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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. 656

Colorants Solutions 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: Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[3-(dodecylsulfonyl)phenyl]-2,5-dihydro- (CAS Reg. No. 884862-07-1).
Notifier: Clariant Plastics & Coatings USA, Inc.
Manufacturer/Supplier: Colorants Solutions USA LLC
Intended Use: As a surface modifier in colorants for polymers.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.06 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.
Effective Date: Nov 14, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo