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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. 1041

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. REPLACES FCN 729
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: The FCS will be used as a component of repeat-use food-contact articles.
Limitations/Specifications: The FCS may be used in contact with all food types at temperatures up to and including 100°C.
Effective Date: Apr 9, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo