On 1 June 2026, the European Commission published its long-awaited Roadmap towards phasing out animal testing for chemical safety assessments. It’s a significant moment. This is the most comprehensive plan any regulatory body has produced for ending the use of animals in chemical safety testing, and it covers everything from industrial chemicals and cosmetics to pesticides, biocides and pharmaceuticals.
It’s worth taking a moment to absorb the scale of what’s being proposed here.
The numbers
Between 2015 and 2023, over 15 million animals were used for regulatory testing purposes in the EU. Almost 40% of those were for chemical safety assessments. The roadmap sets out to end that, not as a vague aspiration but through 22 concrete actions and more than 30 specific recommendations for replacing animal tests across every toxicological endpoint.
What’s happening and when
The roadmap is structured in three timeframes. Short-term actions focus on methods that are already validated and can be implemented now or very soon. This includes computational models for acute oral toxicity, in vitro assays for sensitisation, and the waiving of redundant tests based on historical data. These are not future possibilities. They are methods that exist, work, and are ready for regulatory use.
Medium-term actions cover approaches that need further validation or regulatory adaptation before they can be implemented more widely. This includes areas like developmental neurotoxicity, genotoxicity and carcinogenicity where in vitro methods are advancing but not yet fully accepted across all regulatory frameworks.
Long-term actions are about fundamentally redesigning the safety assessment framework itself. The Commission is clear that the future of chemical safety assessment will be built on mechanistic understanding of toxicity at the molecular level, rather than observing adverse effects in animals. That’s a paradigm shift, and the roadmap acknowledges it will take time.
The market opportunity
This isn’t just a regulatory story. The Commission notes that the global market for in vitro toxicological testing is expected to reach up to EUR 30 billion by 2032, with yearly growth rates of 12%. The cell-based technologies market is projected to reach EUR 26.5 billion by 2028. The EU already captures around 30% of the global market for in vitro biotechnologies and the roadmap explicitly frames the transition as a competitiveness opportunity.
What caught our attention
A few things stand out from an XCellR8 perspective.
First, the roadmap recognises that non-animal approaches have the potential to be more cost-efficient, faster, and more human-relevant than the animal tests they replace. That’s language we’ve been using for 18 years and it’s encouraging to see it in an official Commission communication.
Second, the emphasis on supporting SMEs. The roadmap acknowledges that much of the innovation in this space comes from small and medium-sized enterprises and commits to supporting them through funding, the European Innovation Council, and startup matchmaking. For a company like ours, that recognition matters.
Third, the explicit statement that non-animal approaches must deliver “a level of protection equivalent to that of currently established methods.” This is important because it sets the bar clearly. It’s not about lowering standards. It’s about meeting them differently and, in many cases, exceeding them with more human-relevant data.
What it means for companies
If you manufacture or register chemicals in the EU, this roadmap will affect you. The Commission has committed to adopting or making legislative proposals to implement short-term actions by the end of 2029. A public dashboard tracking progress will be launched by the end of 2026. A Roadmap Steering Team involving industry, Member States, NGOs and academia will be set up by mid-2026.
The direction of travel could not be clearer. Companies that are already working with in vitro methods are ahead of the curve. Companies that haven’t started thinking about the transition should be starting now.
Our view
We set up XCellR8 in 2008 because we believed that animal-free, human-relevant testing was better science. Eighteen years later, the European Commission has published a roadmap that says the same thing in 26 pages of policy. The momentum behind this shift is now undeniable, from the UK government’s strategy published last November to this EU roadmap today.
For us, nothing changes operationally. We’ve been doing this all along. But for the industry as a whole, this is a landmark moment. If you want to talk about what it means for your products, your registrations, or your testing strategy, we’re here.
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