Food products such as meat and poultry have been GRAS (Generally Regarded As Safe)-approved for direct contact with Ozone by both the FDA and USDA.
In accordance with GRAS, ozone can be used in the food industry regardless of how it is processed or what levels of ozone it contains, as long as good manufacturing procedures are followed.
FDA approved GRAS status for ozone in 2001, and USDA approved GRAS status in 2002.
History of Ozone Before GRAS status:
U.S. Department of Agriculture approves the use of gaseous ozone for meat storage in 1957. Performing ozone treatment in a closed system for at least five minutes is the minimum requirement for Good Manufacturing Practices (GMP) for the bottled water industry. Ozone treatment for GMP must be at least 0.1 parts per million (0.1 mg/l).
Specifically for bottled water applications, ozone is GRAS-approved by the USDA specifically for bottled water sanitizing applications. In the GRAS approval, it was stated that “all other applications for food additives containing ozone must be presented to the FDA.”
The FDA granted GRAS status to ozone for use in food processing by a panel of experts in the fields of food science and ozone technology on June 14, 1997.
Energy Power Research Institute (EPRI) commissioned this panel of experts for the purpose of applying for GRAS status to ozone. The EPRI compiled the initial petition which was submitted to the FDA and USDA in 2000.
Current Regulations About Ozone
USDA final rule on ozone dated 12/17/2002, FSIS Directive 7120.1
The use of safe and suitable ingredients in meat and poultry production.
FSIS Directive 7120.1 States:
Ozone for use on all meat and poultry products. Ozone can be used in accordance with current industry standards of good manufacturing practice. No other guidelines are given on levels or dosages of ozone.
USDA 21 CFR 173.368 is the reference used in FSIS directive 7120.1
USDA 21 CFR 173.368 States:
Ozone (CAS Reg. No. 10028–15–6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions: (a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen. (b) The additive is used as an antimicrobial agent as defined in § 170.3(o)(2) of this chapter. (c) The additive meets the specifications for ozone in the Food Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Office of Premarket Approval (HFS–200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. (d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice. (e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.
Federal Register Vol. 66 No. 123 states:
The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ozone in gaseous and aqueous phases as an antimicrobial agent on food, including meat and poultry. This action is in response to a petition filed by the Electric Power Research Institute, Agriculture and Food Technology Alliance.(Ref: https://www.govinfo.gov/content/pkg/FR-2001-06-26/html/01-15963.htm)