Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2082
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 cleared, inorganic substances where the 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 for food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | Inorganic pigments containing the FCS are intended for use at levels up to 5% by weight in polymers in contact with all food types under Conditions of Use A through H and J, as described in Tables 1 and 2, respectively. The finished food-contact articles containing the FCS are 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: | Dec 23, 2020 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 50 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 174 kB) |
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