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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. 937

Food Contact Substance: Copolymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 15 to 85 mole percent of ethylene glycol and 85 to 15 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer), and optionally < 0.5 percent (by weight of the finished resin) trimellitic anhydride as a branching agent. The FCS is further identified as follows: Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25640-14-6), manufactured from dimethyl terephthalate (DMT), ethylene glycol (EG), and 1,4-cyclohexanedimethanol (CHDM). Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25038-91-9), manufactured from terephthalic acid (TPA), EG, and CHDM.
Environmental Assessment NEPA Submission: Categorical Exclusion 25.32(j) and Environmental Assessment (in PDF, 78 kB)
FDA Decision: Categorical Exclusion Memo/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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