EPA – Environmental Protection Agency
Ultra-Lyte® is registered with the U.S. Environmental Protection Agency (EPA) as a medical and hospital disinfectant, including effectiveness against:
- Clostridioides difficile (C. diff)
- Candida auris
EPA Registration Number: 86854-1
Classification:
- Category 4 Biocide
- Category 3 (Eye Effect)
FDA – Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has added two Food Contact Substance Notifications (FCNs) submitted by Clarentis Technologies to its inventory of effective food contact substances.
FCN 2188
The FDA determined a Finding of No Significant Impact (FONSI) for the use of hypochlorous acid (CAS Reg. No. 7790-92-3) as an antimicrobial agent in aqueous solutions used during the production and preparation of:
- Whole or cut meat and poultry
- Processed and preformed meat and poultry
- Fish and seafood
- Fruits and vegetables
- Shell eggs
FCN 2316
The FDA also issued a Finding of No Significant Impact (FONSI) for the use of hypochlorous acid (CAS Reg. No. 7790-92-3) as an antimicrobial agent in aqueous solutions used during the production and preparation of:
- Fish and seafood
- Fruits and vegetables
- Shell eggs
This FONSI explains how the FDA satisfied the requirements of the National Environmental Policy Act (NEPA) for FCN 2316.
WHO – World Health Organization
In 2025, the World Health Organization (WHO) added an aqueous solution containing more than 150 ppm hypochlorous acid to its List of Essential Medicines.
Reference: TRS 1064
USDA – United States Department of Agriculture
Ultra-Lyte® received USDA approval as a disinfectant for use on poultry and beef.
Reference:
- FSIS Directive 7120.1, Revision 2, Page 12
- April 12, 2010
- United States Department of Agriculture (USDA) Food Safety and Inspection Service
Research Installation
On April 30, 2012, a Mini-Lyte Unit was purchased and installed at a USDA research facility to generate the solutions used in the study:
Morphological Effects of Pulsed Ultraviolet Light and Anolyte Treatment on Bacterial Cell Wall
- Published: October 2013
- Author: Kathleen T. Rajkowski
- Eastern Regional Research Center
- Agricultural Research Service
- U.S. Department of Agriculture
- Food Safety and Intervention Technologies Research Unit
- 600 East Mermaid Lane, Wyndmoor, PA 19038
USDA Organic
Electrolyzed water is approved for use in organic operations under USDA Organic standards.
Health Canada
Ultra-Lyte® is registered by Health Canada as a Medical & Hospital Disinfectant.
Registration Details
- DIN: 02362546
- CFIA File/Dossier: P681
