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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. 695

Bayer MaterialScience AG

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: 1H-Azepine-1-carboxamide,N,N',N''-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)- triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]tris[hexahydro-2-oxo- (CAS Reg. No. 68975-83-7).
Notifier: Bayer MaterialScience AG
Manufacturer: Bayer MaterialScience AG
Intended Use: To be used as a reactant with one or more of the polybasic acids or polyhydric alcohols in the formation of coatings on metal substrates intended for use in food-contact applications, complying with 21 CFR 175.300(b)(3)(vii).
Limitations/Specifications*: The FCS will be used in contact with all food types under Conditions of Use A through H, as descrthed in Tables 1 and 2.
Effective Date: Jun 15, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)