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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 April 1 2018.

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]
[Revised as of April 1, 2018]
[CITE: 21CFR175.350]



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 175 -- INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

Subpart C--Substances for Use as Components of Coatings

Sec. 175.350 Vinyl acetate/crotonic acid copolymer.

A copolymer of vinyl acetate and crotonic acid may be safely used as a coating or as a component of a coating which is the food-contact surface of polyolefin films intended for packaging food, subject to the provisions of this section.

(a) The copolymer may contain added optional substances to impart desired properties.

(b) The quantity of any optional substance does not exceed the amount reasonably required to accomplish the intended physical or technical effect nor any limitations further provided.

(c) Any optional substance that is the subject of a regulation in parts 174, 175, 176, 177, 178, and 179.45 of this chapter conforms with any specifications in such regulation.

(d) Optional substances as provided in paragraph (a) of this section include:

(1) Substances generally recognized as safe in food.

(2) Substances subject to prior sanction or approval for uses with a copolymer of vinyl acetate and crotonic acid and used in accordance with such sanction or approval.

(3) Substances identified in this subparagraph and subject to such limitations as are provided:

List of substances Limitations
Silica
Japan wax

(e) Copolymer of vinyl acetate and crotonic acid used as a coating or as a component of a coating conforming with the specifications of paragraph (e)(1) of this section are used as provided in paragraph (e)(2) of this section.

(1) Specifications. (i) The chloroform-soluble portion of the water extractives of the coated film obtained with distilled water at 120 deg. F for 24 hours does not exceed 0.5 milligram per square inch of coated surface.

(ii) The chloroform-soluble portion of the n- heptane extractives of the coated film obtained with n- heptane at 70 deg. F for 30 minutes does not exceed 0.5 milligram per square inch of coated surface.

(2) Conditions of use. The copolymer of vinyl acetate and crotonic acid is used as a coating or as a component of a coating for polyolefin films for packaging bakery products and confectionery.

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