Ministero dell'Ambiente e della Sicurezza Energetica
In Italy, the deliberate release into the environment of GMOs for any purpose other than placing on the market, i.e. for experimental purposes, is regulated by Title II of legislative decree 8 July 2003, no 224.
Anyone intending to proceed with a deliberate release of a GMO into the environment shall submit a notification (in electronic format in Italian and English languages) to the Italian competent authority:
Italian Competent Authority
Ministry of Environment and Energy Security
General Directorate Natural Heritage and Sea
Via Cristoforo Colombo 44, 00147 Roma
Tel. 06 5722 8368-5008-3401
Email:
PEC:
The notification shall include:
(a) a technical dossier supplying the information specified in Annex III of legislative decree 8 July 2003, no. 224, “Mandatory information for notification” necessary for carrying out the environmental risk assessment of the deliberate release of a GMO or combination of GMOs, and in particular:
- general information including information on personnel and training,
- information relating to the GMO(s),
- information relating to the conditions of release and the potential receiving environment,
- information on the interactions between the GMO(s) and the environment,
- a plan for monitoring in accordance with the relevant parts of Annex III in order to identify effects of the GMO on human health or the environment,
- information on control, remediation methods, waste treatment and emergency response plans,
- a summary of the information (SNIF) referred to in the previous points, drawn up in Italian and in English (to be presented in word. or pdf. format) in accordance with Council Decision 2002/813/EC of 3 October 2002, which also contains all the information referred to in Article 27(4) of Legislative Decree 8 July 2003, No 224.
(b) the environmental risk assessment and the conclusions required in Annex II, section D of Legislative Decree 8 July 2003, No 224, together with any bibliographic reference and indications of the methods used, on paper and electronic media;
c) a risk assessment for agro-biodiversity, agrarian systems and the agri-food chain, only if the trial concerns a plant species of agronomic interest, in accordance with the Decree of 19 January 2005 "Requirements for risk assessment for agro-biodiversity, agrarian systems and the agri-food chain, in relation to activities involving the deliberate release of GMOs into the environment for any purpose other than placing on the market".
Exchange of information:
The exchange of information pursuanto to Article 14 of legislative decree 8 July 2003, no. 224, between the Member States and the European Commission as of 2022 shall take place via the European Commission's dedicated digital platform (E-Submission Food Chain Platform - ESFC).
The notifier is therefore required to submit the SNIF via the European Commission's ESFC platform at the same time as submitting a notification under Title II of Legislative Decree No 224 of 8 July 2003 to the Italian competent authority.