Dear members, please see below update on the proposed CMR Classification of Ethanol under EU Biocidal Products Regulation. This would impact Northern Ireland as well as the EU, and would impact the use of ethanol as a disinfectant.
Background:
- Ethanol is currently undergoing a parallel evaluation as a biocidal active substance under the Biocidal Product Regulation and for harmonised classification and labelling under the CLP Regulation.
- Under the BPR evaluation, following the BPC Working Groups conclusion on ethanol meeting the exclusion criteria for carcinogenicity and reproductive toxicity, the evaluating Competent Authority (Greece) and ECHA requested to conduct an Analysis of Alternatives (AoA) to determine if viable substitutes exist for ethanol in PT1, 2 and 4. MedTech Europe submitted a response to the consultation launched by ECHA in February 2025 to collect information on potential alternatives to this substance. Since the closing of the consultation, the BPC WGs have been working in developing their recommendations.
Latest developments:
- Over September and October, the BPC Working Group on Human Health Toxicity agreed to recommend a Carc 1A and Repro 1A classification, while it recommended no mutagenicity classification. The BPC is expected to adopt its opinion at meetings on 24-28 November.
- On 16 October 2025, A.I.S.E. held a webinar on the state of play of the BPR assessment of Ethanol and where they announced they had drafted a joint statement to urge EU policymakers and Member States to reject ethanol’s CMR classification, up-hold evidence-based regulation, and safeguard Europe’s health and economic resilience.
- The statement:
- Emphasizes the essential role of ethanol-based biocidal products in hygiene and infection prevention, as well as their importance across various sectors, including agriculture, food production, and transport.
- Warns against the use of oral overconsumption data for ethanol risk assessment, given that exposure to biocidal products primarily occurs through dermal contact or inhalation.
- Highlights the potential consequences of a de facto ban on ethanol-based biocidal products for the general public, and the likely restriction on their professional use.
- Urges national authorities in EU Member States and the European Commission to prevent the classification of ethanol as a CMR substance in biocidal products.
