[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR177.1635]
[Page 312-313]
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. 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methyl
styrene).
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
[[Page 313]]
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,
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.
(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 Sec. 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 Sec. 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]
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