The European Chemicals Agency (ECHA) has released its sixth report on the use of alternatives to animal testing under Article 117(3) of the REACH Regulation. The report reviews the application of alternative approaches in REACH registrations submitted between 2008 and July 2025, highlighting continued progress toward reducing reliance on animal testing in chemical safety assessments.
According to the report, adaptation methods such as read-across, Quantitative Structure-Activity Relationship ((Q)SAR) models, weight of evidence, and data waiving continue to be used more frequently than new experimental studies. Among these approaches, read-across remains the most widely applied alternative method in REACH registration dossiers.
ECHA also noted that a significant proportion of the experimental data included in registration dossiers originates from studies conducted before the REACH Regulation entered into force. This demonstrates the industry’s ongoing efforts to maximize the use of existing data and avoid unnecessary animal testing.
The report highlights notable progress in the adoption of in vitro methods for hazard endpoints such as skin corrosion/irritation, serious eye damage/eye irritation, and skin sensitisation. Most newly generated data for these endpoints during the 2022–2025 reporting period were obtained through non-animal testing methods. However, ECHA acknowledges that significant scientific and regulatory challenges remain for complex endpoints, including repeated dose toxicity, carcinogenicity, and reproductive toxicity, where animal testing is still required in certain cases.
In addition, the report indicates a decline in the number of new substance registrations compared with previous reporting periods. Most new registrations were submitted for substances in lower tonnage bands, contributing to a reduced need for additional testing.
ECHA and the European Commission continue to support the long-term objective of phasing out animal testing for chemical safety assessments. The report emphasizes the growing importance of New Approach Methodologies (NAMs) and ongoing efforts to improve their validation, standardization, and regulatory acceptance. While substantial progress has been achieved, further scientific advancements are still needed to fully replace animal testing for more complex toxicological assessments.