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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. 191

Wacker Chemie/Wacker Silicones

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: Hydrolized tetraethyl silicate (CAS Reg. No. 68412-37-3)
Notifier: Wacker Chemie/Wacker Silicones
Manufacturer/Supplier: Wacker Chemie/Wacker Silicones
Intended Use: As a component of a cork primer used to aid in the adherence of silicone coatings to wine bottle closures.
Limitations/Specifications: Not to exceed 9.22 percent by weight of a primer formulation that is applied at levels not exceeding 0.1 g primer per wine bottle closure.
Effective Date: Apr 20, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo