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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. 1601

Daikin Industries, LTD

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: 2,3,3,4,4,5,5-Heptafluoro-1-pentene polymer with ethene and tetrafluoroethene (CAS Reg. No.. 94228-79-2) .
Notifier: Daikin Industries, LTD
Manufacturer/Supplier: Daikin Industries, LTD
Intended Use: The FCS is intended to be used for the property improvement in extrusion process of all polymers for food packaging, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended to be used at levels up to 2000 ppm in all polymers that contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The finished product is not for use in contact with infant formula and breast milk. Such uses are not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 5, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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