[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1630]
 
[Page 295-298]
 
                        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. 177.1630  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:
 
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    (a) 77 to 83 weight percent or
    (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 <greek-a>-hydro-<greek-o>-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 297]]
 
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 <SUP>2</SUP> (0.5 milligram/inch <SUP>2</SUP>) 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 <SUP>2</SUP> 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 <SUP>2</SUP> 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 298]]
 
    (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]