The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation FLO-40685-2 cut flowers to be imported into the EU for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the newly introduced trait (purple flower colour) was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation FLO-40685-2 for humans. The GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post-market environmental monitoring (PMEM) plan. The GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.