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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 2016.

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, 2016]
[CITE: 21CFR175.320]



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 175 -- INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

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 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-phenylenediamineFor 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'-Isopropylidenediphenolepichlorohydrin 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 copolymer resins (molar ratio 1 [alpha]-methylstyrene to 3 vinyltoluene)For use only in coatings that contact food under conditions of use D, E, F, or G described in table 2 of 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 resinsAs defined in 176.170 of 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. 68139-70-8), as the basic resin, derived from:For use only in coatings for polypropylene films that 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
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 dimerized vegetable oil acids (containing not more than 20% of monomer acids) and ethylenediamine, as the basic resinFor use only in coatings for polyolefin films that contact food at temperatures not to exceed room temperature.
Polyamide resins having a maximum acid value of 5 and a maximum amine value of 8.5 derived from dimerized vegetable oil acids (containing not more than 10 percent of monomer acids), ethylenediamine, and 4,4-bis (4-hydroxyphenyl) pentanoic acids (in an amount not to exceed 10 percent by weight of said polyamide resins); as the basic resinFor use only in coatings that contact food at temperatures not to exceed room temperature provided that the concentration of the polyamide resins in the finished food-contact coating does not exceed 5 milligrams per square inch of food-contact surface.
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
AzelaicFor use in forming polyester resins intended for use in coatings that contact food only of the type identified in 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 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 rosinAs defined in 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 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 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
PolyethylenimineFor use only as a primer subcoat to anchor epoxy surface coatings to the base sheet.
Polystyrene
Polyvinyl acetate
Polyvinyl chloride
Siloxanes and silicones: platinum-catalyzed reaction product of vinyl-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:Platinum content not to exceed 150 parts per million.
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107-54-0), at a level not to exceed 0.53 weight percent;
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
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No. 2554-06-5).
Siloxanes and silicones; platinum-catalyzed reaction product of vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. 68083-19-2 and 68083-18-1), with methyl hydrogen polysiloxane (CAS Reg. No. 63148-57-2). Dimethyl maleate (CAS Reg. No. 624-48-6) and vinyl acetate (CAS Reg. No. 108-05-4) may be used as optional polymerization inhibitorsPlatinum content not to exceed 100 parts per million. For use only as a surface coating under the following conditions:
1. In coatings for olefin polymers provided the coating contacts food only of the types identified in 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 176.170(c) of this chapter.
2. In coatings for olefin polymers provided the coating contacts food only of the types identified in 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 176.170(c) of this chapter.
Siloxanes and silicones; platinum-catalyzed reaction product of vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. 68083-19-2 and 68083-18-1), 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 agentPlatinum content not to exceed 100 parts per million. For use only as a release coating for pressure sensitive adhesives.
Styrene copolymerized with one or more of the following:
Acrylonitrile
[alpha]-Methyl styrene
Styrene polymers made by the polymerization of any combination of styrene or alpha methyl styrene with acrylic acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The styrene and alpha methyl styrene, individually, may constitute from 0 to 80 weight 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 percentFor use only in contact with foods of Types IV-A, V, and VII in table 1 of 176.170(c) of this chapter, under use conditions E through G in table 2 of 176.170(c), and with foods of Types VIII and IX without use temperature restriction.
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 salt Chemical Abstracts Service No. 1804-87-1]For use only in copolymer coatings under conditions of use E, F, and G described in table 2 of 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
(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 (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) mixture, at a ratio of 3 parts to 1 part, respectively, manufactured from methyl-3-mercaptopropionate (CAS Reg. No. 2935-90-2) and optionally containing magnesium nitrate (CAS Reg. No. 10377-60-3) at a concentration equivalent to the isothiazolone active ingredients (weight/weight).For use only as an antimicrobial agent in emulsion-based silicone coatings at a level not to exceed 50 milligrams per kilogram (based on isothiazolone active ingredient) in the coating formulation.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691-65-7)For use as an antimicrobial 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 Reg. No. 110-31-6)For use only in ionomeric resins complying with 177.1330 of this chapter and in ethylene vinyl acetate copolymers complying with 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 of 4% aqueous solution at 20 deg. C of 4 centipoises and percent alcoholysis of 87-100For use only as a dispersing agent at levels not to exceed 6% of total coating weight in coatings for pol-yolefin films provided the finished polyolefin films contact food only of the types identified in 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 dioxideFor use only as a preservative 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 176.170(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 the provisions of 180.22 of this chapter.

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