Report on the implementation of Regulation (EU) No 528/2012
According to Article 65(4), the European Commission is required to prepare every 5 years a report to the European Parliament and to the Council on the implementation of the Regulation. This report should be based on the reports provided by Member States.
Following the submission of the first reports in June 2020, the Commission prepared a report which was published in June 2021. This report is accompanied by a staff working document which presents detailed evidence for the findings outlined in the report.
The report finds that 8 years after the entry into application of the Regulation all its provisions are fully functional. The main problems identified are the slow progress in the execution of the Review Programme for the examination of existing biocidal active substances and the substantial delays in both active substance approval and product authorisation processes. Completion of the Review Programme and of the authorisation procedures within the deadlines are essential for the achievement of the objectives of the Regulation in terms of protection of human health and the environment.
The report also shows that very limited innovation on new active substances occurred under the Regulation EU No 528/2012. The main reason for the delays observed is a systemic lack of resources in the Member States. To tackle this, the Commission calls on Member States to ensure that competent authorities have the appropriate resources and invites them to review the situation of their national fees for the procedures under the Regulation.
Reports from the Member States
The provisions in Article 65(3) of Regulation (EU) No 528/2012 (Biocidal Products Regulation) require Member States to submit, every five years, a report on the implementation of that Regulation in their territories. The reports below were provided by Member States by 30 June 2020 and cover the period from the entry into application of the Regulation (1 September 2013) until 31 December 2019. These reports are the basis for the report of the Commission to the European Parliament and the Council on the implementation of the Biocidal Products Regulation.
* “Member State” refers to EU Member States (situation as of 31 December 2019), Iceland, Liechtenstein, Norway and Switzerland