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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. 377

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: BASF Corporation
Intended Use: The FCS will be used as an antioxidant for styrene block polymers complying with the provisions of 21 CFR 177.1810.
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.1 percent by weight of the finished article; and in contact with all types of foods under Conditions of Use A through H, as described in Tables 1 and 2, respectively.
Effective Date: Jan 1, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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