Will ethanol be banned in Europe as the active ingredient for hand disinfectants?

Image by Tim Sandle

With ethanol be banned in the EU as the basis for hand disinfection? Do epidemiological studies confirm an increased risk for cancer from ethanol in exposed individuals? Why is the EU considering this move now?

I've noticed this report from Chemistry World:

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.

Disinfectant hand gels containing ethanol might no longer be available if the compound is reclassified as toxic to reproduction

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.

Echa’s Biocidal Products Committee (BPC) is reviewing the report. Hanna-Kaisa Torkkeli, an Echa spokesperson, says it’s too early to predict the outcome, but expects an ‘opinion’ at the end of 2024 or, more likely, in 2025. The European Commission will make a final recommendation based on the BPC’s opinion.

To read the full article, see Chemistry World. 

In relation to this topic, this research paper, from 2024, concludes "There is no epidemiological evidence of toxicity for workers handling ethanol-containing products in industry or using EBHR in healthcare settings." EBHR = ethanol-based hand rubs.

Also see:  "Medical associations and expert committees urge that ethanol be approved as a virucidal active substance for use in hand antiseptics under the European Biocidal Products Regulation, without a CMR classification".

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)