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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. 1265

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: 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.
Notifier: Eastman Chemical Company
Manufacturer: Eastman Chemical Company
Intended Use: As articles of components of articles intended to contact food.
Limitations/Specifications*: The FCS may contact Food Types I, II, III, IV-A, IV-B , VI-A, VI-B, VI-C, VII-A, VII-B, and VIII, under Conditions of Use C through H as described in Tables 1 and 2.
Effective Date: May 29, 2013
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (640 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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