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 Martijn van Velthoven and Annemarie Haasnoot, from Rules4Biocides, presented on “Analysis of Alternatives” (AoA).
Their presentation covered key aspects such as approval by derogation, identifying active substances that are candidates for substitution (CfS), the required criteria for an AoA, and how to begin the process. They also demonstrated the OAQ software, which helps find alternative substances. The approval process by derogation has been impacted by recent regulatory shifts. The Green Deal and the COVID-19 pandemic accelerated legislative changes, which have caused delays in the Biocidal Products Committee (BPC) due to new guidance, data requirements, referrals, and differences in interpretation among evaluators in both the Classification, Labelling and Packaging (CLP) Regulation and the Biocidal Products Regulation (BPR). The increased focus on CLP classifications has resulted in a growing number of active substances being labelled as CfS, while at the same time, there is a lack of suitable alternatives, which must be demonstrated for approval.
When dealing with an active substance classified as a CfS, the first step is to prepare and submit an AoA. This involves engaging with the supply chain, strategizing with networks, and identifying relevant data sources. Once the AoA assessment is submitted, it enters into public consultation and if the active substance is excluded it is further assessed through a socio-economic analysis. During the public consultation period, it is crucial to submit feedback on the AoA and maintain active communication within the supply chain network. Afterward, future-proofing innovation by reviewing feedback and updating strategies ensures continued compliance. Effective communication throughout the process is essential. The supply chain provides critical information on identity and properties, technical and economic feasibility, hazards and risks, availability, conclusions, and other relevant comments.
The criteria for a successful AoA require demonstrating that the product is safer, more feasible, and more available than the alternatives. All relevant alternatives must be listed and rated for suitability. To effectively start an AoA, it is advisable to begin early, stay informed about regulatory changes, and the applicant can use specific tools such as OAQ or ChemSec. Future-proofing innovation is also a key factor in ensuring a smooth transition to sustainable alternatives. Annemarie Haasnoot concluded the session by demonstrating the OAQ software, which is available on the Rules4Biocides website. By entering the active substance and product type (PT), users can access various alternative substances that can be used for the AoA process. This tool provides a structured approach to finding suitable alternatives, making the regulatory process more manageable for companies navigating the BPR framework.
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.