The ongoing ECHA procedure relates to the Biocidal Products Regulation and the CLP Regulation ("Classification, Labeling and Packaging"). Experts fear that ethanol will soon be classified as toxic to reproduction and/or carcinogenic category 2 or even the highest hazard category 1 ("Carcinogen Mutagen Reprotoxic", CMR for short). This would also have far-reaching negative consequences for the industrial healthcare sector and thus for healthcare provision. This is because it would make the use of ethanol as a main or auxiliary active ingredient in products and its use in production processes more difficult, as well as severely restricting its use within the framework of the applicable occupational health and safety regulations.
In a joint information paper under Factsheet Ethanol in healthcare, the four associations provide background information on ethanol applications in healthcare:
-Disinfection and hygiene:
Ethanol is an essential active ingredient in disinfectants, as it is particularly effective against bacteria and viruses and is safe and biodegradable. The World Health Organization (WHO) has classified hand disinfectants containing ethanol as indispensable. Ethanol acts specifically and without alternative against non-enveloped viruses such as polioviruses. The number of nosocomial infections can also be reduced by using alcohol-based hand disinfectants. A CMR classification would significantly impair the widespread use of these disinfectants. The demand of the four associations: "In order to be able to continue using products containing ethanol in medical care, ethanol must not be classified as a CMR substance of categories 1 or 2."
-Medical devices and in vitro diagnostics (IVDs):
Medical devices and IVDs would be massively affected by a potential classification of ethanol as a CMR substance:
- Ethanol is used in production processes, for example in the cleaning and disinfection of production facilities, in adhesives and coatings and as a solvent or in occupational safety.
- Ethanol is used as an auxiliary substance in products and reagents in in-vitro diagnostics, for example as a solvent or preservative.
- Ethanol is used as the main active ingredient in medical products and in so-called dual-use products. These disinfectants are intended for use both as disinfectants for medical devices and IVDs and their equipment and as surface/hand disinfectants and are marketed as biocidal and medical devices.
The planned classification as CMR substance 1 would trigger a lengthy conformity assessment procedure as a significant change to products and would probably make placing them on the market under biocide legislation much more difficult.
-Pharmaceuticals and production:
Ethanol is used in pharmaceutical production as a carrier, preservative and extraction agent for active ingredients, essential oils and other substances that are not soluble in water. Ethanol has properties that contribute significantly to the efficacy of a medicinal product, although only very small quantities are required. Especially in the field of herbal medicines, ethanol is indispensable, as alcohol is one of the most important substances in the production of extracts. It also contributes significantly to the stability, shelf life and manufacturability of medicinal products. There is no alternative to the use of ethanol in production processes.
The conclusion of the BPI, BVMed, IHO and VDGH: "In order to ensure a secure supply of disinfectants, cleaning agents, medicinal products and medical devices to the population, as well as the ability to produce and deliver the corresponding end products, the classification of ethanol as a CMR substance of categories 1 or 2 must be urgently avoided. Otherwise, this would run counter to the purpose of the biocide and CLP regulations, which is to improve human health. Instead, there would be a deterioration in hygiene and healthcare. The protection of vulnerable patient groups, particularly in hospitals and the outpatient sector, could no longer be guaranteed. Especially in times of a pandemic, ethanol is indispensable to ensure the supply of effective disinfectants to the entire population and thus to guarantee a decisive pillar in infection protection. That is why the ECHA's planned hazard classification of ethanol in the medical sector must be prevented."
Further links:
Bundesverband der Pharmazeutischen Industrie e. V. (BPI) | Press release | A blessing for medicine: We need ethanol!
Deutsche Gesellschaft für Allgemeine und Krankenhaus-Hygiene e. V. (DGKH) | Statement of the DGKH | Ethanol must not be classified as CMR
