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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS > SUBPART C—Antioxidants and Stabilizers (§178.2010 to §178.2650) > 178.2010—Antioxidants and/or stabilizers for polymers.

CFR

178.2010—Antioxidants and/or stabilizers for polymers.

The substances listed in paragraph (b) of this section may be safely used as antioxidants and/or stabilizers in polymers used in the manufacture of articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section:
(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect.
(b) List of substances:
Substances Limitations
N-n-Alkyl-N′-(carboxymethyl)-N,N′-trimethylenediglycine; the alkyl group is even numbered in the range C14-C18 and the nitrogen content is in the range 5.4-5.6 weight percent For use only:1. As component of nonfood articles complying with §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 1.35 percent by weight of natural rubber, butadiene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings complying with § 175.300 , § 176.170 , or § 175.320 of this chapter. The average thickness of such coatings and closure-sealing gaskets shall not exceed 0.004 inch.
Alkylthiophenolics: For use only:
1. Acid-catalyzed condensation reaction products of 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 164907-73-7). 1. At levels not to exceed 2 percent by weight of adhesives complying with § 175.105 of this chapter, of pressure-sensitive adhesives complying with § 175.125 of this chapter, and of rubber articles complying with § 177.2600 of this chapter.
2. Acid-catalyzed condensation reaction products of branched 4-nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742-97-6). 2. Do.
p-tert-Amylphenolformaldehyde resins produced when one mole of p-tert-amylphenol is made to react under acid conditions with one mole of formaldehyde For use only at levels not to exceed 2.1 percent by weight of polyamide resins that are:1. Derived from dimerized vegetable oil acids (containing not more than 20 percent of monomer acids) and ethylenediamine. 2. Used in compliance with regulations in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter.
1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester (CAS Reg. No. 57569-40-1) For use only at levels not to exceed 0.075 percent by weight of olefin polymers complying with § 177.1520 of this chapter.
Code of Federal Regulations 371
2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol (CAS Reg. No. 70321-86-7) For use only:1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter. 2. At levels not to exceed 3.0 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter.
2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3-tetramethylbutyl) phenol (CAS Reg. No. 3147-75-9) For use only at levels not to exceed 0.5 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter: Provided, That the finished resins contact food only under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.
2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol (CAS Reg. No. 2725-22-6). For use only:1. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter in contact with food types I, II, IV-B, VI, VII-B, and VIII described in § 176.170(c) of this chapter, table 1, under conditions of use D through G as described in § 176.170(c) , table 2, of this chapter. 2. At levels not to exceed 0.1 percent by weight of polypropylene complying with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in contact with food under conditions of use A through H as described in § 176.170(c) , table 2, of this chapter. 3. At levels not to exceed 0.04 percent by weight of polyethylene and olefin copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94 gram per cubic centimeter, in contact with food under conditions of use A through H as described in § 176.170 , table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX as described in table 1 of § 176.170(c) of this chapter hold a minimum of 2 gallons (7.6 liters) of food. 4. At levels not to exceed 0.4 percent by weight of ethylene copolymers complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b, having a density of less than 0.94 gram per cubic centimeter, in contact with food under conditions of use B through H, as described in § 176.170(c) , table 2, of this chapter provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a minimum of 5 gallons (18.9 liters) of food. 5. At levels not to exceed 0.04 percent by weight of polyethylene having a density of less than 0.94 gram per cubic centimeter, and olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.3a, 3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food under conditions of use D through G as described in § 176.170(c) of this chapter, table 2, provided that the finished articles used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a minimum of 5 gallons (18.9 liters) of food.
β, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS Reg. No. 37625-75-5); CAS synonym: 1-[(beta-(octadecylthio)ethyl]-3(or 4)-(octadecylthio)cyclohexane For use only:1. At levels not to exceed 0.3 percent by weight of all polymers for use in contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions of use B through H as described in tables 1 and 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyolefins complying with § 177.1520 of this chapter, for use in contact with food of types III, IV-A, V, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176.170(c) of this chapter.
Bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate (CAS Reg. No. 52829-07-9) For use only:1. In adhesives complying with § 175.105 of this chapter. 2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhesives complying with § 175.125 of this chapter.
Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite (CAS Reg. No. 145650-60-8) For use only:1. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter. The finished polymers may only be used with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.1 percent by weight of propylene polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.4, or 3.5, or 3.1a (where the density of this polymer is at least 0.85 gram per cubic centimeter and less than 0.91 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.1 percent by weight of high-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use C (maximum temperature 70 °C) through G described in table 2 of § 176.170(c) of this chapter. Provided, that the finished food contact articles have a volume of at least 18.9 liters (5 gallons). 4. At levels not to exceed 0.01 percent by weight of low-density ethylene polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. Provided, that the average thickness of such polymers in the form in which they contact food shall not exceed 0.001 inch.
Code of Federal Regulations 372
1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)-hydrazine (CAS Reg. No. 32687-78-8) For use only:1. As provided in § 175.105 of this chapter. 2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene-styrene copolymers used in accordance with parts 175, 176, 177, and 181 of this chapter . 3. At levels not exceeding 0.1 percent by weight of polyoxymethylene copolymers complying with § 177.2470 of this chapter and of polyoxymethylene homopolymers complying with § 177.2480 of this chapter.
2,6-Bis(1-methylheptadecyl)-p-cresol For use only at levels not exceeding 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. The average thickness of such polymers in the form in which they contact fatty food or food containing more than 8 percent of alcohol shall not exceed 0.004 inch.
3,9-Bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane (CAS Reg. No. 154862-43-8), which may contain not more than 2 percent by weight of triisopropanolamine (CAS Reg. No. 122-20-3) For use only: 1. At levels not to exceed 0.15 percent by weight of all polymers, except as specified below. 2. At levels not to exceed 0.2 percent by weight of polycarbonate resins complying with § 177.1580 of this chapter. 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins complying with § 177.1595 of this chapter.
5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7) For use only:1. At levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.02 percent by weight of: (a) Propylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymer may only be used in contact with food of types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; or (b) Ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers is at least 0.94 gram per cubic centimeter), or 5. The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the finished food-contact articles have a volume of at least 18.9 liters (5 gallons). 3. At levels not to exceed 0.02 percent by weight of ethylene polymers and copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these polymers is less than 0.94 gram per cubic centimeter). The finished polymers may only be used in contact with food of the types identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter; provided that the average thickness of such polymers in the form in which they contact food shall not exceed 50 micrometers (0.002 inch).
Code of Federal Regulations 373
3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy}-1,1-dimethylethyl]-2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. No. 90498-90-1) For use only:1. At levels not to exceed 0.2 percent by weight of polypropylene complying with § 177.1520(c) , item 1.1 of this chapter. The finished polymer is to be used in contact with food only under conditions of use D through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520(c) of this chapter, item 2.1, provided that the polymer has a minimum density of 0.94 grams per cubic centimeter and is used in contact with food only under conditions of use D through G described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight percent of polymer units derived from propylene. The finished polymer is to be used in contact with food of types I, II, IV-B, VI-A, VI-B, VI-C, VII-B, and VIII under conditions of use A through H described in tables 1 and 2 of § 176.170(c) of this chapter.
4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-butylphenol (CAS Reg. No. 991-84-4) For use only:1. At levels not to exceed 0.5 percent by weight: in styrene block copolymers complying with § 177.1810 of this chapter; in rosins and rosin derivatives complying with § 175.300(b)(3)(v) of this chapter; in can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins complying with § 175.320(b)(3) of this chapter; in rosin and rosin derivatives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with § 176.170(b)(2) of this chapter; in terpene resins complying with § 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in accordance with § 176.170(b)(1) of this chapter; in resins and polymers complying with § 176.180(b) of this chapter; in closures with sealing gaskets complying with § 177.1210 of this chapter; in petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b) of this chapter; and in reinforced wax complying with § 178.3850 of this chapter. 2. At levels not to exceed 0.2 percent by weight of the finished cellophane complying with § 177.1200 of this chapter. 3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber-modified polystyrene complying with § 177.1640 of this chapter: Provided, That the finished polystyrene and rubber-modified polystyrene polymer contact food only under conditions of use B through G described in table 2 of § 176.170(c) of this chapter. 4. In adhesives complying with § 175.105 of this chapter; in pressure-sensitive adhesives complying with § 175.125 of this chapter; and as provided in § 177.2600 of this chapter.
Code of Federal Regulations 374
4,4′-Bis(α,α-dimethylbenzyl)diphenyl-amine (CAS Reg. No. 10081-67-1) For use at levels not to exceed 0.3 percent by weight of polypropylene complying with § 177.1520(c) of this chapter. The polypropylene articles are limited to use in contact with non-fatty foods only.
Boric acid (CAS Reg. No. 10043-35-3) For use only at levels not to exceed 0.16 percent by weight of ethylene-vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3) and (d) of this chapter.
1,3-Butanediol
Butylated reaction product of p-cresol and dicyclopentadiene produced by reacting p-cresol and dicyclopentadiene in an approximate mole ratio of 1.5 to 1, respectively, followed by alkylation with isobutylene so that the butyl content of the final product is not less than 18 percent For use only:1. As components of nonfood articles complying with §§ 175.105 and 177.2600(c)(4)(iii) of this chapter. 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/styrene copolymers. The finished copolymers may be used in contact with food of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions of use B through H, as described in tables 1 and 2 of § 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-C, VII-A, and IX under conditions of use C through G as described in tables 1 and 2 of § 176. 170(c) of this chapter.
Butylated, styrenated cresols produced when equal moles of isobutylene, styrene, and a metacresol-paracresol mixture having a no more than 3 °C distillation range including 202 °C are made to react so that the final product meets the following specifications: Not less than 95 percent by weight of total alkylated phenols consisting of 13-25 percent by weight of butylated m- and p-cresols, 26-38 percent by weight of styre-nated m- and p-cresols, 37-49 percent by weight of butylated styrenated m- and p-cresols, and not more than 10 percent by weight total of alkylated xylenols, alkylated o-cresol, alkylated phenol, and alkylated ethylphenol; acidity not more than 0.003 percent; and refractive index at 25 °C of 1.5550-1.5650, as determined by ASTM method D1218-82, “Standard Test Method for Refractive Index and Refractive Dispersion of Hydrocarbon Liquids,” which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. For use only:1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber-modified polystyrene, or olefin polymers complying with § 177.1520 (c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or complying with other sections in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter, used in articles that contact food only unded the conditions described in § 176.170(c) of this chapter, table 2, under conditions of use C through G.
Code of Federal Regulations 375
2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cumenyl bis(p-nonylphenyl) phosphite; the nonyl group is a propylene trimer isomer and the phosphorus content is in the range 3.8-4.0 weight percent For use only:1. As components of nonfood articles complying with §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 1.35 percent by weight of natural rubber, butadiene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene polymers that are used in contact with nonalcoholic food at temperatures not to exceed room temperature and that are employed in closure-sealing gaskets complying with § 177.1210 of this chapter or in coatings complying with § 175.300 , § 175.320 , or § 176.170 of this chapter. The average thickness of such coatings and closure-sealing gaskets shall not exceed 0.004 inch.
2-(3′-tert-Butyl-2′-hydroxy-5′-methyl-phenyl)-5-chlorobenzotriazole with a melting point of 137-141 °C For use only at levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, provided that the finished polymer contacts foods only of the types identified in Categories I, II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter.
4,4′-Butylidenebis(6-tert-butyl-m-cresol) For use only.1. As provided in §§ 175.105 and 177.2600 of this chapter. 2. At levels not to exceed 0.5 percent by weight of polypropylene complying with § 177.1520 of this chapter and for use at levels not to exceed 0.3 percent by weight of polyethylene complying with § 177.1520 of this chapter, provided that the finished polypropylene and polyethylene contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII.
Butyric acid, 3,3-bis(3-tert-butyl-4-hydroxyphenyl)ethylene ester (CAS Reg. No. 32509-66-3) For use only:1. At levels not to exceed 0.5 percent by weight of olefin copolymers complying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that when used in contact with foods described as types III, IV-A, V, VII-A, and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers may only be used under conditions of use E, F, and G set forth in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.5 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 1.1, 3.1, or 3.2 (where the copolymers complying with items 3.1 and 3.2 contain not less than 85 weight-percent of polymer units derived from propylene). 3. At levels not to exceed 0.2 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2.
Calcium benzoate.
Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy-benzyl)phosphonate] (CAS Reg. No. 65140-91-2) For use only:1. At levels not to exceed 0.25 percent by weight of polypropylene that complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3. 2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density less than 0.94 gram per cubic centimeter shall be used in contact with food only under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 3. In adhesives complying with § 175.105 of this chapter. 4. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhesives complying with § 175.125 of this chapter. 5. At levels not to exceed 0.5 percent by weight of rosins and rosin derivatives complying with § 175.300(b)(3)(v) of this chapter. 6. At levels not to exceed 0.5 percent by weight of can end cement formulations complying with § 175.300(b)(3)(xxxi) of this chapter. 7. At levels not to exceed 0.5 percent by weight of side seam cement formulations complying with § 175.300(b)(3)(xxxii) of this chapter. 8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3) of this chapter. 9. At levels not to exceed 0.5 percent by weight of rosin and rosin derivatives complying with § 176.170(a)(5) of this chapter; and petroleum alicyclic hydrocarbon resins, or the hydrogenated product thereof, complying with § 176.170(b)(2) of this chapter. 10. At levels not to exceed 0.5 percent by weight of resins and polymers used as components of paper and paperboard in contact with dry food in compliance with § 176.180 of this chapter. 11. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with § 177.1210 of this chapter. 12. At levels not to exceed 0.5 percent by weight of the finished rubber article complying with § 177.2600 of this chapter. 13. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin and rosins and rosin derivatives complying with § 178.3800(b) . 14. At levels not to exceed 0.5 percent by weight of reinforced wax complying with § 178.3850 . 15. At levels not to exceed 0.3 percent by weight of polyethylene phthalate polymers, complying with § 177.1630 of this chapter. Provided, that the finished polymers contact food only under conditions of use B through H described in Table 2 of § 176.170(c) of this chapter.
Code of Federal Regulations 376
Calcium myristate.
Calcium ricinoleate For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter.
Calcium stearate.
Carbethoxymethyl diethyl phosphonate (CAS Reg. No. 867-13-0) At levels not to exceed 0.07 percent by weight of polyethylene phthalate polymers complying with § 177.1630 of this chapter.
Cerium stereate (CAS Reg. No. 10119-53-6) For use only at levels not to exceed 0.5 percent by weight in rigid and semirigid vinyl chloride homo- and copolymer articles modified in accordance with § 178.3790(b)(1) of this chapter that contact food under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.
Cupric acetate and lithium iodide For use at levels not exceeding 0.025 percent cupric acetate and 0.065 percent lithium iodide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0012 inch.
Cuprous iodide For use at levels not exceeding 0.01 percent cuprous iodide by weight of nylon 66T resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.001 inch.
Cuprous iodide and cuprous bromide For use at levels not exceeding 0.0025 percent cuprous iodide and 0.0175 percent cuprous bromide by weight of nylon 66 resins complying with § 177.1500 of this chapter; the finished resins are used or are intended to be used to contain foods during oven baking or oven cooking at temperatures above 250 °F. The average thickness of such resins in the form in which they contact food shall not exceed 0.0015 inch.
Cyanoguanidine For use only at levels not to exceed 1 percent by weight of polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this chapter.
Cyclic neopentanetetrayl bis(octadecyl phosphite) (CAS Reg. No. 3806-34-6); the phosphorus content is in the range of 7.8 to 8.2 weight percent For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter that contact food under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.
Code of Federal Regulations 377
Cyclic neopentanetetrayl bis(octadecyl phosphite) (CAS Reg. No. 3806-34-6) (which may contain not more than 1 percent by weight of triisopropanolamine (CAS Reg. No. 122-20-3)); the phosphorus content is in the range of 7.8 to 8.2 weight percent For use only:1. At levels not to exceed 0.25 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1. 2. At levels not to exceed 0.25 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, item 2.2, that contact food Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 3. At levels not to exceed 0.15 percent by weight of olefin polymers complying with § 177.1520 , items 1.1 and 3.2, that contact food Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter under conditions of use B (for boil-in-bag applications), C, D, E, F, G, and H described in table 2 of § 176.170(c) of this chapter. 4. At levels not to exceed 0.20 percent by weight of polystyrene and/or rubber modified polystyrene complying with § 177.1640 of this chapter that contact food under conditions of use E, F, and G described in table 2 of § 176.170(c) of this chapter.
4,4′-Cyclohexylidenebis(2-cyclohexylphenol) For use only at levels not to exceed 0.1 percent by weight of olefin polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymers contact food only of the types identified in § 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII.
Dicetyl thiodipropionate having a melting point of 59°-62 °C as determined by ASTM method E324-79, “Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,” and a saponification value in the range 176-183 as determined by ASTM method D1962-67 (Reapproved 1979), “Standard Test Method for Saponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,” which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. The concentration of this additive and any other permitted antioxidants in the finished food-contact article shall not exceed a total of 0.5 milligram per square inch of food-contact surface.
Didodecyl- 1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate (CAS Reg. No. 36265-41-5) For use only at levels not to exceed 0.3 percenmt by weight in rigid polymer articles modified in accordance with § 178.3790 that contact food, under conditions of use E, F, and G described in table 2 of § 176.170 of this chapter.
2,6-Di(α-methyl benzyl)-4-methyl phenol [Chemical Abstracts Service Registry No. 1817-68-1] For use only at levels not to exceed 0.2 percent by weight of olefin polymers complying with item 3.4 in § 177.1520(c) of this chapter, provided that such olefin polymers are limited to use at a level not to exceed 25 percent by weight in other olefin polymers complying with § 177.1520 of this chapter; and the total amount in such finished olefin polymers not to exceed 0.05 percent by weight, including the level that may be contributed by its presence at 6 percent in the item “butylated, styrenated cresols * * * ” listed in this paragraph; and further provided that the finished olefin polymers are intended for contact with foods, except those containing more than 8 percent alcohol.
2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS Reg. No. 134701-20-5) For use only:1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene-styrene copolymers used in accordance with applicable regulations in parts 175, 176, 177, and 181 of this chapter , under conditions of use C through H as described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl chloride, under conditions of use A through H as described in table 2 of § 176.170(c) of this chapter.
Dimethyl succinate polymer with 4-hydroxy-2,2,6,6-tetramethyl-1-piperidineethanol (CAS Reg. No. 65447-77-0) For use only:1. At levels not to exceed 0.3 percent by weight of olefin polymers complying with § 177.1520 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter. 2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate copolymers complying with § 177.1350 of this chapter and under conditions of use B through H described in table 2 of § 176.170(c) of this chapter.
Code of Federal Regulations 378
Dimethyltin/monomethyltin isooctylmercaptoacetates consisting of 5 to 90 percent by weight of monomethyltin tris (isooctylmercaptoacetate) (CAS Reg. No. 54849-38-6) or monomethyltin tris(2-ethylhexylmercaptoacetate) (CAS Reg. No. 57583-34-3) and 10 to 95 percent by weight of dimethyltin bis (isooctylmercaptoacetate) (CAS Reg. No. 26636-01-1) or dimethyltin bis(2-ethylhexylmercaptoacetate) (CAS Reg. No. 57583-35-4), and no more than 0.4 percent by weight of trimethyltin compounds, and having the following specifications: Tin content (as Sn) in the range of 15 to 21 percent and mercaptosulfur content in the range of 11 to 13.5 percent. Other alkyltin compounds are not to exceed 20 ppm For use only at levels not to exceed 2 percent by weight:1. In rigid polyvinyl chloride used in the manufacture of pipes intended for contact with water in food-processing plants, and 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying with § 177.1950 of this chapter or § 177.1980 of this chapter for use in contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII, and IX described in table 1 of § 176.170(c) of this chapter under conditions of use C through G described in table 2 of § 176.170(c) of this chapter at temperatures not to exceed 88 °C (190 °F).
Dimyristyl thiodipropionate having a melting point of 48°-52 °C as determined by ASTM method E324-79, “Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals,” and a saponification equivalent in the range 280-290 as determined by ASTM method D1962-67 (Reapproved 1979), “Standard Test Method for Saponification Value of Drying Oils, Fatty Acids, and Polymerized Fatty Acids,” which are incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 1916 Race St., Philadelphia PA 19103, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. Finished food-contact articles containing this additive shall meet the extractives limitations prescribed in § 176.170(c) of this chapter.
Di(n-octyl)tin bis(2-ethylhexyl maleate) [CAS Reg. No. 10039-33-5] having 12.5 to 15.0 percent by weight of tin (Sn) and having a saponification number of 260 to 280. The additive is made from di(n-octyl)tin oxide meeting the specifications of § 178.2650(a)(1) For use only at levels not to exceed 0.5 percent by weight of acrylonitrile copolymers complying with §§ 177.1020 and 177.1030 of this chapter and used in contact with all food types under conditions of use C through G described in table 2 of § 176.170(c) of this chapter.
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