Ethanol: MedTech Europe joins 800+ stakeholders alliance challenging the reclassification under the Biocidal Products Regulation

Ethanol: MedTech Europe joins 800+ stakeholders alliance challenging the reclassification under the Biocidal Products Regulation

Posted on 04.12.2025

Ethanol is currently under review as a biocidal active substance under the Biocidal Products Regulation. Following the Biocidal Product Committee (BPC) Working Group recommendation to classify ethanol as Carcinogenic 1A and Reproductive Toxicity 1A, MedTech Europe joined a broad cross-sector coalition in signing a joint statement challenging the proposed classification.

Ethanol is widely used in healthcare and the medical technology sector, particularly for disinfection and sterilization. During the European Chemicals Agency (ECHA) consultation earlier this year, MedTech Europe provided feedback on the availability of alternatives for ethanol in biocidal product types 1 and 2, noting that no current option offers the same combination of antimicrobial effectiveness, rapid evaporation, material compatibility, and large-scale usability at healthcare settings.

More recently, MedTech Europe joined over 800 representatives from industry, healthcare, and academia in signing a statement calling for EU institutions and Member States to carefully consider the implications of the proposed classification.

On 26 November 2025, ECHA announced that the BPC concluded its discussions without adopting an opinion and will continue the evaluation in 2026. Further discussions on ethanol's approval as a biocidal active substance are expected to resume in February 2026. Once the BPC finalises its opinion, ECHA will submit its recommendation to the European Commission, which will inform the Commission's final decision on ethanol's approval in biocidal products.

MedTech Europe will continue to follow developments and provide the medical technology sector's views as the evaluation progresses.

For further information, please contact Alina Rachiteanu, Senior Officer Sustainability & Environment.