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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. 1627

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: Vinyltrimethoxysilane (CAS Reg. No. 2768-02-7).
Notifier: Kuraray Company, Ltd.
Manufacturer/Supplier: Kuraray Company, Ltd.
Intended Use: As a modifier for ethylene-vinyl acetate-vinyl alcohol copolymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use as a modifier for ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers at a maximum level of 0.16 wt% in the copolymer. EVOH modified with up to 0.16 weight-percent of the FCS may be used in articles in contact with food under FDAs Conditions of Use B through H as described in Table 2. EVOH modified with up to 0.16 weight-percent of the FCS may be used at levels of up to 20% in blends with unmodified EVOH under FDAs Conditions of Use A through H as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 10, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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