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The EU's Roadmap towards phasing out animal testing represents a critical milestone in modernizing chemical management frameworks. However, as experts gathered at the Helsinki Chemical Forum 2026, it became clear that while the vision is ambitious, the path to implementation is fraught with methodological, regulatory, and global coordination challenges.
The panel discussion, titled "Challenges to implement the Commission's roadmap to end animal testing," brought together key voices from the OECD, ECHA, EPAA, and NGOs to discuss how to bridge the gap between current regulatory requirements and a future defined by New Approach Methodologies (NAMs).
Harmonization: The Pillar of Global Acceptance
The reduction of animal testing is not just a European issue but a global one. As highlighted by Patience Browne from the OECD, the Mutual Acceptance of Data (MAD) is a key pillar of global chemical safety.
"If we have animal alternatives accepted in one OECD member country but not another, that compromises the mutual acceptance of data," Browne warned. "Unless non-animal approaches are similarly harmonized, the number of animals used in toxicity testing will not be meaningfully reduced."
Building confidence in these new approaches requires transparency, reproducibility, and a shared understanding of regulatory needs. The panel emphasized that the transition is not just about replacing one test with another but about ensuring that every stakeholder, from academic developers to global regulators, is "brought along" in this change.
"The roadmap is a communication, not a law," noted Julia Pochat from the Eurogroup for Animals, during our exclusive interview. She highlighted that the scientific advancements in this space have been discussed for many years at the OECD level, with ECHA constantly engaging partners in the United States, Canada, and beyond.
A Paradigm Shift in Risk Assessment
One of the most significant hurdles identified by the panel is the need for a fundamental "paradigm shift" in how chemical safety is assessed. Georg Streck, from the European Commission, emphasized that for complex toxicological endpoints, a simple one-to-one replacement of animal tests with non-animal methods is not possible.
"Non-animal approaches usually give a different kind of information than that which we receive from animal testing," Streck noted. "We need to rethink the risk assessment methodology and how we use NAM information in regulatory assessments. This is not a short-term undertaking."
This "paradigm shift" involves moving away from traditional endpoint-based assessments toward more integrated approaches. Case studies, such as those conducted through the European Partnership for Alternative Approaches to Animal Testing (EPAA), were cited as essential tools for demonstrating that non-animal data can meet protection goals with the same, if not better, certainty than traditional methods.
Building Confidence and Regulatory Acceptance
For NAMs to be successful, they must gain the trust of both regulators and industry. Ophelia Bercaru, Director at ECHA, highlighted the agency's commitment to building this confidence through tools like the QSAR Assessment Framework and the development of in vitro toxicological kinetics.
A key initiative announced during the forum is the Collaborative Platform for Alternative Animal Test (CPAAT), set to kick off in June 2026. This platform aims to:
Ensure capacity building among Member State competent authorities.
Develop a shared understanding of alternative methods in regulatory contexts like REACH and Biocides Regulation.
Identify regulatory needs and communicate them to research consortia.
"CPAAT will help us improve coordination and build trust across Member States and stakeholders," Bercaru explained.
From Hazard to Integrated Safety Decisions
As the roadmap progresses, the focus is shifting toward a more integrated view of safety. This includes better modeling of exposure and understanding use patterns, particularly for downstream users. By integrating hazard assessment with exposure data, regulators can make more informed, risk-based decisions.
Pochat pointed out that the roadmap should trigger a moment of reflection: "How can we deliver on safety via our commitments to phase out animal testing?" This question should be the starting point for every new regulatory challenge, ensuring that non-animal approaches are the default rather than the alternative.
The Road Ahead: From Slogan to Reality
The roadmap is currently a "non-binding communication," which poses its own set of challenges. To move from a "flamboyant slogan" to a concrete reality, the panel identified several priorities:
Funding: Ensuring dedicated streams for validation, qualification, and standardization of NAMs.
Legislative Cohesion: Aligning the roadmap with the 15+ pieces of EU chemical legislation.
Stakeholder Involvement: Constant engagement with NGOs, industry, and academia, including the younger generation of scientists.
"It is a long-term commitment," Bercaru concluded. "We need to learn from each other and modify our regulatory frameworks to enable this paradigm shift."
Exclusive Interview:
To explore in depth what progress has been made in phasing out animal testing, ChemLinked's journalist Ola Lilaj has arranged an interview with one of the distinguished panelists, Julia Pochat from the Eurogroup for Animals. The video clip can be accessed below:
