[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: 21CFR178.3790]
[Page 439-440]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 178 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
Subpart D Certain Adjuvants and Production Aids
Sec. 178.3790 Polymer modifiers in semirigid and rigid vinyl
chloride plastics.
The polymers identified in paragraph (a) of this section may be
safely admixed, alone or in mixture with other permitted polymers, as
modifiers in semirigid and rigid vinyl chloride plastic food-contact
articles prepared from vinyl chloride homopolymers and/or from vinyl
chloride copolymers complying with Sec. 177.1950, Sec. 177.1970, and/
or Sec. 177.1980 of this chapter, in accordance with the following
prescribed conditions:
(a) For the purpose of this section, the polymer modifiers are
identified as follows:
(1) Acrylic polymers identified in this subparagraph provided that
such polymers contain at least 50 weight-percent of polymer units
derived from one or more of the monomers listed in paragraph (a)(1)(i)
of this section.
(i) Homopolymers and copolymers of the following monomers:
n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
Methyl methacrylate.
(ii) Copolymers produced by copolymerizing one or more of the
monomers listed in paragraph (a)(1)(i) of this section with one or more
of the following monomers:
Acrylonitrile.
Butadiene.
a-Methylstyrene.
Styrene.
Vinylidene chloride.
[[Page 440]]
(iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this
section containing no more than 5 weight-percent of total polymer units
derived by copolymerization with one or more of the following monomers:
Acrylic acid.
1,3-Butylene glycol dimethacrylate.
Divinylbenzene.
Methacrylic acid.
(iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii),
and (iii) of this section; provided that no chemical reactions, other
than addition reactions, occur when they are mixed.
(2) Polymers identified in paragraph (a)(1) of this section combined
during their polymerization with butadiene-styrene copolymers; provided
that no chemical reactions, other than addition reactions, occur when
they are combined. Such combined polymers may contain 50 weight-percent
or more of total polymer units derived from the butadiene-styrene
copolymers.
(b) The polymer content of the finished plastic food-contact article
consists of:
(1) Not less than 80 weight-percent of polymer units derived from
the vinyl chloride polymers identified in the introduction to this
section and not more than 5 weight-percent of polymer units derived from
polymers identified in paragraph (a)(1) of this section and may
optionally contain up to 15 weight-percent of polymer units derived from
butadiene-styrene copolymers; or
(2) Not less than 50 weight-percent of polymer units derived from
the vinyl chloride polymers identified in the introduction to this
section, not more than 50 weight-percent of polymer units derived from
homopolymers and/or copolymers of ethyl acrylate and methyl
methacrylate, and not more than 30 weight-percent of polymer units
derived from copolymers of methyl methacrylate, a-methylstyrene and
acrylonitrile and may optionally contain up to 15 weight-percent of
polymer units derived from butadiene-styrene copolymers.
(c) No chemical reactions, other than addition reactions, occur
among the vinyl chloride polymers and the modifying polymers present in
the polymer mixture used in the manufacture of the finished plastic
food-contact article.
(d) The finished plastic food-contact article, 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 Sec. 176.170(c) of
this chapter, yields extractives not to exceed the limits prescribed in
Sec. 177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by
the methods prescribed in Sec. 177.1010 (c) of this chapter.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
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