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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. 2169

National Coatings, Inc.

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: National Coatings, Inc.
Manufacturer/Supplier: National Coatings, Inc.
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 human milk and ready-to-consume infant formula and infant formula concentrate (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with (a) powdered infant formula (i.e., excluding ready-to-consume infant formula and infant formula concentrate) at room temperature and below (i.e., Condition of Use E through G); and (b) all food types, other than infant formula and human milk, under Conditions of Use A through H, as described in Table 2. 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.
Effective Date: Oct 26, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo