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U.S. Department of Health and Human Services

Inventory of Environmental Impact Decisions for Food Contact Substance Notifications

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FCN No. 461

Food Contact Substance: Acrylic resin, silane coupling agent, and urethane polymer, cross-linked reaction product of. The acrylic resin consists of a copolymer of styrene, methyl methacrylate, methacrylic acid, t-butyl methacrylate, and hydroxyethyl methacrylate. The silane coupling agent is γ-isocyanatopropyl-trimethoxysilane (IPSi). The urethane polymer is an NCO-terminated prepolymer consisting of trimethylol propane adducts of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (isophorone diisocyanate, or IPDI) and 1,3-bis(isocyanatomethyl)benzene (m-xylylene diisocyanate, m-XDI).
National Environmental Policy Act (NEPA) Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
FCN Premarket Authorization Issued: FCN 461 description