Focus on ethanol – what manufacturers need to know
BPC confirms safe use of ethanol (CAS No. 64‑17‑5) in biocidal products.
On February 23, 2026, the BPC finally adopted, by simple majority, the view that the safe use of ethanol as a disinfectant in product types 1, 2, and 4 has been demonstrated.
However, the decisive issue remains unresolved: The committee did not reach a final toxicological conclusion regarding a possible classification as carcinogenic or reprotoxic. Uncertainty therefore continues with regard to a future CLP classification—although the CMR classification, originally based on the oral consumption of alcoholic beverages, is, for the time being, off the table. Consequently, ethanol will also not be considered a candidate for substitution under Article 10 of the BPR for the time being.
It is expected that the Standing Committee on Biocidal Products will follow the BPC’s recommendation and approve the active substance for disinfection purposes. The ongoing new studies addressing more realistic exposure routes also offer further hope that a CMR classification can also be avoided in the future.
What might your next steps be?
Should the European Commission approve ethanol for the relevant product types as anticipated, manufacturers will—based on the current situation—be required to submit their product dossiers to ECHA no earlier than March 2028 in order to continue marketing their ethanol-containing biocidal products.
If you market ethanol-containing products and are unsure which requirements you will face, we at Dr. Brill Regulatory Services are here as your reliable partner. We support you in understanding regulatory requirements, developing strategic options, and efficiently planning and implementing the entire authorisation process for your products.
In addition, we are planning to establish a consortium to coordinate the product authorisation of ethanol-based disinfectants in the European healthcare sector.
If you are interested, please feel free to contact us.
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