AG opinion: organisms obtained by mutagenesis are exempted from GMO Directive

Sophie ten Bosch

Yesterday, the Advocate General’s Opinion in Case C-528/16 on the interpretation of the GMO-Directive (Directive 2001/18/EC) with regard to mutagenesis was published. In this case the Court of Justice is invited by the French Conseil d’État to clarify among other things the exact scope of the GMO-Directive, and more specifically the mutagenesis exemption, and to assess its validity.

Although this case concerns one specific type of mutagenesis, it shall have consequences for whether new plant genetic modification techniques (such as CRISPR) will fall under the GMO-Directive and will therefore be regulated in the European Union. There has been quite some debate on the regulation of new plant-breeding techniques such as CRISPR. The European Commission has indicated that it is the sole prerogative of the ECJ to render a final and binding opinion on this. A spokesperson of the European Commission was quoted recently as saying that the Commission shall not provide a legal interpretation of the regulatory status of products generated by new plant-breeding techniques until the ECJ has rendered a decision in this case.

According to Advocate General Bobek, organisms obtained by mutagenesis are, in principle, exempted from the obligations in the GMO-Directive, provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by one or more of the methods listed in Annex I B of the GMO-Directive (you can read his full opinion here and a summary in the press release here).

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