Title 21 CFR reference

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. Identity.(a) 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. Optional adjuvant substances.(b) 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. Specifications.http://www.usp.orghttp://www.archives.gov/federal-register/cfr/ibr-locations.html.(c) 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…

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. p(3) An aqueous solution containing potassium iodide, sodium -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 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: Table | Substances | Limitations | | --- | --- | | N-n-03N′03N,N′-03Alkyl--(carboxymethyl)-trimethylenediglycine; the alkyl group is even numbered in the range C C and the nitrogen content is in the range 5.4-5.6 weight percent | For use only: 1. As component of nonfood articles complying with §§ 175.105 and 177.2600 of this chapter.2. At levels not to exceed 1.35 percent by weight of natural rubber, butadiene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings…

-tert-4-Hydroxymethyl-2,6-dibutyl-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.

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…

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: Table | List of substances | Limitations | | --- | --- | | Azodicarbonamide | For use as a blowing agent in polyethylene complying with item 2.1 in § 177.1520(c) of this chapter at a level not to exceed 5 percent by weight of finished foamed polyethylene. | | 1,1-Difluoroethane (CAS Reg. No. 75-37-6) | For use as a blowing agent in polystyrene. | | Isopentane | For use as a blowing agent in polystyrene. | | n03-Pentane | Do. | | 1,1,2,2-Tetra-chloroethylene | For use only as a blowing agent adjuvant in polystyrene at a level not to exceed 0.3 percent by weight of finished foamed polystyrene intended for use in contact with food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI, and VIII. | | Toluene | For use only as a blowing agent adjuvant in polystyrene at a level not to exceed 0.35 percent by weight of finished foamed polystyrene. | [47 FR 22090, May 21, 1982, as amended at 58 FR 64895, Dec. 10, 1993]

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…

The substances listed in this section may be used as anticorrosive agents in food-contact materials subject to the provisions of this section: Table | Substances | Limitations | | --- | --- | | Zinc hydroxy phosphite (CAS Reg. No. 55799-16-1) | For use only as a component of resinous and polymeric food-contact coatings intended for repeated use in contact with dry foods. | [50 FR 21835, May 29, 1985]

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: Table | List of substances | Limitations | | --- | --- | | N03-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or derived from the combined fatty acids of coconut oil | For use only: 1. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of polyolefin film used for packaging meat, fresh fruits, and fresh vegetables. The average thickness of such polyolefin film shall not exceed 0.003 inch.2. As antistatic and/or antifogging agent at levels not to exceed a total of 0.15 pct by weight of ethylene-vinyl acetate copolymer film complying with § 177.1350 of this chapter and used for packaging meat, fresh fruits, fresh vegetables, and dry food of Type VIII described in table 1 of § 176.170(c) of this chapter. The average thickness of such ethylene-vinyl acetate copolymer film shall not exceed 0.003 inch when used for…

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: Table | Use | Limitations | | --- | --- | | 1. As a lubricant for vinyl chloride polymers used in the manufacture of articles or components of articles authorized for food-contact use | For use only at levels not to exceed 4 pct by weight of vinyl chloride polymers. | | 2. As a component of cellophane | Complying with § 177.1200 of this chapter. | | 3. As a component of resinous and polymeric coatings | Complying with § 175.300 of this chapter. | | 4. As a component of paper and paperboard in contact with aqueous and fatty food | Complying with § 176.170 of this chapter. | | 5. As a component of closures with sealing gaskets for food containers | Complying with § 177.1210 of this chapter. | | 6. As a component of cross-linked polyester resins | Complying with § 177.2420 of this chapter. | | 7. As a component of olefin polymers complying with §…

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.

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: Table | Substances | Limitations | | --- | --- | | Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]-(CAS Reg. No. 151841-65-5) | For use only as a clarifying agent at levels not to exceed 0.25 percent by weight of polypropylene and polypropylene copolymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2. The finished polymers contact food only of types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and IX as identified in Table 1 of § 176.170(c) of this chapter, under conditions of use C through G described in Table 2 of § 176.170(c) of this chapter. | | p03Bis(-ethylbenzylidene) sorbitol (CAS Reg. No. 79072-96-1) | For use only as a clarifying agent at a level not to exceed 0.35 percent by weight of olefin polymers complying with §…

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: colorant(a) The term 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…

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: Table | List of substances | Limitations | | --- | --- | | Dicyclohexylamine and its salts of fatty acids derived from animal or vegetable oil | | Dicyclohexylamine nitrite | | Morpholine and its salts of fatty acids derived from animal or vegetable oils | Table | List of substances | Limitations | | --- | --- | | Propylene glycol |

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…

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.

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: Provided,(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: 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. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) Synthetic fatty alcohols identified in…

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.

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. [50 FR 1503, Jan. 11, 1985]

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…

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: (b) Isoparaffinic petroleum hydrocarbons may contain antioxidants authorized for use in food in an amount not to exceed that reasonably required to accomplish the intended technical effect. (c) Isoparaffinic petroleum hydrocarbons are used in the production of nonfood articles. The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect, and the residual remaining in the finished article shall be the minimum amount reasonably attainable. Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984]

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…

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.

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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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: (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…

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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(i) Saybolt color 20 minimum as determined by ASTM method D156-82, “Standard Test Method for Saybolt Color of Petroleum Products…

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: Table | Wavelength (Mµ) | Maximum absorbance per centimeter optical pathlength | | --- | --- | | 280 to 289 | 4 | | 290 to 299 | 3.3 | | 300 to 329 | 2.3 | | 330 to 360 | 0.8 | Table | Use | Limitations | | --- | --- | | As a plasticizer and absorber oil in the manufacture of polyolefin articles authorized for food contact use | In an amount not to exceed that required to produce intended effect, consistent with good manufacturing practice. | | As a lubricant of fibers of textiles authorized…

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. Identity.(a) 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. Specifications.(b) Pentaerythritol adipate-stearate has the following specifications: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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,”…

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…

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. n12521452165218521252145216521852(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 -alkyl (C, C, C, and C) methacrylate esters where the C and C alkyl groups are derived from coconut oil and the C and C groups are derived from…

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.

Subject to the provisions of this regulation, the substances listed in this section may be safely used as pigment dispersants in food-contact materials. Table | Substances | Limitations | | --- | --- | | Dimethylolpropionic acid (CAS Reg. No. 4767-03-7) | For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all foods under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. | | Phosphorylated tall oil fatty acids (CAS Reg. No. 68604-99-9), prepared by the reaction of dimethyl hydrogen phosphite with tall oil fatty acids | For use only at levels not to exceed 1.0 percent by weight of the pigment. The pigmented polymeric films may contact all food under conditions of use D, E, F, and G described in table 2 of § 176.170(c) of this chapter. | | Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. with 1,1′,1″-nitrilotris [2-propanol] (1: 1) (CAS Reg. No. 221281-21-6) | For use only at levels not to exceed 0.45 percent by weight of the pigment. The pigmented articles may contact all food under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. | |…

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. [85 FR 72907, Nov. 16, 2020]

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. Table | Substances | Limitations | | --- | --- | | 1,3-Butylene glycoladipic acid polyester (1,700-2,200 molecular weight) terminated with a 16 percent by weight mixture of myristic, palmitic, and stearic acids | For use at levels not exceeding 33 percent by weight of polyvinyl chloride homopolymers used in contact with food (except foods that contain more than 8 percent of alcohol) at temperatures not to exceed…

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.

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.

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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(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,…

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. Identity.alphaalphaalpha(a) 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 -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 -olefins, obtained from the polymerization of ethylene, have 20 to 50 carbon atoms and contain a…

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: (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: (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: (iv) Mixtures of polymers…

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: Table | List of substances | Limitations | | --- | --- | | Copper-8-quinolinolate | | Mineral spirits | | Paraffin wax | Used singly or in combination so as to constitute not less than 50% of the solids. | | Petroleum hydrocarbon resin, produced by the homo- and copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene type from distillates of cracked petroleum stocks | Do. | | Pentachlorophenol and its sodium salt | Not to exceed 50 p.p.m. in the treated wood, calculated as pentachlorophenol. | | Rosins and rosin derivatives | As provided in § 178.3870. | | Zinc salt of sulfonated petroleum |

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…

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: Table | List of substances | Limitations | | --- | --- | | Erucamide (erucylamide) | | Formaldehyde, polymer with 1-naphthalenol (CAS Reg. No. 25359-91-5) | For use only as an antiscaling or release agent, applied on the internal parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million. | | N,N′03-Dioleoylethylenediamine | For use only in polyvinyl chloride films in amounts such that the concentration of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film. | | Oleyl palmitamide | | Polybutene, hydrogenated; complying with the identity prescribed under §…

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…

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.

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). Provided,(4) Light petroleum hydrocarbons identified in paragraph (a)(4)(i) of this section: 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…

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.

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.

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.