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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 937

Eastman Chemical Company

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

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.
Notifier: Eastman Chemical Company
Manufacturer: Eastman Chemical Company
Intended Use: As articles or components of articles intended to contact food.
Limitations/Specifications*: The minimum inherent viscosity of the finished resin will be 0.60. For use in contact with aqueous, acidic, low-alcohol (up to 13 percent by volume), and fatty foods under Conditions of Use C through G as described in Table 2, and for use in contact with foods containing up to 50 percent by volume alcohol under conditions of use E through G as described in Table 2.
Effective Date: Jan 21, 2010
National Environmental Policy Act (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)