Development of an LLM-augmented bioinformatics workflow for transcriptomics-based chemical grouping in support of EFSA risk assessment

The European Food Safety Authority (EFSA) is procuring a 24-month service contract (reference EFSA/2026/OP/0002) to design, implement and validate an end-to-end Large Language Model augmented bioinformatics workflow that discovers, downloads, annotates, processes and clusters public transcriptomics data for chemical substances and compares derived groupings with EFSA Cumulative Assessment Groups. The maximum budget is €500,000 and tender submission is exclusively electronic via the EU Funding and Tenders Portal with a receipt deadline of 30 March 2026 at 14:30 CET. Eligible lead tenderers must be established in EU or EEA countries or in countries with an EU adequacy decision for personal data protection and must demonstrate specified financial, technical and professional capacity including toxicogenomics, transcriptomics, LLM expertise and required team profiles. All developed code must be open source, AI use is mandatory for the work, and award will be based on a best price-quality ratio with minimum quality thresholds prior to price evaluation.

Opportunity snapshot (tender EFSA/2026/OP/0002)

Essential facts

What it funds:design, implementation and validation of an end-to-end, LLM-augmented bioinformatics workflow that automatically discovers, downloads and reanalyses public transcriptomics datasets for given chemicals; harmonises metadata; produces standardised transcriptomic signatures; clusters chemicals by inferred mode of action; and compares groups with EFSA Cumulative Assessment Groups. All developed code must be open source.

Who runs the call:European Food Safety Authority (EFSA). Submission exclusively via the EU Funding & Tenders Portal eSubmission system EFSA procurement page ¹

Who can apply:Economic operators established in eligible countries (EU/EEA or countries with an EC adequacy decision). Single contractors or consortia; subcontracting is permitted. Applicants must demonstrate relevant organisational experience (toxicogenomics, LLMs, transcriptomics, code/pipeline development) and provide specified expert profiles.

Budget and contract type:Estimated total value €500,000 (maximum available). Service contract, open procedure; award by best price‑quality ratio.

Key dates and duration:Deadline for tenders: 30 March 2026 14:30 (Europe/Rome). Virtual public opening: 31 March 2026 14:30. Contract duration up to 24 months; expected start May 2026.

1. 1Main tasks: repository discovery and access design; LLM-based automatic sample annotation and human-curated benchmarking; production-grade pipeline for raw RNA‑seq (and microarray if needed) processing; clustering and chemical group characterisation; comparison with EFSA CAGs and final reporting.
2. 2Deliverables: milestone reports (WP1–WP4), pipeline code and manuals, human‑curated benchmark, support/hypercare to EFSA; monthly progress meetings.
3. 3AI use: LLMs/AI systems are mandatory for WP1 tasks; tenderers must declare AI use in the offer and describe risk mitigation and human oversight measures.

Evaluation and award:compliance check, exclusion/selection criteria (financial, technical, professional capacity) and award by best price‑quality ratio. Minimum technical thresholds apply (detailed in tender specifications).

Practical notes:tenders must follow the published tender specifications and draft contract (Annexes). Questions to EFSA must be submitted via the Portal Q&A before the published cut-off; EFSA may stop answering questions 6 working days before the deadline. Tenderers need a Participant Identification Code (PIC) and must submit signed Declarations on Honour as required.

Footnotes

1. 1Full procurement documents (invitation to tender, tender specifications, draft contract) and Q&A are on the F&T Portal: ec.europa.eu

Lead contracting authority:European Food Safety Authority (EFSA). Procedure: Open procedure for a direct services contract. CPV: 73200000 Research and development consultancy services. Nature of contract: Services. Award method: Best price-quality ratio. Maximum contract duration: 24 months. Estimated total value and maximum budget: €500,000. All tendering and communication are via the EU Funding and Tenders Opportunities portal.

Official sources and documents are available on the EU portal:the call notice and workspace, the Invitation to Tender, the Tender Specifications, and the Draft Direct Service Contract. See the portal entry and documents for full legal and procedural details.

• Portal call page: [[EFSA/2026/OP/0002 on EU Funding and Tenders portal||ec.europa.eu
• Invitation to Tender (PDF): Invitation to tender_V1.pdf
• Tender Specifications (PDF): Tender specs - chemical grouping_V1.pdf
• Draft Contract (PDF): Draft Direct Service Contract_V1.pdf

Opportunity scope and technical objectives

EFSA seeks the design, implementation and validation of an end-to-end, LLM-augmented bioinformatics workflow that, given a chemical substance, automatically discovers, downloads, annotates and reanalyses public transcriptomics datasets. The system will harmonise metadata, produce standardised transcriptomic signatures, cluster chemicals by inferred mode of action, and compare these clusters against EFSA Cumulative Assessment Groups to support regulatory risk assessment. All code developed will be open source and made publicly available.

Key technical goals:Repository discovery and access definition (e.g. GEO, SRA, ArrayExpress, ENA/EBI, OmicsDI) including APIs and compliant programmatic methods. LLM-based sample-level annotation robust to imperfect or heterogeneous metadata with accuracy sufficient for downstream differential expression and clustering, benchmarked against a human-curated gold standard. A production-ready pipeline to fetch, download, and annotate raw RNA-seq data, with microarray if necessary. A standardised RNA-seq preprocessing pipeline for QC, trimming, mapping or quantification, counting and normalisation. A downstream analytics pipeline to derive harmonised transcriptomic signatures, infer mode of action and cluster chemicals. Comparative analysis of derived clusters versus EFSA CAGs, including evaluations of concordance, refinements, and regulatory fitness-for-purpose, and a thorough characterisation of strengths, weaknesses, and limitations, especially of LLM-driven steps. Open-source release of all code and supporting materials.

Work packages, tasks, deliverables and timeline

1. 1WP1 Data discovery and LLM-driven annotation. Task 1.1: Select repositories and programmatic access methods; Deliverable 1.1: Intermediate report at 1 month from kick-off. Task 1.2: Demonstrate and evaluate an LLM for discovery and robust sample-to-metadata mapping using a human-curated benchmark, reporting precision, recall and annotation accuracy with limitations; Deliverable 1.2: Report at 6 months. Task 1.3: Productionise the codebase and execute the pipeline to fetch, download and annotate raw data across relevant chemicals; Deliverable 1.3: Report and pipeline plus manual at 12 months.
2. 2WP2 Standardised pipelines. Task 2.1: Create or adopt a standardised RNA-seq preprocessing pipeline (and microarray if necessary) with code, manual and rationale; Deliverable 2.1 at 3 months. Task 2.2: Create or adopt a pipeline to cluster chemicals by transcriptomics profiles and inferred mode of action with code, manual and rationale; Deliverable 2.2 at 6 months.
3. 3WP3 Hypercare. Task 3.1: Ongoing support for EFSA on delivered pipelines and code including bug fixes and user assistance; Deliverable 3.1 running to month 24.
4. 4WP4 Application and regulatory comparison. Task 4.1: End-to-end application of WP2 pipelines to WP1 dataset and characterisation of clusters from chemical, biological and industrial perspectives; Deliverable 4.1 at 18 months. Task 4.2: Comparison with EFSA CAGs, analysis of concordance and proposed refinements, with documented strengths and limitations; Deliverable 4.2 at 22 months. Task 4.3: Final report consolidating methods, results and regulatory fitness-for-purpose; Deliverable 4.3 at 24 months.

Meetings and reporting cadence:Kick-off teleconference by month 2 after contract entry into force. Monthly progress meetings thereafter. Interim physical meeting in Parma at month 14 from kick-off. Final meeting at month 24.

Payment structure:Interim payment 1 of 20 percent upon EFSA approval of Deliverables 1.1, 1.2, 2.1, 2.2. Interim payment 2 of 30 percent upon EFSA approval of Deliverable 1.3. Balance payment of 50 percent upon EFSA approval of Deliverables 3.1, 4.1, 4.2 and 4.3. Invoices require a statement on pre-existing rights in deliverables.

Who should apply and eligibility conditions

Eligible Applicant Types:Eligible economic operators include legal entities able to provide research and development consultancy services and the specified expertise and capacity. Typical eligible types are SMEs, large enterprises, universities, research institutes, nonprofit organisations, and public or private laboratories. Joint tenders are allowed and subcontracting is permitted. Tenderers must meet professional capacity and technical capacity requirements and must not be in exclusion situations. For personal data processing, entities must be established in EU or EEA countries or in countries with a European Commission adequacy decision. Procurement is not covered by the WTO GPA. Hungarian public interest trusts established under Act IX of 2021 or entities they maintain are ineligible for legal commitments.

Funding Type:Procurement of services through a direct service contract. It is not a grant. The contracting authority pays the contractor for services delivered in line with the contract.

Consortium Requirement:Single applicants or joint tenders are permitted. A consortium is optional, not mandatory. Subcontracting is allowed for all tasks. In a joint offer, a leader must be designated and joint and several liability applies unless derogations foreseen in the special conditions.

Beneficiary Scope (Geographic Eligibility):Eligibility is open to tenderers established in eligible countries per EFSA procurement rules. For personal data processing, only tenderers established in EU and EEA countries or in countries with a European Commission adequacy decision are allowed. Subcontractors may be established elsewhere, but subcontracting cannot be used to circumvent access rules. Entities subject to EU restrictive measures are excluded.

Target Sector:Food and feed risk assessment, toxicology and toxicogenomics, bioinformatics, transcriptomics, artificial intelligence and large language models, software and data engineering, cheminformatics and regulatory science. Cross-cutting with health, environment, agriculture and food safety, data science and software services.

Mentioned Countries:Italy is specified for EFSA’s location and meeting in Parma. Hungary is referenced in relation to ineligibility of Hungarian public interest trusts. Regions referenced include EU and EEA.

Project Stage:Development, validation and production hardening of pipelines, followed by application and demonstration against regulatory groupings.

Funding Amount:Estimated total value €500,000. Maximum budget available €500,000. Any offer exceeding €500,000 will be excluded.

Application Type:Open call for tenders with single submission via electronic eSubmission on the EU Funding and Tenders Opportunities portal. No paper or email submissions are accepted.

Nature of Support:Money. Payments are made against accepted deliverables under the service contract. No co-funding is requested; prices must be all-inclusive and VAT-exempt for EFSA.

Application Stages:Single-stage submission. Evaluation follows EFSA’s sequence: opening, compliance with tender specifications, exclusion criteria, selection criteria, and award based on quality and price.

Success Rates:Success rates are not disclosed in the procurement documents.

Co-funding Requirement:No. This is a procurement contract with a fixed maximum budget. The financial offer must be all-inclusive, VAT-exempt for EFSA, and cover all costs including travel, subsistence, overheads and any third-party licensing needed to deliver.

Mandatory qualifications, team and capacity

Professional capacity and team composition:Organisational experience must cover toxicogenomics, large language models, transcriptomics data, and code development. Provide a list of three major projects or publications of at least one year each from the past five years that collectively cover all areas. Team composition must include at minimum: one senior bioinformatician with at least five years in toxicogenomics, transcriptomics, and code development; one junior bioinformatician with at least three years in the same; one senior toxicology expert with at least five years; and one LLM expert with at least one year. The LLM expert role may be covered by another profile if competencies are demonstrated, but each bioinformatician profile must individually meet the stated requirements. The team leader must have excellent written and spoken English; for non-native speakers, either a C1 certificate or evidence of at least three years working in an English-speaking environment. Provide detailed CVs and a one-page team summary mapping individuals to profiles. EFSA recommends the EU CV format.

Technical capacity and infrastructure:Tenderers must demonstrate computational capacity adequate to store and process large volumes of raw RNA-seq data and to run end-to-end pipelines. Commercial cloud platforms are permitted since data are public and non-confidential and not for commercial use. Tenderers can propose their preferred execution environment, schedulers and container technologies. No EFSA-side LLM infrastructure is prescribed. Tenderers should describe any programmatic access to licensed literature, if needed.

Economic and financial capacity:Minimum overall annual turnover of €250,000 in each of the last three closed financial years 2024, 2023 and 2022. A Declaration on Honour is required, and EFSA may request further evidence.

Intellectual property, data protection and use of AI

Intellectual property and open source:EFSA acquires ownership of the results and intellectual property created for EFSA under the contract. Pre-existing rights incorporated in deliverables must be licensed to EFSA on a royalty-free, non-exclusive, irrevocable basis for the specified uses. All code developed will be open source and made publicly available. Deliverables and supporting datasets may be published on EFSA’s Knowledge Junction on Zenodo with attribution to the contractor.

Personal data protection and confidentiality:Processing of personal data must comply with Regulation EU 2018/1725 and, where relevant, GDPR principles. Bids are treated confidentially per Regulation 1049/2001 case law, with redactions applied to protect commercial interests and IP as needed.

Mandatory use of AI and transparency requirements:Use of AI systems or models, including general-purpose AI and LLMs, is mandatory for the tasks in WP1. Tenderers must explain their AI implementation, risk mitigation, human oversight and quality validation. They must comply with the AI Act Regulation EU 2024/1689 as applicable and ensure EUDPR and GDPR compliance including no solely automated decisions without human oversight. Any deliverable produced with AI must include an explicit acknowledgement of AI use and human validation. If during contract implementation the contractor proposes to introduce new AI systems not described in the original offer, prior written EFSA approval is required.

Evaluation and award

Compliance and exclusion:Tenders must comply with all minimum requirements and the fixed maximum budget. Exclusion situations per Article 138 of the Financial Regulation apply, including EU restrictive measures. Access-to-market restrictions apply as stated in the specifications. The contracting authority may reject tenders that deviate from the draft contract terms.

Selection criteria:Economic and financial capacity: minimum turnover threshold. Professional capacity: organisational expertise across defined areas, specific team roles and English proficiency. Technical capacity: computational capacity statement. Environmental management information is requested via Annex 3 but is not scored.

Award criteria and thresholds:Quality criteria total 100 points with minimum 60 percent per criterion and at least 70 points overall. Criterion 1 Methodology 70 points: WP1 20, WP2 20, WP3 20, overall interdependencies 10. Criterion 2 Project organisation 15 points: planning and deadlines 5, distribution of tasks and the role of partners or subcontractors 5, EFSA communication 5. Criterion 3 Risk management 15 points: identification and mitigation 10, measures to ensure deadlines and quality 5. Price criterion: 30 percent of the total score. Total score computed as 30 times the cheapest price divided by price of tender X plus 70 times the total quality score divided by 100. Only tenders meeting both quality thresholds proceed to price assessment.

Deadlines, timetable and milestones

Submission method and portal requirements

Submission is exclusively electronic via eSubmission on the EU Funding and Tenders Opportunities portal. Each member of a joint tender must have an EU Participant Identification Code. Subcontractors do not need a PIC for submission but are covered by declarations. Only one tender per tenderer will be considered; if multiple are submitted, only the latest non-withdrawn tender counts. All tender documents are encrypted on upload. File size limits typically 50 MB per attachment, up to 200 attachments per tender as per system requirements. Use current versions of supported browsers such as Google Chrome or Mozilla Firefox. Attachments must follow the system’s file naming rules. Draft submissions may be edited until the deadline. After submission, the content is encrypted and cannot be viewed; tenderers may withdraw and resubmit a new version before the deadline. Public opening is virtual; up to two representatives may attend upon request with proof of submission. The system is multilingual and supports all 24 EU official languages. Character set encoding is UTF-8 and encryption uses asymmetric keys.

Financial offer, pricing and VAT

The financial offer must use EFSA’s Annex 1 Financial Offer Template and state a single all-inclusive total price in euros, free of VAT and other taxes or duties as EFSA is tax-exempt. Prices are fixed and not subject to revision. The all-inclusive price must cover overheads, travel, accommodation, subsistence, cloud costs if any, programmatic literature access if required, and any licensing of pre-existing rights incorporated into deliverables for EFSA’s intended use. The total in eSubmission must match the uploaded financial offer; in case of discrepancies, the uploaded financial offer prevails.

Frequently clarified points from the public Q&A

• Each of the two required bioinformatician profiles must individually meet the stated expertise requirements.
• The technical tender format is flexible beyond what is required in the tender specifications and eSubmission.
• Analytical methods and the number of chemicals are not prescribed; tenderers propose solutions meeting objectives and deliverables.
• Use of commercial cloud platforms is permitted for storage and processing of public data.
• For subcontractors, submit the signed Declaration on Honour on Exclusion Criteria and comply with all other applicable requirements.
• Ongoing projects may be included in the organisational experience list, counted up to the date of tender submission.
• EFSA does not specify arrangements for licensed literature access; tenderers should describe any programmatic access needs.
• The human-curated benchmark required for LLM evaluation is the responsibility of the contractor to design and prepare.
• No specific EFSA-side infrastructure is prescribed for LLMs or compute. Tenderers should propose the environment, schedulers, and container technologies.
• Economic operators in an EU Member State may use subcontractors in third countries, subject to task organisation and access rules.
• Contract conditions are not negotiable under the open procedure; the deadline is strict unless officially extended.
• The financial offer template wording must be followed; an XLS version is not required.

Templates and structure of the application

Technical offer recommended structure:Executive summary. Methodology per WP1, WP2, WP3 including interdependencies and end-to-end delivery, detailing repository discovery, LLM annotation strategy and benchmarking, preprocessing and clustering pipelines, integration and production hardening, open-source release plan and documentation, and comparison to EFSA CAGs. Risk management with identification, likelihood and impact assessments, mitigation measures, contingency plans for data access, LLM accuracy and compute availability. Project management, governance, milestones, deliverables, quality assurance, version control, reproducibility and testing, user support plan for hypercare, and communication plan with EFSA. Ethical, legal and regulatory compliance including AI Act alignment, data protection, and transparency statements for AI use in deliverables. Exploitation and IP section detailing pre-existing materials and licensing, and open-source licensing strategy. Team and resources with CVs, role mapping, English proficiency, and computational capacity statement. References and prior work with at least three relevant projects or publications of one year duration each over the last five years. Annexes as required by EFSA, including Declarations on Honour and environmental management information.

Mandatory forms and annexes:Declaration on Honour sections A Exclusion and C Confirmatory statement of resources and professional conflicting interest for the tenderer and, where applicable, all partners and identified subcontractors. Declaration on Honour section B Selection criteria completed by the leading partner in a joint offer. Annex 1 Financial Offer Template stating the all-inclusive total price. Annex 3 Information on environmental management completed by the tenderer or leading partner. Detailed CVs and a one-page team summary mapping roles. Evidence of economic and financial capacity upon request. Pre-existing rights statement to accompany interim and final invoices.

Administrative and legal highlights

• Language: English for all tasks, meetings and deliverables at a high standard requiring no proofreading.
• Ownership of results: EFSA acquires IP on results created for EFSA; pre-existing rights must be licensed to EFSA and identified. Knowledge Junction publication may apply.
• AI and transparency: AI use is mandatory for WP1; include clear disclosures and human oversight in all AI-assisted deliverables.
• Open source: All code must be released under an open-source license, with documentation and manuals.
• Payments: No pre-financing. Interim and balance payments within 90 days of invoice and acceptance.
• Force majeure, suspension and termination clauses apply as per the draft contract.
• Confidentiality obligations apply; EFSA may disclose limited information during public opening and may publish deliverables with attribution.
• Independence and conflicts: Individual declarations of interest may be required for team members influencing scientific outputs prior to contract signature.
• Anti-fraud: The contractor’s project manager must complete EFSA’s Anti-Fraud Module before contract start.

Key dates, identifiers and contact

Answers to the categorisation questions

Eligible Applicant Types:SME, large enterprise, university, research institute, nonprofit, public or private laboratory, and other economic operators capable of delivering the services. Joint tenders and subcontracting are permitted. Individuals cannot apply alone unless they qualify as an economic operator and meet all selection criteria.

Funding Type:Procurement contract for services. The authority purchases specified services and pays against accepted deliverables.

Consortium Requirement:Optional. Single applicant or a consortium through a joint offer. Subcontracting allowed.

Beneficiary Scope (Geographic Eligibility):EU and EEA tenderers are eligible. For personal data processing, adequacy decision countries are also acceptable. Subcontractors may be located outside but cannot be used to circumvent access rules. Entities subject to EU restrictive measures are excluded. Hungarian public interest trusts and their maintained entities are ineligible for legal commitments.

Target Sector:Food and feed safety risk assessment, toxicology and toxicogenomics, transcriptomics, bioinformatics and computational biology, artificial intelligence and large language models, software and data engineering, cheminformatics and regulatory science.

Mentioned Countries:Italy, Hungary. Regions: EU, EEA.

Project Stage:Development, validation and demonstration with production hardening and hypercare support.

Funding Amount:Up to €500,000 total. Fixed maximum budget; offers above this are rejected.

Application Type:Open call, one-step electronic submission via eSubmission on the EU portal.

Nature of Support:Money through contractual payments upon acceptance of deliverables, plus non-financial interaction through EFSA oversight, meetings and feedback.

Application Stages:1 stage. Evaluation covers exclusion, compliance, selection and award criteria with a public opening session followed by assessment.

Success Rates:Not provided in the published documentation.

Co-funding Requirement:No co-funding required. The contractor proposes an all-inclusive price and EFSA pays per the agreed schedule.

Practical tips for a competitive tender

• Demonstrate credible experience delivering large-scale, automated RNA-seq ingestion and analysis with robust metadata harmonisation across GEO, SRA, ArrayExpress and ENA. Show prior open-source pipeline work and reproducibility.
• Propose and justify an LLM solution with evidence of prompt engineering, retrieval augmentation, fine-tuning or instruction strategies tailored to experimental metadata and publication context; define the human-curated benchmark and clear metrics such as precision, recall, F1, and calibration on metadata extraction tasks.
• Detail portability and sustainability of pipelines including containerisation, workflow languages, CI or CD, logging, monitoring, and error recovery for production execution.
• Explain how clusters will be biologically interpreted, linked to modes of action and cross-referenced to AOPs, pathways, targets, chemical structure and use categories, culminating in traceable comparisons to EFSA CAGs.
• Quantify compute, storage and egress needs and how these will be met securely and cost-effectively on prem or in cloud, including cost controls.
• Address AI risks such as hallucinations, bias, reproducibility, and dependency on vendor APIs; propose fallbacks using local models where feasible and describe human-in-the-loop validation and audit trails.
• Plan documentation, training materials, and a responsive hypercare model with SLAs for bug fixes and user assistance through month 24.

Summary

This EFSA open tender funds the development, production hardening and demonstration of an end-to-end, large language model augmented bioinformatics workflow to automatically discover, retrieve, annotate and reanalyse public transcriptomics datasets for any chemical. The system must harmonise metadata, generate standardised signatures, cluster chemicals by inferred modes of action, and compare results with EFSA’s Cumulative Assessment Groups to support regulatory risk assessment. The contractor must supply strong toxicogenomics, bioinformatics, LLM and software engineering expertise, deliver open-source code and documentation, and provide hypercare support. The budget is capped at €500,000 over 24 months with payments tied to milestone deliverables. Evaluation emphasises a robust and convincing methodology across all work packages, credible project organisation and risk management, and value for money. Eligible applicants are EU and EEA economic operators and those in countries with an adequacy decision for personal data processing, with the option to form consortia and to subcontract. Proposals are submitted electronically via the EU Funding and Tenders portal and must include declarations on honour, evidence of capacity and an all-inclusive VAT-exempt financial offer. This opportunity advances the integration of OMICs and AI into next-generation risk assessment, providing EFSA with a transparent, production-ready, and openly available toolchain for transcriptomics-based chemical grouping.

Executive Summary

The European Food Safety Authority is seeking contractors to develop an advanced Large Language Model (LLM) augmented bioinformatics workflow that automatically discovers, downloads, processes and clusters transcriptomics data for chemical substances. The resulting tool will support EFSA's regulatory risk assessment by comparing derived chemical groupings with existing EFSA Cumulative Assessment Groups (CAGs). This is a 24-month service contract with a maximum budget of €500,000, awarded on a best price-quality ratio basis.

Opportunity Overview

Reference and Identification:Reference: EFSA/2026/OP/0002. TED Publication Date: 24 February 2026. TED Notice Number: 127772-2026. Contracting Authority: European Food Safety Authority, Parma, Italy. Nature of Contract: Research and development consultancy services (CPV code 73200000).

Procurement Type and Procedure:Open procedure. Electronic submission required via eSubmission portal. Single contract award. Submission method is mandatory electronic only.

Key Dates and Deadlines:Tender launch: 23 February 2026. Deadline for clarification requests: 20 March 2026 at 23:59 CET. EFSA reply deadline: 24 March 2026. Deadline for tender receipt: 30 March 2026 at 14:30 CET. Tender opening session: 31 March 2026 at 14:30 CET/CEST (Rome time). Estimated notification of results: April 2026. Estimated contract signature: Beginning May 2026.

Financial Information

Budget and Pricing:Maximum available budget: €500,000 total for entire 24-month contract. Any tender exceeding this amount will be rejected from evaluation. Prices must be quoted in euros, all-inclusive, with no VAT (EFSA is exempt from taxes and duties). The price offered is understood to cover all expenses including but not limited to overheads, travel, accommodation, licensing of pre-existing rights, and any additional costs incurred during contract performance.

Payment Structure and Terms:Three interim payments are planned: first payment of 20 percent upon approval of deliverables 1.1, 1.2, 2.1 and 2.2; second interim payment of 30 percent upon approval of deliverable 1.3; final balance payment of 50 percent (which equals 100 percent minus the cumulative interim payments) upon approval of all remaining deliverables including 3.1, 4.1, 4.2 and 4.3. Payment approval period: 90 days from invoice receipt by EFSA. Pre-financing is not applicable. Price revision is not applicable to this contract.

What EFSA Needs to Buy - Objectives and Scope

Project Objectives:The contractor must design, implement and validate an end-to-end LLM-augmented bioinformatics workflow. Given the name of a chemical substance, the system shall automatically search, download, annotate and reanalyse transcriptomics datasets from selected public repositories including but not limited to GEO/SRA, ArrayExpress, ENA/EBI and OmicsDI. The resulting clusters shall be compared with existing EFSA Cumulative Assessment Groups to assess concordance and support regulatory risk assessment. All code developed must be open source and made publicly available.

Key Deliverables and Work Packages:

The contract is structured around four work packages spanning 24 months. Work Package 1 focuses on data discovery and LLM development, including repository identification, LLM-based metadata annotation system development with human-curated validation, and production-ready pipeline hardening. Deliverable 1.1 (month 1): Intermediate report on repository selection and access methods. Deliverable 1.2 (month 6): Intermediate report detailing LLM system evaluation results and annotation accuracy. Deliverable 1.3 (month 12): Intermediate report with pipeline code, manual and results of full data processing. Work Package 2 covers transcriptomics preprocessing and clustering pipelines. Deliverable 2.1 (month 3): Standardised QC and preprocessing pipeline code with manual and rationale. Deliverable 2.2 (month 6): Chemical clustering pipeline code based on transcriptomic signatures and mode of action inference. Work Package 3 provides ongoing hypercare and support throughout the 24-month period. Deliverable 3.1: Continuous support including bug fixes and user assistance. Work Package 4 delivers end-to-end application and regulatory comparison. Deliverable 4.1 (month 18): Report on cluster characterisation from chemical, biological and industrial perspectives. Deliverable 4.2 (month 22): Final report detailing comparison with existing EFSA CAGs, concordance analysis, refinement proposals and limitations assessment. Deliverable 4.3 (month 24): Final comprehensive summary report including fitness-for-purpose evaluation for regulatory assessment.

Technical Requirements:

The LLM system must be capable of automatically figuring out what each sample in a transcriptomics study represents (treatment, control, dose, time point, sex, tissue, species) even when uploaded metadata are messy, incomplete or use different wording from source publications. The LLM annotations must be accurate enough to support downstream differential expression analysis, clustering and similar statistical analyses. Given task complexity, frontier LLM models with massive parameter counts and API-based capabilities are anticipated to be necessary. The contractor must implement or adopt a standardised transcriptomics preprocessing pipeline including quality control, trimming, mapping and quantification, and counting and normalisation. The system shall primarily process RNA-seq data, with microarray support if necessary. Raw transcriptomics data (read counts or FASTQ files) must be discoverable and downloadable from selected repositories. Metadata harmonisation is required to generate standardised transcriptomic signatures. Chemical clustering shall be based on inferred mode of action. The resulting clusters shall be characterised from chemical structural features, biological targets and pathways including Adverse Outcome Pathways, and industrial use categories perspectives.

Regulatory Context and Fitness-for-Purpose:The work supports EFSA's regulatory mandate under Regulation (EC) 178/2002 and amendments including Regulation (EU) 2019/1381. EU policy including the Farm to Fork strategy and EU Chemicals Strategy for Sustainability call for innovation in evidence streams such as OMICS to support next-generation risk assessment. The project aligns with EFSA's Strategy 2027 emphasis on strengthening methods and data to enhance risk-assessment capability. ¹ Systematic comparison with existing EFSA Cumulative Assessment Groups will assess concordance, identify potential refinements and evaluate fitness-for-purpose for regulatory assessment, alongside comprehensive characterisation of strengths, weaknesses and limitations at each analysis step.

Who Can Apply - Eligibility and Selection Criteria

Geographic Eligibility:Only tenderers established in EU Member States, EEA countries or countries with European Commission Adequacy Decisions for personal data protection may apply as lead tenderers. This is mandatory for processing personal data as specified under the contract. Subcontractors are not subject to geographic restrictions and may be established in other eligible countries. Hungarian public interest trusts established under Hungarian Act IX of 2021 and entities they maintain cannot be awarded contracts following Council Implementing Decision (EU) 2022/2506.

Economic and Financial Capacity:Tenderers must demonstrate minimum economic and financial capacity by declaring overall annual turnover of at least €250,000 in each of the three most recently closed financial years (2024, 2023 and 2022). Evidence of audited accounts or equivalent financial documentation may be requested. For joint tenders, this requirement applies to the lead partner. For consortia or joint offers where partners or subcontractors provide financial capacity, if during contract implementation changes to subcontractors or legal entities occur, financial capacity will be verified for the last two most recent closed financial years rather than the three years published with this call.

Professional and Technical Capacity:

At organisational level, tenderers must demonstrate extensive and demonstrable experience covering four core areas: toxicogenomics, Large Language Models, transcriptomics data, and code development of tools, pipelines and scripts. Evidence required: list of three major projects or publications, each with minimum one-year duration, related to the contract subject matter carried out within the past five years. One project may cover multiple areas, but all four areas must be covered collectively by the listed projects. Tenderers must provide detailed CVs for all proposed project team members in EU CV format, clearly showing relevant experience and expertise in the specified domains.

Required Team Composition and Expert Profiles:

The contractor must assemble a multidisciplinary team meeting the following minimum profile requirements. Profile A: One senior bioinformatician with expertise in toxicogenomics, transcriptomics and code development, minimum five years of demonstrated experience in these combined areas. Profile B: One junior bioinformatician with expertise in toxicogenomics, transcriptomics and code development, minimum three years of demonstrated experience. Profile C: One senior expert in toxicology with minimum five years of experience. Profile D: One expert in Large Language Models with minimum one year of experience. The profile D expert may be covered by one of the other three profiles if that person demonstrates simultaneous expertise. Total minimum team size is thus three or more experts. Each profile must individually meet the specified expertise and experience requirements. Tenderers must submit a one-page summary naming each project team member and clearly indicating which profile(s) each person covers. All team members must be identified by name, title and CV.

English Language Requirements:The Team Leader, Project Manager or Coordinator must demonstrate excellent level of spoken and written standard UK English. For non-native speakers, this must be evidenced by official certificate of English proving C1 level CEFR, OR at least three years of work in an English-speaking environment. Supporting evidence must be included in detailed CV.

Computational and Technical Infrastructure Capacity:Tenderers must declare computational capacity to perform all analyses described in the contract, particularly emphasizing capacity to store and process large volumes of raw RNAseq data. Submitting a statement describing available computational infrastructure and confirming fitness-for-purpose is required. Infrastructure requirements include sufficient storage, processing power for transcriptomics analysis pipelines, and capacity to handle the demanding computational needs throughout the 24-month contract duration. Use of commercial cloud platforms (AWS, Google Cloud, Microsoft Azure) is permitted for storing and processing public, non-confidential data.

Exclusion Criteria:

Tenderers must not be in any exclusion situation specified in Article 138 of the Financial Regulation (EU, Euratom) 2024/2509. Exclusion grounds include bankruptcy, insolvency, professional misconduct, corruption, fraud, grave professional misconduct violations, environmental or labour law violations, terrorist financing, money laundering or obstruction of justice. Tenderers must declare they are not subject to EU restrictive measures under Article 29 TEU or Article 215 TFEU. EFSA reserves the right to verify against publicly available information. This prohibition applies throughout the entire contract performance period.

Professional Conflicting Interests:If EFSA assesses that the tenderer has professional conflicting interests such that their previous or ongoing professional activities affect their capacity to perform the contract to appropriate quality standards, the tenderer may be rejected. Individual declarations of interest will be required from project team members having influence and control over scientific outputs, to be submitted and assessed by EFSA's Authorising Officer prior to and as a condition of contract signature. Tenderers must provide updated declarations during contract implementation if team members' circumstances substantially change.

Application Process and Key Requirements

How to Submit and Where:Tenders must be submitted exclusively via the electronic eSubmission system accessible from the EU Funding and Tenders Portal at [[ec.europa.eu. Paper submissions, email submissions or submissions via any other channel will be rejected. All submitted documents will be encrypted and protected until the official opening session.

Pre-Submission Registration:Economic operators must register in the European Commission's Participant Register before submitting a tender. Each organisation obtains a Participant Identification Code (PIC), a nine-digit unique identifier. Organisations already registered must reuse their existing PICs. Registration is performed once and information can be updated or reused in other EU calls for tenders or proposals.

Submission Deadline and Critical Timing:The receipt time limit is strictly 30 March 2026 at 14:30 CET/CEST (Rome time). The eSubmission system will not accept tenders submitted after this deadline. Tenderers must upload all required documents well in advance, as the time to upload documents can vary significantly depending on concurrent submissions, file sizes and internet connection quality. EFSA recommends uploading all documents on 29 March 2026 to ensure timely submission. Proof of submission with official timestamp constitutes evidence of compliance with the deadline. If no submission receipt is received within reasonable time after submission, contact the eSubmission Helpdesk immediately.

Required Submission Documents and Format:

Tenders must include:signed and dated Declaration on Honour on Exclusion Criteria (Section A) either by hand (requiring scanned attachment) or with qualified/advanced electronic signature; signed and dated Declaration on Honour on Selection Criteria (Section B) completed by the lead partner in joint offers; signed and dated Declaration on Honour on Professional Conflicting Interest (Section C) completed by lead partner and all partners or subcontractors; detailed technical offer addressing all tender specification requirements including methodology, project organisation, risk management and quality measures; detailed financial offer using the mandatory template including cost breakdown if desired; detailed CVs of proposed team members in EU CV format; one-page summary of team composition and profiles covered; statement on computational infrastructure capacity and fitness-for-purpose; evidence of selection criteria compliance including references to three major projects; certificates or evidence of English language proficiency where applicable for non-native speakers; Information on Environmental Management (Annex 3) indicating environmental management system certifications or practices (this information will not be evaluated under any criteria but is requested); any other supporting documents listed in the tender specifications.

Technical Specifications for File Submission:Maximum file size per attachment: 50 MB. Multiple attachments allowed up to maximum 200 files per tender. Supported file types include PDF, Word, Excel, and other standard formats; system requirements available at eSubmission portal. All documents must be in English language. Hyperlinks within offers leading to external websites will not be considered for evaluation; however hyperlinks to selection criteria evidence such as certificates or scientific publications will be considered. Declaration on Honour documents must be converted to PDF format and signed by authorised representatives either by hand or with qualified electronic signature.

Single Tender Submission Rule:Only one tender per economic operator may be considered. If the same tenderer submits multiple tenders without withdrawing earlier ones, only the latest tender will be evaluated. A withdrawn tender cannot be referenced to complement, clarify or correct a later tender. Withdrawal must be formally notified to EFSAProcurement@efsa.europa.eu before the deadline, and a withdrawal receipt from eSubmission serves as proof.

Evaluation Methodology and Award Criteria

Evaluation Order and Process:EFSA will evaluate tenders in the following order: opening of tenders to verify submission compliance; exclusion criteria verification; selection criteria verification including economic, financial, technical and professional capacity; compliance with tender specifications and minimum requirements; award criteria evaluation; final best price-quality ratio calculation. Exclusion and selection evaluations precede quality evaluation. Tenders failing at any stage may be rejected without proceeding to the next stage. EFSA may request missing information or clarifications from tenderers during evaluation, particularly for selection criteria evidence, exclusion status, and conflicts of interest. Such information requests shall not substantially change the tender.

Quality Award Criteria - Detailed Scoring:

Quality evaluation is divided into three criteria totalling 100 possible points, each with minimum threshold of 60 percent, and overall minimum threshold of 70 points required to proceed to price evaluation. Criterion 1 - Methodology (70 points maximum, 60% minimum threshold): Subcriteria include convincing justification and clear description of Work Package 1 methodology (20 points); convincing justification and clear description of Work Package 2 methodology (20 points); convincing justification and clear description of Work Package 3 methodology (20 points); convincing description of overall approach and interdependencies between WP1, WP2 and WP3 (10 points). Tenderers must demonstrate clear understanding of tasks and present concise yet comprehensive methodology addressing each requested deliverable. Repetition of mandatory requirements without detailed proposal will receive very low scores. Criterion 2 - Project Organisation (15 points maximum, 60% minimum threshold): Subcriteria include convincing description of project planning, phases, timelines, milestones and deadline achievement measures (5 points); clear detailed information on task distribution among project team members clearly explaining who does what, when and why, including justification for partner and subcontractor role assignments (5 points); clear description of communication procedures with EFSA including frequency, channels and responsible parties (5 points). Criterion 3 - Risk Management (15 points maximum, 60% minimum threshold): Subcriteria include identification of potential risks to project objectives such as difficulties in automatic data retrieval or inadequacies in LLM-generated annotations, assessment of risk impact and likelihood, and proposed effective mitigating actions (10 points); proposed measures to ensure meeting deadlines and maintaining deliverable quality (5 points).

Price Evaluation and Best Price-Quality Ratio Calculation:Only tenders achieving minimum quality score of 70 points and passing all previous evaluation stages proceed to price evaluation. Price offers must be within the €500,000 maximum budget and satisfy all formal financial requirements. The best price-quality ratio is calculated using the formula: Total Score = 30 percent times (cheapest price / tender price) plus 70 percent times (total quality score of tender / 100). This weighting allocates 70 percent importance to quality and 30 percent to price. The tender achieving the highest total score will be awarded.

Minimum Compliance Requirements for Tender Specifications:

Tenders will be rejected if they fail to comply with minimum requirements including:failure to comply with any minimum requirement in tender specifications; proposal of a solution materially different from the imposed approach; price exceeding the €500,000 maximum; contractual terms or conditions deviating from the draft contract Annex 2 unless concerning subscription contracts for IT tools which will be assessed under Sections 1.5 and 1.6; submission as variants when specifications do not authorise variants; failure to comply with applicable environmental, social and labour law obligations under Union law, national law, collective agreements or international provisions listed in Annex X Directive 2014/24/EU; failure to comply with Regulation (EU) 2016/679 (GDPR) and Regulation (EU) 2018/1725 (EDPR) data protection obligations; failure to comply with Regulation (EU) 2024/1689 (AI Act) requirements. Rejection for non-compliance is not linked to award criteria and tenderer will be informed of rejection grounds without feedback on tender content.

Use of Artificial Intelligence and LLMs in Tender Preparation:Tenderers must clearly indicate in their offer whether Large Language Models such as ChatGPT, Microsoft Copilot or similar tools were utilised in preparing their tender. This declaration is mandatory for transparency purposes.

Contract Implementation and Special Conditions

Contract Duration and Performance Timeline:Maximum contract duration: 24 months from the kick-off meeting. Performance of the contract cannot start before contract entry into force. The contract period may be extended only with express written agreement of both parties before expiration. Monthly progress meetings are required starting from the kick-off meeting. Interim meetings include physical meeting in Parma at month 14 and final teleconference at month 24.

Intellectual Property Rights and Use of Results:EFSA acquires irrevocable worldwide ownership of all newly created results and intellectual property rights produced under the contract, including software source code, object code, documentation and all technological solutions. The contractor cannot file patents, trademarks, copyrights or other intellectual property protections without prior written authorisation and explicit consent from EFSA. All code developed must be open source. Results will be published on EFSA's Knowledge Junction repository with attribution to the contractor, and cross-linked to final reports published on Wiley Online Library. EFSA may exploit results in all modes including reproduction, distribution, communication to the public, modification, translation, inclusion in open access databases, and sublicensing to third parties working for EFSA. Pre-existing materials and rights are licensed royalty-free to EFSA on non-exclusive irrevocable basis. Contractor must warrant all results are free of third-party claims and must list all pre-existing rights incorporated. Any materials subject to copyright or licensing requiring special arrangements must be explicitly declared and contractors must obtain necessary permissions.

Mandatory Requirements for AI System Use:Use of AI systems and models including LLMs in service delivery to EFSA is mandatory for this contract. ² Contractors must adhere to Regulation (EU) 2024/1689 (AI Act) as it becomes applicable. Under all circumstances, compliance with EDPR Article 24 and GDPR Article 22 regarding human oversight and validation for all automated processing is mandatory. Contractors must specify in technical offer: how AI systems and models will be implemented aligned with contract context and EFSA requirements; how identified AI risks will be mitigated; any additional AI risks identified and mitigation measures; how human oversight and quality validation will be guaranteed. For deliverables incorporating AI systems or LLMs, contractors must insert explicit mention acknowledging the AI system used, confirming human oversight and validation. Any introduction of new AI systems during contract implementation not specified in the original tender requires prior written EFSA approval with detailed justification of added value, risks and mitigation measures. EFSA will register endorsed AI systems in a register potentially provided to market surveillance authorities. Prohibited AI practices under Article 5 of the AI Act may never be applied.

Data Protection and Personal Data Processing:Processing of personal data shall comply with Regulation (EU) 2018/1725 (EDPR) applicable to EU institutions. EFSA acts as data controller. Contractor acts as processor or sub-processor. Personal data shall be processed only within EU and EEA territories in data centres within those territories with no access outside these regions. Contractor may not change data processing location without prior EFSA written authorisation. Contractor must adopt appropriate technical and organisational security measures including encryption, ability to ensure confidentiality, integrity, availability and resilience, and processes for regularly testing security effectiveness. Personal data breaches must be notified to EFSA within 48 hours. Contractor must maintain records of all data processing operations, transfers, security breaches and requests for data subject rights. Upon contract expiry, contractor shall return or delete all personal data unless EU or national law requires longer storage.

Subcontracting and Liability:Subcontracting beyond third parties mentioned in the tender requires prior written EFSA authorisation. Contractor remains solely responsible for contract performance and compliance regardless of subcontracting. EFSA may require replacement of subcontractors found in exclusion situations. Contractor liability for damage caused to EFSA is limited to three times the total contract amount, except for gross negligence, wilful misconduct, physical injury, or breach of intellectual property rights where liability is unlimited. For joint tenders, all members are jointly and severally liable.

Termination and Performance Standards:EFSA may terminate the contract if: services do not start within 15 days of scheduled date; contractor cannot obtain required permits or licenses; contractor fails to perform per tender specifications or substantially breaches obligations; contractor is in exclusion situations; procedure or performance subject to irregularities, fraud or breach; contractor violates environmental, social or labour law; conflict of interest situations arise; contractor's legal, financial, technical or ownership situation substantially changes; force majeure making performance impossible; data protection obligation breaches; or manifest future material performance failure occurs. Either party may terminate with three months written notice. Contractor remains bound to perform only actual services provided before termination. EFSA may claim damages including additional costs to engage replacement contractor unless termination is due to force majeure or EFSA breach. Contractor must provide transition assistance at no additional cost unless substantial additional resources are required, in which case costs must be negotiated in good faith.

Strategic Context and EFSA Background

Cumulative Assessment Groups (CAGs) and Regulatory Context:EFSA has developed methodology for grouping pesticides into Cumulative Assessment Groups based on similar toxicological properties in specific organs or systems. ¹ CAGs were initially established for pesticides affecting the thyroid and nervous systems. The methodology involves identifying specific adverse toxic effects, characterising their nature and dose-response relationships, collecting data on specific indicators, and grouping pesticides exhibiting similar toxicological effects. This approach enables cumulative risk assessment as required by EU regulations including Regulation (EC) 396/2005, Regulation (EC) 1107/2009. EFSA has conducted pilot cumulative risk assessments considering chronic effects on thyroid systems and acute effects on nervous systems using monitoring data from 2014-2016. Future development includes establishing CAGs for effects on kidneys, reproductive systems, liver and other organs. The current procurement seeks to leverage transcriptomics and artificial intelligence to refine and enhance chemical grouping methodology, potentially identifying new CAGs and validating existing ones through data-driven bioinformatic analysis.

Alignment with EU Policy and Next-Generation Risk Assessment:This procurement aligns with EU policy direction toward innovative evidence streams to replace legacy in vivo testing. The Farm to Fork strategy and EU Chemicals Strategy for Sustainability call for advancing beyond traditional endpoints and animal welfare concerns toward mechanistic insights. EFSA's Strategy 2027 emphasises strengthening methods and data. Recent initiatives including EFSA's Theme Paper on OMICS and Bioinformatics (2022), Roadmap for action on OMICS applications (2024), proposal for NAM qualification system (2024), and JRC/EURL-ECVAM Status Report 2024 on non-animal methods establish the strategic framework supporting this procurement. The integration of OMICS data, bioinformatics and artificial intelligence represents the frontier of next-generation risk assessment methodology.

Key Applicant Considerations and Submission Tips

Critical Strengths for Competitive Proposals:Highly competitive proposals will demonstrate: deep expertise in toxicogenomics evidenced by peer-reviewed publications or major projects; proven experience developing and deploying LLMs in scientific contexts; substantial track record with transcriptomics data processing and bioinformatic pipeline development; previous experience with EFSA or regulatory scientific assessments; computational infrastructure capability for massive bioinformatic analyses; clear understanding of cumulative assessment group methodologies and regulatory requirements; well-structured risk mitigation strategies addressing LLM annotation accuracy uncertainties and data heterogeneity challenges; realistic timeline and resource allocation; multidisciplinary team composition bridging computer science, biology, toxicology and regulatory science; commitment to open source code development and knowledge dissemination; evidence of experience with public repository systems and metadata standardisation.

Common Pitfalls to Avoid:Avoid overly complex methodologies without clear justification. Do not propose solutions that materially differ from tender specifications without explicit approval. Do not exceed €500,000 budget. Do not submit without clearly defined team roles and responsibilities. Do not neglect risk management sections. Do not provide vague project timelines. Do not fail to address LLM quality validation and human oversight mechanisms. Do not ignore intellectual property and open source requirements. Do not submit after the strict deadline. Do not provide incomplete declarations or missing documentation. Do not propose subcontractors for entire work packages without clear justification of unique expertise. Do not neglect computational infrastructure capacity statement.

Q&A Clarifications and EFSA Guidance:Questions must be submitted through F&T Portal Questions and Answers tab by 20 March 2026. EFSA is not obliged to reply to clarifications received less than 6 working days before submission deadline. Thirteen public questions and answers had been published as of mid-March 2026 clarifying: bioinformatician expertise requirements must individually meet specifications, no flexibility on specific roles; technical tender submission requirements are flexible regarding format beyond specifications requirements; WP1 analytical methods and number of chemicals not prescribed, allowing contractor flexibility in approach; commercial cloud platforms permissible for public non-confidential data; local freely-available LLMs acceptable though frontier models anticipated necessary; human-curated benchmark is contractor responsibility; full contract conditions are not negotiable as this is open call not negotiated procedure; deadline of 30 March 2026 is strict, extendable only for technical system failures.

Contact Information and Support

EFSA Procurement Contact Details:European Food Safety Authority, Procurement Team - Finance Unit, Via Carlo Magno 1/A, 43126 Parma, Italy. Email: EFSAProcurement@efsa.europa.eu. Phone: +39 0521 036 149 (Media Relations Office). Questions must be submitted via F&T Portal not by direct email. For technical eSubmission support contact ec-funding-tender-service-desk@ec.europa.eu, available 08:00 to 20:00 CET.

Additional Resources and References:EFSA Guidance for tenderers available on EFSA website. eSubmission Quick Guide available at [[wikis.ec.europa.eu. EU Funding and Tenders Portal at [[ec.europa.eu. EFSA Corporate documents and OMICS/bioinformatics guidance available at [[https://www.efsa.europa.eu]].. FAO and EFSA Memorandum of Understanding on cooperation. EU Chemicals Strategy documents. Privacy Statement on EFSA website. EFSA Independence Policy and Decision on Competing Interest Management.

Footnotes

1. 1EFSA has developed cumulative assessment group methodology for pesticides based on similar toxicological properties affecting specific organs or systems. CAGs enable cumulative risk assessment as required by Regulations (EC) 396/2005, 1107/2009. Pilot cumulative risk assessments have been conducted for thyroid and nervous system effects using EU monitoring programme data from 2014-2016, with future work planned for kidneys, reproductive systems and other organ systems. See EFSA publications on cumulative assessment groups at [[efsa.europa.eu
2. 2The use of AI systems and LLMs in service delivery is mandatory for this contract, particularly for Work Package 1 which requires LLM-based automatic annotation of transcriptomics metadata. Contractors must comply with Regulation (EU) 2024/1689 (AI Act) and ensure human oversight and validation mechanisms. EFSA will register endorsed AI systems in accordance with Article 74.9 of the AI Act for potential provision to market surveillance authorities.