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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. 2074


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: Tungsten carbide containing up to 15 percent nickel with up to 1.5 percent chromium carbide.
Manufacturer/Supplier: EXTRAMET AG
Intended Use: The food contact substances will be used in the manufacture of food processing equipment (specifically, as wear parts in applications of producing foods, e.g., for cutting cheese in blocks, for homogenization of milk (nozzles), and for packaging (cutting) of different types of packaging materials), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in contact with all types of foods and under Conditions of Use A through H as described in Table 1. The FCS is not intended to be used on food packaging used 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 16, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo