On March 26th and 27th 2025, Kerona Scientific held the Dublin Biocides Symposium which dealt with key regulatory aspects relevant to biocidal products. To close the symposium, Ligia Negulici (Policy Officer of DG SANTE, European Commission) presented an update on biocide regulatory issues on behalf of the European Commission.
The Review Programme, which assesses active substances under the Biocidal Products Regulation (BPR), continues to face delays. As of early 2025, only 50% of the programme has been completed, leading to an extension of the deadline to December 31st, 2030, through Commission Delegated Regulation (EU) 2024/1398. The slow progress is attributed to a systemic lack of resources, applicant delays, and the complexity of evaluations. To address these issues, the Commission has dedicated €6.8 million in grants to nine Member States for biocides work. Additionally, new measures such as prioritising backlog reports and implementing stricter rules for missing data submission were presented.
Since the adoption of scientific criteria for endocrine disrupting (EDs) properties in 2018, the assessment of active substances has progressed, but challenges remain. Of the 175 substances assessed, only 51 have completed evaluations, with eight identified as EDs. To enhance regulatory clarity, the Commission introduced new hazard classifications under Delegated Regulation (EU) 2023/707, which took effect in April 2023. A joint Commission report on the application of ED criteria is expected in mid-2025.
While Union authorisation (UA) aims to ensure similar conditions of use for biocidal products across Member States, discrepancies in national regulations and pre-submission inconsistencies have hindered progress. The Commission is drafting new guidance to establish a clearer framework for applicants, requiring them to provide detailed assessments of national regulations before submission. This approach seeks to prevent last-minute objections and streamline the authorisation process.
To modernise and harmonise regulatory procedures, biocidal product regulations have been revised and currently the Commission is introducing three new regulations: Same Biocidal Products Regulation, that clarifies the definition of identical biocidal products and restricts variations that qualify for administrative change; Renewal Regulation, that standardises renewal procedures for mutual recognition authorisations and Changes Regulation that aims to revise classification and notification processes for product modifications.
Looking ahead, the regulatory landscape for biocides will continue to evolve. The European Chemicals Agency (ECHA) will take a more prominent role in evaluating derogations from exclusion criteria under Article 5(2) of the BPR. A formal review of the BPR is scheduled to begin in 2025, incorporating stakeholder input and enforcement findings to refine existing regulations.
If you missed the Dublin Biocides Symposium, a copy of the presentations is available on the Kerona website. For assistance with the authorisation of biocidal products or support for biocide applications and REACH, please do not hesitate to contact Kerona at info@kerona.ie or call us at +353 (0)1 849 5284.