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

In Italy the placing on the market of GMOs as or contained in products is governed by the Title III of legislative decree 8 July 2003 n. 224.

Any person shall, before undertaking a deliberate release into the environment of a GMO, submit a notification to the Italian Competent Authority:

Italian Competent Authority
Ministry for Ecological Transition,
Directorate General for Environmental Assessments and Permits
Via Cristoforo Colombo, 44
CAP 00147, Rome, Italy
PEC: This email address is being protected from spambots. You need JavaScript enabled to view it.


The notification shall contain:

  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, n. 224.