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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. 109

Wacker 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: ((1,2,5,6-η)-1,5-cyclooctadiene)bis((4-(trimethylsilyl)phenyl)ethynyl)platinum (CAS Reg. No. 234112-62-0).
Notifier: Wacker Silicones Corporation
Manufacturer/Supplier: Wacker Silicones Corporation
Intended Use: The platinum catalyst is used at low levels in the polymerization of precursors leading to the formation of silicone elastomers in repeated-use applications that contact food.
Limitations/Specifications*: 1. The platinum-containing catalyst will be present in the finished elastomer at a maximum level of 36 ppm (w) corresponding to 11 ppm platinum. 2. The platinum catalyst itself will not come in contact with food.
Effective Date: Jan 24, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo