The Risk “Assessment of genetically engineered organisms in the EU and Switzerland” (RAGES) project (2016‐2019) 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 thereports 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.

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EFSA notes that:

(1) Data for the agronomic, phenotypic and compositional characterisation of HT GMPs and derived food and feed products are gathered in field trials where GMPs are exposed to conventional and to the intended herbicide(s) in line with good agricultural practices, and thus they provide a robust basis for the comparative analysis of HT GMPs.

(2) All potential routes of environmental exposure of non-target organisms (NTOs) to GMPs for cultivation are typically considered as part of the risk assessment of GMPs, including those producing insecticidal proteins. EFSA appraises and analyses NTO data following a weight of evidence approach and applies the principles and methods available at the time of the risk assessment.

(3) Its guidance documents provide the necessary principles, strategy and data requirements for a comprehensive and adequate risk assessment of nutritionally altered GMPs for food and feed uses.

(4) The current risk assessment approach for stacked events in GMPs is sufficient to address the identification of risks for animals and consumers. EFSA does not consider the use of long-term animal studies with whole food and feed appropriate to explore the safety of GMPs in the absence of specific hypotheses to test.

(5) The approach for the environmental risk assessment of GMPs that can persist and spontaneously propagate in the environment is fit for purpose and consistent with EU requirements and internationally agreed approaches.

(6) It is currently assessing the adequacy and sufficiency of its current guidelines for the risk assessment and post-market environmental monitoring of GMOs produced through new genetic engineering technologies. The risk assessment approaches applied to GMPs are generally considered suitable for GMPs that induce silencing through RNA interference, without the necessity to develop specific guidance

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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.

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