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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 (2020)

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Wiley Online Library

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Abstract

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 2020 under the framework contract and summarizes their outcome. The evaluations of the statistical analysis of applications during 2020 met to a large extent the requirements reported in the guidance documents. Only a few minor non‐compliances were recurrently reported in most of the applications.