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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. 912

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: Benzenesulfonic acid, 4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitro-, calcium salt (2:1) (CAS Reg. No. 12286-66-7).
Notifier: Ciba Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: The FCS will be used as a colorant in the manufacture of polymers intended to contact food.
Limitations/Specifications: The FCS is intended for use in contact with all food types at a concentration not to exceed 0.5 percent by weight. The finished polymers are to contact food only under temperature Conditions of Use A through H as described in Table 2.
Effective Date: Oct 9, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo