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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. 118

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: 2,9-bis(4-(phenylazo)phenyl)anthra (2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H, 9H)-tetrone (C.I. Pigment Red 178; CAS Reg. No. 3049-71-6).
Notifier: BASF Corp.
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant for all polymers intended for use in contact with food.
Limitations/Specifications: For use at a level not to exceed 1 percent by weight of the finished food-contact article. The FCS (C.I. Pigment Red 178) will be used to color food-contact articles that contact all Food Types under Conditions of Use B through H.
Effective Date: Mar 9, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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