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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. 701

Wacker Chemical 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-Ethynyl-1-cyclohexanol (CAS Reg. No. 78-27-3).
Notifier: Wacker Chemical Corporation
Manufacturer/Supplier: Wacker Chemical Corporation
Intended Use: To be used as an inhibitor for platinum catalysts to prevent premature cross linking of vinyl functionalized polysiloxanes with hydrogen functionalized polysiloxanes to form silicone elastomers in compliance with 21 CFR 177.2600 (Rubber articles intended for repeated use).
Limitations/Specifications: The finished, repeat-use polysiloxane article may be used in contact with all food types under Conditions of Use A through H and J as described in Tables 1 and 2. The FCS may be used at levels not to exceed 1000 ppm in the finished article that has a thickness no greater than 2 mm.
Effective Date: May 10, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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