Decree of the Ministry of Social Affairs and Health on principles of risk assessment of the contained use of genetically modified animals, on classification of the contained use, and on containment and other protective measures (No. 771/2014).

This Decree of the Ministry of Social Affairs and Health lays down minimum requirements for risk assessment in relation with genetically modified animals referred to in the Gene Technology Act (377/1995) which have not been authorised for placing on the market as products in accordance with the provisions of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC or Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed. The Decree sets out the risk assessment procedure that must be carried out by an operator. A simplified risk assessment procedure may be used if the species and genetic modification are commonly used and their properties are well known. The Decree defines potentially harmful properties of a genetically modified animal. The Decree sets out rules on the contained use of genetically modified material and waste treatment. Additional rules shall apply to containment and protective measures applied to fish and other aquatic animals.