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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. 544

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: 5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant and/or stabilizer in polystyrene and impact polystyrene, compliant with 21 CFR 177.1640, in contact with all food types.
Limitations/Specifications: The FCS will be used at levels not to exceed 0.1 percent by weight in the finished product under Conditions of Use B through H.
Effective Date: Feb 16, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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