(v) Fillers. Aluminum hydroxide. Asbestos fiber, chrysotile or crocidolite. Carbon black (channel process or furnace combustion process; total carbon black not to exceed 50 percent by weight of rubber product; furnace combustion black content not to exceed 10 percent by weight of rubber products intended for use in contact with milk or edible oils). Cork. Cotton (floc, fibers, fabric). Mica. Nylon (floc, fibers, fabric). Silica. Titanium dioxide. Zinc carbonate. Zinc sulfide. (vi) Colorants. Colorants used in accordance with § 178.3297 of this chapter. (vii) Lubricants (total not to exceed 2 percent by weight of rubber product). Polyethylene. Sodium stearate. (viii) Emulsifiers. Fatty acid salts, sodium or potassium. Naphthalene sulfonic acid-formaldehyde condensate, sodium salt. Rosins and rosin-derivatives identified in Tall oil mixed soap (calcium, potassium, and sodium). (ix) Miscellaneous (total not to exceed 5 percent by weight of rubber product). Animal glue as described in § 178.3120 of this chapter. Azodicarbonamide as chemical blowing agent. 2-Anthraquinone sulfonic acid sodium salt for use only as polymerization inhibitor in chloroprene polymers and not to exceed 0.03 percent by weight of the chloroprene polymers. 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5) for use as a biocide in uncured liquid rubber latex not to exceed 0.02 percent by weight of the latex solids, where the total of all items listed in paragraph (c)(4)(ix) of this section does not exceed 5 percent of the rubber product. n-Butyllithium for use only as polymerization catalyst for polybutadiene. 4-tert-Butyl-o-thiocresol as peptizing agent. tert-Butyl peracetate. p-tert-Butylpyrocatechol. Dialkyl (C8-C18 Di- and triethanolamine. (d) Rubber articles intended for use with dry food are so formulated and cured under conditions of good manufacturing practice as to be suitable for repeated use. (e) Rubber articles intended for repeated use in contact with aqueous food shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with distilled water at reflux temperature, shall yield total extractives not to exceed 20 milligrams per square inch during the first 7 hours of extraction, nor to exceed 1 milligram per square inch during the succeeding 2 hours of extraction.. (f) Rubber articles intended for repeated use in contact with fatty foods shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with n-hexane at reflux temperature, shall yield total extractives not to exceed 175 milligrams per square inch during the first 7 hours of extraction, nor to exceed 4 milligrams per square inch during the succeeding 2 hours of extraction. (g) In accordance with good manufacturing practice finished rubber articles intended for repeated use in contact with food shall be thoroughly cleansed prior to their first use in contact with food. (h) The provisions of this section are not applicable to rubber nursing-bottle nipples. (i) Acrylonitrile copolymers identified in this section shall comply with the provisions of $180.22 of this chapter. [42 FR 14572, Mar. 15, 1977] EDITORIAL NOTE: For FEDERAL REGISTER Citations affecting §177.2600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access. § 177.2710 Styrene-divinylbenzene resins, cross-linked. Styrene-divinylbenzene cross-linked copolymer resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The resins are produced by the copolymerization of styrene with divinylbenzene. (b) The resins meet the extractives limitations prescribed in this paragraph: (1) The resins to be tested are ground or cut into small particles that will pass through a U.S. standard sieve No. 3 and that will be held on a U.S. standard sieve No. 20. (2) A 100-gram sample of the resins, when extracted with 100 milliliters of ethyl acetate at reflux temperature for 1 hour, yields total extractives not to exceed 1 percent by weight of the resins. (c) In accordance with good manufacturing practice, finished articles containing the resins shall be thoroughly cleansed prior to their first use in contact with food. § 177.2800 Textiles and textile fibers. Textiles and textile fibers may safely be used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The textiles and textile fibers are prepared from one or more of the fibers identified in paragraph (d) of this section and from certain other adjuvant substances required in the production of the textiles or textile fibers or added to impart desired properties. (b) The quantity of any adjuvant substance employed in the production of textiles or textile fibers does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of textiles or textile fibers that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of or added to textiles and textile fibers may include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction or approval for use in textiles and textile fibers and used in accordance with such sanction or approval. (3) Substances generally recognized as safe for use in cotton and cotton fabrics used in dry-food packaging. (4) Substances that by regulation in this part may safely be used in the production of or as a component of textiles or textile fibers and subject to provisions of such regulation. (5) Substances identified in this paragraph (d)(5), subject to such limitations as are provided: (i) Fibers: Cotton. List of substances Limitations Ultramarine blue. Waxes, petroleum . Zinc hydrosulfite. List of substances Limitations (e) Textile and textile fibers are used as articles or components of articles that contact dry food only. (f) The provisions of this section are not applicable to jute fibers used as prescribed by $178.3620(d)(2) of this chapter. [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991] § 177.2910 Ultra-filtration membranes. Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section may be safely used in the processing of food, under the following prescribed conditions; (a)(1) Ultra-filtration membranes that consist of paper impregnated with cured phenol-formaldehyde resin, which is used as a support and is coated with a vinyl chloride-acrylonitrile copolymer. (2) Ultra-filtration membranes that consist of a sintered carbon support that is coated with zirconium oxide (CAS Reg. No. 1314–23–4) containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9). (3) Ultra-filtration membranes that consist of an aluminum oxide support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) containing up to 5 percent yttrium oxide (CAS Reg. No. 1314-36-9). molecular size components of liquids during the commercial processing of bulk quantities of food. (d) Ultra-filtration membranes shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential microbial adulteration of the food. (e) Ultrafiltration membranes identified in paragraph (a)(4) may be used to filter aqueous or acidic foods containing up to 13 percent of alcohol at temperatures not to exceed 21 °C (70 °F). (f) To assure safe use of the ultra-filtration membranes, the label or labeling shall include adequate directions for a pre-use treatment, consisting of conditioning and washing with a minimum of 8 gallons of potable water prior to their first use in contact with food. (g) Acrylonitrile copolymers identified in this section shall comply with the provisions of §180.22 of this chapter. [42 FR 14572, Mar. 15, 1977, as amended at 53 FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, 1993; 60 FR 54426, Oct. 24, 1995] PART 178-INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS Subpart A [Reserved] Subpart B-Substances Utilized To Control the Growth of Microorganisms Sec. Subpart C-Antioxidants and Stabilizers 178.2010 Antioxidants and/or stabilizers for polymers. 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol. 178.2650 Organotin stabilizers in vinyl chloride plastics. EDITORIAL NOTE: Nomenclature changes to part 178 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 66 FR 66742, Dec. 27, 2001. Subpart A [Reserved] Subpart B-Substances Utilized To Control the Growth of Microorganisms § 178.1005 Hydrogen peroxide solution. Hydrogen peroxide solution identified in this section may be safely used to sterilize polymeric food-contact surfaces identified in paragraph (e)(1) of this section. (a) Identity. For the purpose of this section, hydrogen peroxide solution is an aqueous solution containing not more than 35 percent hydrogen peroxide (CAS Reg. No. 7722-84-1) by weight, meeting the specifications prescribed in paragraph (c) of this section. (b) Optional adjuvant substances. Hydrogen peroxide solution identified in paragraph (a) of this section may contain substances generally recognized as safe in or on food, substances generally recognized for their intended use in food packaging, substances used in accordance with a prior sanction or approval, and substances permitted by applicable regulations in parts 174 through 179 of this chapter. (c) Specifications. Hydrogen peroxide solution shall meet the specifications of the "Food Chemicals Codex," 3d Ed. (1981), pp. 146–147, which is incorporated by reference (copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408), and the United States Pharmacopeia XX (1980), except that hydrogen peroxide may exceed the concentration specified therein. (d) Limitations. No use of hydrogen peroxide solution in the sterilization of food packaging material shall be considered to be in compliance if more than 0.5 part per million of hydrogen peroxide can be determined in distilled water packaged under production conditions (assay to be performed immediately after packaging). 197-064 D-12 |