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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. 561

Evonik Active Oxygens, 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: A mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and water.
Notifier: PeroxyChem, LLC
Manufacturer/Supplier: Evonik Active Oxygens, LLC
Intended Use: The FCS will be used as a part of the process to treat food-contact surfaces to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR Part 113.
Limitations/Specifications: After application of the mixture (solution) to the food contact surfaces of the food packaging, the surface is rinsed with sterile water. The maximum concentration of HEDP in the treatment solution will not exceed 1 percent. Processed foods packaged in materials treated with the FCS shall conform with 21 CFR Parts 108, 110, 113, and 114, as applicable.
Effective Date: Feb 22, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 433 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement