BPR Ethanol decision on the radar for 2026!
Do you have ethanol based biocidal products? If so, you should read this!
Today ethanol (CAS 64-17-5) can still be used as an active substance, and biocidal products containing it can be sold according to national transition rules. Once there is an approval of ethanol, biocidal products containing this active substance will require product authorisation, following BPR.
Regulatory context – BPR
Ethanol is included in the review programme of the Biocidal Product Regulation as an existing active substance. Its evaluation is ongoing already for over 10 years and it is being conducted by Greece competent authority for PT1, 2, 4 and 6 uses.
During its evaluation, in October 2024, the Biocidal Products Committee (BPC) Working Groups have concluded that ethanol presents carcinogenic and toxic for reproduction properties.
Under the context of the Biocidal Product Regulation (BPR), any substance meeting the “exclusion criteria”, cannot be approve under the BPR on the basis of their intrinsic properties, such as CMR (Carcinogenicity, Mutagenicity, Toxicity for Reproduction), ED (Endocrine Disruption), PBT (Persistent, Bioaccumulative and Toxic) or vPvB (Very Persistent and Very Bioaccumulative).
Due proposed classification for Carcinogenicity and Reproductive toxicity category 1, ethanol is according to Article 10(1) of the BPR, a Candidate for Substitution (CfS).
Public Consultation on availability of alternatives
ECHA has started on 25th Feb 2025 a 60-day public consultation (ended on 28th April 2025). With this consultation ECHA aims to collect information whether ethanol meets at least one of the derogation conditions as well as to gather information and views from all interested parties concerning its use and to determine if viable alternatives exist which could replace it.
What next?
Following the consultation, the BPC opinion should become available in the second half of 2025, and consequently the EU Commission will take a decision on the approval of ethanol, which may be expected in a year time approximately. In the case of a positive decision, an approval may be granted for a maximum of five years and for restricted uses.
However, there is already a huge debate around this topic! Ethanol is everywhere – from hand sanitisers and disinfectants to cosmetics and cleaning products. It’s been considered safe, effective and especially valued for its antimicrobial properties and versatility. But now, a significant regulatory shift is underway in the EU that could reshape ethanol’s future.
The proposal for the classification change was based on studies via oral intake. If this classification is adopted, it won’t only just affect ethanol in alcoholic drinks, it will impact biocidal products, cosmetic, detergents, and many other sectors where ethanol is used as an active substance or ingredient. Ethanol’s approval may be at risk, and consumer products containing ethanol could face restrictions or bans.
Stay informed and plan ahead!
Count on Apeiron to help you!
If the EU Commission approves ethanol for PT1, 2, 4 and 6, it usually takes 2 years from the decision date to the approval date. This means that around 2027/2028 a dossier for biocidal products containing this active substance may be required to be submitted to ECHA.
Do you have ethanol based products on the market and not quite sure what to do next or how this really impacts your products? Apeiron can help you out!
We offer strategic guidance and can help you to understand the legal requirements (and required effort and timing) for biocidal products, to ensure full compliance. Once decided what the best option would be for you, Apeiron can support you throughout the biocidal product authorisation process.
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