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## PART 1  TECHNICAL SPECIFICATIONS - WHAT DOES EFSA NEED TO BUY THROUGH THIS PROCUREMENT PROCEDURE? 

## 1.1 BACKGROUND 

Read-across (RAx) is an approach used in chemical risk assessment that allows for the screening, classification, prioritization and hazard assessment of chemicals based on the toxicological data of similar chemicals and is the most common alternative to animal testing. It provides opportunities for predicting toxicological responses for data-poor chemicals using data from other substances. However, the similarity within the context of the predicted endpoint (response) should be justified. As available datasets, data streams and improved read-across techniques allow greater confidence in this predictive method, it is becoming increasingly important to ensure its regulatory acceptance. 

EFSA has recently initiated a project to develop a guidance on the use of RAx to harmonise its use across different food sectors. In anticipation of this guidance, this procurement procedure aims at investigating the applicability of RAx for toxicological endpoints for risk assessment (RA) of chemicals in food/feed. This procurement will focus on and analyse the repeated-dose toxicity information available to EFSA on pesticide active substances and their metabolites, since pesticides are the group of compounds under EFSA’s remit with the largest amount of information. This project would complement a prior related project which used RAx and similarity analysis for prediction of genotoxicity as carried out by EFSA pesticide unit 2 . It is anticipated that the outcome of this procurement together with the insights already gained from the genotoxicity project will provide a robust scientific basis for the guidance on the use of chemical RAx across EFSA’s remit. 

This c all is based on EFSA’s 20 20-2022 draft Work Programme for grants and operational procurements as presented in Annex IX of the Programming Document 2020 – 2022, available on the EFSA’s website 3 . 

## 1.2 OBJECTIVES 

The aim of this procurement procedure is to qualify the applicability domain (in terms of toxicological endpoints and chemical space) for the use of RAx in food safety. 

Using pesticides as a model, the overall objective of the contract will be to extract chemical and toxicological information for active substances and their metabolites/degradation products (where available) from EFSA’s published conclusions on pesticides peer review and related assessment reports, and (i) test the applicability of the RAx approach for prediction of repeated dose toxicity and (ii) identify supporting biological and toxicological information for in vivo and in vitro studies that will reduce uncertainty in the RAx. 

