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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. 179

Food Contact Substance: Copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 0 mole percent of ethylene glycol and 1 to 100 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer). The FCS is further identified as follows: Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25640-14-6), manufactured from dimethylterephthalate (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. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25135-20-0), manufactured with DMT and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25037-99-4), manufactured with TPA and CHDM.
Environmental Assessment NEPA Submission: Environmental Assessment (in PDF, 4.23 MB)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN description
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