Practical guide on Union authorisation of biocidal products :February 2024

The basic principle in the Biocidal Products Regulation ((EU) No 528/2012 (BPR)) is that a biocidal product (BP) must be authorised before it can be made available on the market or used in the European Union (EU)/European Economic Area (EEA). This takes place in two consecutive steps. As the first step, the active substance is evaluated and, provided the criteria are fulfilled, is then approved in a specified product-type. The second step is the authorisation of each BP consisting of, containing, or generating the approved active substance(s). This document concerns the second step, the authorisation of a BP. The BPR introduces the possibility to have certain BPs authorised at the Union level. UA allows companies to place their BPs on the market throughout the entire EU/EEA, without the need to obtain single national authorisations. The Union authorisation (UA) will give the same rights and obligations in all the Members States (MSs) as those provided by national authorisations. UA can be granted for products with similar conditions of use across the EU. Some BPs are precluded from UA, namely: BPs that contain active substances that meet the exclusion criteria (Article 5 of the BPR) and BPs of product-types (PTs) 14, 15, 17, 20 and 21. It is possible to apply for UA of both BPs and biocidal product families (BPFs). The relevant provisions regarding UA are set out in Chapter VIII of the BPR. UA may be viewed as an alternative to applying for national authorisation followed by mutual recognition(s) provided that the products belong to eligible PTs. See the Practical Guide chapter on national authorisation and Practical Guide chapter on mutual recognition.