[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: 21CFR175.350]
[Page 193-194]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 175 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
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
[[Page 194]]
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 Sec. 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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