Evaluation of microbiome-relevant human biomarkers and in vitro models for xenobiotic risk assessment

Open procedure tender EFSA/2026/OP/0008 issued by the European Food Safety Authority seeks services to systematically identify, evaluate and prioritise human gut microbiome‑relevant biomarkers and in vitro models to support food safety risk assessment of dietary xenobiotics. The maximum budget is €300,000, the contract duration is up to 15 months, and award will be based on the best price‑quality ratio (70% quality, 30% price). No experimental work is funded; deliverables include an evidence‑synthesis protocol, interim technical reports, an online expert workshop and final technical reports with 40% interim and 60% final payments. Electronic tenders must be submitted via the EU Funding & Tenders Portal eSubmission and the deadline for receipt of tenders is 11 June 2026 at 14:30 Europe/Rome.

Opportunity type & lead authority

Call for tenders (EFSA/2026/OP/0008) — European Food Safety Authority

What it funds:a systematic evidence appraisal to identify and prioritise gut microbiome‑relevant human biomarkers and corresponding in vitro models to support future food‑safety risk assessments for dietary xenobiotics. The work includes protocol development, evidence synthesis, a stakeholder workshop and a feasibility assessment for possible future experimental validation.

Who can apply:Organisations or consortia established in eligible countries within the EEA (and countries with an EU data protection adequacy decision). Tenders may be submitted in any EU official language via the EU eSubmission system Funding & Tenders Portal ¹.

1. 1Maximum budget: €300,000 (total contract value).
2. 2Contract duration: up to 15 months from kick-off.
3. 3Award method: best price-quality ratio.

Submission and documents:electronic submission only via eSubmission (EU Login required). Tender documents include invitation letter, draft contract and detailed tender specifications with annexes (protocol templates, team and organisational capacity requirements). See procurement page for downloadable annexes and Q&A Funding & Tenders Portal ¹.

Eligibility & minimum requirements (summary):demonstrable organisational experience in systematic evidence synthesis, microbiome research, toxicology/regulatory science; a project team covering systematic review expertise, microbiome science, toxicology, regulatory science and project management; access to bibliographic databases and systematic‑review tools. See tender specifications for full selection criteria.

Evaluation:two‑stage assessment. Offers must pass exclusion and selection checks; quality scored (methodology, understanding, project organisation) and combined with price to determine the best price‑quality ratio. Quality thresholds apply; only bids within the €300,000 ceiling are considered.

Procurement notes:EFSA will publish clarifications and downloadable annexes on the F&T Portal. Questions must be submitted via the portal Q&A before the stated deadline. Electronic invoicing and e‑payment apply if awarded.

Footnotes

1. 1Full procurement documents, annexes and submission instructions are on the EU Funding & Tenders Portal: ec.europa.eu

Summary

This is an open electronic tender published by the European Food Safety Authority (EFSA) to commission evidence-synthesis work to support the integration of gut microbiome data into food safety risk assessment for dietary xenobiotics. The contractor will systematically identify and evaluate microbiome-relevant human biomarkers and corresponding in vitro model systems, prioritise biomarker-model pairings and assess feasibility for potential future experimental validation. The contract is a services contract with a maximum available budget of €300,000, maximum performance period 15 months from kick-off and an award method based on best price-quality ratio. Submissions are electronic via the EU Funding & Tenders Portal eSubmission system and tenders must be received by 11 June 2026 14:30 (Europe/Rome).

Key administrative facts

Procurement reference EFSA/2026/OP/0008 (TED reference 231664-2026). Procedure type:Open procedure. Submission method: Electronic via eSubmission (EU Login required). Estimated total value: €300,000. Maximum contract duration: 15 months. Award method: Best price-quality ratio. Publication / portal: EU Funding & Tenders Portal and Tenders Electronic Daily (TED). Contracting authority: European Food Safety Authority (EFSA), Parma, Italy.

TED / Portal documents and access:All procurement documents (invitation to tender, draft contract, tender specifications and annexes 1–6 including Annexes 3, 4 and 5 in Word) are available on the EU Funding & Tenders Portal; deliverables and procurement Q&A are published in the portal. See the procurement listing on the portal for document download and subscription F&T Portal tender details ¹.

Detailed categorisation and structured extraction

Eligible Applicant Types

Eligible applicants:legal entities established in eligible countries (EU Member States and EEA countries and other jurisdictions where processing of personal data is permitted under the procurement rules). The tender allows single tenderers or joint offers (consortia). Subcontracting is permitted but subcontractors must comply with access-to-market and data protection rules. Typical eligible applicants are: universities, research institutes, contract research organisations (CROs), SMEs, large enterprises and non-profit organisations with demonstrable relevant technical capacity.

Funding Type

Primary financial mechanism:procurement / service contract (direct service contract). This is not a grant, loan or equity instrument — EFSA will purchase services under a contract.

Consortium Requirement

Consortium:either single tenderer or consortium (joint offer) is accepted. The tender specifications explicitly anticipate joint offers; if a joint offer is submitted, a lead/leader partner must be identified with a power of attorney and joint and several liability applies unless otherwise stated in the special conditions. Minimum team composition (individual experts) is mandatory (see Annex 4).

Beneficiary Scope (Geographic Eligibility)

Geographic eligibility:economic operators established in countries eligible under EFSA procurement rules. The contracting authority is an EU agency based in Italy; applicants established in the EU and EEA are explicitly eligible. Processing of personal data is permitted for applicants established in EU/EEA or in third countries where an EU adequacy decision applies. The place of performance for contract execution is the contractor’s premises (remote/home-based work permitted) and meetings in Parma (EFSA) are foreseen.

Target Sector

Thematic sectors targeted:health (human), microbiome research, toxicology and chemical risk assessment, food safety, regulatory science, laboratory methods and in vitro model development. Cross-disciplinary topics include bioinformatics/ evidence synthesis and New Approach Methodologies (NAMs) such as in vitro gut models and organoids.

Mentioned Countries

Explicitly mentioned locations:Italy (EFSA headquarter and meeting location: Parma) and the wider EU/EEA region as the geographic scope for eligibility and performance. The procurement is an EU-level tender published on the EU Funding & Tenders Portal and Tenders Electronic Daily (TED) and references EU rules and regulations.

Project Stage (Expected maturity)

Expected project maturity:research / evidence synthesis (systematic review and appraisal), evaluation, prioritisation and feasibility assessment. This procurement funds non-experimental work (no wet-lab experiments are to be conducted under this contract). It is preparatory for possible subsequent experimental validation (future development / demonstration stage) and supports regulatory decision-making.

Funding Amount

Estimated total available budget:€300,000 (maximum). Offers exceeding this amount will be excluded. Payment schedule envisaged in the draft contract: interim payment up to 40% after EFSA approval of interim deliverables (D1.0-D1.2) and balance payment 60% after delivery and approval of final reports (D2.1-D2.2).

Application Type

Submission Type:open, competitive call for tenders. Method: electronic submission via eSubmission in the EU Funding & Tenders Portal (EU Login required). Deadline for receipt of tenders: 11 June 2026 at 14:30 Europe/Rome (eSubmission timestamp is decisive).

Nature of Support

Beneficiaries receive monetary remuneration via a service contract (money). The contract purchases deliverables and services (evidence synthesis reports, prioritisation outputs, workshop facilitation). Non-monetary support (access to EFSA expertise and publication/ dissemination opportunities) will be provided through EFSA engagement and the requirement to publish outputs on EFSA Knowledge Junction / Zenodo is included.

Application Stages

Single-stage submission process (one formal tender submission). Evaluation stages include:(a) compliance and exclusion checks; (b) selection criteria verification (economic, financial, technical capacity); (c) quality assessment against award criteria; (d) price assessment for best price-quality ratio. Operationally the procurement includes internal evaluations and may request clarifications. The procurement timeline includes virtual public opening and contract signature after award notification.

Success Rates

No tender-specific historical success rate is provided in the documents. As an open EFSA research tender with a single lot and modest budget, competition is expected among qualified research organisations and consultancies; success depends on meeting minimum selection criteria and achieving high quality scores under the award criteria. Tenderers should assume a competitive selection and prepare a fully compliant, high-quality submission.

Co-funding Requirement

Co-funding is not required. The budget ceiling (€300,000) covers the full contract price. The draft contract specifies that the price covers all purchases under the contract, and reimbursement of expenses / pre-financing is not applicable. Tenderers must include all costs within the all-inclusive price offered (no additional reimbursement unless explicitly foreseen).

What EFSA expects contractors to deliver (technical scope and templates)

The tender specifications define two main work packages:WP1 - systematic identification, evaluation and prioritisation of microbiome-relevant biomarkers and in vitro models; WP2 - technical feasibility and prioritised recommendations for follow-up experimental validation. The contractor must produce a protocol (D1.0), two interim technical reports (D1.1, D1.2), organise an online expert workshop, and produce a draft final report (D2.1) and a final report (D2.2). Key tasks include literature searches, evidence appraisal, model evaluation (maturity, reproducibility, regulatory applicability), development of an explicit prioritisation framework, workshop organisation and a feasibility assessment (technical, resource and infrastructure needs) with Go/No-Go recommendations.

1. 1Develop and register an evidence-synthesis protocol covering literature searches, inclusion/exclusion criteria, data extraction and quality assessment (D1.0).
2. 2Systematically identify candidate biomarkers for host health endpoints and microbiome metabolic capacity; assess evidence quality, reproducibility, analytical readiness and regulatory relevance (Task 1.2).
3. 3Systematically evaluate in vitro gut/microbiome models (e.g., SHIME, M-ARCOL, gut-on-chip, organoids, MBRA, triple co-cultures), documenting maturity/readiness, validation status, throughput, costs, IP and limitations (Task 1.3).
4. 4Design and apply a prioritisation framework with explicit criteria, weights and sensitivity assessment; produce a ranked list of biomarker–model pairings with analytical method suggestions (D1.2).
5. 5Organise and facilitate an online expert workshop to obtain targeted feedback and refine prioritisation; incorporate feedback into final outputs (Task 1.5).
6. 6Conduct WP2 feasibility analyses for the top-priority combinations including technical feasibility, availability/access to models, high-level budget and timeline estimates, and final Go/No-Go recommendations (D2.1 and D2.2).

Deliverables and milestones (summary table)

Selection, eligibility and technical templates required

Mandatory documents and templates described in the tender specifications and annexes must be supplied: administrative forms, Declaration on Honour (sections A, B and C), Annex 3 (Organisational professional capacity evidence), Annex 4 (team of experts and CVs), Annex 5 (technical capacity self-declaration), Annex 6 (environmental management questionnaire, non-evaluated), financial offer template and the contractor’s tender. EU Participant Register (PIC) is required for each organisation participating in the tender. EFSA strongly recommends submitting individual expert CVs using the EU CV format. Individual declarations of interest may be requested prior to contract signature to check competing interests.

Annex 3, 4 and 5 content (templates and expectations):Annex 3: organisational professional capacity evidence. Submit at least three relevant projects/publications from the last five years collectively covering: (a) systematic reviews/evidence synthesis in food safety/toxicology/microbiome/regulatory domains; (b) microbiome research (host-microbiome interactions, biomarker methods, in vitro models); (c) toxicology/chemical risk assessment; (d) regulatory science applied research and scientific reporting. Provide title, dates, description, role and links where available. Annex 4: team composition and expert profiles. Provide CVs (recommended max 3 pages each) for at least 4 experts covering profiles: systematic review expert (≥5 years), microbiome expert (≥5 years), toxicology/chemical risk assessor (≥3 years), regulatory science expert (≥5 years), plus a project leader (≥5 years experience in managing complex scientific projects). Annex 4 also requires proof of English language capacity (C1 or equivalent evidence) for profiles a, d and e. Annex 5: technical capacity self-declaration listing accessible bibliographic databases (e.g., PubMed, Web of Science, Scopus), systematic review management tools (e.g., Covidence, Rayyan, DistillerSR, EPPI-Reviewer), and computational resources for analyses (R, Python environments, high-performance computing if used), plus confirmation of secure collaboration platforms and data storage. Deliver these annexes as specified in the portal templates.

Evaluation and award criteria (how proposals are assessed)

Evaluation is a multi-step process:compliance and exclusion checks; selection criteria (economic/financial capacity: minimum annual turnover thresholds; professional and technical capacity: organisational track record and expert team); quality assessment against award criteria; price assessment and calculation of the best price-quality ratio.

1. 1Selection checks: Exclusion situations (Declaration on Honour, section A) and access-to-market/data-processing eligibility; proof of annual turnover and evidence of capacity (Declaration on Honour section B).
2. 2Technical selection: Annex 3 (organisational projects/publications), Annex 4 (team CVs and profiles), Annex 5 (technical resources).
3. 3Quality award criteria: Understanding of context (20 points), methodology for WP1 & WP2 (60 points), project organisation / risk management / QA (20 points). Minimum thresholds: 60% per criterion; at least 70% overall quality score required to pass.
4. 4Price evaluation: only tenders within the maximum budget (€300,000) are considered. Final ranking uses formula combining price (30%) and quality (70%) to identify best price-quality ratio.

Practical and contractual requirements

Key contractual and practical points from the draft contract and tender specifications:(a) the contracting authority acquires ownership of the delivered results and associated IPR arising from the contract; (b) pre-existing rights incorporated into deliverables must be declared and licensed to EFSA on a royalty-free basis as specified (Annex/Declaration on pre-existing rights); (c) deliverables may be published by EFSA in Knowledge Junction/Zenodo; (d) data protection obligations (Regulation (EU) 2018/1725) must be respected and, when personal data are processed, data must be stored/processed only in the EU/EEA/Switzerland or where an adequacy decision applies; (e) compliance with EFSA conflict-of-interest / independence policies and individual declarations of interest are required before contract signature; (f) payments: EFSA pays within 90 days after approval of invoices/deliverables; interim payment of 40% possible against intermediate deliverables and balance after final acceptance; (g) liquidated damages and reduction of price clauses apply for delays or low quality; (h) contract termination, audits, on-the-spot checks and recovery rules follow the general conditions.

EFSA requires that any use of artificial intelligence tools or large language models by tenderers in preparing offers or by contractors in delivering services be declared. If AI is proposed for service delivery, tenderers must describe purpose, risks, mitigation, human oversight and compliance with the AI Act (Regulation (EU) 2024/1689) and data protection rules. EFSA may approve or refuse the deployment of AI systems during contract implementation and will register any endorsed AI deployments as required.

Practical advice and next steps for applicants

1. 1Register organisations (and any consortium partners) in the EU Participant Register and obtain PIC codes before preparing the eSubmission tender.
2. 2Download and carefully follow the tender specifications and all annexes (Annex 2 draft contract, Annexes 3–6 templates). Annex 3–5 Word versions are provided on the portal.
3. 3Prepare Annex 3 evidence (three relevant projects/publications covering the four expertise areas), Annex 4 CVs (EU CV format recommended) and Annex 5 technical capacity declarations (databases and software/tools names). Provide evidence of English language capacity for the specified profiles.
4. 4Prepare a concise but detailed protocol (D1.0) and a strong methodological description addressing all award criteria, including the prioritisation framework and feasibility assessment approach.
5. 5Provide a realistic, all-inclusive financial offer using the template and ensure total does not exceed €300,000.
6. 6Submit the full tender via eSubmission before the deadline (11 June 2026 at 14:30 Europe/Rome) and monitor the portal for clarifications and Q&A updates.

Key portal links and contact:EFSA procurement mailbox: EFSAProcurement@efsa.europa.eu; eSubmission/eTender portal: F&T Portal tender record (documents and Q&A). EFSA will only accept questions submitted through the portal Questions & Answers tab prior to the stated deadline for clarifications.

Footnotes

1. 1Procurement documents and annexes are available on the EU Funding & Tenders Portal call page: ec.europa.eu. Tenderers must subscribe on the portal and use eSubmission (EU Login) to submit tenders. See the Invitation to Tender and Tender Specifications for full details.

Opportunity Overview

This is an open procedure tender (EFSA/2026/OP/0008) issued by the European Food Safety Authority (EFSA) to support the integration of gut microbiome data into food safety risk assessment of dietary xenobiotics. The project involves systematic evidence appraisal to identify microbiome-relevant biomarkers and in vitro models, assess their feasibility for experimental validation, and provide recommendations for regulatory use. TED reference: 66/2026 231664-2026. Primary source: EU Funding & Tenders Portal.

Key Dates

• TED publication date: 03/04/2026
• Deadline for questions: 03/06/2026 23:59 Europe/Rome
• Deadline for receipt of tenders: 11/06/2026 14:30 Europe/Rome
• Public opening: 12/06/2026 14:30 Europe/Rome

Scope and Objectives

The contract requires development of methodological foundations for assessing dietary xenobiotic effects on human gut microbiome and host health. Focus areas include host health endpoints (e.g. intestinal barrier integrity, inflammation, immune responses), microbiome metabolic capacity (e.g. xenobiotic biotransformation), and relevant composition/function where mechanistically linked to health effects. No experimental work is involved; emphasis is on evidence synthesis and feasibility assessment.

Main Objectives

1. 1Systematic identification, evaluation, and prioritisation of biomarkers and in vitro models (e.g. SHIME, M-ARCOL, organoids) via evidence synthesis, including protocol development, literature review, prioritisation framework, and online expert workshop.
2. 2Feasibility assessment for future experimental validation of prioritised biomarker-model combinations, including technical analysis, resource estimates, and Go/No-Go recommendations.

Contract Details

Estimated Value:€300,000 (maximum budget; offers exceeding this are excluded).

Duration:Maximum 15 months from kick-off meeting.

Nature:Services contract (direct service); performed at contractor premises.

Award Criteria:Best price-quality ratio (70% quality, 30% price). Quality sub-criteria: understanding of context (20 pts), methodology (60 pts), organisation/risk/quality (20 pts). Minimum thresholds apply.

Deliverables and Payments

Payments:40% interim (after D1.0-D1.2), 60% balance (after D2.1-D2.2). 5 meetings including kick-off (Parma preferred), interim teleconferences, online workshop, final meeting.

Eligibility and Who Can Apply

Open to economic operators from EU/EEA or countries with EU data adequacy decisions. Subcontractors limited to adequacy decision countries. No Hungarian public interest trusts. Joint tenders allowed; PIC registration required via EU Login.

Exclusion Criteria

• Situations under Article 138 Financial Regulation (e.g. bankruptcy, fraud, terrorism).
• Declaration on Honour (Section A) required from all (including subcontractors).

Selection Criteria (Minimum Requirements)

Economic/Financial:Annual turnover >= €300,000 (2023-2024). Declaration on Honour (Section B).

Technical/Professional:Organisation: 3+ projects/publications (past 5 years) covering systematic reviews, microbiome, toxicology, regulatory science (Annex 3). Team: >=4 experts with Master's (PhD counts as experience): 5y systematic review, 5y microbiome, 3y toxicology, 5y regulatory science, 5y project management (Annex 4). English C1 for key profiles. Infrastructure: databases (PubMed etc.), review tools (Covidence etc.), collaboration tools (Annex 5). Declaration on Honour (Sections B/C).

Submission Process

Electronic submission only via eSubmission on F&T Portal. Requires EU Login and PIC. Max 200 files (<50MB each). Use Chrome/Firefox. Documents: Declarations on Honour (A/B/C), Annexes 3-6, technical/financial offers. Subscribe for updates/Q&A.

Key Documents Available

• Tender specifications (PDF/Word Annexes 3-5)
• Invitation letter
• Draft contract
• Financial offer template (Annex 1)

All documents downloadable from F&T Portal. Q&A:Annex 3-5 Word versions provided 03/04/2026.

Additional Considerations

IP Rights:EFSA owns results; pre-existing rights licensed royalty-free. Declaration required with invoices.

AI Use:Disclose in tender; comply with AI Act/GDPR. Human oversight mandatory for deliverables.

Conflicts/Independence:Declarations required; Individual DoIs pre-contract.

Footnotes

1. 1Full tender documents and submission via EU F&T Portal. TED Notice: TED.