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178.3130 Antistatic and/or anti&chyph;fogging agents in food-packaging materials.

Home > Regulations > Indirect food additives: Adjuvants, production aids, and sanitizers > 178.3130 Antistatic and/or anti&chyph;fogging agents in food-packaging materials.



[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3130]

[Page 397-400]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 178_INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS--Table of Contents
 
             Subpart D_Certain Adjuvants and Production Aids
 
Sec.  178.3130  Antistatic and/or anti fogging 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   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 Sec.   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 Sec.   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.

[[Page 398]]


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 Sec.   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 Sec.   176.170(c)
                                          of this chapter, and under
                                          conditions of use E, F, and G
                                          described in table 2 of Sec.
                                          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
                                          Sec.   177.1640(c) of this
                                          chapter under conditions of
                                          use B through H described in
                                          table 2 of Sec.   176.170(c)
                                          of this chapter.
Aluminum Borate                          For use only:
 ((9Al2O3)[middot]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 Sec.   177.1520(c) of
 metaboric acid at temperatures in        this chapter, item 1.1, of
 excess of 1000 [deg]C.                   polyethylene films complying
                                          with Sec.   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 Sec.
                                          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 Sec.
                                           176.170(c) of this chapter,
                                          under conditions of use A
                                          through H as described in
                                          Table 2 of Sec.   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 Sec.   177.1520(c) of
                                          this chapter, item 1.1, of
                                          polyethylene films complying
                                          with Sec.   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 Sec.
                                          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 Sec.
                                           176.170(c) of this chapter
                                          under conditions of use B
                                          through H as described in
                                          Table 2 of Sec.   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 Sec.
                                          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 Sec.
                                          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 Sec.
                                          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 Sec.   176.170(c) of this
                                          chapter.

[[Page 399]]


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 Sec.   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 Sec.   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 Sec.   175.320,
                                          Sec.   177.1200, or Sec.
                                          177.1630 of this chapter,
                                          provided that such coatings
                                          contact food only of the types
                                          identified in Sec.
                                          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 Sec.
                                          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 [deg]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 Sec.
                                          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 Sec.   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 Sec.
                                          176.170(c) of this chapter,
                                          and under conditions of use B
                                          through H described in table 2
                                          of Sec.   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 [deg]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'-bis(2-hydroxyethyl)       concentrates, grated cheese,
 piperazine, as determined by paper       light and heavy cream, yogurt,
 chromatography method.                   and foods of Type VIII as
                                          described in table 1 of Sec.
                                          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 Sec.   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    Sec.   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 Sec.
 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[deg]-50
 [deg]C; and a pH of 10.0-11.5 in a 1
 percent by weight aqueous solution.
[alpha]-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
 [deg]C to 92 [deg]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-[alpha]-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 Sec.   176.170(c)
                                          of this chapter. The average
                                          thickness of such polyolefin
                                          film shall not exceed 0.02
                                          centimeter (0.008 inch).

[[Page 400]]


Octadecanoic acid 2-[2-hydroxy ethyl)    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
 diethyl ene 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 Sec.
 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
 866 mg KOH/g as    described in table 2 of Sec.
 determined by a method entitled          176.170(c) of this chapter.
 ``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, 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.html..
------------------------------------------------------------------------


[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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3130


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