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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. 247

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Food Contact Substance:  A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoro-2,5-dimethyl-3,6-dioxanonane vinyl ether (CAS Reg. No. 2599-84-0), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 106108-23-0) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7).
Notifier:  Greene, Tweed and Company, Inc.
Manufacturer:  Greene, Tweed and Company, Inc.
Intended Use:  In the fabrication of molded parts for food processing equipment, such as o-rings, gaskets, diaphragms and other materials, that function being primarily in sealing applications.
Effective Date:  08/13/2002
Limitations/Specifications:  The perfluorocarbon base polymer shall contain no less than 30 weight percent of polymer units derived from tetrafluoroethylene, no less than 60 weight percent of polymer units derived from perfluoro-2,5-dimethyl-3,6-dioxanonane vinyl ether and no more than 4 weight percent of polymer units derived from perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene. The uncured elastomer shall be composed of no more than 6 weight percent of triallylisocyanurate, no more than 5 weight percent of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane, and no more than 12 weight percent carbon black (produced by the furnace combustion process) (CAS Reg. No. 1333-86-4). The PCE must meet extractive limitations prescribed in 21 CFR 177.2400(d) Perfluorocarbon cured elastomers.
Environmental Impact Decisions:  Environmental Decisions Site