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New Genomic Techniques in Food and Feed

On 17 June 2026, the European Parliament adopted new rules on plants obtained by certain new genomic techniques (NGTs), including the famous genetic scissors CRISPR-Cas9, and the food and feed made from these plants. This is the most radical change in the regulation of genetically modified organisms (GMOs) in the EU in the last three decades, starting in 1988 when the European Commission tabled its first proposal to regulate GMOs. Depending on the number and type of modifications of a plant’s genome, the new rules exempt certain NGT plants and their products from investment-choking GMO rules under Directive 2001/18 (NGT1) and lower the risk assessment requirements for certain other NGT plants (NGT2).

In the ongoing geopolitical biotech brawl, it is not just EU policymakers and the legislature who must catch up with technological progress by adopting new rules, but also European consumers who now need to adjust their risk perception of genetic modification or will be nudged to do so. Certain NGOs, as well as the organic sector opposed to GMOs, may now consider questioning the new legislation or any delegated acts adopted under it, particularly as regards whether a high level of protection of human health and the environment has been maintained, where the GMO requirements on risk assessment, traceability and post-market monitoring are effectively removed for plants and products developed using the new techniques. However, the path for this change has been paved long before, with decades of longitudinal data and experience gained in environmental and human health risk assessments concerning conventional genetic modification, and no new hazards have been identified.

Biases Facing Sustainability Benefits

In fact, not only has scientific evidence overwhelmingly shown that NGTs have been regulated more heavily under the existing GMO rules than their scientific risk profiles justified, but research has also shown how the regulation is biased against new techniques. On the latter point, it is difficult to explain in any other way why conventional plant breeding or conventional techniques of genetic modification, such as ionising radiation, have not been subject to the same authorisation requirements as NGTs, despite not being technologically superior in terms of safety. One may dispute how the EU came to stretch the doctrinal logic of applying the precautionary principle to the point of undervaluing new information on evolving technologies, idealising full scientific certainty and ignoring trade-offs and foregone benefits. All of this put the question of GMOs out of the European consumers’ minds. As the Commission’s Food Safety Eurobarometer found out, very few consumers in the EU are actually afraid of GMOs – an outcome not surprising, given that European consumers almost never encounter authorised GMO products on their plates. Be it the forever-lingering trauma of a series of food crises in the 1990s or the expert confirmation bias following GMO scientific controversies in the public eye, the tide has gradually turned: policymakers have changed narratives and started to frame questions about the consumer acceptability of NGTs in different terms, namely, in terms of benefits for sustainability.

A Conservative Change

EU policymakers have shown receptiveness to the warning that falling behind in the platformisation of gene-editing technology in the age of AI would cost the EU its future direly. At the point, when the law is too slow to respond to technological change, the line between law and technology may snap, and a technological disruption may bring about a change in legal path dependencies. However, only to a degree. Following the 2021 Commission’s study on NGTs, the Commission’s proposal went head-to-head with the political resistance to technological change brought by genome editing. In response, the Commission’s proposal was rather conservative: after all, authorisation will be avoided only if the NGT1 plant is altered by no more than 20 base pairs and does not include the trait of pesticide resistance or the production of a known insecticidal substance. In practice, for example, whenever genetic engineers insert or substitute nucleotide bases of DNA, which form complementary pairs (adenine (A), cytosine (C), guanine (G), thymine (T), and uracil (U)) at no more than three gene modification sites of a gene sequence that encodes a protein, they act like conventional breeders and escape authorisation.

Additionally, other techniques are considered equivalent to conventional breeding, such as inserting contiguous DNA from the breeder’s gene pool. It is yet unclear whether genetic engineers could produce one plant in this way, which would be considered an NGT1 type, and then modify the plant a second time and categorise the new plant again as an NGT1 type. The Commission is empowered to increase or decrease the maximum allowed number and the types of genetic modifications based on new scientific evidence, but the distinctions already rest on a thin scientific basis. The Commission can also adopt delegated acts to remove references to prohibited traits for the NGT1 type or to add new traits to the list.

For some, the extent to which NGTs may be used to modify plants without undergoing authorisation is perceived as too risky; for others, the extent is too limited to attract meaningful research and investment.

Changing Risk Perception Under Framing Forces

Consumer research and some limited experiments with citizen deliberation have demonstrated that even if the lowering of a level of protection is only perceived, consumers consider at least three ethical imperatives shaping their risk acceptance: the imperative that the freedom of choice is not compromised, that life itself becomes not one’s property and that benefits are not only mentioned but rightly communicated and seen. These three imperatives have translated largely into technical debates in the trilogue.

The first debate concerned traceability and labelling. In the citizen jury on NGTs convened as an experiment by researchers from the University of Bayreuth in 2024, labelling was the most divisive issue among participants and provoked deep ethical resentment. In the end, a consensus was reached on a policy recommendation to list NGTs separately from GMOs on ingredient lists. However, with NGTs, the ethical dilemma and consumer preferences become a technical problem. The regulatory bias created not only tougher regulations but also resulted in NGTs falling into a de facto regulatory limbo – a factual impossibility of receiving authorisation. The GMO rules were drafted for the reality of transgenic GMOs with foreign DNA and prescribe detection, identification, and quantification (DIQ) methods for the genetic change along the authorisation dossier for placing on the market and deliberate release. For NGTs, the most challenging, if not impossible, is the identification method attributing a genomic change to a specific modification event, i.e., distinguishing between spontaneous mutation and deliberate technical intervention, such as using conventional breeding techniques or CRISPR-Cas9 scissors. The adopted NGT regulation introduces an important change regarding the requirement to provide DIQ methods: it exempts NGT1 plants from this requirement, while for NGT2 plants, it allows citing technical unfeasibility to avoid submitting DIQ methods. As a result, NGT plants and their products will likely be untraceable by analytical methods, and products will not require specific labelling, since only seeds will need to be labelled as NGT. Without technically robust traceability, labelling of credence attributes will unlikely be effectively enforced, particularly in global supply chains where EU trading partners do not impose similar traceability requirements.

The consumer may ask why not invest more in developing DIQ methods and delay relaxing or eliminating the authorisation requirements until such methods are available. Why not, for example, sequence large numbers of samples from each lot of seeds sold to farmers and build a gigantic database of DNA sequences that could help determine whether a given plant has been modified using NGTs and therefore requires labelling? Apart from the uncertainty, cost and practical impossibility of such an endeavour, it may never produce scientifically relevant results. Mutations occur continuously in plant genomes, and no parent and offspring are genetically identical. Such all-encompassing traceability would also affect conventionally bred plants and those modified through conventional genetic modification techniques. The task of identifying NGT plants appears, for now, impossible to achieve, even if one would follow raw laymen’s imaginaries. Economists also suggest that if consumers were confronted with the true cost of satisfying their ethical preferences, they would often be unwilling to pay. Research further indicates that such labels may affect consumers’ purchasing decisions when their preferences are revealed through market behaviour in the short run, but that effect also depends on the design of the label. It also suggests that when products are placed on the market without distinguishable labelling, consumer acceptance is not significantly shaped by GMO origin as a credence attribute. Given these economic and scientific constraints, technological change and the corresponding adjustment in consumer behaviour appear inevitable.

Patents and Access to Benefits

As regards patenting, the adopted legislative text confirmed the possibility of seeking patents for NGT plants under the existing system of protection. That system comprises the protection of rights and exceptions therefrom (breeders’ exemption, farmers’ privilege), which are regulated at the international level (e.g., the UPOV Convention; the European Patent Convention) and at the EU level, with relevance to biotechnological inventions (Directive 98/44/EC). For example, traits or sequences produced naturally or by essentially biological means (crossing or selection) have been excluded from patentability since 2017 under the Guidelines for Examination at the European Patent Office (Part G – Chapter II-40).

Citizens have been particularly sensitive around the question of who owns the biotechnology and how the ownership will be licensed or enforced, particularly vis-Ă -vis small farmers and small and medium-sized enterprises (SMEs). In the Schloss Thurnau citizen jury, for example, the jury demanded a no-patent policy regarding NGTs and an open-source-like approach with utmost transparency. In the first reading, the European Parliament also introduced amendments to exclude patent protection for NGT plants. The question of patent protection became the most hotly debated issue in the legislative process, with the Council spending considerable time resolving the deadlock. The change came only with the Danish presidency, which managed to broker the deal that accepted the patentability of NGT plants as an important component for investment-inducing rules, following several assurances from the Commission. After the trilogue, the legislative text mandated the Commission to monitor the market with regard to patenting practices and their impacts, including the exclusion of SMEs. The Commission will assess the functioning of the licensing platforms, whether they provide transparency on patents and enable SMEs to license under fair and reasonable conditions. The Commission will draft a code of conduct and ensure that SMEs have access to support and guidance on plant-related patent matters. The Commission is also bound to fulfil its reporting duties by submitting a report on the implementation and impact of the NGT regulation (an obligation which the Commission did not fulfil in relation to Directive 2001/18) and a report on the functioning of the code of conduct. Although the law is unlikely to change in the future, the Commission will prospectively examine whether legislative change or soft-law clarification is needed regarding patentability criteria for inventions relating to plant genetic information, the concept of essentially biological processes, and the conditions for compulsory cross-licensing. However, limitations on any prospective change stem from the international obligations of the EU and its Member States regarding the protection of intellectual property rights.

The third debate focuses on the benefits of NGTs and their applications. A considerable number of applications are in development pipelines and promise superior crops in terms of their sustainability impacts. For example, there are cisgenic potatoes resistant to late blight and cisgenic apples resistant to scab, which result in a substantial reduction in fungicide treatments. For crops mostly cultivated outside the EU, NGTs are used to develop bananas to slow down their browning or to prevent Panama disease in rice. The data used in the impact assessment point out that European consumers are now more willing to accept the technology. Some studies have shown that if consumers are aware of the benefits of GMOs or NGTs, their willingness to buy increases. On that note, the new rules encourage voluntary labelling that emphasises the sustainability traits of such products. In the Schloss Thurnau citizen jury, it was recommended that governments strongly support projects at schools and educational institutions to educate about NGTs/GMOs. Recent research has shown that consumers are eager to learn more about NGTs in an unbiased, well-communicated way and to understand their benefits, but extrapolating sustainability consequences from labels of single traits may be difficult for consumers. Perhaps an inspiration in this regard may be found in specific provisions of other legal acts, such as the EU AI Act’s provisions on AI literacy. Biotech literacy could offer a new way of thinking about how to shape future debates over the regulation of biotechnological inventions.

Technological Promise and Inevitability

In 1992, the Bureau Européen des Unions de Consommateurs wrote to the European Commission in response to its GMO directive proposal that if it turns out that – for specific categories of products – there is no need for an extended assessment, then a more rapid procedure can be agreed on at a future date. However, before this can happen, experience with assessments needs to be gathered. That day came today. From an investment perspective, it remains to be seen whether the limit on the number of genetic modifications permitted for NGT1 plants will be sufficient to provide a meaningful incentive to invest. From a consumer perspective, NGT-derived products are expected to reach the market eventually, whether in five or fifteen years, depending on the development timelines of individual products. From a market perspective, following a two-year implementation period, greater diversification of plant varieties and products can be expected, as cultivation and placing of NGT products on the market will no longer be subject to prohibitively high regulatory costs. Technology has matured, but the risk perception that shaped a high level of protection has not kept pace with the leap it has made. Technological progress has outpaced that perception and eventually made the technology inevitable.

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