21 C.F.R. § 175.320 Resinous and polymeric coatings for polyolefin films.
Title 21 - Food and Drugs
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: (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 §176.17(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 the provisions of §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]
Title 21: Food and Drugs
PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
Subpart C—Substances for Use as Components of Coatings
§ 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[prime]-Diphenyl-p- For use only as a phenylenediamine. 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[prime]- 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.................... α-Methyl styrene polymer....... α-Methylstyrene-vinyltoluene For use only in coatings that copolymer resins (molar ratio 1 contact food under conditions α-methylstyrene to 3 of use D, E, F, or G described vinyltoluene). 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 As defined in § 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. 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 § 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- 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;. 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 § 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 § 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- 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...................... α-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 § 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 § 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 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 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 § 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 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[prime]-Dioleoylethylenediamine For use only in ionomeric (CAS Reg. No. 110-31-6). 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 For use only as a dispersing of 4% aqueous solution at 20 °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 § 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.------------------------------------------------------------------------
