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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. 1857

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: An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-1), aluminum nitrate, nonahydrate (CAS Reg. No. 7784-27-2), and phosphoric acid (CAS Reg. No. 7664-38-2).
Notifier: PeroxyChem, LLC
Manufacturer/Supplier: Evonik Active Oxygens, LLC
Intended Use: The FCS is intended for use as an antimicrobial additive that may be used alone or in combination with other processes for the commercial sterilization of aseptic filling systems and packaging prior to filling. The FCS may be used on equipment and food packaging materials intended to contact infant formula products.
Limitations/Specifications: The FCS will be used as a 35 percent by weight aqueous hydrogen peroxide solution, with a maximum of 0.006 percent by weight aluminum nitrate, nonahydrate at the time of application. The concentration of hydrogen peroxide in distilled water packaged under production conditions (assay to be performed immediately after packaging) must not exceed 0.5 parts per million (ppm). The FCS may be used to sterilize polymeric packaging material (including packaging intended for contact with infant formula products) and the non-food contact surfaces of aseptic filling systems. FDAs review of the use of the FCS to sterilize aseptic filling systems is limited to the extent that the FCS residues may transfer from the non-food contact surfaces of the aseptic filling system to food packaging materials.
Effective Date: Feb 24, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 155 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 127 kB)