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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. 1265

Food Contact Substance: Polymer of dimethyl terephthalate, 1,4-cyclohexanedimethanol, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (CAS Reg. No. 261716-94-3) containing repeat units consisting of terephthalate esters of 2,2,4,4-tetramethyl-1,3-cyclobutanediol at up to 40 mole percent (expressed as mole percent of the glycol component of the finished copolyesters) and 1,4- cyclohexanedimethanol at no less than 60 mole percent, and, optionally, ≤0.5 percent (by weight of the finished resin) trimellitic anhydride (CAS Reg. No. 552-30-7) as a branching agent.
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 640 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN description
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