The use of ozone as a disinfectant has fallen under the biocidal regulation (EU) 528/2012 (BPR) since 1-9-2013. This means that ozone equipment intended for disinfection must be certified.
At the moment this certification process is still in full swing. It is expected that this process will be completed in 2020. This means that from then on only certified ozone equipment for disinfection may be in use.
Equipment that is not certified may no longer be used. This applies retroactively, even already existing systems must then be certified!
The certification process consists of two steps:
Submission of an active substance dossier.
The active substance dossier for ozone contains information about the effectiveness, safety, chemical properties, etc.
This dossier has now been submitted for assessment.
Submission of a product dossier
A product dossier contains information about the construction of ozone equipment but also about the construction of an ozone system for a specific application. This dossier can only be submitted when the active substance dossier has been approved.
To be able to draw up a product dossier and have it assessed, access to the active substance dossier is necessary. Without access to the active substance dossier, it is not possible for a manufacturer to certify ozone equipment.
Access to this dossier can be obtained by a manufacturer by means of a so-called Letter of Acces (LoA) or by submitting an active substance dossier itself.
Tol Watertechniek is co-owner of an active substance dossier. This means that we have access to the file and can submit a product dossier in order to certify our equipment.
The exact definition of disinfection is not entirely clear at the moment. In some applications, disinfection means the complete killing of bacteria, fungi, etc. In other applications, disinfection means keeping the bacterial pressure constant.
Which applications will all fall under the biocidal regulation is therefore still uncertain. The fact is that if a party claims to disinfect with ozone, the system must certainly be certified.
Applications such as keeping germs free in storage rooms, swimming pool water disinfection or disinfecting (drinking) water will certainly fall under the regulations.
This is not yet certain for applications in aquaculture such as lowering bacteria count at fish farms, zoos and ponds.
Tol Watertechniek is working hard to certify our systems so that our systems can be used for every application.
Note: AOP (Advanced Oxidation Process) systems using ozone are also covered by the biocidal regulation