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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. 932

Toyo Seikan Kaisha Limited and Nanocor Incorporated

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: Montmorillonite (CAS Registry Number 1318-93-0) surface treated with either quaternary ammonium compounds, (hydrogenated tallow alkyl)bis(hydroxyethyl)methyl, chlorides (CAS Reg. No. 68607-27-2) or 1-octadecanaminium, N,N-bis(2-hydroxyethyl)-N-methyl-, chloride (CAS Reg. No. 3010-24-0).
Notifier: Toyo Seikan Kaisha Limited and Nanocor Incorporated
Manufacturer: Toyo Seikan Kaisha Limited and Nanocor Incorporated
Intended Use: For use as a gas barrier in monolayer PET bottles.
Limitations/Specifications*: For use at levels not to exceed 5 percent by weight in a blend with nylon MXD6, with the blend to be used at levels not to exceed 5 percent by weight in finished PET bottles. The finished article may contact aqueous, acidic, and low and high alcoholic foods under Conditions of Use C through G, and fatty foods under Conditions of Use E through G, as described in Tables 1 and 2.
Effective Date: Dec 30, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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