EUROPEAN COMMISSION

Brussels, 5.7.2023

SWD(2023) 412 final

COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT REPORT

Accompanying the document

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

{COM(2023) 411 final} - {SEC(2023) 411 final} - {SWD(2023) 411 final} - {SWD(2023) 413 final}

Table of contents

1.    Introduction: Scientific, Political, and Legal Context    

1.1.    Scientific context    

1.2.    Political context    

1.3.    Legal context    

1.4.    International dimension    

1.5.    Scope    

1.6.    Interaction with existing legislation and upcoming initiatives    

1.7.    Previous studies on the EU GMO legislation with relevance to NGTs    

2.    Problem definition    

2.1.    What are the problems?    

2.2.    What is the size of the problem and who is affected?    

2.3.    What are the problem drivers?    

2.4.    How likely is the problem to persist?    

3.    Why should the EU act?    

3.1.    Legal basis    

3.2.    Subsidiarity: Necessity of EU action    

3.3.    Subsidiarity: Added value of EU action    

4.     Objectives: What is to be achieved?    

4.1.    General objectives    

4.2.    Specific objectives    

5.    What are the available policy options?    

5.1.    What is the baseline from which options are assessed?    

5.2.    Description of the policy options    

5.3.    Options discarded at an early stage    

6.    What are the impacts of the policy options?    

7.    How do the options compare?    

8.    Preferred Option    

8.1.    Description of the preferred option    

8.2 Simplification and burden reduction, supporting the one-in-one-out approach    

9.    How will actual impacts be monitored and evaluated?    

10.    List of references    

Annex 1: Procedural information    

Annex 2: Stakeholder consultation (Synopsis report)    

Annex 2a: Summary report on feedback received on Inception Impact Assessment: Legislation for plants produced by certain new genomic techniques    

Annex 3: Who is affected and how?    

Annex 4: Analytical methods    

Annex 5: The techniques    

Annex 6: Opinions of scientific advisory bodies and scientific organisations on NGTs    

Annex 7: Applications of NGTs in plants and case studies on potential impacts    

Annex 8: EU legal framework on GMOs    

Annex 9: Problem Tree    

Annex 10: Intervention logic    

Annex 11: Procedure for notification (Option 4)    

Annex 12: SME TEST    

Abbreviations

Glossary of scientific terms

* For the purpose of this document

1.    Introduction: Scientific, Political, and Legal Context

This impact assessment explores economic, environmental, social (including health) impacts, as well as impacts on fundamental rights and administrative burden, of options for a legal framework for the deliberate release, including placing on the market, of plants and their food and feed products developed using certain new genomic techniques (NGTs), namely targeted mutagenesis and cisgenesis 1 .

The term ‘new genomic techniques’ is specific to the EU regulatory environment and encompasses genetic modification techniques that have emerged or have been developed since 2001, when the centrepiece of the current EU legislation on genetically modified organisms (GMOs) was adopted 2 (see section 1.1. below and Annex 5).

Plant breeding, the practice of changing and/or selecting the traits of plants in order to produce desired characteristics, is a constantly evolving field. Humans have made use of natural variation (i.e. mutations) since first cultivating land and breeding livestock around 13 000 years ago, selecting and retaining organisms suitable for agricultural use. For centuries, breeders have used new scientific findings to increase the effectiveness and efficiency of their efforts constantly adding new plant breeding techniques to their toolbox. During the 20th century a gradual shift took place from breeding being conducted mostly in public institutions toward the private sector, mainly due to the introduction of hybrids. This led to consolidation in the industry and the dominance of several key companies in the major field crops. The emergence of biotechnology in agriculture in the 1980s led to a further reorganisation of the sector moving plant breeding to a high-tech industry involving more and more trans-national companies.

Today, the EU market for plant reproductive material (PRM) (agriculture and forestry) has an estimated annual value of EUR 15 billion 3 .  The EU seed market is the third largest after the USA and China and accounts for around 20% of the global market. Its value is estimated at EUR 7-10 billion 4  and it comprises about 7 000 companies (most small and medium sized enterprises, SMEs) with about 52.000 employees. EU companies are highly diverse as regards size, portfolio of crops, geographical area and activities (plant breeding, maintenance of varieties, multiplication, trade). The EU breeding sector is highly innovative and spends around 15% of its annual turnover on R&D.

1.1.    Scientific context 

Development of the techniques

The advent of NGTs in the past two decades, associated to advances in the understanding of how genes function and in genome sequencing techniques, provides new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. NGTs, as any breeding technique applicable in agriculture, make use of genetic diversity either naturally occurring or resulting from human intervention, in order to select or generate plants that feature desirable characteristics. NGTs constitute a diverse group of techniques, each of which can be used in various ways to achieve different results and products. NGT products may or may not contain foreign DNA; when they do, they may result from the introduction into an organism of genetic material derived from the same species or from other species, either crossable or non-crossable. In this respect, NGTs may produce modifications that could or could not be obtained in nature or by conventional breeding. In most cases, these new techniques can lead to more targeted and precise changes than conventional breeding or established genomic techniques.

Targeted mutagenesis and cisgenesis are considered NGTs and differentiated from established genomic techniques because they have introduced novel features (e.g. higher precision and speed, introduction of genetic material from a crossable species). They do not introduce genetic material from a non-crossable species (transgenesis), which is the case with established genomic techniques. In certain cases, genetic modifications introduced by NGTs cannot be identified by analytical methods, while this is always possible for established genomic techniques.

Targeted mutagenesis induces mutation(s) in selected target locations of the genome without insertion of foreign genetic material and, in certain cases, can produce alterations of the genetic material that can also occur naturally or that can be obtained by conventional breeding. Cisgenesis includes the insertion of genetic material, by random or targeted technologies 5 , into a recipient organism from a donor that is sexually compatible (i.e. crossable) and produces alterations that in some cases can also be obtained by natural crossing or conventional breeding. Both targeted mutagenesis and cisgenesis can also produce alterations of the genome that are more complex and challenging to obtain through conventional breeding.

Opinions of scientific bodies

Over the last decade, there have been numerous scientific opinions on NGTs (including on targeted mutagenesis and cisgenesis) in the EU, e.g. by the Commission’s Scientific Advice Mechanism High-Level Group (SAM HLG) 6 , the European Academies' Science Advisory Council (EASAC) 7 , the Commission’s Joint Research Centre (JRC) 8 , and the European Food Safety Authority (EFSA) 9 (see Annex 6). These reflect the majority positions on the relevant scientific issues.

The above-mentioned bodies report on the increasing precision of certain NGTs compared to conventional breeding approaches. Changes introduced with conventional breeding techniques occur randomly, while certain NGTs can produce precisely located alterations to DNA sequences. In view of their increased precision, such NGTs do not require the extensive screening of large plant populations, necessary for conventionally bred plants, to select the organism with the desired characteristics.

In addition, when changes are small and known in other organisms, the resulting products are expected to display more predictable characteristics. For these reasons and for their increased precision, many NGTs shorten the development time to obtain organisms with desired traits. Since NGTs allow to target modifications, they generally result in fewer unintended genetic modifications compared to conventional breeding techniques.

The European Group on Ethics in Science and New Technologies (EGE) published in 2021 an opinion on the ethics of genome editing, which focuses on applications in the human, animal and plant domains 10 . Among its conclusions on plants, EGE recommends a systems approach to evaluate costs and benefits in any future use and regulation proportional to the risk.

The European Union Reference Laboratory for GM food and feed (EURL GMFF) and the European Network of GMO Laboratories (ENGL) issued in 2019 a report on the detection of food and feed plant products obtained by new mutagenesis techniques 11 . They concluded that it is not feasible to differentiate a specific NGT product from conventional ones that contain the same modification(s). An updated report by the EURL-ENGL is expected in 2023 12 .

Overall, the above-mentioned opinions and reports recognise the variety of NGTs techniques, and of the different products with different risk profiles they can generate. They note that similar products obtained by different techniques are not expected to present significantly different risks. Also, when the introduced changes are limited and not novel, the assessment of potential risks might be facilitated.

Regarding targeted mutagenesis and cisgenesis techniques, EFSA and other scientific bodies concluded that there are no new hazards specifically linked to the genomic modification produced via these techniques as compared with conventional breeding or established genomic techniques.

EFSA also considered that on a case-by-case basis, a lesser amount of data might be needed for the risk assessment of plants produced by targeted mutagenesis and cisgenesis and therefore there is a need for flexibility in the data requirements for risk assessments. EFSA and other scientific bodies also concluded that, in targeted mutagenesis, off-target modifications are fewer than those occurring with most mutagenesis techniques and, where such changes occur, they are of the same types as those produced by conventional breeding.

The considerations above are shared by other major scientific bodies outside the EU, including the US National Academies of Sciences, Engineering, and Medicine 13 , Health Canada 14 , the UK Advisory Committee on Releases to the Environment 15 and the Norwegian Biotechnology Advisory Board 16 . FAO acknowledges that issues of safety must be considered 17 . FAO also considers that priorities can be established for regulatory interventions including a food safety assessment while also recognizing that some of the food products produced from gene editing could have food safety characteristics similar to foods with a long history of safe use 18 .

However, some scientific organisations and agencies, such as the German Federal Agency of Nature Conservation, the European Network of scientists for social and environmental responsibility (ENSSER) and TestBiotech, disagree with the above opinions 19 . They raise the concern that NGTs pose new and specific risks to the environment and human health compared to previous applications of genetic engineering 20 . They consider that NGTs can be used to achieve genomic changes beyond what is known from conventional breeding and can alter the genome to a much greater extent with multiple modifications than with any previous breeding method. Furthermore, they refer to unintended genetic changes that, according to them, would be specific to the processes of NGTs and unlikely to occur via random processes or conventional breeding. Furthermore, these organisations question that NGTs are precise, controllable and predictable.

EFSA has evaluated the scientific literature provided by these organisations in the public consultations conducted in the preparation of its opinions and considered that it does not provide new evidence which would alter the validity of its scientific opinions. While acknowledging that the application of NGTs can lead to a complexity of scenarios and that a case-by-case approach is applicable to NGT plants, EFSA has confirmed that NGTs are more precise, controllable and predictable than conventional methods and their precision is continually increasing with technological progress. In addition, there are no unintended modifications that would be specific for NGTs. EFSA has noted that introducing multiple modifications is also not specific to NGT approaches; this can also be achieved by conventional breeding approaches and established genomic techniques.

Research and development

Globally, the majority of the research on crops using NGTs is conducted in China (43%), followed with some distance by the US (18%), with 14% of this research taking place in the EU 21 . Research in the EU, also funded through the Horizon programme 22 , is mainly conducted in France, Germany, Italy, Belgium and the Netherlands. 

The type of plant applications that feature prominently in the research and development pipeline, coupled with the fairly easy and speedy applicability of these new techniques, could deliver benefits to farmers, consumers and to the environment. JRC 23  as well as a database of available literature on the use of genome editing in crop plants maintained by the EU-SAGE network 24  and a recent report from the Food and Agriculture Organization of the United Nations (FAO) 25 , show that research using these techniques concerns a wider variety of crops and traits compared to the transgenic organisms authorised in the EU or globally so far. Examples include plants with improved tolerance or resistance to biotic stress (plant diseases and pests), plants with improved tolerance or resistance to climate change effects in general and abiotic stresses (environmental, e.g., temperature, drought), improved nutrient and water-use efficiency in plants, and plants with improved agronomic (e.g., higher yield/input ratio and improved resilience) and quality characteristics (e.g., taste, shelf-life). NGTs can contribute to the development of new and improved plants and can further support the use of underutilised, neglected and local crop species – this can also support the special needs in the Outermost Regions. The research pipeline also includes applications of NGTs to develop the type of traits that have been the most common in the GMOs authorised so far in the EU or in other countries, such as herbicide-tolerance (see Annex 7).

NGTs have the potential to support the implementation of the UN 2030 Agenda for Sustainable Development and the relevant Sustainable Development Goals (SDG) 26 , in particular (see Annex 3.3):

·SDG2 (End hunger, achieve food security and improved nutrition and promote sustainable agriculture), by facilitating plant breeding applied to a wide variety of crops and beneficial traits, thus contributing to three of the four components of food security (food availability, stability and utilisation).

·SDG3 (Good Health and Well-being), by facilitating the breeding of diverse nutritious and healthy foods.

·SDG9 (Industry, Innovation and Infrastructure), by promoting research in plant breeding, strengthening the research capacity in plant biotechnology and facilitating the development of innovative and sustainable products.

·SDG12 (Responsible consumption and production), by contributing to the sustainable management and efficient use of natural resources (e.g. nutrients and water).

·SDG13 (Take urgent action to combat climate change and its impacts) by contributing to resilience adaptive capacity to climate change, supporting sustainable farming practices (no tilling), the development of crops not requiring land use change and land saving.

1.2.    Political context

GMOs today

GMOs have been a controversial topic in the EU since the adoption of the EU GMO legislation. Since the entry into force of Regulation (EC) No 1829/2003 27 , no draft Commission decision proposing the authorisation of GM food and feed has obtained a favourable opinion by qualified majority of the Member State in the relevant Regulatory Committee, notwithstanding favourable EFSA opinions. The Commission has authorised 284 28 GMOs for food and feed and 6 GMOs for non-food uses 29 , based on favourable EFSA opinions. 20 of these have been renewed following a favourable EFSA opinion. All these GMOs have been judged by EFSA as safe as their conventional counterparts. No regulatory measures (to withdraw, suspend or amend an existing authorisation) have been taken based on evidence of risks to human or animal health or to the environment.

In the EU, the only GMO authorised for cultivation is maize MON810. It is commercially grown in Spain since 1995 and to lesser extent in Portugal. Since 2015, when a “cultivation opt-out” 30 was introduced in the legislation, 18 31 of the 27 EU Member States restricted/prohibited the cultivation of this GMO in all or part of their territories.

The number of field trials in the EU has decreased from 387 (between 2008 and 2014) to 63 (between 2015 and 2022) 32 .

While the market for genetically modified (GM) food products in the EU is small, a substantial market exists for GM feed. The EU is a major importer of high-protein content agricultural commodities for feed use 33 , mainly from countries where cultivation is dominated by GMOs. According to 2016 figures 34 , out of the 36 million tonnes of soybean equivalent imported per year into the EU, around 30 million (i.e. 85%) was GM.

Whereas cultivation of GMOs in the EU is very limited, globally there is now experience of more than 25 years since the first commercialisation of GM crops. Beyond the EU, in 2019, 27 countries grew around 190 million hectares of biotech crops. An additional 17 countries imported biotech crops for food, feed, and processing. Thus, including the EU, a total of 71 countries have adopted biotech crops so far 35 . An extensive study by the US National Academies of Sciences, Engineering and Medicine published in 2016 on GM crops reported no observed adverse effects on health and the environment, while recognising the difficulty to assess long-term environmental impacts 36 .

NGTs in the context of key EU strategies

The debate on NGTs is polarised in the EU, along similar lines as the debate on GMOs. However, it takes place in a context that has changed significantly.

The double crisis of climate change and biodiversity loss have put the focus on long-term resilience and the need for a transition to more sustainable agriculture and food systems. In this context, the European Green Deal’s Farm to Fork Strategy presents the Commission’s plan for a transition to a sustainable food system 37 . It specifically refers to biotechnology as a possible tool for increasing sustainability, provided they are safe for consumers and the environment while bringing benefits for society as a whole. The Biodiversity Strategy 38 aims to support and incentivise the transition to fully sustainable agricultural practices, improving the condition and diversity of agroecosystems.

In its 2022 Communication 39  “Safeguarding food security and reinforcing the resilience of food systems”, the Commission has identified NGTs as potentially contributing to food security. In this context, according to the FAO 40 , although the extent of the impact is still speculative, the introduction of gene-editing technologies will have far-reaching implications for agri-food and social systems in terms of their potential for improving and securing production of food.

The Covid-19 pandemic and Russia’s war of aggression against Ukraine have also revealed the EU’s external dependencies. While EU food security has not been at stake, a global spike in prices of inputs needed for agri-food production, in particular energy, animal feed and feed additives, and fertilisers has shown the EU’s vulnerability to price shocks. In its Trade Policy Review Communication 41 , the Commission has stressed the role of trade openness within the concept of “Open Strategic Autonomy”, notably recalling the importance of an open and fair trade with well-functioning, diversified and sustainable global value chains.

Strategic autonomy and resilience also depend on the diversification of the food system. NGTs are applied to a far larger range of crop species than established techniques and can thereby contribute, for example, to decreasing the EU’s dependence on imports of plant proteins. NGTs and their technical accessibility could also support the diversification of developers and users in the food systems, if access to and affordability of the technologies is assured.

Under the European Climate Law 42 , the EU must continuously progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change. In its Communication ‘Forging a climate-resilient Europe - the new EU Strategy on Adaptation to Climate Change’, the Commission acknowledged that making better use of genetic diversity and non-harmful plant genetic resources for adaptation based on the latest science is among the urgently needed solutions to help farmers and land managers tackle climate risks 43 .

The EU Bioeconomy Strategy 44 supports innovation at the service of the Green Deal objectives, in particular the deployment of a circular bio-based industry contributing to the replacement of fossil resources by sustainably generated bio-based materials and chemicals. It recognises the potential of biotechnology and life sciences to achieve such objectives. The Council's conclusions on the opportunities of the bioeconomy from March 2023 45 specifically mentioned the importance of seizing the opportunities presented by the bioeconomy and called on the Commission to enhance the integration of the bioeconomy into all policies and ensure coherence among policies.

The European Parliament has adopted several resolutions 46 where it refers to new plant breeding techniques and recognises the importance to develop and use such techniques which respond to societal and agricultural demands and enhance the competitiveness of the agriculture and horticulture sectors. In 2021 on a resolution 47 on Farm to Fork Strategy, the European Parliament also referred to the Commission’s plans to initiate a regulatory policy action plants derived from certain new genomic techniques highlighting the precautionary principle and the need to ensure transparency and freedom of choice to farmers, processors and consumers. Against this background, there is currently a strong demand by a range of stakeholders including breeders, farmers and academia, to adapt the regulatory framework to enable the development, marketing and use of NGTs as tools contributing to address current challenges. Other stakeholders, however, consider that the benefits of NGTs are hypothetical and achievable by means other than biotechnology. Some are concerned about safety (e.g., environmental organisations) and/or possible negative impacts on their business (organic and GM-free sectors).

Other factors affecting the development and marketing of NGTs

There is widespread recognition that the development and marketing of NGTs, and the realisation of their potential, depends on various factors. An appropriate regulatory framework is important, but patents, access of farmers, public organisations and SMEs to the technologies and the market, and factors affecting consumer acceptance, will also have an impact.

The intellectual property landscape regarding NGT plants is complex and rapidly evolving 48 . Patents and access to affordable patent licenses for NGT technologies and for genetic material obtained by these techniques will play a role in breeders’ (especially SMEs’) ability to develop and market new plant varieties based on these techniques. Some plant breeders are concerned that the cost of licences to access the technology can be prohibitive, notably for small crops 49 . In addition, there are calls from some stakeholders that patentability should not negatively impact the ability of farmers to choose, afford and propagate harvested NGT plant seeds on their farms.

Consumer acceptance of NGTs has been the subject of several social research studies and national/international surveys conducted across the EU (EU-wide and in Sweden, Norway, Italy, the Netherlands, Belgium, Austria, Germany), as well as in other countries (such as the UK, Switzerland, Canada, US, Australia, Japan, Korea and China), in the last 5 years.

Research so far is limited, and some studies involve limited participation. However, they provide emerging evidence of factors that may drive consumer acceptance of NGTs. General research on consumer perceptions and attitudes to food and food safety has also provided insights into expected consumer views on NGTs.

Regarding citizens’ current perception of NGTs, there are studies reporting on the one hand negative attitudes and on the other hand an increased acceptance of NGT food compared to current perception of GMOs. Attitudes on GMOs in general and NGTs in particular are closely connected to levels of knowledge and the perceived safety levels 50 . Several studies indicate that the majority (60-64%) of Europeans have not heard of NGTs and that consumers' knowledge on NGT organisms and GMOs is limited 51 . However, comparatively, at this stage they appear to be more knowledgeable about GMOs generally than about NGTs 52 . The level of awareness on NGTs varies among different countries but is generally low 53 .

EFSA has recently conducted research into food safety in general as well as on NGTs concretely. Food safety is considered important by the majority (70%) of the EU population. In terms of the most important concerns, 26% expressed concern about GM ingredients and 8% about NGT ingredients. Regarding NGTs, citizens are interested in possible risks (69%), who benefits and who bears the risks (42%), regulation (40%), what benefits NGTs bring (38%), consumers’ choice (38%), and the scientific process and techniques (31%). As regards information on food risks, this research also showed high trust in scientists in all Member States and in EU institutions in several Member States 54 . 

Research conducted globally suggests that the majority of the respondents are receptive to the use of NGT products, particularly in the agricultural sector, as long as they bring societal benefits and promote sustainability 55 , for example through traits adapted to climate change, reduced pesticide use and improved nutritional content. A recent Eurobarometer on citizens expectations on sustainability indicated that for consumers the most important characteristic of sustainability are the health and nutritional aspects (41%), the absence of pesticides (32%) and affordability (29%). 18% of the respondents correlated organic food with sustainability 56 .

The majority of respondents in research studies believe that labelling of NGT products is necessary 57 . In some cases, there is also a preference for distinct labelling of GM and NGT products. Research indicates that consumers may also desire information on the specific trait that has been modified and which genetic technology has been used, to be provided on product labels 58 .

In the context of this initiative, consumer trust is relevant not only as regards acceptance of NGTs but also in relation to organic production. Research shows different results on the importance of the absence of GMOs in the decision to purchase organic food. This decision seems to depend on different factors, such as health awareness, food safety concerns, environmentally friendly production practices, consumer knowledge of organic foods, animal welfare, avoidance of chemical substances, perceived or subjective social norms and availability of organic food options 59 .

In its 2021 opinion, EGE acknowledges the prevalence of public concern in relation to GMOs, including the lack of public dialogue and informed debate, which in its view accompanied the introduction of GMO products, and calls for more attention to public dialogue on NGT plants 60 .

1.3.    Legal context

In the EU, regulatory requirements for GMOs are enshrined in five main legislative acts 61 and have two main objectives: to protect human and animal health and the environment and to ensure the effective functioning of the internal market. They establish harmonised procedures requiring an authorisation for the deliberate release of GMOs into the environment for experimental purposes as well as for the placing on the market and cultivation of GMOs and GM food and feed. This authorisation system is based on an assessment of the risks to human and animal health and the environment, and includes requirements for post-authorisation monitoring, labelling and traceability.

In the context of the Cartagena Protocol on Biosafety, the EU has made a number of international commitments with respect to the safe transfer, handling and use of living modified organisms resulting from modern biotechnology 62 .

In 2018, the Court of Justice of the EU (CJEU) ruled 63  that new mutagenesis techniques are not exempted from to the requirements of the EU GMO legislation (as is the case of old mutagenesis techniques) (Annex 8).

In November 2019, the Council noted that, while the Court ruling clarified the scope of the GMO legislation, concerns remained about the application of the EU legal framework when products obtained with new mutagenesis techniques are not distinguishable from those resulting from natural mutations or from conventional breeding. The Council therefore requested 64 the Commission to prepare a study on the status of NGTs under EU law (hereinafter referred to as ‘Commission NGT study’).

The Commission 2021 NGT study 65  concluded that, based on the reasoning followed by the Court, the EU GMO legislation also applies to organisms produced by other NGTs, including cisgenesis. On the basis of the products in the research and development pipeline, it considered that NGTs can contribute to the achievement of the Green Deal and Farm to Fork objectives, as well as to a more competitive economy. The study considered that the current EU GMO legislation needs adaptation to scientific and technological progress to be suited to certain NGTs and the diversity of products they can deliver. It also reported on the concerns expressed by certain stakeholders and concluded that the application of NGTs in agriculture should not undermine other aspects of food production, e.g., organic agriculture.

In a recent judgment, the Court clarified that organisms obtained by in vitro random mutagenesis techniques/methods are exempted from the GMO legislation (judgment of 7 February 2023, Case C-688/21 Confédération paysanne and Others) 66 . In vitro random mutagenesis techniques are not concerned by this policy initiative since they are exempted from the application of the GMO legislation and are not NGTs.

1.4.    International dimension

Globally, NGT organisms 67 and their products are either considered as GMOs or novel foods, or as conventional products 68 ; some countries require a case-by-case consideration of each product in order to establish the applicable regulatory framework. Various non-EU countries have adapted, or are in the process of adapting, their legislation in order to specifically address NGTs; this includes important EU trade partners such as the US, Japan, Argentina, India and the UK. A recent report by the FAO provides a detailed overview of current regulatory approaches across the world 69 . China, leading country on research, does not have a specific regulatory framework on genome edited crops, but has released guidelines for the safety evaluation of genome edited plants 70  that are intended to provide a more streamlined approval process than for GMOs. The African Union Agenda 2063 71 aims at utilising genome editing to improve agricultural productivity and crop resistance. Kenya and Nigeria have already implemented regulations for a case-by-case review of genome-edited crops 72 . NGTs could be relevant in low- and middle income countries, which would benefit from adapting traditional, local crop species so that they can withstand changing conditions. An enabling framework in the EU could also support use in those countries. 

Switzerland is considering a new authorisation regime 73 for plants that have been obtained using new breeding technologies and are not transgenic. Canada has a product-based legislation; products with novel traits are subject to risk assessment, regardless of the technique used. Other countries, such as New Zealand 74 and South Africa 75 , continue applying their GMO legislation to NGT organisms.

Actions taken by these third countries thus consist in partial or (most frequently) full exemption of certain NGT products from GMO authorisation requirements, including specific GMO labelling and traceability obligations. These exemptions are often linked to the absence of foreign genetic material and whether a specific product could also have been obtained naturally or by conventional breeding.

The determination of the status of these products ranges from self-determination by the developer, voluntary consultation of the competent authority, to compulsory notification or consultation and decision by a national authority. The evidence to be provided ranges from a simple documentary declaration to analytical evidence that the product complies with the exemption criteria.

Third countries that have made adjustments to their regulatory oversight to take into account the specificities of NGTs are expected to see NGT products increasingly arrive on the market in the years to come (as shown for example by the 30 NGT plants that have already cleared a regulatory procedure in the Argentina from 2015 to mid-2022). Emerging evidence from Argentina and Japan shows that a change in legislation has contributed to the shift in developers from international to national companies and from multinationals to public institutions and SMEs.

Currently regulatory developments on NGTs across the world differ to various extents and the resulting alignment or divergence will impact trade in plants, food and feed, and may lead to trade frictions as illustrated by the experience with GMOs.

In the context of the WTO’s Sanitary and Phytosanitary Committee, in 2018, 11 countries 76 co-signed an international statement on agricultural applications of precision biotechnology 77 , acknowledging its role in addressing challenges facing agricultural production and calling for policy alignment in order to minimise unnecessary trade barriers. 

1.5.    Scope

The scope of this initiative are plants produced by targeted mutagenesis and cisgenesis (including intragenesis) and their food and feed products.

The choice of the scope is based on several reasons. There is significant demand in the EU and globally for NGT plants, in the context of their potential to contribute to current challenges in the agri-food system. Numerous advanced and early R&D applications concern plants, and several plant products are already on or very close to the market. Safety data are mainly available for plants obtained by targeted mutagenesis and cisgenesis (addressed in expert opinions from EFSA), whereas it is at this stage difficult to draw relevant conclusions on other techniques and applications in animals and micro-organisms. Furthermore, similar plants can be obtained in certain cases with conventional breeding and targeted mutagenesis and cisgenesis, and the appropriateness of subjecting these products to the same regulatory requirements as transgenic organisms needs to be assessed.

1.6.    Interaction with existing legislation and upcoming initiatives

This initiative is framed by the existing legislation on GMOs and has links to other legislation applicable to plants, food and feed, as well as with planned initiatives implementing the European Green Deal and the Farm to Fork Strategy. Section 7.3 describes the coherence with the relevant legislation and upcoming initiatives 78 .

The initiative on NGT plants aims to establish specific rules applicable to the deliberate release and the placing on the market of these plants and derived food and feed, taking into account their specificity, while maintaining the objectives of the GMO legislation and ensuring coherence with it.

The planned initiative on a legislative framework for a sustainable food system (FSFS) 79 covers the entire food system, thus encompassing NGT plants used for food or feed and the derived food and feed products. The placing on the market and cultivation of plant varieties derived from NGT plants will also have to comply with EU legislation on the marketing of seeds and other plant and forest reproductive material (PRM, FRM), which is currently under revision 80 . In particular, the assessment of the value for cultivation and use (VCU) carried out under this legislation covers various aspects (e.g. yield, pest resistance, nitrogen-use and water-use efficiency) which may be linked to traits introduced by NGTs.

NGT plants could be among the tools that contribute to the reduction target on the use and risk of pesticides set out in the proposal for a regulation on the sustainable use of plant protection products (‘SUR’) 81 . 

EU legislation on organic production and labelling of organic products, the Organic Products Regulation’ 82  bans the use of GMOs and GM food and feed in organic production 83 , and allows organic operators to rely on the labels and accompanying documents available pursuant to the GMO legislation. In addition, organic operators have to implement precautionary measures to avoid the presence of products and substances not authorised for use in organic production. However, GMOs that are exempted today from the requirements of the GMO legislation (such as products obtained by random mutagenesis, i.e. old mutagenesis techniques) are treated as conventional for the purposes of organic production.

Legislation on IPRs will have an impact on the development and marketing of NGT plants. Two types of IPRs are of particular relevance for NGT plants: biotechnology patents and plant variety rights. The Biotechnology Directive 84  on the legal protection of biotechnology inventions provides for the patentability of subject-matter involving biological material which is new, involves an inventive step and is susceptible to industrial application. A patent can cover the biological material as well as the process to produce it, but not plant and animal varieties and essential biological processes for the production of plants and animals. The latter exclusion also extends to plants and animals obtained by such essentially biological processes. 85  Plant variety rights 86 can be granted for plant varieties that are distinct, uniform, stable and new. Breeders may use protected plant varieties for the purpose of breeding and marketing new varieties.

1.7.    Previous studies on the EU GMO legislation with relevance to NGTs

Two external studies on the EU GMO legislation were carried out for the Commission in 2010 (on GM food and feed) 87 and 2011 (GMO cultivation and placing of GMOs on the market) 88 . They noted concerns that the legislative framework was only focused on risks and not suited for the EU to take advantage of new developments in biotechnology. They also referred to detection challenges resulting from the fact that products of targeted mutagenesis might not differ from those obtained via conventional breeding. The studies concluded that, as the rate of innovation in the global biotechnology sector was unlikely to slow down, ensuring that legislation remained relevant was likely to be an ongoing challenge, especially if the focus was on the techniques used rather than on the final products. The Commission 2021 NGT study, using the latest available evidence, confirmed that the findings of the previous studies remain relevant today and that the challenges have grown, especially as regards plants produced by targeted mutagenesis and cisgenesis. The 2010 and 2011 external studies and the Commission 2021 NGT study, have provided an analysis of the relevant problems and evidence. In that context, an additional evaluation of the GMO legislation at this point in time would not yield further information, in the absence of NGT products on the EU market.

2.    Problem definition

2.1.    What are the problems?

The current EU GMO legislation is not fit for purpose for NGT plants obtained by targeted mutagenesis or cisgenesis, and their food and feed products. This was highlighted already in the 2010/2011 external studies and confirmed by the Commission NGT study in 2021. This is also the view of most stakeholder groups in the public consultation for this impact assessment 89 , where 191 (93%) of the respondent academic/research institutions, 102 (84%) of business associations, 66 (80%) of large enterprises, 70 (72%) of SMEs and 29 (83%) of public authorities found the existing regulatory provisions inadequate for these plants. However, other stakeholder groups (47 (58%) of non-governmental organisations (NGO), 16 (80%) of environmental organisations, 3 (60%) of consumer organisations) consider that the existing legislation is adequate. These results are similar to the outcome of the feedback received to the inception impact assessment (Annex 2).

The problem is composed of three main components:

I)The authorisation procedure and risk assessment requirements of the current EU GMO legislation are not adapted to the variety of potential plant products that can be obtained by targeted mutagenesis and cisgenesis, and as a result are disproportionate or inadequate in certain cases. 

Targeted mutagenesis and cisgenesis can produce a diversity of plant products with different risk profiles. Some are similar to plants occurring naturally, or produced by conventional breeding, including random mutagenesis techniques, for which there is no requirement to be authorised or risk assessed as GMOs. Others are similar to plants obtained by established genomic techniques. However, they are all subject to the same authorisation and risk assessment requirements in the current GMO legislation. This results in applying different regulatory oversight and risk assessment requirements to plant products with similar risk profiles or applying the same regulatory oversight and risk assessment requirements to plant products with different risk profiles.

The conclusions of scientific bodies in this regard (section 1.1) were shared by the majority view of stakeholders in the consultation activities. In the public consultation, 829 respondents, 23% of those replying that the legislation is not adequate, indicated as an underlying reason that the risk assessment approach cannot factor in the diverse risk profiles of the plants in question 90 ; in addition, 61% (1331) of total respondents supported a risk assessment approach different from the current one 91 . On the other hand, 22% of respondents (480 responses) 92 were of the view that NGT plants need to be assessed using the current GMO legislation requirements.

II)The current EU GMO legislation raises implementation and enforcement challenges for certain plants produced by targeted mutagenesis or cisgenesis. 

The EU GMO legislation currently requires applicants to provide an analytical laboratory method that is specific to the product for which they seek authorisation, i.e. it can both detect it and differentiate it from other products. The EURL and ENGL have concluded 93 that, if the genetic alteration is not unique for the relevant product, a specific detection method cannot be provided. When the same alteration can be introduced by NGTs or conventional breeding methods, the detection method may be able to detect it, but will not allow determining whether the product is a GMO subject to the GMO legislation or not. In such cases, applicants will be unable to comply with an authorisation requirement, and other food chain operators and authorities will not be able to implement or enforce the legislation. This has been confirmed by the fact-finding studies carried out by the Commission in 2022 in Germany 94 and the Netherlands 95  to gather information on the implementation of controls on organisms and products obtained through NGTs. 

Furthermore, plants produced by targeted mutagenesis and cisgenesis, which could also occur naturally or be produced by conventional breeding, need to comply with the traceability (document-based with specific GMO identifier) and labelling (obligation to label the products as genetically modified) requirements of the EU GMO legislation. Consequently, in certain cases, plant products with similar genetic modifications might be subjected to different labelling and traceability requirements, depending on the breeding technique that was used to obtain them.

Finally, the emergence of targeted mutagenesis and cisgenesis techniques raises questions of interpretation of Directive 2001/18/EC (and other GMO legislation). That legislation lacks definitions of certain key terms or concepts such as ‘mutagenesis’ and ‘genetic material [that] has been altered’. The potential ambiguities can lead to diverging interpretations, regulatory uncertainty and implementation challenges 96 .

III)The current EU GMO legislation applied to NGTs is not conducive to developing innovative beneficial products.

NGTs can bring speed and precision to the development of improved plant varieties with traits that could support a sustainable and resilient EU agri-food system (section 1.1). However, as a result of the regulatory issues mentioned above, the current EU GMO legislation applied to NGTs is not conducive to developing these innovative products and to place them on the market in the EU. In the public consultation, 61% of the total respondents (1329) 97 believed that maintaining plants produced by targeted mutagenesis and cisgenesis under the current framework is expected to have short-, medium- or long-term consequences in their activity or sector. The large majority mentioned negative consequences, relating to loss of tools to achieve the goals of the Green Deal and the Farm to Fork Strategy, as well as obstacles to research and development of improved crops and loss of competitiveness. 19% (424) of the respondents 98 do not expect to experience any consequence.

Overall, the current GMO legislation meets the objective of safety, albeit with higher regulatory burden and cost than would be necessary for certain NGT products. It is not conducive to developing innovative NGT products and to place them on the market in the EU. Thus, contributions of these products to a sustainable transformation of the food system, and to the EU’s strategic autonomy and international competitiveness, cannot be harnessed. See also problem tree (Figure 1 and Annex 9) and Section 3.

2.2.    What is the size of the problem and who is affected?

The problems identified above affect numerous operators across the agri-food system, especially breeders, the agricultural biotechnology innovation and research sector, conventional and organic farmers, bio-based industry, consumers, traders, and EU and national authorities. The overall risk is that the EU would be to a significant extent excluded from the technological developments and economic, social and environmental benefits potentially generated by these new technologies, thereby also weakening the EU’s strategic autonomy. However, since specific regulatory frameworks were introduced in several non-EU countries only recently and given the limited number of products on the global market (none in the EU), very few if any data or estimates on economic, social or environmental impacts of different regulatory regimes for NGT products are available to date. Estimates of the size of the problems for different types of operators if the current GMO legislation continues to apply to NGTs thus depend to a large degree on comparison with past developments inside and outside the EU (e.g. for GMOs obtained by established genomic techniques), expert assessments, projections, stakeholder expectations and relevant data from the scientific literature.

In the targeted survey conducted for this impact assessment, respondents active in plant breeding (45.5%, 56 of 123) pointed to regulatory uncertainty, regulatory costs and time to market as the most important barriers to developing new plant varieties using targeted mutagenesis or cisgenesis. Due to uncertainty 99 , the current regulatory regime is seen as inducing high risk for plant breeders to engage in NGT-related research and product development, in particularly for start-ups and SMEs. A significant share of companies (40%) replied that they delayed product development and release due to this regulatory uncertainty. Large companies respond to this uncertainty by moving R&D on NGTs to non-EU countries, while SMEs may not have the resources to pursue this strategy (100% of the large companies vs. 20% SMEs according to a recent survey) 100 . Regulatory developments in third countries (section 1.4) affect negatively the competitiveness of the EU biotechnology and breeding sectors, in particular of SMEs, on international markets which is also contributing to weakening the EU’s strategic autonomy.

In the public consultation, academic/research institutions emphasised the negative impact of the current situation on the competitiveness of the EU research sector, compared to other countries with a more enabling environment. Researchers consider the current regulatory situation as hindering funding decisions by public and private funders and report that, since the CJEU ruling, several R&D projects were cancelled or shifted abroad. A recent survey suggests a reduction of 33-40% of R&D activities after the ruling 101 . Young researchers indicate that the EU has become less attractive for a career in agricultural biotechnology, leading to a brain drain and recruitment challenges 102 . This could further widen the already established patenting gap between the EU and US/China in agricultural biotechnology that emerged since 1998 103 .

Stakeholders from the bio-based economy consider genome-editing as a key enabling technology 104 . The existing regulatory framework is seen as an obstacle to innovation in this sector, which will increase the EU’s dependence on technological developments coming from other parts in the world 105 .

The existing regulatory problems affect also farmers. Farmers are deprived of tools and products that could contribute to improving the yield/input ratio, to dealing with the challenges of climate change and to meeting reduction targets for pesticides and fertilisers. Climate impacts have led to poorer harvests and higher production costs, affecting price, quantity and the quality of farmed products in parts of the EU. Climate change impacts on agriculture are projected to lead up to 1% average gross domestic product loss by 2050 but with large regional differences 106 . Plant breeding is one effective counter measure against such climate change impacts. Adapting crop varieties to rapid climate change by breeding requires making rapid incremental changes in the best adapted varieties to keep pace with changes in the biotic and abiotic environment, to ensure food security 107 and to support the transition to sustainable agriculture. While conventional breeding has led to a continuous improvement of a wide range of traits 108 , NGTs are crucial technologies enabling a more rapid and targeted breeding progress.

Consumers prepared to accept products of biotechnology will have to forego benefits from products that could be designed to meet their expectations and needs (e.g. improved taste, improved nutrient profile or reduced allergen content). NGTs can improve the taste of green leafy vegetables, which are an important source of vitamins, minerals, and phenolic compounds 109 , or reduce the content of the potential carcinogen acrylamide in wheat 110 .

The current situation has also a negative impact on international trade. In practical terms, the current regulation is seen as an obstacle for the importation of commodities derived from NGTs 111 . The current GMO regulation has resulted in lost trade opportunities due to temporarily closed borders, testing costs, lawsuits, and disputes 112 , whereas asynchronous authorisations create uncertainty for importers and exporters 113 . The situation for NGTs may be even more challenging compared to conventional GMOs due to the existing difficulties in analytical detection possibilities. 

National public authorities will face enforcement challenges. For example, if the same genetic alteration can be introduced by NGTs or conventional breeding methods, the enforcement authorities, by detecting the alteration, will not be able to assess whether the product is a GMO subject to the GMO legislation or not.

Figure 1. Drivers, problems and consequences for plants produced by targeted mutagenesis and cisgenesis.

2.3.    What are the problem drivers?

There are two main drivers behind the problems presented above (Annex 9):

I)The current framework is based on genetic modification techniques as understood in the late 1990s, and lags behind scientific developments. After more than 20 years of rapid scientific progress in this field, the current legal framework is based on an outdated understanding of the technical possibilities offered by modern biotechnology, especially regarding plants produced by targeted mutagenesis and cisgenesis. The current system has been designed based on the experience with transgenic products, with requirements fit for products containing foreign genetic material from sexually incompatible organisms, and which therefore would not generally occur in nature. In addition, the legislation has limitations in keeping up with developments in this rapidly evolving field, where new techniques are discovered and applied. 

II)The authorisation system in the current framework was designed with safety and the functioning of internal market as the primary objectives; it is not conducive to developing innovative NGT products and to placing them on the market, and therefore, translating their sustainability potential to reality. 

2.4.    How likely is the problem to persist? 

If no action is taken, the problems described will persist and be aggravated. Plants obtained by targeted mutagenesis and cisgenesis will continue to be regulated under the current EU GMO legislation, with the current risk assessment, authorisation, traceability and labelling requirements. As the findings of the consultations suggested, limited research and development of NGT products in the EU is expected. A recent survey suggests that a significant share of companies (38%) has delayed product development following the clarification of the CJEU that these products fall under the current EU GMO legislation 114 .

The cultivation and market uptake of these products would remain limited in the EU. The high costs and long time needed for authorisation of NGT products – in addition to the potentially high licensing costs for access to these technologies – would make these products unattractive for SMEs and the existing market structure, with only large companies having the resources to develop and bring them to the market, would persist. For example, according to the information from breeders provided in the targeted survey responses and interviews, in terms of time to market, the length of the current risk assessment for GMOs is estimated to be on average 6 years for cultivation and 4.5 years for food/feed respectively, making the total time to market (including R&D) under the current framework 16.5 years on average. Operators and consumers would face difficulties accessing new products that could meet their expectations and needs. Obstacles would remain for innovative plant biotechnology to contribute to the objectives of the European Green Deal and Farm to Fork Strategy. 

In some cases, applicants will not be able to meet the detection method requirements as they stand today and the NGT plants concerned will not be able to obtain authorisation.

At international level, research and development and commercialisation of these products will increase in most major EU trade partners. With the existing difficulties in analytical detection, the above developments are expected to further complicate the enforcement and implementation of the EU GMO legislation, will negatively impact trade and could raise questions of compatibility with WTO law. More challenging and expensive identity preservation systems for both NGT and NGT-free products from the EU trade partners would be required. Regulatory divergence could lead to forced separation of entire agricultural value chains in and outside the EU, reduced availability of imports due to an unwillingness of trade partners to comply with labelling and segregation requirements, resulting in higher costs and input prices. The organic and GM-free value chain will continue to rely on the labelling and traceability requirements in the existing GMO legislation to build up reliable value chains and consumer trust for their products, and they consider that the current GMO legislation is the appropriate legal instrument to deal with these problems. However, they will also be affected by the challenge of avoiding unintended use of NGT-based inputs such as seed materials, feed, or food ingredients.

The persistence and aggravation of the problem is also illustrated by some of the megatrends identified 115 by JRC. In particular, the megatrends climate change, environmental degradation and aggravating resource scarcity are environmental changes that could create new challenges in terms of food availability and resilience. NGTs could be one tool contributing to the necessary adaptation of the food systems at global level.

3.    Why should the EU act?

3.1.    Legal basis

EU legislation on GMOs is based on Articles 43, 114 and 168(4)(b) of the Treaty on the Functioning of the European Union (TFEU). These articles provide the legal basis for the EU to adopt measures which have as their objective to implement the common agricultural policy (Article 43), and to ensure the good functioning of the internal market (Article 114(1)) while maintaining a high level of human health protection in the veterinary and phytosanitary fields (Article 168(4)(b)). The objectives of this initiative are aligned with these legal bases and, in addition, this initiative tries to ensure that plants obtained by targeted mutagenesis and cisgenesis, and food and feed products produced from them contribute to the sustainability goals of the Green Deal and Farm to Fork strategies. In that regard, the EU’s common agricultural policy’s objectives of ensuring the rational development of agricultural production and the optimal use of the factors of production, as well as to assure food security and the availability of supplies have particular relevance.

3.2.    Subsidiarity: Necessity of EU action

Plants obtained by targeted mutagenesis and cisgenesis are living organisms which, as any other plant, when released into the environment for experimental purposes or as commercial products, may reproduce in the environment and cross national borders. It is essential to achieve a harmonised, high level of protection of human and animal health and the environment in relation to these plants and of food and feed derived from them so that they may circulate freely within a smooth-functioning internal market. In addition, the EU Farm to Fork Strategy recognises the potential of NGTs as a possible tool to increase sustainability of the food system and bring benefits to society as a whole.

The requirements for the deliberate release and the placing on the market of NGT plants and their derived food and feed are already harmonised at EU level under the existing legal framework applicable to GMOs but need to be adapted to the specificities of plants obtained by these new techniques. Carving out NGT plants from the current EU legal framework and leaving it to Member States to regulate them would likely lead to different regulatory requirements and levels of protection in the EU Member States. Differing national requirements for NGT plants would hinder the free movement of these products, fragment the internal market and lead to uneven competition between economic operators. It would also impact access of NGT products to the market and thereby limit their potential to contribute to the international competitiveness, strategic autonomy and sustainability of the EU’s food system.

3.3.    Subsidiarity: Added value of EU action

Compared to individual action by Member States, EU intervention would provide uniform rules for the development and placing on the market of NGT plants and their food and feed products. Harmonised EU-wide rules on the marketing of such products would ensure a level-playing field for operators within the single market and a more predictable and efficient regulatory oversight. Furthermore, there is an urgent need to ensure availability to farmers, food operators and consumers of plant varieties that can cope with challenges of a global nature such as climate change and biodiversity reduction, which have been further aggravated by the present geopolitical and energy crisis in Europe, and to secure food security in the future. The Farm to Fork Strategy recognised the role that biotechnology can play in meeting those global challenges, which need an EU-wide response.

4.     Objectives: What is to be achieved?

The intervention logic is presented in Annex 10.

4.1.    General objectives

I)Maintain a high level of protection of human and animal health and of the environment, in accordance with the precautionary principle.

II)Enable the development and placing on the market of plants and plant products contributing to the innovation and sustainability objectives of the European Green Deal and of the Farm to Fork and Biodiversity strategies.

III)Ensure the effective functioning of the internal market and enhance the competitiveness of the EU agri-food sector at the EU and global level, providing a level-playing field for its operators.

Compared to the current GMO legislation, general objectives (I) and partially (III) are the same, i.e. to protect human and animal health and the environment and to ensure the effective functioning of the internal market. In line with the European Green Deal and its Farm to Fork and Biodiversity Strategies, an objective on sustainability is also included (general objective II). It encompasses the three dimensions of sustainability: economic (e.g., higher yield/input ratio), social/health (e.g., improved nutrient content) and environmental (e.g., resistance to pests, less need for fertilisers). An additional objective relates to the competitiveness of the EU agri-food sector at EU and global level (included in general objective III), which contributes to food security and EU’s strategic autonomy.

4.2.    Specific objectives

I)Procedures for the deliberate release and placing on the market ensure that NGT plants and derived food/feed products are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden.

This objective takes into account the diversity of NGT products, based on their risk profiles, and addresses current implementation and enforcement challenges, in particular for NGT plants that could also occur in nature or be conventionally bred.

In this respect, the objective addresses specifically problem components (I) and (II) and drivers (I) and (II).

II)Deliberate release and placing on the market of NGT plants and derived food/feed products that feature a wide range of plant species and traits by various developers.

This objective is linked to innovation in plant breeding that 1) brings to the market products that cater for the diversity of needs of farmers and consumers and address local and regional specificities; 2) facilitates access of new players (such as SMEs, public institutes) to the market.

In this respect, the objective addresses problem component (III) and driver (II).

III)NGT plants released or placed on the market feature traits that can contribute to a sustainable agri-food system.

This objective aims to steer plant breeding to plants with traits that have been identified as being useful in view of sustainability objectives (economic, environmental, social/health).

In this respect, the objective addresses specifically problem component (III) and driver (II).

Figure 2 presents the relationship between the general and specific objectives.

Figure 2. General and specific objectives.

5.    What are the available policy options?

To respond to the specific objectives, this impact assessment considers a range of policy elements: procedure for the release or placing on the market and risk assessment, traceability, labelling/transparency, detection method requirements and sustainability. Sustainability is a novel element, compared to the current GMO legislation, linked to general objective (II). The others are all elements of the current GMO legislation, and for these, in addition to the status quo, possible adaptations to the specificity of NGT plants are considered.

The possible choices for each of these policy elements reflect the full range of stakeholders’ views submitted in the context of the Commission 2021 NGT study and the inception impact assessment as well as other consultation activities carried out in the context of this impact assessment. They take into account scientific opinions of EFSA and other scientific bodies and relevant scientific literature. Stakeholders concerned about the safety or other aspects of GMOs and NGTs in general favour the continued application of the existing GMO legislation to NGTs. This report takes these views into account by treating the baseline (no change) as a viable policy option with a full assessment of its impacts. Impacts on specific sectors (organic and GM-free) that express concerns about NGTs are specifically assessed for each policy option in section 6.

The key policy choices for each of the policy elements are presented in Figure 3.

Figure 3. Policy elements.

The issue of how to steer the development of varieties with traits that contribute to sustainability is not specific to NGTs. It applies equally to conventionally bred plants and to GMOs not covered by this initiative. Therefore, the policy choices as regards sustainability include (in addition to the possibility of specific provisions in this initiative) addressing this issue in other, horizontal initiatives (FSFS; PRM/FRM) as a feasible option. Assessing such an option reflects the majority view among stakeholder groups resulting from the public consultation and the targeted survey that sustainability tests only in the context of the NGT initiative are not appropriate, and that a holistic assessment of performance – as done in value for cultivation and use (VCU) testing in the context of the PRM/FRM legislation to which NGTs are also subject – will be far more useful.

Certain of the policy choices above (no risk assessment, notification procedure 116 , no tracing as GMO) have only been considered as feasible options for a limited range of NGT plants, namely those which could be obtained naturally or by conventional breeding methods, based on the risk profile of such NGT plants. Therefore, option 4 (which incorporates this policy choice) is only assessed as regards such NGT plants. All other options (baseline, options 1 to 3) are assessed as regards all NGT plants under the scope of the initiative (both those that could or could not occur naturally or be produced by conventional breeding).

The choices for each element have been combined into policy options (see Figure 4). These represent a range of distinct approaches to the regulation of NGTs. Their impacts including the trade-offs between elements are analysed in section 6. These options represent combinations of the different choices for the main elements (risk assessment, regulatory procedure, etc.) that have been considered feasible and coherent (see section 5.3 for a discussion on discarded combinations).

Figure 4. Policy options.

The policy instrument considered under all four policy options is a Regulation. The authorisation procedures in options 1 to 3 as well as the notification system in option 4 are based on fully harmonised criteria and requirements and procedures that should lead to the authorisation or acceptance of a notification for the whole EU, ensuring the same level of protection of health and the environment and the availability of the products concerned across the EU. A Regulation appears to be the most appropriate legal instrument to embody such procedures, as well as to achieve a uniform implementation of the policy intervention, which has an important internal market component. That instrument would be complemented by any necessary amendments of existing legislation

5.1.    What is the baseline from which options are assessed?

The current regulatory framework would remain applicable, meaning that plants obtained by targeted mutagenesis or cisgenesis, whether cultivated in the EU or imported, and food and feed produced from them, would require authorisation for their release including placing on the market. An authorisation would also be required for field trials on such NGT plants carried out within the EU.

The authorisation procedure for the placing on the market of NGT plants (as such or in food and feed products) would be conducted at EU level (risk assessment by EFSA and decision by the Commission), whereas the procedure to authorise the deliberate release of NGT plants for other purposes (e.g., field trials) would be conducted by Member States (national authority to which the application is submitted, with the involvement of EFSA in case of objections raised by the Commission or another Member State).

All current authorisation requirements would apply, i.e. risk assessment to show that the NGT plant does not present more potential hazards than its conventional counterparts, with current requirements that contain only limited scope to adapt according to the risk profile of the plant; the requirement to provide an event-specific detection method (that is, which can both detect the event and differentiate it from other events); tracing as a GMO (obligation to transmit and hold information for a period of five years that a product contains or consists of a GMO, including its unique identifier, and that food or feed is produced from a GMO, at each stage of their placing on the market); labelling requirement for products destined to consumers that contain or consist of GMOs and for food and feed produced from GMOs. Authorised products would be subject to post-market obligations (monitoring for a certain time-period, duty to submit new information relevant to the assessment of risks, renewal every 10 years).

Sustainability would be addressed by sustainability-related provisions included in the relevant horizontal and sectoral legislation (e.g. FSFS, PRM 117 , FRM), where applicable.

5.2.    Description of the policy options

5.2.1.Option 1: Authorisation with adapted risk assessment and detection method requirements

The legislation would be adapted to cater for the diverse risk profiles of plants obtained by targeted mutagenesis and cisgenesis and to address the implementation and enforcement challenges related to detection.

NGT plants and food and feed produced from them would require (as today) an authorisation to be used in field trials, cultivated or placed on the market, granted as today if the NGT plant is shown not to present more potential hazards than its conventionally counterparts. Risk assessment and detection method requirements, adapted to the diversity of these plants, would replace the current requirements, while maintaining the general principles and methodologies.

To that end, general principles for risk assessment would be set in the legislation. They would be accompanied by criteria to inform the adaptation of data requirements to risk profiles. An indicative list of criteria for an adapted risk assessment 118 is presented in Box 1. They provide the starting point for the design of an adapted risk assessment in the legislation. Specific data requirements based on the criteria would be set in tertiary legislation and/or by EFSA.

As regards the authorities competent for the regulatory procedures, as today, the risk assessment would be carried out by EFSA (for placing on the market, including cultivation, for food/feed uses) or by national authorities (for field trials and for placing on the market, including cultivation, for non-food/feed uses). Member States would remain responsible for granting consent for experimental releases within their territories (field trials). Authorisation for the placing on the market for cultivation and food and feed uses would be given at EU-level through an authorisation decision by the Commission.

The requirement for an event-specific detection method would be waived if the applicant can justify that developing a detection method that can, not only detect, but also differentiate a specific NGT product from conventional ones that contain the same modification(s) is not technically possible. The applicant would still need to submit an analytical method capable of detecting the product.

Other legal requirements, such as those on traceability, labelling and post-market provisions, would remain as in the baseline.

Sustainability would be addressed by sustainability-related provisions included in relevant horizontal and sectoral legislation (e.g. FSFS, PRM, FRM), where applicable.

5.2.2.Option 2: Authorisation with incentives for products containing modified traits that have the potential to contribute to sustainability

The legislation would be adapted to cater for the diverse risk profiles of NGT plants and to address the implementation and enforcement challenges related to detection (as in Option 1) and to incentivise the development and placing on the market of plant products that could contribute to a sustainable agri-food system.

NGT plants and food and feed produced from them would require an authorisation to be used in field trials, cultivated or placed on the market, with adapted risk assessment and detection method requirements (as in Option 1). The competent authorities will be as in option 1.

In addition, regulatory incentives – granted by the authorities competent for the procedure concerned (at national or EU level) - would be introduced for NGT plants containing traits that could contribute to sustainability to encourage the development of sustainable products. The regulatory incentives considered in the impact assessment are: the provision of regulatory and scientific advice before and during the authorisation procedure (guidance on the overall development plan and the regulatory procedure, dedicated contact point in EFSA, scientific advice at key development milestones) and measures to facilitate the authorisation process (waiving of detection method validation fees, faster procedures). During the consultation activities various stakeholders, in particular breeders, considered waiving labelling as GMO as the measure that would have greater impact.

Incentives would be linked to the modified trait in the NGT plant and its potential impacts on sustainability (economic, environmental, and social). The basis for this comparison would be data provided by the applicant on the characterisation of the modified trait and a pre-defined list of desirable sustainability impacts to be set out in the legislation. NGT plants would also be subject to all sustainability-related provisions included in relevant horizontal and sectoral legislation (e.g. FSFS, PRM, FRM), where applicable.

Traceability and post-market provisions would remain a requirement as in the baseline. With a view to further steering development towards desirable traits from a sustainability perspective, in addition to the regulatory incentives, the following sub-options on labelling have been considered under this option:

§A sustainability label (claim) would be added to the GMO label for products that contribute to sustainability referring to the introduced trait.

§A factual statement on the intended purpose of the genetic modification would be added to the GMO label.

§The GMO labelling requirement would be waived for products with a modified trait that is considered to have the potential to contribute to sustainability.

5.2.3.Option 3: Authorisation with the requirement that products do not contain modified traits that can be detrimental to sustainability

The legislation would be adapted to cater for the diverse risk profiles of NGT plants and to address the implementation and enforcement challenges related to detection (as in Option 1) and to discourage the development of unsustainable products.

NGT plants and food and feed produced from them would require an authorisation to be used in field trials, cultivated or placed on the market, with adapted risk assessment and detection method requirements (as in Option 1). The competent authorities will be as in option 1.

A prerequisite for authorisation – verified by the authorities competent for the procedure concerned (at national or EU level) - would be that applicants show that the introduced trait is not detrimental to sustainability (economic, environmental, and social). The basis for this comparison would be data provided by the applicant on the characterisation of the modified trait and a pre-defined list of undesirable sustainability impacts to be set out in the legislation. NGT plants would also be subject to any sustainability-related provisions included in relevant horizontal and sectoral legislation (e.g. FSFS, PRM, FRM), where applicable.

The additional requirement of this option is not linked to potential safety issues of the specific NGT plant (i.e. risks to health or the environment that result from the genetic modification). This is addressed by the risk assessment that features in this option (as well as in the baseline and in options 1 and 2, and by the notification criteria in option 4). Rather, the concrete sustainability requirement of this option relates to the fact that NGTs could reach the market featuring traits that, ultimately may have negative effects (e.g. herbicide-tolerant traits that have been found to in some cases to lead to increased pesticide use or development of resistance in weeds).

Traceability, labelling and post-marketing provisions would remain as today (baseline).

5.2.4.Option 4: Notification of products that could also occur naturally or be produced by conventional breeding

Option 4 is intended to apply to only a part of the scope of this initiative, i.e. to NGT plants that could also occur naturally or be produced by conventional breeding. These would be treated similarly to conventional plants.

This option would introduce a notification procedure for NGT plants based on criteria set out in the legislation to verify whether a product could also occur naturally or be produced by conventional breeding. An indicative list of these criteria is presented in Box 2. The criteria are based on a scientific literature analysis and take into account the work of JRC and EFSA as well as feedback received in the consultation activities for this impact assessment. A thorough analysis of the literature confirmed that targeted mutagenesis and cisgenesis techniques can lead to genetic modifications that are similar to mutations occurring naturally or resulting from conventional breeding techniques (including random mutagenesis techniques). These mutations include substitutions, insertions (including translocations and inversions) and deletions of nucleotides in the DNA. Such mutations are commonly observed with conventional breeding techniques and span a range of sizes: substitutions and insertions of limited size as well as deletions of variable dimensions are frequently reported. Larger translocations, inversions and genome duplications may also occur naturally. Insertions of cisgenes or part of cisgenes are also possible through natural processes, crossing or conventional breeding; with natural crossing or conventional breeding, the insertion of a cisgene (or part of) generally takes place in locations where the gene is naturally occurring in its breeders’ gene pool. As regards the total number of modifications introduced by conventional breeding techniques, literature shows that it is also variable depending on the organism and the method used.

The criteria are product rather than technique-based, reflecting the majority scientific view (including of EFSA) that the risk profile is not mainly dependent on the technique used but rather on factors related to the product itself. They are designed to cover the type and extent of modifications that are also observed with conventional breeding techniques, to ensure that the NGT plants fulfilling these criteria would not present more potential hazards for human or animal health and the environment than conventionally bred plants. They are also designed to be objective to ensure predictability for developers and uniform applicability by the assessment bodies (EFSA and Member States authorities).

As shown by the scientific literature analysis, conventional breeding techniques can lead to a high number of modifications. However, certain combinations of modifications would be less likely to occur by conventional methods. To take this into account, following a conservative approach and considering the novelty of new genomic techniques, the criteria would be complemented by thresholds for both size and combination of modifications, also to ensure that plants obtained by complex modifications are excluded from the notification procedure.

The regulatory status of the product would be subject to a decision based on the notification criteria. The authority responsible would be:

·If the determination of status is sought prior to conducting field trials, the verification of the criteria and determination of the status would be done by the Member State where the field trial is intended to be carried out. The national decision would have EU-wide effects.

·If the determination of status is sought prior to the placing on the market of NGT plants and products for which no field trials have been carried out in the EU, including imported NGT plants/products, the determination of the status would be done by the Commission, following verification of the criteria by EFSA.

In both cases, appropriate consultation procedures of Member States, the Commission and EFSA would be established. The procedure is illustrated in Annex 11.

For products that meet the notification criteria, no authorisation requirement would apply for the deliberate release, including placing on the market, or to field trials. In addition, there would be no GMO traceability, labelling and post-market monitoring requirements. Transparency would be ensured in a public register that would include information on the product and the modified trait and would link to the notification assessment. The General Food Law and other relevant legislation on traceability, labelling and monitoring of products on the market as applicable to conventionally bred plants would apply.

Sustainability would be addressed by sustainability-related provisions included in relevant horizontal and sectoral legislation (e.g., FSFS, PRM, FRM), where applicable.

There are two sub-options as regards the use in organic production of NGT plants/products fulfilling the notification criteria. In a first sub-option notified NGT plants/products would remain subject to the current ban of the use of GMOs in organic production (which applies in the baseline and options 1 to 3) (see section 1.6.). In a second sub-option, notified NGT plants/products would be treated as conventional products for the purposes of organic production (as is the case today for the products of random mutagenesis), and could be used under certain circumstances (permission to use non-organic agricultural ingredients in processed organic food and feed, the use of non-organic plant reproductive material). The Organic Product Regulation does not require coexistence measures for cultivation when it comes to conventional agriculture. Precautionary measures are used to segregate organic and non-organic during storage, transport, processing.

5.2.5.Combination of option 4 and one of the other options

Options 1, 2 or 3 apply to all types of NGT products. Option 4 applies only to NGT products, which could occur naturally or be obtained by conventional breeding. Therefore, option 4, if retained, would in all cases apply in combination with options 1, 2 or 3 or the baseline. The potential impacts of option 4 and of one of the other options chosen are independent and therefore can be assessed individually. Relevant cumulative impacts of the possible combinations, especially as regards specific objective I (ensuring safety while avoiding unnecessary burden) are discussed in section 7.

5.3.    Options discarded at an early stage

An option to initiate a broader legislative action, which would have concerned all NGTs, and all organisms (plants, animals, micro-organisms) was discarded in the light of the Commission NGT study. The latter concluded that for other NGTs and for NGT applications in animals and microorganisms, the necessary scientific knowledge is still limited or lacking, especially on safety aspects. As a result, when announcing the follow-up to the study, the Commission indicated that, as regards animals and microorganisms and other NGTs, it intends to continue to build up the required scientific knowledge, in view of possible further policy actions 120 .

An even broader action, covering all genetic modification techniques, was also discarded. This approach would have required an extensive evaluation of the EU GMO legislation, to analyse issues which were not addressed in the Commission NGT study. In its absence, there is no substantial evidence to suggest that the current requirements of the GMO legislation are not suited to the products of established genomic techniques.

The possibility of applying a notification procedure with no risk assessment (as in option 4) to all NGT plants developed with targeted mutagenesis and cisgenesis was discarded in light of the conclusion by EFSA and many other scientific bodies, that targeted mutagenesis and cisgenesis can produce a diversity of plant products with different risk profiles.

An option to exempt targeted mutagenesis from the scope of the GMO legislation entirely, by adding it to Annex IB of Directive 2001/18/EC, was also discarded, although it is requested by certain stakeholders given that random mutagenesis is already exempted in that way. This is linked to the diversity of plant products and risk profiles that can be achieved with all techniques under the scope of this initiative. On that basis, only options entailing a case-by-case regulatory procedure (authorisation or notification) were considered.

As explained above, the policy options each address several elements (procedure for the release or placing on the market and risk assessment, traceability, labelling/transparency, detection method requirements and sustainability) and, in turn, several policy choices were considered for each element. While theoretically this could have led to many different combinations and resulting policy options, policy options 1 to 4 presented above are those that have been considered feasible and internally coherent.

In this regard, it has been considered that products subject to risk assessment call for policy elements such as an authorisation procedure and traceability as GMOs, and these have been packaged together (in options 1, 2 and 3, as in the baseline). Conversely, in the option where risk assessment is not required (option 4), authorisation, traceability and labelling as GMO are not required, as the option is based on the logic of treating the products meeting certain criteria in the same way as the products of conventional breeding.

6.    What are the impacts of the policy options?

Economic, environmental and social (health) impacts of the options were assessed taking into consideration scientific literature, expert views, data collection from public and targeted stakeholder consultations, JRC case studies and quantitative modelling where possible, as explained in Annex IV on the analytical methods. One important input to the impact analysis is the development pipeline of NGT products, i.e. applications that are already being marketed, are at a confirmed pre-market development stage or are at R&D stage but showing market potential, as mapped by the JRC 121 .

However, inherent limitations remain. Since specific regulatory frameworks were introduced in several non-EU countries only recently and given the limited number of products 122 on the global market (none in the EU), very few if any data on economic, environmental or social (health) impacts of NGT products are available to date. Furthermore, EU data on cultivation and coexistence with organic 123 /non-GM crops are very limited as almost no GM crops are cultivated in the EU. To address these issues, the impact estimates depend to a large degree on comparison with past developments inside and outside the EU (e.g. for GMOs obtained by established genomic techniques), expert assessments, projections and stakeholder expectations. Wherever possible, these assessments, projections and expectations were checked against relevant data from the scientific literature. In addition, the JRC has conducted three case studies to analyse the potential economic, environmental and social (health) impacts of selected NGT plants that are in the development pipeline 124 .

Most findings are qualitative, though estimates of costs, especially regulatory, are provided. Potential benefits are explained and quantified to the extent possible throughout.

A number of fundamental rights enshrined in the Charter of Fundamental Rights of the EU can be impacted by this initiative. These concern the protection of human health (Article 35), of the environment (Article 37), of consumers (consumers’ right to information) (Article 38) and the freedom to conduct business (for the agri-food sector and biotechnology operators and researchers) (Article 16). Impacts on those rights are addressed under the economic, environmental, and social impacts analysed below.

1.1.Analysis of the baseline

6.1.1.Economic impacts

Breeders – The current average time to market of an established, single event GMO (including R&D) developed between 2017 and 2022 is 16.5 years and the average costs are approximately EUR 121 m 125 . In the EU, authorisations may be for marketing of food and feed and derived products or for cultivation. Authorisation costs for food and feed uses range from ~EUR 6 m to EUR 20 m (for authorisations of single event GMOs) 126 , and administrative costs range from EUR 2 - 2.7 m 127 . For GMOs developed between 2017 and 2022 by established genomic techniques, the genetic event construction and testing phase represented 55.8% of total costs and 35.6% of the total time. The regulatory phase had the longest duration of the overall process and accounted for 37.6% of total costs and 51.1% of the total time 128 . The time to place NGT products on the market would be shorter than for GMOs obtained by established genomic techniques, because of an accelerated R&D phase: for the latter, the R&D phase can be more than 10 years, while for NGT products the R&D phase is around 5 years 129 , thereby reducing the costs of the most expensive phase in product development. 

There is little experience with authorisation costs for cultivation in the EU 130 , and therefore only approximations are available. Available estimates provided by one company give a range of costs of EUR 17.5 – EUR 28 m for authorisation plus EUR 0.7 – EUR 1 m per year for monitoring. 

Breeders identified the regulatory uncertainty about a product being authorised after several years of R&D, regulatory costs and time to market as the main factors making the development of NGT products under the existing GMO framework unattractive. 54.5% of the stakeholders 131 in the targeted survey consider that attractiveness of developing plant varieties using NGTs will decrease and 43.2% consider it will stay the same under this option. Across all participating stakeholders 132 , there is the expectation to see very few NGT products on the market for the period 2030-35. Breeders delayed product development and release due to regulatory uncertainty and high regulatory costs (40% response in targeted survey) 133 .

It is expected that GMOs, including NGT products, mostly of large-scale commodity crops (e.g., maize, soybean, cotton), would continue to be predominantly developed by large multinational companies, while the high R&D costs, regulatory uncertainty and long duration and costs of authorisations will continue to act as a barrier to market entry for SMEs, which more often focus on niche crops, 134 . The baseline is thus not conducive to the freedom of SMEs to conduct business and to their competitiveness by keeping new, innovative technologies out of their reach.

Academia/Research institutes – While there is only anecdotal evidence and warnings that academic mobility and migration of EU plant scientists may be affected by policies of regulating biotechnologies, according to the research sector, in the baseline the EU risks a brain drain when plant researchers leave Europe for better job opportunities abroad 135 . The sector expects a negative impact on the competitiveness of EU research, due to competition from other countries where NGTs are regulated differently, in particular for applied research in plant pre-breeding and breeding. 41% (n=27) of respondents in the targeted survey expect a decrease in research funding for biotechnology under the baseline option.

Business associations see a negative impact on firm-level innovation in the agricultural biotech sector, also impacting biotechnology research capabilities in the food and feed sectors. However, in EU research activities, the use of NGTs is well established and notable funding is allocated to genomic research and biotechnology in plant and animal breeding.

Public authorities – With no regulatory change, the cost per authorisation (both for food and feed uses and for cultivation) is expected to remain stable. With very few NGT products expected to be authorised, it is likely that the overall costs for public authorities remain stable. National public authorities will face enforcement challenges when the same genetic alteration can be introduced by NGTs (subject to the GMO legislation), or conventional breeding methods.

Conventional farmers – Impacts on farmers concern increased imports of more competitively produced crops from non-EU countries and potential missed opportunities, in particular regarding reduced costs for inputs (reductions in the amount of pesticides, fertilisers), improved yield/input ratio, new income opportunities or better prospects for exports.

The shorter development time of NGT plants compared to conventional breeding not being realised also means that farmers will have to wait longer for new varieties with beneficial traits or offering new income possibilities if no or very few NGT plants come to the market. Farmers will have to forego potential improvements of the yield/input ratio, reduced input use or economic benefits from quality increases of crops. If farmers cultivate NGTs under this option, they have to implement the nationally applicable coexistence measures (for more detail see the analysis of coexistence under option 1).

Organic/GM-free farmers and value chain – The EU organic and non-GMO sectors consider that the baseline option is the one that best protects their sector. If the current situation is maintained, the labelling and traceability requirements in the existing GMO legislation, as well as national coexistence measures, will remain as today and continue to support EU value chains and consumer trust for organic and other GM-free producers. As few NGT products will reach the market, with very limited cultivation, only a small risk of admixture of NGTs can be expected. 

However, certain negative impacts may also materialise. Increased costs for organic operators could arise from NGT products that cannot be analytically differentiated from products that can occur naturally or be produced by conventional breeding, despite the fact that specific GMO traceability and labelling obligations will apply to such NGT products. More challenging and expensive identity preservation systems for NGT-free products would be required, possibly leading to higher prices of GM-free products 136 . Research has shown that coexistence of GM and non-GM products within food supply chains leads to extra costs for the non-GM food product. Depending on the segregation strategy undertaken in rapeseed oil and maize starch supply chains, it was estimated that ensuring coexistence leads to increased prices for the non-GM product of between 7 and 14% 137 . For NGTs that cannot be analytically differentiated, these price increases could be higher as further steps might have to be taken to guarantee the integrity of the supply, such as additional documentation and third-party verification.

Regulatory divergence with non-EU countries (where NGT products may not be subject to traceability and labelling rules or to any transparency obligations) from which organic or other GM-free products are imported may also impact the organic sector. For example, Argentina, where many NGTs are neither traced nor labelled, has been a major exporter of organic products to the EU (in the range of 10 000 – 50 000 tons per year), in particular of fruits, wine and vegetables. To continue imports of NGT-free products from countries with a regulatory framework similar to Argentina’s may require adjustments to supply chain management, for which no quantitative estimates of costs are available. Under the current EU regulatory framework, NGTs should not be used in organic products exported to the EU, therefore, the costs of segregated supply chains in the EU would remain unchanged.

Regulatory divergence may also impact the availability and development of organic varieties. Under the breeders’ exemption 138 , breeders are allowed to freely use protected varieties as sources of further variation for the development of new varieties. If protected varieties of interest for organic breeders originate in non-EU countries that have exempted NGT plants from GMO labelling and traceability obligations, then organic breeders may have no guarantee that those are not derived from NGTs. Consequently, sourcing such varieties may become difficult and in the longer term, organic breeders may thus experience a decrease in the availability of genetic resources for their breeding programmes, leading to fewer improved varieties adapted to the needs of organic agriculture 139 .

Trade impacts – International trade with NGT products will be affected by regulatory divergence with trade partners. Several major trade partners of the EU have introduced exemptions from their GMO legislation – or are preparing to introduce them – for NGT products, and this may lead to asynchronous approvals of NGT products. This could lead to a costly need to separate entire agricultural value chains in and outside the EU 140 . As trade partners might be unwilling or unable to establish such separate value chains 141 , most targeted survey respondents (60.7%, 37) expect a decrease of international trade under this option. The consequences of market disruptions caused by the unintended presence of unauthorised GMOs can be significant. For example, in 2009, a genetically modified flax from Canada, not authorised in the EU, was detected in EU food products 142 and the EU immediately stopped Canadian flax imports. This resulted in an estimated loss of EUR 40 m for the EU flax processing industry and 600 jobs lost 143 .

Impact on SMEs – The current situation with large, multinational companies dominating the market for GMOs is likely to apply to NGTs as well. While R&D costs for NGT products will be considerably lower than for GMOs obtained by established genomic techniques, authorisation costs would remain in the range of EUR 6 – 20 m, which is a significant part of the yearly turnover of a SME.

Competitiveness – The reduced costs of and time needed for R&D of NGT products could lead overall to lower costs for the EU breeding and biotech sector 144 . However, breeders in non-EU countries that exempt NGTs, can save all the costs related to GMO authorisations (35.8% of the total cost to develop and place on the market a GMO obtained by established genomic techniques) and place products faster on the market, while the regulatory entry barriers for NGT products remain higher in the EU. This will give competitors in non-EU countries a considerable advantage.

6.1.2.Environmental impacts

Among environmental impacts, a distinction should be made between environmental impacts specifically linked to the genetic modification or the introduced trait(s) and other environmental impacts that are associated to the use of the plant in the field in relation to its trait(s). While the first are specific for the NGT plant, the second may be common to other plants, regardless of the breeding method used, sharing the same trait and use (an example being the herbicide tolerant plants discussed further below).

As regards potential risks specifically linked to the genetic modification, NGT plants and their products will only be authorised and released in the environment if the risk assessment concludes that they are as safe as their conventional counterparts. In addition, NGT products released or placed on the market will be subject to various monitoring provisions intended to identify and take measures in response to any potential adverse effect.

As regards other environmental impacts, since no or only very few applications for cultivation of NGT plants are expected if they remain regulated by the current GMO legislation, the environmental impacts of these products will be limited. Impacts will be mostly restricted to missed potential benefits stemming from NGT plants contributing to, for example, lower pesticide use, lower fertiliser use, reduced need for agricultural land and more space for nature with higher biodiversity 145 .

The vast majority of survey respondents expect no or moderate (positive or negative) impacts on non-target organisms (such as pollinators, microbial communities, etc.). Four out of five do not expect a change of potential impacts on the environment and biodiversity through gene transfer or accidental consumption during experimental release or placing on the market.

6.1.3.Social, health and safety impacts

Social health and safety impacts – Similarly to environmental impacts, products authorised for placing on the market and cultivation would be risk assessed (and monitored once released or placed on the market) to ensure they do not present more potential hazards to health than their conventional counterparts. The majority of survey respondents does not expect any change in the safety impacts (for example due to toxicity or allergenicity) of products entering the market under the current regulatory framework. Potential positive social and health impacts stemming from NGT products with improved nutritional and functional quality will be largely missed or delayed.

Impacts on consumers – The current GMO legislation ensures information to consumers about the use of genetic modification technologies on the product’s label. This is the preference expressed by a majority of citizens (30%, 733 146 ) in the public consultation, as also confirmed by similar findings from research 147  . It guarantees freedom of choice for those not wishing to use GMOs and would do so in the same way for GMOs obtained by NGTs. 

The current label would not inform specifically about NGTs or their applications, and established consumer attitudes to GMOs would likely extend to NGTs (in the absence of other sources of awareness and information on NGTs) and have a negative impact on NGT acceptance and consequently on uptake. This would be reinforced by the fact that NGTs would remain subject to the GMO legislation as it stands today and applies to transgenic GMOs (as research 148 suggests that governmental decisions also play a role in shaping consumer attitudes).

As no or very few NGT products will come on the market under this option, there could be missed opportunities for consumers willing to consume NGT products. This could be linked to consumer preferences not fulfilled, but also in some cases to health or other needs not being addressed (e.g. when NGTs can be used to reduce allergen or toxic content).

Furthermore, given that more costly identity preservation may need to be applied, the price of some products could rise 149 .

1.2.Analysis of option 1 (Authorisation with adapted risk assessment and detection method requirements)

6.2.1.Economic impacts

Breeders – Significantly shorter development times and lower development costs for NGT products and, in some cases, lower costs and time linked to the generation of data for risk assessment and authorisation, could make the development of certain NGT products more attractive than GMOs obtained by established genomic techniques. For example, in conventional potato breeding, the timeline in which breeders operate is approximately 13-15 years 150 . The cost of developing a conventional potato variety is EUR 2-3 m per variety, while development of NGT potato varieties is expected to cost significantly less money and time, estimated at EUR 0.5 m per variety and introduction into the market within five years 151 . 

Generating the necessary data for risk assessment currently represents the largest share of authorisation costs. For a risk assessment that is adapted to different risk profiles, the costs of generating the application will decrease to a variable degree due to potentially reduced data requirements. In cases where data requirements remain the same as they are today for GMOs, no cost savings are expected, while maximum cost savings of 85% of this component could be expected in cases where minimum data requirements apply based on the product’s risk profile 152 . An adapted risk assessment could also shorten time to market with earlier profit gains. 

Breeders, however, expect only a small improvement concerning the attractiveness to develop NGT plants as this option would apply the current GMO labelling regime to NGT products for which they expect only limited consumer acceptance, and because of the perceived uncertainty about the way the adapted risk assessment would be applied in practice. In this regard, they expect negligible reductions in administrative costs compared to the baseline.

In the targeted survey, respondents expect on average a small increase in NGT plants on the market in 2030-35 compared to the baseline.

Academia/Research institutes – This sector expects a limited impact on research funding from this option both for private and public R&D. Concerns with regard to plant scientists leaving the EU are similar to the baseline.

Public authorities – Member States competent authorities expect cost decreases for risk assessment ranging from 8% - 67% (see table 1). The wide range results from the fact that the adaptation of risk assessment will be case-by-case and is intended to lead to large variability of data requirements (several scenarios were modelled: the lower value is applicable to a risk assessment requiring almost the same data as today, and the highest saving is applicable to a scenario with molecular characterisation and post market monitoring only). There is also a large variability between the Member States which can in part be explained by different administrative set-ups.

Table 1. Estimated cost decreases for Member States if data requirements for risk assessment are adapted to the risk profile of the product (data gathered in the context of Technopolis Group et al. study).

Furthermore, Member States’ authorities will face enforcement challenges in cases where the same genetic alteration can be introduced by NGTs and conventional breeding methods and such plants cannot be distinguished by analytical methods.

Conventional farmers – As, under this option, some NGT plants would reach the market, farmers would be able to benefit from these plants if they feature relevant traits, in particular regarding reduced costs for inputs (pesticides, fertilisers), improvements of the yield/input ratio, new income opportunities or better prospects for exports. For example, a case study 153 on cisgenic late blight resistant potatoes and apples, conducted by the JRC, shows that for potatoes a 50-80% reduction and for apples a 12-58% reduction of fungicide use may be feasible. This would translate into yearly costs savings ranging from (min-max) EUR 49-576 per hectare for potatoes and EUR 39-712 per hectare for apples (see Annex 7). A gene-edited pennycress (Thlaspi arvense) is a new oilseed crop (for which large-scale farm trials will take place starting in 2023 in the US) that can be grown with relatively low greenhouse gas emissions and without causing detrimental land use changes 154 . In the US, this crop is grown as a cash cover crop in maize-soybean rotations providing environmental benefits (preventing soil erosion and nutrient run-off, reduction of pesticide use, carbon sequestration) and expected net returns to farmers from biofuel or animal feed uses of EUR 130-180/ha 155 . Similar efforts are underway in Europe for the establishment of camelina (Camelina sativa) as a cash cover crop 156 .

In cases where the costs of the authorisation process are considerably reduced because of significantly lower data requirements, it is likely that SME breeders and farmers can benefit from this option and that NGT plants from small or neglected crop species will come to the market under the condition that the license cost for the use of the technologies is not prohibitive for SMEs and minor crops 157 .

Combining stakeholder and expert estimates of adoption rates of the currently known pipeline of NGT-applications, as well as expert estimates regarding trait-level impacts, a quantitative exploratory analysis 158 of impacts shows, for a low adoption rate of NGTs (1-5% of the crop market), the following estimated mean and, in brackets, range of impacts on key agronomic parameters for several crop groups (Table 2).

Table 2. Trait-level impacts.

These estimates show that considerable per hectare changes in key agronomic traits are expected by experts, but also indicate that there is disagreement about the direction of change in some of those traits, in particular in pesticide and water use, where some experts expect increased use.

Organic/GM-free farmers and value chain –The labelling and traceability requirements in the existing GMO legislation will continue to support value chains and consumer trust for organic and GM-free producers. However, the regulatory divergence with non-EU countries (where NGT products may not be subject to traceability and labelling rules or to any transparency obligations) from which organic or other GM-free products are imported and detection challenges will impact the organic sector as in the baseline. Under the current EU regulatory framework, NGTs should not be used in organic products exported to the EU, therefore, the costs of keeping segregated supply chains in the EU would remain unchanged.

Coexistence between conventional/organic/GM-free production and NGT production – As more NGT plants are expected to be cultivated in this option compared to the baseline, the risk of admixture will increase and with it the costs for segregation. The purpose of coexistence measures is to allow consumers and producers a choice between conventional, organic and GM production. These measures also take into account the wish of some farmers and operators to ensure that their crops have the lowest possible presence of GMOs, acknowledging that the potential loss of income for producers of particular agriculture products such as organic products is not necessarily limited to exceeding the labelling threshold set out in EU legislation at 0.9% for food and feed. In certain cases, and depending on market demand and on the respective provisions of national legislations (e.g. some Member States have developed national standards for different types of ‘GM-free’ labelling), the presence of traces of GMOs in particular food crops — even at a level below 0.9% — may cause economic damages to operators who would wish to market them as not-containing any GMOs 159 .

Article 26a of Directive 2001/18/EC on the deliberate release of GMOs into the environment allows Member States to take appropriate coexistence measures. A framework for such measures is defined in the Commission Recommendation of 13 July 2010 on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops 160 . Member States have taken a diversity of approaches – legislative and non-legislative and a mixture thereof – to implement this recommendation (15 Member States have adopted some form of coexistence measures). Almost all Member States that have regulated coexistence consider the GMO grower as the operator responsible for the implementation of the measures. In addition to the coexistence measures set out in the GMO legislation and the Commission Recommendation, the Organic Products Regulation requires organic producers to implement precautionary measures to avoid the presence of products and substances not authorised for use in organic production (Article 28).

The analysis below is based on the assumptions that a certain level of NGT cultivation will take place, and first considers the impacts on farmers cultivating NGTs and organic farmers, then the impacts on the respective value chains downstream from the farm.

The SIGMEA project (2004 – 2006), funded under FP6, investigated the costs of measures for GM-cultivating farmers to ensure coexistence for GM and conventional oilseed rape and maize in several regions of the EU using spatially explicit simulation models 161 . At the level of the GM-cultivating farm, two types of coexistence cost are considered: (i) the cost of compliance with the ex-ante coexistence rules in place, developed to prevent cross-pollination and/or admixture, (ii) the expenses for ex-post monitoring, because the product has to be tested for the presence of transgenic DNA. In general, results obtained for different regions demonstrate that coexistence costs depend on the agricultural context (landscapes, cropping systems, field shape, climate), the share of GM crops in the Utilised Agricultural Area (UAA) and the willingness of GM and non-GM farmers to cooperate. The study also concludes that inflexible coexistence rules (such as standardised large isolation distances) impose a severe burden on GM cultivation, while flexible, context-dependent measures do not act as a disincentive to GM cultivation. In the latter case, GM crop adoption is not an issue of costs of compliance with coexistence measures but rather one of the incentives for adopting or rejecting the technology.

Example: Oilseed rape in Beauce (France)

Relative to the benchmark scenario, the study simulated six scenarios by varying (i) the GM crop adoption rate (scenarios 2 and 3), (ii) the share of oilseed rape in the arable area (scenarios 4 and 5), and (iii) the isolation distance requirement (scenario 6). Table 3 reports the estimated average cost for coexistence management.

Table 3. Simulated coexistence management costs of GM and non-GM oil seed rape under alternative scenarios (averages of 10 simulations varying the spatial allocation of crops in the landscape).

Source: Based on SIGMEA Deliverable 5.2 and 5.3; *costs have been adjusted to take inflation since 2006 into account.

These data show that coexistence costs for GM-cultivating farmers can decrease with increasing adoption rate (see scenarios 2 and 3) and that they are highest if large shares of arable land are cultivated with oilseed rape, if the GM adoption rate is in the middle of the range and if isolation distances are large (scenario 7).

Example: Maize in Aragón (Spain)

For this case study the small area of Gurrea de Gallego was selected to implement simulations for coexistence between GM and non-GM maize. The municipality of Gurrea de Gallego has a total UAA of 964 ha cultivated in 489 fields, which results in an average field size of 1.97 ha. In 2005, maize was cultivated in 47 fields, corresponding to 105 ha or an average of field size of 2.2 ha.

Table 4. Coexistence costs of buffer zones for different adoption rates and distances in Aragón (Spain).

*Costs have been adjusted to take inflation since 2006 into account

These data show that, for a given buffer zone size, the coexistence costs for GM farmers are of moderate size and quite insensitive to the GM adoption rate (Table 4). These findings are in line with the results of a simulation study of the costs of coexistence measures per hectare of GM in Switzerland, which finds that the costs amount to 1-3% of total product costs 162 .

Organic operators also have the responsibility to put in place precautionary measures to avoid admixture with any product that is not authorised in organic production, and to regularly review these precautionary measures and to adjust these measures if necessary. A product for which EU law requires GM labelling, e.g. food and feed containing traces of GMOs above 0.9% (or even below 0.9% if the traces are not adventitious or technically unavoidable), must not be marketed under the EU organic logo (Art. 30(4) of Regulation 2018/848). For conventional products which are not subject to such labelling requirements, organic operators must require a vendor declaration to confirm the absence of any GMOs and derived products. However, certain NGT plants cannot be distinguished from conventionally bred plants. In such cases, the analytical control supporting the marketing prohibition under the organic logo might be difficult and in some cases not feasible. Organic farmers would not have direct economic losses in these cases where NGT presence cannot be established, however, there is a risk of loss of trust by some consumers if a certain level of NGT admixture cannot be analytically ruled out. Based on the work of the European Coexistence Bureau 163 , it is reasonable to assume that risk of such admixture can be considered to be low for this option with a low to moderate adoption of NGTs, if NGT farmers comply with coexistence measures and organic farmers with the precautionary measures to avoid admixture required by the Organic Products Regulation.

There are no quantitative estimates of the costs for GM-cultivating and non-GM farmers in cases of admixture as these costs depend on the affected product (e.g. its gross margin and price premium) and (as liability is a component of the costs) on liability regimes, which are the exclusive competence of Member States 164 . For non-organic farmers, the financial risks of liability may tip the balance against the decision to cultivate GM crops 165 . The risk of admixture, and therefore the overall financial risk for organic producers, will depend on the overall adoption rate of NGTs – the higher the adoption rate, the more likely it is that fields neighbouring an organically cultivated field will be cultivated with NGTs, thus increasing the probability of admixture. However, experiences from Spain show that large scale cultivation of GM maize has not been an obstacle to the expansion of organic cultivation. From 2012 – 2021, the area cultivated with organic maize has increased in three regions with a dominant presence of Bt maize cultivation: in Aragón, the organic maize area increased from 159 ha to 526 ha, in Cataluña from 30 ha to 351 ha and in Navarra from 11 ha to 44 ha 166 .

Coexistence in the value chain

As the analysis in the baseline shows, additional costs of 7 – 14% can be expected by organising coexistence between genetically modified and non-GM products in the value chain from production of farm crops up to the production/processing levels of single supply chains. These estimates are based on the assumption that GM can be identified by analytical tests. For NGTs that cannot be analytically differentiated, these price increases could be higher as further steps might have to be taken to guarantee the integrity of the supply, such as additional documentation and third-party verification.

Trade impacts – Under this option some NGT plants are expected on the market, but regulatory divergence with non-EU countries is likely to remain large if this option applies to all NGT plants, posing challenges for value chain management and identity preservation systems. Many targeted survey respondents expect a general decrease of international trade of agricultural products and commodities under this option (31% (21) expect moderate decrease and 15% (10) expect small decrease), but to a lesser extent than in the baseline (44% (27) expect moderate decrease and 16% (10) expect small decrease).

Impacts on SMEs – Certain NGTs are considered to be accessible tools for plant breeding due to their relatively low cost and complexity. The easily adaptable technology used in such NGTs could lead to a lowering of technological barriers to entry of the plant breeding sector, benefitting SMEs, provided that access to the technology and costs associated with IP remain affordable. This has been observed in Argentina after its regulatory shift to excluding certain NGT products from the GMO definition.

With a maximum of 85% reduction, significant cost reductions for adapted risk assessment, overall authorisation costs will, in case of the lowest data requirements, be in the approximate range of EUR 0.9-3 m (15% of costs for food and feed authorisation with full risk assessment). Administrative costs are not expected to change significantly. The combination of significantly lower development costs for NGT plants compared to varieties bred conventionally or developed with established GM technology (e.g., an estimated EUR 0.5 m for an NGT potato variety vs. EUR 2-3 m for a conventional variety) and the significant cost reductions for adapted risk assessment, may make it easier for SMEs in certain circumstances to compete with larger companies.

Competitiveness – This option will improve the competitiveness of EU operators as costs of and time needed for R&D of NGT products can be significantly reduced in comparison to the baseline. Compliance costs related to data requirements for risk assessment will range from negligible reduction (if a similar set of data, as today, is required) to a reduction of around 85% (if minimum data requirements apply). However, breeders in non-EU countries, which have exempted certain NGT products from the requirements of their GMO legislation, can save all the costs related to GMO authorisations for those NGT products, thus having a competitive advantage over breeders in the EU also under this option. Because of potentially higher prices for organic/GM-free products, this sector could experience reduced competitiveness compared to conventional producers 167 .

Simplification – A risk assessment adapted to the diverse risk profiles of NGT plants would be on a case-by-case basis less burdensome for operators compiling the applications as well as for the authorities assessing them.

6.2.2.Environmental impacts

As regards potential risks specifically linked to the genetic modification, any NGT product coming to the market will be risk assessed using criteria and requirements adapted to the product’s risk profile and designed to ensure environmental protection. As under the current legislation, potential risks of NGT plants/products will be assessed in comparison with their conventional counterparts. No change compared to the baseline with regard to safety for the environment is expected as products will only be authorised for placing on the market and cultivation if the risk assessment concludes that they do not present more potential hazards than their conventional counterparts, and post-market monitoring provisions will apply to identify and take measures in response to any potential adverse effect.

Positive environmental benefits are expected if authorised products contain relevant traits, such as the reduction in pesticide use as outlined in the case study presented in Annex 7, resilience to climate change or lower fertiliser input, depending on the number of NGT products placed on the market. Lower fertiliser input and the development of cash cover crops could lower greenhouse gas emissions of agriculture.

Regarding pest- or pathogen control, the expected change in pesticide use is highly controversial, in particular with respect to herbicide-tolerant (HT) crops. The main reasons for the adoption of HT crops have been improved and simplified weed control, less labour and fuel cost, no-till planting/planting flexibility, yield increase, extended time window for spraying, and decreased pesticide input 168 . On the other hand, a recognised negative impact of HT crops is the evolution of herbicide resistance in weeds, which may lead to higher use of other selective herbicides, with the attendant environmental and health externalities, and increased use of tilling and consequently higher GHG emissions 169 . By 2023, 57 weed species have evolved resistance to glyphosate 170 . Herbicide-tolerant weeds also occur in production systems of herbicide-tolerant crops developed using conventional breeding methods 171 .

HT crops do not represent a strong focus of R&D in the field of NGTs. Among NGT products in the pre-commercial and advanced R&D stage, herbicide tolerant plants account for 10 out of 172 products in development 172 . This trait can be developed by established GMO technology, NGTs and by conventional breeding methods 173 . Impacts of HT crops, irrespective of the breeding method used for their development, will depend on how they are used and managed in the field.

Experience with insect resistant GM crops in the EU (Bt maize producing the bacterial protein Cry1Ab, toxic to insects) has shown that, as of 2021, no decrease in the vulnerability to the toxic protein had occurred in the relevant pests 174 .

Effects on the diversity of cultivated crops would depend on how much new varieties can benefit from the lower costs and lower administrative burdens stemming from adapted risk assessment. From 2002 to 2010, niche crops globally accounted for only 5% of approved GMOs 175 , although there is considerable technology and valuable traits to be exploited. There is evidence that this is due in part to regulatory costs of GMO approval 176 , but lack of demand or market rejection may play a role as well. The case study on chicory (see Annex 7) shows that NGTs can contribute to the development of new and improved plants and can further support the use of underutilised, neglected and local crop species 177 , thus leading to increased agrobiodiversity.

Regarding local production systems and the diversity of local and traditional varieties, some stakeholders see a danger in the displacement of local production systems by NGT crops, arguing that increased cultivation of NGT plants would reduce the diversity of crops used in agriculture, as well as the local knowledge of crop species and varieties suited for the local climate 178 . However, in cases where adapted risk assessment leads to considerably lowered regulatory costs, development and cultivation of NGT varieties of niche and locally important crops may become economically more viable. NGT plants can provide more adaptation to climate change and thus could lead to the development of plants more suitable to local climatic conditions and thus maintain or enhance crop diversity 179 .

60% of respondents in the targeted survey do not see potential risks for the environment and biodiversity under this option. This view is, however, disputed by certain stakeholders. Responses mostly coming from citizens, NGOs, consumer organisations and environmental organisations (18.8% of total participants in the public consultation) stress that the current risk assessment system has demonstrated its effectiveness.

6.2.3.Social, health and safety impacts

Social, health and safety impacts – Any NGT product coming to the market will be assessed to consider risks to human and animal health using criteria and requirements adapted to the product’s risk profile and designed to ensure safety for human and animal health. Therefore, similarly to potential risks for the environment, no change compared to the baseline with regard to human and animal health is expected as products will only be authorised for placing on the market and cultivation if the risk assessment has concluded that they do not present more potential hazards than their conventional counterparts.

As some NGT products are expected on the market, certain social and health benefits are expected. Current R&D addresses traits like modified starch, protein and lipid content and composition or increased functional metabolites and traits enhancing market value (e.g. longer shelf life) 180 . In oilseed crops, for example, the most preferred target of genome editing is the production of monounsaturated fatty acids, such as oleic acid, which are generally considered healthier and more stable, and hence are associated with a longer shelf life. An example of a trait having an expected direct health effect is low gluten content in wheat produced by targeted mutagenesis and assessed in one of the JRC case studies (see Annex 7). Such low-gluten, celiac safe wheat can contribute to making low gluten diets more affordable 181 , to a more balanced diet and to decreased costs of medical care 182 . In the JRC market study, modified content is the most common trait addressed in NGT product R&D (see Annex 7).

62% of respondents to the targeted survey expect no change in terms of social impacts under this option. This view is, however, disputed by certain stakeholders, representing 21% of respondents and coming especially from NGOs and consumer organisations, expecting increased potential hazards. 

Impacts on consumers – NGT products would be labelled, and similar considerations as in the baseline apply. Since more NGT products than in the baseline would come on the market, if they contain relevant traits consumers could benefit from further choice of products with increased nutritional and functional qualities.

1.3.Analysis of option 2: Authorisation with incentives for products containing modified traits that have the potential to contribute to sustainability

6.3.1.Economic impacts

Breeders – With regard to adapted risk assessment and the attendant cost reductions, the analysis of option 1 applies. This option is judged by breeders to have overall a neutral or negative impact on time to market or regulatory certainty compared to option 1, for several reasons. In case operators decide to apply for incentives, specific costs will result from the need to comply with a sustainability-related verification and will depend on the criteria and data requirements necessary for that verification. Apart from the extra costs, breeders consider that any pre-market data generation may extend the preparation phase for the applicant, lengthen assessment timelines and diminish the potential benefits of NGTs to speed up plant breeding. This is also due to the view that the proposed incentives will not necessarily lead to a significant decrease of administrative burdens. However, if easily implementable criteria to trigger incentives are designed, stakeholders do see some merit in the sustainability incentives offered under this option. Data from the cost survey 183 identified potentially significant cost savings connected to regulatory (EUR 83300 – 833000) and scientific advice (EUR 35700 – 357000) and through the waiving of fees for the validation of the detection method (EUR 105000, EUR 52500 for SMEs). These cost savings (the estimated savings are dependent on the future data requirement for the sustainability-related verification) will be particularly relevant for SMEs, which, as a rule, do not have dedicated regulatory departments to support the authorisation process. In addition, as the use of incentives is voluntary, companies are free to choose whether to use this possibility or not based on an economic analysis of the costs and expected benefits.

65% of respondents in the targeted survey expect no change, while only 4% of respondents expect a moderate to strong decrease for the attractiveness of developing NGT products compared to option 1. Given that incentives are voluntary, and breeders can choose to operate under this option without triggering them, no decrease in attractiveness appears justified. The option is then equivalent to option 1. If the GMO labelling requirement were to be waived for products with traits that contribute to sustainability, this could have, according to 40% of stakeholders from business associations, companies, public authorities and academia/research organisations a moderate positive impact on the attractiveness to develop such NGT products. If a sustainability label is introduced, interviews with value chain stakeholders point out that such a label is, however, not likely to be used in practice if voluntary.

Academia/Research institutes – This sector expects positive impacts in private and public R&D funding if the GMO label for NGT products with traits that are verified to contribute to sustainability would be waived. This and other incentives are not specifically aimed at Academia/Research Institutes but support the regulatory procedures prior to the commercialisation of products. A regulatory system facilitating the placing on the market of NGTs will also increase the attractiveness of funding NGT research in academia and the research sector. This will in turn support the development of the agricultural biotech sector in the EU. If the GMO label is not waived, no significant positive impact on private or public funding is expected compared to option 1.

Public authorities – For adapted risk assessment, the analysis of option 1 applies. The verification how traits can contribute to sustainability is expected to increase the cost of the authorisation process. The competent authorities’ support of the authorisation process with incentives for plants with traits that contribute to sustainability (e.g., guidance on overall development plan and regulatory procedure, dedicated contact point, scientific advice at key development milestones, fee waivers) is expected to increase costs. Alternatively, cost decreases are expected in cases when the GMO label is waived.

Conventional farmers – If more NGT products will to come to the market, farmers could harness their benefits to a larger extent than under option 1.

A quantitative exploratory analysis 184 of impacts shows, for a medium adoption rate of NGTs (10-23% of the crop market, depending on crop group), the following estimated mean and, in brackets, range of impacts on key agronomic parameters for several crop groups, showing a pattern comparable to option 1 (Table 5).

Table 5. Trait-level impacts.

The analysis of coexistence measures for conventional farmers cultivating NGTs from option 1 also applies for this option.

Organic/GM free sector – Under the sub-option that maintains a GMO label, the impacts on the organic/GM-free sector will be similar to option 1. The impacts from the costs of coexistence will be moderately higher than under option 1, as more NGT products are expected on the market. As in the baseline, the sectors will be impacted because of the regulatory divergence with non-EU countries (where NGT products may not be subject to traceability and labelling rules or to any transparency obligations) from which organic/GM-free products are imported into the EU. Under the current EU regulatory framework, NGTs should not be used in organic products exported to the EU, therefore, the costs of keeping segregated supply chains in the EU would remain unchanged.

The specific impacts of this option relate to labelling options for NGT products featuring traits that can contribute to sustainability. If a sustainability label is provided for, the focus group on sustainability 185 conducted in the context of the external contractor’s study, found that a sustainability claim allowing for higher premiums would be to the disadvantage of sustainable conventional or organic products. 

If NGT products with traits contributing to sustainability would not be labelled, a public register will enable organic operators to identify varieties developed using NGTs and traceability would remain as under current GMO legislation. In addition, as the traceability provisions would apply, the organic/GM-free operators would rely on the business-to-business obligations to be informed that no NGTs have been used.

Impacts on trade – The impacts on trade will be similar to option 1.

Impacts on SMEs – The impacts of the adapted risk assessment would be the same as in option 1. Regulatory incentives linked to scientific / regulatory advice or fee waivers would have the most impact as regards SMEs. Unlike larger companies, SMEs do in general not have dedicated, specialised staff for authorisations. The incentives may help to lower administrative burdens and allow more SMEs to benefit from NGTs. Some of the positive impacts of incentives could, however, be counteracted by the additional burdens of producing the data for the verification of the sustainability contribution of the NGT trait.

Competitiveness – Like in option 1, this option will improve the competitiveness of EU operators as costs of and time needed for R&D of NGT products is reduced compared to the baseline. Incentives can decrease administrative burdens for SMEs and increase their competitiveness. Still, breeders in non-EU countries, which have exempted certain NGT products from the requirements of their GMO legislation, will not have any costs related to authorisations for such products, thus having a competitive advantage also under this option.

Simplification – Like in option 1, a risk assessment adapted to the diverse risk profiles of plants obtained by targeted mutagenesis and cisgenesis would lead to a range of reduction in compliance costs for applicants (from negligible reduction if similar data requirements apply as today to a maximum reduction of 85% in cases with minimum data requirements) and national competent authorities (reduction from 8 – 67%). If an applicant seeks to verify the contribution of the NGT product to sustainability additional procedural steps will be needed, partially cancelling out the simplifications gains made by adapted risk assessment.

6.3.2.Environmental impacts

As regards potential risks specifically linked to the genetic modification, any NGT product coming to the market will be risk assessed using criteria and requirements adapted to the product’s risk profile (as in option 1). Therefore, no change compared to the baseline with regard to safety for the environment is expected as products will only be authorised for placing on the market and cultivation if the risk assessment concludes that they do not present more potential hazards than their conventional counterparts, and post-market monitoring provisions will apply to identify and take measures in response to any potential adverse effect.

With more NGT products on the market (coupled with incentives steering to certain traits), certain stakeholder groups expect positive environmental impacts, such as reduced pesticide and fertiliser use, while others expect negative impacts, such as more large-scale monocultures and a concomitant increased pesticide use. In the targeted survey, roughly equal number of stakeholders expect a positive (40%) or a negative (46%) impact. This polarisation is mostly due to divergent views on the sustainability of HT crops as outlined in section 6.2.1.

The consultations show that stakeholders consider that this option could make a contribution to pushing the application of NGTs to the breeding of crops more in the direction of preferential environmental traits; it was primarily supported by respondents from academia and public authorities and by citizens.

However, this option and option 3 were questioned from the perspective of how the sustainability contribution of a trait could be verified. A large majority of stakeholders, representing very different interests (biotech industry and breeders, farmers, NGOs and organic and GM-free sectors), agree in the public consultation, interviews, the focus group on sustainability and the targeted survey that the sustainability of a crop does not depend on its individual traits but on the interplay of the plant with its environment and the farming system that it is adopted in. There is wide agreement that the holistic, multi-site and multi-year test for value for cultivation and use (VCU), carried out during variety registration of agricultural crops under the PRM legislation is far more suitable to assess in a holistic manner the performance of new varieties 186 . Such an overall performance assessment should not be part of the procedures for the authorisation of GMOs which are focused on the effect of the genetic modification only. Moreover, it is considered that, should such a holistic assessment of the variety be introduced in the NGT authorisation, it would duplicate the VCU assessment to which NGTs are also subject. These stakeholders consider that sustainability analysis should be performed using a system approach rather than one at product level. Furthermore, the discrimination of plants produced by conventional or organic breeding causes concerns among stakeholders as these plants cannot benefit from a sustainability label.

6.3.3.Social, health and safety impacts

Social, health and safety impacts – Any NGT product coming to the market will be risk assessed using criteria and requirements adapted to the product’s risk profile (as in option 1). Therefore, similarly to potential risks for the environment, no change compared to the baseline with regard to human and animal health is expected as products will only be authorised for placing on the market and cultivation if the risk assessment has concluded that they do not present more potential hazards than their conventional counterparts.

If more NGT products will come to the market (coupled with incentives steering to certain traits), social and health benefits, such as from the low gluten wheat presented in Annex 7, are expected. NGTs support healthy diets: examples are mustard greens (Brassica juncea) with a decreased content of pungent compounds 187 or rice lines with lower amylose content, which may reduce the risk of diabetes 188 .

Impacts on consumers – In the public consultation, a majority of EU and non-EU citizens that responded supported the view that specific regulatory provisions for sustainability should be included in this initiative. Survey responses (70%) indicate that a sustainable trait label, also covering the purpose for which the NGT product was developed, could increase consumers’ willingness to buy NGT products with such a label. Respondents to the targeted survey 189  and further studies indicate that sustainability-related labelling will increase clarity for the consumers, allowing them to choose products that contribute to societal benefits and sustainability, based on their preferences 190 .Available research suggests that consumers may accept NGTs in particular when they promote societal benefits and sustainability 191 .

In this regard, the sub-option to label NGT products as GM combined with a sustainability label linked to the introduced trait, would strengthen freedom of choice (by informing about the technology and its application) and increase consumer and market acceptance. Yet the focus group on sustainability 192 found that a sustainability claim allowing for higher premiums would be to the disadvantage of sustainable conventional or organic products.

The sub-option to waive the GMO labelling requirement for NGT plants with traits contributing to sustainability, but including these products in a publicly accessible database, makes accessing the relevant information more burdensome for citizens not using modern IT. This was also highlighted in the public consultation where a majority of the respondent EU citizens (30%, 733) expressed a preference for physical labelling on the final product. Also, not labelling products that, because of their characteristics, are made subject to mandatory risk assessment and authorisation could negatively affect consumer trust.

The sub-option to complement the GMO label with a factual statement on the intended purpose of the genetic modification (e.g. genetically modified for the purpose of improving drought resistance) could provide relevant information to consumers, without featuring claims that could be to the disadvantage of sustainable conventional or organic products. This sub-option could still drive the market demand for products with beneficial traits.

More NGT products than in the baseline would come on the market. If they contain relevant traits consumers could benefit from further choice of products with increased nutritional and functional qualities.

1.4.Analysis of option 3: Authorisation with the requirement that products do not contain modified traits that can be detrimental to sustainability

6.4.1.Economic impacts

Breeders – As for options 1 and 2, significantly shorter development times and lower development costs for NGT plants and, in some cases, lower costs and time linked to the generation of data for risk assessment and authorisation, could make the development of certain NGT plants more attractive than GMOs obtained by established genomic techniques. Additional, mandatory procedural steps such as the necessity to provide data on the characterisation of the modified trait to verify its potential impacts on sustainability are judged by stakeholders to have a mostly negative impact on time to market. More importantly, the possibility that the NGT product may be refused marketing authorisation because sustainability requirements are not met will affect regulatory certainty negatively.

Like in option 2, a wide range of stakeholders doubt that the sustainability impact of a single trait can be reliably verified. The issue of discrimination is also raised for this option, as conventionally bred plants are not subject to the requirement to demonstrate that the plant is not detrimental to sustainability. Therefore, the attractiveness of developing NGT plants under this option is decreased compared to options 1 and 2 because of the introduction of sustainability requirements. 68% of respondents in the targeted survey expect no change or decreased attractiveness of developing NGT plants compared to the situation today.

Public authorities – With regard to adapted risk assessment, the analysis of option 1 applies. In this option, lower savings can be expected as verifying that the modified trait is not detrimental to sustainability is a requirement for all authorisations. As harmonised standards and procedures for this verification would have to be put in place, cost increases for the competent authorities can be expected. However, in the cost survey, Member States’ authorities were not able to provide quantitative estimates of these potential cost increases.

Other sectors – Because of the lower attractiveness of this option for breeders, NGT plants could achieve a lower market share than under options 1 or 2. Regulatory divergence with non-EU countries will be larger than under options 1 and 2, and additional requirements will increase the risk of trade disruptions. The reduction in attractiveness and lower market share would mean that the potential of NGTs might not be delivered to conventional farmers; at the same time, as showing that the trait is not detrimental to sustainability is a requirement, all NGT plants reaching the market will benefit farmers (or consumers). Organic/GM-free farmers would experience lower risks of admixture and attendant economic losses. Impacts on academia/research institutes will be similar to option 1.

Impacts on SMEs – While there can be significant cost reductions for adapted risk assessment, additional data are required to show that the trait is not detrimental to sustainability. Although no estimates for these additional costs are available, there is the risk that these extra costs could negate some of the positive impact of adapted risk assessment. Therefore, there is the possibility that SMEs in the EU will have few or no incentives to develop NGT products under this option. There is furthermore the risk that a NGT product might be refused authorisation for not meeting the sustainability requirements and this leads to regulatory uncertainty, which is economically riskier for SMEs than for larger companies.

Competitiveness – Also under this option, costs of and time needed for R&D of NGT products are reduced in comparison to the baseline (same quantitative estimates as in option 1). Additional costs and administrative burdens will be imposed on breeders by the requirement to provide data demonstrating that the NGT trait is not detrimental to sustainability, thereby cancelling out some of the cost and time savings of option 1. Breeders in non-EU countries, which have exempted certain NGT products from the requirements of their GMO legislation and which have no specific requirements for sustainability, can save all the costs related to GMO authorisations, thus having a competitive advantage also under this option, but more pronounced than in options 1 and 2.

Simplification – Like in option 1, a risk assessment adapted to the diverse risk profiles of plants obtained by targeted mutagenesis and cisgenesis would lead in some cases to significantly reduced administrative costs and burdens for applicants and national competent authorities. Applicants are obliged to demonstrate, and competent authorities need to verify, that the NGT trait is not detrimental to sustainability, thereby fully or partially cancelling out the simplifications gains made by adapted risk assessment.

6.4.2.Environmental impacts

As regards potential risks specifically linked to the genetic modification, any NGT product coming to the market will be risk assessed using criteria and requirements adapted to the product’s risk profile (as in option 1). Therefore, no change compared to the baseline with regard to safety for the environment is expected as products would only be authorised for placing on the market and cultivation if the risk assessment concludes that they do not present more potential hazards than their conventional counterparts, and post-market monitoring provisions will apply to identify and take measures in response to any potential adverse effect.

In addition to refusing authorisation to NGT plants presenting specific risks (as in the baseline and options 1 and 2), this option would refuse authorisation to NGT plants containing traits whose use could have negative environmental effects (e.g. increased use of pesticides). Therefore, in principle, this option would be the most demanding for operators and promising to deliver on sustainability objectives. However, as explained in section 7.3.2., plants with traits whose use could have negative environmental effects can be obtained with different breeding methods, including by conventional means and introducing such a requirement only for NGT plants would be discriminatory.

Since this option adds administrative burden compared to option 1, it is likely that a lower number of NGT products than under option 1 will be developed. Therefore, environmental benefits may be realised to a lower degree than in option 1.

6.4.3.Social, health and safety impacts

For social, health and safety impacts, the same reasoning applies as in section 6.4.2.

Impacts on consumers – NGT products would be labelled as GMO, and similar considerations as in the baseline and option 1 apply. Although this option does not provide for any sustainability-related label (as all NGT products would need to meet a minimum requirement and only the technology would be labelled), if there is widespread information and understanding of the legal framework and the fact that only NGT products with traits that cannot be detrimental to sustainability can be authorised, consumer acceptance of NGTs could increase.

As only a small number of NGT products are expected to come on the market, there could be missed opportunities for consumers willing to consume NGT products with increased nutritional and functional qualities.

1.5.Analysis of option 4: Notification of products that could also occur naturally or be produced by conventional breeding

The impacts of this option (intended to apply in combination with one of the other options) will depend on the share of NGT plants/products that would fall under the notification regime. It is difficult to anticipate this number, as it cannot be predicted which products in the R&D pipeline will be pursued for placing on the market and whether they would meet the notification criteria (data allowing to perform the assessment against the criteria is in most cases not available for the product pipeline).

A hypothetical scenario for the purposes of the analysis, based on the number of products expected to come to the market in the next ten years in the JRC study on NGT applications, is presented in Annex 3.

1.5.1.Economic impacts

Breeders – Under this option, strong effects are expected on the attractiveness to develop and bring to the market NGT plants with genetic alterations that could also be produced naturally or by conventional breeding. Apart from an initial verification that the related criteria are met, such plants would be treated like conventional varieties and therefore the costs for market authorisation would be similar to conventional varieties 193 , while time to market (development time + variety registration, which can be expected to be less than 10 years) would be shorter than for conventionally bred varieties, where variety development alone can take up to 15 years. Additional costs compared to conventional varieties would be due to the necessity to verify whether a product could also occur naturally or be produced by conventional breeding. The total cost savings for breeders will depend on the share of NGT products which will comply with the relevant requirements. As cost and time savings for each variety are considerable (see section 6.2.1.), there will be strong incentives for breeders to focus their R&D on varieties which can fulfill the criteria for a notification.

92% of overall stakeholders see an increase of attractiveness under this option. In a recent survey among European plant breeders, 100% of the larger, 86% of the medium sized and 70% of the small companies would further invest in NGT-related product development if the products would not be subject to the requirements of the GMO legislation 194 .

Academia/Research institutes – Academia and research 195  expect this option to increase investments both from large multinational plant breeders as well as SMEs and public sector research, allowing for both a deeper and broader R&D-base in agricultural biotech due to lower total aggregate R&D-cost, reduced business risk and shorter time-to-market. This will increase research competitiveness of the EU and offer research and employment opportunities for plant scientists, addressing the perceived problem of brain drain.

However, stakeholders from environmental NGOs and the organic sector argue that such intensified R&D focussed on biotechnology might divert R&D from developing other more sustainable farming methods, where they already see a lack of investment.

Trade impacts – Unlike the baseline and options 1-3, this option will reduce regulatory divergence with other jurisdictions. Although different jurisdictions are applying different criteria and a degree of regulatory divergence will remain, in many third countries the equivalence to conventional products is the decisive criterion when adapting their regulation.

Public authorities – National authorities can expect significant cost savings per product (as compared to a situation where the NGT plants concerned would be subject to authorisation). The total amount of savings will depend on the proportion of NGT products that will comply with the requirements for the notification procedure. In the most extreme case, that is if all NGT products brought to market comply with the requirements for the notification procedure, then competent authorities will only have to bear the compliance costs of verifying that the product does indeed meet these requirements. However, the number of NGT products that go through regulatory procedures for the deliberate release including placing on the market could significantly increase compared to a situation where conventional-like NGT products remain subject to authorisation (baseline and options 1 to 3).

Conventional farmers – Conventional farmers could maximise benefits of NGTs as set out in section 6.3.1, for example with regard to pesticide reduction as biotic resistance is the second largest type of traits addressed in the R&D pipeline (113 of 489) thereby contributing to resilience and food security. However, as beneficial traits addressing abiotic resistance (water stress 196 , heat) are generally genetically more complex and the expression of the involved genes are very dependent on environmental conditions it can be expected that many plant products incorporating such traits would not meet the criteria to be treated as a product that could occur naturally or be produced by conventional breeding and be subject to the rules set out for the baseline option or for options 1, 2 or 3 197 . A quantitative exploratory analysis 198 of impacts shows, for a high adoption rate of NGTs (10-27% of the crop market, depending on crop group), the following estimated mean and, in brackets, range of impacts on key agronomic parameters for several crop groups (Table 6).

Table 6. Trait-level impacts

Compared to the estimates for other options, expected gains are particularly pronounced for yield changes in oil and fibre plants and cereals. This reflects the experts’ expectation that a higher adoption rate means that in these crop groups more NGT plants with traits affecting yields are expected to come to market than under the other options.

Some farming stakeholders warn that the widespread use of NGT plants could have a negative impact on them, especially small farmers, and their freedom of choice in the purchase of seeds, linked to patents in this area and the risk of oligopolistic situations 199 .

Organic/GM free sector – Today, NGT plants are subject to the requirements of the GMO legislation and are banned in organic production. As noted in section 5.2.4, two sub-options are considered for NGT plants fulfilling the notification criteria: 1) they are treated like GMOs for the purposes of organic production and are therefore prohibited; 2) they are treated like conventional products for the purposes of organic production and can in some instances be used 200 . This second sub-option applies the logic of the legislation today, where GMO products produced by random mutagenesis and which are exempt from GMO requirements are treated as conventional for the purposes of organic production.

In both sub-options, the public register of notified NGT plants and information in the common catalogues of varieties will enable organic operators to identify varieties developed using NGTs allowing them to ensure that no such varieties are used on their fields and to keep supply chains free from them. This transparency would be based on the traceability system of the supply chain of plant reproductive material, which is based on maintaining a high level of varietal purity.

In this option, the risk of admixture will be higher than for options 1-3 as the highest number of NGTs are expected to be placed on the market/cultivated and the costs of segregation for organic operators will likely increase proportionally to the spread of NGTs. The consequences of such admixture, should it occur, will depend on the two sub-options.

In the first sub-option, the organic sector will rely on the organic traceability requirements and the preventive measures provided for in the Organic Products Regulation. In order to mitigate the impact on organic farming and ensure freedom of choice for farmers, further measures to support maintaining organic production free from NGTs and consumer trust may need to be introduced (e.g. the labelling of seeds could be considered). As in other options (including the baseline), where the admixture cannot be ascertained analytically, and organic producers are able to show they have complied with all necessary precautionary measures, there will not be direct economic losses linked to loss of the organic logo. However, the lack of analytical methods will raise specific challenges in the case of farmers who manage both organic and conventional production on their holdings 201 . These challenges might erode the trust of those consumers who are concerned about the adventitious presence of NGTs in organic products. However, the legal ban on the use of NGTs can also act as reassurance to consumers that all measures are being taken to avoid NGT presence.

With regard to supply chains, there are currently a few areas of organic food production, where there are interfaces to the conventional market 202 . Special precautionary measures for the organic sector are, in particular, needed when purchasing organic raw materials such as maize, soya or rape seed from countries where GMO varieties are also produced or from traders who also trade in GMOs. In order to exclude as far as possible for these origins and purchasing routes possible admixture with GMO raw materials, appropriate contracts with producers and/or traders that define the critical points in production, transport and storage to minimise admixture are concluded. Some suppliers of raw materials or products offer the raw materials from so-called IP (Identity Preserved) programmes. If more NGTs products come the market, the number of interfaces of organic food production to the conventional market may increase, placing more demands on the IP programmes and the precautionary measures organic operators are obliged to take under the Organic Products Regulation in order to avoid products not authorised in organic production. This will place additional costs and burdens on organic operators who will bear segregation costs. There are, however, no quantitative estimates available.

In this first sub-option, as in all other options, the organic and GM-free sectors can be impacted because of regulatory divergence with non-EU countries (where NGT products may not be subject to traceability and labelling rules or to any transparency obligations) from which organic products are imported into the EU. Under the current EU regulatory framework, NGTs should not be used in organic products exported to the EU, therefore, the costs of keeping segregated supply chains in the EU would remain unchanged.

In the second sub-option, notified NGT products could be used in organic production under the applicable derogations for e.g. non-organic untreated seeds. However, organic producers would be able to exclude such plants from organic production through the use of information in the public register of notified NGTs and the precautionary measures provided for in the Organic Products Regulation.

In this sub-option, the organic sector could be impacted regarding imports of organic products, in cases where NGTs that have been considered equivalent to conventional varieties and are prohibited in organic production in third countries.

Moreover, as certain consumers may not accept allowing conventional-like NGTs in organic production, an erosion of consumer trust in the organic market and EU logo could also materialise, possibly leading to emergence of private standards. The same reasoning would apply to the GM-free sector (not regulated under EU law) if it decided to accept notified NGT products.

This sub-option could deliver positive impacts, as organic farmers would be able to benefit from the potential of NGTs supporting sustainable farming practices, in particular with regard to pest resistance and pest tolerance 203 . Organic breeders would also be able to decide to use notified NGT plants in their breeding programmes, if they see benefits in traits relevant to organic cultivation. 

There are different positions among stakeholders from the organic sector about the use in organic farming of NGTs if they would be treated as conventional products. Certain stakeholders consider that NGTs are not compatible with the wider objectives of organic breeding laid down in Organic Products Regulation, and that these objectives inform consumer expectations with regard to organic products. Other stakeholders consider that, if certain products of NGTs are treated in regulatory terms as conventional products, this should equally apply as regards their possible use in organic production.

Impacts on SMEs –This option is the most advantageous for SMEs, other than those involved in organic and GMO-free production, and supports their freedom to do business, as administrative and compliance costs will decrease considerably for NGT products to which the notification procedure is applied. For these NGT products, development costs could be even lower than for conventional varieties. This option would allow SMEs to use advanced technologies to strengthen their competitiveness on European and global markets. In turn, an enabling framework for SMEs could be more conducive to R&D on niche crops and traits.

Competitiveness – A significantly lower regulatory burden will increase investments in R&D, both from large multinational plant breeders as well as SMEs. For plants meeting the notification criteria, development costs can be even lower than for conventionally bred varieties. This will allow operators to compete with operators from non-EU countries which have exempted conventional-like NGT products from their GMO legislation.

Simplification – This option results in a high degree of simplification and reduction of administrative burden for applicants and authorities. For plants meeting the notification criteria, the normal variety registration procedure applies. For agricultural crops undergoing DUS and VCU trials, these costs amount to an average of EUR 4434 per registration.

1.5.2.Environmental impacts

This option would maintain risk oversight through the case-by-case verification of the criteria to determine that a NGT plant would not present more potential hazards than plants occurring naturally or produced by conventional breeding.

The concerns of certain stakeholders about risks to the environment and biodiversity are intensified under this option due to an expected wider cultivation and the absence of risk assessment for products fulfilling the notification criteria. 65% of survey respondents do not see potential risks for the environment and biodiversity under this option, while 32% see potentially increased risks. However, the majority position in the scientific community and in an increasing number of jurisdictions globally is that certain NGT plants do not differ from those occurring naturally or obtained by conventional breeding, including in their level of risk for human, animal health and the environment. Although contested by certain stakeholders, this is confirmed by EFSA’s scientific opinions and numerous other scientific reports. This option would entail verifying, case-by-case and based on predefined criteria (as indicatively presented in section 5.2.4, Box 2), whether risk assessment is necessary. When the NGT plant concerned meets these criteria, it would not present more potential hazards than plants occurring naturally or produced by conventional breeding. The criteria are designed to cover the type and extent of modifications that are also observed with conventional breeding techniques. The principle of comparative assessment against the conventional counterpart remains, therefore, under this option as in the baseline and in the other options. Under this option, the post-market monitoring provisions of the GMO legislation will not apply to products fulfilling the notification criteria. However, mechanisms will remain available under the new framework and in horizontal legislation (e.g. under the General Food Law) to handle any new information on potential risks.

This option offers the largest opportunities to realise the potential environmental benefits of NGTs, as it offers the strongest incentive to develop NGT varieties in the EU, although the development and marketing of NGT products, and the realisation of their potential, depends also on various factors other than an appropriate regulatory framework. Patents, access of public organisations and SMEs to the technologies and the market, access and affordability for farmers (particularly small-scale), and factors driving consumer acceptance, will also have an important impact.

Agrobiodiversity could benefit from this option, as it can become less burdensome and costly to apply the techniques to small and local crops provided that access to the technology, in particular for SMEs and the public sector, is not restricted by high licensing costs. A recent modelling study found that NGT plants, when regulated like conventionally bred crops, required a 96% smaller potential cultivation area to break even on the financial investment when compared to established genetic modification 204 . In addition, the FAO reports that NGT crops are more diverse regarding varieties, traits and institutions developing them (more public organisations and SMEs) in comparison with first generation GM crops. However, some NGT crops with traits contributing to sustainability can face significant financial barriers for development and use 205 . Moreover, if NGT crops are subject to the same regulatory requirements as GM crops, the cost of regulatory approvals is often prohibitive for niche crops 206 . Therefore, it is expected that the reduction of burden and costs under this option would contribute to improve market access to NGTs for public organisations and SMEs that could in turn bring benefits associated to smaller area crops and/or niche traits.

1.5.3.Social, health and safety impacts

Social, health impacts and safety impacts – As regards risks for human health, the same considerations as for environmental risks presented in section 6.5.2. apply. When the NGT plant concerned meets the notification criteria, it would not present more potential hazards to human health than plants occurring naturally or produced by conventional breeding.

Furthermore, this option offers the largest opportunities to realise the potential health benefits of NGT products, as it offers the strongest incentive to develop NGT varieties in the EU.

On potential risks for human and animal health such as toxicity or allergenicity, 64% of respondents expect no change under this option, while 29% expect increased risk.

Impacts on consumers – In a similar way as random mutagenesis today, this option would treat NGT products that fulfil the notification criteria as conventionally bred products, and information would not be provided on the product’s label about the technology used when marketing the product (although all notified products would be entered in a public register). In this regard, the ability to decide not to consume NGT products would not be ensured by this option to the same degree as in the baseline and options 1, 2 (where labelling is not waived) and 3. However, a GM label for products not subject to risk assessment and authorisation as GMOs, and which could occur in nature or be conventionally bred, could create confusion about the product’s characteristics and safety profile. In any event, consumers actively wanting to avoid NGTs would be able to rely on the organic logo (in the sub-option where notified NGTs would remain banned in organic production).

This option would bring the highest number of products to the market. There could thus be more opportunities for consumers to access NGT products with increased nutritional and functional qualities and with other sustainability-relevant traits (e.g. pest resistance) which, according to available research, rank high among consumers’ concerns.

As this option would entail the lowest costs to access the market, it could result in lower prices for NGTs compared to other options (see section 7.2 on efficiency).

7.    How do the options compare?

This section compares the expected impacts of the options in terms of their effectiveness to reach the initiative's objectives, efficiency, coherence and proportionality. This qualitative assessment of the options is based on the overall analysis of key impacts and the comparison is with the performance of the baseline. It takes the scoring of the multicriteria analysis 207 into account, as well as additional evidence gathered during this process. The overall comparison of the options against the relevant criteria is presented in Table 7.

Table 7. Overall comparison of policy options. Options 1-3 cover all NGT products, option 4 only products which could also be obtained naturally or by conventional breeding -- N

--

* -- strong negative effect, - negative effect, 0 neutral effect, + positive effect, ++ strong positive effect; values separated by a slash mean that the size of the impacts can take negative, neutral or positive values depending on choices or alternatives within options.

1.6.Effectiveness

Contributing to achieving the policy objectives

Procedures that ensure safety while avoiding unnecessary administrative burden

The baseline would ensure safety, albeit with unnecessary burden, as it would continue to apply the current requirements of the GMO legislation to NGT plants, despite the fact that, according to the conclusions of EFSA and major scientific bodies (reported in section 1.1 and Annex 6), on a case-by-case basis, a lesser amount of data will be sufficient for the risk assessment of certain plants produced by these techniques. Certain NGT plants do not present more potential hazards than plants produced by conventional breeding. The impact analysis shows that options 1, 2 and 3 (which all feature the same adapted risk assessment to different levels of risk) would allow achieving safety for all NGT plants, however, with a disproportionate burden for NGT plants that could have been obtained naturally or by conventional breeding. Option 4, through the notification procedure, alleviates the burden on the operators for this type of products, while ensuring safety (but was not considered from the outset as an option that could deliver on the objective of safety for other NGT plants). Therefore, this specific objective is best achieved through a combination of option 4 for NGT plants that could have been obtained naturally or by conventional breeding and the adapted risk assessment approach of options 1, 2 and 3 for other NGT plants.

All options are based on the application of the precautionary principle. A regulatory oversight procedure applies in all options to ensure that only NGT plants that are considered as safe as their conventional counterparts are released or placed on the market.

The regulatory framework for NGTs also needs to be designed in a way that it ensures safety, when technologies evolve (future-proofness). The baseline does not achieve this objective. It entails the continued application of a legal framework that has been assessed not to reflect the latest scientific developments. It contains no mechanisms to adapt to scientific or technological progress, or to the wide diversity of NGTs and resulting products, in particular as regards their different risk profiles.

The adapted risk assessment that features in options 1, 2 and 3 contributes to ensuring safety when technologies evolve by recognising the diversity of products and risk profiles. Other aspects of the design of the adapted risk assessment in these options would also contribute to this: the criteria to adapt the risk assessment are based on the characteristics of the product, rather than on specified technologies (see section 5.2.1.); provision would be made to allow for the update by the Commission of the criteria over time based on scientific and technical progress and experience; specific data requirements based on the criteria would not be laid down in the basic act but would be developed subsequently in Commission tertiary legislation and complemented by EFSA guidance.

Future-proofness is embedded in the design of option 4 as well: the criteria to determine whether an NGT plant could have been obtained naturally or by conventional breeding are based on the characteristics of the product, rather than on specified technologies (see section 5.2.4); provision would be made to allow for the update by the Commission of the criteria over time based on scientific and technical progress and experience; the criteria would be complemented by thresholds concerning the size and combination of modifications, which would not be laid down in the basic act, but subsequently in Commission legislation and complemented by EFSA guidance.

Diversity of released and marketed NGT products and of developers

Under the baseline, regulatory costs and time to market will be the same as for GMOs obtained by established genomic techniques and NGT plants will be marketed as GMOs. Breeders, and, in particular, SME breeders in the EU will thus have very limited incentives to develop NGT plants and to go beyond the limited number of traits and crop species to which established genomic techniques have been applied.

A less burdensome, less costly and faster authorisation procedure can be expected under option 1 as a result of the adapted risk assessment. However, while the analysis of impacts shows that the combination of lower R&D costs, faster development time and lower regulatory costs could lead to a moderate to significant market uptake of NGT products from a wider diversity of crop species with more diverse traits, breeders expect only a small increase in the attractiveness to develop NGT products in the EU compared to the baseline. This is linked to the uncertainty perceived by stakeholders about the adapted risk assessment, and the concern that it will still be marked by complexity and lack of predictability (as well as by the GMO label requirement). In any case, the requirement for labelling as GMO under this option will limit the extent of its potential positive effects.

Options 2 adds the possibility of incentives for applications for NGT plants with traits that can contribute to sustainability. With easily implementable criteria to trigger regulatory incentives, stakeholders do see merit in them, especially for SMEs. Incentives would support the diversity of players, as well as the diversity of traits and crop species on the market. As a result, option 2 can have a positive impact compared to baseline. If the incentives are not used, this option is equivalent to option 1 in terms of impacts. Option 2 would considerably incentivise the development and placing on the market of NGT products if labelling as GMO is waived for products with a modified trait that is considered to have the potential to contribute to sustainability. Providing information on the purpose of the trait would increase transparency and could increase consumer acceptance.

The attractiveness of developing diverse NGT products under option 3 is reduced compared to options 1 and 2 through the introduction of sustainability requirements. The risk that authorisation could be refused on grounds related to a potential detrimental impact on sustainability, coupled with the current lack of horizontal definitions and frameworks to assess sustainability and the uncertainty of assessing sustainability based on a single trait, would act as a disincentive to apply. These risks are likely to affect SMEs in particular.

Option 4 has by far the strongest positive impact on enabling the development and placing on the market by SMEs and large companies of NGT products with diverse traits from a wide range of crop species, as it results in a higher degree of simplification and reduction of administrative burden and costs for applicants and authorities.

Contribution to sustainable agri-food systems

The ability of all policy options to contribute to this objective depends on the number of NGT products from diverse crop species, which will come to the market, and on the type of traits which will be developed (addressed by the previous specific objective). The development pipeline as described in the JRC report shows that research addresses a large diversity of crops and that a large share of traits under development could contribute to sustainability, in particular pest resistance, nutrient-use efficiency, tolerance to abiotic impacts (e.g. droughts and improved yield/input ratio, yield stability). This research pipeline is answering to the demand that in turn is also driven by current policy and regulatory developments, such as the revision of the PRM/FRM legislation (with a stronger sustainability focus) and the introduction of targets in initiatives such as the SUR, e.g., as regards a reduction of pesticide use.

Under the baseline, no or only very few NGT plants are expected to be authorised for cultivation or placing on the market, and therefore positive economic, environmental and social impacts of NGTs will be very limited, if any materialise at all.

Like the baseline, option 1 does not contain any provision that would specifically steer towards NGT products containing desirable traits from a sustainability perspective.

Option 2 has an additional, limited positive effect compared to option 1 on the attractiveness for plant breeders to develop in the EU NGT plants that contribute to sustainability objectives.

Option 3 was designed to deliver on this objective to the largest degree by ensuring that only plants with no detrimental effects on sustainability reach the market, but the risk that a NGT product might be refused authorisation for not meeting the sustainability requirements creates regulatory uncertainty and is a disincentive to develop and apply for authorisation.

An important reason why options 2 and 3 show limited gains (option 2) or negative impact (option 3) is because they cannot take into account that the sustainability of a crop does not depend solely on its individual traits but on the interplay of the plant with its environment and the farming system that it is used in, coupled with the fact that different breeding methods can be used to reach the same traits. Sustainability incentives, and even more so requirements, for isolated traits are thus considered not to be efficient. Requirements linked to specific traits but applicable only when the trait is obtained through biotechnology raise specific discrimination problems if the same traits can also be obtained by conventional breeding. However, breeders do see some merit in the regulatory incentives, especially for SMEs which are particularly vulnerable to regulatory complexity and uncertainty. In turn, incentives with a positive impact on SME access to the NGT market have the potential to steer R&D towards crops and traits with sustainability-relevant impacts, beyond the commodity crops with a limited number of traits developed with established genomic techniques. Also, if incentives as envisaged in option 2 are combined with a waiver of GMO labelling for products with a modified trait that is considered to have the potential to contribute to sustainability, this objective would be achieved to a much more considerable extent.

By simplifying the framework for certain NGT plants, and given the traits in the R&D pipeline as well as the demand and policy pressures for traits that contribute to sustainability, option 4 will achieve this objective to the largest degree. However, this will only concern plants that could occur in nature or have been obtained by conventional breeding; this option on its own will not result in plants with more complex traits that could not be achieved conventionally.

Digital by default –labelling and traceability, where relevant, are addressed in a way allowing a wide range of implementations, including purely digital solutions where appropriate. The risk assessment process managed by EFSA is already largely digitalised in line with the ‘digital by default’ principle. This principle will be also applied for the notification procedure.

Other impacts

Competitiveness and SMEs

Certain NGTs are considered relatively accessible tools for plant breeding compared to established genomic techniques. In this regard, NGTs could lead to a lowering of technological barriers to entry of the plant breeding sector, benefitting SMEs in particular. This has been observed in Argentina after its regulatory decision to exclude certain NGT products from the GMO framework 215 .

In the baseline, the current situation with large, multinational companies dominating the market for GMOs will also apply to NGTs, due to the high regulatory burden and costs, perceived regulatory uncertainty, and the fact that products would be marketed as GMOs.

In terms of the competitiveness of SMEs, under option 1 some improvement for SMEs could be expected compared to the baseline. SMEs are vulnerable to complex regulatory requirements. Adapting data requirements to the risk profile of a NGT product will reduce the complexity, duration and costs of the application for authorisation and this would benefit SMEs. Clarity and predictability of risk assessment criteria would be particularly relevant for the access of SMEs.

Options 2 and 3 have the same impacts as option 1 as regards risk assessment. The incentives envisaged under option 2 could provide some benefits to SMEs by addressing the need for support measures such as regulatory/scientific advice and for further cost savings such as fee waivers, while option 3 adds regulatory burden as regards providing mandatory data for verification of the sustainability contribution of a trait and increases regulatory uncertainty as products will not be authorised if they ultimately do not meet the sustainability requirement.

Option 4 is by far the most advantageous for SMEs, as administrative and compliance costs will nearly be eliminated for those NGT products to which the notification procedure is applicable. A clear definition of objective notification criteria would reduce uncertainties and render the regulatory process more predictable for SMEs.

However, the ability of SMEs to enter the NGT market will be also dependent on affordable access to intellectual property. For this reason, some stakeholders consider that their competitive position will not improve under any of the options, unless patent-related issues are resolved 216 .

In terms of general competitiveness, in the baseline, negative impacts can be expected due to factors such as reduced access of the EU breeding sector to a global gene pool for plant breeding. A negative impact on the competitiveness of conventional farming can be expected due to reduced access to new tools developed through science and innovation efforts, and increase in input prices (e.g. for feed supply). Option 1 is expected to offer small improvements as regards competitiveness of breeders and farmers, while under option 2 some additional improvement is expected in particular if the GMO labelling is waived for products with traits contributing to sustainability. Option 3 is not expected to bring improvements. Option 4 has the strongest impact on competitiveness as a lower regulatory burden will enable investments in R&D and subsequent product development, both from large multinational plant breeders as well as SMEs. Equally, in terms of international competitiveness, it is option 4 which will have the strongest impact. In major trading partners of the EU (e.g. the United States or Argentina) NGT plants, and derived food and feed products, that can also result from conventional breeding are not subject to GMO regimes. The European seed sector is the largest exporter in the global seed market and using innovative technologies is a prerequisite for maintaining competitiveness. Option 4 also has the strongest impact on strategic autonomy and resilience of the EU food system. Under this option, NGTs are expected to be applied to a large range of crop species and traits by a diverse set of actors.

Social and health impacts

Impacts related to the protection of human and animal health are addressed above in the section on the specific objective of procedures that ensure safety while avoiding unnecessary administrative burden.

Under the baseline, potential positive social and health impacts of NGT products with improved nutritional and functional quality will be largely missed. Under options 1 and 2 and to a smaller extent under option 3, more NGT products are expected on the market and therefore certain of the social and health benefits of these products could be realised. This would be greater in option 2, with some gains resulting from incentives to NGT plants containing traits with potential positive social and health impacts, and further gains if the GMO labelling is waived for NGT plants with traits that can contribute to sustainability, as well as in option 4.

The baseline and options 1 and 3 ensure information to consumers about the use of genetic modification technologies on the product’s label, according to consumer expectations as they result from consultation activities and available research. However, this could result in low levels of consumer acceptance of NGTs, if the negative connotations of the current GM label extend to NGTs, unless other initiatives are taken to inform and engage consumers about NGTs. In option 2, the sub-option to label NGTs with traits that can contribute to sustainability as GM combined with a sustainability label or a factual statement on the intended purpose of the genetic modification would support freedom of choice and increase consumer and market acceptance, whereas the sub-option in which the GMO label is waived if a product contributes to sustainability would make freedom of choice more burdensome and likely negatively affect trust. The absence of labelling in option 4 would also make freedom of choice more burdensome, but, on the other hand, a GM label for NGT products which could occur in nature or be conventionally bred could create confusion.

Opportunities for consumers to access NGT products with increased nutritional and functional qualities and with other sustainability-relevant traits which, according to available research, rank high among consumers’ concerns would be greatest in option 4 followed by option 2.

Environmental impacts

Impacts related to the protection of the environment are addressed earlier in this section in the subsection concerning the specific objective of procedures that ensure safety while avoiding unnecessary administrative burden.

As no or only very few NGT plants are expected to be authorised for cultivation under the baseline and option 3, the environmental impacts of these plants will be limited. Impacts will be largely restricted to missed potential environmental benefits coming from NGT plants.

As a certain number of NGT products are expected to be placed on the EU market under option 1, some environmental benefits are likely to be realised. The same would apply in option 2, with additional gains resulting from incentives for NGT plants containing traits with potential positive environmental impacts, and further gains if the GMO labelling is waived for NGT plants with traits that can contribute to sustainability. This may in particular apply to plants with biotic resistance, as such traits can be obtained by relatively simple genetic modifications, leading to lower pesticide use. With more NGT products arriving on the market, certain stakeholder groups expect positive environmental impacts, while others expect negative impacts. In the targeted survey, roughly equal number of stakeholders expect a positive (40%) or a negative (46%) impact. However, this polarisation is primarily due to divergent views on the effects of herbicide tolerant crops, which, can, however, be developed by all methods (conventional breeding, established genomic techniques or NGTs), and not to negative impacts specific to the use of NGTs.

Option 4 offers the largest opportunities to realise the potential environmental benefits of NGTs. As for options 1 and 2, the expectation is that the most significant environmental impacts will come through NGT products with traits such as durable pest resistance. The concerns about risks to the environment and biodiversity are similar to those for options 1 and 2. Agrobiodiversity could benefit from this option, as it can become easier to apply the techniques to small and local crops.

All options are aligned with the ‘do no harm’ principle and include procedures to ensure that NGT plants are only released or placed on the market if they are considered to as safe as their conventional counterparts. Option 3 embeds this principle further by setting as a pre-requisite for authorisation that the introduced trait is not detrimental to sustainability.

Impacts on the organic and GM-free sectors

The labelling and traceability requirements in the existing GMO legislation, as well as the national coexistence measures adapted to local circumstances, will continue to apply and allow separate value chains and consumer trust in these sectors under the baseline as well as in options 1, 2 (if GMO labelling is not waived) and 3. The risk of admixture during cultivation, harvest, storage, transport and processing will depend on the adoption rate of NGTs and thus be moderately higher than the baseline in options 1 and 2 and similar to the baseline in option 3 and highest in option 4.

Under option 4, the traceability, labelling and coexistence measures of the current GMO legislation would not apply to notified NGTs. Impacts would differ if the NGTs under notification are treated for the purposes of organic production as GMOs or as conventional products. In the first sub-option organic operators would have the responsibility to put in place precautionary measures, supported by the public register of NGT plants and information in the common catalogues of plant varieties, to avoid the use of and admixture with any product that is not authorised in organic production. If NGT products subject to notification would be treated for the purposes of organic production as conventional products, they could be used in organic production under the applicable derogations (and potentially contribute benefits). However, there is the risk that consumers would not accept NGTs in organic production, and a degree of erosion of consumer trust and related economic losses could materialise.

The labelling sub-options in option 2 would have specific impacts. Under the variant of this option that maintains a GMO label, the impacts on the organic/GM-free sector will be similar to option 1. There are concerns that the variant with sustainability labelling of NGTs would be to the disadvantage of sustainable conventional or organic products, which would not be able to use such a sustainability label. Such NGT products would in any case still be labelled as GM and identified as such by operators and consumers. If NGT products with traits contributing to sustainability would not be labelled, the organic logo would guarantee to consumers that the product is GM-free.

Under all options, some negative impacts on the organic and GM-free sectors can occur due to regulatory divergence with non-EU countries from which organic and GM-free products are imported into the EU, as sourcing of products may become more limited and as more challenging and expensive identity preservation systems for NGT free products in the EU trade partners may be required. Under the current EU regulatory framework, NGTs should not be used in organic products exported to the EU, therefore, the costs of keeping supply chains in the EU segregated would remain unchanged.

1.7.Efficiency analysis

This section compares the cost-effectiveness of the policy measures in the different options for important stakeholder groups, based on the data in Annex 3. The wide range of costs and savings are linked to the potential variability in data requirements, which depend on the risks/type of products.

Table 8. Current cost for authorisation procedure (baseline). The authorisation cost can be subdivided in cost for risk assessment, detection method, risk management and administrative cost.  

Table 9. Costs and savings for authorisation under Option 1 in comparison to the baseline: Negative amounts correspond to financial savings while positive amounts correspond to costs. 

Table 10. Costs and savings for authorisation under Option 2 in comparison to the baseline:  Negative amounts correspond to financial savings while positive amounts correspond to costs. 

Table 11. Costs and savings for authorisation under Option 3 in comparison to the baseline: Negative amounts correspond to financial savings while positive amounts correspond to costs. 

Table 12. Costs and savings for notification under Option 4 in comparison to the baseline: Negative amounts correspond to financial savings while positive amounts correspond to costs.

1.8.Coherence

7.3.1.    Coherence with GMO legislation

NGT plants fall under the scope of the current EU legislation on GMOs. The initiative on NGT plants will propose new measures specifically for NGT plants and food and feed containing, consisting or produced from such plants. Those measures will share the objectives of the GMO legislation to ensure a high level of protection of human health and of the environment in accordance with the precautionary principle and ensure the functioning of the internal market while addressing the specificity of NGT plants. All policy options are coherent with the existing framework as regards those objectives. Options 2 and 3 would add new sustainability elements in the GMO framework only for NGT products.

7.3.2.    Coherence with other legislation and initiatives

Plant Reproductive Material (PRM) and Forest Reproductive Material (FRM) legislation – The objective of the on-going revision of the PRM and FRM legislation is to ensure the availability of PRM and FRM of high quality and diversity, that contribute to food security, sustainable production and protection of biodiversity and that are adaptable to climate change. The objectives of the NGT initiative and the PRM/FRM revision are fully compatible.

While the scope of the NGT initiative covers all plant species, the PRM/FRM revision covers only the economically most important species for European agriculture, horticulture and forestry. This is justified by the different rationales of the legislation on NGTs (regulatory oversight of products obtained by new biotechnologies) and on PRM/FRM (regulatory oversight to ensure the identity, quality and health of the economically most important marketed PRM and FRM regardless of the method by which they have been produced).

Possible issues of coherence between the two initiatives are primarily related to the inclusion of sustainability provisions. Under all options of the PRM/FRM initiative, the assessment of sustainability characteristics will be extended to all crop groups/FRM categories beyond agricultural crops on a voluntary or mandatory basis, depending on the option chosen. Both the current VCU for agricultural crops and vine, and the envisaged extended sustainability assessment under the PRM initiative, examine the overall performance of new varieties compared to varieties in the national catalogues in relation to a number of characteristics that would go beyond one or more introduced traits. The same principle of an overall assessment of basic material in relation to a number of defined sustainability characteristics holds true for FRM. As today, the PRM/FRM systems will not provide for the possibility to reject a variety based on a single trait as inferior characteristics may be discarded if the variety/basic material as a whole offers clear improvements in comparison with existing varieties/basic material.

In the baseline option and options 1 and 4 no specific sustainability provisions will be introduced and no issues of coherence with the PRM/FRM revision would need to be considered.

In Option 2, the specific regulatory incentives considered would not raise a problem of coherence with the PRM/FRM revision, as they are specific to the authorisation procedure for NGT products. The sustainability-related procedures of the two systems should not interfere with each other, because the verification in option 2 relates exclusively to the potential sustainability impact of an individual trait introduced in a specific plant in comparison to the same plant without this genetic modification, while the PRM/FRM legislation considers the overall performance of new agricultural crop varieties. Moreover, assessing during the authorisation process the potential contribution to sustainability of a trait introduced using NGTs could trigger incentives in the NGT framework but would not prejudge the outcome of VCU trials during variety registration. On the other hand, a sustainability claim in the NGT initiative could raise coherence issues as it would be linked to an individual trait irrespective of the overall performance of the variety.

Option 3 would not ensure coherence with the PRM/FRM revision as it would lead to having sustainability as a requirement only for NGT plants, leading to the refusal of the authorisation to place on the market plants featuring certain traits, while conventionally bred plants featuring the same traits would not, for that reason alone, be excluded from the market. Should those plants be subject to VCU examination, the holistic assessment in that context would also not lead to rejection of a variety containing a trait that could have detrimental impact on sustainability, if other, superior characteristics are present.

Planned initiative on a legislative framework for a sustainable food system (FSFS) - Both the FSFS and the NGT initiatives share the objectives of the Green Deal and the Farm to Fork Strategy and are intended to set out enabling frameworks to achieve these common goals. Whereas the NGT initiative will set out a framework to encourage the development of NGT plants that can contribute to those objectives, at the same time ensuring a high level of protection of human and animal health and of the environment, the FSFS is envisaged as an enabling framework for an EU sustainable food system. While the main elements of both initiatives are still being developed, both initiatives will be mutually complementary and work in synergy to achieve their shared sustainability objectives.

Organic Products Regulation (Regulation (EU) 2018/848) and organic target in the Farm to Fork Strategy – That regulation bans the use of GMOs in organic production, and considers as GMOs for the purposes of that Regulation those that are not exempted from the requirements of the GMO Directive. Conversely, GMOs exempted from the requirements of the GMO legislation (e.g., plants obtained from random mutagenesis) are treated as conventional for the purposes of organic production and may be used under certain circumstances. In the baseline, as well as options 1, 2 and 3, NGTs would remain subject to the requirements of the GMO legislation and would be considered GMOs for the purposes of organic production. If option 4 is retained, the proposal may need to clarify the status of NGT products falling under the notification in the context of the organic regulation. In any event, all options include provisions (traceability, labelling or public registries) to allow organic producers to comply with the Organic Production legislation.

The Farm to Fork Strategy aims for at least 25% of the EU's agricultural land to be under organic farming by 2030. This aim can be reconciled with increased NGT cultivation through transparency about NGTs to allow choice in the supply chain in all policy options and the use of appropriate coexistence/precautionary measures. Should organic operators accept the use of notified NGT plants with traits relevant to organic production (e.g. pest resistance, tolerance to drought, nutrient use efficiency, improved yield/input ratio), and if this becomes possible under the legal framework, this could support efforts towards the 25% target. On the other hand, this could also lead to the loss of trust of consumers in the organic EU logo and could impact progress towards the 25% target.

Regulation (EU) 2015/2283 on novel foods (NFR) 242 – This regulation does not apply to food subject to Regulation (EC) No 1829/2003 on genetically modified food and feed. In option 4, NGT food and feed products which meet the notification criteria and are not subject to authorisation as GMOs would no longer be excluded from the NFR. If there would be significant changes in the composition or structure of food derived from NGT plants affecting its nutritional value, metabolism or level of undesirable substances, the food would need to be risk assessed and authorised under the NFR in order to be placed on the market. This would contribute to the overall goal of ensuring safety.

Legislation on labelling: Regulation (EU) No 1169/2011 on the provision of food information to consumers (FIC Regulation) 243 , Regulation (EC) No 1924/2006 on nutrition and health claims, (NHCR) 244 , Regulation (EC) No 767/2009 on the placing on the market and use of feed 245 and initiative on substantiating green claims 246 – The sustainability label (if complementary to the existing GMO label) in option 2 for NGT products featuring a modified trait which contributes to sustainability could raise coherence issues vis à vis current requirements in the FIC Regulation, the NHCR and the Regulation on marketing of feed as well as with the green claims initiative. These regulations set out requirements that have to be met by voluntary information or claims included on the labelling of food intended for the final consumer. Therefore, any claim regarding the properties of the food derived from a NGT plant, and in particular on nutrition properties, would have to also comply with those requirements. As regards environmental claims, the Commission’s green claims initiative would require companies to substantiate environmental claims about their products with a standard methodology to assess their impact on the environment. Any environmental claims made with regard to the modified trait of a NGT plant in option 2 would have to be substantiated in accordance with the new rules on green claims, once adopted, in order to ensure coherence. 

Directive 98/44/EC on the legal protection of biotechnological inventions, European Patent Convention and Regulation (EC) No 2100/94 on Community plant variety rights – The genetic modification made in a plant by means of a NGT is patentable, as well as the technique used to obtain the modification. Plant varieties obtained by NGTs can be protected by Community plant variety rights (CPVRs). In this regard, a balanced intellectual property system, including patent protection, is essential for innovation in agricultural biotechnology, i.e. by incentivising investments in research and development and promoting the dissemination of knowledge. At the same time, concerns have been raised by many stakeholders (farmers, breeders, in particular from the GM-free and organic sectors) on the possible proliferation of patents on NGT plants in the future and on potential claims being made by patent holders on conventionally bred plants that cannot be distinguished from NGT plants, fearing that this scenario could be further exacerbated if NGT plants are not subject to a GMO authorisation. While from the legal point of view the NGT initiative is independent from the rules on the protection of intellectual property and does not address matters relating to the application of the IPR legislation to GMOs, in particular to NGT plants, the Commission has taken note of the concerns brought forward by certain stakeholders on the need to ensure in particular the accessibility of farmers to patented seeds and of breeders to patented genetic material, and will carefully consider them.

1.9.Proportionality

The adapted risk assessment featured in options 1, 2 and 3 will be proportionate as it is intended that the criteria (and subsequent data requirements based on them) for the risk assessment of different NGT plants and derived food and feed are not stricter than necessary to ensure that the potential risks are properly identified and evaluated. This approach of adapted risk assessment would ensure proportionality for all NGT plants except those that could have been obtained naturally or by conventional breeding, where a notification regime as foreseen in option 4 (based on criteria allowing to identify NGT plants equivalent to conventionally bred plants) would suffice to ensure the objective of safety.

The granting of regulatory incentives in option 2 for applications for NGT plants with modified traits that can contribute to sustainability would be subject to a requirement to submit data to substantiate that claim, which would add an administrative and cost burden on operators wishing to benefit from such incentives. However, since the regulatory incentives would result in lower application costs (faster procedures, waiving of detection method validation fees, regulatory and scientific advice during the procedure), such a regime would not result in an overall increase of the regulatory burden, but a reduction thereof. The degree to which the burden would be reduced would depend on the amount of data required to obtain the incentive and on the actual incentives foreseen. Overall, as the incentives regime would be voluntary and not add an extra burden on operators not wishing to use it, such a measure would be proportionate.

Option 3 would impose sustainability requirements on NGT products as a condition for their authorisation and hence for their placing on the market. The fact that under that option NGT plants containing certain traits may not be allowed on the market for reasons related to the impact of the trait on sustainability while non-NGT plants containing a similar trait would not be subject to such a requirement, would render such a measure disproportionate.

Finally, for option 4 the indicative notification criteria (see section 5.2.4 box 2) are designed to reflect the equivalence of the NGT plant with plants that could occur naturally or be obtained by conventional breeding methods, and (complemented by data requirements linked to those criteria) should be adequate to ensure proportionality.

8.    Preferred Option

8.1.    Description of the preferred option

The preferred option is a combination of option 4 for products that could also occur naturally or be produced by conventional breeding and of option 2 for all other products. This combination ensures to the largest possible extent that NGT plants and derived food/feed products are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden, that NGT plants and derived food/feed products featuring a wide range of plant species and traits by various developers are placed on the market and that these plants feature traits that can contribute to a sustainable agri-food system.

Option 4 provides for a notification procedure that would be accessible only to those NGT plants that could occur naturally or be produced by conventional breeding. It achieves the objective to maintain safety while ensuring that requirements are proportionate to the risk involved. The NGT plants concerned, due to their characteristics, would not present more potential hazards than plants produced by conventional breeding. The notification procedure includes a case-by-case assessment based on the molecular characteristics of the product against predefined criteria, and a decision by the relevant authority to establish the status of products (equivalent to conventional or not).

Option 4 is the best performing option to deliver on the objectives of this initiative and shows positive impacts in terms of innovation and interest of developers in marketing these products in the EU, enabling products to contribute to sustainability and food security. This option offers the largest opportunities to realise the potential benefits of NGTs, also bringing more diversity regarding species, traits and institutions developing them. This option reduces regulatory burden and access barriers to SMEs. It is comparable to the approach followed in an increasing number of third countries and would be the least disruptive of trade.

By treating NGT plants that could have been obtained naturally or by conventional breeding in a similar way to conventionally bred plants, this option scores best as regards coherence and proportionality.

Under this option, the NGT products that could occur naturally or be produced by conventional breeding would not be subject to GMO traceability and labelling but would be entered into a public register. This would increase transparency compared to the treatment today, of GMOs exempted from the requirements of the GMO legislation (e.g., the products of random mutagenesis) for operators (organic, GM-free) and consumers and allow operators at the beginning of the food chain – from breeding to seed production – to identify products obtained from NGTs and to avoid them if so wanted. The extent of the impacts of this option in the organic sector will depend on how notified NGT plants are treated for the purposes of organic production (either as GMOs or as conventionally bred plants). Considering the implications of each option as described in this impact assessment as well as the majority position in the organic sector, the policy choice has been made in the preferred option to treat such NGT products as GMOs for the purposes of organic production.

Option 4 is not designed to apply to all NGT plants, but only to those that could occur naturally or be obtained by conventional breeding. Option 2 is the preferred option for NGT plants that are not similar to conventional products.

The option scores high in terms of ensuring safety and proportionality through requirements that are adapted to levels of risk of NGT plants that are not similar to conventional products. An adapted risk assessment would bring a moderate improvement concerning attractiveness to develop NGT plants in the EU. Cost reductions for applicants compared to the baseline range from low to very substantial, depending on which risk assessment criteria need to be applied in specific cases. There would be variable but potentially significant cost decreases for risk assessment. To address concerns expressed about the potential uncertainty and complexity of this approach, work on the criteria for risk assessment (see section 5.2.1) is intended to ensure adaptability and predictability.

Regulatory incentives linked to the authorisation of NGT plants under option 2 would bring moderate positive impacts in terms of steering research and development towards traits with sustainability potential by facilitating access to and navigation of the regulatory framework, especially for SMEs, supporting their competitiveness. To avoid pre-empting the development of horizontal approaches to define and assess contributions to sustainability, and to address other difficulties of a sustainability assessment in the context of this initiative, option 2 would be adjusted to link the incentives to the traits conferred by the genetic modification, instead of linking them to an assessment of sustainability impacts. The incentives would be granted when the trait appears in a pre-defined list of traits selected because of their potential to contribute to sustainability objectives (desirable traits).

NGT plants subject to option 2 would also remain subject to traceability, and the related tools would remain available (as today) to supply chains that do not use GMOs (organic, GM-free sectors) until the final consumer. The impact of option 2 on the organic and GMO-free sector has been considered similar to the baseline when labelling is kept.

Regulatory divergence with non-EU countries is likely to remain large for NGT plants subject to option 2, posing challenges for value chain management and identity preservation systems in the exporting countries.

The current GM-label is perceived as a warning on possible risks (although only plants as safe as comparable conventional plants can be placed on the market) and would impact consumer acceptance, especially of food. It is also a key driver of negative consequences on the attractiveness to develop NGT plants in the EU. However, there is considerable demand for labelling and removing the labelling requirement for products subject to the requirements of risk assessment and authorisation would likely impact consumer trust. NGT plants subject to option 2 would therefore remain subject to labelling GMOs.

There is equally demand from citizens to use this initiative to actively steer the development of varieties with traits that support the Farm to Fork objectives, and to be informed about the sustainability impact of the products they buy. The intended application of the technology (and whether it delivers benefits to society at large) is relevant information to consumers and could be a factor influencing acceptability of NGTs. To this end, option 2 included the possibility to allow sustainability-related claims based on the trait to be mentioned on the label of the final product. However, a sustainability-related claim for certain NGT products raised concerns due to difficulty to assess sustainability based on a single trait, differential treatment vis-à-vis other products and coherence with other legislation on claims. Therefore, as preferred option, the claim will be replaced with the possibility to add a factual statement of the trait for NGT products subject to authorisation, i.e. the GM labelling could be complemented with information on the purpose of the genetic modification (e.g., genetically modified for the purpose of improving resistance to drought). This should allow operators and consumers to make informed choices and is expected to drive market demand for products with beneficial traits.

With the combination of option 2 with option 4, for the most part products subject to authorisation could be differentiated from plants obtained naturally or produced by conventional breeding techniques. In such cases, applicants for authorisation would be able to comply with a requirement to submit a specific detection method, the competent authorities would be able to enforce the legislation and operators would be able to test raw material and products for traceability purposes.

The preferred option creates an enabling framework to meet the demands of farmers for the development and commercialisation of new varieties with beneficial traits to respond to the constraints of their soil and climatic context 247 . For NGT plants subject to notification, the development of such varieties is also steered by the objectives and provisions of other EU policy initiatives, in particular the SUR proposal (which has the objective to reduce the use of pesticides) to which pest-resistant crops can contribute, the PRM/FRM initiative (holistic assessment of the sustainability characteristics of a variety) and the FSFS initiative (steering the EU food systems towards sustainability). For NGT products requiring an authorisation, the preferred option steers developments towards desirable traits by providing regulatory incentives, which would be helpful in particular for SMEs. The factual label of such products could impact consumer choice, thus also steering indirectly the development towards desirable traits. 

Consumer acceptance of NGTs is necessary for the benefits of NGTs to materialise. In this regard, initiatives to inform and engage consumers about NGTs need to be considered to accompany and explain the transparency measures – label in option 2, registry in option 4 – provided for in the legislation.

It will also be important to monitor closely the uptake of NGT products and the accompanying impacts, both positive and negative (see section 9).

The preferred option contributes to three of the four components of food security – food availability, stability and utilisation. It furthermore contributes to sustainability, the long-term ability of food systems to provide food security in a way that does not compromise the economic, social, and environmental bases that generate food security for future generations.

8.2 Simplification and burden reduction, supporting the one-in-one-out approach

The preferred option presents an important simplification of processes of the current authorisation procedure, notably through the adapted risk assessment (option 2) and the new notification procedure (option 4) for products that fulfil the criteria for equivalence to conventional breeding.

Adjustment costs for the preferred option:

For breeders, the preferred option would entail a significant reduction of adjustment costs. Based on the hypothetical scenario described in Annex 3 in which breeders would submit 10 notifications and 5 applications for authorisation per year 248 , the total recurrent savings in adjustment costs per year are estimated to range from a minimum of EUR 99.5 m to a maximum of EUR 163.5 m 249 .

For national administrations, a potential unquantifiable increase in adjustment costs was identified due to the additional support (incentives) for applicants during the authorisation process for certain NGT products with traits that can contribute to sustainability. This potential increase in costs would be counterbalanced by the fact that the preferred option would entail at the same time a significant reduction of the adjustment costs for national administrations. The total recurrent savings in adjustment costs per year for national administrations are estimated to range from EUR 0 to EUR 2.1 m.

There is a wide range of savings for the breeders and for national administration as the risk assessment, which is the main source of adjustment costs for breeder, will be proportionate to the risks/type of products and the data requirements will vary.

For farmers using NGT varieties, recurrent savings in adjustment costs were estimated to range from EUR 22 m (for vegetable crops in the most likely scenario) to EUR 2.7 bn (for cereals in the most likely scenario) due to potential yield improvement of crops. Additional costs related to segregation (e.g. additional documentation, third-party verification) and coexistence measures might be added. These could not be quantified.

For organic farmers, the preferred option would entail a potential but unquantifiable increase in adjustment costs for risk management practices and market monitoring (for accidental presence of GM/NGT product) due to the uncertainties of potential presence of notified NGT plants in conventional seeds in the first sub-option, where notified NGTs remain banned in organic production. In the second sub-option, where notified NGTs would be treated like conventional products with regard to organic production, this cost increase would not occur. The second sub-option, though, could lead to the erosion of consumer trust and lead to economic losses of the organic sector.

Administrative costs for the preferred option

The preferred option would entail an annual overall administrative cost saving for breeders ranging from EUR 16.15 m to EUR 46.25 m. The range reflects the differences in data requirements for products with different risk profiles.

For farmers, including organics farmers, no administrative costs are identified.

For food businesses, a limited unquantifiable increase in administrative cost is expected due to additional information in the GMO label (identification on the label of the purpose of the genetic modification to the label) and related segregation costs. Recurrent savings in administrative costs are expected due to the removal of the traceability and labelling obligation for the notified products; however these could not be quantified.

9.    How will actual impacts be monitored and evaluated?

In order to monitor and evaluate the progress made towards the objectives of this initiative and its economic, environmental and social impacts, indicators have been identified and are listed in the table below (Table 13). The Commission will review these indicators periodically.

Data on most indicators will be collected and published annually and will serve as the basis for regular monitoring reports, that will also be supported by external studies.

The indicators defined will support monitoring of potential risks to health or the environment, achievement of the initiative’s objectives and impact of NGT plants on environmental, economic and social sustainability. Indicators are also proposed to monitor impacts on organic agriculture and on consumers acceptance of NGT products.

A first monitoring report should be presented no sooner than 3 years after the first products have been notified/authorised, to ensure that enough data is available after full implementation of the new legislation, and at regular intervals thereafter. An evaluation should be carried out no sooner than 2 years after the first monitoring report has been published.

Table 13. Monitoring indicators. Indicators that need to be created are marked with ‘*’.

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