European Union regulations regarding ozone therapy

Roberto Quintero, Legal Advisor of AEPROMO e ISCO3


  • The European Union does not have specific legislation on ozone therapy, but there are some provisions that are applicable to ozone therapy. 
  • European Parliament resolution on non-conventional medicines. 
  • European Union Directive applicable to ozone medical equipment.


Complementary and alternative therapies

The European Parliament, since 1997, has asked the European Commission to adopt legislation on non-conventional medicines and establish the difference between complementary and alternative medicines. Legislation that has not yet been adopted. (A4-0075/97 Resolution on the regime of non-conventional medicines. Official Journal of the European Communities No. C 182/67, May 29, 1997).

Ozone therapy is a complementary therapy. This is stated in the Madrid Declaration on Ozone Therapy.


Medical ozone equipment in the European Union

European companies manufacturing medical ozone equipment are obliged to apply Council Directive 93/42/EEC (now the European Union) which includes this equipment in class IIb.

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