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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.1310]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

Subpart B - Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces

Sec. 177.1310 Ethylene-acrylic acid copolymers.

The ethylene-acrylic acid copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section.

(a) The ethylene-acrylic acid copolymers consist of basic copolymers produced by the copolymerization of ethylene and acrylic acid such that the finished basic copolymers contain no more than:

(1) 10 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (b) of this section; and

(2) 25 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (c) of this section.

(b) The finished food-contact articles made with no more than 10 percent total polymer units derived from acrylic acid, when extracted with the solvent or solvents characterizing the type of food and under the conditions of its intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yield net acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods prescribed in § 177.1330(e)(1), (3)(i) through (iv), (4), (5), and (6), except that

(1) The total residue method using 3 percent acetic acid, as prescribed in § 177.1330(e)(6)(i)(a ), does not apply, and

(2) The net acidified chloroform-soluble extractives from paper and paperboard complying with § 176.170 of this chapter may be corrected for wax, petrolatum, and mineral oil as provided in § 176.170(d)(5)(iii)(b ) of this chapter.

If the finished food-contact article is itself the subject of a regulation in parts 174, 175, 176, 177, 178, and § 179.45 of this chapter, it shall also comply with any specifications and limitations prescribed for it by that regulation.

(c) The finished food-contact layer made with basic copolymers containing more than 10 weight-percent but no more than 25 weight-percent of total polymer units derived from acrylic acid and with a maximum thickness of 0.0025 inch (2.5 mils) may be used in contact with food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table 1 of § 176.170(c) of the chapter under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter, and in contact with food types III, IVA, V, VIIA, and IX identified in table 1 of § 176.170(c) of this chapter under conditions of use E through G as described in table 2 of § 176.170(c) of this chapter.

(d) The provisions of this section are not applicable to ethylene-acrylic acid copolymers used in food-packaging adhesives complying with § 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, 1988]

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