EU publishes roadmap to reduce reliance on animal testing
The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for pharmaceuticals.
The plan, published on 1 June, describes how animal testing will be phased out across 15 domains, including chemicals for industrial and consumer use, pesticides and biocides, pharmaceuticals, and food and feed additives.
According to a Commission announcement, the roadmap “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.”
The roadmap states that over 15 million animals have been used for regulatory testing in the EU from 2015 to 2023, with nearly 40% of these animals involved in chemical safety assessments.
The plan has three pillars: accelerating the development and validation of non-animal testing methods, leveraging research, artificial intelligence (AI) and data-driven assessments, and strengthening cross-sector collaboration.
Under the roadmap, the Commission proposes a host of actions to facilitate the transition away from animal testing. Those actions include providing access to the experimental facilities of the Joint Research Centre’s EU Reference Laboratory for developing alternatives to animal testing, introducing a mechanism to identify regulatory needs, and encouraging the development of EU and international standards for non-animal approaches.
The roadmap also highlights more than 30 opportunities to replace, reduce, or refine animal testing for human health and environmental assessments. For the pharmaceutical sector, the roadmap suggests reducing or waiting the need for repeated dose toxicology (RDT) studies for advanced cancers or severely debilitating/life-threatening diseases, reducing the need for certain tests based on in vitro or in silico approaches, and reducing the number of control animals in RDT studies by relying on virtual controls.
The Commission said the initiative supports and enhances the existing REACH framework, the EU's chemicals legislation, and serves as a concrete outcome from the Chemicals Action Plan it presented in July 2025.
The Commission said it will begin implementing the roadmap right away, working closely with member states, EU agencies, and other stakeholders. By 2029, it plans to hold a high-level conference to assess progress. The conference will focus on the use and adoption of non-animal approaches in all relevant EU legislation, including REACH. Additionally, it will involve consultations with stakeholders to discuss the future direction.
Stéphane Séjourné, the Commission’s executive vice-president for prosperity and industrial strategy, stated that “the publication of this roadmap marks a pivotal step towards modernising chemical safety assessments while reinforcing Europe’s leadership in innovation. By phasing out animal testing, we are not only upholding higher ethical standards but also strengthening our competitiveness through cutting-edge, non-animal alternative technologies.”
In a statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said that it supports the roadmap “as an important step forward in advancing ethical, science-based innovation in Europe.”
“The research-based pharmaceutical industry has long supported - and is already making significant progress - on the 3Rs principles of Replacement, Reduction and Refinement of animal testing,” said the group. “We are committed to accelerating the development and qualification of non-animal, human-relevant testing methods.”
The Commission’s efforts to phase out animal testing complement efforts by the US Food and Drug Administration (FDA).
In May 2026, FDA published a draft guidance on transitioning from animal studies to non-animal alternative methodologies for drug development; in the guidance, regulators asked companies to consider adopting new approach methodologies (NAMs), incorporating in vitro human-based systems, such as organs-on-chips and in silico modeling, to assess drug safety (RELATED: FDA drafts guidance on animal testing alternatives, Regulatory Focus 18 May 2026)
More recently, FDA proposed a more targeted guidance on reducing the need for animal testing when developing oncology drugs. American regulators emphasized that, by using the risk-based assessment approach outlined in the draft guidance, it anticipates streamlining the oncology drug development process without compromising patient safety. (RELATED: FDA oncology draft guidance aims to reduce animal testing, Regulatory Focus 1 June 2026)
