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.
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