Document LmxDR1JJw4YLmr8m1qwNkVqq

TENNECOINTER-OFFICE MEMO CHEMICALS, INC To H. B. Carr AT Piscataway Date July 16, 1975 From Subject J.W. Poarch AT Burlington CIBA-CEIGY ANTIOXIDANTS - Irganox 1010 & 1076 Copy to P,A, Lobo R.S. Miller W. Miringoff A.C, Siegel (?.G. Thompson /File R&D is presently evaluating the above antioxidants (Reference J.W,P. to R.S. Miller dated May 15, 1975) for the purpose of preventing color development during stripping. In addition to this use there is a possible application as a short-stop on the higher molecular weight homopolymer resins. The question of FDA approval must be answered if these antioxidants are ever to be used in production of resins for food contact applications. Please evaluate the enclosed list of FDA approvals which CIBA-GEIGY has already obtained to determine if we can fit into any of the categories,or do we need to have a separate approval. Attachment ) JWP/gs Poarch COLORITE 011285 FDA STATUS OF CIBA-GEIGY STABILIZERS JULY. 1973 I. Existing Approvals ~ 1. IRGANOX 1010 A. Olefin polymers, excluding EPDM (121.2566/121.2501) max. con. - 0.5% max. thickness - no restrictions food limitations - no restrictions B. Ethylene-methacrylic acid copolymers (121.2566/121.2582) * dlSs; 5# 8 jit? is;,Eo*o O !t?Qn 0.10 e\i max. cone. - 0.05% max. thickness - 5 mil food limitations - no restrictions max. cone. - 0.5% max. thickness - no restrictions food limitations - nonalcoholic food only C. Ethylene-acrylic acid copolymers (121.2566/121.2564) LU 1 O5 Jr 1 <s CO 1 OI So 3>o- *> -- LU Z rt Sffl -SAo} " (same as "B" above) D. Adhesives (121.2520) max. cone. - no restrictions max. thickness - no restrictions food limitations - no restrictions E. Isobutylene Polymers (121.2566/212.2590) max. cone. - 0.5% max thickness - no restrictions food limitations - nonalcoholic food only F. Ethylene-vinyl acetate copolymers (121.2566/121.2570) (same as "E" above) G. Polystyrene and rubber-modified polystyrene (121.2566/121.2510) (same as "E" above) H. Styrene-butadiene copolymers (used in compliance with regula tions in Subpart F of CFR 121, i.e., SBR is not approved under one Section as are most polymers) (same as "E" above) COLORITE 011286 2- - 2. IRGANOX 1076 A. Olefin polymers, excluding EPDM (121.2566/121.2501) a. non-fatty foods max. cone. - 0.252 max. thickness - no restrictions b. fatty foods the percentage concentration of IRGANOX 1076 multiplied by the thickness in inches of the finished olefin polymer shall not exceed a factor of 0.0025, except that concentrations of 0.05 percent or less may be used without limitation on thickness. B. Polystyrene and rubber-modified polystyrene (121.2566/121.2510) max. cone. - 0.25% max. thickness - no restrictions food limitations - none, except when used in rubber-modified polystyrene with fatty foods, the polymer must contain at least 85% styrene. C. Adhesives (121.2520) max. cone. - no restrictions max. thickness - no restrictions food limitations - no restrictions *3. IRGANOX 1035 Adhesives (121.2520) max. cone. - no restrictions max. thickness - no restrictions food limitations - no restrictions 4. TINUVIN P A. Acrylics, rigid, semirigid and modified (121.2566/121.2591) max. cone. - no restrictions max. thickness -- no restrictions food limitations - no restrictions __ - pa B. Rigid vinyl and vinyl chloride copolymers (121.2566/121.2521) New Addition max. cone. - 0.25% max. thickness - no restrictions food limitations - no restrictions COLORITE 011287 t -3- C. Polystyrene (121.2566/2510) max. cone. - no restrictions Bax. thickness - no restrictions food limitations - dry foods with the surface haying no free fat or oil and Polystyrene and modified polystyrene containing less than 10% rubber (121.2566/2510) max. cone. - 0.25% max. thickness * no restrictions food limitations - nonalcoholic food only 5. TINVUIN 326 Olefin polymers, including EPEM (121.2566/2501) max. cone. - 0.5% max. thickness - no restrictions food limitations - non-fatty foods, food with less than 8% alcohol 6. TINUVIN 328 Adhesives (121.2520) max. cone. - no restrictions max. thickness - no restrictions food limitations - no restrictions II. FDA Opinions in Effect TINUVIN 327 may be used at levels up to 0.5% in polypropylene slit film and related materials in applications involving contact with dry foods containing no free fat or oil. IKGASTAB 2002 may be used at a maximum level of 1.0% in polyolefin films used for holding or transporting dry foodstuffs. Mote: In addition to the use of these stabilizers in the Sections cited above, their use is also permitted in other Sections where the above polymers have further sanctioning. For example, IRGANOX 1010 may be used as a component of polymers under 121.2514 - "Resinous and Polymeric Coatings" and in 121.2526 - "Components of Paper and Paperboard in Contact with Aqueous and Fatty Foods", as long as (1) the polymer is approved, (2) IRGANOX 1010 is approved for use in that polymer and (3) IRGANOX 1010 is used in accordance with 121.2566. UHB:lcj 7/18/73 COLORXTE 011288