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177.1630 Polyethylene phthalate polymers.

Home > Regulations > Indirect food additives: Polymers > 177.1630 Polyethylene phthalate polymers.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1630]

[Page 307-310]
 
                        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.  177.1630  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

[[Page 308]]

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
    (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 National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html. 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.

[[Page 309]]

    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, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 
19428-2959, or may be examined at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    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, 100 
Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may 
be examined at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    The modifier is used at a level not to exceed 5 percent by weight of 
polyethylene 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.

[[Page 310]]

    (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.
    (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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1630


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