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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. 1471

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 percent, 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 (1) polymeric food packaging material, used in contact with infant formula and breast milk, and (2) surfaces of aseptic food packaging equipment for infant food-contact applications.
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. Permitted uses: The FCS may be used in polymeric packaging material intended for contact with infant formula and breast milk and on the surfaces of aseptic food packaging equipment for infant food contact applications.
Effective Date: Oct 30, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.1 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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