Info Session on Applications – GMO – Technical Meeting with Stakeholders on agronomic and phenotypic characterisation of genetically modified plants

18 December 2014

EFSA considers stakeholders’ feedback to finalise GM guidance update

The European Food Safety Authority (EFSA) is set to finalise a new guidance document on genetically modified (GM) plants. The new guidelines update existing ones by further specifying to applicants the kind of data needed for the agronomic and phenotypic characterisation of GM plants. A comprehensive and more harmonised approach will enable EFSA to render its risk assessment in this area more efficient.

EFSA met with stakeholders on 18 and 19 December 2014 in Parma, Italy, to discuss and clarify the over 250 comments received during a six week public consultation on the new draft document. More than 40 participants attended the workshop, representing national risk assessment bodies, academic institutions, biotech companies and one non-governmental organisation.

Stakeholders provided their feedback on four key topics:

  • Objectives of the agronomic and phenotypic characterisation of GM plants.
  • Agronomic and phenotypic endpoints, field trial design and data analysis.
  • Representativeness of field trial sites.
  • Persistence and invasiveness assessment of GM plants.

Both the public consultation and the workshop are testimony to EFSA’s continuous efforts to increase transparency and openness, and EFSA’s commitment to engage in a constructive dialogue with its stakeholders.

The feedback received will contribute significantly to the revision of the guidelines, says Dr Elisabeth Waigmann, the head of the genetically modified organisms unit at EFSA. “EFSA facilitated a highly interactive dialogue with stakeholders to optimise clarity, exchange views and provide technical input. The concerns and suggestions raised will undoubtedly help EFSA to fine-tune the draft document”, says Dr Waigmann.

Comments received during the public consultation as well as feedback from the workshop go back to the working group that had been established to develop the new guidance document. Working group chair Dr Antoine Messéan says that crucial work now lies ahead. “The revision of the draft guidelines will be a challenging task considering the diverging views expressed by different stakeholders. We will consider all relevant suggestions for the completion of these guidelines which will be an essential instrument to risk assessors and applicants alike”, says Dr Messéan.

The final adoption of the new guidance document is expected in spring 2015.

Note to editors

Agronomic characteristics relate to crop management, production and performance (e.g. yield and herbicide regimes). Phenotypic characteristics related to the physical form and development of plants (e.g. height and flower colour).