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178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3790]

[Page 438-439]
 
                        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 
SANITIZERS--Table of Contents
 
             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 439]]


    (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.





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3790


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