Based on the scientific and technical information emerging during the risk assessment, which induces the decision maker to accept or not the assessed risk, with eventual limitations and requirements, the risk management is carried out on the basis of the application of appropriate mechanisms, measures and strategies to regulate, manage and control risks identified and associated with the use, handling and transboundary movement of LMOs.

An important aspect in the process of management of the risk deriving from LMOs is the so-called post-release monitoring, i.e. the activity of observation during the period following the emission in the environment of the LMOs.

Monitoring allows to:

• verify the effectiveness of containment measures taken by the person making the release and their compliance with applicable law;
• check that no adverse effects, arising from factors not included in the risk assessment phase, emerge from LMOs on human and animal health and on the environment.

 

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Deliberate release of GMOs for any other purpose than for placing on the market

The submission of a notification to the Ministry of the Environment and Energy Security for the deliberate release of a GMO into the environment for experimental purposes requires the payment of two separate fees.

As of January 1, 2025, pursuant to Circular RGS of 16/12/2024, No. 41, these payments must be made to the Treasury Single Account at the Bank of Italy:

• Payment of €1,549.37, for the processing of the notification, to be made by the notifier to the Treasury Single Account at the Bank of Italy (Chapter 2592/12, HEADING 32, IBAN CODE IT98T0100003245BE00000001ZM);

• Payment of €51.65, for the issuance of the authorization or refusal decision, to be made by the notifier to the Treasury Single Account at the Bank of Italy (Chapter 2592/12, HEADING 32, IBAN CODE IT98T0100003245BE00000001ZM).

For both payments, the following payment description must be indicated:
Notification of deliberate release of GMOs into the environment for research and development purposes (Art. 38 of Legislative Decree No. 224/2003), Chapter 2592, Article 12, Ministry of the Environment and Energy Security.

 

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Placing on the Market of GMOs as Such or Contained in Products

The submission of a notification to the Ministry of the Environment and Energy Security for the placing on the market of GMOs requires the payment of two separate fees.

As of January 1, 2025, pursuant to Circular RGS of 16/12/2024, No. 41, these payments must be made to the Treasury Single Account at the Bank of Italy:

• Payment of €3,098.74, for the processing of the notification, to be made by the notifier to the Treasury Single Account at the Bank of Italy (Chapter 2592/12, HEADING 32, IBAN CODE IT98T0100003245BE00000001ZM);

• Payment of €51.65, for the issuance of the authorization or refusal decision, to be made by the notifier to the Treasury Single Account at the Bank of Italy (Chapter 2592/12, HEADING 32, IBAN CODE IT98T0100003245BE00000001ZM).

For both payments, the following payment description must be indicated:
Notification of placing GMOs on the market (Art. 38 of Legislative Decree No. 224/2003), Chapter 2592, Article 12, Ministry of the Environment and Energy Security.

 

In Italy, the placing on the market of GMOs is regulated by Title III of legislative decree 8 July 2003, no. 224.

Anyone intending to place a GMO on the EU market is required to:

1. submit a notification (in electronic format in Italian and English) to the Italian competent authority:

Italian Competent Authority

Ministry of the Environment and Energy Security
Directorate-General for the Protection of Biodiversity and the Sea
Via Cristoforo Colombo 44, 00147 Rome
Phone: +39 06 5722 3401
Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 
Certified Email (PEC): This email address is being protected from spambots. You need JavaScript enabled to view it.

2. inform of the submission of the notification the:

Ministry of Health;
Ministry of Agriculture, Food and Forestry;
Ministry of Labour and Social Policy;
Ministry of Economic Development;
Ministry of University and Research.

The notification must include:

1. a copy of the assessment report for the notification regarding deliberate release of a GMO Under article 13, paragraph 3 of legislative decree 8 July 2003, n. 224.
2. the information required, in Annexes III and IV, shall take into account the diversity of sites of use of the GMO and shall include information on data and results concerning the impact of the release on human and animal health and the environment for deliberate release of GMOs for any other purpose than for placing on the market;
3. the environmental risk assessment required in Annex II, section D, shall take into particular consideration risk assessment for agro-biodiversity, natural ecosystem, agricultural systems and food chain;
4. the conditions for the placing on the market of the product, including specific conditions of use and handling;
5. a proposed period for the consent which should not exceed ten years;
6. a plan for monitoring in accordance with Annex VII, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent;
7. a proposal for labelling, which shall comply with the requirements laid down in Annex IV and it shall include the words «this product contains genetically modified organisms».
8. a proposal for packaging;
9. 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 8 July 2003, no. 224.

Exchange of information:
The exchange of information pursuant to legislative decree 8 July 2003, no. 224, between the Member States and the European Commission as of 2022 takes place via the European Commission's special digital platform (E-Submission Food Chain Platform - ESFC).
The notifier is therefore required to submit the notification through the ESFC platform of the European Commission at the same time as he submits a notification under Title III of the legislative decree of 8 July 2003, no. 224, to the Italian competent authority.

Fares

 

Directive (EU) 2015/412, amending directive 2001/18/EC, grants Member States the possibility to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory with two phases mechanism, after the authorisation for cultivation of such GMO.

Directive (EU) 2015/412 also provides transitional measures: from 2 April 2015 until 3 October 2015, Member States could demand that the geographical scope of a notification submitted, or of an authorization for cultivation granted, under Directive 2001/18/EC or Regulation (EC) no 1829/2003 before 2 April 2015 be adjusted.

Nineteen Member States including Italy demanded and obtained the restriction of the geographical scope of six varieties of GM maize (MON810, 1507, 59122, Bt11, GA21 and 1507x59122).

Restrictions of geographical scope of GMO applications/authorisations: EU Coutries demands and outcomes

Commission Implementing Decision (EU) 2016/321, that adjusting the geographical scope of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810, has been published in the Official Journal of the European Union on 5 March 2016.

In Italy, directive (EU) 2015/412 has been implemented by:

• law of 9 July 2015, n. 114 (European delegation law 2014) which delegates to the Government the adoption of the legislative decree implementing the directive;
• law of 29 July 2015, n. 115 (European law 2014) implementing transitional measures.

Pursuant law n. 114/2015, legislative decree 14 November 2016, n. 227, implementing directive (EU) 2015/412, was issued.

Pursuant law n. 115/2015, the Minister of Agriculture, Food and Forestry Policies in agreement with the Minister for the Environment, Land and Sea Protection and the Minister of Health, sent to the European Commission the demands for adjust the geographical scope for six varieties of GM maize; all the demands were accepted.