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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. 2076

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). REPLACES FCN 524
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant/stabilizer in styrene block copolymers for use as a component of food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 0.4 percent by weight of styrene block copolymers for contact with all food types under Conditions of Use A through H described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 19, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet

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