The EU-Monitoring Working Group: Harmonisation and coordination of data

Abstract

According to Directive 2001/18/EC, 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 on the market of a GMO. Therefore, such notifications must contain a plan for monitoring, including a proposal for the time period of the monitoring plan, in accordance with Annex VII to Directive 2001/18/EC. Annex VII to Directive 2001/18/EC should be supplemented by notes providing detailed guidance on the objectives, general principles and design of the monitoring plan referred to in this Annex. On 3 October 2002 the Council of the European Union has adopted a Decision establishing guidance notes supplementing Annex VII to Directive 2001/18/EC. These guidance notes expand on the objectives and general principles for postmarketmonitoring 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 onmonitoring plans or checklists with regard to particular traits, crops or groups of GMOs’. To this aim, the EUMonitoringworking Group has been set up by the Commission and the Competent Authorities under Directive 2001/18/EC. The work of the group is thus under the responsibility of the risk managers, as GMOMonitoring is part of the riskmanagementmeasures to be taken in each decision for authorising a GMO. The major goals of the Monitoring Working Group are to elaborate monitoring concepts, plans, methods and parameters for case specific monitoring as well as for general surveillance on the basis of previous work in other for a provide further guidance for notifiers and competent authorities for the set up and auditing of monitoring plans harmonise the monitoring of GMOs in the EU. The main objective was to elaborate details of monitoring plans for certain GMOs or groups of GMOs. To this aim, specific sets of monitoring parameters, criteria andmethods are being developed, leading to checklists for individual groups of GMOs and for different transgenic phenotypes. The part of the work of the group is the EU-wide coordination of data resulting from post-market monitoring of GMOs; the group is currently in a preliminary phase.

DOI: 10.1007/s00003-007-0255-y

Cite this paper

@article{Bruetschy2007TheEW, title={The EU-Monitoring Working Group: Harmonisation and coordination of data}, author={C. Bruetschy and Anouk Andr{\'e}}, journal={Journal f{\"{u}r Verbraucherschutz und Lebensmittelsicherheit}, year={2007}, volume={2}, pages={6-6} }