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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. 2115

Kuraray Co., 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: Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane (CAS Reg. No. 482589-30-0).
Notifier: Kuraray Co., Ltd.
Manufacturer/Supplier: Kuraray Co., Ltd.
Intended Use: For use at levels of up to 25% in blends with EVOH as an internal, non-food-contact layer of single and repeated-use articles in contact with infant formula and/or human milk.
Limitations/Specifications: The maximum thickness of the internal layer containing the FCS will be 50 μm. The finished food-contact articles may be used in contact with infant formula and/or human milk under Conditions of Use A through H as defined in Table 2.
Effective Date: Mar 12, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 791 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 185 kB)