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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 Mar 22, 2024.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.1312]



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. 177.1312 Ethylene-carbon monoxide copolymers.

The ethylene-carbon monoxide 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) Identity. For the purposes of this section, ethylene-carbon monoxide copolymers (CAS Reg. No. 25052-62-4) consist of the basic polymers produced by the copolymerization of ethylene and carbon monoxide such that the copolymers contain not more than 30 weight-percent of polymer units derived from carbon monoxide.

(b) Conditions of use. (1) The polymers may be safely used as components of the food-contact or interior core layer of multilaminate food-contact articles.

(2) The polymers may be safely used as food-contact materials at temperatures not to exceed 121 deg.C (250 deg.F).

(c) Specifications. (1) Food-contact layers formed from the basic copolymer identified in paragraph (a) of this section shall be limited to a thickness of not more than 0.01 centimeter (0.004 inch).

(2) The copolymers identified in paragraph (a) of this section shall have a melt index not greater than 500 as determined by ASTM method D1238-82, condition E "Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer," 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 American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 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.

(3) The basic copolymer identified in paragraph (a) of this section, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use, as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields net chloroform-soluble extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface when tested by methods described in § 176.170(d) of this chapter.

(4) The provisions of this section are not applicable to ethylene-carbon monoxide copolymers complying with § 175.105 of this chapter.

[57 FR 32422, July 22, 1992]

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