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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. 615

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-dimethyl-propionylamino)phenyl]-2,2-dimethylpropionamide
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: For use as a clarifier for polypropylene (PP) homo- and copolymers.
Limitations/Specifications: The FCS may be used at levels not to exceed 210 ppm in the finished article and may contact all food types under Conditions of Use A through H, as described Table 2.
Effective Date: Aug 4, 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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