The Use of ETHANOX and ETHAPHOS Antioxidants in FDA Regulated Applications

Transcription

1 The Use of ETHANOX and ETHAPHOS Antioxidants in FDA Regulated Applications

2 TABLE OF CONTENTS The Use of ETHANOX AND ETHAPHOS Antioxidants in FDA Regulated Applications... 1 Part Indirect Food Additives: Adhesive Components of Coatings Subpart B - Substances for Use Only as Components of Adhesives Sec Adhesives... 1 Part Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers Subpart C - Antioxidants and Stabilizers Sec Antioxidants and/or stabilizers for polymers... 2 Page Subpart D - Certain Adjuvants and Production Aids Sec Lubricants with incidental food contact... 5 CHARTS Page Chart 1 ETHANOX Chart 2 ETHANOX Chart 3 ETHANOX Chart 4 ETHANOX Chart 5 ETHANOX Chart 6 ETHAPHOS

3 The Use of ETHANOX and ETHAPHOS Antioxidants in FDA Regulated Applications ETHANOX 310, 314, 330, 376, 702 and ETHAPHOS 368 Antioxidants have broad acceptance in applications regulated by the Food and Drug Administration (FDA) PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS Subpart B--Substances for Use Only as Components of Adhesives Sec Adhesives. (a) Adhesives may be safely used as components of articles intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions: (1)The adhesive is prepared from one or more of the optional substances named in paragraph (c) of this section, subject to any prescribed limitations. (2)The adhesive is either separated from the food by a functional barrier or used subject to the following additional limitations: (i) In dry foods. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice. (ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice. (b) Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation. (b) To assure safe usage of adhesives, the label of the finished adhesive container shall bear the statement ``food-packaging adhesive.'' (c) Subject to any limitation prescribed in this section and in any other regulation promulgated under section 409 of the Act which prescribes safe conditions of use for substances that may be employed as constituents of adhesives, the optional substances used in the formulation of adhesives may include the following: (1)Substances generally recognized as safe for use in food or food packaging. (2) Substances permitted for use in adhesives by prior sanction or approval and employed under the specific conditions of use prescribed by such sanction or approval. (3)Flavoring substances permitted for use in food by regulations in this part, provided that such flavoring substances are volatilized from the adhesives during the packaging fabrication process. (4) Color additives approved for use in food. (5) Substances permitted for use in adhesives by other regulations in this subchapter and substances named in this subparagraph, provided, however, that any substance named in this paragraph and covered by a specific regulation in this subchapter, must meet any specifications in such regulation. ETHANOX 310 Antioxidant Tetrakis [methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] methane (CAS Reg. No ). ETHANOX 314 Antioxidant 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-triazine- 2,4,6(1H,3H,5H)trione (CAS Reg. No ). ETHANOX 376 Antioxidant Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No ). ETHANOX 702 Antioxidant 4,4'-Methylenebis (2,6-di-tert-butyl-phenol). (CAS Reg. NO ) 1

4 PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS Subpart C--Antioxidants and Stabilizers Sec 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: ETHANOX 310 Antioxidant Tetrakis [methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)] methane (CAS Reg. No ). For use only: 1. At levels not to exceed 0.5 percent by weight of all polymers used as 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 Sec (a)(5) of 3. At levels not to exceed 1.0 percent by weight of: (a) Pressure sensitive adhesives complying with Sec of (b)can end cement formulations complying with Sec (b)(3)(xxxi) of (c) Petroleum alicyclic hydrocarbon resins complying with Sec (b)(3) of this chapter, Sec (b)(2) of this chapter, or their hydrogenated products complying with Sec (b)(2) of (d)rosin and rosin derivatives used in accordance with parts 175 through 178 of (e) Terpene resins complying with Sec (b)(2)(xi) of this chapter when such terpene resins are used in accordance with Sec (b) of (f) Resins and polymers complying with Sec of (g) Closures with sealing gaskets complying with Sec of (h) Polyoxymethylene copolymer as provided in Sec (b)(1) of (i) Petroleum hydrocarbon resin complying with Sec (j) Reinforced wax complying with Sec ETHANOX 314 Antioxidant 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-triazine- 2,4,6(1H,3H,5H)trione (CAS Reg. No ). For use only: 1. At levels not to exceed 0.25 percent by weight of polypropylene complying with Sec of 2. In polyethylene complying with Sec 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 Sec of this chapter. The maximum thickness of such polymers in the form in which they contact food shall not exceed inch. 4. At levels not exceeding 0.1 percent by weight of olefin copolymers complying with Sec (c) of this chapter, items 3.1, 3.2, 3.3, 3.4, or At levels not exceeding 0.25 percent by weight of olefin copolymers complying with Sec (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 Sec (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 Sec (c) of ETHANOX 330 Antioxidant 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4-hydroxybenzyl) benzene (CAS Reg. No ). For use only: 1. At levels not to exceed 0.5 percent by weight of polymers except nylon resins identified in Sec of 2. At levels not to exceed 1 percent by weight of nylon resins identified in Sec of 2

5 ETHANOX 376 Antioxidant Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No ). For use only: 1. At levels not exceeding 0.25 percent by weight of olefin polymers complying with Sec (c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or As provided in Secs and (a)(5) of 3. At levels not exceeding 0.25 percent by weight of polystyrene and/or rubber-modified polystyrene polymers complying with Sec 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 Sec of 5. At levels not exceeding 0.25 percent by weight of olefin copolymers complying with Sec (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 Sec (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 Sec (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 Sec 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 Sec and that contact food only under conditions of use E, F, and G described in table 2, Sec (c) of 9. At levels not exceeding 0.1 percent by weight of ethylene-vinyl acetate copolymers complying with Sec of 10. At levels not to exceed 0.2 percent by weight of nitrile rubber-modified acrylonitrile-methyl acrylate copolymers that comply with Sec of this chapter when used in articles that contact food only under conditions of use D, E, F, and G described in table 2, Sec (c) of 11. At levels not exceeding 0.3 percent by weight of styrene block polymers complying with Sec of this chapter when used in articles that contact food only of the types identified in Sec (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 Sec (c) of 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 18 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 percent by weight of chlorinated isobutylene-isoprene copolymers complying with Sec (a)(3) of 14. At levels not exceeding 0.5 percent by weight of the finished rubber article complying with Sec of ETHANOX 702 Antioxidant 4,4'-Methylenebis (2,6-di-tert-butyl-phenol). (CAS Reg. NO For use only: 1. As provided in Sec of polymers complying with Sec (c) of this 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 Sec of 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 Sec of 4. At levels not to exceed 0.5 percent by weight of polyethylene complying with Sec 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, Sec (c) of 5. At levels not to exceed 0.5 percent by weight of polybutadiene used in rubber articles complying with Sec 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, Sec (c) of 3

6 ETHAPHOS 368 Antioxidant Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. No ). For use only: 1. At levels not to exceed 0.5 percent by weight of elastomers used in rubber articles complying with Sec of 2. At levels not to exceed 1 percent by weight of nylon resins complying with Sec of this chapter: Provided, That the finished polymer contacts food only under conditions of use E, F, and G described in table 2 of Sec (c) of 3. At levels not to exceed 0.3 percent by weight of polycarbonate resins complying with Sec of 4. At levels not to exceeds 0.2 percent by weight of polystyrene and rubber-modified polystyrene polymers complying with Sec 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 Sec (c) of 5. At levels not to exceed 0.25 percent by weight of olefin polymers complying with Sec (c) of this chapter, item 1.1, 1.2, or At levels not to exceed 0.2 percent by weight of olefin polymers complying with Sec (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 millimeter (0.002 inch), either shall have a level of tris(2,4-di-tert- butylphenyl)phosphite that shall not exceed milligram per square inch of food-contact surface or shall contact all food types identified in Table 1 of Sec (c) of this chapter only under conditions of use E, F, and G described in Table 2 of Sec (c) of 7. At levels not to exceed 0.2 percent by weight of ethylene-vinyl-acetate copolymers complying with Sec 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 Sec (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 Sec (c) of this chapter, item 4. The finished polymers having a thickness greater than millimeter (0.002 inch), shall contact food only under conditions of use E, F, and G described in table 2 of Sec (c) of 9. At levels not to exceed 0.5 percent by weight of acrylic and modified acrylic plastics, semirigid and rigid, complying with Sec of 10. At levels not to exceed 0.1 percent by weight of isobutylene polymers complying with Sec of 11. In adhesives complying with Sec of 12. At levels not to exceed 0.5 percent by weight of pressure sensitive adhesives complying with Sec of 13. At levels not to exceed 0.5 percent by weight of can end cement formulations complying with Sec (b)(3) (xxxi) of 14. At levels not to exceed 0.5 percent by weight of side seam cement formulations complying with Sec (b)(3) (xxxii) of 15. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins complying with Sec (b)(3) of 16. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hydrocarbon resins or their hydrogenated products complying with Sec (b)(2) of 17. At levels not to exceed 0.5 percent by weight of resins and polymers complying with Sec (b) of this chapter. 18. At levels not to exceed 0.5 percent by weight of rosins and rosin derivatives complying with Sec (d)(3) of 19. At levels not to exceed 0.5 percent by weight of closures with sealing gaskets complying with Sec of 20. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon resin, and rosins and rosin derivatives complying with Sec (b). 21. At levels not to exceed 0.5 percent by weight of reinforced wax complying with Sec At levels not to exceed 0.5 percent by weight of olefin copolymers complying with Sec (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 Sec (c) of 23. At levels not to exceed 0.15 percent by weight of poly-1-butene resins and butene/ethylene copolymers complying with Sec of this chapter: Provided, that the finished polymer contacts food only under conditions of use B through H described in table 2 of Sec (c) of 4

7 PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS Subpart D--Certain Adjuvants and Production Aids Sec Lubricants with incidental food contact. Lubricants with incidental food contact may be safely used on machinery used for producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section: (a) The lubricants are prepared from one or more of the following substances: (1) Substances generally recognized as safe for use in food. (2) Substances used in accordance with the provisions of a prior sanction or approval. (3) Substances identified in this paragraph (a)(3). ETHANOX 310 Antioxidant Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]methane (CAS Reg. No ). For use only as an antioxidant in lubricants at a level not to exceed 0.5 percent by weight of the lubricant. ETHAPHOS 368 Antioxidant Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO ). For use only as a stabilizer at levels not to exceed 0.5 percent by weight of the lubricant. 5

8 Chart 1 ETHANOX 310 Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydrocinnamate)]methane In all polymers used as indirect 0.5% no restrictions no restrictions no restrictions additives in food packaging In petroleum wax or synthetic 0.1% no restrictions no restrictions no restrictions petroleum wax complying with (a) (5) In pressure sensitive adhesives 1.0% no restrictions no restrictions no restrictions complying with In can end cement formulations 1.0% no restrictions no restrictions no restrictions complying with (b) (3) (xxxi) In petroleum alicyclic 1.0% no restrictions no restrictions no restrictions hydrocarbon resins complying with (b) (3) and (b) (2) or their hydrogenated products complying with (b) (2) In rosin and rosin derivatives used 1.0% no restrictions no restrictions no restrictions in accordance with parts 175 through 178 In terpene resins complying with 1.0% no restrictions no restrictions no restrictions (b) (2) (xi) when used in accordance with (b) In resins and polymers complying 1.0% no restrictions no restrictions no restrictions with In closures with sealing gaskets 1.0% no restrictions no restrictions no restrictions complying with In polyoxymethylene copolymer 1.0% no restrictions no restrictions no restrictions as provided in (b) (1) In petroleum hydrocarbon resin 1.0% no restrictions no restrictions no restrictions complying with In reinforced wax complying with 1.0% no restrictions no restrictions no restrictions FDA Approvals for Indirect Food Contact (see CFR for full wording) In lubricants for use only as an 0.5% no restrictions no restrictions no restrictions antioxidant complying with FDA Approvals for Indirect Food Contact (see CFR for full wording) In adhesives complying with Not to exceed no restrictions no restrictions no restrictions limits of good manufacturing practice 6

9 Chart 2 ETHANOX 314 1,3,5-Tris-(3,5-di-tert-butyl-4-hydroxybenzyl)-s-triazine-2,4,6(1H,3H,5H)trione In polypropylene complying 0.25% no restrictions no restrictions no restrictions with In polyethylene complying with 0.1% no restrictions no restrictions no restrictions % no restrictions nonfatty foods no restrictions In ethylene-propylene-5-0.5% 5 mils no restrictions on no restrictions ethylidine-2-norbornene polymers terpolymers complying with allowed In olefin copolymers complying 0.1% no restrictions no restrictions no restrictions with (c), items 3.1, 3.2, 3.3, 3.4 or 3.5 In olefin copolymers complying 0.25% no restrictions no restrictions no restrictions with (c), item 3.1 and 3.2, and also containing not less than 85 weight % of polymer units derived from propylene In olefin polymers complying 0.2% no restrictions no restrictions A - H of with (c) (4) table 2 FDA Approvals for Indirect Food Contact (see CFR for full wording) In adhesives complying with Not to exceed no restrictions no restrictions no restrictions limits of good manufacturing practice Chart 3 ETHANOX 330 1, 3, 5-Trimethyl-2, 4, 6-tris (3, 5-di-tert-butyl-4-hydroxybenzyl) benzene In polymers except nylon 0.5% no restrictions no restrictions no restrictions resins identified in In nylon resins identified 1.0% no restrictions no restrictions no restrictions in

10 Chart 4 ETHANOX 376 Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate In olefin polymers complying 0.25% no restrictions no restrictions no restrictions with (c), item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 In adhesives complying with no restrictions no restrictions no restrictions no restrictions In semi-rigid and rigid acrylic and.01% no restrictions no restrictions no restrictions modified acrylic plastics complying with (a) (5) 0.2% no restrictions up to 15% alcohol no restrictions In polystyrene and/or rubber-modified 0.25% no restrictions no restrictions no restrictions polystyrene complying with , except that the finished basic rubbermodified polystyrene polymers in contact with fatty foods shall contain not less than 85 weight % of total polymer units derived from styrene monomer. In acrylonitrile-butadiene-styrene 0.5% no restrictions no restrictions no restrictions copolymers used in accordance with prior sanction or regulations in parts and In olefin copolymers complying 0.25% no restrictions I, II, III, IV-B, no restrictions with (c), item 3.4 VI, VII, VIII, and IX of table 1 In olefin copolymers complying 0.25% no restrictions nonfatty foods no restrictions with (c), item 3.5 in I, II, IV-B, VI, VII-B, and VIII, of table 1 In modified semi-rigid and rigid 0.05% no restrictions no restrictions no restrictions vinylchloride plastics modified with methacrylate-butadienestyrenecopolymers in accordance with In rigid polyvinyl chloride 0.2% no restrictions no restrictions no restrictions In polycarbonate resins complying 0.3% no restrictions no restrictions E, F and G of with table 2 In ethylene-vinyl acetate copolymers 0.1% no restrictions no restrictions no restrictions complying with

11 Chart 4 ETHANOX 376 (continued) Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate In nitrile rubber-modified 0.2% no restrictions no restrictions D - G of acrylonitrile-methyl acrylate copolymers complying with table 2 In styrene block polymers 0.3% no restrictions foods in I, II, D - G of complying with IV-B, VI, VII-B, VIII, of table 2 table 1 In vinylidene chloride 0.2% no restrictions no restrictions no restrictions homopolymers and/or vinylidene chloride copolymers complying with regulations in Parts 175, 176, 177, 179, and 181. The vinylidene chloride copolymers shall contain not less than 50 weight % of total polymer units derived from vinylidene chloride. In chlorinated isobutylene % no restrictions no restrictions no restrictions isoprene copolymers complying with (a) (3) In finished rubber article 0.5% no restrictions no restrictions no restrictions complying with FDA Approvals for Indirect Food Contact (see CFR for full wording) In adhesives complying with Not to exceed no restrictions nonfatty foods no restrictions limits of good manufacturing practice 9

12 Chart 5 ETHANOX 702 4, 4 -Methylenebis (2,6-di-tert-butyl-phenol) In adhesives complying with no restrictions no restrictions no restrictions no restrictions In petroleum hydrocarbon resins 0.25% no restrictions no restrictions no restrictions complying with parts , and In terpene resins complying with 0.25% no restrictions no restrictions no restrictions parts and In polyethylene complying 0.5% no restrictions foods in I, II, no restrictions with IV-B, VI, VII-B, and VIII of table 1 In polybutadiene used in rubber 0.5% no restrictions foods in I, II, no restrictions articles complying with IV-B, VI, VII-B, and VIII of table 1 FDA Approvals for Indirect Food Contact (see CFR for full wording) In adhesives complying with Not to exceed no restrictions no restrictions no restrictions limits of good manufacturing practice 10

13 Chart 6 ETHAPHOS 368 Tris(2,4-di-tert-butylphenyl) phosphite In elastomers used in rubber 0.5% no restrictions no restrictions no restrictions articles complying with In nylon resins complying 1.0% no restrictions no restrictions E, F and G of with table 2 In polycarbonate resins 0.3% no restrictions no restrictions no restrictions complying with In polystyrene and rubber- 0.2% no restrictions no restrictions B - H of modified polystyrene complying with table 2 In olefin polymers complying 0.25% no restrictions no restrictions no restrictions with (c), item 1.1, 1.2, or 1.3 In olefin polymers complying 0.2% no restrictions no restrictions no restrictions with (c), item 2.1, 2.2 or 2.3, where the density of the polymers is 0.94 g/cc 0.2% 2 mil no restrictions no restrictions 0.2% > 2 mil no restrictions no restrictions In olefin polymers complying mg/in 2 with (c), item 2.1, food contact 2.2 or 2.3, where the density surface of the polymers is <0.94 g/cc 0.2% > 2 mil no restrictions E, F and G of > mg/in 2 food contact table 2 surface In olefin copolymers complying 0.2% no restrictions no restrictions no restrictions with (c), item 3.1 or % no restrictions aqueous, E, F and G of In ethylene-vinyl-acetate acidic and copolymers complying alcoholic foods table 2 with % 4 mil fatty foods E, F and G of table 2 0.2% 2 mil no restrictions no restrictions In olefin polymers complying with (c), item 4 0.2% > 2 mil no restrictions E, F and G of table 2 In acrylic and modified acrylic plastics, 0.5% no restrictions no restrictions no restrictions semi-rigid and rigid, complying with

14 Chart 6 ETHAPHOS 368 (continued) Tris(2,4-di-tert-butylphenyl) phosphite In isobutylene polymers 0.1% no restrictions no restrictions no restrictions complying with In adhesives complying with no restrictions no restrictions no restrictions no restrictions In pressure sensitive adhesives 0.5% no restrictions no restrictions no restrictions complying with In can end cement formulations 0.5% no restrictions no restrictions no restrictions complying with (b) (3) (xxxi) In side seam cement formulations 0.5% no restrictions no restrictions no restrictions complying with (b) (3) (xxxii) In petroleum alicyclic hydrocarbon resins 0.5% no restrictions no restrictions no restrictions complying with (b) (3) In petroleum alicyclic hydrocarbon 0.5% no restrictions no restrictions no restrictions resins or their hydrogenated products complying with (b) (2) In resins and polymers 0.5% no restrictions no restrictions no restrictions complying with (b) In rosins and rosin derivatives 0.5% no restrictions no restrictions no restrictions complying with (d) (3) In closures with sealing gaskets 0.5% no restrictions no restrictions no restrictions complying with In petroleum hydrocarbon resin, 0.5% no restrictions no restrictions no restrictions and rosins and rosin derivatives complying with (b) In reinforced wax complying 0.5% no restrictions no restrictions no restrictions with In olefin copolymers complying 0.5% no restrictions no restrictions A - H of with (c), item 3.3 table 2 In poly-1-butene resins and 0.15% no restrictions no restrictions B - H of butene/ethylene copolymers complying with table 2 FDA Approvals for Indirect Food Contact (see CFR for full wording) In lubricant for use only as a 0.5% no restrictions no restrictions no restrictions stabilizer complying with

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