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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. 892

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: 3,6-bis([1,1'-biphenyl]-4-yl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione (CAS Reg. No. 88949-33-1)(95 - 98 weight percent); 3-[4-(octadecylthio)phenyl]-6-([1,1'-biphenyl]-4-yl)-2,5 dihydropyrrolo[3,4-c]pyrrole-1,4-dione (CAS Reg. No. 960522-89-8)(2 - 5 weight percent); and 3,6-bis[4-(octadecylthio)phenyl]-2,5 dihydropyrrolo[3,4-c]pyrrole-1,4-dione (CAS Reg. No. 247089-62-9)(<0.1 weight percent).
Notifier: Ciba Corporation
Manufacturer/Supplier: Colors and Effects USA LLC
Intended Use: As a colorant for use in polypropylene homo- and copolymers that are authorized for use in contact with food.
Limitations/Specifications: For use at levels not to exceed 0.2 percent by weight of the finished polymer in contact with all types of food 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: Jul 23, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo