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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. 1884

The Dow 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: 2,5-Furandione, polymer with 1-propene (CAS Reg. No 25722-45-6).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a component of metal coatings, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS is used as a component of an aqueous dispersion optionally containing one or more of the following: polypropylene complying with 21 CFR 177.1520(c)(1.1), polypropylene copolymer complying with FCN 843 or 909, and/or ethylene-acrylic acid copolymer complying with FCN 1087. The FCS is a blend of up to 80 percent by weight of dispersion solid 2,5-furandione, polymer with 1-propene, with a level of maleic anhydride incorporated in the polymer that may not exceed 2 percent by weight, and up to 20 percent by weight of dispersion solid 2,5-furandione, polymer with 1-propene, with a level of maleic anhydride incorporated in the polymer that may not exceed 6 percent by weight. The ethylene-acrylic acid copolymer will be present at no more than 25 percent by weight of the solids in the dispersion. The FCS is a component of finished coatings used in contact with all food types under Conditions of Use A through H, as described in Table 2. The FCS may not be used in contact with infant formula or human milk.
Effective Date: Jun 28, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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