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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. 358

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: Polysiloxane di-methyl, vinyl-terminated, reaction product with 1,2,4-trivinylcyclohexane polymer with polydimethylsiloxane, hydrogen terminated.
Notifier: Wacker Silicones Corporation
Manufacturer: Wacker Silicones Corporation
Intended Use: As a cross-linking agent in the manufacture of silicone release agents complying with 21 CFR 175.300, 175.320 and 176.170 and intended for use as: 1) a component of food packaging articles, 2) in molds used to manufacture food-contact materials, and 3) a component of release coatings (a dehesive) for use with pressure-sensitive labels.
Limitations/Specifications*: The FCS will be used in accordance with good manufacturing practices. Additionally, 1) the food packaging articles will be used in contact with produce, meats and poultry, and seafood; 2) the molds will be used in contact with only fatty foods such as chocolates and/or sticky substances (i.e., candy); 3) the labels will be used only on produce (fruits and vegetables).
Effective Date: Nov 14, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo