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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. 1365

Siltech 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, Me hydrogen, reaction products with polyethylene-polypropylene glycol monoacetate allyl ether (CAS Reg. No. 68037-64-9).
Notifier: Siltech Corporation
Manufacturer/Supplier: Siltech Corporation
Intended Use: As a component of emulsion-based defoamers for the manufacture of food-contact paper and paperboard, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 0.2 ppm relative to the slurry. The FCS may be used in contact with all food under Conditions of Use A through H, as described in Table 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 21, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 639 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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