Authorization of ozone systems pursuant to the EU Biocidal Product Regulation
BWT in the Ozone Registration Group
EU Biocidal Products Regulations: From September 1st 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 1st 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 recognized 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 This special status has now been revoked under the BPR.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 authorization. After September 2017 the transitional periods will come to an end and compliance with the BPR is required.
The authorization 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 authorized as “biocidal product”. It is unlikely that users of ozone equipment will be able to undertake the authorization 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 authorization of ozone equipment to their customers.
Four ozone equipment manufacturers have joined forces as part of the “Ozone Registration Group” to accomplish the authorization of ozone as an active substance. These manufacturers are BWT, Degrémont Technologies (Ozonia), ProMinent 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 1st 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.
More information and pre-registration for a Letter of Access will be available from January 1st 2014 at www.ozone-registration-group.com.