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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. 1430

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) containing hydrogen peroxide at levels of up to 50%, manufactured and characterized as further described in the notification.
Notifier: PeroxyChem, LLC
Manufacturer/Supplier: Evonik Active Oxygens, LLC
Intended Use: As a sterilant/antimicrobial on aseptic polymeric food packaging material and on surfaces of aseptic food packaging equipment, except the FCS is not intended for use on food packaging material and/or aseptic food packaging equipment used with infant formula or breast milk.
Limitations/Specifications: 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) when the FCS is used as intended. The FCS is not intended for use on food packaging material and/or aseptic food packaging equipment used with infant formula or breast milk.
Effective Date: Jun 27, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5.2 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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