On 5 July 2023, the European Commission adopted a proposal for a new Regulation on plants produced by certain new genomic techniques. Its aim is to create a new legal framework that will facilitate the development and placing on the market of innovative New Genomic Techniques products. As European institutions delve into internal negotiations concerning this pivotal proposal, it is imperative to grasp the nuances and implications of the regulation.

The proposed regulation is part of a wider package to support the EU’s Farm to Fork and Biodiversity strategies and is strongly connected to the Sustainable Use of Pesticides (SUR) proposal. Plants produced using new genomic techniques should make it possible to meet the new challenges posed to agriculture by climate change, such as the intensification of droughts and floods, and to reduce the use of pesticides and fertilizers.

Let’s clarify the scientific terms. New Genomic Techniques (NGTs) are genetic modification methods that create plant varieties faster and more precisely than traditional breeding. NGTs like targeted mutagenesis and cisgenesis change the genetic material without adding foreign genes. These techniques modify an organism’s complete set of genetic instructions (genome) to produce various results, such as climate-resistant wheat or pesticide-efficient maize.

NGTs differ from genetically modified organisms (GMOs) because they do not involve foreign DNA. The European Food and Safety Authority (EFSA) found no new specific hazards linked with targeted mutagenesis and cisgenesis in its study, stating that NGT plants which could naturally occur or result from conventional breeding are not hazardous. Based on EFSA’s findings, the Commission proposes that certain NGT plants should not be subjected to the same regulations as GMOs, as is currently the case in Directive 2001/18/EC. This new proposal aims to eliminate barriers hindering scientific progress.

Let’s delve into the key measures of the new proposal

The proposal outlines distinct procedures for introducing NGT plants to the market, with NGT plants and their products being prohibited in organic production. Products are categorised into two groups based on their characteristics and risk profiles:

  1. NGT plants that could naturally occur or result from conventional breeding undergo a verification process, following criteria in the proposal (‘category 1 NGT plants’). If these NGT plants meet the criteria, they are treated like conventional plants and exempted from GMO legislation requirements. This means no risk assessment is necessary, and they can be labeled like conventional plants.
  2. All other NGT plants fall under the current GMO legislation (‘category 2 NGT plants’). Such products need to undergo rigorous risk assessment and can only be marketed through an authorisation procedure. They need to meet traceability and labelling criteria afterwards. 

What’s in for the stakeholders and reactions

For biotechnology companies that own patent licenses for the technology and its resulting products, removing NGT plants from the GMO regulation would simplify their production and sales processes. This change would also benefit plant breeders by streamlining the development and introduction of innovative NGT products to the market. Additionally, farmers would gain access to a wider range of tailored plants and consumers, in turn, would have more options for food products with enhanced taste or improved nutritional qualities. The new regulation may also influence the adoption and regulation of these techniques in other regions of the world, as Europe often sets a precedent in areas of policy and innovation. However, this shift may potentially reduce transparency and safety guarantees.

The reaction to the proposal has sparked intense debate. Green MEPs strongly criticised it, especially the specificities of the ‘category 1 NGT plants.’ They voiced concerns about neglecting the precautionary principle, insufficient transparency for citizens due to the difficulty in detecting genetic modifications, and the potential contamination risk for the organic sector. They received support from various environmental NGOs. In contrast, others, including the EPP, endorsed the proposal, viewing it as crucial for advancing the Farm to Fork strategy’s goals and reducing pesticide usage by providing farmers with new tools.

What’s next?

The Council and Parliament are currently engaged in internal negotiations to define their positions, with ambitious schedules, aiming respectively to adopt a position in December and early February, followed then by inter-institutional negotiations. This dossier is one of the priorities of the Spanish Presidency but with several countries voicing criticism and calling for a more solid scientific basis to move forward, including Austria, Hungary and Germany, progress towards a common position between Member States (General Approach) won’t be straightforward. Adoption before the end of the legislature in June will be quite tricky, but it remains a possibility.

Curious to learn more about the proposal and about the upcoming institutional procedures? Do not hesitate to get in touch with our sustainability team!

Juliette Olivier, Public Affairs Consultant