Ethanol is safe for use in hand washes and general disinfectants, according to the European Chemicals Agency’s (Echa) biocidal products committee (BPC). However, the BPC did not decide whether ethanol should be considered a carcinogenic or reprotoxic substance.
In March 2024, Greek authorities submitted a draft report to Echa proposing that ethanol should be classified as a reprotoxic category 2 substance (category 1 is the highest classification). This means it is a suspected human reproductive toxicant and follows some evidence of an adverse effect on sexual function and fertility, or on development. If ethanol was reclassified as a category 2 substance then biocides containing more than 3% of the chemical would have to be labelled as reprotoxic. This could restrict the supply of ethanol-based disinfectants across the EU. Effective hand-sanitising gels contain at least 60% alcohol.
The BPC, which provides science-based opinions on biocides, approved ethanol for use in human hygiene products, such as hand gels, disinfectants and algaecides not intended for direct contact with humans or animals, as well as products used in food and feed areas. It said it couldn’t reach a conclusion on the hazard ethanol presents because the Greek dossier lacked data on dermal exposure, a key route of exposure for biocidal products. In addition, the available inhalation data had not followed standard guidelines and most of the evidence relating to the carcinogenic and reproductive properties of ethanol derived from drinking alcohol, rather than from biocidal uses. The BPC wants to wait until it has considered new studies on more relevant exposure routes – which are currently underway – before determining carcinogenicity or reprotoxicity. Echa said in July that it aims to reach a decision on the classification of ethanol by the end of the year.
‘This seems a sensible compromise (or fudge),’ says Mel Cooke, a chemicals consultant at Alchemy Compliance. ‘The EU proposal on classification of ethanol has caused consternation and uncertainty in industry. Life-saving biocides could potentially have to be withdrawn from the market. Hand sanitisers are essential products. There is no evidence that their use is harmful. To my mind, a compromise or change in the legislation was required. We have a compromise, maybe the change in legislation will come later.’
Under the biocidal products regulation, all active substances used in biocidal products must be approved before those products can be authorised for use. It prevents biocidal products being approved if the active biocidal ingredient is classified as a carcinogen or reproductive toxicant, presumed to have potential for harm in humans (classification categories 1A or 1B). The BPC’s decision to approve ethanol in these three product groups becomes legally binding after agreement from the EU member states in the standing committee on biocidal products and formal adoption by the European Commission. Companies will then be able to apply for EU authorisation for ethanol-containing products from these three groups. Previously, companies used national legislation for biocidal products containing ethanol.
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