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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. 101

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: Perfluorocarbon cured elastomers produced by polymerizing perfluoro(methyl vinyl ether) (CAS Reg. No. 1187-93-5) with tetrafluoroethylene (CAS Reg. No. 116-14-3) and perfluoro(8-cyano -5-methyl -3,6-dioxa -1-octene) (CAS Reg. No. 69804-19-9), followed by curing with trimethylallyl isocyanurate (CAS Reg. No. 6291-95-8) and/or triallyl isocyanurate (CAS Reg. No. 1025-15-6), and with 2,5 -dimethyl -2,5-di (t-butylperoxy) hexane (CAS Reg. No. 78-63-7) and as further described in this notification.
Notifier: E.I. du Pont de Nemours and Company
Manufacturer/Supplier: E.I. du Pont de Nemours and Company
Intended Use: For use in the fabrication of articles intended for repeated use in contact with food.
Limitations/Specifications*: The perfluorocarbon base polymer shall contain no less than 40 weight-percent of polymer units derived from perfluoro(methyl vinyl ether), no less than 30 weight-percent of polymer units derived from tetrafluoroethylene, and no more than 5 weight-percent polymer units derived from perfluoro(8-cyano-5-methyl-3,6-dioxa-1-octene). The uncured elastomer shall be compounded with no more than 4 parts per hundred of rubber (phr) of trimethylallyl isocyanurate and/or triallyl isocyanurate and no more than 4 phr of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane. The elastomer may also contain up to 1.0 phr of N, N, N', N'-tetramethyl-1-8-naphthalenediamine (CAS Reg. No. 20734-58-1). The perfluorocarbon cured elastomers must meet the total extractive limitations prescribed in 21 CFR 177.2400(d)(1).
Effective Date: Dec 19, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (110 kB)
FDA Decision: Finding of No Significant Impact (FONSI)