21 CFR § 177.1635 - Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).

§ 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).

Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) identified in this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section:

(a)Identity. For the purposes of this section, poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) are basic polymers, manufactured as described in this paragraph, meeting the specifications prescribed in paragraph (c) of this section.

(1) Poly(p-methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced by the polymerization of p-methylstyrene.

(2) Rubber-modified poly(p-methylstyrene) (CAS Reg. No. 33520-88-6) polymer produced by combining styrene-butadiene copolymer and/or polybutadiene with poly(p-methylstyrene), either during or after polymerization of the poly(p-methylstyrene), such that the finished polymers contain not less than 75 weight percent of total polymer units derived from p-methylstyrene) monomer.

(b)Optional adjuvants. The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. Such optional adjuvant substances may include substances permitted for such use by applicable regulations in this chapter, substances generally recognized as safe in food, substances generally recognized as safe in indirect additives, and substances used in accordance with prior sanction or approval.

(c)Specifications.

(1) Poly(p-methylstyrene) basic polymers identified in paragraph (a)(1) of this section shall contain not more than 1 weight percent of total residual p-methystyrene monomer, as determined by a gas chromatographic method titled, “Gas Chromatographic Determination of PMS and PET in PPMS Basic Polymers,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 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.

(2) Rubber-modified poly(p-methylstyrene) basic polymers identified in paragraph (a)(2) of this section shall contain not more than 0.5 weight percent of total residual p-methylstyrene monomer, as determined by the method identified in paragraph (c)(1) of this section

(d)Other specifications and limitations. The poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) identified in and complying with this section, when used as components of the food-contact surface of any article that is the subject of a regulation in parts 175, 176, 177, 178 and § 179.45 of this chapter, shall comply with any specifications and limitations prescribed by such regulation for the article in the finished form in which it is to contact food.

(e)Conditions of use. Poly(p-methylstyrene) basic polymers and rubber-modified poly(p-methylstyrene) basic polymers identified in paragraphs (a)(1) and (a)(2), respectively, of this section shall be used in contact with food only under conditions of use B through H set forth in table 2 of § 176.170(c) of this chapter.

[48 FR 31384, July 8, 1983, as amended at 54 FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, 1990]