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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. 598

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 propylene (CAS Reg. No. 115-07-1), tetrafluoroethylene (CAS Reg. No. 116-14-3), and 3,3,3-trifluoropropene (CAS Reg. No. 677-21-4) cured with a salt of a quarternary ammonium compound and phenol, 4,4'-(2,2,2-trifluoro-1-(trifluoromethyl)ethylidene)bis-.
Notifier: The Chemours Company FC, LLC
Manufacturer/Supplier: The Chemours Company FC, LLC
Intended Use: For repeat use in the fabrication of molded parts such as o-rings and gaskets for food.
Limitations/Specifications: The base fluoropolymer may be compounded with no more than 3.0 weight-percent of the salt of a quarternary ammonium compound and phenol, 4,4'-(2,2,2-trifluoro-1-(trifluoromethyl)ethylidene)bis- which is identified in the FCN. Articles containing the FCS are intended to contact all food types.
Effective Date: Apr 29, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo