[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR177.1990] [Page 314-316] 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. [[Page 315]] (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, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (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 Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (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, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408. (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 [[Page 316]] 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]