Decision 2002/811 - 2002/811/EC: Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms - Main contents

official title

 

Legal instrument	Decision
Number legal act	Decision 2002/811
Original proposal	COM(2002)359
CELEX number i	32002D0811

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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...

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