The European Commission Proposes a Revision of Genome Editing Regulation

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Recognizing the need for new legislation that fosters biotechnological innovation to fight the effects of climate change, the European Union (EU) has proposed a draft distinguishing between genome-edited and GMO plants.

The European Commission took a significant step on July 5th, 2023, by adopting a proposal to address the legislative gap created by innovative biotechnologies. The primary objective of this proposal is to revise existing regulations concerning genetically modified organisms (GMOs) to accommodate the advancements in New Genomic Techniques (NGTs), including genome editing technology. By doing so, it aims to introduce more flexibility in the regulation of plant varieties created using NGTs.

Genome editing regulation in Europe has lagged behind countries like the US, Australia, China and Japan, where genetically edited products have already been distinguished from GMOs. EU studies confirm that current legislation falls short in keeping up with scientific advancements, leading to implementation and legal challenges. Therefore, the EU must update its regulations to embrace New Genomic Techniques and their products.

The previous genome editing regulation, dating back to the 1980s, was designed for a very different biotechnological market. In 2001, a directive was implemented to restrict genetically modified crops, creating a burdensome verification process that proved too costly for any market growth. In 2018, the directive was expanded to include certain new technologies, without specific accommodations for innovation. All genome-edited planted were treated as GMOs, regardless of whether new genes were introduced.

In response to some industry professionals’ and member states' criticism, the European Commission initiated a review in April 2021 to compare genome-edited crops with GMOs, considering the possibility of separate legislation. The review's findings, along with the European Green Deal's emphasis on sustainable development through innovation, led to the proposal of a new framework in July 2023.

The proposed framework would separate traditional GMOs from plants obtained using certain New Genomic Techniques. To understand the difference, the creation of GMOs involves the insertion of foreign genetic material, resulting in a new organism that will never occur naturally. In contrast, genome editing does not include any exogenous element and allows the creation of plants that could be obtained otherwise through classic breeding or evolution in nature, albeit over an extended period of time. These new biotechnologies are instrumental in making new plant varieties within a much-shortened timeline, which is crucial in combating food scarcity and climate change.

This change specifically focuses on plants created through targeted mutagenesis, where a specific gene in a plant is edited, and cisgenesis, which involves breeding two crossable plants to create a new variety. However, plants that couldn't have been obtained through conventional breeding, like those using transgenesis, will still be regulated as GMO varieties.

The new plant varieties obtained through NGTs would undergo a new verification process, which would be less extensive than the current GMO regulation. To address any transparency concerns, the seeds would be clearly labeled and excluded from organic farming.

While this is a step in the right direction, it is important to emphasize that the proposal is still in the early stages and will undergo further discussions with different stakeholders before confirmation.

Passing this legislation would enable the EU to catch up with other countries where biotechnology regulations have advanced more rapidly, creating an environment conducive to the innovation needed for a greener and more sustainable future in the agri-food sector.

If you would like to express your opinion on the new framework, you are welcome to do so on the EU Commission website until September 2023.

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