Regulatory Info

The anti-microbial properties, and related commercial applications, of ozone and aqueous ozone have been known for well over a century. Ozone is widely used in both municipal and industrial wastewater treatment and is now widely used to sanitize drinking water. The first commercialized drinking water treatment facility was implemented in The Netherlands in 1893. Uses for ozone and aqueous ozone have expanded well beyond water treatment.

The following is a summary of various government regulations and approvals:

  • In 1982, United States Food and Drug Administration (“FDA”) grants “GRAS” approval (generally recognized as safe) status for ozone disinfection of bottled water.
  • FDA – The FDA and the Center for Food Safety and Applied Nutrition (“CFSAN”) announced on June 26, 2001, the Final Rule published in Federal Register (21 CFR Part 173, Docket No. 00F-1482) “The FDA amends the food additive regulations to provide for the safe use of ozone in gaseous and aqueous phase as an anti-microbial agent on food, including meat and poultry.” Further citing that ozone is approved as a secondary food additive permitted for human consumption.
  • USDA – The United States Department of Agriculture (“USDA”) along with the Food Safety and Inspection Service (“FSIS”) declared on December 2001, USDA/National Organic Program (“NOP”) Ozone is listed in the NOP Final Rule (Subsection 205.605 (b) (20) p. 437 – nonagricultural (non-organic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients for food group(s)).” (b) Synthetics allowed: (20) Ozone. The use of Ozone on raw and ready-to-eat meat and poultry products just prior to packaging is acceptable. There are no special labeling requirements in regard to treated product.
  • EPA & FIFRA – Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) was first passed in 1947 with the intent of establishing procedures for registering pesticides with the U.S. Department of Agriculture and established labeling provisions. FIFRA mandates that Environmental Protection Agency (“EPA”) regulate the use and sale of pesticides to protect human health and preserve the environment. Under FIFRA’s definition of a pesticide, Ozone falls into this category and requires that a manufacturer of ozone devices register with the EPA. CleanCore’s EPA registration establishment number: #090379-NE-001
  • Health Canada has issued a letter of no objection to the use of our solution as a sanitizer in Canada for the following applications: General Use Sanitizer, Hand Disinfectant, Personal Hygiene Cleaner, Drain Cleaner, Food Packaging Materials, Food Contact (Hard) Surfaces. These and other approvals are be used as directed in Canada. Health Canada reference numbers: IS13041201/02, IS13041209 to IS13041216 & IP13101701.