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Gene drive organisms ( GDOs ) have been suggested as approaches to combat some of the most pressing environmental and public health issues. No such organisms have so far been released into the environment, but it remains unclear whether the relevant regulatory provisions will be fit for purpose to cover their potential environmental, human and animal health risks if environmental releases of  GDOs  are envisaged. We evaluate the novel features of  GDOs  and outline the resulting challenges for the environmental risk assessment. These are related to the definition of the receiving environment, the use of the comparative approach, the definition of potential harm, the stepwise testing approach, the assessment of long-term and large-scale risks at population and ecosystem level and the post-release monitoring of adverse effects. Fundamental adaptations as well as the development of adequate risk assessment methodologies are needed in order to enable an operational risk assessment for globally spreading  GDOs  before these organisms are released into environments in the EU.

Beyond limits – the pitfalls of global gene drives for environmental risk assessment in the European Union