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.
Relevant food consumption data for the estimation of human dietary exposure in GMO applications
Applicants can access summary statistics from the EFSA Comprehensive European 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).
Summary statistics of consumption data (for chronic and acute consumption) for crops relevant to GMO applications are available in the form of Microsoft Excel files. These statistics contain data for the total population (all subjects/all days) and for consumers only/consumption days only, expressed in grams per day per kilogram of body weight (g/kg bw per day) that have been codified under the first version of the FoodEx food classification system.
The Excel files contain consumption statistics for each relevant crop and all derived food commodities filtered by country, dietary survey, age class and special population groups. An additional spreadsheet for each crop provides information on different factors derived from yield factors and standard recipes (as described in the EFSA technical report on the raw primary commodity – RPC – model). To obtain accurate estimations, these factors should be applied to the consumption data before estimating dietary exposure. Embedded in the summary statistics there are also consumption data for certain food commodities for which ad hoc dietary exposure scenarios might be needed (e.g. dietary supplements such as pollen and protein-based supplements).
The Excel files will be updated as needed (e.g. as new consumption data and/or new information on yield factor/recipes become available). Applicants are advised to regularly check the EFSA website to ensure they are using the most up-to-date data.
The EFSA statement on human dietary exposure to GMO food gives guidance on how the summary statistics on the consumption and the concentration data on the constituents under assessment should be used. The approach described in the EFSA statement allows estimating chronic and acute dietary exposure for both average and high consumers.