21 C.F.R. § 177.1040 Acrylonitrile/styrene copoly-mer.
Title 21 - Food and Drugs
Acrylonitrile/styrene copolymers identified in this section may be safely used as a component of packaging materials subject to the provisions of this section. (a) Identity. For the purposes of this section acrylonitrile/styrene copoly-mers are basic copolymers meeting the specifications prescribed in paragraph (c) of this section. (b) Adjuvants. (1) The copolymers identified in paragraph (c) of this section may contain adjuvant substances required in their production, with the exception that they shall not contain mercaptans or other substances which form reversible complexes with acryl-onitrile monomer. Permissible adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted under applicable regulations in this part, and those authorized in paragraph (b)(2) of this section. (2) The optional adjuvants for the acrylonitrile/styrene copolymer identified in paragraphs (c) (1) and (3) of this section are as follows: (c) Specifications. (d) Interim listing. Acrylonitrile copolymers identified in this section shall comply with the provisions of §180.22 of this chapter. (e) Acrylonitrile copolymer identified in this section may be used to fabricate beverage containers only if they comply with the specifications of item 3 in paragraph (c) of this section. [42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, Sept. 8, 1987]
Title 21: Food and Drugs
PART 177—INDIRECT FOOD ADDITIVES: POLYMERS
Subpart B—Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
§ 177.1040 Acrylonitrile/styrene copoly-mer.
------------------------------------------------------------------------ Substances Limitation------------------------------------------------------------------------Condensation polymer of toluene 0.15 pct maximum. sulfonamide and formaldehyde.------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Maximum Maximum residual extractable acrylonitrile Nitrogen fractions at Conformance withAcrylonitrile/styrene copolymers monomer content content of specified certain specifications of finished copolymer temperatures and article times----------------------------------------------------------------------------------------------------------------1. Acrylonitrile/styrene 80 ppm\1\....... 17.4 to 19 pct. Total nonvolatile Minimum number average copolymer consisting of the extractives not molecular weight is copolymer produced by to exceed 0.01 mg/ 30,000.\1\ polymerization of 66-72 parts in \2\ surface by weight of acrylonitrile and area of the food 28-34 parts by weight of contact article styrene; for use with food of when exposed to Type VI-B identified in table 1 distilled water of § 176.170(c) of this and 3 pct acetic chapter under conditions of use acid for 10 d at C, D, E, F, G described in 66 °C (150 table 2 of § 176.170(c) of °F). this chapter. The extracted copolymer shall not exceed 0.001 mg/in \2\ surface area of the food contact article when exposed to distilled water and 3 pct acetic acid for 10 d at 66 °C (150 °F) \1\.2. Acrylonitrile/styrene 50 ppm\1\....... 12.2 to 17.2 Extracted Minimum 10 pct solution copolymer consisting of the pct. copolymer not to viscosity at 25 °C copolymer produced by exceed 2.0 ppm in (77 °F) is polymerization of 45-65 parts aqueous extract 10cP.\1\ by weight of acrylonitrile and or n-heptane 35-55 parts by weigth of extract obtained styrene; for use with food of when 100 g sample Types, I, II, III, IV, V, VI of the basic (except bottles), VII, VIII, copolymer in the and IX identified in table 1 of form of particles § 176.170(c) of this of a size that chapter under conditions B (not will pass through to exceed 93 °C (200 a U.S. Standard °F)), C, D, E, F, G Sieve No. 6 and described in table 2 of § that will be held 176.170(c) of this chapter. on a U.S. Standard Sieve No. 10 is extracted with 250 mil of deionized water or reagent grade n-heptane at reflux temperature for 2 h.\1\3. Acrylonitrile/styrene 0.10 ppm 17.4 to 19 pct. Total nonvolatile Maximum carbon dioxide copolymer consisting of the (calculated on extractives not permeability at 23 copolymer produced by the basis of to exceed 0.01 mg/ °C (73 °F) for polymerization of 66-72 parts the weight of in \2\ surface the finished article by weight of acrylonitrile and the area of the food is 0.04 barrer.\3\ 28-34 parts by weight of acrylonitrile contact article styrene; for use with food of copolymer resin when exposed to Types VI-A and VI-B identified in the finished distilled water in table 1 of § 176.170(c) articles).\2\ and 3 pct acetic of this chapter under acid for 10 d at conditions of use C, D, E, F, G 66 °C (150 described in table 2 of § °F). 176.170(c) of this chapter. The extracted copolymer shall not exceed 0.001 mg/in \2\ surface area of the food contact article when exposed to distilled water and 3 pct acetic acid for 10 d at 66 °C (150 °F).\1\.----------------------------------------------------------------------------------------------------------------\1\ Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average molecular weight, and solution viscosity, titled: ``Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method''; ``Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210 Resin Pellets''; ``Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,'' and ``Analytical Method for 10% Solution Viscosity of Tyril,'' which are incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS- 200), 5100 Paint Branch Pkwy., College Park, MD 20740, 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.php.\2\ As determined by the method titled ``Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylonitrile in Acrylonitrile Copolyemr Solutions,'' which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, 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.php.\3\ As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction by ASTM method D-1434-82, ``Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,'' which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, and 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.php.
