ABSTRACT

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) assessed the monitoring report for the 2010 cultivation season of GM potato EH92-527-1 (variety Amflora) provided by BASF. The EFSA GMO Panel assessed, in close collaboration with the EFSA Unit for Scientific Assessment Support, the methodology applied by the applicant for the four case-specific studies, the General Surveillance (GS) of potato EH92-527-1 and the field study to monitor potential adverse effects on potato-feeding organisms. From the overall dataset submitted by the applicant in its 2010 Amflora monitoring report, the EFSA GMO Panel does not identify adverse effects on the environment, human and animal health due to potato EH92-527-1 cultivation during the 2010 growing season. The outcomes of the 2010 Amflora monitoring report do not invalidate the previous EFSA GMO Panel’s risk assessment conclusions on potato EH92-527-1. Nevertheless, the EFSA GMO Panel notes a number of weaknesses in the methodology for GS and therefore gives specific recommendations for improvement of the strategy, methodology and reporting for GS of potato EH92-527-1. Concerning the field study on potato-feeding organisms as required in the related Commission Decision, the EFSA GMO Panel makes recommendations in order to improve the study. However, the EFSA GMO Panel considers the GS framework as a more proportionate alternative for collecting relevant information on potato-feeding organisms.