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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. 25

BASF Corporation

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: 1-Naphthalenesulfonic acid, 2-((4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl) azo)-, calcium and/or strontium salt (1:1)(C.I. Pigment Yellow 209 and C.I. Pigment Yellow 209:1)
Notifier: BASF Corporation
Manufacturer: BASF Corporation
Intended Use: As colorants for all polymers intended for food-contact applications.
Limitations/Specifications*: The colorants are limited to use levels not exceeding 1 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)
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