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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. 1173

Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray Asia Pacific Pte. 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: Butanedioic acid, 2-methylene-, polymer with ethenyl acetate, hydrolyzed, sodium salts (CAS Reg. No. 122625-12-1).
Notifier: Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray Asia Pacific Pte. Ltd.
Manufacturer/Supplier: Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
Kuraray Asia Pacific Pte. Ltd.
Intended Use: For use as a creping agent in the manufacture of paper.
Limitations/Specifications: For use as a level not to exceed 25μg/in2 of paper, in single-use food-contact applications for all food types.
Effective Date: Jun 27, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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