Background

Robust reporting and systematic evaluation of ecotoxicity studies are essential for ensuring that scientific data can effectively inform regulatory decision-making. Regulatory frameworks increasingly seek to incorporate all available evidence, including both standardised guideline studies and non-standard academic research. However, variability in study design, reporting quality, and methodological transparency often limits the usability of ecotoxicity data in regulatory contexts. Bridging this gap requires harmonised reporting practices and structured evaluation approaches that enhance the reliability, relevance, and accessibility of ecotoxicological evidence.

A central challenge lies in the diversity of ecotoxicity studies. While guideline studies follow established protocols, many academic studies are hypothesis-driven and may not align with regulatory requirements. As a result, insufficient reporting, such as incomplete descriptions of test conditions, exposure characterisation, or statistical analyses, can prevent regulators from assessing study reliability. Clear and comprehensive reporting is crucial. Core elements include precise identification of test substances, detailed exposure conditions, transparent description of test organisms and endpoints, and full documentation of methods and results. Without such information, studies may be excluded from regulatory assessments regardless of their scientific merit.

Beyond reporting, the evaluation of ecotoxicity studies focuses on two key dimensions: reliability and relevance. Reliability refers to the internal validity of a study, encompassing aspects such as experimental design, control of bias, reproducibility, and appropriateness of statistical analyses. Tools and frameworks, such as structured appraisal methods, support consistent evaluation of these factors. Relevance, in contrast, addresses whether the study is suitable for answering specific regulatory questions, including its applicability to environmental conditions, species of concern, and exposure scenarios. Importantly, scientific relevance does not always equate to regulatory relevance; studies that advance knowledge may still lack direct applicability to risk assessment.

Structured approaches are increasingly used to integrate ecotoxicity data. These approaches involve transparent processes for identifying, screening, and evaluating studies, thereby reducing subjectivity and improving consistency across assessments. Evaluation tools can also help categorise studies based on confidence levels, facilitating their integration into broader evidence bases. For example, methods like the CRED (Criteria for Reporting and Evaluating Ecotoxicity Data) approach provide standardised criteria to assess reliability and relevance, enabling more transparent and reproducible decision-making.

Another important consideration is the growing role of non-standard data, including studies using new approach methodologies (NAMs), such as in vitro systems and computational models. These data can provide valuable mechanistic insights and may address endpoints not covered by traditional tests. However, their regulatory uptake depends heavily on clear reporting, validation, and demonstration of relevance to adverse outcomes. Frameworks such as adverse outcome pathways (AOPs) can support the interpretation and integration of such data by linking mechanistic effects to regulatory endpoints.

Improving the regulatory utility of ecotoxicity studies requires coordinated efforts across stakeholders. Researchers must adopt reporting standards and consider regulatory needs during study design. Journals and publishers can enforce reporting guidelines to improve transparency. Regulators, in turn, can provide clear criteria and tools for data evaluation, promoting consistency and efficiency. Training and cross-sector collaboration are also critical, as many researchers lack familiarity with regulatory requirements.

Key reading

Bertram, M. G., Ågerstrand, M., Thoré, E. S., Allen, J., Balshine, S., Brand, J. A., ... & Brodin, T. (2024). EthoCRED: a framework to guide reporting and evaluation of the relevance and reliability of behavioural ecotoxicity studies. Biological Reviews. https://doi.org/10.1111/brv.13154

Borchert, F., Beronius, A. and Ågerstrand, M. 2022. Characterisation and analysis of key studies used to restrict substances under REACH. Environ Sci Eur 34, 83. https://doi.org/10.1186/s12302-022-00662-8

Casado‐Martinez, M., Dell'Ambrogio, G., Campiche, S., Kroll, A., Lauber, E., Marti‐Roura, M. & Ferrari, B. J. 2024. Incorporation of sediment‐and soil‐specific aspects in the Criteria for Reporting and Evaluating Ecotoxicity Data (CRED). Integrated Environmental Assessment and Management. https://doi.org/10.1002/ieam.4948

Due, I., Beronius, A., Baun, A., & Hartmann, N. B. 2026. SciRAPplastic and plasticCRED: tailoring existing tools to assess micro-and nanoplastics (eco) toxicity studies. Microplastics and Nanoplastics. https://doi.org/10.1186/s43591-025-00151-8

Hartmann, N. B., Ågerstrand, M., Lützhøft, H. C. H., & Baun, A. 2017. NanoCRED: A transparent framework to assess the regulatory adequacy of ecotoxicity data for nanomaterials–Relevance and reliability revisited. NanoImpact, 6, 81-89. http://dx.doi.org/10.1016/j.impact.2017.03.004

Jones LB, Mölkänen, S, Sowa G, O’Connor N, Asbury D, Al-Jaibachi R, Malpas T, Mayall H, Bond-Taylor H. 2026. Reevaluating new and existing challenges early career researchers face across regulatory ecotoxicology, Integrated Environmental Assessment and Management vjag022, https://doi.org/10.1093/inteam/vjag022 

Jones LB, Burns CJ, Arnold KE. 2025. Systems-based analysis of the factors affecting the use of academic research in European chemical assessment and management. Environ Int. 205:109859. doi: 10.1016/j.envint.2025.109859

Lahr J, Arts G, Duquesne S, Mazerolles V, de Jong F, Moermond C, van der Steen J, Alalouni U, Baujard E, van den Berg S, Buddendorf B, Faber M, Mahieu K, Montforts M, Smit E, van Spronsen R, Swarowsky K, Chaton P-F, Foldrin J, Lambin S and Pieper S, 2023 Proposal of critical appraisal tools for the evaluation of ecotoxicology studies. EFSA supporting publication 2023:EN-7787. 70 pp. doi:10.2903/j.efsa.2023.EN-7787

Moermond CTA, Kase R, Korkaric M and Ågerstrand M. 2016. CRED: Criteria for reporting and evaluating ecotoxicity data. Environ Toxicol Chem, 35: 1297-1309. https://doi.org/10.1002/etc.3259.

Moermond CTA, Franco A, Casado-Martinez MC, Kidd K, Korkaric M, Ågerstrand M. 2026. Improving the reporting of ecotoxicity data: will SETAC lead the way? Integrated Environmental Assessment and Management, Volume 22, Issue 2, Pages 335–337, https://doi.org/10.1093/inteam/vjaf197

OECD. 2025. Guidance Document on the Generation, Reporting and Use of Research Data for Regulatory Assessments, OECD Series on Testing and Assessment, No. 417, OECD Publishing, Paris, https://doi.org/10.1787/8d49ec1d-en.

The SciRAP tool: https://ki.se/en/imm/scirap-science-in-risk-assessment-and-policy