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

Abstract 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...

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Main Authors: European Food Safety Authority (EFSA), Adrián César‐Razquin, Josep Casacuberta, Tamas Dalmay, Silvia Federici, Sara Jacchia, Dafni Maria Kagkli, Simon Moxon, Nikoletta Papadopoulou
Format: Article
Language:English
Published: Wiley 2024-04-01
Series:EFSA Journal
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Online Access:https://doi.org/10.2903/j.efsa.2024.8744
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author European Food Safety Authority (EFSA)
Adrián César‐Razquin
Josep Casacuberta
Tamas Dalmay
Silvia Federici
Sara Jacchia
Dafni Maria Kagkli
Simon Moxon
Nikoletta Papadopoulou
author_facet European Food Safety Authority (EFSA)
Adrián César‐Razquin
Josep Casacuberta
Tamas Dalmay
Silvia Federici
Sara Jacchia
Dafni Maria Kagkli
Simon Moxon
Nikoletta Papadopoulou
author_sort European Food Safety Authority (EFSA)
collection DOAJ
description Abstract 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).
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spelling doaj-art-3e17b8523b0746d1a07c0c09418698be2025-08-20T03:30:44ZengWileyEFSA Journal1831-47322024-04-01224n/an/a10.2903/j.efsa.2024.8744Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plantsEuropean Food Safety Authority (EFSA)Adrián César‐RazquinJosep CasacubertaTamas DalmaySilvia FedericiSara JacchiaDafni Maria KagkliSimon MoxonNikoletta PapadopoulouAbstract 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).https://doi.org/10.2903/j.efsa.2024.8744DNA sequencinggenetic stabilitygenetically modified organismsmolecular characterisationnext‐generation sequencingNGS
spellingShingle European Food Safety Authority (EFSA)
Adrián César‐Razquin
Josep Casacuberta
Tamas Dalmay
Silvia Federici
Sara Jacchia
Dafni Maria Kagkli
Simon Moxon
Nikoletta Papadopoulou
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
EFSA Journal
DNA sequencing
genetic stability
genetically modified organisms
molecular characterisation
next‐generation sequencing
NGS
title Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
title_full Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
title_fullStr Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
title_full_unstemmed Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
title_short Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
title_sort technical note on the quality of dna sequencing for the molecular characterisation of genetically modified plants
topic DNA sequencing
genetic stability
genetically modified organisms
molecular characterisation
next‐generation sequencing
NGS
url https://doi.org/10.2903/j.efsa.2024.8744
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