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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

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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:  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.
Effective Date:  12/19/2000
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).
Environmental Impact Decisions:  Environmental Decisions Site