EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 5.7.2023  
COM(2023) 411 final  
2023/0226 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on plants obtained by certain new genomic techniques and their food and feed, and 
amending Regulation (EU) 2017/625  
(Text with EEA relevance)  
{SEC(2023)  411 final}  - {SWD(2023)  411 final}  - {SWD(2023)  412 final}  -
 {SWD(2023)  413 final}   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
• 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 dif ferent results. In many cases, these 
new techniques can lead to more targeted and precise modifications to the genome 
than conventional breeding or established genomic techniques2 and these 
modifications could or could not be produced in nature or obtained  by conventional 
breeding techniques.  
Targeted mutagenesis3 and cisgenesis4 (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 crossable5 species. 
Targeted mutagenesis and cisgenesis do not introduce genetic material from non -
crossable species -transgenesis - whereas this is the case wit h 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 breedin g 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 thes e 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 o n 
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 th e environment, there are no specific hazards linked to 
                                                 
1 An umbrella term used to describe a variety of techniques that can alter the genetic material of an 
organism and that have emerged or have been developed since 2001, when the Union legislation on 
genetically modified organisms (GMOs) was adopted.  
2 Genetic  modification techniques developed prior to 2001, when the Union GMO legislation was 
adopted.  
3 An umbrella term used to describe newer techniques of mutagenesis that induce mutation(s) in selected 
target locations of the genome without insertion of foreig n genetic material  
4 Insertion of genetic material (e.g. a gene) into a recipient organism from a donor that is sexually 
compatible (crossable). The exogenous genetic material can be introduced without (cisgenesis) or with 
modifications/rearrangements (int ragenesis).  
5 Crossable means that there are no natural barriers to the interbreeding of two plants from the same or 
different species.  EN 2  EN targeted mutagenesis or cisgenesis6. EFSA also concluded that i n targeted 
mutagenesis, the potential for unintended effects, such as off -target effects, may be 
significantly reduced compared to transge nesis 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 transit ion to more sustainable agriculture and food 
systems. The European Green Deal’s Farm to Fork Strategy7 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 security8. 
The Covid -19 pandemic and Russia’s war of aggression against Ukraine have also 
revealed the Union’s external dependencies. In its Trade Pol icy Review 
Communication9, 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 mai ntained . NGTs could be also relevant in low - and middle income 
countries, which would benefit from adapting traditional, local crop species so that 
                                                 
6 EFSA Panel on Genetically Modified Organisms , Scientific opinion addressing the safety assessment of 
plants developed using Zinc Finger Nuclease 3 and other Site -Directed Nucleases with similar function. 
EFSA Journal  2012;10(10):2943. doi:10.2903/j.efsa.2012.2943.  
 EFSA Panel on Genetically Modified Organisms, ‘Applicability of the EFSA Opinion on SDNs type 3 
for the safety assessment of plants developed using SDNs type 1 and 2 and oligonucleotide -directed 
mutagenesis’, EFSA Journal  2020;18(11):6299. https://doi.org/10.2903/j.efsa.2020.6299  
 EFSA Panel on Genetically Modified Organisms, 2012. Scientific opinion addressing the safety 
assessment of plants developed through cisgenesis and intragenesis. EFSA Journal  2012;10(2):2561.  
 EFSA Panel on Genetically Modified Organisms, 2022. Updated scientific opinion on plants developed 
through cisgenesis and intragenesis. EFSA Journal  2022;20(10):7621, 33 pp. 
https ://doi.org/10.2903/j.efsa.2022.7621 . 
 EFSA Panel on Genetically Modified Organisms, 2021. Scientific Opinion on the evaluation of existing 
guidelines for their adequacy for the molecular characterisation and environmental risk assessment of 
genetically mod ified plants obtained through synthetic biology. EFSA Journal  2021;19(2):6301, 21 pp. 
https://doi.org/10.2903/j.efsa.2021.6301   
 EFSA Panel on Genetically Modified Organisms, 2022. Scientific Opinion  on the evaluation of existing 
guidelines for their adequacy for the food and feed risk assessment of genetically modified plants 
obtained through synthetic biology. EFSA Journal 2022;20 (7):7410, 25 pp. 
https://doi.org/10.2903/j.efsa.2022.7410  
7 A Farm to Fork Strategy for a fair, healthy and environmentally -friendly food system. COM  (2020 ) 381 
final 
8 Safeguarding food security and reinforcing the resilience of food systems. COM (2022) 133 final.  
9 Trade Policy Review - An Open, Sustainable and Assertive Trade Policy. COM  (2021 ) 66 final  EN 3  EN they can withstand changing conditions. An enabling framework in the EU could 
also support use in those coun tries.  
In its judgment of 25 July 2018, in case C -528/1610 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/m ethods 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 study11 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 pot ential 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 bene ficial 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 produc ts 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:  
                                                 
10 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier 
ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C -528/16, 
ECLI:EU:C:2018:583.  
11 SWD(2021) 92  EN 4  EN Gener al objectives  
● 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 strategies12; 
● ensure the effective functioning of the internal market in NGT plants and 
products and food and feed containing, consisting or produ ced 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.  
Specific objectives  
● 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 pla nt 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 scop e 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 cisgen esis 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 en vironment 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 ou t in the Farm to Fork and Biodiversity Strategies and in  the proposal 
for a regulation on the sustainable use of plant protection products13. 
The placing on the market and cultivation of NGT plant and forest reproductive 
material  will also have to comply wi th Union legislation on the marketing of seeds 
                                                 
12 EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final  
 
13 COM (2022)305 final, 2022/0196 (COD), https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A52022PC 0305&qid=1674645473396  EN 5  EN 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 qualit y, 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 ther efore fully compatible.  
This proposal shares objectives related to sustainable agriculture and food production 
with the Union legislation on organic production (Regulation (EU) 2018/84814) 
(‘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 gen omic 
techniques is incompatible with the current concept of organic production in the 
Regulation (EC) 2018/848 and current consumers’ perception of organic products.  
2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis  
The proposal is based on Ar ticles 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 t o 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 with in 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 Str ategy 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 cur rent 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 hi nder the free movement of these  plants and  products, fragment 
the internal market and lead to uneven competition between economic operators.  
                                                 
14 OJ L 150, 14.6.2018, p. 1 –92. 
15  SWD(2023) 411  EN 6  EN • 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) der ived 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 produce d 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 deriv ed 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 pro tection 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.  
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• 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 de velopments 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 co nfirmed 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 strategy18 was prepared to gath er 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 
                                                 
16 Food Chain Evaluation Consortium (2010)  
17 GHK Consulting (2011)  
18 https://food.ec.europa.eu/system/files/2022 -09/sc_modif -genet_consultation -strategy -ngts.pdf   EN 7  EN agri-food sector; academic and research stakehold ers 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 Assessment19 (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 framewor k. 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 diffe rent 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 assessmen t 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, ornamenta l 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 majori ty 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 no t 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 
                                                 
19 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/13119 -Legislation -for-plants -
produced -by-certain -new-genomic -techniques_en  
20 https://ec.europa.eu/info/law/better -regulation/have -your-say/initiatives/13119 -Legislation -for-plants -
produced -by-certain -new-genomic -techniques/public -consultation_en  EN 8  EN single trait. On the other s ide, 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), w hile 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 techni que 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 an d 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 curre nt 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 techn iques.  
• 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 techniques21; 
● 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 pipeline22. The impact assessment also relies on the 
                                                 
21  https://doi.org/10.2875/282347  
22 Schneider, K., Barreiro -Hurle, J., Kessel, G., et al ., 2023. Economic and environmental impacts of 
disease resistant crops developed with cisgenesis. EUR 31355, Publication office of the European 
Union, Luxembourg ; Sánchez , B., Barro, F., Smulders, M. J. M. et al. 2023. Socioeconomic impact of 
low-gluten, celiac -safe wheat developed through gene editing, EUR 31380 EN, Publications Office of 
the European Union, Luxembourg.  EN 9  EN two JRC reports (on market applications23 and latest scientific developments 
relating to NGTs24) supporting the Commission NGT study;  
● two mandates were given to EFSA to suppo rt this impact assessment 
(statement on criteria for risk assessment25 and update of EFSA’s 2012 opinion 
on cisgenesis26). 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 202327. 
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 targ eted 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 co uld 
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 p rofiles 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.  
                                                 
23 Parisi, C. and Rodriguez Cerezo, E., Current and f uture market applications of new genomic techniques, 
EUR 30589 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978 -92-76-
30206 -3, doi:10.2760/02472, JRC123830.  
24 Broothaerts, W., Jacchia, S. , Angers, A.  et al ., New Genomic Techniques:  State -of-the-Art Review, 
EUR 30430 EN, Publications Office of the European Union, Luxembourg, 2021, ISBN 978 -92-76-
24696 -1, doi:10.2760/710056, JRC121847 ; European Commission, Directorate -General for Research 
and Innovation, New techniques in agricultural  biotechnology, Publications Office, 2017, 
https://data.europa.eu/doi/10.2777/574498  
25 EFSA Panel on Genetically Modified Organisms, 2022. Statement on criteria for risk assessment of 
plants produce d by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 
12 pp. https://doi.org/10.2903/j.efsa.2022.7618  
26 EFSA Panel on Genetically Modified Organisms, 2022. Updated scientific opinion on plants developed 
through cisgenesis and intragenesis. EFSA Journal 2022;20(10):7621, 33 pp., 
https://doi.org/10.2903/ j.efsa.2022.7621  
27 SWD(2023) 41 2 EN 10  EN 5. Option 4 : verification  procedure28 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, r isk 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 equival ence 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 ensu res 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 t hat 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 
enab ling 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 propo rtionate 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 administrat ions, 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 a gri-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 t he 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 
                                                 
28 In the impact assessment, this verification procedure is referred to as ‘notification procedure’. That 
terminology is not used in the legislative proposal to avoid confusion with the notification procedure in 
Directive 20 01/18/EC.  EN 11  EN Union. Regulatory incentives would help steer the development of NGTs to wards 
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 t he 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 s ub-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 produc tion. 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  Law29 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 Clima te Change30 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  consumpt ion and production),  SDG13  (Take  
                                                 
29 Regulation (EU) 2021/1119  
30 COM  (2021) 82 final  EN 12  EN 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  asses sment  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 effectivene ss, 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 202331. 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 comprehensi ve 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 thi s 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 bur den 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 asse ssment 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 facil itating 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 
                                                 
31 SEC(2023) 411  EN 13  EN 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 o f 
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 o f 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 requireme nts 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 complia nce costs for operators.   
4. BUDGETARY  IMPLICATIONS  
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 b udgetary  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 w ill 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.  EN 14  EN 5. OTHER  ELEMENTS  
• 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 p resented 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 n o sooner than two years after the first monitoring 
report has been published.  
• Explanatory  documents  (for directives)  
n/a 
• 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 o ne 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.  
Chapte r 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 pla nts 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 EN 15  EN 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 D irective 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 pro file monitoring requirements and the need for 
regular renewal.  
Regulatory incentives (section 4 Art. 2 2) 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 sustainab ility 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 t raceability 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. 2 3). 
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 s uch NGT plants in organic and conventional crops  (section 4  Art. 2 4). 
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).  EN 16  EN 2023/0226 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
on plants obtained by certain new genomic techniques and their food and feed, and 
amending Regulation (EU) 2017/625  
(Text with EEA  relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Articles 43, 114 and 168(4) (b) thereof,  
Having regard to the proposal from the European Comm ission,  
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opinion of the European Economic and Social Committee,  
Having regard to the opinion of the Committee of the Regions,  
Acting in accordance with the o rdinary legislative procedure,  
Whereas:  
(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the 
Council (1), on the deliberate release of genetically modified organisms (GMOs) into 
the environment was adopted, significant progress in biotechnology has led to the 
development of new genomic techniques (NGTs), most prominently genome editing 
techniques that enabl e changes to be made to the genome at precise locations.  
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used 
in various ways to achieve different results and products. They can result in organisms 
with modifications equ ivalent to what can be obtained by conventional breeding 
methods or in organisms with more complex modifications. Among NGTs, targeted 
mutagenesis and cisgenesis (including intragenesis) introduce genetic modifications 
without inserting genetic material fr om non -crossable species (transgenesis). They rely 
only on the breeders’ gene pool, i.e. the total genetic information that is available for 
conventional breeding including from distantly related plant species that can be 
crossed by advanced breeding techn iques. Targeted mutagenesis techniques result in 
modification(s) of the DNA sequence at precise locations in the genome of an 
organism. Cisgenesis techniques result in the insertion, in the genome of an organism, 
of genetic material already present in the breeders’ gene pool.  Intragenesis is a subset 
of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic 
material composed of two or more  DNA sequences already present in the breeders’ 
gene pool.  
                                                 
1 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the 
deliberate release into the environment of genetically modified organisms and repealing  Council 
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).  EN 17  EN (3) There is ongoing public and private research using NGTs on a wider variety of crops 
and traits compared to those obtained through transgenic techniques authorised in the 
Union or globally(2). This includes plants with improved tolerance or resistance to 
plant diseases and pests, plan ts with improved tolerance or resistance to climate 
change effects and environmental stresses, improved nutrient and water -use efficiency, 
plants with higher yields and resilience and improved quality characteristics. These 
types of new plants, coupled wit h the fairly easy and speedy applicability of those new 
techniques, could deliver benefits to farmers, consumers and to the environment. Thus, 
NGTs have the potential to contribute to the innovation and sustainability goals of the 
European Green Deal (3) and of the ‘Farm to Fork’ (4), Biodiversity (5) and Adaptation 
to Climate Change(6) Strategies, to global food security (7), the Bioeconomy Strategy 
(8) and to the Union’s strategic autonomy (9).  
(4) The deliberate release into the environment of organisms  obtained by NGTs, including 
products containing or consisting of such organisms, as well as the placing on the 
market of food and feed produced from these organisms, are subject to Directive 
2001/18/EC and, Regulation (EC) No 1830/2003 (10) of the European  Parliament and 
of the Council and, in the case of food and feed, also to Regulation (EC) No 
1829/2003 (11), while the contained use of plant cells is subject to Directive 
                                                 
2 Insights and solutions stemming from EU -funded research and innovation projects on plant breeding 
strategies may contribute to address detection challenges, ensure traceability and authenticity, and 
promote innovation in the area of new genomic techniques. More than 1,000 projects were funded 
under the Seventh Framework Programme and successor Horizon 2020 programme with an investment 
of over 3 billion Euros. Horizon Europe support to new collabor ative research projects on plant 
breeding strategies is also ongoing, SWD(2021) 92.  
3 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions, The European Green  Deal, 
COM/2019/640 final.  
4 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, 
healthy and environmentally friendly fo od system, COM/2020/381 final.  
5 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: 
Bringing nature back into our lives,  COM/2020/380 final.  
6 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions forging a Climate -Resilient Europe 
- The New E U Strategy on Adaptation to Climate Change , COM(2021) 82 final  
7 Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions, Safeguarding food 
security and reinforcing the resili ence of food systems, COM (2022) 133 final; Food and Agriculture 
Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978 -
92-5-137417 -7. 
8 European Commission, Directorate -General for Research and Innovation, A sust ainable bioeconomy for 
Europe – Strengthening the connection between economy, society and the environment: updated 
bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130 . 
9 Communication from the Commission to the Europea n Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, 
Sustainable and Assertive Trade Policy, COM(2021)66 final.  
10 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 
concerning the traceability and labelling of genetically modified organisms and the traceability of food 
and feed products produced from genetically modified organisms and amending Directive 2001/18/EC 
(OJ L 268, 18.10.2 003, p. 24).  
11 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 
on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).  EN 18  EN 2009/1/EC, and transboundary movements of NGT plants to third countries are 
regulated  by Regulation (EC) No 1946/2003 (‘the Union GMO legislation’).  
(5) In its judgment in case C -528/16  Confédération paysanne and Others12 the Court of 
Justice of the European Union held that  GMOs obtained by means of new 
techniques/methods of mutagenesis tha t had appeared or had been mostly developed 
since Directive 2001/18/EC was adopted could not be considered excluded from the 
scope of that Directive.   
(6) The Council, in Decision (EU) 2019/190413, requested the Commission to submit, by 
30 April 2021, a stu dy 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, depending on the conclusions of the study.  
(7) The Commission’s study on new genomic techniques (14) concluded that the Union 
GMO legislation is not fit for the purpose of regulating the deliberate release of plants 
obtained by certain NGTs and the placing on the market of related products including 
food and feed. In particular, the study c oncluded that the authorisation procedure and 
risk assessment requirements for GMOs under the Union GMO legislation are not 
adapted to the variety of potential organisms and products that can be obtained with 
some NGTs, namely targeted mutagenesis and cisg enesis (including intragenesis), and 
these requirements can be disproportionate or inadequate. The study showed that this 
is particularly the case for plants obtained by these techniques, given the amount of 
scientific evidence that is already available, i n particular on their safety. Furthermore, 
the Union GMO legislation is difficult to implement and enforce for plants obtained 
by targeted mutagenesis and cisgenesis and related products. In certain cases, genetic 
modifications introduced by these techniqu es are indistinguishable with analytical 
methods from natural mutations or from genetic modifications introduced by 
conventional breeding techniques, whereas the distinction is generally possible for 
genetic modifications introduced by transgenesis. The Un ion GMO legislation is also 
not conducive to developing innovative and beneficial products that could contribute 
to sustainability, food security and resilience of the agri -food chain.   
(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by 
targeted mutagenesis and cisgenesis and related products when deliberately released 
into the environment or placed on the market .  
(9) Based on the current scientific and technical knowledge in particular on safety aspects, 
this Regulation  should be limited to GMOs that are plants, i.e. organisms in the 
taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi 
and animals for which the available knowledge is more limited. For the same reason, 
this Regulation should on ly cover plants obtained by certain NGTs: targeted 
mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not 
by other new genomic techniques. Such NGT plants do not carry genetic material from 
                                                 
12 Judgement of the Court of Justice of 25 July 2018, Confédération paysanne and Others v Premier 
ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, C -528/16, 
ECLI:EU:C:2018:583.  
13 Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit a study in 
light of the Court of Justice’s judgment in Case C -528/16 regarding the status of novel genomic 
techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study ( OJ L 
293, 14.11.2019, p. 1 03). 
14 Study on the status of new genomic techniques under Union law and in light of the Court of Justice 
ruling in Case C -528/16 , SWD(2021) 92 final . EN 19  EN non-crossable species. GMOs produ ced by other new genomic techniques that 
introduce into an organism genetic material from non -crossable species (transgenesis) 
should remain subject only to the Union GMO legislation, given that the resulting 
plants might bear specific risks associated to the transgene. Moreover, there is no 
indication that current requirements in the Union GMO legislation for GMOs obtained 
by transgenesis need adaptation at the present time.  
(10) The legal framework for NGT plants should share the objectives of the Union G MO 
legislation to ensure a high level of protection of human and animal health and of the 
environment and the good functioning of the internal market for the concerned plants 
and products, while addressing the specificity of NGT plants. This legal framewor k 
should e nable the development and placing on the market of plants, food and feed 
containing, consisting of or produced from NGT plants  and other products containing 
or consisting of NGT plants (‘NGT products’) so as to contribute to the innovation and 
sustainability objectives of the European Green Deal and the Farm to Fork , 
Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of 
the Union agri -food sector at Union and world level.  
(11) This Regulation constitutes lex special is with regard to the Union GMO legislation. It 
introduces specific provisions for NGT plants and NGT products. However, where 
there are no specific rules in this Regulation, NGT plants and products (including food 
and feed) obtained from them should remai n subject to the requirements of the Union 
GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation 
(EU) 2017/625 on official controls or the legislation on certain products like  plant and  
forest reproductive material . 
(12) The pot ential risks of NGT plants vary, ranging from risk profiles similar to 
conventionally -bred plants to various types and degrees of hazards and risks that might 
be similar to those of plants obtained by transgenesis. This Regulation should 
therefore lay down  special rules to adjust the risk assessment and risk management 
requirements according to the potential risks or lack thereof posed by NGT plants and 
NGT products.  
(13) This Regulation should distinguish between two categories of NGT plants.  
(14) NGT plants that could also occur naturally or be produced by conventional breeding 
techniques and their progeny obtained by conventional breeding techniques (‘category 
1 NGT plants’) should be treated as plants that have occurred naturally or have been 
produced by conventional breeding techniques, given that they are equivalent and that 
their risks are comparable, thereby derogating in full from the Union GMO legislation 
and GMO related requirements in sectoral legislation . In order to ensure legal 
certaint y, this Regulation should set out the criteria to ascertain if a NGT plant is 
equivalent to naturally occurring or conventionally bred plants and lay down a 
procedure for competent authorities to verify and take a decision on the fulfillment of 
those crite ria, prior to the release or placing on the market of NGT plants or NGT 
products. Those criteria should be objective and based on science . They should cover 
the type and extent of genetic modifications that can be observed in nature or in 
organisms obtaine d with conventional breeding techniques and should include 
thresholds for both size and number of genetic modifications to the genome of NGT 
plants.  Since scientific and technical knowledge evolves rapidly in this area, the 
Commission should be empowered in accordance with Article 290 of the Treaty on the 
Functioning of the European Union to update  these criteria in light of scientific and EN 20  EN technical progress  as regards the type and extent of genetic modifications that can 
occur in nature or through conventi onal breeding . 
(15) All NGT plants that are not category 1 (‘category 2 NGT plants’) should remain 
subject to the requirements of the Union GMO legislation because they feature more 
complex sets of modifications to the genome.  
(16) Category 1 NGT plants an d products should not be subject to the rules and 
requirements of the Union GMO legislation  and to provisions in other Union 
legislation  that apply to GMOs. For legal certainty for operators and transparency, a 
declaration of the category 1 NGT plant statu s should be obtained prior to deliberate 
release, including the placing on the market.  
(17) This declaration should be obtained prior to any deliberate release of any category 1 
NGT plants for any other purpose than placing on the market, such as for field  trials 
that are to take place in the territory of the Union, since the criteria are based on data 
that is available before the field trials and does not depend on these field trials. When 
no field trials are to take place in the territory of the Union, op erators should obtain 
that declaration before placing the category 1 NGT product on the market.  
(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring 
or conventionally bred plants are unrelated to the type of activit y that requires the 
deliberate release of the NGT plant, a declaration of the category 1 NGT plant status 
made prior to its deliberate release for any other purpose than placing on the market in 
the territory of the Union should also be valid for the placi ng on the market of related 
NGT products. In view of the high uncertainty existing at the field trial stage about the 
product reaching the market and the likely involvement of smaller operators in such 
releases, the verification procedure of category 1 NGT  plant status prior to field trials 
should be conducted by national competent authorities as this would be less 
administratively burdensome for operators, and a decision should be taken at Union 
level only in case there are comments  to the verification rep ort by other national  
competent authorities. Where the verification request is submitted prior to the placing 
on the market of NGT products, the procedure should be conducted at Union level in 
order to ensure effectiveness of the verification procedure and  consistency of the 
category 1 NGT plant status declarations.  
(19) The competent authorities of the Member States, the Commission and the European 
Food Safety Authority (‘the Authority’) should be subject to strict deadlines to ensure 
that category 1 NGT p lant status declarations are made within a reasonable time.  
(20) The verification of category 1 NGT plant status is of technical nature and does not 
involve any risk assessment or risk management considerations and the decision on the 
status is only decla ratory. Therefore, when the procedure is conducted at Union level, 
such implementing decisions should be adopted by the advisory procedure,  supported 
by scientific and technical assistance by the Authority.  
(21) Decisions declaring  the category 1 NGT plant  status  should assign an identification 
number to the NGT plant concerned in order to ensure transparency and traceability of 
such plants when they are listed in the database and for the purpose of labelling of 
plant reproductive material derived  from them .  
(22) Category 1 NGT plants should remain subject to any regulatory framework that 
applies to conventionally bred plants. As is the case for conventional plants and 
products, those NGT plants and their products will be subject to the applicable sectoral 
legislation on seed and other plant reproductive material, food, feed and other EN 21  EN products, and horizontal frameworks, such as the nature conservation legislation and 
environmental liability. In this regard, category 1 NGT food featuring a significantly 
chan ged composition or structure that affects the nutritional value, metabolism or level 
of undesirable substances of the food will be considered as novel food and thus fall 
into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the 
Coun cil (15) and will be risk assessed in that context.  
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic 
production and labelling of organic products and repealing Council Regulation (EC) 
834/2007(16) prohibits the use of GMOs and products from and by GMOs in organic 
production. It defines GMOs for the purposes of that Regulation by reference to 
Directive 2001/18/EC, excluding from the prohibition GMOs which have been 
obtained through the techniques of genetic modification liste d in Annex 1.B of 
Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic 
production. However, it is necessary to clarify the status of category 1 NGT plants for 
the purposes of organic production. The use of new genomic techniqu es is currently 
incompatible with the concept of organic production in the Regulation (EC) 2018/848 
and with consumers’ perception of organic products. The use of category 1 NGT 
plants should therefore be also prohibited in organic production.  
(24) Provisi on should be made to ensure transparency as regards the use of category 1 NGT 
plant varieties, to ensure that production chains that wish to remain free from NGTs 
can do so and thereby safeguard consumer trust. NGT plants that have obtained a 
category 1 NG T plant status declaration should be listed in a publicly available 
database. To ensure traceability, transparency and choice for operators, during 
research and plant breeding, when selling seed to farmers or making plant reproductive 
material available to  third parties in any other way, plant reproductive material of 
category 1 NGT plants should be labelled as category 1 NGT.   
(25) Category 2 NGT plants should remain subject to the requirements of the Union GMO 
legislation given that on the basis of curren t scientific and technical knowledge, their 
risks need to be assessed. Special rules should be provided in order to adapt the 
procedures and certain other rules laid down in Directive 2001/18/EC and Regulation 
(EC) No 1829/2003 to the specific nature of ca tegory 2 NGT plants and the differing 
levels of risk that they may pose.  
(26) Category 2 NGT plants and products, in order to be released into the environment or 
placed on the market, should remain subject to a consent or authorisation in 
accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003. However, 
given the wide variety of those NGT plants, the amount of information necessary for 
the risk assessment will vary on a case -by-case basis. The Authority, in its scientific 
opinions on plants de veloped through cisgenesis and intragenesis17 and on plants 
                                                 
15 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on 
novel fo ods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council 
and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and 
Commission Regulation (EC) No 1852/2001  (OJ L 327, 11.12.2015, p. 1 ). 
16 Regul ation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic 
production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ 
L 150, 14.6.2018, p. 1).  
17 EFSA GMO Panel (EFSA Panel on Genetica lly Modified Organisms), Mullins E, Bresson J -L, Dalmay 
T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogu é F, 
Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta, J, Fernandez Dumont A, 
Gennaro A, Lenzi , P, Lewandowska A, Munoz Guajardo IP, Papadopoulou N and Rostoks N, 2022. 
 EN 22  EN developed through targeted mutagenesis18 recommended flexibility in data 
requirements for the risk assessment of these plants. Based on the Authority’s ‘Criteria 
for risk assessment of plants produced by targeted mutagenesis, cisgenesis and 
intragenesis’ (19), considerations on the history of saf e use, familiarity for the 
environment and the function and structure of the modified/inserted sequence(s) 
should assist in determining the type and amount of data required to perform the risk 
assessment of those NGT plants. It is therefore necessary to es tablish general 
principles and criteria for the risk assessment of these plants, while providing for 
flexibility and possibility to adapt risk assessment methodologies to scientific and 
technical progress.  
(27) Requirements on the content of notifications  for consent for the placing on the market 
of products containing or consisting of GMOs other than food or feed and on the 
content of applications for authorisation for the placing on the market of genetically 
modified food and feed are laid down in differe nt pieces of legislation. To ensure 
consistency between the notifications for consent and applications for authorisation for 
category 2 NGT products, the content of such notifications and applications  should be 
the same, except those concerning the assessm ent of food and feed safety assessment 
as these are only relevant to category 2 NGT food and feed.  
(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in 
collaboration with the European Network of GM Laboratories (ENGL), concluded th at 
analytical testing is not considered feasible for all products obtained by targeted 
mutagenesis and cisgenesis (20). When the introduced modifications of the genetic 
material are not specific to the NGT plant in question , they do not allow the 
differenti ation of the NGT plant from conventional plants. In cases where it is not 
feasible to provide an analytical method that detects, identifies and quantifies, if duly 
justified by the notifier or the applicant, the modalities to comply with analytical 
method requirements should be adapted. This should be done in the implementing acts 
adopted pursuant to this Regulation. Provision should also be made for the EURL, 
assisted by the ENGL, to adopt guidance for applicants on the minimum performance 
requirements for  analytical methods. Modalities for performing method validation may 
also be adapted.  
                                                                                                                                                         
Updated scientific opinion on plants developed through cisgenesis and intragenesis. EFSA Journal 
2022;20(10):7621, 33 pp. https://doi.org/10.2903/j.efsa.2022.7621 . 
18 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Naegeli H, Bresson J -L, Dalmay 
T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Mullins E, Nogu é F, 
Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A, Par askevopoulos 
K, Raffaello T and Rostoks N, 2020. Applicability of the EFSA Opinion on site -directed nucleases type 
3 for the safety assessment of plants developed using site -directed nucleases type 1 and 2 and 
oligonucleotide -directed mutagenesis. EFSA Jou rnal 2020;18(11):6299, 14 pp. https://doi. 
org/10.2903/j.efsa.2020.629 9. 
19 EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), Mullins E, Bresson J -L, Dalmay 
T, Dewhurst IC, Epstein MM, Firbank LG, Guerche P, Hejatko J, Moreno FJ, Naegeli H, Nogué F, 
Rostoks N, Sánchez Serrano JJ, Savoini G, Veromann E, Veronesi F, Fer nandez A, Gennaro A, 
Papadopoulou N, Raffaello T and Schoonjans R, 2022. Statement on criteria for risk assessment of 
plants produced by targeted mutagenesis, cisgenesis and intragenesis. EFSA Journal 2022;20(10):7618, 
12 pp. https://doi.org/10.2903/j.efsa .2022.7618.  
20 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained 
by new mutagenesis techniques, 26 March 2019 (JRC116289) ; 13 June 2023 (JRC133689; EUR 31521 
EN)  EN 23  EN (29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs 
after their deliberate release or placing on the market but provides for flexibilit y as to 
the design of the plan taking into account the environmental risk assessment, the 
characteristics of the GMO, of its expected use and of the receiving environment. 
Genetic modifications in category 2 NGT plants may range from changes only needing 
a limited risk assessment to complex alterations requiring a more thorough analysis of 
potential risks. Therefore, post -market monitoring requirements for environmental 
effects of category 2 NGT plants should be adapted in the light of the environmental 
risk assessment and the experience in field trials, the characteristics of the NGT plant 
concerned, the characteristics and scale of its expected use, in particular any history of 
safe use of the plant and the characteristics of the receiving environment. The refore, a 
monitoring plan for environmental effects should not be required if the category 2 
NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or 
unforeseen effects on human health or on the environment.  
(30) For reasons of proportionality, after a first renewal of the authorisation, the 
authorisation should be valid for an unlimited period, unless decided differently at the 
time of that renewal based on the risk assessment and the available information on the 
NGT plant co ncerned, subject to reassessment when new information has become 
available.  
(31) For reasons of legal certainty and good administration, the timeline for the Authority 
to deliver its opinion on an application for authorisation should only be extended when  
additional information is necessary to carry out the assessment of the application, and 
the extension should not be longer than the originally foreseen time limit unless it is 
justified by the nature of the data or exceptional circumstances.  
(32) To incr ease transparency and consumers’ information, operators should be allowed to 
complement the labelling of category 2 NGT products  as GMO with information on 
the trait conferred by the genetic modification. In order to avoid misleading or 
confusing indicatio ns, a proposal for such a labelling should be provided in the 
notification for consent or in the application for authorisation and should be specified 
in the consent or in the authorisation decision.  
(33) Regulatory incentives should be offered to potentia l notifiers or applicants for 
category 2 NGT plants and products containing traits with the potential to contribute 
to a sustainable agri -food system, in order to steer the development of category 2 NGT 
plants towards such traits. The criteria to trigger t hese incentives should focus on 
broad trait categories with the potential to contribute to sustainability (such as those 
linked to tolerance or resistance to biotic and abiotic stresses, improved nutritional 
characteristics or increased yield) and should b e based on the contribution to the value 
for sustainable cultivation and use as defined in [Article 52(1) of the Commission’s 
Proposal for a Regulation of the European Parliament and of the Council on the 
production and marketing of plant reproductive material in the Union21]. The 
applicability of the criteria across the EU does not allow a  narrower definition of traits 
to focus on specific issues or address local and regional specificities .  
(34) Incentives should consist in an accelerated procedure for  risk assessment as regards 
applications handled by a fully centralised procedure (food and feed products) and 
enhanced pre -submission advice to help developers prepare  the dossier for the purpose  
of the environmental and food and feed safety assessments, without affecting the 
                                                 
21  COM(2023) 414 final  EN 24  EN general provisions on pre -submission advice, notification of studies and consultation 
of third parties pursuant to Articles 32a, 32b and 32c of Regulation (EC) No 
178/2002(22).  
(35) Additional incentives should be afforded when the no tifier or applicant is a small or 
medium -sized enterprise (SME), to promote access to the regulatory procedures by 
these enterprises, support diversification of developers of NGT plants and encourage 
the development by small breeders of crop  species  and tr aits by means of NGTs, by 
granting fee waivers for the validation of detection methods to SMEs and more 
extensive pre -submission advice covering also the design of studies to be carried out 
for the purpose of risk assessment.  
(36) Herbicide tolerant plant s are bred to be intentionally tolerant to herbicides, in order to 
be cultivated in combination with the use of those herbicides. If such cultivation is not 
done under appropriate conditions , it may lead to development of weeds resistant to 
those herbicides or to the need to increase of quantities of herbicides applied , 
regardless of the breeding technique . For this reason, NGT plants featuring herbicide -
tolerant traits should not be eligible for incentives under this framework. However, 
this Regul ation should not take other specific measures on herbicide tolerant NGT 
plants, because such measures are taken horizontally in [the Commission’s Proposal 
for a Regulation of the European Parliament and of the Council on the production and 
marketing of pla nt reproductive material in the Union ]. 
(37) In order to enable NGT plants to contribute to the sustainability objectives of the 
Green Deal and the Farm to Fork and Biodiversity Strategies, cultivation of NGT 
plants in the Union should be facilitated. This  requires predictability for breeders and 
farmers as regards the possibility to cultivate such plants in the Union. Therefore, the 
possibility for Member States to adopt measures restricting or prohibiting the 
cultivation of category 2 NGT plants in all or  part of their territory, set out in Article 
26b of Directive 2001/18/EC would undermine those goals.   
(38) The special rules laid down in this Regulation concerning the authorisation procedure 
for category 2 NGT plants are expected to result in more cult ivation in the Union of 
category 2 NGT plants compared to the situation so far under the current Union GMO 
legislation. That renders necessary for Member States’ public authorities to define 
coexistence measures to balance the interests of producers of con ventional, organic 
and GM plants and thereby allow producers a choice between different types of 
production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land 
under organic farming by 2030.  
(39) To achieve the goal of ensuring t he effective functioning of the internal market, NGT 
plants and related products should benefit from the free movement of goods, provided 
they comply with the requirements of other Union law.  
(40) Given the novelty of the NGTs, it will be important to mon itor closely the 
development and presence on the market of NGT plants and products and evaluate any 
accompanying impact on human and animal health, the environment and 
environmental, economic and social sustainability. Information should be collected 
regul arly and within five years after the adoption of the first decision allowing the 
                                                 
22 Regulation (EC) No 178/ 2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety  (OJ L 031 1.2.2002, p. 1). EN 25  EN deliberate release or the marketing of NGT plants or NGT products in the Union, the 
Commission should carry out an evaluation of this Regulation to measure the progress 
made t owards the availability of NGT plants containing such characteristics or 
properties on the EU market.  
(41) In order to provide a high level of protection of health and environmental protection in 
relation to NGT plants and NGT products, requirements arisin g from this Regulation 
should apply in a non -discriminatory manner to products originating in the Union and 
imported from third countries.  
(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States but can be better a chieved at Union level, so that NGT plants and NGT products  
may circulate freely within the internal market , the Union may adopt measures, in 
accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on 
European Union. In accordan ce with the principle of proportionality as set out in that 
Article, this Regulation does not go beyond what is necessary in order to achieve those 
objectives.  
(43) The types of NGT plants developed and the impact of certain traits on environmental, 
socia l and economic sustainability are continuously evolving. Therefore, based on the 
available evidence of such developments and impacts, the Commission should be 
empowered in accordance with Article 290 of the Treaty on the Functioning of the 
European Union to adapt the list of traits that should be incentivized or discouraged to 
achieve the goals of the Green Deal and the Farm to Fork, Biodiversity and Climate 
Adaptation strategies.’  
(44) It is of particular importance that the Commission carry out appropria te consultations 
during its preparatory work, including at expert level, and that those consultations be 
conducted in accordance with the principles laid down in the Interinstitutional 
Agreement of 13 April 2016 on Better Law -Making (23). In particular, to ensure equal 
participation in the preparation of delegated acts, the European Parliament and the 
Council receive all documents at the same time as Member States’ experts, and their 
experts systematically have access to meetings of Commission expert groups dealing 
with the preparation of delegated acts.  
(45) In order to ensure uniform conditions for the implementation of this Regulation , 
implementing  powers should be conferred on the Commission as regards the 
information required to demonstrate that a NGT pl ant is a category 1 NGT plant, as 
regards the preparation and the presentation of the notification for that determination, 
and as regards the methodology and information requirements for the environmental 
risk assessments of category 2 NGT plants  and of N GT food and NGT feed, in 
accordance with the principles and criteria laid down in this Regulation . Those powers 
should be  exercised in accordance with Regulation (EU) No 182/2011 of the European 
Parliament and of the Council(24). 
(46) The Commission should regularly collect information in order to assess the 
performance of the legislation in achieving the development and availability of NGT 
plants and NGT products in the market that can contribute to the objectives of the 
Green Deal and the Farm to Fork, Bio diversity and Climate Adaptation strategies and 
                                                 
23 OJ L 123, 12.5.2016, p. 1  
24 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerning mechanisms for control by the Member States 
of the Commission's exerc ise of implementing powers (OJ L 55, 28.2.2011, p. 13).  EN 26  EN in order to inform an evaluation of the legislation. A broad set of indicators have been 
identified25 and should be periodically reviewed by the Commission. The indicators 
should support monitoring of potentia l risks to health or the environment of category 2 
NGT plants and related NGT products, impact of NGT plants on environmental, 
economic and social sustainability as well as impact on organic agriculture and on 
consumers acceptance of NGT products. A first monitoring report should be presented 
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. The Commission should c arry out an evaluation of this Regulation 
two years after the first monitoring report has been published, in order to allow for the 
impact of the first products going through the verification or authorisation to fully 
materialise.  
(47) Certain references t o provisions of the Union GMO legislation in Regulation (EU) 
2017/625 of the European Parliament and of the Council (26) need to be amended to 
include the specific provisions in this legislation applicable to NGT plants.  
(48) Since the application of this R egulation requires the adoption of implementing acts, it 
should be deferred in time to allow for the adoption of such measures,  
HAVE ADOPTED THIS REGULATION:  
CHAPTER I  
GENERAL PROVISIONS  
Article 1  
Subject matter  
This Regulation lays down specific rules for the deliberate release into the environment for 
any other purpose than placing on the market of plants obtained by certain new genomic 
techniques (‘NGT plants’) and for the placing on the market of food and feed  containing, 
consisting of or produced from such plants, and of products, other than food or feed, 
containing or consisting of such plants.  
Article 2  
Scope  
This Regulation shall apply to:  
(1) NGT plants;  
                                                 
25  SWD(2023) 412  
26 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official 
controls and other official activities performed to ensure the application of foo d and feed law, rules on 
animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 
999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 
652/2014, (EU) 2016/429 and (EU) 2016/ 2031 of the European Parliament and of the Council, Council 
Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 
2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) 
No 882/20 04 of the European Parliament and of the Council, Council Directives 89/608/EEC, 
89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 
92/438/EEC (Official Controls Regulation)  (OJ L 95, 7.4.2017, p. 1 ). EN 27  EN (2) food containing , consisting of or produced from NGT plants , or containing 
ingredients produced from NGT plants;   
(3) feed containing, consisting or produced from NGT plants;  
(4) products, other than food and feed, containing or consisting of NGT plants.  
Article 3  
Definitions  
For the pu rposes of this Regulation, the following definitions shall apply:  
(1) the definitions of ‘organism’, ‘deliberate release’ and ‘placing on the market’ set out 
in Directive 2001/18/EC, those of ‘food’ and ‘feed’ set out in Regulation (EC) No 
178/2002, that o f ‘traceability’ set out in Regulation (EC) No 1830/2003, that of 
‘plant’ set out in Regulation (EU) 2016/2031 of the European Parliament and of the 
Council(27) and that of ‘plant reproductive material’ set out in [ the Commission’s 
Proposal for a Regulation  of the European Parliament and of the Council on the 
production and marketing of plant reproductive material in the Union28];  
(2) ‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or  
cisgenesis, or a combination thereof, on the condition that it does not contain any 
genetic material originating from outside the breeders’ gene pool that temporarily 
may have been inserted during the development of the NGT plant;  
(3) ‘genetically modified organism’ or ‘GMO’ means a genetically modified organism 
as defined in Article 2(2) of Directive 2001/18/EC, excluding organisms obtained 
through the techniques of genetic modification listed in Annex I B to Directive 
2001/18/EC;  
(4) ‘targeted mutagenesis’ means mutagenesis techniques resulting  in modification(s) of 
the DNA sequence at precise locations in the genome of an organism;  
(5) ‘cisgenesis’ means techniques of genetic modification resulting in the insertion, in 
the genome of an organism, of genetic material already present in the breed ers’ gene 
pool;  
(6) ‘breeders’ gene pool’ means the total genetic information available in one species 
and other taxonomic species with which it can be cross -bred, including by using 
advanced techniques such as embryo rescue, induced polyploidy and bridge  crosses ; 
(7) ‘category 1 NGT plant’ means a NGT plant that:  
(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I, or  
(b) is progeny of the NGT plant(s) referred to in point (a), including progeny 
derived by crossing of such p lants, on the condition that there are no further 
modifications that would make it subject to Directive 2001/18/EC or 
Regulation 1829/2003;  
                                                 
27 Regulation (EU)  2016/2031 of the European Parliament and of the Council of 26 October 2016 on 
protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 
652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repe aling Council 
Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC  
(OJ L 317, 23.11.2016, p. 4 ). 
28  COM(2023) 414 final  EN 28  EN (8) ‘category 2 NGT plant’ means a NGT plant  other than a category 1 NGT plant;  
(9) ‘NGT plant for food use’ means a  NGT plant that may be used as food or as a source 
material for the production of food;   
(10) ‘NGT plant for feed use’ means a NGT plant that may be used as feed or as a source 
material for the production of feed;  
(11) ‘produced from a NGT plant’ means der ived, in whole or in part, from a NGT plant, 
but not containing or consisting of a NGT plant;  
(12) ‘NGT product’ means a product, other than food and feed, containing or consisting 
of a NGT plant and food and feed containing, consisting of or produced from  such a 
plant;  
(13) ‘category 1 NGT product’ means a NGT product where the NGT plant it contains, 
consists of or, in the cases of food or feed, is produced from, is a category 1 NGT 
plant;  
(14) ‘category 2 NGT product’ means a NGT product where the NGT pla nt it contains, 
consists of or, in the cases of food or feed, is produced from, is a category 2 NGT 
plant;  
(15) ‘small or medium sized enterprise (SME)’ means a SME within the meaning of 
Commission Recommendation 2003/361/EC2. 
Article 4  
Deliberate release  of NGT plants for any other purpose than placing on the market and 
placing on the market of NGT products  
Without prejudice to other requirements of Union law, a NGT plant may only be deliberately 
released into the environment for any other purpose than placing on the market, and a NGT 
product may only be placed on the market, if:  
(1) the plant is a category 1 NGT plant and  
(a) has obtained a decision declaring that status in accordance with Article 6 or 7; 
or 
(b) is progeny of plant(s) referred to in point (a); or  
(2) the plant is a category 2 NGT plant  and has been authorised in accordance with 
Chapter III.  
CHAPTER II  
Category 1 NGT plants and category 1 NGT products  
Article 5  
Status of category 1 NGT plants  
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 
NGT plants.  
2. For the purposes of Regulation (EU) 2018/848, the rules set out in its Articles 5 (f) 
(iii) and 11 shall apply to category 1  NGT plants  and to products produced from or 
by such plants . EN 29  EN 3. The Commission is empowered to adopt delegated acts  in accordance with Article 26 
amending the criteria of equivalence of NGT plants to conventional plants laid down 
in Annex I in order to adapt them to scientific and technological progress  as regards 
the types and extent of modifications which can occur naturally or through 
conventional breeding . 
Article 6  
Verification procedure of category 1 NGT plant status prior to the deliberate release for 
any other purpose than placing on the market  
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1) , 
point (a),  before undertaking a deliberate release of a NGT plant for any other 
purpose than placing on the market, the person intending to undertake the deliberate 
release shall submit  a request to verify  whether the criteria set out in Annex I are met 
(‘verification request’ ) to the competent authority designated in accordance with 
Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the 
release is to take place in accordance with paragraphs 2 and 3 and the implementing 
act ad opted in accordance with  Article 27, point (b).  
2. Where a person intends to undertake such a deliberate release simultaneously in 
more than one Member State, that person shall submit the verification request to the 
competent authority of one of those Member States.  
3. The verification request referred to  in paragraph 1 shall be submitted in accordance 
with standard data formats, where they exist pursuant to Article 39f of Regulation 
(EC) No 178/2002, and shall include, without prejudice to any additional information 
that may be required in accordance with  Article 32b of Regulation (EC) No 
178/2002:  
(a) the name and the address of the requester;  
(b) the designation and specification of the NGT plant;  
(c) a description of the trait(s) and characteristics which have been introduced or 
modified;  
(d) a copy of  the studies, which have been carried out and any other available 
material to demonstrate that:  
(i) the plant is a NGT plant, including that it does not contain any genetic 
material originating from outside the breeders’ gene pool where such 
genetic materi al has been temporarily  inserted during the development of 
the plant, in accordance with the information requirements specified in 
the implementing act adopted in accordance with  Article 27, point (a) ; 
(ii) the NGT plant meets the criteria set out in Annex  I; 
(e) in the cases referred to in paragraph 2, an indication of the Member States in 
which the requester intends to undertake the deliberate release;  
(f) an identification of the parts of the verification request and any other 
supplementary information t hat the requester demands to be treated as 
confidential, accompanied by verifiable justification, pursuant to Article 11 of 
this Regulation and Article 39 of Regulation (EC) No 178/2002.  EN 30  EN 4. The competent authority shall acknowledge receipt of the verificat ion request to the 
requester without undue delay, stating the date of receipt. It shall make available the 
request to the other Member States and to the Commission without undue delay.  
5. If the verification request does not contain all the necessary info rmation, it shall be 
declared inadmissible by the competent authority within 30 working days within the 
date of receipt of a verification request. The competent authority shall inform the 
requester, the other Member States and the Commission without undue delay of the 
inadmissibility of the verification request and shall provide the reasons of its 
decision.  
6. If the verification request is not deemed inadmissible in accordance with paragraph 
5, the competent authority shall verify whether the NGT plant fu lfils the criteria set 
out in Annex I and prepare a verification report within 30 working days from the date 
of receipt of a verification request. The competent authority shall make available the 
verification report to the other Member States and to the Co mmission without undue 
delay.  
7. The other Member States and the Commission may make comments to the 
verification report within 20 days from the date of receipt of that report.  
8. In the absence of any comments from a Member State or the Commission, withi n 10 
working days from the expiry of the deadline referred to in paragraph 7, the 
competent authority that prepared the verification report shall adopt a decision  
declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the 
decision wi thout undue delay to the requester, the other Member States and to the 
Commission.  
9. In cases where a comment  is made by another Member State or by the Commission 
by the deadline referred to in paragraph 7, the competent authority that prepared the 
verif ication report shall forward the  the comment (s) to the Commission  without 
undue delay.  
10. The Commission , after having consulted the European Food Safety Authority (‘the 
Authority’),  shall prepare a draft decision declaring whether the NGT plant is a 
category 1 NGT plant within 45 working days from the date of receipt of the 
comment(s) , taking the latter into account. The decision shall be adopted in 
accordance with the procedure refe rred to in Article 28(2) .  
11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 
and 10 in the Official Journal of the European Union .  
Article 7  
Verification procedure of category 1 NGT plant status prior to the placing on the 
market of NGT products  
1. Where a declaration of category 1 NGT plant status  referred to in Article 4(1), point 
(a), has not already been made in accordance with Article 6, to obtain  such a 
declaration before placing on the market a NGT product, the person intending to 
place the product on the market shall submit a verification request to the Authority in 
accordance with paragraph 2 and the implementing act  adopted in accordance with  
Article 27, point (b).  
2. The verification  request referred to in paragraph 1 shall be submitted to the Authority 
in accordance with standard data formats, where they exist, pursuant to Article 39f of EN 31  EN Regulation (EC) No 178/2002, and shall include, without prejudice to any additional 
information that may be required i n accordance with Article 32b of Regulation (EC) 
No 178/2002:  
(a) the name and the address of the requester;  
(b) the designation and specification of the NGT plant;  
(c) a description of the trait(s) and characteristics which have been introduced or 
modifie d; 
(d) a copy of the studies, which have been carried out and any other available 
material to demonstrate that:  
(i) the plant is a NGT plant, including that it does not contain any  genetic 
material originating from outside the breeders’ gene pool where suc h 
genetic material has been temporarily  inserted during the development of 
the plant, in accordance with the information requirements specified in 
the implementing act adopted in accordance with  Article 27, point (a) ; 
(ii) the NGT plant meets the criteria set out in Annex I;  
(e) an identification of the parts of the verification  request and any other 
supplementary information that the requester demands to be treated as 
confidential, accompanied by verifiable justification, pursuant to Article 11 of 
this Reg ulation and Article 39 of Regulation (EC) No 178/2002.  
3. The Authority shall acknowledge receipt of the verification  request to the requester 
without delay, stating the date of receipt. It shall make available the verification  
request to the Member States  and to the Commission without undue delay and make 
public the verification  request, relevant supporting information and any 
supplementary information supplied by the requester, in accordance with article 
38(1) of Regulation  (EC) No 178/2002, after omissio n of any information identified 
as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 
178/2002 and Article 11 of this Regulation . 
4. If the verification  request does not contain all the necessary information, it shall be 
declared inad missible by the Authority within 30 working days within the date of 
receipt of a verification  request. The Authority shall inform the requester, the 
Member States and the Commission without undue delay of the inadmissibility of the 
verification  request and  shall provide the reasons of its decision.  
5. If the verification request is not deemed inadmissible in accordance with paragraph 
4, the Authority shall deliver its statement on whether the NGT plant fulfils the 
criteria set out in Annex I within 30 working days from the date of receipt of a 
verification request. The Authority shall make available the statement to the 
Commission and the Member States. The Authority, in accordance with Article 38(1) 
of Regulation (EC) No 178/2002, shall make its statem ent public, after omission of 
any information identified as confidential in accordance with Articles 39 to 39e of 
Regulation (EC) No 178/2002 and Article 11 of this Regulation.  
6. The Commission shall prepare a draft decision declaring whether the NGT plan t is a 
category 1 NGT plant within 30 working days from the date of receipt of the 
statement of the Authority, taking the latter into account. The decision shall be 
adopted in accordance with the procedure referred to in Article 28(2).  EN 32  EN 7. The Commission sh all publish a summary of the decision in the Official Journal of 
the European Union .  
Article 8  
System of exchange of information between Member States, the Commission and the 
Authority  
The Commission shall set up and maintain an electronic system for the submission of 
verification requests in accordance with Articles 6 and 7 and the exchange of the information 
under this Title.  
Article 9  
Database of decisions declaring the category 1 NGT plant status  
1. The Commission shall establish and maintain a datab ase listing the decisions 
declaring the category 1 NGT plant status adopted in accordance with Article 6( 8) 
and (1 0) and Article 7(6).   
The database shall contain the following information:  
(a) name and the address of the requester;  
(b) the designation of the category 1 NGT plant;  
(c) a summarised description of the technique(s) used to obtain the genetic 
modification;  
(d) a description of the trait(s) and characteristics which have been introduced or 
modified;  
(e) an identification number, and  
(f) the decision referred to in Article 6( 8) or (1 0), and Article 7(6), as appropriate.  
2. The database shall be publicly available.  
Article 10  
Labelling of category 1 NGT plant reproductive material, including breeding material  
Plant reproductive material, including for breeding and scientific purposes, that contains or 
consists of category 1 NGT plant(s) and is made available to third parties, whether in return 
for payment or free of charge, shall bear a label indicating the words ‘cat 1 NGT’, followed 
by the identification number of the NGT plant(s) it has been derived from.  
Article 11  
Confidentiality  
1. The requester referred to in Articles 6 and 7 may submit a request to the Member 
State competent authority or to the Authority, as appropriate, to treat c ertain parts of 
the information submitted under this Title as confidential, accompanied by verifiable 
justification, in accordance with paragraphs 3 and 6.  
2. The competent authority or the Authority, as appropriate, shall assess the 
confidentiality reque st referred to in paragraph 1.  EN 33  EN 3. The competent authority or the Authority, as appropriate, may grant confidential 
treatment only with respect to the following items of information, upon verifiable 
justification, where the disclosure of such information i s demonstrated by the  
requester to potentially harm its interests to a significant degree:  
(a) items of information referred to in points (a), (b) and (c) of Article 39(2) of 
Regulation (EC) No 178/2002;  
(b) DNA sequence information; and  
(c) breeding p atterns and strategies.  
4. The competent authority or the Authority, as appropriate, shall, after consultation 
with the requester, decide which information is to be treated as confidential and shall 
inform the requester of its decision.  
5. Member States,  the Commission and the Authority shall take the necessary measures 
to ensure that confidential information notified or exchanged under this Chapter is 
not made public.  
6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall  
apply mutatis mutandis.  
7. In the event of a withdrawal of the verification request by the requester, Member 
States, the Commission and the Authority shall respect the confidentiality as granted 
by the competent authority or the Authority in accordance w ith this Article. Where 
the withdrawal of the verification request takes place before the competent authority 
or the Authority has decided on the relevant confidentiality request, Member States, 
the Commission and the Authority shall not make public the in formation for which 
confidentiality has been requested.  
CHAPTER III  
Category 2 NGT plants and category 2 NGT products  
Article 12 
Status of Category 2 NGT plants and category 2 NGT products  
The rules which apply to GMOs in Union legislation in so far as they are not derogated from 
by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.  
SECTION  1  
DELIBERATE RELEASE OF  CATEGORY 2 NGT  PLANTS FOR ANY OTHE R PURPOSE 
THAN FOR PLACING ON THE MARKET  
Article 13  
Content of the notification referred in Article 6 of Directive 2001/18/EC  
As regards the deliberate release of a category 2 NGT plant for any other purpose than placing 
on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall 
include:  
(a) the name and the address of the notifier;  EN 34  EN (b) a copy of the studies, which have been carried out and any other available material to 
demonstrate that the plant is a NGT plant, including that it does not contain any 
genetic material originating from outsi de the breeders’ gene pool where  such genetic 
material has been temporarily inserted during the development of the plant, in 
accordance with the information requirements specified in the implementing act 
adopted in accordance with  Article 27, point (a) ; 
(c) a technical dossier supplying the information specified in Annex II necessary to carry 
out the environmental risk assessment of the deliberate release of a NGT plant or 
combination of NGT plants:  
(i) general information including information on personnel  and training;  
(ii) information relating to the category 2 NGT plant(s);  
(iii) information relating to the conditions of release and the potential receiving 
environment;  
(iv) information on the interactions between the category 2 NGT plant(s) and the 
environment;  
(v) a plan for monitoring in order to identify effects of the category 2 NGT plant(s) 
on human health or the environment;  
(vi) where relevant, information on control, remediation methods, waste treatment 
and emergency response plans;  
(vii) an identification of the parts of the notification and any other supplementary 
information that the notifier requests to be treated as confidential, accompanied 
by verifiable justification, pursuant to Article 25 of Directive 2001/18;  
(viii)  a summary of the dossier;  
(d) the environmental risk assessment carried out in accordance with the principles and 
criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in 
accordance with  Article 27, point (c).  
SECTION  2 
PLACI NG ON THE MARKET OF CATEGORY 2 NGT  PRODUCTS OTHER THAN FOOD 
OR FEED  
Article 14  
Content of the notification referred to in Article 13 of Directive 2001/18/EC  
1. As regards the placing on the market  of category 2 NGT products other than food 
and feed , the no tification referred to in Article 13(2) of Directive 2001/18/EC, 
without prejudice to any additional information that may be required in accordance 
with Article 32b of Regulation (EC) No 178/2002, shall contain:  
(a) name and address of the notifier and of its representative established in the 
Union (if the notifier is not established in the Union);   
(b) designation and specification of the category 2 NGT plant;  
(c) scope of the notification:  
(i) cultivation;  
(ii) other uses (to be specified in the notification);  EN 35  EN (d) a copy of the studies, which have been carried out and any other available 
material to demonstrate that the plant is a NGT plant, including that it does not 
contain any genetic material originating from outs ide the breeders’ gene pool 
where such genetic material has been temporarily inserted during the 
development of the plant, in accordance with  the information requirements 
specified in the implementing act adopted in accordance with  Article 27, point 
(a); 
(e) the environmental risk assessment carried out in accordance with the principles 
and criteria set out in Parts 1 and 2 of Annex II and with the implementing act 
adopted in accordance with  Article 27, point (c);  
(f) the conditions for the placing on the m arket of the product, including specific 
conditions of use and handling;  
(g) with reference to Article 15(4) of Directive 2001/18/EC, a proposed period for 
the consent, which should not exceed 10 years;  
(h) where appropriate, a monitoring plan for environm ental effects in accordance 
with Annex VII to Directive 2001/18/EC, including a proposal for the time -
period of the monitoring plan; this time -period may be different from the 
proposed period for the consent. If, based on the results of any release notifie d 
in accordance with Section 1, the findings of the environmental risk 
assessment, the characteristics of the NGT plant, the characteristics and scale 
of its expected use and the characteristics of the receiving environment, in 
accordance with the implemen ting act adopted in accordance with  Article 27, 
point (d), the notifier considers that the NGT plant does not need a monitor ing 
plan, the notifier may propose not to submit a monitoring plan;  
(i) a proposal for labelling which shall comply with the requir ements laid down in 
point A.8. of Annex IV to Directive 2001/18/EC, Article 4(6) of Regulation 
(EC) No 1830/2003 and Article 23 of this Regulation;  
(j) proposed commercial names of the products and names of category 2 NGT 
plants contained therein, and a p roposal for a unique identifier for the category 
2 NGT plant, developed in accordance with Commission Regulation (EC) 
No 65/2004  (29). After the consent any new commercial names should be 
provided to the competent authority;  
(k) description of how the produ ct is intended to be used. Differences in use or 
management of that product compared to similar non -genetically modified 
products shall be highlighted;  
(l) methods for sampling (including references to existing official or standardised 
sampling methods), detection, identification and quantification of the NGT 
plant. In cases where it is not feasible to provide an analytical method that 
detects, identifies and  quantifies, if duly justified by the notifier, the modalities 
to comply with analytical method requirements shall be adapted as specified in 
the implementing act adopted in accordance with  Article 27, point (e) and the 
guidance referred to in Article 29(2 );  
                                                 
29 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the 
development and assignment of unique identifiers for genetically modified organisms  (OJ L 10, 
16.1.2004, p. 5 ). EN 36  EN (m) samples of the category 2 NGT plant and their control samples, and 
information as to the place where the reference material can be accessed;  
(n) where applicable, the information to be provided for the purpose of complying 
with Annex II to the Cart agena Protocol on Biosafety to the Convention on 
Biological Diversity;  
(o) an identification of the parts of the notification and any other supplementary 
information that the notifier requests to be treated as confidential, accompanied 
by verifiable justif ication, pursuant to Article 25 of Directive 2001/18 /EC and 
Articles 39 to 39e of Regulation (EC) No 178/2002;  
(p) a summary of the dossier in a standardised form.  
2. The notifier shall include in this notification information on data or results from 
releases of the same category 2 NGT plant or the same combination of category 2 
NGT plants previously or currently notified and/or carried out by the notifier either 
inside or outside the Union.  
3. The competent authority that prepares the assessment  report  referred to in Article 14 
of Directive 2001/18/EC shall examine the notification for compliance with 
paragraphs 1 and 2.  
Article 15  
Specific provisions on monitoring  
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify 
monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not 
required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not 
required by the consent.  
Article 16  
Labelling in accordance w ith Article 23  
In addition to Article 19(3) of Directive 2001/18/EC, the written consent shall specify the 
labelling in accordance with Article 23 of this Regulation.  
Article 17  
Duration of the validity of the consent after renewal  
1. The consent granted under Part C of Directive 2001/18/EC shall, after the first 
renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an 
unlimited period, unless the decision referred to in Article 17(6) or (8)  provides that 
the renew al is for a limited period, on justified grounds based on the findings of the 
risk assessment carried out pursuant to this Regulation and on experience with the 
use, including results of monitoring, if so specified in the consent.  
2. The last sentence in Article 17(6)  and (8)  of Directive 2001/18/EC shall not apply.  EN 37  EN SECTION  3 
PLACING ON THE MARKET  OF CATEGORY 2 NGT  PLANTS FOR FOOD OR FEED 
USE AND OF CATEGORY 2 NGT  FOOD AND FEED  
Article 18  
Scope  
This Section shall apply to:  
(a) category 2 NGT plants for food use or for feed use;  
(b) food containing, consisting or produced from category 2 NGT plants or containing 
ingredients produced from category 2 NGT plants (‘category 2 NGT food’);  
(c) feed containing, consisting or produced from category 2 NGT plants ( ‘category 2 
NGT feed’).  
Article 19  
Specific provisions on the a pplication for authorisation referred to in Articles 5 and 17 
of Regulation (EC) No 1829/2003  
1. By way of derogation from Articles 5(3), point (e), and 17(3), point (e), of 
Regulation (EC) No 1829/2003, and without prejudice to any additional information 
that may be required in accordance with Article 32b of Regulation (EC) No 
178/2002, an application for authorisation of a category 2 NGT plant for food or feed 
use, or category 2 NGT food or fe ed shall be accompanied by a copy of the studies, 
including, where available, independent, peer -reviewed studies, which have been 
carried out and any other available material to demonstrate that:  
(a) the plant is a NGT plant, including that it does not con tain any genetic material 
originating from outside the breeders’ gene pool where such genetic material 
has been temporarily inserted during the development of the plant, in 
accordance with the information requirements specified in the implementing 
act adop ted in accordance with  Article 27, point (a);  
(b) the food or the feed complies with the criteria referred to in Article 4(1) or 
Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety 
assessment of the food or feed carried out in ac cordance with the principles and 
criteria laid down in Parts 1 and 3 of Annex II to this Regulation and with the 
implementing act adopted in accordance with  Article 27, point (c) . 
2. By way of derogation from Articles 5(3), point (i), and 17(3), point (i),  of Regulation 
(EC) No 1829/2003, an application for authorisation shall be accompanied by 
methods for sampling (including references to existing official or standardised 
sampling methods), detection, identification and quantification of the NGT plant and,  
where applicable, for the detection and identification of the NGT plant in the NGT 
food or feed.  
In cases where it is not feasible to provide an analytical method that detects, 
identifies and quantifies, if duly justified by the applicant or concluded by  the 
European Union Reference Laboratory referred to in Article 32 of Regulation (EC) 
No 1829/2003  during the procedure referred to in Article 20(4) , the modalities to 
comply with analytical method requirements shall be adapted as specified in the EN 38  EN implemen ting act adopted in accordance with  Article 27, point (e) and the guidance 
referred to in Article 29(2);  
3. By way of derogation from Articles 5(5) and 17(5) of Regulation (EC) No 
1829/2003, in the case of category 2 NGT plants or food or feed containing o r 
consisting of category 2 NGT plants, the application shall also be accompanied by:  
(a) the environmental risk assessment carried out in accordance with the principles 
and criteria set out in Parts 1 and 2 of Annex II and with the implementing act 
adopted in accordance with  Article 27, point (c);  
(b) where appropriate, a monitoring plan for environmental effects in accordance 
with Annex VII to Directive 2001/18/EC, including a proposal for the duration 
of the monitoring plan. This duration may be different from the duration of the 
authorisation. If, based on the results of any release notifie d in accordance with 
Section 1, the findings of the environmental risk assessment, the characteristics 
of the NGT plant, the characteristics and scale of its expected use and the 
characteristics of the receiving environment, in accordance with the 
implemen ting act adopted in accordance with  Article 27, point (d), the 
applicant considers that the NGT plant does need  a monitoring plan , the 
applicant may propose not to submit a monitoring plan.  
4. The application shall also contain a proposal for labelling in accordance with Article 
23.  
Article 20  
Specific provisions on the opinion of the Authority  
1. By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of 
Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the 
applicati on for authorisation referred to in Article 19 of this Regulation within six 
months as from the receipt of a valid application.  
Where the Authority or the competent authority of the Member State carrying out the 
environmental risk assessment or  the safety  assessment of the food or feed pursuant 
to Article 6(3) , points (b) and (c) and Article 18(3) , points (b) and (c) of Regulation 
(EC) No 1829/2003 considers that additional information is necessary, the Authority, 
or the national competent authority throug h the Authority, shall ask the applicant to 
submit that information within a specified time limit. In that case, the six months 
period shall be extended by that additional period. The extension shall not exceed six 
months unless it is justified by the natu re of the data requested or by exceptional 
circumstances.  
2. In addition to the tasks referred to in Article 6(3) and Article 18(3) of Regulation 
(EC) No 1829/2003, the Authority shall verify whether all the particulars and 
documents submitted by the appli cant are in conformity with Article 19 of this 
Regulation.  
3. By way of derogation from Article 6(3), point (d), and Article 18(3), point (d), of 
Regulation (EC) No 1829/2003, the Authority shall forward to the Union reference 
laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 the particulars 
referr ed to in Article 19(2) of this Regulation and in Article 5(3), point (j), and 
Article 17(3), point (j), of Regulation (EC) No 1829/2003.  EN 39  EN 4. The Union reference laboratory shall test and validate the method of detection, 
identification and quantification p roposed by the applicant in accordance with Article 
19(2) or assess whether the information provided by the applicant justifies the 
application of adapted modalities to comply with detection method requirements 
referred to in that paragraph.  
5. By way of d erogation from Article 6(5), point (f), and Article 18(5), point (f), of 
Regulation (EC) No 1829/2003, in the event of an opinion in favour of authorising 
the food or the feed, the opinion shall also include:  
(a) the method, validated by the Union referenc e laboratory, for detection, 
including sampling, and, where applicable, identification and quantification of 
the NGT plant and detection and identification of the NGT plant in the NGT 
food or feed, and a justification of any adaptation of the method in the cases 
referred to in Article 19(2), subparagraph 2;  
(b) an indication of where appropriate reference material can be accessed.  
6. In addition to the particulars mentioned in Article 6(5), point (d) and Article 18(5), 
point (d) of Regulation (EC) No  1829/2003, the opinion shall also include a proposal 
for labelling in accordance with Article 23  of this Regulation.  
Article 21  
Duration of the validity of the authorisation after renewal  
By way of derogation from Article 11(1) and Article 23(1) of Regul ation (EC) No 1829/2003, 
after the first renewal, the authorisation shall be valid for an unlimited period, unless the 
Commission decides to renew the authorisation for a limited period, on justified grounds 
based on the findings of the risk assessment car ried out pursuant to this Regulation and on 
experience with the use, including results of monitoring, if so specified in the authorisation . 
SECTION  4 
COMMON PROVISIONS FOR  CATEGORY 2 NGT  PLANTS AND CATEGORY  2 NGT  
PRODUCTS  
Article 22  
Incentives for categor y 2 NGT plants and category 2 NGT products containing traits 
relevant for sustainability  
1. The incentives in this Article shall apply to category 2 NGT plants and category 2 
NGT products, where at least one of the intended trait(s) of the NGT plant convey ed 
by the genetic modification is contained in Part 1 of Annex III and it does not have 
any traits referred to in Part 2 of that Annex.   
2. The following incentives shall apply to applications for authorisation submitted in 
accordance with Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction 
with Article 19:  
(a) by way of derogation from Article 20(1), subsection (1) of this Regulat ion, the 
Authority shall deliver its opinion on the application within 4 months from the 
receipt of a valid application, unless the complexity of the product requires 
application of the time limit referred to in Article 20(1). The time limit shall be 
exten dable under the conditions set out in Article 20(1), subsection (2);  EN 40  EN (b) where the applicant is a SME, it shall  be exempted from the payment of the 
financial contributions to the Union Reference Laboratory and to the European 
Network of GMO Laboratories re ferred to in Article 32 of Regulation (EC) No 
1829/2003.  
3. The following pre -submission advice for the purposes of the risk assessment 
conducted in accordance with Annex II shall, in addition to Article 32a of Regulation 
(EC) No 178/2002, apply prior to n otifications submitted in accordance with Article 
13 of Directive 2001/18/EC in conjunction with Article 14 and to applications for 
authorisation submitted in accordance with Articles 5 or 17 of Regulation (EC) No 
1829/2003 in conjunction with Article 19:  
(a) the staff of the Authority shall, at the request of a potential applicant or notifier, 
provide advice on plausible risk hypotheses that the potential applicant or 
notifier has identified based on the properties of a plant,  product or 
hypothetical plant  or product, that need to be addressed by providing the 
information under Parts 2 and 3 of Annex II. The advice shall not, however, 
cover the design of studies to address the risk hypotheses;  
(b) where the potential applicant or notifier is a SME, it may n otify the Authority 
of how it intends to address the plausible risk hypotheses referred to in point 
(a) that it has identified based on the properties of a  plant,  product or 
hypothetical plant or product, including the design of the studies it intends to 
perform in accordance with the requirements laid down Part s 2 and 3 of Annex 
II. The Authority shall provide advice on the notified information, including on 
the design of the studies.  
4. The pre -submission advice referred to in paragraph 3 shall comply wit h the 
following requirements:  
(a) it shall be without prejudice and non -committal as to any subsequent 
assessment of applications or notifications by the Panel on Genetically 
Modified Organisms of the Authority. The staff of the Authority providing the 
advice shall not be involved in any preparatory scientific or technical work that 
is directly or indirectly relevant to the application or notification that is the 
subject of the advice;  
(b) for potential notifications in accordance with Article 13 of Directi ve 
2001/18/EC in conjunction with Article 14 and for potential applications under 
Articles 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 
19 concerning a category 2 NGT plant to be used as seeds or other plant 
reproductive material, th e pre -submission advice shall be provided by the 
Authority together, or in close collaboration with the competent authority of 
the Member State to which the notification or application is going to be 
submitted;  
(c) the Authority shall make public without d elay a summary of the pre -
submission advice once an application or notification has been considered 
valid. Articles 38(1a) shall apply mutatis mutandis ; 
(d) potential applicants or notifiers demonstrating that they are a SME can request 
the pre -submission advice referred to in paragraph 3, point (a), at different 
points in time.  
5. Any request for the incentives shall be submitted to the Authority at the time of 
request of advice referred to in paragraph 3 or the application referred to in Articles 5 EN 41  EN or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 19, and 
accompanied by the following information:  
(a) the information necessary to establish that the intended trait(s) conveyed by the 
genetic modification of the category 2 NGT plant meet the conditions referred 
to in paragraph 1;  
(b)  where applicable, the information necessary to demonstrate the (potential) 
applicant or notifier is a SME;   
(c) for the purpose of paragraph 3, information on the aspects listed in Part 1 of 
Annex II as far as it  can already be provided and any other relevant 
information.  
6. Article 26 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 
shall apply to information submitted under this article to the Authority, as 
appropriate.  
7. The Authority sha ll lay down the practical arrangements to implement paragraphs (3) 
to (6).  
8. The Commission is empowered to adopt delegated acts in accordance with Article 26 
amending the lists of traits of NGT plants laid down in Annex III in order to adapt 
them to scie ntific and technological progress and to new evidence relating to the 
impact on sustainability of those traits, subject to the following conditions:  
(a) the Commission shall take into account the monitoring of the impacts of this 
Regulation in accordance w ith Article 30(3);  
(b) the Commission shall conduct an up -to-date scientific literature review of the 
impact on environmental, social and economic sustainability of the trait(s) it 
intends to add to or delete from the list in Annex III;  
(c) where applicabl e, the Commission shall take into account the results of 
monitoring which was carried out in accordance with Article 14, point (h), or 
Article 19(3), of NGT plants harbouring the trait(s) conveyed by their genetic 
modification.  
Article 23  
Labelling of auth orised category 2 NGT products  
In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, 
Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003, and Article 4(6) to (7) of 
Regulation (EC) No 1830/2003, and without pr ejudice to the requirements under other Union 
legislation, the labelling of authorised category 2 NGT products may also mention the trait(s) 
conveyed by the genetic modification, as specified in the consent or the authorisation pursuant 
to Sections 2 or 3 of Chapter III of this Regulation.  
Article 24  
Measures to avoid the unintended presence of category 2 NGT plants  
Member States shall take appropriate measures to avoid the unintended presence of category 2 
NGT plants in products not subject to Directive 2 001/18 or Regulation 1829/2003.  EN 42  EN Article 25  
Cultivation  
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plants.  
CHAPTER IV  
FINAL PROVISIONS  
Article 26  
Exercise of the delegation  
1. The power to adopt the delegated acts is conferred on  the Commission subject to the 
conditions laid down in this Article.  
2. The power to adopt the delegated acts referred to in Article 5(3) and Article 22(8) 
shall be conferred on the Commission for a period of 5 years from [date of entry into 
force of this Regulation] . The Commission shall draw up a report in respect of the 
delegation of power not later than 9 months before the end of the 5 -year period. The 
delegation of power shall be tacitly extended for periods of an identical duration, 
unless the Europea n Parliament or the Council opposes such extension not later than 
3 months before the end of each period.  
3. The delegations of power referred to in Article 5(3) and Article 22(8) may be 
revoked at any time by the European Parliament or by the Council. A d ecision to 
revoke shall put an end to the delegation of the power specified in that decision. It 
shall take effect the day following the publication of the decision in the Official 
Journal of the European Union  or at a later date specified therein. It shal l not affect 
the validity of any delegated acts already in force.  
4. Before adopting a delegated act, the Commission shall consult experts designated by 
each Member State in accordance with the principles laid down in the 
Interinstitutional Agreement of 13 April 2016 on Better Law -Making(30).  
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
6. A delegated act adopted pursuant to Articles Article 5(3) and Article 22(8) sh all enter 
into force only if no objection has been expressed either by the European Parliament 
or by the Council within a period of two months of notification of that act to the 
European Parliament and the Council or if, before the expiry of that period, t he 
European Parliament and the Council have both informed the Commission that they 
will not object. That period shall be extended by 2 months at the initiative of the 
European Parliament or of the Council.  
Article 27  
Implementing acts  
The Commission shall  adopt implementing acts concerning:  
                                                 
30 OJ L 123, 12.5.2016, p. 1.  EN 43  EN (a) the information required to demonstrate that a plant is a NGT plant;  
(b) the preparation and the presentation of the verification requests  referred to in Articles 
6 and 7;  
(c) the methodology and information require ments for the environmental risk assessment 
of category 2 NGT plants and the safety assessments of category 2 NGT food and 
feed, in accordance with the principles and criteria laid down in Annex II;  
(d) the application of Articles 14 and 19, including rule s concerning the preparation and 
the presentation of the notification or application;  
(e) adapted modalities to comply with analytical method requirements referred to in 
Article 14(1), point (l), and Article 19(2).  
Before adopting the implementing acts ref erred to in points (a) to (d), the Commission shall 
consult the Authority. The implementing acts shall be adopted in accordance with the 
procedure referred to in Article 28(3).  
Article 28  
Committee procedure  
1. The Commission shall be assisted by the committee set up by Article 58 of 
Regulation (EC) No 178/2002.  
2. Where reference is made to this paragraph, Article 4 of Regulation (EC) No 
182/2011 shall apply.  
3. Where reference is made to this paragraph, Article 5 of Regulation (EC) No 
182/2011 shall apply.  
Article 29  
Guidance  
1. Before the date of application of this Regulation, the Authority shall publish detailed 
guidance to assist the notifier or the applicant in the preparation and the presentation 
of the notifications and the application referre d to in Chapters II and III and for the 
implementation of Annex II.  
2. Before the date of application of this Regulation, the European Union Reference 
Laboratory for Genetically Modified Food and Feed established pursuant to Article 
32 of Regulation (EC) No 1829/2003 , assisted by the European Network of GMO 
Laboratories, shall publish detailed guidance to assist the notifier or the applicant for 
the application of Article 14(1), point (l), and Article 19(2) . 
Article 30  
Monitoring, reporting and evaluation  
1. No sooner than three years after the first decision is adopted in accordance with 
Article 6( 8) or (1 0) or Article 7(6) or in accordance with Sections 2 or 3 of Chapter 
III, whichever is the earliest , and thereafter every five years, the Commission shall 
forward to the European Parliament, the Council, the European Economic and Social 
Committee and the Committee of the Regions a report on the implementation of this 
Regulation.  EN 44  EN 2. The report shall also address any ethical issues that have arisen with the application 
of this Regulation.  
3. For the purpose of the reporting referred to in paragraph 1, the Commission, by [24 
months after the date of entry into force of this Regulation]  at the latest, shall 
establish, after consulting the competent authorities of the Member States in 
accordance with Directive 2001/18/EC and Regulation (EC) No 1829/2003, a 
detailed programme for monitoring, based on indicators, the impact of this 
Regulati on. It shall specify the action to be taken by the Commission and by the 
Member States in collecting and analysing the data and other evidence.  
4. No sooner than two years after the publication of the first report referred to in 
paragraph 1 the Commission shall carry out an evaluation of the implementation of 
this Regulation and its impact on human and animal health, the environment, 
consumer information, the functioning of the internal market, and economic, 
environmental and social sustainability.  
5. The C ommission shall present a report on the main findings of the evaluation 
referred to in paragraph 4 to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions.  
Article 31  
References in other Union le gislation  
With regard to category 2 NGT plants, references in other Union legislation to Annex II or 
Annex III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex 
II to this Regulation.  
Article 32  
Administrative review  
Any decision taken under , or failure to exercise,  the powers vested in the Authority by this 
Regulation may be reviewed by the Commission on its own initiative or in response to a  
request from  a Member State or from any person directly  and individually concern ed. 
To this effect a request shall be submitted to the Commission within two months  from the day 
on which the party concerned became aware of the act or omission in question .  
The Commission shall prepare a draft decision within two months  requiring, if ap propriate, 
the Authority to withdraw its decision or to remedy its failure to act . 
Article 33  
Amendments to Regulation (EU) 2017/625  
Article 23 of Regulation (EU) 2017/625 is amended as follows:  
(1) in paragraph 2, point (a)(ii) is replaced by the followin g: 
‘(ii) the cultivation of GMOs for food and feed production and the correct 
application of the plan for monitoring referred to in Article 13(2), point (e), of 
Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of 
Regulation ( EC) No 1829/2003 and in Article s 14(1), point (h) and  19(3), point 
(b) of Regulation [ reference to this Regulation ];’; EN 45  EN (2) in paragraph 3, point (b) is replaced by the following:  
‘(b) the cultivation of GMOs for food and feed production and the correct 
application of the plan for monitoring referred to in Article 13(2), point (e), of 
Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of 
Regulation (EC) No 1829/2003 and in Article s 14(1), point (h) and  19(3), point 
(b) of Regulation [ reference to this Regulation ];’. 
Article 34  
Entry into force and application  
1. This Regulation shall enter into force on the twentieth day following that of its 
publication in the Official Journal of the European Union . 
2. It shall apply from [ 24 months  from the date of entry into force of this Regulation ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President  EN 1  EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE  
1.1. Title of the proposal/initiative  
1.2. Policy area(s) concerned  
1.3. The proposal/initiative relates to:  
1.4. Objective(s)  
1.4.1.  General objective(s)  
1.4.2. Specific objective(s)  
1.4.3.  Expected result(s) and impact  
1.4.4.  Indicators of performance  
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 
roll-out of the implement ation of the initiative  
1.5.2.  Added value of Union involvement (it may result from different factors, e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from Union intervention, which is additional to the value that would have been 
otherwise created by Member States alone.  
1.5.3.  Lessons learned from similar experiences in the past  
1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies 
with other appropriate instruments  
1.5.5.  Assessment of the different available financing options, including scope for 
redeployment  
1.6. Duration and financial impact of the proposal/initiative  
1.7. Method(s) of budget implementation planned  
2. MANAGEMENT  MEASURES  
2.1. Monitoring and reporting rules  
2.2. Management and control system(s)  
2.2.1.  Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy  proposed  
2.2.2.  Information concerning the risks identified and the internal control system(s) set up 
to mitigate them  
2.2.3.  Estimation and justification of the cost -effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds mana ged"), and assessment of the expected levels 
of risk of error (at payment & at closure)  
2.3. Measures to prevent fraud and irregularities  
3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE  EN 2  EN 3.1. Heading(s) of the multiannual financial framework and ex penditure budget 
line(s) affected  
3.2. Estimated financial impact of the proposal on appropriations  
3.2.1.  Summary of estimated impact on operational appropriations  
3.2.2.  Estimated output funded with operational appropriations  
i. Summary of estimated impa ct on  EFSA’s Hunan Resourses  
3.2.3.  Summary of estimated impact on administrative appropriations  
3.2.4.  Compatibility with the current multiannual financial framework  
3.2.5.  Third -party contributions  
3.3. Estimated impact on revenue  EN 3  EN 1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE   
1.1. Title of the proposal/initiative  
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  
1.2. Policy area(s) concerned   
1 - Single Market, Innovation and Digital  
2 - Cohesion, Resilience and Values  
1.3. The proposal/initiative relates to:  
 a new action   
 a new action following a pilot project/preparatory action1  
 the extension of an existing action   
 a merger or redirection of one or more actions towards another/a new action   
1.4. Objective(s)  
1.4.1.  General objective (s) 
The general objectives of the new legislation are:  
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 sus tainability 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.  
1.4.2.  Specific objective(s)  
Specific objective No  
1. Procedures for the deliberate release and placing on the market that ensure 
NGT plants and derived food/feed products are as safe as their conventional 
counterparts, while not entailing unnecessary regulatory burden.  
2. 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  
3. NGT plants released  or placed on the market feature traits that can contribute 
to a sustainable agri -food system.  
1.4.3.  Expected result(s) and impact  
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.  
                                                 
1 As referred to in Article 58(2)(a) or (b) of the Financial Regulation.  EN 4  EN The authorisation procedures and risk assessemt requirements of plants obtained by 
certain new genomic techniques would be fit to the diversity of products. Regulatory 
costs and administrative burden would be  reduced, which would also reduce the 
entry barr iers to SMEs and public institutions in plant breeding.  
Breeders’ global competitiveness and innovative power would be supported by 
simplification and future -proofing through a framework that is adaptable to scientific 
and technological development. Breede rs, operators, especially SMEs, would see 
reduced burden and costs as well as a more predictible timeline to develop new 
products.  
Farmers would have more varieties adapted to current needs, in particular more plant 
traits that contribute to a sustainable agri-food system.  
Consumers would benefit from products that are designed to meet their expectations 
and needs (e.g. improved taste, improved nutrient profile or reduced allergen 
content).  
Academic/research institutions would see more (funding) opportunit ies in the EU for 
their research in the area.  
1.4.4.  Indicators of performance  
Specify the indicators for monitoring progress and achievements.  
For NGT plants as safe as their conventional counterparts:  
– Number of products authorised or notified to be placed  on the market  
– Reported cases demonstrating risk to human and animal health and the 
environment due to the genetic modification in authorised/notified product and 
any regulatory action taken  
For NGT plants featuring a wide range of plant species and traits  by various 
developers : 
– Number of crop -trait combinations in notification/authorisation applications  
– Number and proportion of SMEs/public institutions applying for field 
trail/notification/authorisation applications  
For NGT plants featuring traits that can  contribute to a sustainable agri -food system  
– Impact of NGT plants in the EU on economic, environmental and social 
sustainability  e.g., through pesticide use, fertiliser user, biodiversity, 
greenhouse gas emissions, yield, yield stability, health benefits . 
1.5. Grounds for the proposal/initiative  
1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 
roll-out of the implementation of the initiative  
The NGT plants/products can be placed on the market either if they fulfill the 
notification criteria or if they are risk assessed to be safe and consequently 
authorised. Verification of the notification criteria and the risk assessment will be 
carried out , in certain cases,  by a EU regulatory body  (in other cases, the pro cedures 
will be handled by the Member States) . 
The European Food Safety Authority (EFSA)  is already a key actor  in the application 
of the GMO legislative framewo rk, whose tasks need to be extended in order to EN 5  EN properly implement the notification and authori sation requirements for the new 
plants/products in terms of data analysis and risk assessment.  
The tasks of EFSA would need to be implemented from 2025 onwards.  
New IT tools would also be needed for the NGT plants/products by integrating them 
in the alread y running FIP/ESFC system, which will limit the costs of IT needs.  
1.5.2.  Added value of Union involvement (it may result from different factors, e.g. 
coordination gains, legal certainty, great er effectiveness or complementarities).  For 
the purposes of thi s point 'added value of Union involvement' is the value resulting 
from Union intervention, which is additional to the value that would have been 
otherwise created by Member States alone.  
Reasons for action  at European level (ex -ante):  
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 the high level of safety for humans, 
animals and for the protection  of environment throughout the EU, a level playing 
field for operators within the single market and a more predictable and efficient 
regulatory oversight.  
There is a need to ensure availability to farmers, food operators and consumers of 
plant varieties t hat 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.  
1.5.3.  Lessons learned  from similar experiences in the past  
The Regulation is based on experiences from the legislation s for deliberate release of 
GMO (Directive 2001/18/EC) and for the placing on the market of GMO for food 
and feed uses  (Regulation (EC) 1829/2003).  
The proposa l takes into account the diversity of products that can be obtained by new 
genomic techniques based on latest scientific knowledge and provides requirements 
that are better tailored for the different types of products.  
1.5.4.  Compatibility with the Multian nual Financial Framework and possible synergies 
with other appropriate instruments  
The Regulation is to be part of the Single Market Programme Food Strand and will 
work in synergy with the Common Agriculture Policy. While this proposal will tend 
to promote  the use of NGT plants,  and products derived from NGT plant s, with traits 
that can contribute to sustainability, the CAP includes  various instrument s to tackle 
climate  change  through investments and advice on new methods and technology.  
1.5.5.  Assessment of the different available financing options, including scope for 
redeployment  
The amount required for EFSA to conduct the new tasks (2. 3 million EUR in the 
current MFF period) will be covered by  an increase of the EFSA annual subsidy 
from the unallocated margin under Heading 2b, to be compensated by an equivalent 
decrease of the Food chain strand of the Single Market Programme, which will result 
in an increase of the unallocated margin under Heading 1.  Furthermore,  0,1 million 
EUR will be redeployed inter nally within the Food strand of the Single Market EN 6  EN Programme  to cover IT expenditure . The mandate of EFSA contributes to the 
objectives of the food strand of the SMP to contribute to a high level of health and 
safety for humans, animals and plants in plant,  animal, food and feed areas.  
 EN 7  EN 1.6. Duration and financial impact of the proposal/initiative  
 limited duration  
–  in effect from [DD/MM]YYYY to [DD/MM]YYYY  
–  Financial impact from YYYY to YYYY for commitment appropriations and 
from YYYY to YYYY for payment appropriations.  
 unlimited duration  
– Implementation with a start -up period from YYYY to YYYY,  
– followed by full -scale operation.  
1.7. Method(s) of budget imp lementation planned2  
 Direct management  by the Commission  
–  by its departments, including by its staff in the Union delegations;  
–  by the executive agencies  
 Shared management  with the Member States  
 Indirect management  by entrusting budget implementation tasks to:  
–  third countries or the bodies they have designated;  
–  international organisations and their agencies (to be specified);  
–  the EIB and the European Investment Fund;  
–  bodies referred to in Articles 70 and 71 of the Financial Regulation;  
–  public law bodies;  
–  bodies governed by private law with a public service mission to the extent that 
they are provided with adequate financial guarantees;  
–  bodies governed by the private law of a Member State that are entrus ted with 
the implementation of a public -private partnership and that are provided with 
adequate financial guarantees;  
–  bodies or persons entrusted with the implementation of specific actions in the 
CFSP pursuant to Title V of the TEU, and identified in th e relevant basic act.  
– If more than one management mode is indicated, please provide details in the ‘Comments’ section.  
Comments  
 
 
                                                 
2 Details of budget implementation methods  and references to the Financial Regulation may be found on 
the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budge t/financial -rules/budget -
implementation/Pages/implementation -methods.aspx  EN 8  EN 2. MANAGEMENT  MEASURES   
2.1. Monitoring and reporting rules  
Specify frequency and conditions.  
All Union agencies work under a strict monitoring system involving an internal 
control coordinator, the Internal Audit Service of the Commission, the Management 
Board, the Commission, the Court of Auditors and the Budgetary Authority. This 
system is reflec ted and laid down in the European Food Safety Authority’s (EFSA) 
founding regulation. In accordance with the Joint Statement on the EU decentralised 
agencies (the ‘Common Approach’), the framework financial regulation (2019/715) 
and related Commission Comm unication C(2020)2297, the annual work programme 
and Single Programming Document of the Authority comprise detailed objectives 
and expected results, including a set of performance indicators.  
The Single Programming Document combines multiannual and annual  programming 
as well as “strategy documents”, e.g. on independence. DG SANTE comments 
through the Authority ’s Management Board and prepares a formal Commission 
Opinion on the Single Programming Document. The activities of the Authority will 
be measured aga inst these indicators in the Consolidated Annual Activity Report.  
The European Food Safety Authority will monitor periodically the performance of its 
internal control system to ensure that data is collected efficiently, effectively and 
timely and to ident ify internal control deficiencies, register and assess the results of 
controls, control deviations and exceptions. The results of the internal control 
assessments, including significant weaknesses identified and any differences as 
compared to internal and external audit findings will be disclosed in the Consolidated 
Annual Activity report.  
2.2. Management and control system(s)  
2.2.1.  Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control str ategy proposed  
The annual EU subsidy will be transferred to the Authority in accordance with its 
payment needs and upon its request. The Authority will be subject to administrative 
controls including budgetary control, internal audit, annual reports by the  European 
Court of Auditors, the annual discharge for the execution of the EU budget and 
possible investigations conducted by OLAF to ensure, in particular, that the 
resources allocated to the Authority are put to proper use. Through its representation 
in the Authority's Management Board and Audit Committee, the Commission will 
receive audit reports and ensures that adequate actions are defined and timely 
implemented by the Authority to address the issues identified. All payments will 
remain pre -financing p ayments until the Authority’s accounts have been audited by 
the European Court of Auditors and the Authority has submitted its final accounts. If 
necessary, the Commission will recover unspent amounts of the instalments paid to 
the Authority.  
The activitie s of the Agency will also be subject to the supervision of the 
Ombudsman in accordance with Article 228 of the Treaty. These administrative 
controls provide a number of procedural safeguards to ensure that account is taken of 
the interests of the stakehold ers. EN 9  EN EFSA’s Internal Control Framework is designed to provide reasonable assurance 
regarding the achievement of five objectives set out in Article 301 of the EFSA 
Financial Regulation.  
2.2.2.  Information concerning the risks identified and the internal con trol system(s) set up 
to mitigate them  
The main risks relate to the Authority’s performance and independence in 
implementing the tasks entrusted to it. Underperformance or impaired independence 
could hamper the achievement of the objectives of this initiat ive and also reflect 
negatively on the Commission’s reputation.  
The Commission and the Agency have put in place internal procedures that aim at 
covering the risks identified above. The internal procedures are in full compliance 
with the Financial Regulatio n and include anti -fraud measures and cost -benefit 
considerations. First and foremost, sufficient resources should be made available to 
the Authority in both financial and staffing terms to achieve the objectives of this 
initiative.  
Furthermore, quality management will include both the integrated quality -
management activities and risk -management activities within the Authority. A risk 
review is a continuous, proactive and systematic process, conducted annually, with 
risks being assess ed at a residual level, i.e. taking into account controls and 
mitigations already in place. Conducting self -assessments (as part of the EU 
Agencies benchmarking programme), annual reviews of sensitive functions and ex -
post controls also fall within this ar ea, as does maintain a register of exceptions.  
To preserve impartiality and objectivity in every aspect of the Authority’s work, a 
number of policies and rules on management of competing interests have been put in 
place and will be regularly updated, desc ribing specific arrangements, requirements 
and processes applying to the Authority’s Management Board, scientific committee 
members and experts, the Authority’s  staff and candidates, as well as consultants and 
contractors.  
EFSA’s risk -based internal contr ol and auditing scheme under the new integrated 
management system framework, and with the cohesive planning and reporting of 
respective Assurance Management activities in EFSA.  The Commission will be 
informed timely of relevant management and independence issues encountered by 
the Authority and will react upon notified issues timely and adequately.  
2.2.3.  Estimation and justification of the cost -effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure)  
The Commission’s and the Agency’s internal control strategies take into 
consideration the main cost drivers, and the efforts already taken over several years 
to reduce the cost of controls, wi thout compromising the effectiveness of controls. 
The existing control systems proved to be able to prevent and/or to detect errors 
and/or irregularities, and in case of errors or irregularities, to correct them.  
                                                 
1 Objectives emphasised under Art. 30 of EFSA’s Financial Regulation: (i) effectiveness, efficiency and 
economy of operations; (ii) reliability of reporting; (iii) safeguarding of as sets and information; (iv) 
prevention, detection, correction and follow -up of fraud and irregularities; and (v) adequate 
management of risks relating to the legality and regularity of the underlying transactions.  EN 10  EN In the past five years, the Commission’s y early costs of controls under indirect 
management represented less than 1% of the annual budget spent on subsidies paid to 
the Authority. The Authority allocated 5% of its total annual budget on control 
activities centering around integrated quality manage ment, audit, anti -fraud 
measures, finance and verification processes, corporate risk management, risk 
assessment  and self -assessment activities.  
2.3. Measures to prevent fraud and irregularities  
Specify existing or envisaged prevention and protection meas ures, e.g. from the Anti -Fraud Strategy.  
As for its activities in indirect management, the Commission shall take appropriate 
measures ensuring that the financial interests of the European Union are protected by 
the application of preventive measures agains t fraud, corruption and any other illegal 
activities, by effective checks and, if irregularities are detected, by the recovery of 
the amounts wrongly paid and, where appropriate, by effective, proportional and 
deterrent penalties.  
To this effect, the Comm ission adopted an anti -fraud strategy, latest update of April 
2019 (COM(2019)176), covering preventive, detective and corrective measures.  
The Commission or its representatives and the European Court of Auditors shall 
have the power of audit, on the basis of documents and on -the-spot, over all grant 
beneficiaries, contractors and subcontractors who have received Union funds. OLAF 
shall be authorised to carry out on -the-spot checks and inspections on economic 
operators concerned indirectly by such funding.  
As regards the European Food Safety Authority, the anti -fraud measures are 
provided for in Article 25 point 9 of Regulation (EC) No 178/2002 and the 
framework financial Regulation (2019/715). The Management Board shall adopt the 
Authority's financial regula tion which specifies in particular the procedure for 
drawing up and implementing the Authority's budget, in accordance with Article 142 
of the Financial Regulation of 21 December 1977 applicable to the general budget of 
the European Communities(26) and wit h the legislative requirements concerning 
investigations conducted by the European Anti -Fraud Office.In line with the 
Common Approach and Article 42 of the framework financial Regulation, an anti -
fraud strategy has been developed, in accordance with the Eu ropean Anti -Fraud 
Office methodology and guidance, and is followed by the Authority.  
EFSA set up and implemented measures to counter fraud and any illegal activities 
affecting the interests of the EFSA by putting in place a sound anti -fraud strategy and 
implementing rules to improve the prevention, detection and conditions for 
investigating fraud, and to set out reparation and deterrence actions, with 
proportionate and dissuasive measures. The validity of the EFSA’s Anti -Fraud 
Strategy is aligned with EFSA  Strategy. The Authority’s Anti -fraud strategy is 
accompanied by a corresponding action plan, outlining both specific focus areas and 
actions for the next years, and several continuous actions that are carried out every 
year, such as a specific standalone fraud risk assessment, with the identified fraud 
risks included in the overall Agency risk register. Mandatory anti -fraud trainings are 
organised as part of the awareness anti -fraud sessions. Tailored training sessions to 
selected Process Owners /Managers are developed in order to address the risks 
associated to the areas that resulted potentially more exposed to fraud . Staff are 
made aware of how to report any suspects of wrongdoings and disciplinary 
procedures are in place as per the rules of the Staff R egulations.  EN 11  EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE   
3.1. Heading(s) of the multiannual financial framework and expenditure budget 
line(s) affected  
 Existing budget lines  
In order  of multiannual financial framework headings and budget lines.  
Heading of 
multiannual 
financial 
framework  Budget line  Type of  
expenditure  Contribution  
Number  
 Diff./Non -
diff.1 from 
EFTA 
countries2 from 
candidate 
countries 
and 
potential 
candidates3 fromother 
third 
countries  other assigned 
revenue  
 03 02 06 Contributing to a high level of 
health and welfare for humans, animals 
and plants   Diff. NO NO NO NO 
 06 10 02 European Food Safety Authority  Diff.  YES  NO NO NO 
                                                 
1 Diff. = Differentiated appropriations / N on-diff. = Non -differentiated appropriations.  
2 EFTA: European Free Trade Association.  
3 Candidate countries and, where applicable, potential candidates from the Western Balkans.   
EN 12  EN 3.2. Estimated financial impact of the proposal on appropriations  
3.2.1.  Summary of estimated impact on operational appropriations  
–  The proposal/initiative does not require the use of operational appropriations  
–  The proposal/initiative requires the use of operational appropriations, as explained below:  
EUR million (to three decimal places)  
Heading of multiannual financial  
framework  Number  1 - Single Market, Innovation and Digital  
 
DG: SANTE      Year  Year  Year  
TOTAL  
2025  2026  2027 et  seqq  
 Operational appropriations          
 03 02 06 Contributing to a high level of health and 
welfare for humans, animals and plants  Commitments  (1a) 0,100  0,000  0,000  0,100  
  Payments  (2a) 0,050  0,050  0,000  0,100  
Appropriations of an administrative nature financed from the envelope of specific 
programmes          
 Budget line    -3 0 0 0 0  
TOTAL appropriations for DG SANTE  Commitments  =1a+1b +3  0,100  0,000  0,000  0,100   
 
Payments  .=2a+2b +3  
0,050  0,050  0,000  0,100   
   
 
  
EN 13  EN  TOTAL operational appropriations Commitments  -4 0,100  0,000  0,000  0,100  
Payments  -5 0,050  0,050  0,000  0,100  
 TOTAL appropriations of an administrative nature financed 
from the envelope for specific programmes -6 0,000  0,000  0,000  0,000  
TOTAL appropriations  
Commitments  =4+6  0,100  0,000  0,000  0,100  under HEADING 1 - Single Market, 
Innovation and Digital  
of the multiannual financial framework  Payments  =5+6  0,050  0,050  0,000  0,100  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
EN 14  EN EUR million (to three decimal places)  
Heading of multiannual financial  
framework  2 2b - Cohesion, Resilience and Values  
 
DG: SANTE      Year  Year  Year  
TOTAL  
2025  2026  2027 et  seqq  
 Operational appropriations          
06 10 02 European Food Safety Authority  Commitments  (1a) 0,405 0,830  1,099 2,334 
  Payments  (2a) 0,081 0,287 1,966  2,334 
Appropriations of an administrative nature financed from the envelope of 
specific programmes          
 Budget line    -3 0 0 0 0  
TOTAL appropriations for DG SANTE  Commitments  .=1a +3  0,405 
 0,830  
 1,099 
 2,334 
  
 
Payments  .=2a+3  0,081 0,287 1,966  2,334  
   
   
EN 15  EN  
 
 TOTAL operational appropriations Commitments  (4) 0,405 0,830  1,099 2,334 
Payments  (5) 0,081 0,287 1,966  2,334 
 TOTAL appropriations of an administrative nature financed 
from the envelope for specific programmes (6) 0,000  0,000  0,000  0,000  
TOTAL appropriations  
Commitments  =4+6  0,405 
 0,830  
 1,099 
 2,334 
 under HEADING 2 -Cohesion, Resilience 
and Values  
of the multiannual financial framework  Payments  =5+6  0,081 0,287 1,966  2,334 
 
 
Heading of multiannual financial  
framework  7 ‘Administrative expenditure’  
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement  (Annex 5 to the Commission decision on the internal rules for the implementation of the Commission section of the general 
budget of the European Union), which is uploaded to DECID E for interservice consultation purposes.  
 
 
 
 
 
 
 
 
  
EN 16  EN                                                                                                                                                                                                                EUR million (to three decimal places)  
    Year  Year  Year  Year  
TOTAL  
2025  2026  2027  2027 et  seqq  
DG: SANTE                
 Human resources  0,000  0,000  0,000  0,000  0,000  
 Other administrative expenditure  0,000  0,000  0,000  0,000  0,000  
TOTAL DG SANTE  Appropriations  0,000  0,000  0,000  0,000  0,000  
 
       TOTAL appropriations  (Total 
commitments = 
Total payments)    0,000  0,000  0,000  0,000  0,000  under HEADING  7 
of the multiannual financial framework   
 
 
 
                                                                                                                                                                                                  EUR million (to three decimal places)  
    Year  Year  Year  
TOTAL  
2025  2026  2027 et seqq  
TOTAL appropriations  
Commitments  0,505  0,830  1,099  2,434  under HEADINGS 1 to 7  
of the multiannual financial framework   Payments  0,131  0,337  1,966  2,434  
 
 
 
 
For information, reduction of the SMP Food Chain line to increase Heading 1 unallocated margin to compensat e for  the increase of EFSA line from the Heading 2b 
unallocated margin.   
EN 17  EN  
EUR million (to three decimal places)  
HEADING 1 - Single Market, 
Innovation and Digital       Year  Year  Year  
TOTAL  
2025  2026  2027  
 Operational appropriations          
 03 02 06 Contributing to a high level of 
health and welfare for humans, animals and 
plants  Commitments  (1a) 0,405 - 0,830 - 1,099 - 2,334 
 
3.2.2.  Estimated output funded with operational appropriations  
Commitment appropriations in EUR million (to three decimal places)  
Indicate objectives and outputs      Year  Year  Year  TOTAL  
  2025  2026  2027 et seqq  
 OUTPUTS  
  Type[1]  Average 
cost 
No Cost 
No Cost 
No Cost Total 
No Total 
cost 
  
SPECIFIC OBJECTIVE No 1 : 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.           
Verification on equivalence of NGT plants to conventional plants : New 
EFSA task  to  determine before placing on the market or before fi eld trials 
whether the notified NGT plant meets pre -defined equivalence criteria     
(Preparatory work, Assessment of equivalence to predefined criteria)        
0,041   0,217   0,330   0,589  
EN 18  EN Placing on the market of NGT plants and food/feed - related tasks - 
Extension of the EFSA capacity to risk assess new applications for the 
placing on the market of NGT plants and food/feed and to provide 
scientific/technical advice before the  authorisation procedure in pre -
determined cases ( Preparatory work and Risk Assessment of NGT 
applications)        
0,113   0,286   0,412   0,812  
Verification on equivalence of NGT plants to conventional plants -
Outsourcing for molecular dat a verification (18 notifications)        0,090    0,090    0,090    0,270  
Expansion of the E -Submission Food Chain (ESFC) to include exchange of 
information and maintenance  and development and maintenance of a public 
register for:A new domain in the FIP/ESFC system        
0,100    0,000    0,000    0,100  
Placing on the market of NGT plants and food/feed - related tasks -
Preparatory work (Cost of indemnities and expert meetings   and Cost of 
contracts supporting RA )        
0,150    0,150    0,150    0,450  
Subtotal for specific o bjective No 1    0,494   0,744   0,982   2,221 
SPECIFIC OBJECTIVE No 2 .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           
Verification on equivalence of NGT plants to conventional plants - New 
EFSA task  to  determine before placing on the market or before fi eld trials 
whether the notified NGT plant meets pre -defined equivalence criteria : 
Intake steps        
0,000    0,048   0,065   0,113 
Placing on the market of NGT plants and food/feed - related tasks - 
Extension of the EFSA capacity to risk assess new applications for the 
placing on the market of NGT plants and food/feed and to provide 
scientific/technical advice before the authorisation procedure in pre -
determined cases (Pre -submission advice  and Intake steps)        
0,011   0,038   0,052   0,100 
Subtotal for specific objective No 2    0,011   0,086   0,117   0,214  
EN 19  EN TOTALS    0,505   0,830    1,099   2,434 
 
 
 
 
 
i. Summary of estimated impact on  EFSA’s  Human Resources   
 
 
 
 
                                                                                                                                                              in EUR million (to three decimal places)  
Temporary agents (AD Grades)  0,165  0,505  0,687  1,358 
Temporary agents (AST grades)  0,000  0,084  0,172  0,256 
Contract staff  0,000  0,000  0,000  0,000  
Seconded National Experts  0,000  0,000  0,000  0,000  
Total  0,165  0,590  0,859  1,614 
 
                                                                                                                                                               
 
Staff requirements (FTE): Total posts Union funded  
 
Temporary agents (AD 
Grades)  2,0 4,0 4,0 4,0     
Total  
2025  2026  2027 and  et seqq   
EN 20  EN Temporary agents (AST 
grades)  0,0 1,0 1,0 1,0 
Contract staff                             0,0                               0,0                                         0,0                                                         0,0 
Seconded National Experts  0,0 0,0 0,0 0,0 
Total  2,0 5,0 5,0 5,0 
 
 
The staff costs have been adjusted in such a way that the newly recruited staff is accounted for 6 months during the year of recruitment. 
EN 21  EN 3.2.3.  Summary of estimated impact on administrative appropriations  
–  The proposal/initiative does not require the use of appropriations of an 
administrative nature  
–  The proposal/initiative requires the use of appropriations of an administrative 
nature,  as explained below:  
EUR million (to three decimal places)  
 Year 
N 1 Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary to show the 
duration of the impact (see point 1.6)  TOTAL  
 
HEADING 7  
of the multiannual 
financial framework          
Human resources          
Other administrative 
expenditure          
Subtotal HEADING 7  
of the multiannual 
financial framework          
 
Outside HEADING 72 
of the multiannual 
financial framework  
         
Human resources          
Other expenditure  
of an administrative 
nature          
Subtotal  
outside HEADING 7  
of the multiannual 
financial framework          
 
TOTAL          
The appropriations required for human resources and other expenditure of an administrative nature will be met by 
appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the 
DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light  of budgetary constraints.  
                                                 
1 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first 
year of implementation (for instance: 2021) . The same for the following years . 
2 Technical and/or administrative assistance and expenditure in support of the implementation of EU  programmes 
and/or actions (f ormer ‘BA’ lines), indirect research, direct research.   
EN 22  EN 3.2.3.1.  Estimated requirements of human resources  
–  The proposal/initiative does not require the use of human resources.  
–  The proposal/initiative requires the use of human resources, as explained 
below:  
Estimate to be expressed in full time equivalent units  
 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  
 Establishment plan posts (officials and temporary staff)  
20 01 02 01  (Headquarters and Commission’s Representation 
Offices)         
20 01 02 03 (Delegations)         
01 01 01 01   (Indirect research)         
 01 01 01 11 (Direct research)         
Other budget lines (specify)         
 External staff (in Full Time Equivalent unit: FTE)1 
 
20 02 01  (AC, END, INT from the ‘global envelope’)         
20 02 03 (AC, AL, END, INT and JPD in the delegations)         
XX 01  xx yy zz  2 
 - at Headquarters  
        
- in Delegations         
01 01 01 02  (AC, END, INT - Indirect research)         
 01 01  01 12 (AC, END, INT - Direct research)         
Other budget lines (specify)         
TOTAL         
XX is the policy area or budget title concerned.  
The human resources required will be met by staff from the DG who are already assigned to management of the 
action and/or have been redeployed within the DG, together if necessary with any additional allocation which 
may be granted to the managing DG under the annual allocati on procedure and in the light of budgetary 
constraints.  
Description of tasks to be carried out:  
Officials and temporary staff  1) managing (AD) and supporting (AST) the GMO panel in its risk assessment 
activities for NGT plants under the authorisation procedure  
2) Assessing (AD) and supporting the assessment (AST) the equivalence to 
predefinded criteria of NGT plants under the notifica tion procedure  
3) Supporting the applicants and performing the completeness check (AD) for 
NGT plants under the notification procedure  
4) Giving scientific advice (AD) to the the applicant to NGT plants containing 
traits that contribute to sustainability under the authorisation procedure  
5) Supporting the applicant and performing the completeness (AD) check for 
NGT plants under the authorisation prodecudre  
External staff   
                                                 
1 AC= Contract Staff; AL = Local Staff; END= Seconded National Expert; INT = agency staff; 
JPD=  Junior Professionals in Delegations.  
2 Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines).   
EN 23  EN 3.2.4.  Compatibility with the current multiannual financial frame work  
The proposal/initiative : 
–  can be fully financed through redeployment within the relevant  heading of the 
Multiannual Financial Framework (MFF).  
The increase of appropriations for EFSA budget line 06 10 02 European Food Safety Authority in 
years 2025 to 2027 by 2, 3 million EUR, will be  covered from the  unallocated margin under Heading 
2b. To prese rve the neutrality of this proposal towards the  EU budget,  an equal reduction of  the  SMP 
Food  chain  budget line  03 02 06  will be applied, resulting in an increase of the Heading 1 margin by 
the same amount . The required financing of 0,100 million EUR under the line 03 02 06 - Contributing 
to a high level of health and welfare for humans, animals and plants will be covered b y internal 
redeployment.  
–  requires use of the unallocated margin under the relevant heading of the MFF 
and/or use of the special instruments as defined in the MFF Regulation.  
–  As a consequence of the budgetary mechanism described above, the unallocated ma rgin of 
Heading 2b will decrease by EUR 2,3 million  over the years 2025 -2027 while the unalocated 
margin of Heading 1 will increase by the same amount.  requires a revision of the 
MFF . 
Explain what is required, specifying the headings and budget lines conc erned and the corresponding 
amounts.  
3.2.5.  Third -party contributions  
The proposal/initiative:  
–  does not provide for co -financing by third parties  
–  provides for the co -financing by third parties estimated below:  
Appropriations in EUR million (to three decimal places)  
 
Year 
N1 Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6)  Total  
Specify the co -financing 
body           
TOTAL appropriations 
co-financed          
 
 
                                                 
1 Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the 
expected first year of implementation (for instance: 2021). The same for the following years.   
EN 24  EN 3.3. Estimated impact on revenue  
–  The proposal/initiative has no financial impact on revenue.  
–  The proposal/initiative has the following financial impact:  
–  on own resources  
–  on other revenue  
– please indicate, if the revenue is assigned to expenditure lines   
     EUR million (to three decimal places)  
Budget revenue line:  Appropriations 
available for 
the current 
financial year  Impact of the proposal/initiative2 
Year 
N Year 
N+1 Year 
N+2 Year 
N+3 Enter as many years as necessary to show 
the duration of the impact (see point 1.6)  
Article ………….          
For assigned revenue, specify the budget expenditure line(s) affected.  
 
Other remarks (e.g. method/formula used for calculating the impact on revenue or any other 
information).  
 
                                                 
2 As regards traditi onal own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20 % for collection costs.