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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. 1605

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: Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant for polyurethane resins complying with 21 C.F.R. 177.1680, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The maximum level of the FCS will not exceed 667 parts per million (ppm) by weight. The resins may only contact bulk quantities of dry food (Type VIII) under Conditions of Use A through H as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 9, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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