Published on 5 June 2025

Procedure for the recognition of a Union authorization

With the new procedure for the Union authorisation the European Biocidal Products Regulation (BPR)1 makes it possible for a biocidal product to be authorised for the entire EEA Market (plus Switzerland)2, thereby obviating the need for an application in the individual states for national authorisations or recognition.

Procedure

  • The procedure is based on an evaluation of the product by a national authority. The applicant is entitled to choose the evaluating authority. However, in each case the national authority must clearly state its readiness to carry out the evaluation. In order to facilitate the evaluation, it is reasonable to choose an authority that also evaluated and authorised the active substance.
  • ECHA advises those companies that intend to submit an application with ECHA for Union authorisation, to submit a «pre-submission» at the latest 6 months beforehand. This is used to confirm whether the product may actually be considered for a Union authorisation and that the requirements for the similar conditions for use in the entire EEA are met.
  • Once the evaluation has been completed the ECHA Committee for Biocidal Products (with the participation of Switzerland) draws up an opinion of ECHA for the product. Based on this opinion and possible requests for derogation from the EU Member states (Art. 44 para. 5, 2 section BPR), the European Commission decides upon the approval requirements and grants the Union authorisation.
  • The Union authorisation is not directly valid in Switzerland but is confirmed by the Notification Authority in a highly simplified procedure; i.e. the Union authorisation is recognised in Switzerland within 30 days of the European Commission's decision by means of autonomous subsequent implementation (i.e. automatically) and thus authorised for the Swiss market. Pursuant to the MRA, Switzerland can provide for derogations before the Union authorisation is adopted, pursuant to Article 44 para. 5, 2nd section OBP. Following the Swiss decision on the Union authorisation the Notification Authority delivers the authorisation to the authorisation holder for the Swiss Market.

Fees

The decision of the Notification Authority for the Union authorisation is free of charge.