[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1360]
[Page 268-269]
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 269]]
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]
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