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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. 1116

E.I. du Pont de Nemours and Company

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 tetrafluoroethylene (CAS Reg. No. 116-14-3) and trifluoromethyl trifluorovinyl ether (CAS Reg. No. 1187-93-5), and optionally employing a halogenated alkene.
Notifier: E.I. du Pont de Nemours and Company
Manufacturer: E.I. du Pont de Nemours and Company
Intended Use: For repeat-use in the fabrication of molded parts, such as o-rings, sanitary seals, butterfly valve seats, weir diaphragms, and heat exchanger gaskets.
Limitations/Specifications*: Articles containing the FCS will be used in contact with all food types under Conditions of Use A through H and J. The FCS may contain food-contact substances that are otherwise cleared for the intended uses, subject to any limitations on use of the adjuvant substances. The uncured perfluoroelastomer shall be compounded with no more than 4 parts per hundred of rubber (phr) of triallyl isocyanurate and 2 phr of 2,5-dimethyl-2,5-di(tert-butylperoxy) hexane or 2,5-dimethyl-2,5-di(tert-butylperoxy)hexyne-3.
Effective Date: Nov 24, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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