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Law, Regulation or Guideline
Record information and status
Record ID
115264
Status
Published
Date of creation
2019-11-08 16:05 UTC (chantal.bruetschy@ec.europa.eu)
Date of publication
2019-11-08 16:05 UTC (chantal.bruetschy@ec.europa.eu)

General Information
Country
  • European Union
Jurisdiction
  • European Union
Title of document
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
Legislative details
Type of document
  • National Guideline
Subject areas
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
  • Risk assessment and management
Types of LMOs addressed
  • Plants
Brief description of the document including objective and scope:
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
Date of entry into force
2018-10-01
Document details
Document text
EN
https://www.efsa.europa.eu/en/efsajournal/pub/5345
Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
Regulatory contact information
Contact person
European Food Safety Authority (EFSA) GMO Panel
European Food Safety Authority
Largo N. Palli 5/A 

Parma
Italy, 43121
Phone:+39 0521 036566
Email:Elisabeth.Waigmann@efsa.europa.eu
Url:http://www.efsa.europa.eu/