Managing Director
BODE Chemie GmbH
BODE Chemie GmbH
Arne Roettger
60% of hand sanitizers are ethanol-based. This means that in a pandemic, 60% of the products would not be available.
The European Chemicals Agency’s (ECHA) Biocidal Products Committee (BPC) concluded its discussions on the approval of ethanol as an active substance in disinfectants without adopting an opinion. The Committee will resume its work in February 2026 and aims to adopt the opinion later that year. This means that no regulatory changes are expected for the time being, and the use of ethanol-containing products remains permitted in all approved applications. HARTMANN, together with partner associations and the healthcare industry, will continue to actively advocate for a scientifically sound assessment in the coming months.
Ethanol decision postponed
The European Chemicals Agency (ECHA) has postponed its opinion on classifying ethanol as a CMR substance until 2026. This means the current status remains unchanged: ethanol-based disinfectants can continue to be used safely and without restriction. The postponement indicates that further clarification is needed — particularly regarding the scientific evidence for the safe dermal and inhalation use of ethanol-based disinfectants. Numerous studies demonstrate that the amounts absorbed during proper use are toxicologically safe. There is no proven risk of reproductive toxicity or carcinogenicity when these products are used as intended.
Professional associations oppose reclassification
Leading medical professional associations — including the German Society for General and Hospital Hygiene (DGKH), the German Medical Technology Association (BVMed), the Robert Koch Institute (RKI), the World Health Organization (WHO), and numerous European and international expert committees — have unanimously spoken out against a CMR classification of ethanol. These institutions emphasize that ethanol-based disinfectants are indispensable for daily hygiene in hospitals, care facilities, and laboratories.
The postponement offers an opportunity to continue integrating scientific evidence into the decision-making process. “We welcome the fact that ECHA is further reviewing the assessment of ethanol. We will continue to advocate for a fact-based and differentiated evaluation — together with the German healthcare industry, scientific partners, and professional associations,” says Arne Roettger, Managing Director of the Disinfection Division at the HARTMANN GROUP.
HARTMANN will actively monitor the process and advocate to ensure that ethanol-based disinfectants remain reliably available to protect patient safety and infection control across Europe. Once ECHA publishes its advice on the classification of ethanol, HARTMANN will provide timely and comprehensive information — including a transparent summary of the advice, scientific evaluations, and potential implications for the healthcare sector. Our goal is to keep customers, partners, and professional stakeholders clearly informed at an early stage and to jointly assess the next steps.
What is at stake?
The European Chemicals Agency (ECHA) is planning an opinion to reclassify ethanol as a CMR substance (carcinogenic, mutagenic, toxic for reproduction). This classification is based primarily on oral absorption through the consumption of alcoholic beverages – but not on its use in disinfectants, as is common and indispensable in healthcare.
Why it is imperative to distinguish between oral and dermal absorption of ethanol?
When ethanol is taken orally, the alcohol enters the bloodstream directly, is broken down in the liver and can be harmful to health. In contrast, ethanol is only absorbed through the skin in infinitesimally small quantities when used dermally – for example, through hand sanitizer [3, 4]. The Robert Koch Institute (RKI) compares the exposure to disinfectants with the ethanol content in apple juice: even with frequent use of alcoholic hand sanitizers, the systemic exposure is lower than with regular drinking of apple juice [5].
Even inhalation of disinfectant vapors only leads to minimal ethanol concentrations in the blood, which are well below critical levels [3, 4].
Conclusion: the assessment of the health risks of ethanol must take into account the different routes of exposure. While oral intake can pose health risks, external application does not pose a relevant risk when used properly.
Ethanol has been an essential ingredient in alcoholic hand disinfectants for decades and contributes significantly to the prevention of hospital-acquired infections. In Germany, around 600,000 nosocomial infections occur each year, resulting in 15,000 to 18,000 deaths [1]. Ethanol-based disinfectants have been shown to reduce these infection rates, thus protecting patients and medical staff [2].
Various professional associations are clearly opposed to the reclassification. Organizations such as the German Society for General and Hospital Hygiene (DGKH), the German Hospital Federation (DKG)and the Federal Union of German Associations of Pharmacists (ABDA) emphasize that ethanol does not pose a relevant health risk when used properly.
The position of major health organizations on the subject of ethanol can be found here:
- “Ethanol is indispensable in the medical field” | BVMed
- “Ethanol is indispensable in the medical field – and must remain so!” | BPI, BVMed, IHO and VDGH
- “Ethanol must not be classified as CMR” | DGKH
- “Ethanol is indispensable in the medical field – and must remain so!” | VDGH
- “Alcohol in disinfectants soon to be banned?” | BÄK
[1] Gastmeier P, Geffers C. [Nosocomial infections in Germany. What are the numbers, based on the estimates for 2006?]. Dtsch Med Wochenschr. 2008;133(21):1111-5. https://doi. org/10.1055/s-2008-1077224 PMID: 18478503.
[2] WHO (2009) WHO Guidelines on Hand Hygiene in Health Care.
[3] Ahmed-Lecheheb D, et al. Dermal and pulmonary absorption of ethanol from alcohol-based hand rub. J Hosp Infect, 2012. 81: 31-35.
[4] Below H, et al. Dermal and pulmonary absorption of propan-1-ol and propan-2-ol from hand rubs. Am J Infect Control, 2012. 40: 250-257.
[5] Epid. Bulettin 2. Mai 2016/Nr. 17 DOI 10.17886/EpiBull-2016-029