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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. 802

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: Benzoic acid, 2-hydroxy-, monosodium salt (CAS Reg. No. 54-21-7).
Notifier: PeroxyChem, LLC
Manufacturer/Supplier: Evonik Active Oxygens, LLC
Intended Use: As a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in treating food-contact surfaces of polymeric food containers to reduce or eliminate microbial contamination.
Limitations/Specifications: (1) The final peroxyacetic acid mixture shall not contain more than 2200 milligrams per liter of the FCS at the time of application to food packaging. (2) After application of the final peroxyacetic acid mixture to the food-contact surfaces of food packaging, these surfaces will be rinsed with sterile water. (3) The peroxyacetic acid mixture containing the FCS may be used by itself or in combination with other processes to treat polymeric food containers prior to fill to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR 113 or as an antimicrobial on packaging for any acidic food. (4) Packaging materials treated with the final peroxyacetic acid mixture may be used for packaging all acidic foods under Conditions of Use A through H as described in Tables 1 and 2.
Effective Date: May 1, 2008
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 538 kB)
FDA Decision: Finding of No Significant Impact (FONSI)