[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: 21CFR177.1990]
[Page 330-331]
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. 177.1990 Vinylidene chloride/methyl acrylate copolymers.
The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No.
25038-72-6) identified in paragraph (a) of this section may be safely
used as an article or as a component of an article intended for use in
contact with food subject to the provisions of this section.
(a) Identity. For the purposes of this section vinylidene chloride/
methyl acrylate copolymers consist of basic copolymers produced by the
copolymerization of vinylidene chloride and methyl acrylate such that
the copolymers contain not more than 15 weight-percent of polymer units
derived from methyl acrylate.
(b) Optional adjuvant substances. The basic vinylidene chloride/
methyl acrylate copolymers identified in paragraph (a) of this section
may contain optional adjuvant substances required in the production of
such basic copolymers. 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 or approval.
(c) Specifications. (1) The methyl acrylate content is determined by
an infrared spectrophotometric method titled ``Determination of
Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate Copolymers,''
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) The weight average molecular weight of the copolymer is not less
than 50,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatograph is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, ``Standard
Test Method for Molecular Weight Averages and Molecular Weight
Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel
Permeation Chromatography-GPC),'' which is incorporated by reference.
Copies are available from University Microfilms International, 300 North
Zeeb Rd., Ann Arbor, MI 48106, 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) Residual vinylidene chloride and residual methyl acrylate in the
copolymer in the form in which it will contact food (unsupported film,
barrier layer, or as a copolymer for blending) will not exceed 10 parts
per million and 5 parts per million, respectively, as determined by
either a gas chromatographic method titled ``Determination of Residual
Vinylidene Chloride and Methyl Acrylate in Vinylidene Chloride/Methyl
Acrylate Copolymer Resins and Films,'' or, alternatively, ``Residual
Methyl Acrylate and Vinylidene Chloride Monomers in Saran MA/VDC Resins
and Pellets by Headspace Gas Chromatography,'' dated March 3, 1986,
which are incorporated by reference in accordance with 5 U.S.C. 552(a).
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.
[[Page 331]]
(d) Extractives limitations. The basic copolymer resin in the form
of granules that will pass through a U.S. Standard Sieve No. 45 (350
microns) shall meet the following extractives limitations:
(1) 10-gram samples of the resin, when extracted separately with 100
milliliters of distilled water at 121 [deg]C (250 [deg]F) for 2 hours,
and 100 milliliters of n-heptane at 66 [deg]C (150 [deg]F) for 2 hours,
shall yield total nonvolatile extractives not to exceed 0.5 percent by
weight of the resin.
(2) The basic copolymer in the form of film when extracted
separately with distilled water at 121 [deg]C (250 [deg]F) for 2 hours
shall yield total nonvolatile extractives not to exceed 0.047 milligram
per square centimeter (0.3 milligram per square inch).
(e) Conditions of use. The copolymers may be safely used as articles
or components of articles intended for use in producing, manufacturing,
processing, preparing, treating, packaging, transporting, or holding
food, including processing of packaged food at temperatures not to
exceed 135 [deg]C (275 [deg]F).
(f) Other specifications and limitations. The vinylidene chloride-
methyl acrylate copolymers identified in and complying with this
section, when used as components of the food contact surface of any
article that is subject to a regulation in parts 174 through 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.
[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended at
53 FR 47185, Nov. 22, 1988; 54 FR 24898, June 12, 1989]
Additives that reference this regulation: |
