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National Competent Authority

As described in article 2.1 of the Legislative Decree 8 July 2003 No. 224, which puts EU Directive 2001/18/CE on the deliberate release into the environment of genetically modified organisms (GMOs) into effect, the Ministery of the Environment is identified as the Italian National Competent Authority with regard to GMOs.

The National Competent Authority, as reported in article 5.2c of the Legislative Decree 8 July 2003 No. 224, is required to consult with the public during the decision-making process for the deliberate release of GMOs into the environment.

The National Competent Authority reports the results of these public consultations to the Interministrial Evaluation Commission for consideration in the final decision regarding the possible release of the specific GMO in question.

Following a favourable decision, the National Competent Authority provides the authorisation for the deliberate release of the GMOs on the basis of:

1. verification by the Release Evaluation Commission that the authorisation to deliberately release the GMO into the environment is consistent with Decree No. 224;
2. the assessment of possible effects on human health, animal health and on the environment with particular attention to natural ecosystems;
3. the level of compatibility with existing management practises regarding biodiversity, agriculture systems, and particularly organic and traditional produce.

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