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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. 573

Unimatec Company, Ltd.

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: Copolymer of tetrafluoroethylene, perfluoromethylvinylether and 1-iodo-2-bromotetrafluoroethane intended to be cross-linked with triallylisocyanurate. REPLACES FCN 278
Notifier: Unimatec Company, Ltd.
Manufacturer: Unimatec Company, Ltd.
Intended Use: As an O-ring or gasket in food-processing machinery.
Limitations/Specifications*: For use in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2, respectively.
Effective Date: Mar 30, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo