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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. 260

Dyneon LLC

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: Dyneon LLC
Manufacturer: Dyneon LLC
Intended Use: As a processing additive for polyolefins for use in contact with food.
Limitations/Specifications*: The FCS may be used at levels up to 2000 parts per million (ppm) in food-contact polyolefins. The FCS may be used in contact with all food types, as described in Table 1 under Conditions of Use B through H, as described in Table 2. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 177.1520.
Effective Date: Oct 3, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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