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177.1990 Vinylidene chloride/methyl acrylate copolymers.

Home > Regulations > Indirect food additives: Polymers > 177.1990 Vinylidene chloride/methyl acrylate copolymers.



[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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1990


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