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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. 1454

Clariant International AG

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: 2-((1-(((2,3-Dihydro-2-oxo-1H-benzimidazol-5-yl)amino)carbonyl)-2-oxopropyl)azo)benzoic acid (CAS Reg. No. 31837-42-0).
Notifier: Clariant International AG
Manufacturer/Supplier: Clariant International AG
Intended Use: As a colorant in food-contact polymers, including repeat-use polymers that may contact infant formula and breast milk.
Limitations/Specifications: The FCS will be used at levels not to exceed 5% by weight in the finished polymers that may contact all food types under Conditions of Use A through H as described in Tables 1 and 2. Permitted uses in contact with infant formula and breast milk: the FCS may be used in repeat-use articles intended for feeding infants.
Effective Date: Sep 18, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo