• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2020.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2020]
[CITE: 21CFR177]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)
 
PART 177INDIRECT FOOD ADDITIVES: POLYMERS
 

Subpart C - Substances for Use Only as Components of Articles Intended for Repeated Use

Sec. 177.2210 Ethylene polymer, chlorosulfonated.

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.

Methods for the specifications in this paragraph (b), titled "Chlorine and Bromine - Coulometric Titration Method by Aminco Chloridometer," "Hypolon (R) Synthetic Rubber - Determination of Sulfur by Parr Bomb," and ASTM method D2857-70 (Reapproved 1977), "Standard Test Method for Dilute Solution Viscosity of Polymers," are incorporated by reference. Copies of the ASTM method may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959. Copies of the other two methods are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Copies of all three methods 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.

(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).

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989]

Sec. 177.2250 Filters, microporous polymeric.

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 deg.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 deg.F for each square foot of filter, prior to the filter's first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]

Sec. 177.2260 Filters, resin-bonded.

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:

List of Substances and Limitations

(1) Fibers:

Cellulose pulp.

Cotton.

Nylon. (From nylon resins complying with the provisions of applicable regulations in subchapter B of this chapter.

Polyethylene terephthalate complying in composition with the provisions of § 177.1630; for use in inline filtration only as provided for in paragraphs (e) and (f) of this section.

Rayon (viscose).

(2) Substances employed in fiber finishing:

BHT.

Butyl (or isobutyl) palmitate or stearate.

2,5-Di-tert -butyl hydroquinone for use only in lubricant formulations for rayon fiber finishing and at a usage level not to exceed 0.1 percent by weight of the lubricant formulations.

Dimethylpolysiloxane.

4-Ethyl-4-hexadecyl morpholinium ethyl sulfate for use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in paragraph (d)(1) of this section at a level not to exceed 0.03 percent by weight of the finished fibers.

Fatty acid (C10-C18) diethanolamide condensates.

Fatty acids derived from animal or vegetable fats and oils, and salts of such acids, single or mixed, as follows:

Aluminum.

Ammonium.

Calcium.

Magnesium.

Potassium.

Sodium.

Triethanolamine.

Fatty acid (C10-C18) mono- and diesters of polyoxyethylene glycol (molecular weight 400-3,000).

Methyl esters of fatty acids (C10-C18).

Mineral oil.

Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740 (b) of this chapter.

Polyoxyethylene (4 mols) ethylenediamine monolauramide for use only in lubricant formulations for rayon fiber finishing and at a usage level not to exceed 10 percent by weight of the lubricant formulations.

Ricebran oil.

Titanium dioxide.

(3) Resins:

Acrylic polymers produced by polymerizing ethyl acrylate alone or with one or more of the monomers: Acrylic acid, acrylonitrile, N- methylolacrylamide, and styrene. The finished copolymers shall contain at least 70 weight percent of polymer units derived from ethyl acrylate, no more than 2 weight percent of total polymer units derived from acrylic acid, no more than 10 weight percent of total polymer units derived from acrylonitrile, no more than 2 weight percent of total polymer units derived from N- methylolacrylamide, and no more than 25 weight percent of total polymer units derived from styrene. For use only as provided in paragraph (m) of this section.

Melamine-formaldehyde.

Melamine-formaldehyde chemically modified with one or more of the amine catalysts identified in § 175.300(b)(3)(xiii) of this chapter.

Melamine-formaldehyde chemically modified with methyl alcohol.

Melamine-formaldehyde chemically modified with urea; for use only as provided for in paragraphs (e), (f), (g), (h), and (i) of this section.

Phenol-formaldehyde resins.

Polyvinyl alcohol.

Polyvinyl alcohol with the copolymer of acrylic acid-allyl sucrose.

Polyvinyl alcohol with melamine formaldehyde.

Polyvinyl acetate with melamine formaldehyde.

p--Toluenesulfonamide-formaldehyde chemically modified with one or more of the amine catalysts identified in § 175.300 (b)(3)(xiii) of this chapter.

(4) Adjuvant substances:

Dimethyl polysiloxane with methylcellulose and sorbic acid (as an antifoaming agent).

Phosphoric acid.

(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 deg.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 deg.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 deg.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 deg.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 deg.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 deg.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 deg.F, provided that the finished filter when exposed to distilled water at 100 deg.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 deg.F, provided that the finished filter when exposed to distilled water at 145 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]

Sec. 177.2280 4,4'-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins.

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 etherAs curing system additive.
Di- and tri-glycidyl ester mixture resulting from the reaction of epichlorohydrin with mixed dimers and trimers of unsaturated C18 monobasic fatty acids derived from animal and vegetable fats and oilsAs 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-phenoxypropaneAs curing system additive.
Glyoxal Do.
4,4'-Isopropylidenediphenol Do.
4,4'-Methylenedianiline Do.
m-Phenylenediamine 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.

[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984]

Sec. 177.2355 Mineral reinforced nylon resins.

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 deg.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 1/8-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 solvent per square inch of surface tested, shall meet the following extractives limitations:

(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.

[42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]

Sec. 177.2400 Perfluorocarbon cured elastomers.

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:

Phenol, 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene] bis-,dipotassium salt - not to exceed 5 parts.

1,4,7,10,13,16-Hexaoxacyclo-octadecane - not to exceed 5 parts.

(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 (R) 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 490deg. +/-15 deg.C (914 deg.F). Less than 1.5 percent of the elastomers will volatilize below 400 deg.C (752 deg.F) when run under nitrogen at a 10 deg.C or 18 deg.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.

[49 FR 43050, Oct. 26, 1984]

Sec. 177.2410 Phenolic resins in molded articles.

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:

p-tert- Amylphenol.

p-tert- Butylphenol.

o-, m-, and p- Cresol.

p- Octylphenol.

Phenol.

o- and p- Phenylethylphenol mixture produced when phenol is made to react with styrene in the presence of sulfuric acid catalyst.

(2) Aldehydes:

Acetaldehyde.

Formaldehyde.

Paraldehyde.

(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 hydroxideFor use as catalyst.
Calcium stearateFor use as lubricant.
Carbon black (channel process)
Diatomaceous earth
Glass fiber
HexamethylenetetramineFor use as curing agent.
Mica
Oxalic acidFor use as catalyst.
Zinc stearateFor 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.

Sec. 177.2415 Poly(aryletherketone) resins.

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 deg.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 sulfoneNot 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.

[63 FR 20315, Apr. 24, 1998]

Sec. 177.2420 Polyester resins, cross-linked.

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:

Adipic.

Fatty acids, and dimers thereof, from natural sources.

Fumaric.

Isophthalic.

Maleic.

Methacrylic.

Orthophthalic.

Sebacic.

Terephthalic.

Trimellitic.

(2) Polyols and polyepoxides:

Butylene glycol.

Diethylene glycol.

2,2-Dimethyl-1,3-propanediol.

Dipropylene glycol.

Ethylene glycol.

Glycerol.

4,4'-Isopropylidenediphenol-epichlorohydrin.

Mannitol.

a- Methyl glucoside.

Pentaerythritol.

Polyoxypropylene ethers of 4,4'-isopropylide-nediphenol (containing an average of 2-7.5 moles of propylene oxide).

Propylene glycol.

Sorbitol.

Trimethylol ethane.

Trimethylol propane.

2,2,4-Trimethyl-1,3-pentanediol.

(3) Cross-linking agents:

Butyl acrylate.

Butyl methacrylate.

Ethyl acrylate.

Ethylhexyl acrylate.

Methyl acrylate.

Methyl methacrylate.

Styrene.

Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in coatings contacting bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under type VIII.

Vinyl toluene.

(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.
Benzoquinone0.01 percent.
tert-Butyl catechol
TBHQ
Di-tert-butyl hydroquinone
Hydroquinone
2. Accelerators:Total not to exceed 1.5 percent.
Benzyl trimethyl ammonium chloride0.05 percent.
Calcium naphthenate
Cobalt naphthenate
Copper naphthenate
N, N-Diethylaniline0.4 percent.
N, N-Dimethylaniline Do.
Ethylene guanidine hydrochloride0.05 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
tert-Butyl perbenzoate
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
p-Menthane hydroperoxide
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 glycolAs 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
[alpha]-Methylstyrene
Polyethylene glycol 6000
Silicon dioxide
Wax, petroleumComplying 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.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, 1989]

Sec. 177.2430 Polyether resins, chlorinated.

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.

Sec. 177.2440 Polyethersulfone resins.

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
DiphenylsulfoneNot to exceed 0.2 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section.
Dimethyl sulfoxideNot to exceed 0.01 percent as residual solvent in the finished basic resin described in paragraph (a)(1) of this section.
N-methyl-2-pyrrolidoneNot 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.

[44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013]

Sec. 177.2450 Polyamide-imide resins.

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 deg.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 deg.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 deg.F for 2 hours: Not to exceed 0.01 milligram per square inch.

(2) Three percent acetic acid at 212 deg.F for 2 hours: Not to exceed 0.05 milligram per square inch.

(3) Fifty percent ethyl alcohol at 160 deg.F for 2 hours: Not to exceed 0.03 milligram per square inch.

(4) n- Heptane at 150 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]

Sec. 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.

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)
DiethylamineNot to exceed 0.16 percent as residual catalyst.
Methyl alcoholNot to exceed 0.02 percent as residual solvent.
TolueneNot 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:

where:

t = Solution efflux time.

t o = Solvent efflux time.

c = Concentration of solution in terms of grams per deciliter.

(2) Extractives limitations. Total resin extracted not to exceed 0.02 weight-percent when extracted with n- heptane at 160 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, 1998]

Sec. 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers.

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.

[59 FR 5948, Feb. 9, 1994]

Sec. 177.2470 Polyoxymethylene copolymer.

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)

Calcium ricinoleate.

Cyanoguanidine.

Hexamethylene bis(3,5-di-tert -butyl-4-hydroxyhydrocinnamate) (CAS Reg. No. 35074-77-2).

Melamine-formaldehyde resin.

2,2'-Methylenebis(4-methyl-6-tert- butylphenol).

Nylon 6/66, weight ratio 2/3.

Tetrakis [methylene (3,5-di-tert- butyl-4-hydroxyhydrocinnamate)] methane.

(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 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR 24898, June 12, 1989]

Sec. 177.2480 Polyoxymethylene homopolymer.

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-tert-butyl-4-hydroxy-hydrocinnamate) (CAS Reg. No. 35074-77-2)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-tert-butylphenol)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: 3/2/4At 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-tert-butyl-4-hydroxy-hydrocinnamate)] methaneAt 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 deg.C and 184 deg.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 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989]

Sec. 177.2490 Polyphenylene sulfide resins.

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 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, 1989]

Sec. 177.2500 Polyphenylene sulfone resins.

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 deg.C as determined by the use of differential scanning calorimetry.

[65 FR 15058, Mar. 21, 2000]

Sec. 177.2510 Polyvinylidene fluoride resins.

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. (Note: 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 their first use in contact with food.

Sec. 177.2550 Reverse osmosis membranes.

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 deg.C (176 deg.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 deg.C (176 deg.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.

[49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994]

Sec. 177.2600 Rubber articles intended for repeated use.

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.

Acrylonitrile-butadiene copolymer.

Brominated isobutylene-isoprene copolymers complying with § 177.1210.

Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers containing not more than 5 weight percent of polymer units derived from ethylene glycol dimethacrylate.

Butadiene-acrylonitrile-methacrylic acid copolymer.

Butadiene-styrene-methacrylic acid copolymer.

Chloroprene polymers.

Chlorotrifluoroethylene-vinylidene fluoride copolymer.

Ethylene-propylene copolymer elastomers which may contain not more than 5 weight-percent of total polymer units derived from 5-methylene-2-norbornene and/or 5-ethylidine-2-norbornene.

Ethylene-propylene-dicyclopentadiene copolymer.

Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 weight percent of total polymer units derived from 1,4-hexadiene.

Hydrogenated butadiene/acrylonitrile copolymers (CAS Reg. No. 88254-10-8) produced when acrylonitrile/butadiene copolymers are modified by hydrogenation of the olefinic unsaturation to leave either: (1) Not more than 10 percent trans olefinic unsaturation and no [alpha], [beta]-olefinic unsaturation as determined by a method entitled "Determination of Residual [alpha], [beta]-Olefinic and Trans Olefinic Unsaturation Levels in HNBR," developed October 1, 1991, by Polysar Rubber Corp., 1256 South Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic unsaturation and Mooney viscosities greater than 45 (ML 1 + 4 @ 100 deg.C), as determined by ASTM Standard Method D1646-92, "Standard Test Method for Rubber - Viscosity and Vulcanization Characteristics (Mooney Viscometer)," which are both incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of these methods may be obtained from 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 may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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. A copy of ASTM Standard Method D1646-92 may also be obtained from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428-2959.

Isobutylene-isoprene copolymer.

Polyamide/polyether block copolymers (CAS Reg. No. 77402-38-1 prepared by reacting a copolymer of omega -laurolactam and adipic acid with poly(tetramethylene ether glycol). The polyamide and polyether components are reacted in ratios such that the polyamide component constitutes a minimum of 30 weight-percent of total polymer units. The copolymers may be used in contact with foods of Types I, II, III, IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter at temperatures not to exceed 150 deg.F except that those copolymers prepared with less than 50 weight-percent of polyamide are limited to use in contact with such foods at temperatures not to exceed 100 deg.F.

Polybutadiene.

Polyester elastomers derived from the reaction of dimethyl terephthalate, 1,4-butanediol, and [alpha]-hydro-omega-hydroxypoly (oxytetramethylene). Additionally, trimethyl trimellitate may be used as a reactant. The polyester elastomers may be used only in contact with foods containing not more than 8 percent alcohol and limited to use in contact with food at temperatures not exceeding 150 deg.F.

Polyisoprene.

Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived from the reaction of diphenylmethane diisocyanate with 1,4-butanediol and polytetramethylene ether glycol.

Polyurethane resins derived from reactions of diphenylmethane diisocyanate with adipic acid and 1,4-butanediol.

Rubber, natural.

Silicone basic polymer as described in ASTM method D1418-81, "Standard Practice for Rubber and Rubber Latices - Nomenclature," 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.

Silicone (Si) elastomers containing methyl groups.

Silicone (Psi) elastomers containing methyl and phenyl groups.

Silicone (Vsi) elastomers containing methyl and vinyl groups.

Silicone (Fsi) elastomers containing methyl and fluorine groups.

Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl groups.

Styrene-butadiene copolymer.

Vinylidene fluoride-hexafluoropropylene copolymers (minimum number average molecular weight 70,000 as determined by osmotic pressure in methyl ethyl ketone).

Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymers (minimum number average molecular weight 100,000 as determined by osmotic pressure in methyl ethyl ketone).

(ii) Vulcanization materials - (a ) Vulcanizing agents.

4,4'-Bis(aminocyclohexyl)methane carbamate for use only as cross-linking agent in the vulcanization of vinylidene fluoridehexafluoropropylene copolymer and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymer elastomers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 2.4 percent by weight of such copolymers.

Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate) for use as a cross linking agent in the vulcanization of natural rubber, styrene-butadiene copolymer, acrylonitrile-butadiene copolymer, and ethylene-propylene terpolymers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 2.4 percent by weight of such copolymers.

Hexamethylenediamine carbamate for use only as cross-linking agent in the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer and vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene copolymer elastomers identified under paragraph (c)(4)(i) of this section and limited to use at levels not to exceed 1.5 percent by weight of such copolymers.

Sulfur, ground.

(b ) Accelerators (total not to exceed 1.5 percent by weight of rubber product).

2-Benzothiazyl-N,N -diethylthiocarbamyl-sulfide.

Benzoyl peroxide.

1,3-Bis(2-benzothiazolylmercaptomethyl) urea.

N-tert- Butyl-2-benzothiazole sulfenamide.

Butyraldehyde-aniline resin (iodine number 670-705).

Carbon disulfide-1,1'-methylenedipiperidine reaction product.

Copper dimethyldithiocarbamate.

N- Cyclohexyl-2-benzothiazole sulfenamide.

Dibenzoyl-p- quinone dioxime.

Dibenzylamine.

Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio-bis-thioformate, O,O-di(1-methylethyl)tetrathio-bis-thioformate, and O,O-di(1-methylethyl)pentathio-bis-thioformate).

Di (4-methylbenzoyl) peroxide (CAS Reg. No. 895-85-2) for use only as a crosslinking agent in silicone polymers and elastomers identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by weight of such polymers and elastomers where the total of all accelerators does not exceed 1.5 percent by weight of rubber product.

Di-tert- butyl peroxide.

Dibutyl xanthogen disulfide.

2,4-Dichlorobenzoyl peroxide.

Dicumyl peroxide.

N,N- Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.

2,6-Dimethylmorpholine thiobenzothiazol.

Dipentamethylenethiuram hexasulfide (CAS Reg. No. 971-15-3).

Diphenylguanidine.

Diphenylguanidine phthalate.

1,3-Diphenyl-2-thiourea.

2,2'-Dithiobis[benzothiazole].

4,4'-Dithiodimorpholine.

N,N'- Di-o- tolylguanidine.

Di-o- tolylguanidine salt of pyrocatecholborate.

Ethylenediamine carbamate.

Heptaldehyde-aniline resin (iodine number 430-445).

Hexamethylenetetramine.

2-Mercaptobenzothiazole.

2-Mercaptothiazoline.

N- Oxydiethylene-benzothiazole-2-sulfenamide.

Piperidinium pentamethylenedithiocarba-mate.

Potassium pentamethylenedithiocarbamate.

p- Quinone dioxime.

Sodium dibutyldithiocarbamate.

Sodium dimethyldithiocarbamate.

Stannous oleate for use only as an accelerator for silicone elastomers.

Tetrabutylthiuram monosulfide.

Tetraethylthiuram disulfide.

(1,1,4,4-Tetramethyltetramethylene)bis [tert- butyl peroxide].

Tetramethylthiuram monosulfide.

Thiram (tetramethylthiuram disulfide).

Triallyl cyanurate.

Triethylenetetramine.

1,3,5-Triethyl-hexahydro-s- triazine (triethyltrimethylenetriamine).

Triphenylguanidine.

Zinc butyl xanathate.

Zinc dibenzyl dithiocarbamate.

Zinc dibutyldithiocarbamate.

Zinc diethyldithiocarbamate.

Zinc 2-mercaptobenzothiazole.

Ziram (zinc dimethyldithiocarbamate).

(c ) Retarders (total not to exceed 10 percent of weight of rubber product).

Cyanoguanidine.

Phthalic anhydride.

Salicylic acid.

(d ) Activators (total not to exceed 5 percent by weight of rubber product except magnesium oxide may be used at higher levels).

Diethylamine.

Fatty acid amines, mixed.

Fatty acids.

Magnesium carbonate.

Magnesium oxide, light and heavy.

Oleic acid, dibutylamine salt (dibutylammonium oleate).

Stannous chloride.

Tall oil fatty acids.

Tetrachloro-p- benzoquinone.

Triethanolamine.

Zinc salts of fatty acids.

(iii) Antioxidants and antiozonants (total not to exceed 5 percent by weight of rubber product).

Aldol-a- naphthylamine.

Alkylated (C4 and/or C8) phenols.

BHT (butylated hydroxytoluene).

4-<4,6-bis(octylthio)-s -triazin-2-yl]amino]-2,6-di-tert -butylphenol (CAS Reg. No. 991-84-4) for use only as a stabilizer at levels not to exceed 0.5 percent by weight of the finished rubber product.

Butylated reaction product of p -cresol and dicyclopentadiene as identified in § 178.2010(b) of this chapter.

Butylated, styrenated cresols identified in § 178.2010(b) of this chapter.

4,4'-Butylidinebis(6-tert- butyl-m- cresol).

N- Cyclohexyl-N'- phenylphenylenediamine.

p,p'- Diaminodiphenylmethane.

2,5-Di-tert- amylhydroquinone.

Diaryl-p- phenylenediamine, where the aryl group may be phenyl, tolyl, or xylyl.

2,6-Di-tert- butyl-p- phenylphenol.

1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline.

1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline.

1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline.

4,4'-Dimethoxydiphenylamine.

4,6-Dinonyl-o- cresol.

N,N'- Dioctyl-p- phenylenediamine.

Diphenylamine-acetone resin.

Diphenylamine-acetone-formaldehyde resin.

N,N'- Diphenylethylenediamine.

N,N'- Disalicylalpropylenediamine.

N,N'- Di-o- tolylethylenediamine.

Hydroquinone monobenzyl ether.

Isopropoxydiphenylamine.

N -Isopropyl-N'- phenyl-p- phenylenediamine.

2,2'-Methylenebis(6-tert- butyl-4-ethylphenol).

2,2'-Methylenebis(4-methyl-6-tert- butylphenol).

2,2'-Methylenebis(4-methyl-6-nonylphenol).

2,2'-Methylenebis(4-methyl-6-tert- octylphenol).

Monooctyl- and dioctyldiphenylamine.

N,N' -Di-[beta]-naphthyl-p- phenylenediamine.

Phenyl-a- naphthylamine.

Phenyl-[beta]-naphthylamine.

Phenyl-[beta]-naphthylamine-acetone aromatic amine resin (average molecular weight 600; nitrogen content 5.3 percent).

o- and p- Phenylphenol.

Polybutylated (mixture) 4,4'-isopropylidenediphenol.

Sodium pentachlorophenate.

Styrenated cresols produced when 2 moles of styrene are made to react with 1 mole of a mixture of phenol and o-, m-, and p- cresols so that the final product has a Brookfield viscosity at 25 deg.C of 1400 to 1700 centipoises.

Styrenated phenol.

4,4'-Thiobis (6-tert -butyl-m- cresol).

Toluene-2,4-diamine.

N-o- Tolyl-N'- phenyl-p- phenylenediamine.

p(p- Tolylsufanilamide) diphenylamine.

Tri(mixed mono- and dinonylphenyl) phosphite.

Tri(nonylphenyl) phosphite-formaldehyde resins produced when 1 mole of tri(nonylphenyl) phosphite is made to react with 1.4 moles of formaldehyde or produced when 1 mole of nonylphenol is made to react with 0.36 mole of formaldehyde and the reaction product is then further reacted with 0.33 mole of phosphorus trichloride. The finished resins have a minimum viscosity of 20,000 centipoises at 25 deg.C, as determined by LV-series Brookfield viscometer (or equivalent) using a No. 4 spindle at 12 r.p.m., and have an organic phosphorus content of 4.05 to 4.15 percent by weight.

(iv) Plasticizers (total not to exceed 30 percent by weight of rubber product unless otherwise specified).

n -Amyl n -decyl phthalate.

Butylacetyl ricinoleate.

n -Butyl ester of tall oil fatty acids.

Butyl laurate.

Butyl oleate.

Butyl stearate.

Calcium stearate.

Castor oil.

Coumarone-indene resins.

2,2'-Dibenzamidodiphenyl disulfide.

Dibenzyl adipate.

Dibutoxyethoxyethyl adipate.

Dibutyl phthalate.

Dibutyl sebacate.

Didecyl adipate.

Didecyl phthalate.

Diisodecyl adipate.

Diisodecyl phthalate.

Diisooctyl adipate.

Diisooctyl sebacate.

Dioctyl adipate.

Dioctyl phthalate.

Dioctyl sebacate.

Dipentene resin.

Fatty acids.

Fatty acids, hydrogenated.

Isooctyl ester of tall oil fatty acids.

Lanolin.

a -Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a -methylstyrene to 3 vinyltoluene).

Mineral oil; (1) In rubber articles complying with this section, not to exceed 30 percent by weight; (2) Alone or in combination with waxes, petroleum, total not to exceed 45 percent by weight of rubber articles that contain at least 20 percent by weight of ethylene-propylene copolymer elastomer complying with paragraph (c)(4)(i) of this section, in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX idenified in table 1 of § 176.170(c) of this chapter.

Montan wax.

n -Octyl n -decyl adipate.

n -Octyl n -decyl phthalate.

Petrolatum.

Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.

Petroleum hydrocarbon resin (produced by the homo- and copolymerization of dienes and olefins of the aliphatic, alicyclic, and monobenzenoid arylalkene types from distillates of cracked petroleum stocks).

Petroleum hydrocarbon resin (produced by the catalytic polymerization and subsequent hydrogenation of styrene, vinyltoluene, and indene types from distillates of cracked petroleum stocks).

Petroleum oil, sulfonated.

Phenol-formaldehyde resin.

Pine tar.

Polybutene.

Polystyrene.

Propylene glycol.

n -Propyl ester of tall oil fatty acids.

Rapeseed oil vulcanized with rubber maker's sulfur.

Rosins and rosin derivatives identified in § 175.105(c)(5) of this chapter.

Soybean oil vulcanized with rubber maker's sulfur.

Styrene-acrylonitrile copolymer.

Terpene resins.

Triethylene glycol dicaprate.

Triethylene glycol dicaprylate.

Waxes, petroleum.

Xylene (or toluene) alkylated with dicyclopentadiene.

Zinc 2-benzamidothiophenate.

(v) Fillers.

Aluminum hydroxide.

Aluminum silicate.

Asbestos fiber, chrysotile or crocidolite.

Barium sulfate.

Carbon black (channel process or furnace combustion process; total carbon black not to exceed 50 percent by weight of rubber product; furnace combustion black content not to exceed 10 percent by weight of rubber products intended for use in contact with milk or edible oils).

Cork.

Cotton (floc, fibers, fabric).

Mica.

Nylon (floc, fibers, fabric).

Silica.

Titanium dioxide.

Zinc carbonate.

Zinc sulfide.

(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).

Polyethylene.

Sodium stearate.

(viii) Emulsifiers.

Fatty acid salts, sodium or potassium.

Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.

Rosins and rosin-derivatives identified in § 175.105(c)(5) of this chapter.

Sodium decylbenzenesulfonate

Sodium dodecylbenzenesulfonate

Sodium lauryl sulfate.

Tall oil mixed soap (calcium, potassium, and sodium).

(ix) Miscellaneous (total not to exceed 5 percent by weight of rubber product).

Animal glue as described in § 178.3120 of this chapter.

Azodicarbonamide as chemical blowing agent.

2-Anthraquinone sulfonic acid sodium salt for use only as polymerization inhibitor in chloroprene polymers and not to exceed 0.03 percent by weight of the chloroprene polymers.

1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5) for use as a biocide in uncured liquid rubber latex not to exceed 0.02 percent by weight of the latex solids, where the total of all items listed in paragraph (c)(4)(ix) of this section does not exceed 5 percent of the rubber product.

n -Butyllithium for use only as polymerization catalyst for polybutadiene.

4-tert -Butyl-o -thiocresol as peptizing agent.

tert -Butyl peracetate.

p-tert -Butylpyrocatechol.

Dialkyl (C8-C18) dimethylammonium chloride for use only as a flocculating agent in the manufacture of silica.

Di- and triethanolamine.

Diethyl xanthogen disulfide.

4-(Diiodomethylsulfonyl) toluene, Chemical Abstracts Service Registry No. 20018-09-01, for use as an antifungal preservative at levels not to exceed 0.3 percent by weight of the sealants and caulking materials.

Dodecyl mercaptan isomers, single or mixed.

2-Ethoxyethanol.

Iodoform.

p -Menthane hydroperoxide.

a -(p -Nonylphenyl)-omega -hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters, barium salt; the nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 9 moles; for use only as residual polymerization emulsifier at levels not to exceed 0.7 percent by weight of ethylene-propylene-1,4-hexadiene copolymers identified under paragraph (c)(4)(i) of this section.

4,4'-Oxybis (benzenesulfonhydrazide) as chemical blowing agent.

Phenothiazine.

Potassium persulfate.

Sodium formaldehyde sulfoxylate.

Sodium polysulfide.

Sodium nitrite.

Sodium salt of ethylenediamine tetraacetic acid and glycine.

Sodium sulfide.

Styrene monomer.

Tall oil.

Thioxylenois as peptizing agents.

Tridecyl mercaptan.

Zinc 4-tert -butylthiophenate as peptizing agent.

(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.

[42 FR 14572, Mar. 15, 1977]

Editorial Note:

For Federal Register citations affecting § 177.2600, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Sec. 177.2710 Styrene-divinylbenzene resins, cross-linked.

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.

Sec. 177.2800 Textiles and textile fibers.

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
BoraxFor use as preservative only.
Butyl-acetyl ricinoleate
Colorants used in accordance with § 178.3297 of this chapter.
Di-tert-butyl hydroquinone
Dimethylpolysiloxane
Ethylenediaminetetraacetic acid, sodium salt
4-Ethyl-4-hexadecyl morpholinium ethyl sulfateFor 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:
n-Butyl and isobutyl alcohol
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
FormaldehydeFor 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 oilFor use only at a level not to exceed 0.15 percent by weight of finished fibers.
Mono- and diisopropylated m- and p-cresols (isothymol derivative).
N-Oleyl, N'-acetyl, N'-[beta]-hydroxy-ethylenediamine
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 fluorideFor 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.

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991]

Sec. 177.2910 Ultra-filtration membranes.

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 deg.C (70 deg.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.

[42 FR 14572, Mar. 15, 1977, as amended at 53 FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, 1993; 60 FR 54426, Oct. 24, 1995]

Authority: 21 U.S.C. 321, 342, 348, 379e.
Source: 42 FR 14572, Mar. 15, 1977, unless otherwise noted.

-
-