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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. 1889

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: N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5). REPLACES FCN 1794
Notifier: The Dow Chemical Company
Manufacturer/Supplier: The Dow Chemical Company
Intended Use: As a crosslinking agent used in aqueous polyolefin dispersions authorized for food contact use to produce metal coatings or components of metal coatings, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a maximum level of 0.57 mg/in2 of coating surface, not to exceed 6.2 percent by weight of the polyolefin dispersion coating. The finished coating on a given article will have a maximum average thickness of 35 microns or less in containers having volumes of two gallons and more and an average thickness of 15 microns or less in containers having volumes of less than two gallons. The finished coating may be used in contact with all food types, except infant formula or human milk, under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in 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: Jul 5, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo