Europe, US take steps to phase out animal testing of chemicals

In a converging policy shift on both sides of the Atlantic, European regulators this week published a roadmap toward fully replacing animal testing for chemical safety assessments, while the US Environmental Protection Agency issued a rare update to its list of alternative test methods.

The EPA on June 2 added 13 new approach methods (NAMs) to the list of tests accepted for chemical assessments under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 

It’s the first update in 5 years, but the agency is asking scientists and industry to nominate additions for future, more frequent updates. It launched a “science-driven pathway” to grow the list of NAMs, starting with an open invitation to submit potential additions via email. EPA scientists will evaluate submissions and add accepted methods to the list, the agency says in an announcement.

Meanwhile, on June 1, the European Commission released a roadmap outlining 22 action points to gradually replace animal testing for chemical safety assessments in 15 policy domains, including chemicals for industrial and consumer uses, pesticides, pharmaceuticals, and food and feed additives.

The roadmap sorts action points into three pillars. The first pillar covers 31 “opportunities” for replacing, reducing, or refining animal testing for specific end points, such as using computational models for acute oral toxicity testing or omitting certain assays for carcinogenicity testing.

The second pillar aims to leverage artificial intelligence and large datasets for developing new test methods. The third pillar looks at boosting collaboration among stakeholders within the European Union (EU) and with regulators in third countries. Measures include setting up an electronic information hub on NAMs by the end of 2027.

The commission developed the roadmap in response to a 2023 European Citizens’ Initiative demanding a Europe without animal testing, which gathered more than 1.2 million signatures.

Validation bottlenecks and vague timelines for phasing out animal testing

While industry welcomed the commission’s 26-page plan, a lack of concrete deadlines and unresolved hurdles to validating NAMs have stymied enthusiasm among animal-welfare groups.

Kirsty Reid, director of science policy at the European Federation of Pharmaceutical Industries and Associations (EFPIA) says the roadmap “reflects a shared ambition: to phase-in more predictive, science-driven approaches that can better protect both patients and the environment, while reducing reliance on animal testing.”

“While animal testing cannot yet be fully replaced in all areas, accelerating the development, qualification and regulatory acceptance of alternative methods offers significant opportunities for both science and society,” Reid adds in a LinkedIn post.

But Cruelty Free Europe, an animal-welfare group, questions how firmly the European Commission can commit to a plan that contains no legal deadlines. “This roadmap is a very welcome step in the right direction – we believe it can bring about the transformative change that European citizens want, but only if it is implemented effectively with ambition and strong leadership,” Emma Grange, the group’s director of science and regulatory affairs, says in a statement.

Julia Baines, head of science policy at People for the Ethical Treatment of Animals (PETA) UK, says Europe will need a solid framework for establishing scientific confidence in NAMs if they are to enter the regulatory sphere. Before a method can be used for regulatory purposes in the EU, it must be validated and entered into official test guidelines by the Organisation for Economic Co-operation and Development (OECD)—a slow process that sets a high evidentiary bar.

While the roadmap acknowledges barriers to validation, it doesn’t provide specific solutions, Baines says in an email: “As long as validation remains slow, so will implementation.”

The European Commission says it will start implementing the roadmap “immediately.” A high-level conference to take stock of progress is due in 2029. 

Meanwhile, the European Chemicals Agency launched a collaborative platform where regulators, industry, academia, and civil society can discuss scientific and technical challenges to implementing the roadmap. The first meeting of the platform will take place in Helsinki on June 11 and 12.