Hernández-Jerez Antonio, Hougaard Bennekou Susanne, Hoogenboom Laurentius Ron, Mcardle Henry, Pieper Christina, Schwerdtle Tanja, Van Loveren Hendrik, Al Harraq Zainab, Croera Cristina, Christodoulidou Anna, De Sesmaisons Agnès, Eskes Chantra, Levorato Sara, Valtueña Martínez Silvia, Bompola Georgia, Farcal Lucian
EFSA J. 2024 Dec 17;22(12):e9153. doi: 10.2903/j.efsa.2024.9153. eCollection 2024 Dec.
This Scientific Report was carried out in the context of the self-task mandate (M-2023-00097) of the EFSA's Scientific Committee on 'Guidance on the use of biomarkers of effect in regulatory risk assessment of chemicals'. In the first phase, the project on biomarkers of effect started with a feasibility study (EFSA-Q-2024-00128), with the intention to look closer at definitions and descriptions of biomarkers of effect, as well as to explore several concepts related to the context of application and other scientific principles to be further considered for its development. In addition, relevant activities, initiatives and knowledge in this area were collected and analysed within a complementary mapping study. The outcome of this phase aimed to create a structured basis for future guidance, to identify challenges and to recommend a way forward for its development. The recommendations refer especially to terminologies, the scope of the guidance and several scientific and technical aspects of the selection and interpretation of biomarkers of effect that need to be addressed in future guidance. Moreover, further recommendation refers to the collaborative process to be established with other regulatory organisations that should support the harmonisation and reduce divergencies in the application of methodologies across organisations or sectors.
本科学报告是在欧洲食品安全局（EFSA）科学委员会关于“化学物质监管风险评估中效应生物标志物使用指南”的自主任务授权（M - 2023 - 00097）背景下开展的。在第一阶段，效应生物标志物项目始于一项可行性研究（EFSA - Q - 2024 - 00128），旨在更深入地研究效应生物标志物的定义和描述，并探讨与应用背景相关的几个概念以及其发展中需进一步考虑的其他科学原则。此外，在一项补充性映射研究中收集并分析了该领域的相关活动、倡议和知识。此阶段的成果旨在为未来指南创建结构化基础，识别挑战并为其发展推荐前进方向。这些建议尤其涉及术语、指南范围以及效应生物标志物选择和解释的若干科学技术方面，这些在未来指南中都需要加以解决。此外，进一步的建议涉及与其他监管组织建立协作流程，这应有助于实现方法应用在各组织或部门间的协调统一并减少差异。
