Food and Drug Administration, HHS § 177.1480

§ 177.1440 4,4′-Isopropylidenediphenol- in other sections of subchapter B of epichlorohydrin resins minimum this chapter. molecular weight 10,000. 4,4′-Isopropylidenediphenol-epichlo- § 177.1460 Melamine-formaldehyde resins in molded articles. rohydrin resins having a minimum molecular weight of 10,000 may be safely Melamine-formaldehyde resins may used as articles or components of arti- be safely used as the food-contact sur- cles intended for use in producing, face of molded articles intended for use manufacturing, packing, processing, in producing, manufacturing, packing, preparing, treating, packaging, trans- processing, preparing, treating, pack- porting, or holding food in accordance aging, transporting, or holding food in with the following prescribed condi- accordance with the following pre- tions: scribed conditions: (a) 4,4′-Isopropylidenediphenol-ep- (a) For the purpose of this section, ichlorohydrin resins consist of basic melamine-formaldehyde resins are resins produced by the condensation of those produced when 1 mole of mel- equimolar amounts of 4,4′- amine is made to react with not more isopropylidenediphenol and than 3 moles of formaldehyde in water epichlorohydrin terminated with phe- solution. nol, to which may have been added cer- (b) The resins may be mixed with re- tain optional adjuvant substances re- fined woodpulp and the mixture may quired in the production of the resins. contain other optional adjuvant sub- (b) The optional adjuvant substances stances which may include the fol- required in the production of the resins lowing: may include substances generally rec- List of substances Limitations ognized as safe in food, substances used in accordance with a prior sanction or Colorants used in accord- approval, and the following: ance with § 178.3297 of this chapter. Dioctyl phthalate ...... For use as lubricant. List of substances Limitations Hexamethylenetetramine For use only as polymerization reaction control agent. Butyl alcohol ...... Not to exceed 300 p.p.m. as re- Phthalic acid anhydride .. Do. sidual solvent in finished resin. Zinc stearate ...... For use as lubricant. Ethyl alcohol. Toluene ...... Not to exceed 1,000 p.p.m. as residual solvent in finished resin. (c) The molded melamine-formaldehyde articles in the finished form in (c) 4,4′-Isopropylidenediphenol-ep- which they are to contact food, when ichlorohydrin resins shall meet the fol- extracted with the solvent or solvents lowing nonvolatile extractives limita- characterizing the type of food and tions: under the conditions of time and tem- (1) Maximum extractable nonvolatile perature as determined from tables 1 fraction of 2 parts per million when ex- and 2 of § 175.300(d) of this chapter, tracted with distilled water at 70 °C for shall yield net chloroform-soluble ex- 2 hours, using a volume-to-surface tractives not to exceed 0.5 milligram ratio of 2 milliliters per square inch. per square inch of food-contact surface. (2) Maximum extractable nonvolatile [42 FR 14572, Mar. 15, 1977, as amended at 56 fraction of 3 parts per million when ex- FR 42933, Aug. 30, 1991] tracted with n-heptane at 70 °C for 2 hours, using a volume-to-surface ratio § 177.1480 Nitrile rubber modified ac- of 2 milliliters per square inch. rylonitrile-methyl acrylate copoly- (3) Maximum extractable nonvolatile mers. fraction of 6 parts per million when ex- Nitrile rubber modified acrylonitrile- tracted with 10 percent (by volume) methyl acrylate copolymers identified ethyl alcohol in distilled water at 70 °C in this section may be safely used as for 2 hours, using a volume-to-surface components of articles intended for ratio of 2 milliliters per square inch. food-contact use under conditions of (d) The provisions of this section are use D, E, F, or G described in table 2 of not applicable to 4,4′-isopropylidene- § 176.170(c) of this chapter, subject to diphenol-epichlorohydrin resins listed the provisions of this section.

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(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.

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