On 1st June, the European Commission published the Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments (the Roadmap). EDC-Free Europe calls for using the implementation of the Roadmap to strengthen the protection of human health and the environment. 


EDC-Free Europe is a coalition representing more than 70 public interest groups, which share a concern about endocrine-disrupting chemicals (EDCs) and their impact on our health and wildlife. Our coalition partners include trade unions, consumers, public health and healthcare professionals, advocates for cancer prevention, environmentalists, and women's groups. 

The 2020 EU Chemicals Strategy for Sustainability (CSS) has described the need for a comprehensive knowledge base on chemicals, where regulatory decisions are made based on robust and relevant, up-to-date knowledge on chemical hazards and risks. However, significant data gaps still exist on the risks of chemicals that are today on the market, as well as the high number of newly developed chemicals entering it. This presents a challenge for regulators.

In this context, the coalition views the Roadmap as an important opportunity towards not only reducing the dependency on animal testing but also simultaneously strengthening the regulatory management of chemicals in the EU by improving the quality, efficiency, and speed of regulatory action on harmful chemicals. Helpful elements for this include the foreseen identification of regulatory needs as well as the funding of validation of methods.

With many methodologies still in need of further development and validation, several promising tools are already available. The envisaged transition to non-animal chemical safety assessments needs to include group approaches and read-across to structurally related chemicals. These are essential tools to speed up assessments, flag harmful properties and act as a basis for risk management, without generating new animal data. The current approach of regulating chemicals one-by-one takes a long time and has repeatedly resulted in regrettable substitutions, as seen for example with halogenated flame retardants, phthalates, bisphenols and PFAS.

While the coalition supports and shares the efforts to reduce and limit tests on laboratory animals to the minimum, it must be acknowledged that new approach methods (NAMs) with regulatory acceptance are not yet available to fully replace animal tests for the regulatory identification and risk management of the most serious hazards such as carcinogenicity, reproduction toxicity and endocrine disrupting properties. Therefore, the coalition calls for a cautious transition to new test methods, always prioritising protection of health and wildlife, in line with the core principle of the Roadmap that “non-animal approaches must deliver a level of protection equivalent to that of currently established methods”. This will require broader acceptance of NAMs data by all stakeholders in support of regulatory action, for example in classifications or restrictions.

A narrow focus on using NAMs to demonstrate safety limits their full potential, as their greatest contribution lies in enabling faster, more predictive, and more systematic chemical assessments that support timely regulatory action on substances of concern. Therefore, the publication of the Roadmap is just the first step, it is now up to its future implementation to strengthen the protection against harmful chemicals, while working on the Three Rs (replacement, reduction and refinement) as laid out under Pillar 1 of the Roadmap. The implementation of the roadmap will require joint efforts and the experience from many stakeholders. In our view, it is therefore important to build on available expertise and avoid duplication of existing efforts. In this regard, the Roadmap implementation should be strongly coordinated with the work on an EU Testing and Validation Strategy under the One Substance, One Assessment framework.

Additional resources on the topic: