Submission procedure of notifications for the deliberate release of GMOs for experimental purposes

In Italy the authorization procedure for the deliberate release of GMOs for any other purpose than for placing on the market is governed by the Title II of Legislative Decree 8 July 2003 n. 224 implementing Directive 2001/18/EC.

Any person shall, before undertaking a deliberate release of a GMO, submit a notification (one electronic copy in Italian and one electronic copy in English language) to the National Competent Authority :

Italian National Competent Authority
Ministry for Environment, Land and Sea Protection,
Directorate General for Environmental Assessments and Permits
Via Cristoforo Colombo, 44
Cap.00147, Rome, Italy
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
PEC: This email address is being protected from spambots. You need JavaScript enabled to view it.

Pursuant to Article 3 of Legislative Decree n. 224/2003, notification means: “the submission, ..... , by any mean capable of producing a written record, to the national competent authority under Article 2 or the submission of the same information to the competent authority of another EU Member State ".

The notification shall contain:

  1. a technical dossier, on paper and in e-format, supplying the information specified in Annex III of Legislative Decree 8 July 2003 n. 224, “Mandatory information for the notification” for carrying out the environmental risk assessment for the deliberate release of a GMO, in particular:
    1) general information including information on personnel and training;
    2) information relating to the GMO(s);
    3) information relating to the conditions of the release and the potential receiving environment;
    4) information on the interactions between the GMO(s) and the environment;
    5) a monitoring plan in accordance with the relevant parts of Annex III in order to identify effects of the GMO(s) on human and animal health or on the environment;
    6) information on control, remediation methods, waste treatment and emergency response plans,
    7) a summary of the dossier, in Italian and in English, in accordance to Decision 2002/813/EC, which shall contain all information specified in article 27, paragraph 4 of Legislative Decree n. 224/2003.

  2. the environmental risk assessment and the conclusions required in Annex II, section D of Legislative Decree n. 224/2003, together with any bibliographic reference and indications of the methods used, on paper and in e-format.
  3. the risk assessment for agro-biodiversity, agricultural systems and food chain, in accordance to the procedure laid down in Decree 19 January 2005 concerning “Requirements for risk assessment for agro-biodiversity, agricultural systems and food chain for the activities of deliberate release into the environment of GMOs for any other purpose than for placing on the market".

 

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