Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis

The European Commission requested that the EFSA Panel on Genetically Modified Organisms deliver a scientific opinion related to risk assessment of cisgenic and intragenic plants. The EFSA GMO Panel considers that the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are applicable for the evaluation of food and feed products derived from cisgenic and intragenic plants and for performing an environmental risk assessment and do not need to be developed further. It can be envisaged that on a case-by-case basis lesser amounts of event- specific data are needed for the risk assessment. The EFSA GMO Panel compared the hazards associated with plants produced by cisgenesis and intragenesis with those obtained either by conventional plant breeding techniques or by transgenesis. The Panel concludes that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants. The Panel is of the opinion that all of these breeding methods can produce variable frequencies and severities of unintended effects. The frequency of unintended changes may differ between breeding techniques and their occurrence cannot be predicted and needs to be assessed case by case. Independent of the breeding method, undesirable phenotypes are generally removed during selection and testing programmes by breeders. The risks to human and animal health and the environment will depend on exposure factors such as the extent to which the plant is cultivated and consumed.