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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. 813

BYK-Chemie GmbH

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: Urea, N,N''-1,3-propanediylbis[N'-octadecyl- (CAS Registry No. 35674-65-8).
Notifier: BYK-Chemie GmbH
Manufacturer: BYK-Chemie GmbH
Intended Use: As a component in defoamer formulations to be used in food-contact coatings.
Limitations/Specifications*: The FCS may be used at a level not to exceed 0.008 weight percent of the finished food-contact coating. Finished food-contact coatings containing the FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Jun 27, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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