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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. 425

Japan Crown Cork 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: Hexanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl), 3-methyl-1,5-pentanediol and 1-methyl-1,3-propanediylbis[(6-isocyanatohexyl)carbamate] (CAS Reg. No. 622366-97-6).
Notifier: Japan Crown Cork Co. Ltd.
Manufacturer: Japan Crown Cork Co. Ltd.
Intended Use: As a sealing gasket for glass jars and bottles.
Limitations/Specifications*: The FCS may be used in contact with all food types, excluding carbonated beverages, under Use Conditions A through H as described in Table 2.
Effective Date: Aug 20, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo