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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. 76

Wacker Silicones/ Wacker Chemie GmbH

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: A modified, branched poly dimethyl hydrogen methylsiloxane (containing small amounts of trivinyl cyclohexane, CAS Reg. No. 2855-27-8), synthesized as described in the notification, from trivinylcyclohexane and sigma, omega' -dihydropolydimethyl siloxane with platinum catalysis followed by reaction with polyhydrogen methyl dimethylsiloxane.
Notifier: Wacker Silicones/ Wacker Chemie GmbH
Manufacturer/Supplier: Wacker Silicones/ Wacker Chemie GmbH
Intended Use: As a cross linking agent in the manufacture of poly dimethyl hydrogen methylsiloxane complying with 21 CFR 175.300 and 175.320 and intended for use: 1) as a component of food packaging articles; 2) in molds used to manufacture food-contact material; and 3) as a component of release coatings (a dehesive) for use with pressure-sensitive labels.
Limitations/Specifications*: The FCS will be used in accordance with good manufacture practices. Additionally, 1. the food packaging articles will be used in contact with only produce, meats, 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); and 3. the labels will be used only on produce (fruits and vegetables).
Effective Date: Aug 24, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (192 kB)
FDA Decision: Finding of No Significant Impact (FONSI)