21 C.F.R. § 178.3130 Antistatic and/or antifogging agents in food-packaging materials.
Title 21 - Food and Drugs
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: [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]
Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids
§ 178.3130 Antistatic and/or antifogging agents in food-packaging materials.
------------------------------------------------------------------------ List of substances Limitations------------------------------------------------------------------------N-Acyl sarcosines where the acyl group For use only: is lauroyl, oleoyl, or derived from 1. As antistatic and/or the combined fatty acids of coconut antifogging agent at levels oil. 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 packaging meat, fresh fruits, and fresh vegetables.Alpha-(Carboxymethyl)-omega- For use only as an antistatic (tetradecyloxy)polyoxyethylene). and/or antifogging agent at levels not to exceed 0.2 pct by weight in polyolefin film not exceeding 0.001 inch thickness.Alkyl mono- and disulfonic acids, For use only: sodium salts (produced from n-alkanes 1. As antistatic agents at in the range of C10-C18 with not less levels not to exceed 0.1 than 50 percent C14-C16). percent by weight of polyolefin films that comply with § 177.1520 of this chapter: Provided, that the finished olefin polymers contact foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. 2. As antistatic agents at levels not to exceed 3.0 percent by weight of polystyrene or rubber-modified polystyrene complying with § 177.1640(c) of this chapter under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.Aluminum Borate For use only: ((9Al2O3)·2(B2O3), CAS Reg. No. 1. At levels not to exceed 1 11121-16-7) produced by reaction percent by weight of between aluminum oxide and/or aluminum polypropylene films complying hydroxide with boric acid and/or with § 177.1520(c) of metaboric acid at temperatures in this chapter, item 1.1, of excess of 1000 °C. polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter, under conditions of use A through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch. 2. At levels not to exceed 2 percent by weight of polypropylene films complying with § 177.1520(c) of this chapter, item 1.1, of polyethylene films complying with § 177.1520(c) of this chapter, items 2.1 and 2.2 and having a density greater than 0.94 gram per cubic centimeter, and of polyolefin copolymer films complying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The finished polymers may be used in contact with all food types identified in Table 1 of § 176.170(c) of this chapter under conditions of use B through H as described in Table 2 of § 176.170(c) of this chapter. The thickness of the films shall not exceed 0.005 inch.N,N-Bis(2-hydroxyethyl)alkyl(C12- For use only as an antistatic C18)amine. agent at levels not to exceed 0.1 pct by weight of polyolefin food-contact films.N,N-bis(2-hydroxyethyl)alkyl (C13-C15) For use only: amine (CAS Reg. No. 70955-14-5). 1. As an antistatic agent at levels not to exceed 0.2 percent by weight in molded or extruded high-density polyethylene (having a density >=0.95 g/cm\3\ and polypropylene containers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under types I, VI-B, VII-B, and VIII, under the conditions of use E through G described in Table 2 of § 176.170(c) of this chapter, provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.1 percent by weight in molded or extruded polypropylene homopolymers and copolymers that contact food only of the types identified in § 176.170(c) of this chapter, Table 1, under Types II, III, IV, V, VII-A, and IX, under the conditions of use C through G described in Table 2 of § 176.170(c) of this chapter.N,N-Bis(2-hydroxyethyl) alkylamine, For use only: where the alkyl groups (C1-C18) are 1. As an antistatic agent at derived from tallow. levels not to exceed 0.15 pct by weight in molded or extruded polyethylene containers that contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and VIII, under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter provided such foods have a pH above 5.0. 2. As an antistatic agent at levels not to exceed 0.10 mg. per square inch of food- contact surface in vinylidene chloride copolymer coatings complying with § 175.320, § 177.1200, or § 177.1630 of this chapter, provided that such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, IV, VII, VIII, and IX under the conditions of use E through G described in table 2 of § 176.170(c) of this chapter. The finished copolymers shall contain at least 70 weight pct of polymer units derived from vinylidene chloride; and shall contain not more than 5 weight pct of total polymer units derived from acrylamide, acrylic acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl methacrylate, and vinyl sulfonic acid.N,N-Bis(2-hydroxyethyl)dodecanamide For use only: produced when diethanolamine is made 1. As an antistatic agent at to react with methyl laurate such that levels not to exceed 0.5 the finished product: Has a minimum percent by weight of molded or melting point of 36 °C; has a extruded polyethylene minimum amide assay of 90 percent; containers intended for contains no more than 2 percent by contact with honey, chocolate weight of free diethanolamine; and syrup, liquid sweeteners, contains no more than 0.5 percent by condiments, flavor extracts weight of N,N, bis(2- and liquid flavor hydroxyethyl)piperazine, as determined concentrates, grated cheese, by paper chromatography method. light and heavy cream, yogurt, and foods of Type VIII as described in table 1 of § 176.170(c) of this chapter. 2. As an antistatic agent at levels not to exceed 0.2 percent by weight in polypropylene films complying with § 177.1520 of this chapter, and used in contact with food of Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. The average thickness of such polypropylene film shall not exceed 0.001 inches (30 micrometers).N,N-Bis(2-hydroxyethyl) dodecanamide For use only as an antistatic produced when diethanolamine is made agent at levels not to exceed to react with methyl laurate such that 0.5 percent by weight of the finished product: Has a minimum molded or extruded melting point of 36 °C; has a polyethylene containers minimum amide assay of 90 percent; intended for contact with contains no more than 2 percent by honey, chocolate syrup, liquid weight of free diethanolamine; and sweeteners, condiments, flavor contains no more than 0.5 percent by extracts and liquid flavor weight of N,N[prime]-bis(2- concentrates, grated cheese, hydroxyethyl) piperazine, as light and heavy cream, yogurt, determined by paper chromatography and foods of Type VIII as method. described in table 1 of § 176.170(c) of this chapter.N,N-Bis(2-hydroxyethyl) octadecylamine, For use only as an antistatic Chemical Abstracts Service Registry agent at levels not to exceed No. 10213-78-2, N-(2-hydroxyethyl)-N- 0.45 percent by weight in octadecylglycine (monosodium salt), polypropylene films complying Chemical Abstracts Service Registry with § 177.1520 of this No. 66810-88-6, and N,N-Bis(2- chapter, and used for hydroxyethyl)-N-(carboxymethyl) packaging food of Types I, II, octadecanaminum hydroxide (inner III, IV, V, VI-B, VII, VIII, salt), Chemical Abstracts Service and IX described in table 1 of Registry No. 24170-14-7, as the major § 176.170(c) of this components of a mixture prepared by chapter, and under conditions reacting ethylene oxide with of use B through H described octadecylamine and further reacting in table 2 of § this product with sodium 176.170(c). The average monochloroacetate and sodium thickness of such hydroxide, such that the final product polypropylene film shall not has: A nitrogen content of 3.3-3.8 exceed 0.002 inch. percent; a melting point of 42°-50 °C; and a pH of 10.0-11.5 in a 1 percent by weight aqueous solution.α-n-Dodecanol-omega-hydroxypoly For use only as an antistatic (oxyethylene) produced by the agent at levels not to exceed condensation of 1 mole of n-dodecanol 0.2 pct by weight in low- with an average of 9.5 moles of density polyethylene film ethylene oxide to form a condensate having an average thickness having a hydroxyl content of 2.7 to not exceeding 0.005 inch. 2.9 pct and having a cloud point of 80 °C to 92 °C in 1 pct by weight aqueous solution.Glycerol ester mixtures of ricinoleic As an antifogging agent at acid, containing not more than 50 levels not exceeding 1.5 pct percent monoricinoleate, 45 pct by weight of permitted diricinoleate, 10 pct triricinoleate, plasticized vinyl chloride and 3.3 pct free glycerine. homo-and/or copolymers.N-Methacryloyloxyethyl-N, N- For use only as an antistatic dimethylammonium-α-N-methyl agent at levels not to exceed carboxylate chloride sodium salt, 0.2 percent by weight of octadecyl methacrylate, ethyl polyolefin films that contact methacrylate, cyclohexyl methacrylate, foods under the conditions of N-vinyl-2-pyrrolidone copolymer (CAS use B through H described in Reg. No. 66822-60-4). table 2 of § 176.170(c) of this chapter. The average thickness of such polyolefin film shall not exceed 0.02 centimeter (0.008 inch).Octadecanoic acid 2-[2-hydroxyethyl) For use only as an antistatic octadecylamino]ethyl ester (CAS Reg. agent at levels such that the No. 52497-24-2), (octadecylimino) product of film thickness in diethylene distearate (CAS Reg. No. microns times the weight 94945-28-5), and octadecyl percent additive does not bis(hydroxyethyl)amine (CAS Reg. No. exceed 16, in polypropylene 10213-78-2), as the major components films complying with § of a mixture prepared by reacting 177.1520(c)1.1 of this ethylene oxide with octadecylamine and chapter, and used for further reacting this product with packaging food (except for octadecanoic acid, such that the final food containing more than 8 product has: a maximum acid value of 5 percent alcohol) under mg KOH/g and total amine value of conditions of use B through H 86±6 mg KOH/g as determined by described in table 2 of § a method entitled ``Total Amine 176.170(c) of this chapter. Value,'' which is incorporated by reference. Copies of the method are available from the Center for Food Safety and Applied Nutrition (HFS- 200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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.php..------------------------------------------------------------------------
