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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. 1682

Kuraray Company, 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: Polycyclooctene (PCOE; CAS Reg. No. 25267-51-0) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0). REPLACES FCN 1432
Notifier: Kuraray Company, Ltd.
Manufacturer/Supplier: Kuraray Company, Ltd.
Intended Use: The FCS is intended for use in blends with ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers as a non-food contact layer of multilayered packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: PCOE will be used at a maximum level of 8 percent in blends with authorized EVOH copolymers. Cobalt stearate will be present in the PCOE/EVOH blend at a maximum level of 0.04 percent as cobalt (0.42 percent as cobalt stearate). The maximum thickness of the FCS/EVOH blend will be 100 microns (μm). The finished food-contact packaging containing the FCS may contact all food types under conditions of use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 20, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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