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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. 1876

Eckart GmbH
Altana AG

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: Fluorphlogopite-based pearlescent pigments
Notifier: Eckart GmbH
Altana AG
Manufacturer/Supplier: Eckart GmbH
Altana AG
Intended Use: As a colorant in all food contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: 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 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 25, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF)

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