EU Adopts Two-Tier Regulatory Framework for Gene-Edited Crops, Opening New Path for CRISPR Innovation
核心洞察
The European Union has introduced a two-tier system distinguishing NGT-1 crops with limited genetic changes from more extensively modified NGT-2 crops, with NGT-1 plants no longer regulated as GMOs.
CRISPR-edited crops meeting NGT-1 criteria—20 or fewer modifications and no foreign DNA—will face reduced regulatory burdens, potentially accelerating market access.
Scientists remain divided: some argue CRISPR is more precise than older mutagenesis methods, while others warn of hundreds to thousands of unintended DNA damage sites from the editing process.
The European Union is poised to fundamentally reshape its regulatory landscape for gene-edited crops, introducing a two-tier classification system that will free certain genetically modified plants from the stringent requirements that have governed genetically modified organisms (GMOs) since the 1990s. The European Parliament vote on new genomic techniques (NGTs) is scheduled for June 17, marking what could be the most significant policy shift in EU agricultural biotechnology in three decades.
Under the new framework, gene-edited crops are divided into two categories: NGT-1 and NGT-2. NGT-1 plants are defined as those carrying a limited number and type of changes—specifically 20 or fewer genetic modifications—that could have occurred through conventional breeding, and which contain no foreign genetic material from outside the conventional gene pool. Once verified as meeting these criteria, NGT-1 crops will be regulated like conventional plants, no longer subject to GMO risk assessments, labeling, and traceability requirements.
NGT-2 plants, by contrast, encompass those with more than 20 genetic modifications or those engineered for specific excluded traits such as herbicide tolerance or insecticidal substance production. These remain under the existing GMO regulatory framework, including mandatory safety assessments.
A new era for CRISPR-edited crops
The regulatory change carries particular significance for crops edited using CRISPR-Cas (搜索), the Nobel Prize-winning gene-editing tool. Ben Tolley, European patent attorney at law firm Mewburn Ellis (搜索), noted that the new regulation is "technology agnostic," meaning it does not target any specific gene-editing platform. Provided CRISPR-edited crops satisfy NGT-1 requirements, they will no longer face the burdensome GMO regulation that previously applied following a 2018 European Court of Justice decision that had placed newer gene-editing techniques within the scope of the EU's GMO directive.
Detlef Weigel, director of the molecular biology department at Germany's Max Planck Institute for Biology (搜索), endorsed the approach. "If a CRISPR-edited plant contains no foreign DNA and carries only changes that could also arise through natural mutation processes, then from a scientific point of view, there is no convincing reason to treat it like a classical transgenic plant," Weigel said. "The EU is therefore moving in the right direction by distinguishing between NGT-1 and NGT-2 plants."
Weigel emphasized that CRISPR represents an improvement over older mutagenesis methods used by plant breeders, such as chemical and radiation-induced mutation, which he described as often less predictable. "CRISPR is more precise in this respect than many older methods," he said. "This does not automatically make the biology risk-free, just as not every naturally occurring plant is automatically edible. But it makes it difficult to see why such plants should be inherently more dangerous than conventionally bred plants."
Scientific disagreement over safety
Not all scientists share this assessment. Michael Antoniou, professor of molecular genetics at King's College London, contends that gene-edited plants are fundamentally different from conventionally bred crops because the CRISPR process itself can cause unintended changes to plant DNA.
"The scientific evidence shows that when considered as a whole, the CRISPR gene editing process causes large-scale random, unintended sites of damage to the DNA of the plant, and those sites of damage can number in the hundreds or thousands," Antoniou said.
Antoniou pointed to GABA tomatoes (搜索)—the world's first commercially available CRISPR gene-edited food, cultivated in Japan and marketed for their high neurotransmitter content purportedly aiding blood pressure reduction and stress relief—as an example of unknown risks. "Yes, they look like a normal tomato, but what unintentional changes to its biochemistry and composition have also taken place? We don't know," he said. He argues the EU's proposed rules do not adequately account for such unintended genetic alterations and believes developers should be obliged to use molecular profiling methods to assess wider genomic changes.
Patent concerns and market concentration
Even as the regulatory path clears, patentability remains a contentious issue. Tolley confirmed that gene-edited plants, whether classified as NGT-1 or NGT-2, remain patentable under the new framework, which he said "preserves the investment incentive and the innovation incentive."
The non-profit Corporate Europe Observatory (搜索) has raised concerns that deregulating gene-edited crops could "trap farmers and breeders" in a "patent minefield." In response, the new regulation includes transparency measures: when requesting NGT-1 verification, applicants must declare any patents or published applications covering the plant, whether held by themselves or third parties, and may optionally declare a willingness to license patents to third parties.
Matin Qaim, professor of agricultural economics at the University of Bonn, argued that the EU has historically been overly cautious. "Issues of public acceptance have led to costly and lengthy regulatory procedures for transgenic GM crops, not because these crops are really dangerous but because anti-GM activists have managed to depict them as dangerous in the public perception," Qaim said. "The best answer is typically not to ban specific technologies but to identify smart policies that help to maintain competition and fair access to relevant innovations by all."
Implications for food security and innovation
Proponents of the regulatory shift argue that making NGT-1 crops available to farmers could help address climate change by enabling development of crops with enhanced resistance to drought, pests, and disease, while potentially reducing reliance on fertilizers and pesticides. CRISPR-Cas (搜索) has already been used to develop more nutritious tomatoes, non-browning avocados, and seedless blackberries.
The new regulation, which will come into effect in two years, is expected to allow biotechnology companies to bring products to market more quickly. The World Health Organization maintains that all GM foods should be assessed on a case-by-case basis, while noting that currently available products are likely to pose risks to human health.
Weigel offered a final caution on the regulatory framework itself: "What is important, however, is that the categories remain scientifically meaningful, transparent and verifiable. We need regulation that is scientifically grounded, proportionate and practically workable."