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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. 1121


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: Tetrafluoroethylene-hexafluoropropylene-vinylidene fluoride copolymers (CAS Reg. No 25190-89-0).
Notifier: 3M
Manufacturer/Supplier: 3M
Intended Use: As a processing additive for all polymers (excluding polymers used in metal and paper coatings).
Limitations/Specifications: The FCS may be used at levels up to 2000 parts per million (ppm) in food-contact polymers, in contact with all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Jan 17, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo