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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. 808

New Japan Chemical 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: D-Glucitol, bis-O-[(4-methylphenyl)methylene)- (CAS Reg. No. 54686-97-4).
Notifier: New Japan Chemical Company Ltd.
Manufacturer/Supplier: New Japan Chemical Company Ltd.
Intended Use: The FCS is to be used as a nucleating agent in food contact articles, specifically, single use film wrap and bottle caps and repeat use food trays and containers.
Limitations/Specifications: The FCS is to be used at a level not to exceed 0.32 percent by weight of finished propylene homopolymers and copolymers used for single- and repeat use articles intended to contact all food types under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Jul 26, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo