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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. 826

Dow Corning 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: Siloxanes and Silicones, di-Me vinyl, hydroxy-terminated, reaction products with trimethoxy[3-(oxiranylmethoxy)propyl]silane (CAS Reg. No. 102782-94-5).
Notifier: Dow Corning Corporation
Manufacturer: Dow Corning Corporation
Intended Use: The FCS is intended for use as an anchor agent in silicone release coatings that are currently regulated for food contact applications.
Limitations/Specifications*: For single use and formulated into silicone coatings at a level not to exceed 4 weight percent. The FCS will be used in pressure sensitive adhesives (PSAs) on fruits and vegetables (under food types (I and II) under Conditions of Use E and F and in PSAs for beverage and food containers under Conditions of Use E through G with food types I, II, III, VI-A, VI-B, and VI-C as described in Table 2.
Effective Date: Sep 3, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo