The European Commission has released a long-awaited roadmap towards phasing out animal testing for chemical safety assessments, having pledged to develop such an initiative in response to the European citizen’s initiative titled ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing’, which was submitted to the Commission back in 2023. The roadmap has been designed to strike a balance between supporting the transition to non-animal methods (NAMs), whilst preserving the integrity of safety assessments provided by current methods.
The roadmap consists of twenty-two actions that fall under three pillars, with pillar one setting out the pathways for making change happen, pillar two ensuring Europe remains at the forefront of research and innovation and pillar three promoting cross-collaboration across Europe. Whilst the aim of the roadmap is to replace animal testing, the Commission’s communication acknowledges that both reduction and refinement (in the context of the 3Rs) will be important ‘stepping stones’ along the path.
It is acknowledged that certain endpoints are challenging to replace with NAMs, meaning that both the methods and the overall safety assessment framework must change. This new framework, once agreed, will require revision of legislation or guidance governing chemical safety assessments, but will also be seen as an opportunity to harmonise across many different sectors (the recommendations of the roadmap span across 15 legislative domains) via the ‘One Substance, One Assessment’ (OSOA)’ approach. OSOA is an EU legislative framework enabling more coordinated, efficient and transparent chemical safety assessments. Legislation with unique requirements for safety and efficacy testing in animals, such as veterinary pharmaceuticals, is not within the scope of the roadmap.
Under Pillar I of the roadmap, over 30 recommendations have been identified to replace, reduce or refine animal testing, ranging from short-term to long-term objectives, such as reducing control animals used in repeated dose toxicology (RDT) testing through the use of virtual control groups via in silico approaches. This is outlined in Table 2 of the Communication. The roadmap also proposes creating regulatory exploration spaces and utilising safe-space models at other European agencies. The European Medicines Agency (EMA) provides this through initiatives such as the Innovation Task Force (ITF), scientific advice and voluntary data submission, whilst the European Food Safety Authority (EFSA) and the European Chemical Agency (ECHA) currently lack such mechanisms for providing scientific advice on alternative approaches or exploratory dialogue on their regulatory acceptability. Addressing this may allow new approaches a degree of regulatory predictability, de-risking such innovations and facilitating the transition to non-animal safety assessments.
The Commission also plans to provide access to experimental facilities of the Joint Research Centre (JRC) EU Reference Labs to help companies that need to test, scale and validate alternative-approach-related products. They will also develop a mechanism for identifying and prioritising regulatory requirements for acceptance of alternative approaches to animal testing, with regulators determining what information is required for alternative methods to meet the relevant sector-specific safety standard, with this information being collated by the Commission. Insufficient funding for validation or standardisation studies was noted as a key obstacle in the stakeholders’ consultations. The Commission aims to provide greater clarity on funding options for validation, qualification or standardisation of NAMs, along with supporting the development of both EU and international standards for these methods.
The roadmap expects artificial intelligence (AI) to play a vital role in achieving the goal of phasing out animal testing, with NAMs being increasingly reliant on the support of AI tools. The roadmap was developed to create synergies with other initiatives, such as the EU Apply AI Strategy, AI in Science Strategy, as well as the European Health Data Space (EHDS), where access to large quantities of human-relevant data forms an important part of the development of NAMs and in which EHDS could possibly support. There is also the European Virtual Human Twins Initiative, which examines how human data and computational modelling can support chemical assessments. There are also research partnerships, such as the Animal-free Safety assessment for chemicals: Project cluster for Implementation of novel Strategies (ASPIS) and industry led initiatives, coordinated through organisations such as Animal Health Europe, supporting the delivery of the roadmap.
Funding will also be a key component in supporting the phasing out of animal testing; for the 2026-27 Horizon Europe work programme, there is €49 million of EU support for non-animal approaches. Other initiatives aim to support the commercial viability of scaling-up innovators, such as the European Innovation Council, which includes an Advanced Innovation Challenge dedicated to new approach methodologies in its 2026 work programme. The roadmap is set to work with several innovation strategies on the European Commission’s 2024-2029 policy agenda, such as the proposed EU Biotech Act, expected to be adopted later this year, and the future European Innovation Act.
Under pillar three, a governance structure is proposed, in which the Commission will work with ECHA, EFSA and EMA to form the Roadmap Steering Team, which will also offer seats to relevant stakeholders to oversee the transition. EU agency collaborative structures will assist with the implementation, such as ECHA’s Collaborative Platform on Alternatives to Animal Testing (CP-AAT) and the EMA’s 3Rs Working Party, and an inter-agency working group should be developed to optimise the coordination across agencies.
Monitoring the success of the roadmap’s implementation will be crucial, four indicator groups will feed into the development of an indicator framework, namely engagement indicators (e.g. capturing public awareness), status indicators (e.g. industry adoption), counter-progress indicators (e.g. barriers to regulatory acceptance) and progress indicators (e.g. reducing the number of animals used for chemical safety tests).
By 2029, the report references organising a high-level conference to review the progress, particularly the use and uptake of NAMs. Table One of the roadmap’s Annex provides timelines for the various actions outlined in the report, some of which can be expected later in 2026, with an accompanying staff working document which goes into the greater detail of some of the actions outlined in the roadmap, such as the development, conditions and parameters of a new safety assessment framework, as outlined earlier in the article.
