Guidance on the characterisation of microorganisms in support of the risk assessment of products used in the food chain
Susanne Hougaard Bennekou, Ana Allende, Angela Bearth, Josep Casacuberta, Laurence Castle, Tamara Čoja, Amélie Crépet, Þórhallur I. Halldórsson, Ron Hoogenboom, Pikka Jokelainen, Helle Katrine Knutsen, Claude Lambré, Søren Saxmose Nielsen, Dominique Turck, Antonio Vicent Civera, Roberto Edoardo Villa, Holger Zorn, Margarita Aguilera Gómez, Stéphane Bretagne, Henrik Christensen, Pier Sandro Cocconcelli, Lieve Herman, Miguel Prieto Maradona, Baltasar Mayo, Carmen Peláez, Maria Saarela, José Sánchez Serrano, Laurence Vernis, Andrey Yurkov, Jaime Aguilera, Montserrat Anguita, Nicole Bozzi Cionci, Rosella Brozzi, Sandra Correia, Yolanda García‐Cazorla, Frédérique Istace, Elisa Pettenati, Joana Revez, Reinhilde Schoonjans, Piera Valeri, Boet Glandorf
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.