Interest in ozone has expanded in recent years in response to consumer demands for ‘greener’ food additives, regulatory approval and the increasing acceptance that ozone is an environmentally friendly technology. The multi-functionality of ozone makes it a promising food processing agent. Excess ozone auto-decomposes rapidly to produce oxygen and thus leaves no residues in foods from its decomposition. In particular, the US Food and Drug Administration’s (FDA) rulings on ozone usage in food have resulted in increased interest in potential food applications worldwide. Ozone as an oxidant is used in water treatment, sanitizing, washing and disinfection of equipment, odor removal, and fruit, vegetable, meat and seafood processing.

Ozone is approved by the US Food and Drug Administration and the United States Department of Agriculture as an antimicrobial agent for use with food processing. With regulatory approval, ozone has become a great option for cost-effectively disinfecting food.

Ozone is listed on the National Organic Program. Ozone can be used as a gaseous and aqueous phases as an antimicrobial agent on food, including meat, seafood, produce and poultry. Ozone does not need any labeling of the final product.

National Organic Program:

Organic food products are gaining popularity throughout the world. As concerns from potentially harmful chemicals, hormones, and other synthetic based products grow, the allure of organic foods continues to increase. Organic foods are typically foods that are grown without pesticides, herbicides, chemicals, or growth hormones. This means the food you are eating is more natural and free of synthetic products.

The National Organic Program (NOP) was established by the USDA to create rules and guidelines to ensure that organic labeled foods are truly organic. The NOP is responsible for administrating and enforcing the regulatory framework for the national organic standards. The NOP regulations cover in detail all aspects of food production, processing, delivery, and sale. Ozone can be used as an ingredient in organic foods and maintain it’s organic labeling.


Vol. 66, No. 123
Tuesday, June 26, 2001


1. The authority citation for 21 CFR part 173 continues to read as follows: Authority: 21 U.S.C. 321, 342, 348.
2. Section 173.368 is added to subpart D to read as follows:

Sec. 173.368 Ozone.
Ozone (CAS Reg. No. 10028-15-6) may be safely used for 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 Sec. 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.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]

National Organic Rule 2000 Excerpt

The National List of Allowed and Prohibited Substances

205.600 Allowed and prohibited substances and ingredients in organic production and handling 

To be sold or labeled as “organic,” or “made with organic (specified ingredients),” the product must be produced and handled without the use of:

(a) Synthetic substances and ingredients, except as provided in §205.601 and § 205.603.
(b) Nonagricultural substances used in or on processed products, except as otherwise provided in § 205.605;
(c) Nonsynthetic substances prohibited in § 205.602 or § 205.604; and
(d) Materials, processes, or techniques prohibited in § 205.301.
205.601 Synthetic substances allowed for use in organic crop production.

In accordance with restrictions specified in this section and § 205.102 and § 205.200 through § 205.207, the following synthetic substances may be used:

2) Chlorine Materials – Except, That, residual chlorine levels in the water
shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. (i) Calcium Hypochlorite
(ii) Chlorine Dioxide
(iii) Sodium Hypochlorite

205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients).”
The following nonagricultural substances may be used only in accordance with any restrictions specified in this section and § 205.102, § 205.270, and § 205.300 through § 205.310.

9) Chlorine Materials – disinfecting and sanitizing food contact surfaces, Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act.
(i) Calcium Hypochlorite (ii) Chlorine Dioxide
(iii) Sodium Hypochlorite
(21) Ozone