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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. 635

Food Contact Substance: Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid with ethylene glycol and with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol. The finished polymer shall contain a total of not more than 10 mole-percent of diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units.
National Environmental Policy Act (NEPA) Submission: Environmental Assessment (in PDF) (482 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
FCN Premarket Authorization Issued: FCN 635 description