Ethanol, a prevalent ingredient in hand sanitizers and disinfectants, has been deemed acceptable for use in these items by the European Chemicals Agency’s (Echa) biocidal products committee (BPC). However, the committee has not reached a conclusion regarding the classification of ethanol as a carcinogenic or reprotoxic substance. In March 2024, Greek authorities presented a report to Echa proposing that ethanol be categorized as a reprotoxic category 2 substance, suggesting it might be a potential reproductive toxicant. This reclassification might necessitate labeling products containing more than 3% ethanol as reprotoxic, which could affect the availability of ethanol-based disinfectants within the EU.
While the BPC sanctioned the use of ethanol for human hygiene, disinfectants, and algaecides not meant for direct human or animal contact, they pointed out that the Greek dossier did not provide enough data on dermal exposure, a crucial exposure pathway for biocidal products. Furthermore, there were reservations about the existing inhalation data and its conformity to established guidelines, with most evidence originating from the consumption of alcoholic drinks rather than biocidal applications. The BPC is awaiting additional studies on relevant exposure pathways prior to making a decision regarding ethanol’s carcinogenicity or reprotoxicity.
Mel Cooke, a chemicals consultant, underscored the ambiguity and apprehension within the industry triggered by the EU proposal on ethanol classification, emphasizing the critical function of hand sanitizers. He pointed out the necessity for a legislative compromise to ensure the continued provision of essential biocidal products.
The biocidal products regulation mandates that active substances in biocidal products must be authorized prior to use. Approval for ethanol will become legally binding upon agreement from EU member states and formal endorsement by the European Commission, enabling companies to pursue EU authorization for products containing ethanol in the designated categories.