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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. 2125

Polynt Composites USA 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: Polynt Composites USA Inc.
Manufacturer/Supplier: Polynt Composites USA Inc.
Intended Use: The FCS is intended for use as a monomer in the production of polyester resins for use as coatings for metal substrates used in the manufacture of single-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: The FCS may be 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 FCS may be used at a maximum level not to exceed 19.4 percent by weight of the final coating. 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: Jun 1, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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