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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. 1749

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: 2,2,4,4-Tetramethylcyclobutane-1,3-diol (CAS Reg. No. 3010-96-6).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: As a monomer, alone or in combination with the polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii)(c), in the production of polyester resins used as coatings for (1) metal substrates, used in the manufacture of single-use food-contact articles or components of such articles; and (2) any suitable substrate used in the manufacture of repeated-use food-contact articles or components of such articles; except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels not to exceed 29 mole % of the final coating. The polyester resins and the final coatings will otherwise comply with FDA regulations for their intended use. The FCS-containing coatings may be used in contact with all food types, except for high alcohol (>15 volume % ethanol) foods, under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in the 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: Apr 18, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(I) and (j)
FDA Decision: Categorical Exclusion Memo