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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. 766

Food Contact Substance: Polyester-urethane composition comprising (1) a base material component of polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a), which may be prepared with 2,2-bis(hydroxymethyl)butanoic acid, as an optional polyhydric alcohol, and with 2,2-dimethyl-1,3-propanediol, as an optional polyhydric alcohol, and (2) a curing agent component of urethane cross-linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane
National Environmental Policy Act (NEPA) Submission: Environmental Assessment (in PDF) (917 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN 766 description