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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. 984

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: 1,4-Cyclohexanedicarboxylic acid, polymer with 1,4-cyclohexanedirnethanol, 2-(3-hydroxypropyl)-6-[(3-hydroxylpropyl)aniino]-1H-benz[de]isoquinoline-1,3-(2H)-dione and 1,3-pentanediamine, 2-hydroxy-3-phenoxypropyl ester (CAS Reg. No. 519050-54-5).
Notifier: DayGlo Color Corporation
Manufacturer: DayGlo Color Corporation
Intended Use: To be used in polypropylene films and molded articles that may contact all food types under Conditions of Use B through H, and J as described in Tables 1 and 2. The FCS, used as a colorant, will be subject to the provisions set forth in 21 CFR 178.3297.
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.25 weight percent in the final product when intended for contact with all food types under FDA's Conditions of Use B through H, at levels not to exceed 0.25 weight percent in the final product when intended for contact with food types I, II, IVB, VIA-B, VIIB, and VIII under FDA's Condition of Use J (microwave only), and at levels not to exceed 0.10 weight percent in the final product when intended for contact with food types III, IVA, V, VIIA, and IX under FDA's Condition of Use J (microwave only).
Effective Date: Aug 3, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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