First applications for Union authorisation submitted to ECHA

First applications for Union authorisation submitted to ECHA

ECHA/PR/15/12

The first two applications for Union authorisation of biocidal products have recently been submitted to ECHA according to the procedure established by the Biocidal Products Regulation (BPR).

Helsinki, 22 July 2015 – The first two applications for Union authorisation are for biocidal product families containing the active substance iodine. The products are used as disinfectants for veterinary hygiene purposes (biocidal product type 3). The ability for companies to apply for Union authorisation for their products rather than for national authorisation and subsequently for mutual recognitions in all Member States is one of the main advantages of the regulation that replaced the previous directive. Yet, it has taken nearly two years after the entry into operation of the new regulation for the first such applications to arrive.
 
ECHA will make technical checking of the two applications – including the receipt of the corresponding fee - before sending them to the evaluating competent authority (eCA) through R4BP 3. The eCA will make sure that the applications are complete and will assess the dossiers within one year before providing the outcome to ECHA's Biocidal Products Committee.

The opinions of the Biocidal Products Committee are expected to be adopted within a maximum period of six months. The Commission will ultimately take the decision on the authorisation of the biocidal products at the Union level. It is a challenge for all authorities involved to reduce the overall period as much as feasible to prove the validity and benefit of the new authorisation system.

Once a biocidal product is granted a Union authorisation, it can be marketed in all European markets without the need for multiple further authorisation processes in many Member States. When considered successful, it is expected that many more companies will avail of this novel route for the authorisation of biocidal products in the future. A further factor that may influence the number of Union applications is the level of the fees for the two alternative authorisation systems. The EU fee regulation is – in line with the BPR - subject to review by the European Commission over the coming months.