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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. 426

Sun Chemical Corporation

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 diemethylquinacridone and C.I. Pigment Red 122 (CAS Reg. No. 980-26-7).
Notifier: Sun Chemical Corporation
Manufacturer: Sun Chemical Corporation
Intended Use: As a colorant in food-contact polymers.
Limitations/Specifications*: The FCS will be used at levels not to exceed 1.5 percent by weight in finished food-packaging polymer in contact with aqueous, acidic, and low-alcohol foods (food types I, II, IV-B, VI-A, VI-B, VI-C (containing up to 15 percent (v/v) alcohol), VII-B, and VIII as described in Table 1) under the Conditions of Use A through H as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in paragraphs a and b of 21 CFR 178.3297 ("Colorants for polymers").
Effective Date: Aug 27, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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