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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. 280

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: Copolyesters of dimethyl terephthalate or terephthalic acid with ethylene glycol, 1,4-cyclohexanedimethanol and diethylene glycol (CAS Reg. No. 148105-13-9 and 156209-91-5).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: The FCS will be used as a component of food contact articles intended to contact aqueous and fatty foods and alcoholic foods containing up to 15 percent ethanol by volume. Food-contact articles prepared from the FCS are intended for use under Conditions of Use C (see limitations on hot-fill temperature, below) through G as described Table 2.
Limitations/Specifications: 1. The sum of 1,4-cyclohexanedimethanol and diethylene glycol shall not exceed 35 mole percent of the total glycol component and diethylene glycol not to exceed 12 mole percent of the total glycol component. 2. The finished polymer shall meet the inherent viscosity specification in 21 CFR 177.1315(b)(1). 3. The copolymer may not be used as the base resin for single-use beverage bottles. 4. The copolymer may be used at hot fill temperature not to exceed 75°C.
Effective Date: Feb 1, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 413 kB)
FDA Decision: Finding of No Significant Impact (FONSI)