EBO2 (EBOO) Around the World: What Regulators Outside the US Have Said

EBO2 (also called EBOO) is not approved by any regulator whose documents we hold, in the United States or anywhere else. In the US, ozone therapy is not FDA-approved for any condition [1]. Outside the US, we hold primary documents from Italy, Germany, Brazil, the United Kingdom, Canada, and Australia. None of them approves EBOO, and only one names it: a German insurance review from 2001 that judged the first EBOO study in patients unsuitable as evidence of efficacy [2][3][4][5][6][7]. This guide sets out what each says, with the original words and our English rendering, and what kind of document each one is, so that a claim of approval abroad can be checked against the document itself. Our guide on FDA status covers the United States.

What kind of document each one is

A foreign document can matter a great deal or very little, depending on what kind of decision it records. A warning to one advertiser or one clinic is not a ruling on the technique.

The documents side by side

Each quotation below is copied exactly from the document. Where the original is not in English, the translation that follows it is ours. Status is as we found it on October 2, 2026.

Italy: where EBOO began, and where it is limited to trials

The research group that described EBOO in the late 1990s and 2000s worked in Siena, in Tuscany [19][20]. Italy’s national position comes from a Health Ministry circular of January 2005 to the regional health departments [2]. It says that a 2002 ministry note confining oxygen-ozone therapy to hospital trials is not legally binding, so a doctor may still use the method “sotto la propria diretta ed esclusiva responsabilità” (our translation: “under his or her own direct and exclusive responsibility”) with the patient’s informed consent [2]. It warns that departing from the Superior Health Council’s views could expose a doctor, after an incident, to criminal or civil liability, and it relays that council’s 2003 opinion that the therapy should be given only in ethics-approved trials in hospitals, with the words quoted in the table [2].

Tuscany’s regional bodies have addressed the therapy four times. In 2006 the regional health council limited the therapy’s indications to symptomatic disc herniation treated by injection [9]. In 2007 it said oxygen-ozone therapy is possible only in controlled clinical trials, apart from the doctor’s own responsibility, “non esistendo alcuna indicazione suffragata da evidenze” (our translation: “since no indication supported by evidence exists”) [15]. In 2015 it classed ozone therapy as an invasive procedure that needs authorized premises, and attached the National Blood Centre’s opinion on autohemotherapy with added ozone and oxygen, the Italian text closest to EBOO: the practice must be prepared under sterile conditions and is “introduzione di materiale autologo manipolato” (our translation: “introduction of manipulated autologous material”), not venipuncture [16]. In 2018 the region’s clinical governance body ruled on an intravenous “liquid polyatomic oxygen” therapy, said it is not oxygen-ozone therapy, allowed it only in authorized facilities within controlled trials, and recorded that Italian ozone therapy societies “hanno vietato questo uso dal 1984” (our translation: “have banned this use since 1984”) for direct intravenous injection of the gas [14][13].

At the national level, a consensus conference that the ISS held on the therapy in 2006 addressed paravertebral injections for disc-related sciatica, not blood treatments [21]. In March 2020, after press reports that it had approved ozone therapy for COVID-19 patients, the ISS said that issuing such authorizations is not its role and that it had issued none [17].

Germany: excluded from statutory health insurance since 2001

On December 11, 2000, Germany’s Federal Committee of Physicians and Health Insurance Funds assigned ozone therapy to Annex B, “nicht anerkannte Methoden” (our translation: “methods not recognized”), of its guidelines for evaluating medical methods in statutory health insurance; the decision, which the Federal Ministry of Health did not object to, was published in March 2001 and has been in force since March 23, 2001 [3]. The committee’s 2001 report covers ozone therapy, ozone autohemotherapy, oxygen-ozone autohemotherapy, oxyon therapy, and hyperbaric ozone therapy, and concluded that for every indication reviewed it found no reliable evidence of benefit and medical necessity [3].

Of the foreign documents in this guide, the report is the only one that names EBOO. Its literature appendix summarizes the first EBOO report in patients, published in 2000 by the Siena group: a system for ozonating blood outside the body, tested first in sheep and then in a pilot study of seven patients with advanced arteriosclerosis, who had two one-hour sessions a week, 14 in all [3]. The paper’s own abstract gives no patient total, as our guide to the evidence notes; the count of seven is the committee’s. The committee’s verdict on that paper is the one in the table: not suitable as evidence of efficacy [3].

The exclusion is still in force. In the methods guideline of today’s Federal Joint Committee (G-BA) as amended on March 19, 2026, Annex II, titled “Methoden, die nicht als vertragsärztliche Leistungen zu Lasten der Krankenkassen erbracht werden dürfen” (our translation: “methods that may not be provided as contract-physician services at the expense of the health insurance funds”), lists “Ozon-Therapie, Ozon-Eigenbluttherapie, Sauerstoff-Ozon-Eigenbluttherapie, Oxyontherapie, Hyperbare Ozontherapie” as item 35, and separately lists the intravascular insufflation of oxygen and other gases [10]. The guideline binds statutory insurers, their contracted doctors, and insured patients, and it notes an exception, set by Germany’s Federal Constitutional Court, for patients with a life-threatening disease and no standard treatment [10]. It concerns what public insurance pays for; it does not address treatment that patients pay for privately.

An earlier version of our FDA guide, following a practitioner association’s summary, dated this decision to December 2020. The committee’s own report dates it to December 11, 2000 [3].

Brazil: legal as a complementary procedure, within listed uses

Of the countries in this guide, Brazil is the only one whose documents include a national law on ozone therapy. The 2023 law authorizes it as a complementary procedure on three conditions: a university-level health professional registered with a professional council performs it, using an ozone generator regularized by the health regulator Anvisa, and tells the patient that the procedure is complementary [8].

The Federal Council of Medicine’s 2025 resolution sets the rules for physicians [4]. It authorizes ozone therapy as an adjuvant for diabetic foot ulcers, ischemic arterial ulcers, acute infected wounds, and chronic venous ulcers, applied “exclusivamente por via tópica” (our translation: “exclusively by the topical route”), and for knee osteoarthritis by injection into the joint and disc-related low back pain by spinal injection, with facility and specialist requirements [4]. It bars use on neoplastic wounds outside approved research, requires an Anvisa-regularized generator, and revoked the council’s 2018 resolution [4]. The resolution does not mention EBOO. Its statement of reasons says the studies reviewed for fibromyalgia used “auto-hemotransfusão ozonizada” (our translation: “ozonated autohemotransfusion”), and that for fibromyalgia and other pain conditions the evidence was insufficient or of low quality, so those uses are not recommended outside clinical research [4].

Anvisa’s 2026 technical note lists the uses it recognizes for ozone-emitting devices: skin cleansing with ozonated water vapor, local dental uses, and, as an adjunct, bagged ozone-oxygen gas for diabetic foot ulcers and acute infected wounds in adults [11]. It warns that exposure to ozone by routes, forms, or concentrations other than the approved indications “pode levar à ocorrência de danos severos” (our translation: “may lead to severe harm”) [11]. No Brazilian document we hold authorizes treating blood with ozone outside the body. Anvisa’s page for the note still uses the web address of the 2022 note it replaces; the page records that it was created in June 2022 and modified on June 26, 2026 [22].

United Kingdom: an advertising ruling, not a ruling on the technique

The UK documents we hold come from the advertising regulator. In March 2022 the Advertising Standards Authority upheld a complaint about one clinic’s web page for “IV Ozone Therapy”, which claimed that ozone raises dissolved oxygen in the blood and is anti-inflammatory, antibacterial, antiviral, and antifungal [5]. The clinic sent no evidence; the ASA said it understood IV ozone therapy to be a form of oxygen therapy, found the claims unsubstantiated and misleading, and told the clinic not to repeat them without “a substantive body of evidence” including “clinical trials conducted on people” [5]. Because the clinic kept making health claims, the ASA placed it on its list of non-compliant advertisers on March 31, 2022, and it was still there on October 2, 2026 [18].

The advertising code’s own advice note on oxygen therapy, updated in February 2024, says the ASA and the code’s committee “have yet to see convincing evidence” that oxygen used as an alternative therapy in hyperbaric chambers is effective for health conditions, and it states that it does not bind the ASA [23]. Neither document licenses or bans a treatment.

Canada: a licence is required for ozone saunas, and none has one

Health Canada’s 2022 advisory concerns ozone saunas, steam cabinets fed by an ozone generator. It says they need a medical device licence to be imported and sold, that Health Canada has not licensed any, and that it is illegal to advertise, import, or sell medical devices in Canada without the appropriate licence [6]. It adds that the use of medical devices is part of the practice of medicine, “regulated at the provincial and territorial level”, and points readers to Health Canada’s Medical Devices Active Licence Listing to check whether a device is licensed [6]. The advisory does not mention EBOO.

Australia: two orders against clinics, and what they say about devices

The New South Wales Health Care Complaints Commission barred a Castle Hill ozone clinic, and anyone working under it, from providing any health service while it investigated, from August 2024 until May 2025; the order’s page states no findings [12]. In April 2025 it barred a Penrith clinic from providing any health service, including ozone therapy, for five years [7]. The Commission found that the clinic’s non-registered practitioner used devices “not approved by the TGA”, Australia’s therapeutic goods regulator, including an ozone generator and a UV device; obtained heparin “from an unknown source” and “is not authorised to be in possession of, or to administer” it; had no infection-control procedures or patient records; and, according to expert opinion, most likely caused a patient’s serious infection, which led to septic shock [7].

The Commission’s statement of decision describes the procedures it examined: ozonated saline given by intravenous drip, and ultraviolet blood irradiation in which blood was mixed with ozonated saline and run through a UV device before being returned; the clinic’s website also listed minor autohemotherapy and ozone saunas [24]. None of these is EBOO as our description of the procedure sets it out. It records the Therapeutic Goods Administration’s statements that the devices were not on the Australian Register of Therapeutic Goods and “cannot be used in medical procedures in Australia” [24]. Among the devices, both the Commission and the FDA’s July 2025 warning letter name a product called Champion Full Spectrum. The FDA letter says O3UV makes its Champion Full Spectrum devices, while the Commission attributes the device it found to a firm it calls Q-Tubes and lists quartz cuvettes made by O3UV among the other unregistered items [25][24]. Both orders concern one clinic each. Our guide to EBOO devices and FDA status reports what the FDA’s databases show for that and other device names.

How to check a claim that EBOO is approved abroad

When a clinic, including any listed in our directory, says EBOO is approved, accepted, or standard in another country, these questions separate a regulator’s decision from a reputation:

1. Which body? A ministry, a health regulator, a professional council, an insurer’s committee, an advertising regulator, or a practitioners’ association are different things, and only some of them decide anything.
2. Which document, and what kind? Use the first table above: a law, a professional rule, a coverage decision, an advisory, an advertising ruling, or an order against one clinic.
3. Which condition and which route? Brazil’s authorizations are for named wounds, a joint, and the spine, by topical or injected routes [4]. A permission for one use says nothing about ozonating blood.
4. Is the device registered there? Each country’s documents name its device register: Anvisa regularization in Brazil [8], Health Canada’s licence listing [6], and the Australian Register of Therapeutic Goods [24]. On those regulators’ own accounts, a device that is not on the register may not be sold for medical use (Brazil and Canada) or used in medical procedures (Australia) [11][6][24].
5. Does the document mention EBOO? Only one of the foreign documents in this guide does, the German committee’s 2001 report, and it judged the EBOO study it reviewed unsuitable as evidence of efficacy [3].

What we could not verify

• Countries without a primary document in our files. Practitioner associations publish accounts of where ozone therapy is regulated, including Spain, Greece, Portugal, Russia, and Cuba. Our sourcing rules let us read only public institutions’ own documents directly, and we have none from those countries yet, so we make no claim about them.
• Private practice in Germany. The G-BA documents govern statutory health insurance. We have no German document on whether, or under what conditions, doctors may offer ozone therapy to patients who pay privately.
• Later changes. We could not search the Brazilian medical council’s register of norms for later acts, or Italy’s ministry archive for a document replacing the 2005 circular. Each status above is what the document’s own page showed on October 2, 2026.
• The Castle Hill outcome. The New South Wales order’s page ends with the interim order expiring in May 2025 and records no findings or final order.
• Device registers. We did not search Health Canada’s licence listing, the Australian register, or Anvisa’s product database for EBOO equipment.
• European device law. We hold no document from the European Commission or a national device regulator in the European Union on ozone generators or EBOO systems.
• Translations. The English renderings of Italian, German, and Portuguese passages are ours and have not been checked by a professional translator.

How this guide was made

This guide draws on 25 sources, all of them regulators’, ministries’, and professional bodies’ own documents except two papers by EBOO’s developers that establish where the technique began. We read each document in its original language, from the issuing body’s site or, for the 2005 Italian circular, from the Tuscan region’s published copy, and checked on October 2, 2026 that each regulator’s document was still online and what its page said about its status. Where a quoted passage is not in English, the English rendering is ours. The “From our data” section lists the newest records in our regulatory dataset. Drafting used AI tools. A human editor has not yet checked this guide claim by claim against its sources, and no clinical reviewer has signed off yet.