Dossiers d’évaluation portant sur des OGM : Outils

Representativeness of the field trial sites for the agronomic/phenotypic and compositional characterisation of GM plants

The Guidance on the agronomic and phenotypic characterisation of genetically modified plants explains how agronomic and phenotypic data support the risk assessment of GM plants. A key principle of the guidance is the representativeness of the field trials for the collection of agronomic/phenotypic and compositional data. According to this principle, the environmental and agronomic conditions of the field trials should capture enough variability within the set of possible receiving environments in which the GM plants can be grown.

These tools provide further practical assistance for the selection of field trial sites and the evaluation of their representativeness:

  1. Crop-specific figures (i.e. representativeness maize, representativeness soybean and representativeness cotton) based on the suitability classes of soil characteristics (texture, pH and soil organic carbon content), historical meteorological data of the typical crop growing seasons, as well as meteorological conditions that occurred during the specific crop growing cycle (from planting to harvest).
  2. Excel workbook named “weather sites” is a template proposed for the submission of the meteorological data of field trials. The workbook generates tables and charts to visualise the data.
  3. Excel macro-enabled workbook named “planting dates macro” which compares the sowing/harvesting dates of (US-based) field trials with the sowing/harvesting periods typical of those locations.

Additional information related to the representativeness of the field trial sites for the agronomic/phenotypic and compositional characterisation of GM plants can be found on the slides presented during the ad hoc meeting with applicants in 2017 and in 2019.

GMO analysis software

The opinion on Statistical considerations for the safety evaluation of GMOs provides detailed guidance on the performance of the comparative field trials and their statistical analysis. The principles, concepts and data requirements presented in the above mentioned opinion are endorsed in the 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 guidelines and Regulation EU No 503/2013.

The software allows data entry and data analysis using the latest statistical procedures developed and adopted by EFSA 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).

An output-file listing all the significant differences and the equivalence categories is generated by a single click. The user can also change some settings according to the specific needs of the analysis. The software is user-friendly and data can be imported from different sources (e.g. Excel).

Technical requirements:

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

Last modified: 03/02/2021

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).

Specific 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) 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.