Developing provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Asses...

This is a call for tenders issued by the European Food Safety Authority (EFSA) under the identifier EFSA/2025/OP/0005. The objective of this call is to develop guidance and recommendations for integrating data from New Approach Methodologies (NAMs) into risk assessments, focusing specifically on food nanotechnology. The work involves analyzing lessons learned from existing EFSA case studies and relevant international activities, such as OECD Integrated Approaching to Testing and Assessment (IATA) Case Studies, to establish best practices for the integration of NAMs-based data with available animal and human data to fill gaps in risk assessments.

Eligible applicants are likely to be organizations capable of conducting research and providing consultancy services within the EU or associated countries, as the program is aligned with Horizon Europe guidelines. The funding type falls under a grant with a total estimated value of €500,000, set within the €200,000 to €1,000,000 range. The project is expected to last a maximum of 24 months.

The application process is an open call, whereby submissions must be made electronically. Deadline for submission is June 16, 2025, at 14:30 Europe/Rome. A crucial element of the evaluation will be the best price-quality ratio, and the selection criteria include professional activity suitability, economic and financial standing, and technical and professional ability.

There is no co-funding requirement indicated, and there is no specific page or word limit for the technical tender or methodology section. A new Business Partner Form has replaced prior forms for consortium partners. Questions regarding the tender will not be entertained after June 6, 2025.

In summary, the tender seeks to find a suitable organization or consortium to perform vital research and development tasks relating to food nanotechnology risk assessments, emphasizing the integration of innovative data methodologies.

This is a call for tenders by the European Food Safety Authority (EFSA) with procedure identifier EFSA/2025/OP/0005. The TED reference is 75/2025 248335-2025. The call is for developing provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA), with specific focus on the area of food nanotechnology.

The submission method is electronic and the call is open for submission. The call aims at developing recommendations and first provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA) for risk assessment of regulated products in the food chain, with specific focus on the area of food nanotechnology. The work will build on experience gained from selected case studies of EFSA’s relevance with the aim to develop best practices on the integration of NAMs-based data together with animal/human data to fill data gaps in the risk assessment.

The awarded organisation(s) will be requested to:

1. Collect lessons learnt from EFSA's published case studies on NAMs (e.g. https://doi.org/10.2903/sp.efsa.2023.EN-7793, https://doi.org/10.2903/sp.efsa.2023.EN-7794, https://doi.org/10.2903/sp.efsa.2023.EN-8258, https://doi.org/10.2903/sp.efsa.2023.EN-8230, https://doi.org/10.2903/sp.efsa.2024.EN-8820, https://doi.org/10.2903/sp.efsa.2024.EN-8926) and other relevant international activities (e.g. OECD Integrated Approaching to Testing and Assessment (IATA) Case Studies) to develop best practices for a general framework on the integration of NAMs-based data together with animal/human data (when available) to fill data gaps in the risk assessment.
2. Develop provisions for cross-cutting guidance for assessing and integrating NAMs data in EFSA risk assessments, focusing specifically on nanomaterials risk assessment.

The procedure type is an open procedure. The estimated total value is 500000 EUR. The TED publication date is 16/04/2025. The lead contracting authority is the European Food Safety Authority. The main classification (CPV) code is 73000000 - Research and development services and related consultancy services. The nature of the contract is for services. The maximum contract duration is 24 months. The award method is best price-quality ratio. There is no framework agreement.

The selection criteria are:
Suitability to pursue the professional activity - Please consult the procurement documents.
Economic and financial standing - Please consult the procurement documents.
Technical and professional ability - Please consult the procurement documents.

Milestones:
TED publication date: 16/04/2025
Date and time of public opening: 17/06/2025 14:30 Europe/Rome
Deadline for receipt of tenders: 16/06/2025 14:30 Europe/Rome
Contracting authority is not bound to reply to questions submitted after: 06/06/2025 05:00 Europe/Rome

Documents available:
Invitation to tender (4) Invitation letter, published on 16/04/2025, Version 1, No translations available.
Tender specifications, published on 16/04/2025, Version 1, No translations available.
Direct Service Contract Draft contract, published on 16/04/2025, Version 1, No translations available.

Submissions must be sent exclusively at the address for submission given below. The submission method is electronic.

Questions and Answers:
Question: Is there a page / word limit for the technical tender or the methodology section?
Answer: There is no page/word limit for the technical tender/methodology. Published on 13/05/2025 21:32

Question: Can the Contracting Authority please clarify how the Legal Entity Form (LEF) should be completed by consortium partners and subc...?
Answer: Please note that a new Business Partner Form (available here) has replaced and consolidated into one single form the Legal Entity Form (LEF) and Financial Identification Form (BAF). Published on 08/05/2025 13:26

In summary, this is a call for tenders from the European Food Safety Authority (EFSA) seeking an organization or consortium to develop guidance and recommendations for integrating data from New Approach Methodologies (NAMs) into risk assessments, specifically focusing on food nanotechnology. The project involves analyzing existing EFSA case studies and international activities to establish best practices for using NAMs data, along with animal and human data, to address data gaps in risk assessments. The selected contractor will also create cross-cutting guidance for assessing and integrating NAMs data in EFSA risk assessments, with a particular emphasis on nanomaterials. The tender is an open procedure with an estimated value of 500,000 EUR and a maximum contract duration of 24 months. The deadline for submitting tenders is June 16, 2025. The tender documents include an invitation letter, tender specifications, and a draft service contract. The evaluation will be based on the best price-quality ratio.

Eligible Applicant Types: The opportunity details do not explicitly specify eligible applicant types. However, given the nature of the call for tenders, it is likely open to organizations with research and development capabilities, such as research institutes, universities, consulting firms, and other entities capable of providing the requested services. The selection criteria mention "Suitability to pursue the professional activity," "Economic and financial standing," and "Technical and professional ability," suggesting that the applicants should be organizations with the capacity to conduct research and provide consultancy services.

Funding Type: This is a procurement opportunity, specifically a call for tenders. The "Nature of the contract" is indicated as "services," and the awarded organization(s) will be contracted to perform specific tasks.

Consortium Requirement: The opportunity details do not explicitly state whether a single applicant or a consortium is required. However, the clarification regarding the Business Partner Form (which replaced the Legal Entity Form and Financial Identification Form) for consortium partners suggests that consortia are eligible to apply. It is possible that single applicants are also eligible.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly stated. Given that the contracting authority is the European Food Safety Authority (EFSA), it is highly likely that the opportunity is open to entities located within the European Union. It is possible that entities from EEA countries or other countries with agreements with the EU may also be eligible, but this is not explicitly mentioned.

Target Sector: The target sector is research and development services and related consultancy services, specifically focusing on the area of food nanotechnology and risk assessment in the food chain. The call targets the development of guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA).

Mentioned Countries: No specific countries are mentioned in the opportunity details. The European Food Safety Authority (EFSA) is the lead contracting authority, suggesting a focus on the European Union. The OECD is mentioned in relation to Integrated Approaching to Testing and Assessment (IATA) Case Studies, indicating a possible international dimension.

Project Stage: The project stage is focused on development and validation. The call aims to develop recommendations and first provisions for guidance, building on existing case studies. The work involves collecting lessons learned, developing best practices, and creating provisions for cross-cutting guidance.

Funding Amount: The estimated total value of the contract is 500,000 EUR.

Application Type: The application type is an open call for tenders. The submission method is electronic.

Nature of Support: The beneficiaries will receive money in exchange for services rendered. The contract is for research and development services and related consultancy services.

Application Stages: The number of application stages is not explicitly mentioned, but it is likely a multi-stage process involving submission of a tender, evaluation of the tender based on selection criteria (Suitability to pursue the professional activity, Economic and financial standing, and Technical and professional ability), and contract award.

Success Rates: The success rates are not mentioned in the opportunity details.

Co-funding Requirement: The opportunity details do not explicitly mention a co-funding requirement.

Summary:

This is a call for tenders issued by the European Food Safety Authority (EFSA) with the procedure identifier EFSA/2025/OP/0005. The call aims to contract an organization or organizations to develop recommendations and first provisions for guidance on New Approach Methodologies (NAMs) data integration and implementing hypothesis-driven Next Generation Risk Assessment (NGRA) for risk assessment of regulated products in the food chain, with a specific focus on food nanotechnology. The awarded organization(s) will be required to collect lessons learned from EFSA's published case studies on NAMs and other relevant international activities, such as OECD Integrated Approaching to Testing and Assessment (IATA) Case Studies, to develop best practices for a general framework on the integration of NAMs-based data together with animal/human data to fill data gaps in the risk assessment. They will also need to develop provisions for cross-cutting guidance for assessing and integrating NAMs data in EFSA risk assessments, focusing specifically on nanomaterials risk assessment. The estimated total value of the contract is 500,000 EUR, and the maximum contract duration is 24 months. The procedure type is an open procedure, and submissions must be sent electronically. The deadline for receipt of tenders is 16/06/2025 at 14:30 Europe/Rome. The contracting authority will not reply to questions submitted after 06/06/2025 at 05:00 Europe/Rome. The award method is based on the best price-quality ratio. There is no page/word limit for the technical tender/methodology. A new Business Partner Form has replaced and consolidated the Legal Entity Form (LEF) and Financial Identification Form (BAF).