Food and Drug Administration, HHS § 177.1500 (a) For the purpose of this section, the National Archives and Records Ad- nitrile rubber modified acrylonitrile- ministration (NARA). For information methyl acrylate copolymers consist of on the availability of this material at basic copolymers produced by the graft NARA, call 202–741–6030, or go to: http:// copolymerization of 73–77 parts by www.archives.gov/federallregister/ weight of acrylonitrile and 23–27 parts codeloflfederallregulations/ by weight of methyl acrylate in the ibrllocations.html.Copies are applicable presence of 8–10 parts by weight of bu- to the basic copolymers in the form of tadiene-acrylonitrile copolymers con- particles of a size that will pass taining approximately 70 percent by through a U.S. standard sieve No. 6 and weight of polymer units derived from that will be held on a U.S. standard butadiene. sieve No. 10: (b) The nitrile rubber modified acry- (i) Extracted copolymer not to ex- lonitrile-methyl acrylate basic copoly- ceed 2.0 parts per million in aqueous mers meet the following specifications extract obtained when a 100-gram sam- and extractives limitations: ple of the basic copolymers is extracted (1) Specifications. (i) Nitrogen content with 250 milliliters of demineralized is in the range 16.5–19 percent as deter- (deionized) water at reflux temperature mined by Kjeldahl analysis. for 2 hours. (ii) Intrinsic viscosity in acetonitrile (ii) Extracted copolymer not to ex- at 25 °C is not less than 0.29 deciliter ceed 0.5 part per million in n-heptane per gram as determined by ASTM extract obtained when a 100-gram sam- method D1243–79, ‘‘Standard Test Meth- ple of the basic copolymers is extracted od for Dilute Solution Viscosity of with 250 milliliters of reagent grade n- Vinyl Chloride Polymers,’’ which is in- heptane at reflux temperature for 2 corporated by reference. Copies may be hours. obtained from the American Society (c) Acrylonitrile copolymers identi- for Testing Materials, 100 Barr Harbor fied in this section shall comply with Dr., West Conshohocken, Philadelphia, the provisions of § 180.22 of this chap- PA 19428-2959, or may be examined at ter. the National Archives and Records Ad- (d) Acrylonitrile copolymers identi- ministration (NARA). For information fied in this section are not authorized on the availability of this material at to be used to fabricate beverage con- NARA, call 202–741–6030, or go to: http:// tainers. www.archives.gov/federallregister/ [42 FR 14572, Mar. 15, 1977, as amended at 42 codeloflfederallregulations/ FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, ibrllocations.html. 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, (iii) Residual acrylonitrile monomer Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR content is not more than 11 parts per 14481, Apr. 2, 1996] million as determined by gas chroma- tography. § 177.1500 Nylon resins. (iv) Acetonitrile-soluble fraction The nylon resins listed in paragraph after refluxing the base polymer in ace- (a) of this section may be safely used to tonitrile for 1 hour is not greater than produce articles intended for use in 95 percent by weight of the basic co- processing, handling, and packaging polymers. food, subject to the provisions of this (2) Extractives limitations. The fol- section: lowing extractive limitations are de- (a) The nylon resins are manufac- termined by an infrared tured as described in this paragraph so spectrophotometric method titled, as to meet the specifications prescribed ‘‘Infrared Spectrophotometric Deter- in paragraph (b) of this section when mination of Polymer Extracted from tested by the methods described in Borex ® 210 Resin Pellets,’’ which is in- paragraph (d) of this section. corporated by reference. Copies are (1) Nylon 66 resins are manufactured available from the Center for Food by the condensation of hexamethylene- Safety and Applied Nutrition (HFS– diamine and adipic acid. 200), Food and Drug Administration, (2) Nylon 610 resins are manufactured 5100 Paint Branch Pkwy., College Park, by the condensation of hexamethylene- MD 20740, or available for inspection at diamine and sebacic acid. 279 VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00289 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR § 177.1500 21 CFR Ch. I (4–1–11 Edition) (3) Nylon 66/610 resins are manufac- isophthalic acid (CAS Reg. No. 0121–91– tured by the condensation of equal- 5), and bis(4-amino-3-methylcycl- weight mixtures of nylon 66 salts and ohexyl)methane (CAS Reg. No. 6864–37– nylon 610 salts. 5) such that the composition in terms (4) Nylon 6/66 resins manufactured by of ingredients is 34.4±1.5 weight percent the condensation and polymerization of omega-laurolactam, 26.8±0.4 weight per- Nylon 66 salts and epsilon-caprolactam. cent isophthalic acid, and 38.8±0.5 (5) Nylon 11 resins are manufactured weight percent bis(4-amino-3- by the condensation of 11- methylcyclohexyl)-methane. aminoundecanoic acid. (12) Nylon 6I/6T resins (CAS Reg. No. (6) Nylon 6 resins are manufactured 25750–23–6) are manufactured by the by the polymerization of epsilon- condensation of caprolactam. hexamethylenediamine, terephthalic (7) Nylon 66T resins are manufac- acid, and isophthalic acid such that 65 tured by the condensation of to 80 percent of the polymer units are hexamethyl-enediamine, adipic acid, derived from hexamethylene and terephthalic acid such that com- isophthalamide. position in terms of ingredients is (13)(i) Nylon 6/12 resins (CAS Reg. No. 43.1±0.2 weight percent hexamethyl- 25191–04–2) are manufactured by the co- enediamine, 35.3±1.2 weight percent polymerization of a 1 to 1 ratio by adipic acid, and 21.6±1.2 weight percent weight of epsilon-caprolactam and terephthalic acid. omega-laurolactam. (8) Nylon 612 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No. by the condensation of 25191–04–2) are manufactured by the co- hexamethylenediamine and polymerization of a ratio of at least 80 dodecanedioic acid. weight percent of epsilon-caprolactam (9) Nylon 12 resins are manufactured and no more than 20 weight percent of by the condensation of omega- omega-laurolactam. laurolactam. (14) Nylon 6/69 resins (CAS Reg. No. (10)(i) Impact modified Nylon MXD–6 51995–62–1) are manufactured by the resins (CAS Reg. No. 59655–05–9) manu- condensation of 49.5+0.5 weight percent factured by the condensation of adipic epsilon-caprolactam, 19.4+0.2 weight acid, 1,3-benzenedimethanamine, and percent hexamethylenediamine and alpha-(3-aminopropyl)-omega-(3-amino- 31.2+0.3 weight percent azelaic acid. propoxy)poly- oxyethylene under such (15) Nylon 46 resins (CAS Reg. No. conditions that the alpha-(3-amino- 50327–77–0) are manufactured by the propyl)-omega-(3-aminopropoxy) condensation of 1,4-butanediamine and polyoxyethylene monomer content adipic acid. does not exceed 7 percent by weight of (16) Nylon resins PA 6–3–T (CAS Reg- the finished resin. istry No. 26246–77–5) are manufactured (ii) Nylon MXD–6 resins (CAS Reg. by the condensation of 50 mol percent No. 25718–70–1) manufactured by the 1,4-benzenedicarboxylic acid, dimethyl condensation of adipic acid and 1,3- ester and 50 mol percent of an benzenedimethanamine. equimolar mixture of 2,2,4-trimethyl- (11) Nylon 12T resins are manufac- 1,6-hexanediamine and 2,4,4-trimethyl- tured by the condensation of omega- 1,6-hexanediamine. laurolactam (CAS Reg. No. 0947–04–6), (b) Specifications: Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate 1. Nylon 66 resins .............. 1.14±.015 475–495 Dissolves in .................................. 1.5 1.5 0.2 0.2 1 h. 2. Nylon 610 resins ............ 1.09±.015 405–425 Insoluble .................................. 1.0 2.0 1.0 1.0 after 1 h. 280 VerDate Mar<15>2010 07:41 May 13, 2011 Jkt 223067 PO 00000 Frm 00290 Fmt 8010 Sfmt 8010 Y:\SGML\223067.XXX 223067 wwoods2 on DSK1DXX6B1PROD with CFR Food and Drug Administration, HHS § 177.1500 Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate 3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in .................................. 1.5 2.0 1.0 1.0 1 h. 4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ......do......... .................................. 2.0 2.0 1.5 1.5 silon-caprolactam mon- omer content not to ex- ceed 0.7 percent by weight. 4.2 Nylon 6/66 resins with 1.14±.015 380–425 ......do......... .................................. 0.8 1.0 0.5 0.5 combined caprolactam content greater than 60 percent and residual ep- silon-caprolactam mon- omer content not to ex- ceed 0.4 percent by weight. For use only as specified in § 177.1395 of this chapter (CAS Reg. No. 24993–04–2). 5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble .................................. .30 .35 .25 .3 in articles intended for 1- after 1 h. time use or repeated use in contact with food. 5.2 Nylon 11 resins for use 1.04±.015 355–375 ......do......... .................................. .35 1.60 .35 .40 only: a. In articles intended for repeated use in contact with food. b. In side-seam cements for articles intended for 1-time use in contact with food and which are in compliance with § 175.300 of this chap- ter.