21 CFR § 177.1480 - Nitrile rubber modified acrylonitrile-methyl acrylate copolymers.
Nitrile rubber modified acrylonitrile-methyl acrylate copolymers identified in this section may be safely used as components of articles intended for food-contact use under conditions of use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, subject to the provisions of this section.
(a) For the purpose of this section, nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of basic copolymers produced by the graft copolymerization of 73-77 parts by weight of acrylonitrile and 23-27 parts by weight of methyl acrylate in the presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene.
(b) The nitrile rubber modified acrylonitrile-methyl acrylate basic copolymers meet the following specifications and extractives limitations:
(i) Nitrogen content is in the range 16.5-19 percent as determined by Kjeldahl analysis.
(ii) Intrinsic viscosity in acetonitrile at 25 °C is not less than 0.29 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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.
(iii) Residual acrylonitrile monomer content is not more than 11 parts per million as determined by gas chromatography.
(iv) Acetonitrile-soluble fraction after refluxing the base polymer in acetonitrile for 1 hour is not greater than 95 percent by weight of the basic copolymers.
(2) Extractives limitations. The following extractive limitations are determined by an infrared spectrophotometric method titled, “Infrared Spectrophotometric Determination of Polymer Extracted from Borex ® 210 Resin Pellets,” which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., 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.Copies are applicable to the basic copolymers in the form of particles of a size that will pass through a U.S. standard sieve No. 6 and that will be held on a U.S. standard sieve No. 10:
(i) Extracted copolymer not to exceed 2.0 parts per million in aqueous extract obtained when a 100-gram sample of the basic copolymers is extracted with 250 milliliters of demineralized (deionized) water at reflux temperature for 2 hours.
(ii) Extracted copolymer not to exceed 0.5 part per million in n-heptane extract obtained when a 100-gram sample of the basic copolymers is extracted with 250 milliliters of reagent grade n-heptane at reflux temperature for 2 hours.
(d) Acrylonitrile copolymers identified in this section are not authorized to be used to fabricate beverage containers.