생물다양성과 합성생물학 관련 법적 쟁점과 과제 –2018년 7월 25일 ECJ 판결(EuGH, Urt. v. 25. 7. 2018-C-528/16)을 중심으로–

On July 25th 2018, the European Court of Justice(ECJ) has decided in a spectacular fundamental judgment that organisms obtained by mutagenesis are genetically modified organisms(GMO) and are, in principle, subject to the obligations laid down by the GMO directive. The ECJ held that organisms obtained by mutagenesis are GMOs, because the methods and methods of mutagenesis are used to make a naturally impossible change in the genetic material of an organism. As a consequence those organisms come, in principle within the scope of the GMO Directive and are subject to the obligations of that directive. With regard to the question whether the GMO Directive may also be applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption, the Court considers that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis, since the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism and those new techniques make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis. In view of these shared risks, excluding organisms obtained by new mutagenesis techniques from the scope of the GMO Directive would compromise the objective pursued by that directive, which is to avoid adverse effects on human health and the environment, and would fail to respect the precautionary principle which that directive seeks to implement. It follows that the GMO Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption.