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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. 836

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 (CAS Reg. No. 25267-51-0).
Notifier: Kuraray Company, Ltd.
Manufacturer: Kuraray Company, Ltd.
Intended Use: As a component of a non food-contact layer of multilayered food-contact articles at levels up to 10 percent in blends with polyolefins complying with 21 CFR 177.1520 or ethylene-vinyl acetate-vinyl alcohol copolymers complying with 21 CFR 177.1360.
Limitations/Specifications*: The FCS may comprise up to 5 percent by weight of articles intended for use in contact with all food under Conditions of Use B through H as described in Table 2.
Effective Date: Nov 12, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo