Food and Drug Administration, HHS § 177.1360

§ 177.1360 Ethylene-vinyl acetate-vinyl (1) The film when extracted with dis- alcohol copolymers. tilled water at 21 °C (70 °F) for 48 hours Ethylene-vinyl acetate-vinyl alcohol yields total extractives not to exceed copolymers (CAS Reg. No. 26221–27–2) 0.0047 milligram per square centimeter (0.03 milligram per square inch) of may be safely used as articles or com- food-contact surface. ponents of articles intended for use in (2) The film when extracted with 50 contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for the following prescribed conditions: 48 hours yields total extractives not to (a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen- hol copolymers are produced by the timeter (0.04 milligram per square partial or complete alcoholysis or hy- inch) of food-contact surface. drolysis of those ethylene-vinyl acetate (c) The finished food-contact article copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003 (1) Those copolymers containing a inch) thickness and shall contact foods minimum of 55 percent ethylene and a only of the types identified in table 1 of maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories units by weight may be used in contact III, IV-A, VII-A, and IX under condi- with foods as described in paragraph (b) tions of use F and G described in table of this section. 2 of § 176.170(c) of this chapter. Film (2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch) minimum of 55 percent ethylene and a thickness representing the finished ar- maximum of 15 percent vinyl alcohol ticles shall meet the following extrac- units by weight may be used in contact tive limitation when tested by ASTM with foods as described in paragraph (c) method F34–76 (Reapproved 1980), of this section. ‘‘Standard Test Method for Liquid Ex- (3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’ 40 percent ethylene and 60 to 83 percent which is incorporated by reference. The vinyl alcohol units by weight may be availability of this incorporation by used in contact with foods as described reference is given in paragraph (b) of in paragraph (d) of this section. this section. The film when extracted (b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30 shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to inch) thickness and shall contact foods exceed 0.0078 milligram per square cen- only of the types identified in table 1 of timeter (0.05 milligram per square § 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor- I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid- conditions of use D through G de- ing by a factor of five. scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007 meter (0.005) inch thickness rep- inch) thickness and may contact all resenting the finished article shall foods, except those containing more meet the following extractive limita- than 8 percent alcohol, under condi- tion when tested by ASTM method tions of use B through H described in F34–76 (Reapproved 1980), ‘‘Standard table 2 of § 176.170(c) of this chapter. Test Method for Liquid Extraction of Film samples of 0.018 centimeter (0.007 Flexible Barrier Materials,’’ which is inch) thickness representing the fin- incorporated by reference. Copies may ished articles shall meet the following be obtained from the American Society extractive limitation when tested by for Testing Materials, 100 Barr Harbor ASTM method F34–76 (Reapproved Dr., West Conshohocken, Philadelphia, 1980), ‘‘Standard Test Methods for Liq- PA 19428-2959, or may be examined at uid Extraction of Flexible Barrier Ma- the National Archives and Records Ad- terials,’’ which is incorporated by ref- ministration (NARA). For information erence. The availability of this incor- on the availability of this material at poration by reference is given in para- NARA, call 202–741–6030, or go to: http:// graph (b) of this section. The film when www.archives.gov/federallregister/ extracted with distilled water at 100 °C codeloflfederallregulations/ (212 °F) for 30 minutes yields ethylene- ibrllocations.html. vinyl acetate-vinyl alcohol oligomers

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not to exceed 0.093 milligram per difluoroethylene, and tetrafluoro- square centimeter (0.6 milligram per ethylene. square inch) of food contact surface as (4) Ethylene-chlorotrifluoroethylene determined by a method entitled ‘‘An- copolymer resins produced by copolym- alytical Method of Determining the erization of nominally 50 mole percent Amount of EVOH in the Extractives of ethylene and 50 mole percent of Residue of EVOH Film,’’ dated March chlorotrifluoroethylene. The copoly- 23, 1987, as developed by the Kuraray mer shall have a melting point of 239 to Co., Ltd., which is incorporated by ref- 243 °C and a melt index of less than or erence in accordance with 5 U.S.C. equal to 20 as determined by ASTM 552(a) and 1 CFR part 51. Copies may be Method D 3275–89 ‘‘Standard Specifica- obtained from the Office of Premarket tion for E-CTFE-Fluoroplastic Mold- Approval (HFS–200), Center for Food ing, Extrusion, and Coating Mate- Safety and Applied Nutrition, Food and rials,’’ which is incorporated by ref- Drug Administration, 5100 Paint erence in accordance with 5 U.S.C. Branch Pkwy., College Park, MD 20740, 552(a) and 1 CFR part 51. Copies may be or may be examined at the Center for obtained from the American Society Food Safety and Applied Nutrition’s for Testing and Materials, 1916 Race Library, 5100 Paint Branch Pkwy., Col- St., Philadelphia, PA 19013, or may be lege Park, MD 20740, or at the National examined at the National Archives and Archives and Records Administration Records Administration (NARA). For (NARA). For information on the avail- information on the availability of this ability of this material at NARA, call material at NARA, call 202–741–6030, or 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (e) The provisions of this section are (b) Fluorocarbon resins that are iden- not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section tate-vinyl alcohol copolymers used in and that comply with extractive limi- the food-packaging adhesives com- tations prescribed in paragraph (c) of plying with § 175.105 of this chapter. this section may be used as articles or components of articles intended for use [47 FR 41531, Sept. 21, 1982, as amended at 49 in contact with food as follows: FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, 2000] (1) Fluorocarbon resins that are iden- tified in paragraphs (a)(1), (a)(2), and § 177.1380 Fluorocarbon resins. (a)(3) of this section and that comply only with the extractive limitations Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and used as articles or components of arti- (c)(2) of this section may be used when cles intended for use in contact with such use is limited to articles or com- food, in accordance with the following ponents of articles that are intended prescribed conditions: for repeated use in contact with food or (a) For the purpose of this section, that are intended for one-time use in fluorocarbon resins consist of basic res- contact with foods only of the types ins produced as follows: identified in § 176.170(c) of this chapter, (1) Chlorotrifluoroethylene resins table 1, under Types I, II, VI, VII-B, produced by the homopolymerization and VIII. of chlorotrifluoroethylene. (2) Fluorocarbon resins that are iden- (2) Chlorotrifluoroethylene-1,1- tified in paragraph (a)(4) of this section difluoroethylene copolymer resins pro- and that comply with the extractive duced by copolymerization of limitations prescribed in paragraphs chlorotrifluoroethylene and 1,1- (c)(1) and (c)(2) of this section may be difluoroethylene. used only when such use is limited to (3) Chlorotrifluoroethylene-1,1- articles or components of articles that difluoroethylene-tetrafluoroethylene are intended for repeated use in con- co-polymer resins produced by co- tact with food. polymerization of (3) In accordance with current good chlorotrifluoroethylene, 1,1- manufacturing practice, those food-

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