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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. 824

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: N-[3,5-Bis(2,2-dimethylpropionylamino)phenyl]-2,2-dimethylpropionamide (CAS Reg. No. 745070-61-5).
Notifier: Ciba Corporation
Manufacturer: BASF Corporation
Intended Use: For use as a clarifier for polypropylene (PP) homo- and copolymers used in food-packaging materials.
Limitations/Specifications*: The FCS may be used at levels not to exceed 250 ppm in the finished article and may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Sep 11, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo