[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
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 177_INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
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
section.
(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:
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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
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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
chapter.
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,
VII-A, VII-B, VIII, and IX
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.
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(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.
177.1640(d).
(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://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
(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: |
