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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. 172

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
Manufacturer/Supplier: BASF Corporation
Intended Use: As an antioxidant and/or stabilizer for adhesives and polymers.
Limitations/Specifications: As an antioxidant and/or stabilizer in the following: 1) adhesives complying with 21 CFR 175.105, 2) pressure-sensitive adhesives complying with 21 CFR 175.125 at levels not to exceed 0.2 weight percent of the finished adhesive, and 3) ethylene-vinyl acetate copolymers complying with 21 CFR 177.1350 at levels not to exceed 0.02 weight percent of the ethylene-vinyl acetate in all types of food.
Effective Date: Dec 11, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
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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