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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. 365

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: 1,4-Benzenediamine, N-(1-3-dimethylbutyl)-N'-phenyl-, reaction products with ethylene oxide mono[[C12-richC10-13-branched alkyl thio]methyl] derivatives (CAS Reg. No. 444992-04-5).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: The FCS will be used as an antioxidant in rubber articles intended for repeat-use in contact with food.
Limitations/Specifications: The FCS will be used in contact with all food types, under Conditions of Use A through H, as described in Table 2, and at levels not to exceed 4 weight percent of the finished article.
Effective Date: Dec 9, 2003
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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