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Health
18 October 2023

Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety Lot 1: Comparative statistical analysis (2022)

To guide and assist applicants for the preparation and presentation of genetically modified (GM) plant market authorization applications, the GMO Panel of EFSA has developed guidance for the risk assessment of GM plants and derived food and feed, which describes principles, concepts, data requirements and issues to be considered when performing the risk assessment of GM plants and derived food and feed. The objective of this framework contract is to provide statistical support to the EFSA GMO Panel for the evaluation of GMO application dossiers with respect to the statistical analysis of collected data from field trials carried out for the comparative assessment according to the requirements described in the EFSA guidance on statistical considerations for the safety evaluation of GMOs and EFSA guidance on the risk assessment of food and feed from genetically modified plants. This annual report describes the different tasks performed in 2022 and 2023 under the framework contract and summarizes their outcome. The majority of the applications received during 2022, for the evaluation of the statistical analysis, contained a few minor non‐compliances and met to a large extent the requirements described in the EFSA guidance documents.