Recently, the Biocidal Products Committee (BPC) adopted opinions for product types PT1, PT2 and PT4, with a favourable outcome supporting the approval of ethanol as an active substance. These opinions have been forwarded to the European Commission, which will ultimately decide on the approval or non-approval of ethanol under the Biocidal Products Regulation (BPR). 
At present, no definitive conclusion has been reached regarding the potential carcinogenicity and reproductive toxicity of ethanol, leaving key regulatory questions unresolved. During discussions at BPC level, considerable attention was also given to the overall flow profile of ethanol and the risks associated with its use, particularly in relation to oral exposure. However, for biocidal applications, dermal and inhalation exposure routes are considered more relevant.
In parallel, ethanol is currently under assessment within the Classification, Labelling and Packaging (CLP) framework through the harmonised classification and labelling (CLH) process. Future developments in this area may have significant implications not only for its regulatory status under the BPR, but also across other legislative frameworks where ethanol is widely used, including detergents, cosmetics, medicinal products, medical devices, as well as food chain.
Overall, regulatory uncertainty remains the key challenge for industry stakeholders. Upcoming decisions under the BPR, together with potential outcomes from the CLH process, may directly impact market access, dossier preparation strategies and portfolio management.
In this context, early regulatory planning is essential. This includes anticipating potential data requirements, identifying data gaps, and preparing for future authorisation steps. Such proactive approaches can help optimise costs, avoid delays, and ensure timely access to testing and laboratory capacity. Additionally, participation in industry consortia may support a more coordinated and efficient management of regulatory obligations related to ethanolbased products.
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