A System Shift Is Coming and It Will Affect Your Registration Strategy

Anyone registering chemicals in Europe knows the requirement: for certain substance properties, safety data must be provided and much of this data has traditionally been generated through animal testing. This standard is on the verge of fundamental change. The European Commission has published a roadmap to phase out animal testing in chemical safety assessments (CSAs/CSRs). This is in the form of 22 actions, structured around three pillars, targeting 15 regulatory domains. Including chemicals for industrial and consumer uses, pesticides and biocides, pharmaceuticals, and food and feed additives.

This is not an abstract future project. The Commission is starting implementation immediately, in close collaboration with Member States, EU agencies, and stakeholders. A high-level conference is already scheduled for 2029 to publicly take stock of progress. ECHA has welcomed the roadmap and is moving straight into action: on 11–12 June 2026, the Agency is hosting the inaugural meeting of a newly established Collaborative Platform on Alternatives to Animal Testing in Helsinki; bringing together regulators, industry, academia, and civil society to accelerate the development and regulatory uptake of non-animal approaches. For companies that register substances, or whose suppliers do, this is not merely a political matter. It is a strategic inflection point.

The Three Pillars of the EU Roadmap in Detail

Pillar 1: Making change happen; towards phasing out animal use The first pillar focuses on accelerating the development and uptake of non-animal approaches. More than 30 targeted recommendations have been formulated to replace, reduce, or refine animal testing for human health and environmental safety assessments. New Approach Methodologies (NAMs); including, in vitro test systems, computer simulations (in silico models), organ-on-chip technologies, and other biological test approaches, must not only be developed but must also receive regulatory acceptance. A method that is scientifically valid but not accepted by ECHA will not be accepted in a registration dossier.

Pillar 2: Keeping Europe at the forefront of research and innovation The second pillar focuses on the research and innovation ecosystem. Europe aims to be not just a regulator but a global leader in alternative testing methods. A stated objective is leveraging artificial intelligence and large datasets for method development. This also creates long-term economic opportunities for companies that adopt NAMs early.

Pillar 3: Working together in Europe and beyond The third pillar addresses governance. A framework will be established to coordinate implementation with all relevant EU stakeholders and to foster collaboration with regulators at the international level. The goal is a coherent, internationally recognised transition without fragmentation between Member States or with trading partners.

What This Means in Practice for REACH Registrations

For companies registering substances today or updating existing registrations, the roadmap has several directly relevant implications: Data requirements will change. Companies currently using animal testing data exclusively in their dossiers should expect this data to need supplementing or replacing in the future. The roadmap creates the regulatory framework for NAMs to be recognised progressively as equivalent meaning dossiers based solely on classical animal data may eventually be considered insufficient. Early engagement with NAMs pays off. Companies that begin familiarising themselves with available alternative methods now will gain a head start. This applies both to selecting appropriate test methods and to communicating with ECHA during dossier evaluation.

New methods require new expertise. Interpreting NAM data differs substantially from evaluating classical toxicity studies. For companies without in-house toxicology capacity, external expertise becomes even more important; not just for conducting tests but for their regulatory interpretation.

Do you know which domains apply to you? The roadmap explicitly names 15 regulatory domains, including industrial chemicals, consumer products, pesticides, biocides, and pharmaceuticals. For many companies, several of these areas will be simultaneously relevant. An early portfolio analysis reveals which substances and registrations are most directly in focus.

No Radical Break, But No "Business as Usual" Either

It is important to understand the roadmap in context: it is not an immediate ban on animal testing under REACH. Many methods are still in the validation phase, and regulatory acceptance will develop incrementally. Companies do not need to overhaul their entire testing strategy tomorrow.

What the roadmap and ECHA's accompanying measures signal unequivocally is that the direction has been set and institutional implementation has already begun. The political mandate is clear: more than 1.2 million verified signatures were collected in 2023 for the European citizens' initiative "Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing." The Commission responded with a formal commitment to drive this change, and the launch of the Collaborative Platform demonstrates it is moving beyond declarations. Progress will be publicly reviewed by 2029. Companies that wait until requirements are formally amended will lose valuable preparation time.

Position Your Business Strategically Now

The EU roadmap is more than an ethical signal. It is a regulatory indicator of where REACH requirements are heading. With 22 concrete actions, a clear timeline, and international ambition, this is not a future project it is an ongoing development that already touches registration strategies today. This does not mean changing everything immediately but it does mean knowing your own dossiers, identifying open data gaps, and assessing which NAMs are already accepted today.

CSB Compliance can help you future-proof your REACH registration strategy. Our experts are familiar with the current regulatory landscape and can guide you through the implications of new developments — from dossier analysis to testing strategy. Contact us — Rachel Green and Lars Dobbertin are available for an initial conversation.