The transition to animal-free innovation is now high on the agenda of the European Commission. Within the European Union, there is increasing awareness of the fact that there are major benefits to research without the use of laboratory animals. The Dutch Member State of the European Union, with TPI, is actively seeking out opportunities to speed up the Transition towards Animal-Free Innovation in Europe as well.
European laws and regulations for safety research
Chemical substances and medicines have to be tested to make sure they are safe for humans, animals and the environment, in accordance with European laws and regulations. At present, many laboratory animals are still used for this purpose. These legal frameworks determine which of the new and promising animal-free developments may be used for safety tests.
Bureau REACH and the Ministry of Infrastructure and Water Management created this animation on a European strategy for test methods and validation. This strategy is needed to make test methods more quickly available and acceptable within the legal requirements.
Chemical substances are all around us in every product.
For good reason. They improve these products.
By giving them color,
making them resistant to decay by UV,
fire, grease and dirt, organisms,
or adding other functionalities that enhance the product.
But chemical substances can also cause negative impacts.
They can be toxic.
Or do not break down in the environment.
Chemical substances can be toxic in many different ways.
Some may lead to organ failure or damage the nervous system.
Others may cause cancer or interrupt reproduction.
Some can cause an allergy or disrupt the endocrine system.
To get information on the hazards and risks
of chemical substances tests are performed.
Each hazard needs its own tests.
However, development of new tests is necessary
with increased relevance for upcoming challenges.
to be able to test new types of negative
impacts like endocrine disruption,
methods that are suitable for advanced materials
and methods that do not need laboratory animals.
To change from supply-driven to a
need-based test development process.
Luckily, new and updated methodologies are promising
and in various stages of development.
But all methods have limitations, new or old.
The biological and regulatory relevance
of the test methods needs to be established.
Therefore relevance, is a first important step for validation.
As a second step in validation, reliability
of a test needs to be determined.
Results of a test may differ under different conditions.
To learn if a new test method is reliable,
the test methods need to be able to reproduce
the same results under different conditions.
It should not matter who performs
the test or where it is carried out,
similar results should be obtained.
Together, well-established testing conditions
that produce reliable and relevant results
create trust in new testing methods.
Validated test methods are needed to
assess the safety of chemical substances
to avoid risks for health and environment.
Investing in timely validation is
essential for ongoing safety assessments.
An EU Strategy to ensure test method development
that reflects regulatory needs and ensures validation
would improve the societal impact of public spending.
This will also help prioritization
and coordination on EU level,
building trust among stakeholders,
and a level playing field.
Several actions are initiated to make cooperation within the European Union possible and align national programs to improve research without the use of laboratory animals and to facilitate the international acceptance of validated animal-free innovations.
The ERA-action Accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices
To enable free circulation of researchers, scientific knowledge, and technology in Europe, and to work towards a unified, borderless system for research and innovation, the European Research Area (ERA) was created. Supporting this vision, ERA policy actions are targeted initiatives designed to align national policies, reduce fragmentation, and modernize academic careers across member states. Ultimately, these actions aim to boost Europe’s global competitiveness, accelerate green and digital transitions, and ensure high-quality scientific breakthroughs benefit society as a whole.
The field of NAMs could greatly benefit from increased harmonization and alignment of (national) policies, both at the national and European level. The technology is gaining importance every day. Across Europe, incentives, initiatives and with it efforts to advance the development and implementation of NAMs. However, to reach broad adoption of the technology, standardization, harmonization and alignment of efforts across EU member states, the European Commission and its agencies is needed.
As such, the ERA action ‘Accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices’ was adopted. The Action was jointly initiated by the Netherlands, the European Commission and EU-LIFE, but now has support from 18 EU Member States, as well as several countries from outside the EU.
The goal of this ERA-Action is to propose a harmonized approach to coordinate and streamline Member States’ actions to promote the development, validation/qualification and the uptake of NAMS when they are scientifically proven complementary approaches for biomedical research and effective innovation in medicinal products and medical devices. Coordination with existing initiatives in NAMs and animal testing will be ensured by involving all relevant actors in the Action.
Four working groups (WGs) for the ERA action
Experts from biomedical research, academia, research performing organisations, pharmaceutical and medical technology industry, regulatory agencies, and other relevant stakeholders contributing to scientific evidence collaboratively identify opportunities for the development and implementation of NAMS that could complement or replace animals effectively. This may apply, for instance in specific disease or biological areas, as well as in particular safety, quality, and efficacy assessment endpoints for medicinal products and medical devices. Based on the identified needs and knowledge gaps, experts provide insight and suggest priorities to governments and industry for the further coordinated efforts to leverage promising development of NAMs, taking into consideration the complementarity of scientific strengths, funding priorities and available expertise in the different Member States and regions.
The development and sustainability of key European infrastructures that can provide NAM resources (biobanks, super computers, complex multi-organ cultures, production facilities for therapeutic antibodies, etc..), as well as their access, is also addressed. Existing resources, projects and facilities across Member States are mapped, enabling the identification of opportunities for synergy and collaboration among them.
Consideration will also be given to the global context of medicines development and harmonisation of acceptance criteria for NAMs across regions.
Developers and users of NAMs, and other relevant stakeholders work synergistically with existing initiatives to identify optimal criteria that NAMs must meet to facilitate their uptake in the contexts of basic and applied biomedical research. In partnership with regulatory agencies, they work to define these criteria to enable NAM acceptance for the regulatory assessment of medicinal products and medical devices in defined contexts of use.
They propose priorities for the validation and qualification of NAMs.
Member States and pharma/MedTech industry take the decision to jointly support the validation/qualification of certain NAMs that are sufficiently mature for acceptance and uptake in regulatory testing of medicinal products and medical devices.
Relevant education and training programmes on NAMs and the application of the 3Rs principles7 for animal experimentation in Europe and other continents are mapped. In addition, their quality and outreach for students, researchers, technicians, and regulators are assessed.
Based on this exercise, which incorporates the best practices identified in EU Member States or countries outside of the EU, the working group makes suggestions to Member States for jointly developing education and training modules on NAMs and the application of the 3Rs principles in close partnership with education directors at knowledge institutes. These modules will aim to engage, not only the current professionals (researchers, regulators), but also the next generation of experts in this field.
Ministries, regulators, competent authorities, researchers, journal editors, learned societies and other relevant stakeholders develop common policies to improve the openness and quality of research, especially by giving open access to available protocols on NAMs, and facilitating the publication of results from NAMs and animal experiments, even if these are negative or neutral (or historic, if feasible and appropriate), to avoid unnecessary duplication of animal testing or development of non-valid NAMs. The data should be shared publicly and contain relevant information regarding sex. Synergies with other relevant ERA Actions8 will be established.
The working group considers strategies for sharing best practices to make sure that different ethical committees, funding assessment committees, reviewers, and regulators have a similar level of awareness regarding the latest scientific advancements in available NAMs. It proposes actions to enhance regulators’ confidence in validated and qualified NAMs, fostering a deeper understanding of the strengths and limitations of both NAMs and traditional animal studies.
The working group identifies opportunities for raising awareness among civil society and patients regarding the biomedical research, drug discovery and development process. It highlights the various research methodologies that have been successfully employed in the past, those currently in use, and emerging approaches for the future. In addition, it addresses the potential benefits and challenges associated with these methodologies in developing safe and effective treatments and prevention strategies.
Involved parties
The Action will set up an EU-wide forum consisting of relevant ministries, regulatory agencies, research funding organisations, academia, pharmaceutical and medical technology industry, Contract Research Organisations (CROs), Small and Medium size Enterprises (SMEs), and startups, to align national and regional policies for speeding up the development, validation, acceptance, and uptake of NAMs.
Coordination with existing initiatives in NAMs and animal testing will be ensured by involving all relevant actors in the Action. The Action has commitment from 18 EU Member States, as well as several countries from outside the EU and stakeholders.
Expected Ourcome
This Action will create a framework in which national and regional ministries, funding organisations, regulatory agencies, academia, research performing organisations, and industry, propose solutions to improve the coordination and harmonization of the development, validation/qualification, acceptance, and uptake of NAMs in biomedical research and regulatory testing of medicinal products and medical devices.
It runs until the end of 2028.
Roadmap towards phasing out animal testing for chemical safety assessments
On behalf of more than one million European citizens animal welfare organisations and cosmetics brands have submitted the citizens’ initiative ‘Save Cruelty-free Cosmetics - Commit to a Europe without Animal Testing’ to the European Commission. Subsequently, the European Commission announced that a roadmap towards phasing out animal testing for chemical safety assessments will be developed.
On 1 June 2026, the European Commission presented a roadmap towards phasing out animal testing for chemical safety assessments, which lays out clear, tangible steps to ensure the transition to innovative non-animal approaches. The roadmap will also preserve the integrity of safety evaluations, which ensure a high level of protection for human and animal health and the environment.
This initiative supports and strengthens the existing REACH framework, the EU's chemicals legislation, and is a concrete deliverable under the Chemicals Action Plan presented by the Commission in July 2025. With 22 actions under three pillars, the roadmap envisages gradually replacing animal testing for chemical safety assessments in 15 domains, including chemicals for industrial and consumer uses, pesticides and biocides, pharmaceuticals, and food and feed additives. The roadmap sets out indicators that will help to monitor progress in the implementation of the actions and recommendations.
The Netherlands leading the way
The Netherlands is leading the way when it comes to policy to accelerate the transition to animal-free research. The experience and expertise we have gained in the Netherlands through the TPI partner programme and the policy for animal-free innovations will be used to put the objectives of TPI on the international agenda.
Scientists from Dutch research institutions and companies have a lot of knowledge and expertise when it comes to animal-free innovations. They are working on the development and application of animal-free research models and contribute to the transition to better research without the use of laboratory animals. The TPI partner programme also ensures national coordination and policy in this area. It is a good basis for active cooperation with the European Commission and the other EU member states.
We do this by:
- As a member of the EU, actively advocating for the development of European policy for animal-free research and education on the use of so-called NAMs (New Approach Methodologies), including by working together with EU member states.
- Initiating proposals such as the proposal for a European policy agenda (2025-2027) for the transition to animal-free innovations (ERA). This proposal, which TPI is spearheading, focuses on cooperation and prioritisation between participating countries, in areas including the development and validation of animal-free innovations, education, infrastructure and promoting awareness and transparency.
- Actively participating, as representatives of the Dutch government, in discussions about the European Commission’s roadmap for phasing out animal testing in chemical safety assessments.
- Having Dutch experts (representatives of science, regulatory agencies, companies and policy) share their knowledge and experience with other member states.
Also see:
- News 01-06-2026: Commission accelerates transition away from animal testing in chemical safety assessments
- Summary of ERA-Action Accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices
- Summary ERA Working Groups (Accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices)
- News 27-05-2025: Next step in accelerating the transition towards animal-free innovation in Europe. EU Council endorses the European research area policy agenda for the next three years.
- Resolution ‘Plans and actions to accelerate a transition to innovation without the use of animals in research, regulatory testing and education’
- European Citizens’ Initiative: Save Cruelty Free Cosmetics - Commit to a Europe Without Animal Testing
- News 25-07-2023: Commission acts to accelerate phasing out animal testing in response to a European Citizens’ Initiative
- The Commission roadmap for phasing out animal testing in chemical safety assessments