From September 1st 2013 Ozone is regulated as an biocidal active substance. Under EU law the Biocidal Products Regulation requires both substance approval as well as product authorisation for ozone equipment.
EU Biocidal Products Regulation: From September 1st 2013 Ozone is regulated as an active substance under Regulation (EU) No 528/2012, which firstly requires a dossier for the approval of the substance ozone.
First, ozone itself has to be added to the list of approved “active substances” (AS). This will take place following the approval of ozone as an active substance in turn based upon the submission of an active substance dossier to the European Chemicals Agency (ECHA) and the positive evaluation by a European Competent Authority.
Secondly, the actual in-situ produced substance ozone needs to be authorized as “biocidal product”. it is unlikely that (end-)users of ozone equipment will be able to complete the authorization procedure by own means. this is mainly due to detailed specialist know-how being required and the high cost associated with the process.
The manufacturers of the equipment ideally support their customers for fulfilling the required biocidal product (ozone) authorization of ozone and the involved equipment.
Therefore EurO3zon has filed on the 5th of June 2015 four active substance dossiers for ozone covering the following product types (PT):