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Experimental releases of GMOs in the EU
(Last revised:
February 28, 2006
)
Legislation
Experimental releases in the EU of genetically modified organisms (GMOs) is regulated since the early 1990s. Directive 90/220/EEC was the first main legislation regulating the release of all GMOs (plants, animals, micro-organisms) into the environment. Part B of this regulation stipulated provisions for experimental releases.
On 17 October 2002, Directive 90/220/EC has been repealed by Directive 2001/18/EC. In order to get a consent for experimental release of a GMO nowadays, a notification should be submitted under Part B of the Directive 2001/18/EC.
Conditions
Experimental releases for GMOs can only be granted if certain conditions are fulfilled. The applicant should submit to the competent authority of the Member State where the experimental release will take place, a notification describing the experimental release according to the principles laid down in Directive 2001/18/EC and measures taken to avoid any potential adverse effect for environment and human and animal health. In addition, a summary of the notification, termed SNIF (summary notification information format), should be made available in order to inform the public through its publication on the internet (http://gmoinfo.jrc.it).
Evaluation of the request for experimental release
Once a notification for experimental release has been submitted, it will be evaluated in the Member State where the experimental release will take place for its completeness (is all the requested information given?) and its scientific relevance. On the basis of the evaluation, the national Competent Authority will grant an authorisation for experimental release.
Submitting a notification
For new notifications the standard authorisation procedure needs to be followed by the notifier as described in Article 6 of Directive 2001/18/EC and Article 15-18 of the Belgian Royal Decree of 21 February 2005.
Next to the classical procedure the notifier has the possibility to apply for a differentiated procedure, as mentioned in Article 7 of the Directive 2001/18/EC and in Article 19 of the Belgian Royal Decree of 21 February 2005. If for certain types of Genetically Modified Plants enough knowledge, data and sufficient experience have been obtained concerning the necessary prerequisites for safety to human health and environment, the notifier may request the application of a differentiated procedure. Specific criteria have been established.
Notifications for experimental release submitted in the EU
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submitted under Directive 90/220/EEC and Directive 2001/18/EC: http://gmoinfo.jrc.it
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