Update from the Helsinki Chemicals Forum

Challenges in implementing the European Commission’s 'Roadmap to Phasing Out Animal Testing for Chemical Safety Assessments'

The European Union (EU) has long promoted the principles of Replacement, Reduction, and Refinement (the 3Rs) in animal testing. Building on this commitment, the European Commission is preparing a “Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments.” This roadmap aims to guide and accelerate the move towards non-animal methods in the safety assessment of chemicals and is expected to be published between May and June this year.

The roadmap is also the European Commission’s response to the European Citizens’ Initiative “Save Cruelty Free Cosmetics”, which received the support of 1.2 million EU citizens. Importantly, the EU cosmetics regulation already serves as a concrete example that animal testing can be fully excluded from a regulatory framework: cosmetic products and ingredients placed on the EU market are not allowed to rely on animal testing data, demonstrating that safety assessment without animal tests is possible when clear legal requirements are in place.

Shortly before the roadmap’s expected release, a panel discussion titled “Challenges to Implement the Commission’s Roadmap to End Animal Testing” took place on 16 April at the Helsinki Chemicals Forum. The discussion focused on where Europe currently stands, what steps should come next, and how the roadmap can support a future regulatory system that no longer relies on animal testing. The panel brought together perspectives from EU institutions, industry, and civil society. According to the European Commission, the roadmap provides a comprehensive framework for progressing towards non-animal approaches in chemical safety assessments. While it does not immediately change existing legislation, it offers a shared reference point to support future discussions and continuous improvement.

The transition away from animal testing

From the perspective of the European Chemicals Agency (ECHA), a new group (Community of Practice on Alternatives to Animal Testing (CP-AAT)) will be established in 2026. This group will engage Member States and stakeholders to identify scientific and regulatory gaps, improve coordination among authorities, build trust among regulators, industry, and other stakeholders, and support a more effective, coherent transition away from animal testing.

From the EPAA perspective, achieving the roadmap’s objectives depends on the following three key pillars:

• Bridging the gap between research and regulatory use
• Building confidence in non-animal approaches
• Enabling the transition towards a new global regulatory paradigm.

There is broad recognition that all actors (policy makers, industry, researchers, and NGOs) are committed to moving forward, including the Organisation for Economic Co-operation and Development (OECD), supporting in the standardization of tests and test guidelines production. However, panelists stressed the need for dedicated funding to support research and validation of non-animal methods, ensuring that future policy decisions are grounded in robust science.

Julia Pochat, Political Advisor on Chemicals Strategy at the Eurogroup for Animals, highlighted that this process goes beyond the roadmap itself. It offers a unique opportunity to modernise the EU’s chemical safety assessment system, while also maintaining Europe’s competitiveness at the global level.

The challenges with biologically complex assays

There was general agreement that acute toxicity tests are closest to having reliable non-animal alternatives and could be among the first to be fully replaced. In contrast, chronic toxicity tests and assessments related to endocrine disruption remain more challenging. They are far more biologically complex since they involve longer exposure durations, multiple life stages and endpoints, greater sensitivity to subtle and delayed effects, and, especially for endocrine disruptors, the need to mechanistically link hormonal interference to adverse outcomes. These areas require further research, regulatory dialogue, and consensus to ensure that the phase-out of animal testing does not compromise human health or environmental protection. The New Approach Methodologies (NAMs) must be scientifically strong, accepted by regulatory authorities, standardised to support industry compliance and mutually accepted at EU and international levels.

The panel acknowledged the complexity of the task ahead. At least 15 different regulatory frameworks could be affected by the proposed changes. The roadmap is therefore an important initial step, but it remains a non-binding guidance document, and existing legislation continues to take precedence.
Timelines are difficult to predict. For complex endpoints such as long-term and reproductive toxicity, particularly those relevant to human health, progress may take 10 years or more.

Therefore, the panel was closed with two key messages:

• First, it is important to recognise how much progress has been made compared to two or three years ago, when these discussions began to gain momentum.
• Second, this is not the end; the transition towards a Europe free from animal testing in regulatory safety assessments will continue.

Finally, the panel on phasing out animal testing was part of a larger programme of five thematic panels at the Forum, reflecting the wide range of challenges which EU chemicals policy is currently facing. In addition to the discussion on non-animal testing and next‑generation safety assessment, the Forum hosted four other panels addressing key strategic topics. These included aligning battery and recycling regulations to maximise the reuse of critical raw materials, the role of the chemical industry in addressing the economic and triple environmental crises (climate change, biodiversity loss, and pollution), substitution of hazardous chemicals and pathways for innovation, and strengthening the science–policy interface at the global level. Together, these panels highlighted the interconnected nature of sustainability, competitiveness, and chemicals regulation, and reinforced the message that the transition away from animal testing is part of a wider transformation of the EU’s approach to chemical safety and industrial policy.

Gilberto Dias de Alkimin, PhD, is a Regulatory Ecotoxicologist with the Regulatory Affairs department at Charles River Laboratories. He works in the areas of industrial chemicals, active pharmaceutical ingredients, and biocides. He also leads projects on industrial chemicals and helps clients from non-EU countries register their substance registered in Europe. He received an MSc in Environmental Sciences from São Paulo State University (Brazil) and a PhD in Biology and Ecology of Global Changes – Ecotoxicology from the University of Aveiro (Portugal).