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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. 333

Toppan Printing 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: The reaction product of polyvinyl alcohol (PVOH) and tetraethoxysilane (TEOS), (CAS Reg. No. 9002-89-5 and 78-10-4 respectively).
Notifier: Toppan Printing Co., Ltd.
Manufacturer/Supplier: Toppan Printing Co., Ltd.
Intended Use: For use in a non-food contact layer [to be separated from food by at least 50 micron (2 mil) thick polypropylene layer] in multilayer constructions intended for use in single-use packaging of food of all types (as defined in Table 1) under Conditions of Use A (as defined in Table 2), under retort packaging conditions only.
Limitations/Specifications: NONE
Effective Date: Aug 1, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo