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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. 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).
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:
  1. the substrate for the inorganic pigment; and/or
  2. a coating component for the inorganic pigment.
The inorganic pigment containing the FCS will be used as a colorant in printing inks, except for use in contact with infant formula and human milk (See Limitations/Specifications).
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)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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