The CJEU recently confirmed that microorganisms prepared using gene editing technologies such as CRISPR fall within the Genetically Modified Organisms Directive (GMO Directive; 2002/53). The GMO Directive places a huge regulatory burden on companies looking to generate GMO products and it is apparent that the Decision will require more stringent regulation of food and crop products prepared using new mutagenesis technologies, and may also have implications for the use of these technologies in medical research. Many within the AgriBio industry are particularly concerned that this ruling will drive innovators away from Europe and towards the US or China where regulation is less stringent.
This Decision represents a U-turn from the Advocate General’s Opinion which had suggested that such microorganisms should be exempt from the Directive in view of Article 3 and Annex Ib. The Decision also serves to highlight the difficulties encountered by legislators when they are forced to fit emerging technologies into regulations which were drafted before the technology had even been conceived. Of course, legislation cannot be redrafted with each scientific advancement, but early engagement of regulators and legislators may be advantageous as fundamental new technologies develop.
In the light of the foregoing considerations, the answer to the first question is as follows: – Article 2(2) of Directive 2001/18 must be interpreted as meaning that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs within the meaning of that provision, and – Article 3(1) of Directive 2001/18, read in conjunction with point 1 of Annex I B to that directive and in the light of recital 17 thereof, must be interpreted as meaning that only organisms obtained by means of techniques/methods of mutagenesis which have conventionally been used in a number of applications and have a long safety record are excluded from the scope of that directive.