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

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.