Ethanol as a Reprotoxic Substance?

Ethanol – an ubiquitous alcohol used safely for decades – is a key ingredient in many healthcare, hygiene, and cosmetic products, valued for its proven properties. It has well-documented antimicrobial effects and works as an effective solvent for a broad range of active substances. In biocidal products, ethanol is also a crucial active ingredient with a long use history.

Under Regulation (EU) No. 528/2012 on biocidal products (BPR), ethanol is being included in the systematic review. In the framework of the review in 2024, ethanol was identified as a substance that could be replaced by other alternatives because it allegedly meets at least one of the exclusion criteria under the BPR regulation - namely suspected toxicity to reproduction. These substances cannot be approved unless they are needed to protect health, safety, or critical processes and no alternatives exist.

Following these developments, the European Chemicals Agency (ECHA) has conducted a public consultation to identify alternatives to ethanol in biocidal products. However, this step has raised major concerns across the industry and among experts.

Many experts point out that classifying ethanol as reprotoxicant is based mostly on data related to high oral exposure – typically from the consumption of alcoholic beverages. In contrast, exposure via biocidal or cosmetic use is minimal and significantly lower. When applied on skin, as aerosols or vapours, systemic exposure is very different and generally considered safe.

The impact on industry would be substantial. The obligation to replace ethanol in biocides would not only imply technological complications but also a significant increase in costs. In many cases, alternatives may not even be available that are comparably effective, affordable or safe. Manufacturers would be forced to invest in new products, testing of alternatives and new registrations - which would inevitably be reflected in the price of the final products.

Ethanol played a crucial role, for example during the COVID-19 pandemic, when it was an essential ingredient in disinfectants widely used in hospitals, schools and homes. Adoption of the proposal without sufficient analysis of the real risk of exposure to ethanol could therefore lead to unnecessary restrictions on a substance that has a long proven track record of functionality and safety when used appropriately.

Author: Aneta Dostálová