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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR178.3130]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3130 Antistatic and/or antifogging agents in food-packaging materials.

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:

List of substances Limitations
N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or derived from the combined fatty acids of coconut oilFor 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 packaging meat, fresh fruits, and fresh vegetables.
Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene)For use only as an antistatic 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, sodium salts (produced from n-alkanes in the range of C10-C18 with not less than 50 percent C14-C16)For use only:
1. As antistatic agents at levels not to exceed 0.1 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 ((9Al2O3).2(B2O3), CAS Reg. No. 11121-16-7) produced by reaction between aluminum oxide and/or aluminum hydroxide with boric acid and/or metaboric acid at temperatures in excess of 1000 deg. CFor use only:
1. At levels not to exceed 1 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 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-C18)amineFor use only as an antistatic agent at levels not to exceed 0.1 pct by weight of polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. 70955-14-5)For use only:
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, where the alkyl groups (C14-C18) are derived from tallow.For use only:
1. As an antistatic agent at 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 produced when diethanolamine is made to react with methyl laurate such that the finished product: Has a minimum melting point of 36 deg. C; has a minimum amide assay of 90 percent; contains no more than 2 percent by weight of free diethanolamine; and contains no more than 0.5 percent by weight of N,N, bis(2-hydroxyethyl)piperazine, as determined by paper chromatography methodFor use only:
1. As an antistatic agent at levels not to exceed 0.5 percent by weight of molded or extruded polyethylene containers intended for contact with honey, chocolate syrup, liquid sweeteners, condiments, flavor extracts and liquid flavor concentrates, grated cheese, 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 produced when diethanolamine is made to react with methyl laurate such that the finished product: Has a minimum melting point of 36 deg. C; has a minimum amide assay of 90 percent; contains no more than 2 percent by weight of free diethanolamine; and contains no more than 0.5 percent by weight of N,N'-bis(2-hydroxyethyl) piperazine, as determined by paper chromatography methodFor use only as an antistatic agent at levels not to exceed 0.5 percent by weight of molded or extruded polyethylene containers intended for contact with honey, chocolate syrup, liquid sweeteners, condiments, flavor extracts and liquid flavor concentrates, grated cheese, light and heavy cream, yogurt, and foods of Type VIII as described in table 1 of 176.170(c) of this chapter.
N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts Service Registry No. 10213-78-2, N-(2-hydroxyethyl)-N-octadecylglycine (monosodium salt), Chemical Abstracts Service Registry No. 66810-88-6, and N,N-Bis(2-hydroxyethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner salt), Chemical Abstracts Service Registry No. 24170-14-7, as the major components of a mixture prepared by reacting ethylene oxide with octadecylamine and further reacting this product with sodium monochloroacetate and sodium hydroxide, such that the final product has: A nitrogen content of 3.3-3.8 percent; a melting point of 42deg. -50 deg. C; and a pH of 10.0-11.5 in a 1 percent by weight aqueous solutionFor use only as an antistatic agent at levels not to exceed 0.45 percent by weight in polypropylene films complying with 177.1520 of this chapter, and used for packaging 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). The average thickness of such polypropylene film shall not exceed 0.002 inch.
[alpha]-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of n-dodecanol with an average of 9.5 moles of ethylene oxide to form a condensate having a hydroxyl content of 2.7 to 2.9 pct and having a cloud point of 80 deg. C to 92 deg. C in 1 pct by weight aqueous solutionFor use only as an antistatic agent at levels not to exceed 0.2 pct by weight in low-density polyethylene film having an average thickness not exceeding 0.005 inch.
Glycerol ester mixtures of ricinoleic acid, containing not more than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct triricinoleate, and 3.3 pct free glycerineAs an antifogging agent at levels not exceeding 1.5 pct by weight of permitted plasticized vinyl chloride homo-and/or copolymers.
N-Methacryloyloxyethyl-N,N-dimethylammonium-[alpha]-N-methyl carboxylate chloride sodium salt, octadecyl methacrylate, ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2-pyrrolidone copolymer (CAS Reg. No. 66822-60-4)For use only as an antistatic agent at levels not to exceed 0.2 percent by weight of polyolefin films that contact foods under the conditions of use B through H described in 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) octadecylamino]ethyl ester (CAS Reg. No. 52497-24-2), (octadecylimino) diethylene distearate (CAS Reg. No. 94945-28-5), and octadecyl bis(hydroxyethyl)amine (CAS Reg. No. 10213-78-2), as the major components of a mixture prepared by reacting ethylene oxide with octadecylamine and further reacting this product with octadecanoic acid, such that the final product has: a maximum acid value of 5 mg KOH/g and total amine value of 86+/-6 mg KOH/g as determined by a method entitled "Total Amine 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, 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.For use only as an antistatic agent at levels such that the product of film thickness in microns times the weight percent additive does not exceed 16, in polypropylene films complying with 177.1520(c)1.1 of this chapter, and used for packaging food (except for food containing more than 8 percent alcohol) under conditions of use B through H described in table 2 of 176.170(c) of this chapter.

[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]

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