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Transgenic Research

, Volume 23, Issue 1, pp 1–25 | Cite as

EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead

  • Yann Devos
  • Jaime Aguilera
  • Zoltán Diveki
  • Ana Gomes
  • Yi Liu
  • Claudia Paoletti
  • Patrick du Jardin
  • Lieve Herman
  • Joe N. Perry
  • Elisabeth Waigmann
Review

Abstract

Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA’s scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA’s GMO Unit. This review presents EFSA’s scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA’s risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.

Keywords

Food and feed safety GM animals GM plants GM trees Monitoring New biotechnology-based plant breeding techniques Protection goals Safeguard clauses Safety 

Notes

Acknowledgments

We thank current and previous members of the EFSA GMO Panel (http://www.efsa.europa.eu/en/gmomembers/gmopreviousmembers.htm), the experts of the various Working Groups of the EFSA GMO Panel (http://www.efsa.europa.eu/en/gmo/gmowgs.htm), as well as EFSA GMO Unit colleagues (http://www.efsa.europa.eu/en/staffdirectory/docs/staffdirectory.pdf) for inspiring discussions that helped to develop this publication. We thank two anonymous reviewers for insightful comments that helped to improve this publication.

Supplementary material

11248_2013_9741_MOESM1_ESM.pdf (332 kb)
Supplementary material 1 (PDF 332 kb)

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Copyright information

© Springer Science+Business Media Dordrecht 2013

Authors and Affiliations

  • Yann Devos
    • 1
  • Jaime Aguilera
    • 1
  • Zoltán Diveki
    • 1
  • Ana Gomes
    • 1
  • Yi Liu
    • 1
  • Claudia Paoletti
    • 1
  • Patrick du Jardin
    • 2
  • Lieve Herman
    • 3
  • Joe N. Perry
    • 4
  • Elisabeth Waigmann
    • 1
  1. 1.GMO UnitEuropean Food Safety Authority (EFSA)ParmaItaly
  2. 2.Unité de Biologie végétale, Gembloux Agro-Bio TechUniversity of Liège (ULg)GemblouxBelgium
  3. 3.Unit Technology and Food SciencesInstitute of Agricultural and Fisheries Research (ILVO)MelleBelgium
  4. 4.Oaklands BarnNorfolkUK

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