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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. 638

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: Benzoic acid, 2,2'-[(benzoylimino)bis[2,1-ethanediyl(5-cyano-2-hydroxy-4-methyl-6-oxo-1,3(6H)-pyridinediyl)azo]]bis-, diethyl ester (9CI) (CAS Reg. No. 459856-74-7).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant for use in authorized poly(ethylene phthalate) polymers, including those modified with 1,4-cyclohexanedimethanol.
Limitations/Specifications: The FCS will be used at levels not to exceed 0.1 percent by weight in the finished poly(ethylene phthalate) polymers, for contact with food under Conditions of Use D through G as described in Table 2.
Effective Date: Oct 21, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo