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 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 …

CPV: 73000000 Research and development services and related consultancy services
spriocdháta:
Meith. 16, 2025, 2:30 i.n.
cineál spriocdháta:
tairisceana
áit fhorghníomhaithe:
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
clárlann:
European Food Safety Authority
uimhir dámhachtana:
EFSA/2025/OP/0005

1. Buyer

1.1 Buyer

Official name : European Food Safety Authority
Legal type of the buyer : EU institution, body or agency
Activity of the contracting authority : General public services

2. Procedure

2.1 Procedure

Title : 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
Description : 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.
Procedure identifier : 39e898d8-dc33-4bd6-a4fb-42231fe237d5
Internal identifier : EFSA/2025/OP/0005
Type of procedure : Open
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services

2.1.3 Value

Estimated value excluding VAT : 500 000 Euro

2.1.4 General information

Additional information : In case of unavailability or disruptions in the functioning of the electronic means of communication provided in Section 5.1.11 in the last 5 calendar days before the time limit for receipt indicated in Section 5.1.12, the contracting authority reserves the right to extend this time limit and publish the extension at the Internet address provided in Section 5.1.11, without a preceding publication of a corrigendum to this notice. Economic operators interested in this procurement are invited to subscribe to the call for tenders at the address in Section 5.1.11 in order to get notified when new information or documents are published.
Legal basis :
Regulation (EU, Euratom) 2018/1046

2.1.6 Grounds for exclusion

Bankruptcy : For the full list of exclusion grounds please consult the procurement documents.

5. Lot

5.1 Lot technical ID : LOT-0001

Title : 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
Description : 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.
Internal identifier : EFSA/2025/OP/0005

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 73000000 Research and development services and related consultancy services

5.1.3 Estimated duration

Duration : 24 Month

5.1.5 Value

Estimated value excluding VAT : 500 000 Euro

5.1.6 General information

Reserved participation : Participation is not reserved.
Procurement Project fully or partially financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : no
Information about previous notices :
Identifier of the previous notice : 125779-2025

5.1.9 Selection criteria

Criterion :
Type : Suitability to pursue the professional activity
Description : Please consult the procurement documents.
Criterion :
Type : Economic and financial standing
Description : Please consult the procurement documents.
Criterion :
Type : Technical and professional ability
Description : Please consult the procurement documents.

5.1.10 Award criteria

Criterion :
Type : Quality
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 70
Criterion :
Type : Price
Name :
Description : Please consult the procurement documents.
Category of award threshold criterion : Weight (percentage, exact)
Award criterion number : 30
Description of the method to be used if weighting cannot be expressed by criteria :
Justification for not indicating the weighting of the award criteria :

5.1.11 Procurement documents

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : Bulgarian, Czech, Danish, German, Greek, English, Spanish, Estonian, Finnish, French, Irish, Croatian, Hungarian, Italian, Lithuanian, Latvian, Maltese, Dutch, Polish, Portuguese, Romanian, Slovak, Slovenian, Swedish
Electronic catalogue : Not allowed
Deadline for receipt of tenders : 16/06/2025 14:30 +02:00
Deadline until which the tender must remain valid : 9 Month
Information about public opening :
Opening date : 17/06/2025 14:30 +02:00
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Electronic invoicing : Allowed
Electronic ordering will be used : no
Electronic payment will be used : yes

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system

5.1.16 Further information, mediation and review

Review organisation : Court of Justice of the European Union -

8. Organisations

8.1 ORG-0001

Official name : European Food Safety Authority
Registration number : EFSA
Department : EFSA.ED - Executive Director,EFSA.ED.EMPOWER - Management Services,EFSA.ED.EMPOWER.FIN - Financial Services
Postal address : Via Carlo Magno 1A
Town : Parma
Postcode : I-43126
Country subdivision (NUTS) : Parma ( ITH52 )
Country : Italy
Telephone : +39 0521 036 111
Internet address : https://www.efsa.europa.eu
Roles of this organisation :
Buyer

8.1 ORG-0002

Official name : Court of Justice of the European Union
Registration number : CURIA
Postal address : Rue du Fort Niedergrünewald
Town : Luxembourg
Postcode : L-2925
Country subdivision (NUTS) : Luxembourg ( LU000 )
Country : Luxembourg
Telephone : +352 4303-1
Internet address : http://curia.europa.eu
Roles of this organisation :
Review organisation

8.1 ORG-0003

Official name : European Commission
Registration number : EUCOM
Postal address : Mondrian (CDMA), Rue du Champ de Mars 21
Town : Brussels
Postcode : B-1050
Country subdivision (NUTS) : Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad ( BE100 )
Country : Belgium
Telephone : +32 2 299 11 11
Roles of this organisation :
TED eSender
Notice information
Notice identifier/version : ae4032ac-51e4-482b-831d-dce5e99af008 - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 15/04/2025 10:31 +02:00
Languages in which this notice is officially available : English
Notice publication number : 00248335-2025
OJ S issue number : 75/2025
Publication date : 16/04/2025