The ‘6th report on the use of alternatives to testing on animals for the REACH regulation’, published June 2026 compares long-term trends in REACH registration data (up to July 2025) with more recent practices from 2022–2025, showing a stable and consistent reliance on non-animal approaches. Analysis of nearly 13,000 datasets indicates that only about one-third are based on experimental studies, while approximately 37% rely on adaptations, primarily read-across, followed by data waivers, weight-of-evidence approaches, and QSARs. This pattern has remained steady over time, underlining the continued importance of alternative methods. Legacy data also play a major role, with around half of experimental studies dating back to before REACH entered into force.
Read-Across is Still Dominant Adaptation Method
There has been a clear shift from in vivo to in vitro testing, particularly for endpoints such as skin and eye irritation and skin sensitisation, where up to 89% of studies in recent years are now conducted in vitro. For newly registered substances between 2022 and 2025, the number requiring hazard data has decreased significantly, largely due to a higher proportion falling into lower tonnage bands with less demanding data requirements. Despite this, the proportion of experimental studies remains similar, and read-across continues to be the dominant adaptation method.
Adaptations Are Often Insufficiently Justified
However, important challenges remain. Adaptations are often insufficiently justified, leading regulators to request additional data, sometimes involving animal testing. Moreover, complex toxicological endpoints cannot yet be fully addressed by alternative methods, and not all substances are suitable for in vitro approaches. Regulatory acceptance is another limiting factor, as not all new methods are fully validated, and high certainty is required for decision-making.
ECHA Actively Supports NAMs
To address these challenges, ECHA is actively supporting the development and uptake of new approach methodologies (NAMs), including in vitro systems, computational tools, and advanced modelling approaches. This includes investment in platforms such as the OECD QSAR Toolbox and initiatives to improve data accessibility and harmonisation. Collaboration with international organisations and the establishment of initiatives like the Collaborative Platform on Alternatives to Animal Testing (CP-AAT) aim to coordinate efforts, identify priorities, and accelerate progress.
Replacement of Animal Testing is a Long-Term Objective
Overall, while significant advances have been made, key hurdles remain in validation, standardisation, regulatory acceptance, and integration of diverse data sources. As a result, the full replacement of animal testing is still considered a long-term objective.
With the publication of the EU roadmap to replace animal testing 1st June the practical implementation phase has started. Central will be the CP-AAT hopefully reflecting many of the Roadmap’s recommendations in its work programme and actively engaging stakeholders to move forward together.
At Blue Frog, our dedicated NAMs and Nanomaterials team designs and implements scientifically robust, regulatory-compliant strategies to utilise new approach methodologies (NAMs) in support of chemical, biocide, and plant protection product registrations.
Call or email to discuss how we can support your application of new approach methodologies.
