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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. 1377

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: Glass-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 breast 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 safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 28, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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