How do I obtain an authorisation for my biocidal product in more than one Member State?

1.Union authorisation.

Besides the national authorisation, Biocidal Products Regulation 528/2012 has created the possibility to submit a so-called Union authorisation, which arranges simultaneous authorisation and all Member States of the EU. For a Union authorisation, an application must be submitted to the European Chemicals Agency (ECHA) via the 'Register for Biocidal Products' (R4BP 3). You can find more information on the ECHA website.

2. National authorisation

A national authorisation must be requested from the competent authority of the Member State concerned. However, the application must be submitted to the European Chemicals Agency (ECHA) via the 'Register for Biocidal Products' (R4BP 3). The Member State concerned assesses the dossier and decides within 365 days.

3. Mutual recognition

By means of the mutual recognition process, the competent authority of the Member State in which authorisation is desired can recognise an authorisation that has been issued in a different Member State. This can take place in 2 ways:

• via sequential mutual recognition: The applicant submits an application for authorisation to the competent authority of the Member State in which he or she wishes to acquire authorisation ('the Member State concerned') based on the existing authorisation in another Member State (the 'reference Member State').
• via parallel mutual recognition: the biocidal product has not yet been authorised in any Member State. The applicant submits an application to the competent authority of the Member State of his or her choice (the reference Member State). The reference Member State is responsible for the assessment of the application. Simultaneously, the applicant submits an application for mutual recognition in the other Member States in which he or she wishes an authorisation.