The regulatory landscape for the use of ethanol as an active substance has taken a decisive turn that will set the pace for the chemical and disinfection industry in the coming years. Recently, in February 2026, the Biocidal Products Committee of the European Chemicals Agency (ECHA) adopted fundamental opinions supporting the approval of ethanol under the European Union Biocidal Products Regulation (BPR). This advancement is no minor formality, as it establishes a clear roadmap for substances intended for human hygiene, such as hand disinfectants, as well as for products used in the disinfection of surfaces not intended for direct contact with humans or animals, and those specifically used in food and feed processing environments.
This regulatory milestone activates a compliance timeline that companies in the sector must observe with extreme diligence to guarantee their stay in the European market. The temporal horizon places the end of 2027 as the earliest possible date for the formal approval of the active substance. This moment will be critical, as it will not only represent the official validation of ethanol but will also serve as the unavoidable deadline for the submission of product dossiers for those that have been marketed in Europe to date. The process following this submission is extensive, with an estimated evaluation time of between two and four years before obtaining the final European authorization for a biocidal product family.
The complexity of reaching this goal requires immediately initiating a solid regulatory strategy that includes prior consultations with the evaluating competent authorities. However, the core of the technical work lies in conducting efficacy studies, long-term stability analyses, and the preparation of risk assessments for both human health and the environment. These study-conducting and risk-assessment tasks can consume approximately six months, to which another four months must be added exclusively for the technical preparation and submission of the dossier.
Given the magnitude of these requirements, the sector currently faces a significant logistical challenge. The capacity of specialized laboratories is limited, making it imperative to secure study slots as far in advance as possible to avoid bottlenecks that compromise delivery deadlines. It is vital to consider that, while in some Member States product notifications under national transitional legislation may still be possible, in other States there will no longer be sufficient time to obtain national transitional authorizations.
The transition toward this new legal framework has already begun, and early preparation is the only guarantee to ensure that ethanol-based disinfectant solutions continue to fulfil their essential role in society in a safe and regulated manner.
Ensure your regulatory compliance with Kaeltia Consulting: contact our experts today to anticipate ECHA deadlines and guarantee the continuity of your products in the market.
