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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 adhesive formulated from: 1) Polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a). In addition, 2,2-bis(hydroxymethyl) butanoic acid (CAS Reg. No. 10097-02-6) may be used as an optional polyhydric alcohol, and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7) may be used as a polyhydric alcohol in structures that are intended to contact alcoholic foods containing up to 8 percent ethyl alcohol. 2) Urethane cross-linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane (CAS Reg. No. 187852-79-5).
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 917 kB)
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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