On March 26th and 27th 2025, Kerona Scientific held the Dublin Biocides Symposium which dealt with key regulatory aspects relevant to biocidal products. On the second day of the symposium Elodie Cazelle, Senior Scientific and Regulatory Affairs Manager at the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E), presented on ‘BPR in 2025: What can product formulators expect? Perspective from the cleaning and hygiene products industry’.
Elodie gave an update on active substances approval, spoke about the changes in various procedures for biocidal products authorisation, and finally gave an update on ECHA Guidance. There have been a number of delays in the Active Substances Review Programme (RP) with the deadline being extended to 2030.
Changes in various procedures for biocidal products authorisation were explained:
1) The current Renewal Regulation (Commission Delegated Regulation (EU) No 492/2014) is to be repealed because of the need for clarifications on the procedure. A public consultation is expected in Q2 of 2025.
2) Likewise, the Same Biocidal Product Regulation (Commission Implementing Regulation (EU) No 414/2013) is to be repealed. This would simplify rules and set a procedure for the renewal of Same Biocidal products. It would also mean that the ‘same’ concept would become more restrictive. If the reference product changes or is cancelled, the ‘same’ product should also be changed or cancelled. A public consultation is also expected in Q2 of 2025 for this regulation.
3) The Regulation (Commission Implementing Regulation (EU) No 354/2013) will have amendments, including providing more examples in the current list of changes, and the removal of the possibility to group some changes. A new Commission Guidance on similar conditions of use will be published in Q2 of 2025. Under this new guidance applicants should gather information on conditions of use under which the product can be placed on the market in all Member States. The applicant should provide confirmation of similar conditions of use in a template provided by ECHA, and the pre-submission procedure may be adapted.
4) Finally, the Fee Regulation (Commission Implementing Regulation (EU) No 564/2013) will also be revised to include a 19.5% increase in fees payable to ECHA to match inflation.
Before concluding her presentation, Elodie gave an update on ECHA Guidance. There are official stakeholder consultations ongoing for both the BPR Guidance Volume III Human Health parts B & C and the BPR Guidance Volume II Efficacy with publications due in Q3 and Q4 of 2025 respectively.
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.