New EFSA guidance clarifies the data needs for the agronomic and phenotypic characterisation of genetically modified (GM) plants. The document complements existing guidance on data requirements for the risk assessment of GM plants. It provides applicants seeking market approval for a GM plant in the European Union with recommendations on how to generate, analyse and interpret agronomic and phenotypic data of the GM plant.
Any risk assessment of GM plants includes the comparison of the agronomic and phenotypic characteristics of the GM plant with its conventional counterpart. This comparison aims to detect differences in the plants’ observable appearance such as height and colour – so called phenotypic characteristics – and its agronomic characteristics such as yield and pesticide tolerance. Such differences are not automatically considered as evidence for adverse effects. Should detected differences indicate a potential hazard, however, further assessments need to be carried out to identify possible safety concerns.
Specific data requirements
Based on the experience gained with previous evaluations of GM plant applications, EFSA decided to develop this guidance and make data requirements more specific. The guidance provides concrete recommendations for the generation, analysis and interpretation of agronomic and phenotypic data including on:
- the selection of test materials and sites
- the quality and design of field trials
- the selection of specific plant characteristics to measure its biology and behaviour
This approach will further strengthen risk assessment in this area, making it more comprehensive, consistent and more efficient.
Wednesday June 24, 2015/ EFSA/ European Union.