Eara

The European Commission’s long-awaited “Roadmap towards phasing out animal testing for chemical safety assessment” is expected to be published in early 2026.  
The roadmap is meant to set out the EU’s planned actions to accelerate the replacement, reduction and refinement of animal use in chemical safety testing and to support a transition to new approach methodologies (NAMs). It is the Commission’s formal response to the European Citizens’ Initiative (ECI), Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing, which closed in January 2023. The roadmap aims to establish a more predictable path towards regulatory acceptance of alternatives, while recognising that currently available methods remain insufficient to fully replace animal testing for many endpoints.  
Its development has been coordinated through several technical Working Groups, drawing on contributions from EU member states, agencies, NGOs and research partnerships such as PARC, ASPIS and EPAA.  
The final roadmap is expected to include timelines and targeted actions across short-, medium- and long-term phases, guiding implementation over the coming years. As well as detailing concrete steps to reduce animal use, it is likely to identify key scientific and regulatory barriers currently slowing the uptake of NAMs, and to propose specific actions to address them.  
It is also expected to introduce new monitoring mechanisms to track progress, including indicators for NAM adoption and the reduction of animal tests across regulatory frameworks.  
To support implementation, the Commission is expected to launch a joint action in 2026, aimed at facilitating coordinated rollout across member states. This will build on the work of the existing technical Working Groups. More detailed updates on how key frameworks such as REACH and the Classification, Labelling and Packaging (CLP) Regulation will align with the roadmap are also anticipated.  

Long-tailed macaques (Macaca fascicularis) are among the most widely used non-human primates (NHPs) in biomedical research, playing a critical role in immunology, oncology, vaccine development, pharmacologyand regenerative medicine. Six of the 25 most prescribed drugs were developed with their help, and macaques were essential to preclinical testing of COVID-19 vaccines, including those developed by Pfizer-BioNTech, Oxford-AstraZeneca and Janssen. 
However, the global supply of NHPs has been under severe pressure since 2020, when China — historically the primary source of purpose-bred macaques — imposed an export ban at the onset of the COVID -19 pandemic. The impact of the export ban was felt across the US, the EU and the UK, with prices more than doubling and some research programmes being delayed or abandoned altogether. The shortage has raised serious strategic concerns: as the US, China and Europe compete for the same limited pool of research animals, the availability of NHPs has become not just a scientific issue but a geopolitical one. China’s domestic pharmaceutical industry continues to benefit from unrestricted access to its own primate populations, potentially giving it a competitive advantage in drug development while researchers elsewhere face growing constraints. 
EU Directive 2010/63/EU includes a requirement under Article 10 that took effect from November 2022, non-human primates used in research must be at least second-generation captive-bred (F2) or sourced from self-sustaining colonies — effectively restricting the use of F1 animals, whose parents were taken from the wild. The aim was to end the EU’s reliance on wild capture for breeding purposes. However, the European Commission’s own second feasibility study, published in 2022, concluded that it is not currently possible to determine whether the aspiration of sourcing NHPs exclusively from self-sustaining colonies can be achieved, and that given recent changes in supply, demand and breeding practices, this goal is unlikely to be met for all commonly used primate species in the foreseeable future. Competent authorities in Member States may grant exemptions on the basis of scientific justification, but the restriction nonetheless places additional pressure on European researchers at a time when global NHP availability is already severely constrained. Combined with China’s ongoing export ban, the F1 restriction risks further reducing Europe’s capacity to conduct essential preclinical research and could drive studies to jurisdictions with lower welfare standards — undermining the welfare improvements the Directive was designed to achieve. 
Against this backdrop, the international trade in long-tailed macaques has come under increasing scrutiny from animal rights organisations, which have sought to restrict or halt the supply of research animals through various campaigns. These campaigns have targeted multiple fronts simultaneously — from international conservation frameworks (CITES and IUCN) to national endangered species legislation — often using contested and ultimately non-scientific claims, many of which have been rejected. 
In 2022, the International Union for Conservation of Nature (IUCN) reclassified the long-tailed macaque as “Endangered” — a decision that has been strongly contested by the scientific community. The National Association for Biomedical Research (NABR), citing peer-reviewed evidence, challenged the IUCN’s assessment, presenting peer-reviewed evidence that the underlying population data were flawed and misrepresented. Notably, the IUCN itself recognises the long-tailed macaque as one of the world’s most invasive species. In October 2024, the US Fish and Wildlife Service rejected a petition by PETA and other groups to list the species under the US Endangered Species Act, finding the petition did not present credible evidence of population-level threats. Despite this, the IUCN retained its “Endangered” designation in October 2025, a decision NABR described as bowing to pressure from animal activists in the face of overwhelming scientific evidence to the contrary. 
Efforts to restrict supply through CITES have also been unsuccessful. In February 2025, the CITES Standing Committee rejected a proposed trade suspension on long-tailed macaques from Cambodia, with no country speaking in favour of the measure. Japan, the US, Canada and others emphasised the need for evidence-based decision-making. The Committee agreed to allow the CITES Secretariat to conduct a thorough assessment and send a formal delegation to Cambodia. In November 2025, the Standing Committee released a comprehensive evaluation confirming that Cambodia’s breeding and export practices meet international regulatory standards, citing well-coordinated customs procedures and strong traceability systems. Following the report, the increasingly adversarial stance of animal rights groups such as PETA called for the CITES leadership to resign — a response that underscored the increasingly adversarial stance of animal rights groups toward the institutions tasked with regulating international wildlife trade. 
EARA continues to monitor these developments closely and works with partners including NABR to ensure that policy decisions affecting the supply of research animals are grounded in sound science rather than ideological campaigns. Maintaining ethical, well-regulated supply chains for NHPs is essential — not only for ongoing biomedical research, but for global pandemic preparedness. As the COVID-19 experience demonstrated, restrictions on NHP availability directly affect the speed and capacity of vaccine and therapeutic development, with potentially significant consequences for public health worldwide. 

In 2023, the European Citizens’ Initiative (ECI) “Save Cruelty-Free Cosmetics: Sign for a Europe without animal testing” gathered more than 1.4 million signatures. However, despite its title, the ECI went far beyond the cosmetics testing ban already in place since 2013. It called not only for stronger controls on testing related to cosmetics and other consumer products, but also for a comprehensive roadmap to phase out all animal use in scientific research and regulatory testing across Europe. 
In response, EARA warned that the initiative’s broader aims risk undermining medical and safety research essential for human and animal health. The complete elimination of animal research, before scientifically validated non-animal methods (NAMs) are available and approved for regulatory use, would jeopardise progress in biomedical science, drug development, and environmental safety assessment. 
A recurring claim made by organisations behind the ECI is that the widespread adoption of NAMs is being held back by tradition or by researchers’ reliance on “old-fashioned” methods. EARA strongly rejects this characterisation. Across Europe, the scientific community is actively investing in, developing and applying NAMs wherever they can answer the research or regulatory question. The real barriers are not resistance to change, but scientific limitations, validation requirements and regulatory acceptance, all of which are necessary to ensure that new methods provide reliable and protective data. 
The European Commission’s response to the ECI acknowledged both the importance of advancing alternatives and the reality that animal research remains necessary in some areas for the foreseeable future. The Commission committed to supporting NAM development and improving their uptake by means of drafting a “phase-out roadmap”, while stopping short of endorsing a blanket phase-out of animal research. The first roadmap that is currently being drafted is the “Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments”. 
Read EARA’s full statement here. 

Developments in the Netherlands in 2025 underscored ongoing political and societal tensions around primate research. In October, the Dutch Senate approved the 2026 science budget, including a parliamentary amendment that will progressively redirect public funding away from primate research at the Biomedical Primate Research Centre (BPRC), rising to 100% allocation to alternatives by 2030. 
The proposal immediately raised alarm across the Dutch and European research and health community. Ahead of the vote, a joint letter, co-led by EARA and signed by major organisations, urged senators to pause and properly weigh the consequences. That pressure initially worked: senators from multiple parties delayed the vote, requesting written questions to clarify what the amendment would mean in practice for research capacity, expertise and welfare standards at BPRC. Nevertheless, the Dutch Senate ultimately approved the budget including the amendment. 
This is another example of political pressure on animal research that ignores scientific reality and real-life consequences. An independent committee of experts that reviewed the importance of NHP research at the request of the same Dutch Parliament published their findings earlier in the year. In response, the Minister of Science stated that research at the BPRC should be maintained, and explicitly cautioned against politicians deciding which research should or should not take place. 
The scientific community also expressed its concerns regarding this type of political pressure via a stakeholder survey conducted by the National Committee for the protection of animals used for scientific purposes (NCad). Particularly in neuroscience and safety testing, there is scepticism among researchers towards the current Dutch approach to a transition to animal-free innovation, due to a lack of viable alternatives. 
Read the letter to the Dutch Senate, co-lead by EARA.