Every day in hospitals across the world, millions of healthcare workers use alcohol-based hand rubs before touching their patients. This simple act, powered primarily by ethanol, prevents infections and saves lives. Ethanol rapidly kills bacteria, fungi, and viruses, and is proven to reduce hospital-acquired infections by nearly half. Yet today, this essential substance is undergoing regulatory scrutiny in Europe, where it is being considered for classification as both a carcinogen and a reprotoxic substance—a designation for chemicals that may increase cancer risk or impair fertility under certain exposure conditions.
Ethanol is currently being evaluated by the European Chemicals Agency (ECHA). The scientific review is conducted by the Risk Assessment Committee (RAC). If it supports reclassification, the Biocidal Products Committee (BPC) will assess its implications for disinfectants, including those used in hospitals. The European Commission will make the final legal decision, which would apply across all member states.
The burden of infections
At the global level, the World Health Organization estimates that one in every 10 patients admitted to hospital acquires an infection during care. Hospital-acquired infections contribute to nearly five million deaths associated with antimicrobial resistance each year. These infections prolong hospital stays, lead to complications such as sepsis, and place a heavy economic burden on healthcare systems.
Alcohol-based hand rubs are a primary defence against these infections, and any disruption to their use would have an immediate impact on patient outcomes. Alcohol-based hand rubs act rapidly, require no water, and do not drive antimicrobial resistance. If ethanol were restricted, hospitals would be forced to rely on alternatives such as chlorhexidine, benzalkonium chloride, or povidone-iodine. These agents are slower, less effective against certain viruses, or associated with skin irritation and reduced compliance among healthcare workers, leading to higher infection rates and mortality.
Ethanol in other industries
Beyond hospitals, ethanol is an essential component in pharmaceuticals, vaccines, antiseptic formulations, diagnostic laboratories, and cleaning agents. It is also used in food-grade processing and various industrial applications. A restrictive classification without appropriate exemptions would therefore have consequences that impact multiple sectors far beyond medical care.
Let us take the example of a non-medical use of ethanol that has enormous implications in the cultural, economic, and aesthetic domains. Ethanol is the primary medium that enables perfumes to evaporate and disperse. If it were classified as a carcinogen and reprotoxic substance, manufacturers may be required to relabel or reformulate products, which could reduce consumer confidence and send signals of safety concerns into global markets.
European regulatory decisions often influence international standards, and a shift in ethanol classification could lead to disruptions in export markets and affect an industry of global cultural relevance. Alternative systems such as water-based or oil-based perfumes are being explored, but they are not yet widely adopted.
What regulators say
International health authorities have taken a clear position. The World Health Organization continues to strongly endorse ethanol-based formulations as essential for infection control. The United States Food and Drug Administration recognises ethanol hand sanitisers as safe and effective. Health authorities in India, Australia, Canada, and West Asia have not raised concerns regarding carcinogenic or reproductive risks with normal topical use. No other major jurisdiction is considering restrictions on ethanol in medical disinfection, highlighting that the current European review is a deviation from global scientific consensus.
Europe’s current evaluation follows a hazard-based approach, where a substance is classified according to its inherent properties without accounting for real-world exposure levels. In contrast, a risk-based approach, used by global public health authorities such as WHO and the U.S. FDA, takes into account how a substance is used, the extent of exposure, and the balance between benefits and theoretical risks. Ethanol used in hand hygiene evaporates rapidly and results in negligible systemic absorption, which is why risk-based regulators continue to support its use in healthcare.
The way ahead
The central question facing regulators is whether a substance that plays a critical role in infection prevention should be treated primarily on the basis of theoretical hazard rather than proven safety in real-world use. Ethanol has been used in healthcare settings for decades without evidence of increased cancer or reproductive harm among healthcare workers.
It is vital that ethanol remains available for medical use without restrictions that could compromise hand hygiene standards. In other sectors, regulatory developments should encourage scientific innovation while preserving public and market confidence. Decisions must be guided by evidence, proportionality, and global public health priorities.
The world cannot afford to lose its most effective infection-control tool at this crucial moment.
(Dr. Abdul Ghafur is a senior consultant in infectious diseases at Apollo Hospital, Chennai. drghafur@hotmail.com)
Published – October 29, 2025 03:22 pm IST
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