(Science|Business) Council, Parliament agree on long-awaited regulation for new genomic techniques

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The EU presidency and the European Parliament have reached a provisional agreement on a proposed regulation for new genomic techniques (NGTs) such as gene editing. After years of haggling over sustainability and patenting concerns, this promises a way forward for the use of NGTs in plant breeding.

“New genomic techniques can help us do more with less,” said Jacob Jensen, Denmark’s minister for food, agriculture and fisheries, in a statement from the Danish presidency. “The regulation will allow us to develop new plant varieties that are more resilient to climate change and require less fertilisers or pesticides.”

For Jessica Polfjärd, MEP from the European People’s Party and rapporteur on the file, “today’s agreement is a breakthrough that boosts not only our farmers’ competitiveness, but also Europe’s position in research and innovation.”

Tripartite discussions between the Danish presidency, the Parliament and the European Commission concluded during the night of December 3. The agreement must now be endorsed by the EU Council and the Parliament as a whole.

Europe’s problem with NGTs dates back to a 2018 ruling by the Court of Justice of the EU that gene editing techniques should be covered by existing rules for genetically modified organisms (GMOs), designed to strictly control methods that move genes between different species. The result was effectively a ban on growing gene-edited crops in Europe and putting products derived from them onto the market.

Attempts to break the deadlock began in 2023, when the Commission proposed a relaxation of the rules in order to harness the benefits of gene editing for both competitiveness and food security. NGTs are used to design or enhance traits of interest in plant species that improve their nutritional profile or increase their resistance to disease and harsh climatic conditions.

From now on, genetically modified plants will be split into two categories. In Category 1, NGT plants are considered equivalent to plants produced by conventional breeding methods, and therefore exempt from the GMO legislation; in Category 2, plants with more complex or less “natural-equivalent” genomic modifications must stick to GMO rules, the Council said.

“The agreement generally preserves the original intent of the Commission proposal to provide an enabling framework for the development and growing of conventional-like NGT plants,” industry lobby group Euroseeds said in a statement.

“Yesterday is not a surprise, given the pressure that was put by the presidency, among others, to strike an agreement,” Eric Gall, deputy director of the organic food and farming lobby group IFOAM Organics Europe, said in a press briefing. “But we really wonder to what extent it reflects the majorities of the different political parties in the European Parliament.”

Labels and traits

MEPs went into the discussion asking for additional sustainability criteria through to the final product, in order to differentiate NGT plants from traditionally bred varieties and to allow operators to establish NGT-free food chains. This blanket requirement fell by the wayside, and the final agreement states that NGT-1 plants will not be labelled, except for seeds and other plant reproductive material.

However, there will be an exclusion list of intended traits. NGT plants that are tolerant to herbicides or produce known insecticidal effects will be excluded from Category 1 and classed as NGT-2. Just like transgenic GMOs, they will be subject to authorisation, traceability and labelling requirements, “with the possibility of a voluntary label to indicate the purpose of the genetic modification,” according to a statement by the Commission.

Meanwhile, member states will be allowed to opt out from the cultivation of NGT-2 plants on their territory.

Patents and varieties

Another major sticking point related to NGT patenting. Being able to patent NGT plant varieties will give companies stronger intellectual property protection than the lighter EU-wide Plant Variety Right (PVR) system, which covers traditional breeding methods, but according to Gall, it puts at risk the European model of innovation in breeding.

The Parliament had asked for a full ban on patents to avoid giving multinational seed companies a monopoly, depriving farmers and small breeders from accessing NGT varieties.

Instead, the agreement states that companies and breeders applying to register an NGT plant or product in Category 1 must submit information on all existing or pending patents, which will be publicly available. MEPs however managed to retain safeguards, including measures to prevent market concentration and guarantee affordable and fair access for farmers.

A patenting group composed of experts from all member states, the European Patent Office and the Community Plant Variety Office is to be created to monitor progress, and the Commission is expected to draw up an EU code of conduct on patents in this area.

“The Commission will oversee transparency and licencing practices related to patents, and provide guidance where needed,” the Commission said. “It will also assess the impact of patents on breeders’ access to genetic material and on farmers’ access to plant varieties, with a view to proposing follow-up measures if necessary.”

Industrial dependence

Despite these safeguards, environmental groups are concerned that the agreement hands too much power to large companies. 

“We are caught in patent system where licensing costs will go sky high, small companies will disappear or be dependent on patent-owing companies,” said Frans Carree, head of the breeding department at De Bolster Organic Seeds, in the press briefing. “Our whole breeding system will fall apart and we will be dependent on a few big agrochemical companies that will decide what we eat.”

In particular, the agreement makes no mention of the breeder’s exemption which, as a core principle of the PVR system, enables other breeders to use a protected variety to develop others without the authorisation of the PVR holder, promoting cumulative innovation in plant breeding. However, this already features in the national patent laws in France, Germany, the Netherlands and Switzerland.

Finally, NGTs will be excluded from organic food production. “The Commission will assess whether this regulation creates any administrative, economic or practical burdens for organic operators, including relating to their own perception and that of consumers,” the Parliament said.