6/7 February 2024
In recent years, the biocide regulation in Europe has led to a whole series of changes in the disinfectant landscape. The manufacturers of corresponding active ingredients and formulations are now obliged to approve their products accordingly in the EU. Regulation (EU) No. 528/2012 regulates the manufacture, labeling, placing on the market and use of biocidal products intended to protect humans, animals, materials or products from harmful organisms, such as parasites or bacteria. The directive was adopted by the European Parliament and the Council in Brussels on May 22, 2012, and entered into force on July 17, 2012. In the future, an authorization application must be filed for all biocidal products, even if these products have been in use for decades. According to Art 25 in connection with Annex I, only 19 simple chemicals are eligible for a simplified authorization. Not even alcohol, hydrogen peroxide or isopropanol are included in Annex I of the list.
This leads to interesting developments and discussions. For example, the approval of ethanol has been under review since 2007, due to concerns about the inclusion of alcohol from ethanol-based hand sanitizers (EBHR). At issue is whether ethanol could be classified by the European Chemicals Agency (ECHA) as carcinogenic, mutagenic or toxic to reproduction. This is a bit curious for two reasons. On the one hand, ethanol is much more effective as a disinfectant for infection prevention than the related propanols, especially in the case of non-enveloped viruses. On the other hand, ethanol is the basis of all alcoholic beverages and is consumed by people worldwide in not inconsiderable quantities, with some types of rum reaching 60%, in one case even 80%. So it is quite comparable to the concentrations used in infection prevention.
A task force of the WHO Collaborating Center for Patient Safety, the Commission for Hospital Hygiene and Infection Prevention (KRINKO) and the Robert Koch Institute have now addressed the question of whether ethanol would be dispensable as an agent for infection prevention. For this, it was evaluated whether ethanol is toxicologically uncritical and indispensable for antisepsis of the hands due to its unique activity against non-enveloped viruses and the resulting lack of alternatives. Analyzed was:
They conclude that:
"The body of evidence shows EBHRs have strong efficacy in killing non-enveloped viruses, whereas 1-propanol and 2-propanol do not kill non-enveloped viruses, that pose significant risk of infection. Ethanol absorbed through the skin during hand hygiene is similar to consumption of beverages with hidden ethanol content (<?0.5% v/v), such as apple juice or kefir. There is no risk of carcinogenicity, mutagenicity or reprotoxicity from repeated use of EBHR. Hence, the WHO Task Force strongly recommend retaining ethanol as an essential constituent in hand rubs for healthcare."
For more details, see the related Task Foce publication in BMC (BioMedCentral): "Ethanol is indispensable for virucidal hand antisepsis: memorandum from the alcohol-based hand rub (ABHR) Task Force, WHO Collaborating Centre on Patient Safety, and the Commission for Hospital Hygiene and Infection Prevention (KRINKO), Robert Koch Institute, Berlin, Germany".