EFSA’s Methodology and Scientific Support Unit has launched a public consultation on the draft guidance on the use of read-across for chemical safety assessment in food and feed. The document details a structured workflow to standardise and justify the read-across approach, aiming to minimise uncertainties and ensure regulatory alignment.
The document includes the following chapters:
- Chapter 1: it lays out the terms of reference, identifies the target audience, use, and degree of obligation of this guidance. In addition, it introduces the concept of read-across, highlighting its significance as an alternative to animal testing for addressing data gaps in the chemical safety assessment.
- Chapter 2: it reviews existing frameworks and guidance from organisations such as ECHA and OECD, which have laid the groundwork for the methodologies proposed in this document.
- Chapter 3: it presents the read-across context and requirements at EFSA and the utility of the read-across approach in regulatory risk assessments for food and feed.
- Chapter 4: it includes a description of the read-across workflow and the practical guidance on performing read-across: problem formulation, target substance characterisation, source substance identification, source substance evaluation, data gap filling, uncertainty assessment, conclusion and reporting.
- Chapter 5: it includes aspects and examples related to the applicability domain and characterisation of the boundaries for the read-across.
https://connect.efsa.europa.eu/RM/sfc/servlet.shepherd/document/download/069Tk000009xQEDIA2