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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. 619

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: Platinum, [(2,5,6-.eta.)-3-(1-acetyl-2-oxopropyl)bicyclo[2.2.1]hept-5-en-2-yl](2,4-pentanedionato-O,O').
Notifier: Wacker Chemical Corporation
Manufacturer: Wacker Chemical Corporation
Intended Use: For use as a catalyst in the crosslinking reaction of vinyl functional polysiloxanes with hydrogen functional polysiloxanes to form silicone elastomers complying with 21 CFR 177.2600(c)(4)(i) for repeated use food contact articles.
Limitations/Specifications*: The maximum use level of the FCS is 45 ppm in finished silicone elastomers that may contact with food under all Conditions of Use, consistent with the limitations as described in 21 CFR 177.2600(c)(4)(i).
Effective Date: Sep 12, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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