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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. 1280

Sudarshan Chemical Industries Limited

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: Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-2,9-dimethyl, also known as 2,9-dimethylquinacridone and C.I. Pigment Red 122 (CAS Reg. No. 980-26-7).
Notifier: Sudarshan North America
a division of Sudarshan Chemical Industries Limited
Manufacturer: Sudarshan Chemical Industries Limited
Intended Use: As a colorant in food-contact polymers.
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, IV-B, VI-A, VI-B, VI-C (containing up to 15 percent (v/v) alcohol), VII-B, and VIII under Conditions of Use A through H, as described in Table 2 of 21 CFR176.170(c).; 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, IV-A, V, VI-C (containing greater than 15 percent (v/v) alcohol), VII-A, and IX only under Conditions of Use D through G, as described in Table 2 of 21 CFR 176.170(c).; and 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 of 21 CFR 176.170(c).
Effective Date: Jul 9, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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