The European Commission has adopted its roadmap to phase out animal testing in chemical safety assessment, with a long-term vision for significant regulatory reforms.
Switching to non-animal methods will ultimately require a new safety assessment framework, the Commission says. This would drastically change how industry and regulators work.
The roadmap does not define a timescale for these "long-term" goals but says that "both the methods and the overall safety assessment framework must change". This includes redesigning classification criteria for CLP.
The roadmap outlines a long-term goal of moving away from assessing toxicity based on adverse effects in organisms and instead using molecular changes to understand how substances interact with biological pathways in humans and the environment.
"Protection goals must be redefined for the new sources of information available," said Katrin Schutte, policy officer at DG ENV, during a conference on animal-free chemical safety assessment and roadmap implementation in Brussels on 2 June.
"The goal is not to lower the protection of human health and the environment versus today," she said. Current safety assessments often rely on derived no-effect levels (DNELs) derived from animal data, but "we need to find something to replace that with the information that we obtain from computational or in vitro methods", she added.
Funding
The roadmap prioritises validating new alternative test methods, but the Commission has not set aside dedicated funding, initially relying on existing EU-funded projects.
It will "track and report" the level of funding provided for validation by member state and commission programmes between 2026 and 2029. "There is not one funding budget for the roadmap," said Georg Streck from the Commission’s DG GROW, at the conference. "It’s not the end of the story when it comes to funding," he said. "We need to have more funding for validation, standardisation and qualification, so we will look into that."
The roadmap is the result of a 2021 European citizens’ initiative (ECI), Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing.
"The focus must now swiftly turn from ambition to delivery," said ECI chairperson Sabrina Engel, on behalf of Cruelty Free Europe, Eurogroup for Animals, European Coalition to End Animal Experiments (ECEAE), Humane World for Animals and PETA.
The roadmap’s steering group includes ECHA, the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA).
"With key legislation under the political spotlight, including REACH, it is vital that ECHA, EMA, EFSA, Commission services, and member states implement the roadmap consistently and transparently, in line with the ECI’s objectives," Engel said.
"Calling the end of animal testing a ‘long-term’ goal, without saying when, risks turning ambition into indefinite delay, a risk that animals can’t afford," Julia Baines, head of science policy for PETA UK, told Chemical Watch News & Insight. "However, I remain optimistic that with the right governance structure in place, with accountability mechanisms and key indicators to track progress, we’ll get there sooner rather than later."
"It’s no surprise that there is a lot of uncertainty in how and when the long-term goals will be realised," said Emma Grange, director of science and regulatory affairs at Cruelty Free International. "The need for action now, to realise short-term goals but also to make progress towards the ultimate goals of phasing out all animal tests for chemicals, is what’s most critical."
Roadmap goals
The short- and medium-term roadmap recommendations are based on existing regulatory frameworks and focus on replacing, reducing and refining animal testing while providing the same or similar information.
The initial focus is on making the most of existing alternatives and ensuring animal testing is used only as a last resort. This includes wider use of read-across, weight-of-evidence approaches, in vitro testing, and computer modelling.
In the short- to medium-term, testing with fish embryos or invertebrates is considered an acceptable refinement if it reduces reliance on vertebrate testing beyond early life stages. However, a total phase-out will include tests on fish embryos, currently considered new approach methodologies (NAMs) in some quarters.
To support the implementation of the roadmap, ECHA is establishing a Collaborative Platform on Alternatives to Animal Testing (CP-AAT). The platform will focus on the development and regulatory update of non-animal approaches in chemical safety assessments, including aspects related to validation, standardisation and regulatory use.
CP-AAT will bring together regulators, industry, academia and civil society to exchange knowledge on the efficient regulatory use of animal-free test methods. The platform members will also discuss existing scientific and technical challenges, with the first meeting taking place in Helsinki on 11-12 June.
Pillars of the roadmap
The roadmap has three main pillars:
- to replace, reduce or refine animal testing in the short to long term;
- to keep Europe at the forefront of research and innovation by applying non-animal approaches; and
- to build an organisational framework to facilitate the implementation of proposed actions and promote collaboration among EU member states, regulatory sectors and international partners.
Under the first pillar, the Commission will introduce a "mechanism" to identify regulatory needs for alternative approaches in different legislative areas. "Regulators are best placed" to determine which information is needed to ensure that alternative approaches effectively fulfil protection goals, it says. The roadmap steering team will compile regulatory needs in a report.