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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. 228

Wacker Silicones Corp.

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: Silaneamine, 1,1,1-trimethyl-N-(trimethylsylyl)-, hydrolysis products with silica (CAS Reg. No. 68909-20-6) or Silica ((dimethylvinylsilyl)oxy)- and ((trimethylsily)oxy)-modified (CAS Reg. No. 68988-89-6).
Notifier: Wacker Silicones Corp.
Manufacturer/Supplier: Wacker Silicones Corp.
Intended Use: As a filler for silicone elastomers complying with 21 CFR 177.2600.
Limitations/Specifications: For use at levels between 33 and 50 percent by weight of the silicone elastomer.
Effective Date: Jun 12, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo