Deep Dive

European hand gel evaluation leads to loud protests

19 November, 2025

ECHA is conducting a risk assessment of ethanol hand gels. These may receive the label ‘carcinogenic’ and ‘a risk to reproduction’. Infectious disease experts fear that the end of alcohol-based disinfection is imminent, whilst no suitable alternatives exist.

Ethanol is a valued ingredient in beer and wine, but it is also a widely used biocide. Hand gels and sprays containing more than 70% ethanol are effective against bacteria, fungi and viruses. Such hand gels are therefore found in hospitals, and the WHO considers them indispensable for reducing the transmission of infections. It was no coincidence that pumps filled with gel were stationed in hospitality venues and supermarkets during the coronavirus pandemic.

Yet the use of ethanol in hand gel is firmly under scrutiny. ECHA’s Biocidal Products Committee has been evaluating the potential risks of using ethanol as a disinfectant for some time now. The focus is primarily on carcinogenic properties and reproductive harm through skin contact and inhalation. Should ethanol be classified as carcinogenic and reprotoxic, this would have direct consequences for its use in hand gels.

That dark cloud on the horizon has already prompted loud protests from infectious disease specialists, medical societies and industry. A petition under the banner #HandsUpForEthanol has now been signed by 700 European organisations. They fear that a reclassification will lead to a ‘de facto ban on ethanol-based biocides.’

The authors of the petition state that ECHA is basing its risk assessment of ethanol on data from the consumption of alcoholic beverages. ‘These data do not accurately reflect the use of biocides, where exposure through skin absorption or inhalation is negligible.’

That drinking alcohol increases the risk of various forms of cancer is not in dispute. The International Agency for Research on Cancer (IARC) assigned ethanol the label ‘Group 1 carcinogen’ long ago. In recent years it has also become clear that there is effectively no safe lower threshold: even light drinkers are already at risk. The same applies to foetal harm: alcohol consumption during pregnancy causes developmental disorders in the child, even at relatively small quantities.

The remaining question is whether drinking alcohol can be compared with applying ethanol gel to one’s hands. Much of the applied alcohol evaporates within half a minute; a portion is absorbed through the skin. Can that cause harm? No, say proponents of alcohol gel, as epidemiological studies involving people who frequently disinfect their hands have shown no elevated cancer risk. The same holds true for foetal harm: people who use alcohol gel achieve lower blood levels than people who have just drunk fruit juice or alcohol-free beer — beverages that contain a minimal amount of ethanol.

If there are any indications of risks associated with hand gel use, they come from model-based toxicological risk studies. The RIVM, for instance, concluded that using hand gel does not lead to significant health risks, but the report does flag a slightly elevated risk of breast cancer. Women who use hand gel ten times a day for a year see their lifetime risk of developing breast cancer increase by 0.001%, from 143,000 in 1,000,000 to 143,006 in 1,000,000. According to some critics, even that low risk is a considerable overestimate based on unrealistic assumptions.

The reassessment of ethanol in hand gel is a complex process that began back in 2007; in March 2024, dossier holder Greece submitted a draft report. This includes, among other things, a proposal to assign ethanol the label category 2 reprotoxic. In October of this year, an internal ECHA working group reached broadly the same conclusion: ethanol increases the risk of cancer and birth defects.

Should ECHA’s Biocidal Products Committee adopt these recommendations, ethanol hand gel would require additional warning labels — at present, the gel is classified only as flammable. More importantly, the question arises as to whether and for how long hand gels will continue to be sold. European policy is unambiguous: if ethanol is deemed carcinogenic, it automatically becomes a ‘candidate for substitution.’ Alternatives must therefore be considered.

One example of an alternative is isopropanol, a substance that has already been approved. However, according to infectious disease specialists, isopropanol acts more slowly and less effectively against non-enveloped viruses such as noroviruses and adenoviruses. Furthermore, far less is known about the biocidal performance of many alternatives, including optimal concentration and duration of action.

ECHA leaves some room for manoeuvre in an explainer. Even if ethanol is labelled a hazardous substance, its use in hand gel is not automatically ruled out. ‘Ethanol can still be approved and products containing ethanol can still be placed on the market, provided that safe use is established and alternatives are considered.’ This would mean that if no adequate alternatives exist and exposure carries no risks, disinfection with ethanol hand gel would still be permissible.

According to the signatories of #HandsUpForEthanol, we should not expect miracles from such exemptions. It falls to individual member states to permit ethanol hand gel, following a comprehensive risk and alternatives assessment. Such exemptions are, moreover, only valid for a few years. ECHA’s Biocidal Products Committee meets from 25 to 27 November, after which it will adopt a position. That opinion will then go to the European Commission, which has the final say.

Update 3-12-2025

ECHA’s Biocidal Products Committee did not manage to adopt a position on the risks of ethanol as a disinfectant and possible alternatives by the end of November. There is a lack of consensus, ECHA reports. The discussion will continue early next year and is expected to lead to an opinion in May. In the meantime, concerns are growing in the European Parliament about the implications of such a decision for healthcare and food safety.