The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
This report reviews current scientific literature and risk assessment frameworks for assessing food and feed safety of GM plants, in cases where the comparative approach, as applied by EFSA, may not be fully applicable. This may apply to a range of GM traits coming onto the market which have received substantial modifications to the composition, metabolism and physiology of the plant (GM plants with „novel? traits). A literature review was carried out using the principles of a systematic review to ensure objectivity in reviewing all relevant papers. Of the 983 relevant scientific papers which were initially identified, 92 passed further selection and were subsequently reviewed. The risk assessment approaches for GM plants of seven international bodies were also reviewed. Overall it was found that comparisons were always a cornerstone of food and feed risk assessment of GM plants, whether traits were „novel? or otherwise. No evidence was found in the scientific literature or from international risk assessment bodies where GM plants were not being compared to an appropriate comparator, or a database. The comparative assessment as applied by EFSA is seen by the project team as the most reliable method to identify any unintended effects. However, given the range of GM plants that may require authorisation in the future, a flexible approach to the design of field trials will be required to account for situations where the receiving environment of the GM plant would be substantially different to the appropriate comparator. In addition, exposure assessment will be an important step for the risk assessment process, particularly for GM plants with „novel? quality/output traits which provide nutritional benefits to the consumer. Post market monitoring is an area which has received little attention in the literature, and further work is needed to develop guidance on when this should be carried out.