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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. 84

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: Color Index (C.I.) Pigment Yellow 212 Chemical Name: Benzoic acid, 2-((4,5-dihydro -3-methyl -5-oxo -1-(3-sulfophenyl)-1H-pyrazol-4-yl)azo)-,strontium salt (1:1) (CAS Reg. No. 250640-73-4).
Notifier: BASF Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant in all food-contact polymers.
Limitations/Specifications: For use as a colorant at levels not to exceed one percent by weight of the finished polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H, as described in Table 2. The average thickness of the polymers containing the food contact substance should not exceed 0.5 cm.
Effective Date: Oct 3, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 195 kB)
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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