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177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.

Home > Regulations > Indirect food additives: Polymers > 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1360]

[Page 267-268]
 
                        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 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, 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.
    (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

[[Page 268]]

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 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.
    (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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1360


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