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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. 1746

Food Contact Substance: Polyester-polyurethane adhesive formulated from the following:
  1. Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 822-06-0) and
  2. Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5).
Environmental Assessment NEPA Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
FCN Premarket Authorization Issued: FCN description

More about Environmental Decisions and Definitions of Environmental Terms.
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