[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: 21CFR177.2000]
[Page 332-333]
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. 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate
polymers.
The vinylidene chloride/methyl acrylate/methyl methacrylate polymers
(CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section
may be safely used as articles or as a component of articles intended
for use in contact with food subject to the provisions of this section.
(a) Identity. For the purpose of this section, vinylidene chloride/
methyl acrylate/methyl methacrylate polymers consist of basic polymers
produced by the copolymerization of vinylidene chloride/methyl acrylate/
methyl methacrylate such that the basic polymers or the finished food-
contact articles meet the specifications prescribed in paragraph (d) of
this section.
(b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate/methyl methacrylate polymers identified in paragraph (a)
of this section may contain optional adjuvant substances required in the
production of such basic polymers. These optional adjuvant substances
may include substances permitted for such use by regulations in parts
170 through 179 of this chapter, substances generally recognized as safe
in food, and substances used in accordance with a prior sanction of
approval.
(c) Conditions of use. The polymers may be safely used as articles
or as components of articles intended for use in producing,
manufacturing, processing, preparing, treating, packaging, transporting,
or holding food, including processing of packaged food at temperatures
up to 121 [deg]C (250 [deg]F).
(d) Specifications and limitations. The vinylidene chloride/methyl
acrylate/methyl methacrylate basic polymers and/or finished food-contact
articles meet the following specifications and limitations:
(1)(i) The basic vinylidene chloride/methyl acrylate/methyl
methacrylate polymers contain not more than 2 weight percent of polymer
units derived from methyl acrylate monomer and not more than 6 weight
percent of polymer units derived from methyl methacrylate monomer.
(ii) The basic polymers are limited to a thickness of not more than
0.005 centimeter (0.002 inches).
(2) The weight average molecular weight of the basic polymer is not
less than 100,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatography is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, which is
incorporated by reference. Copies are available from the American
Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-
[[Page 333]]
2959, 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.
(3) The basic polymer or food-contact article described in paragraph
(a) of this section, when extracted with the solvent or solvents
characterizing the type of food and under the conditions of time and
temperature characterizing the conditions of its intended use as
determined from tables 1 and 2 of Sec. 176.170(c) of this chapter,
yields net chloroform-soluble extractives in each extracting solvent not
to exceed .08 milligram per square centimeter (0.5 milligram per square
inch) of food-contact surface when tested by the methods described in
Sec. 176.170(d). If the finished food-contact article is itself the
subject of a regulation in parts 174 through 178 and Sec. 179.45 of
this chapter, it shall also comply with any specifications and
limitations prescribed for it by the regulation.
[49 FR 29578, July 23, 1984]
Back to Top
© 2007 Betterchem Corp.
|
