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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.

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

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.1320]



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. 177.1320 Ethylene-ethyl acrylate copolymers.

Ethylene-ethyl acrylate copolymers may be safely used to produce packaging materials, containers, and equipment intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions:

(a) Ethylene-ethyl acrylate copolymers consist of basic resins produced by the catalytic copolymerization of ethylene and ethyl acrylate, to which may have been added certain optional substances to impart desired technological properties to the resin. Subject to any limitations prescribed in this section, the optional substances may include:

(1) Substances generally recognized as safe in food and food packaging.

(2) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, prior sanction, or approvals.

(b) The ethyl acrylate content of the copolymer does not exceed 8 percent by weight unless it is blended with polyethylene or with one or more olefin copolymers complying with § 177.1520 or with a mixture of polyethylene and one or more olefin copolymers, in such proportions that the ethyl acrylate content of the blend does not exceed 8 percent by weight, or unless it is used in a coating complying with § 175.300 or § 176.170 of this chapter, in such proportions that the ethyl acrylate content does not exceed 8 percent by weight of the finished coating.

(c) Ethylene-ethyl acrylate copolymers or the blend shall conform to the specifications prescribed in paragraph (c)(1) of this section and shall meet the ethyl acrylate content limits prescribed in paragraph (b) of this section, and the extractability limits prescribed in paragraph (c)(2) of this section, when tested by the methods prescribed for polyethylene in § 177.1520.

(1) Specifications - (i) Infrared identification. Ethylene-ethyl acrylate copolymers can be identified by their characteristic infrared spectra.

(ii) Quantitative determination of ethyl acrylate content. The ethyl acrylate can be determined by the infrared spectra. Prepare a scan from 10.5 microns to 12.5 microns. Obtain a baseline absorbance at 11.6 microns and divide by the plaque thickness to obtain absorbance per mil. From a previously prepared calibration curve, obtain the amount of ethyl acrylate present.

(iii) Specific gravity. Ethylene-ethyl acrylate copolymers have a specific gravity of not less than 0.920 nor more than 0.935, as determined by ASTM method D1505-68 (Reapproved 1979), "Standard Test Method for Density of Plastics by the Density-Gradient Technique," 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.

(2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may be used in contact with food except as a component of articles used for packaging or holding food during cooking provided they meet the following extractability limits:

(i) Maximum soluble fraction of 11.3 percent in xylene after refluxing and subsequent cooling to 25 deg.C.

(ii) Maximum extractable fraction of 5.5 percent when extracted with n- hexane at 50 deg.C.

(d) The provisions of paragraphs (b) and (c)(2) of this section are not applicable to ethylene-ethyl acrylate copolymers used in the formulation of adhesives complying with § 175.105 of this chapter.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19, 1984]

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