The European Commission has published a five-year report and a staff working document on the implementation the Biocidal Products Regulation (BPR). It covers the period from 1 September 2013, when the BPR started to apply, until 31 December 2019. The report is mostly based on information gathered by EU countries.
Conclusions (from the paper)
Eight years after the adoption of the BPR, all provisions are fully operational. The importance of biocides, notably of disinfectants for human hygiene and surface disinfection, was particularly highlighted during the COVID-19 pandemic. The use of the derogation provisions in place under the BPR to react to emergency situations allowed to address the severe shortages in the supply of disinfectants following the steep increase in the demand. The concerted efforts of industry, Member States and the Commission allowed to address the unprecedented situation created by the COVID-19 pandemic.
The main problems identified in this report are the slow progress with the evaluation of active substances included in the Review Programme and the continuous substantial delays in both active substance approval and product authorisation processes. The slow progress with the evaluation of the active substances in the Review Programme, already identifiedunder the BPD, continued after the entry into application of the BPR. Thus, 5 years before the twice extended deadline of 31 December 2024, only 35% of the work programme has been completed.
Very limited innovation on new active substances occurred under the BPR. According to stakeholders, innovation is hindered by high regulatory costs and very long procedures, the relatively small market for biocides and its fragmentation, and the small returns on investment.
The slow progress with the Review Programme has been a further disincentive for developing new active substances, since products containing active substances in the Review Programme and still under evaluation can be made available on the market under national rules without having to respect restrictions put in place under the BPR to protect health and environment.
Public investment into research could help to increase innovation in this area.
The completion of the Review Programme is thus crucial for the achievement of the objectives of the BPR. The longer the completion of the work programme is delayed, the longer biocidal products containing active substances not yet evaluated for safety and efficacy may be made available on the market. It is therefore imperative to accelerate the pace of the evaluation of existing active substances and complete the Review Programme as soon as possible.
In addition, the Commission receives an increasing number of correspondence from companies, who cannot find an evaluating Member State for the approval or renewal of approval of active substances or for the authorisation of biocidal products (either as reference Member State for mutual recognition or evaluating Member State for Union authorisation), as all Member States approached refuse to do so. The main reason for all delays observed – and the difficulties for companies finding reference or evaluating Member States accepting applications – is a systemic lack of resources in the Member States.
The Commission therefore calls on Member States to ensure that Competent Authorities have the appropriate resources to fulfil all their obligations under the BPR within the applicable deadlines. The Commission invites Member States to review the situation of the fees collected for BPR procedures, with regard to the appropriateness of their level and the potential need to ring-fence the revenue derived from them for activities related to the BPR.
The Commission will also launch a call to set up a contract for providing Member States’ Competent Authorities specific technical support to complete their evaluations. A full evaluation of the BPR, planned for 2025, will analyse in-depth the fitness of the current regulatory framework as a basis for deciding on the need for further action.
If Member States do not take the necessary measures to ensure that their authorities can execute the role of evaluating authority for applications for approvals, authorisations and renewals, the regulatory system set out in the BPR cannot function properly.