Public electronic register established pursuant to Article 30 of Legislative Decree 8 July 2003, n. 224, which provides the location of GMOs released into the environment for experimental purposes.

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PLANTS

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Notification number	Notifier	Project title	Documents
B/IT/25/03	University of Turin	Field trial with tomato (Solanum lycopersicum L.), San Marzano variety, with functional deactivation of the DMR6_1 gene through genome editing techniques for tolerance to biotic and abiotic stresses	Notification summary Assesment report Authorisation decree
B/IT/25/02	Fondazione Edmund Mach	Open-field experimentation with Apple (Malus x domestica) by inserting the Rvi12_Cd5 (Vb) gene through cisgenesis in the Gala variety to assess the reduction in pesticide use and tolerance to apple scab (Acronym - Gala Plus).	Notification summary Assesment report Authorisation decree
B/IT/25/01	University of Milan	Evaluation of blast tolerance during field cultivation without fungicides of rice plants, varieties Telemaco and Vialone nano, lines Tommaso and Pacifico, modified with genome editing techniques. Acronym: Ris8imo	Notification summary Assesment report Authorisation decree
B/IT/24/04	Fondazione Edmund Mach	Open-field trial with genetically modified grapevine plants with inactivation of the DMR6-1 and DMR6-2 genes through genome editing techniques to increase resistance to the oomycete Plasmopara viticola, the causal agent of the disease known as grapevine downy mildew. Acronym: Chardonnay+	Notification summary Assesment report Authorisation decree
B/IT/24/03	EdiVite S.r.l.	Open-field trial with grapevine (Vitis vinifera L.), Chardonnay variety, with deletions in the DMR6.1 gene for resistance to grapevine downy mildew. Acronym: VITEA.1	Notification summary Assesment report Authorisation decree
B/IT/24/02	CREA-OF	Open-field trial with tomato plants (Solanum lycopersicum L.), Ailsa Craig variety, with deletion of the D27 and CCD7 genes for resistance to broomrape. Acronym: ORTOevo1	Notification summary Assesment report Authorisation decree
B/IT/24/01	University of Milan	Assessment of blast tolerance during open-field cultivation without fungicides of Telemaco rice plants (Oryza sativa) with deletions in three genes. Acronym: RIS8imo	Notification summary Assesment report Authorisation decree Notifier's final report Assessment of the notifier's final report
B/IT/04/03	University of Catania	Evaluation of transgenic lemon (Citrus limon L. Burm. f.) for resistance to fungal pathogens	Notification summary Denial of authorisation
B/IT/04/02	Metapontum Agrobios	Study of the stability of the transgene and ITS heritability in genetically modified wheat grown in open field conditions	Notification summary Denial of authorisation
B/IT/04/01	Metapontum Agrobios	Safety Assessment in Food and Environment - S:A:F:E	Notification summary Authorisation decree Final report Additional info for final report Notifier's final report
B/IT/03/01	Metapontum Agrobios	Italian Lycopersycon (ITA.LYCO): Biologia avanzata e innovazione di processo al servizio della qualità del pomodoro da industria italiano	Notification summary Authorisation decree Final report

 

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OTHER THAN PLANTS

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Notification number	Notifier	Project title	Documents
B/IT/25/04	Aviado Bio Limited	Phase 1/2, open-label, dose-escalation, multicenter study to evaluate the safety and preliminary efficacy of AVB-101 administered via bilateral intrathalamic infusion in subjects with frontotemporal dementia with progranulin mutations (FTD-GRN)	Notification summary Assessment report Authorisation decree
B/IT24/05 withdrawn by the notifier	Sanofi Pasteur Inc.	Parallel-group study, Phase III, randomized, observer-blind, placebo-controlled, multicenter, multinational, multiple-arm to demonstrate the non-inferiority of the immune response of a low dose compared to the standard dose and to evaluate the safety of a vaccine against respiratory syncytial virus (administered intranasally) in infants and young children	Notification summary
B/IT/22/01	Arcoblu s.r.l. Italy	Vaccination of chickens with a herpes virus of turkey vaccine carrying a VP2 gene of infectious bursal disease virus and a F gene of Newcastle disease virus	Notification summary Assessment report Authorisation decree Notifier's final report Assessment of the notifier's final report
B/IT/21/01	Arcoblu s.r.l. Italy	Vaccination of chickens with a turkey herpesvirus vaccine containing an infectious bursal disease virus VP2 gene	Notification summary Assessment report Authorisation decree Notifier's final report Assessment of the notifier's final report
B/IT/19/01	REGENXBIO Inc.	AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH). Lazio - Sicilia	Notification summary Assessment report Authorisation decree Notifier's final report Assessment of the notifier's final report
B/IT/17/03 withdrawn by the notifier	Transgene SA France	TG6006.01: A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) - Emilia Romagna - Parma	Notification summary Authorisation decree
B/IT/17/02	Transgene SA France	TG6006.01: A phase I/IIa trial to evaluate the safety and efficacy of the combination of the oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first-line treatment of advanced hepatocellular carcinoma (HCC) - Emilia Romagna - Modena	Notification summary Authorisation decree Renewal authorisation decree Notifier's final report Assessment of the notifier's final report
B/IT/17/01 withdrawn by the notifier	Targovax Oy	A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS 102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma	Notification summary Authorisation decree
B/IT/16/02 withdrawn by the notifier	University of Pennsylvania, Philadelphia, United States of America	AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - Sicilia, Veneto.	Notification summary Authorisation decree
B/IT/16/01 withdrawn by the notifier	University of Pennsylvania, Philadelphia, United States of America	AAV8-mediated Low Density Lipoprotein Receptor (LDLR) Gene Replacement in Subjects with Homozygous Familial Hypercholesterolemia (HoFH) - Lombardia, Lazio, Sicilia.	Notification summary Authorisation decree
B/IT/10/01	Istituto Zooprofilattico Sperimentale dell'Umbria e delle Marche	Improve tools and strategies for the prevention and the control of classical swine fever	Notification summary Authorisation decree Final report
B/IT/09/01	Merial	Development of a vaccine against canine leishmaniasis. Efficacy in dogs of a recombinant vaccine candidate against Canine Visceral Leishmaniasis. Evaluation by natural challenge in an experimental kennel	Notification summary Authorisation decree Final report

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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: 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. 

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:

1. general information including information on personnel and training,
2. information relating to the GMO(s),
3. information relating to the conditions of release and the potential receiving environment,
4. information on the interactions between the GMO(s) and the environment,
5. 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,
6. information on control, remediation methods, waste treatment and emergency response plans,
7. 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.

Fares and payment methods

• First step (preliminary evaluation of the notification): Any person who intends to place a GMO on the market, for the first time in Italy, shall submit a notification to the Italian Competent Authority (CA), following the procedures set out below. The notification must include all the information listed in Article 16, paragraph 3 of legislative decree 8 July 2003, no. 224, including the Summary of Notification Information (SNIF). At the same time, the notifier must also present the notification through the ESFC platform of the European Commission. The CA carries out the preliminary assessment of the notification and if it is positive, sends the SNIF to the European Commission, to the competent authorities of other Member States and to the Italian Regions and Autonomous Provinces. The CA publishes the SNIF and the environmental risk assessment on the Italian BCH for public information.
  All communication between the CA, the European Commission and the Competent Authorities of other Member States is done through the ESFC platform.
• Second step (notification assessment report): after the preliminary assessment, the CA sends the notification to the Institute for Environmental Protection and Research (ISPRA). Within 75 days from the receipt of the notification, ISPRA transmits to the CA a proposal of assessment report in accordance with the guidelines of Annex VI of the legislative decree July 8, 2003, no. 224. The CA, on the basis of the assessment proposed by ISPRA, and after consulting the Ministries of Health and of Agricultural, Food and Forestry Policies, elaborates the notification assessment report that specifies if the GMO can be placed on the market or not and under which conditions, and sends it to the notifier. At the same  time the CA sends the entire notification and assessment report to the European Commission and to the competent authorities of the other Member States.
• Third step (authorization or rejection of the placing on the market): if the assessment report is positive:
  • the CA shall give consent to the placing on the market to the notifier 60 days after the submission of the notification assessment report in case of absence of reasoned objections from Member States or from the European Commission;
  • the CA shall give consent to the placing on the market to the notifier 105 days after the submission of the notification assessment report if reasoned objections from Member States or from the European Commission have been resolved.

After 60 days from the submission of the assessment report, in case of reasoned and unresolved objections from Member States or from the European Commission, the CA shall adopt a decision on the basis of the decision adopted by the European Commission under the comitology procedure (Article 30, paragraph 2 of Directive 2001/18/EC): if the Commission’s decision is positive, the CA shall give the authorisation.

If the assessment report indicates that the GMO shall not be placed on the market, the CA immediately transmits the negative assessment report to the notifier and within 105 days of receipt of the notification, to the European Commission.

The authorisation decision is published in the Italian BCH. The authorisation is valid for a maximum period of 10 years from the date of authorisation.

To date, no notifications for the placing on the market of GMOs have been submitted in Italy.

 

 

Submission procedure of notifications for placing on the market of GMOs as or contained in products

Notifications authorised in the European Union under Part C of Directive 2001/18/EC

• First step (preliminary evaluation of the notification): any person shell, before undertaking a deliberate release into the environment of a GMO for experimental purposes, submit a notification to the Italian Competent Authority (CA) following the procedure set out below. The notification shall include a technical dossier supplying all the information specified in Annex III of legislative decree 8 July 2003, no. 224, the environmental risk assessment and conclusions required in Annex II, section D of the legislative decree and, the risk assessment for agrobiodiversity if the experimentation concerns a plant species of agronomic interest. At the same time, the notifier must submit the summary of the notification information (SNIF) through the European Commission's ESFC platform. Upon receiving the notification, the CA shall, within 15 days, carry out a preliminary evaluation of the compliance of the notification with the provisions of the legislative decree of 8 July 2003, no. 224. If the preliminary evaluation of the notification is positive, the CA provides the summary of the notification available to the to the European Commission and transmit a copy of the complete notification to the Ministry of Health, to the Ministry of Agriculture, Food and Forestry Policies, to the Institute for Environmental Protection and Research (ISPRA) and to the regions and autonomous provinces concerned by the experimentation. The other Member States, having received the SNIF through the ESCF portal, have 30 days to submit any observations.
• Second step (public consultation and ISPRA opinion): the CA carries out the public consultation by making available on the Italian BCH, for 30 days, the summary of the information of the notification, the environmental risk assessment and the conclusions required by annex II, section D of the legislative decree of 8 July 2003, no. 224. Within 60 days from the conclusion of the public consultation, ISPRA, taking into account the comments received during the public consultation, transmits its opinion to the CA.
• Third step (authorization or rejection of the deliberate release into the environment): within 15 days from the receipt of the opinion of ISPRA, the CA shall, after consulting the Ministries of Health and Agriculture, Food and Forestry Policies, inform the notifier that the deliberate release into the environment of the GMO may proceed, requiring specific conditions, or communicate to the notifier the reasons for the rejection of authorization. The CA informs the concerned Regions and Autonomous Provinces of the final decision taken. The CA publishes the authorisation or rejection decision on the Italian BCH and on the ESFC platform.
  

The period of time for the authorization procedure is 120 days.

The notifier may proceed with deliberate release into the environment for experimental purposes only after authorisation by the Italian Competent Authority and in compliance with all the conditions specified therein.

 

Public register of notifications submitted in Italy (see also GMO Register of the European Commission)

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