Italian regulations

With specific reference to the situation in Italy, it is worth noting that regulations issued by the EU are directly applicable in single member states. Apart from these regulations, the Italian law is currently based on the following rules: Legislative Decree no. 224 of 8 July 2003; Ministerial Decree of 19 January 2005; law no. 5 of 28 January 2005 and Ministerial Decree of 18 March 2005.

Legislative decree no. 224/2003 enacts Directive 2001/18/EC. The decree acknowledges all principles contained in the Directive, in some cases describing them in a more precise and specific manner. With respect to the previously existing Italian regulations (Legislative Decree no. 92/93 and Legislative Decree no. 206/2001), it introduced some changes in the management of GMO issues. Among these is the transfer of the National Authority in charge from the Minister of Health to the Minister for the Environment and Territorial Protection. Therefore in Italy, both experimenting and launching a GMO on the market requires presenting a request to the Ministry for the Environment and Territorial and Marine Protection. In order to evaluate requests, the Ministry has a duly established Interministerial Evaluation Commission (art.6 of Legislative Decree no. 224/2003) composed of members and experts from different administrations (about ten members from Ministries, research institutes, Regions and Agencies among which the APAT). The decree also contains articles that provide for the preparation of implementation decrees for an improved definition of aspects regarding management of safety in agricultural systems and in the Italian agrofood industry.

Indeed, Ministerial Decree of 19 January 2005 satisfies this specific need and “defines regulations for the evaluation of risks for agrobiodiversity, agricultural systems and the agrofood industry related to the deliberate emission of GMOs in the environment, for any purpose other than commercial”. The Decree provides for autonomous Regions and Provinces to identify the relevant Regional or Provincial Authority in charge and the places, within their jurisdiction, where experimentation will be allowed. Therefore, unlike what has occurred in the past, in Italy GMO experimentation will only be allowed in sites that have been identified and indicated by the regions. In any case, the National Authority in charge can grant derogations on the basis of motivated requests. These are submitted to the technical evaluation of the Interministerial Commission and the relevant Regional Authority. An integral part of the same decree is the technical attachment that describes the objectives, principles and methods to be followed to evaluate risks specifically for agrobiodiversity and the agrofood industry. In addition, a decree of the Ministry of Agricultural and Forest Policies is currently being prepared. This provides for the publication of specific technical protocols for the different cultures. These must be followed during planning and experimentation stages as well as during risk management.

Law no. 5 of 28 January 2005, which acknowledges Recommendation 2003/556/CE, provides indications to assure coexistence between transgenic, conventional and biological agricultural forms. The law does not contain technical specifications but only the principles and objectives that need to be followed to protect consumers’ and farmers’ liberty of choice. It also contains the provided sanctions, the allocation of responsibilities and modalities for adopting coexistence plans.  The law also provides for the establishment of a Consultation Committee, at the Ministry of Agricultural and Forest Policies, which will draw up guidelines to ensure coexistence between the different cultures and separation of the production systems. Regulations for coexistence will be defined on the basis of these guidelines and issued with a decree of the Ministry of Agricultural and Forest Policies. Regional coexistence plans will then be enacted with provisions of single autonomous regions and provinces.

The Decree of 18 March 2005 was issued by the Ministry of Agricultural and Forest Policies to enable a derogation of article 37, paragraph 1 of the seed selection law no. 1096 of 25 November 1971. According to this article, in Italy only varieties registered in the National or European Variety Register could be cultivated. Therefore this did not permit any GMO varieties.  The new decree provides for this exception. It describes the modalities for the presentation of requests, maximum quantities admitted and the modalities for circulation of conventional and GM seeds. 

It is also worth noting that with Legislative Decree no. 206 of 12 April 2001, Italy enforced Directive no. 98/81/EC which "amends the previous Directive no. 90/219/EC on the limited use of GM Microorganisms" and estalishes measures for the confined use of GM Microorganisms aimed at protecting human and environmental safety. This decree replaces and annuls Legislative Decree no. 91 of 3 March 1993, which acknowledged the previous Directive.