Considerations on COM(2002)359 - Guidance notes supplementing Annex VII to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms

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(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.