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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. 245

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Food Contact Substance:  A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-5), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexane (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 193018-53-0) 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 primarily in sealing applications.
Effective Date:  08/13/2002
Limitations/Specifications:  The perfluorocarbon base polymer shall contain no less than 50 weight percent of polymer units derived from tetrafluoroethylene, no less than 40 weight percent of polymer units derived from perfluoromethyl 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 9 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