On February 24, 2025, the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) concluded that ethanol can be approved for use in hand and general disinfectants. The committee did not take a position on whether ethanol should be considered a carcinogen or a reproductive toxicant. At the meeting in February, the BPC passed an opinion supporting the approval of ethanol as an active substance for the following product types.
- Product Type 1: Human hygiene products, such as hand sanitizers;
- Product Type 2: Disinfectants and algaecides not intended for direct application to humans or animals;
- Product Type 4: Products used in the food and feed area.
The committee, in its opinion, confirmed the safety of all uses in these product types. The BPC did not reach a conclusion on the carcinogenicity or reproductive toxicity of ethanol, nor did it propose any new hazard classification.
According to the BPC, the following factors contributed to the inability to reach a definitive conclusion on the hazards:
- Although the applicant's data were complete, they lacked skin contact data, which is the primary exposure route for biocidal products. The existing inhalation data were also not conducted according to standard guidelines.
- Most of the evidence related to the carcinogenicity and reproductive toxicity of ethanol comes from voluntary consumption of alcoholic beverages, which the committee considers not an appropriate basis for decisions in the context of these biocidal uses.
- New studies addressing more relevant exposure routes are currently underway, and the Biocidal Products Committee (BPC) believes that these study results must be considered before determining carcinogenicity or reproductive toxicity. However, waiting for these study results to be published could significantly delay the approval process.
Next Steps
The ECHA will submit its opinion to the European Commission for decision-making. The European Commission will draft an implementing regulation proposing either the approval or non-approval of the active substance. This draft will be submitted to the member states of the EU, where it will be voted on by the Standing Committee on Biocidal Products. If supported, the European Commission will formally adopt the decision, which will then have legal binding force.
If approved, biocidal products containing ethanol can be authorized under the EU Biocidal Products Regulation (BPR). Companies must apply for product authorization either nationally or at the EU level. If not approved, products containing ethanol must be withdrawn from the EU market within the applicable transition period.
Regulatory Background
In the European Union, disinfectants are generally regulated under the EU Biocidal Products Regulation (BPR). A biocide typically refers to substances and mixtures that achieve the destruction, prevention, control, or mitigation of harmful organisms by means other than physical or mechanical action, such as disinfectants, preservatives, sanitary insecticides, rodenticides, and anti-fouling products.
The EU Biocidal Products Regulation (Regulation (EU) 528/2012, referred to as EU BPR) came into effect on September 1, 2013. The EU BPR requires that all active substances in biocidal products obtain approval from the European Commission before being placed on the EU market. Additionally, biocidal products containing these active substances must also obtain product authorization at the national or EU level.
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