EFSA clarifies data requirements for GM plant risk assessment

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.

Comparative approach

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.

Continuous engagement with stakeholders

EFSA actively engaged with stakeholders in an open scientific debate on the draft guidance. Following a six-week public consultation, over 40 representatives of national risk assessment bodies, academic institutions, industry representatives and one non-governmental organisation discussed their input at a workshop in December 2014 in Parma, Italy. The draft guidance was also discussed at the open plenary meeting of the Panel on Genetically Modified Organisms ( GMO Genetski modificirani organizam (engl. genetically modified organism (GMO)) jest organizam koji sadržava genetski materijal koji je namjerno izmijenjen i koji se ne pojavljuje prirodno oplemenjivanjem ili selekcijom.) in March 2015 and at the meeting of the Scientific Network of Member States for Risk Assessment of GMOs in May 2015. 

EFSA considered all feedback carefully. Some input triggered substantial revisions of the guidance (see technical report). As Dr Elisabeth Waigmann, the head of the GMO unit at EFSA, explains: “The input we received from our stakeholders was very useful. Our guidance has gained in clarity, technical precision and scientific quality. It will be an essential instrument for the risk assessment of GM plants.”

• Guidance on the agronomic and phenotypic characterisation of genetically modified plants