Ministerial Decree implementing Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified microorganisms.

According to Article 5, paragraph 2 of Legislative Decree No. 206 of 12 April 2001, users as well as holders of installations using genetically modified microorganisms are required to carry out an assessment of the contained uses of such GMMs, following as a minimum the principles set out in Annex III of the Legislative Decree. The above-mentioned principles are hereby supplemented. The Annex to this Decree, in fact, contains guidelines for risk assessment of the contained use of genetically modified microorganisms. When such assessment is made, users and holders shall take into particular account potentially harmful effects to human health and to the environment. Point 2 of the Annex describes the full risk assessment process, which consists of two procedures. Procedure 1 deals with the identification of harmful properties of the GMMs. Procedure 2 regards the determination of the final classification and containment measures.