21 CFR 175.320 Resinous and polymeric coatings for polyolefin films.

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′-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

α-Methyl styrene polymer

α-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 α-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 α-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 resins

As 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 resin

For 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 resin

For 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

Azelaic

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.

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 § 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

α-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-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 inhibitors

Platinum 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 agent

Platinum 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

α-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 percent

For 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 α-pinene, β-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 stearate

Dibutyl sebacate

2-Ethylhexyl diphenyl phosphate

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 °C of 4 centipoises and percent alcoholysis of 87-100

For 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 dioxide

For 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.