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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. 798

Modern Chemical Corporation Limited

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: 12H-Phthaloperin-12-one, 8,9,10, 11-tetrachloro- (CAS Reg. No. 20749-68-2).
Notifier: Ciba Corporation
Manufacturer/Supplier: Modern Chemical Corporation Limited
Intended Use: As a colorant for use in polyethylene terephthalate polymers complying with 21 CFR 177.1630.
Limitations/Specifications: For use in contact with all types of food at levels not to exceed 0.2 percent by weight in the polymer, under Conditions of Use D through G, as described in Table 2.
Effective Date: Apr 19, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo