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).
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 filters shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential microbial adulteration of the food.
(g) To assure safe use of the microporous polymeric filters, the label or labeling shall include adequate directions for a pre-use treatment, consisting of washing with a minimum of 2 gallons of potable water at a temperature of 180 °F for each square foot of filter, prior to the filter's first use in contact with food.
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:
(1) Fibers:
(2) Substances employed in fiber finishing:
(3) Resins:
(4) Adjuvant substances:
(5) Colorants: Colorants used in accordance with § 178.3297 of this chapter.
(e) Resin-bonded filters conforming with the specifications of paragraph (e) (1) of this section are used as provided in paragraph (e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to distilled water at 100 °F for 2 hours, yields total extractives not to exceed 2.8 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at operating temperatures not to exceed 100 °F.
(f) Resin-bonded filters conforming with the specifications of paragraph (f) (1) of this section are used as provided in paragraph (e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to distilled water at 145 °F for 2 hours, yields total extractives not to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at operating temperatures not to exceed 145 °F.
(g) Resin-bonded filters conforming with the specifications of paragraph (g) (1) of this section are used as provided in paragraph (g)(2) of this section:
(1) Total extractives. The finished filter, when exposed to n-hexane at reflux temperature for 2 hours, yields total extractives not to exceed 0.5 percent by weight of the filter.
(2) Conditions of use. It is used to filter edible oils.
(h) Resin-bonded filters conforming with the specifications of paragraph (h) (1) of this section are used as provided in paragraph (h)(2) of this section:
(1) Total extractives. The finished filter, when exposed to distilled water at 212 °F for 2 hours, yields total extractives not to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk, coffee, tea, and potable water at temperatures not to exceed 212 °F.
(i) Resin-bonded filters conforming with the specifications of paragraph (i) (1) of this section are used as provided in paragraph (i)(2) of this section:
(1) Total extractives. The finished filter, when exposed to distilled water for 2 hours at a temperature equivalent to, or higher than, the filtration temperature of the aqueous food, yields total extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk quantities of nonalcoholic, aqueous foods having a pH above 5.0.
(j) Resin-bonded filters conforming with the specifications of paragraph (j) (1) of this section are used as provided in paragraph (j)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 5 percent (by weight) acetic acid for 2 hours at a temperature equivalent to, or higher than, the filtration temperature of the aqueous food, yields total extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk quantities of nonalcoholic, aqueous foods having a pH of 5.0 or below.
(k) Resin-bonded filters conforming with the specifications of paragraph (k) (1) of this section are used as provided in paragraph (k)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 8 percent (by volume) ethyl alcohol in distilled water for 2 hours at a temperature equivalent to, or higher than, the filtration temperature of the alcoholic beverage, yields total extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk quantities of alcoholic beverages containing not more than 8 percent alcohol.
(l) Resin-bonded filters conforming with the specifications of paragraph (l) (1) of this section are used as provided in paragraph (l)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 50 percent (by volume) ethyl alcohol in distilled water for 2 hours at a temperature equivalent to, or higher than, the filtration temperature of the alcoholic beverage, yields total extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk quantities of alcoholic beverages containing more than 8 percent alcohol.
(m) Resin-bonded filters fabricated from acrylic polymers as provided in paragraph (d)(3) of this section together with other substances as provided in paragraph (d), (1), (2), and (4) of this section may be used as follows:
(1) The finished filter may be used to filter milk or potable water at operating temperatures not to exceed 100 °F, provided that the finished filter when exposed to distilled water at 100 °F for 2 hours yields total extractives not to exceed 1 percent by weight of the filter.
(2) The finished filter may be used to filter milk or potable water at operating temperatures not to exceed 145 °F, provided that the finished filter when exposed to distilled water at 145 °F for 2 hours yields total extractives not to exceed 1.2 percent by weight of the filter.
(n) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.
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:
| 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 unsaturated C | As modifier at levels not to exceed equal parts by weight of the 4,4′-isopropylidenediphenol-epichlorohydrin basic resin and limited to use in contact with alcoholic beverages containing not more than 8 percent of alcohol. |
| 1,2-Epoxy-3-phenoxypropane | As curing system additive. |
| Glyoxal | Do. |
| 4,4′-Isopropylidenediphenol | Do. |
| 4,4′-Methylenedianiline | Do. |
| Do. | |
| Tetrahydrophthalic anhydride | Do. |
(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.
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.
(c) The mineral reinforced nylon resins with or without the optional substance described in paragraph (b) of this section, and in the form of
(1) Total extractives not to exceed 5.0 milligrams per square inch of food-contact surface tested for each solvent.
(2) The ash after ignition of the extractives described in paragraph (c)(1) of this section, not to exceed 0.5 milligram per square inch of food-contact surface tested.
(d) In accordance with good manufacturing practice, finished articles containing the mineral reinforced nylon resins shall be thoroughly cleansed prior to their first use in contact with food.
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.
(a) Identity. (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, calculated as parts per 100 parts of terpolymer, are as follows:
(b) Optional adjuvant substances. The perfluorocarbon cured elastomer identified in paragraph (a) of this section may contain the following optional adjuvant substances, subject to any limitations cited on their use:
(1) Substances generally recognized as safe (GRAS) in food or food packaging.
(2) Substances used in accordance with a prior sanction.
(3) Substances authorized under applicable regulations in this part and in parts 175 and 178 of this chapter and subject to any limitations prescribed therein.
(4) Substances identified in this paragraph (b)(4) subject to such limitations as are provided:
| Substances | Limitations |
|---|---|
| Carbon black (channel process of furnace combustion process) (CAS Reg. No. 1333-86-4) | Not to exceed 15 parts per 100 parts of the terpolymer. |
| Magnesium oxide (CAS Reg. No. 1309-48-4) | Not to exceed 5 parts per 100 parts of the terpolymer. |
(c) Specifications - (1) Infrared identification. Perfluorocarbon cured elastomers may be identified by the characteristic infrared spectra of the pyrolysate breakdown product that is obtained by heating and decomposing the elastomer using the method entitled “Qualitative Identification of Kalrez ® by Infrared Examination of Pyrolysate.” This method is incorporated by reference. Copies of the method 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Thermogravimetry. Perfluorocarbon cured elastomers have a major decomposition peak occurring at 490° ±15 °C (914 °F). Less than 1.5 percent of the elastomers will volatilize below 400 °C (752 °F) when run under nitrogen at a 10 °C or 18 °F per minute heating rate using a Du Pont Thermal Analyzer Model 1099 with Model 951 TGA unit or the equivalent.
(d) Extractive limitations. Articles fabricated from perfluorocarbon cured elastomers having a thickness of at least 1.0 millimeter (0.039 inch) when extracted at reflux temperatures for 2 hours separately with distilled water, 50 percent ethanol, and n-heptane, shall meet the following extractability limits:
(1) Total extractives not to exceed 3.1 milligrams per square decimeter (0.2 milligrams per square inch).
(2) Fluoride extractives calculated as fluorine not to exceed 0.47 milligram per square decimeter (0.03 milligram per square inch).
(e) Conditions of use. In accordance with current good manufacturing practice, finished food contact articles containing the perfluorocarbon cured elastomers shall be thoroughly cleaned prior to their first use in contact with food.
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):
(1) Phenols:
(2) Aldehydes:
(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:
| Asbestos fiber | |
| Barium hydroxide | For use as catalyst. |
| Calcium stearate | For use as lubricant. |
| Carbon black (channel process) | |
| Diatomaceous earth | |
| Glass fiber | |
| Hexamethylenetetramine | For use as curing agent. |
| Mica | |
| Oxalic acid | For use as catalyst. |
| Zinc stearate | For use as lubricant. |
(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 per square inch of food-contact surface.
(3) No extracted aniline when tested by a spectrophotometric method sensitive to 0.006 milligram of aniline per-square inch of food-contact surface.
(d) In accordance with good manufacturing practice, finished molded articles containing the phenolic resins shall be thoroughly cleansed prior to their first use in contact with food.
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.
(a) Identity. For the purposes of this section, poly(aryletherketone) resins are poly(p-oxyphenylene p-oxyphenylene p-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.
(b) Optional adjuvant substances. 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:
| Substance | Limitations |
|---|---|
| Diphenyl sulfone | Not to exceed 0.2 percent by weight as a residual solvent in the finished basic resin. |
(c) Extractive limitations. 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 to exceed 0.05 milligrams per square inch of food contact surface: Distilled water, 50 percent (by volume) ethanol in distilled water, 3 percent acetic acid in distilled water, and n-heptane. In testing the final food contact article, a separate test sample shall be used for each extracting solvent.
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:
| List of substances | Limitations (limits of addition expressed as percent by weight of finished resin) |
|---|---|
| 1. Inhibitors: | Total not to exceed 0.08 percent. |
| Benzoquinone | 0.01 percent. |
| TBHQ | |
| Di | |
| Hydroquinone | |
| 2. Accelerators: | Total not to exceed 1.5 percent. |
| Benzyl trimethyl ammonium chloride | 0.05 percent. |
| Calcium naphthenate | |
| Cobalt naphthenate | |
| Copper naphthenate | |
| 0.4 percent. | |
| Do. | |
| Ethylene guanidine hydrochloride | 0.05 percent. |
| 3. Catalysts: | Total not to exceed 1.5 percent, except that methyl ethyl ketone peroxide may be used as the sole catalyst at levels not to exceed 2 percent. |
| Azo-bis-isobutyronitrile | |
| Benzoyl peroxide | |
| Chlorbenzoyl peroxide | |
| Cumene hydroperoxide | |
| Dibutyltin oxide (CAS Reg. No. 818-08-6) | For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin. |
| Dicumyl peroxide | |
| Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0) | For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin. |
| Lauroyl peroxide | |
| Methyl ethyl ketone peroxide | |
| Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4) | For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin. |
| 4. Solvents for inhibitors, accelerators, and catalysts: | |
| Butyl benzyl phthalate (containing not more than 1.0 percent by weight of dibenzyl phthalate) | |
| Dibutyl phthalate | |
| Diethylene glycol | As a solvent for benzyl trimethyl ammonium chloride or ethylene guanidine hydrochloride only. |
| Dimethyl phthalate | |
| Methyl alcohol | |
| Styrene | |
| Triphenyl phosphate | |
| 5. Reinforcements: | |
| Asbestos | |
| Glass fiber | |
| Polyester fiber 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 listed in paragraph (a)(2) of this section | |
| 6. Miscellaneous materials: | |
| Castor oil, hydrogenated | |
| α-Methylstyrene | |
| Polyethylene glycol 6000 | |
| Silicon dioxide | |
| Wax, petroleum | Complying with § 178.3710 of this chapter. |
(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 solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of their intended use, as determined from tables 1 and 2 of § 176.170(c) of this chapter, shall meet the following extractives limitations:
(1) Net chloroform-soluble extractives not to exceed 0.1 milligram per square inch of food-contact surface tested when the prescribed food-simulating solvent is water or 8 or 50 percent alcohol.
(2) Total nonvolatile extractives not to exceed 0.1 milligram per square inch of food-contact surface tested when the prescribed food-simulating solvent is heptane.
(d) In accordance with good manufacturing practice, finished articles containing the cross-linked polyester resins shall be thoroughly cleansed prior to their first use in contact with food.
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:
(1) Poly(oxy-p-phenylenesulfonyl-p-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.
(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 Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200 or 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) The basic resins identified in paragraphs (a)(1) and (a)(2) of this section may contain optional adjuvant substances described in § 174.5(d) of this chapter and the following:
| List of substances | Limitations |
|---|---|
| Diphenylsulfone | Not to exceed 0.2 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section. |
| Dimethyl sulfoxide | Not to exceed 0.01 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section. |
| Not to exceed 0.01 percent as residual solvent in the finished basic resin described in paragraph (a)(2) of this section. |
(c) The finished food-contact article, when extracted at reflux temperatures for 2 hours with the following four solvents, yields net chloroform-soluble extractives in each extracting solvent not to exceed 0.02 milligram per square inch of food-contact surface: distilled water, 50 percent (by volume) ethyl alcohol in distilled water, 3 percent acetic acid in distilled water, and n-heptane. (Note: In testing the finished food-contact article, use a separate test sample for each required extracting solvent.)
(d) In accordance with good manufacturing practice, finished food-contact articles containing the polyethersulfone resins shall be thoroughly cleansed before their first use in contact with food.
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:
(a) Identity. (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 p,p′-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.
(b) Specifications. (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 Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), sections 7.016-7.020, which is incorporated by reference in accordance with 5 U.S.C. 552(a). Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) Polyamide-imide resins identified in paragraph (a)(1) of this section shall have a solution viscosity of not less than 1.200. Polyamide-imide resins identified in paragraph (a)(2) of this section shall have a solution viscosity of not less than 1.190. Solution viscosity shall be determined by a method titled “Solution Viscosity” which is incorporated by reference in accordance with 5 U.S.C. 552(a). 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(3) The polyamide-imide resins identified in paragraph (a)(1) of this section are heat cured at 600 °F for 15 minutes when prepared for extraction tests and the residual monomers: p,p-diphenylmethane diisocyanate should not be present at greater than 100 parts per million and trimellitic anhydride should not be present at greater than 500 parts per million. Residual monomers are determined by gas chromatography (the gas chromatography method titled “Amide-Imide Polymer Analysis - Analysis of Monomer Content,” is incorporated by reference in accordance with 5 U.S.C. 552(a). 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.).
(c) Extractive limitations are applicable to the polyamide-imide resins identified in paragraphs (a) (1) and (2) of this section in the form of films of 1 mil uniform thickness after coating and heat curing at 600 °F for 15 minutes on stainless steel plates, each having such resin-coated surface area of 100 square inches. The cured-resin film coatings shall be extracted in accordance with the method described in § 176.170(d)(3) of this chapter, using a plurality of spaced, coated stainless steel plates, exposed to the respective food simulating solvents. The resin shall meet the following extractive limitations under the corresponding extraction conditions:
(1) Distilled water at 250 °F for 2 hours: Not to exceed 0.01 milligram per square inch.
(2) Three percent acetic acid at 212 °F for 2 hours: Not to exceed 0.05 milligram per square inch.
(3) Fifty percent ethyl alcohol at 160 °F for 2 hours: Not to exceed 0.03 milligram per square inch.
(4) n-Heptane at 150 °F for 2 hours: Not to exceed 0.05 milligram per square inch.
(d) In accordance with good manufacturing practice, those food contact articles, having as components the polyamide-imide resins identified in paragraph (a) of this section and intended for repeated use shall be thoroughly cleansed prior to their first use in contact with food.
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.
(a) Identity. 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.
(b) Optional adjuvant substances. 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:
| List of substances | Limitations (expressed as percent by weight of finished basic resin) |
|---|---|
| Diethylamine | Not to exceed 0.16 percent as residual catalyst. |
| Methyl alcohol | Not to exceed 0.02 percent as residual solvent. |
| Toluene | Not to exceed 0.2 percent as residual solvent. |
(c) Specifications and extractives limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide basic resins meet the following:
(1) Specifications. Intrinsic viscosity is not less than 0.30 deciliter per gram as determined by ASTM method D1243-79, “Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,” which is incorporated by reference, modified as follows. Copies of the incorporation by reference may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(i) Solvent: Chloroform, reagent grade containing 0.01 percent tert-butylcatechol.
(ii) Resin sample: Powdered resin obtained from production prior to molding or extrusion.
(iii) Viscometer: Cannno-Ubbelohde series 25 dilution viscometer (or equivalent).
(iv) Calculation: The calculation method used is that described in appendix X.1.3 (ASTM method D1243-79, cited and incorporated by reference in paragraph (c)(1) of this section) with the reduced viscosity determined for three concentration levels (0.4, 0.2, and 0.1 gram per deciliter) and extrapolated to zero concentration for intrinisic viscosity. The following formula is used for determining reduced viscosity:
(2) Extractives limitations. Total resin extracted not to exceed 0.02 weight-percent when extracted with n-heptane at 160 °F for 2 hours as determined using 200 milliliters of reagent grade n-heptane which has been freshly distilled before use and 25 grams of poly (2,-6-dimethyl-1,4-phenylene) oxide resin. The resin as tested is in pellet form having a particle size such that 100 percent of the pellets will pass through a U.S. Standard Sieve No. 6 and 100 percent of the pellets will be held on a U.S. Standard Sieve No. 10.
(d) Other limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in and complying with this section, when used as components of the food-contact surface of any article that is the subject of a regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter, shall comply with any specifications and limitations prescribed by such regulation for the article in the finished form in which it is to contact food.
(e) Uses. The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in and complying with the limitations in this section may be used as articles or components of articles intended for repeated food-contact use or as articles or components of articles intended for single-service food-contact use only under the conditions described in § 176.170(c) of this chapter, table 2, conditions of use H.
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.
(a) Identity. For the purpose of this section, polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers are produced by the polymerization of methylmethacrylate and trimethoxysilylpropylmethacrylate.
(b) Conditions of use. (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.
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:
(a) Identity. 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.
(b) Optional adjuvant substances. 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, substances permitted under applicable regulations in parts 170 through 189 of this chapter, and the following:
(1) Stabilizers (total amount of stabilizers not to exceed 2.0 percent and amount of any one stabilizer not to exceed 1.0 percent of polymer by weight)
(2) Lubricant: N,N′Distearoylethyl-enediamine.
(c) Specifications. (1) Polyoxymethylene copolymer can be identified by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the copolymer is 15,000 as determined by a method titled “Number Average Molecular Weight,” which is 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(d) Extractive limitations. (1) Polyoxymethylene copolymer in the finished form in which it is to contact food, when extracted with the solvent or solvents characterizing the type of food and under conditions of time and temperature 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.
(2) Polyoxymethylene copolymer with or without the optional substances described in paragraph (b) of this section, when ground or cut into particles that pass through a U.S.A. Standard Sieve No. 6 and that are retained on a U.S.A. Standard Sieve No. 10, shall yield total extractives as follows:
(i) Not to exceed 0.20 percent by weight of the copolymer when extracted for 6 hours with distilled water at reflux temperature.
(ii) Not to exceed 0.15 percent by weight of the copolymer when extracted for 6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) The polyoxymethylene copolymer is for use as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 °F.
(3) In accordance with good manufacturing practice, finished articles containing polyoxymethylene copolymer shall be thoroughly cleansed before their first use in contact with food.
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:
(a) Identity. 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.
(b) Optional adjuvant substances. 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:
(1) Stabilizers. The homopolymer may contain one or more of the following stabilizers. The total amount of stabilizers shall not exceed 1.9 percent of homopolymer by weight, and the quantity of individual stabilizer used shall not exceed the limitations set forth below:
| Substances | Limitations |
|---|---|
| Hexamethylenebis(3,5-di- | At a maximum level of 1 percent by weight of homopolymer. The finished articles shall not be used for foods containing more than 8 percent alcohol. |
| 2,2′-Methylenebis(4-methyl-6- | At a maximum level of 0.5 percent by weight of homopolymer. |
| Nylon 66/610/6 terpolymer, respective proportions of nylon polymers by weight are: 3/2/4 | At a maximum level of 1.5 percent by weight of homopolymer. |
| Nylon 612/6 copolymer (CAS Reg. No. 51733-10-9), weight ratio 6/1 | Do. |
| Tetrakis[methylene(3,5-di- | At a maximum level of 0.5 percent by weight of homopolymer. |
(2) Lubricant. N,N′-Distearoylethyl-enediamine.
(3) Molding assistant. Polyethylene glycol 6,000.
(c) Specifications. (1) Polyoxymethylene homopolymer can be identified by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the homopolymer is 25,000.
(3) Density of the homopolymer is between 1.39 and 1.44 as determined by ASTM method D1505-68 (Reapproved 1979), “Standard Test Method for Density of Plastics by the Density-Gradient Technique,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(4) Melting point is between 172 °C and 184 °C as determined by ASTM method D2133-66, “Specifications for Acetal Resin Injection Molding and Extrusion Materials” (Revised 1966), which is incorporated by reference. Copies are available from American Society for Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(d) Extractive limitations. (1) Polyoxymethylene homopolymer, in the finished form which is to contact food, when extracted with the solvent or solvents characterizing the type of food and under conditions of time and temperature characterizing the conditions of intended use under paragraphs (c)(3) and (d) of § 175.300 of this chapter and as limited by paragraph (e) of this section, shall yield net chloroform-soluble extractives not to exceed 0.5 milligram per square inch of food-contact surface.
(2) Polyoxymethylene homopolymer, with or without the optional adjuvant substances described in paragraph (b) of this section, when ground or cut into particles that pass through a U.S.A. Standard Sieve No. 6 and that are retained on a U.S.A. Standard Sieve No. 10, shall yield extractives as follows:
(i) Formaldehyde not to exceed 0.0050 percent by weight of homopolymer as determined by a method titled “Formaldehyde Release and Formaldehyde Analysis,” which is incorporated by reference. Copies are available from 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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(ii) Total extractives not to exceed 0.20 percent by weight of homopolymer when extracted for 6 hours with distilled water at reflux temperature and 0.15 percent by weight of homopolymer when extracted for 6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) Polyoxymethylene homopolymer is for use as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 °F.
(3) In accordance with good manufacturing practice, finished articles containing polyoxymethylene homopolymer shall be thoroughly cleansed prior to first use in contact with food.
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.
(a) Polyphenylene sulfide resins consist of basic resins produced by the reaction of equimolar parts of p-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: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(1) Sulfur content: 28.2-29.1 percent by weight of finished resin.
(2) Minimum inherent viscosity: 0.13 deciliters per gram.
(3) Maximum residual p-dichlorobenzene: 0.8 ppm.
(b) Subject to any limitations prescribed in parts 170 through 189 of this chapter, the following optional substances may be added to the polyphenylene sulfide basic resins in an amount not to exceed that reasonably required to accomplish the intended physical or technical effect.
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with prior sanction or approval.
(3) Substances the use of which is permitted in coatings under regulations in parts 170 through 189 of this chapter.
(c) The finished coatings are thermally cured at temperatures of 700 °F and above.
(d) Polyphenylene sulfide resin coatings may be used in contact with food at temperatures not to exceed the boiling point of water; provided that the finished cured coating, when extracted at reflux temperatures for 8 hours separately with distilled water, 50 percent ethanol in water, and 3 percent acetic acid, yields total extractives in each extracting solvent not to exceed 0.02 milligram per square inch of surface and when extracted at reflux temperature for 8 hours with heptane yields total extractives not to exceed 0.1 milligram per square inch of surface.
(e) Polyphenylene sulfide resin coatings containing perfluorocarbon resins complying with § 177.1550 may be used in contact with food at temperatures up to and including normal baking and frying temperatures; provided that the finished cured coating, when extracted at reflux temperatures for 2 hours separately with distilled water, 50 percent ethanol in water, 3 percent acetic acid and heptane, yields total extractives in each extracting solvent not to exceed 0.2 milligram per square inch of surface and when extracted at reflux temperature for 1 hour with diphenyl ether yields total extractives not to exceed 4.5 milligrams per square inch of surface.
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.
(a) Identity. 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 p-dichlorobenzene, and has a minimum weight average molecular weight of 5,000 Daltons.
(b) Optional adjuvant substances. 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.
(c) Specifications. The glass transition temperature of the polymer is 360±5 °C as determined by the use of differential scanning calorimetry.
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.
(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 n-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. (
(c) In accordance with good manufacturing practice, finished food-contact articles containing the polyvinylidene fluoride resins shall be thoroughly cleansed prior to their first use in contact with food.
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:
(a) Identity. 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 composite membrane is on the food-contact surface and its maximum weight is 4.7 milligrams per square decimeter (0.3 milligrams per square inch) as a thin film composite on a suitable support. The maximum weight of the 2,4-toluenediisocyanate component of the thin film composite is 0.47 milligrams per square decimeter (0.03 milligrams per square inch).
(3) For the purpose of this section, the reverse osmosis membrane consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid, calcium salt (2:1) polymer with 1,3-benzenediamine, 1,3-benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride (CAS Reg. No. 39443-76-0). The membrane is the food contact surface and may be applied as a film on a suitable support. Its maximum weight is 512 milligrams per square decimeter (33 milligrams per square inch).
(4) A cross-linked high molecular weight polyamide reaction product of poly(N-vinyl-N-methylamine) (CAS Reg. No. 31245-56-4), N,N′-bis(3-aminopropyl)ethylenediamine (CAS Reg. No. 10563-26-5), 1,3-benzenedicarbonyl dichloride (CAS Reg. No. 99-63-8) and 1,3,5-benzenetricarbonyl trichloride (CAS Reg. No. 4422-95-1). The membrane is the food-contact surface. Its maximum weight is 20 milligrams per square decimeter (1.3 milligrams per square inch) as a thin film composite on a suitable support.
(5) A polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride polymer (CAS Reg. No. 4422-95-1) with piperazine (CAS Reg. No. 110-85-0) and 1,2-diaminoethane (CAS Reg. No. 107-15-3). The membrane is the food-contact layer and may be applied as a film on a suitable support. Its maximum weight is 15 milligrams per square decimeter (1 milligram per square inch).
(b) Optional adjuvant substances. The basic polymer identified in paragraph (a) of this section may contain optional adjuvant substances required in the production of such basic polymer. These optional adjuvant substances may include substances permitted for such use by regulations in parts 170 through 186 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval.
(c) Supports. Suitable supports for reverse osmosis membranes are materials permitted for such use by regulations in parts 170 through 186 of this chapter, substances generally recognized as safe in food, and substances used in accordance with a prior sanction or approval.
(d) Conditions of use. (1) Reverse osmosis membranes described in paragraphs (a)(1), (a)(2), (a)(3), and (a)(5) of this section may be used in contact with all types of liquid food at temperatures up to 80 °C (176 °F).
(2) Reverse osmosis membranes described in paragraph (a)(4) of this section may be used in contact with all types of liquid food, except food containing more than 8 percent alcohol, at temperatures up to 80 °C (176 °F).
(3) Reverse osmosis membranes shall be maintained in a sanitary manner in accordance with current good manufacturing practice so as to prevent microbial adulteration of food.
(4) To assure their safe use, reverse osmosis membranes and their supports shall be thoroughly cleaned prior to their first use in accordance with current good manufacturing practice.
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 regulation in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter conforms with any specification in such regulation.
(i) Elastomers.
(ii) Vulcanization materials - (a) Vulcanizing agents.
(b) Accelerators (total not to exceed 1.5 percent by weight of rubber product).
(c) Retarders (total not to exceed 10 percent of weight of rubber product).
(d) Activators (total not to exceed 5 percent by weight of rubber product except magnesium oxide may be used at higher levels).
(iii) Antioxidants and antiozonants (total not to exceed 5 percent by weight of rubber product).
(iv) Plasticizers (total not to exceed 30 percent by weight of rubber product unless otherwise specified).
(v) Fillers.
(vi) Colorants. Colorants used in accordance with § 178.3297 of this chapter.
(vii) Lubricants (total not to exceed 2 percent by weight of rubber product).
(viii) Emulsifiers.
(ix) Miscellaneous (total not to exceed 5 percent by weight of rubber product).
(d) Rubber articles intended for use with dry food are so formulated and cured under conditions of good manufacturing practice as to be suitable for repeated use.
(e) Rubber articles intended for repeated use in contact with aqueous food shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with distilled water at reflux temperature, shall yield total extractives not to exceed 20 milligrams per square inch during the first 7 hours of extraction, nor to exceed 1 milligram per square inch during the succeeding 2 hours of extraction.
(f) Rubber articles intended for repeated use in contact with fatty foods shall meet the following specifications: The food-contact surface of the rubber article in the finished form in which it is to contact food, when extracted with n-hexane at reflux temperature, shall yield total extractives not to exceed 175 milligrams per square inch during the first 7 hours of extraction, nor to exceed 4 milligrams per square inch during the succeeding 2 hours of extraction.
(g) In accordance with good manufacturing practice finished rubber articles intended for repeated use in contact with food shall be thoroughly cleansed prior to their first use in contact with food.
(h) The provisions of this section are not applicable to rubber nursing-bottle nipples.
(i) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.
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 for use in textiles and textile fibers and used in accordance with such sanction or approval.
(3) Substances generally recognized as safe for use in cotton and cotton fabrics used in dry-food packaging.
(4) Substances that by regulation in this part may safely be used in the production of or as a component of textiles or textile fibers and subject to provisions of such regulation.
(5) Substances identified in this paragraph (d)(5), subject to such limitations as are provided:
| List of substances | Limitations |
|---|---|
| (i) Fibers: | |
| Cotton | |
| Polyethylene terephthalate complying in composition with the provisions of § 177.1630(e)(4)(ii) | For use only in the manufacture of items for repeated use. |
| Rayon | |
| (ii) Adjuvant substances: | |
| Aluminum stearate | |
| Borax | For use as preservative only. |
| Butyl-acetyl ricinoleate | |
| Colorants used in accordance with § 178.3297 of this chapter. | |
| Di- | |
| Dimethylpolysiloxane | |
| Ethylenediaminetetraacetic acid, sodium salt | |
| 4-Ethyl-4-hexadecyl morpholinium ethyl sulfate | For use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in paragraph (d)(5)(i) of this section at a level not to exceed 0.03 percent by weight of the finished fibers. |
| Eugenol | |
| Fats, oils, fatty acids, and fatty alcohols derived from castor, coconut, cottonseed, fish, mustardseed, palm, peanut, rapeseed, ricebran, soybean, sperm, and tall oils and tallow. | |
| Fats, oils, fatty acids, and fatty alcohols described in the preceding item reacted with one or more of the following substances: | |
| Diethylene glycol | |
| Diethanolamine | |
| Glycerol | |
| Hexylene glycol (2-methyl-2,4-pentanediol) | |
| Hydrogen | |
| Isopropyl alcohol | |
| Methyl alcohol | |
| Oxygen | |
| Polyethylene glycol (molecular weight 400-3,000) | |
| Potassium hydroxide | |
| Propylene glycol | |
| Sodium hydroxide | |
| Sulfuric acid | |
| Formaldehyde | For use as preservative only. |
| Glyceryl mono-12-hydroxystearate | |
| 2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2-imidazolinium ethyl sulfate. | |
| Hexylene glycol (2-methyl,-2,4-pentanediol) | |
| Isobutyl alcohol | |
| Isopropyl alcohol | |
| Kerosene | |
| Methyl ester of sulfated ricebran oil | |
| Mineral oil | For use only at a level not to exceed 0.15 percent by weight of finished fibers. |
| Mono- and diisopropylated | |
| Petrolatum | |
| Petroleum sulfonate | |
| Pine oil | |
| Polybutene, hydrogenated; complying with the identity prescribed under 21 CFR 178.3740(b) of this chapter. | |
| Polyethylene, oxidized (air blown) | |
| Polyvinyl acetate | |
| Polyvinyl alcohol | |
| Potassium soap of a saponified sulfated castor oil | |
| Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate | |
| Sodium dioctyl sulfosuccinate | |
| Sodium dodecyl benzenesulfonate | |
| Sodium fluoride | For use as preservative only. |
| Sodium hydrosulfite | |
| Sodium hypochlorite | |
| Sodium lauryl sulfate | |
| Sodium 2-mercaptobenzothiazole | Do. |
| Sodium pentachlorophenate | Do. |
| Styrene-butadiene copolymer | |
| Sulfated butyl, isobutyl and propyl oleate | |
| Tallow | |
| Tallow, sulfonated | |
| Titanium dioxide | |
| Triethanolamine | |
| Ultramarine blue | |
| Waxes, petroleum | |
| Zinc hydrosulfite |
(e) Textile and textile fibers are used as articles or components of articles that contact dry food only.
(f) The provisions of this section are not applicable to jute fibers used as prescribed by § 178.3620(d)(2) of this chapter.
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 specifications of such regulation.
(c) Ultra-filtration membranes are used in the physical separation of dissolved or colloidally suspended varying molecular size components of liquids during the commercial processing of bulk quantities of food.
(d) Ultra-filtration membranes shall be maintained in a sanitary manner in accordance with good manufacturing practice so as to prevent potential microbial adulteration of the food.
(e) Ultrafiltration membranes identified in paragraph (a)(4) may be used to filter aqueous or acidic foods containing up to 13 percent of alcohol at temperatures not to exceed 21 °C (70 °F).
(f) To assure safe use of the ultra-filtration membranes, the label or labeling shall include adequate directions for a pre-use treatment, consisting of conditioning and washing with a minimum of 8 gallons of potable water prior to their first use in contact with food.
(g) Acrylonitrile copolymers identified in this section shall comply with the provisions of § 180.22 of this chapter.