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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. 461

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: The FCS is a cross-linked reaction product of an acrylic resin, a silane coupling agent, and a urethane polymer. This reaction product is formed in situ as a layer applied to an appropriate base film. The acrylic resin consists 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). The silane coupling agent consists of gamma-isocyanatopropyl-trimethoxysilane (IPSi) (CAS Reg. No. 15396-00-6). The urethane prepolymer is an NCO-terminated prepolymer consisting of trimethylol propane (CAS Reg. No. 77-99-6) adducts of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (isophorone diisocyanate, or IPDI) and 1,3-bis(isocyanatomethyl)benzene (m-xylylene diisocyanate, m-XDI).
Notifier: Toppan Printing Company, Ltd.
Manufacturer: 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 the food by a 20 micron or thicker layer of low-density polyethylene (LDPE) or by a poly(ethylene terephthalate) (PET) or other 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