Brussels, 18 October 2002
Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L280/ 18.10.2002). Full text [NB links expire 45 days from publication date]
Council Decision of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products (OJ L280/37 18.10.2002). Full text
Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market (OJ L280/62 18.10.2002). Full text
Extract from guidance notes:
B. GENERAL PRINCIPLES
Monitoring as detailed in Articles 13, 19 and 20 of Directive 2001/18/EC and in the context of this guidance note refers to post-market monitoring, which takes place after consent for the placing of a GMO on the market has been granted.
Article 13(2)(e) of the Directive requires notifiers to submit, as part of their notifications, a plan for monitoring in accordance with Annex VII.
The consent should, under Article 19(3)(f), specify the time period of the monitoring plan and, where appropriate, any obligations on persons selling the product or any user of it, inter alia, in the case of cultivation, concerning a level of information deemed appropriate on their location.
On the basis of reports submitted by notifiers, in accordance with the consent and the framework for the monitoring plan specified, the competent authority receiving the original notification should inform the Commission and the Competent Authorities about the results and may, as detailed in Article 20(1), and, where necessary, in consultation with the other Member states, adapt the monitoring plan after the first monitoring period.
Planning is essential withrespect to all types of monitoring and when developing monitoring plans, both case-specific monitoring and general surveillance should be considered. In addition, monitoring of potential adverse cumulative long-term effects should be considered as a compulsory part of the monitoring plan.
Case-specific monitoring should, when included in the monitoring plan, focus on potential effects arising from the placing on the market of a GMO that have been highlighted as a result of the conclusions and assumptions of the environmental risk assessment. However, whilst it is possible to predict that certain effects may occur, on the basis of risk assessment and available scientific information, it is considerably more difficult to plan for potential effects or variables that cannot be foreseen or predicted. It may, however, be possible through appropriate planning of monitoring and surveillance plans to optimise the chances for early detection of such effects. The design of the monitoring plan should, therefore incorporate general surveillance for unanticipated or unforeseen adverse effects.
The cost-effectiveness of case-specific monitoring and general surveillance should be taken into account in this context. Furthermore, the monitoring plan should be in accordance with the latest scientific insights and practices.
Member States may themselves also assist with monitoring via the general duty under Article 4(5), which requires that the competent authority organises inspections and other control measures as appropriate, to ensure compliance with the Directive. Indeed, Member States are entitled, in accordance with the Treaty, to take further measures for monitoring and inspection, for example by national authorities, of GMOs as or in products placed on the market. However, it should be recognised that such action is not a substitute for the monitoring plan for which notifiers are responsible (although, with the consent of the relevant parties, may form part of it).
Interpretation of the data collected via monitoring should take account of existing environmental conditions and activities in order to determine an appropriate baseline. General surveillance and environmental monitoring programmes in general may similarly assist in this context. Where unexpected changes in the environment are observed, further risk assessment may need to be considered to establish whether they have arisen as a consequence of the placing on the market of the GMO or as a result of other factors. Against this background, measures necessary to protect human health and the environment may also have to be considered....
Official Journal of the EC, L280 18.10.2002
Official Journal of the EC, L280 18.10.2002