AGRICULTURAL LAND USED FOR DELIBERATE EXPERIMENTAL RELEASES OF GENETICALLY MODIFIED PLANTS (GMPs)

Directive (EU) 2001/18;

Regulation (EC) 1829/2003; 

Legislative Decree 224/2003; 

Ministerial Decree 19 January 2005; 

Directive (EU) 2015/412; 

Legislative Decree no. 227/2016;

MATTM decree 8 November 2017; 

MATTM decree n. 58 of 1 March 2018; 

Law 13 June 2023, n. 68.

The deliberate release into the environment, for experimental purposes, of PGMs on Italian territory is authorized on the basis of Legislative Decree of 8 July 2003, n. 224 "Implementation of Directive 2001/18/EC concerning the deliberate release into the environment of genetically modified organisms". In accordance with the directive, the decree establishes that before authorizing any release of GMOs into the environment, a risk assessment for the environment and human health must be carried out, which ensures that they are not dangerous. 

Legislative Decree 224/2003 attributes the role of competent national authority to the Ministry of the Environment and Land Protection and establishes the Register of locations where releases of Genetically Modified Organisms (GMOs) take place for both experimental and commercial purposes.

Law 13 June 2023, n. 68 establishes that for the testing of GMOs produced with techniques editing genomic through site-directed mutagenesis or cisgenesis, until 31 December 2025, the risk assessment for agrobiodiversity, agricultural systems and the agri-food chain and the requirements established by the decree of the Minister of Agriculture Ministerial Decree 19 January 2005 do not apply.

In accordance with article 32 of Legislative Decree 2003/224, the Decree of 8 November 2017 of the Minister of the Environment and Protection of Land and Sea was also adopted which defines the general plan for the supervisory activity on the deliberate release into the environment of genetically modified organisms. The plan defines the fields of application of the decree, the forms of coordination between the competent administrations, the criteria and methods for updating the plan itself to be carried out on an annual basis. The general surveillance plan is implemented by a National Operational Plan in which the number and scope of inspections to be conducted are identified and described annually. With the same decree, the national register of inspectors was established, who, in carrying out their supervisory activity, carry out judicial police functions. 

In 2018 ISPRA, on the basis of decree no. 58 of 1 March 2018 issued by the Ministry of the Environment and Protection of Land and Sea, acquired the consultative and support functions for the competent national authority previously exercised by the Inter-Ministerial Evaluation Commission (ex art. 2 Legislative Decree 224/2003).