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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. 1815

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 peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), with oxalic acid (CAS Reg. No. 144-62-7) and/or maleic acid (CAS Reg. No. 110-16-7).
Notifier: PeroxyChem, LLC
Manufacturer/Supplier: Evonik Active Oxygens, LLC
Intended Use: The FCS will be used as an antimicrobial agent for the commercial sterilization of aseptic filling equipment and polymeric food packaging prior to filling, except for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging.
Limitations/Specifications: The FCS may be used in the following applications. For each application, the concentration of PAA may not exceed 4000 parts per million (ppm) in the FCS.
  1. The FCS is applied as a fine mist or vapor on polymeric food packaging containers and closures without a rinse prior to filling with food. For this application of the FCS, the sum of the concentrations of oxalic and maleic acid may not exceed 267 ppm in the FCS. The maximum application rate in milliliters of FCS per packaging container is given by the formula: 70 x (container capacity in fluid ounces)/[PAA ppm] in the FCS.
  2. Food packaging containers and closures are filled with the FCS, drained, and rinsed with sufficient sterile water to achieve a theoretical 60-fold dilution of the FCS residue assumed to be 1 mg/cm2 on the interior container surface following draining.
  3. The FCS is applied as a spray to sterilize the non-food contact surfaces of aseptic filling equipment and subsequently rinsed with sterile water. 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.

The FCS is not intended for use on food packaging used in contact with infant formula or human milk or on aseptic filling equipment used to fill such packaging. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 29, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 186 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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