Comment: New genes policy is a smart one

The EU has reached a provisional political agreement to create a two-tier regulatory system for plants derived from New Genomic Techniques (NGTs). Whilst somewhat unexpected in its earlier timing, it’s an agreement that should overwhelmingly be welcomed. It heralds a significant step forward.

It shows that regulators recognise and accept that agricultural breeding technologies have continued to advance, that NGT plants are no longer inevitably GMO, and they cannot simply be treated as GMOs.

First proposed in 2017, the new law will relax restrictions for some NGT plants, but maintain stricter oversight for others that aim to boost innovation in sustainable agriculture.

The EU Council made the following comments when it announced the agreement: “The [proposed NGT] regulation aims to improve the competitiveness of the agrifood sector and ensure a level playing field for European operators, while boosting food security and reducing external dependencies. The regulation ensures robust protection for human and animal health, as well as the environment, while contributing to EU sustainability goals.

“The provisional agreement guarantees a simplified process for NGT plants equivalent to conventional plants and addresses concerns regarding intellectual property and access to seeds…”

It added: “The regulation will allow us to develop new plant varieties that are more resilient to climate change and require less fertilisers or pesticides. Our farmers and agri-food sector will be better equipped to innovate and continue to produce healthy and safe food for our citizens.”

As we await the regulation’s formal approval and enactment, it would be timely for regulators to consider the required flow-on adjustments to procedural formalities, which must properly recognise NGT plants’ independent status and eligibility for protection.

For example, the requirement that physical plant material must exist on the date someone files for protection, as the only means to establish a new NGT variety’s characteristics or traits, is very much part of the ‘old world’.

Category management

There are some key points to note here, and the headline one is that this provisional regulation establishes two distinct categories of NGT plant. Category 1, or NGT1, will be considered equivalent to plants that could either be produced by conventional breeding methods, or occur naturally.

Typically, this will be gene edited (for example, using Crispr technologies) without the introduction of any foreign DNA. And they will be largely exempt from the strict requirements of the EU’s existing GMO legislation, including mandatory risk assessments.

• Marketing approval: A simplified verification procedure will be used to confirm NGT1 status before market introduction.
• Labelling: NGT1 plants will not require consumer labelling as GMO, but their seeds and reproductive material must be labelled to ensure transparency for farmers and the organic sector.
• Exclusions: Plants with any prescribed traits – including herbicide tolerance – will be specifically excluded from Category 1 and will be subject to stricter rules, potentially as an NGT2 plant.
• Organics: NGT1 plants will be banned from use in organic agriculture.

Category 2, or NGT2, will include all other NGT plants with more complex modifications that do not meet the Category 1 criteria.

These will continue to be regulated under adapted GMO legislation, and require full risk assessment and authorisation before market approval.

• Labelling: NGT2 will need to be labelled as GMO at consumer level, with all trait modifications included.
• Incentives: The regulation will offer incentives, such as expedited procedures, for NGT2 plants developed with sustainability traits – excluding herbicide tolerance.
• Member States may elect to exclude the right to cultivate NGT2 plants in their territory.
• Member States may adopt coexistence measures, which means they can take measures to avoid the unintended presence of NGT2 plants in other products.

Patent pending

Back in March, when the EU Council issued its mandate for negotiations with the European Parliament over the terms of the proposed NGT regulation, a major point of contention was patenting.

The final agreement requires NGT1 registration applicants to submit information on all existing or pending patents for the plant or product, and this must be listed in a publicly available database. Applicants can also provide information on the patent-holder’s intention to license the use of a patented NGT1 plant or product.

Meanwhile, a newly established group of experts will study the impact of patents on breeders’ and farmers’ access to NGT plant materials. The EC has committed to reporting that research, as well as any recommended follow-up measures, within one year of the new law coming into effect.

Next steps

The provisional agreement between the European Parliament and the Council of the EU must be formally approved by both institutions to become law.

Whilst this is expected some time in 2026, the legislation won’t formally come into effect until two years after an endorsement in the Official Journal is published – so, effectively, late 2028 at the earliest.

Darron Saltzman is the Principal and founder of Hort-IP Law, a Melbourne-based firm specializing in intellectual property (IP) law for the horticulture and agriculture sectors.