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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. 2114

Al-Farben, S.A.

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: Chromium(3+) iron(3+) trioxidandiide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg No. 12737-27-8).
Notifier: Al-Farben, S.A.
Manufacturer/Supplier: Al-Farben, S.A.
Intended Use: The intended use of the FCS is as a colorant in all food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 3 percent by weight of finished polymers. The finished polymers are intended to contact all types of food under Conditions of Use A through H in Tables 1 and 2. The FCS is not intended to be used on food packaging used 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: Mar 5, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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