On September 1st 2013 the new regulation concerning the making available on the market and use of biocidal products (BPR), Regulation (EU) No. 528/2012, became law. Similar to REACH, the BPR aims to harmonise the European domestic market and to ensure a high level of protection for humans, animals and the environment. It is more onerous than REACH, since BPs need to pass through a complex two-step process. First, the active substance needs to be approved on an EU-level and, second, the actual biocidal product needs to be authorised.
For producers or importers of active substances that are not yet involved in the approval process they either need to file a new active substance application or they need to get listed on the Article 95 list to become part of the proceedings for the "existing" active substances. In the first case, companies will need to wait for the decision of the EU-commission on the active substance before the biocidal product can be placed on the market. In the second case, companies are allowed to place biocidal products on the market until EU-commission has taken a decision on the active substance.
After the approval of an active substance on an EU-level, all biocidal products containing this substance are subject to authorisation. Furthermore, BPR explicitly defines treated articles and in situ generated actives and sets up specific regulations.
Our team knows the requirements and challenges of biocides regulation from both sides (industry and authorities) and we are able to bring a unique perspective to the processes resulting from the BPR regulations and to use this unique insight to your advantage.
The following sections describe the major challenges of the BPR and how we are able to support you.