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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. 516

Dow 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: Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethers with polyoxyethylene mono-Me ether and polyoxypropylene mono-Me ether (CAS Reg. No. 472975-82-9).
Notifier: Dow Corning Corporation
Manufacturer/Supplier: Dow Silicones Corporation
Intended Use: As a defoaming agent in printing inks and ink coatings applied to both the food contact side and non-food contact side of paper, paperboard, films, and foils used in food packaging.
Limitations/Specifications: For use at levels not to exceed 0.5 percent of the coating formulation. Coating thicknesses can vary from 0.5 to 10 microns. The finished FCS may be used in contact with all food types, under Conditions of Use B through H, as described in Tables 1 and 2, respectively.
Effective Date: Oct 13, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo