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The Court of Justice of the European Union (EU) has determined that some organisms obtained through the process of gene-editing technologies such as mutagenesis are genetically-modified organisms (GMOs), and are therefore subject to the requirements of the EU’s GMO Directive (Directive 2001/18/EC).
The ruling is the result of a case brought by France’s Council of State, which sought validation for French legislation that exempts organisms obtained by mutagenesis from obligations under the Directive. The legislation was being legally challenged by several French agriculture unions, who argued that advanced gene-editing techniques are now being used to produce organisms that are resistant to certain herbicides, posing a significant potential risk to the environment as well as human and animal health.
According to a report by the Reuters News Service, recent studies of certain gene-editing techniques, such as CRIPR/Cas9, can cause unexpected genetic damage to the underlying DNA, resulting in potentially harmful changes to some cells.
In its ruling, the Court determined that, in general, organisms obtained by mutagenesis are, in fact, GMOs under the meaning of the GMO Directive, and are subject to the Directive’s provisions. However, the Court also noted that some organisms obtained by mutagenic techniques that have a long safety record and which have been conventionally used in a number of applications are not subject to the Directive, although Member States are free to develop further legislation in this area, consistent with EU law.
The complete text of press release by the EU Court of Justice on its ruling is available here.