The main objective of the decree is to protect human health and the environment when carrying out the deliberate release into the environment of genetically modified organisms (GMOs) or GMO-derived products.
The decree applies to the deliberate release of GMOs into the environment for the purpose of research and development and to the placing on the EU market of GMOs or products containing GMOs. Furthermore the decree applies to applications of GM technology in human medicine, such as gene therapy clinical trials.
In particular, the Decree lays down the EU definition of a GMO, specifies common methodology and principles for the environmental risk assessment before any GMO release into the environment and provides rules for information to the public.
In case of placing on the EU market of genetically modified food or feed, the Decree is supplemented by Regulation (EC) 1829/2003. In case of marketing of medicinal products containing or consisting of GMOs, it is supplemented by Regulation (EC) 726/2004.