The Court of Justice for the European Union has held that techniques to edit an organism’s genes without inserting foreign DNA—such as CRISPR/Cas9—result in the creation of genetically modified organisms (GMOs) subject to the EU GMO Directive. Confédération paysanne v. Premier ministre, No. C-528/16 (CJEU, entered July 25, 2018).

The plaintiff, a French agricultural union, argued that French legislation exempting organisms produced with mutagenesis techniques such as CRISPR from GMO regulation conflicts with EU legislation governing GMOs. The court found that the mutagenesis techniques “alter the genetic material of an organism in a way that does not occur naturally, within the meaning of that provision. It follows that organisms obtained by means of techniques/methods of mutagenesis must be considered to be GMOs within the meaning of [the GMO Directive].”

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