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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. 592

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), coupled with the trimethoxysilane-based coupling agent described in the notification.
Notifier: Toppan Printing Company, Ltd.
Manufacturer: Toppan Printing Company, Ltd.
Intended Use: 1. As a non-food-contact layer in multilayer constructions intended for use in packaging food of all types under Conditions of Use B through H as specified in Table 2, and at higher temperatures only in retort packaging processes. 2. When used under Condition of Use B through H, the food-contact substance layer will be separated from food by at least a 20 micron thick layer of low density polyethylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 20 microns of low density polyethylene. 3. When used in retort packaging processes, the food-contact substance layer will be separated from food by at least a 50 micron thick layer of polypropylene or other polymer layer sufficiently thick so as to provide equivalent or better barrier properties than 50 microns of polypropylene.
Limitations/Specifications*: SEE INTENDED USE
Effective Date: Mar 31, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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