At the Dublin Biocides Symposium 2024, Kerona Scientific was delighted to host Dr Joost van Galen, Chair of the Biocidal Product Committee (BPC) at the European Chemicals Agency. Joost offered a comprehensive overview of the current activities undertaken by the BPC.
The BPC serves as a pivotal body responsible for providing opinions on critical aspects related to biocidal products. Joost emphasized that the BPC’s opinions significantly influence decision-making processes within the European Union.
One of the focal points of Joost’s presentation was the evaluation of active substances. He noted that while the majority of active substance dossiers stem from the review program, there has been a recent surge in renewal submissions. To allow the evaluation of all existing active substances the review program was extended until 2030. The achievement of this new deadline still poses challenges like dealing with old dossiers, ensuring compliance with the BPR requirements, and addressing specific concerns such as endocrine disruption (ED) criteria.
Joost also shed light on the complexities surrounding Union Authorizations. He highlighted the fluctuating number of opinions and the challenges faced by European Competent Authorities (eCAs) in managing large product family dossiers and ensuring their quality. With 142 Union Authorization applications currently in the validation/evaluation phase, the strain on resources underscores the need for efficient processes and enhanced collaboration.
The BPR Art. 75(g) mandates the BPC to prepare opinions in response to requests from the European Commission on any other questions that arise from the operation of the BPR relating to technical guidance or risks to human health, animal health or the environment. Joost outlined the additional assessments involved, such as analysis of alternatives, evaluating Tier 2 efficacy data, and developing guidance.
In discussing future developments, Joost outlined initiatives aimed at improving the efficacy of the procedures. He emphasized the adoption of a short process for opinion formation, focusing on substances meeting exclusion criteria, and transitioning further towards a “1 Substance 1 Assessment” approach. Moreover, the establishment of a common data platform and the emphasis on data collection through IUCLID are indicative of a concerted effort to modernize regulatory practices.
For the most important requirement to meet the deadlines and accelerate the opinion outcome, the collaboration between the applicants, evaluating authorities and the BPC is required.
If you need help with the registration of your biocidal products, or any other aspect of the Biocidal Products Regulation (EU) No. 528/2012 please contact Kerona’s Biocide Team at info@kerona.ie If you missed the symposium, you can download the slides here: Dublin Biocides Symposium 2024 – Speakers Presentations – Kerona Scientific Ltd.