Novel strategy for allergenicity risk assessment of proteins in regulated food and feed products
Overview
The European Food Safety Authority (EFSA) invites tenders (reference EFSA/2026/OP/0010) for a single framework contract to develop a novel strategy for allergenicity risk assessment of proteins in food and feed, including open-source in silico prediction and appraisal tools, experimental validation, estimation of thresholds and a tiered decision-making framework. The total budget is €1,300,000 and the framework may run for up to 48 months, implemented through four specific contracts (SC1–SC4) with defined phase budgets. Eligible tenderers are economic operators established in eligible countries and must demonstrate financial capacity (minimum annual turnover €600,000 for 2022–2024) and technical experience in regulatory allergenicity assessment and in silico, in vitro and in vivo methodologies. Tenders must be submitted electronically via the EU Funding & Tenders Portal eSubmission by 23 June 2026 14:30 CEST and will be evaluated by best price-quality ratio.
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Highlights
What it funds
Overview
Open public tender (EFSA/2026/OP/0010) to develop a novel, regulatory-ready strategy for allergenicity risk assessment (RA) of proteins in food and feed. Work includes: development of open-source in silico prediction and appraisal tools for clinically relevant cross-reactivity and de novo sensitisation; curation of an allergen database; experimental in vitro and in vivo validation; estimation of thresholds of allergological concern; and a systematic tiered decision-making framework and training materials for EFSA and stakeholders.
Budget and duration:Estimated total value €1,300,000; framework up to 48 months. Specific contract/order form budgets: SC1 €160,000, SC2 €430,000, SC3 €430,000, SC4 €280,000. Apply and submit tenders electronically by 23 June 2026, 14:30 CEST 1.
Who can apply
Open procedure for economic operators established in eligible countries (EEA). Suitable applicants include research organisations, R&D consultancies, academic groups, SMEs and consortia with documented experience in allergenicity RA, in silico modelling, in vitro/in vivo testing and bioinformatics. Applicants must register in the Participant Register (PIC) and submit via eSubmission.
Key deliverables
- 1Inception report and literature review on in silico prospects
- 2Curated allergen database and benchmark datasets
- 3Open-source in silico tools for cross-reactivity and de novo sensitisation (code, container images, user guides)
- 4Experimental validation datasets (in vitro and in vivo) and tool validation reports
- 5Estimated thresholds of allergological concern and a tested tiered decision-making framework with training/dissemination materials
Practical notes
Submission is electronic via the Funding & Tenders Portal eSubmission system; EU Login (with 2-factor authentication) and a valid PIC are required. Award method: best price-quality ratio; contract type: single framework contract implemented by specific contracts/order forms. Maximum contract duration 48 months; award announced and documents available on the Portal.
| Phase / Specific Contract | Duration (months) / Max budget (EUR) |
|---|---|
| SC1 (Objective 1) | M1–M6 / 160,000 |
| SC2 (Objectives 2–4 Part I) | M7–M22 / 430,000 |
| SC3 (Objectives 2–4 Part II) | M23–M38 / 430,000 |
| SC4 (Objectives 4–5) | M39–M48 / 280,000 |
Footnotes
- 1Procurement documents, tender specifications, draft framework contract and electronic submission details are available on the Funding & Tenders Portal EU Funding & Tenders Portal.
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Breakdown
Basic tender facts
Tender reference EFSA/2026/OP/0010. Contracting authority:European Food Safety Authority (EFSA). Procedure type: open procedure for a single framework service contract. Nature of contract: services. CPV main classification: 73000000 Research and development services and related consultancy services. Estimated total value: €1 300 000. Maximum framework duration: up to 48 months (one year + renewals up to a maximum of four consecutive years as specified in the draft contract). Submission method: electronic only via the Funding & Tenders Portal eSubmission system. TED notice and supporting procurement documents published on the F&T Portal and TED. Deadline for receipt of tenders: 23 June 2026, 14:30 CEST. Virtual public opening session: 24 June 2026, 14:30 CEST. Contract award method: best price-quality ratio. Framework agreement: yes, framework agreement without reopening of competition. All procurement documents, invitation to tender, tender specifications and draft framework contract are published on the F&T Portal and form part of the procurement package. EFSA will not accept tenders submitted by any other means. See EFSA procurement pages and F&T Portal for documents and Q&A F&T Portal tender page.1
What EFSA is buying and project scope
Overall objective:support the development of a novel strategy for allergenicity risk assessment (RA) of proteins in food and feed. The work covers two complementary allergenicity mechanisms: clinically relevant IgE-mediated cross-reactivity to known allergens and de novo sensitisation (the potential of novel proteins to induce new allergies). The framework contract is structured in five specific objectives that collectively include methodology, tool development, experimental validation, threshold estimation and development of a systematic tiered decision-making approach with training and dissemination.
Objective 1:Overall methodological approach and a comprehensive literature review on future prospects for in silico tools, including an inception report describing the methodology for Objectives 2 to 5 and a literature review protocol and final review suitable for peer review publication.
Objective 2:Develop an open-source in silico prediction and appraisal tool for clinically‑relevant cross-reactivity. Components: an up-to-date curated allergen database ranked by clinical relevance; integrated analysis modules combining sequence homology, phylogenetics and structure prediction/similarity; an automated appraisal layer to support decision-making considering exposure, likelihood and clinical relevance; a user-friendly UI; containerised deployment (Docker/Apptainer/Singularity); source code published under an OSI-approved open-source licence (e.g., EUPL).
Objective 3:Develop an open-source in silico prediction and appraisal tool for de novo sensitisation. Components: modelling antigenic potential focusing on HLA binding and molecular patterns, integration of available allergenicity models, an automated appraisal layer and same technical and deployment standards as Objective 2. The specification recognises higher uncertainty and requires clear statement of limitations, performance targets and maintenance plans.
Objective 4:Generate experimental in vitro and in vivo human or animal data to validate the in silico predictions from Objectives 2 and 3. Deliver a validation plan, batched experimental datasets, predefined performance metrics and external user testing. In case of tool discrepancies, perform re-evaluation and fine-tuning.
Objective 5:Estimate thresholds of allergological concern for representative allergens (excluding application to allergen labelling exemptions) and develop a systematic tiered approach with decision-making criteria to integrate validated in silico predictions and thresholds into regulatory allergenicity RA. Deliver implementation guidelines, training/dissemination materials and support to EFSA for training development.
Tasks, deliverables, timeline and payment structure
The FWC is implemented using four specific contracts/order forms (SC1/OF1 to SC4/OF4). Each SC has defined tasks, interim deliverables and timelines. Maximum budgets per SC are specified and the total ceiling is €1 300 000. All deliverables must follow EFSA report templates and be in high-quality English.
- 1SC1/OF1 Month 1–6 Budget €160 000: Objective 1 tasks including inception report (draft M1, final M6) and literature review protocol (M1) and final literature review (M6) to be peer‑reviewed.
- 2SC2/OF2 Month 7–22 Budget €430 000: Develop allergen database, draft and final (M14 and M22), draft and final models for de novo sensitisation (M14 and M22), and first two experimental data batches (M14 and M22).
- 3SC3/OF3 Month 23–38 Budget €430 000: Prototypes and final in silico tools (cross-reactivity and de novo) including code and container images (M30 and M38), further experimental validation data batches (M30 and M38).
- 4SC4/OF4 Month 39–48 Budget €280 000: Final validation of in silico tools and user guides (M44), thresholds of allergological concern report (M44) and final systematic tiered approach deliverable plus dissemination/training materials (final report M48).
| Specific Contract | Duration | Main deliverables | Max budget EUR |
|---|---|---|---|
| SC1/OF1 | M1–M6 | Inception report; literature review protocol and final review | 160 000 |
| SC2/OF2 | M7–M22 | Allergen database; draft/final de novo models; batched experimental data | 430 000 |
| SC3/OF3 | M23–M38 | In silico tool prototypes and finalised code (containers); additional experimental batches | 430 000 |
| SC4/OF4 | M39–M48 | Validated tools and user guides; thresholds; final systematic tiered approach and training material | 280 000 |
Milestones include a kickoff meeting in Parma (or teleconference) within one month of FWC entry into force, interim teleconferences ahead of each interim deliverable and the virtual public opening of tenders. Payments are linked to EFSA approval of deliverables and the draft framework contract provides standard payment, invoice and approval timelines including EFSA’s 90-day payment target once documentation is approved. Subcontracting is allowed. A standard EFSA template format will be provided at kick-off for all reports.
Applicant and administrative eligibility
Eligible applicant types:Eligible tenderers: economic operators established in eligible countries (see Participant Register and F&T Portal). EFSA accepts single tenderers and joint offers; subcontractors are allowed. Officially eligible applicants include universities, research institutes, SMEs and large enterprises, non-profit research organisations and consortia formed by them. Tenderers must be established in countries permitted by the procurement rules and conform to rules on access to the EU market. Subcontractors established in third countries may be subject to data protection adequacy constraints. The procurement documentation requires registration in the Participant Register (PIC) and use of EU Login for submissions.
Minimum selection requirements:Economic and financial capacity: consolidated annual turnover of at least €600 000 in each of the last three closed financial years (2022–2024) for the tenderer (or evidence as accepted by contracting authority). Technical and professional capacity: demonstrable experience in allergenicity risk assessment, in silico, in vitro and in vivo allergenicity methods. Mandatory project team expertise: at least one expert with regulatory allergenicity RA experience including thresholds; at least one in in silico bioinformatics and computational modelling covering sequence homology, phylogenetics, 3D structure prediction and ML-based allergenicity tools; at least one with in vitro allergenicity testing experience; at least one with in vivo allergenicity testing experience; at least one with expertise in literature review/systematic review methods. Evidence requested: three relevant projects or scientific publications in the last five years and detailed CVs for proposed team members. English proficiency: experts must have excellent written and spoken English evidenced by C1 certificate or equivalent experience/publications.
Evaluation and award
Evaluation comprises exclusion checks, compliance with tender specifications, selection criteria and award criteria. EFSA will check exclusion grounds (debarment/financial regulation grounds) and may request additional evidence during evaluation. Offers will be assessed for compliance before quality evaluation.
Award (quality and price) criteria and scoring:Quality criteria total 100 points. Minimum thresholds: at least 70% score for Award criterion 1 (Methodology) and at least 70% overall on quality criteria to pass. Quality subcriteria include: methodology for Objectives 1–5 (70 points across items a–f), project organisation and communication (20 points), and risk management and quality assurance (10 points). Price: only tenders within the maximum budget and satisfying formal requirements proceed. Final ranking uses a best price-quality ratio formula combining price (30%) and quality (70%).
Administrative and submission requirements
Tenders must be submitted exclusively via eSubmission. Tenderers must register in the Participant Register and obtain a PIC. EFSA requires signed Declarations on Honour: Section A (exclusion), Section B (selection), Section C (professional conflicts). Tender documents must include a technical offer addressing all technical specifications and award criteria and a financial offer using the provided financial template. Maximum file attachment rules and technical requirements of eSubmission apply. EFSA F&T Portal subscription is recommended to receive call updates and Q&A. Tenderers must respect system and file naming requirements and EU Login 2‑factor authentication rules if applicable.
Submission support and deadlines:Electronic submission address: eSubmission via F&T Portal. Deadline for clarifications: 15 June 2026 23:59 CEST. Deadline for tenders: 23 June 2026 14:30 CEST. Contract signature estimated September 2026. Tenderers should register and test eSubmission well before the deadline and follow the published eSubmission quick guide and system requirements. EFSA will not accept tenders submitted after the deadline; the eSubmission timestamp is the proof of timely submission.
Legal, IP, data protection and contractual obligations
Draft framework contract is published as part of the procurement package. Key contractual points: EFSA acquires ownership of results and intellectual property rights arising from work done under the contract. Pre-existing materials must be clearly identified in the tender and a declaration provided at final invoicing; for any incorporated pre-existing rights, the tenderer must secure and document licence rights allowing EFSA full use and dissemination as described in the draft contract. Contractor remains fully liable for third-party rights and for ensuring licensing and permissions for any third-party content used in deliverables. Personal data processing must comply with Regulation (EU) 2018/1725; contractors acting as processors must implement appropriate technical and organisational measures. Confidentiality obligations apply; EFSA will redact commercially confidential content when legally required. EFSA has an Anti-Fraud Strategy and auditing rights. The contractor must support checks, audits and possible OLAF actions up to five years after final payment.
Technical and IT requirements for in silico tools, code and data
All in silico code must follow software best practices, be well documented, testable and containerised (Docker/Apptainer/Singularity). Preferred languages: R, Python, Java/JavaScript, C/C++/C#, Nextflow, shell scripting, SQL as applicable. Source code must be released under an OSI-approved open-source licence (suggested EUPL). Tool interfaces must be user-friendly, implement security measures and scalable configuration. The tender must include maintenance and curation plans and identify which parts of the system will require updates. Security guidance of the platform vendor must be respected and deviations documented and agreed with EFSA Information Security Officer. EFSA may require signing subscription agreements for third-party tools at EFSA’s discretion and cost-free to EFSA, subject to compliance with EFSA data protection requirements.
Evaluation and award logistics
Evaluation order:exclusion checks, compliance with tender specifications, selection criteria, quality evaluation and price check. EFSA reserves the right to request clarifications, missing documents or confirmatory evidence. Tenderers will be notified of outcomes via the email address in their eSubmission record. Tenderers may request to attend the virtual opening and must follow the Invitation to Tender procedure for registration to attend. The Contracting Authority is not bound to reply to clarifications submitted after the deadline for questions.
- Key documents published on the F&T Portal: Invitation to tender letter, Tender Specifications, Draft Framework Contract and Annexes.
- Tenderers must use EFSA templates where requested and follow EFSA reporting formats.
- All deliverables to be provided in English and of a high editorial quality.
- Subcontracting allowed but lead contractor remains fully responsible.
Answers to standard classification questions
Eligible Applicant Types:Eligible applicant types are organisations established in eligible countries and able to comply with EU procurement rules and EFSA access-to-market rules. Practical eligible applicants include: universities, public research institutes, non-profit research organisations, independent research laboratories, SMEs and large enterprises with relevant capabilities, consortia and public-private partnerships formed by the above. Individual natural persons are not eligible to receive the FWC as sole contractors; however individuals may be proposed as experts within a tendering organisation's team. Subcontractors may be used but must be declared and meet relevant selection rules. All entities must register in the Participant Register and supply PICs where requested.
Funding Type:This procurement uses a service contract framework agreement mechanism. The primary financial mechanism is a public procurement award of a framework service contract with specific contracts/order forms executed under the FWC. The contracting authority pays for services provided under specific contracts.
Consortium Requirement:Consortium or single applicant allowed. The tender accepts single tenderers and joint offers (consortium). If submitting as a consortium, a lead partner must be appointed and declarations must be provided for each partner. Selection and capacity evidence must be provided for each partner if their capacity is used to meet minimum selection requirements. Joint tenders are jointly and severally liable unless national law prevents joint liability; in such cases EFSA may accept evidence of limited liability with legal justification.
Beneficiary Scope (Geographic Eligibility):Geographic eligibility: bidders established in countries eligible under the F&T Portal procurement rules may apply. The contracting authority is an EU agency based in Italy and procurement is open to economic operators established in the European Economic Area and other countries allowed by procurement rules. Tenderers should consult the Invitation to Tender and the EFSA Guidance for Tenderers for detailed lists and Participant Register requirements.
Target Sector:The thematic sector is health/food safety/biotechnology and regulatory science. More specifically: allergenicity risk assessment, food/feed safety, computational biology/bioinformatics, immunology, toxicology, in vitro and in vivo allergenicity testing, regulatory risk assessment for GM or novel foods, and software/tool development for regulatory use (DeepTech, bioinformatics, machine learning in allergenicity prediction).
Mentioned Countries:The tender is published by EFSA, an EU agency based in Parma, Italy. No specific list of countries for bidders is printed in the summary beyond the usual procurement eligibility rules; the eligible geography is the European Economic Area and other countries allowed by EU procurement rules. The contracting authority location: Italy (Parma).
Project Stage:Expected project maturity: development through to validation and demonstration. The work encompasses literature review and methodology definition (research), development of in silico tools (development), experimental validation (validation/demonstration), and preparation of a tiered decision framework with training materials and implementation guidance (demonstration/ready-for-regulatory uptake). Commercialisation is not the primary objective; emphasis is on regulatory utility and open-source release.
Funding Amount:Total estimated framework value: €1 300 000. Indicative maximum budgets per specific contract: SC1 €160 000; SC2 €430 000; SC3 €430 000; SC4 €280 000. Tenderers must submit a single all-inclusive total price (EUR) for evaluation using the provided financial template not exceeding the overall ceiling. Amounts exclude VAT where applicable.
Application Type:Open procedure with published tender documents on the F&T Portal. Submission method: open call through the eSubmission electronic system. Not invitation-only. Questions may be submitted via the Portal Q&A tab by registered EU Login users before the clarifications deadline.
Nature of Support:Monetary support: payment for services under a public procurement contract. Non-monetary services: delivery of tools, datasets, documentation, training materials and support for training development. EFSA will acquire ownership of results and will publish outputs in EFSA repositories where appropriate.
Application Stages:The procurement evaluation follows these stages: 1) formal eligibility and exclusion checks; 2) compliance with tender specification review; 3) selection criteria evaluation (economic, financial, technical capacity); 4) quality assessment against award criteria; 5) price check and best price-quality selection and award. Practically applicants pass through up to five administrative/evaluation stages as indicated.
Success Rates:Not specified in documentation. EFSA procurement open procedures are competitive; success rates depend on number and quality of offers. No historical success rate is provided in the tender documents.
Co-funding Requirement:Co-funding: Not required beyond the all-inclusive priced offer. Tenderers must provide an all-inclusive price. The draft contract contemplates possible additional repeat services via negotiated procedure up to 50% of the initial envelope but that is at EFSA discretion and does not require co-funding by the contractor.
Templates and application structure:Required application documents and templates are published with the tender. Tenderers must include: administrative forms and Business Partner Form; signed Declarations on Honour (sections A, B, C) using EFSA templates; detailed technical offer addressing each objective and award criteria; CVs for proposed experts (EU CV format recommended); evidence of selection criteria (3 projects/publications in last 5 years); a financial offer using the Annex 1 Financial Offer Template. A draft framework contract and model specific contract and order forms are provided. All deliverables must follow EFSA reporting templates that will be issued at kick-off. The technical offer must include methodology, staff assignment, GANTT chart, risk register and quality assurance plan. If AI systems/models are used the tender must include an AI description, risk management, human oversight and compliance information as specified in tender specifications.
- 1Administrative forms and Business Partner Form: complete and signed.
- 2Declarations on Honour: Sections A, B and C signed and scanned where required.
- 3Technical offer: methodology, team, GANTT, QA, risk management, compliance with objectives and tool specifications.
- 4CVs: detailed CVs of team members evidencing selection criteria and English proficiency evidence where required.
- 5Evidence of technical capacity: access to databases, container and code management platforms confirmation.
- 6Financial offer: completed Annex 1 financial template and all-inclusive totals not exceeding tender ceilings.
- 7Any proposed subcontracting should be clearly identified and justified.
All documents must be uploaded via eSubmission before the deadline. Tenderers should ensure compliance with file size and format requirements and follow the eSubmission Quick Guide. Tenderers registering for the F&T Portal should enable EU Login 2-factor authentication when required by June 2026 system changes; EFSA reminds bidders to ensure their EU Login accounts are up to date and have required two-factor authentication configured as the Portal will require it for submissions.
How to prepare a competitive tender — technical advice
High scoring proposals will have:a clear and justified methodological approach tailored to each objective, realistic and detailed workplan with milestones and resource allocation, an experienced multidisciplinary team meeting the mandatory expertise requirements, practical quality assurance, reproducible open-source code and containerised deliverables, strong validation plans with experimental design and ethical/QA considerations, a realistic plan for curation and long-term maintenance of datasets and code, clear exploitation and dissemination plans including training materials, and robust risk identification and mitigation measures. Proposals using AI must include compliance statements and human oversight arrangements as required by the tender.
Summary and explanation
What is this opportunity about and how to explain it:EFSA invites tenders to contract a comprehensive programme to develop and validate a new regulatory-ready strategy for assessing protein allergenicity in food and feed. The work integrates state-of-the-art in silico tool development, open-source code release, curated allergen databases, experimental validation, estimation of thresholds of allergological concern and production of a systematic tiered decision framework and training materials. The contract is structured as a framework agreement implemented through sequential specific contracts over up to 48 months with an overall ceiling of €1.3 million. Applicants should be multidisciplinary teams with computational biology, immunology, in vitro/in vivo allergenicity experience and regulatory expertise. The procurement is an open electronic procedure; offers must be submitted through the F&T Portal within the deadline and meet all administrative, selection and award requirements. Successful bidders will deliver reproducible open-source tools, validated experimental datasets, threshold analyses and a tiered approach to support EFSA’s allergenicity risk assessment and regulatory decision-making. The outputs will be owned by EFSA and published or archived in EFSA repositories following contractual provisions.
Footnotes
- 1Procurement documents and the tender dossier are available on the F&T Portal Tender Details page: Tender details EFSA/2026/OP/0010
Short Summary
Impact Develop and validate a regulatory-ready, harmonised strategy (tools, databases, thresholds and decision framework) that improves the reliability, speed and transparency of allergenicity risk assessment for proteins in food and feed. | Impact | Develop and validate a regulatory-ready, harmonised strategy (tools, databases, thresholds and decision framework) that improves the reliability, speed and transparency of allergenicity risk assessment for proteins in food and feed. |
Applicant A multidisciplinary team with demonstrated expertise in regulatory allergenicity risk assessment, bioinformatics/in silico modelling (including HLA and ML methods), in vitro and in vivo allergenicity testing, systematic literature review, and experience delivering containerised open-source software and validated experimental datasets. | Applicant | A multidisciplinary team with demonstrated expertise in regulatory allergenicity risk assessment, bioinformatics/in silico modelling (including HLA and ML methods), in vitro and in vivo allergenicity testing, systematic literature review, and experience delivering containerised open-source software and validated experimental datasets. |
Developments Creation and open-source release of curated allergen databases and containerised in silico tools for clinically relevant cross-reactivity and de novo sensitisation, generation of experimental validation datasets (in vitro and in vivo), and estimation of thresholds to support a tiered decision-making framework and training materials. | Developments | Creation and open-source release of curated allergen databases and containerised in silico tools for clinically relevant cross-reactivity and de novo sensitisation, generation of experimental validation datasets (in vitro and in vivo), and estimation of thresholds to support a tiered decision-making framework and training materials. |
Applicant Type Researchers (research organisations and R&D consultancies) and profit SMEs/startups with the required multidisciplinary regulatory, computational and laboratory capabilities. | Applicant Type | Researchers (research organisations and R&D consultancies) and profit SMEs/startups with the required multidisciplinary regulatory, computational and laboratory capabilities. |
Consortium Single applicants or joint offers are allowed; consortiums/joint tenders may apply but are not mandatory. | Consortium | Single applicants or joint offers are allowed; consortiums/joint tenders may apply but are not mandatory. |
Funding Amount Total framework ceiling €1,300,000 with maximum allotments per phase:SC1 €160,000, SC2 €430,000, SC3 €430,000, SC4 €280,000. | Funding Amount | Total framework ceiling €1,300,000 with maximum allotments per phase:SC1 €160,000, SC2 €430,000, SC3 €430,000, SC4 €280,000. |
Countries Bidders must be established in countries eligible under EU procurement rules (EEA and other F&T Portal‑eligible countries) and comply with EU access-to-market and data-protection requirements. | Countries | Bidders must be established in countries eligible under EU procurement rules (EEA and other F&T Portal‑eligible countries) and comply with EU access-to-market and data-protection requirements. |
Industry Health / food safety / regulatory science (allergenicity risk assessment, computational biology/bioinformatics and immunotoxicology). | Industry | Health / food safety / regulatory science (allergenicity risk assessment, computational biology/bioinformatics and immunotoxicology). |
Additional Web Data
Funding Opportunity Overview
The European Food Safety Authority (EFSA) is seeking support for the development of a novel strategy for allergenicity risk assessment of proteins in food and feed products. This framework contract aims to enhance the reliability, speed, and harmonisation of allergenicity risk assessment through the development of open-source in silico prediction tools, experimental validation, and a systematic tiered approach with decision-making framework.
Opportunity Details
Contracting Authority:European Food Safety Authority (EFSA), based in Parma, Italy
Procedure Type:Open call for framework contract (single FWC) without reopening of competition
Reference Number:EFSA/2026/OP/0010
Total Budget:€1,300,000 for the entire framework contract period
Contract Duration:48 months (one year plus automatic renewal up to three times for an overall maximum of four consecutive years)
Key Deadlines
- Deadline for clarification requests: 15 June 2026 at 23:59 (CEST)
- Deadline for tender submission: 23 June 2026 at 14:30 (CEST)
- Virtual tender opening: 24 June 2026 at 14:30 (CEST)
- Estimated notification of results: August 2026
- Estimated contract signature: September 2026
Project Objectives and Scope
The project comprises five interconnected objectives spanning 48 months. The contractor must develop a comprehensive novel strategy for allergenicity risk assessment addressing both clinically-relevant cross-reactivity and de novo sensitisation. The work integrates methodological development, tool creation, experimental validation, and practical implementation guidance.
Objective 1: Methodological Approach and Literature Review (Months 1-6)
Development of an inception report detailing the methodological approach for all project objectives, and a comprehensive literature review on future prospects of in silico prediction tools, considering factors such as protein digestibility, food matrix, and processing effects on allergenic potential. The literature review must be published in a peer-reviewed journal.
Objective 2: In Silico Tool for Cross-Reactivity (Months 7-38)
Development of an open-source in silico prediction and appraisal tool for clinically-relevant cross-reactivity assessment. The tool must include an up-to-date curated allergen database ranked by clinical relevance, integrated phylogenetics and sequence homology analysis, and automated appraisal features. Technology must use license-free open-source programming languages (R, Python, Java/Javascript, C/C++/C#, Nextflow, shell scripting, SQL) and run in Docker, Apptainer, or Singularity containers.
Objective 3: In Silico Tool for De Novo Sensitisation (Months 7-38)
Development of an open-source in silico tool for predicting and appraising de novo sensitisation (probability of new, clinically relevant allergies). The tool must model antigenic potential based on Human Leukocyte Antigen (HLA) binding capacity and other sensitisation indicators, with automated appraisal features and performance metrics. The contractor must acknowledge that higher uncertainty exists for de novo sensitisation predictions compared to cross-reactivity predictions.
Objective 4: Validation of In Silico Predictions (Months 7-44)
Generation of experimental in vitro and in vivo data (including skin prick tests and oral food challenges) for validation of both cross-reactivity and de novo sensitisation predictions. The validation process must include testing scenarios, predefined performance assessment criteria, external user testing, and fine-tuning of tools based on discrepancies between predictions and experimental results.
Objective 5: Thresholds and Systematic Tiered Approach (Months 39-48)
Estimation of thresholds of allergological concern for both cross-reactivity and de novo sensitisation, and development of a systematic tiered approach with decision-making framework. The contractor must provide implementation guidelines and comprehensive dissemination and training materials for EFSA staff, experts, and stakeholders, with support for training delivery by other contractors.
Budget Allocation by Phase
| Specific Contract/Order Form | Duration | Maximum Budget | Objectives |
|---|---|---|---|
| SC1/OF1 | 6 months (M1-M6) | €160,000 | Objective 1 |
| SC2/OF2 | 16 months (M7-M22) | €430,000 | Objectives 2-4 |
| SC3/OF3 | 16 months (M23-M38) | €430,000 | Objectives 2-4 |
| SC4/OF4 | 10 months (M39-M48) | €280,000 | Objectives 4-5 |
Eligibility and Selection Criteria
Access to EU Market
Tenderers (single or joint tender partners) must be established in eligible countries. Subcontractors not compliant with access to market rules must be established only in countries subject to an Adequacy Decision for personal data protection. Tenderers must not be subject to EU restrictive measures.
Economic and Financial Capacity
Tenderers must have generated an overall annual turnover of at least €600,000 in each of the last three closed financial years (2022, 2023, and 2024). Evidence must be provided through a signed Declaration on Honour, with EFSA retaining the right to request further proof of annual turnover.
Technical and Professional Capacity
Tenderers must demonstrate extensive and demonstrable experience in regulatory allergenicity risk assessment of proteins in food and feed, including expertise on thresholds of allergological concern, and in in silico, in vitro, and in vivo methodologies for allergenicity assessment. Evidence must include three relevant scientific projects (minimum six months duration) or published scientific articles from the past five years.
Required Team Expertise
The contractor must provide a team of scientists meeting the following minimum expertise requirements, each demonstrated through three relevant scientific projects or publications from the past five years:
- At least one scientist with professional experience in regulatory allergenicity risk assessment of proteins in food and feed, including expertise on thresholds of allergological concern
- At least one scientist with professional experience in in silico methodologies for allergenicity assessment, with broad knowledge of bioinformatic and computational approaches including sequence homology analysis, phylogenetic analysis, 3D structural modelling, machine learning-based allergen prediction tools, HLA binding prediction models, and scripting languages (Python, R), machine learning algorithms, and containerisation technologies
- At least one scientist with professional experience in in vitro methodologies for allergenicity assessment of proteins in food and feed
- At least one scientist with professional experience in in vivo methodologies for allergenicity assessment of proteins in food and feed
- At least one scientist with professional experience in intelligence gathering such as systematic literature review
Language Requirements
All proposed team members must have an excellent level of spoken and written English. Non-native speakers must demonstrate this through an official C1 level English certificate, at least three years of work in an English-speaking environment, or proof of co-authorship of at least five scientific publications and/or reports in English.
Technical Infrastructure Requirements
Tenderers must have access to at least three multidisciplinary and biomedical bibliographic databases (such as Web of Science, Scopus, PubMed, Embase), a reference manager software compatible with EndNote20, license-free open-source programming languages (R, Python, Java/Javascript, C/C++/C#, Nextflow, shell scripting, SQL), Docker/Apptainer/Singularity containers, and code versioning and tracking platforms (such as Azure DevOps or GitHub).
Award Criteria and Evaluation
Tenders will be evaluated based on the best price-quality ratio using the following formula: Total Score = 30 multiplied by (Cheapest price offer divided by tender price) plus 70 multiplied by (Total quality score divided by 100). Tenders must achieve at least 70 percent on the methodology criterion and at least 70 percent of the maximum possible total points on quality criteria to proceed to price evaluation.
Quality Award Criteria (100 points maximum)
- Methodology Proposed for Implementation (70 points, minimum threshold 70 percent): Detailed descriptions of proposed strategy and methodology for each objective, including inception report and literature review (5 points), cross-reactivity tool development (15 points), de novo sensitisation tool development (15 points), experimental validation (15 points), thresholds and tiered approach (15 points), and dissemination and training materials (5 points)
- Project Organisation (20 points): Overall project planning clarity with GANTT chart and task distribution (10 points), and internal team communication and EFSA communication plans (10 points)
- Risk Management and Quality of Deliverables (10 points): Risk identification and mitigation actions (5 points), and measures to ensure deadline and quality compliance (5 points)
Submission Requirements
All tenders must be submitted electronically via the eSubmission system accessible from the EU Funding and Tenders Portal. Tenderers must register in the Participant Register to obtain a Participant Identification Code (PIC). Submissions must include signed Declarations on Honour (sections A, B, and C), technical tender addressing all requirements, and financial tender with complete price breakdown.
Submission Address:eSubmission Portal
Procurement Documents:EU Funding and Tenders Portal
Key Contractual Conditions
The contract will be a framework agreement with specific contracts or order forms. EFSA acquires ownership of all results and intellectual property rights on newly created materials. The contractor must ensure all pre-existing rights are properly licensed to EFSA. All deliverables will be published on EFSA's Knowledge Junction repository on Zenodo. The contractor must comply with Regulation (EU) 2018/1725 on personal data protection and Regulation (EU) 2024/1689 (AI Act) if using artificial intelligence systems.
Important Considerations for Applicants
- The current strategy for allergenicity risk assessment relies on 2003 Codex Alimentarius guidelines and requires updating to align with state-of-the-art scientific advances
- EFSA has previously funded related research including work on ranking clinical relevance of allergen molecules and assessing in silico tools, which serves as the scientific basis for this project
- Subcontracting is allowed for all tasks, but the contractor remains solely responsible for implementation
- All working language for contract implementation, meetings, and deliverables must be English at a high standard requiring no proofreading
- Tenderers must clearly indicate if Large Language Models such as ChatGPT were used in tender preparation
- If AI systems are proposed for service delivery, detailed information on purpose, added value, risks, and mitigation measures must be provided
- The contractor must support training delivery by other EFSA-appointed contractors through provision of subject-matter input and content validation
- Environmental management information must be provided but will not be considered under selection or award criteria
Contact Information
EFSA Procurement Team:Email: efsaprocurement@efsa.europa.eu
EFSA Website:EFSA
For technical support on eSubmission, contact the eSubmission support team from 08:00 to 20:00 CET at ec-funding-tender-service-desk@ec.europa.eu
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