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Societal Impact Statement Summary The European Union is in the midst of changing the current regulatory framework for new genomic techniques (NGTs) to accelerate the production of plant varieties, in order to achieve the goals of the European Green Deal. These techniques are highly contested, with divergent views on how they should be governed. So far, there has been little effort to engage citizens in this legislative reform process. By engaging with Dutch citizens, we give the public a voice in shaping the future of agriculture and the food system. By facilitating the exchange of multiple views, we allow for more effective governance arrangements. The European Commission (EC) has proposed a new regulation for plants obtained by new genomic techniques (NGTs). Currently, food crops developed with NGTs are subject to the EU Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). The current proposal for a new regulation differentiates between two categories of NGT plants. Category 1 NGT plants will be subject to the new regulation, whereas Category 2 plants will remain subject to the GMO legislation, although the risk assessment may be adapted. In this paper, we analyze the views of Dutch citizens on NGT crops and their governance, prior to the publication of the new proposal. We find significant reservations arising from doubts about NGT crops delivering on their promises, the likelihood of unanticipated consequences, and unnaturalness. We extrapolate our findings to anticipate citizen's response to the new proposal and reflect on ways to move forward, both for policy making, and for the plant science community. [ABSTRACT FROM AUTHOR]

The detection of genetically modified organisms (GMO) is crucial for regulatory compliance and market control. Therefore, detection methods are constantly being developed and improved. New genomic techniques (NGT) present unique challenges for detection due to the minimal genetic changes they introduce. The 'International Conference on GMO Analysis and New Genomic Techniques' held in March 2023 in Berlin, explored advances in detection methods, such as Next-Generation Sequencing and digital PCR, and highlighted the need for global cooperation and capacity-building initiatives. The conference emphasized international collaboration and addressed the challenges of establishing robust methods for identifying NGT-derived organisms. [ABSTRACT FROM AUTHOR]

EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non‐viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT‐Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT‐Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT‐Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are 'partially applicable', therefore on a case‐by‐case basis for specific NGT‐Ms, fewer requirements may be needed. Some of the EFSA guidances are 'not sufficient' and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

(Series Information) European Papers - A Journal on Law and Integration, 2024 9(1), 21-38 | European Forum Insight of 15 April 2024 | (Table of Contents) I. Introduction. - II. Context. - III. The draft regulation in detail. - III.1 Category 1 NGT plants. - III.2 Category 2 NGT plants. - III.3. Provisions for delegated and implementing acts as well as guidance material. - IV. Assessment of different scientific aspects in the regulation. - IV.1. Scientific reasoning of equivalence criteria as given in Annex I. - IV.2. Scientific reasoning of risk assessment criteria as given in Annex II. - V. Assessment of different legal aspects in the draft regulation. - V.1. Deliberate releases of cat 1 plants and committee procedure. - V.2 Precautionary principle. - V.3. Cartagena protocol. - v.4. Amendment of Annex I via delegated act. - VI. Ongoing discussion | (Abstract) This Insight explains in detail, yet easily understandable, the contents of the European Commission’s draft regulation on plants obtained by certain new genomic techniques and their food and feed. It critically comments on the underlying scientific considerations and discusses potential legal issues – the precautionary principle being one of them, though arguably not the most important one. Finally, the Insight summarizes the ongoing discussions and developments regarding the draft regulation. The Authors also hint at potential amendments, which might resolve some of the remaining problems.

Abstract The EU is about to relax its oversight of genetically modified organisms, focusing on plants and products that are obtained through certain new genomic techniques. The aim is to promote new genomic techniques as an innovative technology and employing it as a means to transform agriculture to sustainability. The present contribution describes and evaluates the planned reform. It discusses whether standards of legal certainty and legitimacy are met, how environmental side-effects are taken into account, how sustainability goals are integrated, what socio-economic effects are to be expected, and whether higher rank law is respected. As several shortcomings are found an alternative approach is submitted that combines a certain easing of administrative oversight with better integration of sustainability goals. Auspices for organic and conventional GMO-free agriculture are also sketched out.

The EU is about to relax its oversight of genetically modified organisms, focusing on plants and products that are obtained through certain new genomic techniques. The aim is to promote new genomic techniques as an innovative technology and employing it as a means to transform agriculture to sustainability. The present contribution describes and evaluates the planned reform. It discusses whether standards of legal certainty and legitimacy are met, how environmental side-effects are taken into account, how sustainability goals are integrated, what socio-economic effects are to be expected, and whether higher rank law is respected. As several shortcomings are found an alternative approach is submitted that combines a certain easing of administrative oversight with better integration of sustainability goals. Auspices for organic and conventional GMO-free agriculture are also sketched out. [ABSTRACT FROM AUTHOR]

With scientific progress and the development of new genomic techniques (NGTs), the spectrum of organisms modified for various purposes is rapidly expanding and includes a wide range of taxonomic groups. An improved understanding of which newly developed products may be introduced into the market and released into the environment in the near and more distant future is of particular interest for policymakers, regulatory authorities, and risk assessors. To address this information need, we conducted a horizon scanning (HS) of potential environmental applications in four groups of organisms: terrestrial animals (excluding insects and applications with gene drives), fish, algae and microorganisms. We applied a formal scoping review methodology comprising a structured search of the scientific literature followed by eligibility screening, complemented by a survey of grey literature, and regulatory websites and databases. In all four groups of organisms we identified a broad range of potential applications in stages of basic as well as advanced research, and a limited number of applications which are on, or ready to be placed on, the market. Research on GM animals including fish is focused on farmed animals and primarily targets traits which increase performance, influence reproduction, or convey resistance against diseases. GM algae identified in the HS were all unicellular, with more than half of the articles concerning biofuel production. GM algae applications for use in the environment include biocontrol and bioremediation, which are also the main applications identified for GM microorganisms. From a risk assessor’s perspective these potential applications entail a multitude of possible pathways to harm. The current limited level of experience and limited amount of available scientific information could constitute a significant challenge in the near future, for which risk assessors and competent authorities urgently need to prepare.

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.

A manuscript published in the scientific journal "Nature" in 1996 reported on the cloning of sheep by somatic cell nuclear transfer (SCNT) into enucleated oocytes. The donor nuclei came from an established cell line, which in turn were derived from a sheep fetus. This method provided fundamental insights into understanding the molecular basis of cellular totipotency, pluripotency and the mechanisms underlying nuclear genome reprogramming. However, it was not until the birth of the cloned sheep "Dolly" that cloning came to the attention of the general public. However, new technologies often only unfold their impact in combination with other findings. In the case of cloning by somatic nuclear transfer, this is the combination with genome editing, as the combination of these two techniques enables the efficient generation of animals with edited genomes. This summary therefore aims to provide a comprehensive overview of the animals that have already been cloned in the past and the current status of edited farm animals in the context of commercial and pre-commercial applications. This overview will explicitly cover applications in the agricultural and food sector and does not claim to be exhaustive with regard to applications that serve biomedical purposes. In terms of content, the opportunities and risks associated with these technologies are addressed, with particular reference to the current legal framework in various countries around the world. [ABSTRACT FROM AUTHOR]

Nontransgenic New Genomic Techniques (NGTs) have emerged as a promising tool for food industries, allowing food cultures to contribute to an innovative, safe, and more sustainable food system. NGTs have the potential to be applied to microorganisms, delivering on challenging performance traits like texture, flavour, and an increase of nutritional value. This paper brings insights on how nontransgenic NGTs applied to food cultures could be beneficial to the sector, enabling food industries to generate innovative, safe, and sustainable products for European consumers. Microorganisms derived from NGTs have the potentials of becoming an important contribution to achieve the ambitious targets set by the European 'Green Deal' and 'Farm to Fork' policies. To encourage the development of NGT-derived microorganisms, the current EU regulatory framework should be adapted. These technologies allow the introduction of a precise, minimal DNA modification in microbial genomes resulting in optimized products carrying features that could also be achieved by spontaneous natural genetic evolution. The possibility to use NGTs as a tool to improve food safety, sustainability, and quality is the bottleneck in food culture developments, as it currently relies on lengthy natural evolution strategies or on untargeted random mutagenesis. [ABSTRACT FROM AUTHOR]

Abstract Background New genomic techniques (NGTs) allow new genotypes and traits to be developed in different ways and with different outcomes compared to previous genetic engineering methods or conventional breeding (including non-targeted mutagenesis). EU GMO regulation requires an assessment of their direct and indirect effects that may be immediate, delayed or cumulative. Such effects may also result from the interactions of NGT organisms simultaneously present in a shared receiving environment or emerge from a combination of their traits. This review elaborates such potential interactions based on a literature review and reasoned scenarios to identify possible pathways to harm. Main findings NGT organisms might be introduced into the environment and food chains on a large-scale, involving many traits, across a broad range of species and within short periods of time. Unavoidably, this would increase the likelihood that direct or indirect effects will occur through interactions between NGT organisms that are, for example simultaneously present within a shared environment. It has to be assumed that the cumulative effects of these NGT organisms may exceed the sum of risks identified in the distinct ‘events’. Consequently, risk assessors and risk managers not only need to consider the risks associated with individual NGT organisms (‘events’), but should also take account of risks resulting from their potential interactions and combinatorial effects. In addition, a prospective technology assessment could help the risk manager in defining criteria to minimize potential unintended interactions between NGT organisms through limiting the scale of releases. Conclusions If genetically engineered (GE) organisms derived from NGTs are released into the environment, their potentially negative impacts need to be minimized. As with all GE organisms, it is, therefore, crucial to not only assess the risks of the individual events, but also their potential interactions which can trigger direct and indirect effects with adverse impacts. It is necessary to develop hypotheses and specific scenarios to explore interactions between NGT organisms and possible pathways to harm from the perspective of the precautionary principle. In addition, the introduction prospective technology assessment could provide an instrument for the risk manager to control the scale of releases of NGT organisms.

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well.

One of the EU's strategic goals is to reduce the environmental and climate footprint of the EU food system and strengthen its resilience, while ensuring food security for European citizens. Thus, the EU Farm to Fork strategy, which is one of the central pillars of the European Green Deal, set ambitious targets for 2030 to reduce pesticide use in agriculture by 50% and fertilizers use by 20%, with a concomitant 50% reduction of nutrient leakage to surface and groundwater. Additionally, it is recommended that at least 25% of the EU agricultural land shall be kept under organic farming. These goals are far-reaching, but several recent studies indicate that implementing them without significant progress in research and innovation (R & I) may result in a yield decrease by up to 30%, depending on the crop, and an increase in the price of agricultural commodities by up to 18%. Especially affected would be horticulture due to its high dependence on plant protection against pests and diseases. Therefore, the studies recommend accelerating plant breeding in order to produce new plant cultivars genetically resistant to pests and diseases and better equipped to cope with abiotic stresses like limited nutrition and water deficit. The progress in classical plant breeding is a lengthy process. It is especially slow in the case of woody species, like most fruit plants, due to their long juvenile periods and limited genetic variance. Recent advances in functional genomics, bioinformatics, and molecular methods provided tools that speed up the breeding process significantly. Several site-directed mutation technologies allow modifying a specific gene at a predefined site, by deletion or insertion of single or multiple nucleotides, without affecting off-target genes. Several valuable cultivars have been bred so far using these methods, and a large number of others are under trials. However, their release will be severely impeded by the decision of the Court of Justice of the European Union, dated 25 July 2018, that the release of organisms obtained by site-specific mutations, as opposed to organisms obtained by induced random mutation, is controlled by Directive 2001/18/EC2 on genetically modified organisms. This paper reviews the new generation breeding techniques, especially site-directed mutagenesis, and their benefits as well as potential hazards to consumers and the environment.

The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulation framework ensures a high level of protection with a mandatory environmental risk assessment (ERA) of genetically modified (GM) products prior to the authorization of individual GMOs for environmental release or marketing. However, the guidance available from the European Food Safety Authority (EFSA) for conducting such an ERA is not specific enough regarding the techniques under discussion and needs to be further developed to support the policy goals towards ERA, i.e., a case-by-case assessment approach proportionate to the respective risks, currently put forward by the EC. This review identifies important elements for the case-by-case approach for the ERA that need to be taken into account in the framework for a risk-oriented regulatory approach. We also discuss that the comparison of genome-edited plants with plants developed using conventional breeding methods should be conducted at the level of a scientific case-by-case assessment of individual applications rather than at a general, technology-based level. Our considerations aim to support the development of further specific guidance for the ERA of genome-edited plants. [ABSTRACT FROM AUTHOR]

Background: New genomic techniques (NGTs) allow new genotypes and traits to be developed in different ways and with different outcomes compared to previous genetic engineering methods or conventional breeding (including non-targeted mutagenesis). EU GMO regulation requires an assessment of their direct and indirect effects that may be immediate, delayed or cumulative. Such effects may also result from the interactions of NGT organisms simultaneously present in a shared receiving environment or emerge from a combination of their traits. This review elaborates such potential interactions based on a literature review and reasoned scenarios to identify possible pathways to harm. Main findings: NGT organisms might be introduced into the environment and food chains on a large-scale, involving many traits, across a broad range of species and within short periods of time. Unavoidably, this would increase the likelihood that direct or indirect effects will occur through interactions between NGT organisms that are, for example simultaneously present within a shared environment. It has to be assumed that the cumulative effects of these NGT organisms may exceed the sum of risks identified in the distinct 'events'. Consequently, risk assessors and risk managers not only need to consider the risks associated with individual NGT organisms ('events'), but should also take account of risks resulting from their potential interactions and combinatorial effects. In addition, a prospective technology assessment could help the risk manager in defining criteria to minimize potential unintended interactions between NGT organisms through limiting the scale of releases. Conclusions: If genetically engineered (GE) organisms derived from NGTs are released into the environment, their potentially negative impacts need to be minimized. As with all GE organisms, it is, therefore, crucial to not only assess the risks of the individual events, but also their potential interactions which can trigger direct and indirect effects with adverse impacts. It is necessary to develop hypotheses and specific scenarios to explore interactions between NGT organisms and possible pathways to harm from the perspective of the precautionary principle. In addition, the introduction prospective technology assessment could provide an instrument for the risk manager to control the scale of releases of NGT organisms. [ABSTRACT FROM AUTHOR]

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well. [ABSTRACT FROM AUTHOR]

End of April 2021, the European Commission published its study on New Genomic Techniques (NGTs). The study involved a consultation of Member States and stakeholders. This study reveals a split on whether current legislation should be maintained or adapted to take account of scientific progress and the risk level of NGT products. This split was predictable. New technological developments challenge both ethical viewpoints and regulatory institutions; and contribute to the growing divide between science and society that value 'technological innovations' differently. Such controversies are often characterized as 'unstructured' because of nearly unbridgeable positions on entangled scientific and value-laden issues. Initiatives for stakeholder involvement, such as consultation or participation, often focus on reaching a 'shared vision' without exploring the diverse societal concerns and values behind these positions. To resolve the EU stalemate in NGT regulation, we advocate to bring back politics in the EU decision-making process instead of hiding it under the veil of science, the need for regulatory change and public support. A more productive and justified use of genuine stakeholder participation is possible, if participants and deliberation design meet the criteria of what we call participation ethics. Drawing from our applied experience exploring the ethics of genetic modification, we believe that this approach can lead to more robust political decision-making and restore societal confidence in the governance of contested issues such as NGTs. [ABSTRACT FROM AUTHOR]

Soybean (Glycine max Merr.) is the world's most important oilseed crop and its ability to fix atmospheric nitrogen makes it a cornerstone of sustainable agriculture. Despite its importance, Europe relies heavily on imports, leading to environmental and economic vulnerabilities. To address these challenges, the European Union has implemented policies to boost local soybean production, emphasizing sustainable practices and reduced dependency on imports. However, conventional breeding methods are time-consuming and may not keep pace with the rapid environmental and consumer habit changes. Genome-editing technologies, such as CRISPR-Cas, offer precise and efficient tools for developing soybean varieties tailored to European conditions. These technologies can enhance traits related to precocity, stress responses, yield and quality that are essential for adapting to climate change and promoting ecological sustainability. This review explores the integration of genome editing (GE) in soybean breeding, highlighting its potential in advancing the agroecological transition in Europe. By having a clear regulation and enhancing breeding efforts, GE can significantly contribute to developing resilient and sustainable soybean varieties, fostering a competitive and environmentally friendly European agriculture., (© 2025 The Author(s). The Plant Journal published by Society for Experimental Biology and John Wiley & Sons Ltd.)

This article presents a proposal on how the European Union’s regulatory framework on genetically modified (GM) plants should be reformed in light of recent developments in genomic plant breeding techniques. The reform involves a three-tier system reflecting the genetic changes and resulting traits of GM plants. The article is intended to contribute to the ongoing debate over how best to regulate plant gene editing techniques in the EU.

In 2012, EFSA issued an opinion on plants developed through cisgenesis and intragenesis. With the development of New Genomic Techniques (NGTs) in the last decade, cisgenic and intragenic plants can now be obtained with the insertion of a desired sequence in a precise location of the genome. EFSA has been requested by European Commission to provide an updated scientific opinion on the safety and the risk assessment of plants developed through cisgenesis and intragenesis, in order to (i) identify potential risks, comparing them with those posed by plants obtained by conventional breeding and Established Genomic Techniques (EGTs) and (ii) to determine the applicability of current guidelines for the risk assessment of cisgenic and intragenic plants. The conclusions of the previous EFSA opinion were reviewed, taking into consideration the new guidelines and the recent literature. The GMO panel concludes that no new risks are identified in cisgenic and intragenic plants obtained with NGTs, as compared with those already considered for plants obtained with conventional breeding and EGTs. There are no new data since the publication of the 2012 EFSA opinion that would challenge the conclusions raised in that document. The conclusions of the EFSA 2012 Scientific Opinion remain valid. The EFSA GMO Panel reiterates from these conclusions that with respect to the source of DNA and the safety of the gene product, the hazards arising from the use of a related plant‐derived gene by cisgenesis are similar to those from conventional plant breeding, whereas additional hazards may arise for intragenic plants. Furthermore, the EFSA GMO Panel considers that cisgenesis and intragenesis make use of the same transformation techniques as transgenesis, and therefore, with respect to the alterations to the host genome, cisgenic, intragenic and transgenic plants obtained by random insertion do not cause different hazards. Compared to that, the use of NGTs reduces the risks associated with potential unintended modifications of the host genome. Thus, fewer requirements may be needed for the assessment of cisgenic and intragenic plants obtained through NGTs, due to site‐directed integration of the added genetic material. Moreover, the GMO panel concludes that the current guidelines are partially applicable and sufficient. On a case‐by‐case basis, a lesser amount of data might be needed for the risk assessment of cisgenic or intragenic plants obtained through NGTs. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7618/full [ABSTRACT FROM AUTHOR]

EFSA was asked by the european Commission to develop criteria as advice for consideration for the risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA proposes in this statement six main criteria to assist the risk assessment of these plants. The first four criteria are related to the molecular characterisation of the genetic modification introduced in the recipient plant. The four criteria evaluate whether any exogenous DNA sequence(s) is/are present (Criterion 1), whether such sequence derives from the breeders' gene pool (Criterion 2), the type of integration (Criterion 3) and whether any endogenous plant gene is interrupted (Criterion 4). Depending on the evaluation of the above criteria, the product can be a genome edited plant where no exogenous DNA sequence is present, or a cisgenic or intragenic plant where the cisgenic and intragenic sequence are introduced by targeted insertion and no plant endogenous genes are interrupted. In these cases, two more criteria are assessed to evaluate the history of safe use (Criterion 5) and the structure and function of the new allele (Criterion 6). If cisgenic and intragenic sequence are introduced by random integration without interruption of an endogenous gene, or when no risk is identified when an endogenous gene is interrupted, the criteria 5 and 6 will also be assessed. Evaluating the history of safe use is an important part of the proportionate risk assessment of cisgenic, intragenic and genome‐edited plants since the newly introduced allele may already be present in nature. However, when the history of safe use cannot be sufficiently demonstrated, the function and structure of the introduced allele should be carefully assessed. Recommendations are also included on the aspects that need further elaboration for full applicability of the criteria proposed herein are also included. This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7621/full [ABSTRACT FROM AUTHOR]

The article discusses amendment options (no significant change, lowering of administrative burdens or exemption of certain products from the legislation) for the European Union (EU) authorization procedures of New Genomic Techniques’ (NGT) products and their consequences for the sector and research institutions, particularly in the context of internal functioning, placing products on the market and international trade. A reform of the EU regulatory system requires a change in the procedures for the authorization of NGT products, otherwise EU researchers and investors may still be at a competitive disadvantage (as compared to Argentina, Brazil, Canada, United States or the United Kingdom) due to the inefficiency of the current system and the committee procedure for authorization. New legislation, currently being adopted in the United Kingdom is also presented for comparison.

The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulation framework ensures a high level of protection with a mandatory environmental risk assessment (ERA) of genetically modified (GM) products prior to the authorization of individual GMOs for environmental release or marketing. However, the guidance available from the European Food Safety Authority (EFSA) for conducting such an ERA is not specific enough regarding the techniques under discussion and needs to be further developed to support the policy goals towards ERA, i.e., a case-by-case assessment approach proportionate to the respective risks, currently put forward by the EC. This review identifies important elements for the case-by-case approach for the ERA that need to be taken into account in the framework for a risk-oriented regulatory approach. We also discuss that the comparison of genome-edited plants with plants developed using conventional breeding methods should be conducted at the level of a scientific case-by-case assessment of individual applications rather than at a general, technology-based level. Our considerations aim to support the development of further specific guidance for the ERA of genome-edited plants.

In the article we provide a comparison of approaches to the regulation of products of new genomic techniques in the European Union (EU), and its major trading partners in imported agricultural goods (Argentina, Brazil, Canada and the USA). We show the trade data and indicate potential problems resulting from discrepancies in the approach to the object of regulation in the compared countries, as well as resulting from practical difficulties in detection and supervision of products deregulated in non-EU countries. The wide application of genome editing in plant breeding, and lack of harmonisation in the legal classification of its products will result not only in problems with the world trade of agri-food products, but also with compliance with the EU GMO legislation. These discrepancies may also slow down the implementation of modern biotechnology innovations into plant breeding.

Abstract The European Commission requested EFSA to provide an overview on the risk assessment of plants developed through new genomic techniques (NGTs), taking into account its previous scientific opinions, its ongoing work on the topic as well as opinions published by competent authorities and national institutions since 2012, where available. In this report, NGTs are defined as techniques capable to change the genetic material of an organism and have emerged or developed since the adoption of the 2001 genetically modified organism (GMO) legislation. EFSA considered 16 scientific opinions issued by European member states (‘MS opinions’) as well as three EFSA GMO Panel scientific opinions on NGTs. A procurement to evaluate and summarise the MS opinions was conducted. Relevant information on the description of each NGT and information on the risk assessment of plants developed through one or a combination of the defined NGTs was extracted and summarised. The baseline for the types and nature of NGTs to be included in this report was defined based on the JRC, 2011 report on new plant breeding techniques as well as on the Explanatory Note on New Techniques in Agricultural Biotechnology from the European Commissioner for Health and Food Safety (EC‐SAM, 2017) for some more recently developed NGTs, taking into account the NGT definition provided by the European Commission for this mandate. EFSA was not requested to develop new opinions on plants developed through specific NGTs, and thus, no critical appraisal of the reviewed scientific opinions was carried out.

The current public health crisis has shed light on one of food systems' most pressing challenges: reaching sustainable food security for all in a way that meets environmental and socio-economic sustainability. It has further confirmed that the logic of industrial agriculture has led our food systems down an unsustainable path, and that we must urgently change course. Agroecology is increasingly offered as the transformative and comprehensive solution that delivers benefits across all dimensions of sustainability. Yet, proponents of "business-as-usual" approaches continue to insist that producing higher, more resilient yields – particularly through new genomic techniques such as CRISPR/Cas – will serve as the means to ensure long-term food system resilience. Given the urgency for food systems transformation and drawing on agroecology as the paradigm shift we need, this article considers how new technologies can be assessed to evaluate their compatibility with food systems sustainability. Using the example of CRISPR/Cas, this article offers a preliminary framework for assessment based on FAO's 10 Elements of Agroecology. The purpose here is not to offer a comprehensive and definite assessment of CRISPR/Cas, but to serve as an example to highlight the need for holistic assessment tools when considering the development and uptake of new agricultural technologies. [ABSTRACT FROM AUTHOR]

The European Commission requested EFSA to provide an overview on the risk assessment of plants developed through new genomic techniques (NGTs), taking into account its previous scientific opinions, its ongoing work on the topic as well as opinions published by competent authorities and national institutions since 2012, where available. In this report, NGTs are defined as techniques capable to change the genetic material of an organism and have emerged or developed since the adoption of the 2001 genetically modified organism (GMO) legislation. EFSA considered 16 scientific opinions issued by European member states (‘MS opinions’) as well as three EFSA GMO Panel scientific opinions on NGTs. A procurement to evaluate and summarise the MS opinions was conducted. Relevant information on the description of each NGT and information on the risk assessment of plants developed through one or a combination of the defined NGTs was extracted and summarised. The baseline for the types and nature of NGTs to be included in this report was defined based on the JRC, 2011 report on new plant breeding techniques as well as on the Explanatory Note on New Techniques in Agricultural Biotechnology from the European Commissioner for Health and Food Safety (EC‐SAM, 2017) for some more recently developed NGTs, taking into account the NGT definition provided by the European Commission for this mandate. EFSA was not requested to develop new opinions on plants developed through specific NGTs, and thus, no critical appraisal of the reviewed scientific opinions was carried out.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-1973/full [ABSTRACT FROM AUTHOR]

[Display omitted] • Consumers from the United States were more open towards NGTs than Swiss. • The regulatory context might have acted as a risk cue for consumers. • Acceptance was related to social trust, various values and personal preferences. • The organic sector's presumptions about their customers' views might be outdated. The terms "New Genomic Techniques" (NGTs) or "Genome Editing" refer to various methods that allow finding, cleaving, and repairing specific sequences in the genome. These techniques could contribute to managing various challenges in plant breeding and agriculture. Aside from regulatory uncertainties, the lack of consumer acceptance has frequently been cited as a significant barrier to the widespread use of NGTs in plant breeding and agriculture across the planet. This study was based on an anonymous online survey (N = 1202). It investigated what consumers from two countries that differ in gene technology regulation, namely the United States of America and Switzerland, thought about three specific applications of NGTs in plant breeding (i.e., blight-resistant potato, gluten-free wheat, cold-resistant soybean). The study highlights the importance of the affect heuristic for acceptance, as half of the participants in both countries expressed positive feelings regarding the three applications, a quarter of the participants expressed negative, and the remaining participants expressed torn or neutral emotions. Some evidence was provided that the regulatory context might have acted as a risk cue, as participants in Switzerland expressed more negative feelings, perceptions, and lower acceptance than participants from the United States of America. Lastly, our findings underscore the importance of a collaboration between the life sciences and social sciences in balancing technological innovations and public perceptions and acceptance, which have been shown in this study to be impacted by affect, values, and context. [ABSTRACT FROM AUTHOR]