Implementation dialogue on biocides with Commissioner Olivér Várhelyi

The first Implementation Dialogue hosted by Olivér Várhelyi, Commissioner for Health and Animal Welfare, took place on 15 July 2025. The dialogue involved companies manufacturing, supplying and distributing biocidal products, as well as other stakeholders interested in this sector.

The dialogue will feed into the ongoing evaluation of the EU Biocide Regulation (EU) 528/2012, which sets out the rules for approving active substances in biocidal products, authorising the supply and use of biocidal products, as well as the supply of articles treated with biocidal products. The aim was to hear what the main obstacles are for companies in the EU when it comes to complying with the Biocides rules and to gather ideas on how these can be overcome. 

Documents

• List of participants

Outcome

The Implementation Dialogue on the Regulation on Biocidal Products was held in Brussels on 15 July 2025 with the participation of stakeholders representing businesses (active substance manufacturers, product formulators and downstream users) and civil society.

The dialogue aimed to gather feedback from companies on the main challenges faced in bringing biocidal active substances and products to the market and their ideas on how to address them and, more in general, on how to simplify the regulatory framework for biocidal products and encourage innovation. At the same time, it aimed to obtain views of non-industry stakeholders on the implementation of the Biocidal Products Regulation and on its contribution to a high level of safety for humans, animals and the environment.

The discussion highlighted a broad consensus on the need to have a clear, stable and predictable regulatory framework and to reduce the delays that affect approval and authorisation processes, in particular to complete the review programme of existing active substances. The long time-to-market process for both active substances and products, coupled with high regulatory costs and complex procedures were highlighted by companies as main factors that stifle innovation in the biocides sector. At the same time, most participants acknowledged the importance of the ambitious goals set by the Biocidal Products Regulation to ensure a high level of safety for humans, animals and the environment, which will only be fully achieved with the completion of the review programme of existing active substances, and the fact that that the current rules have allowed to achieve a certain degree of harmonisation. Participants also stressed the need to ensure appropriate data protection as a way of protecting investments by companies and indirectly driving innovation. Additionally, participants raised concerns about frequent changes in technical guidance during ongoing evaluation procedures as well as inconsistent interpretation and application of technical guidance and data requirements in the 27 Member States. Some stakeholders called for a tiered approach to generation of data needed for the assessment of active substances depending on the volumes placed on the market and for a need to increase reliance on non-animal or computational methods for data generation to limit testing on vertebrate animals. Several participants advocated for a strengthened role of the European Chemicals Agency in the system.

Commissioner Várhelyi concluded that the Dialogue provided a good overview of the hurdles that companies are currently facing as well as expectations from civil society. He reassured that the issues raised will be considered in the context of the evaluation of the Biocidal Products Regulation that will start this year and that possible solutions for the issues raised in relation to data protection could be considered in a forthcoming simplification package.