Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants

Adrián César-Razquin, Josep Casacuberta, Tamas Dalmay, Silvia Federici, Sara Jacchia, Dafni Maria Kagkli, Simon Moxon, Nikoletta Papadopoulou, European Food Safety Authority (EFSA)

Research output: Contribution to journalComment/debate


As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. This Technical Note to the applicants puts together requirements and recommendations for the quality assessment of the methodology, analysis and reporting when DNA sequencing is used for the molecular characterisation of GM plants. In particular, it applies to the use of Sanger sequencing and next-generation sequencing for the characterisation of the inserted genetic material and its flanking regions at each insertion site, the determination of the copy number of all detectable inserts and the analysis of the genetic stability of the inserts. This updated document replaces the EFSA 2018 Technical Note and reflects the current knowledge in scientific-technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. It does not take into consideration the verification and validation of the detection method which remains under the remit of the Joint Research Centre (JRC).
Original languageEnglish
Article numbere8744
JournalEFSA Journal
Issue number4
Early online date17 Apr 2024
Publication statusPublished - Apr 2024


  • DNA sequencing
  • genetic stability
  • genetically modified organisms
  • molecular characterisation
  • next-generation sequencing
  • NGS
  • risk assessment

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