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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. 1878

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: A copolyester made from dimethyl terephthalate (DMT), ethylene glycol (EG), and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (TMCD).
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, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS may be used at temperatures up to 100°C. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 8, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

679662  

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