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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. 33

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: Silica, ((ethenyldimethylsilyl)oxy)- and ((trimethylsilyl)oxy)-modified (CAS Reg. No. 68988-89-6)
Notifier: Dow Corning Corporation
Manufacturer/Supplier: Dow Corning Corporation
Intended Use: To be used in combination with siloxane and silicone coating components permitted for use under 21 CFR 175.300 (b) (3) (xxviii) to manufacture silicone paper coatings intended for use in contact with pressure-sensitive, self-stick labels and tapes to adjust the force required to release the label/tapes which are to be applied to food surfaces.
Limitations/Specifications*: The silicone coatings may contain the subject silicone resin at up to 50 percent by weight of the total coating solids. The self stick labels and/or tapes are to be used in accordance with 21 CFR 175.125 Pressure sensitive adhesives.
Effective Date: May 18, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (211 kB)
FDA Decision: Finding of No Significant Impact (FONSI)