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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. 458

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: Tetracarbonyl di-μ-chlorodirhodium (I) (CAS Reg. No. 14523-22-9) Trade name: Rhodium carbonyl chloride dimer Formula: (Rh(CO)2Cl)2
Notifier: Wacker Chemical Corporation
Manufacturer/Supplier: Wacker Chemical Corporation
Intended Use: As a catalyst to accelerate the cross-linking reaction of vinyl-functionalized polydimethylsiloxanes with hydrogen-functionalized polydimethylsiloxanes in forming a silicone elastomer that will be used in repeat use articles such as baking molds and milk tubes, which may contact all food types under all conditions, consistent with the limitations of 21 CFR 177.2600(c)(4)(i).
Limitations/Specifications: The FCS will be used at levels not to exceed 30 ppm in the finished elastormer.
Effective Date: Nov 30, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo