Genetically Modified Organisms Research Articles

Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.

Legal and Technical Challenges of Developing Robust Traceability Systems for Genetically Modified Organisms

This article examines the legal and technical challenges in developing effective traceability systems for genetically modified organisms (GMOs), focusing on the European Union's Directive 2001/18/EC framework. Using qualitative research methods and a doctrinal approach, we analyze legal texts, case law, and scholarly literature to evaluate current regulations and tracking technologies. Our objective is to identify key barriers to implementing comprehensive traceability and propose potential solutions within existing legal frameworks. The study employs content analysis of EU directives, particularly Directive 2009/41/EC on the contained use of GMMs, and conducts semi-structured interviews with legal experts and regulators. Results indicate significant complexities in harmonizing tracking across member states and technical challenges in maintaining the "high level of protection" mandated by EU law. We recommend refining legal definitions, enhancing risk assessment protocols, and exploring advanced detection methods compatible with current regulations. This research contributes to ongoing debates on balancing scientific innovation, environmental protection, and consumer rights in governance.

Guideline for the verification of digital PCR methods in analytical GMO testing

The international working group “Development of methods for identification of foodstuffs produced by means of genetic engineering techniques” was established pursuant to § 64 of the German Food and Feed Code (LFGB). It has developed a guideline for implementing and verifying digital PCR methods previously validated as real-time PCR techniques. While event-specific methods in testing of genetically modified organisms (GMO) have traditionally relied on real-time PCR, new digital PCR technologies offer significant advantages and therefore, leading to an increased use by control laboratories. This guideline provides practical recommendations for transferring the real-time PCR to digital PCR and for verifying the digital PCR method. The guideline is applicable to analysis of GMO in food, feed and seed and is freely available on the website of the Federal Office of Consumer Protection and Food Safety (BVL).

The evolution of media reportage on GMOs in Ghana following approval of first GM crop

ABSTRACT Ghana’s parliament in 2011 passed the Biosafety Act to allow for the application of genetically modified organism (GMO) technology in the country’s agriculture. In a vibrant democracy, there have been extensive media discussions on whether GM crops will benefit or harm citizens. In June 2022, the state GMO regulator, the National Biosafety Authority (NBA), approved the country’s first GM crop (Bt cowpea) for environmental release, declaring the crop does not present an altered environmental risk or a food/feed safety concern. This study identified 3 of the country’s most vibrant digital news outlets and did a content analysis of all GMO stories reported 18 months pre- and post-approval to assess whether the approval changed the focus of GMO issues the media reports on. 91 articles were identified. The results show media reports on the likely impact of GMOs on the country’s food security shot up after the approval. However, media reports on the possible health, sociocultural, and environmental impact of GMOs declined. We observe the media and the public appear interested in deliberations on how the technology could address or worsen food insecurity and urge agricultural biotechnology actors in Ghana to focus on that in their sensitization activities.

Adoption of Biotechnology in Livestock Production

Purpose: The general objective of this study was to investigate the adoption of biotechnology in livestock production. Methodology: The study adopted a desktop research methodology. Desk research refers to secondary data or that which can be collected without fieldwork. Desk research is basically involved in collecting data from existing resources hence it is often considered a low cost technique as compared to field research, as the main cost is involved in executive’s time, telephone charges and directories. Thus, the study relied on already published studies, reports and statistics. This secondary data was easily accessed through the online journals and library. Findings: The findings reveal that there exists a contextual and methodological gap relating to the adoption of biotechnology in livestock production. Preliminary empirical review revealed that the adoption of biotechnology in livestock production offered significant benefits for productivity, animal health, and environmental sustainability. Genetic improvements, disease management, and reproductive technologies were highlighted as key areas where biotechnology had a positive impact. However, the study identified barriers such as high costs, regulatory challenges, and limited access in developing regions. Recommendations included supportive policies, increased investment in research, and capacity-building efforts to enhance the adoption of biotechnology, ultimately aiming to transform livestock systems and contribute to global food security and sustainable development Unique Contribution to Theory, Practice and Policy: The Theory of Planned Behaviour, Diffusion of Innovations Theory and Technology Acceptance Model may be used to anchor future studies on the adoption of biotechnology in livestock production. The study recommended integrating socio-economic factors into theoretical frameworks, enhancing practical training and capacity-building for farmers, and harmonizing regulatory frameworks to promote biotechnology adoption. It also emphasized public education campaigns to address misconceptions, suggested environmental sustainability practices, and called for ongoing research and innovation. These recommendations aimed to enhance productivity, sustainability, and resilience in the livestock sector, ultimately contributing to global food security and sustainable development. Keywords: Biotechnology, Genetic Engineering, Molecular Markers, Reproductive Technologies, Artificial Insemination (AI), Embryo Transfer (ET), In Vitro Fertilization (IVF), Genetically Modified Organisms (GMOs)

Novel strategies for predicting allergenicity: development of a ranking method and screening tools to assess the allergy risk of innovative proteins

Abstract To protect individuals who already have or are at risk of developing immune‐mediated adverse reactions to food, novel foods and genetically modified organisms (GMOs) undergo an allergenicity risk assessment. There are shortcomings in this process that could be improved through use of well‐defined clinically relevant allergen molecules with different allergenic potential. The objective of this project was to develop novel strategies for predicting allergenicity of innovative/novel proteins that address this issue. We undertook a systematic review of allergen molecules in foods listed on Annex II of the Food Information for Consumers Regulation together with additional foods known to cause IgE‐mediated food allergies in at least one European region with a prevalence of 0.5%. Around 750 in‐scope papers were quality assessed to allow clinical relevance of allergen molecules to be ranked. The best characterised clinically relevant allergens were identified in peanut, hazelnut, cow's milk, fish and crustacean shellfish with data lacking for allergens from foods such as pecan, Macadamia, lupin and melon. Furthermore, an assessment of in silico tools allergenicity prediction found that, whilst many were able to correctly predict allergenicity, none were able to provide an output that could be linked to the clinical relevance. Building on these outcomes an approach for allergenicity risk assessment has been developed that brings together elements of exposure assessment, combining in silico, in vitro, and in vivo methods. Tools for assessment of risks of cross‐reactive allergies are more mature and only require refinement to improve the outputs to inform the allergenicity risk assessment process. However, as mechanisms underlying development of food allergy are not fully elucidated, and remain a matter of ongoing research, prediction of de novo sensitisation is uncertain.

Enzymatic Activity of Fungi for Hydrolysis of Wheat Bran and Cultivation of Oleaginous Yeasts

Sustainable alternatives to petrochemical raw materials in oleochemical, laundry detergent and personal care industry need to be implemented. Presently, palm oil is the predominant cost-efficient option. While it is a renewable source, it has negative environmental and socioeconomic implications. Therefore, the request for ecologically certified and palm oil-free cleaning agents and household care products is rapidly growing, supported by concepts of waste-free biorefinery. Oleaginous yeasts are currently the most promising source for microbial lipid production. Additionally, wheat bran is a cereal milling by-product, which is available in high quantities and provides an excellent feedstock. Enzymatically generated wheat bran hydrolysate provides an excellent microbial cultivation medium for the sustainable production of high value biological additives. Indeed, wheat bran consists predominantly of lignocellulose, and therefore of cellulose, hemicellulose and lignin, which can be hydrolyzed by established enzyme systems. Currently, such enzymatic systems are mainly obtained for the market from genetically modified organisms (GMO). This represents a problem because GMO products or process components cannot be included in eco-certified household care formulations. Therefore, innovative GMO-free biotechnological processes need to be implemented, as well as the isolation of novel GMO-free hydrolase enzyme systems. Fungal strains are an interesting source for the efficient screening and isolation GMO-free hydrolases (see figure).This contribution is part of a project, which aims to use a holistic biotechnological approach to convert mill residues into customized specialty ingredients of eco-certified detergents. The project focuses on three main tasks:investigation of a microbial group of eight Ascomycete fungi,production of enzymes for hydrolysis of wheat bran, anduse of the resulting biomass hydrolysate to cultivate oleaginous yeasts.Hydrolase producing fungal strains were cultivated on different substrates to investigate their ability to generate specific enzyme systems capable of hydrolyzing wheat bran. The activity of the enzymes was qualitatively and quantitatively characterized to determine the optimal strains for the degradation of wheat bran and suited to implement a large-scale process. Supernatants of different fungal strains cultivations were tested in the hydrolysis step to compare the hydrolysis performances of differently active enzyme mixes. The biomass hydrolysate was used to cultivate lipid generating yeasts to investigate their ability to grow on the microbial cultivation medium.

Challenges for the Post-Market Environmental Monitoring in the European Union Imposed by Novel Applications of Genetically Modified and Genome-Edited Organisms.

Information on the state of the environment is important to achieve the objectives of the European Green Deal, including the EU's Biodiversity Strategy for 2030. The existing regulatory provisions for genetically modified organisms (GMOs) foresee an obligatory post-market environmental monitoring (PMEM) of potential adverse effects upon release into the environment. So far, GMO monitoring activities have focused on genetically modified crops. With the advent of new genomic techniques (NGT), novel GMO applications are being developed and may be released into a range of different, non-agricultural environments with potential implications for ecosystems and biodiversity. This challenges the current monitoring concepts and requires adaptation of existing monitoring programs to meet monitoring requirements. While the incorporation of existing biodiversity monitoring programs into GMO monitoring at the national level is important, additional monitoring activities will also be required. Using case examples, we highlight that monitoring requirements for novel GMO applications differ from those of GM crop plants previously authorized for commercial use in the European Union.

Using Multimedia to Help Agricultural Producers Communicate with Consumers about GMOs

Genetically modified organisms (GMOs) and their uses are often misunderstood. Consumers are regularly unsure what GMOs are, or if they are safe for consumption and the environment. Contradictory and sometimes inaccurate information is available from numerous sources, and challenges consumers and others to separate the facts from sensationalized stories. Agricultural producers often communicate with consumers, neighbors, and members of the general public; however, they do not have information to share about GMOs. Multimedia resources can provide agricultural producers with science-based information to share with consumers. Agricultural communicators and Extension educators can create science-based multimedia resources to bridge the communication gap.

120 Gene editing: From the general public perspective

Abstract The public controversy around genetically engineered (GE) products, aka genetically modified organisms (GMO), has been ongoing for almost 40 yr fueled in part by well-funded misinformation campaigns disseminated by activist organizations. Polls reveal that public perception of GE animals is generally negative, with biomedical applications being more positively perceived than agricultural applications. Opposition to GE animals is often conflated with opposition to use of animals in research in general, as well as opposition to aspects of intensive animal agriculture. In general, concerns about animal biotechnology are influenced by views around the moral status of animals, the boundary between “natural” and “unnatural,” and perceived risks and benefits of GE animals to health and the environment (personal and cultural characteristics); the purpose of the application (e.g., disease resistance > fast growth), the method(s) being used, and the motivation of the research group making the genetic modification (public or private); and the species being modified (animal characteristics). There were three factors that aggravated opposition to GE products including 1) a lengthy and expensive regulatory step uniquely associated with commercializing products developed using that breeding method, 2) competing business interests (e.g., organic, non-GMO project) that were able to monetarize fear around the method to extract value (rent seeking) and selling their value-added (more expensive) product that avoided the use of GE, and 3) there is a mandatory labeling requirement to track/differentiate products produced with (or without) that breeding method to enable value-added marketing. Even so, when GE products that people wanted were allowed to reach the market (e.g., Impossible Burger with GE heme, GloFish, AquAdvantage salmon), they met with commercial acceptance. Now it has been suggested that the public will similarly reject animal products derived from gene edited (GnEd) animals, but that idea has only recently been put to the test as such food products were not previously available. A 2022 Japanese paper noted that with regard to GnEd food (gene knock-out tomatoes and fish) there was a “gap between anticipated and actual public response”. They noted that “even though there were some petitions against the use of genome-editing made by consumer groups; they did not develop into a mass mobilization, and media coverage was mostly positive.” These GnEd food products were developed by startups from Japanese universities, required no unique regulatory step before commercialization or mandatory labeling with Japanese regulatory agencies transparently sharing a summary of the information and notification on their websites, and businesses were encouraged to share information on products to respect The right of consumers to know. Successful commercialization of GnEd animal products has so far occurred in countries (e.g., Argentina, Brazil, Japan) where regulations treat simple GnEd products with no “foreign DNA” to be “non-GMO” and analogous to conventional breeding.

Susceptibility to poor arguments: The interplay of cognitive sophistication and attitudes.

Despite everyday argumentation being crucial to human communication and decision-making, the cognitive determinants of argument evaluation are poorly known. This study examined how attitudes and aspects of cognitive sophistication, i.e., thinking styles and scientific literacy, relate to people's acceptance of poorly justified arguments (e.g., unwarranted appeals to naturalness) on controversial topics (e.g., genetically modified organisms (GMOs)). The participants were more accepting of poorly justified arguments that aligned with their attitudes compared to those that opposed their attitudes, and this was true regardless of one's thinking styles or level of scientific literacy. Still, most of the examined aspects of cognitive sophistication were also positively related to fallacy detection. The strongest cognitive predictors of correctly recognizing the fallacies were one's scientific reasoning ability and active open-mindedness. The results thus imply that decreasing misleading attitude effects, and increasing certain aspects of analytic and scientific thinking, could improve argumentation.

Sustainable Organic Farming Maturity Model

Organic farming is of the utmost importance in promoting environmentally sustainable agricultural practices, minimizing environmental contamination, and avoiding using chemical fertilizers and genetically modified organisms (GMOs). Even inexperienced and seasoned farmers frequently encounter formidable obstacles when attempting to authenticate their organic farming status by acquiring organic agriculture certification. The current level of agricultural land maturity is accurately assessed by a comprehensive model presented in this study, which also provides a framework for the transition to organic farming standards. These maturity models were formulated through an exhaustive analysis of agricultural standards, an extensive review of pertinent literature, and expert interviews conducted in 15 distinct locations, with each expert holding certification in a minimum of three organic agricultural standards. Identifying characteristics germane to organic standards, integrating them into maturity models, and establishing maturity items and dimensions are also components of the study. The outcome of our investigation is the Sustainable Organic Farming Maturity (SOFaM) model, which consists of five levels and eight dimensions, as well as a standard operating procedure manual for organic agricultural standard certification applications. This model's potential as an assessment instrument for determining the maturity level of agricultural land has been validated by experts who hold credentials in three distinct domains and three locations. The SOFaM model has the potential to function as a paradigm shift in the agricultural sector, streamline the certification process following organic farming standards, and guarantee adherence to predetermined criteria.

Role of genetically modified organisms in food, crop production, their regulations, and controversy

Abstract Estimates suggest that over one-third of food is lost or wasted along the food supply chain, with significant environmental and economic effects. This is one of the primary problems with today’s food systems, along with decreased agricultural yield and food quality. Many people attribute the decline in output and the deterioration of food quality to a lack of technology and ignorance about modern technologies. As a result, scientists are working hard to find innovative solutions to these problems and create new food production methods to feed the world’s growing population. Increased agricultural yields and quality may be achieved in a variety of settings by employing genetically engineered techniques. Newer techniques and technologies involving genetic modification and recombinant (r) deoxyribonucleic acid could be very helpful in the pursuit of significant improvements in food production and food supply, and biotechnology is a key part of this. Recent progress in genetic engineering, where it came from, the current trend, and its potential future are all discussed in this overview. Genetically modified organisms (GMOs) are major aspects of the industrial food system, and most packaged foods contain GMOs ingredients that have been bred to be resistant to pesticides and herbicides. There are a number of factors that raise red flags concerning GMOs, including safety, consequences on the environment and present ineffective employment of pesticides have also been considered. Furthermore, GMOs regulation and controversy among different scientists has also been discussed. Many individuals are concerned about GMOs, yet they may not fully grasp the concerns at hand. Therefore, the level of GMO knowledge revealed by this review can be calculated.

Studies on Benefits of Organic Food Products in Human Life during Covid-19

Organic food products have gained considerable attention in recent years due to their perceived health and environmental benefits. This comprehensive review examines the scientific evidence surrounding the advantages of consuming organic foods compared to conventionally produced counterparts. Firstly, organic farming practices emphasize the use of natural fertilizers and biological pest control methods, avoiding synthetic pesticides and genetically modified organisms (GMOs). Numerous studies have demonstrated that organic produce tends to have lower pesticide residues, reducing the potential health risks associated with pesticide exposure. Moreover, organic farming promotes soil health and biodiversity by minimizing the use of synthetic chemicals and fostering sustainable agricultural practices. Healthy soils are essential for nutrient-rich crops and contribute to long-term environmental sustainability. Additionally, organic agriculture typically utilizes crop rotation and intercropping techniques, which enhance soil fertility and resilience. Furthermore, organic livestock production adheres to stringent animal welfare standards, including access to outdoor grazing and the prohibition of routine antibiotic use and growth hormones. As a result, organic meat, dairy, and poultry products often contain higher levels of beneficial nutrients such as omega-3 fatty acids and antioxidants. In terms of nutritional quality, several meta-analyses have suggested that organic fruits and vegetables may have slightly higher levels of certain vitamins, minerals, and antioxidants compared to conventionally grown counterparts. While the differences may be modest, the cumulative effects of consuming organic foods over time could contribute to improved overall health outcomes. Beyond individual health benefits, supporting organic agriculture also has positive implications for environmental conservation and sustainable food systems. By minimizing chemical inputs and promoting biodiversity, organic farming helps mitigate soil erosion, water pollution, and greenhouse gas emissions associated with conventional agriculture.

THE LEGAL MECHANISMS FOR THE USE OF GENETICALLY MODIFIED FOODS

Genetically modified foods are among the most significant outcomes of biotechnology, and they are one of the most contentious topics among scientists and legal experts regarding their potential effects on human health and the environment. The principle of scientific uncertainty and legal instability prevails in countries handling of regulating its trading, as opinions were divided between supporters and opponents of genetically modified organisms (GMOs), and positions and legislations varied among nations on this matter. Efforts worldwide have been focused on creating a roadmap for the trade and evaluating its risks concerning the preservation of biodiversity and human health. Research raises several closely related issues, notably the gap between providing sufficient food for nearly eight billion people in a world with a continuously increasing population and the inadequacy of this food supply due to global warming and climate change. Other challenges are associated with the lack of legislative and regulatory harmonization for the trade of these substances between domestic and international laws and the stance of the Algerian legislator on this matter

Challenges and opportunities for access to Advanced Therapy Medicinal Products in Brazil

Background aimsThe marketing authorization of Advanced Therapy Medicinal Products (ATMPs) in Brazil is recent. The features of these therapies impose specialized regulatory action and are consequently challenging for developers. The goal of this study was to identify the industry's experience in clinical development, marketing authorization and access to ATMPs through the Unified Health System (SUS, acronym in Portuguese), from a regulatory perspective. MethodsA survey containing structured questions was conducted among research participants who work at companies that commercialize ATMPs. A descriptive analysis was performed. ResultsWe invited 15 foreign pharmaceutical companies, of which 10 agreed to participate. Overall, participants assessed that Brazil has a well-established regulatory system, especially the sanitary registration by the National Health Surveillance Agency (Anvisa), which ensures the quality, safety, and efficacy of the products. The Agency's good interaction with the regulated sector, the harmonization of sanitary and ethical assessment systems with other countries, and the analysis time in the biosafety assessment of Genetically Modified Organisms (GMOs) stand out as positive in industry's evaluation. On the other hand, it is important to advance the pricing regulation for these products since Brazilian regulations do not establish specific criteria for ATMP. One of the biggest challenges is the difficulty for the SUS in reimbursing these very high-cost therapies, especially using current Health Technology Assessment (HTA) methods. ConclusionsConsidering the increasing number of approvals of cell and gene therapies in Brazil in the coming years, a close dialogue between the industry and the public sector is recommended to advance regulatory improvements (pricing and HTA). Additionally, the construction of policies to promote the national Health Economic-Industrial Complex, based on a mission-oriented vision that encourages innovative models of financing, especially those that consider risk-sharing and co-financing technologies, will help provide the population with universal, equitable and sustainable access to ATMP in the SUS.

An overview on the impact of genetically engineered organisms on crop yield and safety

Genetically Engineered Organisms (GEOs) have ushered in a new era in agriculture, revolutionizing crop yield and safety through techniques like transgenic modification and genome editing. This review delves into the profound impact of GEOs on agricultural landscapes, elucidating their role in enhancing crop traits, and bolstering resistance to pests, diseases, and adverse environmental conditions, thereby ensuring food security for a burgeoning global population. However, amidst these advancements, persistent concerns regarding GEOs' environmental and health ramifications persist. The review critically examines potential unintended consequences within ecosystems and addresses human health implications, particularly allergenicity. Furthermore, it scrutinizes existing regulatory frameworks and the pivotal role of public perception in shaping the trajectory of GEOs. While emphasizing the intricate interplay between genetic engineering and crop production, the review advocates for continued research and informed decision-making to harness the benefits of GEOs while mitigating potential risks. Additionally, it underscores the significance of enhancing science communication and regulatory measures to address ethical concerns and combat misinformation. With advancements in precision gene-integration technologies and emerging research in biofortification and stress tolerance, GEOs are promising to enhance commercial agriculture's productivity and profitability. However, achieving this potential necessitates proactive measures such as improved regulation, risk mitigation strategies, and enhanced communication with stakeholders to ensure GEOs' responsible and sustainable integration into agricultural systems.

Quantitative and qualitative analysis of three DNA extraction methods from soybean, maize, and canola oils and investigation of the presence of genetically modified organisms (GMOs)

The objective of this study was to develop a DNA-based method for the identification and tracking of edible oils, which is important for health management. Three different DNA extraction methods (CTAB, MBST kit, and manual hexane-based method) were used to obtain high-purity DNA from crude and refined soybean, maize, and canola oils. PCR was then conducted using specific primers to identify the presence of genes related to each oil type and to assess transgenicity. The results showed that DNA was present in crude and refined oils, but in very low amounts. However, using method 3 for DNA extraction provided sufficient quantity and quality of DNA for successful PCR amplification. The study concluded that the main challenge in DNA extraction from oils is the presence of PCR inhibitors, which can be overcome using the manual hexane-based method. Also, the examination of protein presence in the oils using SDS-PAGE did not indicate any protein bands.

Post-harvest Biotechnology or Genetic Engineering Solutions: Extending Shelf Life and Reducing Food Waste

Post-harvest losses and food waste have become critical challenges in the global food supply chain, contributing to economic losses, environmental degradation, and food insecurity. This article explores the innovative applications of post-harvest biotechnology and genetic engineering as promising solutions to address these issues by extending the shelf life of perishable products and minimizing food waste. Advancements in genetic engineering techniques have paved the way for the development of crops with enhanced resistance to pests, diseases, and environmental stresses. Additionally, the manipulation of genes associated with ripening and senescence has allowed scientists to engineer fruits and vegetables with extended shelf life. These genetically modified organisms (GMOs) exhibit improved post-harvest characteristics, providing a longer window for transportation, storage, and consumption. Biotechnological interventions also include the use of biocontrol agents and beneficial microorganisms to suppress post-harvest pathogens, thereby reducing spoilage and decay. The development of bio-preservatives, such as antimicrobial peptides and natural compounds, offers an eco-friendly alternative to traditional chemical preservatives, contributing to both food safety and sustainability. Furthermore, the integration of smart packaging technologies with genetic modifications enhances the monitoring and control of environmental conditions during storage and transportation. Intelligent packaging materials equipped with sensors can detect changes in temperature, humidity, and gas composition, enabling real-time adjustments to prolong the freshness of perishable goods.

Where does the EU-path on new genomic techniques lead us?

Recently, the European Commission (EC) published a regulatory proposal on plants generated with new genomic techniques (NGTs) (5 July 2023). According to this proposal, NGT plant applications are categorized into category 1 NGT (NGT1) and category 2 NGT (NGT2) based on their molecular characteristics, which diverges from the current legislation centered around Directive 2001/18/EC. To demonstrate where the path of the proposal leads to in practice, we applied the proposed criteria for categorization to a list of NGT plant applications currently in the commercialization pipeline. Combining literature research and a descriptive statistical approach, we can show that 94% of the plant applications affected by the EC proposal, would be classified as NGT1 and thus would receive market approval without risk assessment, monitoring, and sufficient labeling provisions. The remaining 6% of applications would be classified as NGT2 plants, for which, in deviation from the current regulation, an adapted risk assessment is proposed. Screening of the intended traits in the pipeline highlights that certain NGT1 plants can pose similar environmental risks (e.g., invasiveness) to other genetically modified organisms (GMOs), as defined in Directive 2001/18/EC. For example, NGT1 applications based on RNA interference technology can exhibit insecticidal effects with potential side effects on non-target organisms (i.e., other insects). Our quantitative and case-specific elaboration of how the current EC regulatory proposal would affect the environment, health, and consumer protection will be informative for decision-makers and politicians.