Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2261
Merck KGaA, Darmstadt, Germany and its affiliated companies
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: | Aluminum oxide (CAS Reg. No. 1344-28-1). |
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Notifier: | Merck KGaA, Darmstadt, Germany and its affiliated companies |
Manufacturer/Supplier: | Merck KGaA, Darmstadt, Germany and its affiliated companies |
Intended Use: |
As a component of inorganic pigments in combination with other authorized, inorganic substances wherethe FCS will function as:
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Limitations/Specifications: | For use in printing inks in contact with all food types under Conditions of Use A through H, and J, as described in Tables 1 and 2, respectively. 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: | Jan 18, 2023 |
National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 776 kB) |
FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 251 kB) |
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