In the European Union, genetically modified organisms (GMO) and genetically modified micro-organisms (GMM) are defined respectively according to Directives 2001/18/EC on deliberate release of GMO and 2009/41/EC on the contained use of GMM (2). In accordance with the legislation, a GMO/GMM is defined as "an organism/micro-organism ... in which the genetic material has been altered in a way that does not occur naturally by mating and/or naturalrecombination". This definition must be read together with a series of annexes that list techniques (i) that result in genetic modification, (ii) that are not considered to result in genetic modification, or (iii) that result in genetic modification but yield organisms that are excluded from the scopeof the Directives.A novel organism will therefore fall under the scope of the GMO regulation only if it has been developed with the use of defined techniques. With the advance of scientific knowledge, techniques which are applied in genetic modification of organisms have emerged that may challenge the current regulatory definition of a GMO because it is not always clear whether the products obtained through these techniques are subject to the prevailing European GMOlegislation or not.Several initiatives have been taken at the European level in order to evaluate some of these new techniques in the context of the existing legislative framework. The Division of Biosafety and Biotechnology (SBB ) is actively contributing to this work.
