Focus on ethanol: Important regulatory developments for biocidal applications

Do you use biocidal products containing ethanol (CAS No. 64-17-5)? If so, please pay close attention!

Biocidal products containing ethanol as an active substance currently benefit from national transitional measures that simplify the marketing process. In Germany, for example, such products can currently be marketed without authorisation. However, this situation could soon change. The competent Greek authority has been evaluating ethanol for product types PT1, PT2 and PT4 for over 15 years. As a 'backlog dossier', it still falls under the transitional provisions of the old Biocidal Products Directive (BPD, Directive 98/8/EC).

In October 2024, the BPC Human Health Working Group concluded that ethanol potentially exhibits carcinogenic and reprotoxic properties. This means that the active substance meets the ‘exclusion criteria’ of the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012) and is considered a candidate for substitution in accordance with Article 10(1). A public consultation was then launched.

Public consultation and decision-making

From 25 February to 28 April 2025, the European Chemicals Agency (ECHA) conducted a public consultation to gather information on possible alternatives to ethanol and any potential exemptions. In response to this call, the Agency received 365 submissions from industry, associations, and institutions.

The BPC's opinion is expected at the end of November 2025. The decision on approval of ethanol by the Standing Committee on Biocidal Products, consisting of representatives from the Member States, is expected in spring 2026 at the earliest.

What are your next steps?

If the EU Commission approves ethanol for the relevant product types, a two-year transition period will begin. This means that, from today's perspective, manufacturers must submit their product dossiers to the ECHA by 2027/28 at the latest if they want to continue selling their products.

If you manufacture or sell ethanol-containing products and are unsure about the steps you need to take, Dr. Brill Regulatory Services can support you.

We can help you to understand the regulatory requirements, evaluate options for action, and design the entire authorisation process for your affected products strategically and efficiently.

We are planning to establish a consortium to coordinate the approval of ethanol-based disinfectants for use in the European healthcare sector.

If you are interested, please feel free to contact us.

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