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175.320 Resinous and polymeric coatings for polyolefin films.

Home > Regulations > Indirect food additives: Adhesives and components of coatings > 175.320 Resinous and polymeric coatings for polyolefin films.



[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: 21CFR175.320]

[Page 189-193]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 175_INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
--Table of Contents
 
         Subpart C_Substances for Use as Components of Coatings
 
Sec.  175.320  Resinous and polymeric coatings for polyolefin films.

    Resinous and polymeric coatings may be safely used as the food-
contact surface of articles intended for use in producing, 
manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding food, in accordance with the following 
prescribed conditions:
    (a) The coating is applied as a continuous film over one or both 
sides of a base film produced from one or more of the basic olefin 
polymers complying with Sec.  177.1520 of this chapter. The base 
polyolefin film may contain optional adjuvant substances permitted for 
use in polyolefin film by applicable regulations in parts 170 through 
189 of this chapter.
    (b) The coatings are formulated from optional substances which are:
    (1) Substances generally recognized as safe for use in or on food.
    (2) Substances the use of which is permitted under applicable 
regulations in parts 170 through 189 of this chapter, by prior 
sanctions, or approvals.
    (3) Substances identified in this paragraph (b)(3) and subject to 
such limitations as are provided:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
(i) Resins and polymers:
  Acrylic acid polymer and its ethyl or
   methyl esters.
  Acrylamide copolymerized with ethyl
   acrylate and/or styrene and/or
   methacrylic acid, and the copolymer
   subsequently reacted with
   formaldehyde and butanol.
  Butadiene-acrylonitrile copolymer....
  Butadiene-acrylonitrile-styrene
   terpolymer.
  Butyl rubber.........................
  N,N'-Diphenyl-p-phenylenediamine.....  For use only as a
                                          polymerization inhibitor in 2-
                                          sulfoethyl methacrylate,
                                          sodium salt.
  2-Ethylhexyl acrylate copolymerized
   with one or more of the following:
    Acrylonitrile......................
    Itaconic acid......................
    Methacrylonitrile..................
    Methyl acrylate....................
    Methyl methacrylate................
  4,4'-
   Isopropylidenediphenolepichlorohydri
   n average molecular weight 900.
  Melamine-formaldehyde as the basic
   polymer or chemically modified with
   methyl alcohol.
  Methacrylic acid and its ethyl or
   methyl esters copolymerized with one
   or more of the following:
    Acrylic acid.......................
    Ethyl acrylate.....................
    Methyl acrylate....................
  [alpha]-Methyl styrene polymer.......
  [alpha]-Methylstyrene-vinyltoluene     For use only in coatings that
   copolymer resins (molar ratio 1        contact food under conditions
   [alpha]-methylstyrene to 3             of use D, E, F, or G described
   vinyltoluene).                         in table 2 of Sec.
                                          176.170(c) of this chapter,
                                          provided that the
                                          concentration of [alpha]-
                                          methylstyrene-vinyltoluene
                                          copolymer resins in the
                                          finished food-contact coating
                                          does not exceed 1.0 milligram
                                          per square inch of food-
                                          contact surface.
  Petroleum alicyclic hydrocarbon        As defined in Sec.   176.170 of
   resins.                                this chapter. Blended with
                                          butyl rubber for use as a
                                          component of coatings on
                                          polyolefin fabric for bulk
                                          packaging of raw fruits and
                                          vegetables and used at a level
                                          not to exceed 30 percent by
                                          weight of the total coating
                                          solids.
  Polyamide resins (CAS Reg. No. 68139-  For use only in coatings for
   70-8), as the basic resin, derived     polypropylene films that
   from:                                  contact food at temperatures
                                          not to exceed room
                                          temperature.
    Dimerized vegetable oil or tall oil
     acids containing not more than 20
     percent of monomer acids.

[[Page 190]]


    Azelaic acid (CAS Reg. No. 123-99-
     9) in an amount not to exceed 3.7
     percent by weight of the polyamide
     resin.
    Ethylenediamine (CAS Reg. No. 107-
     15-3).
    Piperazine (CAS Reg. No. 110-85-0)
     in an amount not to exceed 6.4
     percent by weight of the polyamide
     resin.
  Polyamide resins, derived from         For use only in coatings for
   dimerized vegetable oil acids          polyolefin films that contact
   (containing not more than 20% of       food at temperatures not to
   monomer acids) and ethylenediamine,    exceed room temperature.
   as the basic resin.
  Polyamide resins having a maximum      For use only in coatings that
   acid value of 5 and a maximum amine    contact food at temperatures
   value of 8.5 derived from dimerized    not to exceed room temperature
   vegetable oil acids (containing not    provided that the
   more than 10 percent of monomer        concentration of the polyamide
   acids), ethylenediamine, and 4,4-bis   resins in the finished food-
   (4-hydroxyphenyl) pentanoic acids      contact coating does not
   (in an amount not to exceed 10         exceed 5 milligrams per square
   percent by weight of said polyamide    inch of food-contact surface.
   resins); as the basic resin.
  Polyester resins formed by reaction
   of one or more of the following
   polybasic acids and monobasic acids
   with one or more of the following
   polyhydric alcohols:
    Polybasic acids:
      Adipic...........................
      Azelaic..........................  For use in forming polyester
                                          resins intended for use in
                                          coatings that contact food
                                          only of the type identified in
                                          Sec.   176.170(c) of this
                                          chapter, table 1, under
                                          Category VIII, and under
                                          conditions of use E, F, or G,
                                          described in table 2 of Sec.
                                          176.170(c) of this chapter.
      Dimerized fatty acids derived
       from:
        Animal, marine or vegetable
         fats and oils.
        Tall oil.......................
      Fumaric..........................
      Isophthalic......................
      Maleic...........................
      o-Phthalic.......................
      Sebacic..........................
      Terephthalic.....................
      Trimellitic......................
    Monobasic acids:
      Fatty acids derived from:
        Animal, marine, or vegetable
         fats and oils.
        Gum rosin......................  As defined in Sec.   178.3870
                                          of this chapter. For use in
                                          forming polyester resins
                                          intended for use in coatings
                                          that contact food only of the
                                          type identified in Sec.
                                          176.170(c) of this chapter,
                                          table 1, under Category VIII,
                                          and under conditions of use E,
                                          F, or G described in table 2
                                          of Sec.   176.170(c) of this
                                          chapter.
    Polyhydric alcohols:
      1,3-Butylene glycol..............
      Diethylene glycol................
      2,2-Dimethyl-1,3-propanediol.....
      Dipropylene glycol...............
      Ethylene glycol..................
      Glycerol.........................
      Mannitol.........................
      [alpha]-Methyl glucoside.........
      Pentaerythritol..................
      Propylene glycol.................
      Sorbitol.........................
      Trimethylol ethane...............
      Trimethylol propane..............
  Polyethylenimine.....................  For use only as a primer
                                          subcoat to anchor epoxy
                                          surface coatings to the base
                                          sheet.
  Polystyrene..........................
  Polyvinyl acetate....................
  Polyvinyl chloride...................  ...............................
Siloxanes and silicones: platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     150 parts per million.
 containing dimethylpolysiloxane (CAS
 Reg. No. 68083-18-1 and CAS Reg. No.
 68083-19-2) with methylhydrogen
 polysiloxane (CAS Reg. No. 63148-57-2)
 and dimethylmethylhydrogen
 polysiloxane (CAS Reg. No. 68037-59-
 2). The following substances may be
 used as optional polymerization
 inhibitors:.
  3,5-Dimethyl-1-hexyne-3-ol (CAS Reg.
   No. 107-54-0), at a level not to
   exceed 0.53 weight percent;.

[[Page 191]]


  1-Ethynylcyclohexene (CAS Reg. No.
   931-49-7), at a level not to exceed
   0.64 weight percent;.
    Bis(methoxymethyl)ethyl maleate
     (CAS Reg. No. 102054-10-4), at a
     level not to exceed 1.0 weight
     percent;.
  Methylvinyl cyclosiloxane (CAS Reg.
   No. 68082-23-5); and.
  Tetramethyltetravinylcyclotetrasiloxa
   ne (CAS Reg. No. 2554-06-5)..
Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a surface coating
 Reg. Nos. 68083-19-2 and 68083-18-1),    under the following
 with methyl hydrogen polysiloxane (CAS   conditions:
 Reg. No. 63148-57-2). Dimethyl maleate  1. In coatings for olefin
 (CAS Reg. No. 624-48-6) and vinyl        polymers provided the coating
 acetate (CAS Reg. No. 108-05-4) may be   contacts food only of the
 used as optional polymerization          types identified in Sec.
 inhibitors.                              176.170(c) of this chapter,
                                          table 1, under Types I, II,
                                          VI, and VII-B when used under
                                          conditions of use E, F, and G
                                          described in table 2 in Sec.
                                          176.170(c) of this chapter.
                                         2. In coatings for olefin
                                          polymers provided the coating
                                          contacts food only of the
                                          types identified in Sec.
                                          176.170(c) of this chapter,
                                          table 1, under Types III, IV,
                                          V, VII-A, VIII, and IX when
                                          used under conditions of use A
                                          through H described in table 2
                                          in Sec.   176.170(c) of this
                                          chapter.
Siloxanes and silicones; platinum-       Platinum content not to exceed
 catalyzed reaction product of vinyl-     100 parts per million. For use
 containing dimethylpolysiloxane (CAS     only as a release coating for
 Reg. Nos. 68083-19-2 and 68083-18-1),    pressure sensitive adhesives.
 with methyl hydrogen polysiloxane (CAS
 Reg. No. 63148-57-2). Dimethyl maleate
 (CAS Reg. No. 624-48-6), vinyl acetate
 (CAS Reg. No. 108-05-4), dibutyl
 maleate (CAS Reg. No. 105-76-0) and
 diallyl maleate (CAS Reg. No. 999-21-
 3) may be used as optional
 polymerization inhibitors. The polymer
 may also contain C16-C18 olefins (CAS
 Reg. No. 68855-60-7) as a control
 release agent.
  Styrene copolymerized with one or
   more of the following:
    Acrylonitrile......................
    [alpha]-Methyl styrene.............
  Styrene polymers made by the           For use only in contact with
   polymerization of any combination of   foods of Types IV-A, V, and
   styrene or alpha methyl styrene with   VII in table 1 of Sec.
   acrylic acid, methacrylic acid, 2-     176.170(c) of this chapter,
   ethyl hexyl acrylate, methyl           under use conditions E through
   methacrylate, and butyl acrylate.      G in table 2 of Sec.
   The styrene and alpha methyl           176.170(c), and with foods of
   styrene, individually, may             Types VIII and IX without use
   constitute from 0 to 80 weight         temperature restriction.
   percent of the polymer. The other
   monomers, individually, may be from
   0 to 40 weight percent of the
   polymer. The polymer number average
   molecular weight (Mn) shall be at
   least 2,000 (as determined by gel
   permeation chromatography). The acid
   number of the polymer shall be less
   than 250. The monomer content shall
   be less than 0.5 percent.
  Styrene-isobutylene copolymer........
  Terpene resins consisting of polymers
   of [alpha]-pinene, [beta]-pinene,
   and/or dipentene; acid value less
   than 5, saponification number less
   than 5, and color less than 4 on the
   Gardner scale as measured in 50
   percent mineral spirits solution.
  2-Sulfoethyl methacrylate, sodium      For use only in copolymer
   salt Chemical Abstracts Service No.    coatings under conditions of
   1804-87-1].                            use E, F, and G described in
                                          table 2 of Sec.   176.170(c)
                                          of this chapter and limited to
                                          use at a level not to exceed
                                          2.0 percent by weight of the
                                          dry copolymer coating.
  Vinyl chloride-acetate, hydroxyl-
   modified copolymer or maleic acid-
   modified copolymer.
  Vinyl chloride copolymerized with one
   or more of the following:
    Acrvlonitrile......................
    Vinyl acetate......................
    Vinylidene chloride................
  Vinylidene chloride copolymerized
   with one or more of the following:
    Acrylic acid and its methyl, ethyl,
     propyl, butyl, or octyl esters.
    Acrylonitrile......................
    Itaconic acid......................
    Methacrylic acid and its methyl,
     ethyl, propyl, butyl, or octyl
     esters.
    Methacrylonitrile..................
    Vinyl chloride.....................

[[Page 192]]


(ii) Plasticizers:
  Acetyl tributyl citrate..............
  Acetyl triethyl citrate..............
  Butyl phthalyl butyl glycolate.......
  Butyl stearate.......................
  Dibutyl sebacate.....................
  Diethyl phthalate....................
  2-Ethylhexyl diphenyl phosphate......
  Ethyl phthalyl ethyl glycolate.......
  Glycerol monooleate..................  ...............................
  Glycerol triacetate..................
  Triethyl citrate.....................
(iii) Adjuvants (release agents, waxes,
 and dispersants):
  Acetone..............................
  Amides (unsubstituted) of fatty acids
   from vegetable or animal oils.
  n-Butyl acetate......................
  n-Butyl alcohol......................
  Candelilla wax.......................
  Carnauba wax.........................
5-Chloro-2-methyl-4-isothiazolin-3-one   For use only as an
 (CAS Reg. No. 26172-55-4) and 2-methyl-  antimicrobial agent in
 4-isothiazolin-3-one (CAS Reg. No.       emulsion-based silicone
 2682-20-4) mixture, at a ratio of 3      coatings at a level not to
 parts to 1 part, respectively,           exceed 50 milligrams per
 manufactured from methyl-3-              kilogram (based on
 mercaptopropionate (CAS Reg. No. 2935-   isothiazolone active
 90-2) and optionally containing          ingredient) in the coating
 magnesium nitrate (CAS Reg. No. 10377-   formulation.
 60-3) at a concentration equivalent to
 the isothiazolone active ingredients
 (weight/weight)..
  1,2-Dibromo-2,4-dicyanobutane (CAS     For use as an antimicrobial
   Reg. No. 35691-65-7).                  agent at levels not to exceed
                                          500 milligrams per kilogram in
                                          emulsion-based silicone
                                          coating.
  Ethyl acetate........................
  Fatty acids from vegetable or animal
   oils and their aluminum, ammonium,
   calcium, magnesium, and sodium salts.
  Hexane...............................
  Methyl ethyl ketone..................
  N,N'-Dioleoylethylenediamine (CAS      For use only in ionomeric
   Reg. No. 110-31-6).                    resins complying with Sec.
                                          177.1330 of this chapter and
                                          in ethylene vinyl acetate
                                          copolymers complying with Sec.
                                            177.1350 of this chapter at
                                          a level not to exceed 0.0085
                                          milligram per square
                                          centimeter (0.055 milligram
                                          per square inch) in the
                                          finished food-contact article.
  Petroleum waxes conforming to
   specifications included in a
   regulation in subchapter B of this
   chapter.
  Polyvinyl alcohol, minimum viscosity   For use only as a dispersing
   of 4% aqueous solution at 20 [deg]C    agent at levels not to exceed
   of 4 centipoises and percent           6% of total coating weight in
   alcoholysis of 87-100.                 coatings for pol-yolefin films
                                          provided the finished
                                          polyolefin films contact food
                                          only of the types identified
                                          in Sec.   176.170(c) of this
                                          chapter, table 1, under Types
                                          V, VIII, and IX.
  Sodium dioctyl sulfosuccinate........
  Sodium dodecylbenzenesulfonate.......
  Sodium lauryl sulfate................
  Sorbitan and sorbitol esters of fatty
   acids from vegetable or animal oils.
  Spermaceti wax.......................
  Tetrahydrofuran......................
  Toluene..............................
(iv) Preservatives:
  Silver chloride-coated titanium        For use only as a preservative
   dioxide.                               in latex emulsions at a level
                                          not to exceed 2.2 parts per
                                          million (based on silver ion
                                          concentration) in the dry
                                          coating.
------------------------------------------------------------------------

    (c) The coating in the finished form in which it is to contact food, 
when extracted with the solvent or solvents characterizing the type of 
food, and under conditions of time and temperature characterizing the 
conditions of its intended use as determined from tables 1 and 2 of 
Sec.  176.17(c) of this chapter, shall yield net chloroform-soluble 
extractives not to exceed 0.5 milligram per square inch of coated 
surface.
    (d) Acrylonitrile copolymers identified in this section shall comply 
with

[[Page 193]]

the provisions of Sec.  180.22 of this chapter.

[42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978; 45 
FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497, Sept. 
18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1, 1991; 61 FR 
14246, Apr. 1, 1996; 63 FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, 
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, June 13, 2000]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 175, Section 320


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