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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

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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.
Effective Date:  12/09/2004
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.
Environmental Impact Decisions:  Environmental Decisions Site