• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

  • Print
  • Share
  • E-mail
-

FCN No. 2198

Bioionix, Inc.

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: Hypochlorous acid (CAS Reg. No. 7790?92?3).
Notifier: Bioionix, Inc.
Manufacturer/Supplier: Bioionix, Inc.
Intended Use: For single use as an antimicrobial agent in an aqueous solution in the production and preparation of whole or cut meat and poultry; processed and preformed meat and poultry; fish and seafood; fruits and vegetables; plant-based proteins used as meat substitutes; shell eggs and cheese, except in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be manufactured by a device on-site and the concentration of available free chlorine at the point-of use of the FCS will not exceed 60 ppm for any process but is limited to a maximum 6 ppm for cheese salt brining. The aqueous solution containing the FCS may be used in processing facilities as follows:
  1. in process water or ice which comes into contact with food as a spray, wash, rinse, dip, chiller water, and scalding water for whole or cut meat and poultry, including carcasses, parts, trim, and organs;
  2. in process water, ice, or brine used for washing, rinsing, or cooling of processed and pre-formed meat and poultry products;
  3. in process water or ice for washing, rinsing or cooling fruits and vegetables;
  4. in process water or ice for washing, rinsing or cooling whole or cut fish and seafood;
  5. in process water for washing or rinsing shell eggs;
  6. in process water for washing, rinsing or cooling plant-based proteins used as meat substitutes; and
  7. in process water for washing, rinsing, or cooling cheese and in brine for producing cheese.
When used in water to process fruits and vegetables, the treatment will be followed by potable water rinse to remove, to the extent possible, residues of the FCS. Treated seafood products intended to be consumed raw shall be followed by a potable water rinse prior to consumption. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 28, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1.3 MB)
FDA Decision: Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 257 kB)

96  

-
-