Application of Human Biomonitoring (HBM) data in EFSA’s Chemical Risk Assessment

European Food Safety Authority (EFSA) invites tenders to develop a strategy for integrating Human Biomonitoring (HBM) data into its chemical risk assessment processes, including mapping HBM data sources, reviewing methodologies, developing use cases and delivering practical recommendations and SOPs. The direct service contract has a maximum budget of €600,000, a duration of up to 24 months, and will be awarded on the best price-quality ratio. Eligible economic operators established in the EEA may submit electronic tenders via the EU Funding & Tenders Portal eSubmission tool, with the submission deadline set at 3 June 2026 at 14:30:59 CEST. Key deliverables include a data landscape and access protocols, prioritised assessment questions, methodological gap analysis including PBK readiness, at least two pilot case studies, and a consolidated implementation strategy.

Tender overview

Essential facts

What it funds:a service contract to develop a strategy and operational guidance for integrating Human Biomonitoring (HBM) data into EFSA chemical risk assessment workflows, including mapping HBM data sources, methodological appraisal, at least two pilot case studies and final recommendations.

Who can apply:Economic operators established in eligible countries in the EEA (single tenderers or consortia). Applicants must demonstrate organisational experience in HBM, exposure assessment, PBK modelling, data management and GDPR compliance ¹.

1. 1Estimated total value: €600,000 (maximum available budget).
2. 2Contract duration: up to 24 months; award by best price-quality ratio.

Submission method:electronic only via the EU Funding & Tenders Portal eSubmission. Tender documents, draft contract and specifications are published on the Portal (subscribe to the call to receive updates).

Evaluation and requirements

Award method:best price-quality ratio. Applicants must meet exclusion and selection criteria (including minimum turnover requirements and technical/professional capacity) and achieve minimum quality thresholds in the technical evaluation.

What EFSA expects from the contractor:Deliverables include: 1) HBM data landscape and access protocols; 2) prioritised Assessment Questions; 3) methodological gap analysis and QA/QC guidance; 4) at least two pilot case studies; 5) final strategic recommendations and workflow for EFSA integration ¹.

1. 1Eligibility: entities registered in the Participant Register (PIC) and able to submit via eSubmission.
2. 2Language: working language English; tenders may be submitted in any EU official language.
3. 3Award criteria highlights: methodology, project organisation, risk management, quality control and timelines.

Footnotes

1. 1Full tender specifications, draft contract and submission instructions are available on the Funding & Tenders Portal (see the call EFSA/2026/OP/0011). Subscribe on the Portal to receive updates and Q&A.

Basic facts

Identifiers, contracting authority and deadlines

Title:Application of Human Biomonitoring (HBM) data in EFSA’s Chemical Risk Assessment. Reference: EFSA/2026/OP/0011. Contracting authority: European Food Safety Authority (EFSA), Parma, Italy. Procedure type: Open call for tenders (services). CPV main classification: 73200000 Research and development consultancy services. Estimated total value: €600 000. Maximum contract duration: 24 months. Award method: best price-quality ratio. TED reference: 76/2026 268330-2026. TED publication date: 20/04/2026. Deadline for receipt of tenders: 03/06/2026 14:30 Europe/Rome. Virtual public opening: 04/06/2026 14:30 Europe/Rome.

Where to find procurement documents:All procurement documents, including the Invitation to Tender, Tender Specifications (with annexes) and the Draft Direct Service Contract are available from the EU Funding & Tenders Portal F&T Portal - HBM@EFSA tender. Detailed submission is done via the eSubmission tool on the same portal eSubmission.

Note:tenderers must have an EU Login account to subscribe, ask questions in the Portal Q&A and submit electronically. Two-factor authentication for EU Login is required (mandatory roll-out in 2026) and the tender documents detail the accepted e-submission file formats, size limits and signature requirements ¹.

Opportunity description and objectives

Purpose:EFSA seeks a contractor to develop a comprehensive, fit-for-purpose strategy to integrate Human Biomonitoring (HBM) data into EFSA chemical risk assessment workflows. The work covers mapping available HBM datasets, assessing accessibility, governance and GDPR/ethical constraints, reviewing and proposing methodological approaches (including PBK/PBTK readiness and reverse dosimetry), co-creating and prioritising Assessment Questions (AQs) relevant to EFSA, conducting at least two pilot case studies that apply HBM data to regulatory assessment questions, and delivering actionable recommendations and practical SOPs/workflows for EFSA adoption.

Scope and specific tasks:Key workstreams include: systematic inventory and evaluation of EU and national HBM data sources (coverage, populations, biomarkers, governance and data access models); co-development of prioritised Assessment Questions with EFSA; critical review of methodological barriers (biomarker selection, LOQs, sampling, normalisation, QA/QC, uncertainty); PBK model readiness assessment and guidance for forward and reverse dosimetry; execution of at least two pilot case studies (one persistent and one non-persistent chemical example) applying HBM data, modelling and mixture considerations; and a consolidated final strategy document with decision trees, workflows and recommendations for study design, biomarker selection, target populations and data management to support regulatory use.

Deliverables, meetings and reporting

The contract is structured into five main deliverables with deadlines tied to project months measured from the kick-off: Deliverable 1 mapping and evaluation of HBM data (month 6 final); Deliverable 2 elaboration and prioritisation of Assessment Questions (month 10 final); Deliverable 3 methodological challenges and proposed solutions including PBK readiness (month 15 final); Deliverable 4 case studies (at least 2) including analysis plans and workshops (month 21 final); Deliverable 5 final recommendations and consolidated strategy (month 24 final).

1. 1Deliverable 1: Detailed HBM data landscape, SOPs for data access, FAIRness and interoperability assessment (IPC HEM linkage prospects).
2. 2Deliverable 2: Catalogue of Assessment Questions (AQs), AQ–Data–Method matrix, workshop materials and report.
3. 3Deliverable 3: Practical guidance notes, PBK readiness and gap analysis, QA/QC and uncertainty characterization, workflow/decision tree.
4. 4Deliverable 4: Design, draft and final reports for at least two case studies, CS workshop material and brief reports, workflows and analysis outcomes.
5. 5Deliverable 5: Final integrated strategy report in MS Word with annexes (datasets, SOPs, templates).

Project management:regular interim teleconferences (specified at months 1, 2, 4, 9, 11, 14, 16, 18, 21, 23.5), two in-person workshops at EFSA HQ in Parma (one to discuss AQs; one to present and discuss case studies and a practical workflow), meeting minutes within 5 working days, and a final document in English. Financial payments are milestone-linked: interim payment of 40% linked to approved intermediate deliverable(s) and final payment of 60% upon EFSA approval of final deliverables (detailed invoicing procedures in draft contract).

Eligibility, selection and award

Submission method:electronic only via eSubmission on the Funding & Tenders Portal. Tender language: any official EU language, but deliverables and meetings must be in high-standard English. Tender validity: 9 months. Tenderers must register organisation(s) in the Participant Register and use their PIC. Tenderers must complete and sign the Declaration on Honour (exclusion and selection declarations).

Eligible applicant types:Eligible applicants: economic operators established in eligible countries (anywhere in the EEA as stated in the call). Typical eligible applicant organisations include: universities, research institutes, SMEs, large enterprises, consultancies and nonprofits with relevant technical capacity. Subcontracting is permitted but the rules on market access and exclusion apply; tenderers must declare consortium or subcontracting partners and submit the required documents.

Selection criteria (summary):Key mandatory selection requirements include: minimum annual turnover of €500 000 in each of the last two closed financial years (leading partner for joint offers); demonstrable organisational experience managing HBM programmes and projects; availability of a project team with minimum key experts (senior HBM expert with ≥10 years, risk assessment expert ≥5 years, exposure sciences expert ≥5 years, additional HBM, PBK modelling, data discovery and project manager experts); English language competence requirements (C1 for senior expert / project manager, B2 for rest). Tenderers must provide CVs (EU format recommended), three relevant projects/publications and evidence of data access tools/databases.

Award criteria and scoring:Award: best price-quality ratio. Quality criteria (total 100 points) cover methodology (40 points), project organisation (30 points), risk management (10), quality assurance (10) and measures to meet deadlines (10). Minimum thresholds: 60% per quality subcriterion and minimum 70 points overall on quality to pass. Price weighting: the combined scoring formula uses 70% quality and 30% price in the evaluation of the most economically advantageous tender.

Contractual, legal and financial details

Contract type:Direct service contract for services (draft Direct Service Contract published). Maximum available budget: €600 000. Place of performance: contractor premises; contract duration: up to 24 months. Payment terms: interim payment (40%) and final payment (60%) subject to EFSA approval of deliverables and submission of invoices and required statements on pre-existing rights. Intellectual property: EFSA acquires ownership of results produced under the contract; pre-existing materials must be declared and licensed to EFSA as detailed in the contract. Data protection: personal data processing follows Regulation (EU) 2018/1725 and the contract details controller/processor responsibilities. The contract contains clauses on confidentiality, fraud prevention, and AI use requirements (tenderers must declare any LLM use in offer drafting and indicate planned AI use in service delivery).

Use of Artificial Intelligence:Tenderers must declare whether Large Language Models or other generative AI tools were used to draft the tender. If AI systems or models will be used during contract performance, the tender must describe the purpose, stages of use, added value, risk mitigation, and how human oversight and quality validation will be ensured. Compliance with the AI Act (Regulation (EU) 2024/1689) and data protection rules is mandatory; EFSA reserves the right to accept or refuse any introduction of new AI-based delivery methods during contract execution.

Application logistics and support

How to apply:submit a single electronic tender via eSubmission on the Funding & Tenders Portal before the deadline. Required files include: signed Declaration on Honour (sections A, B, C as applicable), technical offer responding to tender specifications and award criteria, CVs and team composition, evidence for selection criteria, and a financial offer using the provided financial offer template. For joint offers submit declarations for each member as specified. Only one tender per tenderer; if multiple tenders are submitted only the last will be considered.

eSubmission and EU Login requirements:Submission requires an EU Login account with two-factor authentication (mandatory roll-out in 2026). Tenderers must register organisations in the Participant Register and reuse PICs. The eSubmission system enforces file format and size limitations (attachments up to 50 MB per file; total max number of attachments documented). For technical problems contact the eSubmission Helpdesk and follow the eSubmission Quick Guide in the procurement documents.

Categorisation and structured answers

1. 1Eligible Applicant Types: Universities, research institutes, SMEs, large enterprises, consultancies, non-profit research organisations, public research bodies and consortiums combining these entities. Individual natural persons may not be suitable as lead tenderer; joint offers are allowed. Subcontractors permitted with disclosure.
2. 2Funding Type: This is a tender for a direct service contract (procurement) where EFSA pays a contractor. Primary financial mechanism: service contract (procurement) with monetary payments to the contractor; not a grant, loan or equity.
3. 3Consortium Requirement: Other. Single tenderer is possible; joint offers (consortium) are also allowed. If submitting a joint tender, a lead partner must be designated and the joint and several liability rules apply (with certain national law derogations allowed if documented).
4. 4Beneficiary Scope (Geographic Eligibility): Anywhere in the European Economic Area (EEA). EFSA is an EU agency based in Italy; tender is open to entities established in eligible countries (EEA / EU).
5. 5Target Sector: Chemical risk assessment, public health, exposure science, environmental health, toxicokinetics (PBK/PBTK), human biomonitoring and food safety; primarily health / environment / chemicals / exposure sciences within EFSA remit.
6. 6Mentioned Countries: Italy (EFSA based in Parma); EU/EEA region indicated for geographic eligibility. Tender documents and system references are EU-level (Funding & Tenders Portal).
7. 7Project Stage: Research / development and validation of methodologies and demonstration via pilot case studies; the maturity expected: from research and development to demonstration (pilot), preparing for operational integration in EFSA workflows.
8. 8Funding Amount: Total estimated contract value: €600,000 (maximum available budget).
9. 9Application Type: Open procedure; single-stage competitive call for tenders submitted electronically via the Funding & Tenders Portal eSubmission system. Public Q&A available in the Portal; deadline for clarification questions: 26/05/2026.
10. 10Nature of Support: Money in return for services (service contract) plus non-monetary deliverables (reports, datasets, workflows). The contractor will receive monetary payments tied to deliverables; EFSA acquires the results and IP as contractually defined.
11. 11Application Stages: 1 main submission stage (single-stage tender). Evaluation phases: compliance check, exclusion/selection screening, quality evaluation (technical), price evaluation and best price-quality ratio award stage. No separate two-stage bid submission is used.
12. 12Success Rates: Not specified in the documentation. As an open single-procurement call with a single contract and an estimated budget of €600,000, competition is expected; success rates are unknown and depend on number and quality of tenders received.
13. 13Co-funding Requirement: No co-funding requirement is stated. EFSA provides the full contract budget (up to €600,000). Tenderers must bear their proposal preparation costs.
14. 14Templates: The procurement package includes a Financial Offer Template (Annex 1), Draft Direct Service Contract (Annex 2) with full special and general conditions, and Annex 3 environmental management information form. Tenderers must use the provided Declaration on Honour templates (sections A, B, C) and are advised to provide CVs in the EU CV format. The technical offer should address all specified award criteria and tender specification tasks.

Practical guidance to applicants

Make sure your technical offer explicitly addresses each award criterion:methodology justification (with a step-by-step workplan and feasibility evidence), project organisation and staffing matrix, risk management and mitigation plan, QA mechanisms for deliverables, and measures to ensure on-time delivery. Provide CVs in EU format, a clear one-page summary of personnel and roles, three major relevant projects/publications from the past five years, and a statement on available databases and IT tools. Use the Financial Offer Template in Annex 1 and ensure the total financial offer does not exceed €600,000. Declare any AI use in producing the tender and any planned AI use during contract delivery.

Tenderers must sign Declaration on Honour (exclusion) and the selection declarations; when submitting declarations signed by hand, include scanned signed PDFs in eSubmission. If using joint offer or subcontractors, include the required declarations and power of attorney documents. The tender specifications include detailed timelines, meeting schedule and contractual provisions; read the draft contract carefully and raise any contract-specific clarifications prior to the clarification deadline (26/05/2026).

Risks and considerations for applicants

Critical risks:inability to secure required HBM datasets due to governance/consent restrictions; insufficient PBK models or parameterisation for substances in chosen case studies; personnel availability leading to missed deliverables; failure to meet EFSA quality standards or to address conflicts of interest. Address these risks in the tender with mitigation strategies, data access plans (data sharing agreements, anonymisation, DUA templates), and clear experience demonstrating prior HBM project delivery and PBK modelling application.

Final summary

What this opportunity is about and how to explain it:EFSA is procuring expert services to define and pilot an operational strategy to use Human Biomonitoring data in its chemical risk assessment work. The contractor will map existing HBM data sources, evaluate data access and governance, co-create assessment questions with EFSA scientists, review methodological needs (including PBK model readiness and reverse dosimetry), run at least two demonstration case studies, and produce a consolidated implementation strategy, workflows and practical recommendations. The outcome will enable EFSA to better integrate internal exposure human data with dietary and other exposure evidence for more realistic, harmonised and transparent chemical risk assessments. Tenderers must provide a technically strong, EFSA-focused methodology, a multi-disciplinary team (HBM, exposure, PBK, data, project management), and a realistic delivery plan for the 24-month direct service contract worth up to €600,000. Submission is electronic via the Funding & Tenders Portal eSubmission system; follow the tender specifications and annexes exactly and respect all administrative, selection and declaration requirements.

Footnotes

1. 1eSubmission and the full procurement package are published on the F&T Portal: ec.europa.eu. Follow the eSubmission Quick Guide and EU Login instructions available through the portal.

Funding Opportunity Overview

This is a European Food Safety Authority (EFSA) tender call designed 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. The project aims to establish access to available HBM data, review methodologies for HBM data use, elaborate relevant use cases for EFSA, and formulate key recommendations for advancing human health risk assessment practices.

Key Dates and Deadlines

The tender was published on 3 March 2026 as a planned call for tenders. The submission deadline is 3 June 2026 at 14:30:59 CEST. This is a time-sensitive opportunity with limited time remaining for proposal preparation and submission.

Funding Details

Budget Classification:This tender is classified as a planned call for tenders valued at €140,000 or above, indicating a substantial contract value for the successful contractor.

Scope of Work

The project encompasses four primary components:establishing and documenting access to available Human Biomonitoring data sources across Europe; conducting a comprehensive review of existing methodologies and best practices for integrating HBM data into chemical risk assessment; developing and elaborating specific use cases that demonstrate how HBM data can be applied within EFSA's risk assessment framework; and formulating evidence-based key recommendations for EFSA's future integration of HBM data into its chemical risk assessment processes.

What is Human Biomonitoring (HBM)?

Human Biomonitoring is an important tool to survey the real-life body burden or internal exposure of humans resulting from total exposure to chemicals via different routes including inhalation, skin contact, and ingestion. HBM data provides measured evidence of actual chemical exposure in populations, which can be used to validate and enhance chemical risk assessment processes. The approach involves identifying biomarkers of exposure and establishing links to adverse health effects or chemical concentrations in target organs.

Eligibility and Applicant Profile

While specific eligibility criteria are not detailed in the available search results, EFSA typically accepts proposals from research institutions, academic organizations, specialized consultancies in chemical risk assessment and biomonitoring, and organizations with demonstrated expertise in toxicology, epidemiology, and regulatory science. Applicants should have strong technical capacity in human health risk assessment, access to or knowledge of HBM data sources, and experience with EU regulatory frameworks for chemical safety.

Strategic Context

This tender aligns with EFSA's broader data collection and risk assessment modernization efforts. EFSA operates a Data Collection Framework (DCF) and Scientific Data Warehouse (sDWH) to manage chemical monitoring data, including information on food additives, contaminants, and pesticides. The integration of HBM data represents an advancement in EFSA's capacity to conduct more evidence-based chemical risk assessments by incorporating measured human exposure data alongside traditional hazard assessment methodologies.

Related EFSA Activities

EFSA is simultaneously conducting multiple related data collection initiatives in 2026. Open calls for food additives analytical data and use levels are accepting submissions through 30 June 2026, with validation and acceptance continuing through 31 August 2026. These parallel activities demonstrate EFSA's comprehensive approach to strengthening its chemical monitoring and risk assessment infrastructure during 2026.

Application Process

Interested organizations should submit proposals through the EU Funding and Tenders Portal. The tender specifications and detailed requirements are available through the portal at the provided opportunity URL. Applicants must carefully review all tender documentation, including technical specifications and evaluation criteria, before preparing their submissions.

Key Considerations for Applicants

• Demonstrate existing expertise or partnerships in human biomonitoring data collection and analysis
• Show familiarity with EFSA's current risk assessment methodologies and regulatory framework
• Provide evidence of access to or ability to identify relevant HBM data sources across European member states
• Outline a clear methodology for reviewing and synthesizing existing HBM methodologies
• Propose realistic and practical use cases that can be implemented within EFSA's existing systems
• Include a strong team with complementary expertise in toxicology, epidemiology, biostatistics, and regulatory science
• Ensure compliance with all EU procurement and data protection regulations

Submission Deadline Alert

The submission deadline of 3 June 2026 at 14:30:59 CEST is firm. Proposals must be submitted through the official EU portal before this time. Late submissions will not be accepted. Organizations should allow sufficient time for proposal preparation, internal review, and technical submission to avoid last-minute complications.

Footnotes

1. 1Additional information on EFSA's data collection framework and scientific cooperation plans is available through the EFSA website and the EU Funding and Tenders Portal.