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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. 2337

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: Acetic acid ethenyl ester, polymer with 2,5-furandione, hydrolyzed, sodium salts (CAS Reg. No. 1428741-30-3).
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 component of:
  1. coatings for paper and paperboard
  2. creping agents used in the manufacture of paper, and;
  3. adhesives used in the manufacture of paper and paperboard tubes, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed:
  1. 1.2 g/m2 when used as a component of coatings,
  2. 0.070 g/m2 of paper when used as a component of creping agents, and;
  3. 1.2 g/m2 when used as a component of adhesives.
The FCS is intended for use in contact with all food types under Conditions of Use C through H, as described in Tables 1 and 2. The FCS is not 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: Jul 13, 2024
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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