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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. 462

Toppan Printing 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: Cross-linked reaction product of polyvinyl alcohol (PVOH; CAS Reg. No. 9002-89-5) and tetraethoxysilane (TEOS; CAS Reg. No. 78-10-4).
Notifier: Toppan Printing Company, Ltd.
Manufacturer/Supplier: Toppan Printing Company, Ltd.
Intended Use: As a non-food contact layer in multilayer films intended for use in packaging food of all types under the Conditions of Use B through H as defined in Table 2.
Limitations/Specifications: The FCS layer will be separated from food by a 20-micron or thicker layer of low density polyethylene (LDPE) or a non-LDPE polymer layer of a thickness sufficient to provide equivalent or better barrier properties than 20 microns of LDPE.
Effective Date: Dec 9, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo