Opinion pronounced: Ethanol remains unrestricted for use in infection control

The HARTMANN GROUP welcomes this opinion, as it confirms the high level of infection and patient protection in the healthcare sector. “We consider this conclusion with regard to infection protection to be absolutely correct. Ethanol remains a central element of infection prevention,” explains Arne Roettger, Managing Director of the Disinfection Division at the HARTMANN GROUP. Numerous organizations at national and European level had already taken a clear position on this issue: Ethanol-based disinfectants have been used safely for decades and are a cornerstone of infection prevention in hospitals, care facilities, doctors' offices, and laboratories throughout Europe.

According to the current state of scientific knowledge, ethanol is considered safe when used properly for skin or surface disinfection. There is no reliable evidence of reproductive toxicity or carcinogenic effects when used externally. “The ECHA has taken the available scientific evidence into account in a differentiated manner and has arrived at a fact-based, appropriate classification,” says Arne Roettger.

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 [1, 2]. 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 [3].

Even inhalation of disinfectant vapors only leads to minimal ethanol concentrations in the blood, which are well below critical levels [1,2].

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 [4]. Ethanol-based disinfectants have been shown to reduce these infection rates, thus protecting patients and medical staff [5].

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] Ahmed-Lecheheb D, et al. Dermal and pulmonary absorption of ethanol from alcohol-based hand rub. J Hosp Infect, 2012. 81: 31-35.

[2] 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.

[3] Epid. Bulettin 2. Mai 2016/Nr. 17 DOI 10.17886/EpiBull-2016-029

[4] 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.

[5] WHO (2009) WHO Guidelines on Hand Hygiene in Health Care.

*
Product-type 1: Human hygiene products, such as hand disinfectants;
Product-type 2: Disinfectants and algaecides not intended for direct contact with humans or animals; and
Product-type 4: Products used in food and feed areas