TY - JOUR
T1 - Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
AU - César-Razquin, Adrián
AU - Casacuberta, Josep
AU - Dalmay, Tamas
AU - Federici, Silvia
AU - Jacchia, Sara
AU - Kagkli, Dafni Maria
AU - Moxon, Simon
AU - Papadopoulou, Nikoletta
AU - European Food Safety Authority (EFSA)
PY - 2024/4
Y1 - 2024/4
N2 - 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).
AB - 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).
KW - DNA sequencing
KW - genetic stability
KW - genetically modified organisms
KW - molecular characterisation
KW - next-generation sequencing
KW - NGS
KW - risk assessment
UR - http://www.scopus.com/inward/record.url?scp=85190838919&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2024.8744
DO - 10.2903/j.efsa.2024.8744
M3 - Comment/debate
VL - 22
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
IS - 4
M1 - e8744
ER -