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The Biocidal Products Regulations (EU) 528/2012 (BPR) came into force on 1 September 2013 repealing the Biocidal Product Directive (Directive 98/8/EC) from this date. From 1 September 2013, Ozone is regulated as an “active substance” under the BPR.
Under the BPR, anyone who wishes to market an ozone generator for a Biocidal application within the EU must have their product authorised in accordance with the BPR. This process currently first requires an “active substance” dossier in respect of ozone to be submitted by September 2016 and thereafter a specific application for each product to be marketed within the EU to be submitted once the active dossier has been approved. This legislation may evolve further of course e.g. through updates to, and clarifications of, its scope.
The challenges that compliance with this regulation poses are too great for many companies to handle on their own both financially and technically.
As a consequence of this we have established EUOTA as a new Trade Association for ozone generator manufacturers supplying the European Market. The purpose of EUOTA is to pull together the numerous manufacturers of ozone generators into one organisation and create a functioning forum for discussing and advancing issues relevant to market participants for mutual benefit. The prohibitive costs and the multitude of compliance issues related to the BPR is obviously the key issue to be addressed at the present time. For the above reasons, EUOTA will also be used as a forum for actively considering the creation of a separate Registration Group for ozone as an active substance under the BPR. The rationale for establishing a new Registration Group would be to ensure access to an active substance dossier on ozone for all participating members on terms which are transparent, commercially fair and at a cost which would enable most ozone generator manufacturers to participate.