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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. 1959

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 in coatings for food-contact paper and paperboard and food-contact polymer films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The maximum application rate for the FCS is 5g/m2. The FCS is intended for use in contact with all types of food and under Conditions of Use C through H. The FCS is not intended 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: May 19, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

679662  

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