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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. 1816

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: 1,6-Hexanediol (CAS Reg. No. 629-11-8).
Notifier: Eastman Chemical Company
Manufacturer/Supplier: Eastman Chemical Company
Intended Use: The FCS is intended for use as a monomer in the manufacture of polyester or polyester/polyurethane resins for use as components of coatings for food-contact articles, except for use in contact with infant formula and human milk (see Limitations/ Specifications). The coatings may be applied to (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.
Limitations/Specifications: The FCS may be safely reacted with monomers listed in 21 CFR 175.300 (b) (3) (vii) (a, b, c, and d) and polybasic acids and their anhydrides, monobasic acids, polyhydric alcohols, and monohydric alcohols that are subject of an effective FCN for use as components of polyester coating resins. The polyester resin produced from the FCS may constitute up to 100% of the final food-contact coating formulation. The FCS may be used at a maximum level not to exceed 30 mol-% of the polyester resin. The FCS may be used at a maximum level not to exceed 13.1 % by weight of the final coating. Unless specified by a regulation or an effective FCN, coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS will not be used in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 31, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo