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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. 332

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 FCS is the cross-linked reaction product of (1) an acrylic resin, consisting of a copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No. 80-62-6), methacrylic acid (CAS Reg. No. 79-41-4), t-butyl methacrylate (CAS Reg. No. 585-07-9), and hydroxyethyl methacrylate (CAS Reg. No. 868-77-9); (2) a silane coupling agent, consisting of y-isocyanatopropyltrimethoxysilane (CAS Reg. No. 15396-00-6); and (3) a urethane prepolymer which is an isocyanate-terminated polymer consisting of trimethylol propane (CAS Reg. No. 77-99-6) adducts of isophorone diisocyanate (CAS Reg. No. 4098-71-9) and m-xylylene diisocyanate (CAS Reg. No. 3634-83-1).
Notifier: Toppan Printing Co., Ltd.
Manufacturer: Toppan Printing Co., Ltd.
Intended Use: As an adhesive layer in a multi-layer film intended for use in packaging food.
Limitations/Specifications*: The FCS will be used in contact with all types of food under retort packaging conditions.
Effective Date: Aug 1, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo