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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. 1255

3M

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 vinylidene fluoride and hexafluoropropene (CAS Reg. No. 9011-17-0).
Notifier: 3M
Manufacturer: 3M
Intended Use: As a processing aid in all polymers (excluding polymers used in metal and paper coatings).
Limitations/Specifications*: The FCS may used at a maximum level of 2000 ppm by weight of the finished polymer. The finished polymers will otherwise comply with FDA regulations for their intended use. The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Apr 12, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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