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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. 2313

Sun Chemical 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: 2,5-Dihydro-3,6-bis(4-methylphenyl)pyrrolo[3,4-c]pyrrole-1,4-dione (CAS Reg. No. 84632-66-6).
Notifier: Colors and Effects Switzerland AG
Manufacturer/Supplier: Sun Chemical Corporation
Intended Use: As a colorant in all food contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels up to 0.2% by weight of polymers in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2, respectively. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 2, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 158 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 121 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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