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Before deliberately releasing a GMO, a notification must be submitted to the competent authority of the Member State within whose territory the release is to take place. The notification shall include a technical dossier supplying the information specified in Annex III as well as an environmental risk assessment. The notifier may proceed with the release only after receiving the written consent of the competent authority, and in conformity with any conditions required in the consent (Art 6). The competent authority shall send a summary of each notification it receives to the Commission, which forwards it to the other Member States. The latter have thirty days to present observations. The competent authority that received the notification then makes a final decision of which it must inform the Commission, including, where relevant, the reasons for rejecting the notification. (Art 11.)
The public and, where appropriate, relevant groups shall be consulted on a proposed deliberate release. Subject to the provisions on confidentiality in Article 25, Member States also must make available to the public information on all Part B releases of GMOs in their territory. (Art 9.)
Subject to certain conditions, differentiated procedures may be approved for use in cases where sufficient experience has already been obtained of releases of certain GMOs in certain ecosystems and the GMOs concerned meet the criteria set out in Annex V (Art 7).
The introduction of GMOs into the environment should be carried out according to the so-called ‘step by step’ principle, that is, the containment is reduced and the scale of release increased gradually, step by step, but only if evaluation of the earlier steps indicates that the next step can be taken.
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