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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. 934

Dow Silicones 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: Dimethyl, methylvinyl siloxane, hydroxyl-terminated reaction with beta-(3,4-epoxycyclohexyl)-ethyltrimethoxysilane (CAS Reg. No. 917773-10-5).
Notifier: Dow Corning Corporation
Manufacturer/Supplier: Dow Silicones Corporation
Intended Use: As a component in silicone release coatings that are currently regulated for food contact applications.
Limitations/Specifications: For use in silicone release coatings at levels not to exceed 4 percent by weight. The silicone coatings containing the FCS will be used on base substrates for pressure sensitive adhesives that are intended for use on raw fruits and vegetables (Food Types I and II) under Conditions of Use E and F, as described in Tables 1 and 2.
Effective Date: Dec 31, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo