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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. 446

Wacker Chemical Corporation (formerly known as 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: Di-μ-chlorobis((1,2,5,6-η)-1,5-cyclooctadiene)dirhodium (CAS Reg. No. 12092-47-6).
Notifier: Wacker Chemical Corporation (formerly known as Wacker Silicones Corporation)
Manufacturer: Wacker Chemical Corporation (formerly known as Wacker Silicones Corporation)
Intended Use: For use as a catalyst in the preparation of silicone elastomers complying with 21 CFR 177.2600.
Limitations/Specifications*: The FCS will not exceed 0.01 percent (or 100 ppm) in the finished elastomer, corresponding to 41.7 ppm rhodium.
Effective Date: Oct 5, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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