Background

On 5 July 2023, the European Commission (“EC”) put forward a proposal for a regulation on plants obtained by certain new genomic techniques (“NGT”) and their food and feed (the “draft NGT Regulation”).

The term NGT is used to describe a variety of methods capable of modifying an organism’s genetic material that has appeared or has been developed after 2001 when the current European Union (“EU”) legislation on genetically modified organisms (“GMO”) was adopted. Targeted mutagenesis and cisgenesis (including intragenesis) are considered NGTs.

NGT plants currently fall under the scope of the existing EU framework of GMO legislation, which is among the strictest in the world. However, a study presented by the European Commission in 2021 concluded that current EU GMO legislation may not be fit to regulate NGT plants obtained by targeted mutagenesis or cisgenesis, and products derived from them. Among the problems identified in the study is the fact that the risk assessment requirements and authorisation procedure under the current EU GMO legislation are in many cases inadequate or disproportionate for NGT plants. It was also concluded that, overall, the legislation does not foster the development of innovative and potentially beneficial NGT products. This was identified as a problem as NGTs enable to precisely and efficiently alter the genomic material of plants to make plants that are climate resilient, pest resistant, require fewer fertilisers and pesticides, or ensure higher yields. One could think of rice tolerant to salt, tomato plants for growth in urban areas, corn with more grain rows, or non-browning bananas. As such, NGTs could potentially contribute to the sustainability objectives of the EU Green Deal, ‘Farm to Fork, ‘Biodiversity’ and ‘Adaptation to Climate Change’ strategies.

In this context, the European Commission proposed a draft NGT Regulation aimed at creating a more enabling legal framework not only for NGT plants (targeted mutagenesis and cisgenesis only), but also for food and feed containing, consisting of, or produced from NGT plants, or containing ingredients produced from NGT plants, as well as products, other than food and feed, containing or consisting of NGT plants.

The draft NGT Regulation, however, was met with mixed reactions. Agri-food industry groups were overall supportive of the more relaxed framework with some qualifying the proposal as “game-changing” and “a step in the right direction”. On the other hand, the majority of environmental organisations, NGOs and organic food and farming interest groups expressed strong criticism, stressing the dangers of GMO contamination on conventional and organic production as well as the potential increased dependency of farmers on large seed corporations.

Two categories of NGT plants

The proposed NGT Regulation distinguishes two types of plants: NGT plants ‘considered equivalent to conventional plants’ (category 1) and all other plants obtained through NGTs (category 2).

• Category 1 NGT plants: would not be subject to the requirements of the currently applicable EU GMO legislation. They would instead be subject to requirements that apply generally to conventional plants. Category 1 NGT plant status would be obtained through a verification procedure. This procedure is intended to bring a high degree of simplification and decrease of administrative burdens and costs for developers, especially due to the reduced data requirements. Developers would only have to submit to the competent authority data supporting that the NGT plant or product meets the criteria for equivalence to naturally occurring or conventionally bred plants listed in Annex I to the NGT Regulation, instead of having to present data on the detection method and carrying out a risk assessment, which would not be required as part of this new verification procedure.

• Category 2 NGT plants: would be subject to the EU GMO rules as they have a more complex set of modifications to their genetic material and their risks need to be assessed. At the same time, the draft NGT Regulation introduces special rules to adapt and simplify the current procedures under the EU GMO legislation, notably by providing for an adapted risk assessment, flexible modalities to comply with detection method requirements and the possibility to adapt post-market monitoring requirements to the risk profile of the NGT plant.

Labelling

As regards applicable labelling requirements, Category 1 NGT plants would be assigned an identification number and would need to be listed in a publicly available database. They would not be subject to traceability and labelling requirements as GMOs. Further, Category 1 NGT seeds would bear a label indicating “cat 1 NGT”.

The traceability and labelling requirements of the EU GMO legislation, however, would remain applicable to Category 2 NGT plants and products. In addition, the draft NGT Regulation introduces the possibility of also mentioning the trait(s) conveyed by the genetic modification on the labelling.

Organic production

The EU Organic Products Regulation (Regulation (EU) 2018/848) prohibits the use of GMOs and products produced from or by GMOs in organic production. Under the NGT Regulation, both Category 1 and 2 NGT plants would be forbidden in organic production. EU member states would also be required to adopt measures to prevent the unintended presence of Category 2 NGT plants in organic and conventional crops.

Regulatory incentives

Certain incentives, such as an accelerated procedure for risk assessment, enhanced pre-submission advice and a waiver of fees for SMEs are provided for Category 2 NGT plants and products containing the traits listed in Annex III of the draft NGT Regulation (e.g., resistance to plant diseases and pests, more efficient use of resources, reduced need for pesticides and fertilisers). The objective of these incentives is of course to guide R&D efforts towards plants and products with characteristics that support sustainability.

Latest developments and what next?

On 7 February 2024, the European Parliament (“EP”) adopted its position on the draft NGT Regulation with some important amendments, including a new article on one of the most controversial topics: patentability. The EP amendment introduces a complete ban on patentability applicable to NGT plants, responding to fears that patenting could make small farmers and breeders captive of large seed corporations dominating the market. Other changes include the exclusion of NGT plants with herbicide-tolerant traits from the possibility of being qualified as Category 1 NGT plants and strengthened labelling requirements for Category 1 NGT plants and products (which would be required to bear a label indicating “New Genomic Techniques”). The current draft continues to provide for a 2-year transition period after which the NGT Regulation would apply.

Belgium, currently holding the rotating Presidency of the Council of EU Member States and as such leading the discussions, is eager to reach an agreement on this proposal before the EP elections taking place from 6 to 9 June 2024. However, this seems increasingly unlikely with several EU Member States still opposing various measures included in the draft text and the Council reported to be at a standstill. Moreover, the EP has requested the European Food Safety Authority (EFSA) for an opinion “to be ready before the end of July 2024” on the criteria for qualifying NGT plants as Category 1.

Discussions on this file will clearly continue for quite some time to come.

Our team routinely advises on food, feed and related biotechnology matters. Please contact the authors or the Hogan Lovells attorneys with whom you work regularly for additional information.

Authored by Samantha Van Dijk, Cláudia Mendes Pinto, and Jacqueline Mailly.