AGRICULTURAL AREA INVOLVED IN DELIBERATE RELEASES OF GENETICALLY MODIFIED PLANTS (GMPS) FOR EXPERIMENTAL PURPOSES

Directive (EU) 2001/18 (repealing Council Directive 90/200/EEC); 

Regulation (EC) No 1829/2003; 

Legislative Decree No. 224/2003; 

Ministerial Decree of 19 January 2005; 

Directive (EU) 2015/412; 

Legislative Decree No. 227/2016; 

Ministerial Decree of 8 November 2017; 

Ministerial Decree No. 58 of 1 March 2018; 

Law No. 68 of 13 June 2023.

Field trials of GMPs for  in Italy are authorised under Legislative Decree No. 224 of 8 July 2003, which implements Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). In accordance with the Directive, the decree establishes that, prior to authorizing any GMO’ release, an environmental and human health risk assessment must be carried out to verify its safety.

Legislative Decree No. 224/2003 designates the Ministry of the Environment and Protection of Land and Sea as the competent national authority and establishes the Register of GMOs release sites, both for experimental and commercial purposes.

The Law No. 68 of 13 June 2023 stipulates that, until 31 December 2025, experimental releases of GMOs produced using genome editing techniques (site-directed mutagenesis or cisgenesis) are exempted from the risk assessment for agrobiodiversity, farming systems and the agri-food chain, as well as from the requirements laid down by Ministerial Decree of 19 January 2005.

In accordance with Article 32 of the Legislative Decree No. 224/2003, the Ministerial Decree of 8 November 2017 adopted the general surveillance plan for the deliberate release into the environment of GMOs. The plan defines the objective of scope of the different inspection activities  foreseen, the coordination mechanisms between the different competent authorities, and the criteria and procedures for updating every 4 years, if needed. The general surveillance plan is implemented by an Operative National plan which identifies and describes the number and scope of inspections to be conducted annually. This decree also establishes the National Register of Inspectors, who act as judicial police officers during inspections.

In 2018, ISPRA (Italian Institute for Environmental Protection and Research), pursuant to Ministerial Decree No. 58 of 1 March 2018, was assigned the advisory and technical support functions to the competent authority, previously held by the Interministerial Evaluation Committee (pursuant to Article 2 of Legislative Decree No. 224/2003).