Biocides and biocidal products
Since 1 September 2013, the new Biocidal Products Regulation (BPR Regulation (EU) No 528/2012) has been in force in the European Economic Area (EEA). This means that the provision and use of biocidal products, in situ generated biocides and treated goods in the European countries is governed by a Regulation. Since that date, biocidal products to be marketed in Europe must be authorised before being placed on the market. For a certain transitional period, a notification or submission of a provisional dossier to the competent authority will suffice. In Germany, for example, biocidal products must be notified to the Federal Institute for Occupational Safety and Health (BAuA). This transitional regulation concerns biocidal products containing only existing active substances that are evaluated in accordance with the Review Regulation (Regulation (EU) No 1062/2014).
The authorisation of biocidal products can be applied for via the ECHA (European Chemicals Agency) for all European countries (Union authorisation). Alternatively, as before, authorisation can be granted in one European country and this authorisation can then be extended to other countries through reciprocal recognition. The authorisation process has a two-stage structure, is complex and there are very extensive data requirements.
First, the approval of the biocidal active substance for the respective product type(s) takes place via a European procedure, which is then followed by the respective approval of the biocidal product. Intensive communication with the manufacturers of the biocidal active substance, possibly with companies that have already received approval for the biocidal product, and with the authorities is necessary.
We advise you in the field of biocidal product regulation and explain the process and the requirements, but we also carry out the process on your behalf from the word go to the successful approval.