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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. 26

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: A solid solution of 2-naphthalenesulfonic acid, 5-(((5-chloro -4-methyl-2- sulfophenyl) azo) -6-hydroxy)-, strontium salt (1:1) and 2-naphthalenesulfonic acid, 5-((4-chloro -5-ethyl -2-sulfophenyl) azo) -6-hydroxy)-, strontium salt(1:1) (C.I. Pigment Red 276)
Notifier: BASF Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant for polymers intended for food-contact applications.
Limitations/Specifications: The colorants are limited to use levels not exceeding 2 percent by weight of the polymer and are subject to the provisions and definitions set forth in title 21 CFR 178.3297 Colorants for polymers. The finished food-contact articles may contact food 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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