This open call is launched to support the development of a comprehensive and fit-for-purpose strategy for integrating Human Biomonitoring (HBM) data into EFSA’s chemical risk assessment processes by establishing access to available HBM data, reviewing methodologies for HBM data use, elaborating relevant use cases for EFSA, and formulating key recommendations.
See the official notice for the place of performance.
The tenderer must have generated an overall annual turnover of at least 500.000 € in each of the last 2 closed financial years (2023 and 2024).
overall at organisational level: The tenderer overall must have extensive and demonstrable experience in: · Managing human biomonitoring (HBM) programmes. · Coordinating multi-stakeholder scientific projects, including collaboration with public health authorities, research institutions, and regulatory bodies. · Implementing harmonised protocols and procedures consistent with established EU or international HBM frameworks (e.g., HBM4EU guidelines). · Experience in chemical risk assessment within the food chain, including the evaluation of substances requiring regulatory approval. · Data management, quality assurance, and data protection in accordance with GDPR and other applicable ethical and legal frameworks. · Statistical analysis and interpretation of HBM data, including exposure assessment, trend analysis, and risk characterization. · Application of PBK/PBPK modelling with HBM data. · Reporting technical and scientific results, producing high-quality deliverables, and communicating findings to expert and non-expert audiences. · Ensuring project governance and oversight, including risk management, timelines, budgeting, and resource allocation. · Using digital tools for project coordination, sample tracking, data integration, and secure information exchange.
Ability to provide a team of experts compliant with specific expertise requirements (minimum 6 experts overall): The tenderer must be able to provide a team of experts compliant with these specific expertise requirements (1 expert can cover one or more profiles, with minimum of 6 experts overall in the team): a) 1 Senior expert in human biomonitoring (HBM) study design and data interpretation with at least 10 years of experience. The scientist should lead scientific interpretation of biomarkers and exposure pathways. With insight into: Knowledge of biomarkers of exposure/effect (persistent & non-persistent); Experience with EU/National HBM systems, HBM4EU outputs, IPCHEM; Understanding of regulatory relevance for EFSA. With expertise in GDPR for human data and secondary data use and understanding of ethics approvals, safeguards, and dataset access modalities. b) 1 expert in chemical risk assessment or regulatory context with at least 5 years of experience; demonstrable experience in developing and prioritising EFSA-relevant Assessment Questions (AQs). Experience in risk assessment within EFSA's remit (pesticides, contaminants, mixtures). Ability to define evidence needs, criteria, feasibility, decision contexts; Use of analytical tools for prioritising (e.g., SWOT), experience in case studies development and integrating different lines of evidence. c) 1 expert in Exposure Sciences, with 5 years' experience in the support assessment of exposure relevance, prioritisation, and comparison. With knowledge of exposure pathways and combined exposure concepts, and understanding of mixture assessment and vulnerable populations; Knowledge of biomarkers of exposure/effect. d) 1 expert in human biomonitoring (HBM) study design and data interpretation with at least 5 years of experience. Knowledge of biomarkers of exposure/effect (persistent & non-persistent), IPCHEM. e) 1 technical expert on Data Analysis & Discovery, with at least 3 years' experience of helping to identify, catalogue, and evaluate HBM datasets across EU/National (member states) resources. With knowledge in Systematic search methods (databases, repositories, literature); Metadata, data formats, interoperability, linkage feasibility; Knowledge of OECD OHTs, GDPR data access constraints, IPCHEM. f) 1 expert with at least 3 years' experience in PBK modelling application and interpretation of reverse dosimetry from external to internal and from internal to external (dose reconstruction). g) 1 expert with at least 3 years' experience in project management, overseeing work plans, timelines, coordination, and delivery of all project outputs.
English language capacity of the team overall + project manager: The Senior expert (profile a) and project manager (profile g) (also acting as the point of contact with EFSA) must have an excellent level of spoken and written standard UK English. For non-native speakers, this must be demonstrated by: i) an official certificate of English proving a C1 level, or ii) at least 5 years of studies or work in an English-speaking environment and/or in international projects where English is the working language. The team of experts must have overall an excellent level of spoken and written standard UK English. For non-native speakers, this must be demonstrated by an Official certificate of English proving a B2 level OR at least 2 years of work in an English-speaking environment and/or in international projects where English is the working language.
overall at organisational level: The tenderer must have access to the appropriate information sources (e.g. databases, knowledgebases, scientific journals) for the execution of the objectives 1, 2, 3 and 4.
a) Signed declaration on honour.
a) Signed declaration on honour.
Environmental protection is an integral part of EFSA's governance. EFSA has established, implemented and maintains a certified environmental management system in accordance with the international standard ISO 14001 and the European EMAS regulation. Environmental impacts of EFSA's activities are identified, managed and monitored in order to improve environmental performance. This commitment to environmental sustainability requires us to consider a life-cycle perspective when purchasing our services. For this reason we are asking you some information on the environmental management of your activities, to be provided filling in Annex 3 (Information on environmental management). To be completed by the tenderer or leading partner. The answers will not be considered under any criteria, neither selection nor award criteria.
In accordance with articles 143(1)(d) and 170(1)(c) of the Financial Regulation and paragraphs 166 and 167 of the recitals, if EFSA, based on the assessment of the technical and professional capacity evidence, as well as the information within the Declaration of honour (section C), concludes that the tenderer has a professional conflicting interest and therefore does not possess the professional capacity to perform the contract to an appropriate quality standard, the tenderer may be rejected.
Published 20 April 2026 · rebuilt nightly from the official notice.