Preparatory support on bioinformatics for the evaluation of the risk assessment of GMO dossiers

EFSA/2026/OP/0001 is an open call for a single framework service contract to provide preparatory support on the completeness, compliance and quality of bioinformatics analyses in GMO dossiers for EFSA risk assessment. The contract has a financial ceiling of €320,000 over up to four years (12-month initial term plus up to three 12-month renewals) and the tender submission deadline is 27 May 2026 at 14:30 Rome time via the EU eSubmission portal. Eligible economic operators must be established in the EU/EEA or in countries with an EU adequacy decision, meet a minimum annual turnover of €160,000 for 2022–2024, and demonstrate required technical team qualifications. Subcontracting of core confidential tasks is prohibited and the use of AI in tender preparation or delivery is not allowed without EFSA written approval.

What is funded

Scope

Framework tender to provide preparatory work to assess completeness, regulatory compliance and scientific quality of applicants’ bioinformatics analyses included in GMO dossiers (flanking region analyses, ORF/NEP allergenicity and toxicity checks, horizontal gene transfer searches, RNAi off-targets, database and algorithm evaluation, archiving and annual reporting).

Estimated budget and duration:Estimated total value €320,000; framework contract maximum overall duration up to 4 years (implemented as 12-month FWC with up to 3 automatic renewals). ¹

1. 1Procedure: Open procedure (electronic submission via eSubmission on the EU Funding & Tenders Portal).
2. 2Deadline for receipt of tenders: 27 May 2026, 14:30 Europe/Rome (public opening 28 May 2026 at 14:30).
3. 3Contracting authority: European Food Safety Authority (EFSA).

Who can apply

Economic operators (sole tenderer or consortium) established in eligible countries. Tenderers must register in the Participant Register (PIC) and use EU Login to submit via eSubmission. Offers may be submitted in any EU official language.

Key eligibility and selection highlights

1. 1Minimum economic capacity: annual turnover at least €160,000 in each of the last three closed financial years (2022–2024).
2. 2Technical capacity: demonstrable experience in bioinformatics analyses, sequencing data handling, reproducible workflows and scientific reporting; proposed team must include at least one senior bioinformatics expert (PhD, ≥10 years) and one molecular biology/bioinformatics expert (MSc, ≥5 years).
3. 3Subcontracting: not allowed for tasks involving EFSA confidential GMO dossier data (confidentiality declarations and data‑protection commitments required).

Tenders must follow the published tender specifications, draft framework contract and Annexes available on the EU Funding & Tenders Portal. Financial offer template and draft contract are attached in the procurement documents.

Technical and procedural notes:Offers will be evaluated on quality (methodology, organisation, risk and quality assurance) and price; minimum quality thresholds apply. Tenderers must follow EFSA rules on confidentiality, data protection and conflict of interest; use of AI/generative LLMs in delivering services is prohibited unless expressly authorised by EFSA. ¹

Footnotes

1. 1EU Login two-factor authentication will be required for portal access; EFSA reminders and details on EU Login 2FA registration are on the Funding & Tenders Portal and the EU Login guidance pages.

Basic procurement facts

Procuring authority:European Food Safety Authority (EFSA). Procedure type: Open procedure (call for tenders / procurement). Nature of contract: services under a framework service contract (FWC). Main CPV: 73110000 Research services. Funding mechanism: procurement (service contract) with fixed financial ceiling. Submission method: electronic only via eSubmission on the EU Funding & Tenders Portal. Deadlines: initial TED / Portal publication 16/04/2026. Deadline for receipt of tenders 27/05/2026 14:30 (CEST). Public opening 28/05/2026 14:30 (CEST).

Estimated total value:€320,000 (total financial ceiling for specific contracts under the FWC over up to four consecutive years; includes a contingency of up to 10% and possible price indexation provisions). ¹

What EFSA is buying (scope and objectives)

Purpose:preparatory work to assess the completeness, compliance and quality of bioinformatics (BI) analyses submitted by applicants in GMO dossiers. The chosen contractor will operate under a framework contract implemented by order forms / specific contracts. Duration: framework contract initial 12 months with automatic renewal up to three times (maximum 4 years). Place of performance: contractor premises (work performed remotely) and delivery of electronic reports and an EFSA-accessible repository. Outputs: interim and final reports per assessed GM event; archiving of outcomes in a searchable repository; annual summary reports; a mid-term proposal (after 12–24 months) for refinements to the BI submission form used by applicants.

Context and technical tasks:EFSA requires quality checks of applicants’ BI packages submitted for single events, stacked events and renewal dossiers, and for mandates where BI data are supplied. BI analyses covered include: flanking region analysis (5’ and 3’), interruption of plant genes, identification and evaluation of newly predicted open reading frames (ORFs) and newly expressed proteins (NEPs) for similarity to known allergens and toxins, DNA similarity searches for horizontal gene transfer (plant-to-microbe), assessment of databases and algorithms used, assessment of RNAi off-target transcript analyses, and quality of reporting and raw data (alignments, parameters, algorithm versions). The contractor must produce checklists, interim reports that identify missing/insufficient elements, final reports after any applicant clarifications, update final reports if applicants submit revised BI packages, maintain a searchable archive of assessments, and prepare an annual summary and a proposal for submission form refinements (Objective 2).

Eligibility and who should apply

Eligible economic operators:organisations established in eligible countries (EU and EEA countries or third countries with an EU adequacy decision for personal data processing). EFSA accepts joint offers (groups of economic operators) but the framework is a single FWC to be awarded to one contractor. Subcontracting is not allowed for the core tasks, because assessments involve confidential dossier material. Tender language(s): any official EU language; working language for contract implementation and deliverables: English.

1. 1Eligible applicant types: research institutes, universities, specialised bioinformatics consultancy firms, SMEs and large companies with documented bioinformatics capacity, non-profit scientific organisations, professional scientific service providers (consortia/joint offers permitted; single contractor will be awarded the FWC).
2. 2Ineligible approaches: subcontracting of core assessment tasks is not permitted due to handling of confidential GMO application data.

Selection and minimum requirements (technical and financial)

Key selection thresholds and documentary requirements (to be supplied with the tender):

1. 1Economic and financial capacity: minimum overall annual turnover of €160,000 in each of the last three closed financial years (2022, 2023, 2024) (Declaration on Honour section B required; EFSA may request supporting documents).
2. 2Professional/technical capacity – organisational: demonstrable experience preparing scientific publications and technical reports and experience performing and evaluating bioinformatics analyses (examples/publications or 3 major projects in last 5 years).
3. 3Professional/technical capacity – team composition: at least two experts: (a) Bioinformatics expert with minimum 10 years’ relevant experience and PhD or equivalent; (b) Molecular biology + bioinformatics expert with minimum 5 years’ relevant experience and MSc or equivalent. Additional required capabilities: at least one expert with 5 years BI data management experience and at least one with 5 years’ experience managing/coordinating scientific projects. Detailed CVs in EU CV format and confidentiality declarations for experts are required.
4. 4Language: team must demonstrate excellent spoken and written UK English (C1 certificate OR 3 years work in English-speaking environment OR 5 years international projects where English is the working language).
5. 5Declarations and forms: Declaration on Honour (sections A, B, C), administrative forms and Business Partner form / PIC data, Annex 3 environmental management form (informative), Annex 4 confidentiality statement.

Award criteria and evaluation

Award method:best price-quality ratio. Quality scoring (100 points total) and price weighting: quality 70% of final weighting; price 30%.

1. 1Quality award criteria (maximum 100 points): methodology for implementation (50 points), project organisation (20 points), risk management (15 points), quality assurance measures (5 points), measures to meet deadlines (10 points). Minimum thresholds: 60% per criterion; overall quality threshold 70% of maximum (i.e. 70 points).
2. 2Price assessment: financial offers must be within the maximum budget (FWC envelope) and satisfy formal requirements. Evaluation formula: Score = 30 * (cheapest price / price of tender X) + 70 * (total quality score/100).

Contract form, duration, budget and payments

Contract model:Framework service contract (FWC) to one contractor (single FWC) implemented by Specific Contracts / Order Forms. Maximum FWC total envelope: €320,000 (covering up to four consecutive years including up to 10% contingency and possible indexation). EFSA may, within legal limits, award follow-on services by negotiated procedure up to 50% increase of the initial envelope under specified conditions. FWC initial duration 12 months with automatic renewal 3 times (total up to 4 years). The contractor has 5 working days to sign and return any given specific contract/order form. Place of performance: contractor premises. Payments: interim payments may be agreed in specific contracts; final payment (balance) after EFSA approval of deliverables; EFSA payment term: within 90 days from receipt of invoice and approving deliverables (payment workflow and timelines specified in FWC draft). No pre-financing; no performance guarantee required. Price revision: indexation mechanism in draft contract using HICP indices.

Financial offer template and price structure:The procurement documents include Annex 1 Financial Offer template (Excel). The tender requires unit price entries and scenario-based totals: typical scenarios shown in template include assessments for 18 events (C1 and C2), 10 events (C3), 1 annual report (C4) and 1 refined proposal (C5). The total tender price used for evaluation is the sum of scenario outcomes (C1+C2+C3+C4+C5).

Submission, timelines and process steps

Submission method:exclusively electronic via eSubmission on the EU Funding & Tenders Portal (EU Login required). Tenderers must be registered in the Participant Register and use their PIC. Key dates: Contract notice / portal publication 16/04/2026; deadline for clarification questions 19/05/2026; EFSA response to clarifications by 21/05/2026; tender submission deadline 27/05/2026 14:30 CEST; virtual opening 28/05/2026 14:30 CEST; estimated notification of evaluation results July 2026; estimated contract signature July–August 2026. EFSA will not respond to questions submitted less than 6 working days before submission deadline. Submission confirmations / timestamps from eSubmission constitute proof of timely receipt. System-specific rules: attachments <50 MB, max 200 files, supported browsers Chrome/Firefox, EU Login 2-factor authentication required (be prepared — 2FA mandatory rollout during 2026).

• Application submission components: Declaration on Honour sections A–C (signed/scanned or e-signed), technical offer (methodology addressing Part 1 requirements and each quality award criterion), team CVs and confidentiality declarations for proposed experts, list of recent projects/publications, Annex 3 environmental info (informative), Annex 1 financial offer Excel (completed).
• System requirements and administrative items: PIC mandatory, EU Login with 2FA for eSubmission, follow eSubmission Quick Guide and system requirements, name attachments per system requirements, adhere to allowed file types and sizes.

Eligible geography, legal and data rules

Geographic eligibility:entities established in EU and EEA countries or in countries with an EU adequacy decision for personal data processing. EFSA (Parma, Italy) is the contracting authority; the law governing the FWC is EU law complemented by Italian law where necessary; the General Court of the European Union has exclusive jurisdiction for disputes. The contract contains strict confidentiality, data protection (Regulation EU 2018/1725) and anti-fraud obligations; personal data processing and secure handling of confidential GMO dossier material is explicitly regulated in the draft contract. Use of AI: EFSA prohibits the use of AI systems, including generative LLMs, in delivering services under the FWC unless expressly authorized in writing by EFSA; tenderers must declare if LLMs were used in preparing their tender.

Mentioned countries and locations:EFSA headquarters: Parma, Italy (contracting authority location). Geographic eligibility: EU and EEA countries and countries with EU adequacy decisions for personal data processing. TED / contract notice indicates Anywhere in the European Economic Area. The portal and processes are EU-wide. ¹

Eligibility and application specifics — structured checklist for tenderers

1. 1Register organisation in Participant Register and obtain PIC; ensure EU Login account and activate 2-factor authentication well in advance of the deadline.
2. 2Complete administrative forms including Business Partner form and Declaration on Honour sections A, B and C, signed or advanced e-signed; for joint offers each member completes section A and C; only lead partner completes section B.
3. 3Provide evidence of financial capacity (Declaration on Honour; EFSA may request supporting turnover proof). Minimum turnover requirement: €160,000 each year for 2022–2024.
4. 4Prepare technical offer addressing the tender specifications and each quality award criterion. Provide methodology, report templates (interim and final), project organisation, risk register and QA measures.
5. 5Provide team CVs (EU CV format recommended), confidentiality declarations signed by every proposed expert, and a one-page team summary.
6. 6Upload the completed Annex 1 Financial Offer template (Excel) with unit prices and scenario totals. Ensure total price is within FWC envelope assumptions.
7. 7Submit whole tender package via eSubmission before the deadline. Keep backup copies and retain submission receipt (timestamp).

Consortium / partnership rules

Although the framework contract will be awarded to a single contractor (single FWC), EFSA permits joint offers (groups of economic operators). If applying as a group, the lead partner must submit the selection/declaration documents on behalf of the group where required; the group members must submit Declarations on Honour for exclusion criteria. Subcontracting of core tasks (assessment of BI data) is explicitly disallowed due to confidentiality of GMO dossier data; any subcontracting proposal will be subject to strict restrictions and EFSA written authorisation (the tender specifications state subcontracting is not allowed for the core tasks).

Project maturity and expected activities

Project maturity:the opportunity targets operational assessment and quality assurance of existing applicant-submitted bioinformatics packages; activities are post-submission evaluation/validation and archiving rather than primary research. Expected project stage for bidders: established operational capability for bioinformatics analyses, demonstrated reproducible pipelines and experience assessing/validating sequence-similarity based analyses and allergen/toxin screening workflows.

Nature of support, co-funding and legal obligations

Nature of support:paid service contract (monetary compensation to the contractor). Co-funding: not required; this is a procurement for services with an agreed price. Legal and compliance obligations: strict confidentiality clauses, data protection adherence (Regulation (EU) 2018/1725), anti-fraud training obligations and rules on conflicts of interest; use of AI in delivery is prohibited unless EFSA authorises it in writing.

Application stages, success rates and practical odds

Application stages:single-stage submission process (electronic tender submission) followed by evaluation (administrative compliance, exclusion and selection checks, quality scoring and price assessment) and award/contract signature. Practically, EU public procurement processes have: submission (stage 1) and evaluation & award (stage 2).

Success rates:not published by EFSA for this specific tender. Typical competitive framework: single-award FWC with quality thresholds (minimum 60% per award criterion, 70% overall) and price screening. As a procurement for specialist scientific services handling confidential regulatory dossiers, competition may be limited but specialized: expect modest numbers of highly qualified competing tenders (success rates variable; EFSA does not provide a numeric success probability for this call).

Templates and structure of application forms (practical outline)

Procurement documents include multiple annexes and mandatory forms. Tenderers must follow the exact document templates provided on the Portal. Key templates and required content are summarised below.

1. 1Declaration on Honour template (sections A, B and C): Section A (exclusion) must be completed and signed by each group member; Section B (selection criteria / economic & financial statements) completed by lead partner for joint offers; Section C (confirmatory statement of resources and professional conflicting interest) completed by lead and other partners as requested.
2. 2Annex 1 Financial Offer template (Excel): unit-price based structure with scenario columns. Tenderers must insert unit prices (A), number of units in scenarios (B), and the calculated scenario outcomes (C). Typical scenario rows in template: assessments for 18 events (two categories), 10 events, 1 annual report, 1 refined proposal; the TOTAL price used for evaluation is the sum of scenario outcomes.
3. 3Tender specifications (Annex I) and Draft Framework Contract (Annex II): tenderers must read and accept the draft contract provisions; any proposed deviations to the contract must be raised as clarifications prior to tender submission; incompatibilities or deviations may lead to rejection.
4. 4Technical offer structure recommended: Executive summary; Understanding of objectives and compliance checklists aligned to Table 1 references; Detailed methodology and workflows; Proposed report templates (concise interim and final report templates as required by award criteria); Project organisation and staffing plan; Risk register and mitigation; Quality assurance measures; Timeline and deliverables; Data security and confidentiality procedures; Evidence of previous projects/publications.
5. 5CVs and confidentiality declarations of proposed experts: CVs in EU CV format strongly recommended; confidentiality statement template provided in Annex 4 must be signed by each expert assigned to the project.
6. 6Environmental information: Annex 3 (information on environmental management) — informative only (not scored).

Administrative, IT and practical notes for bidders

eSubmission system notes and action checklist:ensure organisational PIC is valid; EU Login account active and 2-factor authentication (prepare device, security key, passkey or eID as per EU Login guidance); use Chrome or Firefox latest versions; maximum file sizes and number of attachments (attachments <50 MB, max 200 files); name attachments following system requirements; do not rely on hyperlinks to host essential content — hyperlinks to selection evidence are permitted but the evaluation will consider only documents uploaded in eSubmission; be aware that EFSA may reject non-compliant tenders; tender validity period 9 months; EFSA will not reimburse tender preparation costs.

Co-funding and intellectual property

Co-funding:none required. Intellectual property: EFSA acquires ownership of results/deliverables produced specifically under the contract; pre-existing materials incorporated in deliverables must be clearly declared and licensed to EFSA on a royalty-free, non-exclusive, irrevocable basis sufficient for EFSA exploitation modes described in the FWC. The tender requires a declaration of any pre-existing rights; absence of declaration will be treated as confirmation that no pre-existing rights are implicated or that necessary authorisations have been obtained.

Security, confidentiality and data protection specifics

Handling of GMO dossier data:contractor will process and store highly confidential dossier material. The draft contract and tender specifications set strict confidentiality obligations, requirements for EFSA-issued personalised confidentiality declarations for individuals working on tasks, secure digital environment usage, data return or destruction at contract end, and explicit prohibition on the use of AI systems for contract activities unless EFSA authorises in writing. The contractor must comply with Regulation (EU) 2018/1725 for personal data processing and is subject to EFSA privacy policy and audit rights.

Key procurement references and where to get documents

All procurement documents (Invitation to Tender, Tender Specifications with Annexes, Annex 1 Financial Offer template Excel, Draft Framework Contract) are available from the EU Funding & Tenders Portal Tender Details page for EFSA/2026/OP/0001. Bidders must download all annexes and templates from the portal and use the published templates without alteration. ¹

Quick practical checklist for a compliant bid

1. 1Register organisation (if not already) in Participant Register and obtain PIC.
2. 2Ensure EU Login account is created and 2-factor authentication is set up well before submission date.
3. 3Download all procurement documents from the Portal (Invitation, Tender specs, Annexes, Draft Contract, Financial Template).
4. 4Complete Declaration on Honour sections A–C as required and obtain authorised signature(s) or advanced electronic signature.
5. 5Prepare technical offer addressing all quality award criteria and tender specifications including the proposed report templates and QA procedures.
6. 6Assemble team CVs in EU CV format and signed confidentiality declarations (Annex 4) for each proposed expert.
7. 7Complete the Annex 1 Financial Offer Excel template following the specified scenario units and totals; verify the total price and that it conforms to instructions.
8. 8Upload full tender package to eSubmission before the deadline; retain submission receipt (timestamp).
9. 9Monitor the Portal ‘Questions & answers’ tab and EFSA notifications; respond to any EFSA clarifications requests promptly.

This summary preserves the facts and requirements published by EFSA in the Invitation to Tender, Tender Specifications and draft FWC and the TED notice; it reproduces the key obligations and templates that bidders must use. For full legal and contractual details bidders must consult and follow the official procurement documents available on the Funding & Tenders Portal. ¹

Footnotes

1. 1Full procurement documentation, including Invitation to Tender, Tender Specifications (with Annexes), Annex 1 Financial Offer template (Excel) and Draft Framework Contract can be downloaded from the EU Funding & Tenders Portal tender details page for Call EFSA/2026/OP/0001: ec.europa.eu

This is an open call for tenders issued by the European Food Safety Authority (EFSA) for a single framework service contract to provide preparatory support on the completeness, compliance, and quality of bioinformatics (BI) analyses in genetically modified organism (GMO) dossiers. The contract supports EFSA's risk assessment of GMO applications for food, feed, import, processing, and cultivation under relevant EU regulations.

Opportunity Overview

The tender seeks expertise to evaluate BI analyses submitted by applicants in GMO dossiers, covering single events, stacked events, renewals, and mandates. BI analyses must use up-to-date databases and address gene interruptions, allergenicity, toxicity, horizontal gene transfer, and RNAi off-target effects, per EFSA guidelines listed in Table 1 of the tender specifications.

Key Dates:TED publication: 16 April 2026. Deadline for questions: 19 May 2026 (23:59 Rome time). Tender deadline: 27 May 2026 (14:30 Rome time). Public opening: 28 May 2026 (14:30 Rome time). Estimated contract signature: July-August 2026.

Financial Ceiling:€320,000 over maximum 48 months (1 year initial + 3 automatic 12-month renewals). Includes 10% contingency and price indexation. Possible negotiated increase up to 50% if envelope at risk.

Who Can Apply

Open to economic operators established in EU/EEA countries or those with EU Adequacy Decisions for data processing. Exclusions apply per Article 138 of Financial Regulation (e.g., bankruptcy, fraud). Joint tenders allowed; PIC registration required via Participant Register.

Economic and Financial Capacity

• Annual turnover >= €160,000 for each of last 3 years (2022-2024). Declaration on Honour (Section B); further proof may be requested.

Technical and Professional Capacity

• Organisation: Extensive experience in BI analyses (sequencing data, programming in Python/R, large datasets, reproducible workflows, molecular biology). List 3 relevant projects/publications (past 5 years).
• Team: 1 Bioinformatics expert (PhD + 10y exp. in allergenicity/toxicity/ORF/HGT/RNAi); 1 Molecular Biology/Bioinformatics expert (MSc + 5y exp.); 1 with 5y BI data management; 1 with 5y project coordination. CVs (EU format, no photos), confidentiality declarations, 1-page team summary.
• English: C1 level or equivalent (CVs).
• Declarations: Honour Sections B/C; environmental info (Annex 3).

No subcontracting allowed due to confidential data handling. AI use prohibited in tender/delivery without EFSA approval.

Scope of Work

Objective 1: BI Analysis Evaluation (Per GM Event)

1. 1Checklist for completeness/compliance/quality vs. guidelines (files, flanking regions, ORFs/NEPs vs. allergens/toxins, HGT, RNAi off-targets, databases/algorithms).
2. 2Interim report (10 working days): Issues/questions for applicants.
3. 3Review applicant replies; final report (6 working days post-reply).
4. 4Archive outcomes in searchable repository (e.g., Excel).
5. 5Annual report: Applications reviewed, issues, improvements (15 working days post-request).

Objective 2: BI Submission Refinements

After 12-24 months:Proposal to refine BI submission forms (Appendices H/F in EFSA 2021a/b) for clarity/harmonisation/usability (2 months post-request).

Meetings and Deliverables

• Kick-off (half-day teleconf, 1 month post-FWC).
• Annual interim (half-day).
• Ad-hoc (2h, ~1/application). Contractor minutes (1 week). No order forms for meetings.

Contract Structure and Payments

Single FWC (contractor premises, English). Implemented via Specific Contracts/Order Forms (5 working days to sign). Unit prices from Annex 1 template. No pre-financing/reimbursements. Interim payments (>6 months SC); balance post-final approval (90 days). Price revision via HICP index (year 2+).

Evaluation Criteria

Best price-quality:70% Quality + 30% (cheapest/offer price). Electronic submission via eSubmission (EU Login, PIC required; 2FA from June 2026).

Key Documents and Submission

• Invitation to Tender, Tender Specs (Annex I), Financial Template (Annex 1), Draft FWC (Annex 2), Confidentiality (Annex 4).
• Portal: EU Funding & Tenders Portal. TED: TED Notice.

Tenders in any EU language; max 200 files (<50MB each). Validity:9 months. Disputes: General Court EU. Governing law: EU/Italian.

Additional Considerations

• Strict confidentiality (BI data; personalised declarations; no AI).
• IPR: EFSA owns results; pre-existing rights licensed.
• Liability: Up to 3x SC value (unlimited for gross negligence/IPR).
• Checks/audits: 5 years post-final payment.

Prior contract (2022, EcoMole s.r.o.) indicates recurring need. Detailed specs essential for competitive pricing.