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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. 370

Colors and Effects USA LLC, 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: Dibutyl sebacate (CAS Reg. No. 000109-43-3).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer/Supplier: Colors and Effects USA LLC, BASF Corporation
Intended Use: As a dispersing agent for pigments used as colorants in all polymers.
Limitations/Specifications: For use at a maximum level of 0.015 percent by weight in the finished polymer under conditions of use A through H as described in Table 2. The finished polymer may be used in contact with all food types as described in Table 1.
Effective Date: Dec 23, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 193 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement