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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. 505

Colors and Effects USA LLC

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: Benzamide, 3,3'-[(2-chloro-5-methyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1-ethanediyl)azo]]bis[4-chloro-N-(3-chloro-2-methylphenyl)-(9Cl) (CAS Reg. No. 5580-57-4).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: For use as a colorant for food-contact polymers.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.2 weight percent in food-contact polymers in contact with all foods under 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 21 CFR 178.3297.
Effective Date: Jul 12, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo