Assessment of the outcomes of the project “Risk Assessment of Genetically Engineered Organisms in the EU and Switzerland” (RAGES)

Abstract

The "Risk Assessment of genetically engineered organisms in the EU and Switzerland" (RAGES) project (2016)(2017)(2018)(2019)) evaluated the risk assessment of genetically modified plants (GMPs) as performed by the European Food Safety Authority (EFSA) and its Swiss counterpart. RAGES claims shortcomings in several areas of the European risk assessment of GMPs, in particular: (1) the risk posed by herbicide tolerant GMPs on animal and human health; (2) the risk assessment approach of GMPs producing insecticidal proteins; (3) the risk assessment of nutritionally altered GMPs; (4) the assessment of GMPs combining different traits; (5) the environmental risk assessment of GMPs that can persist and spontaneously propagate in the environment; and (6) genetically modified organisms (GMOs) produced using new genetic engineering technologies. Following a request of the European Commission, EFSA reviewed the main scientific arguments raised by RAGES, and assessed whether the reports published by RAGES contain elements that could lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. EFSA confirms that its risk assessment approach and data requirements are adequate and sufficient for the risk assessment of current GMPs, and that they are consistent with the applicable EU legislation and internationally agreed standards. Moreover, EFSA has gained more than 20 years of experience in the risk assessment of GMPs, and conducts a continued scientific review of all relevant evidence by following the scientific and technical developments in the GMO area. Overall, EFSA concludes that the final RAGES reports do not contain elements that would lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. Therefore, EFSA considers that the previous GMO Panel risk assessment conclusions remain valid.