2002/811/EC: 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

• Published date: 18 October 2002
• Subject Matter: Internal market - Principles,Research and technological development,Environment
• Official Gazette Publication: Official Journal of the European Communities, L 280, 18 October 2002

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2002/811/EC: 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

Official Journal L 280 , 18/10/2002 P. 0027 - 0036

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

(2002/811/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2001/18/EC of the European Parliament and of the Council(1), and in particular the first paragraph of Annex VII thereto,

Having regard to the proposal from the Commission,

Whereas:

(1) Directive 2001/18/EC stipulates that, before a genetically modified organism (hereinafter referred to as GMO) as or in products is placed on the market, a notification must be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time.

(2) 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 pursuant to Article 13(2), Article 19(3) and Article 20 of that Directive. Therefore, such notification 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.

(3) 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 that Annex.

(4) The committee set up under Article 30(2) of Directive 2001/18/EC was consulted on 12 June 2002 and has not delivered an opinion on the Commission's proposal for a Decision,

HAS ADOPTED THIS DECISION:

Article 1

The guidance notes set out in the Annex to this Decision shall be used as a supplement to Annex VII of Directive 2001/18/EC.

Article 2

This Decision is addressed to the Member States.

Done at Luxembourg, 3 October 2002.

For the Council

The President

F. Hansen

(1) OJ L 106, 17.4.2001, p. 1.

ANNEX

INTRODUCTION

Directive 2001/18/EC introduces an obligation for notifiers to implement monitoring plans in order to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after they have been placed on the market.

Notifiers are required, under Article 13(2)(e) of that Directive, to submit as part of the notification for the placing on the market of a GMO, a plan for monitoring in accordance with Annex VII of that Directive. This should include a proposal for the time-period of the monitoring plan, which may be different from the proposed period for the consent. Annex VII describes in general terms the objective to be achieved and the general principles to be followed to design a monitoring plan referred to in Article 13(2), Article 19(3) and Article 20.

This guidance note supplements the information provided in Annex VII, and in the context of the Directive:

- expands on the objectives for monitoring,

- expands on the general principles for monitoring,

- provides an outline for a general framework for the development of appropriate post-market monitoring plans.

Following the placing on the market of a GMO, the notifier, under Article 20(1) of the Directive, has a legal obligation to ensure that monitoring and reporting are carried out according to the conditions specified in the consent. Article 19(3)(f) details that the written consent should, in all cases, explicitly specify monitoring requirements in accordance with Annex VII, including obligations to report to the Commission and competent authorities. In addition, to ensure transparency in accordance with Article 20(4), the results of the monitoring should also be made publicly available.

Monitoring plans for GMOs to be placed on the market will clearly need to be developed on a case by case basis taking account of the environmental risk assessment, the modified characteristics specific to the GMO in question, their intended use and the receiving environment. This guidance note makes reference to a general framework but does not attempt to provide explicit details for the development of monitoring plans to cover all GMOs.

It might be necessary to complement this framework with more specific, supplementary guidance on monitoring plans or checklists with regard to particular traits, crops or groups of GMOs.

Monitoring can be defined, in general as the systematic measurement of variables and processes over time and assumes that there are specific reasons for collection of such data, for example, to ensure that certain standards or conditions are being met or to examine potential changes with respect to certain baselines. Against this background, it is essential to identify the type of effects or variables to be monitoring and importantly, the tools and systems to measure them and an appropriate time-period for measurements. Monitoring results may, however, be important in the development of further research.

Effective monitoring and general surveillance requires that appropriate methodology has been developed and is available prior to the commencement of monitoring programmes. Monitoring should not be regarded as research per se but as a means to evaluate or verify results and assumptions arising from previous research and evaluation of potential risk and research.

A. OBJECTIVES

Before a GMO or a combination of GMOs as or in products is placed on the market, a notification must be submitted to the competent authority of the Member State where the GMO is to be placed on the market for the first time. This notification should, in accordance with Article 13(2), contain a technical dossier of information including a full environmental risk assessment.

The environmental risk assessment aims, on a case by case basis, to identify and evaluate potential adverse effects of the GMO, either direct and indirect, immediate or delayed, on human health and the environment arising from its placing on the market. This assessment may also need to take account of potential long-term effects associated with the interaction with other organisms and the environment. The evaluation of such potential adverse effects should be founded on common methodology based on independently verifiable scientific evidence.

Individual GMOs are likely to differ considerably in terms of the inherent characteristics of the modified species as well as the specific modification and resultant characteristics. These characteristics will largely determine the nature of any potential effects arising from the placing on the market of a GMO.

It is also necessary to confirm that the pre-market risk assessment for a GMO is accurate, following its placing on the market. Moreover, the possibility of the occurrence of potential adverse effects that were not foreseen in the evaluation cannot be ignored. Post-market monitoring, as required under Article 20 of the Directive, is foreseen for this purpose.

Against this background, it is foreseen that the objectives of post-market monitoring, as detailed under Annex VII, are to:

- confirm that any assumptions regarding the occurrence and impact of potential adverse effects of the GMO or its use in the environmental risk assessment are correct, and

- identify the occurrence of adverse effects of the GMO or its use on human health or the environment which were not anticipated in the environmental risk assessment.

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 with respect 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...