EU: What’s the latest with ethanol?
December 1, 2025
Last week, the ECHA Biocidal Products Committee (BPC) postponed its opinion on the approval of ethanol as a biocidal active substance with carcinogenic, mutagenic, or toxic for reproduction (CMR) classification. So, the uncertainty continues. Sagentia Regulatory’s biocides team outlines practical steps to aid business risk management, whatever lies ahead.
Download our paper ‘EU: What’s the latest with ethanol’ below and reach out to find out how we can support you
“Uncertainty around ethanol’s regulatory future in Europe is leaving biocidal product manufacturers in limbo. The outlook for ethanol-based products such as hand sanitisers and surface disinfectants is unclear. While these are challenging times, manufacturers can take practical steps now to make sure their portfolios are ready for greater scrutiny, possible substitution, or rationalisation.”
Dr Samantha Walker, Head of Biocides and Cosmetics
Sagentia Regulatory
Ethanol: The current regulatory picture
At present, ethanol has a harmonised classification under the CLP Regulation as a highly flammable liquid and vapour. For a biocidal product containing it to be BPR-compliant, the ethanol supplier must appear on ECHA’s Article 95 list for the relevant product type.
Biocidal products containing ethanol, for use in human hygiene, veterinary hygiene, and feed and food area applications, can be placed on the EU market under transitional national legislation. This means manufacturers must comply with the individual rules of each Member State where a product is sold. EU-wide product authorisation under BPR is not required while ethanol remains under review as an active substance.
ECHA’s BPC has postponed its opinion on the approval and classification of ethanol until 2026. As the timeline shifts again, how should manufacturers of ethanol-based biocidal products respond?
Read our paper to learn more, as well as to discover five practical steps for biocidal product manufacturers can take now.