The Biocidal Product Committee (BPC) is expected to release its long-anticipated opinion regarding the active substance approval of ethanol at the end of November for product types 1, 2 and 4. Critically, this will include the potential re-classification of ethanol, which, if agreed , would see ethanol defined as a CMR substance. The classifications under consideration (Carc 1A/B, Muta. 1A/B and Repr. 1A/B) would fulfil the exclusion criteria under BPR Article 5 and the definition of a candidate for substitution under BPR Article 10. Under the exclusion criteria, such substances shall not be approved for use as a biocide, unless it is shown that:
Risk to humans, animals or the environment under realistic worst conditions of use are negligible.
The active substance is essential to prevent/control a serious danger to humans, animals or the environment.
Non-approval would have a disproportionate negative impact on society compared to the risk.
So, candidates for substitution remain listed as biocidal actives if the essential use derogation can be applied. Some of the considerations that would apply are availability of alternatives, costs, ensuring the control of target organisms and outcomes of risk assessments.
The outcomes of the human, animal and environmental risk assessments may have the biggest impact on the future of ethanol. An answer released by the European Parliament on 25.10.2025 regarding the future of ethanol stated: “Ethanol may still be approved for use in biocidal products, regardless of the conclusion on the hazard classification, if deemed safe for human, animal health and the environment”. This means the BPC are not just considering the hazard, but the potential risk posed by ethanol’s use as an active substance. Reviewing the submitted dossier, it becomes clear that the CMR properties of ethanol seems to occur after routine or excessive ingestion, as a result of repeated irritation to the digestive track and liver. However, there are no concerns that appear to be raised via dermal or inhalation, which would be the primary route of exposure when used as a biocide.
Are Ethanol Restrictions Likely?
We predict heavy restrictions will be in place for the use of ethanol for general use, and likely professional use to a lesser extent. Despite having negligible or no risk of ingestion, products such as hand gels, wipes, and sprays will be heavily impacted by the de facto ban of CMR substances for public use. The only exception to this foreseen is if the European Commission agrees to amend the BPR legislation itself.
Could Ethanol be Banned?
We predict that the BPC opinion will conclude that the active substance is approved, even if the new classifications are adopted, as ethanol is likely to be assessed to fulfil the essential use criteria. A reduced approval period may be in place, both for ethanol as an active substance and its biocidal products. This precedent is used with other candidates of substitution, in order to keep track of alternatives that may be a suitable replacement, or if new data regarding the active safety is generated. Typically, the cycle is halved, so we could see a 7 year cycle for ethanol as the active substance, and 5 year approvals for the biocidal products. This would be likely if the BPC conclude that there would be a need to replace ethanol in the future.
Critically, the current regulation stipulates that when an active falls into the CMR criteria, use for the general public is no longer permitted. Given the use of ethanol in hand sanitisers for many years, including throughout the pandemic, this would result in a loss of a key products utilised for the protection of public health. If the BPC or European Commission allow the use of ethanol in products for general public use, the precedence will be set moving forward about how CMR actives would be reviewed, potentially pushing the EU to adopt a risk based approach to the general public, rather than the hazard based approach in current use.
Potential Long-Term Impact
If no changes are made to the BPR legislation itself, and the CMR classifications are concluded ethanol will no longer be able to be used in biocidal products supplied to the for general public. For professionals, significant restrictions may also be in place. So while it could be expected that ethanol would be approved, it would no longer be readily available.
If however, the CMR classifications are put in place but the BPC or EC concede that changes to the BPR legislation are made to allow ethanol-based biocidal products to be supplied to the general public, then the EU could be about to set a precedence with their process. The active substance dossier authors have mentioned they believe their proposed classifications should not have an impact on the use of ethanol as a chemical, and strong defence from industry, which we are seeing, may force the EU’s hand. This could support a growing argument in the EU regarding moving from a strict hazard only based approach to a wider risk based approach seen in other jurisdictions (such as the US). With potential reforms for chemical regulations including the BPR ongoing, it is possible this is a change to BPR processes going forward.
What Should Manufacturers or Suppliers of Ethanol-Based Biocidal Products Do Now?
If you are a manufacturer or supplier of ethanol-based biocidal products, we strongly recommend closely reviewing the BPC outcome on ethanol. If the CMR classification is accepted, but the active substance is approved, submissions for product authorisations will soon need to be made. Blue Frog Scientific can support you to understand how the conclusions from the BPC meeting may impact your product portfolio and what actions to take next.
