Parma, Italy
October 6, 2014
New software from the European Food Safety Authority (EFSA) provides stakeholders with a tool for carrying out complex data analysis as part of the risk assessment of genetically modified (GM) plants. The user-friendly program, which can be downloaded free of charge from EFSA’s website, allows stakeholders such as Member States and industry applicants to analyse field trial data with a single mouse click.
Under EU law, genetically modified organisms (GMOs) must undergo a risk assessment before entering the market. An integral part of this scientific review is the evaluation of field trials that provide data for comparative assessment - an approach that compares GM plants with their conventional counterparts.
EFSA, in collaboration with Wageningen University and Research Centre, in the Netherlands, has developed a software tool to perform the statistical analysis necessary for comparative assessment in a way that complies with EFSA guidelines and European Union legislation.
Dr Claudia Paoletti, of EFSA’s GMO Unit, said: “This software is a valuable working tool for anyone wishing to produce data in line with the recommendations in EFSA guidance. Stakeholders, including applicants, who apply the GMO software tool properly can be sure the comparative data are fit for purpose for risk assessment. However, the software is a supporting tool made available by EFSA to help all stakeholders. Its use is not obligatory.”
The software conducts the simultaneous analysis of the GM plant compared to its control and non-GM reference varieties (test of difference and test of equivalence respectively, as described in Regulation (EU) 503/2013). An output-file listing all the significant differences and the respective equivalence categories is generated with a single click. The software is flexible and allows stakeholders to change some settings according to the specific needs of the analysis being performed. It also permits the introduction of different factors depending on the unique environmental conditions of individual field trials.
“We tested and debugged the system before going live,” added Dr. Paoletti. “But this is new software and initial minor problems cannot be fully excluded. We have set up a dedicated mailbox and encourage any user to provide feedback so we can refine the program further.”
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