Italy is a Member State of the European Union and therefore the EU legislation on genetically modified organisms (GMOs), which has been put in place since the early 1990s, is either directly applicable in Italy or has been implemented into Italian law. The EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main legislative acts on GMOs, adopted by the European Parliament and the Council as co-legislators, are: - Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. - Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed. - Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. - Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms. - Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003. - Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. - Commission Regulation 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired. - Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. - Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory. - Commission directive (EU) 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms - Commission implementing decision (EU) 2018/1790 of 16 November 2018, repealing decision 2002/623/EC, establishing guidance notes on the environmental risk assessment of genetically modified organisms. Italy has fully implemented existing EU legislation into national law through: - Legislative decree 12 April 2001, n. 206 implementing directive 98/81/EC on the confined use of genetically modified micro-organisms. - Legislative decree 8 July 2003 n. 224 "Implementation of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms." - Decree 19 January 2005 concerning requirements for risk assessment for agro-biodiversity, agricultural systems and food chain for the activities of the deliberate release into the environment of GMOs for any other purpose than marketing." - Legislative decree 21 March 2005, n. 70 "Penalties for violations to regulations (EC) n. 1829/2003 and n. 1830/2003". - Legislative decree 27 January 2010 implementing directive 2008/68/CE on the inland transport of dangerous goods. - Legislative decree 14 November 2016, n. 227 "Implementation of directive (EU) 2015/412, amending directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory". - Decree 8 November 2017 adopting the general plan for the supervisory activities on the deliberate release into the environment of genetically modified organisms. - Decree 18 June 2019 adopting the regulation amending the Annexes II, III, III B and IV of the legislative decree 8 July 2003 n. 224, implementing Directive 2001/18/EC concerning the deliberate release into the environment of genetically modified organisms, in compliance with Commission Directive (EU) 2018/350 of 8 March 2018.

EU pharmaceutical legislation provides that a medicinal product may be placed on the market in the EU only if it has received a marketing authorisation. As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of directive 2001/18/EC. Regulation 1946/2003 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.

Regulation (EC) No 1946/2003 addresses transboundary movement of GMOs with the aim to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol. According to Article 13 of regulation (EC) n. 1946/2003 the exporter from the EU shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision. Transit procedures through the EU are regulated by transport legislation and the Union Customs Code (Regulation (EU) No 952/2013 laying down the Union Customs Code). Notably, the transport of dangerous goods in the EU is subject to specific legislation, such as Directive 2008/68/EC on the inland transport of dangerous goods, covering transport by road, rail and inland waterways; or Regulation (EU) 2018/1139 on common rules in the field of civil aviation, which includes the safe handling of dangerous goods. Imports of GMOs to the EU for contained use must comply with the rules for contained use of GMOs. Genetically modified micro-organisms are governed by Directive 2009/41/EC on the contained use of genetically modified micro-organisms, as transposed into Member States’ national law. In Italy the contained use of genetically modified micro-organisms is governed by legislative decree 12 April 2001, n. 206. The confined use of genetically modified organisms other than microorganisms is regulated by legislative decree No. 224/2003 through the verification of containment measures adopted to limit the contact of these organisms with the population and the environment.

As a Member State of the EU, Italy applies its domestic legislative framework implementing EU legislation on GMOs instead of the Protocol's advanced informed agreement (AIA) procedure. This framework is in line with the provisions of the Protocol. Please see reply to Question 13 for the description of EU and Italian legislative measures. A developer intending to market a GMO in the EU for intentional introduction into the environment (referred to as “deliberate release into the environment in the EU regulatory framework on GMOs) must first obtain an authorisation to this end. The authorisation procedure for placing the GMO on the market involves all Member States, as authorised products are granted free movement throughout the territory of the EU. The so-called "notification" or "application" submitted by the interested developer must include a full evaluation of potential risks to human and animal health and to the environment. It is only after a decision for authorisation is finally adopted based on a prior risk assessment that the developer can proceed with the marketing of the GMO in the EU. A developer who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the competent national authority of the Member State within whose territory the experimental release should take place. The authorisation is given on the basis of an assessment of the potential risks presented by the GMO – or the GMOs - for the environment and human health.

The EU has developed a comprehensive legal framework on GMOs, which also applies to the import of GMOs intended for direct use as food or feed, or for processing. The main piece of legislation in this area, governing the placing on the market of GMOs for food or feed use and of GM food and feed, is Regulation 1829/2003 on genetically modified food and feed. The EU has declared with reference to Article 14(4) of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU. The EU has also declared that it applies the EU GMO framework to imports of GMOs into the EU instead of the procedures of the Cartagena Protocol, in accordance with Article 14(4) of the Cartagena Protocol. With regard to the decisions taken for placing on the market of LMOs intended for direct use as food or feed, or for processing it has to be noted that those decisions are taken for the whole European territory and not by the Member States individually.

The relevant provisions are set in article 20 of directive 2001/18/CE, article 23 of legislative decree 8 July 2003, n. 224, and article 10 and 22 of regulation (EC) n. 1829/2003

EU has not made use of the simplified procedure for import of LMOs as specified in Article 13.

Please see the answer to question 72 in the EU national report. Article 5 of legislative decree 8 July 2003, n. 224, states that any person, before submitting a notification for the deliberate release into the environment of GMOs for experimental or commercial purposes, must carry out an environmental risk assessment following the requirements of Annex II. Annex III, of the same legislative decree, specifies the information necessary to carry out the risk assessment and the Annex VII provides guidelines for defining the monitoring plan.

Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.

The EU and its Member States legal framework address the requirements for handling, transport, packaging and identification of living modified organisms (Art. 18 of Cartagena Protocol) in the following acts: As regards Article 18(1) of Cartagena Protocol: - Directive 2008/68/EC on the inland transport of dangerous goods contains rules on the safe transport, handling and packaging. As regards Article 18(2)(a) of Cartagena Protocol: - Regulation (EC) No 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed have to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable. - Regulation (EC) No 1830/2003 provides that business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. In particular, the Regulation requires that: -- Operators are to have systems and standardized procedures in place to identify to whom and from whom products are made available. -- At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product: (a) that it contains or consists of GMOs; (b) the unique identifier(s) assigned to those GMOs; and -- in the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, written information on the unique identifier(s) assigned to the GMOs of which the product consists or which are contained in it, may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture. - Regulation (EC) No 65/2004 established a system for the development and assignment of unique identifiers for genetically modified organisms. - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist. Article 12 further stipulates that for GMOs intended for direct use as food or feed, or for processing, the above information must be supplemented by a declaration by the exporter: -- stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and -- giving details of the contact point for further information. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing, the above identification requirements may be replaced by a list of unique identifiers used to constitute the mixture. In relation to Article 18(2)(b) of Cartagena Protocol, the EU legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol: - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist. Article 12 further stipulates that for GMOs intended for contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify: -- any requirements for the safe handling, storage, transport and use of these GMOs. -- the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned. Finally, as regards Article 18(2)(c) of Cartagena Protocol, Regulation No (EC) 1946/2003 requires exporters of GMOs destined for deliberate release into the environment to ensure that documentation accompanying the GMO states: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist; In addition, this information shall be supplemented by a declaration by the exporter which shall specify: -- the identity and relevant traits and characteristics of the GMOs; -- any requirements for the safe handling, storage, transport and use of these GMOs; -- the contact points for further information and, as appropriate, the name and address of the importer and exporter; and -- a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter. The above requirements regarding identification and documentation of GMOs are in line with Article 18 of the Protocol and without prejudice to further specific requirements imposed by EU legislation. In Italy, official controls for the identification and detection of GMOs are conducted by the National Reference Centre for GMO Research (CROGM), scientific coordinator of the Italian Network of GMO Laboratories (NILO). The CROGM is responsible for coordinating controls for the GMO sector in accordance with CE Regulations 1829/2003, 1830/2003, EU Regulation 2017/625 and the Italian Decree 8 November 2017. The CROGM activities take place within the National Health Service (NHS), in support of the GMO testing official control laboratories, the national and regional Competent Authorities, and the European Commission. CROGM website: http://www.izslt.it/crogm/en/la-rete-italiana-dei-laboratori-del-controllo-ufficiale-ogm/

The European Union and the EU Member States have designated their own national focal points and competent authorities. There are close collaboration and information sharing between EU and national administrations (see articles 11 and 31 of directive 2001/18/EC and articles 14 and 31 of legislative decree 8 July 2003, n. 224). Regulation (EU) 2017/625 requires Member States to establish a Multiannual National Control Plan (MANCP) describing the system of official controls throughout the food chain in order to verify the correct application of EU legislation in various areas, including the genetically modified food and feed and the deliberate release into the environment of GMOs for food and feed production. In Italy the MANCP is prepared by the Ministry of Health in coordination with the Ministry of Agriculture, Food Sovereignty and Forestry, the Ministry of the Environment and Energy Security, the Ministry of Defence, and other central and local administrations, has a duration of 5 years. The annual national operational programme (NOP) for monitoring of the deliberate release of GMOs into the environment is adopted by the Ministry of the Environment in coordination the Ministry of Health, the Ministry of Agriculture, Food Sovereignty and Forestry, and the Italian Regions.

The European Commission is the National Focal Point (NFP) for managing communication between the Secretariat of the Convention on Biological Diversity (SCBD) and the EU. As decided in the Informal Advisory Committee on the Biosafety Clearing-House (IAC-BCH) meeting in March 2011, regular contacts and good cooperation with the Secretariat have also been established by interlinking the BCH records to the European Commission database "GMOMETHODS" providing information of EU reference methods for GMO analysis. To fulfil the EU legal obligations under the Protocol for the period Novembre 20219 – December 2025, the European Commission has published or update 267 records into the BCH Central Portal and a total of 405 records since its entry into force.

The EU applies its domestic legislative framework, which is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign developers of GMOs. All scientific data and information supporting requests for authorisations of GMOs is made publicly available in a proactive manner and easily accessible as early as possible in the risk assessment process. Directive 2001/18/EC on the deliberate release into the environment of GMOs, Regulation (EC) No 1829/2003 on genetically modified food and feed and Regulation (EC) No 1946/2003 on transboundary movements of GMOs allow notifiers, applicants and exporters, respectively, to indicate which information submitted by them should be treated as confidential, based on verifiable justification. Decisions regarding those confidentiality claims are adopted by the European Food Safety Authority or the Member States. The European Commission, the European Food Safety Authority and the Member States take the necessary measures to ensure that confidential information notified or exchanged under the Directive or the Regulations is not made public. Article 27 of Legislative Decree July 8, 2003, No. 224, establishes which data and information must be treated as confidential.

Please see the answer in the EU national report and the provisions under articles 12 and 26 and of annex VIII of the legislative decree 8 July 2003, n. 224. See also the national websites: BCH italiana https://bch.mase.gov.it/index.php/it/ MASE- Biosicurezza, OGM e accesso alle risorse genetiche https://www.mase.gov.it/portale/biosicurezza-ogm-e-accesso-alle-risorse-genetiche Ministero della Salute - Biotecnologie MOGM https://www.salute.gov.it/new/it/tema/biotecnologie-mogm/ Ministero della Salute - OGM https://www.salute.gov.it/new/it/tema/prevenzione-e-controllo-malattie-degli-animali/ogm/ MASAF - ogm-legislazione-e-coltivazione https://www.protezionedellepiante.it/ogm-legislazione-e-coltivazione/

As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol. As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation (EC) No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol. Copies of the respective documents are sent to the competent authority of the EU Member State from which the GMO is exported and to the European Commission (Article 6). Since entry into force of Regulation (EC) No 1946/2003 in November 2003, most notifications of exports of LMOs intended for deliberate release related to exports of LMOs for use in small-scale field trials. EU exports of LMOs to third countries will be reported in the national reports of individual Member States from which they are exported.

According to Directive 2001/18/EC, the Member States are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. EU legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of EU legislation. These penalties shall be effective, proportionate and dissuasive. Specific requirements on Member States to determine penalties applicable to breaches of European and national GMO rules can be found in: - Article 33 of the Directive 2001/18/EC on the deliberate release into the environment of GMOs; - Article 18 of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms; and - Article 45 of Regulation (EC) No 1829/2003 on genetically modified food and feed. Article 53 of Regulation (EC) No 178/2002 laying down general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety provides for the obligation to adopt appropriate Union emergency measures for food and feed imported from a third country in order to protect human health, animal health and the environment, when there is a serious risk to human or animal health or to the environment and when this risk cannot be contained satisfactorily by means of measures taken by the Member States concerned. On this legal basis the Commission adopted in 2008 emergency measures regarding the unauthorised genetically modified rice Bt 63 in products originating in or consigned from China (Commission Decision 2008/289/EC). The Commission adopted stricter requirements with a new Decision on emergency measures in 2011 (Commission Decision 2011/884/EU) with further amendments introduced in 2013 (Commission Decision 2013/287/EU). The Decision is still in force. In Italy the penalties applicable to illegal transboundary movements are established by: - Article 35 of legislative decree 8 July 2018, n. 224 - Articles 2 and 5 of legislative decree 21 March 2005, n. 70 - Articles from 3 to 6 of legislative decree 5 April 2006, n. 190

Cultivation is an issue with strong national, regional and local dimensions, given its link to land use, to local agricultural structures and to the protection or maintenance of local habitats, ecosystems and landscapes. In this respect, as set out in Directive 2001/18/EC (following its amendment in 2015), an EU Member State may decide to restrict the cultivation of an authorised GMO, based on grounds related to environmental or agricultural policy objectives, or other compelling grounds including socioeconomic impacts, which might arise from the cultivation of the GMO on the territory of the Member State concerned.

Objectives under Goal B.4 Objective B.4.1: At EU level, capacity building for EU Member States on detection, identification and quantification of GMOs is carried out by EU Reference Laboratory for GM Food and Feed (EURL GMFF). For EU Member States plus Norway, Switzerland and Turkey, the European Network of GMO Laboratories (ENGL) supports work on these topics (for details see reply to Q126). Until 2016, the EURL GMFF also organised capacity building events for non-EU countries. All relevant material is still available. EFSA aims to maintain and improve a harmonised risk assessment culture at EU level via the strengthening of its external relations and engagement activities with EU and international cooperation fora and channels. EFSA works in partnership with international networks and fora to strengthen capacity building, co-develop risk assessment methodologies and reduce scientific divergences. For example, under the Cartagena Protocol, an EFSA expert contributed in 2023 to the development of guidance material to support case-by-case risk assessments of LMOs containing engineered gene drives. Objective B.4.2: Public participation is an integral part of the EU’s regulatory framework on GMOs (see reply to Q139). The Better Regulation Agenda ensures that decision-making is evidence-based and is open and transparent for citizens, businesses and other stakeholders and that citizens and stakeholders can contribute to the policy and law-making process through stakeholders’ consultations, online public consultations, implementation dialogues, reality checks and feedback to Commission calls for evidence and acts (https://commission.europa.eu/law/law-making-process/better-regulation_en). Objective B.4.3: The EU has in place, since the 1990s, a comprehensive legal framework on GMOs. All the necessary legal, administrative, and technical measures are in place for biosafety, including risk assessment and risk management.

National legislation in 27 Member States transposing Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage. In Italy legislative decree n. 152, April 3, 2006, has implemented the provisions of Directive 2004/35/EC