Toelichting bij COM(2023)411 - Met bepaalde nieuwe genomische technieken verkregen planten en de daarvan afgeleide levensmiddelen en diervoeders - Hoofdinhoud
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| dossier | COM(2023)411 - Met bepaalde nieuwe genomische technieken verkregen planten en de daarvan afgeleide levensmiddelen en diervoeders. |
|---|---|
| bron | COM(2023)411  |
| datum | 05-07-2023 |
•Reasons for and objectives of the proposal
New genomic techniques (NGTs) 1 provide new opportunities to alter the genetic material of an organism allowing the rapid development of plant varieties with specific characteristics. NGTs constitute a diverse group of techniques, each of which can be used in various ways to achieve different results. In many cases, these new techniques can lead to more targeted and precise modifications to the genome than conventional breeding or established genomic techniques 2 and these modifications could or could not be produced in nature or obtained by conventional breeding techniques.
Targeted mutagenesis 3 and cisgenesis 4 (including intragenesis) are considered NGTs. They are different from established genomic techniques because they have novel features, for example, higher precision and speed in introducing the desired genetic modifications and the insertion of genetic material only from a crossable 5 species. Targeted mutagenesis and cisgenesis do not introduce genetic material from non-crossable species -transgenesis- whereas this is the case with established genomic techniques. In addition, in some cases, products containing or consisting of plants with genetic modifications introduced by NGTs cannot be differentiated from products containing or consisting of plants bred with conventional breeding methods by analytical methods, whereas this is always possible for established genomic techniques.
The scope of this initiative are plants produced by targeted mutagenesis and cisgenesis (including intragenesis), products containing or consisting of these plants and food and feed containing, consisting or produced from these plants. The choice of the scope is based on several reasons. Numerous advanced and early ‘research & development’ applications concern plants, and several plant products are already on or very close to the market. In certain cases, substantially equivalent plants can be obtained with conventional breeding methods and with targeted mutagenesis and cisgenesis. Safety data are mainly available for plants obtained by targeted mutagenesis and cisgenesis, whereas it is at this stage difficult to draw relevant conclusions on other NGTs and applications in animals and micro-organisms.
The European Food Safety Authority (EFSA) concluded that, as regards risks for human and animal health and the environment, there are no specific hazards linked to targeted mutagenesis or cisgenesis 6 . EFSA also concluded that in targeted mutagenesis, the potential for unintended effects, such as off-target effects, may be significantly reduced compared to transgenesis or conventional breeding. Therefore, due to how these novel techniques work, and compared to transgenesis, a lesser amount of data might be needed for the risk assessment of these plants and products made from them.
There is significant demand in the Union and globally for NGT plants, because of their potential to contribute to addressing current challenges in the agri-food system. Climate change and biodiversity loss have put the focus on long-term resilience of the food chain and the need to transition to more sustainable agriculture and food systems. The European Green Deal’s Farm to Fork Strategy 7 specifically identifies new techniques, including biotechnology, that are safe for consumers and the environment and bring benefits to society as a whole, as a possible tool to increase sustainability of agri-food systems and contribute to guaranteeing food security 8 .
The Covid-19 pandemic and Russia’s war of aggression against Ukraine have also revealed the Union’s external dependencies. In its Trade Policy Review Communication 9 , the Commission stressed the role of trade openness within the concept of “Open Strategic Autonomy”, recalling the importance of an open and fair trade with well-functioning, diversified and sustainable global value chains. NGTs are applied to a far larger range of crop species than established genomic techniques and can contribute, for example, to decreasing the Union’s dependence on imports of plant proteins. They can also support the special needs in the Outermost Regions. NGTs are more technically accessible than established genomic techniques as they have low entry and operating costs. This could mean that the developers and users of these techniques are more diversified if access to and affordability of the technologies is maintained. NGTs could be also 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.
In its judgment of 25 July 2018, in case C-528/16 10 the Court of Justice of the European Union held that Directive 2001/18 cannot be interpreted as excluding from its scope Genetically Modified Organisms (‘GMOs’) obtained by means of new techniques/methods of mutagenesis which have appeared or have been mostly developed since that Directive was adopted.
The Council, in Decision (EU) 2019/1904 of 8 November 2019, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, in view of the outcomes of the study.
The Commission delivered the requested study 11 on 29 April 2021 (the ‘Commission NGT study’). It concluded that there are strong indications that the current Union GMO legislation is not fit to regulate NGT plants obtained by targeted mutagenesis or cisgenesis, and products (including food and feed) derived from them and that that legislation needs to be adapted to scientific and technical progress in this area. The study identified the following problems:
●the risk assessment requirements and authorisation procedure of the current 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;
●the current GMO legislation will be difficult to implement and enforce for certain plants produced by targeted mutagenesis or cisgenesis, in particular those for which a specific detection method cannot be provided;
●the application of the current GMO legislation to NGTs is not conducive to the development of innovative products that are potentially beneficial for breeders, farmers, food business operators, consumers and the environment.
These problems affect numerous operators across the agri-food system, especially breeders, the agricultural biotechnology innovation and research sector, farmers, bio-based industry and consumers, traders, and Union and national authorities. In addition, outside the Union, various third countries have already taken measures on NGTs, adapting the degree of regulatory oversight to the specific nature of NGT plants and products made from them. The Union risks being excluded to a significant extent from the technological developments and economic, social and environmental benefits that these new technologies can potentially generate, if its GMO framework is not adapted to NGTs. In turn, this would lead to less strategic autonomy for the Union.
Therefore, the Union’s regulatory framework should be adapted to make NGTs subject to the appropriate level of regulatory oversight. The objectives of the proposal are the following:
Inhoudsopgave
●maintain a high level of protection of human and animal health and of the environment, in accordance with the precautionary principle;
●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 12 ;
●ensure the effective functioning of the internal market in NGT plants and products and food and feed containing, consisting or produced from NGT plants, and enhance the competitiveness of the Union agri-food sector at the Union and global levels, including a level-playing field for operators.
●procedures for the deliberate release and placing on the market ensure that NGT plants and their food and feed are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden;
●deliberate release and placing on the market of NGT plants and their food and feed that feature a wide range of plant species and traits by various developers;
●NGT plants released or placed on the market feature traits that can contribute to a sustainable agri-food system.
•Consistency with existing policy provisions in the policy area
NGT plants fall under the scope of the current Union legislation on GMOs (Directive 2001/18/EC, Regulation (EC) No 1829/2003, Regulation (EC) No 1830/2003, Directive 2009/41/EC). This proposal sets new requirements specifically for NGT plants obtained by targeted mutagenesis and cisgenesis and products containing or consisting in these plants and food and feed containing, consisting or produced from these plants. This proposal shares 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 to ensure the functioning of the internal market, while addressing the specificity of NGT plants. The proposal is coherent with the existing framework.
•Consistency with other Union policies
The proposal is part of the overall policies of the European Green Deal and related strategies: the Farm to Fork and Biodiversity strategies, the Union’s Strategy on Adaptation to Climate Change and the planned initiative on a legislative framework for a sustainable food system. It is consistent with these strategies’ objectives.
For example, through the development of pest-resistant plants, NGT plants could be among the tools that contribute to the reduction target on the use and risk of pesticides set out in the Farm to Fork and Biodiversity Strategies and in the proposal for a regulation on the sustainable use of plant protection products 13 .
The placing on the market and cultivation of NGT plant and forest reproductive material will also have to comply with Union legislation on the marketing of seeds and other Plant and Forest Reproductive Material (‘PRM’, ‘FRM’) which is also undergoing a revision. The aim of that revision is to ensure availability and choice within the Union of PRM and FRM of high quality, adaptable to the current and foreseeable climatic changes, and that contributes to food security, sustainable production and protection of biodiversity. The objectives of the NGT initiative, on the one hand and the PRM/FRM revision on the other are therefore fully compatible.
This proposal shares objectives related to sustainable agriculture and food production with the Union legislation on organic production (Regulation (EU) 2018/848 14 ) (‘Organic Products Regulation’). The Organic Products Regulation bans the use of GMOs and GM food and feed in organic production. Under this proposal the ban continues to apply to all NGT plants and food and feed falling within its scope. This is consistent with the Organic Products Regulation because the use of new genomic techniques is incompatible with the current concept of organic production in the Regulation (EC) 2018/848 and current consumers’ perception of organic products.
•Legal basis
The proposal 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 Union 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 ) and a high level of human health protection in the veterinary and phytosanitary fields (Article 168(4)(b)).
•Subsidiarity (for non-exclusive competence) 15
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 and cross national borders. The requirements for the deliberate release and the placing on the market of NGT plants and food and feed derived from them are already harmonised at Union level under the existing legal framework applicable to GMOs. In order to ensure that these plants, products and food and feed can circulate freely within the internal market, while ensuring a high level of protection of human and animal health and the environment, the regulatory framework needs to be adapted to the specificities of plants obtained by these techniques. In addition, the EU Farm to Fork Strategy recognises the potential of new techniques, including biotechnology, to increase sustainability of the food system and bring benefits to society as a whole.
For these reasons, action needs to be taken by the Union. Carving out NGT plants from the current Union legal framework and leaving it to Member States to regulate them would likely lead to different regulatory requirements and levels of protection in the Union. Differing national requirements for NGT plants and products derived from them would hinder the free movement of these plants and products, fragment the internal market and lead to uneven competition between economic operators.
•Proportionality
The principle of proportionality has been taken into account in the comparison of the different options evaluated in the impact assessment. The proposal does not go beyond what is necessary to achieve its objectives. The procedures for the deliberate release and placing on the market of NGT plants and products (including food and feed) derived from them have been designed to cater for the diversity of risk profiles of these plants and products. The proposal provides for a verification procedure for those NGT plants and products derived from them that could also occur naturally or be produced by conventional breeding and an authorisation procedure with a risk assessment adapted to the risk profile for all other NGT plants and derived products. These different procedures enable competent authorities to verify that NGT plants and products derived from them are as safe as their conventional counterparts, and are no stricter than necessary to ensure that the potential risks to human or animal health or the environment are properly identified and evaluated.
•Choice of the instrument
The chosen policy instrument is a Regulation. The authorisation procedure as well as the verification procedure are based on fully harmonised criteria, requirements and procedures that should lead to a decision for the whole Union, ensuring the same high level of protection of health and the environment and the availability of the products concerned across the Union. A Regulation is the most appropriate legal instrument to embody such procedures and to achieve a uniform implementation of the policy intervention, which has an important internal market component.
•Ex-post evaluations/fitness checks of existing legislation
Two external studies on the Union GMO legislation were carried out on behalf of the Commission in 2010 (on GM food and feed) 16 and 2011 (GMO cultivation and placing of GMOs on the market) 17 . They noted concerns that the legislative framework was only focused on risks and not suited for the Union 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. These 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 NGT study confirmed that the findings of those prior studies remain relevant and that the challenges have increased, especially as regards plants produced by targeted mutagenesis and cisgenesis.
•Stakeholder consultations
A consultation strategy 18 was prepared to gather views and evidence from several key stakeholder groups: the general public; operators active in the agri-food and feed system; operators of plant and bio-based industries active in sectors other than the agri-food sector; academic and research stakeholders active in the field of biotechnology in general and agricultural/plant biotechnology; civil society/non-governmental organisations with interest in the topic; Union Member States’ and third country public authorities; union institutions; third country food safety agencies; other stakeholders such as consultancies and think-tanks with interest in the topic.
The following consultations took place:
●feedback on the Commission’s Inception Impact Assessment 19 (24 September 2021 – 22 October 2021);
●Commission’s public consultation (29 April 2022 – 22 July 2022) 20 ;
●targeted stakeholder survey (28 June 2022 – 05 September 2022);
●interviews (June 2022 – December 2022);
●focus groups on sustainability and traceability (22 and 23 September 2022).
The majority of stakeholders in academia/research, breeders, farmers (except in organic agriculture and GM-free production), other agri-food chain operators and public authorities called for the adaptation of the current legislation to a more enabling framework. Conversely, a majority of environmental organizations, non-governmental organisations (NGOs), and retail and consumer organisations support maintaining the status quo. The consultation activities attracted considerable citizen interest, reflecting different views (large campaign advocating for the preservation of the current system during the inception impact assessment, while the majority of citizens' contributions in the public consultation and the non-campaign replies in the inception impact assessment favoured the adaptation of legislation).
Some respondents (majority of academia/research institutions, biotechnology/bio-based industry, farming, feed, food processing/manufacturing, plant breeding/seeds, plants protection products/fertilisers, ornamental plants sector, trade sectors and public authorities) argue that the current risk assessment requirements are disproportionate for plants produced through targeted mutagenesis or cisgenesis; some of these respondents (public authorities, academic/research institutions, a majority of citizens in the public consultation) believe that risk assessment should have requirements adapted to the characteristics and risk profile of a plant. Various stakeholders (biotechnology/biotech industry, plant breeding/seeds, plant protection products/fertilisers, feed, ornamental plants sector and trade sector) believe that risk assessment is not needed when these plants could have been produced through conventional plant breeding or classical mutagenesis. Conversely, a majority of NGOs, and consumer organisations consider that the current legislation is fit for purpose and effective in terms of risk assessment.
A significant share of stakeholders (agri-food chain operators, NGOs, consumer and environmental organisations) do not support the inclusion of sustainability provisions in the legislation and advocate a systemic approach to sustainability, suggesting that it should not be linked solely to the plant breeding process and in particular not to a single trait. On the other side, such provisions are supported by a majority of respondent academic/research institutions, citizens, as well as nearly half of the public authorities.
In terms of sustainability, traits affecting the better use of resources, abiotic stress tolerance (e.g., drought, heat), and biotic stress (e.g. plant pests) are considered as the most relevant, as well as yield or other agronomic characteristics and better composition (e.g., better content of nutrients or lower content of toxic substances/allergens), while herbicide/insecticide tolerance and quality-related characteristics (e.g. colour, flavour) score lowest.
Responses regarding traceability and information for plants produced by targeted mutagenesis and cisgenesis vary. Consumer organisations and the majority of NGOs, the organic and GM-free sectors call for physical labels on the final product, while the remaining stakeholders prefer alternative solutions such as public databases and registries. Furthermore, the view that transparency about the technique is unnecessary for NGT plants that could have been obtained conventionally was expressed by some academic/research institutions, and the majority of farmers (except those in organic agriculture and GM-free production), biotechnology/biotech industry and plant breeding/seeds sectors.
Coexistence with the organic and GM-free sectors has also been raised prominently in the consultations. The organic and GM-free sectors call for the status quo to be maintained, with NGT plants remaining subject to the current GMO requirements, in particular as regards traceability and labelling, and for strengthened provisions on coexistence and harmonised rules on liability. Other stakeholders (in particular from the research, breeding and farming sectors) consider that NGT plants, when they could have been obtained conventionally, should be treated as conventional products including for the purposes of organic production.
The issue of patents on NGTs was raised by many stakeholders. Concerns have been expressed by breeders and farmers’ organisations on the need to ensure breeders’ access to patented genetic material and access by of farmers to PRM from NGT plants bearing in mind that certain NGT plants are undistinguishable from plants obtained by conventional breeding techniques.
•Collection and use of expertise
The following studies were conducted to support the impact assessment:
●Technopolis Group, Arcadia International and Wageningen University & Research. Study to support the impact assessment of legislation for plants produced by certain new genomic techniques 21 ;
●Commission’s Joint Research Centre (JRC) case studies to analyse the potential economic, environmental and social (health) impacts of selected NGT plants in the development pipeline 22 . The impact assessment also relies on the two JRC reports (on market applications 23 and latest scientific developments relating to NGTs 24 ) supporting the Commission NGT study;
●two mandates were given to EFSA to support this impact assessment (statement on criteria for risk assessment 25 and update of EFSA’s 2012 opinion on cisgenesis 26 ). Other, previous relevant EFSA opinions (referenced above) also underpin the impact assessment.
•Impact assessment
This proposal is based on an impact assessment which received a positive opinion from the Regulatory Scrutiny Board on 26 May 2023 27 .
After screening the potential measures, they were grouped into five policy options:
1.Baseline: plants obtained by targeted mutagenesis and cisgenesis would continue to be subject to the current requirements of the GMO legislation (risk assessment, authorisation, traceability and labelling) with no change.
2.Option 1: plants obtained by targeted mutagenesis and cisgenesis would require (as today) an authorisation. The risk assessment would be adapted to cater for their diverse risk profiles and to address detection challenges. Traceability and labelling would be maintained as in the baseline.
3.Option 2: plants obtained by targeted mutagenesis and cisgenesis would require (as today) an authorisation. The risk assessment would be adapted to cater for their diverse risk profiles and to address detection challenges. Measures would be introduced to incentivise plant products that could contribute to a sustainable agri-food system. Traceability would be maintained as in the baseline. Several labelling alternatives were considered: a GM label accompanied by a sustainability label, a factual statement on the trait introduced, or no GMO label if the NGT trait has the potential to contribute to sustainability.
4.Option 3: plants obtained by targeted mutagenesis and cisgenesis would require (as today) an authorisation. The risk assessment would be adapted to cater for their diverse risk profiles and to address detection challenges. Traceability and labelling would be maintained as in the baseline. In addition, applicants for authorisation would be required to show that the introduced trait is not detrimental to sustainability.
5.Option 4: verification procedure 28 for plants obtained by targeted mutagenesis or cisgenesis that could also occur naturally or be produced by conventional breeding. Such plants would be treated similarly to conventional plants and would not require authorisation, risk assessment, traceability and labelling as GMOs; a transparency register would be established for these plants. This option is intended to apply in combination with the baseline or options 1, 2 or 3 (for NGT plants not fulfilling the criteria of equivalence to conventional plants).
The preferred option is a combination of option 4 for NGT plants and products that could also occur naturally or be produced by conventional breeding and of option 2 for all other NGT plants and products. This combination ensures to the largest possible extent that NGT plants and products derived from them (including food and feed) are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden. It also ensures to the greatest possible extent that a wide range of NGT plants, of different species and with traits that can contribute to a sustainable agri-food system, from a variety of developers and derived products including food/feed are placed on the market. The preferred option creates an enabling framework to meet the demands of farmers for the development of new varieties and the commercialisation of plant reproductive material with beneficial traits to respond to the constraints of farmers’ agroecological context.
The verification procedure for plants obtained by targeted mutagenesis or cisgenesis that could also occur naturally or be produced by conventional breeding achieves a high level of protection of human and animal health and the environment while ensuring that requirements are proportionate to risks. These plants are not subject to traceability and labelling as GMOs. This regime is expected to have by far the strongest positive impact on the development and placing on the market of NGT plants and products (including food and feed), as it results in a higher degree of simplification and reduction of administrative burden for applicants and authorities. The savings for breeders per verification procedure are estimated to range from EUR 9.95 million to EUR 11.2 million. For administrations, the total savings for verification procedures are estimated to be up to EUR 1.4 million per year. In light of the traits under development, this option also shows the highest potential to facilitate the contribution of NGTs to sustainability of the agri-food system. It is the most advantageous for SMEs, as administrative and compliance costs will substantially decrease, has the strongest impact on competitiveness and would be the least disruptive of trade.
The authorisation procedure with adapted risk assessment for NGT plants and products not covered by the verification procedure ensures a high level of protection of human and animal health and the environment, while being proportionate as the data requirements for the risk assessment are adapted to the risk profile. The savings for breeders per authorisation are estimated to range from EUR 0 to EUR 10 365 000 (from negligible reduction if similar data requirements apply as today to a maximum reduction of 85% in cases with minimum data requirements). For administrations, total savings for authorisation are estimated to range from EUR 0 to 700 000 per year. These savings will increase attractiveness to develop such NGT plants in the Union. Regulatory incentives would help steer the development of NGTs towards traits with the potential to contribute to the sustainability of the agri-food chain and would support the competitiveness of SMEs. The waiving of fees for the validation of the detection methods adds an extra saving of EUR 105 000 (EUR 52 500 for SMEs) for breeders in the authorisation procedure.
NGT plants subject to authorisation would also remain subject to traceability and labelling as GMOs. The existing GM label would be complemented with the possibility to inform purchasers of the purpose of the genetic modification, to allow operators and consumers to make informed choices. This is expected to drive market demand for products with beneficial traits. The content of this statement on the trait will be determined in the authorisation, and its use will be voluntary for operators, to address concerns identified during the impact assessment linked to its burden if made mandatory (especially in certain circumstances where it would require further segregation, e.g. for commodity consignments which are mixed or processed with others). In any case, the GM label would remain mandatory.
As regards the treatment in organic production of NGT plants and derived products that meet the criteria to be considered equivalent to conventional breeding, two possible sub-options were considered in the Impact Assessment: to treat them as GMOs or as conventional products. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and current consumers’ perception of organic products. This was reflected in the concerns of the majority of the organic sector in the impact assessment. Therefore, the former scenario has been chosen. As a consequence, these NGT plants will remain prohibited in organic production. To allow choice at the beginning of the supply chain to support maintaining organic production free from NGTs and preserve consumer trust, in addition to the information in public registries considered in the impact assessment, an additional measure is proposed: the indication of the use of NGTs in the labelling of seeds.
In full alignment with the ‘do no significant harm’ principle, the preferred option includes procedures to ensure that NGT plants are only released or placed on the market if they are considered as safe as their conventional counterparts.
The European Climate Law 29 requires relevant Union institutions and the Member States to ensure continuous progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change. Against this background, the EU Strategy on Adaptation to Climate Change 30 considers that a 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. In this context, by enabling the development and marketing of NGTs, the current proposal responds to the objective adaptation and resilience and, by doing so, also to land-based climate mitigation in support of the Unions’s 2050 climate neutrality target.
The proposal has the potential to contribute towards the implementation of several of the United Nations’ Sustainable Development Goals (‘SDG’): SDG2 (End hunger), SDG3 (Good Health and Well-being), SDG9 (Industry, Innovation and Infrastructure); SDG12 (Responsible consumption and production), SDG13 (Take urgent action to combat climate change and its impacts) (see section 1.1 of the impact assessment).
A first version of the Impact Assessment Report was submitted to the Regulatory Scrutiny Board (RSB) on 15 February 2023. The Board’s overall opinion was negative because of a lack of a clear, consistent, and hierarchical set of general and specific objectives, insufficient detail with regard to the main elements of the options and the key policy choices, an insufficient assessment of the impact on consumer trust, the organic sector, the environment and health, a lack of a comprehensive overview of the costs and benefits and the lack of a comprehensive assessment of all relevant (combinations of) options in terms of effectiveness, efficiency and coherence. These points were all addressed in a revised version (see Annex 1 of the impact assessment).
The revised impact assessment received a positive opinion with reservations on 26 May 2023 31 . The comments of the Board concerned the need for further information on the verification procedure and criteria, further clarity in the preferred option regarding the use in organic production of NGT plants/products fulfilling the criteria of equivalence to conventional plants, and a comprehensive overview of benefits and costs. They have all been addressed (see Annex 1 of the impact assessment).
•Regulatory fitness and simplification
The proposal represents an important simplification of the current authorisation procedure as regards NGTs, notably through the adapted risk assessment and the new verification procedure for products that fulfil the criteria for equivalence to conventional breeding, and is expected to lead to a considerable reduction in costs for developers and to the accelerated development of new products. NGTs are considered relatively accessible tools for plant breeding compared to established genomic techniques. In this regard, NGTs are expected to lead to a lowering of technological barriers to entry into the plant breeding sector, benefitting SMEs in particular.
Verification procedure: Breeders are expected to experience a considerable reduction in administrative burden and in compliance costs, primarily due to reduced data requirements for the verification procedure compared to the current situation (only data to show compliance with the criteria for equivalence to conventional breeding instead of data for risk assessment and on the detection method).
Authorisation: regulatory incentives linked to the authorisation of NGT plants are expected to bring 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. Compared to the current situation, breeders are expected to experience a reduction in compliance costs linked to the data requirements for the adapted risk assessment. The savings may vary but they may be as high as 85% of the current costs.
The proposal is expected to support competitiveness of the Union plant breeding and farming sectors. In major trading partners of the Union, NGT plants, , that could also result from conventional breeding and food and feed derived from them are not subject to GMO regimes. The Union seed sector is the largest exporter of seeds in the world and the ability to use innovative technologies is a prerequisite to maintain competitiveness on the global market. This proposal is also expected to have an impact on strategic autonomy and resilience of the Union food system, as NGTs are expected to be applied to a large range of crop species and traits by a diverse set of actors.
•Fundamental rights
The initiative is in line with the precautionary principle and the proposal contributes to achieving a high level of human health protection and is therefore consistent with Article 35 of the Charter of Fundamental Rights of the Union. Regulatory oversight procedures apply to ensure that only NGT plants and derived products that are considered as safe for human health and for the environment as their conventional counterparts are released or placed on the market. Labelling of products subject to the requirements of risk assessment and authorisation remains in order to guarantee consumers’ right to information (Article 38 of the Charter).
As for the NGT products that could occur naturally or be produced by conventional breeding, these 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.
Adapting data requirements to the risk profile of NGT plants and product will reduce the complexity, duration and costs of the application for authorisation, where such authorization is required, and the verification procedure will significantly reduce administrative and compliance costs for operators.
The budgetary implications are set out in the legislative financial statement attached to the proposal. Overall, the proposal will be budget neutral. Indeed, the costs of this proposal, estimated at EUR 2,434 million will be fully covered by redeployments within existing financial envelopes of the current MFF.
The budgetary implications are mainly related to additional tasks to be carried out by EFSA in terms of new scientific and administrative tasks as regards the adapted risk assessment, the verification procedure for certain NGT plants and pre-submission advice. The Commission proposes to reinforce the budgetary envelope of EFSA by EUR 2,334 million from the unallocated margin of Heading 2b, which will be compensated through a reduction of the Single Market Programme, whose objectives are directly linked to those of this initiative, resulting in an increase of the unallocated margin of Heading 1.
In addition, new IT tools and database are also needed to implement the legislation. An amount of EUR 100 000 is foreseen under the Single Market Programme to integrate the NGT plants/products in the already existing Food Innovation Platform (FIP) and E-Submission Food Chain (ESFC) system.
•Implementation plans and monitoring, evaluation and reporting arrangements
In order to monitor and evaluate the progress made towards the objectives of this proposal and its economic, environmental and social impacts, a first monitoring report should be presented no sooner than three 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 two years after the first monitoring report has been published.
•Explanatory documents (for directives)
•Detailed explanation of the specific provisions of the proposal
Chapter I (Arts. 1-4) lays down the subject-matter, scope and the principle of lex specialis vis-a-vis the GMO legislation. It makes the deliberate release and placing on the market of NGT plants and products (including food and feed) derived from them subject to one of two procedures: verification procedure to establish equivalence with conventional plants/products (Chapter II) or authorisation in accordance with Directive 2001/18 for products or Regulation (EC) No 1829/2003 (Chapter III) for food and feed.
Chapter II (Arts. 5-11) provides for a verification procedure and criteria to verify whether NGT plants obtained by targeted mutagenesis or cisgenesis could also have been obtained naturally or by conventional breeding techniques, based on the criteria of Annex I (‘category 1 NGT plants’). Category 1 NGT plants are exempted from the requirements of the GMO legislation and are subject to the provisions applicable to conventional plants. However, they remain prohibited in organic production (Art.
5).
In case of verification prior to field trials, compliance with the criteria is done by the Member State that receives the verification request, as it is currently the case for field trials which are subject to the notification procedure in part B of Directive 2001/18. However, in the case of NGT plants, verification of compliance with the criteria of Annex I by the Member State that received the request will be in the form of a decision, valid for the whole of the Union and which will cover the subsequent placing on the market of the NGT plant, of products containing or consisting of such plant and of food and feed containing, consisting or produced from such plant (Art.
6). When no field trials have been carried out in the Union, including in the case of imported food or feed, the verification request will be submitted to EFSA, who will provide scientific advice on compliance with the criteria and the decision will be taken by the Commission (Art.
7).
Transparency about category 1 NGT plants is ensured through the setting up of a public database, through the labelling of seeds (Arts. 9-10) and through the inclusion of a mention in the catalogues provided for in the PRM/FRM legislation, that the variety is a category 1 NGT plant.
Chapter III (Arts. 12-25) applies to NGT plants which do not meet the criteria to consider that they could also be obtained naturally or by conventional breeding and, therefore, do not fall under the procedure laid down in Chapter II (‘category 2 NGT plants’). In this case, the procedures of the GMO legislation apply with some adaptations: (i) section 1 (Art. 13) adapts the procedure in part B of Directive 2001/18 for the deliberate release for purposes other than placing on the market; (ii) section 2 (Arts. 14-17) adapts the procedure in part C of Directive 2001/18 for the placing on the market of products other than food and feed; and (iii) section 3 (Arts. 18-21) adapts the procedure of Regulation (EC) No 1829/2033 for the placing on the market of GM food and feed.
The main adaptations are a risk assessment based on Annex II to the present Regulation; the modalities to comply with detection method requirements in cases where it is not feasible to provide a method that detects, identifies and quantifies; and the possibility to tailor to the risk profile monitoring requirements and the need for regular renewal.
Regulatory incentives (section 4 Art. 22) apply for category 2 NGT plants containing the traits listed in Part 1 of Annex III. These are traits that could contribute to the overall performance of varieties as regards sustainability and provided they do not contain traits listed in Part 2 of Annex III (herbicide-tolerant).
Category 2 NGT plants and products remain subject to traceability and labelling requirements in the Union’s GMO legislation with the possibility to add a factual statement on the intended purpose of the genetic modification (section 4 Art. 23). The possibility for Member States to restrict or prohibit cultivation in their territory of GMOs pursuant to Directive 2001/18 will not apply to such NGT plants. Member States will be required to adopt coexistence measures to avoid the unintended presence of such NGT plants in organic and conventional crops (section 4 Art. 24).
Chapter IV (Arts. 26-34) contains the provisions on delegated and implementing acts (Arts. 16-28), guidance (Art. 29), monitoring, reporting and evaluation (Art. 30), references in other Union legislation (Art. 31), administrative review (32) and amendments of other legislation (Art. 33).