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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. 1198

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: Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers complying with 21 CFR 177.1360(a)(3) (CAS Reg. No. 26221-27-2).
Notifier: Kuraray Company, Ltd.
Manufacturer: Kuraray Company, Ltd.
Intended Use: As a basic polymer as a component of films, bottles, and molded articles that may contact all types of food under FDA’s Condition of Use A through H as defined in Tables 1 and 2.
Limitations/Specifications*: The FCS may contain optional adjuvant substances permitted for such use by regulation in 21 CFR Parts 170 through 179 or by an effective FCN.
Effective Date: Oct 25, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI)
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