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Risk Assessment and Regulation of Genome Edited Plants

All organisms, including those produced by new molecular genetic methods, are covered by the regulations for risk assessment, release, placing on the market, labeling and traceability of genetically modified organisms (GMOs). The actual genetic changes in any given organism are not relevant according to a ruling of the European Court of Justice (ECJ) in Juli 2018 on the interpretation of the EU Release Directive 2001/18/EC concerning the legal classification of modified organisms utilizing genome editing.

One of the consequences of the ECJ ruling is that genome edited plants with simple point mutations or gene inactivations, which could also have accidentally occurred in nature or achieved by conventional breeding methods, must also be regulated as GMOs. It is irrelevant whether the origin of the genetic modification can be assigned to a method.

The planned statement is intended to analyze the consequences of the ECJ interpretation of the release directive for research and application of genome editing in closed systems, for agriculture and biotechnology in Germany. One objective is to develop proposals on how the legislator can reach a legal regulation appropriate to scientific progress, for example through product-based evaluation and dynamic legal references.


  • National Academy of Sciences Leopoldina (responsible)
  • Union of the German Academies of Science and Humanities
  • German Research Foundation (DFG)

Members of the Working Group

  • Prof. Dr. Regina Birner, Hans-Ruthenberg-Institut, Universität Hohenheim,
  • Prof. Dr. Ralph Bock ML, Max-Planck-Institut für Molekulare Pflanzenphysiologie
  • Prof. Dr. Hans-Georg Dederer, Juristische Fakultät, Universität Passau
  • Prof. Dr. Bärbel Friedrich ML, Nationale Akademie der Wissenschaften Leopoldina
  • Prof. Dr. Bernd Müller-Röber, Lehrstuhl für Molekularbiologie, Universität Potsdam
  • Prof. Dr. Holger Puchta, Botanisches Institut, Karlsruher Institut für Technologie, Karlsruhe
  • Prof. Dr. Matin Qaim ML, Lehrstuhl für Welternährungswirtschaft, Georg-August-Universität Göttingen
  • Prof. Dr. Chris-Carolin Schön ML, Wissenschaftszentrum Weihenstephan für Ernährung, Landnutzung und Umwelt, Technische Universität München
  • Prof. Dr. Klaus Tanner ML, Theologische Fakultät, Universität Heidelberg
  • Prof. Dr. Jochen Taupitz ML, Juristische Fakultät, Universität Mannheim
  • Prof. Dr. Jörg Vogel ML, Helmholtz-Institut für RNA-basierte Infektionsforschung, Würzburg
  • Prof. Dr. Detlef Weigel ML, Max-Planck-Institut für Entwicklungsbiologie, Tübingen
  • Dr. Ralf Wilhelm, Julius Kühn-Institut, Institut für die Sicherheit biotechnologischer Verfahren bei Pflanzen, Quedlinburg
  • Prof. Dr. Ernst-Ludwig Winnacker ML, Genzentrum der Ludwig-Maximilians-Universität München

ML = Member of the Leopoldina



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