Public register of GMOs field trial locations

Notifications authorised pursuant Title II of Legislative Decree 8 July 2003, n. 224
Competent Authority
: Ministry of Environment,  Land and Sea Protection


PLANTS


 

Notification number Notifier Project title Documents 
 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

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

 


OTHER THAN PLANTS


 

Notification number Notifier Project title Documents
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

Authorisation decree

B/IT/17/03

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

 B/IT/17/01 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

Clinical trial withdrawn by the notifier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

Clinical trial 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

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.

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

Italian 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.

The notification shall contain:

  1. a technical dossier 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 8 July 2003, n. 224.

  2. the environmental risk assessment and the conclusions required in Annex II, section D of legislative decree 8 July 2003, n. 224, 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 “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".

Fares

Authorisation procedure for placing on the market of genetically modified food and feed pursuant regulation (EC) n. 1829/2003

First step (application for authorisation): to obtain the authorisation for placing on the market of genetically modified food and feed in the European Union an application shall be submitted to the competent authority of a Member State. Within 14 days of the receipt of the application, the AC shall make available the application the European Food Safety Authority (EFSA). The EFSA shall make the application available to the European Commission and to the other Member States and the summary of the dossier available to the public.

Second step (EFSA opinion): within 180 days of the receipt of the application for authorisation, the EFSA shall give its opinion and shall send it to the European Commission, to Member States and to the applicant. The EFSA shall make its opinion available to the public. The public may make comments to the European Commission within 30 days from such publication.

Third step (authorisation for placing on the market): within 90 days from the receipt of EFSA opinion, the European Commission shall submit to the Standing Committee on plants, animals, food and feed - Section genetically modified food and feed and environmental risk a draft of the decision to be taken in respect of the application, taking into account the opinion of the EFSA.
If the Standing Committee give a favorable opinion, the authorization for the placing on the market is granted, the Commission shall inform the applicant of its decision and published it on the Official Journal of the European Union.

If the Standing Committee give an unfavorable opinion, the application for authorisation is rejected.

If the Standing Committee give no opinion, the comitology procedure begins.

The authorization shall be valid for 10 years.

 Titolo III EN 224 2003

Applications submitted in the European Union pursuant regulation (EC) n. 1829/2003

Action Plan for capacity building for biosafety

Strengthening of human resources and institutional capacities in the field of biosafety.

During the COP-MPO 1, with the decision BS-I/5 – Annex 1 - was adopted the Action Plan for strengthening human resources and institutional capacities in the field of biosafety for the effective implementation of the Cartagena Protocol, subsequently revised during the COP-MOP 3, with the decision BS-III/3 – Annex.

The aim of the Action Plan is to facilitate and support, in a timely manner, the development and strengthening of capacities for the ratification and effective implementation of the Protocol at the national, subregional, regional and global levels, including the provision of financial services, technical and technological support to developing countries and countries with economies in transition.

Authorization procedure for placing on the market of GMOs pursuant Part C of directive 2001/18/EC

First step (preliminary examination of the notification): before a GMO is placed on the market in the European Union, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. After receipt of the notification, the AC shall immediately forward the summary of the dossier to the European Commission and the competent authorities of the other Member States. The AC shall, without delay, examine if the notification complies with the requirements of Article 13 (2) of Directive 2001/18 /EC and shall, if necessary, ask the notifier for additional information. If the notification is in accordance with article 13(2) of directive 2001/18/CE, the AC shall forward a copy of the notification to the European Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Second step (assessment report of the notification): within 90 days of the date of receipt of the notification, the AC shall prepare an assessment report and send it to the notifier. Not earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification, the CA shall send a copy of the assessment report to the Commission which, within 30 days of receipt, forward it to the competent authorities of the other Member States.

Third step (consent to the placing on the market of the GMO): when the assessment report indicates that the GMO may be placed on the market, the CA shall give consent to the placing on the market and shall inform, within 30 days, the other Member States and the European Commission:

  • after 60 days from sending the assessment report to the European Commission, in the absence of reasoned objections from the CA of another Member State and/or from the European Commission;
  • after 105 days from sending the assessment report, if reasoned objections from the CA of another Member State and/or from the Commission have been resolved.

After 60 days from sending the assessment report, if reasoned objections from the CA of another Member State and/or from the Commission are not resolved (are raised and mantained), the CA shall adopt a decision in accordance with the decision adopted by the European Commission: if a favourable decision is taken, the CA shall give the consent to the placing on the market, shall trasmitt it to the notifier and shall inform the competent authorities of the other Member States and the European Commission. The decision is published.

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

The consent shall be given for a maximum period of 10 years starting from the date on which the consent is issued.

200 18 CE parte C EN

Notifications authorized in the European Union pursuant directive 2001/18/EC