[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR177.1820] [Page 305-306] 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: [[Page 306]] ---------------------------------------------------------------------------------------------------------------- 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) of will be held on a U.S. standard this chapter under conditions a U.S. standard sieve No. 20. of use B, C, D, E, F, G, and H sieve No. 20. 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. ---------------------------------------------------------------------------------------------------------------- (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, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (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]