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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. 402

Precision Polymer Engineering, 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: A copolymer of tetrafluoroethylene and perfluoromethylvinyl ether (CAS Reg. No. 26425-79-6) \ modified with 3,3,4,4,5,5,6,6,7,7,8,8-dodecafluoro-1,9-diene and 1,3,5-triallyl cyanurate or 1,3,5-triallyl isocyanurate.
Notifier: Precision Polymer Engineering, Ltd.
Manufacturer: Precision Polymer Engineering, Ltd.
Intended Use: As a gasket or seal for food processing equipment.
Limitations/Specifications*: The finished copolymers are intended for repeat-use only as components of gaskets or seals used in food processing equipment intended to contact all food types at temperatures not to exceed 212°F.
Effective Date: Jul 2, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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