The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) has recently supported the approval of ethanol for use in disinfectants (PT1, PT2 and PT4).

Despite the BPC opinion, the classification has not yet been finalised for CMR or ED, but restrictions/RMM for some indoor uses for PT2 and 4 (disinfectants) should be expected. The final classification is expected in December 2026.

While we’re still waiting for formal approval from the European Commission, this is a strong signal about what’s coming next.

In short, if ethanol is part of your product portfolio, now is the time to start preparing.

Waiting until the final approval is published might seem tempting, but it often leads to rushed timelines, limited resources, and unnecessary disruption. Getting ahead now puts you in control.

So, what does this mean for you?

If you place ethanol-based disinfectants on the EU market, you will need to ensure that your products can remain on the market through appropriate transitional arrangements, and that your data package and authorisation route are aligned with current BPR expectations.

 

Why Timing Matters

Starting now means you can:

  • Stay in control of timelines instead of reacting under pressure
  • Make better strategic decisions, like streamlining your portfolio, choosing the right authorisation route.
  • Identify and address data gaps early, avoiding delays later
  • Plan costs more efficiently, especially around testing and data access

 

Next Steps – How We Can Help

If you’re not sure where to start, that’s exactly where we come in. We can help turn this into a clear, actionable plan.

 

Pre-submission preparation

We can help you with strategic preparations ahead of approval:

  • Prepare and submit transitional (pre-BPR) authorisations
  • Portfolio review and product rationalisation
  • Biocidal product family design

 

Data Gap Analysis

We’ll review what you already have and what’s missing, including:

  • Identifying required studies
  • Highlighting data access needs
  • Exploring opportunities for waivers or read-across

 

Registration & Testing Strategy

We’ll help you map out the most efficient route forward:

  • Choosing the right authorisation route e.g. national (with mutual recognition), union authorisation etc
  • Building a cost-effective testing plan
  • Supporting data sharing, Letters of Access, and consortium engagement

And when the time comes…

 

Dossier Preparation & Submission

  • Prepare complete dossiers (including PAR, IUCLID and SPC)
  • Manage translations, submissions and authority interactions
  • Support you through the evaluation process to approval

Let’s Talk

If ethanol forms part of your product portfolio, it may be worth taking some time now to understand your position and consider next steps.

We’re happy to talk through your situation and help you map out the most practical next steps.

If you need support please contact our Head of Regulatory Affairs, Priya Patel at priya.patel@enviresearch.com