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 puts together requirements and
recommendations for when DNA sequencing is part of the molecular
characterisation of GM plants, in particular for the
characterisation of the inserted genetic material at each insertion
site and flanking regions, the determination of the copy number of
all detectable inserts, and the analysis of the genetic stability
of the inserts, when addressed by Sanger sequencing or NGS
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