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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. 736

Dyneon (a 3M Company)

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: 1-Propene,1,1,2,3,3,3-hexafluoro-, polymer with 1,1-difluoroethene (CAS Reg. No. 9011-17-0) modified with a halogenated ethylene as described in the food contact notification.
Notifier: Dyneon (a 3M Company)
Manufacturer: Dyneon (a 3M Company)
Intended Use: As a processing additive for all polymers for use in contact with food.
Limitations/Specifications*: The FCS may be used at levels up to 1000ppm in the finished polymer. The FCS will be manufactured as described in the notification. The FCS will be used in contact with all food types and under Conditions of Use A through H, as described in Table 2.
Effective Date: Oct 26, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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