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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. 2038

Colors and Effects USA LLC

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: Benzenesulfonic acid, 2-[2-(2,4-diamino-1,6-dihydro-6-oxo-5-pyrimidinyl)diazenyl]-5-methyl- (CAS Reg No. 1021701-36-9).
Notifier: BASF Schweiz AG
Manufacturer/Supplier: Colors and Effects USA LLC
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 is intended for use at a level not to exceed 0.5 percent by weight in polymers in contact with all foods under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not intended 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: Apr 9, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.0 MB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 106 kB)