Title 21 CFR reference

Semirigid and rigid acrylic and modified acrylic plastics may be safely used as articles intended for use in contact with food, in accordance with the following prescribed conditions. The acrylic and modified acrylic polymers or plastics described in this section also may be safely used as components of articles intended for use in contact with food. (a) The optional substances that may be used in the formulation of the semirigid and rigid acrylic and modified acrylic plastics, or in the formulation of acrylic and modified acrylic components of articles, include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, substances permitted for use in such plastics by regulations in parts 170 through 189 of this chapter, and substances identified in this paragraph. At least 50 weight-percent of the polymer content of the acrylic and modified acrylic materials used as finished articles or as components of articles shall consist of polymer units derived from one or more of the acrylic or methacrylic monomers listed in paragraph (a)(1) of this section. (1) Homopolymers and copolymers of the following monomers: (2) Copolymers…

Acrylonitrile/butadiene/styrene copolymer identified in this section may be safely used as an article or component of articles intended for use with all foods, except those containing alcohol, under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter. Identity.(a) For the purpose of this section, the acrylonitrile/butadiene/styrene copolymer consists of: (1) Eighty-four to eighty-nine parts by weight of a matrix polymer containing 73 to 78 parts by weight of acrylonitrile and 22 to 27 parts by weight of styrene; and (2) Eleven to sixteen parts by weight of a grafted rubber consisting of (i) 8 to 13 parts of butadiene/styrene elastomer containing 72 to 77 parts by weight of butadiene and 23 to 28 parts by weight of styrene and (ii) 3 to 8 parts by weight of a graft polymer having the same composition range as the matrix polymer. Adjuvants.(b) The copolymer identified in paragraph (a) of this section may contain adjuvant substances required in its production. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted in this part, and the following:…

Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer identified in this section may be safely used as an article or component of articles intended for use with food identified in table 1 of § 176.170(c) of this chapter as Type I, II, III, IVA, IVB, V, VIB, (except bottles intended to hold carbonated beverages), VIIA, VIIB, VIII and IX, under conditions of use C, D, E, F, and G described in table 2 of § 176.170(c) of this chapter with a high temperature limitation of 190 °F. Identity.(a) For the purpose of this section, acrylonitrile/butadiene/styrene/methyl methacrylate copolymer consists of: (1) 73 to 79 parts by weight of a matrix polymer containing 64 to 69 parts by weight of acrylonitrile, 25 to 30 parts by weight of styrene and 4 to 6 parts by weight of methyl methacrylate; and (2) 21 to 27 parts by weight of a grafted rubber consisting of (i) 16 to 20 parts of butadiene/styrene/elastomer containing 72 to 77 parts by weight of butadiene and 23 to 28 parts by weight of styrene and (ii) 5 to 10 parts by weight of a graft polymer having the same composition range as the matrix polymer. Adjuvants.(b) The copolymer identified in paragraph (a) of this section may contain…

Acrylonitrile/styrene copolymers identified in this section may be safely used as a component of packaging materials subject to the provisions of this section. Identity.(a) For the purposes of this section acrylonitrile/styrene copoly-mers are basic copolymers meeting the specifications prescribed in paragraph (c) of this section. Adjuvants.(b) (1) The copolymers identified in paragraph (c) of this section may contain adjuvant substances required in their production, with the exception that they shall not contain mercaptans or other substances which form reversible complexes with acryl-onitrile monomer. Permissible adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted under applicable regulations in this part, and those authorized in paragraph (b)(2) of this section. (2) The optional adjuvants for the acrylonitrile/styrene copolymer identified in paragraphs (c)(1) and (3) of this section are as follows: Specifications.(c) Interim listing.(d) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter. (e) Acrylonitrile copolymer…

Acrylonitrile/styrene copolymer modified with butadiene/styrene elastomer identified in this section may be safely used as a component of bottles intended for use with foods identified in table I of § 176.170(c) of this chapter as Type VI-B under conditions for use E, F, or G described in table 2 of § 176.170(c) of this chapter. Identity.(a) For the purpose of this section, acrylonitrile/styrene copoly- mer modified with butadiene/styrene elastomer consists of a blend of: (1) 82-88 parts by weight of a matrix copolymer produced by polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts of styrene; and (2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12 parts of butadiene/styrene elastomer containing 77-82 parts by weight of butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by weight of a graft copolymer consisting of 70-77 parts by weight of acrylonitrile and 23-30 parts by weight of styrene. Adjuvants.(b) The modified copoly-mer identified in paragraph (a) of this section may contain adjuvant substances required in its production. Such adjuvants may include substances generally recognized as safe in food, substances used in…

n-Alkylglutarimide/acrylic copolymers identified in this section may be safely used as articles or components of articles intended for use in contact with food subject to provisions of this section and part 174 of this chapter. Identity.nn-(a) For the purpose of this section, -alkylglutarimide/acrylic copolymers are copolymers obtained by reaction of substances permitted by § 177.1010(a)(1), (2), and (3) with the following substance: Monomethylamine (CAS Reg. No. 74-89-5), to form methylglutarimide/acrylic copolymers. Adjuvants.(b) The copolymers identified in paragraph (a) of this section may contain adjuvant substances required in their production. The optional adjuvant substances required in the production of the basic polymer may include substances permitted for such use by applicable regulations, as set forth in part 174 of this chapter. Specifications.(c) Maximum nitrogen content of the copolymer determined by micro-Kjeldahl analysis, shall not exceed 8 percent. Limitations.n-(d) (1) The alkylglutarimide/acrylic copolymers in the finished form in which they shall contact food, when extracted with the solvent or solvents characterizing the type of food and under the…

Cellophane may be safely used for packaging food in accordance with the following prescribed conditions: (a) Cellophane consists of a base sheet made from regenerated cellulose to which have been added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties. (b) Subject to any limitations prescribed in this part, the optional substances used in the base sheet and coating may include: (1) Substances generally recognized as safe in food. (2) Substances for which prior approval or sanctions permit their use in cellophane, under conditions specified in such sanctions and substances listed in § 181.22 of this chapter. (3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of cellophane. (4) Substances named in this section and further identified as required. List of substances:(c) (d) Any optional component listed in this section covered by a specific food additive regulation must meet any specifications in that regulation. (e) Acrylonitrile copolymers identified in this section shall comply…

Closures with sealing gaskets may be safely used on containers intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) Closures for food containers are manufactured from substances generally recognized as safe for contact with food; substances that are subject to the provisions of prior sanctions; substances authorized by regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; and closure-sealing gaskets, as further prescribed in this section. (b) Closure-sealing gaskets and overall discs are formulated from substances identified in § 175.300(b) of this chapter, with the exception of paragraph (b)(3)(v), (xxxi), and (xxxii) of that section, and from other optional substances, including the following: (1) Substances generally recognized as safe in food. (2) Substances used in accordance with the provisions of a prior sanction or approval within the meaning of section 201(s) of the act. (3) Substances that are the subject of regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter and used in accordance with the…

Cross-linked polyacrylate copolymers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food in accordance with the following prescribed conditions: Identity.(a) For the purpose of this section, the cross-linked polyacrylate copolymers consist of: N,N(1) The grafted copolymer of cross-linked sodium polyacrylate identified as 2-propenoic acid, polymers with -di-2-propenyl-2-propen-1-amine and hydrolyzed polyvinyl acetate, sodium salts, graft (CAS Reg. No. 166164-74-5); or (2) 2-propenoic acid, polymer with 2-ethyl-2-(((1-oxo-2-propenyl)oxy)methyl)-1,3-propanediyl di-2-propenoate and sodium 2-propenoate (CAS Reg. No. 76774-25-9). Adjuvants.(b) The copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such copolymers. The optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. Extractives limitations.(c) The copolymers identified in…

Copolymer of 1,4-cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate may be safely used as an article or component of articles used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The copolymer is a basic polyester produced by the catalytic condensation of dimethyl terephthalate and dimethyl isophthalate with 1,4-cyclohexanedimethanol, to which may have been added certain optional substances required in its production or added to impart desired physical and technical properties. (b) The quantity of any optional substance employed in the production of the copolymer does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of the copolymer that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of the copolymer include: (1) Substances generally recognized as safe in food. (2)…

The ethylene-acrylic acid copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section. (a) The ethylene-acrylic acid copolymers consist of basic copolymers produced by the copolymerization of ethylene and acrylic acid such that the finished basic copolymers contain no more than: (1) 10 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (b) of this section; and (2) 25 weight-percent of total polymer units derived from acrylic acid when used in accordance with paragraph (c) of this section. (b) The finished food-contact articles made with no more than 10 percent total polymer units derived from acrylic acid, when extracted with the solvent or solvents characterizing the type of food and under the conditions of its intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yield net acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods prescribed in § 177.1330(e)(1), (3)(i) through (iv), (4), (5), and (6),…

The ethylene-carbon monoxide copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food subject to the provisions of this section. Identity.(a) For the purposes of this section, ethylene-carbon monoxide copolymers (CAS Reg. No. 25052-62-4) consist of the basic polymers produced by the copolymerization of ethylene and carbon monoxide such that the copolymers contain not more than 30 weight-percent of polymer units derived from carbon monoxide. Conditions of use.(b) (1) The polymers may be safely used as components of the food-contact or interior core layer of multilaminate food-contact articles. (2) The polymers may be safely used as food-contact materials at temperatures not to exceed 121 °C (250 °F). Specifications.(c) (1) Food-contact layers formed from the basic copolymer identified in paragraph (a) of this section shall be limited to a thickness of not more than 0.01 centimeter (0.004 inch). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) The copolymers identified in paragraph (a) of this section shall have a melt index not greater than 500 as…

Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may be safely used as articles or components of articles intended for use in contact with food subject to provisions of this section and of part 174 of this chapter. Identity.(a) For the purposes of this section, ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers (1,4-benzene dicarboxylic acid, dimethyl ester, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6) or (1,4-benzenedicarboxylic acid, polymerized with 1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9) are basic copolymers meeting the specifications prescribed in paragraph (b) of this section, to which may have been added certain optional substances required in their production or added to impart desired physical or technical properties. Specifications:(b) Analytical method for determination of extractability.652452252252452252352(c) The total extracted terephthaloyl moieties can be determined in the extracts, without evaporation of the solvent, by measuring the ultraviolet (UV) absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or equivalent) is zeroed with a sample of…

Ethylene-ethyl acrylate copolymers may be safely used to produce packaging materials, containers, and equipment intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) Ethylene-ethyl acrylate copolymers consist of basic resins produced by the catalytic copolymerization of ethylene and ethyl acrylate, to which may have been added certain optional substances to impart desired technological properties to the resin. Subject to any limitations prescribed in this section, the optional substances may include: (1) Substances generally recognized as safe in food and food packaging. (2) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, prior sanction, or approvals. (b) The ethyl acrylate content of the copolymer does not exceed 8 percent by weight unless it is blended with polyethylene or with one or more olefin copolymers complying with § 177.1520 or with a mixture of polyethylene and one or more olefin copolymers, in such proportions that the ethyl acrylate content of the blend does not…

Ionomeric resins manufactured from either ethylene-methacrylic acid copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl acetate copolymers (and/or their ammonium, calcium, magnesium, potassium, sodium, and/or zinc partial salts,), or methacrylic acid polymers with ethylene and isobutyl acrylate (and/or their potassium, sodium and/or zinc partial salts) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the ethylene-methacrylic acid copolymers consist of basic copolymers produced by the copolymerization of ethylene and methacrylic acid such that the copolymers contain no more than 20 weight percent of polymer units derived from methacrylic acid, and the ethylene-methacrylic acid-vinyl acetate copolymers consist of basic copolymers produced by the copolymerization of ethylene, methacrylic acid, and vinyl acetate such that the copolymers contain no more than 15 weight percent of polymer units derived from methacrylic acid. (b) For the purpose of this section, the…

Ethylene-methyl acrylate copolymer resins may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the ethylene-methyl acrylate copolymer resins consist of basic copolymers produced by the copolymerization of ethylene and methyl acrylate such that the copolymers contain no more than 25 weight percent of polymer units derived from methyl acrylate. (b) The finished food-contact article, 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, yields net chloroform-soluble extractives (corrected for zinc extractives as zinc oleate) in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods described in § 176.170(d) of this chapter. If the finished food-contact article is itself the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter, it shall also comply with any…

Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) identified in paragraph (a) of this section may be safely used, subject to the provisions of this section, as the non-food-contact layer of laminate structures subject to the provisions of § 177.1395, and in blends with polyethylene terephthalate polymers complying with § 177.1630. Identity.(a) For the purpose of this section, ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer consists of the basic copolymer produced by the catalytic polycondensation of isophthalic acid and terephthalic acid with ethylene glycol and 1,3-bis(2-hydroxyethoxy)benzene such that the finished resin contains between 42 and 48 mole-percent of isophthalic moieties, between 2 and 8 mole-percent of terephthalic moieties, and not more than 10 mole-percent of 1,3-bis(2-hydroxyethoxy)benzene moieties. SpecificationsDensity.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) —(1) Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer identified in paragraph (a) of this section has a density of 1.33±0.02 grams per cubic centimeter…

Ethylene-vinyl acetate copolymers may be safely used as articles or components 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)(1) Ethylene-vinyl acetate copolymers consist of basic resins produced by the catalytic copolymerization of ethylene and vinyl acetate to which may have been added certain optional substances to impart desired technological or physical properties to the resin. Subject to any limitations prescribed in this section, the optional substances may include: (i) Substances generally recognized as safe in food and food packaging. (ii) Substances the use of which is permitted under applicable regulations in parts 170 through 189 of this chapter, prior sanction, or approvals. (iii) Substances identified in § 175.300(b)(3)(xxv), (xxvii), (xxx), and (xxxiii) of this chapter, and colorants used in accordance with § 178.3297 of this chapter. (iv) Erucamide as identified in § 178.3860 of this chapter. (v) Xanthan gum as identified in § 172.695 for use as a thickening agent at a level not to exceed 1 percent by weight…

Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No. 26221-27-2) may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by the partial or complete alcoholysis or hydrolysis of those ethylene-vinyl acetate copolymers complying with § 177.1350. (1) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 30 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (b) of this section. (2) Those copolymers containing a minimum of 55 percent ethylene and a maximum of 15 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (c) of this section. (3) Those copolymers containing 17 to 40 percent ethylene and 60 to 83 percent vinyl alcohol units by weight may be used in contact with foods as described in paragraph (d) of this section. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The finished food-contact article shall not exceed 0.013 centimeter (0.005 inch) thickness…

Fluorocarbon resins may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, fluorocarbon resins consist of basic resins produced as follows: (1) Chlorotrifluoroethylene resins produced by the homopolymerization of chlorotrifluoroethylene. (2) Chlorotrifluoroethylene-1,1-difluoroethylene copolymer resins produced by copolymerization of chlorotrifluoroethylene and 1,1-difluoroethylene. (3) Chlorotrifluoroethylene-1,1-difluoroethylene-tetrafluoroethylene co-polymer resins produced by copolymerization of chlorotrifluoroethylene, 1,1-difluoroethylene, and tetrafluoroethylene. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(4) Ethylene-chlorotrifluoroethylene copolymer resins produced by copolymerization of nominally 50 mole percent of ethylene and 50 mole percent of chlorotrifluoroethylene. The copolymer shall have a melting point of 239 to 243 °C and a melt index of less than or equal to 20 as determined by ASTM Method D 3275-89 “Standard Specification for E-CTFE-Fluoroplastic Molding, Extrusion, and Coating…

(a) The high-temperature laminates identified in this section may be safely used for food contact at temperatures not exceeding 135 °C (275 °F) unless otherwise specified. These articles are layered constructions that are optionally bonded with adhesives. The interior (food-contact) layer(s) may be separated from the exterior layer(s) by a functional barrier, such as aluminum foil. Upon review of the physical properties of a particular construction, the Food and Drug Administration may consider other layers to serve as functional barriers. This regulation is not intended to limit these constructions as to shape, degree of flexibility, thickness, or number of layers. These layers may be laminated, extruded, coextruded, or fused. (b) When containers subject to this regulation undergo heat sterilization to produce shelf-stable foods, certain control measures (in addition to the food additive requirements in paragraphs (c) and (d) of this section) are necessary to ensure proper food sterilization and package integrity. Refer to parts 108, 110, 113, and 114 of this chapter for details. (c) Subject to the provisions of this paragraph, food-contact articles produced from…

(a) The laminates identified in this section may be safely used at the specified temperatures. These articles are layered structures that are optionally bonded with adhesives. In these articles, the food-contact layer does not function as a barrier to migration of components from non-food-contact layers. The layers may be laminated, extruded, coextruded, or fused. (b) Laminate structures may be manufactured from: (1) Polymers and adjuvants complying with § 177.1390 of this chapter. (2) Any polymeric resin listed in these regulations so long as the use of the resin in the structure complies with the conditions of use (food type and time/temperature) specified in the regulation for that resin. (3) Optional adjuvant substances used in accordance with § 174.5 of this chapter. (4) The following substances in non-food-contact layers only: Table | Substances | Limitations | | --- | --- | | Ethylene/1,3-phenylene oxyethylene isophthalate/terephthalate copolymer (CAS Reg. No. 87365-98-8) complying with § 177.1345 | m03For use only with polyethylene terephthalate as the food-contact layer, complying with § 177.1630 under conditions of use C through G described in table 2 of §…

Water-insoluble hydroxyethyl cellulose film may be safely used for packaging food in accordance with the following prescribed conditions: (a) Water-insoluble hydroxyethyl cellulose film consists of a base sheet manufactured by the ethoxylation of cellulose under controlled conditions, to which may be added certain optional substances of a grade of purity suitable for use in food packaging as constituents of the base sheet or as coatings applied to impart desired technological properties. (b) Subject to any limitations prescribed in parts 170 through 189 of this chapter, the optional substances used in the base sheet and coating may include: (1) Substances generally recognized as safe in food. (2) Substances permitted to be used in water-insoluble hydroxyethyl cellulose film by prior sanction or approval and under conditions specified in such sanctions or approval, and substances listed in part 181, subpart B of this chapter. (3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of water-insoluble hydroxyethyl cellulose film. (4) Substances identified in and used in compliance with § 177.1200(c). (c) Any substance…

Isobutylene polymers may be safely used as components 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) For the purpose of this section, isobutylene polymers are those produced as follows: (1) Polyisobutylene produced by the homopolymerization of isobutylene such that the finished polymers have a molecular weight of 750,000 (Flory) or higher. (2) Isobutylene-isoprene copolymers produced by the copolymerization of isobutylene with not more than 3 molar percent of isoprene such that the finished polymers have a molecular weight of 300,000 (Flory) or higher. (3) Chlorinated isobutylene-isoprene copolymers produced when isobutylene-isoprene copolymers (molecular weight 300,000 (Flory) or higher) are modified by chlorination with not more than 1.3 weight-percent of chlorine. (b) The polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of the polymers. The optional adjuvant substances required in the production of the polymers may include substances generally…

Isobutylene-butene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section. n(a) For the purpose of this section, isobutylene-butene copolymers consist of basic copolymers produced by the copolymerization of isobutylene with mixtures of -butenes such that the finished basic copolymers contain not less than 45 weight percent of polymer units derived from isobutylene and meet the specifications prescribed in paragraph (b) of this section when tested by the methods described in paragraph (c) of this section. Specifications:(b) (c) The analytical methods for determining whether isobutylene-butene copolymers conform to the specifications in paragraph (b) are as follows: Molecular weight.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(1) Molecular weight shall be determined by American Society for Testing and Materials (ASTM) method D2503-82, “Standard Test Method for Molecular Weight (Relative Molecular Mass) of Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,” which is incorporated by reference. Copies…

4,4′-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum molecular weight of 10,000 may be safely used as articles or components 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) 4,4′-Isopropylidenediphenol-ep-ichlorohydrin resins consist of basic resins produced by the condensation of equimolar amounts of 4,4′-isopropylidenediphenol and epichlorohydrin terminated with phenol, to which may have been added certain optional adjuvant substances required in the production of the resins. (b) The optional adjuvant substances required in the production of the resins may include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following: (c) 4,4′-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet the following nonvolatile extractives limitations: (1) Maximum extractable nonvolatile fraction of 2 parts per million when extracted with distilled water at 70 °C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch. n-(2)…

Melamine-formaldehyde resins may be safely used as the food-contact surface of molded articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food in accordance with the following prescribed conditions: (a) For the purpose of this section, melamine-formaldehyde resins are those produced when 1 mole of melamine is made to react with not more than 3 moles of formaldehyde in water solution. (b) The resins may be mixed with refined woodpulp and the mixture may contain other optional adjuvant substances which may include the following: (c) The molded melamine-formaldehyde articles in the finished form in which they are to contact food, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature as determined from tables 1 and 2 of § 175.300(d) of this chapter, shall yield net chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface. Table | List of substances | Limitations | | --- | --- | | Colorants used in accordance with § 178.3297 of this chapter | | Hexamethylenetetramine | For use only as…

Nitrile rubber modified acrylonitrile-methyl acrylate copolymers identified in this section may be safely used as components of articles intended for food-contact use under conditions of use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, subject to the provisions of this section. (a) For the purpose of this section, nitrile rubber modified acrylonitrile-methyl acrylate copolymers consist of basic copolymers produced by the graft copolymerization of 73-77 parts by weight of acrylonitrile and 23-27 parts by weight of methyl acrylate in the presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers containing approximately 70 percent by weight of polymer units derived from butadiene. (b) The nitrile rubber modified acrylonitrile-methyl acrylate basic copolymers meet the following specifications and extractives limitations: Specifications.(1) (i) Nitrogen content is in the range 16.5-19 percent as determined by Kjeldahl analysis. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(ii) Intrinsic viscosity in acetonitrile at 25 °C is not less than 0.29 deciliter per gram as determined by ASTM method D1243-79,…

The nylon resins listed in paragraph (a) of this section may be safely used to produce articles intended for use in processing, handling, and packaging food, subject to the provisions of this section: (a) The nylon resins are manufactured as described in this paragraph so as to meet the specifications prescribed in paragraph (b) of this section when tested by the methods described in paragraph (d) of this section. (1) Nylon 66 resins are manufactured by the condensation of hexamethylene-diamine and adipic acid. (2) Nylon 610 resins are manufactured by the condensation of hexamethylene-diamine and sebacic acid. (3) Nylon 66/610 resins are manufactured by the condensation of equal-weight mixtures of nylon 66 salts and nylon 610 salts. epsilon(4) Nylon 6/66 resins manufactured by the condensation and polymerization of Nylon 66 salts and -caprolactam. (5) Nylon 11 resins are manufactured by the condensation of 11-aminoundecanoic acid. epsilon-(6) Nylon 6 resins are manufactured by the polymerization of caprolactam. (7) Nylon 66T resins are manufactured by the condensation of hexamethyl-enediamine, adipic acid, and terephthalic acid such that composition in terms of ingredients…

The olefin polymers listed in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, subject to the provisions of this section. (a) For the purpose of this section, olefin polymers are basic polymers manufactured as described in this paragraph, so as to meet the specifications prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (1)(i) Polypropylene consists of basic polymers manufactured by the catalytic polymerization of propylene. (ii) Propylene homopolymer consists of basic polymers manufactured by the catalytic polymerization of propylene with a metallocene catalyst. (2)(i) Polyethylene consists of basic polymers manufactured by the catalytic polymerization of ethylene. (ii) Fumaric acid-grafted polyethylene (CAS Reg. No. 26877-81-6) consists of basic polymers manufactured by the catalytic polymerization of ethylene followed by reaction with fumaric acid in the absence of free radical initiators. Such polymers shall contain grafted fumaric acid at levels not to exceed 2 percent by weight of the finished polymer. (3) Olefin basic…

Perfluorocarbon resins identified in this section may be safely used as articles or components of articles intended to contact food, subject to the provisions of this section: Identity.(a) For the purpose of this section, perfluorocarbon resins are those produced by: (1) The homopolymerization and/or copolymerization of hexafluoropropylene and tetrafluoroethylene, and (2) the copolymerization of perfluoropropylvinylether and tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the extractives limitations in paragraph (d) of this section. Optional components.(b) The perfluorocarbon resins identified in paragraph (a) of this section as well as articles or coating made from these resins may include the following optional components except that the resin identified in paragraph (a)(2) of this section may not be used with the optional component, lithium polysilicate, mentioned in paragraph (b)(4) of this section. (1) Substances generally recognized as safe (GRAS) in food or food packaging subject to any limitations cited on their use. (2) Substances used in accordance with a prior sanction or approval, subject to any limitations cited in the prior sanction or…

Polyarylate resins (CAS Reg. No. 51706-10-6) may be safely used as articles or components of articles intended for use in contact with food in accordance with the following prescribed conditions: Identity.(a) Polyarylate resins (1, 3-benzenedicarboxylic acid, diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4′-(1-methylethylidine) bis(phenol)) are formed by melt polycondensation of bisphenol-A with diphenylisophthalate and diphenylterephthalate. Specifications.(b) (1) The finished copolymers shall contain from 70 to 80 weight percent of polymer units derived from diphenylisophthalate and 20 to 30 weight percent of polymer units derived from diphenylterephthalate. (2) Polyarylate resins shall have a minimum weight average molecular weight of 20,000. (3) Polyarylate resins may be identified by their characteristic infrared spectra. Extractive limitations.(c) The finished polyarylate resins in sheet form at least 0.5 millimeter (0.020 inch) thick, when extracted with water at 121 °C (250 °F) for 2 hours, shall yield total nonvolatile extractives not to exceed 2.33 micrograms per square centimeter (15 micrograms per square inch) of the exposed resin surface.…

The poly(oxy-1,4-phenylenecarbonyl-1,4-phenyleneoxy-1,4-phenylenecarbonyl-1,4-phenylenecarbonyl-1,4-phenylene) resins (CAS Reg. No. 55088-54-5 and CAS Reg. No. 60015-05-6 and commonly referred to as polyaryletherketone resins) identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food, subject to the provisions of this section. Identity.(a) Polyaryletherketone resins consist of basic resins produced by reacting 4,4′-diphenoxy benzophenone and terephthaloyl dichloride in such a way that the finished resins have a minimum weight average molecular weight of 20,000 grams per mole, as determined by light scattering measurements in sulfuric acid at room temperature. Optional adjuvant substances.(b) The basic polyaryletherketone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. These adjuvants may include substances used in accordance with § 174.5 of this chapter and the following: (1) Benzoyl chloride, poly(tetrafluoro ethylene). (2) [Reserved] Extractive limitations.n(c) The finished food-contact article…

Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used as articles or components of articles intended for use in contact with food, at temperatures up to and including normal baking temperatures, in accordance with the following prescribed conditions: Identity.ppp-pppphttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(a) Polyarylsulfone resins are copolymers containing not more than 25 percent of oxy--phenylene-oxy--phenylenesulfonyl-phenylene polymer units and not less than 75 percent of oxy--phenylenesulfonyl--phenylene-oxy--phenylenesulfonyl--phenylene polymer units. The copolymers have a minimum reduced viscosity of 0.40 deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” which is incorporated by reference. Copies may be obtained from the American Society for Testing and 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,…

The poly-1-butene resins and butene/ethylene copolymers identified in this section may be safely used as articles or components of articles intended for use in contact with food subject to the provisions of this section. Identity.(a) Poly-1-butene resins are produced by the catalytic polymerization of 1-butene liquid monomer. Butene/ethylene copolymers are produced by the catalytic polymerization of 1-butene liquid monomer in the presence of small amounts of ethylene monomer so as to yield no higher than a 6-weight percent concentration of polymer units derived from ethylene in the copolymer. Specifications and limitations.(b) Poly-1-butene resins and butene/ethylene copolymers shall conform to the specifications prescribed in paragraph (b)(1) of this section, and shall meet the extractability limits prescribed in paragraph (b)(2) of this section. SpecificationsInfrared identification.(1) —(i) Poly-1-butene resins and butene/ethylene copolymers can be identified by their characteristic infrared spectra. Viscosity.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(ii) Poly-1-butene resins and the butene/ethylene copolymers have an intrinsic…

Polycarbonate resins may be safely used as articles or components 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) Polycarbonate resins are polyesters produced by: (1) The condensation of 4,4′-iso-propylidenediphenol and carbonyl chloride to which may have been added certain optional adjuvant substances required in the production of the resins; or by (2) The reaction of molten 4,4′-iso-propylidenediphenol with molten diphenyl carbonate in the presence of the disodium salt of 4,4′-isopropylidenediphenol. aa-m-(3) The condensation of 4,4′-isopro- pylidenediphenol, carbonyl chloride, and 0.5 percent weight maximum of 2,6-bis (6-hydroxytolyl) mesitol to which may have been added certain optional adjuvant substances required in the production of branched polycarbonate resins. (b) The optional adjuvant substances required in the production of resins produced by the methods described in paragraph (a)(1) and (3) of this section may include substances generally recognized as safe in food, substances used in accordance with a prior…

Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, or holding food, in accordance with the following prescribed conditions: p(a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced by the condensation of 4,4′-isopropylidenediphenol, carbonyl chloride, terephthaloyl chloride, and isophthaloyl chloride such that the finished resins are composed of 45 to 85 molepercent ester, of which up to 55 mole-percent is the terephthaloyl isomer. The resins are manufactured using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1 and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or greater. The resins are also properly identified by CAS Reg. No. 114096-64-9 when produced with the use of greater than 2 but not greater than 5 weight percent -cumylphenol (CAS Reg. No. 599-64-4), as an optional adjuvant substance in accordance with paragraph (b)(2) of this section. Optional adjuvants.(b) The optional adjuvant substances required in the production of resins identified in paragraph (a) of this section may include: (1)…

The polyester elastomers identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under Type VIII, in accordance with the following prescribed conditions: (a) For the purpose of this section, polyester elastomers are those produced by the ester exchange reaction when one or more of the following phthalates—dimethyl terephthalate, and dimethyl isophthalate—is made to react with alpha-hydroomega-hydroxypoly (oxytetramethylene) and/or 1,4-butanediol such that the finished elastomer has a number average molecular weight between 20,000 and 30,000. (b) Optional adjuvant substances employed in the production of the polyester elastomers or added thereto to impart desired technical or physical properties may include the following substances: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) An appropriate sample of the finished polyester elastomer in the form in which it contacts food when subjected to ASTM method D968-81, “Standard Test Methods for Abrasion Resistance of…

The polyetherimide resin identified in this section may be safely used as an article or component of an article intended for use in contact with food, subject to the provisions of this section. Identity.m(a) For the purpose of this section, the polyetherimide resin is 1,3-isobenzofurandione, 5,5′[(1-methyl-ethylidene)bis(4,1-phenyleneoxy)] bis-polymer with 1,3-benzenediamine (CAS Reg. No. 61128-46-9), and is derived from the condensation reaction of -phenylenediamine and bisphenol A-dianhydride. Optional adjuvants.(b) The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of basic resins or finished food-contact articles. The optional adjuvant substances required in the production of the basic polymer may include substances permitted for such use by applicable regulations as set forth in part 174 of this chapter. Specifications and extractives limitationsSpecifications.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) —(1) Polyetherimide resin identified in paragraph (a) of this section shall have an intrinsic viscosity in chloroform at 25 °C (77 °F) of not less…

Carboxyl-modified polyethylene resins may be safely used as the food-contact surface of articles intended for use in contact with food in accordance with the following prescribed conditions: (a) For the purpose of this section, carboxyl-modified polyethylene resins consist of basic polymers produced when ethylene-methyl acrylate basic copolymers, containing no more than 25 weight percent of polymer units derived from methyl acrylate, are made to react in an aqueous medium with one or more of the following substances: (b) The finished food-contact article, 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, yields total extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in § 176.170(d) of this chapter; and if the finished food-contact article is itself the subject of a regulation in parts 174, 175, 176, 177, 178, and § 179.45 of this chapter, it shall also comply with any specifications and…

Chlorinated polyethylene identified in this section may be safely used as articles or components of articles that contact food, except for articles used for packing or holding food during cooking, subject to the provisions of this section. n-http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.n(a) For the purpose of this section, chlorinated polyethylene consists of basic polymers produced by the direct chlorination of polyethylene conforming to the density, maximum hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed under item 2.1 of the table in § 177.1520(c). Such chlorinated polyethylene contains a maximum of 60 percent by weight of total chlorine, as determined by ASTM 1method D1303-55 (Reapproved 1979), “Standard Test Method for Total Chlorine in Vinyl Chloride Polymers and Copolymers,” 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,…

Fluorinated polyethylene, identified in paragraph (a) of this section, may be safely used as food-contact articles in accordance with the following prescribed conditions: (a) Fluorinated polyethylene food-contact articles are produced by modifying the surface of polyethylene articles through action of fluorine gas in combination with gaseous nitrogen as an inert diluent. Such modification affects only the surface of the polymer, leaving the interior unchanged. Fluorinated polyethylene articles are manufactured from basic resins containing not less than 85 weight-percent of polymer units derived from ethylene and identified in § 177.1520 (a)(2) and (3)(i). (b) Fluorinated polyethylene articles conform to the specifications and use limitations of § 177.1520(c), items 2.1 and 3.1. (c) The finished food-contact article, 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, yields fluoride ion not to exceed 5 parts per million calculated on the basis of the volume of food held by the food-contact…

Oxidized polyethylene identified in paragraph (a) of this section may be safely used as a component of food-contact articles, in accordance with the following prescribed conditions: n-(a) Oxidized polyethylene is the basic resin produced by the mild air oxidation of polyethylene conforming to the density, maximum hexane extractable fraction, and maximum xylene soluble fraction specifications prescribed under item 2.3 of the table in § 177.1520(c). Such oxidized polyethylene has a minimum number average molecular weight of 1,200, as determined by high temperature vapor pressure osmometry, contains a maximum of 5 percent by weight of total oxygen, and has an acid value of 9 to 19. bNote:04(b) The finished food-contact article, 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, yields net acidified chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface when tested by the methods described in § 177.1330(c), except that net acidified chloroform-soluble…

Polyethylene phthalate polymers identified in this section may be safely used as, or components of plastics (films, articles, or fabric) intended for use in contact with food in accordance with the following prescribed conditions: (a) Polyethylene phthalate films consist of a base sheet of ethylene terephthalate polymer, ethylene terephthalate-isophthalate copolymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters described in § 177.1315(b)(3), to which have been added optional substances, either as constituents of the base sheet or as constituents of coatings applied to the base sheet. (b) Polyethylene phthalate articles consist of a base polymer of ethylene terephthalate polymer, or ethylene-1,4-cyclohexylene dimethylene terephthalate copolyesters described in § 177.1315(b)(3), to which have been added optional substances, either as constituents of the base polymer or as constituents of coatings applied to the base polymer. (c)(1) Polyethylene phthalate spunbonded nonwoven fabric consist of continuous filaments of ethylene terephthalate polymer and ethylene terephthalate-isophthalate copolymer to which may have been added optional adjuvant substances…

Poly(phenyleneterephthalamide) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated contact with food. Identity.p(a) For the purpose of this section, the poly(phenylene- terephthalamide) resins (CAS Reg. No. 26125-61-1) are produced by the polymerization of terephthalolyl chloride with -phenylenediamine. The poly(phenyleneterephthalamide) resin fibers and yarns may contain optional adjuvant substances required in their preparation and finishing. Optional adjuvant substances.(b) The poly(phenyleneterephthalamide) resins identified in paragraph (a) of this section may contain the following optional adjuvant substances, subject to any limitation on their use: (1) Optional adjuvant substances authorized for this use in accordance with § 174.5 of this chapter. (2) Optional finish components, total weight not to exceed 1 percent by weight of the base polymer, as follows: Specifications.(c) (1) Poly(phenyleneterephthalamide) resins in the form of continuous filament yarns or fibers that have been scoured in accordance with paragraph (d)(1) of this section, when refluxed in a 50 percent ethanol/water mixture…

ppPoly(-methylstyrene) and rubber-modified poly(-methylstyrene) identified in this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section: Identity.pp(a) For the purposes of this section, poly(-methylstyrene) and rubber-modified poly(-methylstyrene) are basic polymers, manufactured as described in this paragraph, meeting the specifications prescribed in paragraph (c) of this section. pp(1) Poly(-methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced by the polymerization of -methylstyrene. pppp(2) Rubber-modified poly(-methylstyrene) (CAS Reg. No. 33520-88-6) polymer produced by combining styrene-butadiene copolymer and/or polybutadiene with poly(-methylstyrene), either during or after polymerization of the poly(-methylstyrene), such that the finished polymers contain not less than 75 weight percent of total polymer units derived from -methylstyrene) monomer. Optional adjuvants.(b) The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. Such optional adjuvant substances may include substances…

Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food in accordance with the following conditions: Identity.(a) For the purpose of this section, poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins (CAS Reg. No. 24968-11-4) are polymers formed by catalytic transesterification of 2,6-dimethylnaphthalene dicarboxylate with ethylene glycol followed by catalytic polycondensation. SpecificationsDensity.(b) —(1) The density of poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins shall be between 1.33 and 1.40 grams per cubic centimeter. Inherent viscosity.phttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(2) The finished food-contact article shall have a minimum inherent viscosity of 0.55 deciliter per gram in a solution of 0.1 gram of polymer in 100 milliliters of a 25/40/35 (weight/weight/weight) solution of -chlorophenol/tetrachloroethane/phenol. The viscosity is determined by Eastman Chemical Co.'s method ECD-A-AC-G-V-1-5, “Determination of Dilute…

Polystyrene and rubber-modified polystyrene identified in this section may be safely used as components of articles intended for use in contact with food, subject to the provisions of this section. Identity.(a) For the purposes of this section, polystyrene and rubber-modified polystyrene are basic polymers manufactured as described in this paragraph so as to meet the specifications prescribed in paragraph (c) of this section when tested by the method described in paragraph (d) of this section. (1) Polystyrene consists of basic polymers produced by the polymerization of styrene. (2) Rubber-modified polystyrene consists of basic polymers produced by combining styrene-butadiene copolymers and/or polybutadiene with polystyrene, either during or after polymerization of the polystyrene, such that the finished basic polymers contain not less than 75 weight percent of total polymer units derived from styrene monomer. Optional adjuvants.(b) The basic polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. Such optional adjuvant substances may include substances permitted for such use by regulations…

Polysulfide polymer-polyepoxy res- ins may be safely used as the food-contact surface of articles intended for packaging, transporting, holding, or otherwise contacting dry food, in accordance with the following prescribed conditions: (a) Polysulfide polymer-polyepoxy resins are the reaction products of liquid polysulfide polymers and polyfunctional epoxide resins, cured with the aid of tri(dimethylaminomethyl) phenol, to which have been added certain optional substances to impart desired technological properties to the resins. Subject to any limitations prescribed in this section, the optional substances may include: (1) Substances generally recognized as safe in food and food packaging. (2) Substances the use of which is permitted under applicable regulations in this part, prior sanctions, or approvals. (3) Substances named in this subparagraph and further identified as required: (b) The resins are used as the food-contact surface for dry food. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) An appropriate sample of the finished resin in the form in which it contacts food, when subjected to ASTM method D968-81, “Standard Test…

Polysulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, polysulfone resins are: pppp(1) Poly(oxy--phenylenesulfonyl--phenyleneoxy--phenyleneisopropylidene--phenylene) resins (CAS Reg. No. 25154-01-2) consisting of basic resins produced when the disodium salt of 4,4′-isopropylidenediphenol is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resins have a minimum number average molecular weight of 15,000, as determined by osmotic pressure in monochlorobenzene; or (2) 1,1′-Sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) (CAS Reg. No. 88285-91-0) produced when a mixture of 4,4′-isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (maximum 8 percent) is made to react with 4,4′-dichlorodiphenyl sulfone in such a way that the finished resin has a minimum number average molecular weight of 26,000, as determined by osmotic pressure in…

Poly(tetramethylene terephthalate) (poly (oxytetramethyleneoxyter-ephthaloyl)) [Chemical Abstracts Service Registry No. 24968-12-5] identified in this section may be safely used as articles or components of articles intended to contact food, in accordance with the following prescribed conditions: Identity.(a) For the purpose of this section, poly (tetramethylene terephthalate) is the reaction product of dimethyl terephthalate with 1,4-butanediol to which may have been added certain optional substances to impart desired technological properties to the polymer. Optional adjuvant substances.(b) Poly(tetramethylene terephthalate) identified in paragraph (a) of this section may contain optional adjuvant substances. The quantity of any optional adjuvant substance employed in the production of the polymer does not exceed the amount reasonably required to accomplish the intended technical or physical effect. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, and substances permitted under applicable regulations in this part. Specifications.(c) (1) Inherent viscosity of a 0.50 percent solution of the polymer in…

Polyvinyl alcohol film may be safely used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Types V, VIII, and IX, in accordance with the following prescribed conditions: (a) The polyvinyl alcohol film is produced from polyvinyl alcohol having a minimum viscosity of 4 centipoises when a 4-percent aqueous solution is tested at 20 °C. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) The finished food-contact film for use in contact with Food Types V or IX, when extracted with the solvent characterizing the type of food and under the conditions of time and temperature characterizing its intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields total extractives not to exceed 0.078 milligram per square centimeter (0.5 milligram per square inch) of food-contact surface when tested by ASTM method F34-76 (Reapproved 1980), “Standard Test Method for Liquid Extraction of Flexible Barrier Materials,” 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,…

The polyurethane resins identified in paragraph (a) of this section may be safely used as the food-contact surface of articles intended for use in contact with bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under Type VIII, in accordance with the following prescribed conditions: (a) For the purpose of this section, polyurethane resins are those produced when one or more of the isocyanates listed in paragraph (a)(1) of this section is made to react with one or more of the substances listed in paragraph (a)(2) of this section: (1) Isocyanates: (2) List of substances: (b) Optional adjuvant substances employed in the production of the polyurethane resins or added thereto to impart desired technical or physical properties may include the following substances: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) An appropriate sample of the finished resin in the form in which it contacts food, when subjected to ASTM method D968-81, “Standard Test Methods for Abrasion Resistance of Organic Coatings by the Falling Abrasive Tester,” which is incorporated by reference (Copies may be obtained from the…

The styrene block polymers identified in paragraph (a) of this section may be safely used as articles or as components of articles intended for use in contact with food, subject to provisions of this section. (a) For the purpose of this section, styrene block polymers are basic polymers manufactured as described in this paragraph, so that the finished polymers meet the specifications prescribed in paragraph (b) of this section, when tested by the methods described in paragraph (c) of this section. (1) Styrene block polymers with 1,3-butadiene are those produced by the catalytic solution polymerization of styrene and 1,3-butadiene. (2) Styrene block polymers with 2-methyl-1,3-butadiene are those produced by the catalytic solution polymerization of styrene and 2-methyl-1,3-butadiene. (3) Styrene block polymers with 1,3-butadiene, hydrogenated are those produced by the catalytic solution polymerization of styrene and 1,3-butadiene, and subsequently hydrogenated. Specifications:(b) (c) The analytical methods for determining whether styrene block polymers conform to the specifications prescribed in this section are as follows and are applicable to the finished polymer. Molecular…

Styrene-maleic anhydride copolymers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for use in contact with food, subject to provisions of this section. (a) For the purpose of this section, styrene-maleic anhydride copolymers are those produced by the polymerization of styrene and maleic anhydride so that the finished polymers meet the specifications prescribed in paragraph (b) of this section, when tested by the methods described in paragraph (c) of this section. Specifications:(b) (c) The analytical methods for determining conformance with specifications for styrene-maleic anhydride copolymers prescribed in this section are as follows: Molecular weight.(1) Molecular weight shall be determined by membrane osmometry. Residual styrene monomer content.(2) Residual styrene monomer content shall be determined by the method described in § 177.1640(d). Residual maleic anhydride monomer content.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(3) Residual maleic anhydride monomer content shall be determined by a gas chromatographic method titled “Determination of Residual Maleic…

Styrene-methyl methacrylate copolymers identified in this section may be safely used as components of plastic articles intended for use in contact with food, subject to the provisions of this section. (a) For the purpose of this section, styrene-methyl methacrylate copolymers consist of basic copolymers produced by the copolymerization of styrene and methyl methacrylate such that the finished basic copolymers contain more than 50 weight percent of polymer units derived from styrene. (b) The finished plastic food-contact article, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of intended use as determined from tables 1 and 2 of § 176.170(c) of this chapter, yields extractives not to exceed the following when tested by the methods prescribed in § 177.1010(c); (1) Total nonvolatile extractives not to exceed 0.3 milligram per square inch of surface tested. (2) Potassium permanganate oxidizable distilled water and 8 and 50 percent alcohol extractives not to exceed an absorbance of 0.15. (3) Ultraviolet-absorbing distilled water and 8 and 50 percent alcohol extractives not to…

Textryls identified in this section may be safely used as articles or components 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) Textryls are nonwoven sheets prepared from natural or synthetic fibers, bonded with fibryl (Fibryl consists of a polymeric resin in fibrous form commingled with fiber to facilitate sheet formation and subsequently heat cured to fuse the fibryl and effect bonding). (b) Textryls are prepared from the fibers, fibryls, and adjuvants identified in paragraph (c) of this section, and subject to limitations prescribed in that paragraph, provided that any 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 for that substance as a component of polymeric resins used as food contact surfaces. (c) The fibers, fibryls, and adjuvants permitted are as follows: (d) Textryls meeting the conditions of test prescribed in paragraph (d)(1) of this section are used as prescribed in paragraph (d)(2) of this section. Conditions…

Urea-formaldehyde resins may be safely used as the food-contact surface of molded articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, urea-formaldehyde resins are those produced when 1 mole of urea is made to react with not more than 2 moles of formaldehyde in water solution. (b) The resins may be mixed with refined wood pulp and the mixture may contain other optional adjuvant substances which may include the following: (c) The finished food-contact article, 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) of this chapter, yields total extractives in each extracting solvent not to exceed 0.5 milligram per square inch of food-contact surface as determined by the methods described in § 175.300(e) of this chapter. Table | List of substances | Limitations | | --- | --- | | Hexamethylenetetramine | For use only as polymerization-control agent. | | Tetrachlorophthalic acid anhydride | Do. | | Zinc stearate | For use as…

The vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for contact with food, under conditions of use D, E, F, or G described in table 2 of § 176.170 (c) of this chapter, subject to the provisions of this section. (a) For the purpose of this section, vinyl chloride-ethylene copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and ethylene such that the finished basic copolymers meet the specifications and extractives limitations prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (b) The basic vinyl chloride-ethylene copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. The optional adjuvant substances required in the production of the basic vinyl chloride-ethylene copolymers may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) The…

The vinyl chloride-hexene-1 copolymers identified in paragraph (a) of this section or as components of articles intended for use in contact with food, under conditions of use D, E, F, or G described in table 2 of § 176.170(c) of this chapter, subject to the provisions of this section. Identity.(a) For the purposes of this section vinyl chloride-hexene-1 copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and hexene-1 such that the finished copolymers contain not more than 3 mole-percent of polymer units derived from hexene-1 and meet the specifications and extractives limitations prescribed in paragraph (b) of this section. The copolymers may optionally contain hydroxypropyl methylcellulose and trichloroethylene used as a suspending agent and chain transfer agent, respectively, in their production. Specifications and limitations.(b) The vinyl chloride-hexene-1 basic copolymers meet the following specifications and extractives limitations: Specifications.(1) (i) Total chlorine content is 53 to 56 percent as determined by any suitable analytical procedure of generally accepted applicability.…

The vinyl chloride-lauryl vinyl ether copolymers identified in paragraph (a) of this section may be used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. Identity.(a) For the purposes of this section vinyl chloride-lauryl vinyl ether copolymers consist of basic copolymers produced by the copolymerization of vinyl chloride and lauryl vinyl ether such that the finished copolymers contain not more than 3 weight-percent of polymer units derived from lauryl vinyl ether and meet the specifications and extractives limitations prescribed in paragraph (c) of this section. Optional adjuvant substances.(b) The basic vinyl chloride-lauryl vinyl ether copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. Specifications and limitations.(c) The vinyl chloride-lauryl vinyl…

The vinyl chloride-propylene copolymers identified in paragraph (a) of this section may be safely used as components of articles intended for contact with food, subject to the provisions of this section. (a) For the purpose of this section, vinyl chloride-propylene copolymers consist of basic copolymers produced by the copolymezation of vinyl chloride and propylene such that the finished basic copolymers meet the specifications and extractives limitations prescribed in paragraph (c) of this section, when tested by the methods described in paragraph (d) of this section. (b) The basic vinyl chloride-propylene copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. The optional adjuvant substances required in the production of the basic vinyl chloride-propylene copolymers may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. (c) The vinyl chloride-propylene basic copolymers meet the following specifications and extractives…

The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No. 25038-72-6) identified in paragraph (a) of this section may be safely used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. Identity.(a) For the purposes of this section vinylidene chloride/methyl acrylate copolymers consist of basic copolymers produced by the copolymerization of vinylidene chloride and methyl acrylate such that the copolymers contain not more than 15 weight-percent of polymer units derived from methyl acrylate. Optional adjuvant substances.(b) The basic vinylidene chloride/methyl acrylate copolymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic copolymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval. Specifications.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(c) (1) The methyl acrylate…

The vinylidene chloride/methyl acrylate/methyl methacrylate polymers (CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section may be safely used as articles or as a component of articles intended for use in contact with food subject to the provisions of this section. Identity.(a) For the purpose of this section, vinylidene chloride/methyl acrylate/methyl methacrylate polymers consist of basic polymers produced by the copolymerization of vinylidene chloride/methyl acrylate/methyl methacrylate such that the basic polymers or the finished food-contact articles meet the specifications prescribed in paragraph (d) of this section. Optional adjuvant substances.(b) The basic vinylidene chloride/methyl acrylate/methyl methacrylate polymers identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymers. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 179 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction of approval. Conditions of use.(c) The polymers may be safely…

Ethylene polymer, chlorosulfonated as identified in this section may be safely used as an article or component of articles intended for use in contact with food, subject to the provisions of this section. (a) Ethylene polymer, chlorosulfonated is produced by chlorosulfonation of a carbon tetrachloride solution of polyethylene with chlorine and sulfuryl chloride. (b) Ethylene polymer, chlorosulfonated shall meet the following specifications: (1) Chlorine not to exceed 25 percent by weight. (2) Sulfur not to exceed 1.15 percent by weight. (3) Molecular weight is in the range of 95,000 to 125,000. (c) The additive is used as the article, or a component of articles, intended for use as liners and covers for reservoirs intended for the storage of water for drinking purposes. (d) Substances permitted by § 177.2600 may be employed in the preparation of ethylene polymers, chlorosulfonated, subject to any limitations prescribed therein. (e) The finished ethylene copolymers, chlorosulfonated shall conform to § 177.2600(e) and (g). http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.Methods for the specifications in this paragraph (b), titled…

Microporous polymeric filters identified in paragraph (a) of this section may be safely used, subject to the provisions of this section, to remove particles of insoluble matter in producing, manufacturing, processing, and preparing bulk quantities of liquid food. (a) Microporous polymeric filters consist of a suitably permeable, continuous, polymeric matrix of polyvinyl chloride, vinyl chloride-propylene, or vinyl chloride-vinyl acetate, in which finely divided silicon dioxide is embedded. Cyclohexanone may be used as a solvent in the production of the filters. (b) Any substance employed in the production of microporous polymeric filters that is the subject of a regulation in parts 170 through 189 of this chapter must conform with any specification in such regulation. (c) Cyclohexanone when used as a solvent in the production of the filters shall not exceed 0.35 percent by weight of the microporous polymeric filters. (d) The microporous polymeric filters may be colored with colorants used in accordance with § 178.3297 of this chapter. (e) The temperature of food being processed through the microporous polymeric filters shall not exceed 180 °F. (f) The microporous polymeric…

Resin-bonded filters may be safely used in producing, manufacturing, processing, and preparing food, subject to the provisions of this section. (a) Resin-bonded filters are prepared from natural or synthetic fibers to which have been added substances required in their preparation and finishing, and which are bonded with resins prepared by condensation or polymerization of resin-forming materials, together with adjuvant substances required in their preparation, application, and curing. (b) The quantity of any substance employed in the production of the resin-bonded filter does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of resin-bonded filters that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of resin-bonded filters include the following, subject to any limitations provided: Fibers:(1) Substances employed in fiber finishing:(2) Resins:(3) Adjuvant substances:(4) Colorants:(5) Colorants used in…

4,4′-Isopropylidenediphenol-epichlo-rohydrin thermosetting epoxy resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The basic thermosetting epoxy resin is made by reacting 4,4′-isopropylidenediphenol with epichlorohydrin. (b) The resin may contain one or more of the following optional substances provided the quantity used does not exceed that reasonably required to accomplish the intended effect: (c) In accordance with good manufacturing practice, finished articles containing the resins shall be thoroughly cleansed prior to their first use in contact with food. (d) The provisions of this section are not applicable to 4,4′-isopropylidenedi-phenol-epichlorohydrin resins listed in other sections of parts 174, 175, 176, 177, 178 and 179 of this chapter. Table | Column 1 | Column 2 | | --- | --- | | Allyl glycidyl ether | As curing system additive. | | Di- and tri-glycidyl ester mixture resulting from the reaction of epichlorohydrin with mixed dimers and trimers of…

Mineral reinforced nylon resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with nonacidic food (pH above 5.0) and at use temperatures not exceeding 212 °F. in accordance with the following prescribed conditions: (a) For the purpose of this section the mineral reinforced nylon resins consist of nylon 66, as identified in and complying with the specifications of § 177.1500, reinforced with up to 40 weight percent of calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl) propylamine (Chemical Abstracts Service Registry No. 000919302) based on the weight of the calcium silicate. (b) The mineral reinforced nylon resins may contain up to 0.2 percent by weight of titanium dioxide as an optional adjuvant substance. 1/8(c) The mineral reinforced nylon resins with or without the optional substance described in paragraph (b) of this section, and in the form of -inch molded test bars, when extracted with the solvents, i.e., distilled water and 50 percent (by volume) ethyl alcohol in distilled water, at reflux temperature for 24 hours using a volume-to-surface ratio of 2 milliliters of…

Perfluorocarbon cured elastomers identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with nonacid food (pH above 5.0), subject to the provisions of this section. Identity.(a) (1) For the purpose of this section, perfluorocarbon cured elastomers are produced by terpolymerizing tetrafluorethylene (CAS Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-5), and perfluoro-2-phenoxypropyl vinyl ether (CAS Reg. No. 24520-19-2) and subsequent curing of the terpolymer (CAS Reg. No. 26658-70-8) using the crosslinking agent, phenol, 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) ethylidene] bis-,dipotassium salt (CAS Reg. No. 25088-69-1) and accelerator, 1,4,7,10,13,16-hexaoxacyclooctadecane (CAS Reg. No. 17455-13-9). (2) The perfluorocarbon base polymer shall contain no less than 40 weight-percent of polymer units derived from tetrafluoroethylene, no less than 40 weight-percent of polymer units derived from perfluoromethyl vinyl ether and no more than 5 weight-percent polymer units derived from perfluoro-2-phenoxy-propyl vinyl ether. (3) The composition limitations of the cured elastomer,…

Phenolic resins identified in this section may be safely used as the food-contact surface of molded articles intended for repeated use in contact with nonacid food (pH above 5.0), in accordance with the following prescribed conditions: (a) For the purpose of this section, the phenolic resins are those produced when one or more of the phenols listed in paragraph (a)(1) of this section are made to react with one or more of the aldehydes listed in paragraph (a)(2) of this section, with or without aniline and/or anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine): Phenols:(1) Aldehydes:(2) (b) Optional adjuvant substances employed in the production of the phenolic resins or added thereto to impart desired technical or physical properties include the following: (c) The finished food-contact article, when extracted with distilled water at reflux temperature for 2 hours, using a volume-to-surface ratio of 2 milliliters of distilled water per square inch of surface tested, shall meet the following extractives limitations: (1) Total extractives not to exceed 0.15 milligram per square inch of food-contact surface. (2) Extracted phenol not to exceed 0.005 milligram…

Poly(aryletherketone) resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food subject to the provisions of this section. Identity.ppp(a) For the purposes of this section, poly(aryletherketone) resins are poly(-oxyphenylene -oxyphenylene -carboxyphenylene) resins (CAS Reg. No. 29658-26-2) produced by the polymerization of hydroquinone and 4,4′-difluorobenzophenone, and have a minimum weight-average molecular weight of 12,000, as determined by gel permeation chromatography in comparison with polystyrene standards, and a minimum mid-point glass transition temperature of 142 °C, as determined by differential scanning calorimetry. Optional adjuvant substances.(b) The basic resins identified in paragraph (a) may contain optional adjuvant substances used in their production. These adjuvants may include substances described in § 174.5(d) of this chapter and the following: Extractive limitations.n(c) The finished food contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields in each extracting solvent net chloroform soluble extractives not…

Cross-linked polyester resins may be safely used as articles or components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: (a) The cross-linked polyester resins are produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols or epoxides listed in paragraph (a)(2) of this section, followed by copolymerization with one or more of the cross-linking agents listed in paragraph (a)(3) of this section: (1) Acids: (2) Polyols and polyepoxides: (3) Cross-linking agents: (b) Optional adjuvant substances employed to facilitate the production of the resins or added thereto to impart desired technical or physical properties include the following, provided that the quantity used does not exceed that reasonably required to accomplish the intended physical or technical effect and does not exceed any limitations prescribed in this section: (c) The cross-linked polyester resins, with or without the optional substances described in paragraph (b) of this section, and in the finished form in which they are to contact food, when extracted with the solvent or…

Chlorinated polyether resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The chlorinated polyether resins are produced by the catalytic polymerization of 3,3-bis(chloromethyl)-oxetane, and shall contain not more than 2 percent residual monomer. (b) In accordance with good manufacturing practice, finished articles containing the chlorinated polyether resins shall be thoroughly cleansed prior to their first use in contact with food.

Polyethersulfone resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food in accordance with the following prescribed conditions: (a) For the purpose of this section, polyethersulfone resins are: pp(1) Poly(oxy--phenylenesulfonyl--phenylene) resins (CAS Reg. No. 25667-42-9), which have a minimum number average molecular weight of 16,000. (2) 1,1′-sulfonylbis[4-chlorobenzene] polymer with 4,4′-(1-methylethylidene)bis[phenol] (maximum 8 percent) and 4,4′-sulfonylbis[phenol] (minimum 92 percent) (CAS Reg. No. 88285-91-0), which have a minimum number average molecular weight of 26,000. http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(3) In paragraphs (a)(1) and (a)(2) of this section, the minimum number average molecular weight is determined by reduced viscosity in dimethyl formamide in accordance with ASTM method D2857-70 (Reapproved 1977), “Standard Test Method for Dilute Solution Viscosity of Polymers,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West…

Polyamide-imide resins identified in paragraph (a) of this section may be safely used as components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: Identity.pp(a) (1) For the purpose of this section the polyamide-imide resins are derived from the condensation reaction of substantially equimolar parts of trimellitic anhydride and ,′-diphenylmethane diisocyanate. (2) The polyamide-imide resins (CAS Reg. No. 31957-38-7) derived from the condensation reaction of equimolar parts of benzoyl chloride-3,4-dicarboxylic anhydride and 4,4′-diphenylmethanediamine. Specifications.http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(b) (1) Polyamide-imide resins identified in paragraph (a)(1) of this section shall have a nitrogen content of not less than 7.8 weight percent and not more than 8.2 weight percent. Polyamide-imide resins identified in paragraph (a)(2) of this section shall have a nitrogen content of not less than 7.5 weight percent and not more than 7.8 weight percent. Nitrogen content is determined by the Dumas Nitrogen Determination as set forth in the “Official Methods of…

The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of this section may be used as an article or as a component of an article intended for use in contact with food subject to the provisions of this section. Identity.(a) For the purposes of this section, poly(2,6-dimethyl-1,4-phenylene) oxide resins consist of basic resins produced by the oxidative coupling of 2,6-xylenol such that the finished basic resins meet the specifications and extractives limitations prescribed in paragraph (c) of this section. Optional adjuvant substances.(b) The basic poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. The optional adjuvant substances required in the production of the basic poly(2,6-dimethyl-1,4-phenylene) oxide resins may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following: Specifications and extractives limitations.(c) The poly(2,6-dimethyl-1,4-phenylene)…

Polymethylmethacrylate/poly(trimethoxysilylpropyl) methacrylate copolymers (CAS Reg. No. 26936-30-1) may be safely used as components of surface primers used in conjunction with silicone polymers intended for repeated use and complying with § 175.300 of this chapter and § 177.2600, in accordance with the following prescribed conditions. Identity.(a) For the purpose of this section, polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers are produced by the polymerization of methylmethacrylate and trimethoxysilylpropylmethacrylate. Conditions of use.(b) (1) The polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers are used at levels not to exceed 6.0 percent by weight of the primer formulation. (2) The copolymers may be used in food contact applications with all food types under conditions of use B through H as described in table 2 of § 176.170(c) of this chapter. [59 FR 5948, Feb. 9, 1994]

Polyoxymethylene copolymer identified in this section may be safely used as an article or component of articles intended for food-contact use in accordance with the following prescribed conditions: Identity.(a) For the purpose of this section, polyoxymethylene copolymers are identified as the following: The reaction product of trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg. No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of formaldehyde) and a maximum of 5 percent by weight of butanediol formal (CAS Reg. No. 25214 85-1). Both copolymers may have certain optional substances added to impart desired technological properties to the copolymer. Optional adjuvant substances.(b) The polyoxymethylene copolymer identified in paragraph (a) of this section may contain optional adjuvant substances required in its production. The quantity of any optional adjuvant substance employed in the production of the copolymer does not exceed the amount reasonably required to accomplish the intended technical or physical effect. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction,…

Polyoxymethylene homopolymer identified in this section may be safely used as articles or components of articles intended for food-contact use in accordance with the following prescribed conditions: Identity.(a) For the purpose of this section, polyoxymethylene homopolymer is polymerized formaldehyde [Chemical Abstracts Service Registry No. 9002-81-7]. Certain optional adjuvant substances, described in paragraph (b) of this section, may be added to impart desired technological properties to the homopolymer. Optional adjuvant substances.(b) The polyoxymethylene homopolymer identified in paragraph (a) of this section may contain optional adjuvant substances in its production. The quantity of any optional adjuvant substance employed in the production of the homopolymer does not exceed the amount reasonably required to accomplish the intended effect. Such adjuvants may include substances generally recognized as safe in food, substances used in accordance with prior sanction, substances permitted under applicable regulations in this part, and the following: Stabilizers.(1) The homopolymer may contain one or more of the following stabilizers. The total amount of stabilizers shall not…

Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins) may be safely used as coatings or components of coatings of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions. p-http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.(a) Polyphenylene sulfide resins consist of basic resins produced by the reaction of equimolar parts of dichlorobenzene and sodium sulfide, such that the finished resins meet the following specifications as determined by methods titled “Oxygen Flask Combustion-Gravimetric Method for Determination of Sulfur in Organic Compounds,” “Determination of the Inherent Viscosity of Polyphenylene Sulfide,” and “Analysis for Dichlorobenzene in Ryton Polyphenylene Sulfide,” which are incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or available for inspection 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: (1) Sulfur content: 28.2-29.1…

The polyphenylene sulfone resins (CAS Reg. No. 31833-61-1) identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with food, subject to the provisions of this section. Identity.p(a) For the purpose of this section, polyphenylene sulfone resins consist of basic resin produced by reacting polyphenylene sulfide with peracetic acid such that the finished resins meet the specifications set forth in paragraph (c) of this section. The polyphenylene sulfide used to manufacture polyphenylene sulfone is prepared by the reaction of sodium sulfide and -dichlorobenzene, and has a minimum weight average molecular weight of 5,000 Daltons. Optional adjuvant substances.(b) The basic polyphenylene sulfone resins identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic resins. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 189 of this chapter, substances generally recognized as safe in food, or substances used in accordance with a prior sanction or approval. Specifications.(c)…

Polyvinylidene fluoride resins may be safely used as articles or components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions: (a) For the purpose of this section, the polyvinylidene fluoride resins consist of basic resins produced by the polymerization of vinylidene fluoride. n-Note:04(b) The finished food-contact article, when extracted at reflux temperatures for 2 hours with the solvents distilled water, 50 percent (by volume) ethyl alcohol in distilled water, and heptane, yields total extractives in each extracting solvent not to exceed 0.01 milligram per square inch of food-contact surface tested; and if the finished food-contact article is itself the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter, it shall also comply with any specifications and limitations prescribed for it by that regulation. ( In testing the finished food-contact article, use a separate test sample for each required extracting solvent.) (c) In accordance with good manufacturing practice, finished food-contact articles containing the polyvinylidene fluoride resins shall be thoroughly cleansed prior to…

Substances identified in paragraph (a) of this section may be safely used as reverse osmosis membranes intended for use in processing bulk quantities of liquid food to separate permeate from food concentrate or in purifying water for food manufacturing under the following prescribed conditions: Identity.(a) For the purpose of this section, reverse osmosis membranes may consist of either of the following formulations: (1) A cross-linked high molecular weight polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The membrane is on the food-contact surface, and its maximum weight is 62 milligrams per square decimeter (4 milligrams per square inch) as a thin film composite on a suitable support. (2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6), identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and 1,2-dichloroethane, whose surface is the reaction product of this copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final polymer is 99811-80-0) for use as the food-contact surface of reverse osmosis membranes used in processing liquid food. The…

Rubber articles intended for repeated use may be safely used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) The rubber articles are prepared from natural and/or synthetic polymers and adjuvant substances as described in paragraph (c) of this section. (b) The quantity of any substance employed in the production of rubber articles intended for repeated use shall not exceed the amount reasonably required to accomplish the intended effect in the rubber article and shall not be intended to accomplish any effect in food. (c) Substances employed in the preparation of rubber articles include the following, subject to any limitations prescribed: (1) Substances generally recognized as safe for use in food or food packaging. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances that by regulation in parts 170 through 189 of this chapter may be safely used in rubber articles, subject to the provisions of such regulation. (4) Substances identified in this paragraph (c)(4), provided that any substance that is the subject of a…

Styrene-divinylbenzene cross-linked copolymer resins may be safely used as articles or components of articles intended for repeated use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, in accordance with the following prescribed conditions: (a) The resins are produced by the copolymerization of styrene with divinylbenzene. (b) The resins meet the extractives limitations prescribed in this paragraph: (1) The resins to be tested are ground or cut into small particles that will pass through a U.S. standard sieve No. 3 and that will be held on a U.S. standard sieve No. 20. (2) A 100-gram sample of the resins, when extracted with 100 milliliters of ethyl acetate at reflux temperature for 1 hour, yields total extractives not to exceed 1 percent by weight of the resins. (c) In accordance with good manufacturing practice, finished articles containing the resins shall be thoroughly cleansed prior to their first use in contact with food.

Textiles and textile fibers may safely be used as articles or components 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 textiles and textile fibers are prepared from one or more of the fibers identified in paragraph (d) of this section and from certain other adjuvant substances required in the production of the textiles or textile fibers or added to impart desired properties. (b) The quantity of any adjuvant substance employed in the production of textiles or textile fibers does not exceed the amount reasonably required to accomplish the intended physical or technical effect or any limitation further provided. (c) Any substance employed in the production of textiles or textile fibers that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation. (d) Substances employed in the production of or added to textiles and textile fibers may include: (1) Substances generally recognized as safe in food. (2) Substances subject to prior sanction or approval…

Ultra-filtration membranes identified in paragraphs (a)(1), (a)(2), (a)(3), and (a)(4) of this section may be safely used in the processing of food, under the following prescribed conditions; (a)(1) Ultra-filtration membranes that consist of paper impregnated with cured phenol-formaldehyde resin, which is used as a support and is coated with a vinyl chloride-acrylonitrile copolymer. (2) Ultra-filtration membranes that consist of a sintered carbon support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9). (3) Ultra-filtration membranes that consist of an aluminum oxide support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4) containing up to 5 percent yttrium oxide (CAS Reg. No. 1314-36-9). (4) Ultrafiltration membranes that consist of a microporous poly(vinylidene fluoride) membrane with a hydrophilic surface modifier consisting of hydroxypropyl acrylate/tetraethylene glycol diacrylate copolymer. (b) Any substance employed in the production of ultra-filtration membranes that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with the…