Ethanol underwent evaluation in the EU Biocidal Products Regulations (BPR, Regulation (EU) 528/2012) framework to determine whether it could be approved as an active substance in biocidal products, particularly disinfectants. It was included in the biocidal active substances review programme which assesses substances that were already on the market prior to the BPR coming into force. Ethanol was mainly evaluated for Product Types (PT) 1, 2 and 4 – human hygiene, surface disinfectants and food/feed area disinfectants. Greece was appointed the Rapporteur Member State (RMS) responsible for the evaluation.
A potential classification as carcinogenic and reprotoxic, category 1A or 1B, under the BPR, was mooted and on 26th November 2025 the expected decision was postponed because the committee failed to reach a consensus. This classification under the BPR had the potential to end the use of ethanol in disinfectants, sparking widespread concern for the implications, especially in healthcare. The committee decided to further examine risks from different exposure routes as the ethanol dossier is grounded in data on oral intake. Industry representatives submitted additional data on risks from dermal and inhalation exposure during a public consultation on alternatives to the substance.
During the 23 February 2026 meeting, the BPC backed the approval of ethanol for use in hand and surface disinfectants without pursuing a new hazard classification, saying it “did not reach a conclusion” on the chemical’s carcinogenic or reprotoxic properties. Evidence for ethanol’s carcinogenic and reprotoxic effects primarily stemmed from data on the consumption of alcohol. The committee said this is not an “appropriate basis” for decisions on biocidal uses of ethanol, which result in dermal and inhalation exposure. In 2021, WHO reassessed the occupational exposure to ethanol-based products. This reassessment showed that, despite high concentrations in some workplaces, the exposure pathways from disinfectants – inhalation, skin and eye – posed no cause for concern.
The BPC found that “safe use has been demonstrated” for ethanol in Product Types (PT) 1, 2 and 4 and proposed approval for these uses.
This conclusion by the BPC is only the first step. The EU Commission must now adopt an Implementing Act confirming the approval of ethanol as an active substance for biocidal use. Ethanol will then be subject to a vote in the Standing Committee on Biocidal Products (SCBP). If the outcome is positive, then the decision becomes legally binding.
If ethanol is approved as an active substance in disinfectants, then producers of Hand Sanisitsers and Disinfectants can prepare dossiers for product authorisation at either National level or by Union authorisation. If not approved, affected products must be withdrawn from the EU market within transition periods, which will be defined by ECHA.
In the meantime, attention will shift to a separate classification for ethanol under the CLP Regulation, Reproductive Cat 2, H361d. Greece is expected to submit a harmonised classification proposal under the CLP Regulation by 31 December 2026. Therefore, ethanol remains exposed to regulatory uncertainty. The absence of a hazard conclusion means companies should closely monitor future classification discussions. Potential changes to carcinogenic or reproductive toxicity status could trigger downstream impacts under CLP, REACH and workplace safety legislation.
Businesses using ethanol in their biocidal products should review their regulatory strategies and prepare for authorisation requirements to avoid disruption once the Commission decision is finalised.es/complex objects contain SVHCs above 0.1% w/w. This information becomes publicly accessible via ECHA’s database of substances of concern in products.
Published March 11th, 2026
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