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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 524

BASF Corporation

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: Tris (2,4-di-tert-butylphenyl) phosphite (CAS Reg. No. 31570-04-4).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant/stabilizer in styrene block copolymers complying with 21 CFR 177.1810 Styrene block polymers
Limitations/Specifications*: May be used at levels not to exceed 0.4 percent by weight of the finished styrene block polymer, and in contact with all types of food, and under Conditions of Use A through H for which such styrene block polymers are permitted by 21 CFR 177.1810
Effective Date: Sep 30, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32 (i) and (j)
FDA Decision: Categorical Exclusion Memo