Next week, EU regulators will convene for what is shaping up to be a decisive moment in the future of ethanol. A substance regarded as indispensable to Europe’s hygiene and infection-control infrastructure, as its continued use in hand sanitisers and disinfectants comes under scrutinity.
From 25 to 27 November 2025, the European Chemicals Agency (ECHA) will bring together its Biocidal Products Committee (BPC) to review the status of ethanol under the Biocidal Products Regulation. It is the active substance used in many hand sanitisers and surface disinfectants.
The committee will assess whether ethanol should retain its current approval or face stricter conditions that could significantly reshape its use in hygiene products. Should the committee conclude that ethanol has the hazard potential to cause cancer or harm human reproduction, it would meet the substitution criteria set out in the EU’s Biocidal Products Regulation.
Even in that case, regulators could still approve ethanol and allow products containing it to remain on the market. In that case, they would have to demonstrate safe use and duly consider the availability of alternatives. The assessment is ongoing and conclusions are expected next week. The European Commission will take the final decision on the basis of the Committee’s scientific opinion.
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The political backdrop
In a written parliamentary question submitted in July 2025, MEP Alice Teodorescu Måwe (EPP/SWE) described ethanol as “an essential substance” used across hand sanitisers, disinfectants, medicines and hygiene products. The Romanian-Swedish member stressed that users rely on it because it is “effective, easily accessible and safe when used correctly”. The question underlined that in many cases there are “no viable alternatives”. And where they do exist, they tend to be “more expensive or less effective”.
From a preparedness perspective, Ms Teodorescu Måwe said it was “very worrying” that the Commission was considering classifying ethanol as a CMR 1 substance. The classification would put it in the highest category of chemicals deemed carcinogenic or mutagenic under EU Law. It could result in the outright banning of several essential products. Such a decision could “seriously undermine our crisis-response capabilities”.
The Parliament pressed the Commission to clarify what impact assessments it had carried out on the effects of banning ethanol in consumer and hygiene products on critical functions within society. It also demanded clarity on how the classification process would account for real-world exposure, societal benefits and the scarcity of alternatives in critical applications.
Approval still possible
In his response of 20 October, Commissioner Oliver Várhelyi said the Commission will take the decision, considering the opinion of the European Chemicals Agency’s Biocidal Products Committee, which it expects to adopt by the end of 2025. And that the decision will apply only to uses of ethanol in biocidal products.
Mr Várhelyi said: “Ethanol may still be approved for use in biocidal products, regardless of the conclusion on the hazard classification. (This will happen if the substance is) deemed safe for human, animal health and the environment. The authorisation of biocidal products containing ethanol will take place subsequently under the responsibility of member states. They may consider socioeconomic impacts, such as availability of disinfectants.”
The commissioner pointed to the public consultation conducted by ECHA on alternatives to ethanol in biocidal products (25 February–30 April 2025) . He said the Commission will do its utmost to duly consider all relevant aspects in the decision-making process.
Industry, health aware of high stakes
Industry and public health stakeholders have responded with a warning. In a joint statement published on 4 November, a broad coalition of sectors urged EU decision-makers to “act now to prevent a de facto ban on ethanol-based hand sanitisers, disinfectants, and antiseptics, for the sake of Europe’s health, economy, and public trust”.
Describing ethanol as “indispensable to public health, economic prosperity, and industrial resilience across the EU,” the signatories argued that no alternative substance matches its proven “efficacy, safety and availability.” They pointed to the estimated 3.5 million cases of healthcare-associated infection recorded annually in the EU and EEA, leading to more than 90,000 deaths. They stressed that ethanol-based biocidal products remain a cornerstone of infection prevention. That applies not only to hospitals but also across sectors ranging from agriculture and food to transport, hospitality, and cosmetics.
The statement warns that the BPC’s consideration of reclassifying ethanol as a CMR Category 1A substance is based on data derived from the overconsumption of alcoholic beverages. It contrasts this with real-world exposure through skin contact or inhalation in biocidal use, which it argues is “negligible”.
A de facto ban
A reclassification, the group cautions, would in practice create a de facto ban for the general public. This would severely restrict professional use. And it would replace a widely trusted hygiene tool with complex, time-limited derogations. It would also turn ethanol into a “candidate for substitution”, accompanied by significant administrative burden.
Users rely on (ethanol) because it is effective, easily accessible and safe when used correctly. — MEP Alice Teodorescu Måwe (EPP/SWE)
Beyond public health risks, it warns of disruption to European production capacity, weakened supply chains and reduced preparedness for future pandemics. It concludes that policymakers now face a critical choice between safeguarding access to a “safe, indispensable and lifesaving” substance. Introducing a regulatory outcome could undermine both Europe’s scientific credibility and its ability to manage future health crises.
Once the Biocidal Products Committee concludes its discussions, ECHA will adopt a formal opinion on ethanol’s status as an active substance under the Biocidal Products Regulation. The European Commission will then consider that opinion and take the final decision on whether ethanol remains approved for use in biocidal products and under what conditions.
Why this matters
Should approval be confirmed, national authorities will subsequently handle the authorisation of individual products on their markets. In doing so, they will take into account both regulatory and socioeconomic considerations.
The outcome of next week’s deliberations touches three intertwined policy arenas: chemical safety regulation, public health preparedness and industrial supply chains. If regulators restrict ethanol, the consequences could ripple across hospital hygiene protocols, food-processing sanitation, and disinfectant manufacturing.
Conversely, a decision to retain ethanol under certain conditions would uphold the status quo. It would also underscore the importance of rigorous exposure-and benefit-assessments in future chemical regulation.
