Food and Drug Administration, HHS § 177.1312

conforms with any specification in ic acid, when extracted with the sol- such regulation. vent or solvents characterizing the (d) Substances employed in the pro- type of food and under the conditions duction of the copolymer include: of its intended use as determined from (1) Substances generally recognized tables 1 and 2 of § 176.170(c) of this chap- as safe in food. ter, yield net acidified chloroform-solu- (2) Substances subject to prior sanc- ble extractives not to exceed 0.5 milli- tion or approval for use in the copoly- gram per square inch of food-contact mer and used in accordance with such surface when tested by the methods sanction or approval. prescribed in § 177.1330(e)(1), (3)(i) (3) Substances which by regulation in through (iv), (4), (5), and (6), except parts 174, 175, 176, 177, 178 and § 179.45 of that this chapter may be safely used as (1) The total residue method using 3 components of resinous or polymeric percent acetic acid, as prescribed in coatings and film used as food-contact § 177.1330(e)(6)(i)(a), does not apply, and surfaces, subject to the provisions of (2) The net acidified chloroform-solu- such regulation. ble extractives from paper and paper- (e) The copolymer conforms with the board complying with § 176.170 of this following specifications: chapter may be corrected for wax, pet- (1) The copolymer, when extracted rolatum, and mineral oil as provided in with distilled water at reflux tempera- § 176.170(d)(5)(iii)(b) of this chapter. ture for 2 hours, yields total extrac- tives not to exceed 0.05 percent. If the finished food-contact article is (2) The copolymer, when extracted itself the subject of a regulation in with ethyl acetate at reflux tempera- parts 174, 175, 176, 177, 178, and § 179.45 of ture for 2 hours, yields total extrac- this chapter, it shall also comply with tives not to exceed 0.7 percent. any specifications and limitations pre- (3) The copolymer, when extracted scribed for it by that regulation. with n-hexane at reflux temperature (c) The finished food-contact layer for 2 hours, yields total extractives not made with basic copolymers containing to exceed 0.05 percent. more than 10 weight-percent but no more than 25 weight-percent of total [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, polymer units derived from acrylic 1984, as amended at 55 FR 34555, Aug. 23, 1990] acid and with a maximum thickness of § 177.1310 Ethylene-acrylic acid co- 0.0025 inch (2.5 mils) may be used in polymers. contact with food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table The ethylene-acrylic acid copolymers 1 of § 176.170(c) of the chapter under identified in paragraph (a) of this sec- conditions of use B through H as de- tion may be safely used as components scribed in table 2 of § 176.170(c) of this of articles intended for use in contact chapter, and in contact with food types with food subject to the provisions of III, IVA, V, VIIA, and IX identified in this section. table 1 of § 176.170(c) of this chapter (a) The ethylene-acrylic acid copoly- under conditions of use E through G as mers consist of basic copolymers pro- described in table 2 of § 176.170(c) of this duced by the copolymerization of chapter. ethylene and acrylic acid such that the (d) The provisions of this section are finished basic copolymers contain no not applicable to ethylene-acrylic acid more than: copolymers used in food-packaging ad- (1) 10 weight-percent of total polymer hesives complying with § 175.105 of this units derived from acrylic acid when chapter. used in accordance with paragraph (b) of this section; and [42 FR 14572, Mar. 15, 1977, as amended at 51 (2) 25 weight-percent of total polymer FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, units derived from acrylic acid when 1988] used in accordance with paragraph (c) of this section. § 177.1312 Ethylene-carbon monoxide (b) The finished food-contact articles copolymers. made with no more than 10 percent The ethylene-carbon monoxide co- total polymer units derived from acryl- polymers identified in paragraph (a) of

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this section may be safely used as com- (3) The basic copolymer identified in ponents of articles intended for use in paragraph (a) of this section, when ex- contact with food subject to the provi- tracted with the solvent or solvents sions of this section. characterizing the type of food and (a) Identity. For the purposes of this under the conditions of time and tem- section, ethylene-carbon monoxide co- perature characterizing the conditions polymers (CAS Reg. No. 25052–62–4) con- of its intended use, as determined from sist of the basic polymers produced by tables 1 and 2 of § 176.170(c) of this chap- the copolymerization of ethylene and ter, yields net chloroform-soluble ex- carbon monoxide such that the copoly- tractives in each extracting solvent mers contain not more than 30 weight- percent of polymer units derived from not to exceed 0.5 milligram per square carbon monoxide. inch of food-contact surface when test- (b) Conditions of use. (1) The polymers ed by methods described in § 176.170(d) may be safely used as components of of this chapter. the food-contact or interior core layer (4) The provisions of this section are of multilaminate food-contact articles. not applicable to ethylene-carbon mon- (2) The polymers may be safely used oxide copolymers complying with as food-contact materials at tempera- § 175.105 of this chapter. tures not to exceed 121 °C (250 °F). (c) Specifications. (1) Food-contact [57 FR 32422, July 22, 1992] layers formed from the basic copoly- § 177.1315 Ethylene-1, 4-cyclohexylene mer identified in paragraph (a) of this dimethylene terephthalate copoly- section shall be limited to a thickness mers. of not more than 0.01 centimeter (0.004 inch). Ethylene-1, 4-cyclohexylene (2) The copolymers identified in para- dimethylene terephthalate copolymer graph (a) of this section shall have a may be safely used as articles or com- melt index not greater than 500 as de- ponents of articles intended for use in termined by ASTM method D1238–82, contact with food subject to provisions condition E ‘‘Standard Test Method for of this section and of part 174 of this Flow Rates of Thermoplastics by Ex- chapter. trusion Plastometer,’’ which is incor- (a) Identity. For the purposes of this porated by reference in accordance section, ethylene-1,4-cyclohexylene with 5 U.S.C. 552(a) and 1 CFR part 51. dimethylene terephthalate copolymers Copies may be obtained from the Amer- (1,4-benzene dicarboxylic acid, di- ican Society for Testing Materials, 100 methyl ester, polymerized with 1,4- Barr Harbor Dr., West Conshohocken, cyclohexanedimethanol and 1,2- Philadelphia, PA 19428-2959, or may be ethanediol) (CAS Reg. No. 25640–14–6) or examined at the Center for Food Safety and Applied Nutrition (HFS–200), Food (1,4-benzenedicarboxylic acid, polym- and Drug Administration, 5100 Paint erized with 1,4-cyclohexanedimethanol Branch Pkwy., College Park, MD 20740, and 1,2-ethanediol) (CAS Reg. No. or at the National Archives and 25038–91–9) are basic copolymers meet- Records Administration (NARA). For ing the specifications prescribed in information on the availability of this paragraph (b) of this section, to which material at NARA, call 202–741–6030, or may have been added certain optional go to: http://www.archives.gov/ substances required in their production federallregister/ or added to impart desired physical or codeloflfederallregulations/ technical properties. ibrllocations.html. (b) Specifications:

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