Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain

Abstract

This document provides guidance to assist in the preparation of applications for regulated products to be used in the food chain containing, made from or produced by using microorganisms, genetically modified or not, that are subject to risk assessment within EFSA's remit before their placement on the EU market. This guidance focuses on the scientific requirements to characterise the microorganisms and, to some extent, their products. It provides the basis for hazard identification in support of the risk assessment of microorganisms and establishes the data requirements to conduct the risk assessment.