Preparatory support for the evaluation of toxicity studies supporting the GM food and feed safety assessment.

The European Food Safety Authority (EFSA) intends to launch a planned negotiated procedure (EFSA/2026/MVP/0015-EXA) to establish a middle/low value framework agreement (estimated total value €120,000; maximum duration 24 months) for preparatory evaluations of in vivo toxicity studies submitted in GM plant food and feed authorisation dossiers. The contractor will assess experimental design and statistical analysis of primarily 90-day and 28-day rodent oral toxicity studies, identify deviations from EU regulatory requirements and EFSA guidance, formulate clarification questions and verify applicant responses, with an estimated output of approximately 20 reports per year. Expressions of interest open 16 April 2026 and close 16 May 2026 with submissions required via EU Login on the EU Funding & Tenders Portal, and all work must be delivered in English. Full tender specifications will be published on the launch date of the negotiated procedure on the Funding & Tenders Portal.

Opportunity summary

What is being procured

Contracted experts will review each in vivo toxicity study (primarily 90-day and 28-day rodent oral studies and additional case-by-case studies) to evaluate overall experimental design and statistical analysis versus EU regulatory requirements and EFSA guidance. Reviews must identify deviations, data gaps, inconsistencies or uncertainties, formulate clarification questions for applicants and verify responses.

Who can apply:Organisations (single tenderers or consortia) with extensive, verifiable experience in scientific evaluation of regulatory in vivo toxicity studies and relevant statistical methodologies; familiarity with OECD test guidelines, GLP principles and EFSA/GMO guidance; English-language capacity for team members.

1. 1Planned negotiated procedure for middle/low value contract (framework agreement).
2. 2Lead contracting authority: European Food Safety Authority (EFSA).

Language for the assignment:English. Submissions of expression of interest are electronic via EU Login. This publication is an advance notice of intent to launch a future negotiated procedure; full tender specifications will be published at call launch EU Funding & Tenders Portal. ¹

Footnotes

1. 1Full procedure details, tender specifications and submission instructions will be available on the EU Funding & Tenders Portal at the procedure identifier link above.

Opportunity summary

Type:Tender. Contracting authority: European Food Safety Authority (EFSA). Procedure identifier: EFSA/2026/MVP/0015-EXA. Procedure type: Planned negotiated procedure for middle/low value contract. Nature of contract: services. Main classification (CPV): 73000000 - Research and development services and related consultancy services. Estimated total value: €120 000. Maximum contract duration: 24 months. Framework agreement: yes, framework agreement without reopening of competition. Language of implementation: English.

Purpose and background

EFSA requires external preparatory scientific support to evaluate in vivo toxicity studies submitted in applications for authorisation of genetically modified (GM) plants for food and feed uses in the EU. Applicants normally submit 90-day repeated-dose oral toxicity studies in rodents performed with whole GM food/feed; 28-day studies may be submitted for newly expressed proteins or newly produced compounds; additional studies may be requested case-by-case. The Nutrition and Food Innovation Unit supports the GMO Panel and seeks to outsource part of the preliminary verification activities for compliance with EU regulatory requirements, OECD guidelines, Good Laboratory Practice and EFSA guidance documents.

Objectives and scope of work

For each in vivo toxicity study received, the Contractor shall evaluate the adequacy of the overall experimental design and the statistical analysis methodology in relation to applicable EU regulatory requirements and EFSA guidance. The evaluation must: identify deviations from applicable requirements; identify data gaps, inconsistencies and uncertainties; formulate clear questions for the applicant where clarifications are needed; verify whether applicant responses have adequately addressed issues and highlight any remaining outstanding points. The estimated deliverable volume is approximately 20 reports per year.

Tasks to be performed (summary)

1. 1Scientific evaluation of experimental design for each in vivo toxicity study (e.g., sample size, randomisation, dose groups, control selection, study duration).
2. 2Review and assessment of statistical analysis methodologies applied in the studies (e.g., statistical tests, handling of missing data, multiplicity adjustments, assumptions checks).
3. 3Verification of compliance with applicable EU regulatory framework, OECD guidelines and EFSA guidance documents.
4. 4Identification and documentation of deviations, data gaps, inconsistencies and uncertainties in study design and analyses.
5. 5Preparation of clear questions for applicants requesting clarification or additional information.
6. 6Verification of applicant responses and identification of any remaining outstanding issues.
7. 7Production of approximately twenty evaluation reports per year (deliverables).

Professional and organisational requirements

Tenderers must demonstrate extensive and verifiable experience in:scientific evaluation of in vivo regulatory toxicity studies; statistical analysis methodologies applied to such studies; and familiarity with the applicable regulatory framework and guidance relevant to toxicity studies supporting GM food and feed safety assessments. The Tenderer must ensure adequate resourcing to fully cover the tasks described in the forthcoming tender specifications. Team members must demonstrate adequate English proficiency for execution of the assignment.

Guidance documents and test guidelines (non-exhaustive list):OECD Principles of Good Laboratory Practice (1998); OECD Test Guideline 407 (1998); OECD Test Guideline 408 (1998, 2018, 2025); EFSA Scientific Committee, 2011, Guidance on conducting repeated-dose 90-day oral toxicity studies in rodents on whole food/feed; EFSA, 2014, Explanatory statement on applicability of the EFSA Scientific Committee (2011) guidance for GMO risk assessment; EFSA GMO Panel (2011), Guidance for risk assessment of food and feed from genetically modified plants; Regulation (EU) No 503/2013 – Annex II, Section 1.4 (Toxicology); Directive 2004/10/EC regarding principles of Good Laboratory Practice and verification for chemical tests.

Eligibility and who should apply

Eligible tenderers are organisations (single legal entities or consortia as defined in the tender specifications) capable of delivering expert scientific reviews and statistical assessments of in vivo toxicity studies under EU regulatory frameworks. Suitable applicant types include: universities, research institutes, contract research organisations (CROs) with regulatory evaluation experience, consultancies with toxicology and biostatistics expertise, nonprofit scientific organisations, and large enterprises or SMEs with demonstrable relevant track records. Individual experts may be part of a tendering organisation or consortium but contracting is with the legal entity. The tender specifications published at launch will clarify formal eligibility rules and any restrictions.

Detailed categorisation (answered questions)

The following structured answers extract and categorise all key administrative, eligibility and operational aspects of the opportunity.

Eligible Applicant Types:Universities; research institutes; contract research organisations (CROs); SMEs and large enterprises active in regulatory toxicology and biostatistics; nonprofit scientific organisations; consultancies specialising in toxicology and statistical analysis; public research bodies. Consortia of the above are likely permissible pending the tender specifications.

Funding Type:Procurement service contract (purchase of services). This is not a grant, loan or equity instrument. The authority will contract a supplier for services through a negotiated procedure.

Consortium Requirement:Other: The announcement does not mandate a consortium; it indicates tenderers (single organisations) must demonstrate capacity. The tender specifications may allow or require consortia; therefore both single legal entities and consortia should prepare availability and consortia arrangements. Final requirement will be in the tender documents.

Beneficiary Scope (Geographic Eligibility):EU-wide procurement by EFSA. Tenderers established in EU Member States are the primary target. As an EU contracting authority, EFSA procurement rules typically allow economic operators established in EU Member States and possibly in EEA/EU-associated countries in accordance with procurement rules; exact geographical eligibility will be defined in the tender specifications and applicable procurement regulations.

Target Sector:Health and safety assessment; food safety; regulatory toxicology; biotechnology (GM crops); statistical analysis and study design evaluation. Cross-cutting sectors include laboratory studies compliance (GLP), regulatory affairs and risk assessment.

Mentioned Countries:European Union (EU) is explicitly mentioned. No individual Member States are named in the announcement.

Project Stage:Implementation/operational service delivery: evaluation of completed or submitted in vivo toxicity studies. This is a review/evaluation stage (validation and verification) rather than research or product development.

Funding Amount:Estimated total value €120 000 for the framework agreement. The planned contract duration is up to 24 months. The remuneration model (e.g., per-deliverable rates) and distribution across the contract period will be specified in the tender documents.

Application Type:Expression of interest followed by a negotiated procedure. The announcement is an ex ante publicity; the contracting authority intends to launch a future negotiated low or middle value procedure. Expressions of interest must be submitted electronically via EU Login by the stated deadline.

Nature of Support:Money in the form of payment for contracted services. Beneficiaries will be remunerated under a service contract (procurement). Non-monetary outcomes include specification of issues to applicants and delivery of scientific evaluation reports.

Application Stages:Two-stage flow expected: 1) Expression of interest (electronic submission via EU Login within the published window). 2) Participation in the negotiated procedure (submission of tender documents as requested). The negotiated procedure itself may include evaluation and possible clarifications. Exact number of formal selection stages and evaluation steps will be detailed in the tender specifications and contract notice.

Success Rates:Not provided. For a negotiated low/middle value procedure with a single or limited number of awards, success rates depend on number of applicants and the contracting authority’s evaluation; cannot be estimated from the published notice.

Co-funding Requirement:No co-funding is indicated or expected. This is a procurement of services where EFSA pays for delivered services. Tenderers should absorb any proposal preparation costs; contract financing and payment terms will be included in tender documents.

Milestones and administrative deadlines

How to express interest and submit

Expressions of interest must be submitted electronically via the Funding & Tenders Portal. An EU Login account is required for electronic submission and as of 30 June 2026 two-factor authentication will be mandatory for EU Login access; tenderers should ensure their accounts are operational and secure. Submissions must be sent exclusively to the address for submission indicated in the Portal and follow the format required in the forthcoming tender specifications.

Method of submission:Electronic via EU Login / Funding & Tenders Portal. Ensure compliance with two-factor authentication requirements and register devices or keys as needed before deadlines. The announcement emphasises that this is an intention notice and not yet a full invitation to tender.

Deliverables and expected outputs

Estimated deliverables:approximately 20 evaluation reports per year. Each deliverable report should: evaluate experimental design adequacy and statistical methodology; document deviations from regulatory requirements and guidance; list data gaps, inconsistencies and uncertainties; include applicant questions requesting clarifications; include verification of applicant responses and note unresolved issues. Format, templates, deadlines and quality criteria for reports will be provided in the tender specifications.

Suggested application structure and templates (what to prepare)

The tender specifications will publish formal templates. Based on the announcement and standard EFSA procurement practice, tenderers should prepare the following materials for submission: capability and competence statements; curricula vitae of key experts demonstrating experience in regulatory toxicology and statistics; examples of previous evaluation reports of in vivo toxicity studies (redacted if needed); methodological approach describing how study evaluations and statistical reviews will be conducted; quality assurance and management procedures; staffing plan and resourcing to meet estimated deliverable volumes; pricing model and rates per deliverable/hour; declarations of compliance with GLP/OECD/EFSA guidance knowledge; evidence of legal and financial capacity; and any required administrative forms.

1. 1Technical proposal describing evaluation methodology, workflow, timelines and quality control.
2. 2Team composition and CVs demonstrating experience in toxicology and biostatistics.
3. 3Organisational capacity statement and evidence of previous similar contracts or work.
4. 4Sample evaluation report(s) or redacted case studies of previous toxicity study assessments.
5. 5Price proposal consistent with tender specifications and deliverable estimates.
6. 6Administrative and legal documents as required by the tender (registration, declarations, insurances).

Evaluation criteria and expectations

The announcement emphasises that tenderers must demonstrate extensive and verifiable experience in scientific evaluation of in vivo regulatory toxicity studies and statistical methodologies. Evaluation under the negotiated procedure will assess technical competence, methodological approach, quality assurance, capacity to deliver the estimated number of reports, and price. Familiarity with OECD test guidelines, GLP, specific EFSA and GMO guidance, and Regulation (EU) No 503/2013 are explicit expectations.

Contract management and duration

The framework agreement has a maximum duration of 24 months. The framework is without reopening of competition, meaning selected suppliers under the framework may be awarded individual contracts or tasks during the term. Specific contracting and payment schedules will be provided in the tender documents and contract.

Key risks and considerations for applicants

• Prepare demonstrable evidence of regulatory evaluation experience and statistical expertise; EFSA will require verifiable records.
• Plan resourcing to sustain delivery of ~20 reports/year and possible peak workloads.
• Ensure team members have high-level English proficiency for report writing and communication.
• Confirm organisational policies on confidentiality, data protection and handling of potentially confidential study reports.
• Register and test EU Login accounts and two-factor authentication well ahead of submission deadlines.

EFSA emphasises compliance with regulatory documents and guidance listed in this announcement; tenderers should align methodologies and reporting templates to those references and be ready to cite them when justifying evaluations. ¹

Summary: what this opportunity is about and explanation

This opportunity is a planned EFSA procurement to contract expert scientific services to perform preparatory evaluations of in vivo toxicity studies submitted within GM plant food and feed authorisation dossiers. The contract will commission specialists to review experimental designs and statistical analysis methods of submitted 90-day and 28-day rodent studies and any additional requested toxicity studies, ensuring compliance with EU regulatory requirements, OECD guidelines, Good Laboratory Practice and EFSA guidance. Contractors will identify deviations, data gaps, inconsistencies and uncertainties, prepare questions for applicants, verify applicant responses and produce structured evaluation reports. The procurement is a negotiated low/middle value procedure, estimated at €120 000 total value over a maximum 24-month framework. Expressions of interest must be submitted electronically via the Funding & Tenders Portal by the published deadlines. The final tender specifications will provide the formal eligibility, selection, award criteria, templates and contractual conditions. Interested organisations with strong regulatory toxicology and biostatistics track records should prepare technical proposals, expert CVs, sample reports and pricing aligned to the expected deliverable volume and ensure EU Login access with two-factor authentication is configured before submission.

Footnotes

1. 1Tenderers should consult the full tender specifications that will be published at launch on the EU Funding & Tenders Portal at the opportunity reference EFSA/2026/MVP/0015-EXA for exact requirements, templates and contractual terms. The Portal also contains practical information about EU Login and two-factor authentication.

This is a planned negotiated procedure for a middle/low value framework agreement tender issued by the European Food Safety Authority (EFSA). The procurement aims to outsource preparatory evaluations of in vivo toxicity studies submitted in applications for authorisation of genetically modified (GM) plants for food and feed uses in the EU.

Opportunity Details

Procedure Identifier:EFSA/2026/MVP/0015-EXA

Estimated Total Value:€120,000

Contract Duration:Maximum 24 months

Nature of Contract:Services under framework agreement without reopening of competition

CPV Code:73000000 - Research and development services and related consultancy services

Key Dates

1. 1Start date for expression of interest: 16 April 2026 (Europe/Brussels)
2. 2Deadline for expression of interest: 16 May 2026, 00:59 (Europe/Rome)
3. 3Indicative date of launch of negotiated procedure: 29 May 2026 (Europe/Rome)

Note:This is not a full call for tenders but an ex ante publicity announcing EFSA's intention to launch a negotiated low/middle value procedure. Tender specifications will be published on the launch date.

Objectives and Scope

The contractor will evaluate the adequacy of experimental design and statistical analysis methodology for each in vivo toxicity study, primarily 90-day and 28-day oral toxicity studies in rodents conducted with whole GM food/feed or newly expressed proteins/compounds. Evaluations will identify deviations from EU regulatory requirements and EFSA guidance, data gaps, inconsistencies, uncertainties, and formulate clarification questions for applicants. The estimated output is twenty reports per year.

Eligibility and Professional Capacity Requirements

Tenderers must demonstrate extensive verifiable experience in scientific evaluation of in vivo regulatory toxicity studies and statistical analysis methodologies applied to such studies. Familiarity with the EU regulatory framework is required, including:

• OECD Principles of Good Laboratory Practice (1998)
• OECD Test Guideline 407 (1998)
• OECD Test Guideline 408 (1998, 2018, 2025)
• EFSA Scientific Committee (2011) Guidance on conducting repeated-dose 90-day oral toxicity studies in rodents on whole food/feed
• EFSA (2014) Explanatory statement on applicability of the 2011 guidance for GMO risk assessment
• EFSA GMO Panel (2011) Guidance for risk assessment of food and feed from GM plants
• Regulation (EU) No 503/2013 – Annex II, Section 1.4 (Toxicology)
• Directive 2004/10/EC (principles of good laboratory practice)

Tenderers must ensure adequate resourcing. All work must be conducted in English, with team members demonstrating proficient English skills. Full tender specifications will detail tasks upon launch.

Application Process

An EU Login account is required for electronic submission of expressions of interest via the EU Funding & Tenders Portal EU Funding & Tenders Portal. From 30 June 2026, 2-factor authentication will be mandatory; prepare by registering methods in advance 2FA Guidance.

Background Context

EFSA's Nutrition and Food Innovation Unit supports the GMO Panel in assessing toxicity studies for GM authorisations. This procurement outsources preliminary compliance checks against EU standards to enhance efficiency. Similar prior contracts exist, such as preparatory support for toxicity and statistical evaluations of GM studies.

For full details and to express interest, visit the primary opportunity page Tender Details. Questions can be submitted via the portal's Q&A section once logged in.