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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. 1596

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).
  2. Polyester component (CAS Reg. No. 1429057-80-6) prepared by the reaction of 1,3-benzenedicarboxylic acid and diethylene glycol, trans-esterified with castor oil.
Environmental Assessment NEPA Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
FCN Premarket Authorization Issued: FCN description
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