Inventory of Effective Food Contact Substance (FCS) Notifications
FCN No. 245
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), 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/Supplier:||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.|
|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.|
|Effective Date:||Aug 13, 2002|
|National Environmental Policy Act (NEPA)** Submission:||Categorical Exclusion 25.32(j)|
|FDA Decision:||Categorical Exclusion Memo|