U.S. FDA Regulatory Approval of Ozone as an Antimicrobial

In June 2001, the U.S. Food and Drug Administration (FDA) officially approved the use of ozone as an antimicrobial agent for food treatment, storage, and processing. This regulatory milestone allowed ozone to be applied directly to food products—including meat, poultry, fruits, and vegetables—provided it is used in accordance with Good Manufacturing Practices (GMP).

Prior to this approval, ozone had already been widely recognized for its disinfectant properties in water treatment applications, including bottled water. In fact, ozone was granted GRAS (Generally Recognized As Safe) status by the FDA in 1982 for use in bottled water processing. However, its broader use in food systems remained limited due to regulatory classification requirements under the Federal Food, Drug, and Cosmetic Act, which mandates approval for any substance that comes into contact with food.

Subsequent evaluations, including a 1997 Expert Panel convened by the Electric Power Research Institute (EPRI), reaffirmed ozone’s safety and effectiveness as a food disinfectant. This led to the submission of a consolidated Food Additive Petition in 2000, ultimately resulting in FDA approval for both aqueous and gaseous ozone applications across a wide range of food processing environments.

Today, ozone is used in various antimicrobial applications such as surface sanitation, cold storage preservation, wash water treatment, and pathogen reduction in raw agricultural commodities. The FDA approval also clarified that ozone used in food processing is not classified as a pesticide chemical, distinguishing it from ozone generator equipment, which remains regulated as a pesticide device under the U.S. Environmental Protection Agency (EPA) through FIFRA.

The following technical document summarizes the regulatory history behind ozone’s GRAS affirmation, outlines FDA approval criteria, and presents application-specific treatment concentrations for effective microbial control in food products.

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