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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. 1531

Food Contact Substance: Polyester-urethane adhesive formulated from:
  1. Polyester resin prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7), and glycerol polyoxypropylene triol (CAS Reg. No. 25791-96-2).
  2. Urethane cross-linking agent comprising not more than 40 percent by weight of the cured adhesive and formulated from 1,6-hexanediisocyanate (CAS Reg. No. 822-06-0) adducted with isobutanol (CAS Reg. No. 78-83-1) and the reaction with the polyester resin and 1,3-bis(isocyanatomethyl) benzene (CAS Reg. No. 3634-83-1) and/or 3-isocyanatomethyl-3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0).
  3. Optional trimethoxysilane coupling agents containing amino, epoxy, ether, and/or mercapto groups not to exceed 3 percent by weight of the cured adhesive.
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 5.5 Mb)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN description

More about Environmental Decisions and Definitions of Environmental Terms.
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