Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation - INRAE - Institut national de recherche pour l’agriculture, l’alimentation et l’environnement Access content directly
Journal Articles EFSA Supporting Publications Year : 2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Konstantinos Paraskevopoulos
  • Function : Author
Matthew Ramon
  • Function : Author
Tamas Dalmay
  • Function : Author
Patrick Du Jardin
  • Function : Author
Josep Casacuberta
  • Function : Author
Philippe Guerche
Huw Jones
  • Function : Author
Fabien Nogué
Christophe Robaglia
  • Function : Author
Nils Rostoks
  • Function : Author

Abstract

Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any DNA sequence inserted in the GM plant genome. When a GM plant is designed to produce one or more newly expressed proteins, an aspect of the risk assessment process is to characterise these proteins and to reliably determine their levels in the GM plant tissues. A number of methods to measure protein expression levels are used and several experimental factors within these methods are of critical importance in order to obtain reliable results. This explanatory note provides details on key methodological aspects for the determination of newly expressed protein levels that should be considered and reported by applicants in order to harmonise the information in GM plant applications submitted to EFSA.
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hal-04009571 , version 1 (01-03-2023)

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Konstantinos Paraskevopoulos, Matthew Ramon, Tamas Dalmay, Patrick Du Jardin, Josep Casacuberta, et al.. Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation. EFSA Supporting Publications, 2018, 15 (8), pp.1-13. ⟨10.2903/sp.efsa.2018.EN-1466⟩. ⟨hal-04009571⟩
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