EFSA Guidance – Comments 6 November 2014

PRRI comments on the EFSA Guidance Document on the Agronomic and Phenotypic Characterisation of GM Plants. 6 November 2014



On 25 September 2014, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) launched an open consultation on a draft Guidance Document on the agronomic and phenotypic characterisation of genetically modified plants.

As the introduction to the consultation explains, the aim of the draft Document is to provide guidance for the agronomic and phenotypic characterisation of GM plants, and will assist applicants in the generation, analysis and interpretation of the agronomic/phenotypic dataset submitted as part of their GM plant applications in the frame of Regulation (EC) No 1829/2003.


Comments PRRI

In general, PRRI welcomes initiatives that strengthen the science base and harmonisation of  agronomic and phenotypic characterisation of GM plants for risk assessment in the context of regulatory decision making.

However, the draft EFSA guidance document appears to be of little use in this context, and will in fact be counterproductive if adopted in its current form as well as very inhibitive for public sector institutions.

The problem with the current draft is that it mixes and confounds so many issues that it is not really possible – nor meaningful – to indicate specific points to be revised, as a fundamental revision would be appropriate.

PRRI therefore limits its comments in this stage to the general observations below, and will specify and illustrate these points at the Technical Meeting with Stakeholders on agronomic and phenotypic characterisation of genetically modified plants Parma, 18 December 2014.

The draft guidance:

  • seems to aim at the collection of data that could be interesting for academic or variety registration, rather than focusing on the collection of agronomic and phenotypic data that are biologically relevant in the context of risk assessment,
  • has lost sight of the fundamental distinction of ‘need to know and nice to know’,
  • lacks scientific justification for the changes and significant expansion of data collection it proposes vis a vis current practices,
  • mixes data requirements for food/feed assessments and for environmental risk assessment for cultivation,
  • is inconsistent with practices elsewhere in the world.