hydrogenation of the olefinic unsaturation to leave either: (1) Not more
than 10 percent trans olefinic unsaturation and no [alpha], [beta]-
olefinic unsaturation as determined by a method entitled "Determination
of Residual [alpha], [beta]-Olefinic and Trans Olefinic Unsaturation
Levels in HNBR," developed October 1, 1991, by Polysar Rubber Corp.,
1256 South Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4
percent to 20 percent olefinic unsaturation and Mooney viscosities
greater than 45 (ML 1 + 4 @ 100 deg.C), as determined by ASTM Standard
Method D1646-92, "Standard Test Method for Rubber--Viscosity and
Vulcanization Characteristics (Mooney Viscometer)," which are both
[[Page 341]]
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of these methods may be obtained from the Division of
Petition Control (HFS-215), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or may be examined at the Center for Food Safety
and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park,
MD 20740, or at the Office of the Federal Register, 800 North Capitol
St. NW., suite 700, Washington, DC. A copy of ASTM Standard Method
D1646-92 may also be obtained from the American Society for Testing and
Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428-2959.
Isobutylene-isoprene copolymer.
Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 prepared
by reacting a copolymer of omega-laurolactam and adipic acid with
poly(tetramethylene ether glycol). The polyamide and polyether
components are reacted in ratios such that the polyamide component
constitutes a minimum of 30 weight-percent of total polymer units. The
copolymers may be used in contact with foods of Types I, II, III, IV, V,
VI, VII, VIII, and IX identified in table 1 of Sec. 176.170(c) of this
chapter at temperatures not to exceed 150 deg.F except that those
copolymers prepared with less than 50 weight-percent of polyamide are
limited to use in contact with such foods at temperatures not to exceed
100 deg.F.
Polybutadiene.
Polyester elastomers derived from the reaction of dimethyl
terephthalate, 1,4-butanediol, and [alpha]-hydro-omega-hydroxypoly
(oxytetramethylene). Additionally, trimethyl trimellitate may be used as
a reactant. The polyester elastomers may be used only in contact with
foods containing not more than 8 percent alcohol and limited to use in
contact with food at temperatures not exceeding 150 deg.F.
Polyisoprene.
Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from
the reaction of diphenylmethane diisocyanate with 1,4-butanediol and
polytetramethylene ether glycol.
Polyurethane resins derived from reactions of diphenylmethane
diisocyanate with adipic acid and 1,4-butanediol.
Rubber, natural.
Silicone basic polymer as described in ASTM method D1418-81, "Standard
Practice for Rubber and Rubber Latices--Nomenclature," which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
Silicone (Si) elastomers containing methyl groups.
Silicone (Psi) elastomers containing methyl and phenyl groups.
Silicone (Vsi) elastomers containing methyl and vinyl groups.
Silicone (Fsi) elastomers containing methyl and fluorine groups.
Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl
groups.
Styrene-butadiene copolymer.
Vinylidene fluoride-hexafluoropropylene copolymers (minimum number
average molecular weight 70,000 as determined by osmotic pressure in
methyl ethyl ketone).
Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymers
(minimum number average molecular weight 100,000 as determined by
osmotic pressure in methyl ethyl ketone).
(ii) Vulcanization materials--(a) Vulcanizing agents.
4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking
agent in the vulcanization of vinylidene fluoridehexafluoropropylene
copolymer and vinylidene fluoride-hexafluoropropylene-
tetrafluoroethylene copolymer elastomers identified under paragraph
(c)(4)(i) of this section and limited to use at levels not to exceed 2.4
percent by weight of such copolymers.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use
as a cross linking agent in the vulcanization of natural rubber,
styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and
ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of
this section and limited to use at levels not to exceed 2.4 percent by
weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in
the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer
and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene
copolymer elastomers identified under paragraph (c)(4)(i) of this
section and limited to use at levels not to exceed 1.5 percent by weight
of such copolymers.
Sulfur, ground.
(b) Accelerators (total not to exceed 1.5 percent by weight of
rubber product).
2-Benzothiazyl-N,N-diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert-Butyl-2-benzothiazole sulfenamide.
[[Page 342]]
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N-Cyclohexyl-2-benzothiazole sulfenamide.
Dibenzoyl-p-quinone dioxime.
Dibenzylamine.
Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-
methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-
thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).
Di(4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a
crosslinking agent in silicone polymers and elastomers identified under
paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by
weight of such polymers and elastomers where the total of all
accelerators does not exceed 1.5 percent by weight of rubber product.
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis[benzothiazole].
4,4'-Dithiodimorpholine.
N,N'-Di-o-tolylguanidine.
Di-o-tolylguanidine salt of pyrocatecholborate.
Ethylenediamine carbamate.
Heptaldehyde-aniline resin (iodine number 430-445).
Hexamethylenetetramine.
2-Mercaptobenzothiazole.
2-Mercaptothiazoline.
N-Oxydiethylene-benzothiazole-2-sulfenamide.
Piperidinium pentamethylenedithiocarba-mate.
Potassium pentamethylenedithiocarbamate.
p-Quinone dioxime.
Sodium dibutyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Stannous oleate for use only as an accelerator for silicone elastomers.
Tetrabutylthiuram monosulfide.
Tetraethylthiuram disulfide.
(1,1,4,4-Tetramethyltetramethylene)bis [tert-butyl peroxide].
Tetramethylthiuram monosulfide.
Thiram (tetramethylthiuram disulfide).
Triallyl cyanurate.
Triethylenetetramine.
1,3,5-Triethyl-hexahydro-s-triazine (triethyltrimethylenetriamine).
Triphenylguanidine.
Zinc butyl xanathate.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc 2-mercaptobenzothiazole.
Ziram (zinc dimethyldithiocarbamate).
(c) Retarders (total not to exceed 10 percent of weight of rubber
product).
Cyanoguanidine.
Phthalic anhydride.
Salicylic acid.
(d) Activators (total not to exceed 5 percent by weight of rubber
product except magnesium oxide may be used at higher levels).
Diethylamine.
Fatty acid amines, mixed.
Fatty acids.
Magnesium carbonate.
Magnesium oxide, light and heavy.
Oleic acid, dibutylamine salt (dibutylammonium oleate).
Stannous chloride.
Tall oil fatty acids.
Tetrachloro-p-benzoquinone.
Triethanolamine.
Zinc salts of fatty acids.
(iii) Antioxidants and antiozonants (total not to exceed 5 percent
by weight of rubber product).
Aldol-a-naphthylamine.
Alkylated (C4 and/or C8) phenols.
BHT (butylated hydroxytoluene).
4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-butylphenol
(CAS Reg. No. 991-84-4) for use only as a stabilizer at levels not to
exceed 0.5 percent by weight of the finished rubber product.
Butylated reaction product of p-cresol and dicyclopentadiene as
identified in Sec. 178.2010(b) of this chapter.
Butylated, styrenated cresols identified in Sec. 178.2010(b) of this
chapter.
4,4'-Butylidinebis(6-tert-butyl-m-cresol).
N-Cyclohexyl-N'-phenylphenylenediamine.
p,p'-Diaminodiphenylmethane.
2,5-Di-tert-amylhydroquinone.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or
xylyl.
2,6-Di-tert-butyl-p-phenylphenol.
1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline.
4,4'-Dimethoxydiphenylamine.
4,6-Dinonyl-o-cresol.
N,N'-Dioctyl-p-phenylenediamine.
Diphenylamine-acetone resin.
Diphenylamine-acetone-formaldehyde resin.
N,N'-Diphenylethylenediamine.
[[Page 343]]
N,N'-Disalicylalpropylenediamine.
N,N'-Di-o-tolylethylenediamine.
Hydroquinone monobenzyl ether.
Isopropoxydiphenylamine.
N-Isopropyl-N'-phenyl-p-phenylenediamine.
2,2'-Methylenebis(6-tert-butyl-4-ethylphenol).
2,2'-Methylenebis(4-methyl-6-tert-butylphenol).
2,2'-Methylenebis(4-methyl-6-nonylphenol).
2,2'-Methylenebis(4-methyl-6-tert-octylphenol).
Monooctyl- and dioctyldiphenylamine.
N,N'-Di-[beta]-naphthyl-p-phenylenediamine.
Phenyl-a-naphthylamine.
Phenyl-[beta]-naphthylamine.
Phenyl-[beta]-naphthylamine-acetone aromatic amine resin (average
molecular weight 600; nitrogen content 5.3 percent).
o- and p-Phenylphenol.
Polybutylated (mixture) 4,4'-isopropylidenediphenol.
Sodium pentachlorophenate.
Styrenated cresols produced when 2 moles of styrene are made to react
with 1 mole of a mixture of phenol and o-, m-, and p-cresols so that the
final product has a Brookfield viscosity at 25 deg.C of 1400 to 1700
centipoises.
Styrenated phenol.
4,4'-Thiobis (6-tert-butyl-m-cresol).
Toluene-2,4-diamine.
N-o-Tolyl-N'-phenyl-p-phenylenediamine.
p(p-Tolylsufanilamide) diphenylamine.
Tri(mixed mono- and dinonylphenyl) phosphite.
Tri(nonylphenyl) phosphite-formaldehyde resins produced when 1 mole of
tri(nonylphenyl) phosphite is made to react with 1.4 moles of
formaldehyde or produced when 1 mole of nonylphenol is made to react
with 0.36 mole of formaldehyde and the reaction product is then further
reacted with 0.33 mole of phosphorus trichloride. The finished resins
have a minimum viscosity of 20,000 centipoises at 25 deg.C, as
determined by LV-series Brookfield viscometer (or equivalent) using a
No. 4 spindle at 12 r.p.m., and have an organic phosphorus content of
4.05 to 4.15 percent by weight.
(iv) Plasticizers (total not to exceed 30 percent by weight of
rubber product unless otherwise specified).
n-Amyl n-decyl phthalate.
Butylacetyl ricinoleate.
n-Butyl ester of tall oil fatty acids.
Butyl laurate.
Butyl oleate.
Butyl stearate.
Calcium stearate.
Castor oil.
Coumarone-indene resins.
2,2'-Dibenzamidodiphenyl disulfide.
Dibenzyl adipate.
Dibutoxyethoxyethyl adipate.
Dibutyl phthalate.
Dibutyl sebacate.
Didecyl adipate.
Didecyl phthalate.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisooctyl adipate.
Diisooctyl sebacate.
Dioctyl adipate.
Dioctyl phthalate.
Dioctyl sebacate.
Dipentene resin.
Diphenyl ketone.
Fatty acids.
Fatty acids, hydrogenated.
Isooctyl ester of tall oil fatty acids.
Lanolin.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a-
methylstyrene to 3 vinyltoluene).
Mineral oil; (1) In rubber articles complying with this section, not to
exceed 30 percent by weight; (2) Alone or in combination with waxes,
petroleum, total not to exceed 45 percent by weight of rubber articles
that contain at least 20 percent by weight of ethylene-propylene
copolymer elastomer complying with paragraph (c)(4)(i) of this section,
in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX
idenified in table 1 of Sec. 176.170(c) of this chapter.
Montan wax.
n-Octyl n-decyl adipate.
n-Octyl n-decyl phthalate.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the homo- and copolymerization
of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid
arylalkene types from distillates of cracked petroleum stocks).
Petroleum hydrocarbon resin (produced by the catalytic polymerization
and subsequent hydrogenation of styrene, vinyltoluene, and indene types
from distillates of cracked petroleum stocks).
Petroleum oil, sulfonated.
Phenol-formaldehyde resin.
Pine tar.
Polybutene.
Polystyrene.
Propylene glycol.
n-Propyl ester of tall oil fatty acids.
Rapeseed oil vulcanized with rubber maker's sulfur.
Rosins and rosin derivatives identified in Sec. 175.105(c)(5) of this
chapter.
Soybean oil vulcanized with rubber maker's sulfur.
Styrene-acrylonitrile copolymer.
Terpene resins.
Triethylene glycol dicaprate.
Triethylene glycol dicaprylate.
Waxes, petroleum.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zinc 2-benzamidothiophenate.
[[Page 344]]
(v) Fillers.
Aluminum hydroxide.
Aluminum silicate.
Asbestos fiber, chrysotile or crocidolite.
Barium sulfate.
Carbon black (channel process or furnace combustion process; total
carbon black not to exceed 50 percent by weight of rubber product;
furnace combustion black content not to exceed 10 percent by weight of
rubber products intended for use in contact with milk or edible oils).
Cork.
Cotton (floc, fibers, fabric).
Mica.
Nylon (floc, fibers, fabric).
Silica.
Titanium dioxide.
Zinc carbonate.
Zinc sulfide.
(vi) Colorants. Colorants used in accordance with Sec. 178.3297 of
this chapter.
(vii) Lubricants (total not to exceed 2 percent by weight of rubber
product).
Polyethylene.
Sodium stearate.
(viii) Emulsifiers.
Fatty acid salts, sodium or potassium.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
Rosins and rosin-derivatives identified in Sec. 175.105(c)(5) of this
chapter.
Sodium decylbenzenesulfonate
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
Tall oil mixed soap (calcium, potassium, and sodium).
(ix) Miscellaneous (total not to exceed 5 percent by weight of
rubber product).
Animal glue as described in Sec. 178.3120 of this chapter.
Azodicarbonamide as chemical blowing agent.
2-Anthraquinone sulfonic acid sodium salt for use only as polymerization
inhibitor in chloroprene polymers and not to exceed 0.03 percent by
weight of the chloroprene polymers.
1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5) for use as a biocide
in uncured liquid rubber latex not to exceed 0.02 percent by weight of
the latex solids, where the total of all items listed in paragraph
(c)(4)(ix) of this section does not exceed 5 percent of the rubber
product.
n-Butyllithium for use only as polymerization catalyst for
polybutadiene.
4-tert-Butyl-o-thiocresol as peptizing agent.
tert-Butyl peracetate.
p-tert-Butylpyrocatechol.
Dialkyl (C8-C18
Di- and triethanolamine.
Diethyl xanthogen disulfide.
4-(Diiodomethylsulfonyl) toluene, Chemical Abstracts Service Registry
No. 20018-09-01, for use as an antifungal preservative at levels not to
exceed 0.3 percent by weight of the sealants and caulking materials.
Dodecyl mercaptan isomers, single or mixed.
2-Ethoxyethanol.
Iodoform.
p-Menthane hydroperoxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydrogen
phosphate and monohydrogen phosphate esters, barium salt; the nonyl
group is a propylene trimer isomer and the poly (oxyethylene) content
averages 9 moles; for use only as residual polymerization emulsifier at
levels not to exceed 0.7 percent by weight of ethylene-propylene-1,4-
hexadiene copolymers identified under paragraph (c)(4)(i) of this
section.
4,4'-Oxybis (benzenesulfonhydrazide) as chemical blowing agent.
Phenothiazine.
Potassium persulfate.
Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
Sodium nitrite.
Sodium salt of ethylenediamine tetraacetic acid and glycine.
Sodium sulfide.
Styrene monomer.
Tall oil.
Thioxylenois as peptizing agents.
Tridecyl mercaptan.
Zinc 4-tert-butylthiophenate as peptizing agent.
(d) Rubber articles intended for use with dry food are so formulated
and cured under conditions of good manufacturing practice as to be
suitable for repeated use.
(e) Rubber articles intended for repeated use in contact with
aqueous food shall meet the following specifications: The food-contact
surface of the rubber article in the finished form in which it is to
contact food, when extracted with distilled water at reflux temperature,
shall yield total extractives not to exceed 20 milligrams per square
inch during the first 7 hours of extraction, nor to exceed 1 milligram
per square inch during the succeeding 2 hours of extraction.
(f) Rubber articles intended for repeated use in contact with fatty
foods shall meet the following specifications: The food-contact surface
of the rubber article in the finished form in which it is to contact
food, when extracted with n-hexane at reflux temperature, shall yield
total extractives not to exceed
[[Page 345]]
175 milligrams per square inch during the first 7 hours of extraction,
nor to exceed 4 milligrams per square inch during the succeeding 2 hours
of extraction.
(g) In accordance with good manufacturing practice finished rubber
articles intended for repeated use in contact with food shall be
thoroughly cleansed prior to their first use in contact with food.
(h) The provisions of this section are not applicable to rubber
nursing-bottle nipples.
(i) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14572, Mar. 15, 1977]
Editorial Note: For Federal Register citations affecting
Sec. 177.2600, see the List of CFR Sections Affected, which appears in
the Finding Aids section of the printed volume and on GPO Access.
[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: 21CFR177.2710]
[Page 345]
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 C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2710 Styrene-divinylbenzene resins, cross-linked.
Styrene-divinylbenzene cross-linked copolymer resins may be safely
used as articles or components of articles intended for repeated use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
following prescribed conditions:
(a) The resins are produced by the copolymerization of styrene with
divinylbenzene.
(b) The resins meet the extractives limitations prescribed in this
paragraph:
(1) The resins to be tested are ground or cut into small particles
that will pass through a U.S. standard sieve No. 3 and that will be held
on a U.S. standard sieve No. 20.
(2) A 100-gram sample of the resins, when extracted with 100
milliliters of ethyl acetate at reflux temperature for 1 hour, yields
total extractives not to exceed 1 percent by weight of the resins.
(c) In accordance with good manufacturing practice, finished
articles containing the resins shall be thoroughly cleansed prior to
their first use in contact with food.
[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: 21CFR177.2800]
[Page 345-347]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177--INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
Subpart C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2800 Textiles and textile fibers.
Textiles and textile fibers may safely be used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section.
(a) The textiles and textile fibers are prepared from one or more of
the fibers identified in paragraph (d) of this section and from certain
other adjuvant substances required in the production of the textiles or
textile fibers or added to impart desired properties.
(b) The quantity of any adjuvant substance employed in the
production of textiles or textile fibers 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 textiles or textile
fibers 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 or added to textiles
and textile fibers may include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
textiles and textile fibers and used in accordance with such sanction or
approval.
(3) Substances generally recognized as safe for use in cotton and
cotton fabrics used in dry-food packaging.
(4) Substances that by regulation in this part may safely be used in
the production of or as a component of textiles or textile fibers and
subject to provisions of such regulation.
(5) Substances identified in this paragraph (d)(5), subject to such
limitations as are provided:
------------------------------------------------------------------------
List of substances Limitations
------------------------------------------------------------------------
(i) Fibers:
Cotton...............................
[[Page 346]]
Polyethylene terephthalate complying For use only in the manufacture
in composition with the provisions of items for repeated use.
of Sec. 177.1630(e)(4)(ii).
Rayon................................
(ii) Adjuvant substances:
Aluminum stearate....................
Borax................................ For use as preservative only.
Butyl-acetyl ricinoleate...............
Colorants used in accordance with Sec.
178.3297 of this chapter..
Di-tert-butyl hydroquinone.............
Dimethylpolysiloxane...................
Ethylenediaminetetraacetic acid, sodium
salt.
4-Ethyl-4-hexadecyl morpholinium ethyl For use only as a lubricant in
sulfate. the manufacture of
polyethylene terephthalate
fibers specified in paragraph
(d)(5)(i) of this section at a
level not to exceed 0.03
percent by weight of the
finished fibers.
Eugenol................................
Fats, oils, fatty acids, and fatty
alcohols derived from castor, coconut,
cottonseed, fish, mustardseed, palm,
peanut, rapeseed, ricebran, soybean,
sperm, and tall oils and tallow.
Fats, oils, fatty acids, and fatty
alcohols described in the preceding
item reacted with one or more of the
following substances:
n-Butyl and isobutyl alcohol.........
Diethylene glycol....................
Diethanolamine.......................
Glycerol.............................
Hexylene glycol (2-methyl-2,4-
pentanediol).
Hydrogen.............................
Isopropyl alcohol....................
Methyl alcohol.......................
Oxygen...............................
Polyethylene glycol (molecular weight
400-3,000).
Potassium hydroxide..................
Propylene glycol.....................
Sodium hydroxide.....................
Sulfuric acid........................
Formaldehyde........................... For use as preservative only.
Glyceryl mono-12-hydroxystearate.......
2-(9-Heptadecenyl)-1-[2-(10-
octadecenamido)ethyl-2-imidazolinium
ethyl sulfate.
Hexylene glycol (2-methyl,-2,4-
pentanediol).
Isobutyl alcohol.......................
Isopropyl alcohol......................
Kerosene...............................
Methyl ester of sulfated ricebran oil..
Mineral oil............................ For use only at a level not to
exceed 0.15 percent by weight
of finished fibers.
Mono- and diisopropylated m- and p-
cresols (isothymol derivative).
N-Oleyl, N'-acetyl, N'-[beta]-hydroxy-
ethylenediamine.
Petrolatum.............................
Petroleum sulfonate....................
Pine oil...............................
Polybutene, hydrogenated; complying
with the identity prescribed under 21
CFR 178.3740(b) of this chapter.
Polyethylene, oxidized (air blown).....
Polyvinyl acetate......................
Polyvinyl alcohol......................
Potassium soap of a saponified sulfated
castor oil.
Sodium bis(2,6-dimethylheptyl-4)
sulfosuccinate.
Sodium dioctyl sulfosuccinate..........
Sodium dodecyl benzenesulfonate........
Sodium fluoride........................ For use as preservative only.
Sodium hydrosulfite....................
Sodium hypochlorite....................
Sodium lauryl sulfate..................
Sodium 2-mercaptobenzothiazole......... Do.
Sodium pentachlorophenate.............. Do.
Styrene-butadiene copolymer............
Sulfated butyl, isobutyl and propyl
oleate.
Tallow.................................
Tallow, sulfonated.....................
Titanium dioxide.......................
Triethanolamine........................
[[Page 347]]
Ultramarine blue.......................
Waxes, petroleum.......................
Zinc hydrosulfite......................
------------------------------------------------------------------------
(e) Textile and textile fibers are used as articles or components of
articles that contact dry food only.
(f) The provisions of this section are not applicable to jute fibers
used as prescribed by Sec. 178.3620(d)(2) of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981;
49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug.
30, 1991]
[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: 21CFR177.2910]
[Page 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--Table of Contents
Subpart C--Substances for Use Only as Components of Articles Intended
for Repeated Use
Sec. 177.2910 Ultra-filtration membranes.
Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2),
(a)(3), and (a)(4) of this section may be safely used in the processing
of food, under the following prescribed conditions;
(a)(1) Ultra-filtration membranes that consist of paper impregnated
with cured phenol-formaldehyde resin, which is used as a support and is
coated with a vinyl chloride-acrylonitrile copolymer.
(2) Ultra-filtration membranes that consist of a sintered carbon
support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4)
containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9).
(3) Ultra-filtration membranes that consist of an aluminum oxide
support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4)
containing up to 5 percent yttrium oxide (CAS Reg. No. 1314-36-9).
(4) Ultrafiltration membranes that consist of a microporous
poly(vinylidene fluoride) membrane with a hydrophilic surface modifier
consisting of hydroxypropyl acrylate/tetraethylene glycol diacrylate
copolymer.
(b) Any substance employed in the production of ultra-filtration
membranes that is the subject of a regulation in parts 174, 175, 176,
177, 178 and Sec. 179.45 of this chapter conforms with the
specifications of such regulation.
(c) Ultra-filtration membranes are used in the physical separation
of dissolved or colloidally suspended varying molecular size components
of liquids during the commercial processing of bulk quantities of food.
(d) Ultra-filtration membranes shall be maintained in a sanitary
manner in accordance with good manufacturing practice so as to prevent
potential microbial adulteration of the food.
(e) Ultrafiltration membranes identified in paragraph (a)(4) may be
used to filter aqueous or acidic foods containing up to 13 percent of
alcohol at temperatures not to exceed 21 deg.C (70 deg.F).
(f) To assure safe use of the ultra-filtration membranes, the label
or labeling shall include adequate directions for a pre-use treatment,
consisting of conditioning and washing with a minimum of 8 gallons of
potable water prior to their first use in contact with food.
(g) 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 53 FR 17925, May 19, 1988; 58
FR 48599, Sept. 17, 1993; 60 FR 54426, Oct. 24, 1995]
