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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. 1907

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: Dimethyl, methyl vinyl polysiloxane, vinyl group-terminated (CAS Reg. No. 68083-18-1), reaction products with poly(ethylene-co-methyl acrylate) (CAS Reg. No. 25103-74-6).
Notifier: Dow Silicones Corporation
Manufacturer/Supplier: Dow Silicones Corporation
Intended Use: As a friction-reducing agent in polyoxymethylene polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be added to polyoxymethylene polymers compliant with 21 CFR 177.2470 and 21 CFR 177.2480 at a level not to exceed 5 percent by weight. Articles containing the FCS are for repeat-use and may contact all food types at temperatures not to exceed 250°F. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 23, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*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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