Consequences of the Opinion on the Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants on Previous EFSA Assessments of Individual GM Plants Scientific Opinion of the Panel on Genetically Modified Organisms (GMO)

The European Commission has requested the European Food Safety Authority (EFSA) to deliver a scientific opinion on the use of antibiotic resistance genes as marker genes in genetically modified (GM) plants. The scientific opinion should take account of the previous opinion and the statement on the use of antibiotic resistance marker genes in GM plants and explain the rationale leading to the conclusion of whether the use of each particular antibiotic resistance marker gene is likely or not to have adverse effects on human health and the environment. The opinion should also serve as a basis for the case-by-case safety assessment of each GM plant and its processed products. These aspects have been addressed in the EFSA scientific opinion on the use of antibiotic resistance genes as marker genes in genetically modified plants available at http://www.efsa.europa.eu/EFSA/ScientificPanels/GMO/efsa_locale-1178620753812_GMOOpinions455.htm. In addition, the European Commission requested EFSA to indicate the possible consequences of this new opinion on the previous EFSA assessments of individual GM plants containing antibiotic resistance marker genes. This aspect is addressed in this scientific opinion of the GMO Panel. The GMO Panel has issued previously scientific opinions about the safety of two GM plant events that contain the aph(3')-Ila gene (nptll), i.e. maize MON 863 and hybrids and starch potato EH92-527-1. In the light of the new EFSA scientific opinion "Use of Antibiotic Resistance Genes as Marker Genes in Genetically Modified Plants", the GMO Panel is of the opinion that its previous assessments on GMOs containing this antibiotic resistance marker gene are in line with the risk assessment strategy described in the above opinion, and that no new scientific evidence has become available that would prompt the Panel to change its previous opinions.