In the European Union, the use of genetically modified organisms (GMOs) is regulated through a legal framework. According to EU legislation (Regulation (EC) No 1829/2003, Regulation (EU) 503/2013 and Directive 2001/18/EC), GMOs can only be authorized for placing on the EU market following a scientific assessment of any risks that they may pose to human and animal health and the environment.
An integral part of such scientific assessment is the evaluation of field trials performed for the comparative assessment of the compositional, agronomic and phenotypic characteristics of GM plants. In 2009, EFSA’s GMO Panel adopted an opinion on Statistical considerations for the safety evaluation of GMOs to provide detailed guidance on the performance of such field trials and their statistical analysis. The principles, concepts and data requirements presented in the above mentioned opinion are endorsed in the GMO Panel's Guidance for risk assessment of food and feed from genetically modified plants and the more recent implementing Regulation (EU) 503/2013.
To provide further practical assistance for the analysis of comparative data for the risk assessment of GM plants, EFSA, in collaboration with Wageningen UR, has developed a software tool to perform the statistical analysis along with EFSA GMO Panel guidelines and Regulation (EU) 503/2013.
The software allows data entry and data analysis using the latest statistical procedures developed and adopted by EFSA’s GMO Panel for the risk assessment of GM plants. The software conducts a simultaneous analysis of the GM plant compared to its control (test of difference) and non-GM reference varieties (test of equivalence). Moreover different factors can be introduced and analysed.
An output-file listing all the significant differences and the respective equivalence categories is generated by a single click. Additionally, some settings can be changed, according to the specific needs of the analysis being performed.
The software is user-friendly and data can be imported from different sources (e.g. Excel).
- Windows 7
- Microsoft .NET 4 client framework
- R, version 2.15 or higher (http://cran.rstudio.org).
Please refer to the Installation Manual (see below) for detailed instructions on how to set up this software:
The software does not require any license for its installation and utilization by any user.
EFSA welcomes comments which could support improvement of this GMO software tool. Please send your comments at GMO.software [at] efsa.europa.eu.
Food consumption data relevant to applications for GMOs
Applicants can access summary statistics from the EFSA Comprehensive Food Consumption Database. These statistics allow a quick screening for chronic and acute dietary exposure as required for applications for authorisation of genetically modified plants (Commission Implementing Regulation EU 503/2013). The different foods consumed across Europe are codified under FoodEx classification (at the highest level of detail possible).