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

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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 implementing Directive 2001/18/EC.

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

Italian National Competent Authority
Ministry for Environment, Land and Sea Protection,
Directorate General for Environmental Assessments and Permits (DVA)
Via Cristoforo Colombo, 44
Cap.00147, Rome, Italy
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Pursuant to Article 3 of Legislative Decree n. 224/2003, notification means: “the submission, in quadruplicate, of the information required by the present decree, with an additional copy for each region and autonomous province involved in notifications under the Title II, by any mean capable of producing a written record, to the national competent authority under Article 2 or the submission of the same information to the competent authority of another EU Member State ".

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 n. 224/2003.
  2. the information required, in Annexes III and IV of Legislative Decree n. 224/2003, 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 of Legislative Decree n. 224/2003, 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 of Legislative Decree n. 224/2003 and it shall include the words «this product contains genetically modified organisms».
  8. a proposal for packaging;
  9. a summary of the dossier, on paper and in e-format, 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 n. 224/2003.

The notifier may proceed with the placing on the market for the first time in Italy, only when he has received the consent of the competent authority in accordance with article 21, paragraph 2 of Legislative Decree n. 224/2003.