Court Of Justice Ruling: Organisms Obtained By Mutagenesis As GMOs.pdf

## Court of Justice Ruling on Organisms Obtained by Mutagenesis

Key Points:

The Court of Justice ruled on Case C-528/16 regarding the classification and regulation of organisms obtained by mutagenesis (organisms whose genetic material is directly modified).

Main Findings:

1. Organisms by Mutagenesis are GMOs: These organisms, created through techniques altering an organism's genetic material beyond natural variations, fall under the definition of Genetically Modified Organisms (GMOs) as outlined in the GMO Directive 2001/18/EC. They are therefore subject to the directive’s obligations regarding authorization, traceability, labeling, and monitoring.

2. Historical Techniques vs. Newer Mutagenesis:

- Organisms produced by conventional mutagenesis techniques used for various applications with a proven safety record are exempt from GMO Directive obligations.
- Member States can subject these exempt organisms to GMO regulations or other requirements under EU law.
- New mutagenesis techniques, capable of targeted mutations leading to herbicide resistance, are subject to the GMO Directive. This is due to potential environmental and health risks comparable to those posed by GMOs created through transgenesis.

3. Genetically Modified Varieties:

- Genetically modified varieties obtained by mutagenesis must meet the conditions for inclusion in the "common catalogue of varieties" as outlined in another EU directive (Council Directive 2002/53/EC) regarding risk mitigation measures to protect human health and the environment.
- Organisms produced by conventional, safe mutagenesis techniques are exempt from this requirement.

Context:

The case was brought by the Confédération paysanne, a French agricultural union, challenging France's exemption of herbicide-resistant seed varieties developed through mutagenesis from GMO regulations. The Court's ruling clarifies the legal status and regulatory framework for these organisms within the EU.