Authorization procedure for the placing on the market of GMOs pursuant to Title III of the legislative decree 8 July 2003, n. 224

First step (preliminary examination): any person shall, before placing on the market a GMO for the first time in Italy, submit a notification to the Italian competent authority, informing at the same time the Ministry for Health, the Ministry for Agriculture, Food and Forestry Policies, the Ministry of Labour and Social Policies, the Ministry of Economic Development and the Ministry for University and Research. The CA shall, after receiving the notification, carry out a preliminary examination of the compliance of the notification with the provisions of the legislative decree of 8 July 2003, n. 224, and immediately forward the summary of the dossier to the European Commission, to the competent authorities of the other Member States, to the regions and autonomous provinces, and publish the summary of the dossier on the Italian BCH for public information.

Second step (assessment report): after the preliminary examination, the CA shall forward the notification to the Institute for Environmental Protection and Research (ISPRA). Within 75 days of the notification receipt, ISPRA shall send to the CA a proposal of assessment report established in accordance with the guidelines laid down in Annex VI of legislative decree of 8 July 2003, n. 224. The CA shall, on the basis of proposal of ISPRA, after consulting the Ministries of Health and Agriculture, Food and Forestry Policies, prepare an assessment report that specifies if the GMO may be placed on the market and under which conditions and forward it to the European Commission and to the notifier. The European Commission shall, wthin 30 days of its receipt, forward the assessment report 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:

    • 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, the CA shall take a decision in accordance with the decision adopted by the European Commission during the commitee procedure (article 30, paragraph 2, directive 2001/18/EC): 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.

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 is published on the Italian BCH and is valid for a maximum period of 10 years starting from the date on which the consent is issued.

Until today no notification have been submitted for the placing on the market in Italy.

 

Titolo III EN 224 2003

Procedure for submitting a notification for placing on the market of GMOs

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 Ecological Transition
Directorate General for Natural Heritage
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

Public register of GMOs field trial locations

Notifications authorised pursuant Title II of Legislative Decree 8 July 2003, n. 224
Competent Authority
: Ministry for Ecological Transition


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

Clinical trial 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

 B/IT/17/01

Clinical trial 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

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