Scientific Opinion on a request from the European Commission for the assessment of the scientific elements put forward by Hungary to support the prohibition for the placing on the market of GM potato EH92‐527‐1 for cultivation purposes in Hungary

Abstract

Hungary notified to the European Commission its scientific arguments justifying the implementation of a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Hungary, after which the European Commission asked the European Food Safety Authority (EFSA) to assess the scientific information supporting the prohibition. Having considered the information package provided by Hungary and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that (i) no new data specific to the safety of the nptII gene have been provided; (ii) the therapeutic relevance of kanamycin and neomycin was already addressed in the previous EFSA opinion on antibiotic resistance marker genes and kanamycin resistance in Mycobacterium tuberculosisresults largely from chromosomal mutations and not from the transfer of aminoglycoside resistance genes such as nptII; (iii) the knowledge gaps and uncertainties highlighted in the Hungarian document have already been considered in the previous EFSA opinion on antibiotic resistance marker genes, and no new information on the safety of nptII gene as present in the GM potato EH92-527-1 has been identified in the scientific literature that would cause the GMO Panel to change its previous conclusions. Therefore, the EFSA GMO Panel concludes that no grounds exist to date that would lead to reconsideration of its opinion on GM potato EH92-527-1.