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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. 196

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: 1-Dodecene (CAS Reg. No. 112-41-4).
Notifier: Wacker Chemie/Wacker Silicones
Manufacturer/Supplier: Wacker Chemie/Wacker Silicones
Intended Use: The FCS will be used in the manufacture of a vinyl-functional resin, which is a component of a primer used to aid in the adherence of silicone coatings to corks used as wine bottle closures.
Limitations/Specifications: The FCS will be used at a level not to exceed 1.22 percent by weight of a primer formulation that is applied at levels not exceeding 0.1 g primer per wine bottle closure.
Effective Date: May 14, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo