The Italian legislation

Legislative Decree no. 224/2003 (Coordinated text), as amended and supplemented by Legislative Decree 14 November 2016, no. 227, is divided into five titles and eight attachments:

  • Title I "General provisions" (from article 1 to article 6) it defines the objectives of the decree, the tasks of the Ministry of the Environment as a National Competent Authority (NCA), the composition and duties of the Interministerial Commission of Evaluation.
  • Title II (from article 7 to article 14) deals with the authorization procedure on the deliberate release into the environment of GMOs for any other purpose than marketing;
  • Title III (from article 15 to article 26) concerning the modalities for the authorization procedure for placing on the market of GMOs as or in products;
  • Title III-bis (from article 26-bis to article 26-sixies) it defines the procedure to restrict or prohibit the cultivation of GMOs on national territory (title introduced by legislative decree No. 227 of 22 November 2016;
  • The Title IV "Final Provisions" (from article 27 to article 38), concerns the confidentiality of the information contained in the notification, the surveillance and penalties to be applied to those who do not comply with the provisions of the above mentioned Decree.
  • Annex I: Techniques of genetic modification (see Article 3);
  • Annex II: Principles for the environmental risk assessment (see Articles 5, 8, 11 and 16);
  • Annex III: Information required in notifications (see Articles 8 and 16);
  • Annex IV: Additional information (see Articles 16, 24 and 28);
  • Annex V: Criteria for the application of differentiated procedures (see Article 10);
  • Annex VI: Guidelines for the assessment reports (see Articles 17, 20, 22 and 23);
  • Annex VII: Monitoring Plan (see Articles 16, 20, 21 and 22);
  • Annex VIII: Public consultation (see Articles 12 and 26).

National Competent Authorities

National legal acts

Italian case-law