Statement supplementing the environmental risk assessment conclusions and risk management recommendations on genetically modified insect-resistant maize 59122 for cultivation in the light of new scientific information on non-target organisms and regionally sensitive areas

Following a request from the European Food Safety Authority (EFSA), the Panel on Genetically Modified Organisms (GMO Panel) was asked to supplement its environmental risk assessment conclusions and risk management recommendations on maize 59122 for cultivation in the light of new scientific information on non-target organisms and regionally sensitive areas. Having considered additional information relevant to the assessment of potential adverse effects of maize 59122 on non-target organisms, the Panel must revise two of its previous environmental risk assessment conclusions, invalidating its earlier statement on the environmental safety of maize 59122 in its 2013 Scientific Opinion. A gap in the event-specific data on the honeybee study performed by Maggi (2001) was identified, as a result of which uncertainty over the occurrence of adverse effects on pollinators due to potential unintended changes in maize 59122 remains. Therefore, the Panel is no longer in a position to complete its assessment on the occurrence of adverse effects on pollinators. The Panel reassessed the available dataset on ladybirds, including the Califf and Ostrem (2009) study, and considers the latter study does not enable resolving the remaining scientific uncertainty on the potential toxicity of the binary Cry34Ab1/Cry35Ab1 proteins on Coccinella septempunctata or other ladybirds. In both cases, the Panel recommends that an additional laboratory study is performed prior to authorisation. The Panel considered regionally sensitive areas in its assessment, but regards it as premature to recommend specific risk management strategies for susceptible insect species potentially found within and nearby such areas owing to the inconclusive nature of the assessment of potential adverse effects of maize 59122 on non-target organisms.