Public health put at risk by mooted EU classification of ethanol as reprotoxic

Medical experts and health organisations from around the world have expressed concern over what they say would be a ‘misclassification’ of ethanol as a reprotoxic substance when it appears in biocidal products such as hand gels. They say there is no scientific evidence for the reclassification, which would result in significant risks to public health and safety if vital disinfectants were unavailable.

The EU’s evaluation of ethanol’s use in products such as hand gels and disinfectants under the Biocidal Products Regulation (BPR) was assigned to Greek authorities back in 2007. In March, they submitted their draft report to the European Chemicals Agency (Echa) proposing that ethanol should be listed as a reprotoxic category 2 active 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, then biocides containing more than 3% would have to be labelled as reprotoxic. Effective hand-sanitising gels contain at least 60% alcohol.