Services - 252199-2022

13/05/2022    S93

Italy-Parma: ADME4NGRA: Implementing the EFSA New Approach Methodologies (NAMs) Roadmap through Advancing Toxicokinetic Knowledge in Chemical Risk Assessment

2022/S 093-252199

Prior information notice

This notice is for prior information only

Services

Legal Basis:
Regulation (EU, Euratom) No 2018/1046

Section I: Contracting authority

I.1)Name and addresses
Official name: European Food Safety Authority (EFSA)
Postal address: Via Carlo Magno 1A
Town: Parma
NUTS code: ITH52 Parma
Postal code: 43126
Country: Italy
E-mail: EFSAProcurement@efsa.europa.eu
Internet address(es):
Main address: https://www.efsa.europa.eu
Address of the buyer profile: http://www.efsa.europa.eu/en/procurement/tenders.htm
I.3)Communication
Additional information can be obtained from the abovementioned address
I.4)Type of the contracting authority
European institution/agency or international organisation
I.5)Main activity
General public services

Section II: Object

II.1)Scope of the procurement
II.1.1)Title:

ADME4NGRA: Implementing the EFSA New Approach Methodologies (NAMs) Roadmap through Advancing Toxicokinetic Knowledge in Chemical Risk Assessment

Reference number: OC/EFSA/MESE/2022/04
II.1.2)Main CPV code
73000000 Research and development services and related consultancy services
II.1.3)Type of contract
Services
II.1.4)Short description:

The aim of this procurement is to execute a project to support the development of advanced in vitro and in silico ADME (absorption, distribution, metabolism and excretion) models and databases for next generation risk assessment (NGRA) of chemicals using illustrative case studies.

II.1.5)Estimated total value
Value excluding VAT: 3 000 000.00 EUR
II.1.6)Information about lots
This contract is divided into lots: no
II.2)Description
II.2.3)Place of performance
NUTS code: ITH52 Parma
II.2.4)Description of the procurement:

The recently completed EFSA Roadmap on new approach methodologies (NAMs) recommended toxicokinetics as a priority topic for further development in order to implement the NAMs roadmap. This proposal is in line with EFSA’s strategy 2027 specifying the development and integration of advanced NAMs in regulatory assessment as one of the Authority’s key scientific objectives. This procurement aims at promoting the development of advanced in vitro and in silico ADME models and databases through case studies and explore their use in developing quantitative in vitro to in vivo extrapolation (QIVIVE) and physiologically-based kinetic (PB-K) models for next generation risk assessment (NGRA) of chemicals.

The assays and data generated from this call are foreseen to provide valuable new tools to EFSA for the identification of potentially hazardous substances based on their ADME profiles and establishing a future practical platform for reliable and accurate application of NGRA for food/feed-relevant substances. Furthermore, deliverables from this procurement will enhance EFSA’s current risk assessment activities by evaluating the relevance of historical animal data to human health, reduce animal testing and support the prediction of chemical fate following food intake.

The procurement has the following three main objectives with regards to design, development and implementation of ADME data/assays in NGRA:

— Objective 1: advanced in vitro systems for humans and rats to investigate ADME processes;

— Objective 2: advanced in silico models and databases to depict ADME processes;

— Objective 3: integrating QIVIVE and PB-K models in human risk assessment.

II.2.14)Additional information
II.3)Estimated date of publication of contract notice:
30/05/2022

Section IV: Procedure

IV.1)Description
IV.1.8)Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: no

Section VI: Complementary information

VI.3)Additional information:
VI.5)Date of dispatch of this notice:
06/05/2022