240 Part 177—Indirect Food Additives: Polymers

§ 176.320 21 CFR Ch. I (4–1–15 Edition)

§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer. 177.1050 Acrylonitrile/styrene copolymer Sodium nitrate-urea complex may be modified with butadiene/styrene elas- safely used as a component of articles tomer. intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly- facturing, packing, processing, pre- mers. paring, treating, packaging, trans- 177.1200 Cellophane. porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for provisions of this section. food containers. 177.1211 Cross-linked polyacrylate copoly- (a) Sodium nitrate-urea complex is a mers. clathrate of approximately two parts 177.1240 1,4-Cyclohexylene dimethylene urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene (b) Sodium nitrate-urea complex con- dimethylene isophthalate copolymer. forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers. in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly- used as provided in paragraph (b)(2) of mers. 177.1315 Ethylene-1,4-cyclohexylene this section. dimethylene terephthalate copolymers. (1) Limitations. (i) It is used as a plas- 177.1320 Ethylene-ethyl acrylate copoly- ticizer in glassine and greaseproof mers. paper. 177.1330 Ionomeric resins. (ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly- that required to accomplish its in- mer resins. tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene percent by weight of the finished paper. isophthalate/terephthalate copolymer. 177.1350 Ethylene-vinyl acetate copolymers. (2) Conditions of use. The glassine and 177.1360 Ethylene-vinyl acetate-vinyl alco- greaseproof papers are used for pack- hol copolymers. aging dry food or as the food-contact 177.1380 Fluorocarbon resins. surface for dry food. 177.1390 Laminate structures for use at temperatures of 250 °F and above. § 176.350 Tamarind seed kernel pow- 177.1395 Laminate structures for use at tem- der. peratures between 120 °F and 250 °F. Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water- insoluble. safely used as a component of articles 177.1420 Isobutylene polymers. intended for use in producing, manu- 177.1430 Isobutylene-butene copolymers. facturing, packing, processing, pre- 177.1440 4,4′-Isopropylidenediphenol- paring, treating, packaging, trans- epichlorohydrin resins minimum molec- porting, or holding food, subject to the ular weight 10,000. provisions of this section. 177.1460 Melamine-formaldehyde resins in (a) Tamarind seed kernel powder is molded articles. the ground kernel of tamarind seed 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers. (Tamarindus indica L.) after removal of 177.1500 Nylon resins. the seed coat. 177.1520 Olefin polymers. (b) It is used in the manufacture of 177.1550 Perfluorocarbon resins. paper and paperboard. 177.1555 Polyarylate resins. 177.1556 Polyaryletherketone resins. 177.1560 Polyarylsulfone resins. PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/ ADDITIVES: POLYMERS ethylene copolymers. 177.1580 Polycarbonate resins. Subpart A [Reserved] 177.1585 Polyestercarbonate resins. 177.1590 Polyester elastomers. Subpart B—Substances for Use as Basic 177.1595 Polyetherimide resin. Components of Single and Repeated 177.1600 Polyethylene resins, carboxyl modi- Use Food Contact Surfaces fied. 177.1610 Polyethylene, chlorinated. Sec. 177.1615 Polyethylene, fluorinated. 177.1010 Acrylic and modified acrylic plas- 177.1620 Polyethylene, oxidized. tics, semirigid and rigid. 177.1630 Polyethylene phthalate polymers. 177.1020 Acrylonitrile/butadiene/styrene co- 177.1632 Poly(phenyleneterephthalamide) polymer. resins. 177.1030 Acrylonitrile/butadiene/styrene/ 177.1635 Poly(p-methylstyrene) and rubber- methyl methacrylate copolymer. modified poly(p-methylstyrene).

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177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers. ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes. naphthalenediylcarbonyl) resins. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. 177.1640 Polystyrene and rubber-modified polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless 177.1650 Polysulfide polymer-polyepoxy res- otherwise noted. ins. 177.1655 Polysulfone resins. EDITORIAL NOTE: Nomenclature changes to 177.1660 Poly(tetramethylene part 177 appear at 61 FR 14482, Apr. 2, 1996, 66 terephthalate). FR 56035, Nov. 6, 2001, 66 FR 66742, Dec. 27, 177.1670 Polyvinyl alcohol film. 2001, 68 FR 15355, Mar. 31, 2003, and 70 FR 177.1680 Polyurethane resins. 72074, Dec. 1, 2005. 177.1810 Styrene block polymers. 177.1820 Styrene-maleic anhydride copoly- Subpart A [Reserved] mers. 177.1830 Styrene-methyl methacrylate copolymers. Subpart B—Substances for Use as 177.1850 Textryls. Basic Components of Single 177.1900 Urea-formaldehyde resins in molded and Repeated Use Food Con- articles. 177.1950 Vinyl chloride-ethylene copoly- tact Surfaces mers. 177.1960 Vinyl chloride-hexene-1 copoly- § 177.1010 Acrylic and modified acrylic mers. plastics, semirigid and rigid. 177.1970 Vinyl chloride-lauryl vinyl ether Semirigid and rigid acrylic and modi- copolymers. fied acrylic plastics may be safely used 177.1980 Vinyl chloride-propylene copoly- as articles intended for use in contact mers. with food, in accordance with the fol- 177.1990 Vinylidene chloride/methyl acrylate copolymers. lowing prescribed conditions. The 177.2000 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers late/methyl methacrylate polymers. or plastics described in this section also may be safely used as components Subpart C—Substances for Use Only as of articles intended for use in contact Components of Articles Intended for with food. Repeated Use (a) The optional substances that may be used in the formulation of the 177.2210 Ethylene polymer, chlorosulfonated. semirigid and rigid acrylic and modi- 177.2250 Filters, microporous polymeric. fied acrylic plastics, or in the formula- 177.2260 Filters, resin-bonded. tion of acrylic and modified acrylic 177.2280 4,4′-Isopropylidenediphenol- components of articles, include sub- epichlorohydrin thermosetting epoxy stances generally recognized as safe in resins. food, substances used in accordance 177.2355 Mineral reinforced nylon resins. with a prior sanction or approval, sub- 177.2400 Perfluorocarbon cured elastomers. 177.2410 Phenolic resins in molded articles. stances permitted for use in such plas- 177.2415 Poly(aryletherketone) resins. tics by regulations in parts 170 through 177.2420 Polyester resins, cross-linked. 189 of this chapter, and substances 177.2430 Polyether resins, chlorinated. identified in this paragraph. At least 50 177.2440 Polyethersulfone resins. weight-percent of the polymer content 177.2450 Polyamide-imide resins. of the acrylic and modified acrylic ma- 177.2460 Poly(2,6-dimethyl-1,4-phenylene) terials used as finished articles or as oxide resins. components of articles shall consist of 177.2465 Polymethylmethacrylate/poly(tri methoxysilylpropyl) methacrylate copolymer units derived from one or polymers. more of the acrylic or methacrylic 177.2470 Polyoxymethylene copolymer. monomers listed in paragraph (a)(1) of 177.2480 Polyoxymethylene homopolymer. this section. 177.2490 Polyphenylene sulfide resins. (1) Homopolymers and copolymers of 177.2500 Polyphenylene sulfone resins. the following monomers: 177.2510 Polyvinylidene fluoride resins. 177.2550 Reverse osmosis membranes. n-Butyl acrylate. 177.2600 Rubber articles intended for re- n-Butyl methacrylate. peated use. Ethyl acrylate. 177.2710 Styrene-divinylbenzene resins, 2-Ethylhexyl acrylate. cross-linked. Ethyl methacrylate.

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Methyl acrylate. Methacryloxyacetamidoethylethylene urea. Methyl methacrylate. Methacryloxyacetic acid. n-Propyl methacrylate. (2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate. erizing one or more of the monomers listed in paragraph (a)(1) of this section (4) Polymers identified in paragraphs with one or more of the following (a)(1), (2), and (3) of this section are monomers: mixed together and/or with the following polymers, provided that no Acrylonitrile. chemical reactions, other than addi- Methacrylonitrile. tion reactions, occur when they are a-Methylstyrene. Styrene. mixed: Vinyl chloride. Butadiene-acrylonitrile copolymers. Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers. (3) Polymers identified in paragraphs Butadiene-acrylonitrile-styrene-methyl (a)(1) and (2) of this section containing methacrylic copolymers. Butadiene-styrene copolymers. no more than 5 weight-percent of total Butyl rubber. polymer units derived by copolym- Natural rubber. erization with one or more of the Polybutadiene. monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene). and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of ed in paragraph (a)(3)(ii) of this section this chapter. are limited to use only in plastic arti- Polyvinyl chloride. cles intended for repeated use in con- Vinyl chloride copolymers complying with § 177.1980. tact with food. Vinyl chloride-vinyl acetate copolymers. (i) List of minor monomers: (5) Antioxidants and stabilizers iden- Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap- Acrylic acid ter and the following: 1,3-Butylene glycol dimethacrylate. 1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol. Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone. Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2- Divinylbenzene. carboxybenzophenone. Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate. Itaconic acid. p-Methoxyphenol. Methacrylic acid. Methyl salicylate. N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro- N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For 4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2 Propylene glycol dimethacrylate. percent by weight in semirigid and rigid Trivinylbenzene. acrylic and modified acrylic plastics, (ii) List of minor monomers limited where the finished articles contact foods to use only in plastic articles intended containing not more than 15 percent alcohol; and (2) at levels not exceeding 0.01 per- for repeated use in contact with food: cent by weight in semirigid and rigid Allyl methacrylate [Chemical Abstracts acrylic and modified acrylic plastics in- Service Registry No. 96–05–9] tended for repeated food-contact use where tert-Butyl acrylate. the finished article may be used for foods tert-Butylaminoethyl methacrylate. containing more than 15 percent alcohol. sec-Butyl methacrylate. Phenyl salicylate. tert-Butyl methacrylate. (6) Release agents: Fatty acids de- Cyclohexyl methacrylate. Dimethylaminoethyl methacrylate. rived from animal and vegetable fats 2-Ethylhexyl methacrylate. and oils, and fatty alcohols derived Hydroxyethyl methacrylate. from such acids. Hydroxyethyl vinyl sulfide. (7) Surface active agent: Sodium Hydroxypropyl methacrylate. dodecylbenzenesulfonate. Isobornyl methacrylate. (8) Miscellaneous materials: Isobutyl methacrylate. Isopropyl acrylate. Di(2-ethylhexyl) phthalate, for use only as a Isopropyl methacrylate. flow promoter at a level not to exceed 3 Methacrylamide. weight-percent based on the monomers. Methacrylamidoethylene urea. Dimethyl phthalate.

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Oxalic acid, for use only as a polymerization prepared in a still using a block tin catalyst aid. condenser. The 8 and 50 percent (by vol- Tetraethylenepentamine, for use only as a ume) alcohol solvents shall be prepared catalyst activator at a level not to exceed 0.5 weight-percent based on the monomers. from ethyl alcohol meeting the speci- Toluene. fications of the United States Pharma- Xylene. copeia XX and diluted with double-distilled water that has been prepared in a (b) The semirigid and rigid acrylic still using a tin block condenser. The and modified acrylic plastics, in the n-heptane shall be spectrophotometric finished form in which they are to con- grade. Adequate precautions must be tact food, when extracted with the sol- taken to keep all solvents dust-free. vent or solvents characterizing the (4) Blank values on solvents. (i) Dupli- type of food and under the conditions cate determinations of residual solids of time and temperature as determined shall be run on samples of each solvent from tables 1 and 2 of § 176.170(c) of this that have been exposed to the tempera- chapter, shall yield extractives not to ture-time conditions of the extraction exceed the following, when tested by the methods prescribed in paragraph test without the plastic sample. Sixty (c) of this section. The acrylic and milliliters of exposed solvent is modified acrylic polymers or plastics pipetted into a clean, weighed plat- intended to be used as components of inum dish, evaporated to 2–5 milliliters articles also shall yield extractives not on a nonsparking, low-temperature hot ° to exceed the following limitations plate and dried in 212 F oven for 30 when prepared as strips as described in minutes. The residue for each solvent paragraph (c)(2) of this section: shall be determined by weight and the (1) Total nonvolatile extractives not average residue weight used as the to exceed 0.3 milligram per square inch blank value in the total solids deter- of surface tested. mination set out in paragraph (c)(6) of (2) Potassium permanganate oxidiz- this section. The residue for an accept- able distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5 cent alcohol extractives not to exceed milligram per 60 milliliters. an absorbance of 0.15. (ii) For acceptability in the ultra- (3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra- tractives not to exceed an absorbance violet spectrophotometer in 5-centi- of 0.30. meter silica spectrophotometric ab- (4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the extractives not to exceed an absorb- distilled water when measured versus ance of 0.10. air in the reference cell shall not ex- (c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave- extractability conditions. These are to be length region of 245 to 310 mμ. The ab- chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when chapter. measured versus distilled water in the (2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at samples to allow duplicates of all ap- any point in the wavelength region of plicable tests shall be cut from the ar- 245 to 310 mμ. The absorbance of the 50 ticles or formed from the plastic com- percent alcohol when measured versus position under tests, as strips about 2.5 distilled water in the reference cell inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the 0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mμ. The face should be 5 square inches ±0.5- absorbance of the heptane when meas- square inch. The samples, after prepa- ured versus distilled water in the ref- ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245, brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any running hot tapwater (140 °F min- point in the wavelength region of 280 to imum), rinsed with distilled water, and 310 mμ. air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de- iccator. terminations shall be run on samples of (3) Preparation of solvents. The water each solvent that has been exposed to used shall be double-distilled water, the temperature-time conditions of the

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extraction test without the plastic tents to room temperature if nec- sample. An aliquot of the exposed sol- essary. vent shall be measured versus the un- (6) Determination of total nonvolatile exposed solvent in the reference cell. extractives. Remove the plastic strip The average difference in the from the solvent with a pair of clean absorbances at any wavelength in the forceps and wash the strip with 5 milli- region of 245 to 310 mμ shall be used as liters of the appropriate solvent, add- a blank correction for the ultraviolet ing the washings to the contents of the absorbers measured at the same wave- test tube. Pour the contents of the test length according to paragraph (c)(8)(ii) tube into a clean, weighed platinum of this section. dish. Wash the tube with 5 milliliters (iv) The acceptability of the solvents of the appropriate solvent and add the for use in the permanganate test shall solvent to the platinum dish. Evapo- be determined by preparing duplicate rate the solvent to 2–5 milliliters on a permanganate test blanks according to nonsparking, low-temperature paragraph (c)(7)(iv) of this section. For hotplate. Complete the evaporation in this test, the directions referring to a 212 °F oven for 30 minutes. Cool the the sample extract shall be dis- dish in a desiccator for 30 minutes and regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal- in 5-centimeter silica culate the total nonvolatile extractives spectrophotometric cells in the spec- as follows: trophotometer versus the appropriate eb− solvent as reference. The absorbance in Milligrams extractives = distilled water in the wavelength re- per square inch gion of 544 to 552 mμ should be 1.16 but s must not be less than 1.05 nor more Extractives in parts eb than 1.25. The absorbance in the 8 and =×100 50 percent alcohol must not be less per million s than 0.85 nor more than 1.15. where: (v) Duplicate permanganate test de- e=Total increase in weight of the dish, in terminations shall be run on samples of milligrams. distilled water and 8 and 50 percent al- b=Blank value of the solvent in milligrams, cohol solvents that have been exposed as determined in paragraph (c)(4)(i) of to the temperature-time conditions of this section. the extraction test without the plastic s=Total surface of the plastic sample in sample. The procedure shall be as de- square inches. scribed in paragraph (c)(7)(iv) of this (7) Determination of potassium per- section, except that the appropriate ex- manganate oxidizable extractives. (i) Pi- posed solvent shall be substituted pette 25 milliliters of distilled water where the directions call for sample ex- into a clean 125-milliliter Erlenmeyer tract. The average difference in the flask that has been rinsed several absorbances in the region of 544 to 552 times with aliquots of distilled water. mμ shall be used as a blank correction This is the blank. Prepare a distilled for the determination of permanganate water solution containing 1.0 part per oxidizable extractives according to million of p-methoxyphenol (melting paragraph (c)(7)(iv) of this section. point 54–56 °C, Eastman grade or equiv- (5) Extraction procedure. For each ex- alent). Pipette 25 milliliters of this p- traction, place a plastic sample in a methoxyphenol solution into a rinsed clean 25 millimeters × 200 millimeters Erlenmeyer flask. Pipette exactly 3.0 hard-glass test tube and add solvent milliliters of 154 parts per million equal to 10 milliliters of solvent per aqueous potassium permanganate solu- square inch of plastic surface. This tion into the p-methoxyphenol and ex- amount will be between 45 milliliters actly 3.0 milliliters into the blank, in and 55 milliliters. The solvent must be that order. Swirl both flasks to mix the preequilibrated to the temperature of contents and then transfer aliquots the extraction test. Close the test tube from each flask into matched 5-centi- with a ground-glass stopper and expose meter spectrophotometric absorption to the specified temperature for the cells. The cells are placed in the spec- specified time. Cool the tube and con- trophotometer cell compartment with

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the p-methoxyphenol solution in the pose of ascertaining compliance with reference beam. Spectrophotometric the limitations in paragraph (b)(2) of measurement is conducted as in para- this section, the absorbance measure- graph (c)(7)(iv) of this section. The ab- ments obtained on the distilled water sorbance reading in the region 544–552 extracts according to paragraph mμ should be 0.24 but must be not less (c)(7)(iv) of this section shall be multi- than 0.12 nor more than 0.36. This test plied by a correction factor, calculated shall be run in duplicate. For the pur- as follows:

024. = Correction factor for water extracts. Average of duplicate ρ -methoxyphenol absorbance determinations according to this paragraph (c)(7)(i) of this section

(ii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco- ance in the region 544–552 mμ should be hol extracts according to paragraph 0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi- more than 0.39. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

026. = Correction factor for aqueous Average of duplicate ρ -methoxyphenol 8 percent alcohol extracts. absorbance determination according to this paragraph (c)(7)(ii) of this section

(iii) The procedure in paragraph ascertaining compliance with the limi- (c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of cept that, in this instance, the solvent this section, the absorbance measure- shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco- ance in the region 544–552 mμ should be hol extracts according to paragraph 0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi- more than 0.38. This test shall be run in plied by a correction factor, calculated duplicate. For the purpose of as follows:

025. = Correction factor for 50 percent Average of duplicate ρ -methoxyphenol aqueous alcohol extracts. absorbance determinations according to paragraph (c)(7)(ii) of this section

(iv) Water and 8 and 50 percent alcohol the same solvent. This is the blank. extracts. Pipette 25 milliliters of the ap- Into another similarly rinsed flask, pi- propriate solvent into a clean, 125-mil- pette 25 milliliters of the sample ex- liliter Erlenmeyer flask that has been tract that has been exposed under the rinsed several times with aliquots of conditions specified in paragraph (c)(5)

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of this section. Pipette exactly 3.0 mil- propriate correction factor determined liliters of 154 parts per million aqueous according to paragraph (c)(7) (i), (ii), potassium permanganate solution into and (iii) of this section. This test shall the sample and exactly 3.0 milliliters be run in duplicate and the two results into the blank, in that order. Before averaged. use, the potassium permanganate solu- (8) Determination of ultraviolet-absorb- tion shall be checked as in paragraph ing extractives. (i) A distilled water so- (c)(7)(i) of this section. Both flasks are lution containing 1.0 part per million swirled to mix the contents, and then of p-methoxyphenol (melting point 54 aliquots from each flask are trans- °C–56 °C. Eastman grade or equivalent) ferred to matched 5-centimeter shall be scanned in the region 360 to 220 spectrophotometric absorption cells. mμ in 5-centimeter silica spectrophoto- Both cells are placed in the spectrophotometer cell compartment with the metric absorption cells versus a dis- sample solution in the reference beam. tilled water reference. The absorbance The spectrophotometer is adjusted for at the wavelength of maximum absorb- 0 and 100 percent transmittance at 700 ance (should be about 285 mμ) is about mμ. The spectrum is scanned on the ab- 0.11 but must be not less than 0.08 nor sorbance scale from 700 mμ to 500 mμ in more than 0.14. This test shall be run in such a way that the region 544 mμ to duplicate. For the purpose of 552 mμ is scanned within 5 minutes to ascertaining compliance with the limi- 10 minutes of the time that permanga- tations prescribed in paragraph (b) (3) nate was added to the solutions. The and (4) of this section, the absorbance height of the absorbance peak shall be obtained on the extracts according to measured, corrected for the blank as paragraph (c)(8)(ii) of this section shall determined in paragraph (c)(4)(v) of be multiplied by a correction factor, this section, and multiplied by the ap- calculated as follows:

011. = Correction factor for ultraviolet Average of duplicate ρ -methoxyphenol absorbers test. absorbance determinations according to this paragraph (c)(8)(i) of this section

(ii) An aliquot of the extract that has (e) Acrylonitrile copolymers identi- been exposed under the conditions fied in this section shall comply with specified in paragraph (c)(5) of this sec- the provisions of § 180.22 of this chap- tion is scanned in the wavelength re- ter. gion 360 to 220 mμ versus the appro- (f) The acrylic and modified acrylic priate solvent reference in matched 5- polymers identified in and complying centimeter silica spectrophotometric with this section, when used as compo- absorption cells. The height of any ab- nents of the food-contact surface of an sorption peak shall be measured, cor- article that is the subject of a regula- rected for the blank as determined in tion in this part and in parts 174, 175, paragraph (c)(4)(iii) of this section, and 176, and 178 of this chapter, shall com- multiplied by the correction factor de- ply with any specifications and limita- termined according to paragraph tions prescribed by such regulation for (c)(8)(i) of this section. the article in the finished form in (d) In accordance with current good which it is to contact food. manufacturing practice, finished semirigid and rigid acrylic and modi- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. fied acrylic plastics, and articles con- 28, 1977, as amended at 43 FR 54927, Nov. 24, taining these polymers, intended for 1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR repeated use in contact with food shall 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985] be thoroughly cleansed prior to their first use in contact with food.

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§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer rene co-polymer. content of the finished copolymer arti- Acrylonitrile/butadiene/styrene co- cles is not more than 11 parts per mil- polymer identified in this section may lion as determined by a gas be safely used as an article or compo- chromatographic method titled ‘‘De- nent of articles intended for use with termination of Residual Acrylonitrile all foods, except those containing alco- and Styrene Monomers-Gas hol, under conditions of use E, F, and G Chromatographic Internal Standard described in table 2 of § 176.170(c) of this Method,’’ which is incorporated by ref- chapter. erence. Copies are available from the (a) Identity. For the purpose of this Center for Food Safety and Applied Nu- section, the acrylonitrile/butadiene/ trition (HFS–200), Food and Drug Ad- styrene copolymer consists of: ministration, 5100 Paint Branch Pkwy., (1) Eighty-four to eighty-nine parts College Park, MD 20740, or available for by weight of a matrix polymer con- inspection at the National Archives taining 73 to 78 parts by weight of acry- and Records Administration (NARA). lonitrile and 22 to 27 parts by weight of For information on the availability of styrene; and this material at NARA, call 202–741– (2) Eleven to sixteen parts by weight 6030, or go to: http://www.archives.gov/ of a grafted rubber consisting of (i) 8 to federallregister/ 13 parts of butadiene/styrene elastomer codeloflfederallregulations/ containing 72 to 77 parts by weight of ibrllocations.html. butadiene and 23 to 28 parts by weight (d) Extractive limitations. (1) Total of styrene and (ii) 3 to 8 parts by nonvolatile extractives not to exceed weight of a graft polymer having the same composition range as the matrix 0.0005 milligram per square inch sur- polymer. face area when the finished food con- (b) Adjuvants. The copolymer identi- tact article is exposed to distilled fied in paragraph (a) of this section water, 3 percent acetic acid, or n- may contain adjuvant substances re- heptane for 8 days at 120 °F. quired in its production. Such adju- (2) The finished food-contact article vants may include substances gen- shall yield not more than 0.0015 milli- erally recognized as safe in food, sub- gram per square inch of acrylonitrile stances used in accordance with prior monomer when exposed to distilled sanction, substances permitted in this water and 3 percent acetic acid at 150 part, and the following: °F for 15 days when analyzed by a polarographic method titled ‘‘Extracted Substance Limitations Acrylonitrile by Differential Pulse Po- 2-Mercapto- ethanol The finished copolymer shall contain larography,’’ which is incorporated by not more than 100 ppm 2- reference. Copies are available from mercaptoethanol acrylonitrile adduct as determined by a method titled the Center for Food Safety and Applied ‘‘Analysis of Cycopac Resin for Re- Nutrition (HFS–200), Food and Drug sidual b-(2-Hydroxyethylmercapto) Administration, 5100 Paint Branch propionitrile,’’ which is incorporated by reference. Copies are available Pkwy., College Park, MD 20740, or from the Bureau of Foods (HFS– available for inspection at the National 200), Food and Drug Administra- Archives and Records Administration tion, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or available (NARA). For information on the avail- for inspection at the National Ar- ability of this material at NARA, call chives and Records Administration 202–741–6030, or go to: http:// (NARA). For information on the availability of this material at NARA, www.archives.gov/federallregister/ call 202–741–6030, or go to: http:// codeloflfederallregulations/ www.archives.gov/federallregister/ ibrllocations.html. codeloflfederallregulations/ ibrllocations.html. (e) Acrylonitrile copolymers identified in this section shall comply with (c) Specifications. (1) Nitrogen content the provisions of § 180.22 of this chap- of the copolymer is in the range of 16 ter. to 18.5 percent as determined by Micro- (f) Acrylonitrile copolymers identi- Kjeldahl analysis. fied in this section are not authorized

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to be used to fabricate beverage con- Substances Limitations tainers. 2–Mercaptoethanol .. The finished copolymer shall contain [42 FR 14572, Mar. 15, 1977, as amended at 42 not more than 800 ppm 2– FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, mercaptoethanol acrylonitrile adduct as determined by a method titled 1982; 54 FR 24897, June 12, 1989] ‘‘Analysis of Cycopac Resin for Re- sidual b–(2–Hydroxyethylmercapto) § 177.1030 Acrylonitrile/butadiene/sty- propionitrile,’’ which is incorporated rene/methyl methacrylate copoly- by reference. Copies are available mer. from the Bureau of Foods (HFS– 200), Food and Drug Administra- Acrylonitrile/butadiene/styrene/ tion, 5100 Paint Branch Pkwy., Col- lege Park, MD 20740, or available methyl methacrylate copolymer iden- for inspection at the National Ar- tified in this section may be safely chives and Records Administration used as an article or component of arti- (NARA). For information on the availability of this material at NARA, cles intended for use with food identi- call 202–741–6030, or go to: http:// fied in table 1 of § 176.170(c) of this www.archives.gov/federallregister/ chapter as Type I, II, III, IVA, IVB, V, codeloflfederallregulations/ l VIB, (except bottles intended to hold ibr locations.html. carbonated beverages), VIIA, VIIB, VIII (c) Specifications. (1) Nitrogen content and IX, under conditions of use C, D, E, of the copolymer is in the range of 13.0 F, and G described in table 2 of to 16.0 percent as determined by Micro- § 176.170(c) of this chapter with a high Kjeldahl analysis. temperature limitation of 190 °F. (2) Residual acrylonitrile monomer (a) Identity. For the purpose of this content of the finished copolymer arti- section, acrylonitrile/butadiene/sty- cles is not more than 11 parts per mil- rene/methyl methacrylate copolymer lion as determined by a gas consists of: (1) 73 to 79 parts by weight chromatographic method titled ‘‘De- of a matrix polymer containing 64 to 69 termination of Residual Acrylonitrile parts by weight of acrylonitrile, 25 to and Styrene Monomers-Gas 30 parts by weight of styrene and 4 to Chromatographic Internal Standard 6 parts by weight of methyl methacry- Method,’’ which is incorporated by ref- late; and (2) 21 to 27 parts by weight of erence. Copies are available from the a grafted rubber consisting of (i) 16 to Center for Food Safety and Applied Nu- 20 parts of butadiene/styrene/elastomer trition (HFS–200), Food and Drug Ad- containing 72 to 77 parts by weight of ministration, 5100 Paint Branch Pkwy., butadiene and 23 to 28 parts by weight College Park, MD 20740, or available for of styrene and (ii) 5 to 10 parts by inspection at the National Archives weight of a graft polymer having the and Records Administration (NARA). same composition range as the matrix For information on the availability of polymer. this material at NARA, call 202–741– (b) Adjuvants. The copolymer identi- 6030, or go to: http://www.archives.gov/ fied in paragraph (a) of this section federallregister/ may contain adjuvant substances re- codeloflfederallregulations/ quired in its production. Such adju- ibrllocations.html. vants may include substances gen- (d) Extractive limitations. (1) Total erally recognized as safe in food, sub- nonvolatile extractives not to exceed stances used in accordance with prior 0.0005 milligram per square inch sur- sanction, substances permitted under face area of the food-contact article applicable regulations in this part, and when exposed to distilled water, 3 per- the following: cent acetic acid, 50 percent ethanol, and n-heptane for 10 days at 120 °F. (2) The finished food-contact article shall yield not more than 0.0025 milligram per square inch of acrylonitrile monomer when exposed to distilled water, 3 percent acetic acid and n- heptane at 190 °F for 2 hours, cooled to

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120 °F (80 to 90 minutes) and main- used as a component of packaging ma- tained at 120 °F for 10 days when ana- terials subject to the provisions of this lyzed by a polarographic method titled section. ‘‘Extracted Acrylonitrile by Differen- (a) Identity. For the purposes of this tial Pulse Polarography,’’ which is in- section acrylonitrile/styrene copoly- corporated by reference. Copies are mers are basic copolymers meeting the available from the Center for Food specifications prescribed in paragraph Safety and Applied Nutrition (HFS– (c) of this section. 200), Food and Drug Administration, (b) Adjuvants. (1) The copolymers 5100 Paint Branch Pkwy., College Park, identified in paragraph (c) of this sec- MD 20740, or available for inspection at tion may contain adjuvant substances the National Archives and Records Ad- required in their production, with the ministration (NARA). For information exception that they shall not contain on the availability of this material at NARA, call 202–741–6030, or go to: http:// mercaptans or other substances which www.archives.gov/federallregister/ form reversible complexes with acryl- codeloflfederallregulations/ onitrile monomer. Permissible adju- ibrllocations.html. vants may include substances gen- (e) Acrylonitrile copolymers identi- erally recognized as safe in food, sub- fied in this section shall comply with stances used in accordance with prior the provisions of § 180.22 of this chap- sanction, substances permitted under ter. applicable regulations in this part, and (f) Acrylonitrile copolymers identi- those authorized in paragraph (b)(2) of fied in this section are not authorized this section. to be used to fabricate beverage con- (2) The optional adjuvants for the ac- tainers. rylonitrile/styrene copolymer identi- [42 FR 14572, Mar. 15, 1977, as amended at 42 fied in paragraphs (c) (1) and (3) of this FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, section are as follows: 1982; 54 FR 24898, June 12, 1989] Substances Limitation

§ 177.1040 Acrylonitrile/styrene copoly- Condensation polymer of toluene 0.15 pct maximum. mer. sulfonamide and formaldehyde. Acrylonitrile/styrene copolymers identified in this section may be safely (c) Specifications.

Maximum residual acrylonitrile mon- Nitrogen con- Maximum extractable fractions at Conformance with Acrylonitrile/styrene copolymers omer content tent of co- specified temperatures and times certain specifications of finished polymer article

1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av- consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular duced by polymerization of 66– area of the food contact article weight is 30,000. 1 72 parts by weight of acrylo- when exposed to distilled water nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at of styrene; for use with food of 66 °C (150 °F). Type VI-B identified in table 1 of The extracted copolymer shall not § 176.170(c) of this chapter exceed 0.001 mg/in 2 surface under conditions of use C, D, E, area of the food contact article F, G described in table 2 of when exposed to distilled water § 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at 66 °C (150 °F) 1. 2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu- consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25 duced by polymerization of 45– heptane extract obtained when °C (77 °F) is 65 parts by weight of acrylo- 100 g sample of the basic co- 10cP. 1 nitrile and 35–55 parts by weigth polymer in the form of particles of styrene; for use with food of of a size that will pass through a Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and bottles), VII, VIII, and IX identi- that will be held on a U.S. fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex- this chapter under conditions B tracted with 250 mil of deionized (not to exceed 93 °C (200 °F)), water or reagent grade n- C, D, E, F, G described in table heptane at reflux temperature 2 of § 176.170(c) of this chapter. for 2 h.1

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3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di- consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for 72 parts by weight of acrylo- basis of when exposed to distilled water the finished article nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer. 3 of styrene; for use with food of of the ac- 66 °C (150 °F). Types VI-A and VI-B identified in rylonitrile The extracted copolymer shall not table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface chapter under conditions of use resin in the area of the food contact article C, D, E, F, G described in table finished ar- when exposed to distilled water 2 of § 176.170(c) of this chapter. ticles). 2 and 3 pct acetic acid for 10 d at 66 °C (150 °F). 1. 1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average molecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210 Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical Method for 10% Solution Viscosity of Tyril,’’ which are incorproated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na- tional 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/federallregister/codeloflfederallregulations/ibrllocations.html. 2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo- nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na- tional 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/federallregister/codeloflfederallregulations/ibrllocations.html. 3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5100 Paint Branch Pkwy., College Park, MD 20740, and 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/ federallregister/codeloflfederallregulations/ibrllocations.html.

(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene polymers identified in this section elastomer consists of a blend of: shall comply with the provisions of (1) 82–88 parts by weight of a matrix § 180.22 of this chapter. copolymer produced by polymerization (e) Acrylonitrile copolymer identified of 77–82 parts by weight of acrylonitrile in this section may be used to fabricate and 18–23 parts of styrene; and beverage containers only if they com- (2) 12–18 parts by weight of a grafted ply with the specifications of item 3 in rubber consisting of (i) 8–12 parts of bu- paragraph (c) of this section. tadiene/styrene elastomer containing [42 FR 14572, Mar. 15, 1977, as amended at 42 77–82 parts by weight of butadiene and FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 18–23 parts by weight of styrene and (ii) 1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 4–6 parts by weight of a graft copoly- Sept. 8, 1987] mer consisting of 70–77 parts by weight of acrylonitrile and 23–30 parts by § 177.1050 Acrylonitrile/styrene copoly- weight of styrene. mer modified with butadiene/styrene elastomer. (b) Adjuvants. The modified copolymer identified in paragraph (a) of this Acrylonitrile/styrene copolymer section may contain adjuvant sub- modified with butadiene/styrene elas- stances required in its production. tomer identified in this section may be Such adjuvants may include substances safely used as a component of bottles generally recognized as safe in food, intended for use with foods identified substances used in accordance with in table I of § 176.170(c) of this chapter prior sanction, substances permitted as Type VI-B under conditions for use under applicable regulations in this E, F, or G described in table 2 of part, and the following: § 176.170(c) of this chapter. (a) Identity. For the purpose of this section, acrylonitrile/styrene copoly-

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Substances Limitations 202–741–6030, or go to: http:// www.archives.gov/federallregister/ n-Dodecylmercaptan The finished copolymer shall contain not more than 500 parts per million codeloflfederallregulations/ (ppm) dodecylmercaptan as ibrllocations.html. dodecylmercapto-propionitrile as de- (d) Extractives limitations. The fol- termined by the method titled, ‘‘De- lowing extractives limitations are determination of b-Dodecyl- mercaptopropionitrile in NR–16 termined by an infrared spectrophoto- Polymer,’’ which is incorporated by metric method titled ‘‘Infrared reference. Copies are available Spectrophotometric Determination of from the Center for Food Safety ® and Applied Nutrition (HFS–200), Polymer Extracted from Borex 210 Food and Drug Administration, 5100 Resin Pellets,’’ which is incorporated Paint Branch Pkwy., College Park, by reference. Copies are available from MD 20740, or available for inspec- the Center for Food Safety and Applied tion at the National Archives and Records Administration (NARA). For Nutrition (HFS–200), Food and Drug information on the availability of this Administration, 5100 Paint Branch material at NARA, call 202–741– Pkwy., College Park, MD 20740, or 6030, or go to: http:// www.archives.gov/federallregister/ available for inspection at the National codeloflfederallregulations/ Archives and Records Administration ibrllocations.html. (NARA). For information on the availability of this material at NARA, call (c) Specifications. (1) Nitrogen content 202–741–6030, or go to: http:// of the modified copolymer is in the www.archives.gov/federallregister/ range of 17.7–19.8 percent. codeloflfederallregulations/ (2) Intrinsic viscosity of the matrix ibrllocations.html. Copies are applica- copolymer in butyrolactone is not less ble to the modified copolymers in the than 0.5 deciliter/gram at 35 °C, as de- form of particles of a size that will pass termined by the method titled ‘‘Molec- through a U.S. Standard Sieve No. 6 ular Weight of Matrix Copolymer by and that will be held on a U.S. Stand- Solution Viscosity,’’ which is incor- ard Sieve No. 10: porated by reference. Copies are avail- (1) The extracted copolymer shall not able from the Center for Food Safety exceed 2.0 ppm in aqueous extract ob- and Applied Nutrition (HFS–200), Food tained when a 100-gram sample of co- and Drug Administration, 5100 Paint polymer is extracted with 250 milli- Branch Pkwy., College Park, MD 20740, liters of freshly distilled water at or available for inspection at the Na- reflux temperature for 2 hours. tional Archives and Records Adminis- (2) The extracted copolymer shall not tration (NARA). For information on exceed 0.5 ppm in n-heptane when a 100- the availability of this material at gram sample of the basic copol-ymer is NARA, call 202–741–6030, or go to: http:// extracted with 250 milliliters spectral www.archives.gov/federallregister/ grade n-heptane at reflux temperature codeloflfederallregulations/ for 2 hours. ibrllocations.html. (e) Accelerated extraction end test. The (3) Residual acrylonitrile monomer modified copolymer shall yield acrylo- content of the modified copolymer ar- nitrile monomer not in excess of 0.4 ticles is not more than 11 ppm as deter- ppm when tested as follows: mined by a gas chromatographic meth- (1) The modified copolymer shall be od titled ‘‘Determination of Residual in the form of eight strips 1⁄2 inch by 4 Acrylonitrile and Styrene Monomers- inches by .03 inch. Gas Chromatographic Internal Stand- (2) The modified copolymer strips ard Method,’’ which is incorporated by shall be immersed in 225 milliliters of 3 reference. Copies are available from percent acetic acid in a Pyrex glass the Center for Food Safety and Applied pressure bottle. Nutrition (HFS–200), Food and Drug (3) The pyrex glass pressure bottle is Administration, 5100 Paint Branch then sealed and heated to 150 °F in ei- Pkwy., College Park, MD 20740, or ther a circulating air oven or a thermo- available for inspection at the National stat controlled bath for a period of 8 Archives and Records Administration days. (NARA). For information on the avail- (4) The Pyrex glass pressure bottle is ability of this material at NARA, call then removed from the oven or bath

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and cooled to room temperature. A such use by applicable regulations, as sample of the extracting solvent is set forth in part 174 of this chapter. then withdrawn and analyzed for acry- (c) Specifications. Maximum nitrogen lonitrile monomer by a gas content of the copolymer determined chromatographic method titled ‘‘Gas- by micro-Kjeldahl analysis, shall not Solid Chromatographic Procedure for exceed 8 percent. Determining Acrylonitrile Monomer in (d) Limitations. (1) The n-alkylglutar- Acrylonitrile-Containing Polymers and imide/acrylic copolymers in the fin- Food Simulating Solvents,’’ which is ished form in which they shall contact incorporated by reference. Copies, are food, when extracted with the solvent available from the Center for Food or solvents characterizing the type of Safety and Applied Nutrition (HFS– food and under the conditions of time 200), Food and Drug Administration, and temperature described in tables 1 5100 Paint Branch Pkwy., College Park, and 2 of § 176.170(c) of this chapter, MD 20740, or available for inspection at shall yield extractives not to exceed the National Archives and Records Ad- the limitations of § 177.1010(b) of this ministration (NARA). For information chapter, when prepared as strips, as de- on the availability of this material at scribed in § 177.1010(c)(2) of this chapter. NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic copolymers shall not be used as polymer www.archives.gov/federallregister/ modifiers in vinyl chloride homo- or codeloflfederallregulations/ copolymers. ibrllocations.html. (e) Conditions of use. The n- (f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers fied in this section shall comply with are used as articles or components of the provisions of § 180.22 of this chap- articles (other than articles composed ter. of vinyl chloride homo- or copolymers) (g) Acrylonitrile copolymers identi- intended for use in contact with all fied in this section are not authorized foods except beverages containing to be used to fabricate beverage con- more than 8 percent alcohol under containers. ditions of use D, E, F, and G as de- [42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter. 1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898, [54 FR 20382, May 11, 1989, as amended at 58 June 12, 1989] FR 17098, Apr. 1, 1993]

§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane. copolymers. Cellophane may be safely used for n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the mers identified in this section may be following prescribed conditions: safely used as articles or components (a) Cellophane consists of a base of articles intended for use in contact sheet made from regenerated cellulose with food subject to provisions of this to which have been added certain op- section and part 174 of this chapter. tional substances of a grade of purity (a) Identity. For the purpose of this suitable for use in food packaging as section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as polymers are copolymers obtained by coatings applied to impart desired reaction of substances permitted by technological properties. § 177.1010(a) (1), (2), and (3) with the fol- (b) Subject to any limitations pre- lowing substance: Monomethylamine scribed in this part, the optional sub- (CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and methylglutarimide/acrylic copolymers. coating may include: (b) Adjuvants. The copolymers identi- (1) Substances generally recognized fied in paragraph (a) of this section as safe in food. may contain adjuvant substances re- (2) Substances for which prior ap- quired in their production. The op- proval or sanctions permit their use in tional adjuvant substances required in cellophane, under conditions specified the production of the basic polymer in such sanctions and substances listed may include substances permitted for in § 181.22 of this chapter.

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(3) Substances that by any regulation (4) Substances named in this section promulgated under section 409 of the and further identified as required. act may be safely used as components (c) List of substances: of cellophane.

Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

Acrylonitrile-butadiene copolymer resins ...... As the basic polymer. Acrylonitrile-butadiene-styrene copolymer resins ...... Do. Acrylonitrile-styrene copolymer resins ...... Do. Acrylonitrile-vinyl chloride copolymer resins ...... Do. N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to exceed a total of 0.3 percent by weight of the finished packaging cellophane. Alkyl ketene dimers identified in § 176.120 of this chapter. Aluminum hydroxide. Aluminum silicate. Ammonium persulfate. Ammonium sulfate. Behenamide. Butadiene-styrene copolymer ...... As the basic polymer. 1,3-Butanediol. n-Butyl acetate ...... 0.1 percent. n-Butyl alcohol ...... Do. Calcium ethyl acetoacetate. Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Carboxymethyl hydroxyethylcellulose polymer. Castor oil, hydrogenated. Castor oil phthalate with adipic acid and fumaric acid-diethyl- As the basic polymer. ene glycol polyester. Castor oil phthalate, hydrogenated ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Castor oil, sulfonated, sodium salt. Cellulose acetate butyrate. Cellulose acetate propionate. Cetyl alcohol. Clay, natural.

Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base mixture having total alkali (calculated as potassium hydrox- sheet. ide) of 16–18% and having an acid number of 25–35. Copal resin, heat processed ...... As basic resin. Damar resin. Defoaming agents identified in § 176.200 of this chapter. Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent. Dibutylphthalate ...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Dicyclohexyl phthalate ...... Do. Diethylene glycol ester of the adduct of terpene and maleic anhydride. Di(2-ethylhexyl) adipate. Di(2-ethylhexyl) phthalate...... Alone or in combination with other phthalates where total phthalates do not exceed 5 percent. Diisobutyl phthalate ...... Do. Dimethylcyclohexyl phthalate ...... Do.

Dimethyldialkyl (C8-C18) ammonium chloride ...... 0.005 percent for use only as a flocculant for slip agents. Di-n-ocyltin bis (2-ethylhexyl maleate) ...... For use only as a stabilizer at a level not to exceed 0.55 percent by weight of the coating solids in vinylidene chloride copolymer waterproof coatings prepared from vinylidene chloride copolymers identified in this paragraph, provided that such vinylidene chloride copolymers contain not less than 90 percent by weight of polymer units derived from vinylidene chloride.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent. and N-oleoyl-N′linoleoylethylene-diamine mixture produced when tall oil fatty acids are made to react with ethylenediamine such that the finished mixture has a melting point of 212°–228 °F., as determined by ASTM method D127–60 (‘‘Standard Method of Test for Melting Point of Petrolatum and Microcrystalline Wax’’ (Revised 1960), which is incorporated by reference; copies are available from University Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, 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/federallregister/ codeloflfederallregulations/ibrllocations.html.), and an acid value of 10 maximum. N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide). Disodium EDTA. Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent. monoacetate. N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide). Epoxidized polybutadiene ...... For use only as a primer subcoat to anchor surface coatings to the base sheet. Erucamide. Ethyl acetate. Ethylene-vinyl acetate copolymers complying with § 177.1350. 2-Ethylhexyl alcohol ...... 0.1 percent for use only as lubricant. Fatty acids derived from animal and vegetable fats and oils, and the following salts of such acids, single or mixed: Alu- minum, ammonium, calcium, magnesium, potassium, sodium. Ferrous ammonium sulfate. Fumaric acid. Glycerin-maleic anhydride ...... As the basic polymer. Glycerol diacetate. Glycerol monoacetate. Hydroxyethyl cellulose, water-insoluble. Hydroxypropyl cellulose identified in § 172.870 of this chapter. Isopropyl acetate ...... Residue limit 0.1 percent Isopropyl alcohol ...... Do. Itaconic acid. Lanolin. Lauryl alcohol. Lauryl sulfate salts: ammonium, magnesium, potassium, sodium. Maleic acid ...... 1 percent. Maleic acid adduct of butadienestyrene copolymer. Melamine formaldehyde ...... As the basic polymer. Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate. ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-eth- ylamine, imino-bis-propylamine, methyl alcohol, polyamines made by reacting ethylenediamine or trimethylenediamine with dichloroethane or dichloropropane, sulfanilic acid, tetraethylenepentamine, triethanolamine, triethylenetetramine. Methyl ethyl ketone ...... Residue limit 0.1 percent Methyl hydrogen siloxane ...... 0.1 percent as the basic polymer. a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a- methylstyrene to 3 vinyltoluene). Mineral oil, white. Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6 Reg. No. 62362–49–6). percent by weight of coatings for cellophane. Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier. salt. Nitrocellulose, 10.9 percent–12.2 percent nitrogen. Nylon resins complying with § 177.1500. n-Octyl alcohol ...... For use only as a defoaming agent in the manufacture of cellophane base sheet. Olefin copolymers complying with § 177.1520. Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16 to C18). Oleic acid, sulfonated, sodium salt. Oleyl palmitamide.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl- aminoethyl)oleamide). Paraffin, synthetic, complying with § 175.250 of this chapter. Pentaerythritol tetrastearate ...... 0.1 percent. Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem- (containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature. ethylenediamine as the basic resin. Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface. 10 percent by weight of said polyamide resins). Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer bromine number range 210–320). coatings. Polycarbonate resins complying with § 177.1580. Polyester resin formed by the reaction of the methyl ester of rosin, phthalic anhydride, maleic anhydride, and ethylene glycol, such that the polyester resin has an acid number of 4 to 11, a drop-softening point of 70 °C–92 °C, and a color of K or paler. Polyethylene. Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent. aric acid is made to react with equal parts of diethylenetriamine and triethylenetetramine and the reaction product is quaternized with diethyl sulfate. Polyethylene glycol (400) monolaurate. Polyethylene glycol (600) monolaurate. Polyethylene glycol (400) monooleate. Polyethylene glycol (600) monooleate. Polyethylene glycol (400) monostearate. Polyethylene glycol (600) monostearate. Polyethylene, oxidized: complying with the identity prescribed in § 177.1620(a). Polyethylenimine ...... As the basic polymer, for use as a resin to anchor coatings to the substrate and for use as an impregnant in the food-contact surface of regenerated cellulose sheet in an amount not to exceed that required to improve heat-sealable bonding between coated and uncoated sides of cellophane. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel- weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base sheet. Polypropylene complying with § 177.1520. Polystyrene ...... As the basic polymer. Polyvinyl acetate ...... Do. Polyvinyl alcohol (minimum viscosity of 4 percent aqueous solution at 20 °C of 4 centipoises). Polyvinyl chloride ...... As the basic polymer. Polyvinyl stearate ...... Do. n-Propyl acetate ...... Residue limit 0.1 percent. n-Propyl alcohol ...... Do. Rapeseed oil, blown. Rosins and rosin derivatives as provided in § 178.3870 of this chapter. Rubber, natural (natural latex solids). Silica. Silicic acid. Sodium m-bisulfite. Sodium dioctyl sulfosuccinate. Sodium dodecylbenzenesulfonate. Sodium lauroyl sarcosinate ...... 0.35 percent; for use only in vinylidene chloride copolymer coatings. Sodium oleyl sulfate-sodium cetyl sulfate mixture ...... For use only as an emulsifier for coatings; limit 0.005 percent where coating is applied to one side only and 0.01 percent where coating is applied to both sides. Sodium silicate. Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane. ter. Sodium sulfate. Sodium sulfite. Spermaceti wax. Stannous oleate.

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Limitations (residue and limits of addition expressed as percent List of substances by weight of finished packaging cellophane)

2-Stearamido-ethyl stearate. Stearyl alcohol. Styrene-maleic anhydride resins ...... As the basic polymer. Terpene resins identified in § 172.615 of this chapter. Tetrahydrofuran ...... Residue limit of 0.1 percent. Titanium dioxide. Toluene ...... Residue limit of 0.1 percent. Toluene sulfonamide formaldehyde ...... 0.6 percent as the basic polymer. Triethylene glycol. Triethylene glycol diacetate, prepared from triethylene glycol containing not more than 0.1 percent of diethylene glycol. 2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ...... For use only in cellophane coatings and limited to use at a level not to exceed 10 percent by weight of the coating solids except when used as provided in § 178.3740 of this chapter Urea (carbamide). Urea formaldehyde ...... As the basic polymer. Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate. mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-eth- ylamine, imino-bis-propylamine, imino-bis-butylamine, diaminopropane, diaminobutane, aminomethylsulfonic acid, polyamines made by reacting ethylenediamine or trimethylenediamine with dichlorethane or dichloropropane. Vinyl acetate-vinyl chloride copolymer resins ...... As the basic polymer. Vinyl acetate-vinyl chloride-maleic acid copolymer resins ...... Do. Vinylidene chloride copolymerized with one or more of the fol- Do. lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl methacrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl methacrylate, ethyl methacrylate, itaconic acid, methacrylic acid, methyl acrylate, methyl methacrylate, propyl acrylate, propyl methacrylate, vinyl chloride. Vinylidene chloride-methacrylate decyloctyl copolymer ...... Do. Wax, petroleum, complying with § 178.3710 of this chapter.

(d) Any optional component listed in in parts 174, 175, 176, 177, 178 and § 179.45 this section covered by a specific food of this chapter; and closure-sealing additive regulation must meet any gaskets, as further prescribed in this specifications in that regulation. section. (e) Acrylonitrile copolymers identi- (b) Closure-sealing gaskets and over- fied in this section shall comply with all discs are formulated from sub- the provisions of § 180.22 of this chap- stances identified in § 175.300(b) of this ter. chapter, with the exception of paragraph (b)(3) (v), (xxxi), and (xxxii) of [42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, that section, and from other optional 1999] substances, including the following: (1) Substances generally recognized § 177.1210 Closures with sealing gas- as safe in food. kets for food containers. (2) Substances used in accordance Closures with sealing gaskets may be with the provisions of a prior sanction safely used on containers intended for or approval within the meaning of sec- use in producing, manufacturing, pack- tion 201(s) of the act. ing, processing, preparing, treating, (3) Substances that are the subject of packaging, transporting, or holding regulations in parts 174, 175, 176, 177, 178 food in accordance with the following and § 179.45 of this chapter and used in prescribed conditions: accordance with the conditions pre- (a) Closures for food containers are scribed. manufactured from substances gen- (4) Substances identified in para- erally recognized as safe for contact graph (b)(5) of this section, used in with food; substances that are subject amounts not to exceed those required to the provisions of prior sanctions; to accomplish the intended physical or substances authorized by regulations technical effect and in conformance

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with any limitation provided; and fur- conforms with the identity or speci- ther provided that any substance em- fications prescribed. ployed in the production of closure- (5) Substances that may be employed sealing gasket compositions that is the in the manufacture of closure-sealing subject of a regulation in parts 174, 175, gaskets include: 176, 177, 178 and § 179.45 of this chapter

TABLE 1

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Arachidy-l-behenyl amide (C20-C22fatty acid amides) ...... 5 percent. Azodicarbonamide ...... 1. 2 percent. 2. 5 percent; for use only in the manufacture of polyethylene complying with item 2.1 in § 177.1520(c) of this chapter. Balata rubber. Benzyl alcohol ...... 1 percent. Brominated isobutylene-isoprene copolymers, produced when isobutylene-isoprene copolymers complying with § 177.1420(a)(2) are modified by bromination with not more than 2.3 weight-percent of bromine and having a Mooney Viscosity (ML 1+8 (125 °C)) of 27 or higher. The viscosity is determined by the American Society for Testing and Mate- rials (ASTM) method D 1646–81, ‘‘Standard Test Method for Rubber—Viscosity and Vulcanization Characteristics (Moon- ey Viscometer),’’ which is incorporated by reference in accordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504 and the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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/ federallregister/codeloflfederallregulations/ ibrllocations.html.. 1,3-Butanediol. Calcium tin stearate ...... 2 percent. Calcium zinc stearate ...... Do. Carbon, activated ...... 1 percent. Castor oil, hydrogenated ...... 2 percent. Chlorinated isobutylene-isoprene copolymers complying with § 177.1420. Coco amide (coconut oil fatty acids amides) ...... 2 percent. Cork (cleaned, granulated). Diebenzamide phenyl disulfide ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Di(C7, C9-alkyl) adipate ...... Complying with § 178.3740 of this chapter; except that, there is no limitation on polymer thickness. Di-2-ethylhexyl adipate. Di-2-ethylhexyl sebacate ...... 2 percent. Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per hundred by weight of permitted vinyl chloride homo- and/or copolymer resins used in contact with food of Types I, II, IV- B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII- B, and VIII described in § 176.170(c) of this chapter, table 1, and under conditions of use A through H described in § 176.170 (c) of this chapter, table 2. Dihexyl ester of sodium sulfosuccinate ...... 1 percent. Diisodecyl phthalate ...... No limitation on amount used but for use only in closure-sealing gasket compositions used in contact with non-fatty foods containing no more than 8 percent of alcohol. Di-b-naphthyl-p-phenylenediamine ...... 1 percent. Dipentamethylenethiurametetrasulfide ...... 0.4 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Eicosane (technical grade) (water-white mixture of predomi- nantly straight-chain paraffin hydrocarbons averaging 20 carbon atoms per molecule). Epoxidized linseed oil. Epoxidized linseed oil modified with trimellitic anhydride. Epoxidized safflower oil. Epoxidized safflower oil modified with trimellitic anhydride. Epoxidized soybean oil modified with trimellitic anhydride.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Erucylamide ...... 5 percent. Ethylene-propylene copolymer. Ethylene-propylene modified copolymer elastomers produced when ethylene and propylene are copolymerized with 5- methylene-2-norbornene and/or 5-ethylidine-2-norbornene. The finished copolymer elastomers so produced shall contain not more than 5 weight-percent of total polymer units derived from 5-methylene-2-norbornene and/or 5-ethylidine- 2-norbornene, and shall have a minimum viscosity average molecular weight of 120,000 as determined by the method described in § 177.1520(d)(5), and a minimum Mooney viscosity of 35 as determined by the method described in § 177.1520(d)(6). Ethylene-vinyl acetate copolymer. Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent. ricinoleate). Gutta-percha. Hexamethylenetetramine ...... 1 percent. Hexylene glycol ...... 0.5 percent. Isobutylene-isoprene copolymers complying with § 177.1420. Maleic anhydride-polyethylene copolymer ...... 5 percent. Maleic anhydride-styrene copolymer ...... Do. 2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ...... 1 percent. Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated isobutylene-isoprene copolymers complying with § 177.1420, and brominated isobutylene-isoprene copolymers complying with this section. Naphthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent. salt. Natural rubber (crepe, latex, mechanical dispersions). a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent. octadecenyl group is derived from oleyl alcohol and the poly (oxyethylene) content averages 20 moles. Oleyl alcohol ...... 1 percent. 4,4′-Oxybis (benzene sulfonyl hydrazide) ...... 0.5 percent. Paraformaldehyde ...... 1 percent. Polybutadiene. Poly-p-dinitroso benzene (activator for butyl rubber) ...... 1 percent; for use only in vulcanized natural or synthetic rubber gasket compositions. Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent. mal and vegetable fats and oils. Polyisobutylene complying with § 177.1420. Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent. wt. 2750–3000. Polyurethane resins manufactured from diphenylmethane For use only: diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure 26375–23–5).. gasket compositions used in contact with food types VI-A and VI-C (up to 15 percent alcohol) under conditions of use D, E, F, and G, as described in § 176.170(c) of this chapter, tables 1 and 2, respectively. Potassium benzoate ...... 1 percent. Potassium perchlorate ...... Do. Potassium propionate ...... 2 percent. Potassium and sodium persulfate ...... 1 percent. Resorcinol ...... 0.24 percent; for use only as a reactive adjuvant substance employed in the production of gelatin-bonded cord compositions for use in lining crown closures. The gelatin so used shall be technical grade or better. Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of this chapter for use only in resinous and polymeric coatings on metal substrates; for all other uses as defined in § 178.3870 of this chapter. Sodium cetyl sulfate ...... 1 percent. Sodium decylbenzenesulfonate ...... Do. Sodium decyl sulfate ...... Do. Sodium formaldehyde sulfoxylate ...... 0.05 percent. Sodium lauryl sulfate ...... 1 percent. Sodium lignin sulfonate ...... 0.2 percent. Sodium myristyl sulfate (sodium tetradecyl sulfate) ...... 0.6 percent.

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TABLE 1—Continued

Limitations (expressed as percent by weight of closure-sealing List of substances gasket composition)

Sodium nitrite ...... 0.2 percent; for use only in annular ring gaskets applied in aqueous dispersions to closures for containers having a capacity of not less than 5 gallons. Sodium o-phenylphenate ...... 0.05 percent. Sodium polyacrylate ...... 5 percent. Sodium and potassium pentachlorophenate ...... 0.05 percent. Sodium salt of trisopropyl naphthalenesulfonic acid ...... 0.2 percent. Sodium tridecylsulfate ...... 0.6 percent. Stearic acid amide ...... 5 percent. Sulfur ...... For use only as a vulcanizing agent in vulcanized natural or synthetic rubber gasket compositions at a level not to exceed 4 percent by weight of the elastomer content of the rubber gasket composition. Tallow, sulfated ...... 1 percent. Tin-zinc stearate ...... 2 percent. Tri(mixed mono- and dinonylphenyl) phosphite ...... 1 percent. Vinyl chloride-vinyl stearate copolymer. Zinc dibutyldithiocarbamate ...... 0.8 percent; for use only in vulcanized natural or synthetic rubber gasket compositions.

TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES cork, or glass that forms a part of the [In parts per million] food-contact surface of the assembly, when extracted on a suitable glass con- Chloro- Chloro- Chloro- tainer with a solvent or solvents char- form form form Type of closure-sealing gas- fraction fraction fraction acterizing the type of foods, and under ket composition of water of of alco- conditions of time and temperature extrac- heptane hol ex- tives extrac- tractives characterizing the conditions of its use tives as determined from tables 3 and 4 shall 1. Plasticized polymers, in- yield net chloroform-soluble extrac- cluding unvulcanized or tives (corrected for zinc as zinc oleate) vulcanized or otherwise not to exceed the tolerances specified cured natural and synthetic rubber formed in in table 2, calculated on the basis of place as overall discs or the water capacity of the container on annular rings from a hot which the closure is to be used. Employ melt, solution, plastisol, the analytical method described in organisol, mechanical dis- persion, or latex ...... 50 500 50 § 175.300 of this chapter, adapting the 2. Preformed overall discs procedural details to make the method or annular rings of plasti- applicable to closures; such as, for ex- cized polymers, including unvulcanized natural or ample, placing the closed glass con- synthetic rubber ...... 50 250 50 tainer on its side to assure contact of 3. Preformed overall discs the closure’s food-contacting surface or annular rings of vulcan- with the solvent. ized plasticized polymers, including natural or syn- TABLE 3—TYPES OF FOOD thetic rubber ...... 50 50 50 4. Preformed overall discs I. Nonacid (pH above 5.0), aqueous products; or annular rings of poly- may contain salt or sugar or both, and in- meric or resinous-coated cluding oil-in-water emulsions of low- or paper, paperboard, plas- high-fat content. tic, or metal foil substrates 50 250 50 5. Closures with sealing II. Acidic (pH 5.0 or below), aqueous prod- gaskets or sealing com- ucts; may contain salt or sugar or both, positions as described in and including oil-in-water emulsions of 1, 2, 3, and 4, and includ- low- or high-fat content. ing paper, paperboard, III. Aqueous, acid or nonacid products con- and glassine used for dry taining free oil or fat; may contain salt, 1 1 1 foods only ...... ( ) ( ) ( ) and including water-in-oil emulsions of 1 Extractability tests not applicable. low- or high-fat content. IV. Dairy products and modifications: (c) The closure assembly to include A. Water-in-oil emulsions, high- or low-fat. the sealing gasket or sealing com- B. Oil-in-water emulsions, high- or low-fat. pound, together with any polymeric or V. Low-moisture fats and oils. resinous coating, film, foil, natural VI. Beverages:

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A. Containing alcohol. VII. Bakery products. B. Nonalcoholic. VIII. Dry solids (no end-test required).

TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES

Extractant Conditions of use Types of food (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol perature) temperature) (time and temperature)

A. High temperature I, IV–B ...... 250 °F, 2 hr ...... heat-sterilized (e.g., over 212 °F). III, IV–A, VII ...... do ...... 150 °F, 2 hr. B. Boiling water-sterilized II ...... 212 °F, 30 min ...... III, VII ...... do ...... 120 °F, 30 min. C. Hot filled or pasteur- II, IV–B ...... Fill boiling, cool to 100 . ized above 150 °F. °F. III, IV–A ...... do ...... 120 °F, 15 min. V ...... do. D. Hot filled or pasteur- II, IV–B, VI–B ...... 150 °F, 2 hr ...... ized below 150 °F. III, IV–A ...... do ...... 100 °F, 30 min. V ...... do. VI–A ...... 150 °F, 2 hr. E. Room temperature II, IV–B, VI–B ...... 120 °F, 24 hr ...... filled and stored (no thermal treatment in the container). III, IV–A ...... do ...... 70 °F, 30 min. V ...... do. VI–A ...... 120 °F, 24 hr. F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ...... 70 °F, 30 min. (no thermal treatment). VI–B,VII. VI–A ...... 70 °F, 48 hr. G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ...... thermal treatment in the container). 1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.

[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May 9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011; 78 FR 14665, Mar. 7, 2013]

§ 177.1211 Cross-linked polyacrylate (2) 2-propenoic acid, polymer with 2- copolymers. ethyl-2-(((1-oxo-2-propenyl)oxy)methyl)-1,3-propanediyl di-2- Cross-linked polyacrylate copoly- propenoate and sodium 2-propenoate mers identified in paragraph (a) of this (CAS Reg. No. 76774–25–9). section may be safely used as articles (b) Adjuvants. The copolymers identi- or components of articles intended for fied in paragraph (a) of this section use in contact with food in accordance may contain optional adjuvant sub- with the following prescribed condi- stances required in the production of tions: such copolymers. The optional adju- (a) Identity. For the purpose of this vant substances may include sub- section, the cross-linked polyacrylate stances permitted for such use by regu- copolymers consist of: lations in parts 170 through 179 of this (1) The grafted copolymer of cross- chapter, substances generally recog- linked sodium polyacrylate identified nized as safe in food, and substances as 2-propenoic acid, polymers with N,N- used in accordance with a prior sanc- di-2-propenyl-2-propen-1-amine and tion or approval. hydrolyzed polyvinyl acetate, sodium (c) Extractives limitations. The copoly- salts, graft (CAS Reg. No. 166164–74–5); mers identified in paragraph (a) of this or section, in the finished form in which

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they will contact food, must yield low (b) The quantity of any optional sub- molecular weight (less than 1,000 Dal- stance employed in the production of tons) extractives of no more than 0.15 the copolymer does not exceed the percent by weight of the total polymer amount reasonably required to accom- when extracted with 0.2 percent by plish the intended physical or technical weight of aqueous sodium chloride so- effect or any limitation further pro- lution at 20 °C for 24 hours. The low vided. molecular weight extractives shall be (c) Any substance employed in the determined using size exclusion chro- production of the copolymer that is the matography or an equivalent method. subject of a regulation in parts 174, 175, When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter the copolymer, with no other absorp- conforms with any specification in tive media, shall be confined either in such regulation. a finished absorbent pad or in any suit- (d) Substances employed in the pro- able flexible porous article, (such as a duction of the copolymer include: ‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized pressure of 0.15 pounds per square inch as safe in food. (for example, a 4×6 inch square pad is (2) Substances subject to prior sanc- subjected to a 1.6 kilograms applied tion or approval for use in the copoly- mass). The solvent used shall be at mer and used in accordance with such least 60 milliliters aqueous sodium sanction or approval. chloride solution per gram of copoly- (3) Substances which by regulation in mer. parts 174, 175, 176, 177, 178 and § 179.45 of (d) Conditions of use. The copolymers this chapter may be safely used as identified in paragraph (a)(1) of this components of resinous or polymeric section are limited to use as a fluid ab- coatings and film used as food-contact sorbent in food-contact materials used surfaces, subject to the provisions of in the packaging of frozen or refrig- such regulation. erated poultry. The copolymers identi- (e) The copolymer conforms with the fied in paragraph (a)(2) of this section following specifications: are limited to use as a fluid absorbent (1) The copolymer, when extracted in food-contact materials used in the with distilled water at reflux tempera- packaging of frozen or refrigerated ture for 2 hours, yields total extrac- meat and poultry. tives not to exceed 0.05 percent. (2) The copolymer, when extracted [64 FR 28098, May 25, 1999, as amended at 65 with ethyl acetate at reflux tempera- FR 16817, Mar. 30, 2000] ture for 2 hours, yields total extrac- § 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent. dimethylene terephthalate and 1,4- (3) The copolymer, when extracted cyclohexylene dimethylene with n-hexane at reflux temperature isophthalate copolymer. for 2 hours, yields total extractives not Copolymer of 1,4-cyclohexylene to exceed 0.05 percent. dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990] late may be safely used as an article or component of articles used in pro- § 177.1310 Ethylene-acrylic acid co- ducing, manufacturing, packing, proc- polymers. essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers transporting, or holding food, subject identified in paragraph (a) of this sec- to the provisions of this section: tion may be safely used as components (a) The copolymer is a basic poly- of articles intended for use in contact ester produced by the catalytic con- with food subject to the provisions of densation of dimethyl terephthalate this section. and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly- cyclohexanedimethanol, to which may mers consist of basic copolymers pro- have been added certain optional sub- duced by the copolymerization of stances required in its production or ethylene and acrylic acid such that the added to impart desired physical and finished basic copolymers contain no technical properties. more than:

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(1) 10 weight-percent of total polymer hesives complying with § 175.105 of this units derived from acrylic acid when chapter. used in accordance with paragraph (b) [42 FR 14572, Mar. 15, 1977, as amended at 51 of this section; and FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, (2) 25 weight-percent of total polymer 1988] units derived from acrylic acid when used in accordance with paragraph (c) § 177.1312 Ethylene-carbon monoxide of this section. copolymers. (b) The finished food-contact articles The ethylene-carbon monoxide co- made with no more than 10 percent polymers identified in paragraph (a) of total polymer units derived from acryl- this section may be safely used as com- ic acid, when extracted with the sol- ponents of articles intended for use in vent or solvents characterizing the contact with food subject to the provi- type of food and under the conditions sions of this section. of its intended use as determined from (a) Identity. For the purposes of this tables 1 and 2 of § 176.170(c) of this chap- section, ethylene-carbon monoxide co- ter, yield net acidified chloroform-solu- polymers (CAS Reg. No. 25052–62–4) con- ble extractives not to exceed 0.5 milli- sist of the basic polymers produced by gram per square inch of food-contact the copolymerization of ethylene and surface when tested by the methods carbon monoxide such that the copoly- prescribed in § 177.1330(e)(1), (3)(i) mers contain not more than 30 weight- through (iv), (4), (5), and (6), except percent of polymer units derived from that carbon monoxide. (1) The total residue method using 3 (b) Conditions of use. (1) The polymers percent acetic acid, as prescribed in may be safely used as components of § 177.1330(e)(6)(i)(a), does not apply, and the food-contact or interior core layer (2) The net acidified chloroform-solu- of multilaminate food-contact articles. ble extractives from paper and paper- (2) The polymers may be safely used board complying with § 176.170 of this as food-contact materials at tempera- chapter may be corrected for wax, pet- tures not to exceed 121 °C (250 °F). rolatum, and mineral oil as provided in (c) Specifications. (1) Food-contact § 176.170(d)(5)(iii)(b) of this chapter. layers formed from the basic copoly- If the finished food-contact article is mer identified in paragraph (a) of this itself the subject of a regulation in section shall be limited to a thickness parts 174, 175, 176, 177, 178, and § 179.45 of of not more than 0.01 centimeter (0.004 this chapter, it shall also comply with inch). any specifications and limitations pre- (2) The copolymers identified in para- scribed for it by that regulation. graph (a) of this section shall have a (c) The finished food-contact layer melt index not greater than 500 as de- made with basic copolymers containing termined by ASTM method D1238–82, more than 10 weight-percent but no condition E ‘‘Standard Test Method for more than 25 weight-percent of total Flow Rates of Thermoplastics by Ex- polymer units derived from acrylic trusion Plastometer,’’ which is incor- acid and with a maximum thickness of porated by reference in accordance 0.0025 inch (2.5 mils) may be used in with 5 U.S.C. 552(a) and 1 CFR part 51. contact with food types I, II, IVB, VIA, Copies may be obtained from the Amer- VIB, VIIB, and VIII identified in table ican Society for Testing Materials, 100 1 of § 176.170(c) of the chapter under Barr Harbor Dr., West Conshohocken, conditions of use B through H as de- Philadelphia, PA 19428-2959, or may be scribed in table 2 of § 176.170(c) of this examined at the Center for Food Safety chapter, and in contact with food types and Applied Nutrition (HFS–200), Food III, IVA, V, VIIA, and IX identified in and Drug Administration, 5100 Paint table 1 of § 176.170(c) of this chapter Branch Pkwy., College Park, MD 20740, under conditions of use E through G as or at the National Archives and described in table 2 of § 176.170(c) of this Records Administration (NARA). For chapter. information on the availability of this (d) The provisions of this section are material at NARA, call 202–741–6030, or not applicable to ethylene-acrylic acid go to: http://www.archives.gov/ copolymers used in food-packaging ad- federallregister/

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codeloflfederallregulations/ may be safely used as articles or com- ibrllocations.html. ponents of articles intended for use in (3) The basic copolymer identified in contact with food subject to provisions paragraph (a) of this section, when ex- of this section and of part 174 of this tracted with the solvent or solvents chapter. characterizing the type of food and (a) Identity. For the purposes of this under the conditions of time and tem- section, ethylene-1,4-cyclohexylene perature characterizing the conditions dimethylene terephthalate copolymers of its intended use, as determined from (1,4-benzene dicarboxylic acid, di- tables 1 and 2 of § 176.170(c) of this chapter, yields net chloroform-soluble ex- methyl ester, polymerized with 1,4- tractives in each extracting solvent cyclohexanedimethanol and 1,2- not to exceed 0.5 milligram per square ethanediol) (CAS Reg. No. 25640–14–6) or inch of food-contact surface when test- (1,4-benzenedicarboxylic acid, polym- ed by methods described in § 176.170(d) erized with 1,4-cyclohexanedimethanol of this chapter. and 1,2-ethanediol) (CAS Reg. No. (4) The provisions of this section are 25038–91–9) are basic copolymers meet- not applicable to ethylene-carbon mon- ing the specifications prescribed in oxide copolymers complying with paragraph (b) of this section, to which § 175.105 of this chapter. may have been added certain optional [57 FR 32422, July 22, 1992] substances required in their production or added to impart desired physical or § 177.1315 Ethylene-1, 4-cyclohexylene technical properties. dimethylene terephthalate copoly- (b) Specifications: mers. Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer

Maximum extractable fractions of the copolymer in the fin- Ethylene-1,4- ished form at specified tem- cyclohexylene peratures and times (ex- Test for dimethylene Inherent viscosity pressed in micrograms of the orientability Conditions of use terephthalate copolymers terephthaloyl moletles/square centimeter of food-contact surface)

1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in- ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con- dimethylene cent solution of per square inch) of food-containing not more than terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol- mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol, product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer. ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill mixture containing 99 not less than ticle. not to exceed 82.2 °C to 66 mole percent of 0.669 as deter- (180 °F), storage at ethylene glycol and 1 mined by using temperatures not in to 34 mole percent of a Wagner vis- excess of 48.9 °C 1,4-cyclo- cometer (or (120 °F). No thermal hexanedimethanol (70 equivalent) and treatment in the con- percent trans isomer, calculated from tainer. 30 percent cls isomer). the following equation: Inher- ent viscosity = (Natural loga- rithm of (Nr)/(c) where: Nr=Ratio of flow time of the polymer solution to that of the solvent, and c=concentration of the test solution expressed in grams per 100 milliliters.

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...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface when extracted with 3 percent (by volume) aqueous acetic acid added at 82.2 °C (180 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5...... do ...... (4) 0.16 microgram per square ...... do ...... Do. centimeter (1.0 microgram per square inch) of food-contact surface when extracted for 24 hours with 25 percent (by volume) aqueous ethanol at 48.9 °C (120 °F). 2. Oriented ethylene-1,4- ...... do ...... (1) 0.23 microgram per square When extracted In contact with non- cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ- dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev- terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor- terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9 mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther- to 85 mole percent ticle. meter (0.60 mal treatment in the ethylene glycol and 1 microgram per container. to 15 mole percent of square inch) of 1,4-cyclohexane-di- food-contact methanol (70 percent surface. trans isomer, 30 percent cls isomer)...... do ...... (2) 0.23 microgram per square ...... do ...... Do. centimeter (1.5 micrograms per square inch) of food-contact surface of oriented copolymer when extracted with 3 percent (by volume) aqueous acetic acid added at 87.8 °C (190 °F) and allowed to cool to 48.9 °C (120 °F) in contact with the food-contact article...... do ...... (3) 0.08 microgram per square ...... do ...... Do. centimeter (0.5 microgram per square inch) of food-contact surface of oriented copolymer when extracted for 2 hours with n-heptane at 48.9 °C (120 °F). The heptane extractable results are to be divided by a factor of 5.

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...... do ...... (4) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 20 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of thermal 20 percent (by volume) treatment in the con- aqueous ethanol heated to tainer not exceeding 65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for utes and allowed to cool to 20 minutes. Storage at 48.9 °C (120 °F) in contact temperatures not in with the food-contact article. excess of 48.9 °C (120 °F)...... do ...... (5) 0.23 microgram per square ...... do ...... In contact with foods and centimeter (1.5 micrograms beverages containing per square inch) of food-con- up to 50 percent (by tact surface of oriented co- volume) alcohol. Con- polymer when extracted with ditions of fill and stor- 50 percent (by volume) age not exceeding aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No (120 °F) for 24 hours. thermal treatment in the container. 3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding cyclohexylene tion of use, must meet speci- specification, may be dimethylene fications described in used as a base sheet terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in mer is the reaction accordance with con- product of dimethyl ditions of use de- terephthalate or ter- scribed in ephthalic acid with a § 177.1630(f), (g), (h), mixture containing 99 or (j). to 95 mole percent of ethylene glycol and 1 to 5 mole percent of 1,4- cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer).

(c) Analytical method for determination standards prepared in 95:5 percent (v/v) of extractability. The total extracted heptane: tetrahydrofuran. terephthaloyl moieties can be deter- [45 FR 39252, June 10, 1980, as amended at 47 mined in the extracts, without evapo- FR 24288, June 4, 1982; 49 FR 25629, June 22, ration of the solvent, by measuring the 1984; 51 FR 22929, June 24, 1986; 60 FR 57926, ultraviolet (UV) absorbance at 240 Nov. 24, 1995] nanometers. The spectrophotometer (Varian 635–D, or equivalent) is zeroed § 177.1320 Ethylene-ethyl acrylate co- with a sample of the solvent taken polymers. from the same lot used in the extrac- Ethylene-ethyl acrylate copolymers tion tests. The concentration of the may be safely used to produce pack- total terephthaloyl moieties in water, 3 aging materials, containers, and equip- percent acetic acid, and in 8 percent ment intended for use in producing, aqueous alcohol is calculated as bis(2- manufacturing, packing, processing, hydroxyethyl terephthalate) by ref- preparing, treating, packaging, trans- erence to standards prepared in the ap- porting, or holding food, in accordance propriate solvent. Concentration of the with the following prescribed condi- terephthaloyl moieties in heptane is tions: calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly- (C6H4CO2C2H4CO2)3, by reference to mers consist of basic resins produced 265

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by the catalytic copolymerization of Plastics by the Density-Gradient Tech- ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref- may have been added certain optional erence. Copies may be obtained from substances to impart desired techno- the American Society for Testing Ma- logical properties to the resin. Subject terials, 100 Barr Harbor Dr., West to any limitations prescribed in this Conshohocken, Philadelphia, PA 19428- section, the optional substances may 2959, or may be examined at the Na- include: tional Archives and Records Adminis- (1) Substances generally recognized tration (NARA). For information on as safe in food and food packaging. the availability of this material at (2) Substances the use of which is NARA, call 202–741–6030, or go to: http:// permitted under applicable regulations www.archives.gov/federallregister/ in parts 170 through 189 of this chapter, codeloflfederallregulations/ prior sanction, or approvals. ibrllocations.html. (b) The ethyl acrylate content of the (2) Limitations. Ethylene-ethyl acry- copolymer does not exceed 8 percent by late copolymers or the blend may be weight unless it is blended with poly- used in contact with food except as a ethylene or with one or more olefin co- component of articles used for pack- polymers complying with § 177.1520 or aging or holding food during cooking with a mixture of polyethylene and one provided they meet the following or more olefin copolymers, in such pro- extractability limits: portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3 tent of the blend does not exceed 8 per- percent in xylene after refluxing and cent by weight, or unless it is used in subsequent cooling to 25 °C. a coating complying with § 175.300 or (ii) Maximum extractable fraction of § 176.170 of this chapter, in such propor- 5.5 percent when extracted with n- ° tions that the ethyl acrylate content hexane at 50 C. does not exceed 8 percent by weight of (d) The provisions of paragraphs (b) the finished coating. and (c)(2) of this section are not appli- (c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co- mers or the blend shall conform to the polymers used in the formulation of ad- specifications prescribed in paragraph hesives complying with § 175.105 of this (c)(1) of this section and shall meet the chapter. ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49 scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984] and the extractability limits prescribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins. tion, when tested by the methods pre- Ionomeric resins manufactured from scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co- (1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal- fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium, polymers can be identified by their and/or zinc partial salts), ethylene- characteristic infrared spectra. methacrylic acid-vinyl acetate copoly- (ii) Quantitative determination of ethyl mers (and/or their ammonium, cal- acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium, be determined by the infrared spectra. and/or zinc partial salts,), or meth- Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po- at 11.6 microns and divide by the tassium, sodium and/or zinc partial plaque thickness to obtain absorbance salts) may be safely used as articles or per mil. From a previously prepared components of articles intended for use calibration curve, obtain the amount of in contact with food, in accordance ethyl acrylate present. with the following prescribed condi- (iii) Specific gravity. Ethylene-ethyl tions: acrylate copolymers have a specific (a) For the purpose of this section, gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly- than 0.935, as determined by ASTM mers consist of basic copolymers pro- method D1505–68 (Reapproved 1979), duced by the copolymerization of ‘‘Standard Test Method for Density of ethylene and methacrylic acid such

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that the copolymers contain no more determined from table I of paragraph than 20 weight percent of polymer (f) of this section, shall yield net acidi- units derived from methacrylic acid, fied chloroform-soluble extractives as and the ethylene-methacrylic acid- follows: vinyl acetate copolymers consist of (1) For fatty food use. (i) For films of basic copolymers produced by the co- 2 mil (0.002 inches) thickness or less, polymerization of ethylene, meth- extractives shall not exceed 0.70 milli- acrylic acid, and vinyl acetate such gram/square inch 1 (0.109 milligram/ that the copolymers contain no more square centimeter) of food-contact sur- than 15 weight percent of polymer face (n-heptane extractions) when ex- units derived from methacrylic acid. tracted by the abbreviated method (b) For the purpose of this section, cited in paragraph (e)(2)(i) of this sec- the methacrylic acid copolymers with tion. ethylene and isobutyl acrylate consist (ii) For films of greater than 2 mils of basic copolymers produced by the (0.002 inch) thickness, extractives shall copolymerization of methacrylic acid, not exceed 0.40 milligram/square inch 1 ethylene, and isobutyl acrylate such (0.062 milligram/square centimeter) of that the copolymers contain no less food-contact surface (n-heptane extrac- than 70 weight percent of polymer tions) when extracted by the abbre- units derived from ethylene, no more viated method cited in paragraph than 15 weight percent of polymer (e)(2)(i) of this section, or units derived from methacrylic acid, (iii) Alternatively, for films of great- and no more than 20 weight percent of er than 2 mils thickness, extractives polymer units derived from isobutyl shall not exceed 0.70 milligram/square acrylate. From 20 percent to 70 percent inch 1 (0.109 milligram/square centi- of the carboxylic acid groups may op- meter) of food-contact surface (n- tionally be neutralized to form sodium heptane extractions) when extracted by or zinc salts. the equilibrium method cited in para- (c) The finished food-contact article graph (e)(2)(ii) of this section. described in paragraph (a) of this sec- (2) For aqueous foods. (i) The net tion, when extracted with the solvent acidified chloroform-soluble extrac- or solvents characterizing the type of tives shall not exceed 0.02 milligram/ food and under the conditions of time square inch 2(0.003 milligram/square and temperature characterizing the centimeter) of food-contact surface conditions of its intended use as deter- (water, acetic acid, or ethanol/water mined from tables 1 and 2 of § 176.170(c) extractions) when extracted by the ab- of this chapter, yields net acidified breviated method cited in paragraph chloroform-soluble extractives in each (e)(2)(i) of this section. extracting solvent not to exceed 0.5 (ii) Alternatively, the net acidified milligram per square inch of food-con- chloroform-soluble extractives shall tact surface when tested by the meth- not exceed 0.05 milligram/square inch 3 ods described in paragraph (e)(1) of this (0.078 mg/square centimeter) of food- section, and if the finished food-con- contact surface (water, acetic acid, or tact article is itself the subject of a ethanol/water extractions) when ex- regulation in parts 174, 175, 176, 177, 178 tracted by the equilibrium method and § 179.45 of this chapter, it shall also cited in paragraph (e)(2)(ii) of this sec- comply with any specifications and tion. If when exposed to n-heptane, a limitations prescribed for it by that particular film splits along die lines, regulation. thus permitting exposure of both sides NOTE: In testing the finished food-contact of the film to the extracting solvent, article, use a separate test sample for each required extracting solvent. (d) The finished food-contact article 1 Average of four separate values, no single described in paragraph (b) of this sec- value of which differs from the average of ± tion, when extracted according to the those values by more then 10 percent. 2 Average of four separate values, no single methods listed in paragraph (e)(2) of value of which differs from the average of this section and referenced in this those values by more than ±50 percent. paragraph (d), using the solvent or sol- 3 See footnote 2 to paragraph (d)(2)(i) of vents characterizing the type of food as this section.

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the results for that film sample are in- lating solvent is to contact the food- valid and the test must be repeated for contact film at a temperature of 120 °F that sample until no splitting by the until equilibrium is demonstrated. solvent occurs. If the finished food-contact article is itself the subject of a Minimum extraction regulation in parts 174, 175, 176, 177, 178 Solvent times and § 179.45 of this chapter, it shall also (hours) comply with any specifications and n-Heptane ...... 8, 10, 12 limitations prescribed for it by that Water, 3% acetic acid, or 8%/50% ethanol ...... 72, 96, regulation. 120 NOTE: In testing the finished food-contact article, use a separate test sample for each The results from a series of extraction required extracting solvent. times demonstrate equilibrium when (e) Analytical methods—(1) Selection of the net chloroform-soluble extractives extractability conditions for ionomeric res- are unchanging within experimental ins. First ascertain the type of food error appropriate to the method as de- (table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d) (1)(i) and (2)(i) that is being packed or used in contact of this section. Should equilibrium not with the finished food-contact article be demonstrated over the above time described in paragraph (a) of this sec- series, extraction times must be ex- tion, and also ascertain the normal tended until three successive unchang- conditions of thermal treatment used ing values for extractives are obtained. in packaging or contacting the type of In the case where intended uses involve food involved. Using table 2 of § 176.170 temporary food contact above 120 °F, (c) of this chapter, select the food-sim- the food-simulating solvent is to be ulating solvent or solvents and the contacted with the food-contact article time-temperature test conditions that under conditions of time and tempera- correspond to the intended use of the ture that duplicate the actual condi- finished food-contact article. Having selected the appropriate food-simu- tions in the intended use. Subsequently lating solvent or solvents and time- the extraction is to be continued for temperature exaggeration over normal the time period and under the condi- use, follow the applicable extraction tions specified in the above table. procedure. (3) Reagents—(i) Water. All water used (2) Selection of extractability conditions in extraction procedures should be for ionomeric resins. Using table I of freshly demineralized (deionized) dis- paragraph (f) of this section ascertain tilled water. the type of food that is being packed or (ii) n-Heptane. Reagent grade, freshly used in contact with the finished food- redistilled before use, using only mate- contact article described in paragraph rial boiling at 208 °F (97.8 °C). (b) of this section, and also ascertain (iii) Alcohol. 8 or 50 percent (by vol- the food-simulating solvent or solvents ume), prepared from undenatured 95 that correspond to the intended use of percent ethyl alcohol diluted with the finished food-contact article. demineralized (deionized), distilled (i) Abbreviated test. For intended use water. involving food contact at or below 120 (iv) Chloroform. Reagent grade, fresh- °F (49 °C), the appropriate food-simu- ly redistilled before use, or a grade lating solvent is to contact the food- having an established, consistently low contact film for the time and tempera- blank. tures as follows: (v) Acetic acid. 3 percent (by weight), prepared from glacial acetic acid di- Solvent Time Temperature luted with demineralized (deionized), n-Heptane ...... 1 2 120 °F (49 °C). distilled water. 1 ° ° Water, 3% acetic acid, or 8%/ 48 120 F (49 C). (4) Selection of test method. The fin- 50% ethanol. ished food-contact articles shall be 1 Hours tested either by the extraction cell de- (ii) Equilibrium test. For intended use scribed in the Journal of the Association involving food contact at or below 120 of Official Agricultural Chemists, Vol. 47, °F (49 °C), the appropriate food-simu- No. 1, p. 177–179 (February 1964), also

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described in ASTM method F34–76 (Re- (b) Heptane. Milligrams extractives approved 1980), ‘‘Standard Test Method per square inch=(e)/(s)(F) for Liquid Extraction of Flexible Bar- where: rier Materials,’’ which are incorporated e=Milligrams extractives per sample tested. by reference, or by adapting the in-con- s=Surface area tested, in square inches. tainer methods described in § 175.300(e) F=Five, the ratio of the amount of extrac- of this chapter. Copies of the material tives removed by heptane under exagger- incorporated by reference are available ated time-temperature test conditions from the Center for Food Safety and compared to the amount extracted by a Applied Nutrition (HFS–200), Food and fat or oil under exaggerated conditions of Drug Administration, 5100 Paint thermal sterilization and use. e′=Acidified chloroform-soluble extractives Branch Pkwy., College Park, MD 20740, residue. e′ is substituted for e in the and the American Society for Testing above equations when necessary (See Materials, 100 Barr Harbor Dr., West paragraph (e)(6)(ii) of this section for Conshohocken, Philadelphia, PA 19428- method to obtain e′). 2959, respectively, or may be examined at the National Archives and Records If when calculated by the equations in Administration (NARA). For informa- paragraphs (e)(6)(i) (a) and (b) of this tion on the availability of this mate- section, the extractives in milligrams rial at NARA, call 202–741–6030, or go per square inch exceed the limitations to: http://www.archives.gov/ prescribed in paragraphs (c) or (d) of federallregister/ this section, proceed to paragraph codeloflfederallregulations/ (e)(6)(ii) of this section (method for de- ibrllocations.html. termining the amount of acidified chloroform-soluble extractives residue). (5) Selection of samples. Quadruplicate (ii) Acidified chloroform-soluble extrac- samples should be tested, using for tives residue. Add 3 milliliters of 37 per- each replicate sample the number of cent ACS reagent grade hydrochloric finished articles with a food-contact acid and 3 milliliters of distilled water surface nearest to 100 square inches. to the evaporating dish containing the (6) Determination of amount of extrac- dried and weighed residue, e, obtained tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section. the exposure period, remove the test Mix well so every portion of the residue container or test cell from the oven, if is wetted with the hydrochloric acid any, and combine the solvent for each solution. Then add 50 milliliters of replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter lent) flask or beaker, being sure to through Whatman No. 41 filter paper rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva- small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a rate the food-simulating solvents to clean separatory funnel. Shake for 1 about 100 milliliters in the flask, and minute, then draw off the chloroform transfer to a clean, tared evaporating layer into a clean tared evaporating dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the flask three times with small portions chloroform extraction, washing the of solvent used in the extraction proce- dish, the filter paper, and the sepa- dure, and evaporate to a few milliliters ratory funnel with this second portion on a nonsparking, low-temperature of chloroform. Add this filtrate to the hotplate. The last few milliliters original filtrate and evaporate the should be evaporated in an oven main- total down to a few milliliters on a tained at a temperature of 221 °F (105 low-temperature hotplate. The last few °C). Cool the evaporating dish in a des- milliliters should be evaporated in an iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30 Calculate the extractives in milligrams minutes and weigh to the nearest 0.1 per square inch of the container or ma- milligram to get the acidified chloro- terial surface. form-soluble extractives residue, e′. (a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa- percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i) (a) and (b) grams extractives per square inch=e/s. of this section.

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(f) The types of food and appropriate (b) The finished food-contact article, solvents are as follows: when extracted with the solvent or solvents characterizing the type of food TABLE 1 and under the conditions of time and temperature characterizing the condi- Types of food Appropriate solvent tions of its intended use as determined 1. Nonacid (pH above 5.0), aque- Water, n-heptane. from tables 1 and 2 of § 176.170(c) of this ous products; may contain salt chapter, yields net chloroform-soluble or sugar or both, and including extractives (corrected for zinc extrac- oil-in-water emulsions of low- or high-fat content. tives as zinc oleate) in each extracting 2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% solvent not to exceed 0.5 milligram per ous products; may contain salt acetic acid. square inch of food-contact surface or sugar or both, and including when tested by the methods described oil-in-water emulsions of low- or high-fat content. in § 176.170(d) of this chapter. If the fin- 3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% ished food-contact article is itself the ucts containing free oil or fat; acetic acid. subject of a regulation in parts 174, 175, may contain salt, and including 176, 177, 178 and § 179.45 of this chapter, water-in-oil emulsions of low- or high-fat content. it shall also comply with any specifica- 4. Dairy products and modifications and limitations prescribed for it tions: by that regulation. Water, n-heptane. NOTE: In testing the finished food-contact i. Water-in-oil emulsions, high article, use a separate test sample for each or low fat. ii. Oil-in-water emulsions, high required extracting solvent. or low fat. (c) The provisions of this section are 5. Low moisture fats and oils ...... n-heptane. not applicable to ethylene-methyl ac- 6. Beverages: rylate copolymer resins used in food- i. Containing up to 8% alcohol 8% ethanol/water. packaging adhesives complying with ii. Nonalcoholic ...... 3% acetic acid. iii. Containing more than 8% 50% ethanol/water. § 175.105 of this chapter. alcohol. 7. Bakery products ...... Water, n-heptane. § 177.1345 Ethylene/1,3–phenylene oxy- 8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/ oil). quired. terephthalate copolymer. 9. Dry solids (with free fat or oil) .. n-heptane. Ethylene/1,3-phenylene oxyethylene (g) The provisions of paragraphs (c) isophthalate/terephthalate copolymer and (d) of this section are not applica- (CAS Reg. No. 87365–98–8) identified in ble to the ionomeric resins that are paragraph (a) of this section may be safely used, subject to the provisions of used in food-packaging adhesives com- this section, as the non-food-contact plying with § 175.105 of this chapter. layer of laminate structures subject to [45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630. June 12, 1989] (a) Identity. For the purpose of this section, ethylene/1,3-phenylene oxy- § 177.1340 Ethylene-methyl acrylate co- ethylene isophthalate/terephthalate polymer resins. copolymer consists of the basic copoly- Ethylene-methyl acrylate copolymer mer produced by the catalytic resins may be safely used as articles or polycondensation of isophthalic acid components of articles intended for use and terephthalic acid with ethylene in contact with food, in accordance glycol and 1,3-bis(2- with the following prescribed condi- hydroxyethoxy)benzene such that the tions: finished resin contains between 42 and (a) For the purpose of this section, 48 mole-percent of isophthalic the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent mer resins consist of basic copolymers of terephthalic moieties, and not more produced by the copolymerization of than 10 mole-percent of 1,3-bis(2- ethylene and methyl acrylate such hydroxyethoxy)benzene moieties. that the copolymers contain no more (b) Specifications—(1) Density. Ethyl- than 25 weight percent of polymer ene/1,3-phenylene oxyethylene units derived from methyl acrylate. isophthalate/terephthalate copolymer

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identified in paragraph (a) of this sec- of use C at temperatures not to exceed tion has a density of 1.33±0.02 grams per 160 °F (71 °C). cubic centimeter measured by ASTM Method D 1505–85 (Reapproved 1990), [57 FR 43399, Sept. 21, 1992, as amended at 59 FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2, ‘‘Standard Test Method for Density of 1996; 62 FR 34628, June 27, 1997] Plastics by the Density-Gradient Tech- nique,’’ which is incorporated by ref- § 177.1350 Ethylene-vinyl acetate co- erence in accordance with 5 U.S.C. polymers. 552(a) and 1 CFR part 51. Copies may be obtained from the American Society Ethylene-vinyl acetate copolymers for Testing and Materials, 100 Barr may be safely used as articles or com- Harbor Dr., West Conshohocken, Phila- ponents of articles intended for use in delphia, PA 19428-2959, or may be exam- producing, manufacturing, packing, ined at the Center for Food Safety and processing, preparing, treating, pack- Applied Nutrition’s Library, Food and aging, transporting, or holding food in Drug Administration, 5100 Paint accordance with the following pre- Branch Pkwy., College Park, MD 20740, scribed conditions: and at the National Archives and (a)(1) Ethylene-vinyl acetate copoly- Records Administration (NARA). For mers consist of basic resins produced information on the availability of this by the catalytic copolymerization of material at NARA, call 202–741–6030, or ethylene and vinyl acetate to which go to: http://www.archives.gov/ may have been added certain optional federallregister/ substances to impart desired techno- codeloflfederallregulations/ logical or physical properties to the ibrllocations.html. resin. Subject to any limitations pre- (2) Softening point. Ethylene/1,3–phen- scribed in this section, the optional ylene oxyethylene isophthalate/ substances may include: terephthalate copolymer identified in (i) Substances generally recognized paragraph (a) of this section has a soft- as safe in food and food packaging. ening point of 63±5 °C as measured by (ii) Substances the use of which is ASTM Method D 1525–87, ‘‘Standard permitted under applicable regulations Test Method for VICAT Softening Tem- in parts 170 through 189 of this chapter, perature of Plastics,’’ which is incor- prior sanction, or approvals. porated by reference in accordance (iii) Substances identified in with 5 U.S.C. 552(a) and 1 CFR part 51. § 175.300(b)(3) (xxv), (xxvii), (xxx), and The availability of this material is pro- (xxxiii) of this chapter, and colorants vided in paragraph (b)(1) of this sec- used in accordance with § 178.3297 of tion. this chapter. (c) Optional adjuvant substances. (iv) Erucamide as identified in Ethylene/1,3–phenylene oxyethylene isophthalate/terephthalate copolymer, § 178.3860 of this chapter. identified in paragraph (a) of this sec- (v) Xanthan gum as identified in tion, may contain optional adjuvant § 172.695 for use as a thickening agent substances required in their produc- at a level not to exceed 1 percent by tion. The optional adjuvants may in- weight of coating solids in aqueous dis- clude substances used in accordance persions of ethylene-vinyl acetate co- with § 174.5 of this chapter. polymers, where such copolymers are (d) Limitations. Copolymer blends de- used only as coatings or a component scribed above shall not exceed 30 per- of coatings. cent by weight of ethylene/1,3-phen- (vi) The copolymer of vinylidene flu- ylene oxyethylene isophthalate/ oride and hexafluoropropene (CAS Reg. terephthalate copolymer. The finished No. 9011–17–0), containing 65 to 71 per- blend may be used in contact with food cent fluorine and having a Mooney Vis- only under conditions of use C through cosity of at least 28, for use as a proc- G, as described in table 2 of § 176.170(c) essing aid at a level not to exceed 0.2 of this chapter, except that with food percent by weight of ethylene-vinyl ac- identified as Type III, IV-A, V, VII-A, etate copolymers. and IX in § 176.170(c), table 1, the co- (2) Maleic anhydride-grafted ethyl- polymer may be used under condition ene-vinyl acetate copolymers (CAS

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Reg. No. 28064–24–6) consist of basic res- Records Administration (NARA). For ins produced by the catalytic copolym- information on the availability of this erization of ethylene and vinyl acetate, material at NARA, call 202–741–6030, or followed by reaction with maleic anhy- go to: http://www.archives.gov/ dride. Such polymers shall contain not federallregister/ more than 11 percent of polymer units codeloflfederallregulations/ derived from vinyl acetate by weight of ibrllocations.html. Compliance of the total polymer prior to reaction with melt flow index specification shall be maleic anhydride, and not more than 2 determined using conditions and proce- percent of grafted maleic anhydride by dures corresponding to those described weight of the finished polymer. Op- in the method as Condition E, Proce- tional adjuvant substances that may be dure A). The copolymers shall be used added to the copolymers include sub- in blends with other polymers at levels stances generally recognized as safe in not to exceed 17 percent by weight of food and food packaging, substances total polymer, subject to the limita- the use of which is permitted under ap- tion that when contacting food of types plicable regulations in parts 170 III, IV-A, V, VI-C, VII-A, and IX, iden- through 189 of this chapter, and sub- tified in § 176.170(c) of this chapter, stances identified in § 175.300(b)(3)(xxv), Table 1, the polymers shall be used (xxvii), (xxxiii), and (xxx) of this chap- only under conditions of use C, D, E, F, ter and colorants for polymers used in and G, described in § 176.170(c) of this accordance with the provisions of chapter, Table 2. § 178.3297 of this chapter. (c) The provisions of paragraph (b) of (b)(1) Ethylene-vinyl acetate copoly- this section are not applicable to ethyl- mers, with or without the optional sub- ene-vinyl acetate copolymers used in stances described in paragraph (a) of food-packaging adhesives complying this section, when extracted with the with § 175.105 of this chapter. solvent or solvents characterizing the (d) Ethylene-vinyl acetate copoly- type of food, and under conditions of mers may be irradiated under the fol- time and temperature characterizing lowing conditions to produce molecular the conditions of their intended use as crosslinking of the polymers to impart determined from tables 1 and 2 of desired properties such as increased § 176.170(c) of this chapter, shall yield strength and increased ability to net chloroform-soluble extractives cor- shrink when exposed to heat: rected for zinc as zinc oleate not to exceed 0.5 milligram per square inch of an (1) Electron beam source of ionizing appropriate sample. radiation at a maximum energy of 3 (2) Maleic anhydride grafted ethyl- million electron volts: Maximum ab- ene-vinyl acetate copolymers shall sorbed dose not to exceed 150 kiloGray have a melt flow index not to exceed 2.1 (15 megarads). grams per 10 minutes as determined by (2) The finished food-contact film ASTM method D 1238–82, ‘‘Standard shall meet the extractives limitations Test Method for Flow Rates of Thermo- prescribed in paragraph (e)(2) of this plastics by Extrusion Plastometer,’’ section. which is incorporated by reference in (3) The ethylene-vinyl acetate co- accordance with 5 U.S.C. 552(a). Copies polymer films may be further irradi- may be obtained from the American ated in accordance with the provisions Society for Testing Materials, 100 Barr of paragraph (e)(1) of this section: Pro- Harbor Dr., West Conshohocken, Phila- vided, That the total accumulated radi- delphia, PA 19428-2959, or at the Office ation dose from both electron beam of Food Additive Safety (HFS–200), and gamma ray radiation does not ex- Center for Food Safety and Applied Nu- ceed 150 kiloGray (15 megarads). trition, Food and Drug Administration, (e) Ethylene-vinyl acetate copolymer 5100 Paint Branch Pkwy., College Park, films intended for contact with food MD 20740, 240–402–1200, or may be exam- may be irradiated to control the ined at the Center for Food Safety and growth of microorganisms under the Applied Nutrition’s Library, 5100 Paint following conditions: Branch Pkwy., College Park, MD 20740, (1) Gamma photons emitted from a or at the National Archives and cobalt–60 sealed source in the dose

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range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard megarads). Test Method for Liquid Extraction of (2) The irradiated ethylene-vinyl ace- Flexible Barrier Materials,’’ which is tate copolymer films, when extracted incorporated by reference. Copies may with reagent grade n-heptane (freshly be obtained from the American Society redistilled before use) according to for Testing Materials, 100 Barr Harbor methods described under § 176.170(d)(3) Dr., West Conshohocken, Philadelphia, of this chapter, at 75 °F for 30 minutes PA 19428-2959, or may be examined at shall yield total extractives not to ex- the National Archives and Records Ad- ceed 4.5 percent by weight of the film. ministration (NARA). For information on the availability of this material at [42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, NARA, call 202–741–6030, or go to: http:// 1989; 55 FR 18595, May 3, 1990; 56 FR 42932, www.archives.gov/federallregister/ Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR codeloflfederallregulations/ 14665, Mar. 7, 2013] ibrllocations.html. (1) The film when extracted with dis- § 177.1360 Ethylene-vinyl acetate-vinyl tilled water at 21 °C (70 °F) for 48 hours alcohol copolymers. yields total extractives not to exceed Ethylene-vinyl acetate-vinyl alcohol 0.0047 milligram per square centimeter copolymers (CAS Reg. No. 26221–27–2) (0.03 milligram per square inch) of may be safely used as articles or com- food-contact surface. ponents of articles intended for use in (2) The film when extracted with 50 contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for the following prescribed conditions: 48 hours yields total extractives not to (a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen- hol copolymers are produced by the timeter (0.04 milligram per square partial or complete alcoholysis or hy- inch) of food-contact surface. drolysis of those ethylene-vinyl acetate (c) The finished food-contact article copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003 (1) Those copolymers containing a inch) thickness and shall contact foods minimum of 55 percent ethylene and a only of the types identified in table 1 of maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories units by weight may be used in contact III, IV-A, VII-A, and IX under condi- with foods as described in paragraph (b) tions of use F and G described in table of this section. 2 of § 176.170(c) of this chapter. Film (2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch) minimum of 55 percent ethylene and a thickness representing the finished ar- maximum of 15 percent vinyl alcohol ticles shall meet the following extrac- units by weight may be used in contact tive limitation when tested by ASTM with foods as described in paragraph (c) method F34–76 (Reapproved 1980), of this section. ‘‘Standard Test Method for Liquid Ex- (3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’ 40 percent ethylene and 60 to 83 percent which is incorporated by reference. The vinyl alcohol units by weight may be availability of this incorporation by used in contact with foods as described reference is given in paragraph (b) of in paragraph (d) of this section. this section. The film when extracted (b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30 shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to inch) thickness and shall contact foods exceed 0.0078 milligram per square cen- only of the types identified in table 1 of timeter (0.05 milligram per square § 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor- I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid- conditions of use D through G de- ing by a factor of five. scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007 meter (0.005) inch thickness rep- inch) thickness and may contact all resenting the finished article shall foods, except those containing more meet the following extractive limita- than 8 percent alcohol, under condition when tested by ASTM method tions of use B through H described in

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table 2 of § 176.170(c) of this chapter. (a) For the purpose of this section, Film samples of 0.018 centimeter (0.007 fluorocarbon resins consist of basic res- inch) thickness representing the fin- ins produced as follows: ished articles shall meet the following (1) Chlorotrifluoroethylene resins extractive limitation when tested by produced by the homopolymerization ASTM method F34–76 (Reapproved of chlorotrifluoroethylene. 1980), ‘‘Standard Test Methods for Liq- (2) Chlorotrifluoroethylene-1,1- uid Extraction of Flexible Barrier Ma- difluoroethylene copolymer resins pro- terials,’’ which is incorporated by ref- duced by copolymerization of erence. The availability of this incor- chlorotrifluoroethylene and 1,1- poration by reference is given in para- difluoroethylene. graph (b) of this section. The film when (3) Chlorotrifluoroethylene-1,1- extracted with distilled water at 100 °C difluoroethylene-tetrafluoroethylene (212 °F) for 30 minutes yields ethylene- co-polymer resins produced by copolymerization of vinyl acetate-vinyl alcohol oligomers chlorotrifluoroethylene, 1,1- not to exceed 0.093 milligram per difluoroethylene, and tetrafluoro- square centimeter (0.6 milligram per ethylene. square inch) of food contact surface as (4) Ethylene-chlorotrifluoroethylene determined by a method entitled ‘‘An- copolymer resins produced by copolym- alytical Method of Determining the erization of nominally 50 mole percent Amount of EVOH in the Extractives of ethylene and 50 mole percent of Residue of EVOH Film,’’ dated March chlorotrifluoroethylene. The copoly- 23, 1987, as developed by the Kuraray mer shall have a melting point of 239 to Co., Ltd., which is incorporated by ref- 243 °C and a melt index of less than or erence in accordance with 5 U.S.C. equal to 20 as determined by ASTM 552(a) and 1 CFR part 51. Copies may be Method D 3275–89 ‘‘Standard Specifica- obtained from the Office of Food Addi- tion for E-CTFE-Fluoroplastic Mold- tive Safety (HFS–200)), Center for Food ing, Extrusion, and Coating Mate- Safety and Applied Nutrition, Food and rials,’’ which is incorporated by ref- Drug Administration, 5100 Paint erence in accordance with 5 U.S.C. Branch Pkwy., College Park, MD 20740, 552(a) and 1 CFR part 51. Copies may be 240–402–1200, or may be examined at the obtained from the American Society Center for Food Safety and Applied Nu- for Testing and Materials, 1916 Race trition’s Library, 5100 Paint Branch St., Philadelphia, PA 19013, or may be Pkwy., College Park, MD 20740, or at examined at the National Archives and the National Archives and Records Ad- Records Administration (NARA). For ministration (NARA). For information information on the availability of this on the availability of this material at material at NARA, call 202–741–6030, or NARA, call 202–741–6030, or go to: http:// go to: http://www.archives.gov/ www.archives.gov/federallregister/ federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html. (e) The provisions of this section are (b) Fluorocarbon resins that are iden- not applicable to ethylene-vinyl ace- tified in paragraph (a) of this section tate-vinyl alcohol copolymers used in and that comply with extractive limi- the food-packaging adhesives com- tations prescribed in paragraph (c) of plying with § 175.105 of this chapter. this section may be used as articles or components of articles intended for use [47 FR 41531, Sept. 21, 1982, as amended at 49 in contact with food as follows: FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, (1) Fluorocarbon resins that are iden- 2000; 78 FR 14665, Mar. 7, 2013] tified in paragraphs (a)(1), (a)(2), and (a)(3) of this section and that comply § 177.1380 Fluorocarbon resins. only with the extractive limitations Fluorocarbon resins may be safely prescribed in paragraphs (c)(1) and used as articles or components of arti- (c)(2) of this section may be used when cles intended for use in contact with such use is limited to articles or com- food, in accordance with the following ponents of articles that are intended prescribed conditions: for repeated use in contact with food or

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that are intended for one-time use in rated from the exterior layer(s) by a contact with foods only of the types functional barrier, such as aluminum identified in § 176.170(c) of this chapter, foil. Upon review of the physical prop- table 1, under Types I, II, VI, VII-B, erties of a particular construction, the and VIII. Food and Drug Administration may (2) Fluorocarbon resins that are iden- consider other layers to serve as func- tified in paragraph (a)(4) of this section tional barriers. This regulation is not and that comply with the extractive intended to limit these constructions limitations prescribed in paragraphs as to shape, degree of flexibility, thick- (c)(1) and (c)(2) of this section may be ness, or number of layers. These layers used only when such use is limited to may be laminated, extruded, co- articles or components of articles that extruded, or fused. are intended for repeated use in con- (b) When containers subject to this tact with food. regulation undergo heat sterilization (3) In accordance with current good to produce shelf-stable foods, certain manufacturing practice, those food- control measures (in addition to the contact articles intended for repeated food additive requirements in para- use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are to their first use in contact with food. necessary to ensure proper food steri- (c) Extractives limitations are appli- lization and package integrity. Refer cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this pellets that have been ground or cut chapter for details. into small particles that will pass (c) Subject to the provisions of this through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro- and that will be held on a U.S. Stand- duced from high-temperature lami- ard Sieve No. 10. nates may be safely used to package all (1) A 100-gram sample of the resin food types except those containing pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol. liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay- perature for 8 hours, shall yield total ers not separated from food by a func- extractives not to exceed 0.003 percent tional barrier must meet the following by weight of the resins. requirements: (2) A 100-gram sample of the resin (i) Films/layers may consist of the pellets, when extracted with 100 milli- following: liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with alcohol in distilled water at reflux item 2.2 or 3.2 of the table in temperature for 8 hours, shall yield § 177.1520(c). total extractives not to exceed 0.003 (b) Polymeric resin blends formu- percent by weight of the resins. lated from a base polymer complying (3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying tractives not to exceed 0.01 percent by with § 177.1350. weight of the resins. (c) Polymeric resin blends formulated [42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in § 177.1520(c) blended with no more than § 177.1390 Laminate structures for use 38 percent by weight of a homopolymer at temperatures of 250 ≥F and of isobutylene complying with above. § 177.1420(a)(1). (a) The high-temperature laminates (d) Polyethylene phthalate resins identified in this section may be safely complying with § 177.1630(e)(4) (i) and used for food contact at temperatures (ii). not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply erwise specified. These articles are lay- with item 10.3 of the table in ered constructions that are optionally § 177.1500(b) of this chapter when ex- bonded with adhesives. The interior tracted with water and heptane under (food-contact) layer(s) may be sepa- the conditions of time and temperature

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specified for condition of use A, as set trimethylcyclohexyl isocyanate (CAS forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional chapter. trimethoxysilane coupling agents con- (f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or 25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per- the table in § 177.1500(b), for use as cent by weight of the cured adhesive. nonfood-contact layers of laminated (b) Urethane cross-linking agent films and in rigid multilaminate con- comprising not more than 25 percent structions with polypropylene outer by weight of the cured adhesive and layers. Laminate structures with au- formulated from 3-isocyanatomethyl- thorized food-contact materials yield 3,5,5-trimethylcyclohexyl isocyanate no more than 0.15 milligrams of epsilon- (CAS Reg. No. 4098–71–9) adduct of caprolactam and 0.04 milligrams of trimethylol propane (Cas Reg. No. 77– omega-laurolactam per square inch 99–6) and/or 1,3-bis(isocyanatomethyl) when extracted with 95 percent ethanol benzene (CAS Reg. No. 25854–16–4) at 121 °C (250 °F) for 2 hours. adduct of trimethylol propane. (g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe- with an applicable regulation in this sives formulated from the following: chapter which permits food type and (a) Polyester resin formed by the re- time/temperature conditions to which action of polybasic acids and the container will be exposed, includ- polyhydric alcohols listed in ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze- (ii) Adjuvants used in these layers laic acid may also be used as a must comply with an applicable regu- polybasic acid. lation that permits food type and time/ (b) Epoxy resin listed in temperature conditions to which the § 175.300(b)(3)(viii)(a) of this chapter and container will be exposed, including comprising no more than 30 percent by sterilization processing. weight of the cured adhesive. (2) Adhesives. The use of adhesives in these containers is optional. Adhesives (c) Urethane cross-linking agent com- may be formulated from the following prising no more than 14 percent weight substances, subject to the prescribed of the cured adhesive and formulated limitations: from 3-isocyanatomethyl-3,5.5- (i) Any substance suitable for use in trimethylcyclohexyl isocyanate formulating adhesives that complies cyanurate (CAS Reg. No. 53880–05–0). with an applicable regulation of this (vi) Polyurethane-polyester resin- chapter which permits food type and epoxy adhesives formulated from the time/temperature conditions to which following mixture: the container will be exposed, includ- (a)(1) Polyester-polyurethanediol res- ing sterilization processing. ins prepared by the reaction of a mix- (ii) Substances complying with ture of polybasic acids and polyhydric § 175.105 of this chapter may be used in alcohols listed in § 175.300(b)(3)(vii) of these constructions, provided they are this chapter and 3-isocyanatomethyl- separated from the interior (food-con- 3,5,5-trimethylcyclohexyl isocyanate tact) layer(s) by a functional barrier as (CAS Reg. No. 4098–71–9). discussed under paragraph (a) of this (2) Polyester resin formed by the re- section. action of polybasic acids and (iii) Maleic anhydride adduct of poly- polyhydric alcohols listed in propylene complying with § 175.300 of § 175.300(b)(3)(vii) of this chapter. Addi- this chapter. tionally, azelaic acid and 1,6- (iv) Polyester-urethane adhesive for hexanediol may also be used as use at temperatures not exceeding 121 reactants in lieu of a polyhydric alco- °C (250 °F) and formulated from the fol- hol. lowing: (3) Epoxy resin listed in (a) Polyester-urethanediol resin pre- § 175.300(b)(3)(viii)(a) of this chapter and pared by the reaction of a mixture of comprising not more than 5 percent by polybasic acids and polyhydric alcohols weight of the cured adhesive. listed in § 175.300(b)(3)(vii) of this chap- (4) Optional trimethoxy silane curing ter, 3-isocyanatomethyl-3,5,5- agents, containing amino, epoxy, ether,

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or mercapto groups not in excess of 3 (i) Nonvolatile extractives. (a) For use percent of the cured adhesive. at temperatures not to exceed 121 °C (b) Urethane cross-linking agent, (250 °F): The container interior (food- comprising not more than 20 percent contact side) shall be extracted with by weight of the cured adhesive, and deionized distilled water at 121 °C (250 formulated from trimethylol propane °F) for 2 hours. (CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of isocyanatomethyl–3,5,5– the total nonvolatile extractives for trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii), bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per (vii) Polyester-polyurethane resin- square centimeter (0.01 milligram per acid dianhydride adhesives for use at square inch) as determined by a meth- temperatures not to exceed 121 °C (250 od entitled ‘‘Determination of Non- °F), in contact only with food Types I, II, VIA, VIB, VIIB, and VIII as de- Volatile Chloroform Soluble Residues scribed in Table I of § 176.170 of this in Retort Pouch Water Extracts,’’ chapter, and formulated from the fol- which is incorporated by reference. lowing mixture: Copies are available from the Center (a)(1) Polyesterpolyurethanediol res- for Food Safety and Applied Nutrition ins prepared by the reaction of a mix- (HFS–200), Food and Drug Administra- ture of polybasic acids and polyhydric tion, 5100 Paint Branch Pkwy., College alcohols listed in § 175.300(b)(3)(vii) of Park, MD 20740, and may be examined this chapter and 3-isocyanatomethyl- at the Center for Food Safety and Ap- 3,5,5-trimethylcyclohexyl isocyanate plied Nutrition’s Library, 5100 Paint (CAS Reg. No. 4098–71–9). Additionally, Branch Pkwy., College Park, MD 20740, dimethylol propionic acid and 1,6- or at the National Archives and hexanediol may be used alone or in Records Administration (NARA). For combination as reactants in lieu of a information on the availability of this polybasic acid and a polyhydric alco- material at NARA, call 202–741–6030, or hol. go to: http://www.archives.gov/ (2) Acid dianhydride formulated from federallregister/ 3a,4,5,7a-tetrahydro-7-methyl-5- codeloflfederallregulations/ (tetrahydro-2,5-dioxo-3-furanyl)-1,3- ibrllocations.html. isobenzofurandione (CAS Reg. No. (2) The chloroform-soluble fraction of 73003–90–4), comprising not more than the total nonvolatile extractives for one percent of the cured adhesive. containers using adhesives listed in (b) Urethane cross-linking agent, paragraph (c)(2)(v) of this section shall comprising not more than twelve per- not exceed 0.016 milligram per square cent by weight of the cured adhesive, centimeter (0.10 milligram per square and formulated from trimethylol pro- inch) as determined by a method titled pane (CAS Reg. No. 77–99–6) adducts of ‘‘Determination of Non-volatile Chlo- 3-isocyanatomethyl-3,5,5- roform Soluble Residues in Retort trimethylcyclohexyl isocyanate (CAS Pouch Water Extracts,’’ which is incor- Reg. No. 4098–71–9) and/or 1,3- bis(isocyanatomethyl)benzene (CAS porated by reference in paragraph Reg. No. 363–48–31). (c)(3)(i)(a)(1) of this section. (3) Test specifications. These specifica- (b) For use at temperatures not to ex- tions apply only to materials on the ceed 135 °C (275 °F): The container inte- food-contact side of a functional bar- rior (food-contact side) shall be ex- rier, if present. All tests must be per- tracted with deionized distilled water formed on containers made under pro- at 135 °C (275 °F) for 1 hour. duction conditions. Laminated struc- (1) The chloroform-soluble fraction of tures submitted to extraction proce- the total nonvolatile extractives for dures must maintain complete struc- containers using no adhesive, or adhe- tural integrity (particularly with re- sives listed in paragraphs (c)(2) (i), (ii), gard to delamination) throughout the and (iii) of this section shall not exceed test. 0.0020 milligram per square centimeter

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(0.013 milligram per square inch) as de- crons) may be used as the food-contact termined by a method titled ‘‘Deter- surface of the container. mination of Non-volatile Chloroform (3) Container test specifications. On Soluble Residues in Retort Pouch exposure to distilled water at 250 °F Water Extracts,’’ which is incorporated (121 °C) for 2 hours, extractives from by reference. The availability of this the food-contact side of the nylon 12 incorporation by reference is given in multilayered construction shall not ex- paragraph (c)(3)(i)(a)(1) of this section. ceed 0.05 milligram per square inch (2) The chloroform-soluble fraction of (0.0078 milligram per square centi- the total nonvolatile extractives for meter) as total nonvolatile extractives. containers using adhesives listed in paragraph (c)(2)(v) of this section shall [45 FR 2843, Jan. 15, 1980, as amended at 47 not exceed 0.016 milligram per square FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983; centimeter (0.10 milligram per square 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22, inch) as determined by a method titled 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR ‘‘Determination of Non-volatile Chlo- 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996; roform Soluble Residues in Retort 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1, Pouch Water Extracts,’’ which is incor- 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668, porated by reference. The availability Mar. 26, 2004] of this incorporation by reference is given in paragraph (c)(3)(i)(a)(1) of this § 177.1395 Laminate structures for use section. at temperatures between 120 ≥F and (3) The chloroform-soluble fraction of 250 ≥F. the total nonvolatile extractives for (a) The laminates identified in this containers using adhesives listed in section may be safely used at the speci- paragraph (c)(2)(vi) of this section shall fied temperatures. These articles are not exceed 0.008 milligram per square layered structures that are optionally centimeter (0.05 milligram per square bonded with adhesives. In these arti- inch) as determined by a method enti- cles, the food-contact layer does not tled, ‘‘Determination of Non-volatile function as a barrier to migration of Chloroform Soluble Residues in Retort components from non-food-contact lay- Pouch Water Extracts,’’ which is incor- ers. The layers may be laminated, ex- porated by reference in paragraph truded, coextruded, or fused. (c)(3)(i)(a)(1) of this section. (b) Laminate structures may be man- (ii) Volatiles. Volatile substances em- ufactured from: ployed in the manufacture of high-temperature laminates must be removed to (1) Polymers and adjuvants com- the greatest extent possible in keeping plying with § 177.1390 of this chapter. with good manufacturing practice pre- (2) Any polymeric resin listed in scribed in § 174.5(a) of this chapter. these regulations so long as the use of (d) Nylon 12/aluminum foil high-tem- the resin in the structure complies perature laminates: Subject to the pro- with the conditions of use (food type visions of this paragraph, containers and time/temperature) specified in the constructed of nylon 12 laminated to regulation for that resin. aluminum foil may be safely used at (3) Optional adjuvant substances used temperatures no greater than 250 °F in accordance with § 174.5 of this chap- (121 °C) in contact with all food types ter. except those containing more than 8 (4) The following substances in non- percent alcohol. food-contact layers only: (1) The container is constructed of aluminum foil to which nylon 12 film is fused. Prior to fusing the nylon 12, the aluminum foil may be optionally precoated with a coating complying with § 175.300 of this chapter. (2) Nylon 12 resin complying with § 177.1500 and having an average thickness not to exceed 0.0016 inch (41 mi-

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Substances Limitations Substances Limitations

Ethylene/1,3–phenylene oxy- For use only with poly- Nylon 6/69 resins complying For use with nonalcoholic ethylene isophthalate/ ethylene terephthalate as with § 177.1500(b), item 14, foods under conditions of terephthalate copolymer the food-contact layer, of this chapter (CAS Reg. use B, C, D, E, F, G, and (CAS Reg. No. 87365–98–8) complying with No. 51995–62–1). H described in table 2 of complying with § 177.1345. § 177.1630 under condi- § 176.170 of this chapter. tions of use C through G Laminate structures with described in table 2 of authorized food-contact § 176.170(c) of this chap- materials may contain ter. Laminate structures, nylon 6/69 resins pro- when extracted with 8 vided that the nitrogen percent ethanol at 150 °F content of aqueous ex- for 2 hours shall not yield tracts of a representative m-pheny lenedioxy-O,O′- laminate (obtained at 100 diethyl isophthalate or cy- °C (212 °F) for 8 hours) clic bis(ethylene does not exceed 15 isophthalate) in excess of micrograms per square 7.8 micrograms/square centimeter (100 decimeter (0.5 micrograms per square microgram/square inch) of inch). food-contact surface. Nylon 6/12 resins complying For use with nonalcoholic with § 177.1500(b), item foods at temperatures not [52 FR 33575, Sept. 4, 1987, as amended at 53 13.2, of this chapter (CAS to exceed 100 °C (212 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21, Reg. No. 25191–04–2). °F). Laminate structures 1992; 58 FR 32610, June 11, 1993; 62 FR 53957, with authorized food-con- Oct. 17, 1997] tact materials yield no more than 0.15 milligram § 177.1400 Hydroxyethyl cellulose film, of epsilon-caprolactam water-insoluble. and 0.04 milligram of omega-laurolactam per Water-insoluble hydroxyethyl cel- square inch when ex- lulose film may be safely used for tracted with water at 100 °C (212 °F) for 5 hours. packaging food in accordance with the Nylon 6/66 resins complying For use only with: following prescribed conditions: with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) Water-insoluble hydroxyethyl cel- of this chapter (CAS Reg. temperatures not to ex- lulose film consists of a base sheet 24993–04–2). ceed 82.2 °C (180 °F). Laminate structures with manufactured by the ethoxylation of authorized food-contact cellulose under controlled conditions, materials yield no more to which may be added certain optional than 0.15 milligram of ep- substances of a grade of purity suitable silon-caprolactam per square inch when ex- for use in food packaging as constitu- tracted with water at 82.2 ents of the base sheet or as coatings °C (180 °F) for 5 hours. applied to impart desired technological 2. Nonalcoholic foods at properties. temperatures not to exceed 100 °C (212 °F). (b) Subject to any limitations pre- Laminate films with au- scribed in parts 170 through 189 of this thorized food-contact ma- chapter, the optional substances used terials yield no more than in the base sheet and coating may in- 0.15 milligram of epsilon- caprolactam per square clude: inch when extracted with (1) Substances generally recognized water at 100 °C (212 °F) as safe in food. for 5 hours. (2) Substances permitted to be used in water-insoluble hydroxyethyl cellulose film by prior sanction or approval and under conditions specified in such sanctions or approval, and substances listed in part 181, subpart B of this chapter. (3) Substances that by any regulation promulgated under section 409 of the act may be safely used as components of water-insoluble hydroxyethyl cellulose film. (4) Substances identified in and used in compliance with § 177.1200(c).

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(c) Any substance employed in the (b) The polymers identified in para- production of the water-insoluble hy- graph (a) of this section may contain droxyethyl cellulose film described in optional adjuvant substances required this section that is the subject of a reg- in the production of the polymers. The ulation in parts 174, 175, 176, 177, 178 optional adjuvant substances required and § 179.45 of this chapter conforms in the production of the polymers may with any specification in such regula- include substances generally recog- tion. nized as safe in food, substances used in § 177.1420 Isobutylene polymers. accordance with a prior sanction or approval, and aluminum chloride. Isobutylene polymers may be safely (c) The provisions of this section are used as components of articles intended for use in producing, manufac- not applicable to polyisobutylene used turing, packing, processing, preparing, in food-packaging adhesives complying treating, packaging, transporting, or with § 175.105 of this chapter. holding food, in accordance with the following prescribed conditions: § 177.1430 Isobutylene-butene copoly- (a) For the purpose of this section, mers. isobutylene polymers are those pro- Isobutylene-butene copolymers iden- duced as follows: tified in paragraph (a) of this section (1) Polyisobutylene produced by the may be safely used as components of homopolymerization of isobutylene articles intended for use in contact such that the finished polymers have a with food, subject to the provisions of molecular weight of 750,000 (Flory) or this section. higher. (a) For the purpose of this section, (2) Isobutylene-isoprene copolymers isobutylene-butene copolymers consist produced by the copolymerization of of basic copolymers produced by the isobutylene with not more than 3 copolymerization of isobutylene with molar percent of isoprene such that the finished polymers have a molecular mixtures of n-butenes such that the weight of 300,000 (Flory) or higher. finished basic copolymers contain not (3) Chlorinated isobutylene-isoprene less than 45 weight percent of polymer copolymers produced when units derived from isobutylene and isobutylene-isoprene copolymers (mo- meet the specifications prescribed in lecular weight 300,000 (Flory) or higher) paragraph (b) of this section when test- are modified by chlorination with not ed by the methods described in para- more than 1.3 weight-percent of chlo- graph (c) of this section. rine. (b) Specifications:

Maximum Isobutylene-butene copolymers Molecular Viscosity (range) bromine weight (range) value

1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40 § 178.3710 of this chapter. Saybolt at 200 °F. 2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40 with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F. 3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40 §§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F. 178.3570 (provided that addition to food does not exceed 10 parts per million), or § 176.180 of this chapter. 4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90. (foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F. chapter. 5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90 sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.

(c) The analytical methods for deter- (1) Molecular weight. Molecular mining whether isobutylene-butene co- weight shall be determined by Amer- polymers conform to the specifications ican Society for Testing and Materials in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard Test Method for Molecular Weight

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(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re- carbons by Thermoelectric Measure- quired in the production of the resins. ment of Vapor Pressure,’’ which is in- (b) The optional adjuvant substances corporated by reference. Copies may be required in the production of the resins obtained from the American Society may include substances generally rec- for Testing Materials, 100 Barr Harbor ognized as safe in food, substances used Dr., West Conshohocken, Philadelphia, in accordance with a prior sanction or PA 19428-2959, or may be examined at approval, and the following: the National Archives and Records Ad- ministration (NARA). For information List of substances Limitations on the availability of this material at Butyl alcohol ...... Not to exceed 300 p.p.m. as re- NARA, call 202–741–6030, or go to: http:// sidual solvent in finished resin. www.archives.gov/federallregister/ Ethyl alcohol. Toluene ...... Not to exceed 1,000 p.p.m. as re- codeloflfederallregulations/ sidual solvent in finished resin. ibrllocations.html. (2) Viscosity. Viscosity shall be deter- (c) 4,4′-Isopropylidenediphenol-ep- mined by ASTM method D445–74, ‘‘Test ichlorohydrin resins shall meet the fol- for Kinematic Viscosity of Transparent lowing nonvolatile extractives limita- and Opaque Liquids,’’ which is incor- tions: porated by reference. The availability (1) Maximum extractable nonvolatile of this incorporation by reference is fraction of 2 parts per million when ex- given in paragraph (c)(1) of this sec- tracted with distilled water at 70 °C for tion. 2 hours, using a volume-to-surface (3) Maximum bromine value. Maximum ratio of 2 milliliters per square inch. bromine value shall be determined by (2) Maximum extractable nonvolatile ASTM method D1492–78, ‘‘Standard fraction of 3 parts per million when ex- Test Method for Bromine Index of Aro- tracted with n-heptane at 70 °C for 2 matic Hydrocarbons by Coulometric hours, using a volume-to-surface ratio Titration,’’ which is incorporated by of 2 milliliters per square inch. reference. The availability of this in- (3) Maximum extractable nonvolatile corporation by reference is given in fraction of 6 parts per million when ex- paragraph (c)(1) of this section. tracted with 10 percent (by volume) (d) The provisions of this section are ethyl alcohol in distilled water at 70 °C not applicable to isobutylene-butene for 2 hours, using a volume-to-surface copolymers used as provided under ratio of 2 milliliters per square inch. § 175.105 of this chapter. (d) The provisions of this section are ′ [52 FR 11641, Apr. 10, 1987, as amended at 63 not applicable to 4,4 -isopropylidene- FR 36175, July 2, 1998] diphenol-epichlorohydrin resins listed in other sections of subchapter B of § 177.1440 4,4′-Isopropylidenediphenol- this chapter. epichlorohydrin resins minimum molecular weight 10,000. § 177.1460 Melamine-formaldehyde res- 4,4′-Isopropylidenediphenol-epichlo- ins in molded articles. rohydrin resins having a minimum mo- Melamine-formaldehyde resins may lecular weight of 10,000 may be safely be safely used as the food-contact sur- used as articles or components of arti- face of molded articles intended for use cles intended for use in producing, in producing, manufacturing, packing, manufacturing, packing, processing, processing, preparing, treating, pack- preparing, treating, packaging, trans- aging, transporting, or holding food in porting, or holding food in accordance accordance with the following pre- with the following prescribed condi- scribed conditions: tions: (a) For the purpose of this section, (a) 4,4′-Isopropylidenediphenol-ep- melamine-formaldehyde resins are ichlorohydrin resins consist of basic those produced when 1 mole of mel- resins produced by the condensation of amine is made to react with not more equimolar amounts of 4,4′- than 3 moles of formaldehyde in water isopropylidenediphenol and solution. epichlorohydrin terminated with phe- (b) The resins may be mixed with re- nol, to which may have been added cer- fined woodpulp and the mixture may

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contain other optional adjuvant sub- method D1243–79, ‘‘Standard Test Meth- stances which may include the fol- od for Dilute Solution Viscosity of lowing: Vinyl Chloride Polymers,’’ which is incorporated by reference. Copies may be List of substances Limitations obtained from the American Society Colorants used in accord- for Testing Materials, 100 Barr Harbor ance with § 178.3297 Dr., West Conshohocken, Philadelphia, of this chapter. Dioctyl phthalate ...... For use as lubricant. PA 19428-2959, or may be examined at Hexamethylenetetramine For use only as polymerization the National Archives and Records Ad- reaction control agent. ministration (NARA). For information Phthalic acid anhydride .. Do. Zinc stearate ...... For use as lubricant. on the availability of this material at NARA, call 202–741–6030, or go to: http:// (c) The molded melamine-formalde- www.archives.gov/federallregister/ hyde articles in the finished form in codeloflfederallregulations/ which they are to contact food, when ibrllocations.html. extracted with the solvent or solvents (iii) Residual acrylonitrile monomer characterizing the type of food and content is not more than 11 parts per under the conditions of time and tem- million as determined by gas chroma- perature as determined from tables 1 tography. and 2 of § 175.300(d) of this chapter, (iv) Acetonitrile-soluble fraction shall yield net chloroform-soluble ex- after refluxing the base polymer in ace- tractives not to exceed 0.5 milligram tonitrile for 1 hour is not greater than per square inch of food-contact surface. 95 percent by weight of the basic co- [42 FR 14572, Mar. 15, 1977, as amended at 56 polymers. FR 42933, Aug. 30, 1991] (2) Extractives limitations. The following extractive limitations are de- § 177.1480 Nitrile rubber modified ac- termined by an infrared rylonitrile-methyl acrylate copoly- spectrophotometric method titled, mers. ‘‘Infrared Spectrophotometric Deter- Nitrile rubber modified acrylonitrile- mination of Polymer Extracted from methyl acrylate copolymers identified Borex ® 210 Resin Pellets,’’ which is in- in this section may be safely used as corporated by reference. Copies are components of articles intended for available from the Center for Food food-contact use under conditions of Safety and Applied Nutrition (HFS– use D, E, F, or G described in table 2 of 200), Food and Drug Administration, § 176.170(c) of this chapter, subject to 5100 Paint Branch Pkwy., College Park, the provisions of this section. MD 20740, or available for inspection at (a) For the purpose of this section, the National Archives and Records Ad- nitrile rubber modified acrylonitrile- ministration (NARA). For information methyl acrylate copolymers consist of basic copolymers produced by the graft on the availability of this material at copolymerization of 73–77 parts by NARA, call 202–741–6030, or go to: http:// weight of acrylonitrile and 23–27 parts www.archives.gov/federallregister/ by weight of methyl acrylate in the codeloflfederallregulations/ presence of 8–10 parts by weight of bu- ibrllocations.html.Copies are applicable tadiene-acrylonitrile copolymers con- to the basic copolymers in the form of taining approximately 70 percent by particles of a size that will pass weight of polymer units derived from through a U.S. standard sieve No. 6 and butadiene. that will be held on a U.S. standard (b) The nitrile rubber modified acry- sieve No. 10: lonitrile-methyl acrylate basic copoly- (i) Extracted copolymer not to ex- mers meet the following specifications ceed 2.0 parts per million in aqueous and extractives limitations: extract obtained when a 100-gram sam- (1) Specifications. (i) Nitrogen content ple of the basic copolymers is extracted is in the range 16.5–19 percent as deter- with 250 milliliters of demineralized mined by Kjeldahl analysis. (deionized) water at reflux temperature (ii) Intrinsic viscosity in acetonitrile for 2 hours. at 25 °C is not less than 0.29 deciliter (ii) Extracted copolymer not to ex- per gram as determined by ASTM ceed 0.5 part per million in n-heptane

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extract obtained when a 100-gram sam- adipic acid, and 21.6±1.2 weight percent ple of the basic copolymers is extracted terephthalic acid. with 250 milliliters of reagent grade n- (8) Nylon 612 resins are manufactured heptane at reflux temperature for 2 by the condensation of hours. hexamethylenediamine and (c) Acrylonitrile copolymers identi- dodecanedioic acid. fied in this section shall comply with (9) Nylon 12 resins are manufactured the provisions of § 180.22 of this chap- by the condensation of omega- ter. laurolactam. (d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6 fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu- to be used to fabricate beverage con- factured by the condensation of adipic tainers. acid, 1,3-benzenedimethanamine, and alpha-(3-aminopropyl)-omega-(3-amino- [42 FR 14572, Mar. 15, 1977, as amended at 42 propoxy)polyoxyethylene under such FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19, conditions that the alpha-(3-amino- 1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR propyl)-omega-(3-aminopropoxy) 14481, Apr. 2, 1996] polyoxyethylene monomer content does not exceed 7 percent by weight of § 177.1500 Nylon resins. the finished resin. (ii) Nylon MXD–6 resins (CAS Reg. The nylon resins listed in paragraph No. 25718–70–1) manufactured by the (a) of this section may be safely used to condensation of adipic acid and 1,3- produce articles intended for use in benzenedimethanamine. processing, handling, and packaging (11) Nylon 12T resins are manufac- food, subject to the provisions of this tured by the condensation of omega- section: laurolactam (CAS Reg. No. 0947–04–6), (a) The nylon resins are manufac- isophthalic acid (CAS Reg. No. 0121–91– tured as described in this paragraph so 5), and bis(4-amino-3-methylcycl- as to meet the specifications prescribed ohexyl)methane (CAS Reg. No. 6864–37– in paragraph (b) of this section when 5) such that the composition in terms tested by the methods described in of ingredients is 34.4±1.5 weight percent paragraph (d) of this section. omega-laurolactam, 26.8±0.4 weight per- (1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5 by the condensation of hexamethylene- weight percent bis(4-amino-3- diamine and adipic acid. methylcyclohexyl)-methane. (2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No. by the condensation of hexamethylene- 25750–23–6) are manufactured by the diamine and sebacic acid. condensation of (3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic tured by the condensation of equal- acid, and isophthalic acid such that 65 weight mixtures of nylon 66 salts and to 80 percent of the polymer units are nylon 610 salts. derived from hexamethylene (4) Nylon 6/66 resins manufactured by isophthalamide. the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No. Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co- (5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by by the condensation of 11- weight of epsilon-caprolactam and aminoundecanoic acid. omega-laurolactam. (6) Nylon 6 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No. by the polymerization of epsilon- 25191–04–2) are manufactured by the co- caprolactam. polymerization of a ratio of at least 80 (7) Nylon 66T resins are manufac- weight percent of epsilon-caprolactam tured by the condensation of and no more than 20 weight percent of hexamethyl-enediamine, adipic acid, omega-laurolactam. and terephthalic acid such that com- (14) Nylon 6/69 resins (CAS Reg. No. position in terms of ingredients is 51995–62–1) are manufactured by the 43.1±0.2 weight percent hexamethyl- condensation of 49.5+0.5 weight percent enediamine, 35.3±1.2 weight percent epsilon-caprolactam, 19.4+0.2 weight

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percent hexamethylenediamine and by the condensation of 50 mol percent 31.2+0.3 weight percent azelaic acid. 1,4-benzenedicarboxylic acid, dimethyl (15) Nylon 46 resins (CAS Reg. No. ester and 50 mol percent of an 50327–77–0) are manufactured by the equimolar mixture of 2,2,4-trimethyl- condensation of 1,4-butanediamine and 1,6-hexanediamine and 2,4,4-trimethyl- adipic acid. 1,6-hexanediamine. (16) Nylon resins PA 6–3–T (CAS Reg- (b) Specifications: istry No. 26246–77–5) are manufactured

Maximum extractable fraction in selected solvents Melting (expressed in percent point Solubility by weight of resin) Nylon resins Specific (degrees in boiling Viscosity No. gravity Fahr- 4.2N HC1 (mL/g) 95 enheit) percent Ethyl Ben- Water ethyl ace- zene alcohol tate

1. Nylon 66 resins ...... 1.14±.015 475–495 Dissolves in ...... 1.5 1.5 0.2 0.2 1 h. 2. Nylon 610 resins ...... 1.09±.015 405–425 Insoluble ...... 1.0 2.0 1.0 1.0 after 1 h. 3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in ...... 1.5 2.0 1.0 1.0 1 h. 4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ...... do...... 2.0 2.0 1.5 1.5 silon-caprolactam monomer content not to exceed 0.7 percent by weight. 4.2 Nylon 6/66 resins with 1.14±.015 380–425 ...... do...... 0.8 1.0 0.5 0.5 combined caprolactam content greater than 60 percent and residual epsilon-caprolactam monomer content not to exceed 0.4 percent by weight. For use only as specified in § 177.1395 of this chapter (CAS Reg. No. 24993–04–2). 5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble ...... 30 .35 .25 .3 in articles intended for 1- after 1 h. time use or repeated use in contact with food. 5.2 Nylon 11 resins for use 1.04±.015 355–375 ...... do...... 35 1.60 .35 .40 only: a. In articles intended for repeated use in contact with food. b. In side-seam cements for articles intended for 1-time use in contact with food and which are in compliance with § 175.300 of this chapter. 6.1 Nylon 6 resins ...... 1.15±.015 392–446 Dissolves in ...... 1.0 2.0 1.0 1.0 1 h. 6.2 Nylon 6 resins for use 1.15±.015 392–446 ...... do...... 1.5 2.0 1.0 1.0 only in food-contact films having an average thickness not to exceed 0.001 in. 7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble ...... 1.0 1.0 .25 .25 only in food-contact films after 1 h. having an average thickness not to exceed 0.001 in. 8. Nylon 612 resins for use 1.06±.015 406–420 ...... do...... 50 1.50 .50 .50 only in articles intended for repeated use in contact with food at temperatures not to exceed 212 °F.

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9. Nylon 12 resins for use 1.01±.015 335–355 ...... do...... 1.0 2.0 1.50 1.50 only:. a. In food-contact films having an average thickness not to exceed 0.0016 inch intended for use in contact with nonalcoholic food under the conditions of use A (sterilization not to exceed 30 minutes at a temperature not to exceed 250 °F), and B through H of table 2 of § 176.170(c) of this chapter, except as provided in § 177.1390(d) b. In coatings intended for repeated use in contact with all food types described in table 1 of § 176.170(c) of this chapter, except those containing more than 8 percent alcohol, under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in ...... 2.0 2.5 1.0 1.0 pact modified Nylon 1h. MXD–6 film having an average thickness not to exceed 40 microns (0.0016 inch) for use in processing, handling, and packaging of food of types V and IX listed in table 1 of § 176.170(c) of this chapter under conditions of use C, D, E, F, G, and H in table 2 of § 176.170(C) of this chapter. 10.2 Impact modified Nylon 1.21±0.02 437–491 do...... 2.0 2.5 1.0 1.0 MXD–6 resins for use as polymer use as polymer modifiers in Nylon 6 resin films complying with paragraph (a)(6) of this section, at levels not to exceed 13 percent by weight of films whose average thickness will not exceed 15 microns (0.6 mils). The finished film is used for packaging, transporting, or holding food, excluding beverages containing more than 8 percent alcohol (by volume) at temperatures not to exceed 49 °C (120 °F) (conditions of use E, F, and G in table 2 of § 176.170(c) of this chapter).

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10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2 for use only as nonfood- 1 h. contact layers of: (1) Mul- tilayer films and (2) rigid plastic containers composed of polypropylene food-contact and exterior layers, as defined in § 177.1520(c), item 1.1(a) and 1.1(b), of this chapter. The finished food- contact laminate, in the form in which it contacts food, when extracted with the food simulating solvent or solvents characterizing the conditions of the intended use as determined from Table 2 of § 176.170(c) of this chapter, shall yield not more than 0.5 micrograms of m-xylylenediamine-adipic acid cyclic monomer per square inch of food-contact surface, when the food simulating solvent is analyzed by any appropriate, properly validated method. 11. Nylon 12T resins for 1.06±0.015 N/A Insoluble ...... 0.1 ...... 0.5 0.5 use in contact with all after 1 types of food except hour. those containing more than 8 percent alcohol. 12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble ...... 0.2 1.0 0.1 0.1 use in contact with all after 1 types of food except al- hour. coholic beverages containing more than 8 percent alcohol. 13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ...... 1.5 1.5 use only in food-contact 1 hour. films having an average thickness not to exceed 51 microns (0.002 inch). The finished film is intended to contact all foods except those containing more than 8 percent ethanol under conditions of use B, C, D, E, F, G, and H listed in table 2 of § 176.170(c) of this chapter. 13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5 residual epsilon- 1 h. caprolactam not to exceed 0.5 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1395 of this chapter.

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13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ...... 1.0 1.5 0.5 0.5 residual epsilon- 1 h. caprolactam not to exceed 0.8 percent by weight and residual omega-laurolactam not to exceed 0.1 percent by weight. For use only as specified in § 177.1390 of this chapter. 14. Nylon 6/69 resins for 1.09±0.02 270–277 ...... >140 using the meth- 3.0 use only as specified in od described in 21 CFR 177.1395 of this § 177.1500(c)(5)(ii) chapter. of this chapter. 15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in ...... 0.3 0.2 0.2 0.3 only in food-contact 1 h. membrane filters intended for repeated use. The finished membrane filter is intended to contact beverages containing no more than 13 percent alcohol, under conditions of use E, F, and G listed in table 2 of § 176.170(c) of this chapter. 16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble >110 ...... 0.007 0.64 0.003 0 for repeated-use (exclud- after 1 h. ing bottles) in contact with food of type VIA and VIB described in table 1 of § 176.170(c) of this chapter under conditions of use D through H described in table 2 of § 176.170(c) of this chapter with a hot-fill temperature limitation of 40 °C.

(c) Nylon modifier—(1) Identity. Co- (2) Specifications. The finished copoly- polyester-graft-acrylate copolymer is ester-graft-acrylate copolymer shall the substance 1,4-benzenedicarboxylic meet the following specifications: acid, polymer with 1,4-butanediol, (E)- (i) Weight average molecular weight 2-butenedioic acid, 1,2-ethanediol, 15,000–35,000, ethyl 2-propenoate, hexanedioic acid (ii) pH 7.2 to 8.2, and and 2-propenoic acid, graft (CAS Reg. (iii) Glass transition temperature ¥ ¥ ° No. 175419–23–5), and is derived from 15 to 25 C. grafting of 25 weight percent of acrylic (3) Conditions of use. (i) Copolyester- polymer with 75 weight percent of co- graft acrylate copolymer described in paragraph (c)(1) of this section is in- polyester. The copolyester is polym- tended to improve the adhesive quali- erized terephthalic acid (55 mol%), ties of film. It is limited for use as a adipic acid (40 mol%), and fumaric acid modifier of Nylon 6 and Nylon 6 modi- (5 mol%) with ethylene glycol (40 fied with Nylon MXD–6 at a level not mol%) and 1,4-butanediol (60 mol%). to exceed 0.17 weight percent of the ad- The acrylic polymer is made from ditive in the finished film. acrylic acid (70 mol%) and ethyl acry- (ii) The finished film is used for pack- late (30 mol%). aging, transporting, or holding all types of foods under conditions of use B

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through H, described in table 2 of hours in a nitrogen atmosphere then § 176.170(c) of this chapter, except that repeat the test. in the case of Nylon 6 films modified (3) Solubility in boiling 4.2N HCl. The with Nylon MXD–6 (complying with test shall be run on a sample approxi- § 177.1500, item 10.2), the use complies mately the size of a 1⁄8-inch cube in at with the conditions of use specified in least 25 milliliters of 4.2 normal hydro- table 2. chloric acid. (iii) Extractives. Food contact films (4) Maximum extractable fraction in se- described in paragraphs (c)(1) of this lected solvents. The procedure for deter- section, when extracted with solvent or mining the maximum extractable frac- solvents prescribed for the type of food tion of the nylon resins in selected sol- and under conditions of time and tem- vents is as follows: perature specified for the intended use, (i) Film should be cut with ordinary shall yield total extractives not to ex- scissors into pieces of a convenient size ceed 0.5 milligram per inch squared of such as 1⁄4-inch squares, for the extrac- food-contact surface when tested by tion tests described in this section. The the methods described in § 176.170(d) of granules of nylon molding powders are this chapter. in the proper form for the extraction (iv) Optional adjuvant substances. The tests. Samples of fabricated articles substances employed in the production such as pipe, fittings, and other similar of Nylon modifiers listed in paragraph articles must be cut to approximately (c)(1) of this section may include: the size of the molding powder. This can be done conveniently by using a (A) Substances generally recognized small-scale commercial plastics as safe for use in food and food pack- granulator and cutting the sample aging; through a screen having 1⁄4-inch mesh. (B) Substances subject to prior sanc- Fine particles should be separated from tion or approval for use in Nylon resins the cut resin by screening through a 20- and used in accordance with such sanc- mesh screen. The material retained on tions or approval; and the screen is suitable for the extraction (C) Optional substances required in tests. the production of the additive identi- (ii) The organic solvents must be of fied in this paragraph and other op- American Chemical Society analytical tional substances that may be required reagent grade; distilled water is used. to accomplish the intended physical or Approximately 30 grams of the pre- technical effect. pared sample is weighed to the nearest (d) Analytical methods—(1) Specific milligram. The weighed resin is trans- gravity. Specific gravity shall be deter- ferred to a 500-milliliter round-bottom mined by weighing a 1-gram to 5-gram flask equipped with a reflux condenser. sample first in air and then in freshly Approximately 300-milliliters of sol- boiled distilled water at 23 °C±2 °C. vent is added to the flask and the con- (2) Melting point. The melting point tents refluxed gently for 8 hours with a shall be determined as follows: Use a heating mantle. The solvent is then fil- hot-stage apparatus. The use of crossed tered off immediately while still hot, nicol prisms with a microscope hot using a Buchner funnel approximately stage and reading of the thermometer 5 inches in diameter, a suction flask, when the birefringence disappears in- and a hardened filter paper (Whatman creases the accuracy. If the crossed No. 50 or equivalent). The paper is wet nicol apparatus is not available, use with the solvent and a slight suction the lowest temperature at which the applied just before starting the filtra- sample becomes transparent or the tion. The resin is washed twice with sharp edges or corners of the sample approximately 100-milliliter portions of become rounded as the melting point. solvent and the combined filtrate and In case of doubt as to the onset of washings are reduced to approximately melting, the sample is prodded with a 25 milliliters by evaporation at reduced sharp instrument. If it sticks to the pressure (50 millimeters to 100 millime- heating block, it is considered to have ters of mercury, absolute), heating as melted. If the melting point is low, dry necessary. The contents of the flask the sample in an oven at 85 °C for 24 are transferred to an evaporation dish

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(which has been held in a vacuum des- (a) For the purpose of this section, iccator over anhydrous calcium sulfate olefin polymers are basic polymers until constant weight has been at- manufactured as described in this para- tained) and carefully evaporated to graph, so as to meet the specifications dryness. The weight of the solid residue prescribed in paragraph (c) of this sec- is determined by difference after hold- tion, when tested by the methods de- ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section. drous calcium sulfate until constant (1)(i) Polypropylene consists of basic weight has been attained. The percent polymers manufactured by the cata- of solids extracted is calculated by di- lytic polymerization of propylene. viding the weight of the solid residue (ii) Propylene homopolymer consists by the weight of the sample and multi- of basic polymers manufactured by the plying by 100. catalytic polymerization of propylene (5) Viscosity number (VN). (i) The vis- with a metallocene catalyst. cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata- milligrams resin per milliliter) shall be lytic polymerization of ethylene. determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly- ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con- Determination of Viscosity Number,’’ sists of basic polymers manufactured which is incorporated by reference. by the catalytic polymerization of Copies are available from the Center ethylene followed by reaction with fu- for Food Safety and Applied Nutrition maric acid in the absence of free rad- (HFS–200), Food and Drug Administra- ical initiators. Such polymers shall tion, 5100 Paint Branch Pkwy., College contain grafted fumaric acid at levels Park, MD 20740, or available for inspec- not to exceed 2 percent by weight of tion at the National Archives and the finished polymer. Records Administration (NARA). For (3) Olefin basic copolymers consist of information on the availability of this basic copolymers manufactured by the material at NARA, call 202–741–6030, or catalytic copolymerization of: go to: http://www.archives.gov/ (i) Two or more of the 1-alkenes hav- federallregister/ ing 2 to 8 carbon atoms. Such olefin codeloflfederallregulations/ basic copolymers contain not less than ibrllocations.html. 96 weight-percent of polymer units de- (ii) The viscosity number (VN) for rived from ethylene and/or propylene, Nylon 6/69 and Nylon PA–6–3–T resins except that: in a 99 percent cresol solution (5 milli- (a)(1) Olefin basic copolymers manu- grams resin per milliliter) shall be de- factured by the catalytic copolym- ° ° termined at 25 C (77 F) by method ISO erization of ethylene and hexene-1 or 307–1984(E), ‘‘Plastics-Polyamides-De- ethylene and octene-1 shall contain not termination of Viscosity Number,’’ less than 90 weight-percent of polymer which is incorporated by reference. The units derived from ethylene; availability of this incorporation by (2) Olefin basic copolymers manufac- reference is given in paragraph (d)(5)(i) tured by the catalytic copolymeriza- of this section. tion of ethylene and hexene-1 shall con- [42 FR 14572, Mar. 15, 1977] tain not less than 80 but not more than 90 weight percent of polymer units de- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 177.1500, see the List of rived from ethylene. CFR Sections Affected, which appears in the (3) Olefin basic copolymers manufac- Finding Aids section of the printed volume tured by the catalytic copolymeriza- and at www.fdsys.gov. tion of ethylene and pentene-1 shall contain not less than 90 weight-percent § 177.1520 Olefin polymers. of polymer units derived from ethyl- The olefin polymers listed in para- ene. graph (a) of this section may be safely (4) Olefin basic copolymers manufac- used as articles or components of arti- tured by the catalytic polymerization cles intended for use in contact with of ethylene and octene-1 shall contain food, subject to the provisions of this not less than 50 weight-percent of poly- section. mer units derived from ethylene.

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(b) Olefin basic copolymers manufac- derived by copolymerization with 1,4- tured by the catalytic copolymeriza- hexadiene. tion of ethylene and 4-methylpentene-1 (v) Ethylene and butene-1 copolymers shall contain not less than 89 weight- (CAS Reg. No. 25087–34–7) that shall percent of polymer units derived from contain not less than 80 weight percent ethylene; of polymer units derived from ethyl- (c)(1) Olefin basic copolymers manu- ene. factured by the catalytic copolym- (vi) Olefin basic copolymers (CAS erization of two or more of the mono- Reg. No. 61615–63–2) manufactured by mers ethylene, propylene, butene-1, 2- the catalytic copolymerization of methylpropene-1, and 2,4,4- ethylene and propylene with 1,4- trimethylpentene-1 shall contain not hexadiene, followed by reaction with less than 85 weight-percent of polymer fumaric acid in the absence of free rad- units derived from ethylene and/or pro- ical initiators. Such polymers shall pylene; contain not more than 4.5 percent of (2) Olefin basic copolymers manufac- polymer units deriving from 1,4- tured by the catalytic copolymeriza- hexadiene by weight of total polymer tion of propylene and butene-1 shall prior to reaction with fumaric acid and contain greater than 15 but not greater not more than 2.2 percent of grafted fu- than 35 weight percent of polymer maric acid by weight of the finished units derived from butene-1 with the polymer. remainder being propylene. (vii) Ethylene and 2-norbornene (CAS (d) Olefin basic terpolymers manufac- Reg. No. 26007–43–2) copolymers that tured by the catalytic copolymeriza- shall contain not less than 30 and not tion of ethylene, hexene-1, and either more than 70 mole percent of polymer propylene or butene-1, shall contain units derived from 2-norbornene. not less than 85 weight percent poly- (4) Poly(methylpentene) consists of mer units derived from ethylene. basic polymers manufactured by the (e) Olefin basic copolymers manufac- catalytic polymerization of 4- tured by the catalytic polymerization methylpentene-1. of ethylene and octene-1, or ethylene, (5) Polyethylene graft copolymers octene-1, and either hexene-1, butene-1, consist of polyethylene complying with propylene, or 4-methylpentene-1 shall item 2.2 of paragraph (c) of this section contain not less than 80 weight percent which subsequently has 3a,4,7,7a- of polymer units derived from ethyl- tetrahydromethyl-4,7- ene. methanoisobenzofuran-1,3-dione graft- (ii) 4-Methylpentene-1 and 1-alkenes ed onto it at a level not to exceed 1.7 having from 6 to 18 carbon atoms. Such percent by weight of the finished co- olefin basic copolymers shall contain polymer. not less than 95 molar percent of poly- (6) Ethylene-maleic anhydride co- mer units derived from 4- polymers (CAS Reg. No. 9006–26–2) con- methylpentene-1, except that copoly- taining no more than 2 percent by mers manufactured with 1-alkenes hav- weight of copolymer units derived from ing from 12 to 18 carbon atoms shall maleic anhydride. contain not less than 97 molar percent (b) The basic olefin polymers identi- of polymer units derived from 4- fied in paragraph (a) of this section methylpentene-1; or may contain optional adjuvant sub- (iii) Ethylene and propylene that stances required in the production of may contain as modifiers not more such basic olefin polymers. The op- than 5 weight-percent of total polymer tional adjuvant substances required in units derived by copolymerization with the production of the basic olefin poly- one or more of the following monomers or finished food-contact articles mers: may include substances permitted for such use by applicable regulations in 5-Ethylidine-2-norbornene. parts 170 through 189 of this chapter, 5-Methylene-2-norbornene. substances generally recognized as safe (iv) Ethylene and propylene that may in food and food packaging, substances contain as a modifier not more than 4.5 used in accordance with a prior sanc- weight percent of total polymer units tion or approval, and the following:

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Substance Limitations

Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para- erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through 220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de- ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of ‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap- as determined by ASTM Method D 611–82, ‘‘Standard Test ter. Methods for Aniline Point and Mixed Aniline Point of Petro- leum Products and Hydrocarbon Solvents,’’ both of which are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Colorants used in accordance with § 178.3297 of this chapter. 2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene 63–7). homopolymer complying with § 177.1520(c), item 1.1 and olefin copolymers complying with § 177.1520(c), items 3.1 and 3.2 and containing not less than 75 weight percent of polymer units derived from propylene, provided that the maximum concentration of tert-butyl alcohol in the polymer does not exceed 100 parts per million, as determined by a method titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’ which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, 5100 Paint Branch Pkwy., 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/federallregister/ codeloflfederallregulations/ibrllocations.html. Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section, polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com- acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than 3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene. 14–7), and polypropylene (CAS Reg. No. 9003–07–0), resulting from the reaction of a mixture of methyl methacrylate and butyl acrylate with polypropylene. The finished product contains no more than 55 percent by weight of polymer units derived from methyl methacrylate and butyl acrylate as determined by a method entitled, ‘‘Determination of the Total Acrylic in PP-MMA/BA Polymers,’’ which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition’s Li- brary, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/ federallregister/codeloflfederallregulations/ ibrllocations.html..

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Substance Limitations

Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con- °C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin- approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I, by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of 3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap- parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi- rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con- ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of available from the American Society for Testing and Mate- § 176.170(c) of this chapter. rials, 100 Barr Harbor Dr., West Conshohocken, Philadel- phia, PA 19428-2959, or from the Center For Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra- tion, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the National Archives and Records Ad- ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ibrllocations.html.. Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ...... For use only as a surface lubricant or anti-blocking agent in films. Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin 79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev- rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de- Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi- Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H. incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Na- tional 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/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin 68937–54–2). polymers that comply with § 177.1520(c) at levels not to exceed 0.3 percent by weight of the polymer. The finished polymer is used in contact with foods under conditions of use B through H described in table 2 of § 176.170 of this chapter. Triisopropanolamine (CAS Reg. No. 122–20–3) ...... For use as a Zeigler-Natta-type catalyst deactivator and antioxidant in the production of olefin polymers complying with § 177.1520(c), items 2.1, 2.2, and 2.3, and having a minimum density of 0.94 grams per cubic centimeter, and copolymers complying with § 177.1520(c), items 3.1 and 3.2, for use in contact with all foods under the following conditions of use: (a) films with a maximum thickness of 0.102 millimeter (0.004 inch) may be used under conditions A through H defined in table 2 of § 176.170(c) of this chapter; and (b) articles with thickness greater than 0.102 millimeter (0.004 inch) may be used under conditions C through G defined in table 2 of § 176.170(c) of this chapter. Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and (CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1, trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad- 27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers. more than 6 percent.

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Substance Limitations

Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap- by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H. available from the Center for Food Safety and Applied Nutri- tion (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/ federallregister/codeloflfederallregulations/ ibrllocations.html.. Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev- less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de- 100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi- 3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H. Rheological Properties of Thermoplastics with a Capillary Rheometer’’ using a capillary of 15:1 L/D, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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/federallregister/ codeloflfederallregulations/ibrllocations.html..

Maximum extract- Maximum soluble Melting Point able fraction (ex- fraction (ex- (MP) or softening pressed as per- pressed as per- Olefin polymers Density point (SP) (De- cent by weight of cent by weight of grees Centi- the polymer) in N- polymer) in xy- grade)— hexane at speci- lene at specified fied temperatures temperatures

1.1a. Polypropylene described in paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C (a)(1)(i) of this section temperature 1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C paragraph (a)(1)(ii) of this section temperature 1.2. Polypropylene, noncrystalline; for use 0.80–0.88 only to plasticize polyethylene described under items 2.1 and 2.2 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polyethylene 1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C. only: To plasticize polypropylene described by item 1.1 of this table, provided that such plasticized polymers meet the maximum extractable fraction and maximum soluble fraction specifications prescribed for such basic polypropylene, and further provided that such plasticized polypropylene contacts food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII; and for use at levels not to exceed 50 pct by weight of any mixture employed as a food- contact coating provided such coatings contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, IV-B, VI-B, VII-B, and VIII 2.1. Polyethylene for use in articles that con- 0.85–1.00 ...... 5.5 pct at 50 °C 11.3 pct at 25 °C tact food except for articles used for packing or holding food during cooking

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2.2. Polyethylene for use in articles used for 0.85–1.00 ...... 2.6 pct at 50 °C Do. packing or holding food during cooking 2.3. Polyethylene for use only as component 0.85–1.00 ...... 53 pct at 50 °C 75 pct at 25 °C of food-contact coatings at levels up to and including 50 percent by weight of any mixture employed as a food-contact coating 2.4. Olefin polymers described in paragraph (a)(2)(ii) of this section, having a melt flow index not to exceed 17 grams/per 10 minutes as determined by the method described in paragraph (d)(7) of this section, for use in blends with other polymers at levels not to exceed 20 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.1a. Olefin copolymers described in para- 0.85–1.00 ...... 5.5 pct at 50 °C 30 pct at 25 °C graph (a)(3)(i) of this section for use in articles that contact food except for articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(a)(3) of this section and listed in item 3.1c of this table and olefin copolymers described in paragraph (a)(3)(i)(e) of this section and listed in item 3.1b of this table 3.1b. Olefin copolymers described in para- 0.9–1.00 ...... Do Do. graph (a)(3)(i)(e) of this section for use in contact with food only under conditions of use D, E, F, G, and H described in § 176.170(c) of this chapter, table 2 3.1c. Olefin copolymers described in para- Not less than 0.92 graph (a)(3)(i)(a)(3) of this section for use in contact with food only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2; except that such copolymers when used in contact with food of the types identified in § 176.170(c), table 1, under types III, IVA, V, VIIA, and IX, shall be used only under conditions of use D, E, F, and G described in § 176.170(c) of this chapter, table 2

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3.2a. Olefin copolymers described in para- 0.85–1.00 ...... 2.6 pct at 50 °C Do. graph (a)(3)(i) of this section for use in articles used for packing or holding food during cooking; except olefin copolymers described in paragraph (a)(3)(i)(c)(2) of this section and listed in item 3.2b of this table; except that olefin copolymers containing 89 to 95 percent ethylene with the remainder being 4-methyl-pentene-1 contacting food Types III, IVA, V, VIIA, and IX identified in § 176.170(c) of this chapter, table 1, shall not exceed 0.051 millimeter (mm) (0.002 inch (in)) in thickness when used under conditions of use A and shall not exceed 0.102 mm (0.004 in) in thickness when used under conditions of use B, C, D, E, and H described in § 176.170(c) of this chapter, table 2. Additionally, olefin copolymers described in (a)(3)(i)(a)(2) of this section may be used only under conditions of use B, C, D, E, F, G, and H described in § 176.170(c) of this chapter, table 2, in contact with all food types identified in § 176.170(c) of this chapter, table 1 3.2b. Olefin copolymers described in para- Do. graph (a)(3)(i)(c)(2) of this section have a melt flow index no greater than 10 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section, and the thickness of the finished polymer contacting food shall not exceed 0.025 mm (0.001 in). Additionally, optional adjuvants permitted for use in olefin copolymers complying with item 3.2a of this table may be used in the production of this copolymer 3.2c. Olefin copolymers described in para- 0.85–0.92 graph (a)(3)(i)(a)(4) of this section have a melt flow index no greater than 50 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section. Articles manufactured using these polymers may be used with all types of food under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter 3.3a. Olefin copolymers described in paragraph (a)(3)(ii) of this section and manufactured with 1-alkenes having from 6 to 10 carbon atoms 3.3b. Olefin copolymers described in paragraph (a)(3)(ii) of this section, provided that such olefin polymers have a melt temperature of 220 °C to 250 °C (428 °F to 482 °F) as determined by the method described in paragraph (d)(8) of this section and minimum intrinsic viscosity of 1.0 as determined in paragraph (d)(9) of this section.

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3.4. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in par. (a)(3) (iii) of this section provided that such olefin polymers have a minimum viscosity average molecular weight of 120,000 as determined by the method described in par. (d)(5) of this section and a minimum Mooney viscosity of 35 as determined by the method described in par. (d)(6) of this section, and further provided that such olefin copolymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX 3.5. Olefin copolymers, primarily non-crys- 0.85–0.90 talline, described in paragraph (a)(3)(iv) of this section, provided that such olefin polymers have a minimum viscosity average molecular weight of 95,600 as determined by the method described in paragraph (d)(5) of this section, and further provided that such olefin polymers are used only in blends with olefin polymers described under items 1.1, 2.1, and 2.2 of this table at a maximum level of 25 pct by weight, and provided that such olefin copolymers contact food only of the types identified in § 176.170 (c) of this chapter, table 1, under Types I, II, IV-B, VI, VII-B, and VIII at temperatures not exceeding 190 °F 3.6. Olefin copolymers described in para- Not less than 0.88 graph (a)(3)(v) of this section for use in blends with olefin polymer resins have a melt flow index no greater than 5 grams/10 minutes as determined by the method described in paragraph (d)(7) of this section and the thickness of the finished blends shall not exceed 0.1 millimeter (0.004 inch). The ethylene/butene-1 copolymer may be used subject to the following conditions: (1) For use at a level not to exceed 20 weight percent in polypropylene as described under item 1.1 of this table. (2) For use at a level not to exceed 40 weight percent in polyethylene as described under items 2.1 and 2.2 of this table. (3) For use at a level not to exceed 40 weight percent in olefin copolymers as described under items 3.1 and 3.2 of this table

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3.7. Ethylene/propylene copolymers, meeting Not less than 0.86 the identity described in paragraph (a)(3)(i) of this section, containing not less than 80 mole-percent of polymer units derived from ethylene and having a minimum viscosity average molecular weight of 95,000 as determined by the method described in paragraph (d)(5) of this section, and a minimum Mooney viscosity of 13 as determined by the method described in paragraph (d)(6) of this section. Ethylene/propylene copolymers described in this item 3.7 are to be used only in blends with other olefin polymers complying with this section, at levels not to exceed 30 percent by weight of the total polymer blend, and in contact with food only of types identified in § 176.170(c) of this chapter, Table 1, under Types I, II, III, IV-B, VI, VII, VIII, and IX. Additionally, optional adjuvants permitted for use in olefin copolymers complying with item 3.4 of this table may be used in the production of this copolymer 3.8. Olefin polymers described in paragraph (a)(3)(vi) of this section, having a melt flow index not to exceed 9.2 grams per 10 minutes as determined by the method described in paragraph (d)(7) of this section, for use in blends with other polymers at levels not to exceed 8 percent by weight of total polymer, subject to the limitation that when contacting food of types III, IV-A, V, VI-C, VII-A, and IX, identified in § 176.170(c) of this chapter, Table 1, the polymers shall be used only under conditions of use C, D, E, F, and G, described in § 176.170(c) of this chapter, Table 2. 3.9. Olefin copolymers described in paragraph Not less than 1.0 (a)(3)(vii) of this section may only be used in contact with dry foods, Type VIII, as identified in § 176.170(c) of this chapter, Table 1 4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C temperature 5. Polyethylene copolymer described in para- Not less than 0.94 ...... 0.45 pct at 15 °C 1.8 pct at 25 °C graph (a)(5) of this section and having a melt index not to exceed 2, for use, either alone or in blends with other olefin polymers, subject to the limitation that when contacting foods of types III, IV-A, V, VI-C, VII-A, VIII, and IX identified in § 176.170(c) of this chapter, table 1, the thickness of the film (in mils) containing the polyethylene graft copolymer times the concentration of the polyethylene graft copolymer shall not exceed a value of 2 6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ...... 1.36 pct at 50 °C 2.28 pct at 25 °C scribed in paragraph (a)(6) of this section for use as the adhesive component in multilaminate structures, or as the sealant layer in flexible packaging, in contact with food at temperatures not exceeding 49 °C (120 °F)

(d) The analytical methods for deter- this section are as follows, and are ap- mining whether olefin polymers con- plicable to the basic polymer in film form to the specifications prescribed in form not exceeding 4 mils in thickness.

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The film to be tested shall be cut into polypropylene, and poly(methylpentene). approximately 1-inch squares by any A sample is refluxed in the solvent for convenient method that avoids con- 2 hours and filtered at the boiling tamination by dust, dirt, or grease point. The filtrate is evaporated and (NOTE: Do not touch samples with bare the total residue weighed as a measure fingers—use forceps to hold or transfer of the solvent extractable fraction. samples). (a) Apparatus. (1) Erlenmeyer flasks, (1) Density. Density shall be deter- 250-milliliter, with ground joint. mined by ASTM method D1505–68 (Re- (2) Condensers, Allihn, 400-millimeter approved 1979), ‘‘Standard Test Method jacket, with ground joint. for Density of Plastics by the Density- (3) Funnels, ribbed 75-millimeter di- Gradient Technique,’’ which is incor- ameter, stem cut to 40 millimeters. porated by reference. Copies may be (4) Funnels, Buchner type, with obtained from the American Society coarse-porosity fritted disc, 60-milli- for Testing Materials, 100 Barr Harbor meter diameter. Dr., West Conshohocken, Philadelphia, ( ) Bell jar for vacuum filtration into PA 19428-2959, or may be examined at 5 the National Archives and Records Ad- beaker. ministration (NARA). For information (b) Reagent. n-Hexane, commercial ° on the availability of this material at grade, specific gravity 0.663–0.667 (20 C/ ° ° ° NARA, call 202–741–6030, or go to: http:// 20 C), boiling range 66 C-69 C, or www.archives.gov/federallregister/ equivalent. codeloflfederallregulations/ (c) Procedure. Weigh 1 gram of sample ibrllocations.html. accurately and place in a 250-milliliter (2) Melting point or softening point—(i) Erlenmeyer flask containing two or Melting point. The melting point shall three boiling stones. Add 100 milliliters be determined by ASTM method D2117– of solvent, attach the flask to the con- 82, ‘‘Standard Test Method for Melting denser (use no grease), and reflux the Point of Semicrystalline Polymers by mixture for 2 hours. Remove the flask the Hot Stage Microscopy Method,’’ from the heat, disconnect the con- which is incorporated by reference. The denser, and filter rapidly, while still availability of this incorporation by hot, through a small wad of glass wool reference is given in paragraph (d)(1) of packed in a short-stem funnel into a this section. tared 150-millimeter beaker. Rinse the (ii) Softening point. The softening flask and filter with two 10-milliliter point shall be determined by ASTM portions of the hot solvent, and add the method E28–67 (Reapproved 1982), rinsings to the filtrate. Evaporate the ‘‘Standard Test Method for Softening filtrate on a stream bath with the aid Point by Ring-and-Ball Apparatus,’’ of a stream of nitrogen. Dry the res- which is incorporated by reference. The idue in a vacuum oven at 110 °C for 2 availability of this incorporation by hours, cool in a desiccator, and weigh reference is given in paragraph (d)(1) of to the nearest 0.0001 gram. Determine this section. the blank on 120 milliliters of solvent (3) Maximum extractable fraction in n- evaporated in a tared 150-milliliter hexane—(i) Olefin copolymers described beaker. Correct the sample residue for in paragraph (a)(3)(ii) of this section, this blank if significant. Calculation:

Grams of residue = Percent extractable with n-hexane. Grams of sample ×100

(ii) Olefin copolymers described in para- residue weighed as a measure of the graph (a)(3)(i) of this section and poly- solvent extractable fraction. Alter- ethylene. A preweighed sample is ex- natively, the sample is reweighed after tracted at 50 °C for 2 hours and filtered. the extraction period to give a measure The filtrate is evaporated and the total of the solvent extractable fraction. The

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maximum n-hexane-extractable frac- vent temperature has reached 50 °C, tion may be determined by the meth- disconnect the heater, remove the resin ods set forth in paragraphs (d)(3)(ii)(a) kettle from the heating jacket, and de- through (d)(3)(ii)(i) of this section. cant the solvent, while still warm, (a) Extraction apparatus. Two-liter, through a coarse filter paper placed on straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity. ient for this purpose. The cover is Determine the weight of the filtrate re- fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery stirrer driven by an air motor or explo- should be at least 90 percent of the sion-proof electric motor, and a reflux original solvent. Losses due to evapo- condenser. The kettle is fitted with an ration during heating and filtering electric heating mantle of appropriate have been found not to exceed 10 per- size and shape, which is controlled by a cent. Transfer about half of the solvent variable-voltage transformer. filtrate to a 1-liter beaker placed on an (b) Evaporating apparatus. Rapid opening in the steam bath and imme- evaporation of large volumes of solvent diately cover with the special ‘‘gas’’ requires special precautions to prevent cover, the inlet tube of which has been contamination by dust. This is facili- attached with flexible tetrafluoro- tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu- sisting of an inverted flat Pyrex crys- rity nitrogen in series with a stainless tallizing dish of an appropriate size (190 steel heating coil immersed directly in millimeters × 100 millimeters) to fit a the body of the steam bath. Maintain a 1-liter beaker. Through the center of positive flow of warm nitrogen gas the dish are sealed an inlet tube for throughout the evaporation of the sol- preheated, oxygen-free nitrogen, and an outlet tube located 1 inch off center. vent, adding the remainder of the fil- Nitrogen is fed from the supply source trate from the Erlenmeyer flask as the evaporation proceeds. When the volume through a coil of 1⁄4-inch stainless steel tubing immersed in the same steam of the solvent has been reduced to bath used to supply heat for solvent about 50 milliliters, transfer the con- evaporation. All connections are made centrated liquid to a previously tared with flexible tetrafluoroethylene tub- weighing dish of suitable size. Wash the ing. beaker twice with 20–30 milliliter por- (c) Reagents—(1) n-Hexane. Spectro- tions of warm solvent, adding the grade n-hexane. washings to the weighing dish while (2) Nitrogen. High-purity dry nitrogen continuing to evaporate the remainder containing less than 10 parts per mil- of the solvent under the gas cover with lion of oxygen. its flow of warm nitrogen directed to- (d) Procedure. Transfer 2.5 grams (ac- ward the center of the dish. In the curately weighed to nearest 0.001 gram) event that an insoluble residue that of the polymer to the resin kettle. Add cannot be removed with warm solvent 1 liter of solvent and clamp top in posi- remains in the beaker, it may be nec- tion. Start water flowing through jack- essary to heat with a small amount of et of the reflux condenser and apply air a higher boiling solvent such as ben- pressure to the stirring motor to zene or toluene, transferring these produce vigorous agitation. Turn on washings to the weighing dish before heating jacket with transformer set at final evaporation to dryness. Transfer a predetermined voltage to bring the the weighing dish with its residue to a temperature of the contents to 50 °C vacuum desiccator, and allow it to re- within 20–25 minutes. As the thermom- main overnight (at least 12 hours), eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry duce the voltage to the predetermined residue is determined to the nearest setting that will just maintain the 0.0001 gram. Correct the result for any temperature at 50 °C. Do not overshoot solvent blank equivalent to the non- the prescribed temperature. Should volatile matter determined to be con- this occur discard the test and start tained in the amount of solvents used afresh. Exactly 2 hours after the sol- in the test.

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(e) Extraction apparatus for alternate should be prepared by the same process method. Two-liter extraction vessel, as will be used with the production such as a resin kettle or round bottom resin. Using gloves and metal tweezers flask, fitted with an Allihn condenser to avoid sample contamination, cut (size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4 sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1- Water bath maintained at 49.5 °C ±0.5 inch squares using clean sharp scissors. °C containing a submersible magnetic Proceed with Option 1 or 2. stirrer motor with power supply. Other Option 1. Using tweezers and noting suitable means of maintaining tem- the number of film pieces, transfer 2.5 perature control, such as electric heat- grams (accurately weighed to 0.1 milli- ing mantles, may be used provided that gram) of polymer to the extraction ves- the temperature range can be strictly sel. Extract the film sample for 2 maintained. hours. Allow the vessel to cool and fil- (f) Sample basket (Optional). A per- ter the contents through a fritted por- forated stainless steel cylindrical basket that is approximately 1.5 inches in celain funnel. Wash the film pieces diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry- forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a 33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to The basket should pass freely through verify that none were lost during the the 45/50 female joint of the extraction transfer. Place the beaker in the vacu- flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After bolt is attached to the lid for posi- 2 hours, remove and place in a desic- tioning the basket in the extraction cator to cool to room temperature vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh mately 18 inches long and made from the film pieces to the nearest 0.1 milli- 1⁄16 inch outside diameter 316 stainless gram. Calculate the percent hexane- steel welding rod or equivalent and extractables content from the weight hooked at both ends, is used to position loss of the original sample. Multiply the basket in the extraction apparatus. the result by 0.935 and compare with (g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of taining 80 °C ±5 °C and a minimum of this section. Repeat the above proce- 635 millimeters of mercury pressure. dure for successive samples. (h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a milligram per liter), minimum 85 per- tared sample basket and accurately cent n-hexane. This reagent may be reweigh to the nearest 0.1 milligram. used until it contains a maximum of 1.5 Carefully raise the condenser until the grams polyolefin extractables or has hook on the positioning rod is above been used for 12 determinations. the neck of the 2-liter extraction ves- (i) Procedure. Assemble the extraction sel. The basket should be totally below vessel, condenser, and magnetic stir the level of n-hexane solvent. Extract bar. Add n-hexane (1 liter) to the ex- the sample resin film for 2 hours and traction vessel and clamp the assembly into a water bath set at 49.5 °C ±0.5 °C. then raise the basket above the solvent Start the water flowing through the level to drain momentarily. Remove jacket of the reflux condenser. Adjust the basket and rinse the contents by the air flow through the stirring motor immersing several times in fresh n- to give a smooth and uniform stir rate. hexane. Allow the basket to dry be- Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol- hour to bring the temperature to 49.5 vent by briefly blowing the basket with °C±0.5 °C. Temperature is a critical fac- a stream of nitrogen or dry air. Place tor in this analysis and it must not the basket in the vacuum oven for 2 vary more than 1 °C. If the temperature hours at 80 °C ±5 °C. After 2 hours, re- exceeds these limits, the test must be move and place in a desiccator to cool discontinued and restarted. Blown, to room temperature (about 1 hour). compression molded, or extrusion cast After cooling, reweigh the basket to films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate

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the percent hexane extractables con- thylamine in 1 liter of industrial grade tent from the weight loss of the origi- xylene having specific gravity 0.856– nal sample. Multiply the result by 0.935 0.867 (20 °C/20 °C) and boiling range 123 and compare with extraction limits in °C–160 °C. paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of the above procedure for successive sample to the nearest 0.001 gram and samples. The same solvent charge place in a 125-milliliter Pyrex reagent should remain clear and can be used for bottle containing a 1-inch long tetra- at least 12 determinations. Applica- fluoroethylene-resin-coated stirring tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set firmed for each resin type before use. the stopper in lightly, and place the (4) Maximum soluble fraction in xy- bottle in the heating mantle or alu- lene—(i) Olefin copolymers described in minum block maintained at a tempera- paragraph (a)(3)(ii) of this section, poly- ture of 120 °C, and stir with a magnetic propylene, and poly(methylpen-tene). A stirrer until the sample is completely sample is dissolved completely in xy- dissolved. Remove the bottle from the lene by heating and stirring in a bottle heat and allow it to cool 1 hour in the with little free space. The solution is air, without stirring. Then place the allowed to cool without stirring, bottle in a water bath maintained at 25 whereupon the insoluble portion pre- °C ±0.5 °C, and allow to stand 1 hour cipitates and is filtered off; the total without stirring. Next, remove the bot- solids content of the filtrate is then de- tle from the water bath, shake, and termined as a measure of the soluble pour part of the contents into the fraction. coarse-porosity fritted-glass funnel. (a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli- lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more glass-stoppered. slurry to the funnel, and catching the (2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior this section. to the filtration.) Pipet a suitable ali- (3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the heating mantle (combination magnetic filtrate into a tared aluminum dispos- stirrer and hotplate may be used if alu- able dish. Place the dish on a steam minum block is used in place of heat- bath covered with a fresh sheet of alu- ing mantle). minum foil and invert a short-stemmed (4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro- amperes. gen (heated if desired) down through (5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just stirring bar, 1-inch long. ripple the surface of the solvent. When (6) Constant temperature water bath the liquid has evaporated, place the maintained at 25 °C±0.5 °C. dish in a vacuum oven at 140 °C and (7) Aluminum dishes, 18 millimeters × less than 50 millimeters mercury pres- 60 millimeters, disposable. sure for 2 hours. Cool in a desiccator (8) Funnel, Buchner type, with and weigh. (Note: If the residue value coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven meter diameter. for one-half hour to ensure complete (b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula- Dissolve 0.020 gram of phenyl-b- naph- tion:

Grams of residue 100 milliters ××=100 Percent soluble in xylene Grams of sample volume of aliquot in milliliters

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(ii) Olefin copolymers described in para- reflux condenser and apply full voltage graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the lene at reflux temperature for 2 hours voltage to a level just sufficient to and filtered. The filtrate is evaporated maintain reflux. After refluxing for at and the total residue weighed as a least 2 hours, disconnect the power measure of soluble fraction. source to the mantle, remove the ket- (a) Apparatus—(1) Extraction appa- tle, and allow to cool in air until the ratus. Two-liter, straight-walled Pyrex temperature of the contents drops to 50 (or equivalent) resin kettles, fitted °C, after which the kettle may be rap- with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing venient for this purpose. The cover is in a cold water bath. Transfer the ket- equipped with a thermometer and an tle to a constant temperature bath set efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to fitted with an electric heating mantle equilibrate for a least 1 hour (may be of appropriate size and shape which is left overnight if convenient). Break up controlled by a variable-voltage trans- any precipitated polymers that may former. have formed, and decant the xylene so- (2) Constant temperature water bath. It lution successively through a fast filter must be large enough to permit immer- paper and then through a fritted-glass sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil- (3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any consisting of a flat Pyrex crystallizing attempt to collect more of the xylene dish (190 millimeters × 100 millimeters) solution usually results in clogging the inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the through center and an outlet tube 1 weight of the filtrate obtained to the inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate, cover is inserted in an electric heating quantitatively, from the Erlenmeyer mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the age transformer. The outlet tube is at- beaker in its heating mantle, add a tached to an efficient condenser glass-coated magnetic stirring bar, and mounted on a receiving flask for sol- mount the gas cover in place, con- vent recovery and having an outlet for necting the inlet tube to the nitrogen connection to an aspirator pump. The source and the outlet to the condenser heating mantle (with the beaker) is of the receiving flask. Start a flow of mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into An infrared heat lamp is mounted the gas cover and connect an aspirator vertically 3–4 inches above the gas to the receiver using a free-flow rate cover to prevent condensation of the equivalent to 6–7 liters of air per solvent inside the cover. Make all con- minute. With the infrared lamp on, ad- nections with flexible tetrafluoro- just the voltage to the heating mantle ethylene tubing. to give a distillation rate of 12–13 milli- (b) Reagents—(1) Xylene. American liters per minute when the magnetic Chemical Society reagent grade that stirrer is revolving just fast enough to has been redistilled through a promote good boiling. When the vol- fractionating column to reduce the ume of solvent in the beaker has been nonvolatile residue. reduced to 30–50 milliliters, transfer (2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit- containing less than 104 parts per mil- able weighing dish that has been pre- lion oxygen. viously tared (dry). Rinse the beaker (c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the 1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain- and clamp top in position after insert- der of the xylene on an electric ing a piece of glass rod to prevent hotplate set at low heat under the gas bumping during reflux. Start water cover with a stream of nitrogen di- flowing through the jacket of the rected toward the center of the dish.

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Avoid any charring of the residue. termined at 100 °C. The apparatus con- Transfer the weighing dish to a vacu- taining the sample is warmed for 1 um desiccator at room temperature minute, run for 8 minutes, and vis- and allow to remain under reduced cosity measurements are then made. pressure for at least 12 hours (over- (7) Melt flow index. The melt flow night), after which determine the net index of olefin polymers described weight of the residue to the nearest below shall be determined by ASTM 0.0001 gram. Correct the result for non- method D–1238–82, ‘‘Standard Test volatile solvent blank obtained by Method for Flow Rates of Thermo- evaporating the equivalent amount of plastics by Extrusion Plastometer,’’ xylene under identical conditions. Cal- which is incorporated by reference in culate the weight of residue originally accordance with 5 U.S.C. 552(a). The present in the total weight of solvent availability of this incorporation by (840 grams), using the appropriate fac- reference is given in paragraph (d)(1) of tor based on the weight of filtrate this section. The olefin polymers and evaporated. test conditions and procedures are as (5) Viscosity average molecular weight follows: olefin copolymers described in paragraphs List of polymers Conditions/procedures (a)(3) (iii) and (iv) of this section. The viscosity average molecular weight Olefin copolymers described in para- Condition L, proce- shall be determined from the kine- graph (a)(3)(i)(c)(2) of this section. dure A. Olefin copolymers described in para- Condition E, proce- matic viscosity (using ASTM method graph (a)(3)(v) of this section. dure A. D445–74, ‘‘Test for Kinematic Viscosity Olefin polymers described in para- Condition E, proce- of Transparent and Opaque Liquids’’ graph (a)(2)(ii) of this section. dure A. Olefin polymers described in para- Condition E, proce- (Revised 1974), which is incorporated by graph (a)(3)(vi) of this section. dure A. reference; copies are available from American Society for Testing and Ma- (8) Melting peak temperature. The melt terials (ASTM), 100 Barr Harbor Dr., temperature of the olefin polymers de- West Conshohocken, Philadelphia, PA scribed in paragraph (a)(3)(ii) of this 19428-2959, or available for inspection at section shall be determined by ASTM the National Archives and Records Ad- method D 3418–82, ‘‘Standard Test ministration (NARA). For information Method for Transition Temperatures of on the availability of this material at Polymers by Thermal Analysis,’’ which NARA, call 202–741–6030, or go to: http:// is incorporated by reference in accord- www.archives.gov/federallregister/ ance with 5 U.S.C. 552(a). The avail- codeloflfederallregulations/ ability of this incorporation by ref- ibrllocations.html.) of solutions of the erence is given in paragraph (d)(1) of copolymers in solvents and at tempera- this section. tures as follows: (9) Intrinsic viscosity. The intrinsic (i) Olefin polymers described in para- viscosity of the olefin polymers de- graph (a)(3)(iii) of this section in scribed in paragraph (a)(3)(ii) of this decahydronaphthalene at 135 °C. section shall be determined by ASTM (ii) Olefin polymers described in method D 1601–78, ‘‘Standard Test paragraph (a)(3)(iv) of this section in Method for Dilute Solution Viscosity tetrachloroethylene at 30 °C. of Ethylene Polymers,’’ which is incor- (6) Mooney viscosity—olefin copolymers porated by reference in accordance described in paragraph (a)(3)(iii) of this with 5 U.S.C. 552(a). The availability of section. Mooney viscosity is determined this incorporation by reference is given by ASTM method D1646–81, ‘‘Standard in paragraph (d)(1) of this section. Test Method for Rubber—Viscosity and (e) Olefin copolymers described in Vulcanization Characteristics (Mooney paragraph (a)(3) (i) of this section and Viscometer),’’ which is incorporated by polyethylene, alone or in combination, reference (the availability of this in- may be subjected to irradiation bom- corporation by reference is given in bardment from a source not to exceed paragraph (d)(1) of this section), using 2.3 million volts intensity to cause mo- the large rotor at a temperature of 100 lecular crosslinking of the polymers to °C, except that a temperature of 127 °C impart desired properties, such as in- shall be used for those copolymers creased strength and increased ability whose Mooney viscosity cannot be de- to shrink when exposed to heat.

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(f) The olefin polymers identified in (3) Substances authorized under ap- and complying with this section, when plicable regulations in this part and in used as components of the food-contact parts 175 and 178 of this chapter and surface of any article that is the sub- subject to any limitations prescribed ject of a regulation in parts 174, 175, therein. 176, 177, 178, and § 179.45 of this chapter, (4) The following substances, subject shall comply with any specifications to any limitations prescribed: and limitations prescribed by such regulation for the article in the finished List of substances Limitations form in which it is to contact food. Lithium polysilicate containing For use only as a compo- (g) The provisions of this section are not more than 20 weight per- nent of repeated-use not applicable to olefin polymers iden- cent silica, not more than 2.1 coatings not exceeding tified in § 175.105(c) (5) of this chapter percent lithium oxide and 0.030 millimeter (0.0012 and used in food-packaging adhesives having a maximum mole inch) in thickness where ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally complying with § 175.105 of this chapter. cured at minimum sinter- [42 FR 14572, Mar. 15, 1977] ing temperatures of 371 °C (700 °F). Lithium ex- EDITORIAL NOTE: For FEDERAL REGISTER ci- tractives shall not exceed tations affecting § 177.1520, see the List of 1.55 milligrams per CFR Sections Affected, which appears in the square decimeter (0.1 milligram per square inch) Finding Aids section of the printed volume of coating surface when and at www.fdsys.gov. tested in accordance with paragraph (e)(2) of this § 177.1550 Perfluorocarbon resins. section. Naphthalene sulfonic acid For use only: Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re- this section may be safely used as arti- sodium salt. peated-use coatings, cles or components of articles intended based on the to contact food, subject to the provi- perfluorocarbon resin identified in paragraph sions of this section: (a)(1) of this section, not (a) Identity. For the purpose of this to exceed 0.030 milli- section, perfluorocarbon resins are meter (0.0012 inch) in those produced by: (1) The thickness, and at a level not to exceed 0.4 weight homopolymerization and/or copolym- percent of the coating. erization of hexafluoropropylene and 2. As a component of re- tetrafluoroethylene, and (2) the co- peated-use coatings, based on the polymerization of perfluorocarbon resin perfluoropropylvinylether and tetra- identified in paragraph fluoroethylene (CAS Reg. No. 26655–00– (a)(2) of this section, not 5). The resins shall meet the extrac- to exceed 0.10 millimeter (0.004 inch) in thickness, tives limitations in paragraph (d) of and at a level not to ex- this section. ceed 0.4 weight percent (b) Optional components. The of the coating. perfluorocarbon resins identified in paragraph (a) of this section as well as (c) Optional processing. Poly- tetra- articles or coating made from these fluoroethylene resins may be irradi- resins may include the following op- ated by either a cobalt-60 sealed tional components except that the source, at a maximum dose of gamma resin identified in paragraph (a)(2) of radiation not to exceed 7.5 megarads, this section may not be used with the or an electron beam at energy levels optional component, lithium not to exceed 2.5 million electron volts polysilicate, mentioned in paragraph with a maximum dosage of 7.5 (b)(4) of this section. megarads, to produce lubricant pow- (1) Substances generally recognized ders having a particle diameter of not as safe (GRAS) in food or food pack- more than 20 microns for use only as aging subject to any limitations cited components of articles intended for re- on their use. peated use in contact with food. (2) Substances used in accordance (d) Specifications—(1) Infrared identi- with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be ject to any limitations cited in the identified by their characteristic infra- prior sanction or approval. red spectra.

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(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741– carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/ (a)(1) of this section shall have a melt federallregister/ viscosity of not less than 104 poises at codeloflfederallregulations/ 380 °C (716 °F) as determined by ASTM ibrllocations.html. The requirements of method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly- od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of corporated by reference. Copies may be this section. obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon- for Testing Materials, 100 Barr Harbor molded articles having a surface area Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli- the National Archives and Records Ad- meters (0.05 inch) thick shall be ex- ministration (NARA). For information tracted at reflux temperatures for 2 on the availability of this material at hours separately with distilled water, NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and www.archives.gov/federallregister/ ethyl acetate. codeloflfederallregulations/ (2) Perfluorocarbon resins identified ibrllocations.html. The melt viscosity in paragraphs (a)(1) and (2) of this sec- of the perfluorocarbon resins identified tion and intended for use as coatings or in paragraph (a)(1) of this section shall components of coatings shall meet not vary more than 50 percent within extractability limits prescribed in one-half hour at 380 °C (716 °F). paragraph (e)(3) of this section when (ii) Perfluorocarbon resins identified the resins in the form of coatings de- in paragraph (a)(2) of this section shall scribed in paragraphs (e)(2) (i) and (ii) have a melt viscosity of not less than of this section are extracted at reflux 104 poises at 372 °C (702 °F) as deter- temperatures for 2 hours separately mined by a more detailed method ti- with distilled water, 8 percent ethanol, tled ‘‘Determination of Melt Viscosity, and n-heptane: Molecular Weight Distribution Index (i) Perfluorocarbon resin coatings and Viscosity Stability,’’ which is in- based on resins identified in paragraph corporated by reference. Copies are (a)(1) of this section shall be applied to available from the Center for Food both sides of a 0.025-millimeter (0.001 Safety and Applied Nutrition (HFS– inch) thick aluminum foil to a thick- 200), Food and Drug Administration, ness of 0.025 millimeter (0.001 inch) 5100 Paint Branch Pkwy., College Park, after thermal curing at 399 °C (750 °F) MD 20740, or available for inspection at for 10 minutes. If a primer is used, the the National Archives and Records Ad- total thickness of the primer plus top- ministration (NARA). For information coat shall equal 0.025 millimeter (0.001 on the availability of this material at inch) after heat curing. NARA, call 202–741–6030, or go to: http:// (ii) Perfluorocarbon resin coatings www.archives.gov/federallregister/ based on resins identified in paragraph codeloflfederallregulations/ (a)(2) of this section shall be applied to ibrllocations.html. both sides of a 0.025-millimeter (0.001 (3) Thermal instability index. The thermal instability index of the tetra- 1 A more detailed procedure of extraction fluoroethylene homopolymer shall not conditions is entitled, ‘‘Preparation of Ex- exceed 50 as determined by ASTM tracts,’’ which is incorporated by reference. method D1457–56T, ‘‘Test for Thermal Copies are available from the Center for Instablility index of Tetrafluoro- Food Safety and Applied Nutrition (HFS– ethylene Homopolymer’’ (Revised 1956), 200), Food and Drug Administration, 5100 which is incorporated by reference. Paint Branch Pkwy., College Park, MD 20740, Copies are available from University or available for inspection at the National Microfilms International, 300 N. Zeeb Archives and Records Administration (NARA). For information on the availability Rd., Ann Arbor, MI 48106, or available of this material at NARA, call 202–741–6030, for inspection at the National Archives or go to: http://www.archives.gov/ and Records Administration (NARA). federallregister/codeloflfederallregulations/ For information on the availability of ibrllocations.html.

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inch) thick aluminum foil to a thick- (250 °F) for 2 hours, shall yield total ness of 0.10 millimeter (0.004 inch) after nonvolatile extractives not to exceed thermal curing at 427 °C (800 °F) for 10 2.33 micrograms per square centimeter minutes. If a primer is used, the total (15 micrograms per square inch) of the thickness of the primer plus topcoat exposed resin surface. shall equal 0.10 millimeter (0.004 inch) (d) Limitations. Polyarylate resin ar- after heat curing. ticles may be used in contact with all (3) The extracted surfaces shall meet foods except beverages containing the following extractability limits: more than 8 volume percent ethanol (i) Total extractives not to exceed 3.1 under conditions of use A through H, milligrams per square decimeter (0.2 described in table 2 of § 176.170(c) of this milligram per square inch). chapter. (ii) Fluoride extractives calculated as [52 FR 35540, Sept. 22, 1987] fluorine not to exceed 0.46 milligram per square decimeter (0.03 milligram § 177.1556 Polyaryletherketone resins. per square inch). The poly(oxy-1,4-phenylenecarbonyl- (f) Conditions of use. Perfluorocarbon 1,4-phenyleneoxy-1,4- resins identified in paragraph (a)(2) of phenylenecarbonyl-1,4- this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res- ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly reuse. ferred to as polyaryletherketone res- [43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles 1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub- 14481, Apr. 2, 1996] ject to the provisions of this section. (a) Identity. Polyaryletherketone res- § 177.1555 Polyarylate resins. ins consist of basic resins produced by Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone 51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a cles or components of articles intended way that the finished resins have a for use in contact with food in accord- minimum weight average molecular ance with the following prescribed con- weight of 20,000 grams per mole, as de- ditions: termined by light scattering measure- (a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem- benzenedicarboxylic acid, diphenyl perature. ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden- methylethylidine) bis(phenol)) are tified in paragraph (a) of this section formed by melt polycondensation of may contain optional adjuvant sub- bisphenol-A with diphenylisophthalate stances required in the production of and diphenylterephthalate. such basic resins. These adjuvants may (b) Specifications. (1) The finished co- include substances used in accordance polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol- weight percent of polymer units de- lowing: rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro to 30 weight percent of polymer units ethylene). derived from diphenylterephthalate. (2) [Reserved] (2) Polyarylate resins shall have a (c) Extractive limitations. The finished minimum weight average molecular food-contact article yields net total ex- weight of 20,000. tractives in each extracting solvent (3) Polyarylate resins may be identi- not to exceed 0.052 milligram per fied by their characteristic infrared square inch (corresponding to 0.008 mil- spectra. ligram per square centimeter) of food- (c) Extractive limitations. The finished contact surface, when extracted at polyarylate resins in sheet form at reflux temperature for 2 hours with the least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50 when extracted with water at 121 °C percent (by volume) ethyl alcohol in

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distilled water, 3 percent acetic acid paragraph and further identified as re- (by weight) in distilled water, and n- quired: heptane. (d) In testing the finished food-con- Substances Limitations tact article made of Sulfolane ..... Not to exceed 0.15 percent as residual sol- polyaryletherketone resin, use a sepa- vent in the finished basic resin. rate test sample for each required extracting solvent. (c) Extractive limitations. The finished [61 FR 42381, Aug. 15, 1996] polyarylsulfone resin when extracted for 2 hours with the following solvents § 177.1560 Polyarylsulfone resins. at the specified temperatures yields total extractives in each extracting Polyarylsulfone resins (CAS Reg. No. 79293–56–4) may be safely used as arti- solvent not to exceed 0.008 milligram cles or components of articles intended per square centimeter of food-contact surface: distilled water at 121 °C (250 for use in contact with food, at tem- ° peratures up to and including normal F), 50 percent (by volume) ethyl alco- ° ° baking temperatures, in accordance hol in distilled water at 71.1 C (160 F), with the following prescribed condi- 3 percent acetic acid in distilled water ° ° tions: at 100 C (212 F), and n-heptane at 65.6 ° ° (a) Identity. Polyarylsulfone resins C (150 F). are copolymers containing not more NOTE: In testing the finished polyaryl- than 25 percent of oxy-p-phenylene- sulfone resin use a separate test sample for oxy-p-phenylenesulfonyl-p-phenylene each required extracting solvent. polymer units and not less than 75 per- [50 FR 31046, July 24, 1985] cent of oxy-p-phenylenesulfonyl-p- phenylene-oxy-p-phenylenesulfonyl-p- § 177.1570 Poly-1-butene resins and phenylene polymer units. The copoly- butene/ethylene copolymers. mers have a minimum reduced vis- The poly-1-butene resins and butene/ cosity of 0.40 deciliter per gram in 1- methyl-2-pyrrolidinone in accordance ethylene copolymers identified in this with ASTM method D2857–70 (Re- section may be safely used as articles approved 1977), ‘‘Standard Test Method or components of articles intended for for Dilute Solution Viscosity of Poly- use in contact with food subject to the mers,’’ which is incorporated by ref- provisions of this section. erence. Copies may be obtained from (a) Identity. Poly-1-butene resins are the American Society for Testing and produced by the catalytic polymeriza- Materials, 100 Barr Harbor Dr., West tion of 1-butene liquid monomer. Conshohocken, Philadelphia, PA 19428- Butene/ethylene copolymers are pro- 2959, or may be examined at the Na- duced by the catalytic polymerization tional Archives and Records Adminis- of 1-butene liquid monomer in the pres- tration (NARA). For information on ence of small amounts of ethylene the availability of this material at monomer so as to yield no higher than NARA, call 202–741–6030, or go to: http:// a 6-weight percent concentration of www.archives.gov/federallregister/ polymer units derived from ethylene in codeloflfederallregulations/ the copolymer. ibrllocations.html. (b) Specifications and limitations. Poly- (b) Optional adjuvant substances. The 1-butene resins and butene/ethylene co- basic polyarylsulfone resins identified polymers shall conform to the speci- in paragraph (a) of this section may fications prescribed in paragraph (b)(1) contain optional adjuvant substances of this section, and shall meet the required in the production of such extractability limits prescribed in basic copolymers. These optional adju- paragraph (b)(2) of this section. vant substances may include sub- (1) Specifications—(i) Infrared identi- stances permitted for such use by regu- fication. Poly-1-butene resins and lations in parts 170 through 179 of this butene/ethylene copolymers can be chapter, substances generally recog- identified by their characteristic infra- nized as safe in food, substances used in red spectra. accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and proval, and substances named in this the butene/ethylene copolymers have

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an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in ‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter, lution Viscosity of Ethylene Poly- subject to the provisions of this section mers,’’ which is incorporated by ref- and provided that the maximum erence. Copies may be obtained from extractables from test films 0.1 to 0.2 the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick- terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted 2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with tional Archives and Records Adminis- refluxing 95 percent ethanol. tration (NARA). For information on (iii) Poly-1-butene resins may be used the availability of this material at as articles or components of articles NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food www.archives.gov/federallregister/ during cooking, provided that the codeloflfederallregulations/ thickness of such polymers in the form ibrllocations.html. in which they contact food shall not (iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not and butene/ethylene copolymers have a more than 2.5 percent by weight of the density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2 termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane. (Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49 Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2, Density-Gradient Technique,’’ which is 1985] incorporated by reference. The availability of this incorporation by ref- § 177.1580 Polycarbonate resins. erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely this section. used as articles or components of arti- (iv) Melt index. Poly-1-butene resins cles intended for use in producing, have a melt index of 0.1 to 24 and the manufacturing, packing, processing, butene/ethylene copolymers have a preparing, treating, packaging, trans- melt index of 0.1 to 20 as determined by porting, or holding food, in accordance ASTM method D1238–82, condition E, with the following prescribed condi- ‘‘Standard Test Method for Flow Rates tions: of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly- tometer,’’ which is incorporated by ref- esters produced by: erence. The availability of this incor- (1) The condensation of 4,4′-iso- poration by reference is given in para- propylidenediphenol and carbonyl chlo- graph (b)(1)(ii) of this section. ride to which may have been added cer- (2) Limitations. Poly-1-butene resins tain optional adjuvant substances re- and butene/ethylene copolymers for use quired in the production of the resins; in articles that contact food, and for or by articles used for packing or holding (2) The reaction of molten 4,4′-iso- food during cooking shall yield no propylidenediphenol with molten di- more than the following extractables: phenyl carbonate in the presence of the (i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro- as articles or components of articles pylidenediphenol. intended for use in contact with food, (3) The condensation of 4,4′-isopro- provided that the maximum pylidenediphenol, carbonyl chloride, extractables do not exceed 2.5 percent and 0.5 percent weight maximum of by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to molded samples are tested for 2 hours which may have been added certain op- at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in (ii) Butene/ethylene copolymers con- the production of branched taining no more than 6 percent by polycarbonate resins. weight of polymer units derived from (b) The optional adjuvant substances ethylene may be used as articles or required in the production of resins components of articles intended for produced by the methods described in

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paragraph (a)(1) and (3) of this section in infant feeding bottles (baby bottles) may include substances generally rec- and spill-proof cups, including their ognized as safe in food, substances used closures and lids, designed to help train in accordance with a prior sanction or babies and toddlers to drink from cups approval, and the following: (sippy cups).

List of substances Limitations [42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, p-tert-Butylphenol ...... 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Chloroform ...... Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR p-Cumylphenol (CAS Reg. For use only as a chain ter- No. 599–64–4). minator at a level not to ex- 41902, July 17, 2012] ceed 5 percent by weight of the resin. § 177.1585 Polyestercarbonate resins. Ethylene dichloride. Heptane. Polyestercarbonate resins may be Methylene chloride. safely used as articles or components Monochlorobenzene ...... Not to exceed 500 p.p.m. as of articles intended for use in pro- residual solvent in finished resin. ducing, manufacturing, packing, proc- Pentaerythritol tetrastearate For use only as a mold re- essing, preparing, treating, packaging, (CAS Reg. No. 115–83–3). lease agent, at a level not or holding food, in accordance with the to exceed 0.5 percent by weight of the finished resin. following prescribed conditions: Phenol (CAS Reg. No. 108– (a) Polyestercarbonate resins (CAS 95–2). Reg. No. 71519–80–7) are produced by the Pyridine. ′ Toluene: (CAS Reg. No. Not to exceed 800 parts per condensation of 4,4 - 108–88–3). million as residual solvent isopropylidenediphenol, carbonyl chlo- in finished resin. ride, terephthaloyl chloride, and Triethylamine. isophthaloyl chloride such that the finished resins are composed of 45 to 85 (c) Polycarbonate resins shall con- molepercent ester, of which up to 55 form to the specification prescribed in mole-percent is the terephthaloyl iso- paragraph (c)(1) of this section and mer. The resins are manufactured shall meet the extractives limitations using a phthaloyl chloride/carbonyl prescribed in paragraph (c)(2) of this chloride mole ratio of 0.81 to 5.7/1 and section. isophthaloyl chloride/terephthaloyl (1) Specification. Polycarbonate resins chloride mole ratio of 0.81/1 or greater. can be identified by their char- The resins are also properly identified acteristic infrared spectrum. by CAS Reg. No. 114096–64–9 when pro- (2) Extractives limitations. The duced with the use of greater than 2 polycarbonate resins to be tested shall but not greater than 5 weight percent be ground or cut into small particles p-cumylphenol (CAS Reg. No. 599–64–4), that will pass through a U.S. standard as an optional adjuvant substance in sieve No. 6 and that will be held on a accordance with paragraph (b)(2) of U.S. standard sieve No. 10. this section. (i) Polycarbonate resins, when ex- (b) Optional adjuvants. The optional tracted with distilled water at reflux adjuvant substances required in the temperature for 6 hours, shall yield production of resins identified in para- total extractives not to exceed 0.15 per- graph (a) of this section may include: cent by weight of the resins. (ii) Polycarbonate resins, when ex- (1) Substances used in accordance tracted with 50 percent (by volume) with § 174.5 of this chapter. ethyl alcohol in distilled water at (2) Substances identified in reflux temperature for 6 hours, shall § 177.1580(b). yield total extractives not to exceed (3) Substances regulated in 0.15 percent by weight of the resins. § 178.2010(b) of this chapter for use in (iii) Polycarbonate resins, when ex- polycarbonate resins complying with tracted with n-heptane at reflux tem- § 177.1580: perature for 6 hours, shall yield total Provided, That the substances are used extractives not to exceed 0.15 percent in accordance with any limitation on by weight of the resins. concentration, conditions of use, and (d) Polycarbonate resins may be used food types specified in § 178.2010(b) of in accordance with this section except this chapter.

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(c) Polyestercarbonate resins shall ethyl alcohol in distilled water at conform to the specifications pre- reflux temperature for 6 hours, shall scribed in paragraph (c)(1) of this sec- yield total nonvolatile extractives not tion and shall meet the extractive lim- to exceed 0.005 percent by weight of the itations prescribed in paragraph (c)(2) resins. of this section. (iii) Polyestercarbonate resins, when (1) Specifications. Polyestercarbonate extracted with n-heptane at reflux resins identified in paragraph (a) of temperature for 6 hours, shall yield this section can be identified by their total nonvolatile extractives not to ex- characteristic infrared spectrum. The ceed 0.002 percent by weight of the res- resins shall comply with either or both ins. of the following specifications: (3) Residual methylene chloride levels in (i) The solution intrinsic viscosity of polyestercarbonate resins. Polyester- the polyestercarbonate resins shall be carbonate resin articles in the finished a minimum of 0.44 deciliter per gram, form shall not contain residual meth- as determined by a method entitled ylene chloride in excess of 5 parts per ‘‘Intrinsic Viscosity (IV) of Lexan ® million as determined by a method ti- Polyestercarbonate Resin by a Single tled ‘‘Analytical Method for Deter- Point Method Using Dichloromethane mination of Residual Methylene Chlo- as the Solvent,’’ developed by the Gen- ride in Polyestercarbonate Resin,’’ de- eral Electric Co., September 20, 1985, veloped by the General Electric Co., which is incorporated by reference in July 23, 1991, which is incorporated by accordance with 5 U.S.C. 552(a) and 1 reference in accordance with 5 U.S.C. CFR part 51. Copies are available from 552(a) and 1 CFR part 51. Copies are the Office of Premarket Approval, Cen- available from the Center for Food ter for Food Safety and Applied Nutri- Safety and Applied Nutrition (HFS– tion (HFS–215), Food and Drug Admin- 200), Food and Drug Administration, istration, 5100 Paint Branch Pkwy., 5100 Paint Branch Pkwy., College Park, College Park, MD 20740, or may be ex- MD 20740, or may be examined at the amined at the Center for Food Safety National Archives and Records Admin- and Applied Nutrition’s Library, Food istration (NARA). For information on and Drug Administration, 5100 Paint the availability of this material at Branch Pkwy., College Park, MD 20740, NARA, call 202–741–6030, or go to: http:// or at the National Archives and www.archives.gov/federallregister/ Records Administration (NARA). For codeloflfederallregulations/ information on the availability of this ibrllocations.html. material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ [57 FR 3940, Feb. 3, 1992, as amended at 64 FR federallregister/ 27178, May 19, 1999] codeloflfederallregulations/ § 177.1590 Polyester elastomers. ibrllocations.html. (ii) A minimum weight-average mo- The polyester elastomers identified lecular weight of 27,000, as determined in paragraph (a) of this section may be by gel permeation chromatography safely used as the food-contact surface using polystyrene standards. of articles intended for use in contact (2) Extractives limitations. The with bulk quantities of dry food of the polyestercarbonate resins to be tested type identified in § 176.170(c) of this shall be ground or cut into small par- chapter, table 1, under Type VIII, in ac- ticles that will pass through a U.S. cordance with the following prescribed standard sieve No. 6 and that will be conditions: held on U.S. standard sieve No. 10. (a) For the purpose of this section, (i) Polyestercarbonate resins, when polyester elastomers are those pro- extracted with distilled water at reflux duced by the ester exchange reaction temperature for 6 hours, shall yield when one or more of the following total nonvolatile extractives not to ex- phthalates—dimethyl terephthalate, ceed 0.005 percent by weight of the res- dimethyl orthophthalate, and dimethyl ins. isophthalate—is made to react with (ii) Polyestercarbonate resins, when alpha-hydroomega-hydroxypoly extracted with 50 percent (by volume) (oxytetramethylene) and/or 1,4-

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butanediol such that the finished elas- this section may contain optional adju- tomer has a number average molecular vant substances required in the produc- weight between 20,000 and 30,000. tion of basic resins or finished food- (b) Optional adjuvant substances em- contact articles. The optional adjuvant ployed in the production of the poly- substances required in the production ester elastomers or added thereto to of the basic polymer may include sub- impart desired technical or physical stances permitted for such use by ap- properties may include the following plicable regulations as set forth in part substances: 174 of this chapter. (c) Specifications and extractives limita- List of substances Limitations tions—(1) Specifications. Polyetherimide 4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this methyl-benzyl) oxidant. section shall have an intrinsic vis- diphenylamine. cosity in chloroform at 25 °C (77 °F) of Tetrabutyl titanate ...... For use only as a catalyst. not less than 0.35 deciliter per gram as determined by a method titled ‘‘In- (c) An appropriate sample of the fin- trinsic Viscosity of ULTEM ished polyester elastomer in the form Polyetherimide Using Chloroform as in which it contacts food when sub- the Solvent,’’ which is incorporated by jected to ASTM method D968–81, reference. Copies are available from ‘‘Standard Test Methods for Abrasion the Center for Food Safety and Applied Resistance of Organic Coatings by the Nutrition (HFS–200), Food and Drug Falling Abrasive Tester,’’ which is in- Administration, 5100 Paint Branch corporated by reference (Copies may be Pkwy., College Park, MD 20740, or obtained from the American Society available for inspection at the National for Testing Materials, 100 Barr Harbor Archives and Records Administration Dr., West Conshohocken, Philadelphia, (NARA). For information on the avail- PA 19428-2959, or may be examined at ability of this material at NARA, call the National Archives and Records Ad- 202–741–6030, or go to: http:// ministration (NARA). For information www.archives.gov/federallregister/ on the availability of this material at codeloflfederallregulations/ NARA, call 202–741–6030, or go to: http:// ibrllocations.html. www.archives.gov/federallregister/ (2) Extractive limitations. Extractive codeloflfederallregulations/ limitations are applicable to the basic ibrllocations.html.), using No. 50 emery polyetherimide resin in the form of abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi- exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when less than 100 liters per mil of thickness. extracted with distilled water at 121 °C [42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola- FR 10109, Mar. 19, 1984] tile extractives of not more than 12.3 micrograms per square centimeter. § 177.1595 Polyetherimide resin. [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. The polyetherimide resin identified 3, 1985] in this section may be safely used as an article or component of an article in- § 177.1600 Polyethylene resins, tended for use in contact with food, carboxyl modified. subject to the provisions of this sec- Carboxyl-modified polyethylene res- tion. ins may be safely used as the food-con- (a) Identity. For the purpose of this tact surface of articles intended for use section, the polyetherimide resin is 1,3- in contact with food in accordance isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi- ethylidene)bis(4,1-phenyleneoxy)] bis- tions: polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section, Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins the condensation reaction of m- consist of basic polymers produced phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic dianhydride. copolymers, containing no more than (b) Optional adjuvants. The basic 25 weight percent of polymer units de- polymer identified in paragraph (a) of rived from methyl acrylate, are made

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to react in an aqueous medium with (Copies may be obtained from the one or more of the following sub- American Society for Testing Mate- stances: rials, 100 Barr Harbor Dr., West Ammonium hydroxide. Conshohocken, Philadelphia, PA 19428- Calcium carbonate. 2959, or may be examined at the Na- Potassium hydroxide. tional Archives and Records Adminis- Sodium hydroxide. tration (NARA). For information on (b) The finished food-contact article, the availability of this material at when extracted with the solvent or sol- NARA, call 202–741–6030, or go to: http:// vents characterizing the type of food www.archives.gov/federallregister/ and under the conditions of time and codeloflfederallregulations/ temperature characterizing the condi- ibrllocations.html.), and has a 7.0 per- tions of its intended use as determined cent maximum extractable fraction in ° from tables 1 and 2 of § 176.170(c) of this n-hexane at 50 C, as determined by the chapter, yields total extractives in method described in § 177.1520(d)(3)(ii). each extracting solvent not to exceed (b) Chlorinated polyethylene may be 0.5 milligram per square inch of food- used in contact with all types of food, contact surface as determined by the except that when used in contact with methods described in § 176.170(d) of this fatty food of Types III, IV-A, V, VII-A, chapter; and if the finished food-con- and IX described in table 1 of § 176.170(c) tact article is itself the subject of a of this chapter, chlorinated poly- regulation in parts 174, 175, 176, 177, 178, ethylene is limited to use only as a and § 179.45 of this chapter, it shall also modifier admixed at levels not exceed- comply with any specifications and ing 15 weight percent in plastic articles limitations prescribed for it by that prepared from polyvinyl chloride and/ regulation. In testing the finished food- or from vinyl chloride copolymers com- contact articles, a separate test sample plying with § 177.1980. is to be used for each required extract- [42 FR 14572, Mar. 15, 1977, as amended at 49 ing solvent. FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29, (c) The provisions of paragraph (b) of 1994] this section are not applicable to carboxyl-modified polyethylene resins § 177.1615 Polyethylene, fluorinated. used in food-packaging adhesives complying with § 175.105 of this chapter. Fluorinated polyethylene, identified in paragraph (a) of this section, may be § 177.1610 Polyethylene, chlorinated. safely used as food-contact articles in accordance with the following pre- Chlorinated polyethylene identified in this section may be safely used as scribed conditions: articles or components of articles that (a) Fluorinated polyethylene food- contact food, except for articles used contact articles are produced by modi- for packing or holding food during fying the surface of polyethylene arti- cooking, subject to the provisions of cles through action of fluorine gas in this section. combination with gaseous nitrogen as (a) For the purpose of this section, an inert diluent. Such modification af- chlorinated polyethylene consists of fects only the surface of the polymer, basic polymers produced by the direct leaving the interior unchanged. chlorination of polyethylene con- Fluorinated polyethylene articles are forming to the density, maximum n- manufactured from basic resins con- hexane extractable fraction, and max- taining not less than 85 weight-percent imum xylene soluble fraction specifica- of polymer units derived from ethylene tions prescribed under item 2.1 of the and identified in § 177.1520 (a)(2) and table in § 177.1520(c). Such chlorinated (3)(i). polyethylene contains a maximum of 60 (b) Fluorinated polyethylene articles percent by weight of total chlorine, as conform to the specifications and use determined by ASTM 1method D1303–55 limitations of § 177.1520(c), items 2.1 and (Reapproved 1979), ‘‘Standard Test 3.1. Method for Total Chlorine in Vinyl (c) The finished food-contact article, Chloride Polymers and Copolymers,’’ when extracted with the solvent or sol- which is incorporated by reference vents characterizing the type of food

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and under conditions of time and tem- used as provided in §§ 175.105 and 176.210 perature characterizing the conditions of this chapter, and § 177.2800. The proof its intended use as determined from visions of paragraph (b) of this section tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly- ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125 parts per million calculated on the and 176.170(a)(5) of this chapter and basis of the volume of food held by the § 177.1200. food-contact article. § 177.1630 Polyethylene phthalate [48 FR 39057, Aug. 29, 1983] polymers. § 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers Oxidized polyethylene identified in identified in this section may be safely paragraph (a) of this section may be used as, or components of plastics safely used as a component of food-con- (films, articles, or fabric) intended for tact articles, in accordance with the use in contact with food in accordance following prescribed conditions: with the following prescribed condi- (a) Oxidized polyethylene is the basic tions: resin produced by the mild air oxida- (a) Polyethylene phthalate films con- tion of polyethylene conforming to the sist of a base sheet of ethylene density, maximum n-hexane extract- terephthalate polymer, ethylene able fraction, and maximum xylene terephthalate-isophthalate copolymer, soluble fraction specifications pre- or ethylene-1,4-cyclohexylene scribed under item 2.3 of the table in dimethylene terephthalate copoly- § 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to has a minimum number average molec- which have been added optional sub- ular weight of 1,200, as determined by stances, either as constituents of the high temperature vapor pressure os- base sheet or as constituents of coat- mometry, contains a maximum of 5 ings applied to the base sheet. percent by weight of total oxygen, and (b) Polyethylene phthalate articles has an acid value of 9 to 19. consist of a base polymer of ethylene (b) The finished food-contact article, terephthalate polymer, or ethylene-1,4- when extracted with the solvent or sol- cyclohexylene dimethylene vents characterizing the type of food terephthalate copolyesters described in and under the conditions of time and § 177.1315(b)(3), to which have been temperature characterizing the condi- added optional substances, either as tions of its intended use as determined constituents of the base polymer or as from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the chapter, yields net acidified chloro- base polymer. form-soluble extractives not to exceed (c)(1) Polyethylene phthalate 0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of contact surface when tested by the continuous filaments of ethylene methods described in § 177.1330(c), ex- terephthalate polymer and ethylene cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer ble extractives from paper and paper- to which may have been added optional board complying with § 176.170 of this adjuvant substances required in their chapter may be corrected for wax, pet- preparation and finishing. rolatum, and mineral oil as provided in (2) The ethylene terephthalate- § 176.170(d) (5)(iii)(b) of this chapter. If isophthalate copolymer component of the finished food-contact article is the fabric shall not exceed 25 percent itself the subject of a regulation in by weight. The filaments may be blend- parts 174, 175, 176, 177, 178 and § 179.45 of ed with other fibers regulated for the this chapter, it shall also comply with specific use and the spunbonded fabric any specifications and limitations pre- may be further bonded by application scribed for it by such regulations. of heat and/or pressure. (NOTE: In testing the finished food-con- (3) The fabric shall be used only in tact article, use a separate test sample accordance with paragraph (i) of this for each extracting solvent.) section. (c) The provisions of this section are (d) The quantity of any optional sub- not applicable to oxidized polyethylene stance employed in the production of

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polyethylene phthalate plastics does Ethylene-1,4-cyclohexylene dimethylene not exceed the amount reasonably re- terephthalate copolyesters described in quired to accomplish the intended § 177.1315(b)(3). physical or technical effect or any lim- Ethylene terephthalate polymer: Prepared by the condensation of dimethyl itations further provided. Any sub- terephthalate and ethylene glycol. stance employed in the production of Ethylene terephthalate polymer: Prepared polyethylene phthalate plastics that is by the condensation of terephthalic acid the subject of a regulation in parts 174, and ethylene glycol. 175, 176, 177, 178 and 179 of this chapter (iii) Coatings: conforms with any specification in Acrylic copolymers (CAS Reg. No. 30394–86– such regulation. 6): Prepared by reaction of ethyl acrylate (e) Substances employed in the pro- (CAS Reg. No. 140–88–5), methyl methacry- duction of polyethylene phthalate plas- late (CAS Reg. No. 80–62–6), and tics include: methacrylamide (CAS Reg. No. 79–39–0) (1) Substances generally recognized blended with melamine-formaldehyde resin as safe in food. (CAS Reg. No. 68002–20–0). For use in coat- (2) Substances subject to prior sanc- ings for polyethylene phthalate films com- tion or approval for use in poly- plying with paragraph (a) of this section.— ethylene phthalate plastics and used in Ethylene azelate-terephthalate copolymer: The copolymer, dissolved in 1,1,2-trichloro- accordance with such sanction or ap- ethane and/or methylene chloride, may be proval. used as a heat-activated sealant on poly- (3) Substances which by regulation in ethylene terephthalate film intended for parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch- this chapter may be safely used as es that are used as containers of either components of resinous or polymeric nonalcoholic beverages or alcoholic bev- food-contact surfaces subject to the erages containing not more than 15 percent provisions of such regulation. ethyl alcohol. The copolymer has a (4) Substances identified in this para- terephthalate/azelate molecular ratio of 1.25/1.00 and a relative viscosity of not less graph (e)(4) subject to the limitations than 1.5 as determined by a method title prescribed: ‘‘General Procedure of Determining the Relative Viscosity of Resin Polymers,’’ LIST OF SUBSTANCES AND LIMITATIONS which is incorporated by reference. Copies (i) Base sheet: are available from the Center for Food Safety and Applied Nutrition (HFS–200), Ethylene terephthalate copolymers: Pre- Food and Drug Administration, 5100 Paint pared by the condensation of dimethyl Branch Pkwy., College Park, MD 20740, or terephthalate or terephthalic acid with available for inspection, at the National ethylene glycol, modified with one or more Archives and Records Administration of the following: Azelaic acid, dimethyl (NARA). For information on the avail- azelate, dimethyl sebacate, sebacic acid. Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202– pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/ terephthalate or terephthalic acid with federallregister/ ethylene glycol, modified with one or more codeloflfederallregulations/ of the following: Azelaic acid, dimethyl ibrllocations.html. Total residual copoly- azelate, dimethyl sebacate, sebacic acid, mer solvent (1,1,2-trichloroethane and/or pyromellitic dianhydride. The level of methylene chloride) shall not exceed 0.13 pyromellitic dianhydride shall not exceed milligram per square inch of film, and food 0.5 percent by weight of the finished co- contact of the film shall be limited to not polymer which may be used under condi- more than 1 square inch per 250 grams of tions of use E through H as described in beverage. table 2 of § 176.170(c) of this chapter. 2-Ethylhexyl acrylate copolymerized with Ethylene terephthalate-isophthalate copoly- one or more of the following: mers: Prepared by the condensation of Acrylonitrile. dimethyl terephthalate or terephthalic Methacrylonitrile. acid and dimethyl isophthalate or iso- Methyl acrylate. phthalic acid with ethylene glycol. The Methyl methacrylate. finished copolymers contain either: Itaconic acid. (a) 77 to 83 weight percent or Vinylidene chloride copolymerized with one (b) At least 97 weight percent of polymer or more of the following: units derived from ethylene Methacrylic acid and its methyl, ethyl, terephthalate. propyl, butyl, or octyl esters. Acrylic acid and its methyl, ethyl, propyl, (ii) Base sheet and base polymer: butyl, or octyl esters.

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Acrylonitrile. formation on the availability of this ma- Methacrylonitrile. terial at NARA, call 202–741–6030, or go Vinyl chloride. to: http://www.archives.gov/ Itaconic acid. federallregister/ Styrene-maleic anhydride resin, partial 2- codeloflfederallregulations/ butoxyethyl ester, ammonium salt (CAS ibrllocations.html. Reg. No. 68890–80–2). For use only as a coat- The modifier is used at a level not to ex- ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene plying with paragraph (a) of this section, terephthalate film. The average thick- at levels not to exceed 0.025 gram per ness of the finished film shall not exceed square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch). inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3- types VIII and IX in table 1 of § 176.170(c) of benzenedimethanamine (CAS Reg. No. this chapter, under use conditions E, F, 25718–70–1) meeting the specifications in and G in table 2 of § 176.170(c) of this chap- § 177.1500(b), item 10, when tested by the ter. methods given in § 177.1500(c). The modifier is used in polyethylene terephthalate (iv) Emulsifiers: at a level not to exceed 30 percent by Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene juvant in the application of coatings to the terephthalate. base sheet or base polymer. Chloroform-soluble extractives shall not Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5 application of coatings to the base sheet or milligram/inch2) of food-contact surface base polymer. of the modified polyethylene 2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to Reg. No. 1804–87–1). For use only in copoly- the following solvents at temperatures mer coatings on polyethylene phthalate and times indicated: film under conditions of use E, F, and G de- (a) Distilled water at 49 °C (120 °F) for 24 scribed in table 2 of § 175.300(d) of this chap- hours; ter, and limited to use at a level not to ex- (b) n-Heptane at 49 °C (120 °F) for 24 hours; ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 °C (120 °F) polymer coating. for 24 hours. For use in contact with all types of foods (v) Modifier: except (a) those containing more than 8 1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera- polymer with 1,4-butanediol and a-hydro- tures over 49 °C (120 °F). omega-hydroxypoly(oxy-1,4-butanediyl) CAS Reg. No. 9078–71–1) meeting the fol- (f) Polyethylene phthalate plastics lowing specifications: conforming with the specifications pre- Melting point: 200° to 215 °C as determined scribed in paragraph (f)(1) of this sec- by ASTM method D2117–82, ‘‘Standard tion are used as provided in paragraph Test Method for Melting Point of (f)(2) of this section: Semicrystalline Polymers by the Hot (1) Specifications. (i) The food contact Stage Microscopy Method,’’ which is incorporated by reference. Copies may be surface, when exposed to distilled obtained from the American Society for water at 250 °F for 2 hours, yields chlo- Testing Materials, 100 Barr Harbor Dr., roform-soluble extractives not to ex- West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface 19428-2959, or may be examined at the Na- exposed to the solvent; and tional Archives and Records Administra- (ii) The food contact surface, when tion (NARA). For information on the exposed to n-heptane at 150 °F for 2 availability of this material at NARA, hours, yields chloroform-soluble ex- call 202–741–6030, or go to: http:// tractives not to exceed 0.5 mg/in2 of www.archives.gov/federallregister/ codeloflfederallregulations/ food contact surface exposed to the sol- ibrllocations.html. vent. Density: 1.15 to 1.20 as determined by ASTM (2) Conditions of use. The plastics are method D1505–68 (Reapproved 1979), used for packaging, transporting, or ‘‘Standard Test Method for Density of holding food, excluding alcoholic bev- Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed nique,’’ which is incorporated by ref- 250 °F. erence. Copies may be obtained from the (g) Polyethylene phthalate plastics American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, conforming with the specifications pre- Philadelphia, PA 19428-2959, or may be scribed in paragraph (g)(1) of this sec- examined at the National Archives and tion are used as provided in paragraph Records Administration (NARA). For in- (g)(2) of this section.

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(1) Specifications. (i) The food contact including filtration, at temperatures surface meets the specifications in not exceeding 212 °F. paragraph (f)(1) of this section; and (iii) Filtration of bulk alcoholic bev- (ii) The food contact surface when ex- erages, not exceeding 50 percent alco- posed to 50 percent ethyl alcohol at 120 hol by volume, at temperatures not ex- °F for 24 hours, yields chloroform-solu- ceeding 120 °F. ble extractives not to exceed 0.5 mg/in2 (j) Polyethylene phthalate plastics, of food contact surface exposed to the composed of ethylene terephthalate- solvent. isophthalate containing a minimum of (2) Conditions of use. The plastics are 98 weight percent of polymer units de- used for packaging, transporting, or rived from ethylene terephthalate, or holding alcoholic beverages that do not ethylene-1,4-cyclohexylene exceed 50 percent alcohol by volume. dimethylene terephthalate copoly- (h) Uncoated polyethylene phthalate esters described in § 177.1315(b)(3), con- plastics consisting of a base sheet or forming with the specifications pre- base polymer prepared as prescribed scribed in paragraph (j)(1) of this sec- from substances identified in para- tion, are used as provided in paragraph graphs (e)(4)(i) and (ii) of this section (j)(2) of this section. and conforming with the specifications (1) Specifications. (i) The food contact prescribed in paragraph (h)(1) of this surface meets the specifications in section are used as provided in para- paragraph (f)(1) of this section and graph (h)(2) of this section: (ii)(a) Containers with greater than 500 (1) Specifications. (i) The food contact mL capacity. The food-contact surface surface, when exposed to distilled when exposed to 95 percent ethanol at water at 250 °F for 2 hours yields chlo- 120 °F for 24 hours should not yield roform-soluble extractives not to ex- chloroform-soluble extractives in exceed 0.02 milligram/inch 2 of food con- cess of 0.005 mg/in 2. tact surface exposed to the solvent; and (b) Containers with less than or equal to (ii) The food contact surface, when 500 mL capacity. The food contact sur- ° exposed to n-heptane at 150 F for 2 face when exposed to 95 percent eth- hours, yields chloroform-soluble ex- anol at 120 °F for 24 hours should not tractives not to exceed 0.02 milligram/ yield chloroform-soluble extractives in 2 inch of food contact surface exposed excess of 0.05 mg/in 2. to the solvent. (2) Conditions of use. The plastics are (2) Conditions of use. The plastics are used for packaging, transporting, or used to contain foods during oven bak- holding alcoholic foods that do not ex- ing or oven cooking at temperatures ceed 95 percent alcohol by volume. above 250 °F. (i) Polyethylene phthalate fabric, [42 FR 14572, Mar. 15, 1977, as amended at 42 identified in paragraph (c) of this sec- FR 18611, Apr. 8, 1977; 44 FR 40886, July 13, tion and conforming with the specifica- 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844, tions prescribed in paragraph (i)(1) of Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 30361, July 1, 1983; 49 FR 10110, Mar. 19, 1984; this section, is used only as provided in 50 FR 31047, July 24, 1985; 51 FR 3772, Jan. 30, paragraph (i)(2) of this section. 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, (1) Specifications. Chloroform-soluble Apr. 19, 1989; 54 FR 24898, June 12, 1989; 60 FR extractives shall not exceed 0.2 milli- 57927, Nov. 24, 1995; 60 FR 61654, Dec. 1, 1995; gram/inch 2 of food-contact surface 61 FR 46718, Sept. 5, 1996] when exposed to the following solvents at temperatures and times indicated: § 177.1632 (i) Distilled water at 212 °F for 2 Poly(phenyleneterephthalamide) hours. resins. (ii) n-Heptane at 150 °F for 2 hours. Poly(phenyleneterephthalamide) res- (iii) 50 percent ethyl alcohol at 120 °F ins identified in paragraph (a) of this for 24 hours. section may be safely used as articles (2) Conditions of use. The plastics are or components of articles intended for intended for: repeated contact with food. (i) Dry food contact. (a) Identity. For the purpose of this (ii) Bulk food (excluding alcoholic section, the poly(phenylene- beverages) repeated use applications, terephthalamide) resins (CAS Reg. No.

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26125–61–1) are produced by the polym- refluxed in a 50 percent ethanol/water erization of terephthalolyl chloride mixture for 24 hours, yields total with p-phenylenediamine. The extractables not exceeding 0.65 percent poly(phenyleneterephthalamide) resin by weight of the sample. fibers and yarns may contain optional (d) Conditions of use. (1) adjuvant substances required in their Poly(phenyleneterephthalamide) resins preparation and finishing. in the form of continuous filament (b) Optional adjuvant substances. The yarns and fibers may be used as compo- poly(phenyleneterephthalamide) resins nents of articles intended for repeated identified in paragraph (a) of this sec- use in contact with food at tempera- tion may contain the following op- tures not to exceed 260 °C (500 °F). All tional adjuvant substances, subject to items are scoured prior to use by agita- any limitation on their use: tion in a water bath containing 0.5 (1) Optional adjuvant substances au- gram/liter of tetrasodium thorized for this use in accordance with pyrophosphate and 0.5 percent deter- § 174.5 of this chapter. gent. The items are agitated at 80 °C (2) Optional finish components, total (180 °F) for 20 minutes, and then sub- weight not to exceed 1 percent by jected to a cold water rinse. weight of the base polymer, as follows: (2) Poly(phenyleneterephthalamide) resins in the form of pulp may be used List of substances Limitations as gaskets and packing for food proc- Diundecylphthalate (CAS essing equipment at temperatures not Reg. No. 3648–20–2). to exceed 260 °C (500 °F). Mono- and dipotassium salts of lauryl phosphate (CAS [57 FR 3125, Jan. 28, 1992, as amended at 69 Reg. No. 39322–78–6). FR 24512, May 4, 2004] o-Phenylphenol (CAS Reg. For use as a fungicide for fin- No. 90–43–7). ish coating materials. Not § 177.1635 Poly(p-methylstyrene) and to exceed 0.01 percent by weight of the base poly- rubber-modified poly(p-methyl- mer. styrene). Poly(oxyethylene/ Poly(p-methylstyrene) and rubber- oxypropylen- e)monobutylether (CAS modified poly(p-methylstyrene) identi- Reg. No. 9038–95–3). fied in this section may be safely used Poly(oxyethylene) as components of articles intended for mono(nonylphenyl)ether (CAS Reg. No. 9016–45– use in contact with food, subject to the 9). provisions of this section: Polyvinyl methylether (CAS (a) Identity. For the purposes of this Reg. No. 9003–09–2). section, poly(p-methylstyrene) and Poly(oxyethylene) sorbitol monolaurate tetraoleate rubber-modified poly(p-methylstyrene) (CAS Reg. No. 71243–28– are basic polymers, manufactured as 2). described in this paragraph, meeting Poly(oxyethylene) sorbitol hexaoleate (CAS Reg. No. the specifications prescribed in para- 57171–56–9). graph (c) of this section. 4,4′-Butylidenebis (6-tert- For use only as an oxidation (1) Poly(p-methylstyrene) (CAS Reg. butyl-m-cresol) (CAS Reg. inhibitor for finish coating No. 24936–41–2) polymer produced by the No. 85–60–9). materials. Not to exceed 0.01 percent by weight of polymerization of p-methylstyrene. the base polymer. (2) Rubber-modified poly(p- methylstyrene) (CAS Reg. No. 33520–88– (c) Specifications. (1) 6) polymer produced by combining sty- Poly(phenyleneterephthalamide) resins rene-butadiene copolymer and/or in the form of continuous filament polybutadiene with poly(p- yarns or fibers that have been scoured methylstyrene), either during or after in accordance with paragraph (d)(1) of polymerization of the poly(p- this section, when refluxed in a 50 per- methylstyrene), such that the finished cent ethanol/water mixture for 24 polymers contain not less than 75 hours, yields total extractables not ex- weight percent of total polymer units ceeding 0.5 percent by weight of the derived from p-methylstyrene) mon- sample. omer. (2) Poly(phenyleneterephthalamide) (b) Optional adjuvants. The basic resins in the form of pulp, when polymers identified in paragraph (a) of

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this section may contain optional adju- (a)(1) and (a)(2), respectively, of this vant substances required in the produc- section shall be used in contact with tion of such basic polymers. Such op- food only under conditions of use B tional adjuvant substances may in- through H set forth in table 2 of clude substances permitted for such § 176.170(c) of this chapter. use by applicable regulations in this chapter, substances generally recog- [48 FR 31384, July 8, 1983, as amended at 54 nized as safe in food, substances gen- FR 24898, June 12, 1989; 55 FR 52989, Dec. 26, 1990] erally recognized as safe in indirect additives, and substances used in accord- § 177.1637 Poly(oxy-1,2- ance with prior sanction or approval. ethanediyloxycarbonyl-2,6- (c) Specifications. (1) Poly(p- naphthalenediylcarbonyl) resins. methylstyrene) basic polymers identified in paragraph (a)(1) of this section Poly(oxy-1,2-ethanediyloxycarbonyl- shall contain not more than 1 weight 2,6-naphthalenediylcarbonyl) resins percent of total residual p- identified in paragraph (a) of this sec- methystyrene monomer, as determined tion may be safely used as articles or by a gas chromatographic method ti- components of articles intended for use tled, ‘‘Gas Chromatographic Deter- in contact with food in accordance mination of PMS and PET in PPMS with the following conditions: Basic Polymers,’’ which is incorporated (a) Identity. For the purpose of this by reference. Copies are available from section, poly(oxy-1,2- the Center for Food Safety and Applied ethanediyloxycarbonyl-2,6- Nutrition (HFS–200), Food and Drug naphthalenediylcarbonyl) resins (CAS Administration, 5100 Paint Branch Reg. No. 24968–11–4) are polymers Pkwy., College Park, MD 20740, or formed by catalytic transesterification available for inspection at the National of 2,6-dimethylnaphthalene Archives and Records Administration dicarboxylate with ethylene glycol fol- (NARA). For information on the avail- lowed by catalytic polycondensation. ability of this material at NARA, call (b) Specifications—(1) Density. The 202–741–6030, or go to: http:// density of poly(oxy-1,2- www.archives.gov/federallregister/ ethanediyloxycarbonyl-2,6- codeloflfederallregulations/ naphthalenediylcarbonyl) resins shall ibrllocations.html. be between 1.33 and 1.40 grams per (2) Rubber-modified poly(p- cubic centimeter. methylstyrene) basic polymers identi- (2) Inherent viscosity. The finished fied in paragraph (a)(2) of this section food-contact article shall have a min- shall contain not more than 0.5 weight imum inherent viscosity of 0.55 deci- percent of total residual p- methylstyrene monomer, as deter- liter per gram in a solution of 0.1 gram mined by the method identified in of polymer in 100 milliliters of a 25/40/ paragraph (c)(1) of this section 35 (weight/weight/weight) solution of p- (d) Other specifications and limitations. chlorophenol/tetrachloroethane/phenol. The poly(p-methylstyrene) and rubber- The viscosity is determined by East- modified poly(p-methylstyrene) identi- man Chemical Co.’s method ECD-A-AC- fied in and complying with this sec- G-V-1-5, ‘‘Determination of Dilute So- tion, when used as components of the lution Viscosity of Polyesters,’’ dated food-contact surface of any article that May 31, 1988, which is incorporated by is the subject of a regulation in parts reference in accordance with 5 U.S.C. 175, 176, 177, 178 and § 179.45 of this chap- 552(a) and 1 CFR part 51. Copies are ter, shall comply with any specifica- available from the Office of Food Addi- tions and limitations prescribed by tive Safety (HFS–200), Center for Food such regulation for the article in the Safety and Applied Nutrition, Food and finished form in which it is to contact Drug Administration, 5100 Paint food. Branch Pkwy., College Park, MD 20740, (e) Conditions of use. Poly(p- 240–402–1200, or may be examined at the methylstyrene) basic polymers and Center for Food Safety and Applied Nu- rubber-modified poly(p-methylstyrene) trition’s Library, Food and Drug Ad- basic polymers identified in paragraphs ministration, 5100 Paint Branch Pkwy.,

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College Park, MD 20740, or at the Na- styrene, either during or after polym- tional Archives and Records Adminis- erization of the polystyrene, such that tration (NARA). For information on the finished basic polymers contain not the availability of this material at less than 75 weight percent of total NARA, call 202–741–6030, or go to: http:// polymer units derived from styrene www.archives.gov/federallregister/ monomer. codeloflfederallregulations/ (b) Optional adjuvants. The basic ibrllocations.html. polymers identified in paragraph (a) of (c) Extraction limitations. A 0.5 milli- this section may contain optional adju- meter (0.02 inch) thick sheet of resin vant substances required in the produc- when extracted with water at 121 °C tion of such basic polymers. Such op- (250 °F) for 2 hours shall yield total tional adjuvant substances may in- nonvolatile extractives not exceeding clude substances permitted for such 2.0 micrograms per square inch of ex- use by regulations in parts 170 through posed resin surface. 189 of this chapter, substances gen- (d) Conditions of use. The finished erally recognized as safe in food, and food contact article shall be: substances used in accordance with a (1) Used in contact only with food of prior sanction or approval. Types I, II, IVB, VIA, VIB, VIIB, and (c) Specifications. (1) Polystyrene VIII identified in table 1 of § 176.170(c) basic polymers identified in paragraph of this chapter, under conditions of use (a)(1) of this section shall contain not A through H described in table 2 of more than 1 weight percent of total re- § 176.170(c) of this chapter; and with sidual styrene monomer, as determined food of Types III, IVA, V, VIC, VIIA, by the method described in paragraph and IX identified in table 1 of (d) of this section, except that when § 176.170(c) of this chapter, under condi- used in contact with fatty foods of tions of use C through H described in Types III, IV-A, V, VII-A, and IX de- table 2 of § 176.170(c) of this chapter; scribed in table 1 of § 176.170(c) of this and chapter, such polystyrene basic poly- (2) Identified in a manner that will mers shall contain not more than 0.5 differentiate the article from articles weight percent of total residual sty- made of other polymeric resins to fa- rene monomer. cilitate collection and sorting. (2) Rubber-modified polystyrene [61 FR 14965, Apr. 4, 1996, as amended at 78 basic polymers identified in paragraph FR 14666, Mar. 7, 2013] (a)(2) of this section shall contain not more than 0.5 weight percent of total § 177.1640 Polystyrene and rubber- residual styrene monomer, as deter- modified polystyrene. mined by the method described in para- Polystyrene and rubber-modified pol- graph (d) of this section. ystyrene identified in this section may (d) Analytical method for determination be safely used as components of arti- of total residual styrene monomer con- cles intended for use in contact with tent—(1) Scope. This method is suitable food, subject to the provisions of this for the determination of residual sty- section. rene monomer in all types of styrene (a) Identity. For the purposes of this polymers. section, polystyrene and rubber-modi- (2) Principle. The sample is dissolved fied polystyrene are basic polymers in methylene chloride. An aliquot of manufactured as described in this para- the solution is injected into a gas chro- graph so as to meet the specifications matograph. The amount of styrene prescribed in paragraph (c) of this sec- monomer present is determined from tion when tested by the method de- the area of the resulting peak. scribed in paragraph (d) of this section. (3) Apparatus—(i) Gas chromatograph. (1) Polystyrene consists of basic poly- Beckman GC-2A gas chromatograph mers produced by the polymerization with hydrogen flame detector or appa- of styrene. ratus of equivalent sensitivity. (2) Rubber-modified polystyrene con- (ii) Chromatograph column. One-quar- sists of basic polymers produced by ter inch outside diameter stainless combining styrene-butadiene copoly- steel tubing (0.028 inch wall thickness), mers and/or polybutadiene with poly- 4 feet in length, packed with 20 percent

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polyethylene glycol (20,000 molecular (e) Other specifications and limitations. weight) on alkaline treated 60–80 mesh The polystyrene and rubber-modified firebrick. polystyrene identified in and com- (iii) Recorder. Millivolt range of 0–1, plying with this section, when used as chart speed of 30 inches per hour. components of the food-contact surface (4) Reagents. Compressed air, purified; of any article that is the subject of a helium gas; hydrogen gas; methylene regulation in parts 174, 175, 176, 177, 178 chloride, redistilled; and styrene mon- and § 179.45 of this chapter, shall com- omer, redistilled. ply with any specifications and limita- (5) Operating conditions for the gas tions prescribed by such regulation for chromatograph. (i) The column is oper- the article in the finished form in ated at a temperature of 100 °C with a which it is to contact food. helium flow rate of 82 milliliters per (f) Nonapplicability. The provisions of minute. this section are not applicable to poly- (ii) The hydrogen burner is operated styrene and rubber-modified poly- with 15 pounds per square inch of air styrene used in food-packaging adhe- pressure and 7 pounds per square inch sives complying with § 175.105 of this of hydrogen pressure. chapter. (iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer- flame detector is set at 2×102. polyepoxy resins. (6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res- standard solution by weighing accu- ins may be safely used as the food-con- rately 15 to 20 milligrams of styrene tact surface of articles intended for monomer into a 2-ounce bottle con- packaging, transporting, holding, or taining 25.0 milliliters of methylene otherwise contacting dry food, in ac- chloride. Cap the bottle tightly and cordance with the following prescribed shake to thoroughly mix the solution. conditions: (ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy inject 1 microliter of the standard solu- resins are the reaction products of liq- tion into the gas chromatograph. Meas- uid polysulfide polymers and ure the area of the styrene monomer polyfunctional epoxide resins, cured peak which emerges after approxi- with the aid of mately 12 minutes. tri(dimethylaminomethyl) phenol, to (7) Procedure. (i) Transfer 1 gram of which have been added certain optional sample (accurately weighed to the substances to impart desired techno- nearest 0.001 gram to a 2-ounce bottle logical properties to the resins. Subject and add several glass beads. Pipette to any limitations prescribed in this 25.0 milliliters of methylene chloride section, the optional substances may into the bottle. Cap the bottle tightly include: and place on a mechanical shaker. (1) Substances generally recognized Shake until the polymer is completely as safe in food and food packaging. dissolved. If any insoluble residue re- (2) Substances the use of which is mains, allow the bottle to stand (or permitted under applicable regulations centrifuge at a low speed) until a clear in this part, prior sanctions, or approv- supernatant layer appears. als. (ii) By means of a microliter syringe, (3) Substances named in this subpara- inject 3 microliters of the clear super- graph and further identified as re- natant liquid into the gas chro- quired: matograph. (iii) Measure the area of the resulting List of substances Limitations styrene monomer peak. Compare the Bis(2-chloroethyl) formal. sample peak area with the area pro- Bis(dichloropropyl) formal ...... Cross-linking agent. duced by the standard styrene mon- Butyl alcohol ...... Solvent. Carbon black (channel process). omer solution. Calculation: Chlorinated paraffins ...... Cross-linking agent. Epoxidized linseed oil. Percent residual styrene Epoxidized soybean oil. monomer=Milligrams monomer in stand- Epoxy resins (as listed in ard×peak area of sample/Peak area of mon- § 175.300(b)(3)(viii)(a) of this chap- omer standard×sample weight in grams×30 ter)..

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List of substances Limitations isopropylidenediphenol is made to react with 4,4′-dichlorodiphenyl sulfone Ethylene glycol monobutyl ether ...... Solvent. Magnesium chloride. in such a way that the finished resins Methyl isobutyl ketone ...... Solvent. have a minimum number average mo- Naphthalene sulfonic acid-formalde- lecular weight of 15,000, as determined hyde condensate, sodium salt. Sodium dibutyl naphthalene Wetting agent. by osmotic pressure in sulfonate. monochlorobenzene; or Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene] Sodium polysulfide. ′ b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent. polymer with 4,4 -(1- ether. methylethylidene)bis[phenol] (min- Titanium dioxide. imum 92 percent) and 4,4′- Toluene ...... Solvent. Trichloroethane ...... Cross-linking agent. sulfonylbis[phenol] (maximum 8 per- 1,2,3-Trichloropropane ...... Do. cent) (CAS Reg. No. 88285–91–0) pro- Urea-formaldehyde resins. duced when a mixture of 4,4′- Xylene ...... Solvent. isopropylidenediphenol (minimum 92 percent) and 4,4′-sulfonylbis[phenol] (b) The resins are used as the food- (maximum 8 percent) is made to react contact surface for dry food. with 4,4′-dichlorodiphenyl sulfone in (c) An appropriate sample of the fin- such a way that the finished resin has ished resin in the form in which it con- a minimum number average molecular tacts food, when subjected to ASTM weight of 26,000, as determined by os- method D968–81, ‘‘Standard Test Meth- motic pressure in dimethylformamide. ods for Abrasion Resistance of Organic (b) The basic polysulfone resins iden- Coatings by the Falling Abrasive tified in paragraph (a) of this section Tester,’’ which is incorporated by ref- may contain optional adjuvant sub- erence (Copies may be obtained from stances required in the production of the American Society for Testing Ma- such basic resins. The optional adju- terials, 100 Barr Harbor Dr., West vant substances required in the produc- Conshohocken, Philadelphia, PA 19428- tion of the basic polysulfone resins 2959, or may be examined at the Na- may include substances described in tional Archives and Records Adminis- § 174.5(d) of this chapter and the fol- tration (NARA). For information on lowing: the availability of this material at NARA, call 202–741–6030, or go to: http:// List of substances Limitations www.archives.gov/federallregister/ codeloflfederallregulations/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as residual solvent in finished basic ibrllocations.html.), using No. 50 Emery resin in paragraph (a)(1) of this abrasive in lieu of Ottawa sand, shall section. exhibit and abrasion coefficient of not Monochlorobenzene .. Not to exceed 500 parts per million less than 20 liters per mil of film thick- as residual solvent in finished basic resin in paragraph (a)(1) of ness. this section. [42 FR 14572, Mar. 15, 1977, as amended at 49 N-methyl-2- Not to exceed 0.01 percent (100 pyrrolidone. parts per million) as residual sol- FR 10110, Mar. 19, 1984] vent in finished basic resin in paragraph (a)(2) of this section. § 177.1655 Polysulfone resins. Polysulfone resins identified in para- (c) Polysulfone resins, when ex- graph (a) of this section may be safely tracted at reflux temperatures for 6 used as articles or components of arti- hours with the solvents—distilled cles intended for use in contact with water, 50 percent (by volume) ethyl al- food, in accordance with the following cohol in distilled water, 3 percent ace- prescribed conditions: tic acid in distilled water, and n- (a) For the purpose of this section, heptane, yield total extractives in each polysulfone resins are: extracting solvent not to exceed 0.0078 (1) Poly(oxy-p-phenylenesulfonyl-p- milligram per square centimeter (0.05 phenyleneoxy-p- milligram per square inch) of resin sur- phenyleneisopropylidene-p-phenylene) face. Note: In testing the finished resins (CAS Reg. No. 25154–01–2) con- polysulfone resins, use a separate resin sisting of basic resins produced when test sample for each required extract- the disodium salt of 4,4′- ing solvent.

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(d) Polysulfone resins intended for re- concentration of the test solution in peated use in contact with food may be grams per 100 milliliters. used under conditions of use A through (2) Poly(tetramethylene H in table 2 of § 176.170(c) of this chap- terephthalate) in the finished form in ter. The resins intended for single-serv- which it is to contact food shall yield ice food-contact use may be used only total extractives as follows: under condition of use H described in (i) Not to exceed 0.08 milligram per table 2 of § 176.170(c) of this chapter. square inch of food contact surface [51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F 1986; 61 FR 29475, June 11, 1996] with distilled water. (ii) Not to exceed 0.02 milligram per § 177.1660 Poly (tetramethylene square inch of food contact surface terephthalate). when extracted for 2 hours at 150 °F Poly(tetramethylene terephthalate) with n-heptane. (poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F in this section may be safely used as with 3 percent aqueous acetic acid. articles or components of articles in- (iv) Not to exceed 0.02 milligram per tended to contact food, in accordance square inch of food contact surface with the following prescribed condi- when extracted for 2 hours at 65.6 °C tions: (150 °F) with 50 percent ethanol. (a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50 section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29, terephthalate) is the reaction product 1987] of dimethyl terephthalate with 1,4- butanediol to which may have been § 177.1670 Polyvinyl alcohol film. added certain optional substances to Polyvinyl alcohol film may be safely impart desired technological properties used in contact with food of the types to the polymer. identified in § 176.170(c) of this chapter, (b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in Poly(tetramethylene terephthalate) accordance with the following pre- identified in paragraph (a) of this sec- scribed conditions: tion may contain optional adjuvant (a) The polyvinyl alcohol film is pro- substances. The quantity of any op- duced from polyvinyl alcohol having a tional adjuvant substance employed in minimum viscosity of 4 centipoises the production of the polymer does not when a 4-percent aqueous solution is exceed the amount reasonably required tested at 20 °C. to accomplish the intended technical (b) The finished food-contact film for or physical effect. Such adjuvants may use in contact with Food Types V or include substances generally recog- IX, when extracted with the solvent nized as safe in food, substances used in characterizing the type of food and accordance with prior sanction, and under the conditions of time and tem- substances permitted under applicable perature characterizing its intended regulations in this part. use as determined from tables 1 and 2 (c) Specifications. (1) Inherent vis- of § 176.170(c) of this chapter, yields cosity of a 0.50 percent solution of the total extractives not to exceed 0.078 polymer in phenol/tetrachloroethane milligram per square centimeter (0.5 (60/40 weight ratio) solvent is not less milligram per square inch) of food-con- than 0.6 as determined using a Wagner tact surface when tested by ASTM viscometer (or equivalent) and cal- method F34–76 (Reapproved 1980), culated from the following equation: ‘‘Standard Test Method for Liquid Ex- traction of Flexible Barrier Materials,’’ (natural log arithm of N ) which is incorporated by reference. Inherent = r viscos ity Copies may be obtained from the Amer- (c) ican Society for Testing Materials, 100 where: Barr Harbor Dr., West Conshohocken,

Nr=Ratio of flow time of the polymer solu- Philadelphia, PA 19428-2959, or may be tion to that of the solvent and c=polymer examined at the National Archives and

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Records Administration (NARA). For 1,3-Butylene glycol. information on the availability of this 1,4–Cyclohexane dimethanol (CAS Reg. No. material at NARA, call 202–741–6030, or 105–08–8). go to: http://www.archives.gov/ 2,2-Dimethyl-1,3-propanediol. Ethylene glycol. federallregister/ 1,6–Hexanediol (CAS Reg. No. 629–11–8).a– codeloflfederallregulations/ Hydro–w–hydroxypoly(oxy–1,4–butanediyl) ibrllocations.html. (CAS Reg. No. 25190–06–1). (c) The finished food-contact film a-Hydro-omega-hydroxypoly (oxytetra- shall not be used as a component of methylene). food containers intended for use in con- a,a′-(Isopropylidenedi-p-phenylene)bis[omega- tact with water. hydroxypoly (oxypropylene)(3–4 moles)], average molecular weight 675. [42 FR 14572, Mar. 15, 1977, as amended at 49 Maleic anhydride. FR 10110, Mar. 19, 1984] Methyl oxirane polymer with oxirane (CAS Reg. No. 9003–11–6). § 177.1680 Polyurethane resins. Methyl oxirane polymer with oxirane, ether The polyurethane resins identified in with 1,2,3–propanetriol (CAS Reg. No. 9082– paragraph (a) of this section may be 00–2). a,a′a″,a″′-Neopentanetetrayltetrakis [omega- safely used as the food-contact surface hydroxypoly (oxypropylene) (1–2 moles)], of articles intended for use in contact average molecular weight 400. with bulk quantities of dry food of the Pentaerythritol-linseed oil alcoholysis prod- type identified in § 176.170(c) of this uct. chapter, table 1, under Type VIII, in ac- Phthalic anhydride. cordance with the following prescribed Polybutylene glycol. conditions: Polyethyleneadipate modified with ethanol- (a) For the purpose of this section, amine with the molar ratio of the amine to the adipic acid less than 0.1 to 1. polyurethane resins are those produced Poly(oxycarbonylpentamethylene). when one or more of the isocyanates Polyoxypropylene ethers of 4.4′-isopropyl- listed in paragraph (a)(1) of this section idenediphenol (containing an average of 2– is made to react with one or more of 4 moles of propylene oxide). the substances listed in paragraph Polypropylene glycol. (a)(2) of this section: a,a′,a″-1,2,3-Propanetriyltris [omega- (1) Isocyanates: hydroxypoly (oxypropylene) (15–18 moles)], average molecular weight 3,000. Bis(isocyanatomethyl) benzene (CAS Reg. Propylene glycol. No. 25854–16–4). a,a′,a″-[Propylidynetris (methylene)] tris Bis(isocyanatomethyl) cyclohexane (CAS [omega-hydroxypoly (oxypropylene) (min- Reg. No. 38661–72–2). imum 1.5 moles)], minimum molecular 4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi- weight 400. tolylene diisocyanate). a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]- Diphenylmethane diisocyanate. omega-hydroxypoly(oxyethylene) (5 moles), Hexamethylene diisocyanate. average molecular weight 425. 3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- Trimethylol propane. hexyl isocyanate. 4,4-Methylenebis(cyclohexyl isocyanate). (b) Optional adjuvant substances em- Toluene diisocyanate. ployed in the production of the polyurethane resins or added thereto to im- (2) List of substances: part desired technical or physical prop- Adipic acid. erties may include the following sub- 1,4-Butanediol. stances:

List of substances Limitations

1-[(2-Aminoethyl)amino]2-propanol ...... As a curing agent. 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ...... As a preservative. Colorants used in accordance with § 178.3297 of this chapter.. Dibutyltin diacetate ...... As a catalyst. Dibutyltin dichloride ...... Do. Dibutyltin dilaurate ...... Do. N,N-Dimethyldodecylamine ...... Do. N-Dodecylmorpholine ...... Do. a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer. ]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], average molecular weight 15,000. 4,4′-Methylenedianiline ...... As a curing agent.

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List of substances Limitations

1,1′,1″-Nitrilotri-2-propanol ...... Do. 2,2′-(p-Phenylenedioxy) diethanol ...... Do. Polyvinyl isobutyl ether. Polyvinyl methyl ether. Soyaalkyd resin ...... Conforming in composition with § 175.300 of this chapter and containing litharge not to exceed that residual from its use as the reaction catalyst and creosol not to exceed that required as an antioxidant. Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer. mate)]methane (CAS Reg. No. 6683–19–8). N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ...... As a curing agent. Triethanolamine ...... Do. Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent. 57609–64–0).

(c) An appropriate sample of the fin- § 177.1810 Styrene block polymers. ished resin in the form in which it con- The styrene block polymers identi- tacts food, when subjected to ASTM fied in paragraph (a) of this section method D968–81, ‘‘Standard Test Meth- may be safely used as articles or as ods for Abrasion Resistance of Organic components of articles intended for use Coatings by the Falling Abrasive in contact with food, subject to provi- Tester,’’ which is incorporated by ref- sions of this section. erence (Copies may be obtained from (a) For the purpose of this section, the American Society for Testing Ma- styrene block polymers are basic poly- terials, 100 Barr Harbor Dr., West mers manufactured as described in this Conshohocken, Philadelphia, PA 19428- paragraph, so that the finished poly- 2959, or may be examined at the Na- mers meet the specifications prescribed tional Archives and Records Adminis- in paragraph (b) of this section, when tration (NARA). For information on tested by the methods described in the availability of this material at paragraph (c) of this section. NARA, call 202–741–6030, or go to: http:// (1) Styrene block polymers with 1,3- www.archives.gov/federallregister/ butadiene are those produced by the codeloflfederallregulations/ catalytic solution polymerization of ibrllocations.html.), using No. 50 Emery styrene and 1,3-butadiene. abrasive in lieu of Ottawa sand, shall (2) Styrene block polymers with 2- exhibit an abrasion coefficient of not methyl-1,3-butadiene are those produced by the catalytic solution polym- less than 20 liters per mil of film thick- erization of styrene and 2-methyl-1,3- ness. butadiene. [42 FR 14572, Mar. 15, 1977, as amended at 46 (3) Styrene block polymers with 1,3- FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, butadiene, hydrogenated are those pro- 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, duced by the catalytic solution polym- Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] erization of styrene and 1,3-butadiene, and subsequently hydrogenated. (b) Specifications:

Maximum extract- Maximum extractable fraction in dis- able fraction in 50 Molecular Glass transi- tilled water at spec- percent ethanol at Styrene block polymers weight Solubility tion points ified temperatures, specified tempera- (minimum) times, and tures, times, and thicknesses thicknesses

1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01 butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur- components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C food of Types I, II, IV-B, VI, VII-B, (¥96 °F) temperature for (150 °F) for 2 hr and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm § 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick conditions of use D, E, F, and G de- 122 °C thick sample. sample. scribed in table 2 in § 176.170(c) of (252 °F). this chapter.

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(ii) Styrene block polymers with 1,3-bu- 29,000 ...... do ...... do ...... do ...... Do. tadiene; for use as components of pressure-sensitive adhesives that contact food of Types I, II, IV-B, VI, VII-B, and VIII identified in table 1 in § 176.170(c) of this chapter under conditions of use C, D, E, F and G described in table 2 in § 176.170(c) of this chapter, provided the pressure- sensitive adhesives be applied only to closure tapes for sealing containers having a capacity of not less than 160 cc (5.5 fluid ounces) and that the area of the adhesive exposed to food shall not exceed 4.03 cm2 (0.625 in2). The pressure-sensitive adhesive may contain terpene resins as identified in § 175.125(b)(2) of this chapter. 2. Styrene block polymers with 2-meth- 29,000 ...... do ...... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur- or as components of articles that to ¥47 °C face at reflux face at 66 °C contact food of Types I, II, IV-B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr VII-B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm § 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick 122 °C sample. (Option- sample. (Option- (252 °F). ally, maximum ally, maximum net residue solu- net residue soluble in chloroform ble in chloroform shall not exceed shall not exceed 0.00020 mg/cm2 0.00040 mg/cm2 (0.0013 mg/in2) (0.0025 mg/in2) of surface.). of surface.) 3. (i) Styrene block polymers with 1,3- 16,000 ...... do ...... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01 butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur- No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr contact food of Types I, II, IV-B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm VII-B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick § 176.170(c) of this chapter. 98 °C (208 sample. sample. °F). (ii) Styrene block polymers with 1,3-bu- 16,000 ...... do ...... do ...... do ...... Do. tadiene, hydrogenated (CAS Reg. No. 66070–58–4): for use at levels not to exceed 42.4 percent by weight as a component of closures with sealing gaskets that would contact food of Types III, IV-A, V, VII-A, VIII, and IX identified in table 1 in § 176.170(c) of this chapter, and in condition of use D as described under table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- (2) Glass transition points. The glass mining whether styrene block poly- transition points shall be determined mers conform to the specifications pre- by either of the following methods: scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand- and are applicable to the finished poly- ard Method of Test for Dynamic Me- mer. chanical Properties of Plastics by (1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which weight shall be determined by intrinsic is incorporated by reference; copies are viscosity (or other suitable method). available from American Society for Testing and Materials (ASTM), 100

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Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and able for inspection at the National Ar- the maximum net residue solubles in chlo- chives and Records Administration roform. The maximum extractable frac- (NARA). For information on the avail- tions in distilled water and 50 percent ability of this material at NARA, call ethanol, and the maximum net residue 202–741–6030, or go to: http:// solubles in chloroform, shall be deter- www.archives.gov/federallregister/ mined in accordance with § 176.170(d)(3) codeloflfederallregulations/ of this chapter using a sandwich form ibrllocations.html.) modified by using a of the finished copolymer of the speci- forced resonant vibration instead of a fied thickness and for the time and fixed vibration and by using fre- temperature specified in paragraph (b) quencies of 25 to 40 cycles per second of this section. instead of 0.1 to 10 cycles per second. (d) The provisions of this section are (ii) Direct reading viscoelastometric not applicable to butadiene-styrene co- method titled ‘‘Direct Reading Viscoelastrometric Method for Deter- polymers listed in other sections of mining Glass Transition Points of Sty- this subpart. rene Block Polymers’’ (which is incor- (e) The provisions of this section are porated by reference; copies are avail- not applicable to styrene block poly- able from the Center for Food Safety mers with 1,3-butadiene listed in and Applied Nutrition (HFS–200), Food § 175.105 of this chapter. and Drug Administration, 5100 Paint [42 FR 14572, Mar. 15, 1977, as amended at 42 Branch Pkwy., College Park, MD 20740, FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19, or available for inspection at the Na- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898, tional Archives and Records Adminis- June 12, 1989; 58 FR 65546, Dec. 15, 1993] tration (NARA). For information on the availability of this material at § 177.1820 Styrene-maleic anhydride NARA, call 202–741–6030, or go to: http:// copolymers. www.archives.gov/federallregister/ Styrene-maleic anhydride copoly- codeloflfederallregulations/ mers identified in paragraph (a) of this ibrllocations.html.), by which the glass section may be safely used as articles transition points are determined in the or components of articles intended for tensile mode of deformation at a fre- use in contact with food, subject to quency of 35 hertz using a Rheovibron provisions of this section. Model DDV-II (or equivalent) Direct Reading Viscoelastometer. Take maxi- (a) For the purpose of this section, ma in the out-of-phase component of styrene-maleic anhydride copolymers the complex modulus as the glass tran- are those produced by the polymeriza- sition points. For block polymers of tion of styrene and maleic anhydride so low styrene content or for simple block that the finished polymers meet the polymers, the polymer may be treated specifications prescribed in paragraph with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of to accentuate the upper transition this section. point. (b) Specifications:

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Maximum extract- Maximum extract- Molecular Residual able fraction in dis- able fraction in n- weight Residual sty- maleic anhy- tilled water at spec- heptane at speci- Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures, number omer omer times, and particle times, and particle average) size size

1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr maleic anhydride units by weight; for temperature for 1 utilizing particles use as articles or as components of hr utilizing par- of a size that will articles that contact food of Types I, ticles of a size pass through a II, III, IV-A, IV-B, V, VI-B (except car- that will pass U.S. standard bonated beverages), VII-A, VII-B, through a U.S. sieve No. 10 and VIII, and IX identified in table 1 in standard sieve will be held on a § 176.170(c) of this chapter under No. 10 and will U.S. standard conditions of use B, C, D, E, F, G, be held on a sieve No. 20. and H described in table 2 in U.S. standard § 176.170(c) of this chapter. sieve No. 20. 2. Styrene-maleic anhydride copolymer ...... 0.3 ...... 0.1 ...... 0.015 weight per- 1.0 weight percent modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F) No. 27288–99–9) containing not temperature for 1 for 2 hours uti- more than 15 percent maleic anhy- hour utilizing par- lizing particles of dride units by weight and not more ticles of a size a size that will than 20 percent styrene-butadiene that will pass pass through a and/or butadiene rubber units by through a U.S. U.S. standard weight; for use (except carbonated standard sieve sieve No. 10 and beverage bottles) as articles or as No. 10 and will will be held on a components of articles that contact be held on a U.S. standard food of Types I, II, III, IV-A, IV-B, V, U.S. standard sieve No. 20. VI, VII-A, VII-B, VIII, and IX identified sieve No. 20. in table I in § 176.170(c) of this chapter under conditions of use B, C, D, E, F, G, and H described in table 2 in § 176.170(c) of this chapter.

(c) The analytical methods for deter- codeloflfederallregulations/ mining conformance with specifica- ibrllocations.html. tions for styrene-maleic anhydride co- (d) The provisions of this section are polymers prescribed in this section are not applicable to styrene-maleic anhy- as follows: dride copolymers listed in other sec- (1) Molecular weight. Molecular tions of this subpart. weight shall be determined by membrane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47 (2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6, Residual styrene monomer content 1982; 54 FR 24898, June 12, 1989] shall be determined by the method de- § 177.1830 Styrene-methyl methacry- scribed in § 177.1640(d). late copolymers. (3) Residual maleic anhydride monomer content. Residual maleic anhydride Styrene-methyl methacrylate co- monomer content shall be determined polymers identified in this section may by a gas chromatographic method ti- be safely used as components of plastic tled ‘‘Determination of Residual Ma- articles intended for use in contact leic Anhydride in Polymers by Gas with food, subject to the provisions of Chromatography,’’ which is incor- this section. porated by reference. Copies are avail- (a) For the purpose of this section, able from the Center for Food Safety styrene-methyl methacrylate copoly- and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro- and Drug Administration, 5100 Paint duced by the copolymerization of sty- Branch Pkwy., College Park, MD 20740, rene and methyl methacrylate such or available for inspection at the Na- that the finished basic copolymers con- tional Archives and Records Adminis- tain more than 50 weight percent of tration (NARA). For information on polymer units derived from styrene. the availability of this material at (b) The finished plastic food-contact NARA, call 202–741–6030, or go to: http:// article, when extracted with the sol- www.archives.gov/federallregister/ vent or solvents characterizing the

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type of food and under the conditions Substances Limitations of time and temperature characterizing (3) Adjuvant substance, As a solvent in the prepara- the conditions of intended use as deter- dimethylformamide. tion of fibryl. mined from tables 1 and 2 of § 176.170(c) of this chapter, yields extractives not (d) Textryls meeting the conditions to exceed the following when tested by of test prescribed in paragraph (d)(1) of the methods prescribed in § 177.1010(c); this section are used as prescribed in (1) Total nonvolatile extractives not paragraph (d)(2) of this section. to exceed 0.3 milligram per square inch (1) Conditions of test. Textryls, when of surface tested. extracted with distilled water at reflux (2) Potassium permanganate oxidiz- temperature for 1 hour, yield total ex- able distilled water and 8 and 50 per- tractives not to exceed 1 percent. cent alcohol extractives not to exceed an absorbance of 0.15. (2) Uses. Textryls are used for pack- (3) Ultraviolet-absorbing distilled aging or holding food at ordinary tem- water and 8 and 50 percent alcohol ex- peratures and in the brewing of hot tractives not to exceed an absorbance beverages. of 0.30. (4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in molded articles. extractives not to exceed an absorbance of 0.40. Urea-formaldehyde resins may be safely used as the food-contact surface § 177.1850 Textryls. of molded articles intended for use in Textryls identified in this section contact with food, in accordance with may be safely used as articles or com- the following prescribed conditions: ponents of articles, intended for use in (a) For the purpose of this section, producing, manufacturing, packing, urea-formaldehyde resins are those processing, preparing, treating, pack- produced when 1 mole of urea is made aging, transporting or holding food, to react with not more than 2 moles of subject to the provisions of this sec- formaldehyde in water solution. tion. (b) The resins may be mixed with re- (a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may pared from natural or synthetic fibers, contain other optional adjuvant sub- bonded with fibryl (Fibryl consists of a stances which may include the fol- polymeric resin in fibrous form com- lowing: mingled with fiber to facilitate sheet formation and subsequently heat cured List of substances Limitations to fuse the fibryl and effect bonding). Hexamethylenetetramine ...... For use only as polymeriza- (b) Textryls are prepared from the fi- tion-control agent. bers, fibryls, and adjuvants identified Tetrachlorophthalic acid an- Do. in paragraph (c) of this section, and hydride. subject to limitations prescribed in Zinc stearate ...... For use as lubricant. that paragraph, provided that any substance that is the subject of a regula- (c) The finished food-contact article, tion in parts 174, 175, 176, 177, 178 and when extracted with the solvent or sol- § 179.45 of this chapter conforms with vents characterizing the type of food any specifications in such regulation and under the conditions of time and for that substance as a component of temperature characterizing the condi- polymeric resins used as food contact tions of its intended use as determined surfaces. from tables 1 and 2 of § 175.300(d) of this (c) The fibers, fibryls, and adjuvants chapter, yields total extractives in permitted are as follows: each extracting solvent not to exceed 0.5 milligram per square inch of food- Substances Limitations contact surface as determined by the (1) Fibers prepared from pol- Conforming with § 177.1630. methods described in § 175.300(e) of this yethylene terephthalate chapter. resins. (2) Fibryls prepared from As the basic polymer. NOTE: In testing the finished food-contact vinyl chloride-vinyl acetate article, use a separate test sample for each copolymer. required extracting solvent.

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§ 177.1950 Vinyl chloride-ethylene co- codeloflfederallregulations/ polymers. ibrllocations.html. The vinyl chloride-ethylene copoly- (2) Extractives limitations. The fol- mers identified in paragraph (a) of this lowing extractives limitations are de- section may be safely used as compo- termined by the methods described in nents of articles intended for contact paragraph (d) of this section: with food, under conditions of use D, E, (i) Total extractives do not exceed F, or G described in table 2 of § 176.170 0.10 weight-percent when extracted (c) of this chapter, subject to the provi- with n-heptane at 150 °F for 2 hours. sions of this section. (ii) Total extractives do not exceed (a) For the purpose of this section, 0.03 weight-percent when extracted vinyl chloride-ethylene copolymers with water at 150 °F for 2 hours. consist of basic copolymers produced (iii) Total extractives obtained by ex- by the copolymerization of vinyl chlo- tracting with water at 150 °F for 2 ride and ethylene such that the fin- hours contain no more than 0.5 milli- ished basic copolymers meet the speci- gram of vinyl chloride-ethylene copol- fications and extractives limitations ymer per 100 grams of sample tested as prescribed in paragraph (c) of this sec- determined from the organic chlorine tion, when tested by the methods de- content. The organic chlorine content scribed in paragraph (d) of this section. is determined as described in paragraph (b) The basic vinyl chloride-ethylene (d)(3) of this section. copolymers identified in paragraph (a) (d) Analytical methods: The analyt- of this section may contain optional ical methods for determining whether adjuvant substances required in the vinyl chloride-ethylene basic copoly- production of such basic copolymers. mers conform to the extractives limi- The optional adjuvant substances re- tations prescribed in paragraph (c) of quired in the production of the basic this section are as follows and are ap- vinyl chloride-ethylene copolymers plicable to the basic copolymers in may include substances permitted for powder form having a particle size such such use by regulations in parts 170 that 100 percent will pass through a through 189 of this chapter, substances U.S. Standard Sieve No. 40 and 80 per- generally recognized as safe in food, cent will pass through a U.S. Standard and substances used in accordance with Sieve No. 80: a prior sanction or approval. (1) Reagents—(i) Water. All water used (c) The vinyl chloride-ethylene basic in these procedures shall be copolymers meet the following speci- demineralized (deionized), freshly dis- fications and extractives limitations: tilled water. (1) Specifications. (i) Total chlorine (ii) n-Heptane. Reagent grade, freshly content is in the range of 53 to 56 per- distilled n-heptane shall be used. cent as determined by any suitable an- (2) Determination of total amount of ex- alytical procedure of generally accept- tractives. All determinations shall be ed applicability. done in duplicate using duplicate (ii) Intrinsic viscosity in blanks. Approximately 400 grams of cyclohexanone at 30 °C is not less than sample (accurately weighed) shall be 0.50 deciliter per gram as determined placed in a 2-liter Erlenmeyer flask. by ASTM method D1243–79, ‘‘Standard Add 1,200 milliliters of solvent and Test Method for Dilute Solution Vis- cover the flask with aluminum foil. cosity of Vinyl Chloride Polymers,’’ The covered flask and contents are sus- which is incorporated by reference. pended in a thermostated bath and are Copies may be obtained from the Amer- kept, with continual shaking at 150 °F ican Society for Testing Materials, 100 for 2 hours. The solution is then fil- Barr Harbor Dr., West Conshohocken, tered through a No. 42 Whatman filter Philadelphia, PA 19428-2959, or may be paper, and the filtrate is collected in a examined at the National Archives and graduated cylinder. The total amount Records Administration (NARA). For of filtrate (without washing) is meas- information on the availability of this ured and called A milliliters. The fil- material at NARA, call 202–741–6030, or trate is transferred to a Pyrex (or go to: http://www.archives.gov/ equivalent) beaker and evaporated on a federallregister/ steam bath under a stream of nitrogen

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to a small volume (approximately 50–60 aqueous extract or to a vacuum oven at milliliters). The concentrated filtrate 150 °F in the case of the heptane ex- is then quantitatively transferred to a tract. In the case of the aqueous ex- tared 100-milliliter Pyrex beaker using tract, the evaporation to constant small, fresh portions of solvent and a weight is completed in 15 minutes at rubber policeman to effect the transfer. 230 °F; and in the case of heptane ex- The concentrated filtrate is evaporated tract, it is overnight under vacuum at almost to dryness on a hotplate under 150 °F. The residue is weighed and cor- nitrogen, and is then transferred to a rected for the solvent blank. Calcula- drying oven at 230 °F in the case of the tion:

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-ethylene copolymer extract and washings are collected in a content of aqueous extract—(i) Principle. 1,500-milliliter beaker. The solution is The vinyl chloride-ethylene copolymer evaporated carefully on a steam plate content of the aqueous extract can be to a volume of approximately 50 milli- determined by determining the organic liters and then transferred quan- chlorine content and calculating the titatively, a little at a time, to a clean amount of copolymer equivalent to the 22-milliliter Parr cup, also on the organic chlorine content. steam plate. The solution is evaporated (ii) Total organic chlorine content. A to dryness. Next 0.25 gram of sucrose weighed sample of approximately 400 and 0.5 gram of benzoic acid are added grams is extracted with 1,200 milliliters to the cup. One scoop (approximately of water at 150 °F for 2 hours, filtered, 15 grams) of sodium peroxide is then and the volume of filtrate is measured added to the cup. The bomb is assem- (A milliliters) as described in para- bled and ignition is conducted in the graph (d)(2) of this section. usual fashion. (a) A slurry of Amberlite IRA–400, or (d) After the bomb has cooled, it is equivalent, is made with distilled rinsed thoroughly with distilled water water in a 150-milliliter beaker. The and disassembled. The top of the bomb slurry is added to a chromatographic is rinsed into a 250-milliliter beaker column until it is filled to about half with distilled water. The beaker is its length. This should give a volume of resin of 15–25 milliliters. The liquid placed on the steam plate. The bomb must not be allowed to drain below the cup is placed in the beaker and care- top of the packed column. fully tipped over to allow the water to (b) The column is regenerated to the leach out the combustion mixture. basic (OH) form by slowly passing After the bubbling has stopped, the cup through it (10–15 milliliters per minute) is removed from the beaker and rinsed 10 grams of sodium hydroxide dissolved thoroughly. The solution is cooled to in 200 milliliters of water. The column room temperature and cautiously neu- is washed with distilled water until the tralized with concentrated nitric acid effluent is neutral to phenolphthalein. by slowly pouring the acid down a stir- One drop of methyl red indicator is ring rod until the bubbling ceases. The added to the A milliliters of filtered solution is cooled and an equal volume aqueous extract and, if on the basic of acetone is added. side (yellow), nitric acid is added drop (e) The solution is titrated with 0.005 by drop until the solution turns pink. N silver nitrate using standard poten- (c) The extract is deionized by pass- tiometric titration techniques with a ing it through the exchange column at silver electrode as indicator and a po- a rate of 10–15 milliliters per minute. tassium nitrate modified calomel elec- The column is washed with 200 milli- trode as a reference electrode. An ex- liters of distilled water. The deionized panded scale recording titrimeter.

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Metrohm Potentiograph 2336 or equiva- (iii) Calculations. lent, should be used; a complete blank must be run in duplicate.

Milligrams of aqueous extracted TF××64.3 = ×100 copolymer per 100-gram sample Weight of sample in grams

where: (b) Specifications and limitations. The T=Milliliters of silver nitrate (sample minus vinyl chloride-hexene-1 basic copoly- blank)×normality of silver nitrate. mers meet the following specifications F=1,200/A (as defined above) and extractives limitations: (e) The vinyl chloride-ethylene co- (1) Specifications. (i) Total chlorine polymers identified in and complying content is 53 to 56 percent as deter- with this section, when used as compo- mined by any suitable analytical pro- nents of the food-contact surface of cedure of generally accepted applica- any article that is the subject of a reg- bility. ulation in parts 174, 175, 176, 177, 178 (ii) Inherent viscosity in and § 179.45 of this chapter, shall com- cyclohexanone at 30 °C is not less than ply with any specifications and limita- 0.59 deciliters per gram as determined tions prescribed by such regulation for by ASTM method D1243–79, ‘‘Standard the article in the finished form in Test Method for Dilute Solution Vis- which it is to contact food. (f) The provisions of this section are cosity of Vinyl Chloride Polymers,’’ not applicable to vinyl chloride-ethyl- which is incorporated by reference. ene copolymers used as provided in Copies may be obtained from the Amer- §§ 175.105 and 176.180 of this chapter. ican Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, [42 FR 14572, Mar. 15, 1977, as amended at 49 Philadelphia, PA 19428-2959, or may be FR 10110, Mar. 19, 1984] examined at the National Archives and § 177.1960 Vinyl chloride-hexene-1 co- Records Administration (NARA). For polymers. information on the availability of this The vinyl chloride-hexene-1 copoly- material at NARA, call 202–741–6030, or mers identified in paragraph (a) of this go to: http://www.archives.gov/ section or as components of articles in- federallregister/ tended for use in contact with food, codeloflfederallregulations/ under conditions of use D, E, F, or G ibrllocations.html. described in table 2 of § 176.170(c) of this (2) Extractives limitations. The fol- chapter, subject to the provisions of lowing extractives limitations are de- this section. termined by the methods prescribed in (a) Identity. For the purposes of this § 177.1970(d). section vinyl chloride-hexene-1 copoly- (i) Total extractives do not exceed mers consist of basic copolymers pro- 0.01 weight percent when extracted duced by the copolymerization of vinyl with water at 150 °F for 2 hours. chloride and hexene-1 such that the fin- (ii) Total extractives do not exceed ished copolymers contain not more 0.30 weight percent when extracted than 3 mole-percent of polymer units with n-heptane at 150 °F for 2 hours. derived from hexene-1 and meet the specifications and extractives limita- (c) Other specifications and limitations. tions prescribed in paragraph (b) of this The vinyl chloride-hexene-1 copoly- section. The copolymers may option- mers identified in and complying with ally contain hydroxypropyl methyl- this section, when used as components cellulose and trichloroethylene used as of the food-contact surface of any arti- a suspending agent and chain transfer cle that is subject to a regulation in agent, respectively, in their produc- parts 174, 175, 176, 177, 178 and § 179.45 of tion. this chapter, shall comply with any

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specifications and limitations pre- Conshohocken, Philadelphia, PA 19428- scribed by such regulation for the arti- 2959, or may be examined at the Na- cle in the finished form in which it is tional Archives and Records Adminis- to contact food. tration (NARA). For information on [42 FR 14572, Mar. 15, 1977, as amended at 49 the availability of this material at FR 10110, Mar. 19, 1984] NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ § 177.1970 Vinyl chloride-lauryl vinyl codeloflfederallregulations/ ether copolymers. ibrllocations.html. The vinyl chloride-lauryl vinyl ether (2) Extractives limitations. The fol- copolymers identified in paragraph (a) lowing extractives limitations are de- of this section may be used as an arti- termined by the method described in cle or as a component of an article in- paragraph (d) of this section: tended for use in contact with food sub- (i) Total extractives do not exceed ject to the provisions of this section. 0.03 weight-percent when extracted (a) Identity. For the purposes of this with water at 150 °F for 2 hours. section vinyl chloride-lauryl vinyl (ii) Total extractives do not exceed ether copolymers consist of basic co- 0.60 weight-percent when extracted polymers produced by the copolym- with n-heptane at 150 °F for 2 hours. erization of vinyl chloride and lauryl (d) Analytical methods. The analytical vinyl ether such that the finished co- methods for determining total extrac- polymers contain not more than 3 tives are applicable to the basic co- weight-percent of polymer units de- polymers in powder form having a par- rived from lauryl vinyl ether and meet ticle size such that 100 percent will the specifications and extractives limi- pass through a U.S. Standard Sieve No. tations prescribed in paragraph (c) of 40 and such that not more than 10 per- this section. cent will pass through a U.S. Standard (b) Optional adjuvant substances. The Sieve No. 200. basic vinyl chloride-lauryl vinyl ether (1) Reagents—(i) Water. All water used copolymers identified in paragraph (a) in these procedures shall be of this section may contain optional demineralized (deionized), freshly dis- adjuvant substances required in the tilled water. production of such basic copolymers. (ii) n-Heptane. Reagent grade, freshly These optional adjuvant substances distilled n-heptane shall be used. may include substances permitted for (2) Determination of total amount of ex- such use by regulations in parts 170 tractives. Place an accurately weighed through 189 of this chapter, substances sample of suitable size in a clean generally recognized as safe in food, borosilicate flask, and for each gram of and substances used in accordance with sample add 3 milliliters of solvent pre- a prior sanction or approval. viously heated to 150 °F. Maintain the (c) Specifications and limitations. The temperature of the contents of the vinyl chloride-lauryl vinyl ether basic flask at 150 °F for 2 hours using a hot copolymers meet the following speci- plate while also maintaining gentle fications and extractives limitations: mechanical agitation. Filter the con- (1) Specifications. (i) Total chlorine tents of the flask rapidly through No. content is 53 to 56 percent as deter- 42 Whatman filter paper with the aid of mined by any suitable analytical pro- suction. Transfer the filtrate to flat cedure of generally accepted applica- glass dishes that are warmed on a hot bility. plate and evaporate the solvent with (ii) Inherent viscosity in the aid of a stream of filtered air. When cylcoHhexanone at 30 °C is not less the volume of the filtrate has been re- than 0.60 deciliter per gram as deter- duced to 10 to 15 milliliters, transfer mined by ASTM method D1243–79, the filtrate to tared 50-milliliter ‘‘Standard Test Method for Dilute So- borosilicate glass beakers and com- lution Viscosity of Vinyl Chloride plete evaporation to a constant weight Polymers,’’ which is incorporated by in a 140 °F vacuum oven. Carry out a reference. Copies may be obtained from corresponding blank determination the American Society for Testing Ma- with each solvent. Determine the terials, 100 Barr Harbor Dr., West weight of the residue corrected for the

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solvent blank and calculate the result (ii) Intrinsic viscosity in cyclo- as percent of the initial weight of the hexanone at 30 °C is not less than 0.50 resin sample taken for analysis. deciliter per gram as determined by (e) Other specifications and limitations. ASTM method D1243–79, ‘‘Standard The vinyl chloride-lauryl vinyl ether Test Method for Dilute Solution Vis- copolymers identified in and complying cosity of Vinyl Chloride Polymers,’’ with this section, when used as compo- which is incorporated by reference. nents of the food-contact surface of Copies may be obtained from the Amer- any article that is subject to a regula- ican Society for Testing Materials, 100 tion in parts 174, 175, 176, 177, 178 and Barr Harbor Dr., West Conshohocken, § 179.45 of this chapter, shall comply Philadelphia, PA 19428-2959, or may be with any specifications and limitations examined at the National Archives and prescribed by such regulation for the Records Administration (NARA). For article in the finished form in which it information on the availability of this is to contact food. material at NARA, call 202–741–6030, or [42 FR 14572, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/ FR 10110, Mar. 19, 1984] federallregister/ codeloflfederallregulations/ § 177.1980 Vinyl chloride-propylene co- ibrllocations.html. polymers. (2) Extractives limitations. The fol- The vinyl chloride-propylene copoly- lowing extractives limitations are de- mers identified in paragraph (a) of this termined by the methods described in section may be safely used as compo- paragraph (d) of this section: nents of articles intended for contact (i) Total extractives do not exceed with food, subject to the provisions of 0.10 weight-percent when extracted this section. with n-heptane at 150 °F for 2 hours. (a) For the purpose of this section, (ii) Total extractives do not exceed vinyl chloride-propylene copolymers 0.03 weight-percent when extracted consist of basic copolymers produced with water at 150 °F for 2 hours. by the copolymezation of vinyl chlo- (iii) Total extractives obtained by ex- ride and propylene such that the fin- tracting with water at 150 °F for 2 ished basic copolymers meet the speci- hours contain no more than 0.17 milli- fications and extractives limitations gram of vinyl chloride-propylene co- prescribed in paragraph (c) of this sec- polymer per 100 grams of sample tested tion, when tested by the methods de- as determined from the organic chlo- scribed in paragraph (d) of this section. rine content. For the purpose of this (b) The basic vinyl chloride-pro- section, the organic chlorine content is pylene copolymers identified in para- the difference between the total chlo- graph (a) of this section may contain rine and ionic chlorine contents deter- optional adjuvant substances required mined as described in paragraph (d) of in the production of such basic copoly- this section. mers. The optional adjuvant sub- (d) Analytical methods: The analyt- stances required in the production of ical methods for determining whether the basic vinyl chloride-propylene co- vinyl chloride-propylene basic copoly- polymers may include substances per- mers conform to the extractives limi- mitted for such use by regulations in tations prescribed in paragraph (c) of parts 170 through 189 of this chapter, this section are as follows and are ap- substances generally recognized as safe plicable to the basic copolymers in in food, and substances used in accord- powder form having a particle size such ance with a prior sanction or approval. that 100 percent will pass through a (c) The vinyl chloride-propylene U.S. Standard Sieve No. 40 and 80 per- basic copolymers meet the following cent will pass through a U.S. Standard specifications and extractives limita- Sieve No. 80: tions: (1) Reagents—(i) Water. All water used (1) Specifications. (i) Total chlorine in these procedures shall be content is in the range of 53 to 56 per- demineralized (deionized), freshly dis- cent as determined by any suitable an- tilled water. alytical procedure of generally accept- (ii) n-Heptane. Reagent grade, freshly ed applicability. distilled n-heptane shall be used.

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(2) Determination of total amount of ex- to a small volume (approximately 50–60 tractives. All determinations shall be milliliters). The concentrated filtrate done in duplicate using duplicate is then quantitatively transferred to a blanks. Approximately 400 grams of tared 100-milliliter Pyrex beaker using sample (accurately weighed) shall be small, fresh portions of solvent and a placed in a 2-liter Erlenmeyer flask. rubber policeman to effect the transfer. Add 1,200 milliliters of solvent and The concentrated filtrate is evaporated cover the flask with aluminum foil. almost to dryness on a hotplate under The covered flask and contents are sus- nitrogen, and is then transferred to a pended in a thermostated bath and are drying oven at 230 °F in the case of the kept, with continual shaking, at 150 °F aqueous extract or to a vacuum oven at for 2 hours. The solution is then fil- 150 °F in the case of the heptane ex- tered through a No. 42 Whatman filter tract. In the case of the aqueous ex- paper, and the filtrate is collected in a tract the evaporation to constant graduated cylinder. The total amount weight is completed in 15 minutes at of filtrate (without washing) is meas- 230 °F; and in the case of heptane ex- ured and called A milliliters. The fil- tract, it is overnight under vacuum at trate is transferred to a Pyrex (or 150 °F. The residue is weighed and cor- equivalent) beaker and evaporated on a rected for the solvent blank. Calcula- steam bath under a stream of nitrogen tion:

Gramsof corrected residue 1, 200 milliliters Total extractives expressed as ××=100 Grams of sample Volume of filtrate percent by weight of sample. A in milliliters

(3) Vinyl chloride-propylene copolymer sembled, water is added to the recess at content of aqueous extract—(i) Principle. the top of the bomb and ignition is con- The vinyl chloride-propylene copoly- ducted in the usual fashion using a mer content of the aqueous extract can Meeker burner. The heating is contin- be determined by determining the or- ued for 1 minute after the water at the ganic chlorine content and calculating top has evaporated. The bomb is the amount of copolymer equivalent to quenched in water, rinsed with distilled the organic chlorine content. The or- water, and placed in a 400-milliliter ganic chlorine content is the difference beaker. The bomb cover is rinsed with between the total chlorine content and water, catching the washings in the the ionic chlorine content. same 400-milliliter beaker. The bomb is (ii) Total chlorine content. A weighed covered with distilled water and a sample is extracted with water at 150 watch glass and heated until the melt °F for 2 hours, filtered, and the volume has dissolved. The bomb is removed, of filtrate is measured (A milliliters) as rinsed, catching the rinsings in the described in paragraph (d)(2) of this beaker, and the solution is acidified section. Two drops of 50 percent by with concentrated nitric acid using weight sodium hydroxide solution are methyl purple as an indicator. The added to prevent loss of chloride from beaker is covered with a watch glass, ammonium chloride, if present, and the and the contents are boiled gently for solution is evaporated to approxi- 10–15 minutes. After cooling to room mately 15 milliliters. The concentrated temperature the solution is made filtrate is quantitatively transferred to slightly alkaline with 50 percent by a 22-milliliter Parr bomb fusion cup weight sodium hydroxide solution, and gently evaporated to dryness. To then acidified with dilute (1:5) nitric the contents of the cup are added 3.5 acid. Then 1.5 milliliters of 2 N nitric grams of granular sodium peroxide, 0.1 acid per 100 milliliters of solution is gram of powdered starch, and 0.02 gram added and the solution is titrated with potassium nitrate; and the contents 0.005 N silver nitrate to the equivalence are mixed thoroughly. The bomb is as- potential end point using an expanded

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scale pH meter (Beckman Model 76, or equivalent). A complete blank must be run in duplicate. Calculation:

Grams of sample 1,200 milliliters Milliequivalents of total chlorine in ××=100 (B− C) Volume of filtrate aqueous extract of 100 grams of sample A in milliliters

where: solution is evaporated to approxi- A=volume of filtrate obtained in extraction. mately 150 milliliters. The solution is B=milliliters of silver nitrate solution used quantitatively transferred to a 250-mil- × in sample titration normality of silver liliter beaker, methyl purple indicator nitrate solution. C=milliliters of silver nitrate solution used is added, and the solution is neutral- in blank titration×normality of silver ni- ized with 0.1 N nitric acid. For each 100 trate solution. milliliters of solution is added 1.5 mil- (iii) Ionic chlorine content. A weighed liliters of 2 N nitric acid. The solution sample is extracted with water at 150 is titrated with 0.005 N silver nitrate to °F for 2 hours, filtered, and the volume the equivalence potential end point, of filtrate is measured (A milliliters) as using the expanded scale pH meter de- in paragraph (d)(2) of this section. Two scribed in paragraph (d)(3)(ii) of this drops of 50 percent by weight sodium section. A complete blank must be run hydroxide solution are added and the in duplicate. Calculation:

DE− 1, 200 milliliters Milliequivalents of ionic chlorine in ××=100 Grams of sample Volume of filtrate aqueousextract of100 gramsof sample. A in milliliters

where: (b) Vinyl chloride-propylene copolymer A=volume of filtrate obtained in extraction. content. Milligrams of vinyl chloride- D=milliliters of silver nitrate solution used propylene copolymer in aqueous ex- in sample titration×normality of silver tract of 100 grams of sample equal nitrate solution. milliequivalents of organic chlorine in E=milliliters of silver nitrate solution used aqueous extract of 100 grams of sample in blank titration×normality of silver nitrate solution. (as calculated in paragraph (d)(3)(iv) (a) of this section) multiplied by 84.5. (iv) Organic chlorine content and vinyl NOTE: The conversion factor, 84.5, is de- chloride-propylene copolymer content of rived from the equivalent weight of chlorine aqueous extract. The organic chlorine divided by the chlorine content of the content and the vinyl chloride pro- heptane extractable fraction.) pylene copolymer content of the aque- (e) The vinyl chloride-propylene co- ous extract is calculated as follows: polymers identified in and complying (a) Organic chlorine content. Milli- with this section, when used as compo- equivalents of organic chlorine in nents of the food-contact surface of aqueous extract of 100 grams of sample any article that is the subject of a reg- equal milliequivalents of total chlorine ulation in parts 174, 175, 176, 177, 178 in aqueous extract of 100 grams of sam- and § 179.45 of this chapter, shall com- ple (as calculated in paragraph (d)(3)(ii) ply with any specifications and limita- of this section) minus milliequivalents tions prescribed by such regulation for of ionic chlorine in aqueous extract of the article in the finished form in 100 grams of sample (as calculated in which it is to contact food. paragraph (d)(3)(iii) of this section).

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(f) The provisions of this section are (2) The weight average molecular not applicable to vinyl chloride-pro- weight of the copolymer is not less pylene copolymers used in food-pack- than 50,000 when determined by gel per- aging adhesives complying with meation chromatography using tetra- § 175.105 of this chapter. hydrofuran as the solvent. The gel permeation chromatograph is calibrated [42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19, 1984] with polystyrene standards. The basic gel permeation chromatographic meth- § 177.1990 Vinylidene chloride/methyl od is described in ANSI/ASTM D3536–76, acrylate copolymers. ‘‘Standard Test Method for Molecular The vinylidene chloride/methyl acry- Weight Averages and Molecular Weight late copolymers (CAS Reg. No. 25038– Distribution of Polystyrene by Liquid 72–6) identified in paragraph (a) of this Exclusion Chromatography (Gel Per- section may be safely used as an article meation Chromatography-GPC),’’ or as a component of an article in- which is incorporated by reference. tended for use in contact with food sub- Copies are available from University ject to the provisions of this section. Microfilms International, 300 North Zeeb Rd., Ann Arbor, MI 48106, or avail- (a) Identity. For the purposes of this section vinylidene chloride/methyl ac- able for inspection at the National Ar- rylate copolymers consist of basic co- chives and Records Administration polymers produced by the copolym- (NARA). For information on the avail- erization of vinylidene chloride and ability of this material at NARA, call methyl acrylate such that the copoly- 202–741–6030, or go to: http:// mers contain not more than 15 weight- www.archives.gov/federallregister/ percent of polymer units derived from codeloflfederallregulations/ methyl acrylate. ibrllocations.html. (b) Optional adjuvant substances. The (3) Residual vinylidene chloride and basic vinylidene chloride/methyl acry- residual methyl acrylate in the copoly- late copolymers identified in paragraph mer in the form in which it will con- (a) of this section may contain optional tact food (unsupported film, barrier adjuvant substances required in the layer, or as a copolymer for blending) production of such basic copolymers. will not exceed 10 parts per million and These optional adjuvant substances 5 parts per million, respectively, as de- may include substances permitted for termined by either a gas such use by regulations in parts 170 chromatographic method titled ‘‘De- through 179 of this chapter, substances termination of Residual Vinylidene generally recognized as safe in food, Chloride and Methyl Acrylate in Vinyl- and substances used in accordance with idene Chloride/Methyl Acrylate Co- a prior sanction or approval. polymer Resins and Films,’’ or, alter- (c) Specifications. (1) The methyl acry- natively, ‘‘Residual Methyl Acrylate late content is determined by an infra- and Vinylidene Chloride Monomers in red spectrophotometric method titled Saran MA/VDC Resins and Pellets by ‘‘Determination of Copolymer Ratio in Headspace Gas Chromatography,’’ Vinylidene Chloride/Methyl Acrylate dated March 3, 1986, which are incor- Copolymers,’’ which is incorporated by porated by reference in accordance reference. Copies are available from with 5 U.S.C. 552(a). Copies are avail- the Center for Food Safety and Applied able from the Center for Food Safety Nutrition (HFS–200), Food and Drug and Applied Nutrition (HFS–200), Food Administration, 5100 Paint Branch and Drug Administration, 5100 Paint Pkwy., College Park, MD 20740, or Branch Pkwy., College Park, MD 20740, available for inspection at the National or available for inspection at the Na- Archives and Records Administration tional Archives and Records Adminis- (NARA). For information on the avail- tration (NARA). For information on ability of this material at NARA, call the availability of this material at 202–741–6030, or go to: http:// NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ www.archives.gov/federallregister/ codeloflfederallregulations/ codeloflfederallregulations/ ibrllocations.html. ibrllocations.html.

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(d) Extractives limitations. The basic the copolymerization of vinylidene copolymer resin in the form of granules chloride/methyl acrylate/methyl meth- that will pass through a U.S. Standard acrylate such that the basic polymers Sieve No. 45 (350 microns) shall meet or the finished food-contact articles the following extractives limitations: meet the specifications prescribed in (1) 10-gram samples of the resin, paragraph (d) of this section. when extracted separately with 100 (b) Optional adjuvant substances. The milliliters of distilled water at 121 °C basic vinylidene chloride/methyl acry- (250 °F) for 2 hours, and 100 milliliters late/methyl methacrylate polymers of n-heptane at 66 °C (150 °F) for 2 identified in paragraph (a) of this sec- hours, shall yield total nonvolatile ex- tion may contain optional adjuvant tractives not to exceed 0.5 percent by substances required in the production weight of the resin. of such basic polymers. These optional (2) The basic copolymer in the form adjuvant substances may include sub- of film when extracted separately with stances permitted for such use by regu- distilled water at 121 °C (250 °F) for 2 lations in parts 170 through 179 of this hours shall yield total nonvolatile ex- chapter, substances generally recog- tractives not to exceed 0.047 milligram nized as safe in food, and substances per square centimeter (0.3 milligram used in accordance with a prior sanc- per square inch). tion of approval. (e) Conditions of use. The copolymers (c) Conditions of use. The polymers may be safely used as articles or com- may be safely used as articles or as ponents of articles intended for use in components of articles intended for use producing, manufacturing, processing, in producing, manufacturing, proc- preparing, treating, packaging, trans- essing, preparing, treating, packaging, porting, or holding food, including transporting, or holding food, including processing of packaged food at tem- processing of packaged food at temperatures not to exceed 135 °C (275 °F). peratures up to 121 °C (250 °F). (f) Other specifications and limitations. (d) Specifications and limitations. The The vinylidene chloride-methyl acry- vinylidene chloride/methyl acrylate/ late copolymers identified in and com- methyl methacrylate basic polymers plying with this section, when used as and/or finished food-contact articles components of the food contact surface meet the following specifications and of any article that is subject to a regu- limitations: lation in parts 174 through 178 and (1)(i) The basic vinylidene chloride/ § 179.45 of this chapter, shall comply methyl acrylate/methyl methacrylate with any specifications and limitations polymers contain not more than 2 prescribed by such regulation for the weight percent of polymer units de- article in the finished form in which it rived from methyl acrylate monomer is to contact food. and not more than 6 weight percent of [48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. polymer units derived from methyl 31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer. 1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to a thickness of not more than 0.005 cen- § 177.2000 Vinylidene chloride/methyl timeter (0.002 inches). acrylate/methyl methacrylate poly- (2) The weight average molecular mers. weight of the basic polymer is not less The vinylidene chloride/methyl acry- than 100,000 when determined by gel late/methyl methacrylate polymers permeation chromatography using tet- (CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel paragraph (a) of this section may be permeation chromatography is cali- safely used as articles or as a compo- brated with polystyrene standards. The nent of articles intended for use in con- basic gel permeation chromatographic tact with food subject to the provisions method is described in ANSI/ASTM of this section. D3536–76, which is incorporated by ref- (a) Identity. For the purpose of this erence. Copies are available from the section, vinylidene chloride/methyl ac- American Society for Testing Mate- rylate/methyl methacrylate polymers rials, 100 Barr Harbor Dr., West consist of basic polymers produced by Conshohocken, Philadelphia, PA 19428-

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2959, or available for inspection at the Methods for the specifications in this National Archives and Records Admin- paragraph (b), titled ‘‘Chlorine and istration (NARA). For information on Bromine—Coulometric Titration Meth- the availability of this material at od by Aminco Chloridometer,’’ NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter- www.archives.gov/federallregister/ mination of Sulfur by Parr Bomb,’’ and codeloflfederallregulations/ ASTM method D2857–70 (Reapproved ibrllocations.html. 1977), ‘‘Standard Test Method for Di- (3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’ article described in paragraph (a) of are incorporated by reference. Copies this section, when extracted with the of the ASTM method may be obtained solvent or solvents characterizing the from the American Society for Testing type of food and under the conditions Materials, 100 Barr Harbor Dr., West of time and temperature characterizing Conshohocken, Philadelphia, PA 19428- the conditions of its intended use as de- 2959. Copies of the other two methods termined from tables 1 and 2 of are available from the Center for Food § 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS– chloroform-soluble extractives in each 200), Food and Drug Administration, extracting solvent not to exceed .08 5100 Paint Branch Pkwy., College Park, milligram per square centimeter (0.5 MD 20740. Copies of all three methods milligram per square inch) of food-con- may be examined at the National Ar- tact surface when tested by the meth- chives and Records Administration ods described in § 176.170(d). If the fin- (NARA). For information on the avail- ished food-contact article is itself the ability of this material at NARA, call subject of a regulation in parts 174 202–741–6030, or go to: http:// through 178 and § 179.45 of this chapter, www.archives.gov/federallregister/ it shall also comply with any specifica- codeloflfederallregulations/ tions and limitations prescribed for it ibrllocations.html. by the regulation. (c) The additive is used as the article, or a component of articles, intended for [49 FR 29578, July 23, 1984] use as liners and covers for reservoirs intended for the storage of water for Subpart C—Substances for Use drinking purposes. Only as Components of Arti- (d) Substances permitted by § 177.2600 cles Intended for Repeated may be employed in the preparation of Use ethylene polymers, chlorosulfonated, subject to any limitations prescribed § 177.2210 Ethylene polymer, chloro- therein. sulfonated. (e) The finished ethylene copolymers, Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to as identified in this section may be § 177.2600(e) and (g). safely used as an article or component [42 FR 14572, Mar. 15, 1977, as amended at 49 of articles intended for use in contact FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, with food, subject to the provisions of 1989] this section. (a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly- sulfonated is produced by chloro- meric. sulfonation of a carbon tetrachloride Microporous polymeric filters identi- solution of polyethylene with chlorine fied in paragraph (a) of this section and sulfuryl chloride. may be safely used, subject to the pro- (b) Ethylene polymer, chloro- visions of this section, to remove par- sulfonated shall meet the following ticles of insoluble matter in producing, specifications: manufacturing, processing, and pre- (1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food. by weight. (a) Microporous polymeric filters (2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin- by weight. uous, polymeric matrix of polyvinyl (3) Molecular weight is in the range chloride, vinyl chloride-propylene, or of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which

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finely divided silicon dioxide is embed- (c) Any substance employed in the ded. Cyclohexanone may be used as a production of resin-bonded filters that solvent in the production of the filters. is the subject of a regulation in parts (b) Any substance employed in the 174, 175, 176, 177, 178 and § 179.45 of this production of microporous polymeric chapter conforms with any specifica- filters that is the subject of a regulation in such regulation. tion in parts 170 through 189 of this (d) Substances employed in the pro- chapter must conform with any speci- duction of resin-bonded filters include fication in such regulation. the following, subject to any limita- (c) Cyclohexanone when used as a sol- tions provided: vent in the production of the filters shall not exceed 0.35 percent by weight LIST OF SUBSTANCES AND LIMITATIONS of the microporous polymeric filters. (1) Fibers: (d) The microporous polymeric filters may be colored with colorants used in Cellulose pulp. accordance with § 178.3297 of this chap- Cotton. ter. Nylon. (From nylon resins complying with (e) The temperature of food being the provisions of applicable regulations in subchapter B of this chapter. processed through the microporous pol- Polyethylene terephthalate complying in ymeric filters shall not exceed 180 °F. composition with the provisions of (f) The microporous polymeric filters § 177.1630; for use in inline filtration only as shall be maintained in a sanitary man- provided for in paragraphs (e) and (f) of ner in accordance with good manufac- this section. turing practice so as to prevent poten- Rayon (viscose). tial microbial adulteration of the food. (2) Substances employed in fiber fin- (g) To assure safe use of the micro- ishing: porous polymeric filters, the label or labeling shall include adequate direc- BHT. Butyl (or isobutyl) palmitate or stearate. tions for a pre-use treatment, con- 2,5-Di-tert-butyl hydroquinone for use only in sisting of washing with a minimum of lubricant formulations for rayon fiber fin- 2 gallons of potable water at a tem- ishing and at a usage level not to exceed perature of 180 °F for each square foot 0.1 percent by weight of the lubricant for- of filter, prior to the filter’s first use in mulations. contact with food. Dimethylpolysiloxane. 4-Ethyl-4-hexadecyl morpholinium ethyl sul- [42 FR 14572, Mar. 15, 1977, as amended at 56 fate for use only as a lubricant in the man- FR 42933, Aug. 30, 1991] ufacture of polyethylene terephthalate fibers specified in paragraph (d)(1) of this § 177.2260 Filters, resin-bonded. section at a level not to exceed 0.03 percent Resin-bonded filters may be safely by weight of the finished fibers. used in producing, manufacturing, Fatty acid (C10-C18) diethanolamide conden- sates. processing, and preparing food, subject Fatty acids derived from animal or vegetable to the provisions of this section. fats and oils, and salts of such acids, sin- (a) Resin-bonded filters are prepared gle or mixed, as follows: from natural or synthetic fibers to Aluminum. which have been added substances re- Ammonium. quired in their preparation and fin- Calcium. ishing, and which are bonded with res- Magnesium. Potassium. ins prepared by condensation or polym- Sodium. erization of resin-forming materials, Triethanolamine. together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of quired in their preparation, applica- polyoxyethylene glycol (molecular weight tion, and curing. 400–3,000). (b) The quantity of any substance Methyl esters of fatty acids (C10-C18). employed in the production of the Mineral oil. resin-bonded filter does not exceed the Polybutene, hydrogenated; complying with the identity prescribed under § 178.3740 (b) amount reasonably required to accom- of this chapter. plish the intended physical or technical Polyoxyethylene (4 mols) ethylenediamine effect or any limitation further pro- monolauramide for use only in lubricant vided. formulations for rayon fiber finishing and

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at a usage level not to exceed 10 percent by (f) Resin-bonded filters conforming weight of the lubricant formulations. with the specifications of paragraph (f) Ricebran oil. (1) of this section are used as provided Titanium dioxide. in paragraph (e)(2) of this section: (3) Resins: (1) Total extractives. The finished fil- Acrylic polymers produced by polymerizing ter, when exposed to distilled water at ethyl acrylate alone or with one or more of 145 °F for 2 hours, yields total extrac- the monomers: Acrylic acid, acrylonitrile, tives not to exceed 4 percent by weight N-methylolacrylamide, and styrene. The of the filter. finished copolymers shall contain at least (2) Conditions of use. It is used to fil- 70 weight percent of polymer units derived ter milk or potable water at operating from ethyl acrylate, no more than 2 weight temperatures not to exceed 145 °F. percent of total polymer units derived (g) Resin-bonded filters conforming from acrylic acid, no more than 10 weight percent of total polymer units derived with the specifications of paragraph (g) from acrylonitrile, no more than 2 weight (1) of this section are used as provided percent of total polymer units derived in paragraph (g)(2) of this section: from N-methylolacrylamide, and no more (1) Total extractives. The finished fil- than 25 weight percent of total polymer ter, when exposed to n-hexane at reflux units derived from styrene. For use only as temperature for 2 hours, yields total provided in paragraph (m) of this section. extractives not to exceed 0.5 percent by Melamine-formaldehyde. weight of the filter. Melamine-formaldehyde chemically modified with one or more of the amine catalysts (2) Conditions of use. It is used to fil- identified in § 175.300(b)(3)(xiii) of this chapter edible oils. ter. (h) Resin-bonded filters conforming Melamine-formaldehyde chemically modified with the specifications of paragraph (h) with methyl alcohol. (1) of this section are used as provided Melamine-formaldehyde chemically modified in paragraph (h)(2) of this section: with urea; for use only as provided for in (1) Total extractives. The finished fil- paragraphs (e), (f), (g), (h), and (i) of this section. ter, when exposed to distilled water at Phenol-formaldehyde resins. 212 °F for 2 hours, yields total extrac- Polyvinyl alcohol. tives not to exceed 4 percent by weight Polyvinyl alcohol with the copolymer of of the filter. acrylic acid-allyl sucrose. (2) Conditions of use. It is used to fil- Polyvinyl alcohol with melamine formalde- ter milk, coffee, tea, and potable water hyde. at temperatures not to exceed 212 °F. Polyvinyl acetate with melamine formalde- (i) Resin-bonded filters conforming hyde. p--Toluenesulfonamide-formaldehyde chemi- with the specifications of paragraph (i) cally modified with one or more of the (1) of this section are used as provided amine catalysts identified in § 175.300 in paragraph (i)(2) of this section: (b)(3)(xiii) of this chapter. (1) Total extractives. The finished fil- (4) Adjuvant substances: ter, when exposed to distilled water for 2 hours at a temperature equivalent to, Dimethyl polysiloxane with methylcellulose or higher than, the filtration tempera- and sorbic acid (as an antifoaming agent). ture of the aqueous food, yields total Phosphoric acid. extractives not to exceed 4 percent, by (5) Colorants: Colorants used in ac- weight, of the filter. cordance with § 178.3297 of this chapter. (2) Conditions of use. It is used in com- (e) Resin-bonded filters conforming mercial filtration of bulk quantities of with the specifications of paragraph (e) nonalcoholic, aqueous foods having a (1) of this section are used as provided pH above 5.0. in paragraph (e)(2) of this section: (j) Resin-bonded filters conforming (1) Total extractives. The finished fil- with the specifications of paragraph (j) ter, when exposed to distilled water at (1) of this section are used as provided 100 °F for 2 hours, yields total extrac- in paragraph (j)(2) of this section: tives not to exceed 2.8 percent by (1) Total extractives. The finished fil- weight of the filter. ter, when exposed to 5 percent (by (2) Conditions of use. It is used to fil- weight) acetic acid for 2 hours at a ter milk or potable water at operating temperature equivalent to, or higher temperatures not to exceed 100 °F. than, the filtration temperature of the

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aqueous food, yields total extractives not to exceed 1.2 percent by weight of not to exceed 4 percent, by weight, of the filter. the filter. (n) Acrylonitrile copolymers identi- (2) Conditions of use. It is used in com- fied in this section shall comply with mercial filtration of bulk quantities of the provisions of § 180.22 of this chap- nonalcoholic, aqueous foods having a ter. pH of 5.0 or below. (k) Resin-bonded filters conforming [42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991] with the specifications of paragraph (k) (1) of this section are used as provided § 177.2280 4,4′-Isopropylidenediphenol- in paragraph (k)(2) of this section: epichlorohydrin thermosetting (1) Total extractives. The finished fil- epoxy resins. ter, when exposed to 8 percent (by vol- ′ ume) ethyl alcohol in distilled water 4,4 -Isopropylidenediphenol-epichlo- for 2 hours at a temperature equivalent rohydrin thermosetting epoxy resins to, or higher than, the filtration tem- may be safely used as articles or com- perature of the alcoholic beverage, ponents of articles intended for re- yields total extractives not to exceed 4 peated use in producing, manufac- percent, by weight, of the filter. turing, packing, processing, preparing, (2) Conditions of use. It is used in com- treating, packaging, transporting, or mercial filtration of bulk quantities of holding food, in accordance with the alcoholic beverages containing not following prescribed conditions: more than 8 percent alcohol. (a) The basic thermosetting epoxy ′ (l) Resin-bonded filters conforming resin is made by reacting 4,4 - with the specifications of paragraph (l) isopropylidenediphenol with epichloro- (1) of this section are used as provided hydrin. in paragraph (l)(2) of this section: (b) The resin may contain one or (1) Total extractives. The finished fil- more of the following optional sub- ter, when exposed to 50 percent (by vol- stances provided the quantity used ume) ethyl alcohol in distilled water does not exceed that reasonably re- for 2 hours at a temperature equivalent quired to accomplish the intended ef- to, or higher than, the filtration tem- fect: perature of the alcoholic beverage, Allyl glycidyl ether ...... As curing system additive. yields total extractives not to exceed 4 Di- and tri-glycidyl ester mix- As modifier at levels not to percent, by weight, of the filter. ture resulting from the re- exceed equal parts by (2) Conditions of use. It is used in com- action of epichlorohydrin weight of the 4,4′- mercial filtration of bulk quantities of with mixed dimers and isopropylidenediphenol- trimers of unsaturated C18 epichlorohydrin basic resin alcoholic beverages containing more monobasic fatty acids de- and limited to use in con- than 8 percent alcohol. rived from animal and veg- tact with alcoholic bev- (m) Resin-bonded filters fabricated etable fats and oils. erages containing not more than 8 percent of alcohol. from acrylic polymers as provided in 1,2-Epoxy-3-phenoxypropane As curing system additive. paragraph (d)(3) of this section to- Glyoxal ...... Do. gether with other substances as pro- 4,4′-Isopropylidenediphenol ... Do. vided in paragraph (d), (1), (2), and (4) 4,4′-Methylenedianiline ...... Do. of this section may be used as follows: m-Phenylenediamine ...... Do. (1) The finished filter may be used to Tetrahydrophthalic anhydride Do. filter milk or potable water at oper- (c) In accordance with good manufac- ating temperatures not to exceed 100 turing practice, finished articles con- °F, provided that the finished filter taining the resins shall be thoroughly when exposed to distilled water at 100 cleansed prior to their first use in con- °F for 2 hours yields total extractives tact with food. not to exceed 1 percent by weight of (d) The provisions of this section are the filter. not applicable to 4,4′-isopropylidenedi- (2) The finished filter may be used to phenol-epichlorohydrin resins listed in filter milk or potable water at oper- other sections of parts 174, 175, 176, 177, ating temperatures not to exceed 145 178 and 179 of this chapter. °F, provided that the finished filter when exposed to distilled water at 145 [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, °F for 2 hours yields total extractives 1984]

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§ 177.2355 Mineral reinforced nylon § 177.2400 Perfluorocarbon cured resins. elastomers. Mineral reinforced nylon resins iden- Perfluorocarbon cured elastomers tified in paragraph (a) of this section identified in paragraph (a) of this sec- may be safely used as articles or com- tion may be safely used as articles or ponents of articles intended for re- components of articles intended for repeated use in contact with nonacidic peated use in contact with nonacid food (pH above 5.0) and at use tempera- food (pH above 5.0), subject to the pro- tures not exceeding 212 °F. in accord- visions of this section. ance with the following prescribed con- (a) Identity. (1) For the purpose of ditions: this section, perfluorocarbon cured (a) For the purpose of this section elastomers are produced by the mineral reinforced nylon resins terpolymerizing tetrafluorethylene consist of nylon 66, as identified in and (CAS Reg. No. 116–14–3), complying with the specifications of perfluoromethyl vinyl ether (CAS Reg. § 177.1500, reinforced with up to 40 No. 1187–93–5), and perfluoro-2- phenoxypropyl vinyl ether (CAS Reg. weight percent of calcium silicate and No. 24520–19–2) and subsequent curing of up to 0.5 weight percent 3- the terpolymer (CAS Reg. No. 26658–70– (triethoxysilyl) propylamine (Chemical 8) using the crosslinking agent, phenol, Abstracts Service Registry No. 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl) 000919302) based on the weight of the ethylidene] bis-,dipotassium salt (CAS calcium silicate. Reg. No. 25088–69–1) and accelerator, (b) The mineral reinforced nylon res- 1,4,7,10,13,16-hexaoxacyclooctadecane ins may contain up to 0.2 percent by (CAS Reg. No. 17455–13–9). weight of titanium dioxide as an op- (2) The perfluorocarbon base polymer tional adjuvant substance. shall contain no less than 40 weight- (c) The mineral reinforced nylon res- percent of polymer units derived from ins with or without the optional sub- tetrafluoroethylene, no less than 40 stance described in paragraph (b) of weight-percent of polymer units de- this section, and in the form of 1⁄8-inch rived from perfluoromethyl vinyl ether molded test bars, when extracted with and no more than 5 weight-percent the solvents, i.e., distilled water and 50 polymer units derived from perfluoro-2- percent (by volume) ethyl alcohol in phenoxy-propyl vinyl ether. distilled water, at reflux temperature (3) The composition limitations of for 24 hours using a volume-to-surface the cured elastomer, calculated as ratio of 2 milliliters of solvent per parts per 100 parts of terpolymer, are square inch of surface tested, shall as follows: meet the following extractives limita- Phenol, 4,4′-[2,2,2-trifluoro-1- tions: (trifluoromethyl)-ethylidene] bis- (1) Total extractives not to exceed 5.0 ,dipotassium salt—not to exceed 5 parts. milligrams per square inch of food-con- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not tact surface tested for each solvent. to exceed 5 parts. (2) The ash after ignition of the ex- (b) Optional adjuvant substances. The tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden- of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section gram per square inch of food-contact may contain the following optional ad- surface tested. juvant substances, subject to any limi- (d) In accordance with good manufac- tations cited on their use: turing practice, finished articles con- (1) Substances generally recognized taining the mineral reinforced nylon as safe (GRAS) in food or food pack- resins shall be thoroughly cleansed aging. prior to their first use in contact with (2) Substances used in accordance food. with a prior sanction. (3) Substances authorized under ap- [42 FR 54533, Oct. 7, 1977, as amended at 42 FR plicable regulations in this part and in 61594, Dec. 6, 1977] parts 175 and 178 of this chapter and

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subject to any limitations prescribed (2) Fluoride extractives calculated as therein. fluorine not to exceed 0.47 milligram (4) Substances identified in this para- per square decimeter (0.03 milligram graph (b)(4) subject to such limitations per square inch). as are provided: (e) Conditions of use. In accordance with current good manufacturing prac- Substances Limitations tice, finished food contact articles con- Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned process) (CAS Reg. No. terpolymer. 1333–86–4). prior to their first use in contact with Magnesium oxide (CAS Reg. Not to exceed 5 parts per food. No. 1309–48–4). 100 parts of the terpolymer. [49 FR 43050, Oct. 26, 1984]

(c) Specifications—(1) Infrared identi- § 177.2410 Phenolic resins in molded fication. Perfluorocarbon cured articles. elastomers may be identified by the Phenolic resins identified in this sec- characteristic infrared spectra of the tion may be safely used as the food- pyrolysate breakdown product that is contact surface of molded articles in- obtained by heating and decomposing tended for repeated use in contact with the elastomer using the method enti- nonacid food (pH above 5.0), in accord- tled ‘‘Qualitative Identification of ance with the following prescribed con- Kalrez ® by Infrared Examination of ditions: Pyrolysate.’’ This method is incor- (a) For the purpose of this section, porated by reference. Copies of the the phenolic resins are those produced method are available from the Center when one or more of the phenols listed for Food Safety and Applied Nutrition in paragraph (a)(1) of this section are (HFS–200), Food and Drug Administra- made to react with one or more of the tion, 5100 Paint Branch Pkwy., College aldehydes listed in paragraph (a)(2) of Park, MD 20740, or available for inspec- this section, with or without aniline tion at the National Archives and and/or anhydro-formaldehyde aniline Records Administration (NARA). For (hexahydro-1, 3,5-triphenyl-s-triazine): information on the availability of this (1) Phenols: material at NARA, call 202–741–6030, or p-tert-Amylphenol. go to: http://www.archives.gov/ p-tert-Butylphenol. federallregister/ o-, m-, and p-Cresol. codeloflfederallregulations/ p-Octylphenol. ibrllocations.html. Phenol. (2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro- cured elastomers have a major decom- duced when phenol is made to react with position peak occurring at 490° ±15 °C styrene in the presence of sulfuric acid cat- (914 °F). Less than 1.5 percent of the alyst. elastomers will volatilize below 400 °C (2) Aldehydes: (752 °F) when run under nitrogen at a 10 ° ° Acetaldehyde. C or 18 F per minute heating rate Formaldehyde. using a Du Pont Thermal Analyzer Paraldehyde. Model 1099 with Model 951 TGA unit or the equivalent. (b) Optional adjuvant substances em- (d) Extractive limitations. Articles fab- ployed in the production of the phe- ricated from perfluorocarbon cured nolic resins or added thereto to impart elastomers having a thickness of at desired technical or physical properties least 1.0 millimeter (0.039 inch) when include the following: extracted at reflux temperatures for 2 Asbestos fiber. hours separately with distilled water, Barium hydroxide ...... For use as catalyst. 50 percent ethanol, and n-heptane, Calcium stearate ...... For use as lubricant. Carbon black (channel proc- shall meet the following extractability ess). limits: Diatomaceous earth. (1) Total extractives not to exceed 3.1 Glass fiber. Hexamethylenetetramine ...... For use as curing agent. milligrams per square decimeter (0.2 Mica. milligrams per square inch). Oxalic acid ...... For use as catalyst.

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Zinc stearate ...... For use as lubricant. Substance Limitations

(c) The finished food-contact article, Diphenyl sulfone ...... Not to exceed 0.2 percent by weight as a residual sol- when extracted with distilled water at vent in the finished basic reflux temperature for 2 hours, using a resin. volume-to-surface ratio of 2 milliliters of distilled water per square inch of (c) Extractive limitations. The finished surface tested, shall meet the following food contact article, when extracted at extractives limitations: reflux temperatures for 2 hours with the following four solvents, yields in (1) Total extractives not to exceed each extracting solvent net chloroform 0.15 milligram per square inch of food- soluble extractives not to exceed 0.05 contact surface. milligrams per square inch of food con- (2) Extracted phenol not to exceed tact surface: Distilled water, 50 percent 0.005 milligram per square inch of food- (by volume) ethanol in distilled water, contact surface. 3 percent acetic acid in distilled water, (3) No extracted aniline when tested and n-heptane. In testing the final food by a spectrophotometric method sen- contact article, a separate test sample sitive to 0.006 milligram of aniline per- shall be used for each extracting sol- square inch of food-contact surface. vent. (d) In accordance with good manufac- [63 FR 20315, Apr. 24, 1998] turing practice, finished molded articles containing the phenolic resins § 177.2420 Polyester resins, cross- shall be thoroughly cleansed prior to linked. their first use in contact with food. Cross-linked polyester resins may be safely used as articles or components § 177.2415 Poly(aryletherketone) res- of articles intended for repeated use in ins. contact with food, in accordance with Poly(aryletherketone) resins identi- the following prescribed conditions: fied in paragraph (a) of this section (a) The cross-linked polyester resins may be safely used as articles or com- are produced by the condensation of ponents of articles intended for re- one or more of the acids listed in para- peated use in contact with food subject graph (a)(1) of this section with one or to the provisions of this section. more of the alcohols or epoxides listed in paragraph (a)(2) of this section, fol- (a) Identity. For the purposes of this lowed by copolymerization with one or section, poly(aryletherketone) resins more of the cross-linking agents listed are poly(p-oxyphenylene p- in paragraph (a)(3) of this section: oxyphenylene p-carboxyphenylene) res- (1) Acids: ins (CAS Reg. No. 29658–26–2) produced by the polymerization of hydroquinone Adipic. and 4,4′-difluorobenzophenone, and Fatty acids, and dimers thereof, from natural sources. have a minimum weight-average mo- Fumaric. lecular weight of 12,000, as determined Isophthalic. by gel permeation chromatography in Maleic. comparison with polystyrene stand- Methacrylic. ards, and a minimum mid-point glass Orthophthalic. Sebacic. transition temperature of 142 °C, as de- Terephthalic. termined by differential scanning Trimellitic. calorimetry. (2) Polyols and polyepoxides: (b) Optional adjuvant substances. The basic resins identified in paragraph (a) Butylene glycol. may contain optional adjuvant sub- Diethylene glycol. 2,2-Dimethyl-1,3-propanediol. stances used in their production. These Dipropylene glycol. adjuvants may include substances de- Ethylene glycol. scribed in § 174.5(d) of this chapter and Glycerol. the following: 4,4′-Isopropylidenediphenol-epichlorohydrin. Mannitol. a-Methyl glucoside.

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Pentaerythritol. Triglycidyl isocyanurate (CAS Reg. No. 2451– Polyoxypropylene ethers of 4,4′-isopropylide- 62–9), for use only in coatings contacting nediphenol (containing an average of 2–7.5 bulk quantities of dry food of the type moles of propylene oxide). identified in § 176.170(c) of this chapter, Propylene glycol. table 1, under type VIII. Sorbitol. Vinyl toluene. Trimethylol ethane. Trimethylol propane. (b) Optional adjuvant substances em- 2,2,4-Trimethyl-1,3-pentanediol. ployed to facilitate the production of (3) Cross-linking agents: the resins or added thereto to impart desired technical or physical properties Butyl acrylate. include the following, provided that Butyl methacrylate. the quantity used does not exceed that Ethyl acrylate. Ethylhexyl acrylate. reasonably required to accomplish the Methyl acrylate. intended physical or technical effect Methyl methacrylate. and does not exceed any limitations Styrene. prescribed in this section:

Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

1. Inhibitors: Total not to exceed 0.08 percent. Benzoquinone ...... 0.01 percent. tert-Butyl catechol. TBHQ. Di-tert-butyl hydroquinone. Hydroquinone. 2. Accelerators: Total not to exceed 1.5 percent. Benzyl trimethyl ammonium chloride ...... 0.05 percent. Calcium naphthenate. Cobalt naphthenate. Copper naphthenate. N, N-Diethylaniline ...... 0.4 percent. N, N-Dimethylaniline ...... Do. Ethylene guanidine hydrochloride ...... 0.05 percent. 3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ketone peroxide may be used as the sole catalyst at levels not to exceed 2 percent. Azo-bis-isobutyronitrile. Benzoyl peroxide. 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– For use in the polycondensation reaction at levels not to ex- 94–4). ceed 0.2 percent of the polyester resin. 4. Solvents for inhibitors, accelerators, and catalysts: Butyl benzyl phthalate (containing not more than 1.0 percent by weight of dibenzyl phthalate). Dibutyl phthalate. Diethylene glycol ...... As a solvent for benzyl trimethyl ammonium chloride or ethylene guanidine hydrochloride only. Dimethyl phthalate. Methyl alcohol. Styrene. Triphenyl phosphate. 5. Reinforcements: Asbestos. Glass fiber. Polyester fiber produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols listed in paragraph (a)(2) of this section. 6. Miscellaneous materials: Castor oil, hydrogenated. a-Methylstyrene.

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Limitations (limits of addition expressed as percent by weight List of substances of finished resin)

Polyethylene glycol 6000. Silicon dioxide. Wax, petroleum ...... Complying with § 178.3710 of this chapter.

(c) The cross-linked polyester resins, ins shall be thoroughly cleansed prior with or without the optional sub- to their first use in contact with food. stances described in paragraph (b) of this section, and in the finished form in § 177.2440 Polyethersulfone resins. which they are to contact food, when Polyethersulfone resins identified in extracted with the solvent or solvents paragraph (a) of this section may be characterizing the type of food and safely used as articles or components under the conditions of time and tem- of articles intended for repeated use in perature characterizing the conditions contact with food in accordance with of their intended use, as determined the following prescribed conditions: from tables 1 and 2 of § 176.170(c) of this (a) For the purpose of this section, chapter, shall meet the following ex- polyethersulfone resins are: tractives limitations: (1) Poly(oxy-p-phenylenesulfonyl-p- (1) Net chloroform-soluble extrac- phenylene) resins (CAS Reg. No. 25667– tives not to exceed 0.1 milligram per 42–9), which have a minimum number square inch of food-contact surface average molecular weight of 16,000. tested when the prescribed food-simu- (2) 1,1′-sulfonylbis[4-chlorobenzene] lating solvent is water or 8 or 50 per- polymer with 4,4′-(1-methylethyl- cent alcohol. idene)bis[phenol] (maximum 8 percent) (2) Total nonvolatile extractives not and 4,4′-sulfonylbis[phenol] (minimum to exceed 0.1 milligram per square inch 92 percent) (CAS Reg. No. 88285–91–0), of food-contact surface tested when the which have a minimum number aver- prescribed food-simulating solvent is age molecular weight of 26,000. heptane. (3) In paragraphs (a)(1) and (a)(2) of (d) In accordance with good manufac- this section, the minimum number av- turing practice, finished articles con- erage molecular weight is determined taining the cross-linked polyester res- by reduced viscosity in dimethyl form- ins shall be thoroughly cleansed prior amide in accordance with ASTM meth- to their first use in contact with food. od D2857–70 (Reapproved 1977), ‘‘Stand- ard Test Method for Dilute Solution [42 FR 14572, Mar. 15, 1977, as amended at 48 Viscosity of Polymers,’’ which is incor- FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, porated by reference. Copies may be 1989] obtained from the American Society for Testing Materials, 100 Barr Harbor § 177.2430 Polyether resins, Dr., West Conshohocken, Philadelphia, chlorinated. PA 19428-2959, or may be examined at Chlorinated polyether resins may be the Office of Food Additive Safety safely used as articles or components (HFS–200), Center for Food Safety and of articles intended for repeated use in Applied Nutrition, Food and Drug Ad- producing, manufacturing, packing, ministration, 5100 Paint Branch Pkwy., processing, preparing, treating, pack- College Park, MD 20740, 240–402–1200 or aging, transporting, or holding food, in at the National Archives and Records accordance with the following pre- Administration (NARA). For informa- scribed conditions: tion on the availability of this mate- (a) The chlorinated polyether resins rial at NARA, call 202–741–6030, or go are produced by the catalytic polym- to: http://www.archives.gov/ erization of 3,3-bis(chloromethyl)- federallregister/ oxetane, and shall contain not more codeloflfederallregulations/ than 2 percent residual monomer. ibrllocations.html. (b) In accordance with good manufac- (b) The basic resins identified in turing practice, finished articles con- paragraphs (a)(1) and (a)(2) of this sec- taining the chlorinated polyether res- tion may contain optional adjuvant

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substances described in § 174.5(d) of this (b) Specifications. (1) Polyamide-imide chapter and the following: resins identified in paragraph (a)(1) of this section shall have a nitrogen con- List of substances Limitations tent of not less than 7.8 weight percent Diphenylsulfone ...... Not to exceed 0.2 percent as re- and not more than 8.2 weight percent. sidual solvent in the finished Polyamide-imide resins identified in basic resin described in para- paragraph (a)(2) of this section shall graph (a)(1) of this section. Dimethyl sulfoxide ...... Not to exceed 0.01 percent as have a nitrogen content of not less residual solvent in the finished than 7.5 weight percent and not more basic resin described in para- than 7.8 weight percent. Nitrogen con- graph (a)(1) of this section. tent is determined by the Dumas Nitro- N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as residual solvent in the finished gen Determination as set forth in the basic resin described in para- ‘‘Official Methods of Analysis of the graph (a)(2) of this section. Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections (c) The finished food-contact article, 7.016–7.020, which is incorporated by when extracted at reflux temperatures reference in accordance with 5 U.S.C. for 2 hours with the following four sol- 552(a). Copies may be obtained from the vents, yields net chloroform-soluble ex- AOAC INTERNATIONAL, 481 North tractives in each extracting solvent Frederick Ave., suite 500, Gaithersburg, not to exceed 0.02 milligram per square MD 20877, or may be examined at the inch of food-contact surface: distilled National Archives and Records Admin- water, 50 percent (by volume) ethyl al- istration (NARA). For information on cohol in distilled water, 3 percent ace- the availability of this material at tic acid in distilled water, and n- NARA, call 202–741–6030, or go to: http:// heptane. (Note: In testing the finished www.archives.gov/federallregister/ food-contact article, use a separate codeloflfederallregulations/ test sample for each required extract- ibrllocations.html. ing solvent.) (2) Polyamide-imide resins identified (d) In accordance with good manufac- in paragraph (a)(1) of this section shall turing practice, finished food-contact have a solution viscosity of not less articles containing the than 1.200. Polyamide-imide resins polyethersulfone resins shall be thor- identified in paragraph (a)(2) of this oughly cleansed before their first use section shall have a solution viscosity in contact with food. of not less than 1.190. Solution vis- [44 FR 34493, June 15, 1979, as amended at 47 cosity shall be determined by a method FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, titled ‘‘Solution Viscosity’’ which is in- 1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, corporated by reference in accordance Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013] with 5 U.S.C. 552(a). Copies are available from the Center for Food Safety § 177.2450 Polyamide-imide resins. and Applied Nutrition (HFS–200), Food Polyamide-imide resins identified in and Drug Administration, 5100 Paint paragraph (a) of this section may be Branch Pkwy., College Park, MD 20740, safely used as components of articles or available for inspection at the Na- intended for repeated use in contact tional Archives and Records Adminis- with food, in accordance with the fol- tration (NARA). For information on lowing prescribed conditions: the availability of this material at (a) Identity. (1) For the purpose of NARA, call 202–741–6030, or go to: http:// this section the polyamide-imide resins www.archives.gov/federallregister/ are derived from the condensation re- codeloflfederallregulations/ action of substantially equimolar parts ibrllocations.html. of trimellitic anhydride and p,p′- (3) The polyamide-imide resins iden- diphenylmethane diisocyanate. tified in paragraph (a)(1) of this section (2) The polyamide-imide resins (CAS are heat cured at 600 °F for 15 minutes Reg. No. 31957–38–7) derived from the when prepared for extraction tests and condensation reaction of equimolar the residual monomers: p,p- parts of benzoyl chloride-3,4- diphenylmethane diisocyanate should dicarboxylic anhydride and 4,4′- not be present at greater than 100 parts diphenylmethanediamine. per million and trimellitic anhydride

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should not be present at greater than cleansed prior to their first use in con- 500 parts per million. Residual mono- tact with food. mers are determined by gas chroma- [42 FR 14572, Mar. 15, 1977, as amended at 47 tography (the gas chromatography FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19, method titled ‘‘Amide-Imide Polymer 1984; 54 FR 24898, June 12, 1989; 54 FR 43170, Analysis—Analysis of Monomer Con- Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR tent,’’ is incorporated by reference in 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] accordance with 5 U.S.C. 552(a). Copies § 177.2460 Poly(2,6-dimethyl-1,4-phen- are available from the Center for Food ylene) oxide resins. Safety and Applied Nutrition (HFS– The poly(2,6-dimethyl-1,4-phenylene) 200), Food and Drug Administration, oxide resins identified in paragraph (a) 5100 Paint Branch Pkwy., College Park, of this section may be used as an arti- MD 20740, or available for inspection at cle or as a component of an article in- the National Archives and Records Ad- tended for use in contact with food sub- ministration (NARA). For information ject to the provisions of this section. on the availability of this material at (a) Identity. For the purposes of this NARA, call 202–741–6030, or go to: http:// section, poly(2,6-dimethyl-1,4-phen- www.archives.gov/federallregister/ ylene) oxide resins consist of basic res- codeloflfederallregulations/ ins produced by the oxidative coupling ibrllocations.html.). of 2,6-xylenol such that the finished (c) Extractive limitations are appli- basic resins meet the specifications cable to the polyamide-imide resins and extractives limitations prescribed identified in paragraphs (a) (1) and (2) in paragraph (c) of this section. of this section in the form of films of 1 (b) Optional adjuvant substances. The mil uniform thickness after coating basic poly(2,6-dimethyl-1,4-phenylene) and heat curing at 600 °F for 15 minutes oxide resins identified in paragraph (a) on stainless steel plates, each having of this section may contain optional such resin-coated surface area of 100 adjuvant substances required in the square inches. The cured-resin film production of such basic resins. The op- coatings shall be extracted in accord- tional adjuvant substances required in the production of the basic poly(2,6-di- ance with the method described in methyl-1,4-phenylene) oxide resins may § 176.170(d)(3) of this chapter, using a include substances permitted for such plurality of spaced, coated stainless use by regulations in parts 170 through steel plates, exposed to the respective 189 of this chapter, substances gen- food simulating solvents. The resin erally recognized as safe in food, sub- shall meet the following extractive stances used in accordance with a prior limitations under the corresponding sanction or approval, and the fol- extraction conditions: lowing: (1) Distilled water at 250 °F for 2 Limitations (expressed as hours: Not to exceed 0.01 milligram per List of substances percent by weight of finished square inch. basic resin) ° (2) Three percent acetic acid at 212 F Diethylamine ...... Not to exceed 0.16 percent for 2 hours: Not to exceed 0.05 milli- as residual catalyst. gram per square inch. Methyl alcohol ...... Not to exceed 0.02 percent as residual solvent. (3) Fifty percent ethyl alcohol at 160 Toluene ...... Not to exceed 0.2 percent as °F for 2 hours: Not to exceed 0.03 milli- residual solvent. gram per square inch. (4) n-Heptane at 150 °F for 2 hours: (c) Specifications and extractives limita- Not to exceed 0.05 milligram per square tions. The poly(2,6-dimethyl-1,4-phen- inch. ylene) oxide basic resins meet the following: (d) In accordance with good manufac- (1) Specifications. Intrinsic viscosity turing practice, those food contact ar- is not less than 0.30 deciliter per gram ticles, having as components the poly- as determined by ASTM method D1243– amide-imide resins identified in para- 79, ‘‘Standard Test Method for Dilute graph (a) of this section and intended Solution Viscosity of Vinyl Chloride for repeated use shall be thoroughly Polymers,’’ which is incorporated by

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reference, modified as follows. Copies section, when used as components of of the incorporation by reference may the food-contact surface of any article be obtained from the American Society that is the subject of a regulation in for Testing Materials, 100 Barr Harbor parts 174, 175, 176, 177, 178 and § 179.45 of Dr., West Conshohocken, Philadelphia, this chapter, shall comply with any PA 19428-2959, or may be examined at specifications and limitations pre- the National Archives and Records Ad- scribed by such regulation for the arti- ministration (NARA). For information cle in the finished form in which it is on the availability of this material at to contact food. NARA, call 202–741–6030, or go to: http:// (e) Uses. The poly(2,6-dimethyl-1,4- www.archives.gov/federallregister/ codeloflfederallregulations/ phenylene) oxide resins identified in ibrllocations.html. and complying with the limitations in (i) Solvent: Chloroform, reagent grade this section may be used as articles or containing 0.01 percent tert- components of articles intended for re- butylcatechol. peated food-contact use or as articles (ii) Resin sample: Powdered resin ob- or components of articles intended for tained from production prior to mold- single-service food-contact use only ing or extrusion. under the conditions described in (iii) Viscometer: Cannno-Ubbelohde se- § 176.170(c) of this chapter, table 2, con- ries 25 dilution viscometer (or equiva- ditions of use H. lent). (iv) Calculation: The calculation [42 FR 14572, Mar. 15, 1977, as amended at 49 method used is that described in appen- FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23, 1998] dix X.1.3 (ASTM method D1243–79, cited and incorporated by reference in para- § 177.2465 Polymethylmethacrylate/ graph (c)(1) of this section) with the re- poly(trimethoxysilylpropyl)meth- duced viscosity determined for three acrylate copolymers. concentration levels (0.4, 0.2, and 0.1 gram per deciliter) and extrapolated to Polymethylmethacrylate/ zero concentration for intrinisic vis- poly(trimethoxysilylpropyl) methacry- cosity. The following formula is used late copolymers (CAS Reg. No. 26936– for determining reduced viscosity: 30–1) may be safely used as components of surface primers used in conjunction Reduced viscosity in terms tt− with silicone polymers intended for re- = o peated use and complying with § 175.300 of deciliters per gram × tco of this chapter and § 177.2600, in accord- where: ance with the following prescribed con- t=Solution efflux time. ditions. to=Solvent efflux time. (a) Identity. For the purpose of this c=Concentration of solution in terms of section, polymethylmethacrylate/ grams per deciliter. poly(trimethoxysilylpropyl)methacry- (2) Extractives limitations. Total resin late copolymers are produced by the extracted not to exceed 0.02 weight-per- polymerization of methylmethacrylate cent when extracted with n-heptane at and 160 °F for 2 hours as determined using trimethoxysilylpropylmethacrylate. 200 milliliters of reagent grade n- (b) Conditions of use. (1) The heptane which has been freshly dis- polymethylmethacrylate/ tilled before use and 25 grams of poly poly(trimethoxysilylpropyl)methacry- (2,-6-dimethyl-1,4-phenylene) oxide late copolymers are used at levels not resin. The resin as tested is in pellet to exceed 6.0 percent by weight of the form having a particle size such that primer formulation. 100 percent of the pellets will pass (2) The copolymers may be used in through a U.S. Standard Sieve No. 6 food contact applications with all food and 100 percent of the pellets will be types under conditions of use B held on a U.S. Standard Sieve No. 10. through H as described in table 2 of (d) Other limitations. The poly(2,6-di- § 176.170(c) of this chapter. methyl-1,4-phenylene) oxide resins identified in and complying with this [59 FR 5948, Feb. 9, 1994]

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§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec- mer. ular weight of the copolymer is 15,000 Polyoxymethylene copolymer identi- as determined by a method titled fied in this section may be safely used ‘‘Number Average Molecular Weight,’’ as an article or component of articles which is incorporated by reference. intended for food-contact use in ac- Copies are available from the Center cordance with the following prescribed for Food Safety and Applied Nutrition conditions: (HFS–200), Food and Drug Administra- (a) Identity. For the purpose of this tion, 5100 Paint Branch Pkwy., College section, polyoxymethylene copolymers Park, MD 20740, or available for inspec- are identified as the following: The re- tion at the National Archives and action product of trioxane (cyclic Records Administration (NARA). For trimer of formaldehyde) and ethylene information on the availability of this oxide (CAS Reg. No. 24969–25–3) or the material at NARA, call 202–741–6030, or reaction product of trioxane (cyclic go to: http://www.archives.gov/ trimer of formaldehyde) and a max- federallregister/ imum of 5 percent by weight of codeloflfederallregulations/ butanediol formal (CAS Reg. No. 25214 ibrllocations.html. 85–1). Both copolymers may have cer- (d) Extractive limitations. (1) Polyoxy- tain optional substances added to impart desired technological properties to methylene copolymer in the finished the copolymer. form in which it is to contact food, (b) Optional adjuvant substances. The when extracted with the solvent or sol- polyoxymethylene copolymer identi- vents characterizing the type of food fied in paragraph (a) of this section and under conditions of time and tem- may contain optional adjuvant sub- perature as determined from tables 1 stances required in its production. The and 2 of § 175.300(d) of this chapter, quantity of any optional adjuvant sub- shall yield net chloroform-soluble ex- stance employed in the production of tractives not to exceed 0.5 milligram the copolymer does not exceed the per square inch of food-contact surface. amount reasonably required to accom- (2) Polyoxymethylene copolymer plish the intended technical or physical with or without the optional sub- effect. Such adjuvants may include stances described in paragraph (b) of substances generally recognized as safe this section, when ground or cut into in food, substances used in accordance particles that pass through a U.S.A. with prior sanction, substances per- Standard Sieve No. 6 and that are re- mitted under applicable regulations in tained on a U.S.A. Standard Sieve No. parts 170 through 189 of this chapter, 10, shall yield total extractives as fol- and the following: lows: (1) Stabilizers (total amount of stabi- (i) Not to exceed 0.20 percent by lizers not to exceed 2.0 percent and amount of any one stabilizer not to ex- weight of the copolymer when exceed 1.0 percent of polymer by weight) tracted for 6 hours with distilled water at reflux temperature. Calcium ricinoleate. (ii) Not to exceed 0.15 percent by Cyanoguanidine. Hexamethylene bis(3,5-di-tert-butyl-4- weight of the copolymer when ex- hydroxyhydrocinnamate) (CAS Reg. No. tracted for 6 hours with n-heptane at 35074–77–2). reflux temperature. Melamine-formaldehyde resin. (e) Conditions of use. (1) The 2,2′-Methylenebis(4-methyl-6-tert-butyl- polyoxymethylene copolymer is for use phenol). as articles or components of articles Nylon 6/66, weight ratio 2/3. Tetrakis [methylene (3,5-di-tert-butyl-4- intended for repeated use. hydroxyhydrocinnamate)] methane. (2) Use temperature shall not exceed 250 °F. (2) Lubricant: N,N′Distearoylethyl- enediamine. (3) In accordance with good manufac- (c) Specifications. (1) Polyoxymeth- turing practice, finished articles con- ylene copolymer can be identified by taining polyoxymethylene copolymer its characteristic infrared spectrum.

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shall be thoroughly cleansed before Substances Limitations their first use in contact with food. Nylon 66/610/6 terpolymer, At a maximum level of 1.5 [42 FR 14572, Mar. 15, 1977, as amended at 48 respective proportions of percent by weight of FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15, nylon polymers by weight homopolymer. are: 3/2/4. 1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Nylon 612/6 copolymer (CAS Do. May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR Reg. No. 51733-10-9), 24898, June 12, 1989] weight ratio 6/1. Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5 § 177.2480 Polyoxymethylene butyl-4-hydroxy-hydro- percent by weight of homopolymer. cinnamate)] methane. homopolymer. Polyoxymethylene homopolymer (2) Lubricant. N,N′-Distearoylethyl- identified in this section may be safely enediamine. used as articles or components of arti- (3) Molding assistant. Polyethylene cles intended for food-contact use in glycol 6,000. accordance with the following pre- (c) Specifications. (1) scribed conditions: Polyoxymethylene homopolymer can (a) Identity. For the purpose of this be identified by its characteristic in- section, polyoxymethylene homopoly- frared spectrum. mer is polymerized formaldehyde (2) Minimum number average molec- [Chemical Abstracts Service Registry ular weight of the homopolymer is No. 9002–81–7]. Certain optional adju- 25,000. vant substances, described in para- (3) Density of the homopolymer is be- graph (b) of this section, may be added tween 1.39 and 1.44 as determined by to impart desired technological prop- ASTM method D1505–68 (Reapproved erties to the homopolymer. 1979), ‘‘Standard Test Method for Den- (b) Optional adjuvant substances. The sity of Plastics by the Density-Gra- polyoxymethylene homopolymer iden- dient Technique,’’ which is incor- tified in paragraph (a) of this section porated by reference. Copies may be may contain optional adjuvant sub- obtained from the American Society stances in its production. The quantity for Testing Materials, 100 Barr Harbor of any optional adjuvant substance em- Dr., West Conshohocken, Philadelphia, ployed in the production of the PA 19428-2959, or may be examined at homopolymer does not exceed the the National Archives and Records Ad- amount reasonably required to accom- ministration (NARA). For information plish the intended effect. Such adju- on the availability of this material at vants may include substances gen- NARA, call 202–741–6030, or go to: http:// erally recognized as safe in food, sub- www.archives.gov/federallregister/ stances used in accordance with prior codeloflfederallregulations/ sanction, substances permitted under ibrllocations.html. ° applicable regulations in this part, and (4) Melting point is between 172 C ° the following: and 184 C as determined by ASTM method D2133–66, ‘‘Specifications for (1) Stabilizers. The homopolymer may Acetal Resin Injection Molding and Ex- contain one or more of the following trusion Materials’’ (Revised 1966), stabilizers. The total amount of stabi- which is incorporated by reference. lizers shall not exceed 1.9 percent of Copies are available from American So- homopolymer by weight, and the quan- ciety for Testing and Materials tity of individual stabilizer used shall (ASTM), 100 Barr Harbor Dr., West not exceed the limitations set forth Conshohocken, Philadelphia, PA 19428- below: 2959, or available for inspection at the Substances Limitations National Archives and Records Admin- istration (NARA). For information on Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- the availability of this material at butyl-4-hydroxy-hydro- cent by weight of cinnamate) (CAS Reg. No. homopolymer. The finished NARA, call 202–741–6030, or go to: http:// 35074–77–2). articles shall not be used www.archives.gov/federallregister/ for foods containing more codeloflfederallregulations/ than 8 percent alcohol. ibrllocations.html. 2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5 tert-butylphenol). percent by weight of (d) Extractive limitations. (1) homopolymer. Polyoxymethylene homopolymer, in

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the finished form which is to contact cleansed prior to first use in contact food, when extracted with the solvent with food. or solvents characterizing the type of [42 FR 14572, Mar. 15, 1977, as amended at 43 food and under conditions of time and FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19, temperature characterizing the condi- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111, tions of intended use under paragraphs Mar. 19, 1984; 54 FR 24898, June 12, 1989] (c)(3) and (d) of § 175.300 of this chapter and as limited by paragraph (e) of this § 177.2490 Polyphenylene sulfide resins. section, shall yield net chloroform- soluble extractives not to exceed 0.5 Polyphenylene sulfide resins milligram per square inch of food-con- (poly(1,4-phenylene sulfide) resins) may tact surface. be safely used as coatings or components of coatings of articles intended (2) Polyoxymethylene homopolymer, for repeated use in contact with food, with or without the optional adjuvant in accordance with the following pre- substances described in paragraph (b) scribed conditions. of this section, when ground or cut into (a) Polyphenylene sulfide resins con- particles that pass through a U.S.A. sist of basic resins produced by the re- Standard Sieve No. 6 and that are reaction of equimolar parts of p- tained on a U.S.A. Standard Sieve No. dichlorobenzene and sodium sulfide, 10, shall yield extractives as follows: such that the finished resins meet the (i) Formaldehyde not to exceed 0.0050 following specifications as determined percent by weight of homopolymer as by methods titled ‘‘Oxygen Flask Com- determined by a method titled ‘‘Form- bustion-Gravimetric Method for Deter- aldehyde Release and Formaldehyde mination of Sulfur in Organic Com- Analysis,’’ which is incorporated by pounds,’’ ‘‘Determination of the Inher- reference. Copies are available from ent Viscosity of Polyphenylene Sul- Center for Food Safety and Applied Nu- fide,’’ and ‘‘Analysis for trition (HFS–200) Food and Drug Ad- Dichlorobenzene in Ryton ministration, 5100 Paint Branch Pkwy., Polyphenylene Sulfide,’’ which are in- College Park, MD 20740, or available for corporated by reference. Copies are inspection at the National Archives available from the Center for Food and Records Administration (NARA). Safety and Applied Nutrition (HFS– 200), Food and Drug Administration, For information on the availability of 5100 Paint Branch Pkwy., College Park, this material at NARA, call 202–741– MD 20740, or available for inspection at 6030, or go to: http://www.archives.gov/ the National Archives and Records Ad- federallregister/ ministration (NARA). For information codeloflfederallregulations/ on the availability of this material at ibrllocations.html. NARA, call 202–741–6030, or go to: http:// (ii) Total extractives not to exceed www.archives.gov/federallregister/ 0.20 percent by weight of homopolymer codeloflfederallregulations/ when extracted for 6 hours with dis- ibrllocations.html. tilled water at reflux temperature and (1) Sulfur content: 28.2–29.1 percent 0.15 percent by weight of homopolymer by weight of finished resin. when extracted for 6 hours with n- (2) Minimum inherent viscosity: 0.13 heptane at reflux temperature. deciliters per gram. (e) Conditions of use. (1) Polyoxy- (3) Maximum residual p- methylene homopolymer is for use as dichlorobenzene: 0.8 ppm. articles or components of articles in- (b) Subject to any limitations pre- tended for repeated use. scribed in parts 170 through 189 of this (2) Use temperature shall not exceed chapter, the following optional sub- 250 °F. stances may be added to the polyphenylene sulfide basic resins in an (3) In accordance with good manufac- amount not to exceed that reasonably turing practice, finished articles con- required to accomplish the intended taining polyoxymethylene physical or technical effect. homopolymer shall be thoroughly (1) Substances generally recognized as safe in food.

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(2) Substances used in accordance acetic acid such that the finished res- with prior sanction or approval. ins meet the specifications set forth in (3) Substances the use of which is paragraph (c) of this section. The permitted in coatings under regula- polyphenylene sulfide used to manufac- tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared chapter. by the reaction of sodium sulfide and p- (c) The finished coatings are ther- dichlorobenzene, and has a minimum mally cured at temperatures of 700 °F weight average molecular weight of and above. 5,000 Daltons. (d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The ings may be used in contact with food basic polyphenylene sulfone resins at temperatures not to exceed the boil- identified in paragraph (a) of this sec- ing point of water; provided that the tion may contain optional adjuvant finished cured coating, when extracted substances required in the production at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad- rately with distilled water, 50 percent juvant substances may include sub- ethanol in water, and 3 percent acetic stances permitted for such use by regu- acid, yields total extractives in each lations in parts 170 through 189 of this extracting solvent not to exceed 0.02 chapter, substances generally recog- milligram per square inch of surface nized as safe in food, or substances and when extracted at reflux tempera- used in accordance with a prior sanc- ture for 8 hours with heptane yields tion or approval. total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition ligram per square inch of surface. temperature of the polymer is 360±5 °C (e) Polyphenylene sulfide resin coat- as determined by the use of differential ings containing perfluorocarbon resins scanning calorimetry. complying with § 177.1550 may be used in contact with food at temperatures [65 FR 15058, Mar. 21, 2000] up to and including normal baking and frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res- finished cured coating, when extracted ins. at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may rately with distilled water, 50 percent be safely used as articles or compo- ethanol in water, 3 percent acetic acid nents of articles intended for repeated and heptane, yields total extractives in use in contact with food, in accordance each extracting solvent not to exceed with the following prescribed condi- 0.2 milligram per square inch of surface tions: and when extracted at reflux tempera- (a) For the purpose of this section, ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con- yields total extractives not to exceed sist of basic resins produced by the po- 4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride. face. (b) The finished food-contact article, [42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled 1989] water, 50 percent (by volume) ethyl alcohol in distilled water, and n-heptane, § 177.2500 Polyphenylene sulfone res- yields total extractives in each ex- ins. tracting solvent not to exceed 0.01 mil- The polyphenylene sulfone resins ligram per square inch of food-contact (CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food- paragraph (a) of this section may be contact article is itself the subject of a safely used as articles or components regulation in parts 174, 175, 176, 177, 178 of articles intended for repeated use in and § 179.45 of this chapter, it shall also contact with food, subject to the provi- comply with any specifications and sions of this section. limitations prescribed for it by that (a) Identity. For the purpose of this regulation. (NOTE: In testing the fin- section, polyphenylene sulfone resins ished food-contact article, use a sepa- consist of basic resin produced by re- rate test sample for each required ex- acting polyphenylene sulfide with per- tracting solvent.)

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(c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0). turing practice, finished food-contact The membrane is the food contact sur- articles containing the polyvinylidene face and may be applied as a film on a fluoride resins shall be thoroughly suitable support. Its maximum weight cleansed prior to their first use in con- is 512 milligrams per square decimeter tact with food. (33 milligrams per square inch). (4) A cross-linked high molecular § 177.2550 Reverse osmosis membranes. weight polyamide reaction product of poly(N-vinyl-N-methylamine) (CAS Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3- (a) of this section may be safely used as aminopropyl)ethylenediamine (CAS reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3- for use in processing bulk quantities of benzenedicarbonyl dichloride (CAS liquid food to separate permeate from Reg. No. 99–63–8) and 1,3,5- food concentrate or in purifying water benzenetricarbonyl trichloride (CAS for food manufacturing under the following prescribed conditions: Reg. No. 4422–95–1). The membrane is (a) Identity. For the purpose of this the food-contact surface. Its maximum section, reverse osmosis membranes weight is 20 milligrams per square deci- may consist of either of the following meter (1.3 milligrams per square inch) formulations: as a thin film composite on a suitable (1) A cross-linked high molecular support. weight polyamide reaction product of (5) A polyamide reaction product of 1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with 83044–99–9) or piperazine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and 110–85–0). The membrane is on the food- 1,2-diaminoethane (CAS Reg. No. 107– contact surface, and its maximum 15–3). The membrane is the food-con- weight is 62 milligrams per square deci- tact layer and may be applied as a film meter (4 milligrams per square inch) as on a suitable support. Its maximum a thin film composite on a suitable weight is 15 milligrams per square deci- support. meter (1 milligram per square inch). (2) A cross-linked polyetheramine (b) Optional adjuvant substances. The (CAS Reg. No. 101747–84–6), identified as basic polymer identified in paragraph the copolymer of epichlorohydrin, 1,2- (a) of this section may contain optional ethanediamine and 1,2-dichloroethane, adjuvant substances required in the whose surface is the reaction product production of such basic polymer. of this copolymer with 2,4- These optional adjuvant substances toluenediisocyanate (CAS Reg. No. of may include substances permitted for the final polymer is 99811–80–0) for use such use by regulations in parts 170 as the food-contact surface of reverse through 186 of this chapter, substances osmosis membranes used in processing generally recognized as safe in food, liquid food. The composite membrane and substances used in accordance with is on the food-contact surface and its maximum weight is 4.7 milligrams per a prior sanction or approval. square decimeter (0.3 milligrams per (c) Supports. Suitable supports for re- square inch) as a thin film composite verse osmosis membranes are mate- on a suitable support. The maximum rials permitted for such use by regula- weight of the 2,4-toluenediisocyanate tions in parts 170 through 186 of this component of the thin film composite chapter, substances generally recog- is 0.47 milligrams per square decimeter nized as safe in food, and substances (0.03 milligrams per square inch). used in accordance with a prior sanc- (3) For the purpose of this section, tion or approval. the reverse osmosis membrane consists (d) Conditions of use. (1) Reverse os- of a polyaramide identified as 2,4- mosis membranes described in para- diaminobenzenesulfonic acid, calcium graphs (a)(1), (a)(2), (a)(3), and (a)(5) of salt (2:1) polymer with 1,3- this section may be used in contact benzenediamine, 1,3-benzenedicarbonyl with all types of liquid food at tem- dichloride, and 1,4-benzenedicarbonyl peratures up to 80 °C (176 °F).

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(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with tion may be used in contact with all any specification in such regulation. types of liquid food, except food con- (i) Elastomers. taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer. temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers (3) Reverse osmosis membranes shall complying with § 177.1210. be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol accordance with current good manufac- dimethacrylate copolymers containing not turing practice so as to prevent micro- more than 5 weight percent of polymer bial adulteration of food. units derived from ethylene glycol dimethacrylate. (4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co- osmosis membranes and their supports polymer. shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly- their first use in accordance with cur- mer. rent good manufacturing practice. Chloroprene polymers. Chlorotrifluoroethylene-vinylidene fluoride [49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer. FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5 Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units derived from 5-methylene-2-norbornene and/ § 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene. repeated use. Ethylene-propylene-dicyclopentadiene co- Rubber articles intended for repeated polymer. use may be safely used in producing, Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8 weight manufacturing, packing, processing, percent of total polymer units derived preparing, treating, packaging, trans- from 1,4-hexadiene. porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co- provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro- (a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly- from natural and/or synthetic polymers mers are modified by hydrogenation of the and adjuvant substances as described olefinic unsaturation to leave either: (1) Not more than 10 percent trans olefinic in paragraph (c) of this section. unsaturation and no a, b-olefinic (b) The quantity of any substance unsaturation as determined by a method employed in the production of rubber entitled ‘‘Determination of Residual a, b- articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1, quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South fect in the rubber article and shall not Vidal St., Sarnia, Ontario, Canada N7T 7MI; or (2) 0.4 percent to 20 percent olefinic be intended to accomplish any effect in unsaturation and Mooney viscosities great- food. er than 45 (ML 1 + 4 @ 100 °C), as deter- (c) Substances employed in the prep- mined by ASTM Standard Method D1646– aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber— following, subject to any limitations Viscosity and Vulcanization Characteris- prescribed: tics (Mooney Viscometer),’’ which are both (1) Substances generally recognized incorporated by reference in accordance as safe for use in food or food pack- with 5 U.S.C. 552(a) and 1 CFR part 51. Cop- ies of these methods may be obtained from aging. the Office of Food Additive Safety (HFS– (2) Substances used in accordance 200), Center for Food Safety and Applied with the provisions of a prior sanction Nutrition, Food and Drug Administration, or approval. 5100 Paint Branch Pkwy., College Park, (3) Substances that by regulation in MD 20740, 240–402–1200, or may be examined parts 170 through 189 of this chapter at the Center for Food Safety and Applied may be safely used in rubber articles, Nutrition’s Library, 5100 Paint Branch subject to the provisions of such regu- Pkwy., College Park, MD 20740, or at the National Archives and Records Adminis- lation. tration (NARA). For information on the (4) Substances identified in this para- availability of this material at NARA, call graph (c)(4), provided that any sub- 202–741–6030, or go to: http:// stance that is the subject of a regula- www.archives.gov/federallregister/

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codeloflfederallregulations/ Silicone (Fsi) elastomers containing meth- ibrllocations.html. A copy of ASTM Stand- yl and fluorine groups. ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing from the American Society for Testing and phenyl, methyl, and vinyl groups. Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer. Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co- Isobutylene-isoprene copolymer. polymers (minimum number average mo- Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os- Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone). copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene- acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum col). The polyamide and polyether compo- number average molecular weight 100,000 nents are reacted in ratios such that the as determined by osmotic pressure in polyamide component constitutes a min- methyl ethyl ketone). imum of 30 weight-percent of total polymer units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul- tact with foods of Types I, II, III, IV, V, VI, canizing agents. VII, VIII, and IX identified in table 1 of ′ § 176.170(c) of this chapter at temperatures 4,4 -Bis(aminocyclohexyl)methane carbamate not to exceed 150 °F except that those co- for use only as cross-linking agent in the polymers prepared with less than 50 vulcanization of vinylidene weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer use in contact with such foods at tempera- and vinylidene fluoride- tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene Polybutadiene. copolymer elastomers identified under Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim- tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per- butanediol, and a-hydro-omega- cent by weight of such copolymers. hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1 tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio- used as a reactant. The polyester bis-thioformate, O,O-di(1- elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate, with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis- cent alcohol and limited to use in contact thioformate) for use as a cross linking with food at temperatures not exceeding agent in the vulcanization of natural rub- 150 °F. ber, styrene-butadiene copolymer, acrylo- Polyisoprene. nitrile-butadiene copolymer, and ethylene- Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under 1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim- diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per- butanediol and polytetramethylene ether cent by weight of such copolymers. glycol. Hexamethylenediamine carbamate for use Polyurethane resins derived from reactions only as cross-linking agent in the vul- of diphenylmethane diisocyanate with canization of vinylidene fluoride- adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli- Rubber, natural. dene fluoride-hexafluoropropylene-tetra- Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden- method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec- Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex- clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly- erence. Copies may be obtained from the mers. American Society for Testing Materials, Sulfur, ground. 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5 amined at the National Archives and percent by weight of rubber product). Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul- formation on the availability of this mate- fide. rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide. http://www.archives.gov/federallregister/ 1,3-Bis(2-benzothiazolylmercaptomethyl) codeloflfederallregulations/ urea. ibrllocations.html. N-tert-Butyl-2-benzothiazole sulfenamide. Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number groups. 670–705). Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine yl and phenyl groups. reaction product. Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate. yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide.

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Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per- Dibenzylamine. cent of weight of rubber product). Diisopropyl xanthogen polysulfide (a 1:2:1 mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine. bis-thioformate, O,O-di(1- Phthalic anhydride. methylethyl)tetrathio-bis-thioformate, Salicylic acid. and O,O-di(1-methylethyl)pentathio-bis- thioformate). (d) Activators (total not to exceed 5 per- Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except 895–85–2) for use only as a crosslinking magnesium oxide may be used at higher agent in silicone polymers and elastomers levels). identified under paragraph (c)(4)(i) of this section at levels not to exceed 1 percent by Diethylamine. weight of such polymers and elastomers Fatty acid amines, mixed. where the total of all accelerators does not Fatty acids. exceed 1.5 percent by weight of rubber Magnesium carbonate. product. Magnesium oxide, light and heavy. Di-tert-butyl peroxide. Oleic acid, dibutylamine salt Dibutyl xanthogen disulfide. (dibutylammonium oleate). 2,4-Dichlorobenzoyl peroxide. Stannous chloride. Dicumyl peroxide. Tall oil fatty acids. N,N-Dimethylcyclohexylamine salt of Tetrachloro-p-benzoquinone. dibutyldithiocarbamic acid. Triethanolamine. 2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids. Dipentamethylenethiuram hexasulfide (CAS (iii) Antioxidants and antiozonants Reg. No. 971–15–3). Diphenylguanidine. (total not to exceed 5 percent by weight of Diphenylguanidine phthalate. rubber product). 1,3-Diphenyl-2-thiourea. Aldol-a-naphthylamine. 2,2′-Dithiobis[benzothiazole]. Alkylated (C and/or C ) phenols. 4,4′-Dithiodimorpholine. 4 8 BHT (butylated hydroxytoluene). N,N′-Di-o-tolylguanidine. 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]- Di-o-tolylguanidine salt of 2,6-di-tert-butylphenol (CAS Reg. No. 991– pyrocatecholborate. 84–4) for use only as a stabilizer at levels Ethylenediamine carbamate. not to exceed 0.5 percent by weight of the Heptaldehyde-aniline resin (iodine number finished rubber product. 430–445). Hexamethylenetetramine. Butylated reaction product of p-cresol and 2-Mercaptobenzothiazole. dicyclopentadiene as identified in 2-Mercaptothiazoline. § 178.2010(b) of this chapter. N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in sulfenamide. § 178.2010(b) of this chapter. ′ Piperidinium pentamethylenedithiocarba- 4,4 -Butylidinebis(6-tert-butyl-m-cresol). ′ mate. N-Cyclohexyl-N -phenylphenylenediamine. Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane. p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone. Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl. Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol. erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6- Tetrabutylthiuram monosulfide. dodecylquinoline. Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6- (1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline. butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6- Tetramethylthiuram monosulfide. phenylquinoline. Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine. Triallyl cyanurate. 4,6-Dinonyl-o-cresol. Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine. 1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin. (triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin. Triphenylguanidine. N,N′-Diphenylethylenediamine. Zinc butyl xanathate. N,N′-Disalicylalpropylenediamine. Zinc dibenzyl dithiocarbamate. N,N′-Di-o-tolylethylenediamine. Zinc dibutyldithiocarbamate. Hydroquinone monobenzyl ether. Zinc diethyldithiocarbamate. Isopropoxydiphenylamine. Zinc 2-mercaptobenzothiazole. N-Isopropyl-N′-phenyl-p-phenylenediamine. Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol).

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2,2′-Methylenebis(4-methyl-6-tert-butyl- Diisooctyl sebacate. phenol). Dioctyl adipate. 2,2′-Methylenebis(4-methyl-6-nonylphenol). Dioctyl phthalate. 2,2′-Methylenebis(4-methyl-6-tert- Dioctyl sebacate. octylphenol). Dipentene resin. Monooctyl- and dioctyldiphenylamine. Diphenyl ketone. N,N′-Di-b-naphthyl-p-phenylenediamine. Fatty acids. Phenyl-a-naphthylamine. Fatty acids, hydrogenated. Phenyl-b-naphthylamine. Isooctyl ester of tall oil fatty acids. Phenyl-b-naphthylamine-acetone aromatic Lanolin. amine resin (average molecular weight 600; a-Methylstyrene-vinyltoluene copolymer nitrogen content 5.3 percent). resins (molar ratio 1 a-methylstyrene to 3 o- and p-Phenylphenol. vinyltoluene). Polybutylated (mixture) 4,4′- Mineral oil; (1) In rubber articles complying isopropylidenediphenol. with this section, not to exceed 30 percent Sodium pentachlorophenate. by weight; (2) Alone or in combination Styrenated cresols produced when 2 moles of with waxes, petroleum, total not to exceed styrene are made to react with 1 mole of a 45 percent by weight of rubber articles that mixture of phenol and o-, m-, and p-cresols contain at least 20 percent by weight of so that the final product has a Brookfield ethylene-propylene copolymer elastomer viscosity at 25 °C of 1400 to 1700 centipoises. complying with paragraph (c)(4)(i) of this Styrenated phenol. section, in contact with foods of Types I, 4,4′-Thiobis (6-tert-butyl-m-cresol). II, III, IV, VI, VII, VIII, and IX idenified in Toluene-2,4-diamine. table 1 of § 176.170(c) of this chapter. N-o-Tolyl-N′-phenyl-p-phenylenediamine. Montan wax. p(p-Tolylsufanilamide) diphenylamine. n-Octyl n-decyl adipate. Tri(mixed mono- and dinonylphenyl) n-Octyl n-decyl phthalate. phosphite. Petrolatum. Tri(nonylphenyl) phosphite-formaldehyde Petroleum hydrocarbon resin resins produced when 1 mole of (cyclopentadiene type), hydrogenated. tri(nonylphenyl) phosphite is made to Petroleum hydrocarbon resin (produced by react with 1.4 moles of formaldehyde or the homo- and copolymerization of dienes produced when 1 mole of nonylphenol is and olefins of the aliphatic, alicyclic, and made to react with 0.36 mole of formalde- monobenzenoid arylalkene types from dis- hyde and the reaction product is then fur- tillates of cracked petroleum stocks). ther reacted with 0.33 mole of phosphorus Petroleum hydrocarbon resin (produced by trichloride. The finished resins have a min- the catalytic polymerization and subse- imum viscosity of 20,000 centipoises at 25 quent hydrogenation of styrene, °C, as determined by LV-series Brookfield vinyltoluene, and indene types from dis- viscometer (or equivalent) using a No. 4 tillates of cracked petroleum stocks). spindle at 12 r.p.m., and have an organic Petroleum oil, sulfonated. phosphorus content of 4.05 to 4.15 percent Phenol-formaldehyde resin. by weight. Pine tar. Polybutene. (iv) Plasticizers (total not to exceed 30 Polystyrene. percent by weight of rubber product un- Propylene glycol. less otherwise specified). n-Propyl ester of tall oil fatty acids. Rapeseed oil vulcanized with rubber maker’s n-Amyl n-decyl phthalate. sulfur. Butylacetyl ricinoleate. Rosins and rosin derivatives identified in n-Butyl ester of tall oil fatty acids. § 175.105(c)(5) of this chapter. Butyl laurate. Soybean oil vulcanized with rubber maker’s Butyl oleate. sulfur. Butyl stearate. Styrene-acrylonitrile copolymer. Calcium stearate. Terpene resins. Castor oil. Triethylene glycol dicaprate. Coumarone-indene resins. Triethylene glycol dicaprylate. 2,2′-Dibenzamidodiphenyl disulfide. Waxes, petroleum. Dibenzyl adipate. Xylene (or toluene) alkylated with Dibutoxyethoxyethyl adipate. dicyclopentadiene. Dibutyl phthalate. Zinc 2-benzamidothiophenate. Dibutyl sebacate. (v) Fillers. Didecyl adipate. Didecyl phthalate. Aluminum hydroxide. Diisodecyl adipate. Aluminum silicate. Diisodecyl phthalate. Asbestos fiber, chrysotile or crocidolite. Diisooctyl adipate. Barium sulfate.

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Carbon black (channel process or furnace levels not to exceed 0.3 percent by weight combustion process; total carbon black not of the sealants and caulking materials. to exceed 50 percent by weight of rubber Dodecyl mercaptan isomers, single or mixed. product; furnace combustion black content 2-Ethoxyethanol. not to exceed 10 percent by weight of rub- Iodoform. ber products intended for use in contact p-Menthane hydroperoxide. with milk or edible oils). a-(p-Nonylphenyl)-omega-hydroxypoly (oxy- Cork. ethylene) mixture of dihydrogen phosphate Cotton (floc, fibers, fabric). and monohydrogen phosphate esters, bar- Mica. ium salt; the nonyl group is a propylene Nylon (floc, fibers, fabric). trimer isomer and the poly (oxyethylene) Silica. content averages 9 moles; for use only as Titanium dioxide. residual polymerization emulsifier at lev- Zinc carbonate. els not to exceed 0.7 percent by weight of Zinc sulfide. ethylene-propylene-1,4-hexadiene copoly- (vi) Colorants. Colorants used in ac- mers identified under paragraph (c)(4)(i) of cordance with § 178.3297 of this chapter. this section. ′ (vii) Lubricants (total not to exceed 2 4,4 -Oxybis (benzenesulfonhydrazide) as chemical blowing agent. percent by weight of rubber product). Phenothiazine. Polyethylene. Potassium persulfate. Sodium stearate. Sodium formaldehyde sulfoxylate. Sodium polysulfide. (viii) Emulsifiers. Sodium nitrite. Fatty acid salts, sodium or potassium. Sodium salt of ethylenediamine tetraacetic Naphthalene sulfonic acid-formaldehyde con- acid and glycine. densate, sodium salt. Sodium sulfide. Rosins and rosin-derivatives identified in Styrene monomer. § 175.105(c)(5) of this chapter. Tall oil. Sodium decylbenzenesulfonate Thioxylenois as peptizing agents. Sodium dodecylbenzenesulfonate Tridecyl mercaptan. Sodium lauryl sulfate. Zinc 4-tert-butylthiophenate as peptizing Tall oil mixed soap (calcium, potassium, and agent. sodium). (d) Rubber articles intended for use (ix) Miscellaneous (total not to exceed 5 with dry food are so formulated and percent by weight of rubber product). cured under conditions of good manu- Animal glue as described in § 178.3120 of this facturing practice as to be suitable for chapter. repeated use. Azodicarbonamide as chemical blowing (e) Rubber articles intended for reagent. peated use in contact with aqueous 2-Anthraquinone sulfonic acid sodium salt food shall meet the following specifica- for use only as polymerization inhibitor in tions: The food-contact surface of the chloroprene polymers and not to exceed rubber article in the finished form in 0.03 percent by weight of the chloroprene which it is to contact food, when ex- polymers. 1,2-Benzisothiazolin-3-one (CAS Reg. No. tracted with distilled water at reflux 2634–33–5) for use as a biocide in uncured temperature, shall yield total extrac- liquid rubber latex not to exceed 0.02 per- tives not to exceed 20 milligrams per cent by weight of the latex solids, where square inch during the first 7 hours of the total of all items listed in paragraph extraction, nor to exceed 1 milligram (c)(4)(ix) of this section does not exceed 5 per square inch during the succeeding 2 percent of the rubber product. hours of extraction. n-Butyllithium for use only as polymerization catalyst for polybutadiene. (f) Rubber articles intended for re- 4-tert-Butyl-o-thiocresol as peptizing agent. peated use in contact with fatty foods tert-Butyl peracetate. shall meet the following specifications: p-tert-Butylpyrocatechol. The food-contact surface of the rubber Dialkyl (C8–C18) dimethylammonium chlo- article in the finished form in which it ride for use only as a flocculating agent in is to contact food, when extracted with the manufacture of silica. n-hexane at reflux temperature, shall Di- and triethanolamine. Diethyl xanthogen disulfide. yield total extractives not to exceed 4-(Diiodomethylsulfonyl) toluene, Chemical 175 milligrams per square inch during Abstracts Service Registry No. 20018–09–01, the first 7 hours of extraction, nor to for use as an antifungal preservative at exceed 4 milligrams per square inch

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during the succeeding 2 hours of ex- taining the resins shall be thoroughly traction. cleansed prior to their first use in con- (g) In accordance with good manufac- tact with food. turing practice finished rubber articles intended for repeated use in contact § 177.2800 Textiles and textile fibers. with food shall be thoroughly cleansed Textiles and textile fibers may safely prior to their first use in contact with be used as articles or components of ar- food. ticles intended for use in producing, (h) The provisions of this section are manufacturing, packing, processing, not applicable to rubber nursing-bottle preparing, treating, packaging, trans- nipples. porting, or holding food, subject to the (i) Acrylonitrile copolymers identi- provisions of this section. fied in this section shall comply with (a) The textiles and textile fibers are the provisions of § 180.22 of this chap- prepared from one or more of the fibers ter. identified in paragraph (d) of this sec- [42 FR 14572, Mar. 15, 1977] tion and from certain other adjuvant substances required in the production EDITORIAL NOTE: For FEDERAL REGISTER ci- of the textiles or textile fibers or added tations affecting § 177.2600, see the List of CFR Sections Affected, which appears in the to impart desired properties. Finding Aids section of the printed volume (b) The quantity of any adjuvant sub- and at www.fdsys.gov. stance employed in the production of textiles or textile fibers does not ex- § 177.2710 Styrene-divinylbenzene res- ceed the amount reasonably required ins, cross-linked. to accomplish the intended physical or Styrene-divinylbenzene cross-linked technical effect or any limitation fur- copolymer resins may be safely used as ther provided. articles or components of articles in- (c) Any substance employed in the tended for repeated use in producing, production of textiles or textile fibers manufacturing, packing, processing, that is the subject of a regulation in preparing, treating, packaging, trans- parts 174, 175, 176, 177, 178 and § 179.45 of porting, or holding food, in accordance this chapter conforms with any speci- with the following prescribed condi- fication in such regulation. tions: (d) Substances employed in the pro- (a) The resins are produced by the co- duction of or added to textiles and tex- polymerization of styrene with tile fibers may include: divinylbenzene. (1) Substances generally recognized (b) The resins meet the extractives as safe in food. limitations prescribed in this para- (2) Substances subject to prior sanc- graph: tion or approval for use in textiles and (1) The resins to be tested are ground textile fibers and used in accordance or cut into small particles that will with such sanction or approval. pass through a U.S. standard sieve No. (3) Substances generally recognized 3 and that will be held on a U.S. stand- as safe for use in cotton and cotton fab- ard sieve No. 20. rics used in dry-food packaging. (2) A 100-gram sample of the resins, (4) Substances that by regulation in when extracted with 100 milliliters of this part may safely be used in the pro- ethyl acetate at reflux temperature for duction of or as a component of tex- 1 hour, yields total extractives not to tiles or textile fibers and subject to exceed 1 percent by weight of the res- provisions of such regulation. ins. (5) Substances identified in this para- (c) In accordance with good manufac- graph (d)(5), subject to such limitations turing practice, finished articles con- as are provided:

List of substances Limitations

(i) Fibers: Cotton. Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use. the provisions of § 177.1630(e)(4)(ii). Rayon.

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List of substances Limitations

(ii) Adjuvant substances: Aluminum stearate. Borax ...... For use as preservative only. Butyl-acetyl ricinoleate. Colorants used in accordance with § 178.3297 of this chapter.. Di-tert-butyl hydroquinone. Dimethylpolysiloxane. Ethylenediaminetetraacetic acid, sodium salt. 4-Ethyl-4-hexadecyl morpholinium ethyl sulfate ...... For use only as a lubricant in the manufacture of polyethylene terephthalate fibers specified in paragraph (d)(5)(i) of this section at a level not to exceed 0.03 percent by weight of the finished fibers. Eugenol. Fats, oils, fatty acids, and fatty alcohols derived from castor, coconut, cottonseed, fish, mustardseed, palm, peanut, rapeseed, ricebran, soybean, sperm, and tall oils and tallow. Fats, oils, fatty acids, and fatty alcohols described in the pre- ceding 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. Formaldehyde ...... For use as preservative only. Glyceryl mono-12-hydroxystearate. 2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2- imidazolinium ethyl sulfate. Hexylene glycol (2-methyl,-2,4-pentanediol). Isobutyl alcohol. Isopropyl alcohol. Kerosene. Methyl ester of sulfated ricebran oil. Mineral oil ...... For use only at a level not to exceed 0.15 percent by weight of finished fibers. Mono- and diisopropylated m- and p-cresols (isothymol deriva- tive). N-Oleyl, N′-acetyl, N′-b-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 fluoride ...... For use as preservative only. Sodium hydrosulfite. Sodium hypochlorite. Sodium lauryl sulfate. Sodium 2-mercaptobenzothiazole ...... Do. Sodium pentachlorophenate ...... Do. Styrene-butadiene copolymer. Sulfated butyl, isobutyl and propyl oleate. Tallow. Tallow, sulfonated. Titanium dioxide. Triethanolamine. Ultramarine blue. Waxes, petroleum. Zinc hydrosulfite.

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(e) Textile and textile fibers are used practice so as to prevent potential mi- as articles or components of articles crobial adulteration of the food. that contact dry food only. (e) Ultrafiltration membranes identi- (f) The provisions of this section are fied in paragraph (a)(4) may be used to not applicable to jute fibers used as filter aqueous or acidic foods con- prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at chapter. temperatures not to exceed 21 °C (70 °F). [42 FR 14572, Mar. 15, 1977, as amended at 46 (f) To assure safe use of the ultra-fil- FR 37042, July 17, 1981; 49 FR 4372, Feb. 6, tration membranes, the label or label- 1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933, Aug. 30, 1991] ing shall include adequate directions for a pre-use treatment, consisting of § 177.2910 Ultra-filtration membranes. conditioning and washing with a minimum of 8 gallons of potable water Ultra-filtration membranes identi- prior to their first use in contact with fied in paragraphs (a)(1), (a)(2), (a)(3), food. and (a)(4) of this section may be safely (g) Acrylonitrile copolymers identi- used in the processing of food, under fied in this section shall comply with the following prescribed conditions; the provisions of § 180.22 of this chap- (a)(1) Ultra-filtration membranes ter. that consist of paper impregnated with cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53 which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17, ed with a vinyl chloride-acrylonitrile 1993; 60 FR 54426, Oct. 24, 1995] copolymer. (2) Ultra-filtration membranes that PART 178—INDIRECT FOOD ADDI- consist of a sintered carbon support TIVES: ADJUVANTS, PRODUCTION that is coated with zirconium oxide AIDS, AND SANITIZERS (CAS Reg. No. 1314–23–4) containing up to 12 percent yttrium oxide (CAS Reg. Subpart A [Reserved] No. 1314–36–9). (3) Ultra-filtration membranes that Subpart B—Substances Utilized To Control consist of an aluminum oxide support the Growth of Microorganisms that is coated with zirconium oxide Sec. (CAS Reg. No. 1314–23–4) containing up 178.1005 Hydrogen peroxide solution. to 5 percent yttrium oxide (CAS Reg. 178.1010 Sanitizing solutions. No. 1314–36–9). Subpart C—Antioxidants and Stabilizers (4) Ultrafiltration membranes that consist of a microporous 178.2010 Antioxidants and/or stabilizers for poly(vinylidene fluoride) membrane polymers. with a hydrophilic surface modifier 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl- consisting of hydroxypropyl acrylate/ phenol. tetraethylene glycol diacrylate copoly- 178.2650 Organotin stabilizers in vinyl chloride plastics. mer. (b) Any substance employed in the Subpart D—Certain Adjuvants and production of ultra-filtration mem- Production Aids branes that is the subject of a regulation in parts 174, 175, 176, 177, 178 and 178.3010 Adjuvant substances used in the § 179.45 of this chapter conforms with manufacture of foamed plastics. 178.3120 Animal glue. the specifications of such regulation. 178.3125 Anticorrosive agents. (c) Ultra-filtration membranes are 178.3130 Antistatic and/or antifogging used in the physical separation of dis- agents in food-packaging materials. solved or colloidally suspended varying 178.3280 Castor oil, hydrogenated. molecular size components of liquids 178.3290 Chromic chloride complexes. during the commercial processing of 178.3295 Clarifying agents for polymers. bulk quantities of food. 178.3297 Colorants for polymers. 178.3300 Corrosion inhibitors used for steel (d) Ultra-filtration membranes shall or tinplate. be maintained in a sanitary manner in 178.3400 Emulsifiers and/or surface-active accordance with good manufacturing agents.

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