Inventory of Environmental Impact Decisions for Food Contact Substance Notifications
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FCN No. 461
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). |
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Environmental Assessment NEPA Submission: | Categorical Exclusion 25.32(i) |
FDA Decision: | Categorical Exclusion Memo |
FCN Premarket Authorization Issued: | FCN description |
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