21 C.F.R. Subpart C—Antioxidants and Stabilizers


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

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Subpart C—Antioxidants and Stabilizers

§ 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[prime]-               For use only: (carboxymethyl)-N,N[prime]-      1. As component of nonfood articles trimethylenediglycine; the        complying with §§ 175.105 alkyl group is even numbered in   and 177.2600 of this chapter. the range C14-C18 and the        2. At levels not to exceed 1.35 nitrogen content is in the        percent by weight of natural rubber, range 5.4-5.6 weight percent.     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    1. At levels not to exceed 2 percent reaction products of 4-           by weight of adhesives complying with nonylphenol, formaldehyde, and    § 175.105 of this chapter, of 1-dodecanethiol (CAS Reg. No.     pressure-sensitive adhesives 164907-73-7)..                    complying with § 175.125 of this                                   chapter, and of rubber articles                                   complying with § 177.2600 of                                   this chapter.2. Acid-catalyzed condensation    2. Do. reaction products of branched 4- nonylphenol, formaldehyde, and 1-dodecanethiol (CAS Reg. No. 203742-97-6)..p-tert-Amylphenolformaldehyde     For use only at levels not to exceed resins produced when one mole     2.1 percent by weight of polyamide of p-tert-amylphenol is made to   resins that are: react under acid conditions      1. Derived from dimerized vegetable with one mole of formaldehyde.    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,     For use only at levels not to exceed bis[2-(1,1-dimethylethyl)-6-[[3-  0.075 percent by weight of olefin (1,1-dimethylethyl)-2-hydroxy-5-  polymers complying with § methylphenyl]methyl]-4-methyl-    177.1520 of this chapter. phenyl]ester (CAS Reg. No. 57569-40-1).2-(2H-Benzotriazol-2-yl)-4,6-     For use only: bis(1-methyl-1-                  1. At levels not to exceed 0.5 percent phenylethyl)phenol (CAS Reg.      by weight of polyethylene phthalate No. 70321-86-7).                  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,    For use only at levels not to exceed 1, 3, 3-tetramethylbutyl)         0.5 percent by weight of phenol (CAS Reg. No. 3147-75-9).  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)-   For use only: 1,3,5-triazin-2-yl]-5-           1. At levels not to exceed 0.3 percent (octyloxy)phenol (CAS Reg. No.    by weight of olefin polymers 2725-22-6)..                      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)-                  For use only: Bis(octadecylthio)cyclohexyleth  1. At levels not to exceed 0.3 percent ane (CAS Reg. No. 37625-75-5);    by weight of all polymers for use in CAS synonym: 1-[(beta-            contact with foods of Types I, II, IV- (octadecylthio)ethyl]-3(or 4)-    B, VI, VII-B, and VIII under (octadecylthio)cyclohexane.       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-        For use only: piperidinyl) sebacate (CAS Reg.  1. In adhesives complying with § No. 52829-07-9).                  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-          For use only: methylphenyl) ethyl phosphite    1. At levels not to exceed 0.3 percent (CAS Reg. No. 145650-60-8).       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.1,2-Bis(3,5-di-tert-butyl-4-      For use only: hydroxyhydrocinnamoyl)-          1. As provided in § 175.105 of hydrazine (CAS Reg. No. 32687-    this chapter. 78-8).                           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-    For use only at levels not exceeding cresol.                           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-       For use only: phenylethyl)phenoxy]-2,4,8,10-   1. At levels not to exceed 0.15 tetraoxa-3,9-                     percent by weight of all polymers, diphosphaspiro[5.5]undecane       except as specified below. (CAS Reg. No. 154862-43-8),      2. At levels not to exceed 0.2 percent which may contain not more than   by weight of polycarbonate resins 2 percent by weight of            complying with § 177.1580 of triisopropanolamine (CAS Reg.     this chapter. No. 122-20-3).                   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-     For use only: hydroxy-2(3H)-benzofuranone,     1. At levels not to exceed 0.1 percent reaction products with o-xylene   by weight of olefin polymers (CAS Reg. No. 181314-48-7).       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).3,9-Bis[2-{3-(3-tert-butyl-  For use only: 4-hydroxy-5-                     1. At levels not to exceed 0.2 percent methylphenyl)propionyloxy}-  by weight of polypropylene complying 1,1-dimethylethyl]-2,4,8,10-      with § 177.1520(c), item 1.1 of tetraoxaspiro[5.5]undecane (CAS   this chapter. The finished polymer is Reg. No. 90498-90-1).             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- For use only: 2-yl]amino]-2,6-di-tert-         1. At levels not to exceed 0.5 percent butylphenol (CAS Reg. No. 991-    by weight: in styrene block 84-4).                            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.4,4[prime]-Bis(α,α-   For use at levels not to exceed 0.3 dimethylbenzyl)diphenylamine      percent by weight of polypropylene (CAS Reg. No. 10081-67-1).        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-   For use only at levels not to exceed 35-3).                            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-  For use only: cresol and dicyclopentadiene     1. As components of nonfood articles produced by reacting p-cresol     complying with §§ 175.105 and dicyclopentadiene in an       and 177.2600(c)(4)(iii) of this approximate mole ratio of 1.5     chapter. to 1, respectively, followed by  2. At levels not to exceed 1.0 percent alkylation with isobutylene so    by weight of acrylonitrile/butadiene/ that the butyl content of the     styrene copolymers. The finished final product is not less than    copolymers may be used in contact 18 percent.                       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     For use only: produced when equal moles of     1. As provided in §§ 175.105 isobutylene, styrene, and a       and 177.2600 of this chapter. metacresol-paracresol mixture    2. At levels not to exceed 0.5 percent having a no more than 3 °C    by weight of polystyrene, rubber- distillation range including      modified polystyrene, or olefin 202 °C are made to react so   polymers complying with § that the final product meets      177.1520 (c) of this chapter, items the following specifications:     1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, Not less than 95 percent by       3.2, 3.3, or 4, or complying with weight of total alkylated         other sections in parts 174, 175, phenols consisting of 13-25       176, 177, 178 and § 179.45 of percent by weight of butylated    this chapter, used in articles that m- and p-cresols, 26-38 percent   contact food only unded the by weight of styrenated m- and    conditions described in § p-cresols, 37-49 percent by       176.170(c) of this chapter, table 2, weight of butylated styrenated    under conditions of use C through G. 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.php..2-tert-Butyl-a(3-tert-butyl-4-    For use only: hydroxyphenyl)-p-cumenyl bis(p-  1. As components of nonfood articles nonylphenyl) phosphite; the       complying with §§ 175.105 nonyl group is a propylene        and 177.2600 of this chapter. trimer isomer and the            2. At levels not to exceed 1.35 phosphorus content is in the      percent by weight of natural rubber, range 3.8-4.0 weight percent.     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[prime]-tert-Butyl-2[prime]-  For use only at levels not to exceed hydroxy-5[prime]-methyl-phenyl)-  0.5 percent by weight of olefin 5-chlorobenzotriazole with a      polymers complying with § melting point of 137-141 °C.  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[prime]-Butylidenebis(6-tert-  For use only. butyl-m-cresol).                 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-     For use only: butyl-4-hydroxyphenyl)ethylene   1. At levels not to exceed 0.5 percent ester (CAS Reg. No. 32509-66-3).  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-     For use only: tert-butyl-4-hydroxy-            1. At levels not to exceed 0.25 benzyl)phosphonate] (CAS Reg.     percent by weight of polypropylene No. 65140-91-2).                  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.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          At levels not to exceed 0.07 percent phosphonate (CAS Reg. No. 867-    by weight of polyethylene phthalate 13-0).                            polymers complying with §                                   177.1630 of this chapter.Cerium stereate (CAS Reg. No.     For use only at levels not to exceed 10119-53-6).                      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        For use at levels not exceeding 0.025 iodide.                           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        For use at levels not exceeding 0.0025 bromide.                          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          For use only at levels not to exceed bis(octadecyl phosphite) (CAS     0.1 percent by weight of ethylene- Reg. No. 3806-34-6); the          vinyl acetate copolymers complying phosphorus content is in the      with § 177.1350 of this chapter range of 7.8 to 8.2 weight        that contact food under conditions of percent.                          use E, F, and G described in table 2                                   of § 176.170(c) of this chapter.Cyclic neopentanetetrayl          For use only: bis(octadecyl phosphite) (CAS    1. At levels not to exceed 0.25 Reg. No. 3806-34-6) (which may    percent by weight of olefin polymers contain not more than 1 percent   complying with § 177.1520(c) of by weight of                      this chapter, items 1.1, 2.1, and triisopropanolamine (CAS Reg.     3.1. No. 122-20-3)); the phosphorus   2. At levels not to exceed 0.25 content is in the range of 7.8    percent by weight of olefin polymers to 8.2 weight percent.            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[prime]-Cyclohexylidenebis(2-  For use only at levels not to exceed cyclohexylphenol).                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   The concentration of this additive and a melting point of 59°-62     any other permitted antioxidants in °C as determined by ASTM      the finished food-contact article method E324-79, ``Standard Test   shall not exceed a total of 0.5 Method for Relative Initial and   milligram per square inch of food- Final Melting Points and the      contact surface. 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.php..Didodecyl- 1,4-dihydro-2,6-       For use only at levels not to exceed dimethyl-3,5-                     0.3 percenmt by weight in rigid pyridinedicarboxylate (CAS Reg.   polymer articles modified in No. 36265-41-5).                  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-  For use only at levels not to exceed methyl phenol [Chemical           0.2 percent by weight of olefin Abstracts Service Registry No.    polymers complying with item 3.4 in 1817-68-1].                       § 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-                For use only: methylpentadecyl)phenol (CAS     1. At levels not to exceed 0.3 percent Reg. No. 134701-20-5).            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   For use only: 4-hydroxy-2,2,6,6-tetramethyl-1- 1. At levels not to exceed 0.3 percent piperidineethanol (CAS Reg. No.   by weight of olefin polymers 65447-77-0).                      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.Dimethyltin/monomethyltin         For use only at levels not to exceed 2 isooctylmercaptoacetates          percent by weight: consisting of 5 to 90 percent    1. In rigid polyvinyl chloride used in by weight of monomethyltin tris   the manufacture of pipes intended for (isooctylmercaptoacetate) (CAS    contact with water in food-processing Reg. No. 54849-38-6) or           plants, and monomethyltin tris(2-            2. In rigid polyvinyl chloride and in ethylhexylmercaptoacetate) (CAS   rigid vinyl chloride copolymers Reg. No. 57583-34-3) and 10 to    complying with § 177.1950 of 95 percent by weight of           this chapter or § 177.1980 of dimethyltin bis                   this chapter for use in contact with (isooctylmercaptoacetate) (CAS    food of Types I, II, III, IV (except Reg. No. 26636-01-1) or           liquid milk), V, VI, VII, VIII, and dimethyltin bis(2-                IX described in table 1 of § ethylhexylmercaptoacetate) (CAS   176.170(c) of this chapter under Reg. No. 57583-35-4), and no      conditions of use C through G more than 0.4 percent by weight   described in table 2 of § of trimethyltin compounds, and    176.170(c) of this chapter at having the following              temperatures not to exceed 88 °C specifications: Tin content (as   (190 °F). 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.Dimyristyl thiodipropionate       Finished food-contact articles having a melting point of         containing this additive shall meet 48°-52 °C as determined   the extractives limitations by ASTM method E324-79,           prescribed in § 176.170(c) of ``Standard Test Method for        this chapter. 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.php..Di(n-octyl)tin bis(2-ethylhexyl   For use only at levels not to exceed maleate) [CAS Reg. No. 10039-33-  0.5 percent by weight of 5] having 12.5 to 15.0 percent    acrylonitrile copolymers complying by weight of tin (Sn) and         with §§ 177.1020 and having a saponification number    177.1030 of this chapter and used in of 260 to 280. The additive is    contact with all food types under made from di(n-octyl)tin oxide    conditions of use C through G meeting the specifications of     described in table 2 of § § 178.2650(a)(1).            176.170(c) of this chapter.N,N[prime]-Diphenylthiourea.....  For use only:                                  1. At levels not to exceed 0.5 percent                                   by weight of polyvinyl chloride and/                                   or vinyl chloride copolymers                                   complying with § 177.1980 of                                   this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of vinyl chloride-vinyl                                   acetate copolymers containing not                                   more than 20 molar percent of vinyl                                   acetate.2-(4,6-Diphenyl-1,3,5-triazin-2-  For use only yl)-5-hexyloxy)phenol (CAS Reg.  1. At levels not to exceed 0.5 percent No. 147315-50-2).                 by weight of polycarbonate resins                                   complying with § 177.1580 of                                   this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of polyester elastomers                                   complying with § 177.1590 of                                   this chapter.                                  3. At levels not to exceed 0.5 percent                                   by weight of polyethylene phthalate                                   polymers complying with §                                   177.1630 of this chapter, in contact                                   with food under conditions of use A                                   through H described in Table 2 of                                   § 176.170(c) of this chapter.2,6-Di-tert-butyl-4-ethylphenol.  For use only in contact with                                   nonalcoholic foods:                                  1. At levels not exceeding 0.04 mg/in                                   \2\ of food contact surface and not                                   exceeding 0.1 percent by weight in                                   ethylene polymers and copolymers                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 2.3,                                   3.1, 3.2, and 3.3; § 177.1340;                                   and § 177.1350 of this chapter.                                   The average thickness of such                                   polymers and copolymers in the form                                   in which they contact food shall not                                   exceed 0.0025 in.                                  2. At levels not exceeding 0.04 mg/in                                   \2\ of food contact surface in                                   ethylene polymers and copolymers                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 2.3,                                   3.1, 3.2, and 3.3; § 177.1340;                                   and § 177.1350 of this chapter.                                   The average thickness of such                                   polymers and copolymers in the form                                   in which they contact food shall be                                   greater than 0.0025 in but shall not                                   exceed 0.025 in.3,5-Di-tert-butyl-4-              For use only: hydroxyhydrocinnamic acid        1. At levels not to exceed 0.5 percent triester with 1,3,5-tris(2-       by weight of polypropylene complying hydroxyethyl)-s-triazine-2,4,6-   with § 177.1520 of this chapter (1H,3H,5H)-trione (CAS Reg. No.   in articles that contact food not in 34137-09-2).                      excess of high temperature heat-                                   sterilized condition of use A                                   described in § 176.170(c) of                                   this chapter, table 2.                                  2. At levels not to exceed 0.5 percent                                   by weight of polyethylene complying                                   with § 177.1520 of this chapter                                   in articles that contact food not in                                   excess of high temperature heat-                                   sterilized condition of use A                                   described in 176.170(c) of this                                   chapter, table 2.                                  3. In adhesives complying with §                                   175.105 of this chapter.                                  4. At levels not to exceed 0.25                                   percent by weight of olefin                                   copolymers complying with §                                   177.1520(c) of this chapter, items                                   3.1, 3.2, 3.3, 3.4, 3.5, and 4.0.                                  5. At levels not to exceed 2 percent                                   by weight of polyester elastomers,                                   complying with § 177.1590 of                                   this chapter, in contact with dry                                   food only, and finished rubber                                   articles for repeated use, complying                                   with § 177.2600 of this chapter,                                   in contact with all foods, at                                   temperatures not to exceed 150                                   °F.Di-tert-butyl-m-cresyl            For use only: phosphonite condensation         1. At levels not to exceed 0.1 percent product with biphenyl (CAS Reg.   by weight of olefin polymers No. 178358-58-2) produced by      complying with § 177.1520(c) of the condensation of 4,6-di-tert-  this chapter, items 1.1, 2.1, 2.2, butyl-m-cresol with the Friedel-  3.1(a), 3.1(b), 3.2(a), or 3.2(b). Crafts addition product (phosphorus trichloride and biphenyl) so that the food additive has a minimum phosphorus content of 5.0 percent.Di-tert-butylphenyl phosphonite   For use only: condensation product with        1. At levels not to exceed 0.1 percent biphenyl (CAS Reg. No. 119345-    by weight of olefin polymers 01-6) produced by the             complying with § 177.1520(c) of condensation of 2,4-di-tert-      this chapter, items 1.1, 1.2, 1.3, butylphenol with the Friedel-     3.2b, 3.3a, 3.3b, 3.4, 3.5, and 3.1a Crafts addition product           (where the density is not less than (phosphorus trichloride and       0.85 gram per cubic centimeter and biphenyl) so that the food        not more than 0.91 gram per cubic additive has a minimum            centimeter); and 2.1, 2.2, 2.3, 3.1a, phosphorus content of 5.4         3.1b, 3.2a, and 3.6 (where the percent, an acid value not        density is not less than 0.94 gram exceeding 10 mg KOH/gm, and a     per cubic centimeter) and 5. melting range of 85 °C to    2. At levels not to exceed 0.1 percent 110 °C (185 °F to 230     by weight of polycarbonate resins °F).                          complying with § 177.1580 of                                   this chapter.                                  3. At levels not to exceed 0.2 percent                                   by weight of polystyrene and 0.3                                   percent by weight of rubber-modified                                   polystyrene complying with §                                   177.1640 of this chapter.                                  4. At levels not to exceed 0.15                                   percent by weight of olefin 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, and 3.6                                   (where the polyethylene component has                                   a density less than 0.94 gram per                                   cubic centimeter).                                  5. At levels not to exceed 0.1 percent                                   by weight of repeated use rubber                                   articles complying with §                                   177.2600 of this chapter.2,4-Di-tert-butylphenyl-3,5-di-   For use only: tert-butyl-4-hydroxy-benzoate    1. At levels not to exceed 0.6 percent (CAS Reg. No. 4221-80-1).         by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 1.1: (1) when used                                   in single-use articles that contact                                   food of types I, II, IV-B, VI-A, VI-                                   B, VII-B, and VIII, identified in                                   table 1 of § 176.170(c) of this                                   chapter; and (2) when used in                                   repeated-use articles that contact                                   food of types I, II, III, IV, V, VI,                                   VII, VIII, and IX identified in table                                   1 of § 176.170(c) of this                                   chapter. The additive is used under                                   conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter.                                  2. At levels not to exceed 0.25                                   percent by weight of olefin polymers                                   having a density of not less than                                   0.94 gram per cubic centimeter and                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 3.1,                                   and 3.2: (1) when used in single-use                                   articles that contact food of types                                   I, II, IV-B, VI-A, VI-B, VII-B, and                                   VIII, identified in table 1 of §                                   176.170(c) of this chapter; and (2)                                   when used in repeated-use articles                                   that contact food of types I, II,                                   III, IV, V, VI, VII, VIII, and IX                                   identified in table 1 of §                                   176.170(c) of this chapter. The                                   additive is used under conditions of                                   use B through H described in table 2                                   of § 176.170(c) of this chapter.2,4-Di-tert-pentyl-6-[1-(3,5-di-  For use only: tert-pentyl-2-                   1. At levels not to exceed 0.2 percent hydroxyphenyl)ethyl]phenyl        by weight of polypropylene complying acrylate (CAS Reg. No. 123968-    with § 177.1520 of this chapter 25-2).                            in contact with food under conditions                                   of use D through G as described in                                   Table 2 of § 176.170(c) of this                                   chapter, except that polypropylene                                   containing the additive at levels not                                   to exceed 0.075 percent by weight may                                   contact food under conditions of use                                   A through H described in Table 2 of                                   § 176.170(c) of this chapter.                                  2. At levels not to exceed 1.0 percent                                   by weight of of styrene block                                   polymers complying with §                                   177.1810 of this chapter. The                                   additive is used under conditions of                                   use D through G as described in Table                                   2 of § 176.170(c) of this                                   chapter.                                  3. At levels not to exceed 1.0 percent                                   by weight of polystyrene and rubber                                   modified polystyrene complying with                                   § 177.1640 of this chapter in                                   contact with food under conditions of                                   use D through G as described in Table                                   2 of § 176.170(c) of this                                   chapter.N,N[Prime]-1,2-Ethanediylbis[N-   For use only: [3-[[4,6-bis[butyl(1,2,2,6,6-    1. At levels not to exceed 0.06 pentamethyl-4-                    percent by weight of olefin polymers piperidinyl)amino]-1,3,5-         complying with § 177.1520(c) of triazin-2-yl]amino]propyl]-       this chapter, items 1.1a, 1.1b, 1.2, N[prime],N[Prime]-dibutyl-        or 1.3. The finished polymers may N[prime],N[Prime]-bis(1,2,2,6,6-  only be used in contact with food of pentamethyl-4-piperidinyl)-       the Types III, IV-A, V, VI-C, VII-A, 1,3,5-triazine-2,4,6-triamine]    and IX as described in table 1 of (CAS Reg. No. 106990-43-6).       § 176.170(c) of this chapter,                                   and under conditions of use A through                                   H as described in table 2 of §                                   176.170(c) of this chapter.                                  2. At levels not to exceed 0.08                                   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 I, II, IV-B, VI-A, VI-B,                                   VII-B, and VIII as described in table                                   1 of § 176.170(c) of this                                   chapter, and under conditions of use                                   A through H as described in table 2                                   of § 176.170(c) of this chapter.Ethylenebis(oxyethylene)-bis-(3-  1. At levels not to exceed 0.3 percent tert-butyl-4-hydroxy-5-           by weight of polystyrene and/or methylhydrocinnamate) (CAS Reg.   rubber modified polystyrene polymers No. 36443-68-2).                  complying with § 177.1640 of                                   this chapter.                                  2. 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.                                  3. At levels not to exceed 0.75                                   percent by weight of polyoxymethylene                                   copolymers used in accordance with                                   § 177.2470 of this chapter. The                                   finished articles shall not be used                                   for foods containing more than 15                                   percent alcohol.                                  4. At levels not to exceed 0.25                                   percent by weight of polyoxymethylene                                   homopolymers used in accordance with                                   § 177.2480 of this chapter. The                                   finished articles shall not be used                                   for foods containing more than 15                                   percent alcohol.                                  5. At levels not to exceed 0.2 percent                                   by weight of rigid vinyl chloride                                   plastics prepared from vinyl chloride                                   homopolymers and/or vinly chloride                                   copolymers used in accordance with a                                   prior sanction or applicable                                   regulations in parts 175, 176, and                                   177 of this chapter. The vinyl                                   chloride copolymers shall contain not                                   less than 50 weight percent of total                                   polymer units derived from vinyl                                   chloride.                                  6. At levels not to exceed 0.1 percent                                   by weight of vinylidene chloride                                   homopolymers and/or vinylidene                                   chloride copolymers used in                                   accordance with a prior sanction or                                   applicable regulations in parts 175,                                   176, and 177 of this chapter. The                                   vinylidene chloride copolymers shall                                   contain not less than 50 weight                                   percent of total polymer units                                   derived from vinylidene chloride.                                  7. In adhesives used in accordance                                   with § 175.105 of this chapter.2,2[prime]-Ethylidenebis(4,6-di-  For use only: tert-butylphenol) (CAS Reg. No.  1. At levels not to exceed 0.1 percent 35958-30-6).                      by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 1.1, 1.2, 1.3,                                   3.1, or 3.2 (where the polymers                                   complying with items 3.1 and 3.2                                   contain primarily polymer units                                   derived from propylene).                                  2. At levels not to exceed 0.05                                   percent by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 2.1, 2.2, or 2.3.                                   The finished polymers are to be used                                   only under conditions of use B                                   through H described in table 2 of                                   § 176.170(c) of this chapter.                                  3. At levels not to exceed 0.075                                   percent by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 2.1, 2.2, or 2.3                                   (where the density of each of these                                   polymers is not less than 0.94 g/cc)                                   and item 3.1 or 3.2 (where each of                                   these polymers contains primarily                                   polymer units derived from ethylene).                                  4. At levels not to exceed 0.05                                   percent by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 3.3, 3.4, 3.5, or                                   4.                                  5. At levels not to exceed 0.1 percent                                   by weight of ethylene vinyl acetate                                   copolymers complying with §                                   177.1350 of this chapter and under                                   conditions of use C through G                                   described in table 2 of §                                   176.170(c) of this chapter.                                  6. At levels not to exceed 0.1 percent                                   by weight of rigid or semirigid                                   polyvinyl chloride and under                                   conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter.                                  7. At levels not to exceed 0.2 percent                                   by weight of acrylonitrile-butadiene-                                   styrene copolymers containing less                                   than 30 percent by weight of                                   acrylonitrile and under conditions of                                   use D through G described in table 2                                   of § 176.170(c) of this chapter.                                  8. At levels not to exceed 0.1 percent                                   by weight of polystyrene complying                                   with § 177.1640 of this chapter                                   and under conditions of use D through                                   G described in table 2 of §                                   176.170(c) of this chapter.                                  9. At levels not to exceed 0.2 percent                                   by weight of rubber-modified                                   polystyrene complying with §                                   177.1640 of this chapter.                                  10. In adhesives complying with §                                   175.105 of this chapter.2,2[prime]-Ethylidenebis(4,6-di-  For use only: tert-                            1. As provided in § 175.105 of butylphenyl)fluorophosphonite     this chapter. (CAS Reg. No. 118337-09-0).      2. In all polymers 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                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter at levels                                   not to exceed 0.25 percent by weight                                   of polymers.                                  3. In polypropylene complying with                                   § 177.1520(c) of this chapter,                                   item 1.1, in contact with food of                                   types III, IV-A, V, VII-A, and IX,                                   under:                                  (a) Conditions of use B through H                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter at levels                                   not to exceed 0.25 percent by weight                                   of the polymer; or                                  (b) Condition of use A, limited to                                   levels not to exceed 0.1 percent by                                   weight of the polymer; provided that                                   the food-contact surface has an                                   average thickness not exceeding 375                                   micrometers (0.015 inch).                                  4. In olefin copolymers complying with                                   § 177.1520(c) of this chapter,                                   items 3.1a or 3.2a, and containing                                   not less than 85 percent by weight of                                   polymer units derived from propylene,                                   in contact with food of types III, IV-                                   A, V, VII-A, and IX, and under:                                  (a) Conditions of use C through G,                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter, limited                                   to levels no greater than 0.2 percent                                   by weight of the copolymers; or                                  (b) Conditions of use A, B, and H,                                   limited to levels no greater than 0.1                                   percent by weight of the olefin                                   copolymers; provided that the food-                                   contact surface has an average                                   thickness not exceeding 375                                   micrometers (0.015 inch).                                  5. In olefin polymers complying with                                   § 177.1520(c) of this chapter,                                   items 1.2 or 1.3 in contact with food                                   of types III, IV-A, V, VII-A, and IX,                                   under conditions of use A through H,                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter at levels                                   not to exceed 0.1 percent by weight                                   of the polymers; provided that the                                   food-contact surface has an average                                   thickness not exceeding 375                                   micrometers (0.015 inch).                                  6. In polyethylene complying with                                   § 177.1520(c) of this chapter,                                   items 2.1 or 2.2, having a density of                                   not less than 0.94, in contact with                                   food of types III, IV-A, V, VII-A,                                   and IX, and under:                                  (a) Conditions of use B through H,                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter limited to                                   levels not to exceed 0.2 percent by                                   weight of the polymers; or                                  (b) Condition of use A, described in                                   Tables 1 and 2 of § 176.170(c)                                   of this chapter, limited to levels                                   not to exceed 0.1 percent by weight                                   of the polymer; provided that the                                   food-contact surface has an average                                   thickness not exceeding 125                                   micrometers (0.005 inch).                                  7. In olefin copolymers complying with                                   § 177.1520(c) of this chapter,                                   items 3.1a, 3.1b, 3.2a, or 3.2b,                                   containing not less than 85 percent                                   by weight of polymer units derived                                   from ethylene and having a density of                                   not less than 0.94, in contact with                                   food of types III, IV-A, V, VII-A,                                   and IX, and under:                                  (a) Conditions of use C through G,                                   described in Tables 1 and 2 of §                                   176.170(c) of this chapter limited to                                   levels not to exceed 0.2 percent by                                   weight of the copolymers; or                                  (b) Conditions of use A, B, and H,                                   limited to levels not to exceed 0.1                                   percent by weight of the copolymers;                                   provided that the food-contact                                   surface has an average thickness not                                   exceeding 125 micrometers (0.005                                   inch).                                  8. In olefin polymers complying with                                   § 177.1520(c) of this chapter,                                   items 3.1a, 3.1b, 3.2a, or 3.2b                                   containing not less than 85 percent                                   by weight of polymer units derived                                   from ethylene, in contact with food                                   of types III, IV-A, V, VII-A, and IX,                                   under conditions of use A through H,                                   as described in Tables 1 and 2 of                                   § 176.170(c) of this chapter at                                   levels not to exceed 0.1 percent by                                   weight of the copolymer; provided                                   that the food-contact surface has an                                   average thickness not exceeding 75                                   micrometers (0.003 inch).                                  9. In polyethylene phthalate polymers                                   complying with § 177.1630 of                                   this chapter in contact with food of                                   types III, IV-A, V, VI-C, VII-A, and                                   IX, and under:                                  (a) Conditions of use B through H,                                   described in tables 1 and 2 of §                                   176.170(c) of this chapter, limited                                   to levels not to exceed 0.3 percent                                   by weight of the polymers; or                                  (b) Condition of use A with food of                                   types III, IV-A, V, VII-A, and IX,                                   and limited to levels not to exceed                                   0.1 percent by weight of the                                   polymers; provided that the film                                   thickness does not exceed 875                                   micrometers (0.035 inch).Hexadecyl 3,5-di-tert-butyl-4-    For use only at levels not to exceed hydroxybenzoate (CAS Reg. No.     0.5 percent by weight of olefin 67845-93-6).                      polymers complying with §                                   177.1520 of this chapter.Hexamethylenebis (3,5-di-tert-    For use only: butyl-4-hydroxyhydrocinnamate)   1. As provided in § (CAS Reg. No. 35074-77-2).        177.2470(b)(1) and §                                   177.2480(b)(1) of this chapter.                                  2. In adhesives complying with §                                   175.105 of this chapter.                                  3. At levels not to exceed 1 percent                                   by weight in pressure-sensitive                                   adhesives complying with §                                   175.125 of this chapter.                                  4. At levels not to exceed 1 percent                                   by weight in can end cement                                   formulations complying with §                                   175.300(b)(3)(xxxi) of this chapter.                                  5. At levels not to exceed 1 percent                                   by weight in side seam cement                                   formulations complying with §                                   175.300(b)(3)(xxxii) of this chapter.                                  6. At levels not to exceed 1 percent                                   by weight in petroleum alicyclic                                   hydrocarbon resins, polyamide resins,                                   and terpene resins complying with                                   § 175.320 of this chapter.                                  7. At levels not to exceed 1 percent                                   by weight in rosin and rosin                                   derivatives when used in accordance                                   with § 176.170(a)(5) of this                                   chapter.                                  8. At levels not to exceed 1 percent                                   by weight in petroleum alicyclic                                   hydrocarbon resins or their                                   hydrogenated products complying with                                   § 176.170(b)(2) of this chapter.                                  9. At levels not to exceed 1 percent                                   by weight in terpene resins complying                                   with § 175.300(b)(3)(xi) of this                                   chapter, when such terpene resins are                                   used in accordance with §                                   176.170(b)(1) of this chapter.                                  10. At levels not to exceed 1 percent                                   by weight in resins and polymers                                   authorized for use in accordance with                                   § 176.180 of this chapter.                                  11. At levels not to exceed 1 percent                                   by weight in closures with sealing                                   gaskets complying with §                                   177.1210 of this chapter.                                  12. At levels not to exceed 1 percent                                   by weight in rubber articles intended                                   for repeated use complying with                                   § 177.2600 of this chapter.                                  13. At levels not to exceed 1 percent                                   by weight in petroleum hydrocarbon                                   resin and rosins and rosin                                   derivatives used in accordance with                                   § 178.3800 of this chapter.                                  14. At levels not to exceed 1 percent                                   by weight in reinforced wax complying                                   with § 178.3850 of this chapter.N,N[prime]-Hexamethylenebis (3,5- For use only: di-tert-butyl-4-                 1. At levels not to exceed 1 percent hydroxyhydrocinnamamide) (CAS     by weight of nylon resins complying Reg. No. 23128-74-7).             with § 177.1500(b) of this                                   chapter, items 1 through 8, that                                   contact food only of the types                                   identified in categories in §                                   176.170(c) of this chapter, table 1                                   except VI-A and VI-C.                                  2. At levels not to exceed 0.75                                   percent by weight of nylon 12 resins                                   complying with § 177.1500(b) of                                   this chapter, item 9, that contact                                   food only of the types identified in                                   categories in § 176.170(c) of                                   this chapter, table 1, except VI-A                                   and VI-C.                                  3. At levels not to exceed 0.6 percent                                   by weight of polyester resins                                   complying with §                                   175.300(b)(3)(vii) of this chapter.                                  4. At levels not to exceed 0.6 percent                                   by weight of closures with sealing                                   gaskets complying with §                                   177.1210 of this chapter.                                  5. At levels not to exceed 0.6 percent                                   by weight of repeated use rubber                                   articles complying with §                                   177.2600 of this chapter.                                  6. At levels not to exceed 0.5 percent                                   by weight of polyoxymethylene                                   copolymer complying with §                                   177.2470 of this chapter.                                  7. At levels not to exceed 0.5 percent                                   by weight of polyoxymethylene                                   homopolymer complying with §                                   177.2480 of this chapter.1,6-Hexanediamine, N, N[prime]-   For use only as a stabilizer at levels bis(2,2,6,6-tetramethyl-4-        not to exceed 0.3 percent by weight piperidinyl)-, polymers with      of olefin polymers complying with morpholine-2,4,6-trichloro-       § 177.1520(c) of this chapter. 1,3,5-triazine reaction           The finished polymers are to contact products, methylated (CAS Reg.    food only under conditions of use C, No. 193098-40-7).                 D, E, F, and G, as 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).1,6-Hexanediamine, N,N'-          For use only: bis(2,2,6,6-tetramethyl-4-       1. At levels not to exceed 0.5 percent piperidinyl)-, polymer with       by weight of propylene polymers and 2,4,6-trichloro-1,3,5-triazine,   copolymers complying with § reaction products with N-butyl-   177.1520(c) of this chapter, items 1-butanamine and N-butyl-         1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 2,2,6,6-tetramethyl-4-            3.5. The finished polymers may piperidinamine (CAS Reg. No.      contact food only of the types 192268-64-7).                     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 0.3 percent                                   by weight of 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 polymers may                                   contact food only 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 0.5 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, 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 contact food                                   only 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.                                  4. At levels not to exceed 0.05                                   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, 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 contact                                   food only 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.                                  5. At levels not to exceed 0.5 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), or                                   5. The finished polymers may contact                                   food only 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 C through G                                   described in table 2 of §                                   176.170(c) of this chapter.                                  6. At levels not to exceed 0.01                                   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), or 5. The finished                                   polymers may contact food only 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                                   through G described in table 2 of                                   § 176.170(c) of this chapter.2-Hydroxy-4-isooctoxy-            For use only at levels not to exceed benzophenone. Chemical            0.5 percent by weight of olefin Abstracts (CA) name: Methanone,   copolymers complying with § [2-hydroxy-4-(isooctyloxy)        177.1520(c) of this chapter: Items phenyl]phenyl; CA Registry No.    1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 33059-05-1.                       3.2, 3.3 or 4: Provided, That the                                   finished polymer contacts food only                                   of the types identified in §                                   176.170(c) of this chapter, table 1,                                   under Categories I, VII-B and VIII                                   under conditions of use E, F, and G                                   described in table 2 of §                                   176.170(c) of this chapter.2(2[prime]-Hydroxy-5[prime]-      For use only: methylphenyl)benzotriazole       1. As component of nonfood articles meeting the following             complying with § 177.1010 of specification: melting point      this chapter. 126° -132 °C             2. At levels not to exceed 0.25 (258.8° -269.6 °F) (CAS   percent by weight of rigid polyvinyl Reg. No. 2440-22-4).              chloride and/or rigid vinyl chloride                                   copolymers complying with §                                   177.1980 of this chapter.                                  3. In polystyrene that complies with                                   § 177.1640 of this chapter and                                   that is limited to use in contact                                   with dry food of Type VIII described                                   in table 1 of § 176.170(c) of                                   this chapter.                                  4. At levels not to exceed 0.25                                   percent by weight of polystyrene and/                                   or rubber-modified polystyrene                                   polymers complying with §                                   177.1640 of this chapter intended to                                   contact nonalcoholic food: Provided,                                   That the finished basic rubber-                                   modified polystyrene polymers in                                   contact with fatty foods shall                                   contain not less than 90 weight                                   percent of total polymer units                                   derived from styrene monomer.                                  5. At levels not to exceed 0.5 percent                                   by weight of polycarbonate resins                                   complying with § 177.1580 of                                   this chapter. Provided, That the                                   finished polycarbonate resins contact                                   food only of Types I, II, III, IV, V,                                   VI-A, VI-B, VII, VIII, and IX                                   identified in table 1 of §                                   176.170(c) of this chapter and under                                   conditions of use E, F, and G                                   described in table 2 of §                                   176.170(c) of this chapter.                                  6. At levels not to exceed 0.5 percent                                   by weight of ethylene-1,4-                                   cyclohexylene dimethylene                                   terephthalate copolymers complying                                   with § 177.1315 of this chapter                                   and of ethylene phthalate polymers                                   complying with § 177.1630 of                                   this chapter and that contact food                                   only under conditions of use D                                   through G described in table 2,                                   § 176.170(c) of this chapter.2-Hydroxy-4-n-octoxy-             For use only at levels not to exceed benzophenone.                     0.5 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 polymer contacts food only                                   of the types identified in §                                   176.170(c) of this chapter, table 1,                                   under Categories I, IV-B, VII-B, and                                   VIII , and under the conditions of                                   use B through H described in table 2                                   of § 176.170(c) of this chapter.4,4[prime]-                       For use only at levels not exceeding Isopropylidenediphenol            1.0 percent by weight in rigid alkyl(C12-C15) phosphites; the    polyvinyl chloride and/or rigid vinyl phosphorus content is in the      chloride copolymers complying with range of 5.2-5.6 weight percent.  §§ 177.1950, 177.1970 or                                   177.1980 of this chapter, and used in                                   contact with food, except milk, only                                   under the conditions described in                                   § 176.170(c) of this chapter,                                   table 2, under conditions of use D                                   through G.Magnesium salicylate............  For use only in rigid polyvinyl                                   chloride and/or in rigid vinyl                                   chloride copolymers complying with                                   § 177.1980 of this chapter:                                   Provided, That total salicylates                                   (calculated as the acid) do not                                   exceed 0.3 percent by weight of such                                   polymers.2-Methyl-4,6-bis-                 For use only: [(octylthio)methyl] phenol (CAS  1. In adhesives complying with § Reg. No. 110553-27-0).            175.105 of this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of can-end cements and side-                                   seam cements complying with §                                   175.300(b)(xxxi) and (xxxii) of this                                   chapter.                                  3. At levels not to exceed 1 percent                                   by weight of pressure sensitive                                   adhesives complying with §                                   175.125 of this chapter petrolium                                   alicyclic hydrocarbon resins                                   complying with § 176.170 of this                                   chapter, resins and polymers                                   complying with § 176.180 of this                                   chapter, and closures with sealing                                   gaskets complying with §                                   177.1210 of this chapter.                                  4. At levels not to exceed 1.7 percent                                   by weight of the finished rubber                                   products complying with §                                   177.2600 of this chapter.                                  5. At levels not to exceed 0.1 percent                                   by weight of petroleum alicyclic                                   hydrocarbon resins complying with                                   § 175.320 of this chapter;                                   rubber-modified polystyrene complying                                   with § 177.1640 of this chapter;                                   and petroleum hydrocarbon resins and                                   rosins and rosins and rosin                                   derivatives complying with §                                   178.3800 of this chapter.                                  6. At levels not to exceed 0.2 percent                                   by weight of styrene block polymenrs                                   complying with § 177.1810 of                                   this chapter that contact food of                                   Types I, II, IV-B, VI, VII-B, and                                   VIII described in table 1, §                                   176.170(c) of this chapter, only                                   under conditions of use C through H                                   described in table 2, §                                   176.170(c) of this chapter.2,2[prime]-Methylenebis(4,6-di-   For use only at levels not to exceed tert-butylphenyl)2-ethylhexyl     0.25 percent by weight of phosphite (CAS Reg. No. 126050-   polypropylene complying with § 54-2).                            177.1520 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-B, VII-B,                                   and VIII under conditions of use B                                   through H described in table 2,                                   § 176.170(c) of this chapter,                                   and with food of the types identified                                   in § 176.170(c) of this chapter,                                   table 1, under Categories III, IV-A,                                   V, VI-A, VI-C, VII-A, and IX under                                   conditions of use C through G                                   described in table 2, §                                   176.170(c) of this chapter.2,2[prime]-Methylenebis (6-tert-  For use only: butyl-4-ethylphenol).            1. In acrylonitrile-butadiene-styrene                                   copolymers at levels not to exceed                                   0.6 percent by weight of the                                   copolymer.                                  2. In semirigid and rigid acrylic and                                   modified acrylic plastics complying                                   with § 177.1010 of this chapter                                   at levels not to exceed 0.1 percent                                   by weight of the plastic.4,4[prime]-Methylenebis (2,6-di-  For use only: tert-butyl-phenol).              1. As provided in § 175.105 of                                   this chapter.                                  2. At levels not to exceed 0.25                                   percent by weight of petroleum                                   hydrocarbon resins used in compliance                                   with regulations in parts 174, 175,                                   176, 177, 178 and § 179.45 of                                   this chapter.                                  3. At levels not to exceed 0.25                                   percent by weight of terpene resins                                   used in compliance with regulations                                   in parts 174, 175, 176, 177, 178 and                                   § 179.45 of this chapter.                                  4. At levels not to exceed 0.5 percent                                   by weight of polyethylene complying                                   with § 177.1520 of this chapter:                                   Provided, That the polyethylene end                                   product contacts foods only of the                                   types identified in Categories I, II,                                   IV-B, VI, VII-B, and VIII in table 1,                                   § 176.170(c) of this chapter.                                  5. At levels not to exceed 0.5 percent                                   by weight of polybutadiene used in                                   rubber articles complying with §                                   177.2600 of this chapter: Provided,                                   That the rubber end product contacts                                   foods only of the types identified in                                   Categories I, II, IV-B, VI, VII-B,                                   and VIII in table 1, §                                   176.170(c) of this chapter.2,2[prime]-Methylenebis(4-methyl- For use only: 6-tert-butylphenol).             1. At levels not to exceed 0.1 percent                                   by weight of olefin polymers                                   complying with sec. 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                                   used in articles that contact food of                                   the types identified in sec.                                   176.170(c) of this chapter, table 1,                                   under Categories I, II, IV-B, VI, VII-                                   B, and VIII.                                  2. At levels not to exceed 1 percent                                   by weight of polyoxymethylene                                   copolymer as provided in sec.                                   177.2470(b)(1) of this chapter.                                  3. At levels not to exceed 0.5 percent                                   by weight of polyoxymethylene                                   homopolymer as provided in §                                   177.2480(b)(1) of this chapter.2,2[prime]-Methylenebis(4-methyl- For use only: 6-tert-butylphenol)              1. At levels not to exceed 0.5 percent monoacrylate (CAS Reg. No.        by weight of polystyrene and rubber- 61167-58-6).                      modified polystyrene complying with                                   § 177.1640 of this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of styrene block ploymers                                   complying with § 177.1810 of                                   this chapter.                                  3. At levels not to exceed 1 percent                                   by weight of adhesives complying with                                   § 175.105 of this chapter and                                   pressure sensitive adhesives                                   complying with § 175.125 of this                                   chapter.                                  4. At levels not to exceed 0.5 percent                                   by weight of acrylonitrile-butadiene-                                   styrene copolymers that comply with                                   § 177.1020 of this chapter when                                   used in articles that contact food                                   only under conditions of use E, F,                                   and G as described in table 2, §                                   176.170 (c) of this chapter.2,2[prime]-Methylenebis[6-(1-     For use only: methylcyclo-hexyl)-p-cresol].    1. As provided in § 177.1210 of                                   this chapter.                                  2. At levels not to exceed 0.2 percent                                   by weight of polyethylene complying                                   with § 177.1520 of this chapter:                                   Provided, That the finished                                   polyethylene contacts foods only of                                   the type identified in §                                   176.170(c) of this chapter, table 1,                                   under Categories I, II, VI-B, and                                   VIII.                                  3. In polyethylene complying with                                   § 177.1520 of this chapter:                                   Provided, That the finished                                   polyethylene contacts foods only of                                   the types identified in §                                   176.170(c) of this chapter, table 1,                                   under Categories III, IV, V, VI-A,                                   VII, and IX, and only at temperatures                                   not to exceed room temperature: And                                   further provided, That percentage                                   concentration of the antioxidant in                                   the polyethylene, when multiplied by                                   the thickness in inches of the                                   finished polyethylene, shall not be                                   greater than 0.0005.2,2[prime]-Methylenebis(4-methyl- For use only in acrylonitrile- 6-nonylphenol) and 2,6-bis(2-     butadiene-styrene copolymers used in hydroxy-3-nonyl-5-methyl-         contact with nonalcoholic foods. benzyl)-p-cresol mixtures (varying proportions).Methyltin-2-mercaptoethyloleate   For use only in rigid poly(vinyl sulfide, which is defined as      chloride) and rigid vinyl chloride one or more of the following:     copolymers complying with                                   §§ 177.1950 and 177.1980 of                                   this chapter, respectively, used in                                   the manufacture of pipes and pipe                                   fittings intended for contact with                                   water in food processing plants, at                                   levels not to exceed:                                  1. 1.0 percent by weight in pipes, and                                  2. 2.0 percent by weight in pipe                                   fittings.  1. 9-Octadecenoic acid (Z)-, 2-   mercaptoethyl ester, reaction   products with dichlorodime   thylstannane, sodium sulfide,   and trichloromethylstannane   (CAS Reg. No. 68442-12-6);  2. Fatty acids, tall oil, 2-   mercaptoethyl esters,   reaction products with   dichlorodimethylstannane, 2-   mercaptoethyl decanoate, 2-   mercaptoethyl octanoate,   sodium sulfide, and   trichloromethylstannane (CAS   Reg. No. 151436-98-5); or  3. Fatty acids, tall oil, 2-   mercaptoethyl esters,   reaction products with   dichlorodimethylstannane,   sodium sulfide, and   trichloromethylstannane (CAS   Reg. No. 201687-57-2);and   which has the following   specifications: Tin content   (as Sn) 5 to 21 percent by   weight; mercaptosulfur   content 5 to 13 percent by   weight; acid value no greater   than 4.  Methyltin-2-   Mercaptoethyloleate sulfide   may also be used with one or   more of the following   optional substances:  1.1a 2-Mercaptoethyl oleate   (CAS Reg. No. 59118-78-4),  1.1b 2-Mercaptoethyl tallate   (CAS Reg. No. 68440-24-4),  1.1c 2-Mercaptoethyl octanoate   (CAS Reg. No. 57813-59-9),  1.1d 2-Mercaptoethyl decanoate   (CAS Reg. No. 68928-33-6),   alone or in combination; not   to exceed 40 percent by   weight of the stabilizer   formulation;  2.1 2-Mercaptoethanol (CAS   Reg. No. 60-24-2): Not to   exceed 2 percent by weight of   the stabilizer formulation.  3.1 Mineral oil (CAS Reg. No.   8012-95-1): Not to exceed 40   percent by weight of the   stabilizer formulation.  4.1 Butylated hydroxytoluene   (CAS Reg. No. 128-37-0): Not   to exceed 5 percent by weight   of the stabilizer   formulation.  The total of the optional   substances (1.1a through 4.1)   shall not exceed 60 percent   by weight of the stabilizer   formulation.Nylon 66/610/6 terpolymer (see    For use only at levels not to exceed § 177.1500 of this chapter   1.5 percent by weight of for identification)               polyoxymethylene homopolymer as                                   provided in § 177.2480 (b)(1) of                                   this chapter.Nylon 612/6 copolymer. (CAS Reg.  For use only at levels not to exceed No. 51733-10-9), weight ratio 6/  1.5 percent by weight of 1.                                polyoxymethylene homopolymer as                                   provided in § 177.2480(b)(1).Octadecyl 3,5-di-tert-butyl-4-    For use only: hydroxyhydrocinnamate (CAS Reg.  1. At levels not exceeding 0.25 No. 2082-79-3).                   percent by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 1.1, 1.2, 1.3,                                   2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4.                                  2. As provided in §§ 175.105                                   and 177.1010(a)(5) of this chapter.                                  3. At levels not exceeding 0.25                                   percent by weight of polystyrene and/                                   or rubber-modified polystyrene                                   polymers complying with §                                   177.1640 of this chapter, except that                                   the finished basic rubber-modified                                   polystyrene polymers in contact with                                   fatty foods shall contain not less                                   than 85 weight percent of total                                   polymer units derived from styrene                                   monomer.                                  4. At levels not to exceed 0.5 percent                                   by weight of acrylonitrile-butadiene-                                   styrene copolymers used in accordance                                   with prior sanction or regulations in                                   parts 174, 175, 176, 177, 178 and                                   § 179.45 of this chapter.                                  5. At levels not exceeding 0.25                                   percent by weight of olefin                                   copolymers complying with §                                   177.1520(c) of this chapter, items                                   3.4 and 3.5 as follows: (a) item 3.4,                                   Provided, That the finished copolymer                                   contacts foods only of types                                   identified in § 176.170(c) of                                   this chapter, table 1, under                                   Categories I, II, III, IV-B, VI, VII,                                   VIII, and IX; (b) item 3.5, Provided,                                   That the finished copolymer contacts                                   non-fatty foods only of types                                   identified in § 176.170(c) of                                   this chapter, table 1, under                                   Categories I, II, IV-B, VI, VII-B,                                   and VIII.                                  6. At levels not exceeding 0.05                                   percent by weight of modified semi-                                   rigid and rigid vinyl chloride                                   plastics modified with methacrylate-                                   butadiene-styrene copolymers in                                   accordance with § 178.3790.                                  7. At levels not exceeding 0.2 percent                                   by weight of rigid polyvinyl                                   chloride.                                  8. At levels not to exceed 0.3 percent                                   by weight of polycarbonate resins                                   that comply with § 177.1580 and                                   that contact food only under                                   conditions of use E, F, and G                                   described in table 2, §                                   176.170(c) of this chapter.                                  9. At levels not exceeding 0.1 percent                                   by weight of ethylene-vinyl acetate                                   copolymers complying with §                                   177.1350 of this chapter.                                  10. At levels not to exceed 0.2                                   percent by weight of nitrile rubber-                                   modified acrylonitrile-methyl                                   acrylate copolymers that comply with                                   § 177.1480 of this chapter when                                   used in articles that contact food                                   only under conditions of use D, E, F,                                   and G described in table 2, §                                   176.170(c) of this chapter.                                  11. At levels not exceeding 0.3                                   percent by weight of styrene block                                   polymers complying with §                                   177.1810 of this chapter when used in                                   articles that 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, and under conditions of                                   use D, E, F, and G described in table                                   2 of § 176.170(c) of this                                   chapter.                                  12. At levels not exceeding 0.2                                   percent by weight of vinylidene                                   chloride homopolymers and/or                                   vinylidene chloride copolymers                                   complying with applicable regulations                                   in parts 175, 176, 177, 179, and 181                                   of this chapter. The vinylidene                                   chloride copolymers shall contain not                                   less than 50 weight percent of total                                   polymer units derived from vinylidene                                   chloride.                                  13. At levels not exceeding 0.025                                   percent by weight of chlorinated                                   isobutylene-isoprene copolymers                                   complying with § 177.1420(a)(3)                                   of this chapter.                                  14. At levels not exceeding 0.5                                   percent by weight of the finished                                   rubber article complying with §                                   177.2600 of this chapter.7-Oxa-3,20-diazadispiro-          For use only: [5.1.11.2]-heneicosan-21-        1. At levels not to exceed 0.5 percent one,2,2,4,4-tetramethyl-          by weight of olefin polymers ,hydrochloride, reaction          complying with § 177.1520 of products with epichlorohydrin,    this chapter, items 1.1, 3.1, and hydrolyzed, polymerized (CAS      3.2, where the copolymers complying Reg. No. 202483-55-4).            with items 3.1 and 3.2 contain not                                   less than 85 weight percent of                                   polymer units derived from propylene;                                   in contact with all types of food                                   described in Table 1 of §                                   176.170 of this chapter, provided                                   that the finished food-contact                                   article will have a capacity of at                                   least 18.9 liters (5 gallons) when in                                   contact with food of types III, IV-A,                                   V, VII-A, and IX, described in Table                                   1 of § 176.170 of this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of olefin polymers                                   complying with § 177.1520 of                                   this chapter, items 2.1, 2.2, 3.1,                                   and 3.2, having a density of not less                                   than 0.94 gram/milliliter, where the                                   copolymers complying with items 3.1                                   and 3.2 contain not less than 85                                   weight percent of polymer units                                   derived from ethylene; in contact                                   with food only under conditions of                                   use C, D, E, F, and G, described in                                   Table 2 of § 176.170 of this                                   chapter, provided that the finished                                   food-contact article will have a                                   capacity of at least 18.9 liters (5                                   gallons) when in contact with food of                                   types III, IV-A, V, VII-A, and IX,                                   described in Table 1 of §                                   176.170 of this chapter.                                  3. At levels not to exceed 0.3 percent                                   by weight of olefin polymers                                   complying with § 177.1520 of                                   this chapter, items 2.1, 2.2, 3.1,                                   3.2, 3.3, 3.4, 3.5, 3.6, and 4.0,                                   having a density of less than 0.94                                   gram/milliliter, in contact with food                                   only under conditions of use D, E, F,                                   and G, described in Table 2 of §                                   176.170 of this chapter, provided                                   that the finished food-contact                                   article will have a capacity of at                                   least 18.9 liters (5 gallons) except                                   that, films and molded articles                                   containing not more than 0.2 percent                                   by weight of the stabilizer may                                   contact aqueous food of types I, II,                                   IV-B, VI, and VIII, described in                                   Table 1 of § 176.170 of this                                   chapter with no restrictions on the                                   amount of food contacted.Oxidized bis (hydrogenated        For use only: tallow alkyl) amines.            1. At levels not to exceed 0.1 percent                                   by weight of polypropylene polymers                                   complying with § 177.1520(c) of                                   this chapter, item 1.1, 1.2, 1.3,                                   3.1a (density not less than 0.85 gram                                   per cubic centimeter and less than                                   0.91 gram per cubic centimeter),                                   3.2b, 3.4, and 3.5. The finished                                   polymers may be used in contact with                                   food types I, II, IV-B, VII-B and                                   VIII described in table 1 of §                                   176.170(c) of this chapter, under                                   conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter and with                                   food types III, IV-A, V, VI, VII-A,                                   and IX 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.                                  2. At levels not to exceed 0.075                                   percent by weight of high-density                                   polyethylene polymers complying with                                   § 177.1520(c) of this chapter,                                   item 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a,                                   3.6 (density not less than 0.94 gram                                   per cubic centimeter), and 5. The                                   finished polymers may be used in                                   contact with food types I, II, IV-B,                                   VII-B and VIII described in table 1                                   of § 176.170(c) of this chapter,                                   under conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter, and with                                   food types III, IV-A, V, VI, VII-A                                   and IX 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.2,2[prime]-Oxamidobis[ethyl 3-    For use only: (3,5-di-tert-butyl-4-            1. At levels not to exceed 0.5 percent hydroxyphenyl)propionate] (CAS    by weight of polystyrene and rubber- Reg. No. 70331-94-1).             modified polystyrene complying with                                   § 177.1640 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, items 1.1, 1.2, and                                   1.3.                                  3. At levels not to exceed 0.5 percent                                   by weight of olefin polymers                                   complying 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 4.0 that                                   contact food Types I, II, IV-B, VI,                                   VII-B and VIII described in table 1                                   of § 176.170(c) of this chapter.                                  4. At levels not to exceed 0.1 percent                                   by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 2.3,                                   3.1, 3.2, 3.3, and 4.0 that contact                                   food Types III, IV-A, V, VII-A, and                                   IX described in table 1 of §                                   176.170(c) of this chapter; except                                   that olefin copolymers complying with                                   items 3.1 and 3.2 where the majority                                   of polymer units are derived from                                   propylene may contain the additive at                                   levels not to exceed 0.5 percent by                                   weight.                                  5. At levels not to exceed 0.1 percent                                   by weight of olefin polymers                                   complying with item 3.4 of §                                   177.1520(c) of this chapter, that                                   contact food Types III, VII-A, and IX                                   described in table 1 of §                                   176.170(c) of this chapter; except                                   that olefin copolymers complying with                                   item 3.4 where the majority of the                                   polymer units are derived from                                   propylene may contain the additive at                                   levels not to exceed 0.5 percent by                                   weight.Pentaerythritol and its stearate  For use only in rigid polyvinyl ester.                            chloride and/or in rigid vinyl                                   chloride copolymers complying with                                   § 177.1980 of this chapter:                                   Provided, That the total amount of                                   pentaerythritol and/or                                   pentaerythritol stearate (calculated                                   as free pentaerythritol) does not                                   exceed 0.4 percent by weight of such                                   polymers.N-Phenylbenzenamine reaction      For use at levels not to exceed 0.5 products with 2,4,4-              percent by weight of pressure- trimethylpentenes (CAS Reg. No.   sensitive adhesives complying with 68411-46-1).                      § 175.125 of this chapter.Phosphoric acid triesters with    At levels not to exceed 0.1 percent by triethylene glycol (CAS Reg.      weight of polyethylene phthalate No. 64502-13-2).                  polymers complying with §                                   177.1630 of this chapter, such that                                   the polymers contact foods only of                                   Type VI-B described in table 1 of                                   § 176.170(c) of this chapter.Phosphorous acid, cyclic          For use only: butylethyl propanediol, 2,4,6-   1. At levels not to exceed 0.2 percent tri-tert-butylphenyl ester (CAS   by weight of olefin polymers Reg. No. 161717-32-4), which      complying with § 177.1520(c) of may contain not more than 1       this chapter, items 1.1, 1.2, or 1.3, percent by weight of              and items 2.1, 2.2, or 2.3 (where the triisopropanolamine (CAS Reg.     density of these polymers is not less No. 122-20-3).                    than 0.94 gram per cubic centimeter),                                   and items 3.1 or 3.2, provided that                                   the finished polymer contacts foods                                   of types I, II, and VI-B as described                                   in table 1 of § 176.170(c) of                                   this chapter only under conditions of                                   use B, C, D, E, F, G, and H as                                   described in table 2 of §                                   176.170(c) of this chapter.                                  2. 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, or 1.3,                                   that contact food of types III, IV,                                   V, VI-A, VI-C, VII, VIII, and IX as                                   described in table 1 of §                                   176.170(c) of this chapter, only                                   under conditions of use C, D, E, F,                                   and G as described in table 2 of                                   § 176.170(c) of this chapter.                                  3. At levels not to exceed 0.1 percent                                   by weight of olefin copolymers                                   complying with § 177.1520(c) of                                   this chapter, items 3.1a, 3.1b, 3.2a,                                   or 3.2b, having a density less than                                   0.94 grams per cubic centimeter, in                                   contact with food only of types III,                                   IV, V, VI-A, VI-C, VII, VIII, and IX                                   and under conditions of use B, C, D,                                   E, F, G, and H as described in tables                                   1 and 2 of § 176.170(c) of this                                   chapter; provided that the food-                                   contact surface does not exceed 0.003                                   inch (0.076 mm) in thickness.                                  4. At levels not to exceed 0.1 percent                                   by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 2.3,                                   3.1(a), 3.1(b), 3.1(c), 3.2 (a), or                                   3.2(b), having a density not less                                   than 0.94 grams per cubic centimeter,                                   in contact with foods only of types                                   III, IV, V, VI-A, VI-C, VII, VIII,                                   and IX identified in Table 1 of                                   § 176.170(c) of this chapter,                                   and under conditions of use B through                                   H as described in Table 2 of §                                   176.170(c) of this chapter; provided                                   that the food-contact surface does                                   not exceed 0.003 inch (0.076 mm) in                                   thickness.Phosphorous acid, cyclic          For use only at levels not to exceed neopentanetetrayl bis(2,4-di-     0.10 percent by weight of olefin tert-butylphenyl) ester (CAS      polymers complying with § Reg. No. 26741-53-7) which may    177.1520(c) of this chapter, item contain not more than 1 percent   1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, or by weight of                      3.2, and limited to use in contact triisopropanolamine (CAS Reg.     with food only under conditions of No. 122-20-3).                    use B, C, D, E, F, G, and H described                                   in table 2 of § 176.170(c) of                                   this chapter. Olefin polymers that                                   contain more than 50 weight-percent                                   of polymer units derived from                                   ethylene shall have a density equal                                   to or greater than 0.94 gram per                                   cubic centimeter.Phosphorous acid, cyclic          For use only: neopentanetetrayl bis (2,6-di-   1. At levels not to exceed 0.25 tert-butyl-4-methylphenyl)ester   percent by weight of polypropylene (CAS Reg. No. 80693-00-1).        homopolymer and copolymers complying                                   with § 177.1520 of this chapter,                                   for use with all food types described                                   in table 1 of § 176.170(c) of                                   this chapter only under conditions of                                   use B through H described in table 2                                   of § 176.170(c) of this chapter.                                  2. At levels not to exceed 0.05                                   percent by weight of polymers                                   complying with § 177.1520(c) of                                   this chapter, item 3.1 or 3.2, and                                   with a maximum thickness of 100                                   micrometers (0.004 inch) for use with                                   all food types under conditions of                                   use B, C, D, E, F, G, and H described                                   in table 2 of § 176.170(c) of                                   this chapter.Phosphorous acid, cyclic          For use only: neopentanetetrayl bis(2,4-di-    1. At levels not to exceed 0.86 tert-butylphenyl)ester (CAS       percent by weight in polyvinyl Reg. No. 26741-53-7).             chloride and/or vinyl chloride                                   copolymers that comply with                                   §§ 177.1950, 177.1960,                                   177.1970, or 177.1980 of this chapter                                   for use with all food types described                                   in table 1 of § 176.170(c) of                                   this chapter, except those containing                                   more than 15 percent alcohol, under                                   conditions of use B, C, D, E, F, G,                                   and H described in table 2 of §                                   176.170(c) of this chapter.                                  2. At levels not to exceed 0.25                                   percent by weight of polycarbonate                                   resins that comply with §                                   177.1580 of this chapter for use with                                   all food types described in table 1                                   of § 176.170(c) of this chapter,                                   except those containing more than 15                                   percent alcohol, under conditions of                                   use B, C, D, E, F, G, and H described                                   in table 2 of § 176.170(c) of                                   this chapter.                                  3. At levels not to exceed 0.05                                   percent by weight in olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 3.1, that contain                                   more than 50 weight percent of                                   polymer units derived from ethylene                                   and whose density is less than 0.94                                   gram per cubic centimeter. The                                   average thickness of such polymers                                   intended for use in contact with food                                   types V and VII-A described in table                                   1 of § 176.170(c) of this                                   chapter shall not exceed 80                                   micrometers (0.003 inch).Poly(1,4-                         For use only: cyclohexylenedimethylene-        1. In polypropylene complying with 3,3[prime]-thiodipropionate)      § 177.1520(c) of this chapter, partially terminated with         item 1.1, and used in contact with stearyl alcohol and produced      nonfatty, nonalcoholic food. when approximately equal moles   2. At levels not to exceed 0.5 percent of 1,4-cyclohexanedimethanol      by weight of polypropylene complying and 3,3[prime]-thiodipropionic    with § 177.1520(c) of this acid are made to react in the     chapter, item 1.1, and used in presence of stearyl alcohol so    contact with fatty, nonalcoholic that the final product has an     food. The average thickness of such average molecular weight in the   polymers in the form in which they range of 1,800-2,200, as          contact fatty nonalcoholic food shall determined by vapor pressure      not exceed 0.005 inch. osmometry, and has a maximum acid value of 2.5.Poly[(1,3-                        For use only at levels not to exceed dibutyldistannthianediylidene)-   0.2 by percent weight in polyvinyl 1,3-dithio] having the formula    chloride resin where such resin [C8H18Sn2S3]n (where n averages   constitutes not less than 98.7 1.5-2) and produced so as to      percent of a finished semirigid or meet the following                rigid polyvinyl chloride food-contact specifications: Softening         surface, provided that the finished point, 130-145 °C; volatile   food-contact article is employed only components at 150 °C, less    to package meat, cheese, and food than 1.0 percent; sulphur         Types I, VIII, and IX as described in (sulfide) content in the range    table 1 of § 176.170(c) of this 20.5-22.0 percent; tin content    chapter. The finished food-contact in the range 52.0-53.2 percent.   article containing this stabilizer,                                   when extracted with refined                                   cottonseed oil at 120 °F for 48                                   hours, using a volume-to-surface                                   ratio of 2 milliliters per square                                   inch of surface tested, shall yield                                   tin (Sn) not to exceed 0.0005                                   milligram per square inch of food-                                   contact surface.Poly[(6-morpholino-s-triazine-    For use only: 2,4-diyl)[(2,2,6,6-tetramethyl-  1. At levels not to exceed 0.3 percent 4-piperidyl)imino]hexamethylene   by weight of polypropylene complying [(2,2,6,6-tetramethyl-4-          with § 177.1520(c) of this piperidyl)imino]] (CAS Reg. No.   chapter, items 1.1, 1.2, and 1.3, and 82451-48-7).                      of ethylene polymers complying with                                   § 177.1520(c) of this chapter,                                   items 2.1, 2.3, and 3.1, whose                                   specific gravity is not less than                                   0.94. The finished polymers are to                                   contact food only under conditions of                                   use D, E, F, and G described in table                                   2 of § 176.170(c) of this                                   chapter.                                  2. At levels not to exceed 0.3 percent                                   by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.3, and                                   3.1, whose specific gravity is less                                   than 0.94, and of olefin polymers                                   complying with items 3.3., 3.4, 3.5,                                   and 4.0. The finished polymers are to                                   contact food in articles having a                                   volume of at least 18.9 liters (5                                   gallons) only under conditions of use                                   D, E, F, and G described in table 2                                   of § 176.170(c) of this chapter.Poly[[6-[(1,1,3,3-                For use only: tetramethybutyl) amino]-s-       1. At levels not to exceed 0.3 percent triazine-2,4-diyl][2,2,6,6-       by weight of polypropylene complying tetramethyl-4-                    with § 177.1520 of this chapter. piperidyl)imino]hexamethylene[(  2. At levels not to exceed 0.2 percent 2,2,6,6-tetramethyl-4-            by weight of polyethylene complying piperidyl)imino]] (CAS Reg. No.   with § 177.1520 of this chapter, 70624-18-9).                      that has a density equal to or                                   greater than 0.94 gram per cubic                                   centimeter.                                  3. At levels not to exceed 0.3 percent                                   by weight of polyethylene that has a                                   density less than 0.94 gram per cubic                                   centimeter complying with §                                   177.1520 of this chapter, items 2.1,                                   2.2, and 2.3, and of olefin polymers                                   and copolymers complying with items                                   3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.                                   The finished polymers are to contact                                   food only under conditions of use B                                   through H described in table 2 of                                   § 176.170(c) of this chapter,                                   and when contacting fatty foods of                                   Types III, IV-A, V, VII-A, and IX                                   described in table 1 of §                                   176.170(c) of this chapter, the                                   finished articles are to have a                                   volume of at least 18.9 liters (5                                   gallons).Potassium bromide and either      For use at levels not exceeding 0.18 cupric acetate or cupric          percent potassium bromide and 0.005 carbonate.                        percent copper as cupric acetate or                                   cupric carbonate 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.1,3-propanediamine, N,N-1,2-      For use only: ethanediylbis-, polymer with     1. At levels not to exceed 0.3 percent 2,4,6-trichloro-1,3,5-triazine,   by weight of polypropylene complying reaction products with N-butyl-   with § 177.1520(c) of this 2,2,6,6-tetramethyl-4-            chapter, items 1.1, 1.2, and 1.3. piperidinamine (CAS Reg. No.     2. At levels not to exceed 0.2 percent 136504-96-6).                     by weight of olefin polymers having a                                   density greater than or equal to 0.94                                   grams per cubic centimeter and                                   complying with § 177.1520(c) of                                   this chapter, items 2.1, 2.2, 2.3,                                   3.1, and 3.2.                                  3. At levels not to exceed 0.3 percent                                   by weight of olefin polymers having a                                   density less than 0.94 grams per                                   cubic centimeter and complying with                                   § 177.1520(c) of this chapter,                                   items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,                                   3.4, 3.5, 3.6, and 4.0. The finished                                   polymers are to contact food only                                   under conditions of use B through H                                   described in Table 2 of §                                   176.170(c) of this chapter, and when                                   used in contact with fatty foods of                                   Types III, IV-A, V, VII-A, and IX as                                   described in Table 1 of §                                   176.170(c) of this chapter, the                                   finished articles are to have a                                   volume of at least 18.9 liters (5                                   gallons).N,N[prime]-1,3-Propanediylbis     For use only at levels not to exceed (3,5-di-tert-butyl-4-             0.6 percent by weight of rubber hydroxyhydrocinnamamide) (CAS     articles for repeated use complying Reg. No. 69851-61-2).             with § 177.2600 of this chapter.Siloxanes and silicones, methyl   For use as an ultraviolet (UV) hydrogen, reaction products       stabilizer only at levels not to with 2,2,6,6-tetramethyl-4-(2-    exceed 0.33 percent by weight of propenyloxy)piperidine (CAS       polypropylene complying with § Reg. No. 182635-99-0).            177.1520(c) of this chapter, items                                   1.1a, 1.1b, 1.2, and 1.3, under                                   conditions of use D, E, F, and G, as                                   described in Table 2 of §                                   176.170 of this chapter.Stearoylbenzoylmethane (CAS Reg.  For use only at levels not to exceed No. 58446-52-9) consisting of a   0.5 percent by weight of vinyl mixture of β-diketones       chloride homopolymers modified in produced by the condensation of   accordance with § acetophenone and technical        178.3790(b)(1). The finished polymers methyl stearate..                 may be used in contact with food                                   containing up to 50 percent alcohol                                   under conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter.Styrenated diphenylamine (CAS     For use only in adhesives complying Reg. No. 68442-68-2).             with § 175.105 of this chapter                                   and in rubber articles intended for                                   repeated use complying with §                                   177.2600 of this chapter.Tetradecanoic acid, lithium salt  For use only at levels not to exceed (CAS Reg. No. 20336-96-3).        0.15 percent by weight of                                   polypropylene and polypropylene                                   copolymers complying with §                                   177.1520(c) of this chapter, items                                   1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a,                                   and 3.2b. The finished polymers may                                   only be used in contact with food of                                   Types I, II, IV-B, VI-B, VII-B, and                                   VIII as described in table 1 of                                   § 176.170(c) of this chapter                                   under conditions of use B through H                                   as described in table 2 of §                                   176.170(c) of this chapter, and with                                   food of Types III, IV-A, V, VI-A, VI-                                   C, VII-A, and IX described in table 1                                   of § 176.170(c) of this chapter                                   under conditions of use C through G                                   as described in table 2 of §                                   176.170(c) of this chapter.2-[[2,4,8,10-Tetrakis(1,1-        For use only at levels not to exceed dimethylethyl)dibenzo[d,f][1,3,   0.075 percent by weight of olefin 2]-dioxaphosphepin-6-yl]oxy]-     copolymers complying with § N,N-bis[2-[[2,4,8,10-             177.1520(c) of this chapter, items tetrakis(1,1-                     1.1, 1.2, 1.3, 2.1, 2.2, or 2.3: dimethylethyl)dibenzo[d,f][1,3,   Provided, That the density of the 2]dioxaphosphepin-6-              olefin polymers complying with items yl]oxy]ethyl]ethanamine (CAS      2.1, 2.2, or 2.3 is not less than Reg. No. 80410-33-9).             0.94 gram per cubic centimeter: And                                   further provided, That the finished                                   polymers contact food only of Types                                   I, II, IV-B, VI-A, VI-B, VII-B, and                                   VIII described in table 1, of §                                   176.170(c) of this chapter, under                                   conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter and food                                   only of Types III, IV-A, V, VI-C, VII-                                   A, 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.Tetrakis [methylene(3,5- di-tert- For use only: butyl-4- hydroxyhydro-           1. At levels not to exceed 0.5 percent cinnamate)] methane (CAS Reg.     by weight of all polymers used as No. 6683-19-8).                   indirect additives in food packaging,                                   except as specified below.                                  2. At levels not to exceed 0.1 percent                                   by weight of petroleum wax or                                   synthetic petroleum wax complying                                   with § 176.170(a)(5) of this                                   chapter.                                  3. At levels not to exceed 1.0 percent                                   by weight of:                                   (a) Pressure sensitive adhesives                                   complying with § 175.125 of this                                   chapter.                                   (b) Can end cement formulations                                   complying with §                                   175.300(b)(3)(xxxi) of this chapter.                                   (c) Petroleum alicyclic hydrocarbon                                   resins complying with §                                   175.320(b)(3) of this chapter, §                                   176.170(b)(2) of this chapter, or                                   their hydrogenated products complying                                   with § 176.170(b)(2) of this                                   chapter.                                   (d) Rosin and rosin derivatives used                                   in accordance with parts 175 through                                   178 of this chapter.                                   (e) Terpene resins complying with                                   § 175.300(b)(2)(xi) of this                                   chapter when such terpene resins are                                   used in accordance with §                                   176.170(b) of this chapter.                                   (f) Resins and polymers complying                                   with § 176.180 of this chapter.                                   (g) Closures with sealing gaskets                                   complying with § 177.1210 of                                   this chapter.                                   (h) Polyoxymethylene copolymer as                                   provided in § 177.2470(b)(1) of                                   this chapter.                                   (i) Petroleum hydrocarbon resin                                   complying with § 178.3800.                                   (j) Reinforced wax complying with                                   § 178.3850.4,4-Thiobis(6-tert-butyl-m-       For use only: cresol).                         1. As provided in §§ 175.105                                   and 177.2600 of this chapter.                                  2. At levels not to exceed 0.25                                   percent by weight of polyethylene                                   complying with § 177.1520 of                                   this chapter: Provided, That the                                   specific gravity of the polyethylene                                   is not less than 0.926: And further                                   provided, That the finished                                   polyethylene contacts food only of                                   the types identified in §                                   176.170(c) of this chapter, table 1,                                   under Categories I, II, VI-B, and                                   VIII.Thiodiethylene bis(3,5-di-tert-   For use only: butyl-4-hydroxyhydrocinnamate)   1. In adhesives complying with § (CAS Reg. No. 41484-35-9).        175.105 of this chapter.                                  2. At levels not to exceed 0.5 percent                                   by weight of pressure-sensitive                                   adhesives complying with §                                   175.125 of this chapter, petroleum                                   alicyclic hydrocarbon resins                                   complying with § 176.170 of this                                   chapter, resins and polymers                                   complying with § 176.180 of this                                   chapter, closures with sealing                                   gaskets complying with §                                   177.1210 of this chapter, and                                   finished rubber products complying                                   with § 177.2600 of this chapter.Thiodipropionic acid............1,3,5-Trimethyl-2,4,6-tris(3,5-   For use only: di-tert-butyl-4-hydroxybenzyl)   1. At levels not to exceed 0.5 percent benzene (CAS Reg. No. 1709-70-    by weight of polymers except nylon 2).                               resins identified in § 177.1500                                   of this chapter.                                  2. At levels not to exceed 1 percent                                   by weight of nylon resins identified                                   in § 177.1500 of this chapter.Tri(mixed mono-and dinonylphenyl) phosphite (which may contain not more than 1 percent by weight of triisopropanolamine)..1, 11-(3, 6, 9-Trioxaundecyl)     For use only as provided in § bis-3-(dodecylthio) propionate    175.300(b)(3)(xxxi) of this chapter (CAS Reg. No. 64253-30-1).        at 4.0 parts per 100 parts rubber.1,3,5-Tris(3,5-di-tert-butyl-4-   For use only: hydroxybenzyl)-s-triazine-       1. At levels not to exceed 0.25 2,4,6(1H,3H,5H)trione (CAS Reg.   percent by weight of polypropylene No. 27676-62-6).                  complying with § 177.1520 of                                   this chapter.                                  2. In polyethylene complying with                                   § 177.1520 of this chapter:                                   (a) At levels not to exceed 0.1                                   weight percent.                                   (b) At levels not to exceed 0.5                                   weight percent in contact with                                   nonfatty food.                                  3. At levels not to exceed 0.5 percent                                   by weight of ethylene-propylene-5-                                   ethylidine-2-norbornene terpolymers                                   complying with § 177.1520 of                                   this chapter. The maximum thickness                                   of such polymers in the form in which                                   they contact food shall not exceed                                   0.005 inch.                                  4. At levels not exceeding 0.1 percent                                   by weight of olefin copolymers                                   complying with § 177.1520(c) of                                   this chapter, items 3.1, 3.2, 3.3,                                   3.4, or 3.5.                                  5. At levels not exceeding 0.25                                   percent by weight of olefin                                   copolymers complying with §                                   177.1520(c) of this chapter, items                                   3.1 and 3.2, and also containing not                                   less than 85 weight percent of                                   polymer units derived from propylene.                                  6. At levels not to exceed 0.2 percent                                   by weight of olefin polymers                                   complying with § 177.1520(c)(4)                                   of this chapter. The finished                                   polymers may be used in contact with                                   food under conditions of use A                                   through H described in table 2 of                                   § 176.170(c) of this chapter.1,3,5-Tris(3,5-di-tert-butyl-4-   For use only in contact with nonfatty hydro-xyhydrocinnamoyl)           foods: hexahydro-s-triazine.            1. At levels not to exceed 0.25                                   percent by weight of polypropylene                                   complying with § 177.1520 of                                   this chapter.                                  2. At levels not to exceed 0.1 percent                                   by weight of polyethylene complying                                   with § 177.1520 of this chapter.                                  3. At levels not to exceed 0.5 percent                                   by weight of ethylene-propylene-5-                                   ethylidine-2-norbornene terpolymers                                   complying with § 177.1520 of                                   this chapter. The maximum thickness                                   of such polymers in the form in which                                   they contact food shall not exceed                                   0.005 inch.1,3,5-Tris(4-tert-butyl-3-        For use only: hydroxy-2,6-dimethylbenzyl)-     1. At levels not to exceed 0.1 percent 1,3,5-triazine-2,4,6-(1H,3H,5H)-  by weight of olefin polymers trione. [CAS Reg. No. 40601-76-   complying with § 177.1520 of 1].                               this chapter, under conditions of use                                   A 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 polystyrene and rubber-                                   modified polystyrene that comply with                                   § 177.1640 of this chapter,                                   provided that the finished                                   polystyrene and rubber-modified                                   polystyrene contact food only under                                   the conditions described in §                                   176.170(c) of this chapter, table 2,                                   under conditions of use E through G.Tris(2,4-di-tert-                 For use only: butylphenyl)phosphite. (CAS      1. At levels not to exceed 0.5 percent Reg. No. 31570-04-4).             by weight of elastomers used in                                   rubber articles complying with §                                   177.2600 of this chapter.                                  2. At levels not to exceed 1 percent                                   by weight of nylon resins complying                                   with § 177.1500 of this chapter:                                   Provided, That the finished polymer                                   contacts food only under conditions                                   of use E, F, and G described in table                                   2 of § 176.170(c) of this                                   chapter.                                  3. At levels not to exceed 0.3 percent                                   by weight of polycarbonate resins                                   complying with § 177.1580 of                                   this chapter.                                  4. At levels not to exceeds 0.2                                   percent by weight of polystyrene and                                   rubber-modified polystyrene polymers                                   complying with § 177.1640 of                                   this chapter: Provided, that the                                   finished polymer contacts food only                                   under conditions of use B, C, D, E,                                   F, G, and H described in table 2 of                                   § 176.170(c) of this chapter.                                  5. At levels not to exceed 0.25                                   percent by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 1.1, 1.2, or 1.3.                                  6. 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, 2.3,                                   3.1(a), 3.1(b), 3.1(c), 3.2(a), or                                   3.2(b). The finished polymers                                   complying with items 2.1, 2.2, or 2.3                                   having a density less than 0.94 gram                                   per cubic centimeter and a thickness                                   greater than 0.051 millimeter (0.002                                   inch), either shall have a level of                                   tris(2,4-di-tert-                                   butylphenyl)phosphite that shall not                                   exceed 0.062 milligram per square                                   inch of food-contact surface or shall                                   contact all food types identified in                                   Table 1 of § 176.170(c) of this                                   chapter only under conditions of use                                   E, F, and G described in Table 2 of                                   § 176.170(c) of this chapter.                                  7. At levels not to exceed 0.2 percent                                   by weight of ethylene-vinyl-acetate                                   copolymers complying with §                                   177.1350 of this chapter, and that                                   are limited to use in contact with                                   food only under conditions of use E,                                   F, and G described in table 2 of                                   § 176.170(c) of this chapter.                                   The average thickness of such                                   polymers in the form in which they                                   contact fatty food shall not exceed                                   0.1 millimeter (0.004 inch).                                  8. At levels not to exceed 0.2 percent                                   by weight of olefin polymers                                   complying with § 177.1520(c) of                                   this chapter, item 4. The finished                                   polymers having a thickness greater                                   than 0.051 millimeter (0.002 inch),                                   shall contact food only under                                   conditions of use E, F, and G                                   described in table 2 of §                                   176.170(c) of this chapter.                                  9. At levels not to exceed 0.5 percent                                   by weight of acrylic and modified                                   acrylic plastics, semirigid and                                   rigid, complying with § 177.1010                                   of this chapter.                                  10. At levels not to exceed 0.1                                   percent by weight of isobutylene                                   polymers complying with §                                   177.1420 of this chapter.                                  11. In adhesives complying with §                                   175.105 of this chapter.                                  12. At levels not to exceed 0.5                                   percent by weight of pressure                                   sensitive adhesives complying with                                   § 175.125 of this chapter.                                  13. 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.                                  14. 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.                                  15. At levels not to exceed 0.5                                   percent by weight of petroleum                                   alicyclic hydrocarbon resins                                   complying with § 175.320(b)(3)                                   of this chapter.                                  16. At levels not to exceed 0.5                                   percent by weight of petroleum                                   alicyclic hydrocarbon resins or their                                   hydrogenated products complying with                                   § 176.170(b) (2) of this                                   chapter.                                  17. At levels not to exceed 0.5                                   percent by weight of resins and                                   polymers complying with §                                   176.180(b) of this chapter.                                  18. At levels not to exceed 0.5                                   percent by weight of rosins and rosin                                   derivatives complying with §                                   176.210(d)(3) of this chapter.                                  19. At levels not to exceed 0.5                                   percent by weight of closures with                                   sealing gaskets complying with §                                   177.1210 of this chapter.                                  20. At levels not to exceed 0.5                                   percent by weight of petroleum                                   hydrocarbon resin, and rosins and                                   rosin derivatives complying with                                   § 178.3800(b).                                  21. At levels not to exceed 0.5                                   percent by weight of reinforced wax                                   complying with § 178.3850.                                  22. At levels not to exceed 0.5                                   percent by weight of olefin                                   copolymers complying with §                                   177.1520(c) of this chapter, item                                   3.3. The finished polymers may be                                   used in contact with food under                                   conditions of use A through H                                   described in table 2 of §                                   176.170(c) of this chapter.                                  23. At levels not to exceed 0.15                                   percent by weight of poly-1-butene                                   resins and butene/ethylene copolymers                                   complying with § 177.1570 of                                   this chapter: Provided, that the                                   finished polymer contacts food only                                   under conditions of use B through H                                   described in table 2 of §                                   176.170(c) of this chapter.Tris(2-methyl-4-hydroxy-5-tert-   For use only: butylphenyl)butane (CAS Reg.     1. At levels not to exceed 0.25 No. 1843-03-4).                   percent by weight of polymers used as                                   provided in § 176.180 of this                                   chapter.                                  2. At levels not to exceed 0.25                                   percent by weight of the following                                   polymers when used in articles that                                   contact food of Types I, II, IV-B, VI-                                   B, VII-B, and VIII described in table                                   1 of § 176.170(c) of this                                   chapter: 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; vinyl                                   chloride polymers; and/or vinyl                                   chloride copolymers complying with                                   § 177.1980 of this chapter.                                  3. At levels not to exceed 0.1 percent                                   by weight of the following polymers                                   when used in articles that contact                                   food of Types III, IV-A, V, VI-A, VI-                                   C, VII-A, and IX described in table 1                                   of § 176.170(c) of this chapter:                                   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; vinyl chloride                                   polymers; and/or vinyl chloride                                   copolymers complying with §                                   177.1980 of this chapter.                                  4. As provided in § 175.105 of                                   this chapter.                                  5. At levels not to exceed 0.2 percent                                   by weight of polystyrene and/or                                   modified polystyrene polymers                                   identified in § 177.1640 of this                                   chapter.                                  6. At levels not to exceed 0.25                                   percent by weight of acrylonitrile-                                   butadiene-styrene copolymers used in                                   contact with nonalcoholic foods.                                  7. At levels not to exceed 1 percent                                   by weight of closure-sealing gasket                                   compositions complying with §                                   177.1210(b) of this chapter.Zinc dibutyldithiocarbamate (CAS  For use only: Reg. No. 136-23-2).              1. At levels not to exceed 0.2 percent                                   by weight of isobutyleneisoprene                                   copolymers complying with §                                   177.1420 of this chapter: Provided,                                   That the finished copolymers contact                                   food only of the types identified in                                   § 176.170(c) of this chapter,                                   table 1, under Types V, VII, VIII,                                   and IX.                                  2. At levels not to exceed 0.02                                   percent by weight of polypropylene                                   polymers complying with §                                   177.1520(c), item 1.1 of this                                   chapter.Zinc palmitate..................Zinc salicylate.................  For use only in rigid polyvinyl                                   chloride and/or in rigid vinyl                                   chloride copolymers complying with                                   § 177.1980 of this chapter:                                   Provided, That total salicylates                                   (calculated as the acid) do not                                   exceed 0.3 percent by weight of such                                   polymers.Zinc stearate...................------------------------------------------------------------------------\1\ Copies are available from the American Society for Testing and  Materials, 1916 Race Street, Philadelphia, Pa. 19103.

[42 FR 14609, Mar. 15, 1977]

Editorial Note:  For Federal Register citations affecting §178.2010, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 178.2550   4-Hydroxymethyl-2,6-di-tert-butylphenol.

4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an antioxidant in articles intended for use in contact with food, in accordance with the following prescribed conditions:

(a) The additive has a solidification point of 140°–141 °C.

(b) The concentration of the additive and any other permitted antioxidants in the finished food-contact article does not exceed a total of 0.5 milligram per square inch of food-contact surface.

§ 178.2650   Organotin stabilizers in vinyl chloride plastics.

The organotin chemicals identified in paragraph (a) of this section may be safety used alone or in combination, at levels not to exceed a total of 3 parts per hundred of resin, as stabilizers in vinyl chloride homopolymers and copolymers complying with the provisions of §177.1950 or §177.1980 of this chapter and that are identified for use in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in table 1 of §176.170(c) of this chapter, except for the organotin chemical identified in paragraph (a)(3) of this section, which may be used in contact with food of types I through IX at temperatures not exceeding 75 °C (167 °F), and further that the organotin chemicals identified in paragraphs (a) (5) and (6) of this section may be used in contact with food of types I through IX at temperatures not exceeding 66 °C (150 °F), conditions of use D through G described in table 2 of §176.170(c) of this chapter, and further that dodecyltin chemicals identified in paragraph (a)(7) of this section which may be used in contact with food of types I, II, III, IV (except liquid milk), V, VI (except malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX described in table 1 of §176.170(c) of this chapter at temperatures not exceeding 71 °C (160 °F), in accordance with the following prescribed conditions:

(a) For the purpose of this section, the organotin chemicals are those listed in paragraphs (a) (1), (2), (3), (4), (5), (6), and (7) of this section.

(1) Di(n-octyl)tin S,S′-bis(isooctylmercaptoacetate) is an octyltin chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having 8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di(n-octyl)tin dichloride or di(n-octyl)tin oxide. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. Di(n-octyl)tin dichloride has an organotin composition that is not less than 95 percent by weight of di(n-octyl)tin dichloride and not more than 5 percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tin oxide has an organotin composition that is not less than 95 percent by weight of di(n-octyl)tin oxide and not more than 5 percent by weight of bis[tri(n-octyl)tin] oxide, and/or mono n-octyltin oxide.

(2) Di(n-octyl) tin maleate polymer is an octyltin chemical having the formula [(C8H17)2SnC4H2O4]n (where n is between 2 and 4 inclusive), having 25.2 to 26.6 percent by weight of tin (Sn) and having a saponification number of 225 to 255. It is made from di(n-octyl)tin dichloride or di(n-octyl)tin oxide meeting the specifications prescribed for di(n-octyl) tin dichloride or di(n-octyl) tin oxide in paragraph (a)(1) of this section.

(3) C10-16-Alkyl mercaptoacetates reaction products with dichlorodioctylstannane and trichlorooctylstannane (CAS Reg. No. 83447–69–2) is an organotin chemical mixture having 10.8 to 11.8 percent by weight of tin (Sn) and having 8.0 to 8.6 percent by weight of mercapto sulfur. It is made from a mixture of di(n-octyl)tin dichloride and (n-octyl)tin trichloride which has an organotin composition that is not less than 95 percent by weight di(n-octyl)tin dichloride/(n-octyl)tin trichloride, and not more than 1.5 percent by weight of tri(n-octyl)tin chloride. The alkyl radical in the mercaptoacetate is derived from a mixture of saturated n-alcohols which has a composition that is not less than 50 percent by weight tetradecyl alcohol, and that is not more than 50 percent by weight total of decyl alcohol and/or dodecyl alcohol, and/or hexadecyl alcohol.

(4) (n-Octyl)tin S,S′S″ tris(isooctyl-mercaptoacetate) is an octyltin chemical having the formula n-C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No. 26401–86–5) having 13.4 to 14.8 percent by weight of tin (Sn) and having 10.9 to 11.9 percent by weight of mercapto sulfur. It is made from (n-octyl)tin trichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. The (n-octyl)tin trichloride has an organotin composition that is not less than 95 percent by weight of (n-octyl)tin trichloride and not more than 5 percent by weight of tri(n-octyl)tin chloride.

(5) Bis(beta-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) (CAS Reg. No. 63397–60–4) is an estertin chemical having 14.0 to 15.0 percent by weight of tin (Sn) and having 7.5 to 8.5 percent by weight of mercapto sulfur. It is made from bis(beta-carbobutoxyethyl)tin dichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols. The bis(beta-carbobutoxyethyl)tin dichloride has an organotin composition that is not less than 95 percent by weight of bis(beta-carbobutoxyethyl)tin dichloride and not more than 5 percent by weight of bis(beta-carbobutoxyethyltin trichloride. The triestertin chloride content of bis(beta-carbobutoxyethyltin) dichloride shall not exceed 0.02 percent. p

(6) Beta-carbobutoxyethyltin tris(isooctylmercaptoacetate) (CAS Reg. No. 63438–80–2) is an estertin chemical having 13.0 to 14.0 percent by weight of tin (Sn) and having 10.5 to 11.5 percent by weight of mercapto sulfur. It is made from beta-carbobutoxyethyltin trichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohol. The beta-carbobutoxyethyltin trichloride has an organotin composition that is not less than 95 percent by weight of beta-carbobutoxyethyltin trichloride and not more than 5 percent total of triestertin chloride and diestertin chloride.

(7) The dodecyltin stabilizer is a mixture of 50 to 60 percent by weight of n-dodecyltin S,S′,S″-tris(isooctylmercaptoacetate) (CAS Reg. No. 67649–65–4) and 40 to 50 percent by weight of di(n-dodecyl)tin S,S′-di(isooctylmercaptoacetate) (CAS Reg. No. 84030–61–5) having 13 to 14 percent by weight of tin (Sn) and having 8 to 9 percent by weight of mercapto sulfur. It is made from a mixture of dodecyltin trichloride and di(dodecyl)tin dichloride which has not more than 0.2 percent by weight of dodecyltin trichloride, not more than 2 percent by weight of dodecylbutyltin dichloride and not more than 3 percent by weight of tri(dodecyl)tin chloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols.

(b) The vinyl chloride plastic containers, film or panels in the finished form in which they are to contact food, shall meet the following limitations:

(1) The finished plastics intended for contact with foods of the types listed in this section shall be extracted with the solvent or solvents characterizing those types of foods as determined from table 2 of §176.170(c) of this chapter at the temperature reflecting the conditions of intended use as determined therein. Additionally, extraction tests for acidic foods shall be included and simulated by 3-percent acetic acid at temperatures specified for water in table 2 of §176.170(c) of this chapter. The extraction tests shall cover at least three equilibrium periodic determinations, as follows:

(i) The exposure time for the first determination shall be at least 72 hours for aqueous solvents, and at least 6 hours for heptane.

(ii) Subsequent determinations shall be at a minimum of 24-hour intervals for aqueous solvents, and 2-hour intervals for heptane. These tests shall yield total octylin stabilizers not to exceed 0.5 parts per million as determined by analytical method entitled “Atomic Absorption Spectrometric Determination of Sub-part-per-Million Quantities of Tin in Extracts and Biological Materials with Graphite Furnace,” Analytical Chemistry, Vol. 49, p. 1090–1093 (1977), 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/federal_register/code_of_federal_regulations/ibr_locations.php.

(iii) Subsequent determinations for the dodecyltin mixture described in paragraph (a)(7) of this section shall be at a minimum of 24-hour intervals for aqueous solvents and 2-hour intervals for heptane. These tests shall yield di(n-octyl)tin S,S′-bis(isooctylmercaptoacetate), or di(n-octyl)tin maleate polymer, or (C10-C16)-alkylmercaptoacetate reaction products with dichlorodioctylstannane and trichlorooctylstannane, or n-octyltin S,S′,S″-tris(isooctylmercaptoacetate), tris(isooctylmercaptoacetate) and di(n-dodecyl)tin bis(isooctylmercaptoacetate) or any combination thereof, not to exceed 0.5 parts per million as determined by an analytical method entitled “Atomic Absorption Spectrophotometric Determination of Sub-part-per-Million Quantities of Tin in Extracts and Biological Materials with Graphite Furnace,” Analytical Chemistry, Vol. 49, pp. 1090–1093 (1977), which is incorporated by reference in accordance with 5 U.S.C. 552(a). The availability of this incorporation by reference is given in paragraph (b)(1)(ii) of this section.

(2) In lieu of the tests prescribed in paragraph (b) (1) of this section, the finished plastics intended for contact with foods only of Types II, V, VI-A (except malt beverages), and VI-C may be end-tested with food-simulating solvents, under conditions of time and temperature, as specified below, whereby such tests shall yield the octyltin residues cited in paragraph (b)(1) of this section not in excess of 0.5 ppm:

 ------------------------------------------------------------------------                                                             Temperature                         Food-simulating solvent     Time      (degrees                                                    (hours)  Fahrenheit)------------------------------------------------------------------------Type II...............  Acetic acid, 3 pct.......        48         135Type V................  Heptane..................         2         100Type VI-A.............  Ethyl alcohol, 8 pct.....        24         120Type VI-C.............  Ethyl alcohol, 50 percent        24         120------------------------------------------------------------------------

[42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; 54 FR 24898, June 12, 1989]

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