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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. 539

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: A copolymer of 4-bromo-3,3,4,4-tetrafluoro-1-butene, ethylene, tetrafluoroethylene and trifluoromethyl trifluorovinyl ether optionally cured with triallyl isocyanurate and 2,5-dimethyl-2,5-di(tert-butylperoxy)hexane. (CAS Reg. No. 105656-63-1)
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 under Conditions of Use A through H.
Effective Date: Nov 22, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo