EU Ozone Registration Group

From September 1^st 2013 Ozone is regulated as an active substance. Under EU law the Biocidal Product Regulation requires both substance and product registration for ozone equipment. Four manufacturers of ozone equipment have joined forces to prepare and submit an active substance dossier for the approval of ozone.

Since September 1^st 2013 the Biocidal Product Regulation EU/528/2012 (BPR) is in force and is superseding the former Biocidal Product Directive 98/8/EC (BPD). In the past ozone was already recognised as a biocide, but its registration obligations were exempted under the BPD; following special rules for in-situ produced biocides. This special status has now been revoked under the BPR. As a result ozone equipment which is placed in the EU market for biocidal applications (e.g. disinfection) requires EU authorisation. After September 2017 the transitional periods will come to an end and compliance with the BPR is required.

The authorisation is a two-step procedure. First, ozone itself has to be added to the list of approved “active substances” (AS). Second, the ozone generation equipment needs to be authorised as “biocidal product”. It is unlikely that users of ozone equipment will be able to undertake the authorisation procedure alone. This is due to detailed specialist know-how required and the high cost associated with the process. Therefore the manufacturers of the equipment will have to provide the biocidal product authorisation of ozone equipment to their customers.

Four ozone equipment manufacturers have joined forces as part of the “Ozone Registration Group” to accomplish the authorisation of ozone as an active substance. These manufacturers are BWT, Degrémont Technologies (Ozonia), ProMinent (Germany) and Xylem (WEDECO). The target of this joint effort is to submit a so called “active substance dossier” for ozone; addressing several ozone applications (product types) and have ozone finally added to the list of active substances. This can be expected from
September 1^st 2017 onwards.

The Ozone Registration Group will provide access to their AS dossier by means of a “Letter of Access” (LoA). This will be available to anyone in need to carrying out the biocidal product registration and waiving the requirement of writing and submitting an own active substance dossier for ozone. This is providing a huge benefit regarding time and expenditure. The Ozone Registration Group will offer LoAs as regulated under the BPR to any external party.