Policy Making
Post-market monitoring of GMOs (import and cultivation)
 According to Directive 2001/18/EC on the deliberate release of Genetically Modified Organisms into the environment, the notifier must ensure that monitoring and reporting on the deliberate release of GMOs are carried out in accordance with the conditions specified in the authorisation for the placing of the GMO on the market. Therefore a notification must contain a monitoring plan including a proposal for the time period of the monitoring plan in accordance with Annex VII to Directive 2001/18/EC.
It is the function of Post Market Environmental Monitoring (PMEM) to:
- confirm any assumptions regarding possible adverse effects of the GM plant identified in the Environmental Risk Assessment (ERA), i.e. Case Specific Monitoring (CSM)
- detect any unforeseen adverse effects, i.e. General Surveillance (GS)
The general principle is that the PMEM plan:
- is developed on a case-by-case basis with respect to each decision for the placing of a GMO on the
market
- includes General Surveillance and Case Specific Monitoring where identified in the ERA.
Annex VII of Directive 2001/18/EC has been supplemented with guidance notes (Commission Decision 2002/811/EC) which expand on the objectives and general principles of post market monitoring of GMOs as well as on a general framework for the development of appropriate post market monitoring plans. This decision refers to the possible need to complement the existing 'framework with more specific supplementary guidance on monitoring plans or checklists with regard to particular traits, crops or groups of GMOs'. On this basis the EU Monitoring Working Group was established by the Commission and the Competent Authorities under Directive 2001/18/EC in 2004. The main objective of the monitoring working group was to elaborate details of monitoring plans for certain GMOs or groups of GMOs leading ultimately to the development of monitoring checklists. However these checklists do not necessarily reflect the legislative framework with respect to monitoring as outlined above. Rather they represent and comprise a more inclusive list of research studies, monitoring and General Surveillance that could be undertaken after the GM crop has been placed on the market. The explanatory notes serve to explain the status of the checklists, the nature of the different checklists, and the difference between the two potato checklists. The explanatory notes should be read in advance of consulting the checklists.
A second part of the work of the group was to consider the environmental monitoring of GMOs with particular reference to General Surveillance. The Guidance notes provide useful general information and principles required in the monitoring plan, but they do not clearly indicate approaches and methods that should be used either in Case-Specific Monitoring or in General Surveillance which are both components of the monitoring plan. To this end a document has been prepared which goes into the detail of GS methods, means of implementation and other considerations:
The final part of the work of the group was to consider the EU-wide co-ordination of data resulting from post market monitoring of GMOs. To this end a concepts document was adopted by the Competent Authorities in July 2006.
In a follow up document, the applicability of existing monitoring programmes and data infrastructure schemes run at EU level for monitoring GM crops, and options for implementing data coordination and harmonisation, were explored.
Monitoring Working Group Report on the Applicability of existing EU monitoring programmes and data infrastructure schemes for GMO monitoring and options for implementing data coordination and harmonisation.
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