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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. 765

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: Anthra[2'',1'',9'':4,5,6;6'',5'',10'':4',5',6']diisoquino[2,1-a:2',1'-a']diperimidine-12,25-dione (CAS Reg. No. 6859-32-1) and Phenanthro[2'',1'',10'':4,5,6,7'',8'',9'':4',5',6']diisoquino[2,1-a:2',1'-a']diperimidine-8,13-dione (CAS Reg. No. 41635-87-4).
Notifier: BASF Aktiengesellschaft
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: To be used as a colorant in films, bottles, or tubes that may store food made of low-density polyethylene, high-density polyethylene, polyethylene terephthalate, acrylonitrile-butadiene-styrene terpolymer, polypropylene, polycarbonate, polystyrene, and nylon resins.
Limitations/Specifications: The FCS is to be used in repeat-use plastic containers at levels not to exceed 1 percent by weight of the final product that may contact all food types under Conditions of Use E through G, as described in Tables 1 and 2. The usage temperature would not exceed 70oC.
Effective Date: Mar 20, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo