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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. 356

Clariant Corporation, Pigments and Additives Division

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: 5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione (C.I. Pigment Red 122, CAS Reg. No. 980-26-7) also known as 2,9-Dimethylquinacridone.
Notifier: Clariant Corporation, Pigments and Additives Division
Manufacturer: Clariant Corporation, Pigments and Additives Division
Intended Use: As a colorant in single- and repeat-use polymeric, food-contact articles.
Limitations/Specifications*: 1) The colorant is limited to use levels not exceeding 1 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact food types I, II, IVB, VIA, VIB, VIC (containing up to 15 percent (v/v) alcohol), VIIB, and VIII only under Conditions of Use D through G, as described in Table 2. 2) The colorant is limited to use levels not exceeding 0.5 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact food types III, IVA, V, VIC (containing greater than 15 percent (v/v) alcohol), VIIA, and IX only under Conditions of Use D through G, as described in Table 2. 3) The colorant is limited to use levels not exceeding 0.2 percent by weight of the food contact polymers and is subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact polymers may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Nov 14, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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