The guidance outlines methods and approaches for data generation, collection and analysis that must be followed by those submitting applications to EFSA for genetically modified plant risk assessment. These are explained in relation to the different components of the risk assessment, including molecular characterization, field trial design, compositional analysis, toxicological assessment, allergenicity and nutritional assessment. The guidance will also support the European Commission in preparing a legal framework for the risk assessment of genetically modified food and feed.
The document expands on previous EFSA guidance and reflects the latest scientific developments in areas such as assessment of allergenicity and selection of the comparator plant against which the genetically modified plant is compared. It also establishes a new statistical methodology to further strengthen the risk assessment of genetically modified plants.