Products of site-directed mutagenesis are not GMOs according to Art. 3 and Appendix I B of the European Directive 2001/18/EC

Abstract

The European Directive 2001/18/EC regulates the deliberate release of genetically modified organisms (GMO). Mutagenesis is excluded from the scope of the directive under Art. 3 and Annex I B. Does this exception only apply to products of chemical and radiation-induced mutagenesis or to new biotechnological methods of site-directed mutagenesis as well? In our opinion, organisms obtained by mutagenesis are generally exempted from all the provisions of the directive and are therefore also outside the scope of its legal definition of genetically modified organism. Furthermore, the term mutagenesis is to be interpreted dynamically, according to its meaning in science, which also includes site-directed mutagenesis. This means that in the sense of the directive, products of site-directed mutagenesis are not GMOs.