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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. 293

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: Pyrimido(5,4-g)pteridine-2,4,6,8-tetramine,4-methylbenzenesulfonate, base-hydrolyzed (Pigment Yellow 382E; CAS Reg. No. 346709-25-9), which is a mixture consisting of approximately 65.3 percent Pyrimido(5,4-g)pteridine-2,4,6,9-tetramine (CAS Reg. No. 207283-64-5), approximately 7.5 percent 2,6,8-triamino-pyrimido(5,4-g)pteridine-4(1H)-one (CAS Reg. No. 335356-94-0), approximately 16.7 percent 2,8-diamino-pyrimido(5,4-g)pteridine-4,6(1H, 7H)-dione (CAS Reg. No. 207283-72-5), and approximately 0.3 percent 8-amino-pyrimido(5,4-g)pteridine-2,4,6(1H,3H,7H)-trione (CAS Reg. No. 207283-92-9).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant in all food-contact polymers.
Limitations/Specifications: The FCS is used at levels not to exceed 0.5 percent by weight of all polymers in contact with all food types under Conditions of Use A through H.
Effective Date: Feb 13, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo