Food and Drug Administration, HHS § 177.1310

they will contact food, must yield low (b) The quantity of any optional sub- molecular weight (less than 1,000 Dal- stance employed in the production of tons) extractives of no more than 0.15 the copolymer does not exceed the percent by weight of the total polymer amount reasonably required to accom- when extracted with 0.2 percent by plish the intended physical or technical weight of aqueous sodium chloride so- effect or any limitation further pro- lution at 20 °C for 24 hours. The low vided. molecular weight extractives shall be (c) Any substance employed in the determined using size exclusion chro- production of the copolymer that is the matography or an equivalent method. subject of a regulation in parts 174, 175, When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter the copolymer, with no other absorp- conforms with any specification in tive media, shall be confined either in such regulation. a finished absorbent pad or in any suit- (d) Substances employed in the pro- able flexible porous article, (such as a duction of the copolymer include: ‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized pressure of 0.15 pounds per square inch as safe in food. (for example, a 4×6 inch square pad is (2) Substances subject to prior sanc- subjected to a 1.6 kilograms applied tion or approval for use in the copoly- mass). The solvent used shall be at mer and used in accordance with such least 60 milliliters aqueous sodium sanction or approval. chloride solution per gram of copoly- (3) Substances which by regulation in mer. parts 174, 175, 176, 177, 178 and § 179.45 of (d) Conditions of use. The copolymers this chapter may be safely used as identified in paragraph (a)(1) of this components of resinous or polymeric section are limited to use as a fluid ab- coatings and film used as food-contact sorbent in food-contact materials used surfaces, subject to the provisions of in the packaging of frozen or refrig- such regulation. erated poultry. The copolymers identi- (e) The copolymer conforms with the fied in paragraph (a)(2) of this section following specifications: are limited to use as a fluid absorbent (1) The copolymer, when extracted in food-contact materials used in the with distilled water at reflux tempera- packaging of frozen or refrigerated ture for 2 hours, yields total extrac- meat and poultry. tives not to exceed 0.05 percent. (2) The copolymer, when extracted [64 FR 28098, May 25, 1999, as amended at 65 with ethyl acetate at reflux tempera- FR 16817, Mar. 30, 2000] ture for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent. dimethylene terephthalate and 1,4- (3) The copolymer, when extracted cyclohexylene dimethylene with n-hexane at reflux temperature isophthalate copolymer. for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990] late may be safely used as an article or component of articles used in pro- § 177.1310 Ethylene-acrylic acid co- ducing, manufacturing, packing, proc- polymers. essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers transporting, or holding food, subject identified in paragraph (a) of this sec- to the provisions of this section: tion may be safely used as components (a) The copolymer is a basic poly- of articles intended for use in contact ester produced by the catalytic con- with food subject to the provisions of densation of dimethyl terephthalate this section. and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly- cyclohexanedimethanol, to which may mers consist of basic copolymers pro- have been added certain optional sub- duced by the copolymerization of stances required in its production or ethylene and acrylic acid such that the added to impart desired physical and finished basic copolymers contain no technical properties. more than:

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(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) [42 FR 14572, Mar. 15, 1977, as amended at 51 of this section; and FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, (2) 25 weight-percent of total polymer 1988] units derived from acrylic acid when used in accordance with paragraph (c) § 177.1312 Ethylene-carbon monoxide of this section. copolymers. (b) The finished food-contact articles The ethylene-carbon monoxide co- made with no more than 10 percent polymers identified in paragraph (a) of total polymer units derived from acryl- this section may be safely used as com- ic acid, when extracted with the sol- ponents of articles intended for use in vent or solvents characterizing the contact with food subject to the provi- type of food and under the conditions sions of this section. of its intended use as determined from (a) Identity. For the purposes of this tables 1 and 2 of § 176.170(c) of this chap- section, ethylene-carbon monoxide co- ter, yield net acidified chloroform-solu- polymers (CAS Reg. No. 25052–62–4) con- ble extractives not to exceed 0.5 milli- sist of the basic polymers produced by gram per square inch of food-contact the copolymerization of ethylene and surface when tested by the methods carbon monoxide such that the copoly- prescribed in § 177.1330(e)(1), (3)(i) mers contain not more than 30 weight- through (iv), (4), (5), and (6), except percent of polymer units derived from that carbon monoxide. (1) The total residue method using 3 (b) Conditions of use. (1) The polymers percent acetic acid, as prescribed in may be safely used as components of § 177.1330(e)(6)(i)(a), does not apply, and the food-contact or interior core layer (2) The net acidified chloroform-solu- of multilaminate food-contact articles. ble extractives from paper and paper- (2) The polymers may be safely used board complying with § 176.170 of this as food-contact materials at tempera- chapter may be corrected for wax, pet- tures not to exceed 121 °C (250 °F). rolatum, and mineral oil as provided in (c) Specifications. (1) Food-contact § 176.170(d)(5)(iii)(b) of this chapter. layers formed from the basic copoly- If the finished food-contact article is mer identified in paragraph (a) of this itself the subject of a regulation in section shall be limited to a thickness parts 174, 175, 176, 177, 178, and § 179.45 of of not more than 0.01 centimeter (0.004 this chapter, it shall also comply with inch). any specifications and limitations pre- (2) The copolymers identified in para- scribed for it by that regulation. graph (a) of this section shall have a (c) The finished food-contact layer melt index not greater than 500 as de- made with basic copolymers containing termined by ASTM method D1238–82, more than 10 weight-percent but no condition E ‘‘Standard Test Method for more than 25 weight-percent of total Flow Rates of Thermoplastics by Ex- polymer units derived from acrylic trusion Plastometer,’’ which is incor- acid and with a maximum thickness of porated by reference in accordance 0.0025 inch (2.5 mils) may be used in with 5 U.S.C. 552(a) and 1 CFR part 51. contact with food types I, II, IVB, VIA, Copies may be obtained from the Amer- VIB, VIIB, and VIII identified in table ican Society for Testing Materials, 100 1 of § 176.170(c) of the chapter under Barr Harbor Dr., West Conshohocken, conditions of use B through H as de- Philadelphia, PA 19428-2959, or may be scribed in table 2 of § 176.170(c) of this examined at the Center for Food Safety chapter, and in contact with food types and Applied Nutrition (HFS–200), Food III, IVA, V, VIIA, and IX identified in and Drug Administration, 5100 Paint table 1 of § 176.170(c) of this chapter Branch Pkwy., College Park, MD 20740, under conditions of use E through G as or at the National Archives and described in table 2 of § 176.170(c) of this Records Administration (NARA). For chapter. information on the availability of this (d) The provisions of this section are material at NARA, call 202–741–6030, or not applicable to ethylene-acrylic acid go to: http://www.archives.gov/ copolymers used in food-packaging ad- federallregister/

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