[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR177.1360] [Page 261-262] 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. 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers. Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221- 27-2) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by the partial or complete alcoholysis or hydrolysis of those ethylene- vinyl acetate copolymers complying with Sec. 177.1350. (1) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 30 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (b) of this section. (2) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 15 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (c) of this section. (3) Those copolymers containing 17 to 40 percent ethylene and 60 to 83 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (d) of this section. (b) The finished food-contact article shall not exceed 0.013 centimeter (0.005 inch) thickness and shall contact foods only of the types identified in table 1 of Sec. 176.170(c) of this chapter in Categories I, II, IV-B, VI, VII-B, and VIII under conditions of use D through G described in table 2 of Sec. 176.170(c) of this [[Page 262]] chapter. Film samples of 0.013 centimeter (0.005) inch thickness representing the finished article shall meet the following extractive limitation when tested by ASTM method F34-76 (Reapproved 1980), ``Standard Test Method for Liquid Extraction of Flexible Barrier Materials,'' which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (1) The film when extracted with distilled water at 21 [deg]C (70 [deg]F) for 48 hours yields total extractives not to exceed 0.0047 milligram per square centimeter (0.03 milligram per square inch) of food-contact surface. (2) The film when extracted with 50 percent ethyl alcohol at 21 [deg]C (70 [deg]F) for 48 hours yields total extractives not to exceed 0.0062 milligram per square centimeter (0.04 milligram per square inch) of food-contact surface. (c) The finished food-contact article shall not exceed 0.0076 centimeter (0.003 inch) thickness and shall contact foods only of the types identified in table 1 of Sec. 176.170(c) of this chapter in Categories III, IV-A, VII-A, and IX under conditions of use F and G described in table 2 of Sec. 176.170(c) of this chapter. Film samples of 0.0076 centimeter (0.003 inch) thickness representing the finished articles shall meet the following extractive limitation when tested by ASTM method F34-76 (Reapproved 1980), ``Standard Test Method for Liquid Extraction of Flexible Barrier Materials,'' which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b) of this section. The film when extracted with n-heptane at 38 [deg]C (100 [deg]F) for 30 minutes yields total extractives not to exceed 0.0078 milligram per square centimeter (0.05 milligram per square inch) of food-contact surface, after correcting the total extractives by dividing by a factor of five. (d) The finished food-contact article shall not exceed 0.018 centimeter (0.007 inch) thickness and may contact all foods, except those containing more than 8 percent alcohol, under conditions of use B through H described in table 2 of Sec. 176.170(c) of this chapter. Film samples of 0.018 centimeter (0.007 inch) thickness representing the finished articles shall meet the following extractive limitation when tested by ASTM method F34-76 (Reapproved 1980), ``Standard Test Methods for Liquid Extraction of Flexible Barrier Materials,'' which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (b) of this section. The film when extracted with distilled water at 100 [deg]C (212 [deg]F) for 30 minutes yields ethylene-vinyl acetate-vinyl alcohol oligomers not to exceed 0.093 milligram per square centimeter (0.6 milligram per square inch) of food contact surface as determined by a method entitled ``Analytical Method of Determining the Amount of EVOH in the Extractives Residue of EVOH Film,'' dated March 23, 1987, as developed by the Kuraray Co., Ltd., which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (e) The provisions of this section are not applicable to ethylene- vinyl acetate-vinyl alcohol copolymers used in the food-packaging adhesives complying with Sec. 175.105 of this chapter. [47 FR 41531, Sept. 21, 1982, as amended at 49 FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, 2000]