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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. 1359

DayGlo Color 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: Ethanedioic acid, 1,2-diethyl ester, polymer with α-(2-aminomethylethyl)-ω-(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl], 5-amino-1,3,3-trimethylcyclohexanemethanamine and 1,5-dichloro-9,10-anthracenedione, reaction products with succinic anhydride (CAS No. 1427038-10-5).
Notifier: DayGlo Color Corporation
Manufacturer/Supplier: DayGlo Color Corporation
Intended Use: As a colorant in polypropylene products that may contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is to be used at no more than 0.15% by weight in polypropylene films or molded articles that may contact all food types under conditions of use B through H and J as described in Table 2. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Feb 21, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo