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177.1820 Styrene-maleic anhydride copolymers.

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[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: 21CFR177.1820]

[Page 320-321]
                        TITLE 21--FOOD AND DRUGS
                          SERVICES (CONTINUED)
Subpart B_Substances for Use as Basic Components of Single and Repeated 
                        Use Food Contact Surfaces
Sec.  177.1820  Styrene-maleic anhydride copolymers.

    Styrene-maleic anhydride copolymers identified in paragraph (a) of 
this section may be safely used as articles or components of articles 
intended for use in contact with food, subject to provisions of this 
    (a) For the purpose of this section, styrene-maleic anhydride 
copolymers are those produced by the polymerization of styrene and 
maleic anhydride so that the finished polymers meet the specifications 
prescribed in paragraph (b) of this section, when tested by the methods 
described in paragraph (c) of this section.
    (b) Specifications:

[[Page 321]]

                                                                                 Maximum            Maximum
                                                                               extractable        extractable
                                  Molecular                     Residual       fraction in       fraction in n-
                                   weight       Residual         maleic      distilled water       heptane at
   Styrene-maleic copolymers      (minimum       styrene       anhydride       at specified        specified
                                   number        monomer        monomer       temperatures,      temperatures,
                                  average)                                      times, and         times, and
                                                                              particle size      particle size
1. Styrene-maleic anhydride          70,000  0.3 weight      0.1 weight     0.006 weight       0.02 weight
 copolymers containing not more               percent.        percent.       percent at         percent at 73
 than 15 pct maleic anhydride                                                reflux             [deg]F for 2 hr
 units by weight; for use as                                                 temperature for    utilizing
 articles or as components of                                                1 hr utilizing     particles of a
 articles that contact food of                                               particles of a     size that will
 Types I, II, III, IV-A, IV-B,                                               size that will     pass through a
 V, VI-B (except carbonated                                                  pass through a     U.S. standard
 beverages), VII-A, VII-B,                                                   U.S. standard      sieve No. 10 and
 VIII, and IX identified in                                                  sieve No. 10 and   will be held on
 table 1 in Sec.   176.170(c)                                                will be held on    a U.S. standard
 of this chapter under                                                       a U.S. standard    sieve No. 20.
 conditions of use B, C, D, E,                                               sieve No. 20.
 F, G, and H described in table
 2 in Sec.   176.170(c) of this
2. Styrene-maleic anhydride      ..........  0.3...........  0.1..........  0.015 weight       1.0 weight
 copolymer modified with                                                     percent at         percent at 23
 butadiene, (CAS Reg. No. 27288-                                             reflux             [deg]C (73
 99-9) containing not more than                                              temperature for    [deg]F) for 2
 15 percent maleic anhydride                                                 1 hour utilizing   hours utilizing
 units by weight and not more                                                particles of a     particles of a
 than 20 percent styrene-                                                    size that will     size that will
 butadiene and/or butadiene                                                  pass through a     pass through a
 rubber units by weight; for                                                 U.S. standard      U.S. standard
 use (except carbonated                                                      sieve No. 10 and   sieve No. 10 and
 beverage bottles) as articles                                               will be held on    will be held on
 or as components of articles                                                a U.S. standard    a U.S. standard
 that contact food of Types I,                                               sieve No. 20.      sieve No. 20.
 II, III, IV-A, IV-B, V, VI,
 identified in table I in Sec.
  176.170(c) of this chapter
 under conditions of use B, C,
 D, E, F, G, and H described in
 table 2 in Sec.   176.170(c)
 of this chapter.

    (c) The analytical methods for determining conformance with 
specifications for styrene-maleic anhydride copolymers prescribed in 
this section are as follows:
    (1) Molecular weight. Molecular weight shall be determined by 
membrane osmometry.
    (2) Residual styrene monomer content. Residual styrene monomer 
content shall be determined by the method described in Sec.  
    (3) Residual maleic anhydride monomer content. Residual maleic 
anhydride monomer content shall be determined by a gas chromatographic 
method titled ``Determination of Residual Maleic Anhydride in Polymers 
by Gas Chromatography,'' which is incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or available for inspection 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://
    (d) The provisions of this section are not applicable to styrene-
maleic anhydride copolymers listed in other sections of this subpart.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19, 1982; 
47 FR 14698, Apr. 6, 1982; 54 FR 24898, June 12, 1989]

Additives that reference this regulation:

Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1820

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