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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. 387

General Electric Company

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, polymers with silica-1,1,1-trimethyl-N-(trimethylsilyl)silanamine hydrolysis products and silicic acid trimethylsilyl ester (CAS Reg. No. 159002-21-8).
Notifier: General Electric Company
Manufacturer/Supplier: General Electric Company
Intended Use: As a defoamer in the pulping of lignocellulosic materials that will be used to make food-contact paper and paperboard.
Limitations/Specifications: For use at levels not to exceed 2500 grams per metric ton of dry pulp (0.25 weight percent). The FCS may be used in contact with all food types, as described in Table 1.
Effective Date: Jan 14, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 628 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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