EFSA ::. Mandates related to the environmental risk assessment of GM plants
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European Food Safety Authority (EFSA)
Scientific Opinions, Publications & Reports
Mandates related to the environmental risk assessment of GM plants
Each GM plant grown in the European Union has to undergo an extensive environmental risk assessment
to anticipate and, if possible, to identify any adverse effect it may have on the environment. The information
provided by an applicant must also include data covering several seasons of field growing trials so that any
possible adverse effects on the environment can be detected. So far only one type of GM plant, the GM
Maize MON 810 which is resistant against the European corn borer, is cultivated in some countries of the
EU.
In addition, each GM application has to be accompanied by an environmental monitoring plan
demonstrating how the applicant will monitor the GMO product with annual and longer term reporting on
any possible and unexpected adverse environmental impact. This monitoring plan will also provide
important information for the 10-year renewal assessment for a GMO application. Once an authorisation is
given by the European Union for a GMO, it must be reassessed again after a 10-year period in order to
maintain its authorisation on the market.
In parallel to the evaluation process for GM applications, EFSA has continued to update its scientific
approach to environmental risk assessment. EFSA organised for example a
Scientific colloquium on
Environmental Risk Assessment
in June 2007 with leading experts in the field from Europe and beyond.
The Colloquium considered various approaches to environmental risk assessment in the light of current
scientific thinking on issues, such as long-term effects and adverse impact on non-target organisms such as
insects. EFSA has also developed further work on Post Market Environmental Monitoring which, after a
public consultation, resulted in the publication of a specific guidance document.
Based on this work and feedback received at a
meeting with Member States on GMO risk assessment
approaches
in November 2007, EFSA’s GMO Panel will continue to develop its approach to environmental
risk assessment through a self-task activity on so-called “Non-target Organisms”. This will consist of further
developing guidance for assessing potential adverse effects that the GM plants might have on non-target
organisms, such as insects (e.g. butterflies, beetles), not targeted by the specific insect-resistant trait
expressed by the GM plant. Many GMOs are developed to be resistant to certain pests which are referred
to as “target organisms”. Non-target organisms would be those plants or animals which are affected
unintentionally by a GMO resulting in an undesired effect on plants or animals in the environment.
At the same time, EFSA has also discussed and accepted a complementary mandate from DG
Environment of the European Commission. Under this mandate, EFSA will further update the current GMO
Panel’s Guidance Document and will also cover some of the issues discussed during EFSA’s colloquium on
environmental risk assessment. More specifically, the mandate will cover issues, such as potential long-
term environmental effects and the development of criteria for setting up field trials to assess environmental
impact. EFSA “self-tasking” Working Group on statistics and experimental design will assist in this. EFSA’s
GMO Panel will complete this work over the next 24 months.
General mandate: update of EFSA guidance on environmental assessment of GMOs
Initial request from European Commission
Mandate: EFSA reply to European Commission on revised ToR
Acknowledgement of ToR by European Commission
Self-task mandate on non-target organisms
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178697444477.htm
29/04/2008