Statement on a request from the European Commission for the assessment of the scientific elements supporting the prohibition for the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria

Austria notified to the European Commission its ordinance implementing a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Austria, after which the European Commission asked the European Food Safety Authority to assess the scientific elements supporting the prohibition. Having considered the information package provided by Austria and all relevant scientific publications, the GMO and BIOHAZ Panels concluded that: i) no new data specific to the safety of the nptII gene have been provided; ii) the risk posed by the formation of mosaic structures of aminoglycoside phosphotransferase genes could not be assessed without data documenting the existence of such structures among the existing gene variants and such data were not provided; iii) the therapeutic relevance of kanamycin and neomycin was already addressed in the EFSA’s opinion on ARM genes and as of yet there is no evidence to indicate that resistance to these antibiotics in clinically-relevant bacteria has developed as a result of acquisition of the nptII gene; iv) the knowledge gaps and uncertainties highlighted in the Austrian document have already been considered in the EFSA’s opinion on ARM genes. Austria did not provide any new or additional information on the molecular characterisation or PMEM of potato EH92-527-1 after the date of consent for this GM event that would require the reassessment of existing information. The EFSA GMO Panel reiterates its scientific opinion on the 2010 monitoring report of GM potato EH92-527-1 in which it provides specific recommendations to improve the methodology of the PMEM of the GM potato. Further, 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.