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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. 771

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: The FCS is a mixture of 3,6-di-p-tolyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (88.6 percent), 3-p-octadecyloxyphenyl-6-p-tolyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (11.1 percent), and 3,6-di-p-octadecyloxyphenyl-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione (0.3 percent).
Notifier: Ciba Specialty Chemicals Corporation
Manufacturer: BASF Corporation
Intended Use: For use as a colorant in all food-contact polymers.
Limitations/Specifications*: The FCS is to be used at a level not to exceed 0.2 weight percent in the finished food contact article and in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: Mar 6, 2008
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo