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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. 720

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: Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated, 4-methyl-1,3,2- dioxaborinan-2-yl 4-methyl-1,3,2-dioxaborolan-2-yl derivatives (CAS Reg. No. 500224-31-7)
Notifier: Kuraray Company Ltd.
Manufacturer: Kuraray Company Ltd.
Intended Use: To be used in ethylene vinyl alcohol (EVOH) polymers complying with 21 CFR 177.1360 and in polyolefin polymers complying with 21 CFR 177.1520, which may contact food.
Limitations/Specifications*: The FCS will be used at levels not to exceed 5% by weight in EVOH polymers and in polyolefin polymers, which may contact all food types under Conditions of Use B through H as described inTables 1 and 2.
Effective Date: Jul 13, 2007
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo