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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. 17

Greene, Tweed and Company, Inc.

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 perfluorocarbon-cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3), perfluoro(2,5-dimethyl-3,6-dioxanone 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) by crosslinking with triallylcyanurate (CAS Reg. No. 101-37-1) and vulcanizing with 2,5-dimethyl-2,5-di(t-butylperoxy) hexane (CAS Reg. No. 78-63-7), as a 68% dispersion on finely divided silica
Notifier: Greene, Tweed and Company, Inc.
Manufacturer: Greene, Tweed and Company, Inc.
Intended Use: In the fabrication of vulcanized molded parts for food processing equipment, such as o-rings, gaskets, diaphrams and other materials, that function primarily in sealing applications
Limitations/Specifications*: The perfluorocarbon base polymer shall contain no less than 30 weight-percent (wt.-%) of polymer units derived from tetrafluoroethylene, no less than 60 wt.-% of polymer units derived from perfluoro(2,4-dimethyl-3,6-dioxanone vinyl ether), and no more than 4 wt.-% polymer units derived from perfluoro(6,6-dihydro-6-iodo-3-1-hexane). The uncured elastomer shall be composed of no more than 6 parts per hundred of triallylcyanurate and no more than 5 parts per hundred of 2,5-dimethyl-2,5-di(t-butylperoxy)hexane. The PCE must meet any applicable specifications prescribed in 21 CFR 177.2400 Perfluorocarbon cured elastomers.
Effective Date: Mar 30, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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