Project R-9346

Preparatory support for the statistical evaluation of the compliance analysis of GM plant field trials (Research)

In order to be placed in the European market GMO's are subject to legal regulations requiring a scientific assessment of potential risks for human or animal health. It's part of the responsibility of EFSA to provide independent, objective and transparent scientific advice with respect to safety of GMO's. The EFSA GMO Panel considers data generated by applicants during product development, as well as any other relevant scientific information published in the scientific literature. To guide and assist applicants for the preparation and presentation of genetically modified (GM) plant market authorisation applications, the GMO Panel of EFSA has developed guidance for the risk assessment of GM plants and derived food and feed (FF GD). This guidance describes principles, concepts, data requirements and issues to be considered when performing the risk assessment of GM plants and derived food and feed. In particular, the EFSA GMO Panel has worked intensively to develop explicit objective, transparent and harmonized guidance for experimental design and analysis. These include the definition of minimum requirements, and the provision of specific statistical methodologies for field trials both for the comparative safety assessment of GM plants and derived food and feed as needed for food and feed safety (FF) risk assessment. Within this project CenStat will provide proper feedback to EFSA panel on GMO's with respect to the dossiers for application.

13 November 2018 - 12 November 2020