Background
The European Union has a long-standing policy of replacing, reducing and refining animal testing (3Rs). Article 13 of the Treaty on the Functioning of the European Union recognises the need to protect animals as sentient beings. Directive 2010/63/EU1 sets the goal of phasing out animal use for research and for regulatory purposes in the EU, as soon as scientifically possible. Many pieces of chemical legislation contain a requirement to use animal testing only as a last resort.
The European Commission is preparing a “Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments”. This will serve as a guiding plan for accelerating the path towards replacing, reducing and refining animal testing for the safety assessments of chemicals.
The roadmap was announced in Communication C(2023)5041, which was published as a response to the European Citizens’ Initiative (ECI) “Save cruelty-free cosmetics – Commit to a Europe without animal testing”. In the communication, the Commission expressed its commitment to develop a roadmap that “will outline milestones and specific actions, to be implemented in the short to longer term, to reduce animal testing and that would be pre-requisites for a transition towards an animal-free regulatory system”. This response announces further elements that will accompany the roadmap and help reach its goals.
The Commission intends to publish this roadmap by the first quarter of 2026 at the latest.
Phasing out animal testing will require substantial time. For instance, there are currently no available approaches that are sufficient for developing and validating methods. As a result, the roadmap foresees an implementation phase for the years to come.
Learn more about the use of animals in science and alternatives to animal testing under REACH legislation.
Working Groups
The roadmap's development mainly relies on Working Groups (WGs) with representatives from the Commission and Agencies and with experts from all pieces of chemical legislation.
These WGs receive input and ideas from the Commission's partnerships (including the EPAA, PARC, ASPIS, EU countries, NGOs) and stakeholders. For instance, through short papers and consultation activities. They further define specific topics, on which Commission partnerships could provide organisational support. For example, by recommending topics for workshops.
The following WGs below have been established. Click on each tab to learn more about them.
The Human Health Working Group (HH WG) works on breaking down the replacement of animal testing for assessing hazards and risks into different objectives, makes proposals for specific actions, and defines milestones.
The group is working on identifying short and long-term solutions for reducing or replacing animal testing. This requires identifying existing non-animal approaches which could already be implemented for specific endpoints.
It also entails looking at advancing methods that are currently still under development, but could close gaps for areas of concern where there is currently no sufficient non-animal replacement. This group focuses on the human health aspects of the roadmap.
As of 7 April, the HH WG has met 6 times.
Like Human Health, the Environmental Safety Assessment Working Group (ESA WG) works on assessing hazards and risks into different objectives, makes proposals, and defines milestones. It also identifies short and long-term solutions for reducing or replacing animal testing.
As with the HH WG, these solutions include existing approaches, and advancing methods that are still being developed. Compared to Human Health, the ESA WG focuses on environmental safety aspects of the roadmap.
As of 7 April 2025, the ESA WG has met 5 times.
The CM WG collects information on transitional initiatives, such as projects or actions by stakeholders that aim to help phase out animal testing in the regulatory assessment of chemicals.
It also provides input for the consultation strategy on change management and conducting bilateral stakeholder consultations. This is to better understand specific concerns and incentives raised by different stakeholders.
In addition, this group is working on developing indicators to monitor progress towards the final goal of replacing animal testing. The CM WG also develops collaboration models to promote trust among stakeholders, and develop confidence in non-animal assessment strategies.
As of 7 April 2025, the CM WG has met twice, and held several bilateral meetings with different stakeholders, who are listed below.
| 1. EFPIA | 11. CRO |
| 2. CEFIC | 12. Animal Welfare NGOs |
| 3. Animal Health Europe | 13. CONCAWE |
| 4. ICCS + Cosmetics Europe | 14. AISE |
| 5. Ncad | 15. PrecisionTox (ASPIS) |
| 6. Consultant | 16. SMEs |
| 7. Eurometaux | 17. NL ministries & authorities |
| 8. Food Drink Europe | 18. SCCS |
| 9. IFRA | 19. NAMWISE |
| 10. Crop Life Europe | 20. Health & Environmental NGOs |
The Commission Interservice Group (ISG) oversees progress made by these working groups and ensures sufficient collaboration and information sharing between the WGs. Updates on this work were published in December 2024.
Consultation activities
The Commission's consultation strategy will rely on a combination of different approaches, which are listed below.
Call for evidence
The Call for Evidence was open from 17 September until 15 October of 2024. 91 contributions were received.
Summarised by the consultant, the feedback from this call was as follows.
There is more work needed on (or significant challenges associated with) developing and valdiating non-animal methods for complex hazard endpoints. This includes endocrine disruption, carcinogenicity, reproductive toxicity, repeated dose toxicity, and developmental effects.
Stakeholders widely acknowledged the need to speed up the validation process. Many stakeholders emphasised the need for collaboration between actors and sectors for the success of the roadmap.
Stakeholders widely acknowledged the need for both regulatory and non-regulatory actions.
Report on the call for evidence
The report on this call for evidence will be published and available to read online once finished.
Surveys and interviews
First survey
The first survey was used to collect input on topics for developing the roadmap. National authorities, EU agencies, businesses, non-governmental organisations and the scientific community were consulted through an online survey. The deadline for input was 17 January 2025.
Second survey
The second survey will be for requesting feedback on action points, milestones etc. of the roadmap. As with the first one, Member State authorities, EU agencies, businesses, NGOs and the scientific community will be consulted. The survey is planned to be sent out in April 2025 and will be open for about 5 weeks.
Interviews
Since December 2024 and until May 2025, several sets of interviews are being carried out by a consultant. The same interest groups listed above are being interviewed. The interviews cover a wide range of topics, such as
- more detailed feedback on test method development, validation, animal-free methods and expert groups
- a meta-platform for distributing better available information on animal-free methods
- an analysis of the need and feasibility of expert groups
Reports
The reports from the consultant on the above consultation activities will be available to read online once they are published.