European Commission publishes its roadmap towards phasing out animal testing
- Jun 4
- 5 min read
Updated: 3 days ago
© Sania Ristic 2026 — Licensed under CC BY‑NC‑ND 4.0
01 June 2026
In response to the 2023 European citizens’ initiative (ECI) ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing,’ the European Commission (EC) has published its 'Roadmap towards phasing out animal testing for chemical safety assessments'.
This response arrives against the backdrop of more than 15 million animals being used in animal experiments between 2015-2023 by companies to prove that their products, such as industrial chemicals, pharmaceuticals, and biocides are safe for consumers.
The ECI’s called for full implementation of the EU ban on animal testing for cosmetics ingredients, a full transition to non-animal methods for chemical safety tests, and commitment to a plan to phase out all experiments on animals.
In its roadmap, EC sets out what it describes as objectives and steps needed to transition from animal testing methods to non-animal approaches. It starts by reminding that applying non-animal approaches to safety assessment of chemicals is in the interest of both the industry and the consumers, since these approaches can increase competitiveness and shorten time to market of chemicals while enhancing their safety.
The roadmap covers 15 EU legislative domains where chemical safety assessments currently rely on animal testing, including REACH, CLP, detergents, cosmetics, pesticides, and pharmaceuticals regulation.
EC's plan of actions for gradually replacing all animal testing for chemical safety assessments across the EU emphasizes the following:
EC will continue supporting implementation of recommendations from scientific bodies and expert groups (ECHA, EURL ECVAM) for replacement, reduction and refinement of animal testing in the short to long-term.
The roadmap lists over 30 recommendations across toxicological endpoints of which one half concerns human health safety assessments and the other half environmental safety assessments.
Only 2 of these recommendations relate to replacement, while the remaining recommendations relate to reduction and refinement of animal testing.
Notably, cited goals for replacements in the short- and mid-term include replacing in vivo studies across sectors by computational models for oral acute toxicity and by in vitro assays to predict/measure developmental neurotoxicity, malformations and embryofoetal lethality, pyrogenicity and sensitisation. In the pharmaceutical sector, EC confirms its commitment to reduce animal testing through use of complex in vitro methods to predict organ toxicities (DILI, cardiotoxicity).
For more complex endpoints, such as repeated dose toxicity, transition to non-animal approaches will involve the use of different parameters from multiple methods, necessitating change in the overall safety assessment framework. This thought echoes the 2007 National Research Council's report, "Toxicity Testing in the 21st Century: A Vision and a Strategy," which outlined a transformative approach to toxicity testing by relying on a mechanistic understanding of toxicity rather than on black-box empirical observation of adverse effects in animals. Development of a cross-sectorial new assessment framework is cited as a long term goal in this roadmap, albeit without specifying what timeframe long-term refers to.
It is also noteworthy that EC has refrained from specifying dates-years on which it ambitions to reach mid-term goals for replacement of animal testing, making it difficult to anticipate and monitor advancements. While the document states that approaches covered by medium-term actions will be implemented once the steps required for validation, adaptations, etc. have been finalised, it does not specify which new type of action it plans to put in place to significantly accelerate the development, validation, qualification, standardisation and application of non-animal approaches.
The funding for validation or standardisation of non-animal methods was characterized by stakeholders as insufficient, impeding progress. Rather than announcing an ambitious budget increase at this stage, the EC has instead chosen to assess regulatory needs and prioritise the development of methods for validation, qualification, and standardisation. A report on key areas of regulatory needs for alternatives to animal testing will be published in 2027 and updated every three years. It is however unclear how the EC plans to align defined needs with appropriate processes and budgets to ensure rapid and efficient validation of innovative non-animal methods.
As for developers of non-animal methods that have the potential to replace animal experiments, EC will ensure access to 'safe space platforms' that allow applicants to share data confidentially with regulators to explore the acceptability of specific methods for a given case. This concept was already put in place in the UK, where the MHRA has 'regulatory sandboxes' and 'safe spaces' for AI/ML and innovative scientific methods.
In addition, EC will ask ECHA and its Member State Committee to strengthen their efforts to accept animal testing proposed by registrants only as last resort. At the same time, it is important to recognize that REACH already contains the 'last resort' principle. Mere asking has unfortunately no legal force and EC has not indicated that sanctions may be put in place as a reinforcement mechanism.
A workshop on funding opportunities for new approach methodologies organised by EC in 2025 suggested, as priority areas for innovation, domains with high levels of animal use or where animal tests show limited human relevance. The language of prioritisation suggests a redistribution of existing resources rather than an expansion, and the fact that these priorities emerged from a workshop makes the outcome appear informal and non‑binding.
At the same time, because the full extent of species‑specific differences remains unknown and human‑specific biological features continue to be uncovered through human‑based methods, the number of domains in which animal models show poor human relevance and predictivity is likely to be substantially underestimated. The risk that may arise from the use of methods that are not representative of the human physiology underscores the need to advance implementation of human-based methods.
A notable weakness of the roadmap is its reliance on the 3Rs principle as the main vehicle for long‑term replacement. The 3Rs do not question the scientific validity of animal testing and were never designed to drive a paradigm shift. This sits uneasily with the document’s own call for a new assessment framework, which is relegated to a distant long‑term objective.
In its overview of actions, the EC states that it will work to make the validation process more effective and efficient by considering proposals to optimise the work of the EU Network of laboratories for the validation of alternative methods (EU-NETVAL) and the Preliminary assessment of regulatory relevance (PARERE) network by 2027. One cannot help but wonder why the EC waited four years after receiving the ECI before initiating such proposals, and whether these proposals will in fact lead to a meaningful acceleration of the validation of non‑animal methods.
Development and integration of AI-based tools into roadmap actions will power development of predictive models. Through the use of human data and computational modelling, the European Virtual Human Twins Initiative can be a particularly useful tool for supporting chemical assessments.
To keep Europe at the forefront of innovation, innovative non-animal methods will require a substantial increase in dedicated funding. Although Horizon Europe and European Innovation Council Advanced Innovation Challenge are mentioned as potential funding sources, the roadmap stops short of indicating whether any new or additional funding will be allocated to non‑animal methods, leaving the scale of future investment unclear. The European Innovation Council Advanced Innovation Challenge uses ARPA-style funding mechanisms to support high-risk, demand-driven deep tech innovation. Given the scale of ARPA‑driven investment in the United States, the EU cannot afford to under-invest, and ambitious funding in the short to mid‑term would be essential to remain competitive.
While the roadmap is presented as a response to the ECI, it mainly reaffirms existing commitments and does not convincingly demonstrate that the EC’s current organisational structures, approaches, timelines, processes, or funding levels are adequate to accelerate the transition to non‑animal methods.
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