The European Chemicals Agency (ECHA) is currently reviewing ethanol as a biocidal active substance. This substance — used in hand disinfectants (PT1), surface disinfectants (PT2) and in the food and feed area (PT4) — is also under assessment following a proposal for classification as carcinogenic and reprotoxic submitted by Greece in 2020. The implications could significantly affect the professional and industrial use of ethanol across the European Union.
Regulatory context and recent developments
Ethanol is undergoing a dual evaluation: on one side, the review under the Biocidal Products Regulation (EU) No 528/2012 (BPR); on the other, the proposal for harmonised classification under the CLP Regulation (EC) No 1272/2008. In September 2024, ECHA working groups indicated that ethanol could fall within the category of carcinogenic and reprotoxic substances, making it a candidate for exclusion or substitution within the biocides framework.
In view of this scenario, ECHA has opened a public consultation to gather technical evidence and potential alternatives to the use of ethanol. The results will play a crucial role in the final opinion of the Biocidal Products Committee (BPC), whose conclusion has been postponed to 2026.
Consequences for the sector and future outlook
During the meeting held on 26 November 2025, the BPC did not reach a consensus and postponed its decision. The European Commission will evaluate the approval of ethanol by considering its safe use, potentially restricting it to professional applications only. The final opinion is not expected before May 2026.
Should ethanol be excluded, all ethanol-based products would need to be reformulated or replaced, with significant consequences for manufacturers, importers and professional users.
Conclusions
Ethanol remains one of the most effective and safest disinfectants currently available. Given the absence of fully equivalent alternatives and its long-established use, it is essential that the regulatory process carefully considers market needs and the available scientific evidence.
About Renolab S.r.l.
Renolab is a highly specialised analytical laboratory with extensive experience in conducting analyses in compliance with Good Laboratory Practice (GLP) standards. The laboratory operates under the directives of the Italian Ministry of Health for chemical and physical characterisations, as well as residue studies on agrochemicals, biocides, cosmetics, pharmaceuticals, additives and other industrial chemical products.
Renolab’s microbiological studies are carried out in accordance with OECD principles, European directives and Italian regulations, ensuring the highest standards of reliability and compliance. For more information, please visit https://www.renolab-glp.com
Regulatory context and recent developments
Ethanol is undergoing a dual evaluation: on one side, the review under the Biocidal Products Regulation (EU) No 528/2012 (BPR); on the other, the proposal for harmonised classification under the CLP Regulation (EC) No 1272/2008. In September 2024, ECHA working groups indicated that ethanol could fall within the category of carcinogenic and reprotoxic substances, making it a candidate for exclusion or substitution within the biocides framework.
In view of this scenario, ECHA has opened a public consultation to gather technical evidence and potential alternatives to the use of ethanol. The results will play a crucial role in the final opinion of the Biocidal Products Committee (BPC), whose conclusion has been postponed to 2026.
Consequences for the sector and future outlook
During the meeting held on 26 November 2025, the BPC did not reach a consensus and postponed its decision. The European Commission will evaluate the approval of ethanol by considering its safe use, potentially restricting it to professional applications only. The final opinion is not expected before May 2026.
Should ethanol be excluded, all ethanol-based products would need to be reformulated or replaced, with significant consequences for manufacturers, importers and professional users.
Conclusions
Ethanol remains one of the most effective and safest disinfectants currently available. Given the absence of fully equivalent alternatives and its long-established use, it is essential that the regulatory process carefully considers market needs and the available scientific evidence.
About Renolab S.r.l.
Renolab is a highly specialised analytical laboratory with extensive experience in conducting analyses in compliance with Good Laboratory Practice (GLP) standards. The laboratory operates under the directives of the Italian Ministry of Health for chemical and physical characterisations, as well as residue studies on agrochemicals, biocides, cosmetics, pharmaceuticals, additives and other industrial chemical products.
Renolab’s microbiological studies are carried out in accordance with OECD principles, European directives and Italian regulations, ensuring the highest standards of reliability and compliance. For more information, please visit https://www.renolab-glp.com
