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The use of genetically modified organisms - their release into the environment,import, and utilisation as food/feed or food/feed ingredients - is regulated inthe European Union (EU). For placing onto the market, current legislations requirea comprehensive and science-based risk assessment. This risk assessment(RA) is performed by applicants and then evaluated by national authorities inclose cooperation with the European Food Safety Authority (EFSA). The EFSAPanel on Genetically Modified Organisms (GMO) has published a comprehensiveset of guidance documents for applicants and risk assessors for the RA of GMplants (GMP), their products for food and/or feed use, and their cultivation. Inthose documents, the strategy and the criteria to conduct the assessment areexplained, as well as the scientific data to be provided by the applicant. Theassessment starts with the molecular characterisation of the GMP. If the GMPor products derived from it are to be consumed, the evaluation of its composition,potential toxicity and/or allergenicity, and nutritional value constitutefurther cornerstones of the process. The environmental risk assessment (ERA)considers biotic and abiotic interactions and the impacts of the management ofthe GM plant when it is intended for cultivation. In the case of GM trees specialemphasis would be placed on assessing their characteristic features such astheir longevity, ability to disperse and their ecological significance in a rangeof environments. The outcome of the assessment is reflected in a publishedopinion from the EFSA GMO panel that indicates whether the GMP and itsproducts raise any safety issues. This scientific opinion constitutes one of theelements taken into account by the different European regulatory authoritiesprior to a decision regarding authorisation to commercialise the product

Risk assessment of GM trees in the EU: current regulatory framework and guidance