Ethanol, a key ingredient in hand sanitizers and various consumer products, is currently under regulatory review in Europe. The substance is being evaluated for potential classification as both a carcinogen and a reprotoxic material, which could have significant implications for its use in healthcare settings and beyond.
Every day, millions of healthcare professionals globally utilize alcohol-based hand rubs containing ethanol to prevent infections before interacting with patients. This straightforward yet critical practice plays a vital role in reducing hospital-acquired infections, which the World Health Organization estimates affect one in ten hospitalized patients.
Hospital-acquired infections contribute to nearly five million deaths annually linked to antimicrobial resistance, posing significant challenges to healthcare systems worldwide. Ethanol, known for its rapid action against bacteria, fungi, and viruses, is a primary defense against such infections. However, the ongoing scrutiny in Europe, led by the European Chemicals Agency (ECHA), raises concerns about the future availability of this essential antiseptic.
The ECHA”s Risk Assessment Committee is conducting the scientific review, and if it favors reclassification, the Biocidal Products Committee will evaluate the implications for hospital disinfectants. Ultimately, the European Commission will make a legal decision that would affect all member states.
Should ethanol face restrictions, hospitals may need to turn to alternatives like chlorhexidine or benzalkonium chloride. These substitutes are often slower in action, less effective against certain viruses, and can lead to increased skin irritation, which may result in reduced compliance among healthcare workers and higher infection rates.
Beyond healthcare, ethanol is crucial in pharmaceuticals, vaccines, diagnostic laboratories, and cleaning agents, as well as in food processing and various industrial applications. A restrictive classification could disrupt multiple sectors, impacting economic and cultural aspects of industries reliant on ethanol.
For instance, in the fragrance industry, ethanol serves as the primary medium for perfumes, enabling their evaporation and dispersion. A shift in its classification could compel manufacturers to reformulate or relabel products, potentially decreasing consumer confidence and affecting global markets. European regulatory decisions often set precedents that influence international standards, which could result in broader disruptions.
International health authorities, including the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA), assert the safety and importance of ethanol for infection control. Countries like India, Australia, and Canada have not raised concerns regarding the carcinogenic or reproductive risks of ethanol in typical topical applications, highlighting that Europe”s current review diverges from the global scientific consensus.
The evaluation in Europe follows a hazard-based approach, focusing on the inherent properties of substances rather than real-world exposure levels. In contrast, a risk-based approach considers how substances are used and the actual exposure involved, which is why global health authorities continue to endorse ethanol”s use in healthcare.
The key question for regulators is whether a substance integral to infection prevention should be evaluated mainly based on theoretical hazards rather than established safety records. Ethanol has been utilized in healthcare for decades without evidence linking it to increased cancer or reproductive harm among healthcare professionals.
It is crucial that ethanol remains accessible for medical use without restrictions that could jeopardize hand hygiene standards. Furthermore, any regulatory developments should foster scientific innovation while maintaining public confidence. Decisions should be based on evidence and aligned with global public health priorities. Losing access to ethanol as an effective infection-control tool would be detrimental, particularly at such a critical time for healthcare.
Dr. Abdul Ghafur, a senior consultant in infectious diseases at Apollo Hospital in Chennai, emphasizes the importance of ensuring that essential substances like ethanol remain available for medical use.
