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Record information and status
Record ID
Date of creation
2011-07-28 19:47 UTC (andrew.bowers@cbd.int)
Date of last update
2012-05-25 18:50 UTC (manoela.miranda@cbd.int)
Date of publication
2012-06-01 19:03 UTC (dina.abdelhakim@cbd.int)

General Information
Environmental risk assessment of genetically modified plants - concepts and controversies
Angelika Hilbeck, Matthias Meier, Jörg Römbke, Stephan Jänsch, Hanka Teichmann and Beatrix Tappeser
Organization(s) involved in the publication of this resource
Angelika Hilbeck
Ecostrat GmbH
Hottingerstrasse 32
Switzerland, 8032
  • English
Publication date
Summary, abstract or table of contents

Background and purpose

In Europe, the EU Directive 2001/18/EC lays out the main provisions of environmental risk assessment (ERA) of genetically modified (GM) organisms that are interpreted very differently by different stakeholders. The purpose of this paper is to: (a) describe the current implementation of ERA of GM plants in the EU and its scientific shortcomings, (b) present an improved ERA concept through the integration of a previously developed selection procedure for identification of non-target testing organisms into the ERA framework as laid out in the EU Directive 2001/18/EC and its supplement material (Commission Decision 2002/623/EC), (c) describe the activities to be carried out in each component of the ERA and (d) propose a hierarchical testing scheme. Lastly, we illustrate the outcomes for three different crop case examples.

Main features

Implementation of the current ERA concept of GM crops in the EU is based on an interpretation of the EU regulations that focuses almost exclusively on the isolated bacteria-produced novel proteins with little consideration of the whole plant. Therefore, testing procedures for the effect assessment of GM plants on non-target organisms largely follow the ecotoxicological testing strategy developed for pesticides. This presumes that any potential adverse effect of the whole GM plant and the plant-produced novel compound can be extrapolated from testing of the isolated bacteria-produced novel compound or can be detected in agronomic field trials. This has led to persisting scientific criticism.


Based on the EU ERA framework, we present an improved ERA concept that is system oriented with the GM plant at the centre and integrates a procedure for selection of testing organisms that do occur in the receiving environment. We also propose a hierarchical testing scheme from laboratory studies to field trials and we illustrate the outcomes for three different crop case examples.

Conclusions and recommendations

Our proposed concept can alleviate a number of deficits identified in the current approach to ERA of GM plants. It allows the ERA to be tailored to the GM plant case and the receiving environment.
Thematic areas
Background material to the “Guidance on risk assessment of living modified organisms”
Is this document is recommend as background material for the “Guidance on Risk Assessment of Living Modified Organisms”
Section(s) of the “Guidance on Risk Assessment of Living Modified Organisms” this background material is relevant
Additional Information
Type of resource
  • Article (journal / magazine / newspaper)
Publisher and its location
Environmental Sciences Europe - a Springer Open Journal
© 2011 Hilbeck et al; licensee Springer.
12 page PDF file
Keywords and any other relevant information
Citation: Hilbeck et al.: Environmental risk assessment of
genetically modified plants - concepts and controversies. Environmental
Sciences Europe 2011 23:13.