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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. 448

Food Contact Substance: Polyester-polyurethane resin formulated from (a)(1) polyester-polyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 1,6-hexanediol, dimethylolbutanoic acid, 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, and/or 1,3-bis(isocyanatomethyl)benzene and (2) an optional trimethoxysilane coupling agent containing an epoxy group, as described in the notification, not to exceed 3 percent by weight of the cured adhesive and (b) urethane cross-linking agent comprising not more than 20 percent by weight of the cured adhesive, and formulated from trimethylolpropane adduct of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and/or trimethylolpropane adduct of 1,3-bis(isocyanatomethyl)benzene and/or 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate, where the content of the 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate shall not exceed 14 percent by weight of the cured adhesive.
National Environmental Policy Act (NEPA) Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
FCN Premarket Authorization Issued: FCN 448 description