December 22, 2023 by Sylwia Kosmala-Grzechnik

20231210_Vienna Belvedere Christmas Market_Cropped

Earlier in December, I had the privilege of attending the Biocides Europe 2023 conference in Vienna, organized by Chemical Watch. The conference brought together representatives of the European Commission (EC), the European Chemical Agency (ECHA), Member State Competent Authorities (MS CAs), industry and regulatory consultants to discuss the current state and emerging issues related to biocides regulation.

The conference started with a series of presentations from authorities, which provided an update on the progress of the Active Substance Review Program (Review Programme) under EU Biocidal Product Regulation 528/2012 (BPR) and shared their experiences from the evaluation of active substances. One of the topics discussed was the delay in the Review Programme and the proposed extension of the programme until 31st December 2030. The representative of the EC provided an overview of the actions that authorities are undertaking to speed up the programme, including the implementation of a “hard deadline” for submitting data on the endocrine-disrupting (ED) properties of active substances. The CAs, that have not requested the applicants to provide ED data to complete the evaluation, need to send the requests by 30th June 2024 and the applicants will have time until 31st December 2026 to provide the data, or their dossier will be rejected. Therefore, if your active substance dossier does not include ED assessment at the moment, it is recommended to proactively address the data gap without waiting for a CA request, as high demand for testing is anticipated which could affect the timelines for generating the data.

Then, the ECHA’s representatives provided insights into the ‘one substance – one assessment’ concept which is aimed at streamlining the regulatory processes on evaluation of common substances used in products such as medical devices, toys, food, pesticides and biocides and, as a consequence, increasing efficiency and transparency of the assessments. They also provided updates on recently published guidelines and discussed the developments in the new guidelines and tools for biocides, such as implementing Chesar platform for environmental risk assessments which is planned in 2024. Moreover, ECHA highlighted a problem with the dossiers for many active substances being in the “word” or “pdf” format, and which are therefore not compliant with the IUCLID format, currently required for applications under BPR. This creates challenges for the automated processing of data on cross-regulatory platforms, affecting implementation of the ‘one substance – one assessment’ approach. Consequently, starting from mid-2026, companies seeking to renew active substance approval must submit applications with complete data packages in IUCLID format. If your company is planning to apply for the renewal of active substance and your dossier is not currently in IUCLID format, we strongly recommend initiating the preparation of the application in the required format as soon as possible.

The conference was also attended by a representative of the UK authorities, the Health and Safety Executive (HSE), who gave a presentation on the enforcement regime for biocides in Great Britain (GB), divergence from the EU BPR, and shared experience from the assessment of label claims in the GB.

The Cefic and legal experts shared the industry perspective and the main issues that companies face with the active substance and biocidal products approval process. One of the main concerns raised during those presentations was the end of the data protection for existing active substances on 31st December 2025, as specified in Article 95 (5) of BPR, and its impact on the data on the active substances which are still under review due to the delays in the Review Programme.

During the session on the claims and labelling of biocidal products, the presenters shared their challenges related to labelling under BPR, including green claims in the biocidal products and how the biocides are perceived by consumers. Other topics discussed during the conference included the developments and challenges with the ED and risk assessments, ‘borderline products’, treated articles, as well as in the field of efficacy testing.

The conference was well attended and provided an excellent platform to gain updates and perspectives from both regulatory authorities and industry representatives.

Please contact us if you have any questions or enquiries on how we can help with your obligations under BPR. wca have conducted many ED assessments for plant protection products and biocides. If testing is necessary, we have experts in environmental fate and human health and environmental endocrine disruption to assist with suitable test designs and study monitoring. wca are experienced at the preparation of dossiers in IUCLID format and would be able to assist you with your application for renewal of active substance if your dossier is not in IUCLID format, by fully completing the robust study summaries to include all relevant information.