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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. 510

The Chemours Company FC, LLC

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: Copolymer of 1,1-difluoroethylene, hexafluoropropene, tetrafluoroethylene, and a halogenated alkene, optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane.
Notifier: The Chemours Company FC, LLC
Manufacturer: The Chemours Company FC, LLC
Intended Use: For repeat-use in the fabrication of molded parts such as o-rings and gaskets for food processing equipment.
Limitations/Specifications*: The base fluoropolymer may be compounded with no more than 3.0 weight-percent of triallyl isocyanurate and 2.5 weight-percent of 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. Articles containing the FCS are intended to contact all food types.
Effective Date: Oct 13, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo