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European Food Safety Authority (EFSA)

New guidance on environmental risk assessment of GM plants

The European Food Safety Authority (EFSA) has published new, fundamentally revised guidance on the environmental risk assessment of genetically modified (GM) plants. The document specifies which data developers of GM plants have to submit with an application for authorisation in the EU, and how the information is to be collected and analysed.

Catherine Geslain-Lanéelle, Executive Director of the European Food Safety Authority (EFSA), and José Manuel Barroso, President of the European Commission. The European Commission and the Council of Ministers asked EFSA to draw up new guidance on the environmental risk assessment of GM plants over two years ago.

The new guidelines give detailed information about what data is required for the legally prescribed environmental risk assessment of GM plants. For a GM plant to be authorised, any impacts on the environment or on human or animal health must not differ from those of comparable conventional plants. The safety of a new GM plant is not assessed in absolute terms, but in relation to a conventional comparator plant.

The European Commission asked EFSA to revise the guidance on the environmental risk assessment of GM plants at the beginning of 2008, placing greater emphasis on possible long-term effects of GM plants and on potential impacts on non-target organisms.

At the end of 2008, the Environment Council also resolved that the guidance should be critically reviewed in a process involving not only the EU Member States and the relevant national authorities, but also other stakeholders, including environmental NGOs and seed companies. In addition, the draft guidance was laid open for public consultation by EFSA at the beginning of 2010 for two months and the public was invited to give feedback. Nearly 500 comments were received.

The result of this process has now been published: a scientific opinion paper from EFSA’s GMO Panel containing new, much more precise guidance on the environmental risk assessment of GM plants. In future, this guidance will have to be followed by anyone submitting new GM plants for authorisation in the EU.

The following areas in particular will need to be properly clarified when assessing the safety of new GM plants:

  • invasiveness, including plant-to-plant gene transfer,
  • plant-to-micro-organism gene transfer,
  • interaction of the GM plant with target organisms (pests),
  • interaction of the GM plant with non-target organisms,
  • impact of the cultivation and harvesting techniques used with the GM plant,
  • effects of the GM plant on biogeochemical processes (e.g. soil quality),
  • effects of the GM plant on human and animal health.

The EFSA panel has also specified how to select the comparator plants to be used in the environmental risk assessment, and the types of receiving environments in which the relevant trials and studies must be conducted. In addition, the guidance contains a number of other details, like the statistical methods to be used.

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