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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. 23

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: C.I. Pigment Red 277, a solid solution of 1-naphthalenesulfonic acid, 2-((2-hydroxy-6 -sulfo-1-naphthalenyl)azo)-, stronium salt (1:1) (CAS Reg. No. 250639-69-1) and 2-naphthalenesulfonic acid, 5-((4-chloro-5-ethyl-2-sulfophenyl) azo)-6-hydroxy-, strontium salt (1:1) (CAS Reg. No. 197566-90-8)
Notifier: Engelhard Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant in food-contact polymers. The colorant is to be used in compliance with 21 CFR 178.3297.
Limitations/Specifications: At levels up to 2 percent by weight in all types of food-contact polymers under Conditions of Use A through H as described in Table 2.
Effective Date: Apr 8, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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