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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. 1763

Kuraray 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: 2-Methylene-1,3-propanediol (MPDiol) modified ethylene-vinyl alcohol (EVOH) copolymers (CAS Reg. No. 1485481-35-3).
Notifier: Kuraray Company, Ltd.
Manufacturer/Supplier: Kuraray Company, Ltd.
Intended Use: As a component of films, bottles, and molded articles that contact food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may contain up to 3 mole percent of MPDiol. The finished food-contact article containing the FCS may contact all food types under conditions of use A through H, as described in Table 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: May 5, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 688 kB)
FDA Decision: Finding of No Significant Impact (FONSI)