cfr_sections
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47 rows where agency = "FDA" and part_number = 178 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:3.0.1.1.9.2.1.1 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | B | Subpart B—Substances Utilized To Control the Growth of Microorganisms | § 178.1005 Hydrogen peroxide solution. | FDA | [46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984; 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec. 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55 FR 47055, Nov. 9, 1990; 57 FR 32423, July 22, 1992; 78 FR 71467, Nov. 29, 2013] | 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, 7th ed. (2010), pp. 496-497, which is incorporated by reference. Hydrogen peroxide solution shall also meet the specifications for “Acidity,” “Chloride,” and “Other requirements” for Hydrogen Peroxide Concentrate in the United States Pharmacopeia 36th Revision (2013), pp. 3848-3849, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http://www.usp.org ). Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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/cfr/ibr-locations.html. (d) Limitations. No use of hydrogen peroxide solution in the sterilization of food packaging materi… | |||
| 21:21:3.0.1.1.9.2.1.2 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | B | Subpart B—Substances Utilized To Control the Growth of Microorganisms | § 178.1010 Sanitizing solutions. | FDA | [42 FR 14609, Mar. 16, 1977] | Sanitizing solutions may be safely used on food-processing equipment and utensils, and on other food-contact articles as specified in this section, within the following prescribed conditions: (a) Such sanitizing solutions are used, followed by adequate draining, before contact with food. (b) The solutions consist of one of the following, to which may be added components generally recognized as safe and components which are permitted by prior sanction or approval. (1) An aqueous solution containing potassium, sodium, or calcium hypochlorite, with or without the bromides of potassium, sodium, or calcium. (2) An aqueous solution containing dichloroisocyanuric acid, trichloroisocyanuric acid, or the sodium or potassium salts of these acids, with or without the bromides of potassium, sodium, or calcium. (3) An aqueous solution containing potassium iodide, sodium p -toluenesulfonchloroamide, and sodium lauryl sulfate. (4) An aqueous solution containing iodine, butoxy monoether of mixed (ethylene-propylene) polyalkylene glycol having a cloudpoint of 90°-100 °C in 0.5 percent aqueous solution and an average molecular weight of 3,300, and ethylene glycol monobutyl ether. Additionally, the aqueous solution may contain diethylene glycol monoethyl ether as an optional ingredient. (5) An aqueous solution containing elemental iodine, hydriodic acid, a -( p -nonylphenyl)- omega -hydroxypoly-(oxyethylene) (complying with the identity prescribed in § 178.3400(c) and having a maximum average molecular weight of 748) and/or polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 1,900). Additionally, the aqueous solution may contain isopropyl alcohol as an optional ingredient. (6) An aqueous solution containing elemental iodine, sodium iodide, sodium dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block polymers (having a minimum average molecular weight of 1,900). (7) An aqueous solution containing dodecylbenzenesulfonic acid and either isopropyl alcohol or polyoxyethyle… | |||
| 21:21:3.0.1.1.9.3.1.1 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | C | Subpart C—Antioxidants and Stabilizers | § 178.2010 Antioxidants and/or stabilizers for polymers. | FDA | [42 FR 14609, Mar. 15, 1977] | The substances listed in paragraph (b) of this section may be safely used as antioxidants and/or stabilizers in polymers used in the manufacture of 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 quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances: 1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103. | |||
| 21:21:3.0.1.1.9.3.1.2 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | C | Subpart C—Antioxidants and Stabilizers | § 178.2550 4-Hydroxymethyl-2,6-di- | FDA | 4-Hydroxymethyl-2,6-di -tert- butyl-phenol may be safely used as an antioxidant in articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive has a solidification point of 140°-141 °C. (b) The concentration of the additive and any other permitted antioxidants in the finished food-contact article does not exceed a total of 0.5 milligram per square inch of food-contact surface. | ||||
| 21:21:3.0.1.1.9.3.1.3 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | C | Subpart C—Antioxidants and Stabilizers | § 178.2650 Organotin stabilizers in vinyl chloride plastics. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; 54 FR 24898, June 12, 1989] | The organotin chemicals identified in paragraph (a) of this section may be safety used alone or in combination, at levels not to exceed a total of 3 parts per hundred of resin, as stabilizers in vinyl chloride homopolymers and copolymers complying with the provisions of § 177.1950 or § 177.1980 of this chapter and that are identified for use in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, except for the organotin chemical identified in paragraph (a)(3) of this section, which may be used in contact with food of types I through IX at temperatures not exceeding 75 °C (167 °F), and further that the organotin chemicals identified in paragraphs (a)(5) and (6) of this section may be used in contact with food of types I through IX at temperatures not exceeding 66 °C (150 °F), conditions of use D through G described in table 2 of § 176.170(c) of this chapter, and further that dodecyltin chemicals identified in paragraph (a)(7) of this section which may be used in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter at temperatures not exceeding 71 °C (160 °F), in accordance with the following prescribed conditions: (a) For the purpose of this section, the organotin chemicals are those listed in paragraphs (a)(1), (2), (3), (4), (5), (6), and (7) of this section. (1) Di( n -octyl)tin S,S′-bis(isooctylmercaptoacetate) is an octyltin chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having 8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di( n -octyl)tin dichloride or di( n -octyl)tin oxide. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. Di( n -octyl)tin dichloride has an organotin composition that is not less than 95 percent by weight of di( n -o… | |||
| 21:21:3.0.1.1.9.4.1.1 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3010 Adjuvant substances used in the manufacture of foamed plastics. | FDA | [47 FR 22090, May 21, 1982, as amended at 58 FR 64895, Dec. 10, 1993] | The following substances may be safely used as adjuvants in the manufacture of foamed plastics intended for use in contact with food, subject to any prescribed limitations: | |||
| 21:21:3.0.1.1.9.4.1.10 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3400 Emulsifiers and/or surface-active agents. | FDA | [42 FR 14609, Mar. 15, 1977] | The substances listed in paragraph (c) of this section may be safely used as emulsifiers and/or surface-active agents in the manufacture of 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 quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect; and the quantity that may become a component of food as a result of such use shall not be intended to, nor in fact, accomplish any physical or technical effect in the food itself. (b) The use as an emulsifier and/or surface-active agent in any substance or article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. (c) List of substances: (d) The provisions of this section are not applicable to emulsifiers and/or surface-active agents listed in § 175.105(c)(5) of this chapter and used in food-packaging adhesives complying with § 175.105 of this chapter. | |||
| 21:21:3.0.1.1.9.4.1.11 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3450 Esters of stearic and palmitic acids. | FDA | The ester stearyl palmitate or palmityl stearate or mixtures thereof may be safely used as adjuvants in food-packaging materials when used in accordance with the following prescribed conditions: (a) They are used or intended for use as plasticizers or lubricants in polystyrene intended for use in contact with food. (b) They are added to the formulated polymer prior to extrusion. (c) The quantity used shall not exceed that required to accomplish the intended technical effect. | ||||
| 21:21:3.0.1.1.9.4.1.12 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3480 Fatty alcohols, synthetic. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] | Synthetic fatty alcohols may be safely used as components of articles intended for use in contact with food, and in synthesizing food additives and other substances permitted for use as components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) The food additive consists of fatty alcohols meeting the specifications and definition prescribed in § 172.864 of this chapter, except as provided in paragraph (c) of this section. (b) It is used or intended for use as follows: (1) As substitutes for the corresponding naturally derived fatty alcohols permitted for use as components of articles intended for use in contact with food by existing regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter: Provided, That the use is in compliance with any prescribed limitations. (2) As substitutes for the corresponding naturally derived fatty alcohols used as intermediates in the synthesis of food additives and other substances permitted for use as components of food-contact articles. (c) Synthetic fatty alcohols identified in paragraph (c)(1) of this section may contain not more than 0.8 weight percent of total diols as determined by a method titled “Diols in Monohydroxy Alcohol by Miniature Thin Layer Chromatography (MTLC),” 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. (1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl alcohols meeting the specifications and definition prescribed in § 172.864 of this chapter, except that they may contain not more than 0.8 weight percent total diols. (ii) Lau… | |||
| 21:21:3.0.1.1.9.4.1.13 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3500 Glycerin, synthetic. | FDA | Synthetic glycerin may be safely used as a component of articles intended for use in packaging materials for food, subject to the provisions of this section: (a) It is produced by the hydrogenolysis of carbohydrates, and shall contain not in excess of 0.2 percent by weight of a mixture of butanetriols. (b) It is used in a quantity not to exceed that amount reasonably required to produce its intended physical or technical effect, and in accordance with any limitations prescribed by applicable regulations in parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be intended to, nor in fact accomplish, any direct physical or technical effect in the food itself. | ||||
| 21:21:3.0.1.1.9.4.1.14 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3505 Glyceryl tri-(12-acetoxystearate). | FDA | [50 FR 1503, Jan. 11, 1985] | Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be safely used as a component 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 additive is applied to the surface of calcium carbonate at a level not to exceed 1 weight-percent of the total mixture. (b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture is used as an adjuvant in polymers in contact with nonfatty foods at a level not to exceed 20 weight-percent of the polymer. | |||
| 21:21:3.0.1.1.9.4.1.15 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3520 Industrial starch-modified. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27, 1977] | Industrial starch-modified may be safely used as a component 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) Industrial starch-modified is identified as follows: (1) A food starch-modified or starch or any combination thereof that has been modified by treatment with one of the reactants hereinafter specified, in an amount reasonably required to achieve the desired functional effect but in no event in excess of any limitation prescribed, with or without subsequent treatment as authorized in § 172.892 of this chapter. (2) A starch irradiated under one of the following conditions to produce free radicals for subsequent graft polymerization with the reactants listed in this paragraph (a)(2): (i) Radiation from a sealed cobalt 60 source, maximum absorbed dose not to exceed 5.0 megarads. (ii) An electron beam source at a maximum energy of 7 million electron volts of ionizing radiation, maximum absorbed dose not to exceed 5.0 megarads. (b) The following adjuvants may be used as surface-active agents in the processing of industrial starch-modified: Polyethylene glycol (400) dilaurate. Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether. Polyethylene glycol (400) dilaurate. Polyethylene glycol (400) monolaurate. Polyoxyethylene (4) lauryl ether. (c) To insure safe use of the industrial starch-modified, the label of the food additive container shall bear the name of the additive “industrial starch-modified,” and in the instance of an industrial starch-modified which is limited with respect to conditions of use, the label of the food additive container shall contain a statement of such limited use. | |||
| 21:21:3.0.1.1.9.4.1.16 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984] | Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used in the production of nonfood 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 isoparaffinic petroleum hydrocarbons, produced by synthesis from petroleum gases consist of a mixture of liquid hydrocarbons meeting the following specifications: Boiling point 63°-260 °C, as determined by ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” 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. Ultraviolet absorbance: 260-319 millimicrons—1.5 maximum. 320-329 millimicrons—0.08 maximum. 330-350 millimicrons—0.05 maximum. Nonvolatile residue 0.002 gram per 100 milliliters maximum. Synthetic isoparaffinic petroleum hydrocarbons containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under “Specifications” on page 66 of the “Journal of the Association of Official Agricultural Chemists,” Vol. 45 (February 1962), which is incorporated by reference, disregarding the last sentence of that procedure. For hydrocarbons boiling below 121 °C, the nonvolatile residue shall be determined by ASTM method D1353-78, “Standard Test Method for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related Products;” for those boiling above 121 °C, ASTM procedure D381-80, “Standard Test Method for Existen… | |||
| 21:21:3.0.1.1.9.4.1.17 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3570 Lubricants with incidental food contact. | FDA | [42 FR 14609, Mar. 15, 1977] | Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The lubricants are prepared from one or more of the following substances: (1) Substances generally recognized as safe for use in food. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances identified in this paragraph (a)(3). (b) The lubricants are used on food-processing equipment as a protective antirust film, as a release agent on gaskets or seals of tank closures, and as a lubricant for machine parts and equipment in locations in which there is exposure of the lubricated part to food. The amount used is the minimum required to accomplish the desired technical effect on the equipment, and the addition to food of any constituent identified in this section does not exceed the limitations prescribed. (c) Any substance employed in the production of the lubricants described in this section 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. | |||
| 21:21:3.0.1.1.9.4.1.18 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3600 Methyl glucoside-coconut oil ester. | FDA | Methyl glucoside-coconut oil ester identified in § 172.816(a) of this chapter may be safely used as a processing aid (filter aid) in the manufacture of starch, including industrial starch-modified complying with § 178.3520, intended for use as a component of articles that contact food. | ||||
| 21:21:3.0.1.1.9.4.1.19 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3610 α-Methylstyrene-vinyltoluene resins, hydrogenated. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 54 FR 24898, June 12, 1989] | Hydrogenated α-methylstyrene-vinyltoluene copolymer resins having a molar ratio of 1 α-methylstyrene to 3 vinyltoluene may be safely used as components of polyolefin film intended for use in contact with food, subject to the following provisions: (a) Hydrogenated α-methylstyrene-vinyltoluene copolymer resins have a drop-softening point of 125° to 165 °C and a maximum absorptivity of 0.17 liter per gram centimeter at 266 nanometers, as determined by methods titled “Determination of Softening Point (Drop Method)” and “Determination of Unsaturation of Resin 1977,” which are 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. (b) The polyolefin film is produced from olefin polymers complying with § 177.1520 of this chapter, and the average thickness of the film in the form in which it contacts food does not exceed 0.002 inch. | |||
| 21:21:3.0.1.1.9.4.1.2 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3120 Animal glue. | FDA | Animal glue may be safely used as a component 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) Animal glue consists of the proteinaceous extractives obtained from hides, bones, and other collagen-rich substances of animal origin (excluding diseased or rotted animals), to which may be added other optional adjuvant substances required in its production or added to impart desired properties. (b) The quantity of any substance employed in the production of animal glue does not exceed the amount reasonably required to accomplish the intended physical or technical effect nor any limitation further provided. (c) Any substance employed in the production of animal glue and which 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) Optional adjuvant substances employed in the production of animal glue include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction or approval for use in animal glue and used in accordance with such sanction or approval. (3) Substances identified in this paragraph (d)(3) and subject to such limitations as are provided: (e) The conditions of use are as follows: (1) The use of animal glue in any substance or article that is the subject of a regulation in this subpart conforms with any specifications or limitations prescribed by such regulation for the finished form of the substance or article. (2) It is used as an adhesive or component of an adhesive in accordance with the provisions of § 175.105 of this chapter. (3) It is used as a colloidal flocculant added to the pulp suspension prior to the sheet-forming operation in the manufacture of paper and paperboard. (4) It is used as a protective colloid in resinous and polymeric emulsion coatings. | ||||
| 21:21:3.0.1.1.9.4.1.20 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3620 Mineral oil. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989] | Mineral oil may be safely used as a component of nonfood articles intended for use in contact with food, subject to the provisions of this section: (a) White mineral oil meeting the specifications prescribed in § 172.878 of this chapter may be used as a component of nonfood articles provided such use complies with any applicable limitations in parts 170 through 189 of this chapter. The use of white mineral oil in or on food itself, including the use of white mineral oil as a protective coating or release agent for food, is subject to the provisions of § 172.878 of this chapter. (b) Technical white mineral oil identified in paragraph (b)(1) of this section may be used as provided in paragraph (b)(2) of this section. (1) Technical white mineral oil consists of specially refined distillates of virgin petroleum or of specially refined distillates that are produced synthetically from petroleum gases. Technical white mineral oil meets the following specifications: (i) Saybolt color 20 minimum as determined by ASTM method D156-82, “Standard Test Method for Saybolt Color of Petroleum Products (Saybolt Chromometer Method),” 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. (ii) Ultraviolet absorbance limits as follows: Technical white mineral oil containing antioxidants shall meet the specified ultraviolet absorbance limits after correction for any absorbance due to the antioxidants. The ultraviolet absorbance shall be determined by the procedure described for application to mineral oil under “Specification” on page 66 of the “Journal of the Association of Official Agricultural Chemists,” Volume 45 (February 1962) (which is incorporated… | |||
| 21:21:3.0.1.1.9.4.1.21 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3650 Odorless light petroleum hydrocarbons. | FDA | Odorless light petroleum hydrocarbons may be safely used, as a component of nonfood articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive is a mixture of liquid hydrocarbons derived from petroleum or synthesized from petroleum gases. The additive is chiefly paraffinic, isoparaffinic, or naphthenic in nature. (b) The additive meets the following specifications: (1) Odor is faint and not kerosenic. (2) Initial boiling point is 300 °F minimum. (3) Final boiling point is 650 °F maximum. (4) Ultraviolet absorbance limits determined by method specified in § 178.3620(b)(1)(ii), as follows: (c) The additive is used as follows: | ||||
| 21:21:3.0.1.1.9.4.1.22 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3690 Pentaerythritol adipate-stearate. | FDA | [45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 57 FR 18082, Apr. 29, 1992; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] | Pentaerythritol adipate-stearate identified in paragraph (a) of this section may be safely used as a lubricant in the fabrication of rigid and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene copolymers complying with § 177.1980 of this chapter used as articles or components of articles that contact food, excluding food with alcohol content greater than 8 percent under conditions of use of E, F, and G described in table 2 in § 175.300(d) of this chapter, subject to the provisions of this section. (a) Identity. For the purpose of this section, pentaerythritol adipate-stearate is an ester of pentaerythritol with adipic acid and stearic acid and its associated fatty acids (chiefly palmitic), with adipic acid comprising 14 percent and stearic acid and its associated acids (chiefly palmitic) comprising 71 percent of the organic moieties. (b) Specifications. Pentaerythritol adipate-stearate has the following specifications: (1) Melting point (dropping) of 55-58 °C as determined by ASTM method D566-76 (Reapproved 1982), “Standard Test Method for Dropping Point of Lubricating Grease,” 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. (2) Acid value not to exceed 15 as determined by ASTM method D1386-78, “Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes” (Revised 1978), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this mat… | |||
| 21:21:3.0.1.1.9.4.1.23 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3700 Petrolatum. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, 1990] | Petrolatum may be safety used as a component of nonfood articles in contact with food, in accordance with the following conditions: (a) Petrolatum complies with the specifications set forth in the United States Pharmacopeia XX (1980) for white petrolatum or in the National Formulary XV (1980) for yellow petrolatum. (b) Petrolatum meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter: Ultraviolet absorbance per centimeter pathlength: (c) It is used or intended for use as a protective coating of the surfaces of metal or wood tanks used in fermentation process, in an amount not in excess of that required to produce its intended effect. (d) Petrolatum as defined by this section may be used for the functions described and within the limitations prescribed by specific regulations in parts 175, 176, 177, and 178 of this chapter which prescribe uses of petrolatum. For the purpose of cross-reference, such specific regulations include: §§ 175.105, 175.125, 175.300, 176.170, 176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter. (e) Petrolatum may contain any antioxidant permitted in food by regulations issued pursuant to section 409 of the act, in an amount not greater than that required to produce its intended effect. | |||
| 21:21:3.0.1.1.9.4.1.24 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3710 Petroleum wax. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986] | Petroleum wax may be safely used as a component of nonfood articles in contact with food, in accordance with the following conditions: (a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in nature, derived from petroleum, and refined to meet the specifications prescribed in this section. (b) The petroleum wax meets the following ultraviolet absorbance limits when subjected to the analytical procedure described in § 172.886(b) of this chapter. Ultraviolet absorbance per centimeter pathlength: (c) Petroleum wax may contain any antioxidant permitted in food by regulations issued in accordance with section 409 of the act, in an amount not greater than that required to produce its intended effect. (d) Petroleum wax may contain a total of not more than 1 weight percent of residues of the following polymers when such residues result from use of the polymers as processing aids (filter aids) in the production of the petroleum wax: Homopolymers and/or copolymers derived from one or more of the mixed n -alkyl (C 12 , C 14 , C 16 , and C 18 ) methacrylate esters where the C 12 and C 14 alkyl groups are derived from coconut oil and the C 16 and C 18 groups are derived from tallow. (e) Petroleum wax may contain 2-hydroxy-4- n -octoxybenzophenone as a stabilizer at a level not to exceed 0.01 weight percent of the petroleum wax. (f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No. 27029-57-8), as described in § 172.886(c)(2) of this chapter, as a processing aid in the manufacture of petroleum wax. | |||
| 21:21:3.0.1.1.9.4.1.25 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3720 Petroleum wax, synthetic. | FDA | Synthetic petroleum wax may be safely used in applications and under the same conditions where naturally derived petroleum wax is permitted in subchapter B of this chapter as a component of articles intended to contact food, provided that the synthetic petroleum wax meets the definition and specifications prescribed in § 172.888 of this chapter. | ||||
| 21:21:3.0.1.1.9.4.1.26 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3725 Pigment dispersants. | FDA | [61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999; 64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000] | Subject to the provisions of this regulation, the substances listed in this section may be safely used as pigment dispersants in food-contact materials. | |||
| 21:21:3.0.1.1.9.4.1.27 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3730 Piperonyl butoxide and pyrethrins as components of bags. | FDA | [85 FR 72907, Nov. 16, 2020] | Piperonyl butoxide in combination with pyrethrins may be safely used for insect control on bags that are intended for use in contact with dried feed or dried food in compliance with 40 CFR 180.127 and 40 CFR 180.128. | |||
| 21:21:3.0.1.1.9.4.1.28 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3740 Plasticizers in polymeric substances. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986; 87 FR 31089, May 20, 2022] | Subject to the provisions of this regulation, the substances listed in paragraph (b) of this section may be safely used as plasticizers in polymeric substances used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances: (c) The use of the plasticizers in any polymeric substance or article subject to any regulation in parts 174, 175, 176, 177, 178 and 179 of this chapter must comply with any specifications and limitations prescribed by such regulation for the finished form of the substance or article. | |||
| 21:21:3.0.1.1.9.4.1.29 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3750 Polyethylene glycol (mean molecular weight 200-9,500). | FDA | Polyethylene glycol identified in this section may be safely used as a component of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500. (b) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is 350 or higher and no more than 0.5 percent total by weight of ethylene and diethylene glycols if its mean molecular weight is below 350, when tested by the analytical methods prescribed in § 172.820(b) of this chapter. (c) The provisions of paragraph (b) of this section are not applicable to polyethylene glycols used in food-packaging adhesives complying with § 175.105 of this chapter. | ||||
| 21:21:3.0.1.1.9.4.1.3 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3125 Anticorrosive agents. | FDA | [50 FR 21835, May 29, 1985] | The substances listed in this section may be used as anticorrosive agents in food-contact materials subject to the provisions of this section: | |||
| 21:21:3.0.1.1.9.4.1.30 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3760 Polyethylene glycol (400) monolaurate. | FDA | Polyethylene glycol (400) monolaurate containing not more than 0.1 percent by weight of ethylene and/or diethylene glycol may be used at a level not to exceed 0.3 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with § 177.1500 of this chapter. | ||||
| 21:21:3.0.1.1.9.4.1.31 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898, June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR 17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004] | Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids identified in this section may be safely used as components of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) The polyhydric alcohol esters identified in this paragraph may be used as lubricants in the fabrication of vinyl chloride plastic food-contact articles prepared from polyvinyl chloride and/or from vinyl chloride copolymers complying with § 177.1980 of this chapter. Such esters meet the following specifications and are produced by partial esterification of oxidatively refined (Gersthofen process) montan wax acids by either ethylene glycol or 1,3-butanediol with or without neutralization of unreacted carboxylic groups with calcium hydroxide: (1) Dropping point 76°-105 °C, as determined by ASTM method D566-76 (Reapproved 1982), “Standard Test Method for Dropping Point of Lubricating Grease,” 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. (2) Acid value 10-20, as determined by ASTM method D1386-78 (“Standard Test Method for Acid Number (Empirical) of Synthetic and Natural Waxes” (Revised 1978), which is incorporated by reference; copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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. ) using as solvent xylene-ethyl alcohol in … | |||
| 21:21:3.0.1.1.9.4.1.32 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3780 Polyhydric alcohol esters of long chain monobasic acids. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14481, Apr. 2, 1996] | Polyhydric alcohol esters of long chain monobasic acids identified in this section may be safely used as lubricants in the fabrication of polyvinyl chloride and/or polyvinyl chloride copolymer articles complying with § 177.1980 of this chapter that contact food of Types I, II, IV-B, VI-B, VII-B, and VIII identified in table 1 in § 176.170(c) of this chapter under conditions of use E, F, and G described in table 2 in § 176.170(c) of this chapter, subject to the provisions of this section. (a) Identity. For the purpose of this section, polyhydric alcohol esters of long chain monobasic acids consist of polyhydric alcohol esters having number average molecular weights in the range of 1,050 to 1,700. The esters are produced by the reaction of either ethylene glycol or glycerol with long chain monobasic acids containing from 9 to 49 carbon atoms obtained by the ozonization of long chain alpha -olefins, the unreacted carboxylic acids in the formation of the glycerol esters being neutralized with calcium hydroxide to produce a composition having up to 2 percent by weight calcium. The alpha -olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon atoms and contain a minimum of 75 percent by weight straight chain alpha -olefins and not more than 25 percent vinylidene compounds. (b) Specifications. The polyhydric alcohol esters have the following specifications: (1) Melting point of 60-80 °C for the ethylene glycol ester and 90-105 °C for the glycerol ester as determined by the Fisher Johns method as described in “Semimicro Qualitative Organic Analysis—The Systematic Identification of Organic Compounds,” by Cheronis and Entrikin, 2d Ed., Interscience Publishers, NY, 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 … | |||
| 21:21:3.0.1.1.9.4.1.33 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics. | FDA | The polymers identified in paragraph (a) of this section may be safely admixed, alone or in mixture with other permitted polymers, as modifiers in semirigid and rigid vinyl chloride plastic food-contact articles prepared from vinyl chloride homopolymers and/or from vinyl chloride copolymers complying with § 177.1950, § 177.1970, and/or § 177.1980 of this chapter, in accordance with the following prescribed conditions: (a) For the purpose of this section, the polymer modifiers are identified as follows: (1) Acrylic polymers identified in this subparagraph provided that such polymers contain at least 50 weight-percent of polymer units derived from one or more of the monomers listed in paragraph (a)(1)(i) of this section. (i) Homopolymers and copolymers of the following monomers: n -Butyl acrylate. n -Butyl methacrylate. Ethyl acrylate. Methyl methacrylate. n -Butyl acrylate. n -Butyl methacrylate. Ethyl acrylate. Methyl methacrylate. (ii) Copolymers produced by copolymerizing one or more of the monomers listed in paragraph (a)(1)(i) of this section with one or more of the following monomers: Acrylonitrile. Butadiene. a -Methylstyrene. Styrene. Vinylidene chloride. Acrylonitrile. Butadiene. a -Methylstyrene. Styrene. Vinylidene chloride. (iii) Polymers identified in paragraphs (a)(1)(i) and (ii) of this section containing no more than 5 weight-percent of total polymer units derived by copolymerization with one or more of the following monomers: Acrylic acid. 1,3-Butylene glycol dimethacrylate. Divinylbenzene. Methacrylic acid. Acrylic acid. 1,3-Butylene glycol dimethacrylate. Divinylbenzene. Methacrylic acid. (iv) Mixtures of polymers identified in paragraph (a)(1)(i), (ii), and (iii) of this section; provided that no chemical reactions, other than addition reactions, occur when they are mixed. (2) Polymers identified in paragraph (a)(1) of this section combined during their polymerization with butadiene-styrene copolymers; provided that no chemical reactions, oth… | ||||
| 21:21:3.0.1.1.9.4.1.34 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3800 Preservatives for wood. | FDA | Preservatives may be safely used on wooden articles that are used or intended for use in packaging, transporting, or holding raw agricultural products subject to the provisions of this section: (a) The preservatives are prepared from substances identified in paragraph (b) of this section and applied in amounts not to exceed those necessary to accomplish the technical effect of protecting the wood from decay, mildew, and water absorption. (b) The substances permitted are as follows: | ||||
| 21:21:3.0.1.1.9.4.1.35 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3850 Reinforced wax. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982] | Reinforced wax may be safely used as an article or component of articles intended for use in producing, manufacturing, packing, processing, transporting, or holding food subject to the provisions of this section. (a) Reinforced wax consists of petroleum wax to which have been added certain optional substances required in its production, or added to impart desired physical or technical properties. (b) The quantity of any optional adjuvant substance employed in the production of or added to reinforced wax does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation provided in this section. (c) Any substance employed in the production of reinforced wax, including any optional substance, 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) The substances and optional adjuvant substances employed in the production of or added to reinforced wax include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction for use in reinforced wax and used in accordance with such sanction or approval. (3) Substances identified in this subparagraph and subject to any limitations provided therein: (e) Reinforced wax conforming with the specifications in this paragraph is used as provided in paragraph (e)(2) of this section. (1) The chloroform-soluble portion of the water extract obtained by exposing reinforced wax to demineralized water at 70 °F for 48 hours shall not exceed 0.5 milligram per square inch of food-contact surface. (2) It is used as a packaging material or component of packaging materials for cheese and cheese products. | |||
| 21:21:3.0.1.1.9.4.1.36 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3860 Release agents. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996] | Substances listed in paragraph (b) of this section may be safely used as release agents in petroleum wax complying with § 178.3710 and in polymeric resins that contact food, subject to the provisions of this section. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect or any limitations prescribed in this section. (b) Release agents: | |||
| 21:21:3.0.1.1.9.4.1.37 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3870 Rosins and rosin derivatives. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989] | The rosins and rosin derivatives identified in paragraph (a) of this section may safely be used in the manufacture of 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 rosins and rosin derivatives are identified as follows: (1) Rosins: (i) Gum rosin, refined to color grade of K or paler. (ii) Wood rosin, refined to color grade of K or paler. (iii) Tall oil rosin, refined to color grade of K or paler. (iv) Dark tall oil rosin, a fraction resulting from the refining of tall oil rosin produced by multicolumnar distillation of crude tall oil to effect removal of fatty acids and pitch components and having a saponification number of from 110-135 and 32 percent-44 percent rosin acids. (v) Dark wood rosin, all or part of the residue after the volatile terpene oils are distilled from the oleoresin extracted from pine wood. (2) Modified rosins manufactured from rosins identified in paragraph (a)(1) of this section: (i) Partially hydrogenated rosin, catalytically hydrogenated to a maximum refractive index of 1.5012 at 100 °C, and a color of WG or paler. (ii) Fully hydrogenated rosin, catalytically hydrogenated to a maximum dehydroabietic acid content of 2 percent, a minimum drop-softening point of 79 °C, and a color of X or paler. (iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst to a drop-softening point of 95°-105 °C and a color of WG or paler. (iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and from which sufficient nondimerized rosin has been removed by distillation to achieve a minimum drop-softening point of 143 °C, and a color of H or paler. (v) Disproportionated rosin, catalytically disproportionated to a minimum dehydroabietic acid content of 35 percent, a maximum abietic acid content of 1 percent, a maximum content of substituted phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler. (… | |||
| 21:21:3.0.1.1.9.4.1.38 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3900 Sodium pentachlorophenate. | FDA | Sodium pentachlorophenate may be safely used as a preservative for ammonium alginate employed as a processing aid in the manufacture of polyvinyl chloride emulsion polymers intended for use as articles or components of articles that contact food at temperatures not to exceed room temperature. The quantity of sodium pentachlorophenate used shall not exceed 0.5 percent by weight of ammonium alginate solids. | ||||
| 21:21:3.0.1.1.9.4.1.39 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3910 Surface lubricants used in the manufacture of metallic articles. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983; 49 FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874, Sept. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989; 54 FR 24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991; 57 FR 23953, June 5, 1992; 58 FR 17513, Apr. 5, 1993; 64 FR 47110, Aug. 30, 1999; 69 FR 24512, May 4, 2004; 87 FR 31089, May 20, 2022] | The substances listed in this section may be safely used in surface lubricants employed in the manufacture of metallic articles that contact food, subject to the provisions of this section. (a) The following substances may be used in surface lubricants used in the rolling of metallic foil or sheet stock provided that total residual lubricant remaining on the metallic article in the form in which it contacts food does not exceed 0.015 milligram per square inch of metallic food-contact surface: (1) Substances identified in paragraphs (b)(1) and (2) of this section. (2) Substances identified in this paragraph. (3) Mineral oil conforming to the identity prescribed in § 178.3620(c). (4) Light petroleum hydrocarbons identified in paragraph (a)(4)(i) of this section: Provided, That the total residual lubricant on the metallic article in the form in which it contacts food meets the ultraviolet absorbance limits prescribed in paragraph (a)(4)(ii) of this section as determined by the analytical method described in paragraph (a)(4)(iii) of this section. (i) Light petroleum hydrocarbons are derived by distillation from virgin petroleum stocks or are synthesized from petroleum gases. They are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature, and meet the following specifications: ( a ) Initial boiling point is 24 °C minimum and final boiling point is 288 °C maximum, as determined by ASTM method D86-82, “Standard Method for Distillation of Petroleum Products,” 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. ( b ) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum, as determined by ASTM method D381-80, “St… | |||
| 21:21:3.0.1.1.9.4.1.4 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3130 Antistatic and/or antifogging agents in food-packaging materials. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995; 62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999; 76 FR 59249, Sept. 26, 2011] | The substances listed in paragraph (b) of this section may be safely used as antistatic and/or antifogging agents in food-packaging materials, subject to the provisions of this section: (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) List of substances: | |||
| 21:21:3.0.1.1.9.4.1.40 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3930 Terpene resins. | FDA | The terpene resins identified in paragraph (a) of this section may be safely used as components of polypropylene film intended for use in contact with food, and the terpene resins identified in paragraph (b) of this section may be safely used as components of polyolefin film intended for use in contact with food; (a) Terpene resins consisting of the hydrogenated polymers of terpene hydrocarbons obtainable from sulfate turpentine and meeting the following specifications: Drop-softening point of 118°-138 °C; iodine value less than 20. (b) Terpene resins consisting of polymers of beta-pinene and meeting the following specifications: Acid value less than 1; saponification number less than 1; color less than 4 on the Gardner scale as measured in 50 percent mineral spirits solution. | ||||
| 21:21:3.0.1.1.9.4.1.41 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3940 Tetraethylene glycol di-(2-ethylhexoate). | FDA | Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22 parts per million ethylene and/or diethylene glycols may be used at a level not to exceed 0.7 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with § 177.1500 of this chapter. | ||||
| 21:21:3.0.1.1.9.4.1.42 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3950 Tetrahydrofuran. | FDA | Tetrahydrofuran may be safely used in the fabrication of articles intended for packaging, transporting, or storing foods, subject to the provisions of this section. (a) It is used as a solvent in the casting of film from a solution of polymeric resins of vinyl chloride, vinyl acetate, or vinylidene chloride that have been polymerized singly or copolymerized with one another in any combination, or it may be used as a solvent in the casting of film prepared from vinyl chloride copolymers complying with § 177.1980 of this chapter. (b) The residual amount of tetrahydrofuran in the film does not exceed 1.5 percent by weight of film. | ||||
| 21:21:3.0.1.1.9.4.1.5 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3280 Castor oil, hydrogenated. | FDA | [42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990] | Hydrogenated castor oil may be safely used in the manufacture of articles or components of articles intended for use in contact with food subject to the provisions of this section. (a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect. (b) The additive is used as follows: | |||
| 21:21:3.0.1.1.9.4.1.6 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3290 Chromic chloride complexes. | FDA | Myristo chromic chloride complex and stearato chromic chloride complex may be safely used as release agents in the closure area of packaging containers intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The quantity used shall not exceed that reasonably required to accomplish the intended technical effect nor exceed 7 micrograms of chromium per square inch of closure area. (b) The packaging container which has its closure area treated with the release agent shall have a capacity of not less than 120 grams of food per square inch of such treated closure area. | ||||
| 21:21:3.0.1.1.9.4.1.7 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3295 Clarifying agents for polymers. | FDA | [46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR 51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11, 1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000] | Clarifying agents may be safely used in polymers that are articles or components of articles intended for use in contact with food, subject to the provisions of this section: | |||
| 21:21:3.0.1.1.9.4.1.8 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3297 Colorants for polymers. | FDA | [48 FR 46775, Oct. 14, 1983] | The substances listed in paragraph (e) of this section may be safely used as colorants in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions and definitions set forth in this section: (a) The term colorant means a dye, pigment, or other substance that is used to impart color to or to alter the color of a food-contact material, but that does not migrate to food in amounts that will contribute to that food any color apparent to the naked eye. For the purpose of this section, the term “colorant” includes substances such as optical brighteners and fluorescent whiteners, which may not themselves be colored, but whose use is intended to affect the color of a food-contact material. (b) The colorant must be used in accordance with current good manufacturing practice, including use levels which are not in excess of those reasonably required to accomplish the intended coloring effect. (c) Colorants in this section must conform to the description and specifications indicated. If a polymer described in this section is itself the subject of a regulation promulgated under section 409 of the Federal Food, Drug, and Cosmetic Act, it shall also comply with any specifications and limitations prescribed by that regulation. Extraction testing guidelines to conduct studies for additional uses of colorants under this section are available from the Food and Drug Administration free of charge from the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, 240-402-1200 (d) Color additives and their lakes listed for direct use in foods, under the provisions of the color additive regulations in parts 73, 74, 81, and 82 of this chapter, may also be used as colorants for food-contact polymers. (e) List of substances: | |||
| 21:21:3.0.1.1.9.4.1.9 | 21 | Food and Drugs | I | B | 178 | PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS | D | Subpart D—Certain Adjuvants and Production Aids | § 178.3300 Corrosion inhibitors used for steel or tinplate. | FDA | Corrosion inhibitors may be safely used for steel or tinplate intended for use in, or to be fabricated as, food containers or food-processing or handling equipment, subject to the provisions of this section. (a) The corrosion inhibitors are prepared from substances identified in this section and used subject to the limitations prescribed. (b) The following corrosion inhibitors or adjuvants are used in amounts not to exceed those reasonably required to accomplish the intended physical or technical effect: (1) Corrosion inhibitors (active ingredients) used in packaging materials for the packaging of steel or tinplate or articles fabricated therefrom: (2) Adjuvants employed in the application and use of corrosion inhibitors: |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);