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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR number 2015-002

Threshold of Regulation Exemptions are generally applicable and are effective for the food contact substance (FCS) for the listed intended use regardless of manufacturer or supplier.
Food Contact Substance: octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate (CAS Reg. No. 2082-79-3)
Use Limitations*: For use as an antioxidant/stabilizer at a maximum use level of 0.3% by weight of the polymer in polymers of dimethyl terephthalate, 1,4-cyclohexanedimethanol, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (CAS Reg. No. 261716-94-3) containing repeat units consisting of terephthalate esters of 2,2,4,4-tetramethyl-1,3-cyclobutanediol at up to 40 mole percent (expressed as mole percent of the glycol component of the finished polyesters) and 1,4-cyclohexanedimethanol at no less than 60 mole percent, and, optionally, ?0.5 percent (by weight of the finished resin) trimellitic anhydride (CAS Reg. No. 552-30-7) as a branching agent. Food contact articles made with the subject additive are intended only for repeated use in contact with all food types (except infant formula and breast milk) at temperatures up to and including 100°C. Use in contact with infant formula and breast milk was not included as part of the intended use of the substance in the TOR submission.
Requestor: Keller and Heckman, LLP on behalf of Eastman Chemical Company

*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances.