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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. 1399

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: As an internal, non-food-contact layer separated from food by one or more layers having a suitable regulatory status for use in direct contact with food in single service and repeated-use food-contact articles both (1) as a stand-alone layer; or (2) at levels of up to 30% in blends with EVOH, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: (1) The maximum thickness of the internal layer when the FCS is used alone will be 50 μm. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15% alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use A through H as defined in Tables 1 and 2. (2) The maximum thickness of the internal layer when the FCS is used in blends with EVOH will be determined by the relationship: (50 μm)/(x), where x is the fraction of the FCS in the blend. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15% alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use A through H as defined in Tables 1 and 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 29, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 478 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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