Experts Categorically Oppose Proposal to Deregulate New GE Plants in the EU

TWN Info Service on Biosafety
21 December 2023
Third World Network

Dear Friends and Colleagues

Experts Categorically Oppose Proposal to Deregulate New GE Plants in the EU

The debate in Europe over plants obtained from new genetic engineering (new GE or new genomic techniques, NGT) is heating up, with a proposal that would allow the environmental release of such plants without prior risk assessment failing to reach a qualified majority of support among EU agriculture ministers on 11 December.

A number of European scientists issued a joint statement warning against approval of this proposal (Item 1). They conclude that the proposal made by the European Commission cannot ensure health or environmental safety if NGT plants or products derived therefrom are released into the environment or placed on the EU market. They call for the proposal as it stands to be rejected or extensively revised.

The Commission divides NGT plants into two categories: those that need risk assessment and those that may only require registration. However, the scientists point out that the proposed criteria to distinguish between the two categories are not based on science. They state that it is scientifically incorrect to assume that the risks to health or the environment from NGT plants are generally lower compared to transgenic plants and that the risks from both transgenic and NGT plants need to be assessed on a case-by-case basis in accordance with the precautionary principle. The statement also calls for NGT plants to be subject to mandatory traceability and labelling.

Alongside this, more than 100 academics signed an open letter criticizing the proposal from a socio-economic perspective (Item 2). They raise several concerns, including the undemocratic nature of the development of the proposal, the violation of the precautionary principle, the absence of the concept of safety, and the facilitation of liberalization and the biotech industry’s patenting of seeds. They also call for the Commission’s proposal to be rejected.

With best wishes,
Third World Network

Item 1


Joint statement of scientists on the future EU regulation of NGT plants from the perspective of the protection goals

5 December 2023

This statement addresses serious scientific concerns in regard to the proposal on the future regulation of plants obtained from new genetic engineering methods, also known as new genomic techniques (NGTs).1 We want to support the EU in order to avoid decisions that could endanger health, the environment and biodiversity.

Who we are

Numerous scientists are currently engaged in the development and application of new genomic techniques in plants. Many scientists working in this field are also in favour of deregulating plants obtained from NGTs, because they have an interest in speeding up developments and facilitating the marketing of NGT plants. Very often, they are also involved in filing patents on the technology as well as on plants derived thereof.

Our joint statement has been drawn up by experts and scientists working on the future EU regulation of NGT plants from the perspective of the protection goals of health, the environment and biodiversity. All of the scientists involved in drawing up our statement are bound by common scientific standards in natural sciences, but have no financial or career interests in the development, release or marketing of NGT plants. We are scientists with expertise in the field of agroecology, agronomy, biology, developmental biology, ecology, environmental biosafety, environmental science, molecular biology, molecular genetics and toxicology, plant physiology, plant populations genetics, soil microbiology, technology assessment, and veterinary medicine and see one of our roles as supporting independent risk assessment as enshrined in Directive 2001/18/EC2 (Recital 21). This requests that “systematic and independent research on the potential risks involved in the deliberate release or the placing on the market of GMOs is conducted.”

Many of us work with civil society organisations. Within Europe, we represent a major group of those experts that are working on NGTs from the perspective of the protection goals. Our work is carried out independently of any interests in the development or marketing of NGT plants.

Our joint conclusions on the risk assessment of NGT plants

A strong consensus was reached by the signatory scientists and experts who have been working on genetically engineered plants from the perspective of the protection goals (such as health, the environment and biodiversity): In short, the proposal made by the Commission cannot ensure health or environmental safety if NGT plants or products derived thereof are released into the environment or placed on the EU market. Therefore, the proposal as it stands should be rejected or extensively revised.

We are concerned that CRISPR/Cas, and other gene editing methods covered by the proposal, are mostly referred to as tools which can be used to imitate mutations that occur naturally, or can be introduced using conventional breeding. However, there is no doubt that tools such as CRISPR/Cas gene scissors have the potential and capacity to alter gene sequences (genotype), and thus gene function and plant characteristics (phenotype) in a way that is unlikely to occur in conventional breeding, regardless of whether these are intended or unintended changes. Earlier genetic engineering methods involve the transfer of genes across individual plant or species boundaries to achieve new traits (transgenic plants). Now, however, NGTs make it possible to change the characteristics of a species to an extent that would be impossible, or at the very least unlikely, using conventional breeding, even without the insertion of additional genes.

The Commission appears to be aware of this technical potential as they divide NGT plants into two categories: one that needs risk assessment and one that may only require registration. However, the proposed criteria to distinguish between these two categories, i.e. 20 genetic changes, are not based on science.

It is scientifically incorrect to assume that the risks to health or the environment from NGT plants are generally lower compared to transgenic plants. Therefore, in both cases (transgenic plants and NGT plants), the risks to health, the environment and biodiversity need to be assessed on a case-bycase basis.

As highlighted by the EU Court of Justice (CJEU), EU regulation of genetically engineered organisms is based on the precautionary principle (PP), as laid down in Directive 2001/18/EC.3 According to the Commission, this will remain the basis of NGT plant regulation. However, in order to uphold the precautionary principle and to ensure that no substantial harm is caused, a core element of current regulation must be retained and not simply abandoned, i. e. the requirement for mandatory risk assessment of NGT plants which may be released into the environment, including all products derived thereof prior to marketing.

Given the differences in processes and outcomes of NGT compared to conventional breeding, we disagree with the EU Commission proposal. Instead, we conclude that all NGT plants must continue to be subject to a mandatory risk assessment, carried out on a case-by-case and step-by-step basis, before any reasoned assumption can be made on their safety:

In accordance with the precautionary principle, all NGT plants must be examined in detail on a case-by-case basis to determine which intended or unintended genetic changes (genotypes), or biological traits (phenotypes), are present in the plants that are unlikely to be achieved using conventional breeding methods, and, importantly, including an assessment of any associated risks, as currently laid down in Directive 2001/18/EC.

The Commission states that it wants to adapt current legislation to take recent technical developments into account, and secondly to introduce more flexibility. In our opinion, the existing GMO legislation has sufficient clarity and flexibility to deal with applications for the release or marketing of NGT plants and products. Indeed – and as pointed out by the CJEU – NGT plants are genetically engineered organisms as defined in Directive 2001/18/EC, and their regulation under this Directive is necessary as they have similar risk profiles to transgenic plants.4

As already stated, this legal framework already encompasses flexibility: the amount of data needed for risk assessment may vary from case to case, depending on the specific NGT plant (‘event’). Therefore, we cannot see why it is necessary to introduce additional legislation. Our position is backed by the CJEU court ruling stating that current rules applying to NGT plants are appropriate in light of their risk profile. As the court states, they have not “conventionally been used in a number of applications” and do not have a “long safety record” as foreseen in Recital 17 of Directive 2001/18/EC in relation to plants obtained from random mutagenesis.5

If the institutions of the EU nevertheless believe it is necessary to introduce specific legislation regarding NGT plants, this would require a substantial overhaul of the current proposal on several different levels. This must include deleting Category 1 from the proposed regulatory framework, as it would exempt a large group of NGT plants from mandatory risk assessment and only require their registration. Risk assessment must remain mandatory for all NGT plants. As far as Category 2 is concerned, it would require the introduction of some specific requirements and steps within the risk assessment process in order to ensure that safety is not compromised. As it stands, the legislative proposal for Category 2 would, for example, allow risk assessment to be reduced to the intended traits only.

In addition, a broad range of species, e. g. crops, wild plants, forest trees, grasses, as well as traits, e. g. enhanced fitness, drastic modifications in plant physiology or changes in environmental interactions, could in future be engineered with NGTs at fast pace. It would, therefore, be imperative to introduce measures to control and limit the overall scale of releases in terms of the number of organisms and traits. As has already been discussed in other fields of nature protection, any potentially disrupting interference with the environment must be limited and avoided as far as possible.

If releases of several NGT plants with different traits into a shared environment were to be considered, this would necessitate the establishment of clear criteria and methodologies to assess potential interactions and cumulative effects to avoid a disruption of ecosystem function and processes by organisms which have not adapted through evolutionary processes. NGT plants that have the potential to persist, reproduce or spread in the open environment need to be evaluated with the greatest possible scrutiny in respect to their impact on nature and the environment. In case of remaining uncertainty, their release into the environment must be prohibited.

Furthermore, in regard to food safety, it also has to be taken into account that NGT processes can cause unintended DNA changes and unintended effects at (off-)target genomic sites which are unlikely to occur in conventionally bred plants. Without detailed molecular analysis and risk assessment, it cannot be excluded that the resulting alterations in gene functions and biochemistry may impact human or animal health at the stage of consumption.

Additional comments linked to the future regulation of NGT plants

There is a need to launch research programs and establish guidelines for technology assessment so that the supposed benefits of NGT plants can be realistically evaluated. This must include a comparison to lower-risk alternatives.

Patents on NGT seeds must be strictly limited to the technical processes in order to avoid these being extended into conventional breeding: many of these patents claim genetic resources and gene variants that are also needed in conventional breeding. The patents can block access to biodiversity in such a way that traditional breeding carried out by small or medium-sized breeding companies would become impossible in the future.

NGT plants must be subject to mandatory traceability and labelling all the way through up to the consumers in order to enable intervention and retrieval if damage to health, the environment or biodiversity occurs. These cornerstones of the precautionary principle must not be called into question by the new regulation. Furthermore, consumers, food producers, farmers and breeders should be provided with full transparency about NGT plants and their usage at different stages of food and feed production. We should not abandon the above-mentioned advantages provided in current GMO regulation.

Signed in alphabetical order (please see list online)


  1. COM (2023) 411 final 2023/0226 (COD) Proposal for a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625,
  2. The Commission’s proposal constitutes lex specialis with regard to the Union GMO legislation.
  3. Judgment of the Court (Grand Chamber) of 25 July 2018, Case C-528/16, Confédération paysanne, paras 50 and 52.
  4. see above, Confédération paysanne, para 48. 5
  5. see above, Confédération paysanne, para 51.


Item 2


The European Commission has launched a proposal for the (de-)regulation of new genetically modified organisms (GMOs) or New Genomic Techniques (NGTs). As academics, from a vast range of disciplines, including agroecology, political ecology, rural sociology, molecular biology, environmental history, population genetics, evolutionary biology, ecology, agronomy and innovation studies, we are very concerned about the quality of this legislative proposal, the process by which it came into being, and the social, economic and environmental impacts it will have, should it be adopted. Moreover, we have serious questions about the way in which climate and sustainability goals are being used to justify this (de-)regulation.

  • Democratic decision-making

As the intended large-scale deregulation of GMOs represents an irreversible change to our eco- and food systems, we are convinced that this proposal should be treated with the utmost caution. The attempt to rush this proposal through before the European elections, without thorough health, environmental and socio-economic impact analysis or significant public debate, is downright worrying.

Studies show that a very large proportion of European citizens believe that new GMOs (NGTs) should be regulated in a similar way to other GMOs.[1] According to a recent Ipsos poll, only 3% of those surveyed thought neither labelling nor safety tests were necessary.[2]  However, abolishing labelling and safety tests is exactly what is on the table with the current proposal. In 2022, more than 400,000 European citizens signed a petition urging the EU to keep safety testing, transparency and labelling for all GMOs.[3] In March 2023, 340 organisations wrote to Commissioner Timmermans with the same demand.[4] In other words, the Commission is coming up with a proposal that is not supported by the European people, but nevertheless threatens to become legislation without their participation or even their knowledge. Citizens thus risk facing a fait accompli which they do not support. Citizens’ trust in European politics is already low. This proposal threatens to further undermine that trust.

Moreover, the development of the Commission’s proposal is biased and can hardly be called democratic. Stakeholder groups from the agricultural sector,[5] non-governmental environmental organisations and European lobby watchdog groups repeatedly denounced the fact that critical voices were systematically ignored in the drafting of the proposal, even though they were merely defending general interests such as healthy food, a liveable agriculture and a healthy living environment.[6]  The stakeholders who were well heard by the European Commission appear to be mainly actors with a direct financial interest in deregulation.[7]

  • Lip service

Underlying the proposal is a rather arbitrary distinction between Category 1 and 2 plants, with the latter group broadly remaining subject to the current regulations, while the former is fully deregulated. However, the Commission’s criteria for assigning new GM plants to Category 1 are arbitrary and without scientific foundation. There is no evidence to justify the assumption that a new GM plant with less than 20 intended genetic modifications of the types described by the Commission will be any safer or less risky than a new GM plant with more than 20. On the contrary, scientists point out that risk does not depend on the number of genetic modifications, but on what they do. Yet the proposal does not require any investigation of unintended and/or genome-wide effects that may arise from the intended genetic modifications. A recent study by the German Federal Agency for Environmental Protection (BfN) showed that 94% of NGT plant applications which are currently in the pipeline would fall into Category 1, even though they may be very different in their biological properties and effects from the non-GM parent.[8] As a result, under the current proposal, virtually  none of the new GM products in the commercialisation pipeline  will have to be labelled or undergo safety tests.

The importance of this arbitrary distinction cannot be underestimated and lies at the heart of several other forms of misleading argumentation in the Commission’s proposal. Lip service is paid to important rights and principles, while these will be violated by the proposal in actual fact. For example, reference is made to the need to guarantee consumers’ right to information (Article 38 of the Charter), while subsequently this right is only applied to Category 2 NGTs (i.e. the smallest group of new GMOs). The importance of the precautionary principle is stressed, while the same precautionary principle is completely removed for the largest group of Category 1 NGT. For this group, hardly any options are built in to check potential health or environmental effects before food is marketed or even afterwards to trace the cause of any harm  if something goes wrong. A recent analysis prepared by 30 German legal experts shows that the proposal violates the Lisbon Treaty and the Cartagena Protocol exactly because it does not respect the precautionary principle.[9]

The proposal is also marked by tensions, or even contradictions, in other areas. For instance, it recognises that the use of GMOs is incompatible with the definition of organic farming, as defined both by the sector itself and in European legislation (Regulation (EC) 2018/848″). At the same time, the organic sector rightly notes that remaining GMO-free in organic farming risks becoming impossible in practice under the current proposal.[10]  Yet the Green Deal aims to significantly expand the share of organic farming in Europe.

  • Safety and Precision

The concept of safety is conspicuous by its absence in the proposal, even though it is the cornerstone of existing GMO legislation. Curiously, the issue of risk assessments is hardly addressed directly. The proposal merely states that the new GMO techniques are more precise and can produce GMOs that are barely distinguishable from conventionally obtained crops. The problem is that this too easily links different concepts: precision cannot simply be equated with safety. A precise shooter is not necessarily a safe shooter. It depends on what the shooter is aiming at. Moreover, in this case, the shooter’s target is DNA, which is still largely uncharted territory. As the European Commission acknowledges, unintended changes are common with these new GMO techniques (both at the intended site of the intervention and elsewhere in the genome). These accidental changes differ in the location and frequency at which they occur from random changes made with random mutagenesis, which fall outside current GMO legislation.[11] Scientists from the European Network for Social and Environmental Justice ENSSER concluded, after analysing the existing scientific knowledge, that the current proposal does not take into account the unintended damage that new techniques such as CRISPR/Cas introduce into the genome.[12] However, the Commission brushed aside their concerns. At the same time, the proposal itself recognises that even within category 1 NGTs, major changes can happen that can significantly alter the structure and composition of the food and therefore its nutritional value or the amount of unwanted components. The novel food legislation will apply here, at least to the extent it concerns intended effects. For the current proposal, it is especially important  that it shows that with a limited number of changes in DNA, significant changes to the food can still occur.

Besides greater precision, the main argument to cast aside safety concerns is that Category 1 NGTs could theoretically also occur via conventional breeding techniques or naturally, or at least this is what proponents claim. However, just because a plant has similar traits does not mean that the process by which these new organisms are produced would no longer matter. On the contrary, scientists have argued that process-induced unintended changes may present risks to health or the environment.[13] To safeguard European consumers and the environment, proper screening for unintended effects is necessary. For this reason, existing European GMO legislation regulates the genetic modification processes itself. While that legislation has worked well for years, it is now in danger of being  undermined in the space of a few months by the Commission’s proposal. The questions that underpinned the drafting of European GMO legislation in the 1990s – such as the right of Member States not to authorise the cultivation of GMOs, long-term impact monitoring, and labelling for consumers – are as relevant as ever.

Moreover, again, a contradiction creeps into the proposal: on the one hand, these organisms are assumed to be equivalent to plants that could have arisen naturally or through conventional breeding techniques. On the other hand, these crops are considered so innovative and radically different that they can be patented by the developer. Both claims cannot be true. But one thing is certain: All new GMOs are patented (both the technologies and the products) and there is no reason to assume that this will change within the foreseeable future.

  • Sowing GMOs, reaping patents

Patents are a crucial issue to be considered in the proposed deregulation of new GMOs. The ability to patent seeds may be even more important than the introduction of the new traits themselves. Indeed, conventionally grown seeds cannot be patented as easily. This is a thorn in the side of the seed industry. Genetically modified organisms may be the Trojan horse and open the door to possibly patenting all seeds in the future, not just genetically manipulated ones. A recent report by European environmental organisations shows that a search for the term “CRISPR-Cas plant” in international patent application databases yielded no less than 20,000 results.[14] These are often broad patent applications covering all plants with a particular trait, regardless of how the plants are obtained – including via conventional breeding techniques.

It is sometimes argued that the deregulation of GMOs is necessary to also give smaller biotechnology companies and startups a chance. They would not be able to afford expensive safety tests, so the argument goes. Apart from the moral question of whether we should deregulate safety legislation to give smaller market players more economic leverage, this is also too simplistic as a representation. Multinational agrochemical companies typically buy the most promising startups to gain access to their patents. More importantly, this argument only considers small ‘biotech’ companies. Patenting seed threatens the very existence of a much larger group of independent breeding companies and farmers. For this reason they have been fighting patents on plant material for many years. A recent research report concluded that deregulation of a large number of new GMOs will make agriculture in Europe even more dependent on the big multinationals, exactly because of the existing intellectual property structures.[15]

  • Comprehensive liberalisation

Here we seem to be getting close to what the proposal is mainly about: removing barriers to market forces for a Europe eager to be competitive in the world. This is also explicitly cited as one of the central objectives in the proposal. It is about creating a so-called unhindered playing field for the biotech industry, which prefers to operate free from time-intensive risk analyses and safety checks. But, is far-reaching liberalisation and deregulation, regardless of the effects on people and the environment, really what Europe wants to stand for? The proposal to follow the United States, China, the United Kingdom and Argentina in a logic of hyper-liberalisation reads as a remarkable weakness. The logic at stake goes beyond GMO deregulation per se. It is about who or what Europe wants to be: an advocate of sound environmental, agricultural and health policies or a follower in a competitive race to the bottom?

  • Climate and Sustainability

Of course, many commentators will claim that the deregulation proposal is not just about innovation and competitiveness, but also about climate goals, pesticide reduction, and sustainability. However, it is exactly this invocation of sustainability goals to weaken the GMO legislation that worries us most. Using climate and sustainability goals to achieve deregulation and commercialisation of new GMOs feels like an ill chosen joke. Definitely because fundamental pillars of every sound sustainability policy, such as the precautionary principle and proper international regulation, are removed at the same time. The German Federal Environmental Protection Agency study, which we cited earlier, shows that about 30% of NGT applications in plants target consumers (such as allegedly blood pressure-lowering tomatoes). 20% targets industrial efficiency. Only a small number of the investigated NGT plant applications would potentially play a role regarding sustainability, and even for those applications it is far from given that they can actually make a difference. In essence, these applications ignore that the sustainability of an agricultural and food system mainly depends on the whole-system level of interactions between plants, humans and the environment, and to a much lesser extent  on the genetics of a particular crop.[16] Drought resistance and disease and pest resistance can be achieved much more efficiently and sustainably by changing the entire farming system according to agroecological principles.[17]

We conclude that sustainability goals are being opportunistically used to win over citizens and politicians, thereby serving the economic interests of the biotech industry, in a  form of greenwashing. It is remarkable that the European Commission makes this possible just as certain companies are having to withdraw their sustainability claims (from climate neutrality to the contribution to carbon offsetting) from their advertising, because they cannot substantiate the claims with facts.[18] Similarly, the sustainability promises around new GMOs are unlikely to live up to the claims. But this may be of little concern to the biotech industry: by the time this becomes clear, it may be too late to reverse deregulation.

The stakes should not be underestimated. Once genetically manipulated organisms are released into our environments and food systems, they cannot simply be taken out again in the event that environmental or health problems appear. It might even become impossible to simply identify or trace the origins of environmental and health problems. This is of great concern in a society in which health and environmental problems are increasingly the result of complex, interacting and often largely invisible causes. This is obviously not of concern to the agro-chemical industry as it allows them to escape responsibility. This brings us to our last point: when seeds and genetic material falls even further into the hands of agribusiness, it will become ever more difficult for governments and farmers to guarantee robust, sustainable and fair food systems.
In this sense, this is an irreversible decision. We therefore urge you to express your strong reservations and reject the Commission’s proposal.

We look forward to your response.

FIRST 100 SIGNATORIES (alphabetically) – please see list online


[1] Rathenau Instituut (2023). Aanpassen onder voorwaarden – Hoe Nederlanders denken over nieuwe genomische technieken in voedingsgewassen. Den Haag. Auteurs: Habets, M., I. Pirson, P. Macnaghten en P. Verhoef.

[2] The Greens/EFA. (2021). GM crops and consumer rights.


[4] Open letter: regulation of new genomic techniques

[5] Open Letter European Coordination Via Campesina. Supporting the deregulation of new GMOs amounts to destroying GMO-free agriculture. Online publication04.09.2023

[6] EU Commission proposes to deregulate new GMOs in spectacular submission to the biotech industry.Online publication 05.07.23

[7] Corporate Europe Observatory. Researchers with vested interests lobbying to undermine GMO safety rules. Online publication28.09.22

[8] Federal Agency for Nature Conservation (BfN) Where does the EU Commission‘s path lead to? Analysis of case studies. Online publication. 07.09.23.

[9] Legal Opinion. Commission proposal for a regulation on new genomic techniques (NGT): in violation of the precautionary principle Online publication 14.09.2023

[10] IFOAM Resolution of the organic movement in favour of a system-based approach of innovation and sustainability – Keep Organic GMO-free. Online publication. 21.06.2023

[11] Testbiotech. Background. New genetic engineering: EU Commission proposal for new regulation endangers nature, the environment and our future livelihoods. 31.08.2023 Online Publication

[12] Analysis statement by ENSSER (European Network of Scientists for Social and Environmental Responsibility) on the EU Commission’s new GM proposal. Here for Annex 1 on NGT “equivalence criteria” Online publication. 07.07.2023


[14] Dolan et al. 2022. Report “Exposed. How biotech giants use patents and new GMOs to control the future of food”. GLOBAL 2000 – Friends of the Earth Austria, Friends of the Earth Europe, Corporate Europe Observatory (CEO), Arche Noah, IG Saatgut – Interessengemeinschaft für gentechnikfreie Saatgutarbeit and Arbeiterkammer Wien

[15] Ely, Adrian, Patrick van Zwanenberg, Elise Wach and Dominic Glover, 2023. The possible deregulation of certain GMOs in the EU: What would the implications be? A pathways analysis. Brussels, BE: The Greens/EFA group in the European Parliament.

[16] De Schutter, O. 2010. ”Agroecology and the Right to Food”. Report submitted to Human Rights Council by the Special Rapporteur on the right to food, Olivier De Schutter. Publication Online

[17] Altieri, Miguel A., Clara I. Nicholls, Alejandro Henao, and Marcos A. Lana. “Agroecology and the design of climate change-resilient farming systems.” Agronomy for sustainable development 35, no. 3 (2015): 869-890

[18] ;

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