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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. 340

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: Quino[2,3-b]acridine-7,14-dione,5,12-dihydro-2,9-dimethyl- (also known as Pigment Red 122) (CAS Reg. No. 980-26-7).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: The FCS will be used as a colorant for polymers.
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.5 percent by weight of the finished polymer. The FCS in finished articles is intended to contact all food types under Conditions of Use A through H as described in Table 2. Use of the colorant is subject to the provisions and definitions set forth in paragraphs a and b of 21 CFR 178.3297.
Effective Date: Nov 7, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo