The BPR introduces the possibility to have certain BPs authorised at the Union level (Union authorisation). 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 90 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.
Make pre-submission six months in advance A prospective applicant for UA should make a pre-submission to ECHA as soon as possible and at the latest six months before the intended date of submission of a UA application. The pre-submission serves to confirm whether:
- the product falls within the scope of BPR;
- the product has similar conditions of use across the EU; and
- that the appropriate PT has been identified.
Ekotox Centers
- Tel +421 2 45943712
- e-mail on ekotox(at)ekotox.eu