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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. 728

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: 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 (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 of polymeric food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for by 21 CFR Part 113, and as an antimicrobial on all polymers used to package acidic foods.
Limitations/Specifications: The maximum concentration of 1-hydroxyethylidine-1,1-diphosphonic acid in the food-contact substance solution will not exceed one percent of the solution. After application of the solution to the food packaging, the solution is rinsed from the package surface with sterile water. If the packaging surface is a film, the solution may be mechanically stripped in accordance with good manufacturing practice rather than rinsed from the food-contact surface. If the excess solution is to be mechanically stripped rather than rinsed, the concentration of the food-contact substance in the treatment bath must be reduced at least 37.5 fold (i.e. from 15 percent to 4,000 parts per million or less peroxyacetic acid), maintained at that dilution during operations, and drained and recharged with fresh solution when the total volume of the food-contact substance added as makeup reaches 90% of the volume of the solution bath reservoir.
Effective Date: Sep 12, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 482 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement