Reconsideration of the molecular characterisation criteria for marketing authorisation of GM crops

Before a genetically modified (GM) crop can be approved for use in the European Union, it must first be assessed for any risks it may pose to human health and the environment. This environmental risk assessment must pay particular attention to the molecular characterisation of the GM crop and the inserted sequences. Information about the introduced DNA, the regulatory sequences used, and the bioinformatics analysis of the insertion and the adjacent regions provide indications of the characteristics that have or may have been altered.

In 2008 COGEM drew up several criteria for the molecular characterisation of GM crops:
 

1. It must be known which elements have been inserted into the plant genome and in how many copies. The function of these elements must be known.
2. The GM plant must be analysed for the presence of DNA from the transformation vector (the backbone DNA).
3. All insertions must be fully characterised by means of a sequence determination and this characterisation must extend into the flanking sequences of the genome.
4. The sequences spanning the insertion or insertions to the genomic DNA of the plant must be bioinformatically analysed. However, there may be situations in which there are justifiable reasons for omitting this analysis.
5. The analysis of the theoretical fusion ORFs must extend from stop codon to stop codon.
   In the light of recent advances in scientific understanding, the experience that has since been gained with permit applications for the deliberate release into the environment of GM crops, and the discussions held within COGEM when assessing permit applications, it has been decided to expand on and elucidate the criteria from 2008 and publish this in an update to the topic report of 2008.

In the light of recent advances in scientific understanding, the experience that has since been gained with permit applications for the deliberate release into the environment of GM crops, and the discussions held within COGEM when assessing permit applications, it has been decided to expand on and elucidate the criteria from 2008 and publish this in an update to the topic report of 2008.