21 C.F.R. § 177.1630
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:
List of Substances and Limitations
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 § 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.
Ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters described in § 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.
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, 5001 Campus Dr., 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.
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 § 176.170(c) of this chapter, under use conditions E, F, and G in table 2 of § 176.170(c) of this chapter.
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 § 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.
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° to 215 °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 § 177.1500(b) , item 10, when tested by the methods given in § 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/centimeter2 (0.5 milligram/inch2) 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 °C (120 °F) for 24 hours;
(b) n-Heptane at 49 °C (120 °F) for 24 hours;
(c) 8 percent ethyl alcohol at 49 °C (120 °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 °C (120 °F).
21 C.F.R. §177.1630
For FEDERAL REGISTER citations affecting §177.1630, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.