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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. 634

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 sterilizing polymeric food-contact packaging.
Limitations/Specifications: (1) The final peroxyacetic acid mixture shall contain not more than 2200 milligrams per liter of the FCS. (2) After application of the final peroxyacetic acid mixture to the food-contact surfaces of the 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 food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for in 21 CFR 113. (4) Packaging materials treated with the final peroxyacetic acid mixture may be used for packaging all commercially sterile foods under Conditions of Use A through H as described in Table 2. (5) Processed foods packaged in materials treated with the final peroxyacetic acid mixture shall conform with 21 CFR 108, 110, 113, and 114 as applicable.
Effective Date: Oct 7, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 550 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement