Adoption of the Roadmap
On 1 June 2026, the Commission adopted the Roadmap towards phasing out animal testing for chemical safety assessments.
This comprehensive approach encompasses a wide range of legislative domains, including industrial chemicals, pharmaceuticals, and food additives, and outlines over 30 key recommendations to facilitate the transition to alternative testing methods.
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.
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 relied on Working Groups (WGs) with representatives from the Commission and Agencies and with experts from all pieces of chemical legislation.
These WGs received input and ideas from the Commission's partnerships (including the EPAA, PARC, ASPIS, EU countries, NGOs) and stakeholders (e.g., through short papers and consultation activities). They further defined specific topics, on which Commission partnerships could provide organisational support (e.g., by recommending topics for workshops).
Learn more about the established WGs and their activities by clicking on the tabs below.
Human Health Working Group
The Human Health Working Group (HH WG) worked on breaking down the replacement of animal testing for assessing hazards and risks into different objectives, making proposals for specific actions, and defining milestones.
The group worked on identifying short and long-term solutions for reducing or replacing animal testing. This required the mapping of existing non-animal approaches which could already be implemented for specific endpoints.
It also entailed 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 focused on the human health aspects of the roadmap.
Environmental Safety Assessment Working Group
Like Human Health, the Environmental Safety Assessment Working Group (ESA WG) worked on assessing hazards and risks into different objectives, making proposals, and defining milestones. It also identified 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. The ESA WG focused on the environmental safety aspects of the roadmap.
Change Management Working Group
The Change Management Working Group (CM WG) collected 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 provided input for the consultation strategy on change management and conducted bilateral stakeholder consultations. The goal was to better understand specific concerns and incentives raised by different stakeholders.
In addition, this group worked on developing indicators to monitor progress towards the final goal of replacing animal testing. The CM WG also developed collaboration models to promote trust among stakeholders and build confidence in non-animal assessment strategies.
The CM WG held several bilateral meetings with different stakeholders, who are listed below. A summary of the bilateral meetings held is available to read.
| 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) monitored the progress made by these working groups and ensured sufficient collaboration and information sharing between the WGs. Updates on this work were presented in November 2025.
Consultation activities
The Commission's consultation strategy relied 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 a consultant in "Section 2. Factual summary" of the following report, the overall feedback from this call was as follows:
There is more work needed on (or significant challenges associated with) developing and validating 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.
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. Read the report on the first targeted stakeholder survey.
Second survey
The second survey requested 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 were consulted. The survey was sent out in April 2025 and remained open for 5 weeks. Read the full report on this survey.
Interviews
Between December 2024 and May 2025, several sets of interviews were carried out by a consultant. The same interest groups listed above were interviewed. The interviews covered 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
Read the report summarising the outcome of these stakeholder interviews.