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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. 1560

Arkema, 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: Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011-17-0).
Notifier: Arkema, Inc.
Manufacturer/Supplier: Arkema, Inc.
Intended Use: As a processing aid for food contact polymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 2000 ppm in all polymers with a maximum thickness of 10 mils in contact with all food types (I-IX) under Conditions of Use A through H, as defined in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 18, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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