Following the approval of ozone as an active substance, all ozone applications need 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.
Manufacturers of ozone equipment will have effectively the duty to take care about the authorization process based
on the LoA-ownership of an approved active substance dossier.
The product authorizations have to start directly after approval of the active substance, which is expected 2017/2018.
Based on the detailed know-how gathered in the approval process of the BPR, EurO3zon decided to
make a product authorization, which can cover also the biocidal products of EurO3zon LoA-owners and
avoiding huge extra-costs for individual product authorizations.
Negotiations with the authorities on this subject are in process and ongoing.
In the Competent Authority (CA) meeting of September 2015 in Brussels the Dutch CA offered to develop a guidance document to specify information requirements for in situ generated free radicals for substance approval and for product authorisation in the context of the BPR. EurO3zon was invited to participate in this workshop allowing us to represent the interests of the European ozone industries.