Legislation

Union legislation

The European Union has adopted a regulatory framework on GMOs to ensure the necessary levels of safety for the environment and human health as provided by the Cartagena Protocol. In the European Union, GMOs are authorised for deliberate release into the environment for experimental and commercial purposes only after passing a rigorous risk assessment procedure according to the principles and methodology set out in directive 2001/18/EC, to avoid any possible negative effect, unintentional or undesirable, direct or indirect, on the environment and on human health. To know more

The Italian competent authority responsible for complying with requirements of directive 2001/18/EC is the Ministry for Environment and Land and Sea Protection.
  

Italian legislation

Legislative Decree 8 July 2003 n. 224, implementing directive 2001/18/EC, shall, in accordance with the precautionary principle, establish appropriate measures to protect human and animal health and the environment in case of:

  • deliberate release of GMOs for purposes other than placing on the market;
  • placing on the market of GMOs as such or in products. To know more

The Italian competent authority responsable for complying with requirements of legislative decree 8 July 2003, n. 224 is the Ministry for Environment and Land and Sea Protection.

Legislative decree 14 November 2016, no. 227 implementating directive (EU) 2015/412, amending directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) on their territory, amended legislative decree 8 July 2003, n. 224, introducing a mechanism that makes it possible to restrict or prohibit the cultivation of GMOs on Italian territory. To know more.

Pursuant to article 32 of legislative decree 8 July 2003, n. 224, decree of 8 November 2018 was issued adopting "The general plan for the surveillance of the deliberate release into the environment of GMOs".

For the sake of completeness of information it is usefull to mention the legislaton on the contained use of Genetically Modified Microorganisms (GMMO).
Legislative decree 12 April 2001, n. 206 establishes measures for the contained use of GMMOs to protect human health and the environment. The national competent authority is the Ministry of Health.