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United States • Title 21 CFR • Part 175

Part 175PART 175—INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

Part 175 outlines regulations for indirect food additives, specifically adhesives and components of coatings, ensuring their safe use in food packaging and processing. It details permissible substances, limitations, and labeling requirements.

What this part covers

  • Adhesives used in food packaging must be prepared from approved substances and either separated from food by a functional barrier or used with limitations for dry, fatty, and aqueous foods.
  • Labeling for finished adhesive containers must include the statement 'food-packaging adhesive'.
  • The regulation lists a comprehensive set of optional substances that can be used in adhesive formulations, along with specific limitations and conditions for their use.
  • Substances must meet specifications outlined in other regulations within this subchapter if applicable.
  • The use of certain substances is restricted to specific functions like preservatives, stabilizers, or catalysts, with defined maximum usage levels or conditions.

Sections in Part 175

§ 175.105

Adhesives.

(a) Adhesives may be safely used as components of articles intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions: (1) The adhesive is prepared from one or more of the optional substances named in paragraph (c) of this section, subject to any prescribed limitations. (2) The adhesive is either separated from the food by a functional barrier or used subject to the following additional limitations: In dry foods.(i) The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice. In fatty and aqueous foods.a(ii) () The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice. b() Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation. (b) To assure safe usage of adhesives, the label of the finished adhesive container shall bear the statement “food-packaging adhesive”. (c) Subject to any limitation prescribed in this section and in any…

§ 175.125

Pressure-sensitive adhesives.

Pressure-sensitive adhesives may be safely used as the food-contact surface of labels and/or tapes applied to food, in accordance with the following prescribed conditions: (a) Pressure-sensitive adhesives prepared from one or a mixture of two or more of the substances listed in this paragraph may be used as the food-contact surface of labels and/or tapes applied to poultry, dry food, and processed, frozen, dried, or partially dehydrated fruits or vegetables. (1) Substances generally recognized as safe in food. (2) Substances used in accordance with a prior sanction or approval. (3) Color additives listed for use in or on food in parts 73 and 74 of this chapter. (4) Substances identified in § 172.615 of this chapter other than substances used in accordance with paragraph (a)(2) of this section. (5) Polyethylene, oxidized; complying with the identity prescribed in § 177.1620(a) of this chapter. stert(6) 4-[[4, 6-Bis(octylthio)--triazin-2-yl]amino]-2,6-di--butylphenol (CAS Reg. No. 991-84-4) as an antioxidant/stabilizer at a level not to exceed 1.5 percent by weight of the finished pressure-sensitive adhesive. tert(7) 2,2′-(2,5-Thiophenediyl)-bis(5--butylbenzoxazole) (CAS…

§ 175.210

Acrylate ester copolymer coating.

Acrylate ester copolymer coating may safely be used as a food-contact surface of articles intended for packaging and holding food, including heating of prepared food, subject to the provisions of this section: (a) The acrylate ester copolymer is a fully polymerized copolymer of ethyl acrylate, methyl methacrylate, and methacrylic acid applied in emulsion form to molded virgin fiber and heat-cured to an insoluble resin. Provided, however,(b) Optional substances used in the preparation of the polymer and in the preparation and application of the emulsion may include substances named in this paragraph, in an amount not to exceed that required to accomplish the desired technical effect and subject to any limitation prescribed: That any substance named in this paragraph and covered by a specific regulation in subchapter B of this chapter must meet any specifications in such regulation. (c) The coating in the form in which it contacts food meets the following tests: (1) An appropriate sample when exposed to distilled water at 212 °F for 30 minutes shall yield total chloroform-soluble extractables not to exceed 0.5 milligram per square inch. n-(2) An appropriate sample when exposed…

§ 175.230

Hot-melt strippable food coatings.

Hot-melt strippable food coatings may be safely applied to food, subject to the provisions of this section. (a) The coatings are applied to and used as removable coatings for food. (b) The coatings may be prepared, as mixtures, from the following substances: (1) Substances generally recognized as safe in food. (2) Substances identified in this subparagraph. Table | List of substances | Limitations | | --- | --- | | Acetylated monoglycerides | Complying with 172.828 of this chapter. | | Cellulose acetate butyrate | | Cellulose acetate propionate | | Mineral oil, white | For use only as a component of hot-melt strippable food coatings applied to frozen meats and complying with § 172.878 of this chapter. |

§ 175.250

Paraffin (synthetic).

Synthetic paraffin may be safely used as an impregnant in, coating on, or component of coatings on articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) The additive is synthesized by the Fischer-Tropsch process from carbon monoxide and hydrogen, which are catalytically converted to a mixture of paraffin hydrocarbons. Lower molecular-weight fractions are removed by distillation. The residue is hydrogenated and may be further treated by percolation through activated charcoal. This mixture can be fractionated into its components by a solvent separation method, using synthetic isoparaffinic petroleum hydrocarbons complying with § 178.3530 of this chapter. (b) Synthetic paraffin shall conform to the following specifications: Congealing point.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(1) There is no specification for the congealing point of synthetic paraffin components, except those components that have a congealing point below 50 °C when used in contact with food Types III, IVA, V, VIIA, and IX identified…

§ 175.260

Partial phosphoric acid esters of polyester resins.

Partial phosphoric acid esters of polyester resins identified in this section and applied on aluminum may be safely used as food-contact coatings, in accordance with the following prescribed conditions: (a) For the purpose of this section, partial phosphoric acid esters of polyester resins are prepared by the reaction of trimellitic anhydride with 2,2-dimethyl-1,3-propanediol followed by reaction of the resin thus produced with phosphoric acid anhydride to produce a resin having an acid number of 81 to 98 and a phosphorus content of 4.05 to 4.65 percent by weight. (b) The coating is chemically bonded to the metal and cured at temperatures exceeding 450 °F. (c) The finished food-contact coating, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of its intended use, as determined from tables 1 and 2 of § 175.300(d), yields total extractives in each extracting solvent not to exceed 0.3 milligrams per square inch of food-contact surface, as determined by the methods described in § 175.300(e), and the coating yields 2,2-dimethyl-1,3-propanediol in each extracting solvent not to…

§ 175.270

Poly(vinyl fluoride) resins.

Poly(vinyl fluoride) resins identified in this section may be safely used as components of food-contact coatings for containers having a capacity of not less than 5 gallons, subject to the provisions of this section. (a) For the purpose of this section, poly(vinyl fluoride) resins consist of basic resins produced by the polymerization of vinyl fluoride. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The poly(vinyl fluoride) basic resins have an intrinsic viscosity of not less than 0.75 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined 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: Solvent. N,N-(1) Dimethylacetamide, technical grade. Solution.(2) Powdered resin and solvent are heated at 120 °C until the resin is dissolved. Temperature.(3) Flow times…

§ 175.300

Resinous and polymeric coatings.

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 or enamel over a metal substrate, or the coating is intended for repeated food-contact use and is applied to any suitable substrate as a continuous film or enamel that serves as a functional barrier between the food and the substrate. The coating is characterized by one or more of the following descriptions: (1) Coatings cured by oxidation. (2) Coatings cured by polymerization, condensation, and/or cross-linking without oxidation. (3) Coatings prepared from prepolymerized substances. (b) The coatings are formulated from optional substances that may include: (1) Substances generally recognized as safe in food. (2) Substances the use of which is permitted by regulations in this part or which are permitted by prior sanction or approval and employed under the specific conditions, if any, of the prior sanction or approval. (3) Any substance employed in the…

§ 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: (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…

§ 175.350

Vinyl acetate/crotonic acid copolymer.

A copolymer of vinyl acetate and crotonic acid may be safely used as a coating or as a component of a coating which is the food-contact surface of polyolefin films intended for packaging food, subject to the provisions of this section. (a) The copolymer may contain added optional substances to impart desired properties. (b) The quantity of any optional substance does not exceed the amount reasonably required to accomplish the intended physical or technical effect nor any limitations further provided. (c) Any optional substance that is the subject of a regulation in parts 174, 175, 176, 177, 178, and § 179.45 of this chapter conforms with any specifications in such regulation. (d) Optional substances as provided in paragraph (a) of this section include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction or approval for uses with a copolymer of vinyl acetate and crotonic acid and used in accordance with such sanction or approval. (3) Substances identified in this subparagraph and subject to such limitations as are provided: (e) Copolymer of vinyl acetate and crotonic acid used as a coating or as a component of a coating conforming…

§ 175.360

Vinylidene chloride copolymer coatings for nylon film.

Vinylidene chloride copolymer coatings identified in this section and applied on nylon film may be safely used as food-contact surfaces, 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 nylon resins complying with § 177.1500 of this chapter. (b) The coatings are prepared from vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with one or more of the monomers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid, methyl acrylate, methyl methacrylate (CAS Reg. No. 80-62-6; maximum use level 6 weight percent) and 2-sulfoethyl methacrylate (CAS Reg. No. 10595-80-9; maximum use level 1 weight percent). The finished copolymers contain at least 50 weight percent of polymer units derived from vinylidene chloride. The finished coating produced from vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with methyl methacrylate and/or 2-sulfoethyl methacrylate, or with methyl methacrylate and/or 2-sulfoethyl methacrylate together with one or more of the other monomers from this section, is restricted to use at or below room…

§ 175.365

Vinylidene chloride copolymer coatings for polycarbonate film.

Vinylidene chloride copolymer coatings identified in this section and applied on polycarbonate film may be safely used as food-contact surfaces, 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 polycarbonate resins complying with § 177.1580 of this chapter. (b) The coatings are prepared from vinylidene chloride copolymers produced by copolymerizing vinylidene chloride with acrylonitrile, methyl acrylate, and acrylic acid. The finished copolymers contain at least 50 weight-percent of polymer units derived from vinyldene chloride. (c) Optional adjuvant substances employed in the production of the coatings or added thereto to impart desired properties may include sodium dodecylbenzenesulfonate in addition to substances described in § 174.5(d) of this chapter. (d) 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 the 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…

§ 175.380

Xylene-formaldehyde resins condensed with 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins.

The resins identified in paragraph (a) of this section may be safely used as a food-contact coating for articles intended for use in contact with food, in accordance with the following prescribed conditions. (a) The resins are produced by the condensation of xylene-formaldehyde resin and 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins, to which may have been added certain optional adjuvant substances required in the production of the resins or added to impart desired physical and technical properties. The optional adjuvant substances may include resins produced by the condensation of allyl ether of mono-, di-, or trimethylol phenol and capryl alcohol and also may include substances identified in § 175.300(b)(3), with the exception of paragraph (b)(3)(xxxi) and (xxxii) of that section. (b) The resins identified in paragraph (a) of this section may be used as a food-contact coating for articles intended for contact at temperatures not to exceed 160 °F with food of Types I, II, VI-A and B, and VIII described in table 1 of § 176.170(c) of this chapter provided that the coating in the finished form in which it is to contact food meets the following extractives limitations…

§ 175.390

Zinc-silicon dioxide matrix coatings.

Zinc-silicon dioxide matrix 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, subject to the provisions of this section; (a) The coating is applied to a metal surface, cured, and washed with water to remove soluble substances. (b) The coatings are formulated from optional substances which include: (1) Substances generally recognized as safe. (2) Substances for which safe conditions of use have been prescribed in § 175.300. (3) Substances identified in paragraph (c) of this section, subject to the limitations prescribed. (c) The optional substances permitted are as follows: (d) 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 the conditions of its intended use as shown in table 1 and 2 of § 175.300(d) (using 20 percent alcohol as the solvent when the type of food contains approximately 20 percent alcohol) shall yield total extractives not to exceed those prescribed in § 175.300(c)(3); lithium extractives not to exceed 0.025…

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