COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625
Date: 2023-07-05
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, animal health, cultivation techniques, food inspection, food production, genetically modified organism, labelling, market approval, plant health legislation, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 412 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT REPORT      Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 {COM(2023) 411 final} - {SEC(2023) 411 final} - {SWD(2023) 411 final} - {SWD(2023) 413 final}  
 
 
Table of contents 

1. 

Introduction: Scientific, Political, and Legal Context ....................................................................... 1 

1.1. 

Scientific context ..................................................................................................................... 1 

1.2. 

Political context ....................................................................................................................... 5 

1.3. 

Legal context ........................................................................................................................... 9 

1.4. 

International dimension ........................................................................................................ 10 

1.5. 

Scope ..................................................................................................................................... 11 

1.6. 

Interaction with existing legislation and upcoming initiatives .............................................. 12 

1.7. 

Previous studies on the EU GMO legislation with relevance to NGTs .................................. 13 

2.  Problem definition ......................................................................................................................... 13 

2.1.  What are the problems? ....................................................................................................... 13 

2.2.  What is the size of the problem and who is affected? .......................................................... 16 

2.3.  What are the problem drivers? ............................................................................................. 18 

2.4. 

How likely is the problem to persist? .................................................................................... 18 

3.  Why should the EU act?................................................................................................................. 19 

3.1. 

Legal basis .......................................................................................................................... 19 

3.2. 

Subsidiarity: Necessity of EU action .................................................................................. 20 

3.3. 

Subsidiarity: Added value of EU action ............................................................................. 20 

4. 

 Objectives: What is to be achieved?............................................................................................. 20 

4.1.  General objectives ............................................................................................................. 20 

4.2. 

Specific objectives ............................................................................................................. 21 

5.  What are the available policy options? ......................................................................................... 22 

5.1.  What is the baseline from which options are assessed? .................................................. 24 

5.2. 

Description of the policy options ...................................................................................... 25 

5.3.  Options discarded at an early stage .................................................................................. 30 

6.  What are the impacts of the policy options? ................................................................................ 31 

7.  How do the options compare? ...................................................................................................... 58 

8.  Preferred Option ............................................................................................................................ 72 

8.1. 

Description of the preferred option ...................................................................................... 72 

8.2 Simplification and burden reduction, supporting the one-in-one-out approach ....................... 74 

9.  How will actual impacts be monitored and evaluated? ................................................................ 75 

10.  List of references ........................................................................................................................... 77 

Annex 1: Procedural information .......................................................................................................... 91 
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Annex 2: Stakeholder consultation (Synopsis report) ........................................................................... 97 

Annex 2a: Summary report on feedback received on Inception Impact Assessment: Legislation for 
plants produced by certain new genomic techniques ........................................................................ 111 

Annex 3: Who is affected and how?.................................................................................................... 123 

Annex 4: Analytical methods ............................................................................................................... 130 

Annex 5: The techniques ..................................................................................................................... 148 

Annex 6: Opinions of scientific advisory bodies and scientific organisations on NGTs ...................... 154 

Annex 7: Applications of NGTs in plants and case studies on potential impacts ................................ 158 

Annex 8: EU legal framework on GMOs .............................................................................................. 172 

Annex 9: Problem Tree ........................................................................................................................ 177 

Annex 10: Intervention logic ............................................................................................................... 178 

Annex 11: Procedure for notification (Option 4) ................................................................................ 179 

Annex 12: SME TEST ............................................................................................................................ 181 

ii 

 
 
 
 
 
Abbreviations 

Term or acronym  Meaning or definition 

CJEU 
CD 

Court of Justice of the European Union 
Celiac Disease 

DG SANTE 

Directorate-General for Health and Food Safety 

DUS  

EASAC 
EFSA 
ENGL 

ENSSER 

ERA 
EU 
EURL 
EU-SAGE 
FAO 
F2F  
FRM  
FSFS 
FTE 
GHG 
GMO  
GM 
HRI 
HT 
IIA 
IPR 
ISAA 
JRC 
LCA 
MRIO 
NCWS 
NGT 
OECD  
PLB 
PRM 
QALY 
R&D 
RNQP 

Distinctness, Uniformity and Stability 

European Academies’ Science Advisory Council 
European Food Safety Authority  
European  Network  of  GMO  (Genetically  Modified  Organisms) 
Laboratories  
European  Network  of  Scientists  for  Social  and  Environmental 
Responsibility 
Environmental Risk Assessment 
European Union 
European Union Reference Laboratory  
European Sustainable Agriculture Through Genome Editing 
Food and Agriculture Organization of the United Nations 
Farm to Fork Strategy 
Forest reproductive material 
Framework for a sustainable food system 
Full Time Equivalent 
Greenhouse gas 
Genetically Modified Organism 
Genetically modified 
Harmonised Risk Indicator 
Herbicide-tolerant 
Inception impact assessment 
Intellectual property rights 
International Service for the Acquisition of Agri-biotech Applications 
European Commission’s Directorate-General Joint Research Center  
Life-cycle assessment  
Multi-regional input-output modelling  
Non-celiac wheat sensitivity 
New genomic techniques 
Organization for Economic Co-operation and Development 
Potato Late Blight  
Plant reproductive material 
Quality-adjusted life year 
Research and development 
Regulated non-quarantine pest 

iii 

 
 
 
SAM HLG 
SDG 
SME 
SPS 
SUR 
TFEU 
UAA 
UN 
UPOV 
VCU 
WTO 

Scientific Advice Mechanism High-Level Group 
Sustainable Development Goal 
Small and medium-sized enterprise 
Sanitary and phytosanitary measures 
Sustainable use of plant protection products regulation 
Treaty on the Functioning of the European Union 
Utilised Agricultural Area 
United Nations 
Union for the Protection of New Varieties of Plants 
Value for Cultivation and Use 
World Trade Organization 

Glossary of scientific terms 

Term or acronym 

Meaning or definition* 

Agrobiodiversity 

A  measure  of  the  number  and  relative  abundance  of 
species  and  varieties  in  cultivation;  it  also  takes  into 
account the genetic diversity within varieties 

Breeders’ gene pool 

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. 

Cisgenesis / intragenesis 

Clustered regularly 
interspaced short palindromic 
repeat associated 
nucleases/CRISPR associated 
protein (CRISPR/Cas) 

Cover crop/cash cover crop 

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 
with 
modifications/rearrangements (intragenesis).  

(cisgenesis) 

without 

or 

A family of SDNs (see definition below) that recognise a 
precise position in the DNA where a cut will be effected. 

Plants  planted  to  cover  the  soil.  These  crops  are  used  to 
manage,  among  others,  soil  erosion,  soil  fertility,  soil 
quality  and  weeds.  Cash  cover  crops  also  fulfil  this 
function  but  also  supply  harvestable  and  marketable 
products. 

Desoxyribonucleic acid 
(DNA) 

The  genetic  material  carrying  the  information  for  the 
development,  functioning,  growth  and reproduction of all 
known organisms and many viruses. 

iv 

 
 
 
Established genomic 
techniques 

Genetic modification techniques developed prior to 2001, 
when  the  existing  GMO  legislation  was  adopted.  In  the 
context  of  this  impact  assessment,  the  term  does  not 
include  random  mutagenesis 
techniques,  which  are 
exempted from the requirements of the GMO legislation. 

Event-specific detection 
method 

A detection method that is capable to detect and identify a 
specific transformation event. In the context of this impact 
assessment, 
to 
differentiate  a  specific  NGT  product  from  conventional 
ones that contain the same modification(s). 

this  means  a  method 

is  able 

that 

Exogenous DNA 

DNA  produced  by  whatever  means  outside  a  recipient 
organism  from  a  donor  organism  that  can  be  sexually 
compatible or not. 

Foreign DNA 

DNA  produced  by  whatever  means  outside  a  recipient 
organism  from  a  donor  organism 
is  sexually 
incompatible (non-crossable). 

that 

Genetically Modified 
Organism (GMO) 

An  organism,  with  the  exception  of  human  beings,  in 
which the genetic material  has been altered in  a way that 
does  not  occur  naturally  by  mating  and/or  natural 
recombination. 

Genome 

The  entire  genetic  material  present  in  a  cell  of  an 
organism. 

Genome editing (gene 
editing) techniques 

A  subset  of  NGTs  that  allow  precise  modification  of  the 
DNA in targeted positions in the genome. Genome editing 
encompasses  a  variety  of  techniques,  which  may  be 
applied in mutagenesis, cisgenesis or transgenesis. 

Mutagenesis 

Creation  of  mutation(s)  in  an  organism  without  insertion 
of foreign genetic material. 

New Genomic Techniques 
(NGTs) 

Niche crops 

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 existing legislation on the deliberate release of GMOs 
into the environment was adopted. 

Either  neglected  and  underutilized  crops  cultivated  in 
previous centuries for food, feed and fibre uses, but which 
have in recent times been reduced in importance and value 
and for which hardly any breeding activity is ongoing, or 
high value crops produced on relatively small volumes. 

v 

 
 
 
Off-target effects 

Unintended  mutations  that  are  introduced  in  locations  of 
the genome other than the intended one. 

Oligonucleotide directed 
mutagenesis (ODM) 

targeted  mutagenesis 

A 
by  which 
oligonucleotides  (short  pieces  of  DNA)  are  used  to 
introduce small, precise mutations in a genome. 

technique 

Plant Reproductive Material  Any  plant  material  (for  example  seeds,  tubers,  cuttings, 
rootstocks, seedlings, young plants, fully grown trees) that 
is used for the production of other plants. 

Random mutagenesis 

Site-directed nucleases 
(SDN) 

An umbrella term used to describe  conventional  breeding 
techniques  based  on  mutagenesis  that  have  been  used 
since the 1950s; they involve irradiation or treatment with 
chemicals  in  order  to  produce  random  mutations  in  a 
genome, and typically involve screening of a large number 
of mutants to select one with desirable properties. 

Enzymes  that  cut  DNA  at  precise  and  selected  target 
locations.  SDNs  use  a  guiding  molecule  to  target  the  site 
to be cut. Various SDNs exist, depending on the nature of 
the guiding molecule and the type of enzyme, e.g.  ZFNs, 
TALENs,  CRISPR/Cas.  Depending  on  their  type  and 
application, SDNs can be used for mutagenesis, cisgenesis 
and transgenesis. 

Site-directed nuclease type 1 
(SDN-1) 

Site-directed nuclease type 2 
(SDN-2) 

Site-directed nuclease type 3 
(SDN-3) 

targeted  mutagenesis 

to 
A 
introduce  small  mutations  in  a  specific  location  of  the 
genome. In SDN-1, no DNA template is provided, so the 
type of mutation is random. 

technique  using  SDNs 

targeted  mutagenesis 

A 
to 
introduce small, precise mutations in a specific location of 
the genome. In SDN-2, a DNA template is used to obtain a 
pre-determined mutation. 

technique  using  SDNs 

An  application  of  SDNs  that  allows  the  introduction  of 
exogenous  genetic  material  in  a  specific  location  of  the 
genome.  If  the  inserted  material  comes  from  a  donor 
organism  that  is  sexually  compatible  with  the  host 
organism,  the  result  is  cisgenesis;  if  the  inserted  material 
is  sexually 
comes 
incompatible  with 
is 
transgenesis. 

from  a  donor  organism 

the  host  organism, 

the  result 

that 

Sustainability 

The  long-term  ability  of  food  systems  to  provide  food 
security in a way that does not compromise the economic, 
social, and environmental bases that generate food security 

vi 

 
 
 
Targeted Mutagenesis 

Transformation event 

Transgenesis 

for future generation (HLPE 2020). 

An  umbrella  term  used  to  describe  newer  techniques  of 
mutagenesis  that  induce  mutation(s)  in  selected  target 
locations  of  the  genome  without  insertion  of  foreign 
genetic material.  

A  genetically  modified  plant  that  has  exogenous  DNA 
inserted in (a) certain location(s) of the genome 
Insertion  of  foreign  genetic  material  (e.g.  a  gene)  into  a 
recipient organism from a donor organism that is sexually 
incompatible (non-crossable). 

Unique alteration/ 
modification 

An alteration/modification that is not present or unlikely to 
be  present 
in  other  GMOs  or  conventional/natural 
varieties. 

* For the purpose of this document 

vii 

 
 
 
 
Introduction: Scientific, Political, and Legal Context 

1. 
This impact assessment explores economic, environmental, social (including health) impacts, 
as  well  as  impacts  on  fundamental  rights  and  administrative  burden,  of  options  for  a  legal 
framework for the deliberate release, including placing on the market, of plants and their food 
and feed products developed using certain new genomic techniques (NGTs), namely targeted 
mutagenesis and cisgenesis1.  

The  term  ‘new  genomic  techniques’  is  specific  to  the  EU  regulatory  environment  and 
encompasses  genetic  modification  techniques  that  have  emerged  or  have  been  developed 
since  2001,  when  the  centrepiece  of  the  current  EU  legislation  on  genetically  modified 
organisms (GMOs) was adopted2 (see section 1.1. below and Annex 5). 

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

Today, the EU market for plant reproductive material (PRM) (agriculture and forestry) has an 
estimated annual value of EUR 15 billion3.  The EU seed market is the third largest after the 
USA and China and accounts for around 20% of the global market. Its value is estimated at 
EUR  7-10  billion4  and  it  comprises  about  7  000  companies  (most  small  and  medium  sized 
enterprises, SMEs) with about 52.000 employees. EU companies are highly diverse as regards 
size,  portfolio  of  crops,  geographical  area  and  activities  (plant  breeding,  maintenance  of 
varieties,  multiplication,  trade).  The  EU  breeding  sector  is  highly  innovative  and  spends 
around 15% of its annual turnover on R&D.  

Scientific context  
1.1. 
Development of the techniques 

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

1 Unless specified, the term cisgenesis in this document encompasses also intragenesis. 
2 Directive 2001/18/EC  
3 Eurostat, see European Commission, 2023b. Annex 4. 
4 Ragonnaud (2013) 

1 

 
 
 
                                                           
produce  modifications  that  could  or  could  not  be  obtained  in  nature  or  by  conventional 
breeding. In most cases, these new techniques can lead to more targeted and precise changes 
than conventional breeding or established genomic techniques.  

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

Targeted mutagenesis induces mutation(s) in selected target locations of the genome without 
insertion  of  foreign  genetic  material  and,  in  certain  cases,  can  produce  alterations  of  the 
genetic  material  that  can  also  occur  naturally  or  that  can  be  obtained  by  conventional 
breeding.  Cisgenesis  includes  the  insertion  of  genetic  material,  by  random  or  targeted 
technologies5,  into  a  recipient  organism  from  a  donor  that  is  sexually  compatible  (i.e. 
crossable) and produces alterations that in some cases can also be obtained by natural crossing 
or  conventional  breeding.  Both  targeted  mutagenesis  and  cisgenesis  can  also  produce 
alterations  of  the  genome  that  are  more  complex  and  challenging  to  obtain  through 
conventional breeding. 

Opinions of scientific bodies 

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

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

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

The European Group on Ethics in Science and New Technologies (EGE) published in 2021 an 
opinion on the ethics of genome editing, which focuses on applications in the human, animal 

5 Since the first discussions in the EU in 2007, cisgenesis and intragenesis have been included among the new 
genomic techniques, regardless of the technology (random or targeted) used to produce them. 
6 European Commission (2017)  
7 EASAC (2017) 
8 European Commission (2021a)  
9 EFSA (2012, 2020, 2022a, 2022b, 2022c) 

2 

 
 
 
                                                           
and plant domains10. Among its conclusions on plants, EGE recommends a systems approach 
to evaluate costs and benefits in any future use and regulation proportional to the risk.  

The  European  Union  Reference  Laboratory  for  GM  food  and  feed  (EURL  GMFF)  and  the 
European Network of GMO Laboratories (ENGL) issued in 2019 a report on the detection of 
food and feed plant products obtained by new mutagenesis techniques11. They concluded that 
it is not feasible to differentiate a specific NGT product from conventional ones that contain 
the same modification(s). An updated report by the EURL-ENGL is expected in 202312. 

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

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

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

The  considerations  above  are  shared  by  other  major  scientific  bodies  outside  the  EU, 
including  the  US  National  Academies  of  Sciences,  Engineering,  and  Medicine13,  Health 
Canada14, the UK Advisory Committee on Releases to the Environment15 and the Norwegian 
Biotechnology  Advisory  Board16.  FAO  acknowledges  that  issues  of  safety  must  be 
considered17. FAO also considers that priorities can be established for regulatory interventions 
including  a  food  safety  assessment  while  also  recognizing  that  some  of  the  food  products 
produced from gene editing could have food safety characteristics similar to foods with a long 
history of safe use18. 

However, some scientific organisations and agencies, such as the German Federal Agency of 
Nature  Conservation,  the  European  Network  of  scientists  for  social  and  environmental 
responsibility (ENSSER) and TestBiotech, disagree with the above opinions19. They raise the 
concern  that  NGTs  pose  new  and  specific  risks  to  the  environment  and  human  health 
compared to previous applications of genetic engineering20. They consider that NGTs can be 
used to achieve genomic changes beyond what is known from conventional breeding and can 

10 https://ec.europa.eu/info/files/ethics-genome-editing_en 
11 European Network of GMO Laboratories (ENGL) (2019) 
12 European Network of GMO Laboratories (ENGL) (2023)  
13 National Academies of Sciences, Engineering, and Medicine (2016) 
14 Government of Canada (2022) 
15 ACRE (2021) 
16 Norwegian Biotechnology Advisory Board (2018) 
17 FAO (2022) 
18 FAO (2023) 
19 Bundesamt für Naturschutz (2021); ENSSER (2021); Testbiotech (2022) 
20 Kawall (2021) 

3 

 
 
 
                                                           
alter the genome to a much greater extent with multiple modifications than with any previous 
breeding  method.  Furthermore,  they  refer  to  unintended  genetic  changes  that,  according  to 
them, would be specific to the processes of NGTs and unlikely to occur via random processes 
or  conventional  breeding.  Furthermore,  these  organisations  question  that  NGTs  are  precise, 
controllable and predictable.  

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

Research and development 

Globally,  the  majority  of  the  research  on  crops  using  NGTs  is  conducted  in  China  (43%), 
followed with some distance by the US (18%), with 14% of this research taking place in the 
EU21. Research in the EU, also funded through the Horizon programme22, is mainly conducted 
in France, Germany, Italy, Belgium and the Netherlands.  

The  type  of  plant  applications  that  feature  prominently  in  the  research  and  development 
pipeline, coupled with the fairly easy and speedy applicability of these new techniques, could 
deliver benefits to farmers, consumers and to the environment. JRC23 as well as a database of 
available literature on the use of genome editing in crop plants maintained by the EU-SAGE 
network24  and  a  recent  report  from  the  Food  and  Agriculture  Organization  of  the  United 
Nations (FAO)25, show that research using these techniques concerns a wider variety of crops 
and  traits  compared  to  the  transgenic  organisms  authorised  in  the  EU  or  globally  so  far. 
Examples include plants with improved tolerance or resistance to biotic stress (plant diseases 
and pests), plants with improved tolerance or resistance to climate change effects  in general 
and abiotic stresses (environmental, e.g., temperature, drought), improved nutrient and water-
use  efficiency  in  plants,  and  plants  with  improved  agronomic  (e.g.,  higher  yield/input  ratio 
and  improved  resilience)  and  quality  characteristics  (e.g.,  taste,  shelf-life).  NGTs  can 
contribute to the development of new and improved plants and can further support the use of 
underutilised, neglected and local crop species – this can also support the special needs in the 
Outermost Regions. The research pipeline also includes applications of NGTs to develop the 
type of traits that have been the most common in the GMOs authorised so far in the EU or in 
other countries, such as herbicide-tolerance (see Annex 7). 

21 https://www.eu-sage.eu/index.php/genome-search 
22  E.g.  GeneBEcon  –  (https://cordis.europa.eu/project/id/101061015).  In  addition,  Horizon  Europe  includes  a 
forthcoming call HORIZON-CL6-2023-FARM2FORK-01-11: New detection methods on products derived from 
new genomic techniques for traceability, transparency and innovation in the food system. 
23 Parisi & Rodriguez Cerezo (2021) 
24 https://www.eu-sage.eu/index.php/genome-search 
25 FAO (2022) 

4 

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

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

  SDG3 (Good Health and Well-being), by facilitating the breeding of diverse nutritious 

and healthy foods. 

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

  SDG12 (Responsible consumption and production), by contributing to the sustainable 

management and efficient use of natural resources (e.g. nutrients and water). 

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

1.2.  Political context 
GMOs today 

GMOs  have  been  a  controversial  topic  in  the  EU  since  the  adoption  of  the  EU  GMO 
legislation.  Since  the  entry  into  force  of  Regulation  (EC)  No  1829/200327,  no  draft 
Commission  decision  proposing  the  authorisation  of  GM  food  and  feed  has  obtained  a 
favourable  opinion  by  qualified  majority  of  the  Member  State  in  the  relevant  Regulatory 
Committee,  notwithstanding  favourable  EFSA  opinions.  The  Commission  has  authorised 
28428 GMOs for food and feed and 6 GMOs for non-food uses29, based on favourable EFSA 
opinions.  20  of  these  have  been  renewed  following  a  favourable  EFSA  opinion.  All  these 
GMOs have been judged by EFSA as safe as their conventional counterparts. No regulatory 
measures (to withdraw, suspend or amend an existing authorisation) have been taken based on 
evidence of risks to human or animal health or to the environment. 

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

legislation,  1831  of 

introduced 

the 

in 

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

26 https://www.un.org/sustainabledevelopment/sustainable-development-goals/  
27 Regulation (EC) No 1829/2003 
28  This number includes single events and stacked events including their sub-combinations authorised to be 
placed on the market 
29 Cut flowers (carnations) 
30 Directive (EU) 2015/412 
31 Austria, Belgium (Wallonia), Bulgaria, Cyprus, Croatia, Denmark, Germany, France, Greece, Hungary, Italy, 
Latvia, Lithuania, Luxemburg, Malta, the Netherlands, Poland, Slovenia 
32 Parisi & Rodriguez Cerezo (2021)  

5 

 
 
 
                                                           
While  the  market  for  genetically  modified  (GM)  food  products  in  the  EU  is  small,  a 
substantial  market  exists  for  GM  feed.  The  EU  is  a  major  importer  of  high-protein  content 
agricultural commodities for feed use33, mainly from countries where cultivation is dominated 
by  GMOs.  According  to  2016  figures34,  out  of  the  36  million  tonnes  of  soybean  equivalent 
imported per year into the EU, around 30 million (i.e. 85%) was GM. 

Whereas cultivation of GMOs in the EU is very limited, globally there is now experience of 
more than 25 years since the first commercialisation of GM crops. Beyond the EU, in 2019, 
27  countries  grew  around  190  million  hectares  of  biotech  crops.  An additional  17 countries 
imported biotech crops for food, feed, and processing. Thus, including the EU, a total of 71 
countries  have  adopted  biotech  crops  so  far35.  An  extensive  study  by  the  US  National 
Academies of Sciences, Engineering and Medicine published in 2016 on GM crops reported 
no observed adverse effects on health and the environment, while recognising the difficulty to 
assess long-term environmental impacts36. 

NGTs in the context of key EU strategies 

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

The  double  crisis  of  climate  change  and  biodiversity  loss  have  put  the  focus  on  long-term 
resilience and the need  for a transition  to  more sustainable  agriculture and food systems.  In 
this  context,  the  European  Green  Deal’s  Farm  to  Fork  Strategy  presents  the  Commission’s 
plan for a transition to a sustainable food system37. It specifically refers to biotechnology as a 
possible  tool  for  increasing  sustainability,  provided  they  are  safe  for  consumers  and  the 
environment while bringing benefits for society as a whole. The Biodiversity Strategy38 aims 
to support and incentivise the transition to fully sustainable agricultural practices, improving 
the condition and diversity of agroecosystems. 
In  its  2022  Communication39  “Safeguarding  food  security  and  reinforcing  the  resilience  of 
food  systems”,  the  Commission  has  identified  NGTs  as  potentially  contributing  to  food 
security.  In  this  context,  according  to  the  FAO40,  although  the  extent  of  the  impact  is  still 
speculative, the introduction of gene-editing technologies will have far-reaching implications 
for  agri-food  and  social  systems  in  terms  of  their  potential  for  improving  and  securing 
production of food.  

The Covid-19 pandemic and  Russia’s war of aggression against Ukraine  have also  revealed 
the EU’s external dependencies. While EU food security has not been at stake, a global spike 
in prices of inputs needed for agri-food production, in particular energy, animal feed and feed 
additives, and fertilisers has shown the EU’s vulnerability to price shocks. In its Trade Policy 
Review Communication41, the Commission has stressed the role of trade openness within the 
concept of “Open Strategic Autonomy”, notably recalling the importance of an open and fair 
trade with well-functioning, diversified and sustainable global value chains.  

33 EU Feed Protein Balance Sheet (November 2022), https://agriculture.ec.europa.eu/data-and-
analysis/markets/overviews/balance-sheets-sector/oilseeds-and-protein-crops_en  
34  European Commission (2016)  
35 ISAAA (2019) 
36 National Academies of Sciences, Engineering, and Medicine (2016) 
37 European Commission (2020a) 
38 European Commission (2020b) 
39 European Commission (2022a) 
40 FAO (2022) 
41 European Commission (2021b) 

6 

 
 
 
                                                           
Strategic  autonomy  and  resilience  also  depend  on  the  diversification  of  the  food  system. 
NGTs  are  applied  to  a  far  larger  range  of  crop  species  than  established  techniques  and  can 
thereby  contribute,  for  example,  to  decreasing  the  EU’s  dependence  on  imports  of  plant 
proteins.  NGTs  and  their  technical  accessibility  could  also  support  the  diversification  of 
developers and users in the food systems, if access to and affordability of the technologies is 
assured. 
Under the European Climate Law42, the EU must continuously progress in enhancing adaptive 
capacity,  strengthening  resilience  and  reducing  vulnerability  to  climate  change.  In  its 
Communication ‘Forging a climate-resilient Europe - the new EU Strategy on Adaptation to 
Climate Change’, the Commission acknowledged that making better use of genetic diversity 
and non-harmful plant genetic resources for adaptation based on the latest science is among 
the urgently needed solutions to help farmers and land managers tackle climate risks43.  
The  EU  Bioeconomy  Strategy44  supports  innovation  at  the  service  of  the  Green  Deal 
objectives,  in  particular  the  deployment  of  a  circular  bio-based  industry  contributing  to  the 
replacement of fossil resources by sustainably generated bio-based materials and chemicals. It 
recognises  the  potential  of  biotechnology  and  life  sciences  to  achieve  such  objectives.  The 
Council's conclusions on the opportunities of the bioeconomy from March 202345 specifically 
mentioned  the  importance  of  seizing  the  opportunities  presented  by  the  bioeconomy  and 
called on the Commission to enhance the integration of the bioeconomy into all policies and 
ensure coherence among policies. 
The  European  Parliament  has  adopted  several  resolutions46  where  it  refers  to  new  plant 
breeding techniques and recognises the importance to develop and use such techniques which 
respond  to  societal  and  agricultural  demands  and  enhance  the  competitiveness  of  the 
agriculture and horticulture sectors.  In 2021 on a resolution47 on Farm to  Fork Strategy, the 
European  Parliament  also  referred  to  the  Commission’s  plans  to  initiate  a  regulatory  policy 
action  plants  derived  from  certain  new  genomic  techniques  highlighting  the  precautionary 
principle  and  the  need  to  ensure  transparency  and  freedom  of  choice  to  farmers,  processors 
and  consumers.  Against  this  background,  there  is  currently  a  strong  demand  by  a  range  of 
stakeholders including breeders, farmers and academia, to adapt the regulatory framework to 
enable the development, marketing and use of NGTs as tools contributing to address current 
challenges. Other stakeholders, however, consider that the benefits of NGTs are hypothetical 
and  achievable  by  means  other  than  biotechnology.  Some  are  concerned  about  safety  (e.g., 
environmental organisations) and/or possible negative impacts on their business (organic and 
GM-free sectors). 

Other factors affecting the development and marketing of NGTs 

There  is  widespread  recognition  that  the  development  and  marketing  of  NGTs,  and  the 
realisation of their potential, depends on various factors. An appropriate regulatory framework 
is  important,  but  patents,  access  of  farmers,  public  organisations  and  SMEs  to  the 

42 Regulation (EU) 2021/1119 
43 European Commission (2021d) 
44 European Commission (2018) 
45 Council of the European Union (2023) 
46 https://www.europarl.europa.eu/doceo/document/TA-7-2014-0131_EN.html; 
https://www.europarl.europa.eu/doceo/document/TA-8-2016-0251_EN.html; 
https://www.europarl.europa.eu/doceo/document/TA-8-2016-0252_EN.html;  
47 https://www.europarl.europa.eu/doceo/document/TA-9-2021-0425_EN.html  

7 

 
 
 
                                                           
technologies  and  the  market,  and  factors  affecting  consumer  acceptance,  will  also  have  an 
impact.  
The intellectual property landscape regarding NGT plants is complex and rapidly evolving48. 
Patents and access to affordable patent licenses for NGT technologies and for genetic material 
obtained  by  these  techniques  will  play  a  role  in  breeders’  (especially  SMEs’)  ability  to 
develop  and  market  new  plant  varieties  based  on  these  techniques.  Some  plant  breeders  are 
concerned  that  the  cost  of  licences  to  access  the  technology  can  be  prohibitive,  notably  for 
small crops49. In addition, there are calls from some stakeholders that patentability should not 
negatively impact the ability of farmers to choose, afford and propagate harvested NGT plant 
seeds on their farms. 

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

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

Regarding citizens’ current perception of NGTs,  there are studies reporting on the one hand 
negative attitudes and on the other hand an increased acceptance of NGT food compared to 
current  perception  of  GMOs.  Attitudes  on  GMOs  in  general  and  NGTs  in  particular  are 
closely  connected  to  levels  of  knowledge  and  the  perceived  safety  levels50.  Several  studies 
indicate that the majority (60-64%) of Europeans have not heard of NGTs and that consumers' 
knowledge on NGT organisms and GMOs is limited51. However, comparatively, at this stage 
they appear to be more knowledgeable about GMOs generally than about NGTs52. The level 
of awareness on NGTs varies among different countries but is generally low53.  

EFSA  has  recently  conducted  research  into  food  safety  in  general  as  well  as  on  NGTs 
concretely. Food safety is considered important by the majority (70%) of the EU population. 
In terms of the most important concerns, 26% expressed concern about  GM ingredients and 
8% about NGT ingredients. Regarding NGTs, citizens are interested in possible risks (69%), 
who  benefits  and  who  bears  the  risks  (42%),  regulation  (40%),  what  benefits  NGTs  bring 
(38%), consumers’ choice (38%), and the scientific process and techniques (31%). As regards 
information  on  food  risks,  this  research  also  showed  high  trust  in  scientists  in  all  Member 
States and in EU institutions in several Member States54.  

Research conducted globally suggests that the majority of the respondents are receptive to the 
use  of  NGT  products,  particularly  in  the  agricultural  sector,  as  long  as  they  bring  societal 

48 Kock (2021) 
49 See Annex 5, section 2.3.3. in Technopolis et al. (2023) 
50  Strobbe  et  al.  (2023),  FSA.  (2021),  Sprink  et  al  (2022),  Son  &  Lim  (2021),  Bundesinstitut  für 
Risikobewertung (BfR) (2017), GENEinnovate. (2020), Beghin & Gustafson (2021) 
51  European  Commission  (2021c),  section  4.10.2,  EFSA  (November  2021).  FSA  (2021),  Swedish  Gene 
Technology  Advisory  Board,  Department  of  Plant  biology  (SLU),  Novus.  (December  2021),  GENEinnovate. 
(April 2020), The Greens/EFA (2021) 
52 Hu et al. (2022) 
53 Strobbe et al.(2023), Busch et al (2022), Kato-Nitta et al (2021), Beghin & Gustafson (2021) 
54 EFSA. (November 2021), EFSA. (September 2022) 

8 

 
 
 
                                                           
benefits  and  promote  sustainability55,  for  example  through  traits  adapted  to  climate  change, 
reduced pesticide use and improved nutritional  content.  A recent  Eurobarometer on citizens 
expectations on sustainability indicated that  for consumers the most important  characteristic 
of sustainability are the health and nutritional aspects (41%), the absence of pesticides (32%) 
and affordability (29%). 18% of the respondents correlated organic food with sustainability56. 

The  majority  of  respondents  in  research  studies  believe  that  labelling  of  NGT  products  is 
necessary57.  In some  cases, there is  also  a preference for  distinct labelling of GM and NGT 
products. Research indicates that consumers may also desire information on the specific trait 
that  has  been  modified  and  which  genetic  technology  has  been  used,  to  be  provided  on 
product labels58. 

In the context of this initiative, consumer trust is relevant not only as regards acceptance of 
NGTs  but  also  in  relation  to  organic  production.  Research  shows  different  results  on  the 
importance of the absence of GMOs in the decision to purchase organic food. This decision 
seems  to  depend  on  different  factors,  such  as  health  awareness,  food  safety  concerns, 
environmentally friendly production practices, consumer knowledge of organic foods, animal 
welfare,  avoidance  of  chemical  substances,  perceived  or  subjective  social  norms  and 
availability of organic food options59.  

In  its  2021  opinion,  EGE  acknowledges  the  prevalence  of  public  concern  in  relation  to 
GMOs,  including  the  lack  of  public  dialogue  and  informed  debate,  which  in  its  view 
accompanied  the  introduction  of  GMO  products,  and  calls  for  more  attention  to  public 
dialogue on NGT plants60. 

1.3.  Legal context 
In the EU, regulatory requirements for GMOs are enshrined in five main legislative acts61 and 
have  two  main  objectives:  to  protect  human  and  animal  health  and  the  environment  and  to 
ensure the effective functioning of the internal market. They establish harmonised procedures 
requiring  an  authorisation  for  the  deliberate  release  of  GMOs  into  the  environment  for 
experimental purposes as well as for the placing on the market and cultivation of GMOs and 
GM food and feed. This authorisation system is based on an assessment of the risks to human 
and  animal  health  and  the  environment,  and  includes  requirements  for  post-authorisation 
monitoring, labelling and traceability.   

In  the  context  of  the  Cartagena  Protocol  on  Biosafety,  the  EU  has  made  a  number  of 
international  commitments  with  respect  to  the  safe  transfer,  handling  and  use  of  living 
modified organisms resulting from modern biotechnology62. 

55  Swedish  Gene  Technology  Advisory  Board  (2021),  GENEinnovate.  (April  2020),  Kato-Nitta  et  al.  (2021), 
Baum et al (2023), Sikkema (2021), Grain Club (2023), Rathenau Instituut (2023), Saleh  et al. (2021)., Beghin 
& Gustafson (2021) 
56 Special Eurobarometer 505 – Wave EB93.2 – Kantar (December 2020) 
57 YouGov (2022), Lindberg et al. (2023), The Greens/EFA (2021), Rathenau Instituut (2023) 
58 GENEinnovate. (April 2020), Swedish Gene Technology Advisory Board (2021), YouGov (2022), Lindberg 
et al. (2023), The Greens/EFA (2021) 
59 Gundala et al. (2021), Singh & Verma (2017), Paul & Rana (2012), Michaelidou & Hasan (2008), Padel et al. 
(2015),  Torjusen  et  al.  (2004),  Pew  Research  Centre  (2016),  IFOAM,  BEUC,  Special  Eurobarometer  520  – 
Kantar (2022) 
60 European Group on Ethics (EGE) (2021) 
61  Directive  2001/18/EC,  Regulation  (EC)  No  1829/2003,  Regulation  (EC)  No  1830/2003,  Directive 
2009/41/EC. 
62 https://bch.cbd.int/protocol/text/ 

9 

 
 
 
                                                           
In 2018, the Court of Justice of the EU (CJEU) ruled63 that new mutagenesis techniques are 
not  exempted  from  to  the  requirements  of  the  EU  GMO  legislation  (as  is  the  case  of  old 
mutagenesis techniques) (Annex 8). 

In November 2019, the Council noted that, while the Court ruling clarified the scope of the 
GMO legislation, concerns remained about the application of the EU legal framework when 
products  obtained  with  new  mutagenesis  techniques  are  not  distinguishable  from  those 
resulting  from  natural  mutations  or  from  conventional  breeding.  The  Council  therefore 
requested64  the  Commission  to  prepare  a  study  on  the  status  of  NGTs  under  EU  law 
(hereinafter referred to as ‘Commission NGT study’). 
The Commission 2021 NGT study65 concluded that, based on the reasoning followed by the 
Court, the EU GMO legislation also applies to organisms produced by other NGTs, including 
cisgenesis.  On  the  basis  of  the  products  in  the  research  and  development  pipeline,  it 
considered that NGTs can contribute to the achievement of the Green Deal and Farm to Fork 
objectives, as well as to a more competitive economy. The study considered that the current 
EU GMO legislation needs adaptation to scientific and technological progress to be suited to 
certain NGTs and the diversity of products they can deliver. It also reported on the concerns 
expressed by certain stakeholders and concluded that the application of NGTs in agriculture 
should not undermine other aspects of food production, e.g., organic agriculture. 

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

International dimension 

1.4. 
Globally, NGT organisms67 and their products are either considered as GMOs or novel foods, 
or  as  conventional  products68;  some  countries  require  a  case-by-case  consideration  of  each 
product in order to establish the applicable regulatory framework. Various non-EU countries 
have  adapted,  or  are  in  the  process  of  adapting,  their  legislation  in  order  to  specifically 
address  NGTs;  this  includes  important  EU  trade  partners  such  as  the  US,  Japan,  Argentina, 
India  and  the  UK.  A  recent  report  by  the  FAO  provides  a  detailed  overview  of  current 
regulatory approaches across the world69. China, leading country on research, does not have a 
specific  regulatory  framework  on  genome  edited  crops,  but  has  released  guidelines  for  the 
safety  evaluation  of  genome  edited  plants70  that  are  intended  to  provide  a  more  streamlined 
approval process than for GMOs. The African Union Agenda 206371 aims at utilising genome 
editing  to  improve  agricultural  productivity  and  crop  resistance.  Kenya  and  Nigeria  have 
already  implemented regulations for a case-by-case review of genome-edited crops72. NGTs 
could  be  relevant  in  low-  and  middle  income  countries,  which  would  benefit  from  adapting 

63 Judgment of 25.6.2018 in Case C-528/16 Confédération paysanne and Others. ECLI:EU:C:2018:583 
64 Council Decision (EU) 2019/1904  
65 European Commission (2021c) 
66 ECLI:EU:C:2023:75 
67 The term NGT is only used in the EU. Other jurisdictions use other terms such as “genome editing”, “gene-
editing”, “precision breeding” or other variants. These terms may cover different techniques. 
68 European Commission (2021c) 
69 FAO (2022) 
70 USDA (2022)  
71 https://au.int/en/agenda2063/overview 
72 Buchholzer & Frommer (2023) 

10 

 
 
 
                                                           
traditional,  local  crop  species  so  that  they  can  withstand  changing  conditions.  An  enabling 
framework in the EU could also support use in those countries.  
Switzerland  is  considering  a  new  authorisation  regime73  for  plants  that  have  been  obtained 
using  new  breeding  technologies  and  are  not  transgenic.  Canada  has  a  product-based 
legislation;  products  with  novel  traits  are  subject  to  risk  assessment,  regardless  of  the 
technique used. Other countries, such as New Zealand74 and South Africa75, continue applying 
their GMO legislation to NGT organisms.  

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

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

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

Currently regulatory developments on NGTs across the world differ to various extents and the 
resulting alignment or divergence will impact trade in plants, food and feed, and may lead to 
trade frictions as illustrated by the experience with GMOs. 
In the context of the WTO’s Sanitary and Phytosanitary Committee, in 2018, 11 countries76 
co-signed an international statement on agricultural applications of precision biotechnology77, 
acknowledging its role in addressing challenges facing agricultural production and calling for 
policy alignment in order to minimise unnecessary trade barriers.  

Scope 

1.5. 
The  scope  of  this  initiative  are  plants  produced  by  targeted  mutagenesis  and  cisgenesis 
(including intragenesis) and their food and feed products.  

The choice of the scope is  based on several  reasons.  There is  significant  demand in  the EU 
and  globally  for  NGT  plants,  in  the  context  of  their  potential  to  contribute  to  current 
challenges in the agri-food system. Numerous advanced and early R&D applications concern 
plants, and several plant products are already on or very close to the market. Safety data are 
mainly  available  for  plants  obtained  by  targeted  mutagenesis  and  cisgenesis  (addressed  in 
expert opinions from EFSA), whereas it is at this stage difficult to draw relevant conclusions 

73 Bundesversammlung der Schweizerischen Eidgenossenschaft (2022) 
74 Entine et al. (2021) 
75 Republic of South Africa (2021) 
76 Argentina, Australia, Brazil, Canada, the Dominican  Republic, Guatemala, Honduras, Paraguay, Philippines, 
the United States of America and Uruguay. 
77 WTO (2020) 

11 

 
 
 
                                                           
on  other  techniques  and  applications  in  animals  and  micro-organisms.  Furthermore,  similar 
plants can be obtained in certain cases with conventional breeding and targeted mutagenesis 
and  cisgenesis,  and  the  appropriateness  of  subjecting  these  products  to  the  same  regulatory 
requirements as transgenic organisms needs to be assessed.  

Interaction with existing legislation and upcoming initiatives 

1.6. 
This initiative is framed by the existing legislation on GMOs and has links to other legislation 
applicable  to  plants,  food  and  feed,  as  well  as  with  planned  initiatives  implementing  the 
European Green Deal and the Farm to Fork Strategy. Section 7.3 describes the coherence with 
the relevant legislation and upcoming initiatives78. 

The  initiative  on  NGT  plants  aims  to  establish  specific  rules  applicable  to  the  deliberate 
release and the placing on the market of these plants and derived food and feed, taking into 
account  their  specificity,  while  maintaining  the  objectives  of  the  GMO  legislation  and 
ensuring coherence with it.  
The  planned  initiative  on  a  legislative  framework  for  a  sustainable  food  system  (FSFS)79 
covers the entire food system, thus encompassing NGT plants used for food or feed and the 
derived food and feed products. The placing on the market and cultivation of plant varieties 
derived from  NGT plants  will  also  have to comply  with  EU legislation on the marketing of 
seeds and other plant and forest reproductive material (PRM, FRM), which is currently under 
revision80. In particular, the assessment of the value for cultivation and use (VCU) carried out 
under  this  legislation  covers  various  aspects  (e.g.  yield,  pest  resistance,  nitrogen-use  and 
water-use efficiency) which may be linked to traits introduced by NGTs.  

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

EU legislation on organic production and labelling of organic products, the Organic Products 
Regulation’82  bans  the  use  of  GMOs  and  GM  food  and  feed  in  organic  production83,  and 
allows  organic  operators  to  rely  on  the  labels  and  accompanying  documents  available 
pursuant  to  the  GMO  legislation.  In  addition,  organic  operators  have  to  implement 
precautionary measures to avoid  the presence of  products  and substances  not  authorised  for 
use in organic production. However, GMOs that are exempted today from the requirements of 
the GMO legislation (such as products obtained by random mutagenesis, i.e. old mutagenesis 
techniques) are treated as conventional for the purposes of organic production.  

Legislation on  IPRs  will have an impact  on the development  and marketing of NGT plants. 
Two  types  of  IPRs  are  of  particular  relevance  for  NGT  plants:  biotechnology  patents  and 
plant variety  rights.  The Biotechnology  Directive84 on the legal protection of biotechnology 
inventions provides for the patentability of subject-matter involving biological material which 

78 https://agriculture.ec.europa.eu/farming/organic-farming/legislation_en 
79  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13174-Sustainable-EU-food-system-
new-initiative_en 
80 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Plant-and-forest-reproductive-
material-revised-rules-_en 
81 European Commission (2022b) 
82 Regulation (EU) 2018/848 
83  The  Organic  Products  Regulation  also  prohibits  the  use  of  non-food  and  non-feed  products  produced  from 
GMOs or by GMOs in organic food and feed. These categories of products are not subject to the EU legislation 
on the deliberate release of GMOs. 
84 Directive 98/44/EC 

12 

 
 
 
                                                           
is  new,  involves  an  inventive  step  and  is  susceptible  to  industrial  application.  A  patent  can 
cover  the  biological  material  as  well  as  the  process  to  produce  it,  but  not  plant  and  animal 
varieties and essential biological processes for the production of plants and animals. The latter 
exclusion  also  extends  to  plants  and  animals  obtained  by  such  essentially  biological 
processes.85 Plant variety rights86 can be granted for plant varieties that are distinct, uniform, 
stable  and  new.  Breeders  may  use  protected  plant  varieties  for  the  purpose  of  breeding  and 
marketing new varieties.  

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

Problem definition 
2. 
2.1.  What are the problems? 
The current EU GMO legislation is not fit for purpose for  NGT plants obtained by targeted 
mutagenesis or cisgenesis, and their food and feed products. This was highlighted already in 
the 2010/2011 external studies and confirmed by the Commission NGT study in 2021. This is 
also  the  view  of  most  stakeholder  groups  in  the  public  consultation  for  this  impact 
assessment89, where 191 (93%) of the respondent  academic/research institutions, 102 (84%) 
of business associations, 66 (80%) of large enterprises, 70 (72%)  of SMEs and 29 (83%) of 
public  authorities  found  the  existing  regulatory  provisions  inadequate  for  these  plants. 
However, other stakeholder groups (47 (58%) of non-governmental organisations (NGO), 16 
(80%) of environmental organisations, 3 (60%) of consumer organisations) consider that the 
existing  legislation  is  adequate.  These  results  are  similar  to  the  outcome  of  the  feedback 
received to the inception impact assessment (Annex 2). 

The problem is composed of three main components:  

85 See Rule 28(2) of the Implementing Regulations to the European Patent Convention;  Commission Notice on 
certain articles of Directive 98/44/EC of the European Parliament and of the Council on the legal protection of 
biotechnological inventions (2016/C 411/03) 
86 Regulation (EC) No 2100/94 
87 Food Chain Evaluation Consortium (2010) 
88 GHK Consulting (2011) 
89 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  

13 

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

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

The  conclusions  of  scientific  bodies  in  this  regard  (section  1.1)  were  shared  by  the 
majority  view  of  stakeholders  in  the  consultation  activities.  In  the  public  consultation, 
829 respondents, 23% of those replying that the legislation is not adequate, indicated as 
an underlying reason that the risk assessment approach cannot factor in the diverse risk 
profiles  of  the  plants  in  question90;  in  addition,  61%  (1331)  of  total  respondents 
supported  a  risk  assessment  approach  different  from  the  current  one91.  On  the  other 
hand, 22% of respondents (480 responses)92 were of the view that NGT plants need to be 
assessed using the current GMO legislation requirements. 

II)  The  current  EU  GMO 

legislation  raises 

implementation  and  enforcement 

challenges for certain plants produced by targeted mutagenesis or cisgenesis.  

The  EU  GMO  legislation  currently  requires  applicants  to  provide  an  analytical 
laboratory method that is specific to the product for which they seek authorisation, i.e. it 
can both  detect  it and differentiate it from  other products.  The EURL and ENGL have 
concluded93 that, if the genetic alteration is not unique for the relevant product, a specific 
detection  method  cannot  be  provided.  When  the  same  alteration  can  be  introduced  by 
NGTs or conventional breeding methods, the detection method may be able to detect it, 
but  will  not  allow  determining  whether  the  product  is  a  GMO  subject  to  the  GMO 
legislation  or  not.  In  such  cases,  applicants  will  be  unable  to  comply  with  an 

90  89  (21%)  of  the  Academic/research  institutions,  56  (24%)  of  the  Business  associations,  68  (25%)  of 
company/business  organisations,  2  (33%)  of  Consumer  organisations,  560  (23%)  of  EU  citizens,  2  (15%)  of 
Environmental  organisations,  19  (24%)  of  Non-EU  citizens,  14  (19%)  of  Non-governmental  organisations,  17 
(22%) of Public authorities, 1 (7%) of Trade Unions and 2 (25%) of Other.  
91  34%  (738)  of  total  respondents  believed  that  risk  assessment  should  have  requirements  adapted  to  the 
characteristics  and  risk  profile  of  a  plant  (41%  (84)  of  the  Academic/research  institutions,  11%  (13)  of  the 
Business associations, 23% (41) of company/business organisations, 20% (4) of Consumer organisations, 37% 
(552) of EU citizens, 10% (2) of Environmental organisations, 50% (19) of Non-EU citizens, 10% (8) of Non-
governmental  organisations,  49%  (17)  of  Public  authorities,  14%  (2) of  Trade  Unions  and  20%  (1)  of  Other). 
27%  (593)  believed  that  risk  assessment  is  not  needed  when  these  plants  could  have  been  produced  through 
conventional plant breeding or classical mutagenesis (37% (76) of the Academic/research institutions, 54% (66) 
of the Business associations,  42% (75) of company/business organisations, 22% (328) of EU citizens, 10% (2) 
of  Environmental  organisations,  11%  (4)  of  Non-EU  citizens,  27%  (22)  of  Non-governmental  organisations, 
31% (11) of Public authorities, 43% (6) of Trade Unions and 20% (1) of Other).  
92  3%  (6)  of  the  Academic/research  institutions,  16%  (20)  of  the  Business  associations,  22%  (39)  of 
company/business  organisations,  80%  (4)  of  Consumer  organisations,  22%  (328)  of  EU  citizens,  75%  (15)  of 
Environmental organisations, 18% (7) of Non-EU citizens, 54% (44)  of Non-governmental organisations, 17% 
(6) of Public authorities, 36% (5) of Trade Unions and 20% (1) of Other. 
93 ENGL (2019) 

14 

 
 
 
                                                           
authorisation requirement, and other food chain operators and authorities will not be able 
to  implement  or  enforce  the  legislation.  This  has  been  confirmed  by  the  fact-finding 
studies  carried  out  by  the  Commission  in  2022  in  Germany94  and  the  Netherlands95 to 
gather  information  on  the  implementation  of  controls  on  organisms  and  products 
obtained through NGTs.  

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

Finally,  the  emergence  of  targeted  mutagenesis  and  cisgenesis  techniques  raises 
questions  of  interpretation  of  Directive  2001/18/EC  (and  other  GMO  legislation).  That 
legislation lacks definitions of certain key terms or concepts such as  ‘mutagenesis’ and 
‘genetic material [that] has been altered’. The potential ambiguities can lead to diverging 
interpretations, regulatory uncertainty and implementation challenges96.  

III)  The current EU  GMO  legislation applied to NGTs is  not  conducive to developing 

innovative beneficial products. 

NGTs can bring speed and precision to the development of improved plant varieties with 
traits  that  could  support  a  sustainable  and  resilient  EU  agri-food  system  (section  1.1). 
However,  as  a  result  of  the  regulatory  issues  mentioned  above,  the  current  EU  GMO 
legislation  applied  to  NGTs  is  not  conducive  to  developing  these  innovative  products 
and to place them on the market in the EU. In the public consultation, 61% of the total 
respondents (1329)97 believed that maintaining plants produced by targeted mutagenesis 
and cisgenesis under the current framework is expected to have short-, medium- or long-
term  consequences  in  their  activity  or  sector.  The  large  majority  mentioned  negative 
consequences,  relating  to  loss  of  tools  to  achieve  the  goals  of  the  Green  Deal  and  the 
Farm  to  Fork  Strategy,  as  well  as  obstacles  to  research  and  development  of  improved 
crops  and  loss  of  competitiveness.  19%  (424)  of  the  respondents98  do  not  expect  to 
experience any consequence. 

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

94 https://ec.europa.eu/food/audits-analysis/audit-report/details/4543  
95 https://ec.europa.eu/food/audits-analysis/audit-report/details/4544  
96 European Commission (2021c), section 5. 
97 80% of the Academic/research institutions, 89% of the Business Associations, 71% of the Company/business 
organisations, 40% of the Consumer Organisations, 55% of EU citizens, 30% of Environmental organisations, 
63% on Non-EU citizens, 54% of NGOs, 71% of Public Authorities, 93% of Trade Unions.  
98 9% (19) of Academic/research institutions, 9% (11) of Business associations, 22% (40) of Company/business 
organisations,  60%  (3)  of  Consumer  organisations,  20%  (299)  of  EU  citizens,  65%  (13)  of  Environmental 
organisations, 21% (8) of Non-EU citizens, 36% (29) of Non-governmental organisations and 6% (2) of Public 
authorities. 

15 

 
 
 
                                                           
the  agricultural  biotechnology 

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

In  the  targeted  survey  conducted  for  this  impact  assessment,  respondents  active  in  plant 
breeding (45.5%, 56 of 123) pointed to regulatory uncertainty, regulatory costs and time to 
market  as  the  most  important  barriers  to  developing  new  plant  varieties  using  targeted 
mutagenesis  or  cisgenesis.  Due  to  uncertainty99,  the  current  regulatory  regime  is  seen  as 
inducing  high  risk  for  plant  breeders  to  engage  in  NGT-related  research  and  product 
development, in particularly for start-ups and SMEs. A significant share of companies (40%) 
replied that they delayed product development and release due to this regulatory uncertainty. 
Large companies respond to this uncertainty by moving R&D on NGTs to non-EU countries, 
while SMEs may not have the resources to pursue this strategy (100% of the large companies 
vs. 20% SMEs according to  a recent  survey)100. Regulatory developments  in  third countries 
(section  1.4)  affect  negatively  the  competitiveness  of  the  EU  biotechnology  and  breeding 
sectors,  in  particular  of  SMEs,  on  international  markets  which  is  also  contributing  to 
weakening the EU’s strategic autonomy. 

In the public consultation, academic/research institutions emphasised the negative impact of 
the  current  situation  on  the  competitiveness  of  the  EU  research  sector,  compared  to  other 
countries  with  a  more  enabling  environment.  Researchers  consider  the  current  regulatory 
situation as hindering funding decisions by public and private funders and report that, since 
the  CJEU  ruling,  several  R&D  projects  were  cancelled  or  shifted  abroad.  A  recent  survey 
suggests  a  reduction  of  33-40%  of  R&D  activities  after  the  ruling101.  Young  researchers 
indicate  that  the  EU  has  become  less  attractive  for  a  career  in  agricultural  biotechnology, 
leading  to  a  brain  drain  and  recruitment  challenges102.  This  could  further  widen  the  already 
established  patenting  gap  between  the  EU  and  US/China  in  agricultural  biotechnology  that 
emerged since 1998103. 

99 Regulatory certainty is the predictability that a product fulfilling the requirements is authorised for placing on 
market in a given time. 
100 Jorasch (2020) 
101 Ibid. 
102 http;//www.genesproutinitiative.com/about-us/ 
103 WIPO (2019) 

16 

 
 
 
                                                           
Stakeholders  from  the  bio-based  economy  consider  genome-editing  as  a  key  enabling 
technology104. The existing regulatory framework is seen as an obstacle to innovation in this 
sector, which will increase the EU’s dependence on technological developments coming from 
other parts in the world105. 

The  existing  regulatory  problems  affect  also  farmers.  Farmers  are  deprived  of  tools  and 
products  that  could  contribute  to  improving  the  yield/input  ratio,  to  dealing  with  the 
challenges  of  climate  change  and  to  meeting  reduction  targets  for  pesticides  and  fertilisers. 
Climate  impacts  have  led  to  poorer  harvests  and  higher  production  costs,  affecting  price, 
quantity  and  the  quality  of  farmed  products  in  parts  of  the  EU.  Climate  change  impacts  on 
agriculture  are projected to  lead up to  1% average  gross domestic product  loss by 2050  but 
with  large  regional  differences106.  Plant  breeding  is  one  effective  counter  measure  against 
such  climate  change  impacts.  Adapting  crop  varieties  to  rapid  climate  change  by  breeding 
requires  making  rapid  incremental  changes  in  the  best  adapted  varieties  to  keep  pace  with 
changes  in  the  biotic  and  abiotic  environment,  to  ensure  food  security107  and  to  support  the 
transition  to  sustainable  agriculture.  While  conventional  breeding  has  led  to  a  continuous 
improvement of a wide range of traits108, NGTs are crucial technologies enabling a more rapid 
and targeted breeding progress. 

Consumers  prepared to  accept  products  of biotechnology will have to  forego  benefits  from 
products  that  could  be  designed  to  meet  their  expectations  and  needs  (e.g.  improved  taste, 
improved nutrient profile or reduced allergen content). NGTs can improve the taste of green 
leafy  vegetables,  which  are  an  important  source  of  vitamins,  minerals,  and  phenolic 
compounds109, or reduce the content of the potential carcinogen acrylamide in wheat110.  

The  current  situation  has  also  a  negative  impact  on  international  trade.  In  practical  terms, 
the current regulation is seen as an obstacle for the importation of commodities derived from 
NGTs111.  The  current  GMO  regulation  has  resulted  in  lost  trade  opportunities  due  to 
temporarily  closed  borders,  testing  costs,  lawsuits,  and  disputes112,  whereas  asynchronous 
authorisations create uncertainty for importers and exporters113. The situation for NGTs may 
be even more challenging compared to conventional GMOs due to the existing difficulties in 
analytical detection possibilities.  

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

104  Key  enabling  technologies  are  knowledge-intensive  technologies  that  have  been  identified  as  drivers  of 
innovation in different economic sectors and are characterized by a high degree of R&D. 
105 Wesseler et al. (2019). 
106 EEA (2019) Climate change adaptation in the agriculture sector in Europe. 
107 Challinor et al. (2016)  
108 Voss-Fels et al. (2019); this paper, importantly, shows that breeding for increased yields does not necessarily 
come  at  the  expense  of  sustainability-related  traits.  In  wheat,  over  the  past  50  years,  increased  yield  was 
accompanied by improved disease resistance, nutrient use efficiency and photosynthetic efficiency. 
109 Karlson et al. (2022) 
110 Raffan et al. (2023).  
111 Purnhagen & Wesseler (2021) 
112 Smyth (2017) 
113 Zimney & Sowa (2021); Eriksson et al. (2019); Purnhagen & Wesseler (2021).  

17 

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

2.3.  What are the problem drivers? 
There are two main drivers behind the problems presented above (Annex 9): 

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

II) 

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

2.4.  How likely is the problem to persist?  
If no action is taken, the problems described will persist and be aggravated. Plants obtained by 
targeted mutagenesis and cisgenesis will continue to be regulated under the current EU GMO 
legislation,  with  the  current  risk  assessment,  authorisation,  traceability  and  labelling 
requirements.  As  the  findings  of  the  consultations  suggested,  limited  research  and 
development  of  NGT  products  in  the  EU  is  expected.  A  recent  survey  suggests  that  a 
significant  share  of  companies  (38%)  has  delayed  product  development  following  the 
clarification of the CJEU that these products fall under the current EU GMO legislation114. 

The  cultivation  and  market  uptake  of  these  products  would  remain  limited  in  the  EU.  The 
high  costs  and  long  time  needed  for  authorisation  of  NGT  products  –  in  addition  to  the 

114 Jorasch (2020). 

18 

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

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

to  further  complicate 

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

The persistence and aggravation of the problem is also illustrated by some of the megatrends 
identified115 by JRC. In particular, the megatrends climate change, environmental degradation 
and aggravating resource scarcity are environmental changes that could create new challenges 
in  terms  of  food  availability  and  resilience.  NGTs  could  be  one  tool  contributing  to  the 
necessary adaptation of the food systems at global level. 

Legal basis 

3.  Why should the EU act? 
3.1. 
EU  legislation  on  GMOs  is  based  on  Articles  43,  114  and  168(4)(b)  of  the  Treaty  on  the 
Functioning of the European Union (TFEU). These articles provide the legal basis for the EU 
to adopt measures which have as their objective to implement the common agricultural policy 
(Article 43), and to ensure the good functioning of the internal market (Article 114(1)) while 
maintaining a high level of human health protection in the veterinary and phytosanitary fields 

115 On 15 February 2022, the JRC (unit I.2, Competence Centre on Foresight) organised a Megatrends Analysis 
workshop  in  the  context  of  this  impact  assessment.  Megatrends  are  one  of  the  tools  used  in  foresight,  i.e.  the 
structured, systemic and participatory exploration of the future with the aim to better understand and anticipate 
possible developments, and to prepare for and shape the future. Out of the 14 megatrends ‘Aggravating resource 
scarcity’,  ‘Shifting  health  challenges’,  ‘Climate  change  and  environmental  degradation’  and  ‘Continuing 
urbanisation’ were selected as highly relevant for the initiative. Furthermore, ‘Trust’ was identified as a  major 
element for the future development and application of NGTs. 

19 

 
 
 
                                                           
(Article 168(4)(b)). The objectives of this initiative are aligned with these legal bases and, in 
addition,  this  initiative  tries  to  ensure  that  plants  obtained  by  targeted  mutagenesis  and 
cisgenesis,  and  food  and  feed  products  produced  from  them  contribute  to  the  sustainability 
goals  of  the  Green  Deal  and  Farm  to  Fork  strategies.  In  that  regard,  the  EU’s  common 
agricultural  policy’s  objectives  of  ensuring  the  rational  development  of  agricultural 
production and the optimal use of the factors of production, as well as to assure food security 
and the availability of supplies have particular relevance.  

Subsidiarity: Necessity of EU action 

3.2. 
Plants  obtained  by  targeted  mutagenesis  and  cisgenesis  are  living  organisms  which,  as  any 
other plant, when released into the environment for experimental purposes or as commercial 
products,  may  reproduce  in  the  environment  and  cross  national  borders.  It  is  essential  to 
achieve  a  harmonised,  high  level  of  protection  of  human  and  animal  health  and  the 
environment in relation to these plants and of food and feed derived from them so that they 
may circulate freely within a smooth-functioning internal market. In addition, the EU Farm to 
Fork Strategy recognises the potential of NGTs as a possible tool to increase sustainability of 
the food system and bring benefits to society as a whole. 

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

Subsidiarity: Added value of EU action 

3.3. 
Compared  to  individual  action  by  Member  States,  EU  intervention  would  provide  uniform 
rules for the development and placing on the market of NGT plants and their food and feed 
products. Harmonised EU-wide rules on the marketing of such products would ensure a level-
playing  field  for  operators  within  the  single  market  and  a  more  predictable  and  efficient 
regulatory  oversight.  Furthermore,  there  is  an  urgent  need  to  ensure  availability  to  farmers, 
food  operators  and  consumers  of  plant  varieties  that  can  cope  with  challenges  of  a  global 
nature such as climate change and biodiversity reduction, which have been further aggravated 
by  the  present  geopolitical  and  energy  crisis  in  Europe,  and  to  secure  food  security  in  the 
future. The Farm to Fork Strategy recognised the role that biotechnology can play in meeting 
those global challenges, which need an EU-wide response. 

 Objectives: What is to be achieved? 

4. 
The intervention logic is presented in Annex 10.   

4.1. 

General objectives 

I)  Maintain  a  high  level  of  protection  of  human  and  animal  health  and  of  the 

environment, in accordance with the precautionary principle. 

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

20 

 
 
 
III)  Ensure 

the  effective  functioning  of 

the 
competitiveness  of  the  EU  agri-food  sector  at  the  EU  and  global  level,  providing  a 
level-playing field for its operators.  

internal  market  and  enhance 

the 

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

4.2. 
I) 

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

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

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

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

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

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

III)  NGT  plants  released  or  placed  on  the  market  feature  traits  that  can  contribute  to  a 

sustainable agri-food system.  

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

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

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

21 

 
 
 
Figure 2. General and specific objectives. 

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

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

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

22 

 
 
 
 
Figure 3.  Policy elements. 

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

23 

 
 
 
 
Certain of the policy choices above (no risk assessment, notification procedure116, no tracing 
as  GMO)  have  only  been  considered  as  feasible  options  for  a  limited  range  of  NGT  plants, 
namely those which could be obtained naturally or by conventional breeding methods, based 
on  the  risk  profile  of  such  NGT  plants.  Therefore,  option  4  (which  incorporates  this  policy 
choice) is only assessed as regards such NGT plants. All other options (baseline, options 1 to 
3)  are  assessed  as  regards  all  NGT  plants  under  the  scope  of  the  initiative  (both  those  that 
could or could not occur naturally or be produced by conventional breeding). 

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

Baseline

Option 1 - Adapted Risk 
Assessment

Option 2 - Authorisation 
with incentives 

Option 3 - Authorisation 
with requirements

Option 4 - Notification for 
certain products

• Authorisation  under 

current GMO legislation

• Risk assessment of 

current GMO legislation

• Traceability and 

labelling as a GMO
• Detection method -

detecting  and 
differentiating the event

• No sustainability 

provisions, reliance on 
horizontal legislation

• Authorisation  under 

current GMO legislation

• Risk assessment 

adapted to different risk 
profiles

• Traceability and 

labelling as a GMO
• Detection method -

only detecting the event 
when differentiation not 
possible

• No sustainability 

provisions, reliance on 
horizontal legislation

• Authorisation under 

• Authorisation under 

new framework
• Risk assessment 

adapted to different risk 
profiles

• Traceability as a GMO
• Sustainability labelling 
with GMO labelling/ no 
labelling/labelling with 
factual statement on 
the trait

• Detection method –

only detecting the event 
when differentiation not 
possible

• Sustainability incentives

new framework
• Risk assessment 

adapted to different risk 
profiles

• Traceability and 

labelling as a GMO
• Detection method –

only detecting the event 
when differentiation not 
possible

• Sustainability 
requirements

• Notification regime 

under new framework 
for products that can 
also occur naturally or 
be obtained by 
conventional breeding
• For products meeting 

the notification criteria, 
no risk assessment, 
labelling traceability and 
detection method.
• Transparency through 

register

• No sustainability 

provisions, reliance on 
horizontal legislation

Figure 4. Policy options. 

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

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

The authorisation procedure for the placing on the market of NGT plants (as such or in food 
and feed products) would be conducted at EU level (risk assessment by EFSA and decision by 

116 In the legislative proposal, 'notification procedure' is referred to as ‘verification procedure’. 

24 

 
 
 
 
                                                           
the Commission), whereas the procedure to authorise the deliberate release of NGT plants for 
other purposes (e.g., field trials) would be conducted by Member States (national authority to 
which the application is submitted, with the involvement of EFSA in case of objections raised 
by the Commission or another Member State).  

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

Sustainability would be addressed by sustainability-related provisions included in the relevant 
horizontal and sectoral legislation (e.g. FSFS, PRM117, FRM), where applicable.  

5.2.  Description of the policy options 

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

method requirements 

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

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

To that end, general principles for risk assessment would be set in the legislation. They would 
be accompanied by criteria to inform the adaptation of data requirements to risk profiles. An 
indicative list of criteria for an adapted risk assessment118 is presented in Box 1. They provide 
the starting point for the design of an adapted risk assessment in the legislation. Specific data 
requirements based on the criteria would be set in tertiary legislation and/or by EFSA. 

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

117 European Commission (2023b) Annex 5, Section 5. 
118 EFSA (2022c)  

25 

 
 
 
                                                           
Box 1 - Criteria proposed by EFSA for adapted risk assessment of plants obtained by targeted mutagenesis 
and cisgenesis119: 

The  first  four  of  the  six  criteria  related  to  the  molecular  characterisation  of  the  genetic  modification 
introduced in the recipient plant. They evaluate: 

1. 
2. 

If exogenous DNA sequence is present 
If yes, whether the sequence is from the breeders’ gene pool (if it is not, the plant is transgenic and 
therefore out of the scope of this initiative) 

3.  How the sequence is integrated, for example is it random or targeted? 
4. 

If any host plant gene was “interrupted” (split) by the newly introduced sequence 

Criteria 1-4 are designed to establish if cisgenic and intragenic sequences have altered the host plant’s genes. 
If  they  have  not,  or  if  no  risk  is  identified  when  an  exogenous  DNA  sequence  has  been  introduced,  two 
further criteria apply: 

5.  Do the introduced or modified sequence and the associated trait have a history of use? 
6. 

If not, the structure and function of the modified versions of the DNA sequence (“allele”) should be 
carefully assessed. 

These last two criteria apply also to plants produced by targeted mutagenesis. 

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

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

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

5.2.2.  Option 2: Authorisation with incentives for products containing modified 

traits that have the potential to contribute to sustainability 

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

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

In  addition,  regulatory  incentives  –  granted  by  the  authorities  competent  for  the  procedure 
concerned  (at  national  or  EU  level)  -  would  be  introduced  for  NGT  plants  containing  traits 
that could contribute to sustainability to encourage the development of sustainable products. 
The regulatory incentives considered in the impact assessment are: the provision of regulatory 
and scientific  advice before and during the authorisation procedure (guidance on the overall 
development  plan  and  the  regulatory  procedure,  dedicated  contact  point  in  EFSA,  scientific 
advice  at  key  development  milestones)  and  measures  to  facilitate  the  authorisation  process 

119 EFSA (2022d) 

26 

 
 
 
                                                           
(waiving  of  detection  method  validation  fees,  faster  procedures).  During  the  consultation 
activities various stakeholders, in  particular breeders, considered  waiving labelling  as GMO 
as the measure that would have greater impact. 

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

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

  A  sustainability  label  (claim)  would  be  added  to  the  GMO  label  for  products  that 

contribute to sustainability referring to the introduced trait.  

  A factual statement on the intended purpose of the genetic modification would be added to 

the GMO label. 

  The GMO labelling requirement would be waived for products with a modified trait that is 

considered to have the potential to contribute to sustainability.  

5.2.3.  Option 3: Authorisation with the requirement that products do not contain 

modified traits that can be detrimental to sustainability 

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

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

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

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

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

27 

 
 
 
5.2.4.  Option  4:  Notification  of  products  that  could  also  occur  naturally  or  be 

produced by conventional breeding 

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

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

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

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

Box 2 - Indicative list of criteria for the notification procedure: 

A  NGT  plant  is  considered  equivalent  to  conventional  plants  when  it  differs  from  the 
recipient/parental plant by no more than a maximum number of genetic modifications of the types 
referred  to  in  points  1  to  5,  in  predictable  DNA  sequences. A  predictable  DNA  sequence  is  any 
DNA sequence that shares sequence similarity with the targeted site.  

28 

 
 
 
 
 
1. 

2. 

3. 

4. 

5. 

Substitution or insertion of no more than a maximum number of nucleotides 

Deletion of any number of nucleotides.  

On the condition that the genetic modification does not result in an intragenic plant: 

a.  Targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool  

b.  Targeted  substitution  of  an  endogenous  DNA  sequence  with  a  contiguous  DNA 

sequence existing in the breeder’s gene pool 

Targeted inversion of a sequence of any number of nucleotides 

Any  other  targeted  modification  of  any  size,  on  the  condition  that  the  resulting  DNA 
sequences already occur (possibly with modifications as accepted under points 1 and/or 
2) in a species from the breeders’ gene pool.  

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

 

 

If the determination of status is sought prior to conducting field trials, the verification 
of  the  criteria  and  determination  of  the  status  would  be  done  by  the  Member  State 
where  the  field  trial  is  intended  to  be  carried  out.  The  national  decision  would  have 
EU-wide effects. 
If  the  determination  of  status  is  sought  prior  to  the  placing  on  the  market  of  NGT 
plants and products for which no field trials have been carried out in the EU, including 
imported NGT plants/products, the determination of the status would be done by the 
Commission, following verification of the criteria by EFSA. 

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

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

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

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

29 

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

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

5.3.  Options discarded at an early stage 
An option to initiate a broader legislative action, which would have concerned all NGTs, and 
all  organisms  (plants,  animals,  micro-organisms)  was  discarded  in  the  light  of  the 
Commission NGT study. The latter concluded that for other NGTs and for NGT applications 
in animals and microorganisms, the necessary scientific knowledge is still limited or lacking, 
especially  on  safety  aspects.  As  a  result,  when  announcing  the  follow-up  to  the  study,  the 
Commission  indicated  that,  as  regards  animals  and  microorganisms  and  other  NGTs,  it 
intends to continue to build up the required scientific knowledge, in view of possible further 
policy actions120.  

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

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

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

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

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

120 European Commission (2021e)  

30 

 
 
 
                                                           
6.  What are the impacts of the policy options? 
Economic, environmental and social (health) impacts of the options were assessed taking into 
consideration  scientific  literature,  expert  views,  data  collection  from  public  and  targeted 
stakeholder  consultations,  JRC  case  studies  and  quantitative  modelling  where  possible,  as 
explained in Annex IV on the analytical methods. One important input to the impact analysis 
is  the  development  pipeline  of  NGT  products,  i.e.  applications  that  are  already  being 
marketed, are at a confirmed pre-market development stage or are at R&D stage but showing 
market potential, as mapped by the JRC121.  

However,  inherent  limitations  remain.  Since  specific  regulatory  frameworks  were 
introduced  in  several  non-EU  countries  only  recently  and  given  the  limited  number  of 
products122  on  the  global  market  (none  in  the  EU),  very  few  if  any  data  on  economic, 
environmental or social (health) impacts of NGT products are available to date. Furthermore, 
EU  data  on  cultivation  and  coexistence  with  organic123/non-GM  crops  are  very  limited  as 
almost no GM crops are cultivated in the EU. To address these issues, the impact estimates 
depend  to  a  large  degree  on  comparison  with  past  developments  inside  and  outside  the  EU 
(e.g. for GMOs obtained by established genomic techniques), expert assessments, projections 
and  stakeholder  expectations.  Wherever  possible,  these  assessments,  projections  and 
expectations were checked against relevant data from the scientific literature. In addition, the 
JRC  has  conducted  three  case  studies  to  analyse  the  potential  economic,  environmental  and 
social (health) impacts of selected NGT plants that are in the development pipeline124. 

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

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

1.1.  Analysis of the baseline  

6.1.1.  Economic impacts 

Breeders  –  The  current  average  time  to  market  of  an  established,  single  event  GMO 
(including R&D) developed between 2017 and 2022 is 16.5 years and the  average costs are 
approximately  EUR 121 m125.  In  the  EU,  authorisations  may  be  for  marketing  of  food  and 
feed and derived products or for cultivation. Authorisation costs for food and feed uses range 

121 Parisi & Rodriguez Cerezo (2021) 
122 On the market are a higher oleic-acid soybean of Calyxt in the US (‘Calyno’) (ISAAA, 2019a), a tomato with 
a non-proteinogenic amino acid (GABA) commercialised under the name Sicilian Rouge High in Japan (Waltz, 
2021), drought-tolerant soybeans in Brazil and Colombia (ISAA, 2023a), a waxy maize in Japan (ISAA, 2023b) 
and a  non-browning banana in the Philippines (ISAA, 2023c). The commercial  farm production of a  modified 
pennycress (Thlaspi arvense), marketed as CoverCressTM
, started in autumn 2022 in the US. The seeds will be 
used for large-scale farm trials starting in 2023. 
123 See https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Organic_farming_statistics for data on 
organic farming in the EU 
124 Schneider et al. (2023a, b). Sanchez et al. (2023) 
125 AgbioInvestor (2022) 

31 

 
 
 
                                                           
from ~EUR 6 m to EUR 20 m (for authorisations of single event GMOs)126, and administrative 
costs  range  from  EUR 2  -  2.7 m127.  For  GMOs  developed  between  2017  and  2022  by 
established genomic techniques, the genetic event construction and testing phase represented 
55.8%  of  total  costs  and  35.6%  of  the  total  time.  The  regulatory  phase  had  the  longest 
duration of the overall process and accounted for 37.6% of total costs and 51.1% of the total 
time128.  The  time  to  place  NGT  products  on  the  market  would  be  shorter  than  for  GMOs 
obtained  by  established  genomic  techniques,  because  of  an  accelerated  R&D  phase:  for  the 
latter, the R&D phase can be more than 10 years, while for NGT products the R&D phase is 
around  5  years129,  thereby  reducing  the  costs  of  the  most  expensive  phase  in  product 
development.  
There is  little experience with  authorisation  costs for  cultivation  in  the EU130,  and therefore 
only approximations are available. Available estimates provided by one company give a range 
of  costs  of  EUR 17.5  –  EUR 28 m  for  authorisation  plus  EUR 0.7  –  EUR 1 m  per  year  for 
monitoring.  

Breeders identified the regulatory uncertainty about  a product  being authorised after several 
years  of  R&D,  regulatory  costs  and  time  to  market  as  the  main  factors  making  the 
development of NGT products under the existing GMO framework unattractive. 54.5% of the 
stakeholders131 in the targeted survey consider that attractiveness of developing plant varieties 
using NGTs will decrease and 43.2% consider it will stay the same under this option. Across 
all participating stakeholders132, there is the expectation to see very few NGT products on the 
market  for  the  period  2030-35.  Breeders  delayed  product  development  and  release  due  to 
regulatory uncertainty and high regulatory costs (40% response in targeted survey)133. 

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

Academia/Research  institutes  –  While  there  is  only  anecdotal  evidence  and  warnings  that 
academic  mobility  and  migration  of  EU  plant  scientists  may  be  affected  by  policies  of 
regulating  biotechnologies,  according  to  the  research  sector,  in  the  baseline  the  EU  risks  a 
brain  drain  when  plant  researchers  leave  Europe  for  better  job  opportunities  abroad135.  The 
sector expects  a negative impact on the competitiveness of EU research, due to competition 
from other countries where NGTs are regulated differently, in particular for applied research 

126 Annex 7, section 4 in Technopolis Group et al. (2023) 
127 AgbioInvestor (2022) 
128 Ibid. 
129 Lassoued et al. (2019)  
130 There has only been one authorisation for cultivation in the EU (maize MON810). 
131  47.7%  (21)  strongly  decrease,  4.5%  (2)  moderate  decrease,  2.3%  (1)  small  decrease  and  43.2%  (19)  no 
change. Stakeholder's categories are not included in the data. 
132  The  median  is  overall  0.  Across  stakeholders  the  median  is:  Academic/research  organisation  =  0,  Business 
association  = 0, Consumer organisation = 12.5, Large company = 0, NGO = 0, other = 0 
133See also Jorasch (2020) 
134 OECD (2018)  
135 The main root causes for academic migration to countries outside the EU are better salaries and better career 
structures for early-career scientists. See Khan (2021) 

32 

 
 
 
                                                           
in plant pre-breeding and breeding. 41% (n=27) of respondents in the targeted survey expect a 
decrease in research funding for biotechnology under the baseline option. 

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

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

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

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

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

However, certain negative impacts may also materialise. Increased costs for organic operators 
could  arise  from  NGT products  that cannot  be  analytically differentiated from  products  that 
can  occur  naturally  or  be  produced  by  conventional  breeding,  despite  the  fact  that  specific 
GMO  traceability  and  labelling  obligations  will  apply  to  such  NGT  products.  More 
challenging  and  expensive  identity  preservation  systems  for  NGT-free  products  would  be 
required, possibly leading to higher prices of GM-free products136. Research has shown that 
coexistence of GM and non-GM products within food supply chains leads to extra costs for 
the non-GM food product. Depending on the segregation strategy undertaken in rapeseed oil 
and maize starch supply chains, it was estimated that ensuring coexistence leads to increased 
prices  for  the  non-GM  product  of  between  7  and  14%137.  For  NGTs  that  cannot  be 
analytically differentiated, these price increases could be higher as further steps might have to 
be taken to guarantee the integrity of the supply, such as additional documentation and third-
party verification. 

136 IFOAM EU & FiBL (2017) 
137 Gabriel & Menrad (2015) 

33 

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

Regulatory divergence may also impact the availability and development of organic varieties. 
Under  the  breeders’  exemption138,  breeders  are  allowed  to  freely  use  protected  varieties  as 
sources  of  further  variation  for  the  development  of  new  varieties.  If  protected  varieties  of 
interest  for  organic  breeders  originate  in  non-EU  countries  that  have  exempted  NGT  plants 
from  GMO  labelling  and  traceability  obligations,  then  organic  breeders  may  have  no 
guarantee that those are not derived from NGTs.  Consequently, sourcing such varieties may 
become difficult and in the longer term, organic breeders may thus experience a decrease in 
the availability of genetic resources for their breeding programmes, leading to fewer improved 
varieties adapted to the needs of organic agriculture139. 

Trade  impacts  –  International  trade  with  NGT  products  will  be  affected  by  regulatory 
divergence  with  trade  partners.  Several  major  trade  partners  of  the  EU  have  introduced 
exemptions  from  their  GMO  legislation  –  or  are  preparing  to  introduce  them  –  for  NGT 
products, and this may lead to asynchronous approvals of NGT products. This could lead to a 
costly  need  to  separate  entire  agricultural  value  chains  in  and  outside  the  EU140.  As  trade 
partners might be unwilling or unable to establish such separate value chains141, most targeted 
survey respondents (60.7%, 37) expect a decrease of international trade under this option. The 
consequences  of  market  disruptions  caused  by  the  unintended  presence  of  unauthorised 
GMOs can be significant. For example, in 2009, a genetically modified flax from Canada, not 
authorised in  the EU, was  detected in  EU food products142  and the EU immediately stopped 
Canadian  flax  imports.  This  resulted  in  an  estimated  loss  of  EUR 40 m  for  the  EU  flax 
processing industry and 600 jobs lost143.  

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

138 Article 15(1)(iii): The breeder’s right shall not extend to (...) (iii) acts done for the purpose of breeding other 
varieties,  and,  except  where  the  provisions  of  Article  14(5)  apply,  acts  referred  to  in  Article  14(1)  to  (4)  in 
respect of such other varieties. 
139 IFOAM EU & FiBL (2017) 
140 Eriksson et al. (2019) 
141 Gabriel & Menrad (2015) 
142 The genetically modified flax (“Triffid flax”) was a flax variety that was genetically engineered for resistance 
to soil residues of sulfonylurea-based herbicides. To ensure that Triffid flax would not jeopardize future export 
markets, the transgenic flax variety was deregistered in 2001. In late 2009, Triffid  flax was detected in bakery 
goods, cereals, and other products made by companies throughout the EU. See Ryan & Smyth (2019) 
143 Ryan & Smyth (2012) 

34 

 
 
 
                                                           
Competitiveness  –  The  reduced  costs  of  and  time  needed  for  R&D  of  NGT  products  could 
lead  overall  to  lower  costs  for  the  EU  breeding  and  biotech  sector144.  However,  breeders  in 
non-EU  countries  that  exempt  NGTs,  can  save  all  the  costs  related  to  GMO  authorisations 
(35.8% of the total cost to develop and place on the market a GMO obtained by established 
genomic  techniques)  and  place  products  faster  on  the  market,  while  the  regulatory  entry 
barriers  for  NGT  products  remain  higher  in  the  EU.  This  will  give  competitors  in  non-EU 
countries a considerable advantage.  

6.1.2.  Environmental impacts 

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

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

As regards other environmental impacts, since no or only very few applications for cultivation 
of  NGT  plants  are  expected  if  they  remain  regulated  by  the  current  GMO  legislation,  the 
environmental impacts of these products will be limited. Impacts will be mostly restricted to 
missed  potential  benefits  stemming  from  NGT  plants  contributing  to,  for  example,  lower 
pesticide  use,  lower  fertiliser  use,  reduced  need  for  agricultural  land  and  more  space  for 
nature with higher biodiversity145.  

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

6.1.3.  Social, health and safety impacts 

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

Impacts  on  consumers  –  The  current  GMO  legislation  ensures  information  to  consumers 
about  the  use  of  genetic  modification  technologies  on  the  product’s  label.  This  is  the 
preference expressed by a majority of citizens (30%, 733146) in the public consultation, as also 

144 Lassoued et al. (2019) 
145 Phalan (2018), Grass et al. (2019) 
146 The second highest preferences, each at 19% (464), were for digital labelling, information on a website/public 
database,  and  no  labelling  needed  if  products  were  produced  through  conventional  plant  breeding  or  classical 

35 

 
 
 
                                                           
 
confirmed by similar findings from research147 . It guarantees freedom of choice for those not 
wishing to use GMOs and would do so in the same way for GMOs obtained by NGTs.  

The  current  label  would  not  inform  specifically  about  NGTs  or  their  applications,  and 
established consumer attitudes to GMOs would likely extend to NGTs (in the absence of other 
sources  of  awareness  and  information  on  NGTs)  and  have  a  negative  impact  on  NGT 
acceptance  and  consequently  on  uptake.  This  would  be  reinforced  by  the  fact  that  NGTs 
would  remain  subject  to  the  GMO  legislation  as  it  stands  today  and  applies  to  transgenic 
GMOs  (as  research148  suggests  that  governmental  decisions  also  play  a  role  in  shaping 
consumer attitudes).  

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

Furthermore, given that more costly identity preservation may need to be applied, the price of 
some products could rise149. 

1.2.  Analysis of option 1 (Authorisation with adapted risk assessment and 

detection method requirements) 

6.2.1.  Economic impacts 

Breeders  –  Significantly  shorter  development  times  and  lower  development  costs  for  NGT 
products  and,  in  some  cases,  lower  costs  and  time  linked  to  the  generation  of  data  for  risk 
assessment  and  authorisation,  could  make  the  development  of  certain  NGT  products  more 
attractive  than  GMOs  obtained  by  established  genomic  techniques.  For  example,  in 
conventional potato breeding, the timeline in which breeders operate is approximately 13-15 
years150. The cost of developing a conventional potato variety is EUR 2-3 m per variety, while 
development  of NGT potato varieties is  expected to  cost  significantly less money  and time, 
estimated at EUR 0.5 m per variety and introduction into the market within five years151.  

Generating  the  necessary  data  for  risk  assessment  currently  represents  the  largest  share  of 
authorisation costs. For a risk assessment that is adapted to different risk profiles, the costs of 
generating the application will decrease to  a variable degree due to potentially reduced data 
requirements. In cases where data requirements remain the same as they are today for GMOs, 
no cost savings are expected, while maximum cost savings of 85% of this component could 
be  expected  in  cases  where  minimum  data  requirements  apply  based  on  the  product’s  risk 
profile152.  An  adapted  risk  assessment  could  also  shorten  time  to  market  with  earlier  profit 
gains.  

Breeders, however, expect only a small improvement concerning the attractiveness to develop 
NGT plants as this option would apply the current  GMO labelling regime to  NGT products 
for  which  they  expect  only  limited  consumer  acceptance,  and  because  of  the  perceived 

mutagenesis;  the  rest  11%  (269)  indicated  that  transparency  is  not  needed  for  any  plant  produced  by  targeted 
mutagenesis and cisgenesis and 2% (49) expressed no opinion. 
147 Food Standards Agency (FSA) (2021); YouGov (2022); Lindberg et al (2023) 
148 Sendhil et al. (2022).  
149 See Gabriel & Menrad (2015) 
150 Jansky & Spooner (2018) 
151 Annex 5, section 2.3.1. in Technopolis Group et al. (2023) 
152 Annex 7, section 4.2. in Technopolis Group et al. (2023) 

36 

 
 
 
                                                                                                                                                                                     
uncertainty  about  the  way  the  adapted  risk  assessment  would  be  applied  in  practice.  In  this 
regard, they expect negligible reductions in administrative costs compared to the baseline. 

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

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

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

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

SCENARIOS 

SPAIN 

NETHERLANDS 

GERMANY 

BELGIUM 

FRANCE  MIN 

ESTIMATES 
AVERAGE  MAX 

Scenario 1: Full data except for protein 

-10% 

-8% 

-15% 

0% 

-5% 

0% 

-8% 

-15% 

Scenario 2: Molecular characterization 
and Safety data on the trait only 

Scenario 3: Molecular characterization 
and post market monitoring (including 
environmental) only 

-49% 

-26% 

-35% 

0% 

-10% 

0% 

-24% 

-49% 

-67% 

-60% 

-60% 

0% 

-10% 

0% 

-39% 

-67% 

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

Conventional  farmers  –  As,  under  this  option,  some  NGT  plants  would  reach  the  market, 
farmers would be able to benefit from these plants if they feature relevant traits, in particular 
regarding  reduced  costs  for  inputs  (pesticides,  fertilisers),  improvements  of  the  yield/input 
ratio, new income opportunities or better prospects for exports. For example, a case study153 
on  cisgenic  late  blight  resistant  potatoes  and  apples,  conducted  by  the  JRC,  shows  that  for 
potatoes  a  50-80%  reduction  and  for  apples  a  12-58%  reduction  of  fungicide  use  may  be 
feasible. This would translate into yearly costs savings ranging from (min-max) EUR 49-576 
per hectare for potatoes and EUR 39-712 per hectare for apples (see Annex 7). A gene-edited 
pennycress (Thlaspi arvense) is a new oilseed crop (for which large-scale farm trials will take 
place  starting  in  2023  in  the  US)  that  can  be  grown  with  relatively  low  greenhouse  gas 
emissions and without causing detrimental land use changes154. In the US, this crop is grown 
as a cash cover crop in maize-soybean rotations providing environmental benefits (preventing 
soil  erosion  and  nutrient  run-off,  reduction  of  pesticide  use,  carbon  sequestration)  and 

153 Schneider et al. (2023a, b) 
154 Jarvis et al. (2021); the plant was developed for the market by a start-up company called CoverCress Inc. In 
August 2022, Bayer acquired a majority share of 65% in the company.  

37 

 
 
 
 
  
  
  
  
  
 
                                                           
expected  net  returns  to  farmers  from  biofuel  or  animal  feed  uses  of  EUR 130-180/ha155. 
Similar efforts are underway in Europe for the establishment of camelina (Camelina sativa) as 
a cash cover crop156. 

In  cases  where  the  costs  of  the  authorisation  process  are  considerably  reduced  because  of 
significantly lower data requirements, it is likely that SME breeders and farmers can benefit 
from this option and that NGT plants from small or neglected crop species will come to the 
market  under  the  condition  that  the  license  cost  for  the  use  of  the  technologies  is  not 
prohibitive for SMEs and minor crops157. 

Combining stakeholder and expert estimates of adoption rates of the currently known pipeline 
of NGT-applications, as well as expert estimates regarding trait-level impacts, a quantitative 
exploratory analysis158 of impacts shows, for a low adoption rate of NGTs (1-5% of the crop 
market), the following estimated mean and, in brackets, range of impacts on key agronomic 
parameters for several crop groups (Table 2). 

Table 2. Trait-level impacts. 

Crop group 

yield change/ha 

Oil and fibre plants 

Vegetables 

Cereals 

Legumes 

5% 
(1% to 16%) 

9% 
(6% to 24%) 

7% 
(3% to 22%) 

9% 
(6% to 23%) 

change in 
pesticide use/ha 

change in 
fertiliser use 

change in 
water use 

change in 
energy use 

-10% 
(-35% to 5%) 

-9% 
(-5% to -43%) 

-13% 
(-8% to -28%) 

-3% 
(5% to -15%) 

-3% 
(0% to -10%) 

- 

- 

- 

-14% 
(-10% to – 18%) 

-10% 
(-3% to -17%) 

-9% 
(5% to -35%) 

-10% 
(-5% to -20%) 

-2% 
(1% to -5%) 

-5% 
(3% o -16%) 

-6% 
((0% to -11%) 

-3% 
(0% to -10%) 

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

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

Coexistence  between  conventional/organic/GM-free  production  and  NGT  production  –  As 
more  NGT  plants  are  expected  to  be  cultivated  in  this  option  compared  to  the  baseline,  the 
risk  of  admixture  will  increase  and  with  it  the  costs  for  segregation.  The  purpose  of 
coexistence  measures  is  to  allow  consumers  and  producers  a  choice  between  conventional, 
organic and GM production. These measures also take into account the wish of some farmers 

155 https//:www.covercress.com/farmers.cfm 
156 Zanetti et al. (2021) 
157 Section 3.3.10. in Technopolis Group et al. (2023) 
158 Annex 8, section 1 in Technopolis Group et al. (2023) 

38 

 
 
 
                                                           
and  operators  to  ensure  that  their  crops  have  the  lowest  possible  presence  of  GMOs, 
acknowledging  that  the  potential  loss  of  income  for  producers  of  particular  agriculture 
products  such  as  organic  products  is  not  necessarily  limited  to  exceeding  the  labelling 
threshold set out in EU legislation at 0.9% for food and feed. In certain cases, and depending 
on  market  demand  and  on  the  respective  provisions  of  national  legislations  (e.g.  some 
Member States have developed national standards for different types of ‘GM-free’ labelling), 
the presence of traces of GMOs in particular food crops — even at a level below 0.9% — may 
cause economic damages to operators who would wish to market them as not-containing any 
GMOs159.  

Article 26a of Directive 2001/18/EC on the deliberate release of GMOs into the environment 
allows  Member  States  to  take  appropriate  coexistence  measures.  A  framework  for  such 
measures  is  defined in  the Commission Recommendation of 13 July 2010 on guidelines for 
the development of national coexistence measures to avoid the unintended presence of GMOs 
in conventional and organic crops160. Member States have taken a diversity of approaches – 
legislative and non-legislative and a mixture thereof – to implement this recommendation (15 
Member States have adopted some form of coexistence measures). Almost all Member States 
that have regulated coexistence consider the GMO grower as the operator responsible for the 
implementation of the measures. In addition to the coexistence measures set out in the GMO 
legislation and the Commission  Recommendation, the Organic Products Regulation requires 
organic producers to implement precautionary measures to avoid the presence of products and 
substances not authorised for use in organic production (Article 28).  

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

The SIGMEA project (2004 – 2006), funded under FP6, investigated the costs of measures for 
GM-cultivating  farmers  to  ensure  coexistence  for  GM  and  conventional  oilseed  rape  and 
maize in several regions of the EU using spatially explicit simulation models161. At the level 
of  the  GM-cultivating  farm,  two  types  of  coexistence  cost  are  considered:  (i)  the  cost  of 
compliance with the ex-ante coexistence rules in place, developed to prevent cross-pollination 
and/or  admixture,  (ii)  the  expenses  for  ex-post  monitoring,  because  the  product  has  to  be 
tested for the presence of transgenic DNA.  In  general,  results obtained  for different  regions 
demonstrate  that  coexistence  costs  depend  on  the  agricultural  context  (landscapes,  cropping 
systems, field shape, climate), the share of GM crops in the Utilised Agricultural Area (UAA) 
and the willingness of GM and non-GM farmers to cooperate. The study also concludes that 
inflexible  coexistence  rules  (such  as  standardised  large  isolation  distances)  impose  a  severe 
burden  on  GM  cultivation,  while  flexible,  context-dependent  measures  do  not  act  as  a 
disincentive to GM cultivation. In the latter case, GM crop adoption is not an issue of costs of 
compliance  with  coexistence  measures  but  rather  one  of  the  incentives  for  adopting  or 
rejecting the technology. 

Example: Oilseed rape in Beauce (France) 

Relative to the benchmark scenario, the study simulated six scenarios by varying (i) the GM 
crop  adoption  rate  (scenarios  2  and  3),  (ii)  the  share  of  oilseed  rape  in  the  arable  area 

159 European Coexistence Bureau (2010-2018) 
160 OJ C 200, 22.7.2010, p. 1–5 
161 The final report is available at https://cordis.europa.eu/docs/results/501/501986/126792601-6_en.pdf 

39 

 
 
 
                                                           
(scenarios 4 and 5), and (iii) the isolation distance requirement (scenario 6). Table  3 reports 
the estimated average cost for coexistence management. 

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

Adoption 
Rate 

Scenario 

Average cost per 
hectare GM 
(€/ha)* 

Oilseed 
rape 
Share 

1 
(Benchmark) 
2 
3 
4 
5 
6 
7 

50% 

25% 
75% 
50% 
50% 
50% 
50% 

13% 

13% 
13% 
6% 
26% 
13% 
26% 

10m 

10m 
10m 
10m 
10m 
20m 
20 m 

0.47 

0.75 
0.23 
0.33 
1.13 
1.21 
2.72 

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

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

Example: Maize in Aragón (Spain) 

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

40 

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

Buffer zone  Cost per ha GM maize 

10% 

30% 

50% 

90% 

10m 

20m 

50m 

100m 

10m 

20m 

50m 

100m 

10m 

20m 

50m 

100m 

10m 

20m 

50m 

100m 

area (€/ha)* 
34.64 

62.51 

101.71 

117.30 

29.95 

54.23 

94.25 

116.61 

30.64 

55.89 

97.43 

116.89 

29.81 

54.37 

97.15 

117.16 

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

These data show that, for a given buffer zone size, the coexistence costs for GM farmers are 
of moderate size and quite insensitive to the GM adoption rate (Table 4). These findings are in 
line with the results of a simulation study of the costs of coexistence measures per hectare of 
GM in Switzerland, which finds that the costs amount to 1-3% of total product costs162. 

Organic  operators  also  have  the  responsibility  to  put  in  place  precautionary  measures  to 
avoid  admixture  with  any  product  that  is  not  authorised  in  organic  production,  and  to 
regularly  review  these  precautionary  measures  and  to  adjust  these  measures  if  necessary.  A 
product  for  which  EU  law  requires  GM  labelling,  e.g.  food  and  feed  containing  traces  of 
GMOs  above  0.9%  (or  even  below  0.9%  if  the  traces  are  not  adventitious  or  technically 
unavoidable),  must  not  be  marketed  under  the  EU  organic  logo  (Art.  30(4)  of  Regulation 
2018/848).  For  conventional  products  which  are  not  subject  to  such  labelling  requirements, 
organic operators must require a vendor declaration to confirm the absence of any GMOs and 
derived products. However, certain NGT plants cannot be distinguished from conventionally 
bred plants.  In such cases, the analytical  control supporting the marketing prohibition  under 
the organic logo might be difficult and in some cases not feasible. Organic farmers would not 
have  direct  economic  losses  in  these  cases  where  NGT  presence  cannot  be  established, 
however,  there  is  a  risk  of  loss  of  trust  by  some  consumers  if  a  certain  level  of  NGT 
admixture cannot be analytically ruled out.  Based on the work of the European Coexistence 
Bureau163, it is reasonable to assume that risk of such admixture can be considered to be low 
for  this  option  with  a  low  to  moderate  adoption  of  NGTs,  if  NGT  farmers  comply  with 
coexistence  measures  and  organic  farmers  with  the  precautionary  measures  to  avoid 
admixture required by the Organic Products Regulation. 

There  are  no  quantitative  estimates  of  the  costs  for  GM-cultivating  and  non-GM  farmers  in 
cases  of  admixture  as  these  costs  depend  on  the  affected  product  (e.g.  its  gross  margin  and 

162 Vögeli et al. (2010) 
163 European Coexistence Bureau (2010 – 2018) 

41 

 
 
 
                                                           
price premium) and (as liability is a component of the costs)  on liability regimes, which are 
the exclusive competence of Member States164. For non-organic farmers, the financial risks of 
liability  may  tip  the  balance  against  the  decision  to  cultivate  GM  crops165.  The  risk  of 
admixture, and therefore the overall financial risk for organic producers, will depend on the 
overall adoption rate of NGTs – the higher the adoption rate, the more likely it is that fields 
neighbouring an organically cultivated field will be cultivated with NGTs, thus increasing the 
probability of admixture. However, experiences from Spain show that large scale cultivation 
of GM maize has not been an obstacle to the expansion of organic cultivation. From 2012  – 
2021, the area cultivated with organic maize has increased in three regions with a dominant 
presence of Bt maize cultivation: in Aragón, the organic maize area increased from 159 ha to 
526 ha, in Cataluña from 30 ha to 351 ha and in Navarra from 11 ha to 44 ha166. 

Coexistence in the value chain 

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

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

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

With a maximum of 85% reduction, significant  cost  reductions for adapted risk assessment, 
overall authorisation costs will, in case of the lowest data requirements, be in the approximate 
range  of  EUR 0.9-3 m  (15%  of  costs  for  food  and  feed  authorisation  with  full  risk 
assessment). Administrative costs are not expected to change significantly. The combination 
of  significantly  lower  development  costs  for  NGT  plants  compared  to  varieties  bred 

164 Austria, Finland, France, Germany, Hungary, Norway, Poland and Slovakia have specific liability provisions 
addressing  damages  arising  from  admixture.  Compensations  may  differ  substantially  between  Member  States; 
they  may  be  calculated  on  the  difference  in  price  between  a  GM-labelled  product  and  a  non-GM  labelled 
product, while additional costs coming from covering the costs of quality scheme controls or the costs of a new 
organic  certification  process,  which  depend  on  the  type  and  size  of  a  farm  and  are  variable  between  Member 
States, are not taken into account. 
165  Venus  et  al.  (2017)  In  Germany,  the  cost  of  joint  and  strict  liability  for  Bt  maize  (EUR  189/ha)  were 
estimated to be higher than the average additional revenue (EUR 115/ha) and the additional gross margin (EUR 
65/ha).  However,  farmers  planted  Bt  maize  because  the  GM  seed  company  safeguarded  potential  economic 
damage if the GM farmer complied with the coexistence measures. 
166 https://www.mapa.gob.es/es/alimentacion/temas/produccion-eco/default.aspx 

42 

 
 
 
                                                           
conventionally or developed with established GM technology (e.g., an estimated EUR 0.5 m 
for an NGT potato variety vs. EUR 2-3 m for a conventional variety) and the significant cost 
reductions for adapted risk assessment, may make it easier for SMEs in certain circumstances 
to compete with larger companies. 

Competitiveness – This option will improve the competitiveness of EU operators as costs of 
and time needed for R&D of NGT products can be significantly reduced in comparison to the 
baseline. Compliance  costs related to  data requirements  for  risk assessment  will  range  from 
negligible  reduction  (if  a  similar  set  of  data,  as  today,  is  required)  to  a  reduction  of  around 
85% (if minimum  data requirements apply). However, breeders in  non-EU countries,  which 
have  exempted  certain  NGT  products  from  the  requirements  of  their  GMO  legislation,  can 
save  all  the  costs  related  to  GMO  authorisations  for  those  NGT  products,  thus  having  a 
competitive advantage over breeders in the EU also under this option. Because of potentially 
higher  prices  for  organic/GM-free  products, 
this  sector  could  experience  reduced 
competitiveness compared to conventional producers167. 

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

6.2.2.  Environmental impacts  

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

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

Regarding  pest-  or  pathogen  control,  the  expected  change  in  pesticide  use  is  highly 
controversial, in particular with respect to herbicide-tolerant (HT) crops. The main reasons for 
the adoption of HT  crops have been improved  and simplified weed control, less labour and 
fuel  cost,  no-till  planting/planting  flexibility,  yield  increase,  extended  time  window  for 
spraying, and decreased pesticide input168. On the other hand, a recognised negative impact of 
HT crops is the evolution of herbicide resistance in weeds, which may lead to higher use of 
other  selective  herbicides,  with  the  attendant  environmental  and  health  externalities,  and 
increased use of tilling and consequently higher GHG emissions169. By 2023, 57 weed species 

167 Gabriel & Menrad (2015); IFOAM EU & FiBL (2017) 
168 Sankula et al. (2015)  
169 Schütte et al. (2017); Benbrook (2012); Desquilbet et al. (2019); Lu et al. (2022) 

43 

 
 
 
                                                           
have  evolved  resistance  to  glyphosate170.  Herbicide-tolerant  weeds  also  occur  in  production 
systems of herbicide-tolerant crops developed using conventional breeding methods171. 

HT crops do not represent a strong focus of R&D in the field of NGTs. Among NGT products 
in the pre-commercial and advanced R&D stage, herbicide tolerant plants account for 10 out 
of  172  products  in  development172.  This  trait  can  be  developed  by  established  GMO 
technology,  NGTs  and  by  conventional  breeding  methods173.  Impacts  of  HT  crops, 
irrespective of the breeding method used for their development, will depend on how they are 
used and managed in the field. 

Experience with insect resistant GM crops in the EU (Bt maize producing the bacterial protein 
Cry1Ab, toxic to insects) has shown that, as of 2021, no decrease in the vulnerability to the 
toxic protein had occurred in the relevant pests174.  

Effects  on  the  diversity  of  cultivated  crops  would  depend  on  how  much  new  varieties  can 
benefit  from  the  lower  costs  and  lower  administrative  burdens  stemming  from  adapted  risk 
assessment.  From  2002  to  2010,  niche  crops  globally  accounted  for  only  5%  of  approved 
GMOs175, although there is considerable technology and valuable traits to be exploited. There 
is evidence that this is due in part to regulatory costs of GMO approval176, but lack of demand 
or market rejection may play a role as well. The case study on chicory (see Annex 7) shows 
that  NGTs  can  contribute  to  the  development  of  new  and  improved  plants  and  can  further 
support the use of underutilised, neglected and local crop species177, thus leading to increased 
agrobiodiversity.  

Regarding local production systems and the diversity of local and traditional varieties, some 
stakeholders  see  a  danger  in  the  displacement  of  local  production  systems  by  NGT  crops, 
arguing that increased cultivation of NGT plants would reduce the diversity of crops used in 
agriculture, as well as  the local  knowledge of  crop species and varieties suited for the local 
climate178.  However,  in  cases  where  adapted  risk  assessment  leads  to  considerably  lowered 
regulatory costs, development and cultivation of NGT varieties of niche and locally important 
crops  may  become  economically  more  viable.  NGT  plants  can  provide  more  adaptation  to 
climate  change  and  thus  could  lead  to  the  development  of  plants  more  suitable  to  local 
climatic conditions and thus maintain or enhance crop diversity179. 

170 Heap (1993-2023) 
171 Wedger et al. (2022) 
172 Parisi & Rodriguez-Cerezo (2021), time horizon 2030; in the pre-commercial stage, 7 out of 16 products are 
HT-traits; the high proportion of HT-traits in the pre-commercial stage reflects the fact this is a trait well-known 
to developers, with which the new gene-editing technologies can be more easily applied and tested than with 
new traits. This number may thus not reflect developer priorities (which is evident from the trait distribution in 
the early and advanced R&D stage, where HT-traits play a small role) in the medium and longer term. 
173 Fried et al. (2022); the following numbers of conventionally bred HT varieties deriving from the Clearfield 
technology are listed in the EU Common catalogue of varieties of agricultural species (status in December 
2022): turnip rape (Brassica rapa var. silvestris) two out of 39 varieties (5.1%), swede rape (Brassica napus) 
116 out of 1333 (8.7%), sunflower (Helianthus annuus) 276 out of 1635 (16.9%) and rice (Oryza sativa) 40 out 
of 449 (8.9%). 
174 García et al. (2023)  
175 Miller & Bradford (2011); however, a later analysis shows that developers from low- and middle-income 
countries are starting to enter the commercial with a broader spectrum of crops; see Parisi et al. (2016) 
176 Dobres (2008) 
177 Venezia & Creasey Krainer (2021); Yaqoob et al. (2023) 
178 Catacora-Vargas (2011) 
179 Lemmon et al. (2018) 

44 

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

6.2.3.  Social, health and safety impacts 

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

As  some  NGT  products  are  expected  on  the  market,  certain  social  and  health  benefits  are 
expected.  Current  R&D  addresses  traits  like  modified  starch,  protein  and  lipid  content  and 
composition or increased functional metabolites and traits enhancing market value (e.g. longer 
shelf life)180. In oilseed crops, for example, the most preferred target of genome editing is the 
production of monounsaturated fatty acids, such as oleic acid, which are generally considered 
healthier and more stable, and hence are associated with a longer shelf life. An example of a 
trait  having  an  expected  direct  health  effect  is  low  gluten  content  in  wheat  produced  by 
targeted mutagenesis and assessed in one of  the JRC case studies (see Annex 7). Such low-
gluten,  celiac  safe  wheat  can  contribute  to  making  low  gluten  diets  more  affordable181,  to  a 
more  balanced  diet  and  to  decreased  costs  of  medical  care182.  In  the  JRC  market  study, 
modified content is the most common trait addressed in NGT product R&D (see Annex 7). 

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

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

1.3.  Analysis of option 2: Authorisation with incentives for products 

containing modified traits that have the potential to contribute to 
sustainability 

6.3.1.  Economic impacts 

Breeders  –  With  regard  to  adapted  risk  assessment  and  the  attendant  cost  reductions,  the 
analysis  of  option  1  applies.  This  option  is  judged  by  breeders  to  have  overall  a  neutral  or 
negative impact  on time to  market  or regulatory certainty  compared to  option 1, for several 

180 Ku & Ha (2020)  
181  Celiac-safe  wheat  derived  products  are  expected  to  be  10  to  30%  more  expensive  than  those  made  from 
standard  wheat,  but  still  cheaper  than  gluten-free  products,  which  are  on  average  200%  more  expensive  than 
gluten-containing products. 
182 Sánchez et al. (2023) 

45 

 
 
 
                                                           
reasons.  In  case  operators  decide  to  apply  for  incentives,  specific  costs  will  result  from  the 
need to  comply with  a sustainability-related verification and will depend on the criteria and 
data requirements necessary for that verification. Apart from the extra costs, breeders consider 
that  any  pre-market  data  generation  may  extend  the  preparation  phase  for  the  applicant, 
lengthen assessment timelines and diminish the potential benefits of NGTs to speed up plant 
breeding. This is also due to the view that the proposed incentives will not necessarily lead to 
a significant decrease of administrative burdens. However, if easily implementable criteria to 
trigger incentives are designed, stakeholders do see some merit in the sustainability incentives 
offered under this option. Data from the cost survey183 identified potentially significant cost 
savings connected to regulatory (EUR 83300 – 833000) and scientific advice (EUR 35700 – 
357000)  and  through  the  waiving  of  fees  for  the  validation  of  the  detection  method 
(EUR 105000,  EUR  52500  for  SMEs).  These  cost  savings  (the  estimated  savings  are 
dependent  on  the  future  data  requirement  for  the  sustainability-related  verification)  will  be 
particularly relevant for SMEs, which, as a rule, do not have dedicated regulatory departments 
to  support  the  authorisation  process.  In  addition,  as  the  use  of  incentives  is  voluntary, 
companies  are  free  to  choose  whether  to  use  this  possibility  or  not  based  on  an  economic 
analysis of the costs and expected benefits. 

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

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

the  regulatory  procedures  prior 

Institutes  but  support 

to 

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

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

183 See Annex 7 in Technopolis Group et al. (2023) 

46 

 
 
 
                                                           
A quantitative exploratory analysis184 of impacts shows, for a medium adoption rate of NGTs 
(10-23% of the crop market, depending on crop group), the following estimated mean and, in 
brackets, range of impacts on key agronomic parameters for several crop groups, showing a 
pattern comparable to option 1 (Table 5). 

Table 5. Trait-level impacts. 

Crop group 

yield change/ha 

Oil and fibre plants 

Vegetables 

Cereals 

Legumes 

9% 
(4% to 20%) 

9% 
(6% - 24%) 

8% 
(6% to 22%) 

9% 
(6% to 23%) 

change in 
pesticide use/ha 

change in 
fertiliser use 

change in 
water use 

change in 
energy use 

-10% 
(5% to -35%) 

-13% 
(-8% to -28%) 

-3% 
(5% to -15%) 

-3% 
(0% to -10%) 

- 

- 

- 

- 

-16% 
(-14% to -18%) 

-11% 
(-5% to -18%) 

-5% 
(-4% to -7%) 

-10% 
(5% to -35%) 

-10% 
(-5% to -20%) 

-5% 
(3% to -16%) 

-7% 
(-1% to -12% 

-3% 
(0% to -10%) 

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

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

The  specific  impacts  of  this  option  relate  to  labelling  options  for  NGT  products  featuring 
traits  that  can  contribute  to  sustainability.  If  a  sustainability  label  is  provided  for,  the  focus 
group  on  sustainability185  conducted  in  the  context  of  the  external  contractor’s  study,  found 
that  a  sustainability  claim  allowing  for  higher  premiums  would  be  to  the  disadvantage  of 
sustainable conventional or organic products.  

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

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

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

184 Annex 8, section 1 in Technopolis Group et al. (2023) 
185 Annex 6, section 1 in Technopolis Group et al. (2023) 

47 

 
 
 
                                                           
impacts of incentives could, however, be counteracted by the additional burdens of producing 
the data for the verification of the sustainability contribution of the NGT trait.  

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

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

6.3.2.  Environmental impacts  

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

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

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

However,  this  option  and  option  3  were  questioned  from  the  perspective  of  how  the 
sustainability  contribution  of  a  trait  could  be  verified.  A  large  majority  of  stakeholders, 
representing  very  different  interests  (biotech  industry  and  breeders,  farmers,  NGOs  and 
organic and GM-free sectors), agree in the public consultation, interviews, the focus group on 
sustainability and the targeted survey that the sustainability of a crop does not depend on its 
individual traits but on the interplay of the plant with its environment and the farming system 
that it is adopted in. There is wide agreement  that the holistic, multi-site and multi-year test 
for value for cultivation and use (VCU), carried out during variety registration of agricultural 
crops  under  the  PRM  legislation  is  far  more  suitable  to  assess  in  a  holistic  manner  the 
performance of new varieties186. Such an overall performance assessment should not be part 
of  the  procedures  for  the  authorisation  of  GMOs  which  are  focused  on  the  effect  of  the 

186 Annex 6, section 1 in Technopolis Group et al. (2023) 

48 

 
 
 
                                                           
genetic modification only. Moreover, it is considered that, should such a holistic assessment 
of the variety be introduced in the NGT authorisation, it would duplicate the VCU assessment 
to  which  NGTs  are  also  subject.  These  stakeholders  consider  that  sustainability  analysis 
should be performed using a system approach rather than one at product level. Furthermore, 
the  discrimination  of  plants  produced  by  conventional  or  organic  breeding  causes  concerns 
among stakeholders as these plants cannot benefit from a sustainability label. 

6.3.3.  Social, health and safety impacts 

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

If  more  NGT  products  will  come  to  the  market  (coupled  with  incentives  steering  to  certain 
traits), social and health benefits, such as from the low gluten wheat presented in Annex 7, are 
expected. NGTs support healthy diets: examples are mustard greens (Brassica juncea) with a 
decreased content of pungent compounds187 or rice lines with lower amylose content, which 
may reduce the risk of diabetes188. 

Impacts on consumers – In the public consultation, a majority of EU and non-EU citizens that 
responded supported the view that specific regulatory provisions for sustainability should be 
included in this initiative. Survey responses (70%) indicate that a sustainable trait label, also 
covering the purpose for which the NGT product was developed, could increase consumers’ 
willingness to buy NGT products with such a label. Respondents to the targeted survey189 and 
further  studies  indicate  that  sustainability-related  labelling  will  increase  clarity  for  the 
consumers,  allowing  them  to  choose  products  that  contribute  to  societal  benefits  and 
sustainability, based on their preferences190.Available research suggests that  consumers may 
accept NGTs in particular when they promote societal benefits and sustainability191. 

In  this  regard,  the  sub-option  to  label  NGT  products  as  GM  combined  with  a  sustainability 
label linked to the introduced trait, would strengthen freedom of choice (by informing about 
the  technology  and  its  application)  and  increase  consumer  and  market  acceptance.  Yet  the 
focus  group  on  sustainability192  found  that  a  sustainability  claim  allowing  for  higher 
premiums would be to the disadvantage of sustainable conventional or organic products. 

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

187 USDA APHIS (2020)  
188 Sun et al. (2017) 
189 Business associations, large companies, SMEs, some NGOs and academic/research organisations 
190  Swedish  Gene  Technology  Advisory  Board,  Department  of  Plant  biology  (SLU),  Novus.  (2021); 
GENEinnovate (2020); Kato-Nitta et al. (2021); Baum et al. (2023) 
191 Swedish Gene Technology Advisory Board, Department of Plant biology (SLU), Novus. (2021) 
192 Annex 6, section 1 in Technopolis Group et al. (2023) 

49 

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

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

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

6.4.1.  Economic impacts 

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

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

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

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

Impacts on SMEs – While there can be significant cost reductions for adapted risk assessment, 
additional data are required to show that the trait is not detrimental to sustainability. Although 
no  estimates  for  these  additional  costs  are  available,  there  is  the  risk  that  these  extra  costs 
could negate some of the positive impact of adapted risk assessment. Therefore, there is the 

50 

 
 
 
possibility  that  SMEs  in  the  EU  will  have  few  or  no  incentives  to  develop  NGT  products 
under  this  option.  There  is  furthermore  the  risk  that  a  NGT  product  might  be  refused 
authorisation  for  not  meeting  the  sustainability  requirements  and  this  leads  to  regulatory 
uncertainty, which is economically riskier for SMEs than for larger companies. 

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

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

6.4.2.  Environmental impacts  

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

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

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

6.4.3.  Social, health and safety impacts 

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

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

51 

 
 
 
cannot be detrimental to sustainability can be authorised, consumer acceptance of NGTs could 
increase. 

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

1.5.  Analysis of option 4: Notification of products that could also occur 

naturally or be produced by conventional breeding 

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

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

1.5.1.  Economic impacts 

Breeders – Under this option, strong effects are expected on the attractiveness to develop and 
bring to the market NGT plants with genetic alterations that could also be produced naturally 
or by conventional breeding. Apart from an initial verification that the related criteria are met, 
such  plants  would  be  treated  like  conventional  varieties  and  therefore  the  costs  for  market 
authorisation would be similar to conventional varieties193, while time to market (development 
time + variety registration, which can be expected to be less than 10 years) would be shorter 
than  for  conventionally  bred  varieties,  where  variety  development  alone  can  take  up  to  15 
years. Additional  costs compared to  conventional  varieties would be due  to  the necessity to 
verify whether a product could also occur naturally or be produced by conventional breeding. 
The  total  cost  savings  for  breeders  will  depend  on  the  share  of  NGT  products  which  will 
comply  with  the  relevant  requirements.  As  cost  and  time  savings  for  each  variety  are 
considerable  (see  section  6.2.1.),  there  will  be  strong  incentives  for  breeders  to  focus  their 
R&D on varieties which can fulfill the criteria for a notification. 

92%  of  overall  stakeholders  see  an  increase  of  attractiveness  under  this  option.  In  a  recent 
survey  among  European  plant  breeders,  100%  of  the  larger,  86%  of  the  medium  sized  and 
70% of the small companies would further invest in NGT-related product development if the 
products would not be subject to the requirements of the GMO legislation194.  
Academia/Research  institutes  –  Academia  and  research195  expect  this  option  to  increase 
investments both from large multinational plant breeders as well as SMEs and public sector 
research,  allowing  for  both  a  deeper  and  broader  R&D-base  in  agricultural  biotech  due  to 
lower total aggregate R&D-cost, reduced business risk and shorter time-to-market. This will 
increase research competitiveness of the EU and offer research and employment opportunities 
for plant scientists, addressing the perceived problem of brain drain. 

193 The total annual costs to businesses across the EU27 of registering varieties is estimated to be up to 
EUR 73 m with an average cost to businesses per registration of EUR 4434. 
194 Jorasch (2020) 
195 Section 3.1.23. in Technopolis Group et al. (2023) 

52 

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

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

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

Conventional farmers – Conventional farmers could maximise benefits of NGTs as set out in 
section 6.3.1, for example with regard to pesticide reduction as biotic resistance is the second 
largest  type  of  traits  addressed  in  the  R&D  pipeline  (113  of  489)  thereby  contributing  to 
resilience and food security. However, as beneficial traits addressing abiotic resistance (water 
stress196,  heat)  are  generally  genetically  more  complex  and  the  expression  of  the  involved 
genes  are  very  dependent  on  environmental  conditions  it  can  be  expected  that  many  plant 
products incorporating such traits would not  meet the criteria to be treated as a product that 
could occur naturally or be produced by conventional breeding and be subject to the rules set 
out for the baseline option or for options 1, 2 or 3197. A quantitative exploratory analysis198 of 
impacts shows, for a high adoption rate of NGTs (10-27% of the crop market, depending on 
crop  group),  the  following  estimated  mean  and,  in  brackets,  range  of  impacts  on  key 
agronomic parameters for several crop groups (Table 6). 

Table 6. Trait-level impacts 

Crop group 

yield change/ha 

Oil and fibre plants 

Vegetables 

Cereals 

Legumes 

12% 
(9% to 21%) 

9% 
(6% to 24%) 

16% 
(6% to 33%) 

9% 
(6% to 23%) 

change in 
pesticide use/ha 

change in 
fertiliser use 

change in 
water use 

-10% 
(5% to -35%) 

-13% 
(-8% to -28%) 

-3% 
(5% to -15%) 

change in 
energy use 

-3% 
(05 to -10% 

- 

- 

- 

- 

-26% 
(-19% to -32%) 

-16% 
(-10% to -22%) 

-11% 
(-10% to -11%) 

-12% 
(-7% to -17%) 

-10% 
(5% to -35%) 

-10% 
(-5% to -20%) 

-5% 
(3% to -16%) 

-3% 
(0% to -10%) 

Compared to the estimates for other options, expected gains are particularly pronounced for 
yield changes in oil and fibre plants and cereals. This reflects the experts’ expectation that a 

196 Van de Wiel et al. (2022) 
197  There  are  some  cases  where  single-gene  approaches  to  abiotic  stress-tolerance  have  been  successful  in 
transgenic GMOs, see for example González et al. (2020) 
198 Annex 8, section 1 in Technopolis Group et al. (2023) 

53 

 
 
 
                                                           
higher  adoption  rate  means  that  in  these  crop  groups  more  NGT  plants  with  traits  affecting 
yields are expected to come to market than under the other options. 

Some farming stakeholders warn that the widespread use of NGT plants could have a negative 
impact  on  them,  especially  small  farmers,  and  their  freedom  of  choice  in  the  purchase  of 
seeds, linked to patents in this area and the risk of oligopolistic situations199. 

Organic/GM  free  sector  –  Today,  NGT  plants  are  subject  to  the  requirements  of  the  GMO 
legislation and are banned in organic production. As noted in section 5.2.4, two sub-options 
are  considered  for  NGT  plants  fulfilling  the  notification  criteria:  1)  they  are  treated  like 
GMOs for the purposes of organic production and are therefore prohibited; 2) they are treated 
like conventional products for the purposes of organic production and can in some instances 
be  used200.  This  second  sub-option  applies  the  logic  of  the  legislation  today,  where  GMO 
products  produced  by  random  mutagenesis  and  which  are  exempt  from  GMO  requirements 
are treated as conventional for the purposes of organic production. 

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

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

In the first  sub-option, the  organic sector will rely on the organic  traceability  requirements 
and  the  preventive  measures  provided  for  in  the  Organic  Products  Regulation.  In  order  to 
mitigate  the  impact  on  organic  farming  and  ensure  freedom  of  choice  for  farmers,  further 
measures to support maintaining organic production free from NGTs and consumer trust may 
need  to  be  introduced  (e.g.  the  labelling  of  seeds  could  be  considered).  As  in  other  options 
(including the baseline), where the admixture cannot be ascertained analytically, and organic 
producers  are  able  to  show  they  have  complied  with  all  necessary  precautionary  measures, 
there will not be direct economic losses linked to loss of the organic logo. However, the lack 
of analytical methods will raise specific challenges  in the case of farmers who manage both 
organic  and  conventional  production  on  their  holdings201.  These  challenges  might  erode  the 
trust  of  those  consumers  who  are  concerned  about  the  adventitious  presence  of  NGTs  in 
organic products. However, the legal ban on the use of NGTs can also act as reassurance to 
consumers that all measures are being taken to avoid NGT presence. 

199 CEJA (2022) 
200 As there is a lack of organic seeds for many crops, organic farmers are allowed to use non-organic untreated 
seeds  authorised  through  derogation  requests.  For  data  on  the  use  of  non-organic  seeds  see  Solfanelli  et  al. 
(2022).  Organic  production  can  also  use  organisms  produced  by  classical  mutagenesis,  using  irradiation  or 
chemical  mutagens,  which  are  GMOs,  but  are  exempted  from  the  obligations  of  the  GMO  legislation.  For 
example, the cherry variety ‘Sunburst’ was developed by hybridization with mutant variety ‘Stella’ obtained by 
irradiation with x-rays. Both these varieties are used in organic cherry production in the EU. 
201 Approximately 45% of agricultural holdings with organic production also have non-organically managed 
areas; see table 2 in https://ec.europa.eu/eurostat/statistics-
explained/index.php?title=Organic_farming_statistics#Organic_production 

54 

 
 
 
                                                           
With  regard  to  supply  chains,  there  are  currently  a  few  areas  of  organic  food  production, 
where there are interfaces to the conventional market202. Special precautionary measures  for 
the  organic  sector  are,  in  particular,  needed  when  purchasing  organic  raw  materials  such  as 
maize,  soya  or  rape  seed  from  countries  where  GMO  varieties  are  also  produced  or  from 
traders who also trade in GMOs. In order to exclude as far as possible for these origins and 
purchasing  routes  possible  admixture  with  GMO  raw  materials,  appropriate  contracts  with 
producers and/or traders that define the critical points in production, transport and storage to 
minimise admixture are concluded. Some suppliers of raw materials or products offer the raw 
materials  from  so-called  IP  (Identity  Preserved)  programmes.  If  more  NGTs  products  come 
the  market,  the  number  of  interfaces  of  organic  food  production  to  the  conventional  market 
may increase, placing more demands on the IP programmes and the precautionary measures 
organic operators are obliged to take under the Organic Products Regulation in order to avoid 
products not authorised in organic production. This will place additional costs and burdens on 
organic  operators  who  will  bear  segregation  costs.  There  are,  however,  no  quantitative 
estimates available.  

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

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

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

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

This  sub-option  could  deliver  positive  impacts,  as  organic  farmers  would  be  able  to  benefit 
from the potential of NGTs supporting sustainable farming practices, in particular with regard 
to pest resistance and pest tolerance203. Organic breeders would also be able to decide to use 
notified  NGT  plants  in  their  breeding  programmes,  if  they  see  benefits  in  traits  relevant  to 
organic cultivation.  

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

202 IFOAM EU (2014, 2018)  
203 Andersen et al. (2015); Crespo-Herrera & Ortiz (2015) 

55 

 
 
 
                                                           
certain products of NGTs are treated in regulatory terms as conventional products, this should 
equally apply as regards their possible use in organic production. 

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

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

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

1.5.2.  Environmental impacts  

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

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

This option offers the largest opportunities to realise the potential environmental benefits of 
NGTs, as it offers the strongest  incentive to  develop  NGT varieties  in  the EU, although the 
development and marketing of NGT products, and the realisation of their potential, depends 
also  on  various  factors  other  than  an  appropriate  regulatory  framework.  Patents,  access  of 
public  organisations  and  SMEs  to  the  technologies  and  the  market,  access  and  affordability 

56 

 
 
 
for farmers (particularly small-scale), and factors driving consumer acceptance, will also have 
an important impact. 

Agrobiodiversity could benefit from this option, as it can become less burdensome and costly 
to  apply  the  techniques  to  small  and  local  crops  provided  that  access  to  the  technology,  in 
particular for SMEs and the public sector, is not restricted by high licensing costs. A recent 
modelling  study  found  that  NGT  plants,  when  regulated  like  conventionally  bred  crops, 
required  a  96%  smaller  potential  cultivation  area  to  break  even  on  the  financial  investment 
when compared to established genetic modification204. In addition, the FAO reports that NGT 
crops  are  more  diverse  regarding  varieties,  traits  and  institutions  developing  them  (more 
public  organisations  and  SMEs)  in  comparison  with  first  generation  GM  crops.  However, 
some  NGT  crops  with  traits  contributing  to  sustainability  can  face  significant  financial 
barriers  for  development  and  use205.  Moreover,  if  NGT  crops  are  subject  to  the  same 
regulatory requirements as GM crops, the cost of regulatory approvals is often prohibitive for 
niche  crops206.  Therefore,  it  is  expected  that  the  reduction  of  burden  and  costs  under  this 
option  would  contribute  to  improve  market  access  to  NGTs  for  public  organisations  and 
SMEs that could in turn bring benefits associated to smaller area crops and/or niche traits. 

1.5.3.  Social, health and safety impacts 

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

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

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

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

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

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

204 Bullock et al. (2021) 
205 Jordan et al. (2022) 
206 FAO (2022) 

57 

 
 
 
                                                           
7.  How do the options compare? 
This section compares the expected impacts of the options in terms of their effectiveness to 
reach  the  initiative's  objectives,  efficiency,  coherence  and  proportionality.  This  qualitative 
assessment of the options is based on the overall analysis of key impacts and the comparison 
is with the performance of the baseline. It takes the scoring of the multicriteria analysis207 into 
account, as well as additional evidence gathered during this process. The overall comparison 
of the options against the relevant criteria is presented in Table 7. 

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

-- 

Criteria  

Policy Option 1  

Policy Option 2  

Policy 
Option 3  

Policy Option 4  

Effectiveness: contributing to 
achieving the policy objectives   

+  

+  

+  

+208  

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

safe 

are 

as 

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 

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

Effectiveness: specific impacts   

Competitiveness  

SMEs  

Social & health210 impacts  

Environmental impacts211  

Impacts on the organic sector  

0/+  

+ /++209 

0  

++ 

0/+  

0/+  

0/+  

0/+  

0/+ 

0/-  

+  

+  

+  

+  

+  

0/-  

0/+  

++  

0 

0 

0/+  

0 /+ 

0/-  

++  

++  

+ /++ 

+/++  

Notified NGTs treated 
as GMOs in organic 
production: 0/-  

Notified NGTs treated 

207 Technopolis et al. (2013), section 6, Table 11 
208  A  combination  of  option  4  with  an  adapted  risk  assessment  as  envisaged  in  options  1,  2  and  3  would 
maximise this objective (++) 
209 The strong positive effect is due to the variant of waiving the GM label 
210 Only social and health impacts beyond the impacts specific to the genetic modification considered under the 
first policy objective 
211  Only  environmental  impacts  beyond  the  impacts  specific  to  the  genetic  modification  considered  under  the 
first policy objective 

58 

 
 
 
  
  
  
  
  
  
  
  
                                                           
Efficiency  

Administrative and compliance costs  

Savings and benefits  

Coherence  

Proportionality  

Overall  

0/+  

+/++  

+  

+  

0/+  

+212  

+213 

+/-  

+ 

+  

as conventional in 
organic production: -/+ 

+/-  

+/- 214 

-  

++  

++  

Notified NGTs treated 
as GMOs in organic 
production: - 

Notified NGTs treated 
as conventional in 
organic production: +  

-  

0  

++  

+/++ 

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

1.6.  Effectiveness  

Contributing to achieving the policy objectives 

Procedures that ensure safety while avoiding unnecessary administrative burden  

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

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

The regulatory framework for NGTs also needs to be designed in a way that it ensures safety, 
when technologies evolve (future-proofness). The baseline does not achieve this objective. It 

212 Costs are linked to the voluntary provision of data on sustainability of the trait in order to use incentives 
213 Ibid. 
214  Costs  are  linked  to  the  mandatory  provision  of  data  demonstrating  that  the  trait  is  not  detrimental  to 
sustainability 

59 

 
 
 
  
  
  
  
                                                           
entails the continued application of a legal framework that has been assessed not to reflect the 
latest  scientific  developments.  It  contains  no  mechanisms  to  adapt  to  scientific  or 
technological progress, or to the wide diversity of NGTs and resulting products, in particular 
as regards their different risk profiles. 

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

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

Diversity of released and marketed NGT products and of developers 

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

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

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

60 

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

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

Contribution to sustainable agri-food systems 

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

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

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

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

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

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

61 

 
 
 
is  considered  to  have  the  potential  to  contribute  to  sustainability,  this  objective  would  be 
achieved to a much more considerable extent.  

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

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

Other impacts 

Competitiveness and SMEs 

Certain  NGTs  are  considered  relatively  accessible  tools  for  plant  breeding  compared  to 
established  genomic  techniques.  In  this  regard,  NGTs  could  lead  to  a  lowering  of 
technological  barriers  to  entry  of  the  plant  breeding  sector,  benefitting  SMEs  in  particular. 
This  has  been  observed  in  Argentina  after  its  regulatory  decision  to  exclude  certain  NGT 
products from the GMO framework215. 

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

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

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

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

However, the ability of SMEs to enter the NGT market will be also dependent on affordable 
access  to  intellectual  property.  For  this  reason,  some  stakeholders  consider  that  their 
competitive  position  will  not  improve  under  any  of  the  options,  unless  patent-related  issues 
are resolved216.  

215 Whelan et al. (2020); Goberna et al. (2022) 
216 Technopolis Group et al. (2023) 

62 

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

Social and health impacts 

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

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

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

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

63 

 
 
 
Environmental impacts 

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

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

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

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

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

Impacts on the organic and GM-free sectors 

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

Under  option  4,  the  traceability,  labelling  and  coexistence  measures  of  the  current  GMO 
legislation  would  not  apply  to  notified  NGTs.  Impacts  would  differ  if  the  NGTs  under 
notification  are  treated  for  the  purposes  of  organic  production  as  GMOs  or  as  conventional 
products.  In  the  first  sub-option  organic  operators  would  have  the  responsibility  to  put  in 
place precautionary measures, supported by the public register of NGT plants and information 
in  the  common  catalogues  of  plant  varieties,  to  avoid  the  use  of  and  admixture  with  any 
product that is not authorised in organic production.  If NGT products subject to notification 
would be treated for the purposes of organic production as conventional products, they could 

64 

 
 
 
be  used  in  organic  production  under  the  applicable  derogations  (and  potentially  contribute 
benefits).  However,  there  is  the  risk  that  consumers  would  not  accept  NGTs  in  organic 
production,  and  a  degree  of  erosion  of  consumer  trust  and  related  economic  losses  could 
materialise.  

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

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

1.7.  Efficiency analysis 

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

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

Baseline (in thousands EUR)  

Cost for breeders   

Full authorisation costs 
Risk assessment   
Detection method   
Risk management 

Coexistence and segregation measures 

n/a 
12 194  
650  
156 218 

n/a 

 Cost for 
administrations 
209217 
n/a  
n/a  
n/a  

n/a 

Cost for farmers and food 
businesses   
n/a 
n/a 
n/a 

Available data not sufficient 
for quantification219 
Available data not sufficient 
for quantification220 

217 For administration, only costs for an authorisation procedure were estimated.   
218 For breeders, risk management refers to any post-adoption activities, such as post-market monitoring. 
219 Unquantifiable risk management costs for organic farmers are linked to practices and market monitoring of 
accidental presence of GM product. 
220  Coexistence  measures,  which  are  set  up  at  national  level,  have  costs  for  GM  farmers,  which  are  highly 
dependent  on  the  crop  species,  on  farm  structure  and  on  environmental  conditions.  In  addition,  currently  only 
GM maize MON810 is authorised in the EU for cultivation, and its cultivation is limited to Spain and Portugal. 
Therefore,  available  data  on  the  current  costs  for  co-existence  measures  and  their  variability  are  extremely 
limited. The SIGMEA project (2004 – 2006), funded under FP6, mentioned in Section 6 estimates the costs of 
potential coexistence measures to GM farmers based on simulations. 
Coexistence  of  GM  and  non-GM  commodity  in  the  value  chain  creates  segregation  measures  costs  for 
processing chain and for the food businesses. The current costs cannot be quantified with sufficient certainty as 
they vary greatly depending on the GM crop species, its processing and use in the EU. The Co-Extra research 
project  (2008  –  2009)  mentioned  in  Section  6  estimates  the  coexistence  costs  for  the  food  businesses  and  the 
value chain in some products. 

65 

 
 
 
                                                           
Assessment of sustainability claim   
Administrative cost  

Total balance for full authorisation costs  

n/a  
4 940  

17 940 

n/a  
n/a  

209  

n/a  

Available data not sufficient 
for quantification221  
Available data not sufficient 
for quantification 

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

Option 1 (in thousands EUR)  

Cost for administrations  

Full authorisation costs   
Risk assessment   
Detection method   

Risk management   

Coexistence and segregation 
measures 
Assessment of sustainability claim   

n/a   
From 0 to – 10 365  

No change compared to the 
baseline  
No change compared to the 
baseline  
n/a 

n/a   

Administrative cost  

From 0 to – 1 750 

From 0 to -140   
n/a   
n/a   

n/a    

n/a 

n/a   

n/a   

Total balance for full authorisation 
costs  

From 0 to -12 115   

From 0 to -140   

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

Option 2 (in thousands EUR)  

Costs for breeders   

Costs for administrations   Cost for farmers and food 

Full authorisation costs   
Risk assessment   
Detection method   

Risk management   

Coexistence and segregation measures 

Voluntary assessment of sustainability 
claim   

n/a 
From 0 to – 10 365  

No change compared to the 
baseline  
No change compared to the 
baseline  
n/a 

From +1 950 to +390 224 

From 0 to -140   
(+)222 
 n/a   

n/a 

n/a 

(+)225  

Cost for farmers and food 
businesses 
 n/a   
n/a  
n/a  

No change compared to the 
baseline  
No change compared to the 
baseline 
n/a   

No change compared to the 
baseline  
No change compared to the 
baseline  

businesses 
n/a 
n/a  
 n/a  

(+) or no change compared to 
the baseline223 
No change compared to the 
baseline 
n/a   

221 Unquantifiable administrative costs for food businesses due to the GM labelling obligation. 
222 Potential moderate to significant increases in costs for administrations, due to possible incentives to 
encourage the development of sustainable products such as scientific support given to the applicant during 
authorisation process. 
223 In the first scenario, the GMO labelling would be waived for products with a modified trait that is considered 
to have the potential to contribute to sustainability. In that case, an unquantifiable increase in costs is expected 
for organic farmers. 
In the second scenario, the GMO labelling is maintained, but a possible sustainability labelling can be added to 
the GMO labelling. In this case, there is no change in costs compared to the baseline for organic farmers. 
224  Voluntary  compliance  cost.  For  this  analysis,  in  the  absence  of  reliable  information,  it  is  assumed  that  all 
applicants  choose  to  provide  data  to  support  such  a  claim.  Therefore,  the  amount  is  the  same  as  in  the 
corresponding entry in Table 11, where these costs are mandatory for all applicants. 
225 Potential moderate to significant increase in costs for Member States administrations due to the assessment of 
sustainability claim. 

66 

 
 
 
 
 
                                                           
Administrative cost  

Total balance for full authorisation costs  

From +247 to -1 725226  
From +2 197 to -11 700228  

n/a   

Available data not 
sufficient for quantification 

(+) or (-)227 
(+) or (-)229 

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

Option 3 (in thousands EUR)  

Costs for breeders   

Costs for administrations   Cost for farmers and food 

businesses 

Full authorisation costs 
Risk assessment   
Detection method   
Risk management   

From 0 to – 10 365  
No change compared to baseline  

No change compared to the 
baseline  

Coexistence and segregation measures 

n/a 

Mandatory assessment of sustainability 
claim   
Administrative cost  

Total balance for full authorisation costs  

From +1950 to +390231  

From +247 to -1 725  

From +2 197 to -11 700 

From 0 to -140   
n/a   
 n/a   

 (+) or no changes 
compared to the 
baseline230   
n/a 

(+)232  

n/a   

Available data not 
sufficient for 
quantification   

n/a  
n/a  

No change compared to the 
baseline  

No change compared to the 
baseline 
n/a   

No change compared to the 
baseline 
No change compared to the 
baseline  

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

Option 4 (in thousands EUR)  

Costs for breeders   

Costs for administrations   

Full notification costs 

n/a 

From 0 to -140233   

Costs for farmers and 
businesses   
n/a 

226 The administrative costs of the voluntary assessment of sustainability ranges from +247 000 EUR to +25 000 
EUR. 
227 In the first scenario, the GMO labelling would be waived for products with modified trait that is considered to 
have the potential to contribute to sustainability. In that case, an unquantifiable saving in administrative costs for 
food businesses is expected. 
In the second scenario, the GMO labelling is maintained, but a possible sustainability labelling can be added to 
the GMO labelling. In that case, a limited unquantifiable administrative cost increase is estimated due to the 
additional information in the label. 
228  The  total  balance  presented  in  the  table  takes  into  account  the  potential  voluntary  data  produced  for  the 
assessment of sustainability claim.  
The total balance in case no assessment of sustainability is performed would range from 0 to -12 115 000 EUR. 
229 In the first the scenario, the estimated total would be an unquantifiable increase of costs for organic farmers 
and unquantifiable savings for food businesses. 
In the second scenario, it is estimated that there is no change compared to the baseline for organic farmers and 
limited unquantifiable costs for food businesses. 
230 In the first scenario, the GMO labelling would be waived for products with modified trait that is considered to 
have  the  potential  to  contribute  to  sustainability.  In  that  case,  a  slight  increase  in  costs  is  estimated  for  the 
Member States administrations. 
In the second scenario, the GMO labelling is maintained, but a possible sustainability labelling can be added to 
the  GMO  labelling.  In  that  case,  Member  States  competent  authorities  estimated  that  costs  increase  for  risk 
management, due to the necessity to set up additional control systems, would range from negligeable to high.  
231 Mandatory compliance cost. 
232 Potential moderate to significant increase in costs for Member States administrations due to the assessment of 
sustainability claim. 
233  The  full  notification  cost  for  administrations  is  to  be  compared  for  the  authorisation  cost  in  the  baseline 
scenario. 

67 

 
 
 
  
 
 
 
                                                           
Data for notification234   
Detection method   
Risk management   

Coexistence and segregation measures 
Assessment of sustainability claim   
Administrative cost  

Total balance for full notification costs  

From -9 146 to -10 365  
-650  
-156235   

n/a 
n/a   
From – 1 615 to – 3 750  
From -11 567 to -14 921  

n/a 
n/a    
(-)236   

n/a 
n/a   
n/a   

n/a  
n/a  
(+)237 

(+)238 
n/a   
(-)239 

From 0 to -140240 

(+) and (-)241   

1.8.  Coherence  

7.3.1.  Coherence with GMO legislation 

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

7.3.2.  Coherence with other legislation and initiatives 

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

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

234 The comparison was done between the estimated costs of the potential data requirements for the notification 
of an NGT plant compared to the current cost of data requirements for a GMO application. 
235  For  breeders,  risk  management  refers  to  any  post-adoption  activities,  such  as  post-market  monitoring 
activities. 
236 Significant unquantifiable savings are estimated for administrations in risk management due to the removal of 
the traceability and labelling requirements. 
237 Potential unquantifiable increase in costs is expected for organic farmers for risk management practices and 
market monitoring (for accidental presence of GM/NGT product) due to the uncertainties of potential presence 
of notified NGT plants in conventional seeds. 
238  Potential  unquantifiable  cost  increase  for  organic  farmers  (and  others  not  wishing  to  use  NGTs)  due  to 
potential challenges regarding coexistence as the labelling threshold cannot be effectively checked and enforced. 
239 Unquantifiable savings in administrative costs for businesses is expected due to the removal of the traceability 
and labelling obligation. 
240 This total does not take into account the unquantifiable savings from risk management. 
241  Unquantifiable  savings  are  expected  for  non-organic  farmers  and  businesses  while  unquantifiable  costs  are 
expected for organic farmers. 

68 

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

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

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

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

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

Organic Products Regulation (Regulation (EU) 2018/848) and organic target in the Farm to 
Fork Strategy – That regulation bans the use of GMOs in organic production, and considers as 
GMOs for the purposes of that Regulation those that are not exempted from the requirements 
of  the  GMO  Directive.  Conversely,  GMOs  exempted  from  the  requirements  of  the  GMO 
legislation (e.g., plants obtained from random mutagenesis) are treated as conventional for the 

69 

 
 
 
purposes of organic production and may be used under certain circumstances. In the baseline, 
as well  as options 1, 2 and 3, NGTs would remain subject to the requirements of the GMO 
legislation and would be considered GMOs for the purposes of organic production. If option 4 
is  retained,  the  proposal  may  need  to  clarify  the  status  of  NGT  products  falling  under  the 
notification  in  the  context  of  the  organic  regulation.  In  any  event,  all  options  include 
provisions  (traceability,  labelling  or  public  registries)  to  allow  organic  producers  to  comply 
with the Organic Production legislation. 

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

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

Legislation on labelling: Regulation (EU) No 1169/2011 on the provision of food information 
to  consumers  (FIC  Regulation)243,  Regulation  (EC)  No  1924/2006  on  nutrition  and  health 
claims,  (NHCR)244,  Regulation  (EC)  No  767/2009  on  the  placing  on  the  market  and  use  of 
feed245  and  initiative  on  substantiating  green  claims246  –  The  sustainability  label  (if 
complementary to the existing GMO label) in option 2 for NGT products featuring a modified 
trait  which  contributes  to  sustainability  could  raise  coherence  issues  vis  à  vis  current 
requirements  in  the FIC  Regulation,  the NHCR  and the Regulation  on marketing of feed as 
well as with the green claims initiative. These regulations set out requirements that have to be 
met by voluntary information or claims included on the labelling of food intended for the final 
consumer.  Therefore,  any  claim  regarding  the  properties  of  the  food  derived  from  a  NGT 
plant,  and  in  particular  on  nutrition  properties,  would  have  to  also  comply  with  those 
requirements.  As  regards  environmental  claims,  the  Commission’s  green  claims  initiative 
would  require  companies  to  substantiate  environmental  claims  about  their  products  with  a 
standard methodology to assess their impact on the environment.  Any environmental claims 
made  with  regard  to  the  modified  trait  of  a  NGT  plant  in  option  2  would  have  to  be 

242 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015R2283 
243 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32011R1169 
244 https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32006R1924 
245 https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32009R0767 
246 Proposal for a Directive of the European Parliament and of the Council on substantiation and communication 
of explicit environmental claims (Green Claims Directive). COM/2023/166 final; https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=COM:2023:0166:FIN 

70 

 
 
 
                                                           
substantiated  in  accordance  with  the  new  rules  on  green  claims,  once  adopted,  in  order  to 
ensure coherence.  

investments 

incentivising 

in  research  and  development  and  promoting 

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

1.9.  Proportionality 

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

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

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

Finally, for option 4 the indicative notification criteria (see section 5.2.4 box 2) are designed 
to  reflect  the  equivalence  of  the  NGT  plant  with  plants  that  could  occur  naturally  or  be 

71 

 
 
 
obtained by conventional breeding methods, and (complemented by data requirements linked 
to those criteria) should be adequate to ensure proportionality.  

Preferred Option 

8. 
8.1.  Description of the preferred option 
The  preferred  option  is  a  combination  of  option  4  for  products  that  could  also  occur 
naturally  or  be  produced  by  conventional  breeding  and  of  option  2  for  all  other 
products. This combination ensures to the largest possible extent that NGT plants and derived 
food/feed  products  are  as  safe  as  their  conventional  counterparts,  while  not  entailing 
unnecessary  regulatory  burden,  that  NGT  plants  and  derived  food/feed  products  featuring  a 
wide range of plant species and traits by various developers are placed on the market and that 
these plants feature traits that can contribute to a sustainable agri-food system. 

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

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

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

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

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

The option scores high in terms of ensuring safety  and proportionality through requirements 
that are adapted to levels of risk of NGT plants that are not similar to conventional products. 

72 

 
 
 
An adapted risk assessment would bring a moderate improvement concerning attractiveness to 
develop NGT plants in the EU. Cost reductions for applicants compared to the baseline range 
from low to very substantial, depending on which risk assessment criteria need to be applied 
in  specific  cases.  There  would  be  variable  but  potentially  significant  cost  decreases  for  risk 
assessment. To address concerns expressed about the potential uncertainty and complexity of 
this approach, work on the criteria for risk assessment (see section 5.2.1) is intended to ensure 
adaptability and predictability.  

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

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

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

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

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

With  the  combination  of  option  2  with  option  4,  for  the  most  part  products  subject  to 
authorisation  could  be  differentiated  from  plants  obtained  naturally  or  produced  by 

73 

 
 
 
conventional breeding techniques. In such cases, applicants for authorisation would be able to 
comply with  a requirement to  submit a specific detection method, the competent  authorities 
would be able to enforce the legislation and operators would be able to test raw material and 
products for traceability purposes.  

The preferred option creates an enabling framework to meet the demands of farmers for the 
development  and commercialisation of new varieties with  beneficial traits to  respond to  the 
constraints  of  their  soil  and  climatic  context247.  For  NGT  plants  subject  to  notification,  the 
development  of  such  varieties  is  also  steered  by  the  objectives  and  provisions  of  other  EU 
policy initiatives, in particular the SUR proposal (which has the objective to reduce the use of 
pesticides)  to  which  pest-resistant  crops  can  contribute,  the  PRM/FRM  initiative  (holistic 
assessment of the sustainability characteristics of a variety) and the FSFS initiative (steering 
the  EU  food  systems  towards  sustainability).  For  NGT  products  requiring  an  authorisation, 
the  preferred  option  steers  developments  towards  desirable  traits  by  providing  regulatory 
incentives, which would be helpful in particular for SMEs. The factual label of such products 
could  impact  consumer  choice,  thus  also  steering  indirectly  the  development  towards 
desirable traits.  

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

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

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

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

approach 

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

Adjustment costs for the preferred option:  

For  breeders,  the  preferred  option  would  entail  a  significant  reduction  of  adjustment  costs. 
Based on the hypothetical scenario described in Annex 3 in which breeders would submit 10 
notifications  and  5  applications  for  authorisation  per  year248,  the  total  recurrent  savings  in 
adjustment  costs  per  year  are  estimated  to  range  from  a  minimum  of  EUR 99.5 m  to  a 
maximum of EUR 163.5 m249. 

For  national  administrations,  a  potential  unquantifiable  increase  in  adjustment  costs  was 

247 CEJA (2022) 
248 This estimate is based on the number of products expected to come to the market in the next ten years and on 
the assumption that, starting in 2015, 15 products per year will enter the regulatory approval process. 
249 The risk assessment will be proportionate to the risks/type of products, it will be variable, which explains the 
wide range of savings. This is mainly linked to the potential variability in data requirements as laid out in section 
6.2. 

74 

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

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

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

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

Administrative costs for the preferred option 

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

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

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

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

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

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

A first monitoring report should be presented no sooner than  3  years after the first products 

75 

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

that  enough  data 

to  ensure 

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

Specific objectives 

Indicators 

Data 
source/frequency 

Actors 
responsible 
for data 
collection 

S1:  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 

S2:  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 

Reported cases demonstrating risk to human 
and animal health and the environment due to 
genetic modification in authorised or notified 
product, and any regulatory action taken. 
Number of products authorised to be placed 
on the market 
Number of products notified to be placed on 
the market 
Time needed for risk assessment 

Time needed for granting 
authorisation/notification 
Assessment of encountered hurdles and 
barriers in particular for SMEs (qualitative) 

Costs for the notification/authorisation/risk 
assessment 

Number of crop-trait combinations (NGTs 
and GMOs) in notifications/authorisation 
applications 

Number of crop-traits combinations (NGTs 
and GMOs) and developers at global level* 

Number and proportion of SMEs/public 
institutions applying for field 
trials/notifications/authorisation applications* 

Assessment of the impacts of release and 
placing on the market of NGT products in the 
EU on organic agriculture in view of the 25% 
target in F2F* (quantitative / qualitative) 

Consumer acceptance and willingness to buy 
NGT products* 

S3:  NGT plants released or placed on the 
market feature 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 *. 

EC/Annually 

EC 

EC 

EC  

EC 

EC 

EC  

EC 

 EC 

EC 

 EC 

EC 

EC 

 EC  

EC /Annually 

EC/Annually 

EFSA and Member 
States/ Annually 
EC and Member 
States/ Annually 
External study/ 3 
years after the first 
products have been 
notified/authorised 
External study/ 3 
years after the first 
products have been 
notified/authorised 
EC/Annually 

External study/ 
3 years after the first 
products have been 
notified/authorised 
EC/Annually 

External 
study/3years after 
the first products 
have been 
notified/authorised 
Eurobarometer/ 3 
years after the 
adoption of the new 
legislation – to be 
repeated every 4 
years 
External study/ 
3 years after the first 
products have been 
notified/authorised 

76 

 
 
 
 
 
 
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ANNEX 1: PROCEDURAL INFORMATION 

Lead  DG:  European  Commission,  Directorate-General  for  Health  and  Food  Safety,  DG 
SANTE 

Decide reference: PLAN/2021/11456 

The  development  of  this  initiative  was  announced  under  item  4)  in  Annex  1  to  the 
Commission Work Programme 20231. 

Organisation and timing 

The  inception  impact  assessment  (IIA)  on  the  “Legislation  for  plants  produced  by  certain 
new genomic techniques” initiative2 was available for feedback in the period 24 September 
2021  -  22  October  2021.  The  IIA  outlined  the  initiative’s  context  and  aim,  problems  and 
objectives to address them, policy elements to be considered for the development of policy 
options, whilst also discussing expected impacts and presenting the evidence base. 

Nine Inter-service Steering Group (ISSG) meetings were held between September 2021 and 
February  2023,  including  participation  from  the  Secretariat  General,  the  Legal  Service,  the 
Joint  Research  Centre  (JRC)  and  Directorates-General:  AGRI,  CLIMA,  COMP,  ENV, 
GROW, MARE, RTD and TRADE. 

1. Consultation of the RSB 

The file benefitted from an upstream meeting with the Regulatory Scrutiny Board (RSB) on 
20 May 2022. A first version of this Impact Assessment Report was submitted to the RSB on 
15 February 2023, the meeting took place on 15 March 2023 and the RSB written report was 
received  on  17  March  2023.  The  Board’s  overall  opinion  was  negative  based  on  the 
following findings:  

(1) The report does not present a clear, consistent, and hierarchical set of general and specific 
objectives.  
(2) The report does not describe in sufficient detail what the main elements of the options and 
the key policy choices are. 
(3) The report does not sufficiently assess the impact on consumer trust, the organic sector, 
the environment and health. It does not present a comprehensive overview of the costs and 
benefits. 
(4) The report does not provide a comprehensive assessment of all relevant (combinations of) 
options in terms of effectiveness, efficiency and coherence. 

The  table  below  lists  the  changes  in  response  to  the  recommendations  of  the  RSB  in  its 
opinion.  In  addition,  targeted  corrections  and  amendments  have  been  included  in  the  new 
version of the impact  assessment report to  address the technical comments provided by the 
RSB to DG SANTE. 

1https://ec.europa.eu/info/sites/default/files/com_2022_548_1_annexe_en.pdf 
2https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-
produced-by-certain-new-genomic-techniques/feedback_en?p_id=26519622 

91 

 
 
                                                           
Table 1: Recommendations of the RSB and modifications made in the impact assessment report 

RECOMMENDATIONS OF THE RSB 

(1)  The  report  should  present  a  more  comprehensive 
overview of the current context including how NGTs 
are  being  developed  at  global  level,  the  and  the 
implications  for  sustainability  and  for  EU  strategic 
autonomy  and  competitiveness.  It  should  better 
explain 
the  problems  and 
consequences identified.   

the  magnitude  of 

the 

including 

link  between 

(2) The report should present a  clear, consistent,  non 
overlapping  and  hierarchical  set  of  general  and 
specific  objectives.  It  should  more  clearly  outline 
what  the  substantive  key  objectives  of  this  initiative 
are. In particular, it should explain in more detail the 
significance  of 
the  sustainability  objective,  and 
whether this is a new objective requiring the revision 
of  the  Directive.  The  report  should  clarify  to  what 
food 
extent  EU  strategic  autonomy, 
security, is a key objective of this initiative based on 
the  problems  identified.  The  report  should  further 
improve 
the  problems  and 
objectives.  It  should,  clarify  what  objectives  remain 
the  same  (e.g.  human  and  animal  health  and 
environment 
in  accordance  with  precautionary 
principle) and which ones emerge from the identified 
problems. 
(3)  The  report  should  more  fully  describe  the  main 
elements of the options and explain who are the actors 
determining,  implementing,  and  enforcing  them.  It 
should clearly outline how the notification regime and 
adapted risk assessment would work, what parameters 
would apply,  who  would decide, and what follow-up 
would be ensured. The report should set out how the 
sustainability  objective  is  addressed  in  each  option, 
and on  whether there are further alternative elements 
or  combinations  of  options.  It  should  provide  more 
detail  on  what  the  regulatory  incentives  and  the 
different  criteria  presented  would  look  like  in  their 
final  form.  It  should  provide  a  comprehensive 
explanation  of  why 
labelling 
requirement differs across the identified options. The 
report should be clear on the policy choices and trade-
offs,  and  to  how  they  are  addressed  in  the  policy 
options.  In  addition,  the  report  should  clarify  the 
approach  retained  in  the  preferred  option  as  regards 
the organic sector. 
(4) The report should  further  develop the assessment 
of the impact on health, environment, consumer trust 
and 
the  organic  sector.  Concerning  health  and 
environment,  the  report  should  provide  a  more 
balanced analysis accounting for likely environmental 
and  social  benefits  as  well  as  possible  risks  for  the 
environment  and  for  human  and  animal  health  and 
how  they  will  be  monitored  and  mitigated.  It  should 
also  explain  how  the  impacts  on  sustainability  are 

the  choice  of 

IN  THE 

MODIFICATIONS 
IMPACT 
ASSESSMENT REPORT IN RESPONSE TO 
THESE RECOMMENDATIONS 
Section  1.1  has  been  revised  to  better  explain  the 
scientific  context  (safety  profile  of  NGT  plants  and 
stakeholder  positions).  Section  1.2  in  the  political 
context  has  been  revised  to  include  aspects  of 
sustainability  and  strategic  autonomy  and  to  provide 
an  overview  of  recent  social  science  research  and 
surveys on consumer attitudes towards NGT products. 
Section 2.2 has been expanded and revised to explain 
better the size of the problem and who is affected. 
In section 4, general and specific objectives have been 
revised,  clarifying  which  objectives  are  shared  with 
the current GMO legislation and  which are  new, and 
explaining  further  the  sustainability  objective.  Links 
between  problems  and  objectives  have  been  revised. 
Relationship  between  general  and  specific  objectives 
has  been  clarified  (section  4,  figure  2).  The 
Intervention logic (Annex 10) has been updated. 

traceability, 

In Section 5, options have been explained more fully, 
including  actors 
involved,  how  notification  and 
authorisation  criteria  and  procedures  will  work, 
approaches  to  sustainability  and  to  labelling  in  each 
option,  and  concrete  details  on  incentives  considered 
in option 2.  
The  different  choices  for  each  key  element  (risk 
assessment, 
labelling/transparency, 
sustainability)  have  been  presented  in  figure  3  and 
policy  options  in  figure  4.  Explanation  has  been 
provided on the choice of combined options.  
In  section  5.2.4,  the  two  policy  approaches  for  the 
organic sector for option 4 have been added. 
New  section  5.2.5  has  been  added  to  explain  why 
option  4  was  designed  to  apply  only  to  certain  NGT 
products  and,  if  retained,  must  be  combined  with 
options 1, 2, 3 or the baseline.  
In section 5.3 an explanation has been added on why 
other combinations have not been pursued. 

In section 6 impacts on  health and environment have 
been revised to explain further what the achievement 
of  the  objective  means  (assessment  of  options  by 
comparison  to  baseline;  NGT  to  be  demonstrated  to 
be  as  safe  as  conventional  counterpart);  further 
explanations  have  been  added  on  the  distinction 
between the safety aspects associated with the genetic 
modification  and  other  potential  impacts  resulting 
from  certain  traits  (irrespectively  on  the  technique 

92 

 
 
assessed. The report should provide further evidence - 
coming  from  recent  social  science  research  and 
surveys  -  on  consumer  attitudes 
towards  NGT 
products  and  assess  how  consumer  trust  may  impact 
uptake  of  future NGT products. It should discuss the 
risk  that  benefits  might  not  materialise  as  a  result  of 
lack  of  consumer  trust.  The  report  should  further 
develop  the  analysis  of  the  impacts  on  the  organic 
sector  including  quantification  of  the  costs  for  this 
sector. 

report 

(5)  The 
should  present  a  clear  and 
comprehensive overview of the costs and benefits for 
each option. It should better describe the uncertainties 
and  limitations  of  the  analysis  based  on  hypothetical 
scenarios. It should further explain the credibility and 
reliability of the wide ranges of estimates presented. 

a 

of 

the 

consideration 

(6) The report should provide a better comparison of 
options,  with 
different 
combinations of options. It should identify all relevant 
combinations  upfront  and  assess  and  compare  them 
along 
individual  options.  The  effectiveness 
analysis should be based on the revised set of specific 
objectives,  avoiding  any  double  counting.  The 
table  should  be  critically 
comparison  summary 
reviewed to remove overlaps and inconsistencies. The 
efficiency  analysis  should  include  quantified  and 
monetised  cost  and  benefit  estimates.  The  used 
scoring  methodology  should  be  better explained, and 
the  individual  scores  better  justified.  The  report 
should  provide  a  clear  assessment  of  coherence,  in 
particular 
light  of  concerns  expressed  by 
stakeholders  as  regards  Farm  to  Fork  and  the  role  of 
organic farming. 

in 

to 

used).  
In  sections  6  and  7,  the  analysis  of  impacts  on  the 
organic sector has been considerably developed based 
on available evidence on coexistence between GMOs 
and  conventional  and  organic  farming  (e.g.  the  work 
of  the  European  Co-existence  Bureau  established  by 
the  Commission,  further  literature).  The  implications 
of  the  two  scenarios  for  the  treatment  of  notified 
NGTs  (option  4)  in  organic  farming  are  further 
discussed. 
The  sections  “Impacts  on  consumers”  under  each 
option in section 6 and in section 7 have been revised 
to elaborate further on how the different options may 
affect consumer uptake and trust.  
In  section  7.2  the  cost  analysis  for  each  option  was 
revised 
include  costs  of  coexistence  and 
segregation  measures  for  farmers  and  food  business, 
however,  due  to  limited  data,  those  costs  were  not 
quantifiable. 
Regarding costs for the preferred option, Section 8.2. 
and Annex 3 were further developed to ensure a clear 
explanation of the hypothetical scenario for the future 
number  of  authorisations  and  notifications  taken  into 
consideration for the overall cost calculation. 
As regards combinations of options, see (3). 
In  section  7.1  and  7.2,  effectiveness  and  efficiency 
analysis have been revised, making sure, in particular, 
that  no  criteria  are  double-counted  or  overlap.  The 
efficiency analysis includes quantified and monetised 
costs  and  benefits  wherever  this  information  is 
available.  All  scores  are  explained  in  the  detailed 
comparison of options in section 7.1. In section 7.3., 
the  coherence  analysis  has  been  complemented 
regarding  25%  organic  target  laid  down  in  the  Farm 
to Fork Strategy. 

A  revised  version  of  the  Impact  Assessment  Report  was  submitted  to  the  RSB  on  25  April 
2023 for a final opinion. The Board concluded with a positive opinion with reservations on 26 
May 2023. The table below lists the changes in response to the recommendations of the RSB 
in its second opinion. 

Table 2: Recommendation of the RSB and modifications made in the impact assessment report 

RECOMMENDATIONS OF THE RSB 

(1) The  report  should  provide  further  information  on 
the  risk  assessment  via  the  notification  procedure 
retained  in  the  preferred  option.  It  should  better 
explain how the procedure will ensure that the NGTs 
covered  are  plants  that  could  also  occur  naturally  or 
be  produced  by  conventional  breeding.  It  should 
describe  in  more  detail  the  key  elements  of  the  pre-

IN  THE 

MODIFICATIONS 
IMPACT 
ASSESSMENT REPORT IN RESPONSE TO 
THESE RECOMMENDATIONS 
The notification criteria in Box 2 in section 5.2. have 
been  updated  and  clarified,  scientific  considerations 
underpinning  the  criteria  have  been  added  and  a 
diagram  illustrating  how  the  notification  procedure 
would work in practice has been added to Annex 11. 

93 

 
 
the 

regard 

determined  notification  criteria,  their  scientific  basis 
and their implementation in practice. 
(2) As regards the use in organic production of NGT 
plants/products  fulfilling  the  notification  criteria,  the 
report should be clear that the two scenarios presented 
are  in  fact  policy  sub-options.  It  should  indicate  the 
preferred  sub-option  as  regards  use 
in  organic 
production and if no preferred sub-option is chosen, it 
should clearly state this, together with an explanation 
why. The policy choices, implications and impacts of 
each sub-option should be explained, including under 
what  circumstances  notified  NGT  plants/products 
could be used or not. 
the  option  “authorisation  with 
(3)  As 
incentives for products containing modified traits that 
have the potential to contribute to sustainability”, the 
report should be clear on the retained sub-options for 
labelling.  It  should  also  clarify  how  the  label  would 
identify those NGT as “product of biotechnology”. 
(4)  The  report  should  clearly  present  the  reasons 
behind wide ranges such as ‘up to 85%’ cost savings 
on 
further 
risk  assessment,  and  provide 
explanations  of  circumstances  under  which  breeders 
might receive no savings. 
(5)  The  report  should  clarify  the  efficiency  analysis. 
While 
includes  elements  of  costs 
quantification,  in  particular  on  coexistence,  based  on 
relevant  projects  and  studies,  including  the  support 
study,  it  should  clarify  how  these  available  cost 
quantifications  should  be  taken  into  account  in  the 
efficiency analysis of options and in the overview of 
to 
benefits  and  costs,  referring, 
uncertainties  and  data  limitations.  It  should  explain 
why  the  aggregate  cost  for  option  on  “authorisation 
with incentives for products containing modified traits 
that have the potential to contribute to sustainability” 
and option on “authorisation with the requirement that 
products  do  not  contain  modified  traits  that  can  be 
detrimental  to  sustainability”  are  identical  when  the 
‘trait-specific’ 
latter 
requirement  described  as  the  most  demanding  for 
operators. The report should explain why the savings 
on  incentives  are  excluded  from  the  efficiency 
analysis. 

if  appropriate, 

introduces 

additional 

report 

the 

an 

The two scenarios concerning the use of notified NGT 
products  in  organic  production  are  now  presented  as 
sub-options.  In  section  8.1.,  the  report  now  clarifies  
the preferred sub-option. The implications of the sub-
options have been further explained in section 5.2.4. 

Section 8.1. of the report is further clarified as regards 
the retained sub-option on labelling. 

The  report  now  clearly  identifies  in  the  impact 
analysis (e.g. section 6.2.1.) the situations in which no 
or  small  and  large  cost  savings  are  expected,  and 
further explains the reasons for the ranges.  

is 

expected, 

Table 8 and the accompanying footnote 214 in section 
7.2.,  addressing  the  baseline  with  a  limited  extent  of 
NGT  cultivation,  now  clarifies  that  available  data  on 
coexistence  costs  are  too  limited  and  uncertain  to 
derive a quantitative estimate of expected future costs. 
The  same  consideration  applies  to  Tables  9-11.  In 
Table  12,  addressing  an  option  under  which  more 
an 
cultivation 
extensive  NGT 
unquantified increase in coexistence costs is assumed. 
The  costs  for  an  assessment  of  the  sustainability 
contribution of a trait or of showing that a trait is not 
detrimental to sustainability are assumed to be same. 
The 
the  sustainability 
contribution  of  a  trait  is  voluntary  is  reflected  in 
footnote  222,  which  gives  an  estimate  of 
the 
aggregate cost if the sustainability contribution is not 
assessed. 
The  savings  arising  from  incentives  are  included  in 
Annex  3.  They  are  not  included  in  the  efficiency 
analysis  in  section  7  as  the  monetary  benefits  are 
marginal  in  comparison  to  the  other  quantified  costs 
and benefits. 

that  demonstrating 

fact 

2. Evidence, sources and quality 

External expertise 

A  consortium  led  by  Technopolis  developed  a  study  that  contributed  to  the  preparation  of 
this IA. The study started in March 2022. The consortium provided support in gathering and 
analysing  evidence,  in  conducting  consultation  activities  (e.g.,  targeted  consultation  of 
stakeholders,  organisation  of  focus  groups,  analysis  of  stakeholder  feedback,  interviews  of 
stakeholders)  and  a  combination  of  approaches  to  assess  the  economic,  social  and 
environmental  impacts  of  the  policy  options  (including  case  studies,  economic  modelling, 
modelling of environmental impacts and multicriteria analysis). 

94 

 
 
Consultation activities 

The  IA  takes  into  account  the  input  from  a  range  of  stakeholder  consultation  activities.  A 
public  consultation3  was  held  between  29  April  and  22  July  2022  (2300  contributions).  It 
was complemented by a range of targeted consultation activities: 

  Stakeholder interviews (25) to  receive input on the initiative and on the impacts  of 

policy options, including on costs. 

  A targeted survey (from 28 June to 05 September 2022) to which 397 stakeholders 
and  Member  State  authorities  were  invited.  123  responded  and  self-categorised  as 
business  associations  (32),  NGOs,  environmental,  consumer  and  other  civil  society 
organisations  (28),  public  authority/body  (23),  large  company/business  (11), 
academic/research organisation (9), SMEs (8), other (12). 

  Two expert focus groups on sustainability and traceability on 22 and 23 September 

2022. 

  Regulatory cost interviews (23) to map regulatory costs of operators developing and 
marketing NGT plants as well as to assess costs of risk assessment and enforcement 
authorities. 

Annex 2 summarises feedback from stakeholder consultations. 

Other studies and sources 

  JRC case studies to analyse the potential economic, environmental and social (health) 
impacts of selected NGT plants that are in the development pipeline4, conducted for 
the purposes of this impact assessment; the impact assessment also relies on the two 
JRC  reports  (on  market  applications5  and  latest  scientific  developments  relating  to 
NGTs6) supporting the Commission NGT study7. 

  EFSA.  Two  mandates  were  given  to  support  this  impact  assessment  (statement  on 
criteria  for  risk  assessment8  and  update  of  EFSA’s  2012  opinion  on  cisgenesis9. 

3https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-
produced-by-certain-new-genomic-techniques/public-consultation_en  
4 Sánchez, B., Barro, F., Smulders, M. J. M., Gilissen L. J. W. J., Rodríguez Cerezo, E. (2023) Socioeconomic 
impact of low-gluten, celiac-safe wheat developed through gene editing, EUR 31380 EN, Publications Office of 
the European Union, Luxembourg, Schneider, K.; Barreiro-Hurle, J.; Kessel, G.; Schouten, H.J.; Vossen, J.; 
Strassemeyer, J.; Rodriguez-Cerezo, E. (2023). Economic and environmental impacts of disease resistant crops 
developed with cisgenesis. EUR 31355, Publication office of the European Union, Luxembourg., Schneider, K.; 
Barreiro-Hurle, J.; Vossen, J.; Schouten, H.J.; Kessel, G.; Andreasson, E.; Phuong Lieu, N.; Strassemeyer, J.; 
Hristov, J.; Rodriguez-Cerezo, E. (2023). Insights on cisgenic plants with durable disease resistances under the 
European Green Deal. Trends in Biotechnology  
5 Parisi, C. and Rodriguez Cerezo, E., Current and future 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. 
6 Broothaerts, W., Jacchia, S., Angers, A., Petrillo, M., Querci, M., Savini, C., Van den Eede, G. and Emons, H., 
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 
7 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in 
Case C528/16. SWD (2021) 92 final 
8 EFSA Panel on Genetically Modified Organisms, 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  

95 

 
 
                                                           
Other,  previous  relevant  EFSA  opinions  (referenced  in  Annex  6)  also  underpin  tis 
impact assessment. 

  Desk  research,  including  peer-reviewed  literature,  scientific  reports  and  grey 

literature 

  Position papers 
  European Commission fact-finding studies on Member States official controls10 

Limitations and robustness of findings 

The data collection and analysis carried out have some intrinsic limitations, key among those 
the  lack  of  historical  data  on  the  cultivation  and  commercial  use  of  plants  produced  by 
targeted mutagenesis and cisgenesis, as the first of these products have only recently reached 
the markets of non-EU countries, and there is no experience within the EU. The impacts of 
such limitations on the robustness  of findings have been mitigated to  a  maximum possible 
extent utilising a number of analytical approaches such  as specific case studies, modelling, 
extrapolation from third countries etc.  

9 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  
10 https://ec.europa.eu/food/audits-analysis/audit-report/details/4543  
https://ec.europa.eu/food/audits-analysis/audit-report/details/4544    

96 

 
 
 
                                                                                                                                                                                     
ANNEX 2: STAKEHOLDER CONSULTATION (SYNOPSIS 
REPORT) 

1. Introduction  

This report provides an overview of the consultation activities carried out in the context 
of the impact assessment (IA) of legislation for plants produced by certain new genomic 
techniques  (NGTs).  It  provides  an  outline  of  the  consultation  strategy,  lists  the 
consultation activities and provides key results for each of them.  

The following consultations took place: 

  Feedback  on  the  Commission’s  Inception  Impact  Assessment1  (24  September 

2021 - 22 October 2021); 

  Commission’s public consultation (PC) (29 April 2022 - 22 July 2022)2; 
  Targeted stakeholder survey (28 June 2022 – 05 September 2022);  
 
  Focus  groups  on  sustainability  and  traceability  ((22  and  23  September  2022 

Interviews (June 2022 – December 2022); 

respectively). 

The first two consultations were carried out by the Commission services (but the external 
contractor  analysed  the  replies  to  the  PC);  the  last  three  consultations  were  carried  out 
entirely in the context of the external study underpinning this IA.  

The key objectives of the consultations were:  

  Ensure that the public and all relevant stakeholders were given the opportunity to 

contribute to the policy initiative by providing informed insights. 

  Obtain  relevant  information,  views  and  expectations  on  the  problems  presented, 
the  baseline  scenario,  and  on  the  potential  ways  forward  including  the  key 
components  of  the  policy  options  (risk  assessment,  sustainability,  labelling, 
traceability). 

  Obtain evidence, views and expectations on the expected key impacts (economic, 

social, environmental). 

The  following  key  stakeholder  groups  were  identified  as  targeted  audience  in  the 
consultation strategy of the initiative: 

  The general public (EU and non-EU); 
  Operators  active, from farm to  fork, in  the agri-food and feed  system,  including 
sectors  such  as  farmers;  seed  and  plant  breeders; 
traders;  processors; 
manufacturers, retailers and food services; GM-free and organic operators in all of 
the above sectors. 

  Operators of plant and bio-based industries active in  sectors other than the agri-
food sector, including ornamental plants, forestry and industrial biotechnology. 
  Academic  and  research  stakeholders  active  in  the  field  of  biotechnology  in 

general and agricultural/plant biotechnology in particular. 

1 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-
plants-produced-by-certain-new-genomic-techniques_en  
2 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  

 
 
                                                           
  Civil society/non-governmental organisations with interest in the topic, including 

environmental, grass-root farming and consumer organisations. 

  EU institutions, European Food Safety Authority (EFSA), Member State and third 

country authorities 

  Other stakeholders, such as  consultancies and think tanks active or with  interest 

on the topic.  

2. Methodology of the consultation activities 

a)  Feedback on the Commission’s Inception Impact Assessment (IIA) 

The  initiative  was  published  on  the  Commission’s  Have  Your  Say3  website.  The  IIA 
included the context, problem definition and subsidiarity check, presented the objectives 
and  the  main  components  of  the  policy  options,  contained  a  preliminary  assessment  of 
expected main impacts and referred to the evidence base and data collection.   

(14%,  203),  academia/research 

70,894 contributions were received overall; 98% (69,414) of the replies were identified as 
coming from campaigns. The non-campaign replies amounted to 2% of the total (1,480). 
According  to  self-categorisation,  most  contributions  in  the  non-campaign  replies  came 
from citizens (70%, 1,030 replies), followed by business organisations/associations, trade 
unions 
(8%,  115),  NGOs  and 
consumer/environmental  organisations  (5%,  81),  public  authorities  (1%,  9)  and  others 
(3%, 42). Contributions (both campaign and non-campaign) originated from 91 countries, 
including  the  27  Member  States  and  64  non-EU  countries.  Top  contributions  from 
Member  States  were  from  Germany  (32,694),  France  (25,544),  Belgium  (2,732), 
Netherlands  (2,251)  and  Austria  (2,111).  Most  contributions  from  non-EU  countries 
came from Switzerland (782), followed by United Kingdom (759), USA (228), Argentina 
(142)  and  Canada  (114).  The  large  number  of  contributions  shows  the  high  interest  of 
citizens and stakeholders in the Commission’s policy initiative.  

institutions 

b)  Public consultation (PC) 

The  PC  was  published  on  the  Commission’s  Have  Your  SayError!  Bookmark  not  defined. 
website. The survey included 11 closed questions with branching sub-questions and open 
text sections (with 500-800 characters). Furthermore, 7 questions were included as open 
questions  (with  1500  characters).  These  18  questions  in  the  PC  were  analysed  with 
quantitative and qualitative methods. 

Overall,  2300  contributions  were  submitted,  out  of  which  104  were  identified  as 
campaigns and 2196 as individual contributions. The bulk of the contributions came from 
23 EU Member States (MS), with three-quarters of total consultation respondents coming 
from Germany (599; 27.3%), (Italy 515; 23.5%), France (335; 15.3%), and Spain (194; 
8.8%). There were no responses from stakeholders from Cyprus, Luxembourg, Malta or 
Slovenia. There were 105 respondents from outside the EU and they account for 4.9% of 
the total. They came from Switzerland (33), the United States (17), the United Kingdom 
(15),  and  40  contributions  from  25  other  countries.  Most  respondents  self-identified  as 
‘EU  citizen’  (1491;  65.1%),  followed  by  academic/research  institutions  (206;  9.0  %), 
company/business organisations (179; 7.8%) and business associations (122; 5.3%), non-
governmental  organisations  (NGOs  -  81;  3.7%),  non-EU  citizens  (38;  1.7%),  public 
authorities (35; 1.5%), environmental organisations (20; 0.9%), trade unions (14; 0.6%), 
consumer organisations (5; 0.2%), and others  (5; 0.2%). Out of the companies/business 

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13119-Legislation-for-plants-

3 
produced-by-certain-new-genomic-techniques_en 

98 

 
 
                                                           
organisations,  30.2%  (54)  self-identified  as  large  companies  and  69.8%  (125)  as  small 
and  medium  sized  enterprises  (SMEs),  comprised  of  medium  companies  (28;  15.6%), 
small companies (33; 8.4%), and micro-companies (64; 35.8%). 

Views from the PC are not statistically representative.  

c)  Targeted Stakeholder Survey (survey) 

The targeted survey4 aimed to collect information from stakeholders on the performance 
of  the  baseline  scenario  and  on  impacts  of  the  policy  components.  It  was  designed  to 
complement the PC. Whereas the PC addressed  a wider audience  and therefore did not 
ask  for  detailed 
targeted  survey  envisaged  detailed 
information. The survey was sent to stakeholders and Member States representatives and 
included EU as well as non-EU stakeholders, yet with a clear focus on the former.  

technical  assessments, 

the 

The survey was designed with a complex branching to include specific questions for all 
the  categories  of  the  targeted  stakeholders.  None  of  the  questions  was  mandatory  to  be 
filled in.  A total  of 397  were stakeholders invited through  Limesurvey    These included 
academia/research, businesses and their associations (food, feed and non-food operators, 
including  organic  and  GM-free  ones,  across  all  sectors  of  activity:  plant  protection 
products/fertilisers,  seed/plant  breeders,  farmers,  traders,  processors,  manufacturers, 
retailers/services,  bio-based  and  biotechnology  industries,  ornamental  plants,  forestry), 
NGOs,  environmental,  consumer  and  other  civil  society  organisations,  and  public 
authorities  or  bodies,  including  all  EU  relevant  Member  state  national  authorities.  A 
detailed  overview  of  invited  survey  participants  can  be  seen  in  figure  1.  Of  invited 
stakeholders, 123 (31%) provided responses.  

Figure 1: Stakeholders’ categories invited to the targeted survey 

4 https://food.ec.europa.eu/system/files/2022-09/sc_modif-genet_targeted-survey-questionnaire.pdf 

99 

 
 
 
 
                                                           
A  detailed  overview  of  participants  that  completed  the  survey,  according  to  their  self-
categorisation, can be seen in Figure 2: 

Figure 2:Stakeholder categories from the 123 participants that completed the targeted survey. 

Concerning their sector of activity, the participants have self-categorised* as can be seen 
in Figure 3: 

Figure 3: Activity of sectors for the 123 stakeholder participants of the targeted survey 

Respondents  originated  mainly  from  Belgium  (36,  29%),  Germany  (15,  12%),  Italy  (8, 
7%), France (9, 7%), Netherlands (8, 7%), Spain (6, 5%), Austria (5, 4%), Romania (4, 
3%), Denmark (4, 3%),  Ireland (3, 2%), Sweden (2, 2%), Greece (2, 2%), Slovenia (2, 
2%), Poland (2, 2%), Croatia (2, 2%), Luxembourg (1, 1%), Lithuania (1, 1%), Latvia (1, 
1%),  Hungary  (1,  1%),  Finland  (1,  1%),  Czech  Republic  (1,  1%),  Bulgaria  (1,  1%), 
Slovakia (1, 1%), Estonia (1, 1%), Cyprus (1, 1%) and Other countries (6, 5%).  

d)  Interviews  

Interviews  were  devised  to  collect  qualitative  and  quantitative  data  and  information  on 
costs, and to obtain insights and views on specific topics relevant to stakeholders.  

100 

 
 
 
 
Interviews  were  conducted  by  two  study  team  members  via  MS-Teams.  The  notes  of 
each  interview  were  shared  with  the  interview  partners  for  agreement.  Relevant 
information was coded and analysed. The insights from the interviews fed into the main 
study report’s impact section.  

For the cost interviews, the stakeholders were briefed about the needs and requirements 
of  the  interview.  Dedicated  meetings  where  the  relevant  cost  templates  were  explained 
and  discussed  have  been  conducted.  Once  organisations  had  provided  data,  these  were 
analysed and compared, and used for establishing ranges. The qualitative and quantitative 
information was integrated in a dedicated internal data file which was then further used to 
obtain robust cost estimates. 

There  were  25  interviews  with  key  stakeholder  organisations  at  EU-level  and  23  cost 
interviews  at  company,  national  administrative  and  EU-levels.  Several  of  the  general 
interviews were also used to enquire about potential collaboration on cost assessments.  

For  the  cost  assessment  interviews,  overall,  23  different  organisations  throughout  the 
regulatory  trajectory  (SMEs,  large  companies,  public  authorities,  regulatory  authorities, 
etc.)  were  approached.  There  were  no  one-off  interviews  but  consecutive  discussion 
rounds with the stakeholders.  

Stakeholder  categories’  that  took  part  in  the  general  interviews  were  20%  (5) 
Academic/research  institutions,  44%  (11)  business  associations,  8%  (2)  consumer’s 
associations, 16% (4) environmental organisations and 12% (3) trade unions. Stakeholder 
categories’  that  took  part  in  the  cost  interviews  were  13%  (3)  academic/research 
institutions,  30.5%  (7)  company/business  organisations,  43.5%  (10)  public  authorities 
and 13% (3) other. Organisations that took part in the general interviews were all based in 
Belgium  (25,  100%).  Organisations  that  took  part  in  the  cost  interviews  were  based  in 
Austria  (1,  4.3%),  Belgium  (3,  13%),  Czech  Republic  (1,  4.3%),  France  (1,  4.3%), 
Germany  (4,  17.5%),  Netherlands  (1,  4.3%),  Portugal  (1,  4.3%),  Spain  (4,  17.5%), 
Sweden (3, 13%) and other (4, 17.5%).  

e)  Focus groups on sustainability and traceability  

Two  focus  groups,  on  sustainability  and  traceability  respectively,  were  conducted  to 
complement  the  information  obtained  in  interviews  and  the  targeted  survey.  A  concept 
note  was  developed  for  both  focus  groups.  This  included  a  few  high-level  questions 
which  were  developed  based  on  results  of  the  targeted  stakeholder  survey,  as  well  as 
insights  from  the  interviews.  The  focus  groups  were  conducted  under  a  rather  strict 
protocol  where  the  moderators  asked  questions  and  had  the  focus  group  members 
providing  their  views.  In  each  group,  two  study  experts  joined.    The  summaries  of  the 
discussions  were provided to  the participants for validation.  Insights  from  the validated 
reports  fed  into  the  impact  analysis  and  helped  triangulating  findings  on  sustainability 
labelling and traceability vs transparency. 

In  total,  14  stakeholders  participated  in  the  two  groups.  14%  (2)  of  them  were  from 
academic/research institutions, 29% (4) from business associations, 43% (6) from public 
authorities  and  14%  (2)  from  trade  unions.  42.9%  (6)  of  them  were  based  in  Belgium, 
7.1% (1) in Denmark, 21.4% (3) in France, 14.3% (2) in Germany, 7.1% (1) in Norway 
and 7.1% (1) in Spain.  

3 Overview of responses  

For a detailed analysis of the feedback received on the IIA see Annex 2A.  

101 

 
 
The  consultation  activities  that  followed  the  IIA  were  to  a  large  extent  complementary 
and were triangulated with findings from the literature and experts.  

A  summary  report  from  the  consultation  outcome  of  the  PC  was  published  on  16 
September 20225.   

Key findings from the consultation activities of PC, targeted survey, interviews and focus 
groups:  

a)  Is the current legislation fit for purpose?  

Most  respondents  to  consultation  activities  from  Member  States  authorities,  business 
organisations/associations,  trade  unions,  academia/research  institutions  and  a  few 
NGOs/consumer/environmental organisations, welcomed the policy initiative in response 
to the IIA. Among the economic sectors, this view was expressed by the large majority of 
operators  from  biotechnology  and  bio-based  industry,  farming,  feed,  ornamental  plants, 
plant breeding and plant protection and fertilisers, and by the majority of operators from 
trade and food processing/manufacture. 

The view that the current GMO legislation is fit for NGTs, and therefore does not need 
adaptation, was expressed by a large majority of environmental organisations, and by the 
majority of NGOs and consumer organisations. Among the economic sectors, this view 
was  expressed  by  a  large  majority  of  operators  in  food  retail/service,  organic,  GM-free 
and forestry. 

Those indicating the legislation is not adequate find the GMO legislation not sufficiently 
clear or consider that the risk assessment approach of the GMO legislation cannot factor 
in  the  diverse  risk  profiles  of  plants  obtained  by  NGTs.  They  find  the  current 
authorisation,  traceability,  and  labelling  requirements  not  appropriate,  and  they  also 
indicate that the GMO legislation does not consider whether products have the potential 
to  contribute  to  sustainability.  Those  in  favour  of  the  current  legislation  find  it 
sufficiently flexible and still capable of keeping pace with technological  progress. They 
also  find  the  GMO  legislation  sufficiently  clear  and  risk  assessment  rules,  as  well  as 
authorisation, traceability, and labelling requirements appropriate. Sustainability, in their 
view, can also be taken into account under the current legislation.  

The views of citizens that participated in the two consultation activities open to the public 
(feedback  to  the  inception  impact  assessment  and  public  consultation)  varied.  98% 
(69,414) of the replies to the inception impact assessment were identified as coming from 
campaigns  from  respondents  that  self-categorised  as  citizens  and  opposed  the  initiative 
calling  on  the  Commission  to  keep  NGT  plants  and  products  subject  to  the  current 
requirements of the GMO legislation. On the other hand, the majority of responses from 
citizens  to  the  inception  impact  assessment  (not  coming  from  campaigns)  and  to  the 
public consultation generally supported the adaptation of the legal framework. 

b)  Risk assessment 

In  an  open  question  about  the  main  aspects  that  should  be  addressed  by  this  initiative 
(Question  4  of  PC),  "risk  assessment"  was  the  most  frequently  mentioned  topic.  A 
majority of respondents consider that the existing GMO requirements need adaptation for 
plants produced by targeted mutagenesis or cisgenesis.  

5 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   

102 

 
 
                                                           
In  the  PC,  61%  (1331)  of  total  respondents  supported  a  risk  assessment  approach 
different  from  the  current  one  in  the  GMO  framework:  34%  (738)  of  total  respondents 
believed that risk assessment should have requirements adapted to the characteristics and 
risk  profile  of  a  plant  and  27%  (593)  believed  that  risk  assessment  is  not  needed  when 
these plants  could  have  been produced through conventional  plant breeding or  classical 
mutagenesis. The adapted risk assessment approach was the most selected reply by public 
authorities,  academic/research  institutions,  EU  and  non-EU  citizens.  The  approach  that 
no  risk  assessment  is  needed  when  these  plants  could  have  been  produced  by 
conventional  plant  breeding  or  classical  mutagenesis  was  supported  by  the  majority  of 
trade  unions, 
business  associations; 
companies/business organisations. This view was expressed by the majority of operators 
in  ornamental  plants  and  the  large  majority  of  the  operators  in  plant  protection 
products/fertilisers,  plant  breeding/seeds  and  biotechnology/bio-based  industry;  it  was 
also  the  most  selected  reply  among  the  farming,  feed  and  trade  sectors.  These 
respondents emphasise the economic and scientific disadvantage for Europe compared to 
non-European  countries  if  the  current  GMO  legislation  is  applied  to  NGTs.  Also,  the 
view that the risk assessment should be primarily focused on the final product, rather than 
on the process, was expressed by various respondents.  

the  most  selected  reply  of 

it  was  also 

On  the  other  hand,  the  view  that  the  risk  assessment  requirements  of  the  current  GMO 
legislation  should  be  maintained  was  supported  by  the  majority  of  NGOs  and  the  large 
majority of environmental and consumer organisations. Among the economic sectors, this 
view  was  expressed  by  the  majority  of  organic  and  GM-free  operators  and  the  large 
majority of food retail/services and forestry sectors; it was also the most selected reply of 
the food processing/manufacturing sector. These stakeholders, representing 22% (480) of 
total  respondents  in  the  PC,  argue  that  the  application  of  the  current  framework  has 
demonstrated  effectiveness  regarding  risk  assessment,  authorisation,  traceability,  and 
labelling, and safeguards the freedom of choice. 

In the targeted survey, breeders (N = 56) identify  regulatory costs (which include costs 
for risk assessment) and regulatory uncertainty as the most important factors in deciding 
whether to develop NGTs for the EU market in the baseline option. The high costs and 
the  high  perceived  regulatory  uncertainty  mean  that  the  attractiveness  of  developing 
NGTs under the baseline option is very low. A risk assessment adapted to the risk profile 
of  the  NGT  is  seen  by  breeders  (N  =  73)  to  improve  the  attractiveness  of  developing 
NGTs (expressed as the expected percentage of NGT varieties on the market in 2030  – 
35) to some degree. Treating NGT plants that could also occur naturally or be produced 
by  conventional  breeding  like  conventional  plants  is  increasing  the  attractiveness  to 
develop NGT plants to the strongest degree. 

c)  Sustainability 

Regarding  the  questions  whether  a  future  legislation  should  contain  sustainability 
provisions,  stakeholders  from  the  farming  (including  organic  and  GM-free),  breeding, 
processing, manufacturing and trading sectors all advocated for a horizontal and coherent 
sustainability  analysis  for  all  products  regardless  of  the  technique.  Some  consider  that 
adding that it would be discriminatory to only assess the sustainability of NGT products 
and  not  of  products  of  other  breeding  methods.  Breeding  and  farming  operators 
emphasise  that  the  sustainability  assessment  would  increase  the  administrative  and 
financial burden. Operators from the breeding sector add that the value for cultivation and 
use  testing,  which  most  plant  varieties  have  to  undergo  under  the  PRM  legislation, 
considers  sustainability.  Public  authorities,  academia  and  research  organisations  and  a 
majority  of  respondent  citizens  support,  though,  the  inclusion  of  sustainability 
requirements in the legislation (51% of respondents in the public consultation).  
103 

 
 
In  the  PC,  41%  of  the  respondents  replied  that  introducing  sustainability  provisions  in 
this initiative is unnecessary (replies to Question 5 of PC). This view was predominantly 
shared  by  various  stakeholders,  including  business  associations,  NGOs,  environmental 
organisations,  trade  unions,  companies  and  consumer  organisations.  Moreover,  a  wide 
range of economic operators, including those in biotechnology/bio-based industry, feed, 
food  processing/manufacture,  food  retail/services,  GM-free,  organic,  ornamental  plants, 
plant  breeding/seeds,  plant  protection  products/fertilizers,  trade,  farming,  and  forestry 
sectors, expressed a similar viewpoint. 

PC  respondents  have  evaluated  the  relevance  of  specific  traits  according  to  their 
contribution  to  sustainability.  Traits  on  the  better  use  of  resources  (64%),  abiotic  stress 
tolerance  (63%),  and  biotic  stress  (58%)  are  considered 
the  most  relevant. 
Herbicide/insecticide  tolerance  (21%)  and  ‘other  quality-related  characteristics’  (15%) 
score  the  lowest  (relatively  among  all  stakeholder  groups  but  consumer  organisations) 
(Question 6 of PC). The targeted stakeholder survey suggests that the number of NGTs 
would  be  slightly  higher  with  sustainability  incentives  than  under  a  sustainability 
requirement scenario. Under sustainability incentives, plants with traits affecting abiotic 
and biotic stress tolerances would have a higher market share from 2030 onwards, than 
any other trait. 

In the PC, 75% (155 out of 206) of academics and 68% (1014 out of 1491) of citizens are 
in favour to provide information about the sustainability contribution to consumers, while 
76% (93 out of 122) of businesses, 65% (13 out of 20) of environmental organisations, 
68%  (55  out  of  81)  of  NGOs,  and  60%  (3  out  of  5)  of  consumer  organisations  do  not 
agree (Question 8 of PC).  

47% (28 out of 60) of the targeted survey respondents expect only a moderately higher 
willingness to buy NGT products and see only a small increase of clarity for consumers 
with  an  additional  sustainability  label.  55%  (36  out  of  66)  expect  a  strong  increase  in 
compliance costs and administrative burden. The organic sector expressed in interviews 
that such a label would lead to unfair competition with the organic label. 

The focus group on sustainability concluded that sustainability should not be linked to the 
plant breeding process but rather a holistic, systemic approach should be put in place. The 
group  emphasized  that  sustainability  encompasses  various  dimensions  and  is  context-
dependent,  requiring  consideration  of  trade-offs  and  avoiding  discrimination  between 
different breeding methods. They highlighted that sustainability is a multifaceted concept 
encompassing  social,  health,  and  economic  dimensions,  which  vary  depending  on  the 
specific  traits  and  contextual  factors.  Balancing  trade-offs  and  avoiding  discrimination 
between  different  breeding  methods  were  identified  as  challenges.  They  recommended 
addressing  sustainability  through  a  broader  framework,  such  as  the  Sustainable  Food 
Systems Framework, and highlighted the importance of transparency and information for 
the organic sector.  

d)  Traceability and information 

There  is  broad  agreement  among  stakeholders  about  the  need  to  ensure  transparency 
about  NGTs,  but  views  vary  considerably  on  the  means  to  ensure  it.  For  consumer 
organisations,  transparency  should  be  provided  through  labels  (80%,  4  out  of  5)  while 
37%  (65  out  of  177)  of  the  business  associations  and  32%  (80  out  of  251)  of  the 
companies  do  not  find  transparency  necessary  for  plants  produced  by  targeted 
mutagenesis and cisgenesis, when they could have been produced through conventional 
plant breeding or classical mutagenesis (Question 12 of PC). 46% (69 out of 149) of plant 
breeders and 61% (23 out of 38) of biotechnology/bio-based industries do not see a need 
for transparency for such plants, while for 55% (42 out of 77) of the organic, 66% (19 out 

104 

 
 
of 29) of GMO free, 58% (18 out of 31) of food retail and 62% (5 out of 8) of forestry 
sectors, a physical label could provide transparency. In interviews, the PC and the focus 
groups, the organic sector expressed a need for transparency underlining the importance 
of transparency so that organic operators have the freedom to avoid NGTs. 

As regards what should be required when reliable analytical methods that can both detect 
and  differentiate  a  product  cannot  be  provided  for  plants  produced  by  targeted 
mutagenesis  and  cisgenesis,  responses  varied  in  the  PC  (Q11).  30%  (660  responses) 
consider  that,  in  the  absence  of  reliable  analytical  methods  that  can  both  detect  and 
differentiate a product, operators should “not be allowed to place the product in question 
on  the  market”  (a  great  majority  of  consumer  and  environmental  organisations  and  the 
majority of NGOs; most selected view among citizens and trade unions; among economic 
operators,  half  of  the  forestry  sector,  the  majority  of  the  food  retail/services  sector,  as 
well as the great majority of the organic and GM-free sector also expressed this view) 

Conversely, 27% (599) of respondents considered that operators should “not be asked at 
all to provide an analytical method that can both detect and differentiate their product”. 
institutions, 
the  most  expressed  view  among  academic/research 
This  was 
companies/business  organisations  and  non-EU  citizens;  it  was  expressed  by  the  great 
majority  of 
the  plant  protection  product/fertiliser,  plant  breeding/seeds  and 
biotechnology/bio-based industry sectors, and was the most selected response among the 
trade, farming and ornamental plant sectors). 20% (431) believe that operators should “be 
asked  to  provide  a  detection  method,  but  without  the  need  to  differentiate,  if  they  can 
justify  that  the  latter  would  be  impossible”  (the  most  selected  response  among  public 
authorities, as well as half the forestry sector) and 16% (350) respondents consider that 
operators should “not be asked to provide an analytical method that can both detect and 
differentiate their product, if they can justify that this would be impossible”.  

The survey  finds that the scenario requiring no labelling and traceability  if a product  is 
also obtainable naturally or by conventional breeding elicits the strongest expectations of 
positive impacts on total private R&D funding for plant breeding, for funding for biotech 
in academia, for the competitiveness of farming or the SME market share in the breeding 
sector. 

The focus  group on traceability, consisting of experts from  various sectors, emphasized 
the  importance  of  labelling  NGT  plant  products  using  existing  labelling  schemes, 
especially if these products are not regulated as GMOs in the future. Certain participants 
highlighted  that  labelling  should  only  be  appropriate  if  there  is  a  distinguishable 
difference  between  NGT  plants  and  those  obtained  through  conventional  breeding. 
Otherwise,  labelling  would  be  misleading.  The  lack  of  analytical  methods  for 
identification  and  differentiation  was  considered  to  pose  a  significant  enforcement 
challenge. Additionally, traceability requirements for NGT plants should be proportionate 
and  verifiable  by  competent  authorities  through  official  controls.  Document-based 
traceability  systems,  such  as  those  used  in  the  organic  sector,  can  be  valuable  for 
enforcement and traceability, especially in the early stages of the food chain. Introducing 
a  specific  traceability  system  for  NGT  plants  would  be  problematic  due  to  the  lack  of 
distinction  between  NGT  and  conventional  plants  in  many  third  countries.  Alternative 
options  such  as  public  registries,  leveraging  existing  databases  like  the  EU  Common 
Catalogues or national registers, and exploring cost-efficient methods like blockchain for 
traceability  (not  detection)  would  require  international  coordination.  Some  participants 
suggested  that  ruling  out  analytical  methods  prematurely  may  not  be  appropriate,  as 
relevant  research  in  this  area  is  still  in  its  early  stages.  The  costs  and  administrative 

105 

 
 
burden associated with record-keeping systems should be proportionate and manageable, 
considering that the majority of NGT developers are SMEs. 

e)  Coexistence 

The  majority  of  conventional  farmers  emphasise  the  competitive  advantage  NGTs  can 
bring  to  European  farms,  e.g.  with  plants  adapted  to  climatic  changes  and  reduced 
environmental  impact  during  cultivation  (less  fertilizers,  water  and  pesticide  uses). 
Sharing  these  views,  some  organic  farmers  also  see  advantages  in  the  use  of  NGTs,  to 
enable  wider environmental and  economic sustainability, as indicated in  interviews and 
the focus group on sustainability. 

However,  the  majority  position  expressed  by  the  organic  sector  is  that  NGTs  are  not 
compatible with the organic sector. Various points were raised on coexistence matters in 
an open question in the PC (Q15), as well as in interviews. Stakeholders from the organic 
sector  suggest  that  measures  safeguarding  coexistence  should  be  strengthened  at  EU 
level,  e.g.  maintain  labelling  and  traceability,  and  in  addition  provide  for  measures  to 
guarantee  seed  purity  and  protection  against  contamination,  and  that  measures  must 
encompass  the  entire  chain  from  seed  production  to  the  finished  product.  Other 
stakeholders expressed the view that conventional-like NGT plants should be treated the 
same as conventional plants and therefore be suitable for all kind of agriculture, without 
the need of applying any specific coexistence measures. 

In position papers submitted to  the PC, some public authorities expressed the view that 
the  current  legislation  on  the  traceability  and  labelling  of  GMO  is  key  to  enable  and 
guarantee the co-existence with organic and conventional GM-free agriculture as well as 
for  consumer  information  and  liability  issues.  They  call  on  the  Commission  to  ensure 
research and development of detection methods in this context. 

According  to  the  targeted  survey,  strong  and  moderate  negative  impacts  on  organic 
farming are expected predominantly by NGOs (6), SMEs (4), two consumer associations, 
one public authority, one business organisation, and one public agency. No impact on the 
organic  farmers  (14)  are  predominantly  expected  from  business  associations  (8),  public 
authorities (2), as well as one NGO and one academic organisation.  

For  small  scale  farmers,  the  picture  is  very  similar:  out  of  the  14  respondents  that 
expected  strong  or  moderate  negative  economic  effects  on  small  scale  farmers  were 
NGOs  (5),  SMEs  (4),  consumer  and  business  associations  (each  2),  and  one  ‘Other” 
(public agency). In essence, all respondents who saw strong negative economic effects on 
organic farmers, also expected them for small scale farmers. 

f)  Future-proofing 

In terms of future-proofing of the legislation, the two most important  aspects  across all 
stakeholder groups (except consumer and environmental organisations, as well as NGOs) 
are to improve the legal clarity and to put in place mechanisms that facilitate adaptation 
to scientific progress (Question 14 of PC). In addition, an adapted regulatory framework 
that  is  “aligned  globally  with  other  commercial  areas  around  the  world  to  minimize 
commercial conflict potential and ensure EU competitiveness” and that is “proportionate 
and  science-based”  (Question  18  of  PC)  were  key  requirements  mentioned  by 
stakeholders. 

Measures to facilitate the uptake of NGTs by SMEs put forward by various stakeholders 
during  the  consultations.  According  to  the  PC,  “a  reliable  framework  that  gives  them 
certainty  concerning  their  investment”  is  needed,  “the  NGTs  are  suitable  for  local 
contexts”, and that SMEs currently “cannot  afford the high  costs of lengthy investment 
required  for  R&D  and  commercialisation  of  new  crops”  was  shared  by  business 

106 

 
 
associations and academia while companies/business additional regulatory measures and 
citizens and public authorities are divided in their views. 

4. Identified campaigns  

a)  Feedback on the Commission’s Inception Impact Assessment (IIA) 

98%  (69,414)  of  the  replies  were  identified  as  coming  from  campaigns;  campaign 
contributors  self-categorised  as  citizens.  A  user-modifiable,  precompiled  reply  template 
was made available on several websites in different EU-countries. 

The  contributions  from  the  campaign  demand  to  apply  the  precautionary  principle  in 
accordance  with  the  CJEU  ruling  of  25  July  2018  in  Case  C-528/16,  Confédération 
paysanne  and  Others6.  In  the  view  of  these  respondents,  all  GMOs,  including  NGT 
products, must fall under the current GMO legislation, and no artificial distinction should 
be made between different forms of genetic engineering. A robust, process-based, case-
by-case risk assessment for NGT products should be applied. Moreover, the Commission 
should implement policies that are in accordance with the objectives of the Farm to Fork 
strategy.  More  research  on  unexpected  and  unwanted  effects  of  NGT  plants,  including 
long-term effects and on interactions of the plant with the environment, is demanded. It is 
stressed that sustainability and social criteria of NGTs should be assessed in a systematic 
way  and  the  claim  that  NGTs  can  contribute  to  a  sustainable  food  system  is  discarded. 
Campaigners  stress  the  importance  of  traceability  of  NGTs  and  consider  that  NGTs 
should be labelled as GMOs to guarantee freedom of choice. According to the campaigns 
respondents, in case of a deregulation, the costs for the organic and the GM-free sector 
would  drastically  increase  to  avoid  contamination  of  their  products.  They  also  express 
concerns  about  the  patenting  of  NGT  products,  as  they  would  restrict  the  rights  of 
farmers and breeders, and only companies would be able to make profits from them.  

A  small  part  of  campaigners  further  asks  to  ban  products  of  and  research  on  genetic 
engineering in the EU; some ask that their import should also be prohibited. Some state 
that genetic engineering should only be approved in medicine.  

More  details  can  be  found  in  the  summary  report  of  the  feedback  from  the  inception 
impact assessment can be found in Annex 2a.  

b)  Public Consultation (PC) 

Similar sets of replies that could potentially constitute campaigns were identified using a 
combination  of  statistical  software  and  manual  analysis  of  responses,  based  on  the 
identification of more than ten identical contributions to closed questions and at least one 
open question. Overall, five such groups were identified from 109 respondents (4.7% of 
all consultation responses, Error! Reference source not found.). Their main messages 
were: 

Groups  1,  2,  4  and  5:  current  provisions  of  the  GMO  legislation  are  adequate;  risk 
assessment  using  the  current  GMO  legislation  requirements;  no  need  for  specific 
regulatory  provisions  on  sustainability.  Groups  1,  2  and  4:  effective  traceability  can  be 
ensured  via  documentation,  public  databases/registries  and  digital  solutions,  while 
Groups 1, 2 and 5 stated that transparency can be achieved via a physical label. 

Group  3:  current  provisions  of  the  GMO  legislation  are  not  adequate;  no  need  for  risk 
assessment  when  plants  could  have  been  produced  through  conventional  breeding  or 

7 https://demeter.net/keep-new-gm-food-strictly-regulated-and-labelled/  

107 

 
 
                                                           
classical  mutagenesis;  no  need  for  specific  regulatory  provisions  on  sustainability; 
effective  traceability  can  be  ensured  via  public  databases/registries;  transparency  for 
operators and consumers is  not necessary, when  these plants could  have been produced 
through conventional breeding or classical mutagenesis. 

None of the campaigns identified had a significant weight on the overall outcome of the 
consultation, due to the relatively very limited number of respondents involved, ranging 
from 0.4% (10) to 2.1% (48) of the overall respondents.  

Table 1: Overview of identified campaigns in the PC 

Stakeholder types 

Sectors 

Country of origin 

r
e
b
m
u
n
n
g
i
a
p
m
a
C

f
o
r
e
b
m
u
N

s
e
r
a
h
s
/

s
t
n
e
d
n
o
p
s
e
r

1 

13 / 
0.6% 

2 

18 / 
0.8% 

*

/

c
i
m
e
d
a
c
A

h
c
r
a
e
s
e
r

s
s
e
n
i
s
u
B

n
o
i
t
a
i
c
o
s
s
a

u
b
/
y
n
a
p
m
o
C

.
g
r
o
s
s
e
n
i
s

O
G
N

n
e
z
i
t
i
c
U
E

t
n
e
m
n
o
r
i
v
n
E

.
g
r
o

l

a

U
E
-
n
o
N

n
e
z
i
t
i
c

r
e
h
t
O

2 

2 

8 

1  

None 

4 

2 

5 

3 

4 

Switzerland: 10, 
Germany: 1, Italy: 2 

Australia: 1, Belgium: 
1, Finland:1, France: 
1, Germany: 2, 
Greece:1, Hungary:1, 
Italy:1 Spain: 1, 
Sweden: 1, 
Switzerland: 1, UK:1, 
US: 5 

Belgium: 3, Estonia 1, 
Germany: 2, Italy: 3, 
Portugal: 1, 
Romania: 9, Sweden: 
1 

Austria: 1, Belgium: 
4, Denmark: 1, 
France: 2, Germany: 
4, Hungary: 3, 
Poland: 1, Slovakia: 
30, Spain: 1, UK: 1  

Food 
processing/manufact
uring: 1, Plant 
breeding/seeds: 1. 
Farming: 4, Organic: 
4, Trade: 1, Food 
processing/manufact
uring; Food 
retail/services: 1 

Farming: 7, 
Ornamental Plants: 2, 
Plant breeding/seeds: 
2, Food 
processing/manufact
uring: 2. 

Plant breeding/seeds, 
Farming: 4. Food 
processing/manufact
uring, 
Biotechnology/bio-
based industry, 
Trade, Organic: 3. 
Wine: 1 

3 

20 / 
0.9% 

5 

7 

4 

4 

7 

3
4 

5 

1 

1 

1 

48 / 
2.1% 

10 / 
0.4% 

109 / 
4.7% 

4 

5 

T
O
T
A
L 

* Out of total responses: 2 300 

1 

7 

1 

Organic: 1 

Poland: 10 

5. Ad hoc contributions and outreach 

Ad hoc contributions 

141 stakeholders (including Member States) attached one or more position papers to the 
PC.  Following  a  screening  and  de-selecting  literature  already  analysed  during  desk 
research,  lists  of  references,  and  duplicates,  50  papers  were  analysed  in  more  detail. 

108 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Error!  Reference  source  not  found.  presents  the  analyses  of  positions  papers  by 
stakeholder type.  

Excluding  the  topics  addressed  by  the  questions  of  the  PC,  the  position  papers  centred 
around  the  following  topics:  existing  provisions  for  NGTs;  short/medium/long-term 
consequences  on  the  sector  if  no  change  in  the  current  legislation;  risk  assessment; 
impacts (social / environmental / economic / other impacts) on sustainability; incentives 
to  encourage sustainable NGTs;  traceability of NGTs;  on future-proofing of legislation; 
measures  for  coexistence  with  existing  agricultural  practices;  accessibility  to  NGT 
technologies/resources. 

In  addition,  contributions  were  received  via  e-mail.  For  the  PC,  these  originated  from 
France, Sweden, the United States of America, Community Plant Variety Office, Union 
Fleurs  and  IGTC,  while  for  the  targeted  survey  these  originated  from  several  Member 
States  (Germany,  Austria,  Sweden,  Poland,  Hungary,  Lithuania,  Romania  and  the 
Netherlands). All contributions were analysed and considered in the analysis.  

Figure 2: Position papers by stakeholder type 

During  the  public  consultation,  an  email  campaign  with  922  contributions  from  French 
citizens  was  addressed  to  the  Commission.  The  campaign  advocated  that  the  current 
GMO-legislation should not be revised.  

On 7 February 2023, the Commission received a petition7 with 420 000 signatures from a 
coalition  of  55  organisations  in  18  Member  States,  asking  the  Commission  to  maintain 
risk assessment, traceability, and labelling for organism obtained by NGTs. 

Outreach 

On 29 November 2021, the Commission organised a high-level event on “New genomic 
techniques  –  the  way  forward  for  safe  and  sustainable  innovation  in  the  agri-food 
sector”8.  Three  panels,  with  speakers  from  the  European  Parliament,  Member  States, 
academia, NGOs, breeders and farmers, debated on the key elements of the policy action: 

7 https://demeter.net/keep-new-gm-food-strictly-regulated-and-labelled/  
8 https://commission.europa.eu/events/new-genomic-techniques-way-forward-safe-and-sustainable-
innovation-agri-food-sector-2021-11-29_en  

109 

 
 
 
                                                           
sustainability, risk assessment and information to the consumers. The event was followed 
by around 1000 people (registered or via webstreaming).    

The  Commission  organised  three  dedicated  meetings  with  the  Member  States’  GMO 
experts  to  inform  them  on  the  progress  on  the  impact  assessment  (25  May  20229,  24 
October  202210  and  9  February  202311).  Furthermore,  the  Commission  informed 
stakeholders  on  the  progress  of  the  impact  assessment  in  the  context  of  the  Advisory 
Group on the Food Chain and Animal and Plant Health (6 May 202212) and the Advisory 
Group on Sustainability of Food Systems (19 October 202213). 

. 

9 https://food.ec.europa.eu/system/files/2022-09/sc_modif-genet_20220525_jwg_sum.pdf  
10 https://food.ec.europa.eu/system/files/2023-02/sc_modif-genet_20221024_jwg_sum.pdf  
11 https://food.ec.europa.eu/system/files/2023-06/sc_modif-genet_20230209_jwg_sum.pdf 
12 https://food.ec.europa.eu/system/files/2022-06/adv-grp_plenary_20220506_sum.pdf  
13 https://food.ec.europa.eu/system/files/2023-01/adv-grp_plenary_20221019_sum.pdf  

110 

 
 
 
                                                           
ANNEX 2A: SUMMARY REPORT ON FEEDBACK RECEIVED 
ON INCEPTION IMPACT ASSESSMENT: LEGISLATION 
FOR PLANTS PRODUCED BY CERTAIN NEW GENOMIC 
TECHNIQUES 

The Inception Impact Assessment (IIA) aimed to inform citizens and stakeholders about 
the  Commission’s  policy  initiative  on  plants  obtained  by  targeted  mutagenesis  and 
cisgenesis. Citizens and stakeholders  provided feedback from  24 September 2021 to  22 
October 2021. 

70,894  contributions  were  received;  98%  (69,414)  of  the  replies  were  identified  as 
coming  from  campaigns;  contributors  self-categorised  as  citizens.  It  seems  that  a  user-
modifiable,  precompiled  reply  template  was  made  available  on  several  websites  in 
different EU-countries. 

The  non-campaign  replies  amounted  to  2%  of  the  total  (1,480).  According  to  self-
categorisation, most contributions were from citizens (70%, 1,030  replies), followed by 
business  organisations/associations, 
trade  unions  (14%,  203),  academia/research 
institutions (8%, 115), NGOs and consumer/environmental organisations (5%, 81), public 
authorities (1%, 9) and others (3%, 42).  

Figure 3. Breakdown of non-campaign replies (1,480 total) 

Contributions (both campaign and non-campaign) originated from 91 countries, including 
the 27 Member States and 64 non-EU countries. Top contributions from Member States 
were from Germany (32,694), France (25,544), Belgium (2,732), Netherlands (2,251) and 
Austria (2,111). Most contributions from non EU-countries came from Switzerland (782), 
followed by United Kingdom (759), USA (228), Argentina (142) and Canada (114). 

This  large  number  of  campaign  and  non-campaign  contributions  shows  the  interest  of 
citizens  and  stakeholders  on  the  Commission’s  policy  initiative  on  plants  derived  from 
new genomic techniques (NGTs) and on the topic in general. 

the  non-campaign  and  campaign 
The  following  analysis  distinguishes  between 
contributions  and,  for  the  latter,  between  different  stakeholders  groups.  It  organises  the 
111 

 
 
 
comments  according  to  the  following  topics:  the  IIA/policy  initiative  in  general,  risk 
assessment, sustainability, traceability, information to consumers/awareness, liability/cost 
of contamination and intellectual property. 

1.  NON-CAMPAIGN CONTRIBUTIONS 

1.1. Public authorities 

Contributions from nine public authorities were received, among them the Member States 
Denmark  (DK)14,  Estonia  (EE)15,  Austria  (AT)16,  Spain  (ES)17,  Netherlands  (NL)18 and 
France (FR) as well as the Bavarian19 and Flemish authorities20. Furthermore, one reply 
was from Argentina21. 

On IIA/policy initiative  
All  respondents  welcome the policy initiative and support the  IIA. ES, EE, FR and NL 
stress that an update of the current GMO legislation is needed. ES and NL emphasise that 
legal uncertainties must be removed of the GMO legislation. Furthermore, ES states that 
duplication of requirements, leading to administrative burden, that are already addressed 
in more specific legislation, should be avoided. The Flemish authority criticises that the 
IIA  does  not  indicate  how  the  net  administrative  burden  for  obtaining  an  authorisation 
will  be  reduced.  FR  is  not  in  favour  of  developing  new  herbicide  resistance  varieties, 
which has to be considered in the regulatory framework in their point of view. Moreover, 
Argentina promotes to harmonise internationally the regulation of NGT products. 

Concerning the timing of the policy initiative, the Bavarian authority suggests starting the 
public consultation in the 1st quarter of 2022. The action is considered urgent, given the 
rapid  global  developments  in  the  field  of  NGTs.  Regarding  the  scope  of  the  initiative, 
DK,  ES,  NL  and  EE  stress  that  knowledge  of  the  use  of  NGTs  in  microorganisms  and 
animals has to be built up. 

Risk assessment 
EE  underlines  the  importance  of  carrying  out  a  proportionate  risk  assessment  for  NGT 
products, which should be based on a case-by case approach.  

Sustainability 
EE  and  ES  support  the  sustainability  assessment  of  NGT  products  in  the  authorisation 
process.  The  Flemish  authority  states  that  safety  and  sustainability  assessments  must 
remain separate. Furthermore, it stresses that sustainability may not become too stringent 
so  that  innovation  is  possible.  Argentina  stresses  that  NGTs  could  contribute  to  the 
objectives of the European Green Deal and F2F. 

Traceability 
In the point of view of EE, there should not be excessive focus on traceability, given the 
impossibility in certain cases to trace the variety and the fact that plants obtained by new 
genomic methods are known to be as safe as those derived from conventional breeding. 

14 Ministry of Food, Agriculture and Fisheries; Ministry of Environment 
15 Maaeluministeerium 
16 Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz 
17 Ministerio de Agricultura, Pesca y Alimentación 
18 Ministry of Infrastructure and Water Management 
19 Bayerisches Staatsministerium für Umwelt und Verbraucherschutz 
20 Interdepartementaal overlegcomité Life Sciences, Vlaamse Overheid 
21 Ministerio de Agricultura, Ganaderia y Pesca 

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The Flemish authority stresses that the authorisation should not depend on an analytical 
detection method.  

Information to consumers/awareness 
In the opinion of EE, potential consumer attitudes should be assessed under the economic 
impact of the IA. Furthermore, consumers should be better informed about NGTs. 

1.2. Business organisations/associations, trade unions 

On IIA/policy initiative  
Most respondents in this category (167 out of 205, mostly farming, breeding, processing, 
manufacturing  and  trading  operators)  support  a  future-proof  adaptation  of  the  GMO 
legislation  to  scientific  and  technological  progress,  stating  that  the  upcoming  proposal 
needs  proportionate  approval  requirements,  clear  definitions  and  clarification  of  what 
falls under the GMO legislation, and that it should not add administrative complexities. 
Some  suggest  extending  Annex  1B  of  Directive  2001/18/EC  to  NGT  products  not 
containing foreign DNA. Others propose to regulate phenotypes comparable to those of 
natural mutations or conventional breeding by the PRM legislation and not the GMO one. 
Some  suggest  that  NGT  products  without  added  DNA  should  only  be  subject  to  a 
notification procedure like in Japan and stress the importance in their view to harmonise 
the  EU  GMO  legislation  with  other  non-EU  countries.  Some  respondents  in  this  group 
demand  that  the  inter-institutional  negotiation  of  the  proposal  should  take  place  during 
the  current  legislative  term  of  the  European  Parliament,  and  one  suggests  an  ad  hoc 
regulation as in the case of the COVID pandemic. Others ask that the scope of the policy 
initiative  be  enlarged  to  microorganisms  and  to  all  genomic  techniques,  including  to 
those leading to transgenesis. Furthermore, in the view of some respondents the initiative 
needs to address also that the current GMO legislation allows EU countries to opt out of 
GMOs. 

some 

related  operators  as  well  as 

All  organic,  GM-free  and 
farmers’ 
associations/movements  and retailers (38 out of 205) believe that NGT products should 
remain  subject  to  the  current  GMO  authorisation  procedure,  and  do  not  see  a  legal 
uncertainty  that  justifies  the  amendment  of  the  current  GMO  legislation,  which  should 
continue  to  be  applied.  They  argue  that  the  GMO  legislation  is  not  a  ban  of  NGT 
products,  as  research  is  possible  and  products  of  targeted  mutagenesis  and  cisgenesis 
could  be  authorised.  Some  respondents  ask  to  assess  the  costs  for  the  GM-free  and 
organic sector in case of potential contamination by NGT products; they demand that the 
impact  on biodiversity  of NGT products  be assessed and that  ethical  considerations are 
included in the decision whether to allow NGTs in the EU.  

Risk assessment 
Farming,  breeding,  processing,  manufacturing  and  trading  operators  for  the  most  part 
support a proportionate product-based risk assessment on a case-by-case basis, stressing 
that  neither  risk  assessment  nor  monitoring  is  needed  if  NGT  plants  could  have  been 
produced naturally. They  further argue that it should  be ensured that SMEs could  meet 
submission requirements for the risk assessment of NGT products. 

Organic, GM-free and related operators as well as some farmers associations/movements 
call  for  a  proper  comprehensive  risk  assessment  for  NGT  products.  They  demand  a 
process-based,  case-by-case  risk  assessment;  some  propose  that  a  product/trait-based 
assessment should be done additionally.  

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Sustainability 
Several  farming,  breeding,  processing,  manufacturing  and  trading  operators  demand  a 
consistent  and  coherent  sustainability  analysis  for  all  products,  adding  that  it  would  be 
discriminatory to only assess the sustainability of NGT products and not of products of 
other breeding methods. Furthermore, the sustainability criteria should be coherent with 
the sustainability food system framework. Breeding and farming operators emphasise that 
the  sustainability  assessment  would  increase  the  administrative  and  financial  burden. 
Breeding operators add that the VCU testing, which most plant varieties have to undergo 
under 
the 
biotechnology  sector  state  that  sustainability  analysis  should  not  play  a  role  in  NGT 
authorisation, but sustainability related information could be included in a label. 

legislation,  considers  sustainability.  Two  respondents  of 

the  PRM 

Some  organic  and  GM-free  operators  support  the  assessment  of  the  sustainability  and 
socio-economic  impacts  of  NGT  products.  However,  two  respondents  of  this  group 
emphasise that the sustainability assessment should not be linked to the risk assessment.  

Several  farming,  breeding,  processing,  manufacturing  and  trading  operators  agree  that 
NGT products could contribute to the objectives of the Green Deal and the Farm to Fork 
Strategy.  By  contrast,  organic  and  GM-free  operators,  as  well  as  some  farmers’ 
associations, opposes this idea and stress the importance of traditional farming methods 
and agro-ecological practices in this regard.  

Traceability 
Breeders consider that, in order to ensure traceability, information could be provided in 
the EU common catalogue of varieties or the national variety registry. Furthermore, two 
respondents stress that product segregation based only on the breeding technique is very 
costly. 

Organic  and  GM-free  operators  as  well  as  respondents  of  the  retail  sector  call  for  the 
development  of  detection  methods  for  NGT  products.  Some  organic  and  GM-free 
operators state that detection methods of NGT products must be a mandatory prerequisite 
for the approval of NGT products, while other organic and GM-free operators as well as 
some farmers’ associations suggest that documentation traceability would be an option in 
case no detection methods are available.  

Furthermore,  three  respondents  call  for  the  establishment  of  a  transparency  register  for 
NGT products.   

Information to consumers/awareness 
Organic  and  GM-free  operators  as  well  as  respondents  of  the  retail  sector  want  to 
maintain labelling of NGT products. They underline that labelling is important to ensure 
the  freedom  of  choice  of  consumers  and  the  organic  and  GM-free  sector.  Moreover, 
organic and GM-free operators further demand that animal products should be labelled if 
the animals were fed GMO feed. One respondent emphasises that the current GMO label 
should be used for NGT products, instead of introducing a new label. 

Farming,  processing,  manufacturing  and  trading  operators  took  the  opposing  position, 
arguing  that  labelling  should  be  voluntary,  underlining  that  products  of  traditional 
breeding  methods  would  also  need  labelling,  if  NGT  products  are  labelled;  labelling 
similar  products  differently  would  breach  the  principle  of  non-discrimination  and 
proportionality. Others add that if a method for production of a variety is not considered 
as  GMO,  it  should  not  be  labelled  as  such.  Some  emphasise  that  labelling  must  be 

114 

 
 
implementable  and  enforceable  or  suggest  that  it  could  be  used  to  communicate  the 
benefits of the NGT product.  

On the one hand, two respondents stress that a majority of European consumers oppose 
genetic  engineering  in  agriculture.  On  the  other  hand,  one  respondent  argues  that 
consumers differentiate between old and new GMOs and that the acceptance increases if 
NGT  products  show  personal,  health  or  climate  benefits.  Four  respondents  state  that 
citizens should be better informed about NGTs. 

Liability/cost of contamination 
Organic, GM-free and related operators call for strict coexistence rules, arguing that even 
a partial deregulation of NGT products would make it more difficult for the organic and 
GM-free  sector  to  trace  them.  As  there  is  no  “polluter  pays  principle”  in  place,  the 
organic and the GM-free sector would have to bear the cost to avoid the contamination of 
their  products  with  NGT  products.  Furthermore,  these  respondents  stress  that  lack  of 
information would also break the trust of the consumer in organic food. 

Intellectual property 
Especially  breeders  but  also  farming,  processing,  manufacturing  and  trading  operators 
support a broad access to breeding technologies and suggest that the Commission should 
encourage licensing platforms that provide their members access to patented technology 
like  the  International  Licensing  Platform  (ILP)  Vegetable,  Corteva’s  Open  Innovation 
Platform  and  the  Agricultural  Crops  Licensing  Platform  (ACLP).  Some  breeders  that 
support  these  licensing  platforms  also  acknowledge  the  importance  of  plant-related 
innovation  by  patent  protection.  Two  farmers’  associations  call  for  free  access  to  the 
entire  gene  pool  and  all  breeding  processes  while  one  other  supports  access  to  the 
selection  method  used  but  the  breeder  should  be  allowed  to  keep  confidential 
information.  Three  farmers’  associations  demand  that  patents  should  be  applicable  to 
plants  containing  DNA  that  cannot  be  found  in  nature  or  cannot  be  obtained  by 
conventional  breeding methods or old  and new mutagenesis. Another suggestion is  that 
the  Commission  should  establish  a  research  institute  that  will  give  access  to  the 
technology  to  all  European  firms  by  applying  common  property  principles  while  the 
beneficiary company will pay a reasonable amount for it. One breeder calls for a change 
in  the  intellectual  property  landscape  of  plants  with  a  broader  interpretation  of  the 
definition of ‘essential biological processes’ in order to cover mutation breeding in both 
Directive 98/44 and the European Patent Office (EPO) framework. 

Organic and GM-free operators are concerned that patents  on NGT products  can create 
damage to seed availability and lead to the privatisation of modified seeds. Furthermore, 
they argue that they would undermine the breeder’s exemption. One farmers’ association 
states that the patenting of genetic information contained in the seed would run counter to 
the implementation of the rights of farmers on seeds based on the UN Declaration on the 
Rights of Peasants and Other People Working in Rural Areas and the International Treaty 
on Plant Genetic Resources for Food and Agriculture. 

1.3. Academia/research institutions 

On IIA/policy initiative  
Most  respondents  of  this  group  demand  to  modernise  the  current  GMO  legislation 
according  to  current  knowledge,  making  it  proportionate  and  future-proof.  Legal 
uncertainties  regarding  terms  like  “mutagenesis”,  “conventional  use  in  a  number  of 
applications”  and  “long  safety  record”  should  be  removed  and  harmonised  with  the 
Cartagena  protocol.  Within  this  group  some  are  for  simplified  or  product-based 
115 

 
 
authorisation  procedures  for  NGT  products.  Others  ask  that  NGT  products  should  be 
deregulated, or that NGT products should be deregulated if they are not transgenic; others 
support their deregulation only when they are also obtainable by conventional breeding.  

Suggestions  on  how  to  change  the  GMO  legislation  were  made.  These  include  a  pre-
assessment procedure, regulated by a separate piece of legislation, to determine whether 
the product falls under the GMO legislation, like in Argentina. Others propose to modify 
the GMO definition to exempt NGT products by enlarging the mutagenesis exemption or 
introducing  a  new  annex  defining  the  exemptions.  In  addition,  some  ask  that  a  future 
regulation of NGT plants should not allow individual member states to restrict their use. 
Moreover, the international perspective of the GMO legislation and its consequences on 
international trade must be considered, e.g. Distinctness, Uniformity and Stability (DUS) 
testing is challenging if NGT products are regulated as GMOs in the EU, as this is not the 
case  in  other  countries.  Regarding  the  scope  of  the  initiative,  some  stress  that 
microorganisms,  forest-trees  and  forest  biomass  derived  products  should  be  included. 
Others  ask  that  the  impact  assessment  should  consider  the  human  right  to  benefit  from 
scientific  progress  (Art  27  of  the  1948  UDHR  and  Art  15  of  ICESCR),  as  well  as  and 
positive  and  negative  impacts  for  organic  and  GM-free  agriculture.  Moreover,  a  cost-
benefit  analysis  of  the  deployment  of  NGTs  on  all  the  aspects  mentioned  in  the  IIA 
should be carried out.  

Some respondents ask that NGTs continue to be covered by the current GMO legislation 
and that it is too early for a proportionate framework, as possible adverse effects of NGT 
plants  are  not  reliably  known.  Furthermore,  there  is  a  call  for  more  research  on 
unintended impacts on environment and human health of NGT products.  

Risk assessment 
Some  respondents  call  for  a  product-based  risk  assessment  on  a  case-by-case  basis. 
Furthermore, there are proposals for a specific risk assessment for NGT products based 
on  defined  categories  of  risks.  For  one  respondent  of  this  group  the  current  risk 
assessment should apply to  all NGT products,  as it is  too  early to  assume that they  are 
safe.   

Sustainability 
Some  respondents  agree  that  NGT  products  could  contribute  to  the  objectives  of  the 
Green  Deal,  the  F2F,  the  Biodiversity  Strategy  and  the  UN  SDGs.  Moreover,  some 
propose that not only the risks but also the benefits to environment and to society should 
be considered in a legal framework.  

Some  commenters  refer  to  the  Norwegian  Gene  Technology  Act  that  assesses  the 
contribution  to  sustainability,  social  utility  and  ethical  aspect  of  GMOs,  which  could 
serve  as  an  example  for  the  EU  GMO  legislation.  Others  demand  that  a  sustainability 
analysis should not be limited to NGT products but be included in the evaluation of any 
new  plant  variety.  Others  emphasise  that  a  sustainability  analysis  would  increase  the 
administrative  and  economic  burden  and  would  not  contribute  to  international 
harmonisation.  

Traceability 
Some  respondents  highlight  the  importance  of  traceability  for  the  GM-free  and  the 
organic sector, as a lack of transparency, traceability and labelling would set the wrong 
signal.  Moreover,  some  call  for  more  research  on  detection  methods.  As  traceability  is 
not always possible by analytical methods, respondents in this group suggest certification 
to trace NGT products. Others stress that the requirements for detection methods should 
116 

 
 
not be barriers in the approval process, or that NGT and conventional products should be 
treated equally regarding traceability. 

Information to consumers/awareness 
As  for  traceability,  some  emphasise  that  labelling  is  important  for  the  GM-free  and 
organic sector and needed to ensure the freedom of choice for consumers. Others mention 
that  the  public  wants  information  about  the  breeding  method.  Finally,  some  call  for  no 
labelling of NGT products. 

Some respondents  ask  for constructive public dialogs to  better inform  consumers about 
NGTs, arguing that the public attitude is positive on NGT products if they are beneficial 
for  environment  and  society,  and  stressing  that  regulating  NGTs  as  GMOs  would  sow 
doubts in the minds of consumers. 

Liability/cost of contamination 
Some  respondents  comment  that  NGT  and  conventional  breeding  products  are 
indistinguishable.  Therefore,  there  is  no  scientific  basis  not  to  use  NGT  products  in 
organic farming. 

Intellectual property 
One respondent notes that, since GMO products seeking for a patent or Community Plant 
Variety  Rights  (CPVR)  protection  must  meet  intellectual  property  rights  (IPR)  criteria 
such as novelty, inventiveness, industrialisation, distinctiveness, stability and uniformity, 
by  default  such  a  product  would  also  be  characterised  as  non-conventional/traditional, 
unknown,  unnatural/synthetic  and  could  not  legally  be  described  or  labelled  as  natural, 
organic, conventional, traditional, having a history of safe use etc. Others ask that NGT 
products be excluded from patenting. 

1.4. NGOs, consumer/environmental organisations 

On IIA/policy initiative 
This group of respondents is very critical on the IIA. They argue that the IIA follows the 
unverifiable  promises  of  the  industry,  as  it  downplays  the  risks  and  overemphasises 
potential benefits of NGT products, and it does not take into account the benefits for the 
food  sector,  farmers,  the  environment  and  the  public  of  the  current  GMO  legislation. 
Moreover, according to  some of them, the  IIA does not  follow the CJEU ruling by not 
prioritising  the  precautionary  principle  and  by  suggesting  that  the  current  GMO 
legislation is no longer fit for purpose. Respondents in this group demand that the current 
GMO definition is maintained and to not distinguish between different forms of genetic 
engineering.  They  stress  that  if  NGT  products  were  exempt  from  the  GMO  legislation, 
this  would  conflict  with  the  EU  treaty  (Art  169,  Art  114,191  TFEU)  and  the  key 
objectives  of  the  Biodiversity  Strategy.  In  this  group,  most  respondents  demand  a 
thorough  approval  procedure  for  NGT  products,  rejecting  a  facilitated  authorisation, 
suggesting  that,  like  in  the  pharmaceutical  authorisation,  an  evidence-based  benefit 
assessment should be needed for the authorisation of a new GMO. Finally, some call for 
a  general  ban  of  all  GMOs  in  the  EU.  One  NGO  claims  that  apart  from  the  impacts 
mentioned  in  the  IIA,  the  IA  should  also  examine  the  impact  on  social  justice, 
agrobiodiversity,  circular  economy  and  ecosystem  services.  Furthermore,  it  should 
contain a survey on the acceptance by citizens. 

A  few  respondents  from  this  group  support  an  adaptation  of  the  GMO  legislation 
according to scientific knowledge, as it is not fit for purpose. One respondent supports a 

117 

 
 
  
product-oriented  approach  with  a  case-by-case  assessment  regardless  of  the  breeding 
process.  

Risk assessment 
Several respondents demand a risk assessment for all GMOs, regardless of the technique 
used, supporting a process-based risk assessment on a case-by-case basis; some state that 
besides the process also the trait has to be assessed. In addition, one NGO stresses that 
also  the  plant  species  (e.g.  reproduction  methods,  pollinators  involved)  has  to  be 
considered.  Respondents  emphasise  that  the  risk  assessment  must  include  new  and 
additional  risks  emerging  from  NGTs  and  should  not  be  based  on  defined  technique-
based risk levels. They argue that genetic alterations of NGTs go far beyond of those of 
conventional breeding techniques.  

Sustainability 
In  general,  this  group  opposes  the  assumption  that  NGT  products  can  contribute  to 
sustainability, as they are part of an industrial agricultural system. Instead, they suggest 
that  the  Commission  focuses  on  agro-ecology  and  organic  agriculture.  They  argue  that 
the  Commission  downplays  the  dominance  of  herbicide  tolerance  in  current  pre-
commercial NGT crops and call for a ban of pesticide-tolerant varieties.  

Within this group, some are in favour of a sustainability analysis for NGT products. They 
refer to the Norwegian law, where only GMOs contributing to sustainable development 
can be used. Furthermore, they demand the sustainability analysis be based on scientific 
evidence,  follow  strict  quality  requirements,  be  comprehensive,  and  not  be  limited  to  a 
specific category of GMOs.  

Moreover, the importance of the coherence of the sustainability analysis with the policy 
action on a sustainable food system framework is emphasised.  

Traceability 
This  group  calls  for  traceability  of  NGT  products  to  preserve  the  freedom  of  choice 
throughout  the  food  chain  and  specifically  for  the  organic  and  GM-free  sectors.  It 
considers  that  a  weakening  of  the  current  traceability  rules  of  NGT  products  would 
contradict the objectives of the F2F, according to which food information should be made 
more  transparent.  Companies  should  disclose  full  information  about  the  genome 
sequence  of  their  NGT  products,  and  traceability  and  detection  methods  should  be 
mandatory. The need for the development of detection methods was emphasised, asking 
in parallel that existing detection methods be used pro-actively in food and feed controls. 
Respondents  criticise  that,  according  to  Commission’s  NGTs  study,  EU  member  states 
spent only 1,6% of their research funding in NGTs for detection methods, monitoring and 
risk assessment. If detection methods are not available, some suggest the introduction of 
a documentation-based traceability approach like in the organic sector. Finally, some call 
for the establishment of a public international registry including all GMO plant varieties. 

Information to consumers/awareness 
Respondents  argue  that  labelling  is  important  in  order  to  ensure  the  freedom  of  choice 
throughout the food chain as well as the organic and GM-free sector; a weakening of the 
labelling rules would contradict the F2F. Furthermore, they argue that EU consumers are 
in favour of labelling of GMOs. This group of respondents opposes a new NGT-label that 
would replace the current GMO-label, and the replacement of GMO and NGT labelling 
by  a  sustainability  labelling.  They  further  ask  for  the  labelling  of  animal  products,  if 
animals are fed with genetically modified feed. 

118 

 
 
Liability/cost of contamination 
Respondents  believe that deregulation  of NGTs would make the coexistence of organic 
and  GM-free  impossible.  Moreover,  the  cost  to  prevent  and  deal  with  contamination 
would rise dramatically in these sectors. In addition, the seed saving sector already has to 
handle  the  lack  of  transparency  on  NGT  plants  from  third  countries.  Furthermore,  it 
would contradict the General Food Law if the conventional, organic and GM-free sector 
had  to  account  for  all  administrative  and  economic  burden  for  testing  and  segregation 
while  the  potential  benefits  went  to  the  biotechnology  sector.  They  call  for  the 
introduction of the “polluter pays principle”.  

Intellectual property 
Respondents  of 
like 
monopolisation and concentration of the seed market, that apply to GM techniques. They 
ask that NGT research, that receives public funding, be free from patents.  

the  negative  consequences  of  patents, 

this  group  stress 

1.5. Citizens 

On IIA/policy initiative  
Most  of  the  respondents  (815  out  of  1029)  believe  the  GMO  legislation  is  not  fit  for 
purpose  and  support  a  future-proof  update  in  accordance  with  current  scientific 
knowledge.  They  ask  to  remove  inconsistences,  update  definitions,  align  with  global 
regulatory approaches and move to a product-based assessment. They argue that each EU 
country  should  not  be  able  to  prohibit  the  commercialisation  of  a  GMO.  Moreover,  a 
separate  approval  process  for  NGTs  from  GMOs  is  proposed.  They  suggest  including 
NGT  products  not  containing  foreign  DNA  in  the  Annex  1B  of  the  Directive  as  a  first 
step, or to  consider them  in  the same way  as those of traditional breeding.  In the long-
term,  the  legislation  should  be  amended  so  that  it  is  product-based.  Others  propose  to 
introduce  an  authorisation  for  all  plant  varieties  instead  of  just  for  GM  varieties.  Some 
further argue that the authorisation of transgenic plants should be simplified. Moreover, a 
heavy  regulation  on  NGT  products  would  deter  small  and  medium-sized  enterprises 
(SMEs) from using them. 

A  minority  of  respondents  (198  out  of  1029)  oppose  a  change  of  the  legislation  for 
genetically modified organisms (GMOs). According to them, the GMO legislation is fit 
for  purpose  and  there  is  no  legal  uncertainty  that  would  justify  an  amendment.  They 
stress  that  the  ruling  of  the  Court  of  Justice  of  the  EU  (CJEU)  of  July  2018  and  the 
precautionary  principle  have  to  be  respected.  They  oppose  a  deregulation  of  NGT 
products  in order to  prevent  the risk of unintended consequences  and to  control misuse 
and  propose  to  authorise  NGT  products  only  in  the  context  of  industrial  and 
pharmaceutical  biotechnology.  Some  demand  that  the  EU  should  not  allow  the 
development of NGTs within its borders. 

Some  citizens  state  that  societal,  environmental  and  ethical  consideration  should  be 
included in the debate on NGTs. Moreover, theological and anthropological research of 
the impact of NGTs is needed. Furthermore, the likely impacts on the fundamental right 
to freedom of the arts and science as well as the environmental and economic impact of 
refraining from biotechnological innovation should be assessed. 

Risk assessment 
Respondents  have different  opinions about  the risk  assessment of NGT products.  Some 
do not support a change in the risk assessment of NGT products and stress that it should 
stay as it is now, but also additionally allow for a more stringent case-by-case assessment 
if needed. Some emphasise that no experimental data supports the assumption that NGT 
119 

 
 
products have the same risk profile as conventionally bred ones. They argue that NGTs 
their  non-randomness. 
differ  from  conventional  breeding  methods  because  of 
Furthermore, they make the whole genome accessible for changes.  

Others support a proportionate, product-based, case-by-case risk assessment, suggesting 
to  introduce  a  preliminary  assessment  to  determine  whether  a  full  risk  assessment  is 
necessary.  Others  propose  to  classify  genetic  engineering  methods  according  to  risk 
levels, leading to different risk assessment requirements.  

Others believe that no risk assessment of NGT products is needed, as they are similar to 
conventionally bred ones.  

Sustainability 
Some  citizens  think  that  NGT  products  could  contribute  to  the  objectives  of  the  Green 
Deal, the Farm to Fork Strategy (F2F) and the United Nations (UN) Sustainability Goals 
(SDGs). Others doubt the sustainability contributions of NGT products, as they are part 
of  a  farming  model  dependent  on  chemical  use,  and  F2F  aims  at  circular  adapted 
agriculture instead of more agro-industry. 

Some citizens support a sustainability assessment of NGT plants, stressing however that 
such an assessment should not apply only to NGT products. Others oppose the idea of a 
sustainability analysis, as they question the robustness and consistency of the approach, 
and  as  they  consider  that  the  Value  for  Cultivation  and  Use  (VCU)  testing  already 
contains a sustainability assessment. 

Traceability 
Some  citizens  demand  that  traceability  applies  to  NGT  products,  as  it  is  important  to 
guarantee  a  GMO-free  supply  chain.  Others  state  that  traceability  should  not  lead  to 
excessive evaluation costs. If NGT products are difficult or impossible to trace, practical 
solutions should be found instead of banning them from the market. Some suggest using 
document-based  traceability  if  no  detection  method  is  available.  Other  citizens  demand 
more research funding for detection methods. 

Information to consumers/awareness 
Some citizens demand that NGT products have to be labelled to guarantee the freedom of 
choice throughout the food chain and the GM-free sector, while others call for labelling 
animal products if the animals received GMO feed.  

Other  citizens  suggest  to  distinguish  between  NGT  and  GM  products  on  the  label,  to 
include  the  benefits  of  the  NGT  products  on  the  label  or  to  label  every  single  product, 
GMO and non-GMO, with the breeding technique involved. In the point of view of some 
respondents,  targeted  mutagenesis  and  cisgenesis  should  not  be  labelled,  or  GMO 
products should not have to be labelled as they are safe. Some fear that labelling of NGT 
products  could  become  a  hindrance  to  their  marketing  in  the  EU  or  would  make 
necessary imports of some food and feed impossible.  

Some  citizens  call  for  better  communication  on  NGT  and  GMO  products  in  the  EU. 
However,  certain  respondents  also  stress  that,  according  to  surveys,  a  majority  of  the 
European population opposes the use of genetic techniques, which has to be respected by 
the EU. 

120 

 
 
Liability/cost of contamination 
Some citizens fear that a deregulation of NGT products would endanger the coexistence 
of organic agriculture, increasing the costs for farmers and processors of the organic and 
GM-free  sector  to  ensure  no  contamination.  In  their  view,  the  “polluter  pays  principle” 
should be enforced, i.e. that the GMO producer has to prevent  and be held accountable 
for the contamination of non-GMO materials. 

Intellectual property 
Some citizens oppose the patenting of NGT products, proposing to make NGTs available 
to all public and private research institutions. The absence of patents is also essential in 
their view for SMEs to be competitive. They suggest to regulate NGTs according to the 
International Union for the Protection of New Varieties of Plants (UPOV) Convention, as 
there is no real difference between them and classical breeding technologies. Moreover, 
some  citizens  fear  that  the  introduction  of  NGT  products  will  create  a  dependent 
agricultural sector. 

2. 

 CAMPAIGN CONTRIBUTIONS 

On IIA/policy initiative  
The  contributions  from  the  campaign  demand  to  apply  the  precautionary  principle  in 
accordance with the CJEU ruling. Therefore, in the view of these respondents, all GMOs, 
including  NGT  products,  must  fall  under  the  GMO  legislation,  and  no  artificial 
distinction should be made between different forms of genetic engineering. Moreover, the 
Commission should implement policies that are in accordance with the objectives of the 
F2F. More research on unexpected and unwanted effects of NGT plants, including long-
term  effects  and  on  interactions  of  the  plant  with  the  environment,  is  demanded.  It  is 
stressed that sustainability and social criteria of NGTs should be assessed in a systematic 
way.  

A  small  part  of  campaigners  further  asks  to  ban  products  of  and  research  on  genetic 
engineering in the EU; some ask that also their import should be prohibited. Some state 
that genetic engineering should only be approved in medicine. 

Risk assessment 
The  campaign  demands  a  robust,  process-based,  case-by-case  risk  assessment  for  NGT 
products.  Some  respondents  added  that  it  should  be  accompanied  by  a  trait-based  risk 
assessment. An adaptation of the current risk assessment for NGT products would have to 
be  based  on  scientific  evidence  and  would  have  to  assess  new  and  additional  risks 
emerging from NGTs. 

Sustainability 
The  respondents  of  the  campaign  oppose  the  claim  that  NGTs  can  contribute  to  a 
sustainable food system. They are part of a farming system relying on massive chemical 
use. It is stated that, in countries producing GMOs, they have caused great damage to the 
environment and health of the population. The Commission should promote research on 
agro-ecology and organic farming as well as the breeding of peasant and farm seeds.  

Traceability 
The  importance  of  traceability  of  NGTs  is  emphasised  by  the  campaign  respondents. 
They stress that farmers, breeders, food manufacturers, retailers and consumers must be 
able  to  avoid  GMOs.    According  to  them,  the  lack  of  traceability  of  NGTs  would 
endanger  the  organic  and  GM-free  sector.  Moreover,  to  reach  the  25%  of  organic 
agriculture announced in the F2F, it must be possible to avoid NGT products along the 

121 

 
 
food  chain.  Furthermore,  the  F2F  aims  to  foster  the  transparency  in  the  food  chain  for 
consumers.  In  their  view,  the  traceability  of  NGT  products  should  be  a  mandatory 
prerequisite  for  their  approval;  detection  methods  should  be  developed,  and  existing 
methods  should  be  used  pro-actively  for  food  and  feed  controls.  Finally,  campaign 
respondents argue that traceability does not depend on detection methods and call for the 
establishment of a public global registry including all GMO plant varieties. 

Information to consumers/awareness 
The  respondents  of  the  campaign  consider  that  NGTs  should  be  labelled  as  GMOs  to 
guarantee  the  freedom  of  choice.  Otherwise,  the  organic  and  GM-free  sector  would  be 
endangered. Moreover, animal products should be labelled if the animals were fed with 
GM feed. 

Some stress that a majority of Austrians and Germans are against the cultivation of GMO 
plants, even if NGT were used, according to surveys 

Liability/cost of contamination 
According to the respondents, in case of a deregulation, the costs for the organic and the 
GM-free sector would drastically increase to avoid contamination of their products. For 
these two sectors, it is essential to know where GMOS are, and call for the introduction 
of the “polluter pays principle”. 

Intellectual property 
Campaign  respondents  express  concerns  about  the  patenting  of  NGT  products  as  they 
would restrict the rights of farmers and breeders and only companies would make profits 
from them. Companies would claim property rights on the millennia-long breeding work 
of farmers or on natural organisms, which have crossed with GMOs. 

122 

 
 
 
ANNEX 3: WHO IS AFFECTED AND HOW? 

1. Practical implications of the initiative 

The  proposed  measures  guarantee  safety  and  have  positive  implications  for  EU  plant 
breeders,  academic  research,  farmers,  traders,  consumers  and  regulators,  while  organic 
farmers will face challenges under certain conditions. 

For  breeders,  from  large  companies  and  SMEs,  NGTs  will  be  a  new  tool  allowing  the 
rapid,  more  cost-efficient  development  of  plant  varieties  with  specific  characteristics, 
thereby responding to the challenges of climate change, contributing to strengthening the 
sustainability of the food system and to meet diverse, evolving consumer demands. They 
will  benefit  from  simplified  and  accelerated  regulatory  processes  with  regard  to  adapted 
risk  assessment  and  with  regard  to  NGT  plants  that  are  equivalent  to  plants  that  could 
occur  naturally  or  be  produced  by  conventional  breeding.  Certain  NGTs  are  considered 
accessible tools for plant breeding due to their comparatively low cost and complexity. In 
this  regard,  NGTs  are  technologies,  which  could  lead  to  a  lowering  of  technological 
barriers to entry of the plant breeding sector, benefitting SMEs, in particular. 

Academic  researchers  in  the  plant  sciences  expect  increased  funding  from  public  and 
private sources as a result of a regulatory framework that is seen as enabling the marketing 
of  the  products  resulting  from  research,  contributing  to  the  EU  research  base  and 
innovation  capacity  in  plant  biotechnology  and  allowing  researchers  to  use  NGTs  to 
support environmental and other challenges to the EU and global food system.  

Farmers can benefit from varieties with increased resilience, improved pest tolerance and 
lower  fertiliser  needs,  while  delivering  products  satisfying  the  needs  of  processors, 
retailers  and  consumers.  Innovative  products  can  also  open  up  new  income  sources  for 
farmers. 

Organic farmers will be able to rely on the tools of the GMO legislation available today 
as  regards  NGT  plants  subject  to  authorisation  (traceability  and  labelling,  coexistence 
measures  implemented  by  the  farmers  cultivating  NGT  plants)  and  on  transparency 
measures  (public  register,  common  catalogues  of  varieties)  to  identify  those  subject  to 
notification  as  regards  NGT  plants  subject  to  notification.  The  risk  of  admixture  will 
depend on the adoption rate of NGTs. 

Traders  of  NGT  products  will  be  able  to  offer  competitive  products  and  operate  in  a 
system that minimises regulatory divergence with trade partners. 

Consumers can have an increased choice of products, including products with increased 
beneficial and decreased harmful compounds. 

Regulators will benefit from simplified and accelerated regulatory processes. 

2.  Summary of costs and benefits 

The two tables below summarise the benefits and the costs of the preferred option. 

The  preferred  option  is  a  combination  of  option  4  for  products  that  could  also  occur 
naturally  or  be  produced  by  conventional  breeding  and  of  an  option  2  for  all  other 
products. Therefore, in general terms costs and savings for the notification correspond  to 

123 

 
 
the costs and savings of option 4, while costs and savings for the authorisation correspond 
to the costs and savings of option 2.  

However,  not  all  the  costs  and  savings  from  option  2  are  directly  applicable  to  the 
preferred  option.  In  the  preferred  option  there  will  be  a  list  of  traits  contributing  to 
sustainability which will not require additional data from the applicant and nor a specific 
assessment  for  administrations.  Therefore,  those  costs,  presented  in  table  5,  are  not 
necessary for the Annex 3. 

In  addition  to  calculate  the  aggregate  saving  and  costs  of  the  preferred  option,  a 
hypothetical  scenario  in  which  the  breeders  would  submit  10  notifications  and  5 
authorisations per year.  

The  hypothetical  scenario  is  based  on  the  number  of  products  expected  to  come  to  the 
market  in  the  next  ten  years  in  the  JRC  study  on  NGT  applications  attached  to  the 
Commission  NGT  study.  The  JRC  found  134  products  at  pre-marketing  and  advanced 
R&D phase, which correspond to products that could potentially reach the market by 2030, 
i.e. 27 per year from 2025 when legislation could be in place. We assumed that 55% would 
make it to a regulatory approval process, i.e. 15 per year from 2025. This is also consistent 
with the Argentina and US figures for the early years of notification-type systems and with 
the estimates from  the  UK 2022 impact  assessment1 for the new legislation on precision 
breeding organisms. 

Regarding the number of products that would fall under the notification or authorisation, 
we  were  not  able  to  rely  on  the  pipeline  data.  We  relied  on  the  impact  assessment 
conclusions  of  the  expected  attractiveness  of  each  option  and  assumed  that  notification 
would  entail  65%  of  the  total  applications  and  authorisation  would  entail  35%  (10 
notifications and 5 authorisations per year). 

I. Overview of Benefits (total for all provisions) – Preferred Option 

Description 

Cost savings for 
breeders 

Amount 

Direct benefits 

Notification:  Compared to the baseline breeders are expected to 
have a reduction in compliance costs, due to the removal of the 
detection method requirement, the removal of the post-market 
environmental monitoring and to the change in data requirements 
for the notification (data to show compliance with the notification 
criteria instead of data for a risk assessment).  
The savings for the breeders per notification are estimated to range 
from EUR 9 952 000 to EUR 11 171 000. 
Authorisation: Compared to the baseline, breeders are expected to 
have a reduction in compliance costs linked to the data requirement 
for the adapted risk assessment. These savings will be variable as 
the adapted risk assessment will not treat all products in the same 
way. 
The savings for the breeders per authorisation are estimated to 
range from EUR 0 to EUR 10 365 000. 
Incentives: The waiving of fees for the validation of the detection 
methods is considered as a potential incentive would add an extra 
saving for breeders in the authorisation procedure which would be 
of EUR 105 000 except for SME for which the savings would be of 
EUR 52 5002. 
Total savings for breeders under the preferred option: 
Total savings for notification are estimated to range from EUR 99 

Comments 

For the notification, the 
estimated savings are dependent 
on the future data requirements 
for the notification. 

For the authorisation, the 
estimated savings Are 
dependent on the future data 
requirements for the risk 
assessment and by the type of 
NGT 

Total savings for breeders under 
the preferred option: A 
hypothetical scenario was used 
in which the breeders would 
submit 10 notifications and 5 
authorisations per year. These 

1 https://publications.parliament.uk/pa/bills/cbill/58-03/0011/GeneticTechnologyBill_IA_0526.pdf 
2 Fees for the validation of the detection methods for GMO by the EURL are described in Regulation (EC) 
1981/2006. Article 4 of this Regulation currently sets up a 50% reduction of the fees for SMEs. 

124 

 
 
 
 
 
 
 
 
                                                           
Cost savings for 
administrations3 

520 000 to 111 710 000 per year. 
Total savings for authorisation are estimated to range from EUR 0 to 
51 825 000 per year. 
Notification: Compared to the baseline scenario, Member States 
administrations are expected to have cost reductions due to the 
change in data requirements for the notification and to the removal 
of the traceability and labelling obligation.  
The savings for administrations are estimated to be up to EUR 140 
000 for the analysis of the data for notification. In addition, it is 
estimated that Member States would have significant savings in the 
enforcement, due to the removal of the traceability and labelling 
requirement, but these were not quantifiable.  
Authorisation: Compared to the baseline scenario, Member States 
administrations are expected to have costs reductions due to the 
adapted data requirement for the risk assessment. 
The savings for administrations are estimated to range from EUR 0 
to EUR 140 000. 
Total savings for administrations under the preferred option: 
Total savings for notification are estimated to be up to EUR 1 400 
000 per year. 
Total savings for authorisation are estimated to range from EUR 0 to 
700 000 per year. 

are recurrent savings per year. 

For the notification, no data 
were available for the savings as 
the notification is linked to new 
data requirements. The 
monetisation of this saving 
corresponds to a hypothetical 
scenario in which the only 
requirement would be the 
current requirements for 
molecular characterisation of a 
GMO. 

Total savings for 
administrations under the 
preferred option: A hypothetical 
scenario was used in which the 
breeders would submit 10 
notifications and 5 
authorisations per year. These 
are recurrent savings per year. 

Net economic 
impact/market value 
for farmers 

Time to market 

Regulatory certainty 
(likelihood that a 
product is able to be 
admitted to the 
market after the 
R&D-process) 

Trade 

Environmental 
benefits – pesticide 
reduction 

Environmental 
benefits: fertiliser 
reduction 

Range of 9% per hectare yield improvement (for oil and fibre crops) 
to 16% (for cereals) by 2030-2035. This represents, when including 
cost savings from reduced input use, a total annual economic 
market value of EUR244 m (for oil and fibre crops) to EUR2.7 bn (for 
cereals).  
Expected economic benefits to further grow afterwards as more 
NGT plants are authorised / accepted under the notification 
procedure and more crops are introduced. 
Breeders: Reduction of the current 4.5-year risk assessment period 
for imports (6 years for cultivation). Reduction depends on case-
specific data requirements. 
Application of NGTs leads to significant shorter development times 
and lower development costs. For example, the introduction into 
the market of a NGT potato variety is estimated to take five years, at 
a cost of EUR0.5 m instead of 13-15 years for a conventionally bred 
variety, at a cost of EUR2-3 m per variety. 
Work on the criteria for risk assessment is intended to ensure 
adaptability (requirements proportionate to hazards on a case-by-
case basis depending on the plant’s risk profile), and predictability 
(ability of potential applicants to anticipate regulatory 
requirements). Work on the equivalence criteria for notification is 
intended to ensure predictability (ability of potential applicants to 
anticipate whether the requirement for notification would be met) 
and based on the product’s molecular characterisation 
The preferred option minimises (compared to the other options)  
regulatory divergence with EU trade partners. For example, the 
detection of non-authorised GMO Triffid flax in EU food products 
and the subsequent import ban on Canadian flax led to a EUR40 m 
loss for the EU flax processing industry and 600 jobs lost 
According to the JRC study of Schneider et al. (2023a, b; see Annex 
7):  

For cisgenic potatoes: 50-80% reduction of fungicide usage, or 9 kg 
per hectare, without impacts on yield or quality.  

For cisgenic apples bred with monogenic resistance against scab 
disease: reductions between 14% in the Netherlands and 58% in 
France could be achieved, the latter equivalent to 15 kg per hectare 
less fungicide use. 

Projections 2030-2035 based on the contractor’s study: 

A decrease of 0.1% and 4%, depending on crop species and rate of 

3 Cost savings for the EU institutions were not considered for this table.  

125 

Differences in the regulation of 
NGTs increase the likelihood of 
regulatory asynchronicity.  

 
 
 
 
 
 
 
 
  
  
  
                                                           
adoption of NGT plants 

Environmental 
benefits: GHG 
reduction 

Multipurpose use of gene-edited root chicory (production of inulin 
and health-beneficial terpenes): reduction of GHG emissions of 
around 10% compared to the current inulin production process 
when considering the entire value chain. 

Use of gene-edited pennycress (Thlaspi arvense) as a cash cover 
crop for biofuel production without displacing food crops 
Projections 2030-2035 based on the contractor’s study: 

A decrease of up to 3.1% depending on crop species and rate of 
adoption of NGT plants. 

Social benefits – 
Health: nutritional 
impacts-food 
security 

Health benefits for consumers would result from increased 
beneficial bioactive compounds in food and feed, such as increased 
levels of vitamin A, antioxidants, production of monounsaturated 
fatty acids and GABA. Moreover, harmful bioactive compounds such 
as cyanide, glycoalkaloids, allergens could be removed. 

NGTs may affect overall health benefits (in terms of QALYs) in 
different ways, including improving the accessibility to products that 
might lead to healthier diets. 

Such direct and indirect benefits are presented by the JRC study of 
Sanchez et al. (2023), described in Annex 7 on low-gluten wheat.  

Food security benefits are especially relevant for developing 
countries, as Annex 7 demonstrates with the example of Maize 
Lethal Necrosis (MLN) resistance, a severe threat to food security in 
Eastern Africa.  

Consumers will experience improved product choice. 

Administrative cost savings related to the ‘one in, one out’ approach* 

Notification: 
Reduction in administrative costs related to regulatory support is 
expected. The savings for breeders are estimated to range from EUR 
83 300 to EUR 833 000. 
 Reduction in administrative costs related to scientific support. The 
savings for breeders are estimated to range from EUR 35 700 to EUR 
357 000. 
Reduction of the administrative costs as the data requirements for 
notification may not require studies to be performed under GLP/ISO 
guidelines. The savings for breeders are estimated to range from 
EUR 56 000 to EUR 1 120 000.  
Reduction of administrative costs as the notified NGT plant will not 
require the submission of post-market monitoring. The savings for 
breeders are estimated to be EUR 1 200 000. 
Reduction in administrative costs as the notified NGT plants will not 
be subject to a renewal procedure. The savings for breeders are 
estimated to be EUR 240 000. 
The total savings per notification is estimated to range from EUR 1 
615 000 to EUR 3 750 000 
Authorisation: 
Reduction in administrative costs related to regulatory support is 
expected. The savings for breeders are estimated to range from EUR 
0 to EUR 833 000. 
Reduction in administrative costs related to scientific support. The 
savings for breeders are estimated to range from EUR 0 to EUR 357 
000 
Reduction of administrative costs as the data requirement in the 
adapted risk assessment for authorisation may not require or may 
require less studies to be performed under GLP/ISO guidelines. The 
savings for breeders are estimated to range from EUR 0 to EUR 560 
000. 
The total savings per authorisation is estimated to range from EUR 0 
to EUR 1 750 000 
Total administrative cost savings for breeders under the preferred 
option: 
Total administrative cost savings for notification are estimated to 

For the notification, the 
estimated savings are dependent 
on the future data requirement 
for the notification. 

For the authorisation, the 
estimated savings are dependent 
on the future data requirements 
for the risk assessment and by 
the type of NGT 

Total savings for breeders under 
the preferred option: A 
hypothetical scenario was used 
in which the breeders would 
submit 10 notifications and 5 
authorisations per year. These 
are recurrent savings per year. 

Social benefits: 
consumer variety 
and choice 

Administrative cost 
savings for breeders 

126 

 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
range from EUR 16 150 000 to 37 500 000 per year. 
Total administrative cost savings for authorisation are estimated to 
range from EUR 0 to 8 750 000 per year. 
Notification: Unquantifiable recurrent savings are in administrative 
costs for food businesses is expected due to the removal of the 
traceability and labelling obligation. 

Administrative costs 
saving for food 
businesses 

II. Overview of costs – Preferred option 

Breeders 

Administrations 

Farmers and food businesses 

Notification of a 
NGT product 

Indirect costs  

n/a 

n/a 

Recurrent costs for organic farmers. 
Potential unquantifiable increases 
costs risk management practices and 
market monitoring (for accidental 
presence of GM/NGT product) due to 
the uncertainties of potential 
presence of notified NGT plants in 
conventional seeds. 

Recurrent costs for farmers. potential 
unquantifiable costs for 
segregation/coexistence systems. 

Authorisation of a 
NGT product 

Administrative 
costs 

n/a 

n/a 

Recurrent costs for food businesses. 
Limited unquantifiable cost increases 
due to additional information in the 
label (identification on the label of the 
purpose of the genetic modification 
to the label) and related segregation 
costs. 

127 

 
 
 
 
  
 
Incentive for NGT 
products with 
traits that can 
contribute to 
sustainability 

Direct 
adjustment 
costs 

 n/a 

One-off costs: Support 
given to the applicant 
during authorisation 
process due to 
sustainability incentive. 
Potential unquantifiable 
significant increase in cost 
for the administrations 

Costs related to the ‘one in, one out’ approach 

Direct 
adjustment 
costs  
Indirect 
adjustment 
costs 
Administrative 
costs (for 
offsetting)  

n/a 

n/a 

n/a 

n/a 

None 

None 

Total  

n/a 

n/a 

Unquantifiable increase for farmers. 

Recurrent costs for food businesses. 
Limited unquantifiable cost increases 
due to additional information in the 
label (identification on the label of the 
purpose of the genetic modification 
to the label) and related segregation 
costs. 

3.  Relevant sustainable development goals 

III. Overview of relevant Sustainable Development Goals – Preferred Option(s) 

Relevant SDG 

Expected progress towards the Goal 

Comments 

Examples are cisgenic 
potato and cisgenic 
apple as well as a 
virus-resistant maize 
presented in Annex 7. 

SDG no. 2 – End 
hunger, achieve 
food security and 
improved nutrition 
and promote 
sustainable 
agriculture 

-  The initiative facilitates the application of speedy 

- 

innovative plant breeding to a wide variety of crops, 
including regionally important crops, and traits. 
It contributes to three of the four components of food 
security – food availability, stability and utilisation – 
by providing a framework to address traits 
contributing to pest resistance, yield, yield stability, 
pesticide and fertiliser use and resistance to abiotic 
factors (e.g. drought, temperature). 

-  NGTs could be relevant in low- and middle income 
countries, which would benefit from adapting 
traditional, local crop species so that they can 
withstand changing conditions. An enabling 
framework in the EU could also support use in those 
countries. 

SDG no. 3 - Good 
Health and Well-
being 

SDG no. 9 - Build 
resilient 
infrastructure, 
promote inclusive 
and sustainable 
industrialization 
and foster 
innovation 

- The initiative facilitates the breeding of diverse 

nutritious and healthy foods. Health benefits for 
consumers could result from increased beneficial 
bioactive compounds in food.  

- 

- 

The initiatives promotes research in plant breeding, 
strengthens the research capacity in plant 
biotechnology and facilitates the development of 
innovative products 
The NGT R&D pipeline contains plants with traits 
supporting sustainable farming practices and with 
novel functional traits with health benefits for 
consumers 

One example is the 
low-gluten wheat 
presented in Annex 7. 

One example is the 
root chicory presented 
in Annex 7. 

128 

 
 
 
 
 
SDG no 12 - 
Responsible 
consumption and 
production. 

-  NGTs can contribute to the sustainable management 
and efficient use of natural resources by addressing 
traits improving, for example, nutrient and water use 
efficiency.  

SDG no. 13 - Take 
urgent action to 
combat climate 
change and its 
impacts 

-  NGTs can contribute to resilience adaptive capacity 
to climate-change related impacts by supporting 
sustainable farming practices (no tilling), the 
development of biofuel crops not requiring land use 
change and land saving. 

One example is a 
modified maize that is 
more resistant to 
climate stress, for 
which the field trials 
are on-going in the 
EU4. 

Cover cress (Thlaspi 
arvense) is an example 
of a cover crop 
(thereby not requiring 
land use change) 
helping to restore soil 
fertility and which can 
also be used to 
produce biofuels 

4 
https://webgate.ec.europa.eu/fip/GMO_Registers/GMO_Summary.php?NotificationNum=B/BE/22/V3
&Cat=gmp  

129 

 
 
 
 
 
 
 
                                                           
ANNEX 4: ANALYTICAL METHODS 

1.  JRC CASE STUDIES  

Objectives  

The JRC conducted three case studies for the purposes of this impact assessment1:   

  Economic  and  environmental  impacts  of  disease  resistant  apples  and 

potatoes developed with cisgenesis  

  Socio-economic impact of low-gluten celiac-safe wheat developed by gene 

editing  

  Biotic  resistance  in  the  context  of  smallholder  farming  in  East  Africa:  a 
case on gene editing of maize to safeguard food security under the spread 
of the Maize Lethal Necrosis 

Selection criteria for the JRC case studies 

Different  criteria  were  used  to  select  the  three  JRC  case  studies  included  in  this  staff 
working  document:  economic  importance  of  the  crop,  objective  of  the  Green  Deal  to 
which  it  contributes,  and  type  of  technology  used  for  its  development.  In  addition,  the 
product development stage and the information on the traits of the selected case studies 
had to be publicly available.  

The first criterion was the socioeconomic importance of the crop at European and global 
level,  as  well  as  any  potential  contribution  of  the  product  developed  to  the  European 
Green Deal objectives and the Farm to Fork and the Biodiversity Strategies. The fungal-
resistant  potato  and  apple  case  was  selected  because  these  crops  are  important  for  the 
European  agricultural  sector  and  cuisine.  Both  crops  are  currently  intensively  managed 
through  pesticides,  and  the  respective  pathogens  demand  the  majority  of  the  pesticide 
treatments in those crops. The case of low-gluten, celiac-safe wheat was chosen because 
wheat is a fundamental crop for human consumption, and it is highly appreciated for its 
gluten which enables dough production for baking. However, in turn, gluten is the cause 
triggering  gluten-related  disorders  in  genetically  predisposed  individuals  worldwide. 
Lastly,  the  virus-resistant  maize  was  selected  as  case  study  because  maize  is  a  major 
staple  crop  that  significantly  contributes  to  the  sustenance  of  millions  in  East  Africa 
where the control of the MLN disease is challenging due to economic constraints. 

A  second  criterion  corresponded  to  the  technology  used.  The  three  case  studies  use 
techniques  that  are  under  consideration  in  this  policy  initiative  and  were  selected  to 
include products both of cisgenesis and of targeted mutagenesis. In the case of the fungal-
resistant  potato  and  apple,  both  crops  are  notoriously  challenging  to  breed  using 
conventional  approaches.  In  the  case  of  low-gluten,  celiac-safe  wheat,  it  is  extremely 
difficult to apply conventional breeding techniques to obtain comparable wheat varieties. 
Conventional  breeding  approaches  to  achieve  MLN  virus-resistant  maize  plants  are 
estimated to take longer time and higher resources than the gene editing ones. 

The  last  criterion  was  the  product  development  stage  and  the  availability  of  public 
information  on  the  product.  Several  products  in  the  development  pipeline  were  just  in 

1 See Annex 7 for details 

130 

 
 
 
                                                           
proof-of-concept stage, or data were unavailable due to confidentiality provisions. In the 
case  of  fungal-resistant  potato  and  apple,  the  developments  are  beyond  a  proof-of-
concept  with  field-trials  supporting  the  evidence  collection,  and  the  cisgenic  varieties 
have  been  developed  by  European  institutes.  Low-gluten,  celiac-safe  wheat  lines  have 
already  been  cultivated  in  greenhouses,  and  the  varieties  have  been  developed  by  two 
main research centres in the EU with published scientific evidence. Virus-resistant maize 
plants  are  currently  being  tested  in  greenhouse  trials,  and  the  varieties  have  been 
developed by an international research organization in collaboration with an agricultural 
research company.    

Approach  

Economic  and  environmental  impacts  of  disease  resistant  crops  developed  with 
cisgenesis 

To  compute  potential  hectare-level  cost  savings  from  the  cultivation  of  the  cisgenic 
varieties, a stochastic partial budgeting model was used to simulate changes in expenses 
for  plant  protection  products.  The  model  assumes  that  output  and  other  costs  remain 
unchanged,  which  is  supported  by  the  field-trial  data.  Country-specific,  hectare-level, 
economic  data  for  the  years  2014  to  2017  was  obtained  from  the  IFM-CAP  model  and 
used to characterize costs and outputs of typical arable crop (fruit) farms with a revenue 
share  of  more  than  60  %  from  potatoes  (apples).  The  model  assumes  that  the  share  of 
fungicides on total pesticide use equals the cost share of fungicides on expenses for plant 
protection products. Notably, this approximation is unable to account for potential price 
differences between fungicides, insecticides, and herbicides. 

To  aggregate  the  simulated  hectare-level  savings  to  a  country-level  across  different 
scenarios  for  the  adoption  rate,  the  median  parameter  values  for  the  partial  budgeting 
model were used and aggregated the hectare-level results to the Member States' area of 
production multiplied by a given adoption rate. 

To  simulate  potential  sector-wide  implications,  the  Common  Agricultural  Policy 
Regionalised Impact analysis (CAPRI) model was used to shock the cost curve under two 
adoption scenarios. For our discussion on the potential contribution to the national HRI 
reduction, we used estimates of the employed quantities of active substances in German 
potatoes and apples published by the Julius Kühn Institute. Through cross-referencing the 
database  on  the  HRI-categorization,  JRC  derived  that  majority  of  the  currently  used 
active substances are in groups two and higher. 

To  simulated  potential  changes  in  greenhouse  gas  emissions  related  to  agricultural 
activities under the adoption scenarios for the cisgenic potato variety, the CAPRI model 
was used to calculate N2O-emissions and CO2-equivalents due to land-use change under 
the two adoption scenarios. 

To  calculate  country-specific  distributions  of  minimum  distances  between  fields  and 
freshwater  systems,  spatial  data  from  Copernicus  and  D'Andrimont  et  al.  were  used  to 
calculate  the  Euclidean  distances  between  land-use  pixels  and  different  types  of 
freshwaters. To calculate changes in fungicide risk in Lower Saxony, the SYNOPS model 
was used in conjunction with the field trial fungicide spraying schedules, land-use, soil, 
and weather data. In SYNOPS, risk indices are expressed as the Exposure Toxicity Ratio, 
calculated  as  the  ratio  of  the  Predicted  Environmental  Concentration  to  the  toxicity 
endpoints  half  maximum  effect  concentration,  lethal  concentration,  lethal  rate,  lethal 
dose, and no-effect concentration for specific reference species. 

131 

 
 
Socio-economic impact of low-gluten celiac-safe wheat developed by gene editing 

For the impact analysis, it is assumed that the gene-edited low-gluten, celiac-safe wheat 
has passed the mandatory regulatory risk assessment and is accepted for EU cultivation 
and  market.  It  is  assumed  that  low-gluten,  celiac-safe  wheat  will  be  a  niche  product, 
likely bought by CD, NCWS and other patients and consumers willing to reduce gluten 
consumption. Given the lack of observable data since the product is not yet available on 
the market or cultivated in the EU, a literature review on similarities and differences with 
standard wheat and with other similar specific products (e.g. gluten-free products) already 
existing on the market was carried out. Data collected to be used in the impact analysis 
mainly  come  from  scientific  articles  published  in  peer-reviewed  journals  listed  in  the 
Web  of  ScienceTM,  PhD  theses  and  reports  produced  by  different  celiac  and  consumer 
associations.  Data  from  the  European  Commission  database  on  agricultural  production 
and  trade  and  the  EU  FADN  (farm  accountancy  data  network)  were  used  for  the 
economic analysis.  

To assess the social and health impacts different parameters were calculated including i) a 
price comparison between the cost of the current gluten free diet and the current financial 
support to cover it, the standard diet cost, and the diet with low-gluten celiac-safe wheat 
cost;  ii)  the  potential  benefits  of  low-gluten,  celiac-safe  wheat  from  a  nutritional 
perspective  qualitatively  measured;  and  iii)  the  estimation  of  costs  for  the  healthcare 
system post-diagnosis for celiac disease patients consuming low-gluten, celiac-safe wheat 
and, the reduction of related work productivity loss. To assess the economic impacts, an 
analysis  of  whether  potential  cost  fluctuations  could  be  expected  for  the  agricultural 
production of low-gluten, celiac-safe wheat in terms of crop yield changes, changes to the 
use of fertilisers and plant-protection products and changes to management practices was 
carried out. The potential impact of the adoption of the low-gluten, celiac-safe wheat on 
gross  margins  in  the  EU  was  calculated  by  comparing  with  a  standard  farm  budget  for 
standard wheat.  Lastly, the impact of low-gluten, celiac-safe wheat adoption for the EU 
agri-food system was measured as i) potential benefits for the wheat value chain, and ii) 
changes  on  exports  and  imports  depending  on  three  levels  of  adoption  considering  the 
prevalence of gluten-related pathologies. 

Biotic  resistance  in  the  context  of  smallholder  farming  in  East  Africa:  a  case  on  gene 
editing of maize to safeguard food security under the spread of the Maize Lethal Necrosis 

For  this  case  study,  no  original  research  was  carried  out.  In  this  case,  the  JRC  team 
reached  out  to  the  developers  at  CIMMYT  obtain  permission  to  summarize  existing 
research  undertaken  at  this  institution  both  in  terms  of  technology  for  development, 
comparison with conventional breeding and economic impacts based on modelling. The 
original sources are referenced in the case study.  

Use  

Insights from the case studies were integrated both in the contractor’s study report and in 
the section 6 of the Staff Working Document, mainly supporting individual impact areas. 

132 

 
 
 
2.  DOCUMENT REVIEW 

Objective  

Desk  research  was  carried  out  to  identify  relevant  reports,  opinions,  scientific  and  grey 
literature  to  provide  further  evidence  for  the  problem  analysis,  to  identify  experts  for 
interviews, focus groups, and surveys, and identify data to support potential quantitative 
gaps.   

Approach  

The  document  review  followed  a  targeted  search  on  documents  related  to  impacts  and 
main  stakeholder  categories.  This  resulted  in  a  qualitative  scanning  exercise  of  172 
documents.  A  qualitative  assessment  of  the  content  yielded  31  to  71  documents  per 
impact category. The documents were processed in the Atlas.ti and coded. The relevant 
information per impact was then extracted to serve as information per impact area.  

Use  

The  analysis  of  the  documents  helped  in  the  design  of  interviews  and  consultations,  to 
substantiate  the  various  statements  put  forward  in  the  survey  and  the  identified  impact 
areas  and  to  analyse  impacts.  Furthermore,  it  was  used  to  substantiate  the  findings 
through triangulation. 

3.  DESCRIPTION OF REGULATORY SITUATION IN OTHER JURISDICTIONS 

Objective 

The  global  regulatory  situation  may  impact  several  aspects  considered  in  the  impact 
assessment, including trade, enforcement, availability of products,  competitiveness.  The 
objective was to identify countries that have recently adapted the regulatory oversight to 
genome  edited  products  or  have  announced  that  they  are  considering  it.  In  addition, 
examples were sought also on countries that have decided not to do adaptations. 

Approach 

For  the  description  of  the  regulatory  situation  of  NGTs  in  third  countries,  the 
Commission  relied  on  available  information  from  scientific  publications,  official 
websites,  legislation  (referenced  in  section  1.4.).  The  description  covers  the  US,  Japan, 
Argentina, India, the UK, China, Kenya, Nigeria, Switzerland, Canada, New Zealand and 
South Africa. 

Use  

The  analysis  of  the  documents  was  used  to  summarise  the  approach  to  regulatory 
oversight on genome editing in third countries and to assess impacts linked to regulatory 
developments outside the EU (in particular as regards trade and competitiveness). 

133 

 
 
4.  STAKEHOLDER CONSULTATION STRATEGY  

Objective  

In  line  with  Tool  #53  of  the  Better  Regulation  Toolbox,  the  consultation  strategy2  was 
designed  to  gather  evidence  and  views  from  the  public  and  from  a  broad  range  of 
stakeholders across all levels of the agri-food chain, and beyond, who are impacted by or 
interested in the products under the scope of this initiative, and to reach a high degree of 
complementarity  among  the  various  consultation  actions:  Inception  impact  assessment, 
public consultation, targeted survey, targeted interviews, focus groups. More particularly, 
the consultation activities were designed to allow all interested parties to provide relevant 
information on the problems presented, the baseline scenario, and on the potential ways 
forward;  to  assist  the  Commission  in  understanding  the  implications  of  the  possible 
policy  options  for  the  different  stakeholders  involved;  to  enable  identifying  additional 
policy elements and ensure that no impacts are overlooked. 

The  consultation  activities  also  built  on  and  took  into  account  the  information  received 
during the comprehensive targeted consultation with Member State competent authorities 
and EU-level stakeholder associations carried out in the context of the Commission NGT 
study.  

See detailed analysis of stakeholders’ contributions in Annex 2 – Synopsis report. 

Approach  

Following  the  consultation  objectives,  a  broad  range  of  stakeholders  were  identified  in 
the consultation  strategy. This  included operators active, from  farm to  fork, in  the  agri-
food  and  feed  system  (including  farmers,  seed  and  plant  breeders,  traders,  processors, 
manufacturers, retailers and food services, GM-free and organic operators), operators of 
plant and bio-based industries active in sectors other than the agri-food sector, academic 
and 
research  stakeholders,  civil  society/non-governmental  organisations,  public 
authorities at EU and national level in the EU and third country public authorities. They 
represent  stakeholder  categories  directly  relevant,  i.e.  stakeholders  affected  by  the 
legislation  on  GMOs,  and  stakeholders  involved  in  the  implementation  or  with  a  stated 
interest in the policy.  

Stakeholders  invited  to  participate  in  targeted  consultation  activities  were  identified  by 
the  external  contractor,  based  on  the  objectives  and  stakeholder  categories  of  the 
consultation  strategy,  and  with  the  aim  of  ensuring  representation  of  all  stakeholder 
categories. Concerning the mapping of economic operators, country coverage and size of 
enterprises were two important aspects, which does not mean that all EU Member States 
would be equally represented but rather that economic characteristics would be taken into 
account.  In  order  to  capture  the  large  spectrum  of  economic  operators,  EU-level 
associations were identified.   

At  national  level,  public  authorities  in  charge  of  the  implementation  of  the  GMO 
legislation  and  enforcement  of  the  Directive  and  market  surveillance  authorities  were 
addressed in the consultation.  

The mapping of the stakeholders was based on:   

2 https://food.ec.europa.eu/system/files/2022-09/sc_modif-genet_consultation-strategy-ngts.pdf 

134 

 
 
                                                           
  desk research (see section 2)  
 

the  contributions  of  the  Member  States  and  EU-level  associations  to  the 
targeted consultation in the context of the 2021 Commission NGT study  
the analysis of the respondents of the inception impact assessment  

 
  expert contributions  
 
the use of Crunchbase (for companies) and   
  Scopus, for the identification of academic experts 

An internal database of stakeholders was developed to include    

  Research organisations  
  Non-governmental organisations  
  Competent authorities  
  Private-sector organisations  
  Stakeholder organisations (associations)  
 
  Other   

Individual experts  

For  national  authorities,  the  national  competent  authorities  for  the  purposes  of  GMO 
legislation were contacted.  

The database structured the collected information into name, email, organisation, country, 
type  of  organisation  and  stakeholder  type.  It  contained  more  than  650  individuals  from 
around  570  organisations.  In  addition,  about  1.100  researchers  were  identified  through 
Scopus. This list served as a wide reserve in case of a need of academic experts.   

Use   

The  stakeholder  database  was  used  as  the  basis  for  the  selection  of  the  targeted  survey 
respondents and of the interview partners. Interviewees were asked to suggest individual 
organisations  which  could  be  invited  to  the  stakeholder  survey.  The  interviewed 
stakeholders were equally invited to the stakeholder survey. Cost interview partners were 
either  addressed  following  the  general  interviews  or  based  on  further  dedicated  desk 
research. In view of workshops, case studies and focus groups, additional desk research 
was  conducted  to  identify  relevant  experts.  The  focus  groups  benefited  also  from 
organisations which had been interviewed in the first phase.  

135 

 
 
Figure 1 Flow diagram of use of stakeholder in consultation  

Source: Technopolis Group  

5.  INTERVIEWS  

Objectives  

An interview programme was set up by the external contractor. It involved a selection of 
the  main  stakeholder  groups  (economic  operators,  research,  and  non-governmental 
organisations,  as  well  as  authorities  at  EU  and  national  levels).  The  60  interviews  were 
divided into three groups:  

1. 
2. 
3. 

General interviews with key stakeholders. 
Interviews focused on regulatory cost assessment (see section 4).  
Interviews for the case studies (see section 8).  

The objective of the interviews with (1) key stakeholders was to tap into the knowledge of 
the  main  stakeholder  types  regarding  possible  effects  and  impacts  of  the  policy 
components.  The  second  (2)  group  of  interviews  focused  on  current  and  potential 
regulatory  and  administrative  costs.  (3)  For  the  case  studies,  technical  experts  were 
targeted.  In  case  of  third  countries,  relevant  associations  with  the  relevant  geographic 
knowledge were approached.   

Approach  

General interviews  

Through the desk research, document analysis, and exchange with the Commission as well 
as  the  project’s  internal  experts,  the  external  contractor  identified  relevant  organisations 
and  potential 
their  (1) 
expertise/knowledge  and  (2)  strategic  positioning  in  the  debates  on  agricultural 
biotechnology,  and  with  the  aim  of  ensuring  representation  of  the  main  stakeholder 

interviewees.  They  were  selected  based  on 

individual 

136 

 
 
 
categories. In addition, the economic operators were selected on the basis of their potential 
to act as ‘multipliers’ for the dissemination of the targeted survey.  

General interview guideline  

Box 1 provides the guideline for the general interviews used by the external contractor. 

Box 1. Interview guideline for the stakeholder interviews 

The objective of the stakeholder interviews is to collect expert opinions and data in order to 
map potential effects and impacts of the different components of the policy scenarios. We 
aim to tap into the knowledge of the federations and its members through these interviews.  
The objective of the stakeholder interviews differs from the open consultation survey. In the 
survey, each stakeholder has the opportunity to provide their position towards the possible 
components of the policy scenarios and the current GMO/NGT policy.  
With the interviews, we would appreciate a neutral and open conversation regarding 
possible effects and impacts in the value chain and wider economy and society.  
The interview will follow a semi-structured guide and is based on the Theory of Change 
developed during the inception phase of the study. Policy options reflect the public open 
consultation conducted by the Commission. 
Responses are recorded in an interview report and kept anonymous unless indicated 
otherwise by the interviewee.  

I  Introduction 

1.  Introduction of interviewee 

2.  Introduction of the EU-level federation / association and its sectors and main 

activities  

3.  Relevance of NGTs for federation members 

a.  (Expected) development and use of NGTs in respective section of the value 

chain 

b.  General assessment of current obstacles and enablers of development and 

use of NGTs in respective section of the value chain 

II  Risk assessment and detection requirements 

Explain: policy scenario components, implementation effects, value chain and wider impacts  
Risk assessment and detection requirements: explanation of main elements 
0: Unchanged policy and regulation  
A1: Authorisation with risk assessment adapted to risk profile and adapted detection 
method requirements  
Risk assessment proportionate to the NGT product’s risk profile. Detection method required, 
but differentiation of NGT product from conventional product not required if not possible 
A2: Pre-notification of products that are also obtainable naturally or by conventional 
breeding with decision on regulatory status 
Risk assessment not needed if NGT product can also be obtained naturally or by 
conventional breeding. Detection not needed if NGT product can also be obtained naturally 
or by conventional breeding 

Topics to be discussed; probe with developed indicators in area of expertise:  

4.  How do you expect regulatory product approval costs for applicants to change under 

option A1 and option A2? 

5.  To what degree do you expect the policy options to impact the attractiveness of 

introducing new plant varieties on to the market by plant breeders? 

6.  How will these options impact the availability and attractiveness of using new plant 

varieties by farmers? 

7.  In terms of safety of gene-edited/cisgenic crops and derived products, do you 

expect changes in safety under option A1 and A2?  

8.  Could you assess impacts of the policy options on the wider value chain, including 

137 

 
 
 
 
productivity, turnover and value added of economic operators (plant breeders, 
farmers, processors, etc.)? 

9.  Could you assess the impacts of changed risk assessment and detection 

requirements on: 

 

 

EU competitiveness and trade? 

Innovation and research?  

  SME competitiveness? 

III Labelling and Traceability Requirements 
Explain policy scenario components, implementation effects, value chain and wider impacts 
0:  Unchanged policy and regulation 
B1: Additional sustainability label and traceability 
Labelling as today, coupled with additional label for sustainability claims, referring to the 
sustainability contribution of the introduced trait. Traceability as today, coupled with 
additional traceability to ensure information on the sustainability contribution. 
B2: No labelling if sustainable, with traceability and transparency requirements  
No specific labelling needed, but inclusion in public registry, if NGT product contributes to 
sustainability. Traceability as today, coupled with additional traceability to ensure 
information on the sustainability contribution    
B3: No labelling and specific traceability requirements if a product obtainable naturally or by 
conventional breeding. Transparency requirements  
Labelling not needed if NGT product can also be obtained naturally or by conventional 
breeding, but inclusion in public registry. Traceability not needed if NGT product can also be 
obtained naturally or by conventional breeding 

10. Could you assess the most significant impacts of the policy options in terms of 

 

 

Labelling and traceability costs in the value chain? 

Labelling and traceability quality in the value chain? 

11. Could you assess the effect of the policy options on the enforcement quality and 

transparency? 

12. Could you assess the impacts of the policy options on consumer trust and 

information rights? 

IV  Sustainability 
Explain policy scenario components, implementation effects, value chain and wider impacts 
0: Unchanged policy and regulation 
C1: Sustainability incentives for authorisation  
Positive regulatory incentives for authorisation: NGT plant products with traits that 
contribute to sustainability objectives receive regulatory positive incentives for 
authorisation, e.g. regulatory and scientific advice before and during the approval 
procedure, measures to facilitate the approval process (waiving of fees, faster procedures), 
allowing sustainability-related claims to appear on the final product. 
C2: Sustainability requirement: no authorisation if detrimental to sustainability  
NGT Plant products with traits that are detrimental to sustainability objectives are not 
authorised 

13. Do you expect an increase in NGT plant products with traits that contribute to 

sustainability objectives in case of regulatory positive incentives for authorisation? 

14. Could you assess potential environmental impacts under C1/C2 on: 

  Biodiversity 

 

 

Pesticide use 

Fertilizer use 

  Use of natural resources 

V  Collaboration in study 

15. Do you have data on costs and benefits (qualitative and quantitative information) 

relevant to the impact assessment and would you be willing to share this 

138 

 
 
 
 
information? 

Cost interviews 

For  the  cost  assessment  interviews,  23  different  organisations  were  approached  (SMEs, 
large  companies,  public  authorities,  regulatory  authorities,  etc.).  They  were  identified 
through  the  initial  stakeholder  mapping  exercise.  Following  an  initial  list  of  suggested 
organisations and authorities, a first  group of potential  organisations were contacted.  In 
the course of the study, more organisations were approached. The focus here was not on 
coverage of all stakeholder groups, but those involved in the regulatory approval process. 

Consecutive  discussion  rounds  with  public  and  private  entities  have  been  conducted, 
where the purpose of the exercise was explained. During the discussions, several public 
and private entities dropped out from being prospective data providers. Some considered 
that the required level of detail of data was not feasible to provide. This was either due to 
time constraints or due to a mismatch of available company cost categories and the level 
of breakdowns required.  

Overall,  a  caveat  for  the  cost  data  was  the  limited  to  no  experience  with  GMO 
applications in Europe at industry level, the large ranges within estimated cost categories 
and  difficulties  in  triangulating  rather  patchy  data  with  equally  patchy  evidence  from 
literature and insights from experts.  

Case study interviews  

It  has  been  extremely  challenging  to  attract  interview  partners  for  the  case  studies,  in 
particular  those  that  dealt  with  third  countries.  Most  cases  identified  relevant 
organisations during the concept-note phase, yet several did not respond when contacted, 
even after repeated reminders.   

Use  

The  insights  from  the  general  interviews  helped  greatly  to  understand  the  expectations 
and  concerns  of  various  stakeholders  and  identify  relevant  impact  areas.  Together  with 
insights  from  document  analysis, interviews were also  used to  formulate several  survey 
questions. Interviewees were asked to suggest relevant additional individual stakeholders 
(mainly breeders and retailers) which were added to the survey.   

The  cost  interviews  and  the  data  gathered  (calculations  made  and  qualitative 
explanations) provided were the basis for the efficiency sections of the final report.   

6.  TARGETED STAKEHOLDER SURVEY  

Objective  

The goals of the targeted survey were primarily   

 

 

 

to  collect  the  informed  views  and  information  from  stakeholders  on  the 
performance  of  the  current  baseline  scenario  as  a  benchmark  to  support  the 
assessment of efficiency  
to  collect  the  views,  information  and  assessments  on  the  various  impacts  of  the 
policy components  
to test the key elements of policy options on the impact indicators  

139 

 
 
 

to  collect  information  on  costs  or  other  pertinent  data,  e.g.,  on  impacts  of  the 
elements of the policy options and the baseline (current situation). 

The  survey  was  envisaged  as  a  targeted  survey  to  complement  the  (partly  in  parallel 
running)  public  consultation  (PC).  Whereas  the  PC  addressed  a  wider  audience  and 
therefore  did  not  ask  for  detailed  technical  assessments,  the  targeted  survey  envisaged 
detailed information.  

Approach  

The  selection  of  stakeholder  groups  to  be  targeted  by  the  survey  followed  a  further 
characterisation  of  the  stakeholders  collected  in  the  contractors’  database:  all  selected 
stakeholders either:  

  had participated in the targeted survey carried out by the Commission in 2020 in 

the context of the Commission 2021 NGT study;  

  had  participated  in  the  consultation  carried  out  in  the  context  of  the  inception 

impact assessment; or 

  were  suggested  by  interview  partners  -  this  served  the  purpose  to  address  in 

particular SMEs - such as breeding companies - or retailers. 

The  majority  of  the  invited  participants  could  not  easily  be  classified  with  one 
characteristic  such  as  “public  authority”,  “research  organisation’,  “company”, 
‘business/industry  association”,  or  “non-governmental  organisation”  (NGO)  –  but  they 
combined two or more functions/roles. For example, a company could be in breeding, but 
also  be  a  manufacturer,  or  selling.  Therefore,  the  classification  of  the  identified 
stakeholders focused on obtaining a reasonable allocation and leaving it up to the survey 
respondents  to  self-classify  in  the  range  of  stakeholder  types.  Table  1  provides  an 
overview of the invited stakeholders. The vast majority of stakeholders are set in Europe 
with a clear geographic focus of associations based in Belgium.   

The  following  figures  provide  information  about  the  invited  respondents,  using  a 
classification according to the contractor’s study team.   

  Almost  400  public  and  private  stakeholders  (e.g.,  associations,  authorities, 
networks,  companies)  were  targeted  to  provide  their  insights  and  contribute  via 
the survey.   

  At EU-level, 101 organisations were invited, the majority (68) being associations 
representing different sectors of economic operators. A similar number of national 
industry  associations  were  also  targeted  (63).  These  tend  to  be  (conventional  or 
organic) seeds, farmers, breeders, or biotechnology associations.   

  Private sector organisations – large as well as small and medium-sized companies 
were  altogether  the  second  largest  group.  The  latter  group  of  SMEs  brings 
together  the  range  of  actors  of  the  value  chain  from  breeders  to  processors  to 
retailers.  The third largest  – and most heterogeneous  group  – is  the one  of non-
profit  organisations.  As  indicated  above,  this  includes  a  range  of  type  of 
organisations,  including  networks  (e.g.,  (organic)  seed  networks,  agroecological 
or  researchers’  networks),  and  a  broad  variety  of  interest  groups  (e.g.,  opposing 
GMO or not, consumer and environmental advocacy groups, etc.).   

  Public sector organisations were distinguished from public authorities/ministries. 
These  are  often  independent  or  sub-ordinate  executive  entities  but  have  no 
political function like ministries.   

140 

 
 
  The  delineation  between  research  organisation  and  advisory  body  is  somewhat 
artificial. As indicated, some research organisations (public research institutes or 
university  entities)  are  equally  officially  advisory  or  competent  entities  for  a 
public authority. 

Table 1 Overview of invited survey participants  

Type of stakeholder  
Business/industry association  
Private-sector organisation  
Non-profit organisation  
Political entity  
Public sector organisation  
National authority/Ministry  
Research organisation  
Advisory body  
Other  
Grand Total  

EU  
68  
5  
19  
2  
2  

4  
1  

101  

national  
63  
66  
60  

2  
27  
11  
2  
9  
218  

World  
6  
31  
14  

1  
2  

2  
52  

Total  
137  
102  
93  
2  
4  
28  
17  
3  
11  
397  

The  contractor’s  study  team  sent  out  personal  invitations  to  369  identified  stakeholders 
through  Limesurvey.  The  Commission  forwarded  individual  survey  links  to  the  EU 
Member  States  and  EEA  countries  (in  total  28).  Those  were  invited  to  consolidate 
responses per country.   

The  survey  was  translated  from  English  and  available  also  in  Dutch,  French,  German, 
Italian, Polish, and Spanish.  

It  was  sent  to  stakeholders  and  Member  State  representatives  on  28  July  2022  and  was 
planned to remain open for the stakeholders until 10 August and for Member States until 
24  August  2022.  Given  technical  problems  and  the  vacation  period  hampering  the 
availability of experts to be consulted, the survey closed on 5 September 2022.  

The study team received mails from individual stakeholders who informed that they could 
not respond due to time constraints, due to no immediate relevance, or because they found 
the survey’s scenario approach problematic.   

Some Member States voiced that they had difficulties in filling in the survey without being 
able  to  include  explanations;  in  some  cases,  they  have  also  submitted  an  additional 
document.  Out  of  the  Member  States,  which  did  not  fill  in  the  survey,  one  submitted 
available relevant information in a dedicated document.   

The  survey  was  designed  with  a  complex  filtering:  all  respondents  obtained  the  same 
survey but, depending on their self-classification, only specific questions appeared. None 
of  the  questions  was  mandatory  to  be  filled  in.  This  implies  that  for  the  analysis  of  the 
questions,  the  number  of  responses  varies.  Therefore,  in  the  analysis  the  number  of 
responses were provided per question. In questions where responses were not provided for 
all categories, the minimum number was indicated.  

Of  the  397  invitations  that  were  sent  out,  143  opened  the  survey  and  included  some 
information on the respondent but did not proceed further. These entries were deleted and 
not taken into account. Two withdrawals were removed, so that in the end the analysis was 
based on 123 responses.   
141 

 
 
  
  
  
  
  
  
Use  

The  results  of  the  stakeholder  survey  fed  the  impact  assessment  (main  study  report)  by 
impact area, indicator, and across the various scenarios.   

7.  PUBLIC CONSULTATION (PC)  

Objectives  

Following  the  Inception  impact  assessment,  the  PC  was  carried  out  by  the  Commission 
(publication on ‘Have Your Say’ portal) and enquired about the current situation and tested 
the general key components of the potential options.  

Approach  

In  line  with  the  Better  Regulation  Toolbox,  a  number  of  small  campaigns  have  been 
identified and analysed separately.   

The PC replies were analysed by the external contractor with descriptive statistics for the 
closed  questions  by  stakeholder  group  and  provided  a  mixed  qualitative/quantitative 
approach  for  the  open  questions,  equally  by  stakeholder  group.  A  number  of  position 
papers,  statements  and  links  to  additional  references  and  literature  were  provided  by 
respondents. These were classified, analysed and summarised.  

Use  

A PC as such is not a representative survey and therefore, the results need to be taken as 
what  they  are:  a  snapshot  of  views  and  opinions  of  individual  people  and  organisations 
with a strong interest in the subject matter (self-selection bias). The results from the PC fed 
into  the  main  study.  They  complemented  the  targeted  survey,  in  particular  through 
contributions  from  the  research  communities  and  individual  citizens.  Given  the  limited 
number of questions and their broad level, the PC results fed mainly environmental impact 
areas and less so economic or social impacts.   

8.  FOCUS GROUPS  

Objectives  

Two focus groups, one on ‘Sustainability’ and the other on ‘Traceability’ were conducted 
by the external contractor. They were intended to complement the information obtained in 
interviews and the targeted survey. The focus groups aimed at providing specific feedback 
and expertise on the topics of:  

  Traceability  and  enforcement  systems  in  the  agri-food  chain  (including 
tools, registries and procedures used when analytical methods are not available 
or not reliable);  

  Approaches to sustainability analysis in food and agriculture related areas 
(including  approaches  to  assess  potential  positive  or  negative  contributions  to 
sustainability, and regulatory mechanisms to promote sustainability). 

Approach  

A concept note was developed for each of the focus groups. This included a few high-level 
questions which were developed based on results of the targeted stakeholder survey as well 
as insights from the interviews.  

142 

 
 
Relevant potential focus group participants were contacted and invited.  

The  focus  groups’  planning  started  following  the  analysis  of  the  targeted  stakeholder 
survey. In terms of development of key questions, the groups could address, results from 
the PC and the targeted survey were used.   

Following  prior  agreement  of  the  participants,  the  two  focus  group  meetings  were 
recorded.  The  recordings  were  used  to  inform  the  summary  reports.  These  were  sent  for 
validation to the members. Suggested amendments were integrated in the reports.   

Selection/invitation process  

A list of potential participants has been identified on the basis of the stakeholder database 
and dedicated desk research. The following selection criteria have been used:  

  Balance 
perspectives);  

among  geographic 

expertise 

(different  Member  State 

  Balance among different crop/value chains expertise;  

  Balance among different technical sub-fields expertise.  

The  list  included  experts  from  Member  State  ministries  or  authorities,  relevant 
stakeholders, including operators and academia. 

Use  

The insights from the focus groups fed into the main report, predominantly in the relevant 
impact  sections.  Arguments  raised  in  the  focus  group  (such  as  the  needed  system’s 
approach in the sustainability group or the need for transparency in the traceability group) 
were included in the analysis.   

9.  COMPLEMENTARY ANALYSIS 

Objectives  

Complementary  analysis  was  carried  out  for  specific  impacts  for  which  more  detailed 
information was lacking.   

Approach 

Three types of cases were envisaged: 

  A  comparative  case  (geography),  looking  at  third  countries  where  comparable 
regulatory  changes  have  already  led  to  economic,  environmental,  and  societal 
impacts  (Regulatory  developments  for  novel  genomic  techniques:  a  case  study  of 
Argentina) 

  Comparative  cases  (domain/sector),  looking  at  other  sectors  and  regulatory  areas 

where similar challenges/problems are present. 

  Deepening cases, where we develop impacts for specific product/application areas 
to  arrive  at  more  concrete  (e.g.,  quantitative)  estimates  relating  to  the  policy 
options.  (Value  chain  dynamics:  the  case  of  potatoes  in  the  Netherlands;  Root 
chicory). 

The  analysis  was  developed  by  the  external  contractor  based  on  desk  research  and 
document review. A short concept note was developed and discussed  with one or two of 
the  technical  experts  within  the  team  in  order  to  discuss  the  focus  of  the  case.  Ideas  on 

143 

 
 
potential  interview  partners  and/or  further  literature  were  exchanged  and  in  case  of 
identified  interviewees,  they  were  contacted  and  in  case  of  agreement,  interviewed 
eventually.  

Use  

The  insights  were  integrated  in  the  contractor’s  final  study  report,  mainly  supporting 
individual impact areas. 

10. EFFICIENCY /COST BENEFIT ANALYSIS   

Objectives  

Identification and measurement of current and potential regulatory costs.   

Approach  

In the absence of NGTs on the market (commercially, neither in Europe nor in the rest of 
the  world),  there  is  no  quantitative  data  available  that  allows  us  to  measure  directly 
regulatory  costs.  Therefore,  an  approach  was  designed  that  mixes  qualitative  and 
quantitative  information  and  draws  from  experience  with  GMO  authorisation.  Since  also 
GMO products are not available on the European market, the contractor aimed to address 
all stakeholders that have or had relevant experience.    

The activities with regulatory cost implications during the lifecycle of a GM crop include 
the submissions for field trialing, cultivation, for the authorisation of the use of food and 
feed, and the importation into the territory of the European Union. 

Identification of stakeholders  

Stakeholders  covered  in  the  cost  assessment:  biotech  industry/  plant  breeders,  national 
public  authorities,  European  institutions/bodies;  processors,  food  industry,  retail,  organic 
and  GMO-free  farmers,  consumers.  For  the  plant  breeders/  plant  biotech  industry  and 
national  public authorities, costs were monetised while for organic and non-GM farmers, 
processors, the food industry, and retail, costs are described qualitatively. 

The typology of costs follows the Better Regulation Guidelines, Tool #56. A distinction is 
made  between  monetised  costs  and  those  cost  categories  that  remain  with  a  qualitative 
description. 

Table 2 Mapping of costs (monetised/described)(1)  

Cost typology  

Biotech/ 
Plant 
Breeders  

Nat’l Public 
Authorities  

EC & 
Agencies  

Organic and 
GMO -free 
farmers  

Processors  

Retail  

DIRECT 
Compliance  

Administrative costs  

Adjustments costs – capital 
expenditures  

Adjustments costs – 
operation and maintenance 
costs  

Hassle costs  

144 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
ENFORCEMENT 
costs  

Monitoring; Inspection; 
Adjudication/Litigation  

INDIRECT  

Indirect compliance costs  

costs  

Transaction costs  

Offsetting/substitution costs  

Opportunity costs (e.g. 
alternative solutions are 
neglected  

Market Access  

Reduced innovation or 
investment (research, field 
trials relocated outside the 
EU)  

Other indirect costs – 
Competition  

Note (1): monetised described   

Cost assessment - process  

The process is broken down to phases for which costs are estimated (see Better 
Regulation  Guidelines, tool #56) as indicated below. The process  was used for 
the BAU and the policy options where applicable and possible.  

Table 3 Cost assessment – Phases   

Steps  

Description  

Phase I: Preparatory analysis  

Identification and classification of information obligations   

Identification of required actions   

Classification by regulatory origin   

Identification of relevant cost parameters   
Qualitative assessment of significant burdens   
Identification of target group(s)   

Choice of data sources  

Phase II: Data capture and standardisation   
Assessment of the number of entities concerned  

Assessment of the performance of a ‘normally efficient entity’ in each target group, taking into account cost parameters 
identified in step 5  

Phase III: Calculation and reporting   
Extrapolation of validated data to EU level   

Final reporting and transfer to the database   

1   

2   

3   

4  

5   

6  

7  

8   

9   

10  

145 

 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Cost assessment – consultation strategy  

Four stakeholder categories were distinguished:   

1)  Biotech industry and plant breeders: Costs were estimated using inputs from 
dedicated  interviews  (based  on  detailed  cost  templates),  the  targeted 
stakeholder survey and desk research.  

2)  Farmers  (GMO  free  and  organic),  Processors  and  Retailers:  Costs  are 
described  qualitatively  using 
targeted 
stakeholder survey. They were monetised where possible with the combined 
inputs of desk research and interviews.   

inputs  from 

interviews, 

the 

3)  Consumers: Costs can only be described qualitatively, based on interviews 

and desk research.  

The three stakeholder groups were asked on costs for BAU and ‘components’ of the policy 
options via the targeted stakeholder survey.  

Figure 2  Consultation strategy – per stakeholder type  

Use  

The results from the cost assessment were directly incorporated in the final report in the 
efficiency analysis of the options.   

11. MULTICRITERIA ANALYSIS  

Objective 

Aggregation  and  analysis  of  individual  impacts  into  an  assessment  for  each  key  policy 
objective  so  that  policy  scenarios  and  options  can  be  compared  more  easily  and 
systematically. 

Approach 

The approach was based on a multicriteria decision analysis (MCDA), while integrating 
some aspects of the social multi criteria evaluation (SMCE). A formal SMCE requires a 

146 

 
 
 
  
detailed  mapping  of  values  and  preferences  of  each  main  actor  type.  However,  the 
targeted consultations showed that stakeholders have often very idiosyncratic and specific 
views  regarding  the  policy  options,  being  in  favour  of  some  elements  and  not  others, 
highlighting  or  not  specific  criteria  etc.,  and  therefore  it  was  concluded  that  a  formal 
SMCE  is  not  viable.  Instead,  it  was  observed  that  the  objectives  of  the  initiative 
themselves already provide a clear framework for analysis, as stakeholders were typically 
aligned around specific objectives. We thus used the MCDA, which does pay attention to 
different stakeholder categories’ views and interests as part of the criteria. It is important 
to note that the translation to assessment of policy options itself was carried out based on 
a  synthesis  of  these  outcomes  (see  Chapter  6,  main  study  report).  The  multicriteria 
analysis  itself  was  analysed  at  the  level  of  impact  areas  (which  reflect  key  stakeholder 
perspectives  and  (parts  of)  potential  subobjectives).  Further  aggregation  (at  the  level  of 
dimension  or  policy  option  overall)  required  weights  that  involved  political  choices. 
Within  the  impact  areas,  we  therefore  assigned  equal  weighting  to  each  criteria,  as  a 
default  option  in  absence  of  a  credible  alternative.  As  a  further  step,  we  concluded  a 
sensitivity analysis which is described further below. 

The full overview of criteria per impact area is presented in Annex 11 of the contractor’s 
final report3. 

The individual scoring of the individual criteria was carried out at the ordinal level, with 
a  5-point  scale  (--,  -,  0,  +,  ++),  with  the  possibility  to  introduce  a  range  reflecting 
uncertainty.  The  scoring  directly  mirrored  the  impact  assessment  as  carried  out  in  the 
main study report (Chapter 4) for each impact criterion. 

As  such,  the  output  is  a  table  with  an  individual  score  for  each  criterion,  and  an 
aggregated score for each impact area, for each policy scenario. We then translated this 
back to  the policy  options, each consisting of a  combination of one  A-scenario, one B-
scenario and one C-scenario. In order to add up the aggregated score per impact area for 
each option, we applied a weighting of 4:2:1 for A:B:C. This weighting was mainly based 
on the relative importance of factors for determining the uptake of NGTs as indicated by 
stakeholders in  the targeted survey  (SQ11)  and the targeted interviews.  The weights  do 
not  reflect  any  judgement  on  the  importance  of  related  impact  areas,  but  rather  on  the 
degree to which these regulatory components are likely to engender change in economic 
behaviour. 

Use 

The  multicriteria  analysis  contributed  to  the  comparison  of  the  effectiveness  of  policy 
options. 

3 Technopolis Group, Arcadia Int. & Wageningen UR (2023) 

147 

 
 
                                                           
ANNEX 5: THE TECHNIQUES 

1.  INTRODUCTION 

The DNA is the genetic material (genome) of organisms that carries the information for 
the  development,  functioning,  growth  and  reproduction  of  all  known  organisms  and 
many  viruses. The  information  is  stored  and  transmitted  to  progeny  in  DNA  sequences 
based  on  a  four-“letter”  code.  Changes  in  these  sequences  are  called  mutations.  These 
can  be  substitutions/deletions/insertion  of  “letters”  or  of  longer  DNA  sequences.  These 
changes may have no effect or may result in new or altered functions or loss of functions 
in the organisms. Mutations are ubiquitous and natural phenomena that form the basis of 
plant breeding providing plant variety and food diversity. 

Genomic techniques are techniques that can alter the genetic material of an organism. For 
the purpose of this document, the term new genomic techniques (NGTs) is used to refer 
to technologies that have been developed over the past two decades after adoption of the 
current GMO legislation. 

New  genomic  techniques  constitute  a  diverse  group  of  techniques  that  can  be  used  in 
various  ways  to  change  the  genome  of  an  organism  and  achieve  different  results  and 
products. The objectives of the user and the technique determine the type and magnitude 
of the genome modification, which can range from limited changes, that might also occur 
in  nature  or 
to  multiple  and  more  extensive 
modifications. 

through  conventional  breeding, 

the  genome  without 

Among  NGTs,  targeted mutagenesis  techniques  induce  mutation(s)  in  selected  target 
locations  of 
foreign  genetic  material. 
Cisgenesis or intragenesis  techniques  insert  genetic  material  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 (intragenesis). 

insertion  of 

NGTs  can  also  be  used  in  the  same  way  as  older,  established  techniques  of  genetic 
modification, i.e. to insert foreign genetic material into a recipient organism from a donor 
organism that is sexually incompatible (transgenesis), e.g. a gene from an insect into a 
plant.  Transgenesis  is  however  out  of  the  scope  of  this  initiative,  which  covers  only 
targeted mutagenesis and cisgenesis (including intragenesis). 

More details  on mutagenesis, cisgenesis/intragenesis and transgenesis, and the different 
technologies that can be used to affect the respective outcomes, are provided below.  

2.  MUTAGENESIS TECHNIQUES 

In  plants,  substitutions/deletions/insertion  of  “letters”  of  the  plant’s  genome  may  take 
place under natural conditions or by human intervention through different techniques: 

a)  by conventional breeding techniques1: 

i)  combining,  by  crossing,  the  genetic  material  of  different  organisms  that  are 

sexually compatible; 

1 For a detailed description of conventional breeding techniques see SAM explanatory note on new 
techniques in agricultural biotechnology - https://research-and-innovation.ec.europa.eu/knowledge-
publications-tools-and-data/publications/all-publications/new-techniques-agricultural-biotechnology_en 

148 

 
 
                                                           
ii)  by  techniques  of  induced  random  mutagenesis,  i.e.  by  using  chemicals  or 
radiations that increase the frequency of mutations introduced randomly in the 
genome; 

b)  by new genomic techniques of induced targeted mutagenesis (e.g. type 1 and 2 
genome  editing,  see  below,  oligonucleotide  directed  mutagenesis2,  base  editing, 
prime  editing3)  that  target  the  mutations  to  (a)  specific  region(s)  in  the  genetic 
material of an organism. 

Figure 1: Mutagenesis under natural conditions or by human intervention 

3.  CISGENESIS AND INTRAGENESIS TECHNIQUES 

In  addition,  modifications  of  the  genetic  material  of  plants  may  occur  through  the 
insertion/translocation  of  longer  DNA  sequences  from  the  same  species  or  a  crossable 
species.  This  may  take  place  under  natural  conditions  or  by  human  intervention 
through different techniques: 

c)  by  conventional  breeding  techniques,  e.g.  combining,  by  crossing,  the  genetic 

material of different organisms that are sexually compatible 

d)  by new genomic techniques of: 

i)  cisgenesis, inserting an exact copy of a DNA sequence derived from the same 

or a crossable species; 

ii)  intragenesis,  inserting  a  re-arranged  copy  of  a  DNA  sequence  derived  from 

the same or a crossable species. 

In  conventional  breeding,  by  crossing,  the  desired  trait  is  introduced,  but  together  with 
other  unintended/undesirable  traits  from  the  donor  organism.  Removal  of  these 
unintended/undesirable  traits  requires  several  steps  of  backcrossing  (i.e.  repeated 

2 Oligonucleotide directed mutagenesis (ODM) is based on the use of oligonucleotides for the induction of 
targeted mutations in the genome, usually of one or a few adjacent nucleotides. 
3 Base editing and prime editing are other targeted mutagenesis techniques introducing specific genetic 
changes in a targeted sequence without the use of any template DNA. 

149 

 
 
 
                                                           
crossing with the original plant). This can be a long process taking several years (e.g. 8-
10 years for wheat up to 20-25 years for apple4). 

Cisgenesis  and  intragenesis  techniques  are  able  to  introduce  the  desired  trait  only, 
without  other  unintended/undesirable  traits.  The  introduction  of  the  trait  can  be  done 
through  random  insertion  technologies  (which  are  technologies  used  for  GMOs 
authorised  so  far,  such  as  Agrobacterium-mediated  transformation5  or  biolistic 
technologies6)  or  targeted  insertion  technologies  (type  3  genome  editing,  see  below). 
The process is generally more precise and efficient (taking from 2 to 8 years7) compared 
to conventional breeding techniques. 

Cisgenesis and intragenesis have been included among NGTs since 2007, regardless 
of the technology used to produce them (either random or targeted). At that time, a 
working group of Member States’ experts was established by the Commission to evaluate 
whether certain new techniques result in GMOs subject to the EU GMO legislation. For 
this evaluation, the competent authorities provided a list of new techniques that included 
cisgenesis and intragenesis. Cisgenesis and intragenesis were described as new breeding 
techniques that, while using the same genetic modification technologies as transgenesis, 
opened new possibilities through the insertion of genetic material from crossable species. 
A similar description of cisgenesis and intragenesis as new breeding techniques was also 
provided  in  the  2011  JRC  study  “New  plant  breeding  techniques  -  State-of-the-art  and 
prospects for commercial development”8 and in the 2017 SAM explanatory note on new 
techniques in agricultural biotechnology9. 

4.  TRANSGENESIS TECHNIQUES 

Finally,  modifications  of  the  genetic  material  of  plants  may  also  occur  through  the 
insertion of foreign genetic material into a recipient organism from a donor organism that 
is sexually incompatible (non-crossable). This generally may only take place by human 
intervention through transgenesis techniques. Also in this case, the introduction of the 
trait  can  be  done  through  random  insertion  technologies  or  targeted  insertion 
technologies. 

4 JRC case studies.  
5 Technologies using Agrobacterium tumefaciens, a bacterium infecting plants, for its natural ability to 
transfer DNA to plant cells.  
6 Technologies involving microscopic particles coated with the DNA that is to be inserted into the plant. 
These particles are then “shot” under high pressure into the plant tissue. The DNA penetrates the cell 
where it is sometimes spontaneously incorporated into the genome.  
7 JRC case studies.  
8 https://publications.jrc.ec.europa.eu/repository/handle/JRC63971, page 24-25 
9 https://research-and-innovation.ec.europa.eu/knowledge-publications-tools-and-data/publications/all-
publications/new-techniques-agricultural-biotechnology_en, page 67-68 

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Figure 2: Conventional breeding vs Cisgenesis vs Transgenesis 

5.  GENOME EDITING  

Genome editing is  an umbrella term  covering several  technologies that can be used for 
targeted mutagenesis, cisgenesis, intragenesis and transgenesis. Genome editing includes 
Site-directed  nuclease  (SDN)  technologies,  whose  mechanism  is  based  on  the  use  of 
enzymes  (nucleases)  that  cut  the  DNA  at  specific  locations  (cleavage  sites),  as  well  as 
other  technologies  such  as  oligonucleotide  directed  mutagenesis  (ODM),  base  editing, 
prime  editing,  site-directed  recombination10.  These  technologies  can  produce  precisely 
located alterations to DNA sequences, ranging from 'point mutations' (changes of one or 
a  few  DNA  “letters”,  which  may  be  either  random  or  non-random)  to  the  insertion  of 
genes (cisgenes, intragenes, transgenes). 

Depending on their application, SDN technologies, which are currently the most widely 
used genome editing technologies, can be classified in three types of categories: 

1)  type 1 (SDN-1): introduction of random mutations in precise locations; 
2)  type 2 (SDN-2): introduction of non-random mutations in precise locations; 
3)  type 3 (SDN-3): insertion of large segments (such as genes) in precise locations. 

10 Broothaerts et al. (2021) 

151 

 
 
                                                           
Type  1  and  2  are  used  for  targeted  mutagenesis,  while  type  3  is  used  for  cisgenesis, 
intragenesis and transgenesis. 

Figure 3: Targeted technologies: Genome editing 

Genome editing does not exclude 'off-target' modifications, where a change occurs to a 
DNA sequence identical or similar to that in which the change is desired, but in another 
location.  However,  these  off-target  modifications  are  fewer  than  those  occurring  with 
most  random  mutagenesis  techniques.  Where  they  do  occur,  these  changes  are  of  the 
same types as those produced by conventional breeding techniques11. 

6.  OVERVIEW OF THE TECHNIQUES 

Mutagenesis 

Cisgenesis 

Intragenesis 

Transgenesis 

Creation of mutation(s) 
in an organism without 
insertion of foreign 
genetic material 

Insertion of exogenous 
genetic material, 
without prior 
rearrangement, from a 
crossable 
organism/species 

Insertion of exogenous 
genetic material, with 
prior rearrangement, 
from a crossable 
organism/species 

Insertion of foreign 
genetic material  from 
a non-crossable 
organism/species 

Random 
technologies 

Irradiation or treatment 
with chemicals 

Random integration via 
Agrobacterium 
tumefaciens, gene gun 

Random integration via 
Agrobacterium 
tumefaciens, gene gun 

Random integration via 
Agrobacterium 
tumefaciens, gene gun 

Targeted 
technologies 

SDN (e.g. CRISPR) type 1 
or 2, ODM, base editing, 
prime editing, etc. 

SDN (e.g. CRISPR) type 3 
site-directed 
recombination 

SDN (e.g. CRISPR) type 3 
site-directed 
recombination 

SDN (e.g. CRISPR) type  
3 site-directed 
recombination 

For  an  extensive  description  of  the  techniques,  see  JRC  Technical  Report  on  New 
genomic  techniques:  state-of-the-art  review12  and  the  Explanatory  Note  on  new 

11 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, MullinsE, NogueF,Sanchez 
Serrano JJ, Savoini G, Veromann E, Veronesi F, Casacuberta J, Gennaro A,Paraskevopoulos K, Raffaello 
T and Rostoks N, 2020. Applicability of the EFSA Opinion on site-directednucleases type 3 for the safety 
assessment of plants developed using site-directed nucleases type 1and 2 and oligonucleotide-directed 
mutagenesis. EFSA Journal 2020;18(11):6299, 14 pp., https://doi.org/10.2903/j.efsa.2020.6299  
12 Broothaerts, W., Jacchia, S., Angers, A., Petrillo, M., Querci, M., Savini, C., Van den Eede, G. and 
Emons, H., 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 

152 

 
 
  
                                                           
techniques  in  agricultural  biotechnology  by  the  Commission’s  Scientific  Advice 
Mechanism High-Level Group (SAM HLG)13. The latter provides also a comparison of 
the various techniques, in particular as regards precision, speed and unintended effects as 
shown in the figure below (see figure 4 below). 

Figure 4: Overview of new and existing breeding techniques (source: SAM HLG) 

13 European Commission, Directorate-General for Research and Innovation, New techniques in agricultural 
biotechnology, Publications Office, 2017, https://data.europa.eu/doi/10.2777/574498 

153 

 
 
                                                           
ANNEX 6: OPINIONS OF SCIENTIFIC ADVISORY BODIES 
AND SCIENTIFIC ORGANISATIONS ON NGTS 

Over  the  last  decade,  there  have  been  numerous  scientific  reports  and  publications  on 
NGTs. A non-exhaustive overview of relevant opinions of EU scientific advisory bodies 
and scientific organisations is  provided below.  It reflects  a diversity of  views,  but  with 
majority positions emerging on relevant scientific issues. 

In  2017,  the  Scientific  Advice  Mechanism  High-Level  Group  (SAM  HLG)  issued  an 
explanatory  note  on  new  techniques  in  agricultural  biotechnology  applied  to  plants, 
animals and microorganisms1. The note describes the nature and characteristics of NGTs 
known  at  that  time  and  their  similarities  and  differences  compared  to  conventional 
breeding  techniques  and  established  genomic  techniques,  in  particular  as  regards 
precision,  efficiency,  detectability,  cost  and  speed  of  product  development. The  SAM 
HLG  also  issued  a  statement2  in  2018  on  a  “Scientific  perspective  on  the  regulatory 
status of products derived from gene editing and the implications for the GMO Directive” 
where they considered that new scientific knowledge and recent technical developments 
have made the GMO legislation no longer fit for purpose.   

EASAC,  the  European  Academies'  Science  Advisory  Council,  formed  by  the  national 
science  academies  of  the  EU  Member  States,  Norway,  Switzerland  and  the  United 
Kingdom, issued a report in 2017 on scientific opportunities, public interests and policy 
options in the EU on genome editing3.  

The  Commission  Joint  Research  Centre  (JRC)  analysed  in  2021  the  latest  scientific 
developments4 relating to NGTs.  

The  European  Food  Safety  Authority  (EFSA)  published  scientific  opinions  on  NGTs 
applied to plants, in particular on SDN type 1 and 2 and oligonucleotide-directed (ODM) 
mutagenesis5,  and  on  cisgenesis  and  intragenesis  (with  a  recent  opinion  updating  a 

1 European Commission, Directorate-General for Research and Innovation, New techniques in agricultural 
biotechnology, Publications Office, 2017, https://data.europa.eu/doi/10.2777/574498  
2 European Commission, Directorate-General for Research and Innovation, Group of Chief Scientific 
Advisors, A scientific perspective on the regulatory status of products derived from gene editing and the 
implications for the GMO Directive : statement by the Group of Chief Scientific Advisors, Publications 
Office, 2019, https://data.europa.eu/doi/10.2777/407732  
3 EASAC (2017) Genome editing: scientific opportunities, public interests and policy options in the 
European Union  
https://easac.eu/fileadmin/PDF_s/reports_statements/Genome_Editing/EASAC_Report_31_on_Genome_E
diting.pdf 
4 New Genomic Techniques: State-of-the-Art Review https://data.europa.eu/doi/10.2760/710056 
5 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  

154 

 
 
                                                           
previous  one  from  2012)6.  EFSA  also  published  scientific  opinions  on  plants  obtained 
through synthetic biology, where certain applications make use of SDN technologies7. 

Overall,  these  opinions  and  reports  recognise  the  variety  of  techniques  and  of  different 
products with different risk profiles they can generate. They confirm that NGT products 
may  or  may  not  contain  foreign  DNA.  They  also  recognise  similarities  of  certain 
organisms  produced  by  NGTs  with  conventionally  bred  organisms,  while  others  would 
resemble  organisms  produced  by  established  genomic  techniques.  NGTs  may  also 
introduce  into  an  organism  sequences  derived  from  the  same  species  or  from  other 
this  respect,  NGTs  may  produce 
species,  either  crossable  or  uncrossable.  In 
modifications that could or could not be obtained in nature or by conventional breeding. 
In the former case, products obtained by NGTs and those occurring naturally or produced 
by conventional breeding might be indistinguishable from each other.  

The  above-mentioned  bodies  also  report  on  the  increasing  precision  of  certain  NGTs 
compared  to  conventional  breeding  approaches.  In  particular,  genome  editing  enables 
small,  precise  and  specific  changes,  such  as  point  mutations,  or  makes  it  possible  to 
target  insertions,  resulting  in  comparatively  fewer  unintended  effects.  Variations  to  the 
genome may be entirely novel or may occur already in other individuals of the same or of 
another  species.  When  changes  are  small  and  directed  by  similar  desirable  changes 
known  in  other  organisms,  the  resulting  products  are  expected  to  display  more 
predictable characteristics. For these reasons, many NGTs make it possible to shorten the 
development  time  for  organisms  with  desired  phenotypes.  Also,  the  assessment  of  the 
characteristics and potential risks might be facilitated on a case-by-case basis. 

As regards risks, EFSA concluded that there are no new hazards specifically linked to the 
genomic modification produced via SDN-1, SDN-2, ODM as compared with both SDN-
3 and conventional breeding. In assessing different contributions to potential hazards in 
cisgenic/intragenic  plants,  EFSA  concluded  that  no  new  risks  are  identified  in  cisgenic 
and  intragenic  plants  compared  with  plants  obtained  with  conventional  breeding  or 
established  genomic  techniques.  However,  intragenic  plants  may  present  more  hazards 
than cisgenic plants. 

EFSA  also  considered  that  on  a  case-by-case  basis,  a  lesser  amount  of  data  might  be 
needed for the risk assessment of plants produced by SDN-1, SDN-2, ODM, cisgenesis 
and intragenesis and therefore there is a need for flexibility in the data requirements for 
risk  assessments.  EFSA  also  concluded  that  in  targeted  mutagenesis,  the  potential  for 
unintended effects, such as off-target effects, may be significantly reduced compared to 
random  insertions  or  conventional  breeding.  Off-target  modifications  would  be  fewer 

6 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. 
7 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 
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 modified plants obtained through synthetic biology. EFSA Journal 
2021;19(2):6301, 21 pp. https://doi.org/10.2903/j.efsa.2021.6301 8 Modrzejewski, D., Hartung, F., 
Sprink, T., Krause, D., Kohl, C., Wilhelm, R (2019): What is the available evidence for the range of 
applications of genome-editing as a new tool for plant trait modification and the potential occurrence of 
associated off-target effects: A systematic map. Environmental Evidence, 8(1): 

155 

 
                                                           
than those occurring with most mutagenesis techniques and, where such changes occur, 
they would be of the same types as those produced by conventional breeding techniques. 

The scientific literature on off-target effects indicates that there are fewer such effects for 
certain targeted mutagenesis methods compared to conventional mutation breeding. Out 
of 1328 studies analysed using different genome editing techniques, 252 investigated off-
target mutations. These were detected in around 3% of the analysed potential off-target 
sites8. Case studies on rice9 and cotton10 showed that no off-target sequences were found 
with CRISPR/Cas but conventional tissue culture resulted in ~100-250 single nucleotide 
variations.  Nevertheless,  some  scientists  consider  that  there  are  new  types  of  risks 
resulting  from  targeted  mutagenesis  techniques  compared  to  previous  applications  of 
genetic engineering11. 

To  address  the  possible  need  for  flexibility  in  data  requirements  for  risk  assessment, 
EFSA,  upon  a  request  from  the  Commission,  published  a  statement  where  six  main 
criteria  are  proposed  to  assist  the  risk  assessment  of  plants  produced  by  targeted 
mutagenesis, cisgenesis and intragenesis12 (see section 5.2.1, box 1). These criteria relate 
to the molecular characterisation of the genetic modification introduced, to the available 
knowledge based on the history of use and to the structure and function of the modified 
DNA sequence(s). In the statement, EFSA reiterated that for plants in which the newly 
modified DNA sequence is successfully targeted there are cases where the potential for 
unintended  effects,  such  as  off-target  effects,  is  significantly  reduced  compared  to 
random  insertions  or  conventional  breeding.  When  that  happens,  the  data  requirements 
for the risk assessment may be reduced on a case-by-case basis. 

The  European  Union  Reference  Laboratory  for  GM  food  and  feed  (EURL  GMFF)  and 
the  European  Network  of  GMO  Laboratories  (ENGL)  issued  in  2019  a  report  on  the 
detection  of  food  and  feed  plant  products  obtained  by  new  mutagenesis  techniques13. 
They concluded that validation of a specific detection method and its implementation for 
market control is feasible only for genome-edited plant products carrying a known DNA 
alteration  that  has  been  shown  to  be  unique.  Under  the  current  circumstances,  market 
control will fail to detect unknown genome-edited plant products. An updated report by 
the EURL-ENGL is expected in mid-202314. 

8 Modrzejewski, D., Hartung, F., Sprink, T., Krause, D., Kohl, C., Wilhelm, R (2019): What is the available 
evidence for the range of applications of genome-editing as a new tool for plant trait modification and the 
potential occurrence of associated off-target effects: A systematic map. Environmental Evidence, 8(1): 
9 Tang, X., Liu, G., Zhou, J., Ren, Q., You, Q., Tian, L., et al. (2018). A large-scale whole-genome 
sequencing analysis reveals highly specific genome editing by both Cas9 and Cpf1 (Cas12a) nucleases in 
rice. Genome Biol. 19, 84. doi:10.1186/s13059-018-1458-5.10 Li, J., Manghwar, H., Sun, L., Wang, P., 
Wang, G., Sheng, H., et al. (2019): Whole genome sequencing reveals rare off-target mutations and 
considerable inherent genetic or/and somaclonal variations in CRISPR/Cas9-edited cotton plants. Plant 
Biotechnol. J. 17, 858–868. doi: 10.1111/pbi.1302 
10 Li, J., Manghwar, H., Sun, L., Wang, P., Wang, G., Sheng, H., et al. (2019): Whole genome sequencing 
reveals rare off-target mutations and considerable inherent genetic or/and somaclonal variations in 
CRISPR/Cas9-edited cotton plants. Plant Biotechnol. J. 17, 858–868. doi: 10.1111/pbi.1302 
11 Kawall, K. The Generic Risks and the Potential of SDN-1 Applications in Crop Plants. Plants 2021, 10, 
2259. https://doi.org/ 10.3390/plants10112259. 
12 EFSA Panel on Genetically Modified Organisms, 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 
13 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained 
by new mutagenesis techniques, 26 March 2019 (JRC116289). https://gmo-
crl.jrc.ec.europa.eu/doc/JRC116289-GE-reportENGL.pdf 
14 [reference to be added when available] 

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The  European  Group  on  Ethics  in  Science  and  New  Technologies  (EGE)  published  in 
2021  an  opinion  on  the  ethics  of  genome  editing,  which  focuses  on  applications  in  the 
human, animal and plant domains15. Among its conclusions on plants, EGE recommends 
a  systems  approach  to  evaluate  costs  and  benefits  (including  the  impact  of  continuing 
current  agricultural  practices)  in  any  future  use.  It  also  recommends  regulation 
proportional  to  the  risk:  light  touch  regulation  should  be  used  where  the  change  in  the 
plant  could  have  been  achieved  naturally,  or  where  genetic  material  from  sexually 
compatible  plants  is  introduced.  Where  genes  from  non-sexually  compatible  organisms 
or multiple changes are introduced, there should be a comprehensive risk assessment.  

Some  scientific  organisations  and  agencies,  such  as  the  German  Federal  Agency  of 
Nature Conservation16, the European Network of scientists for social and environmental 
responsibility  (ENSSER)17  and  TestBiotech18,  disagree  with  the  above  opinions.  They 
raise  the  concern  that  NGTs  pose  specific  risks  to  the  environment  and  human  health. 
They consider that NGTs can be used to achieve genomic changes beyond what is known 
from conventional breeding and can alter the genome to a much greater extent than with 
any  previous  breeding  method.  Furthermore,  they  refer  to  unintended  genetic  changes 
that, according to them, would be specific to the processes of NGTs and unlikely to occur 
via  random  processes  or  conventional  breeding.  Furthermore,  these  organisations 
question  that  NGTs  are  precise,  controllable  and  predictable  and  have  a  sustainability 
potential as claimed.  

EFSA has evaluated the scientific literature provided by these organisations in the public 
consultations  and  considered  that  it  does  not  provide  new  evidence  challenging  the 
validity of the assessment and conclusions of EFSA scientific opinions19. 

15 https://ec.europa.eu/info/files/ethics-genome-editing_en 
16 https://www.bfn.de/en/publications/position-paper/new-developments-and-regulatory-issues-plant-
genetic-engineering17 https://ensser.org/publications/2021-publications/enssers-response-to-the-inception-
impact-assessment-iaa-on-new-genomic-techniques/ 
17 https://ensser.org/publications/2021-publications/enssers-response-to-the-inception-impact-assessment-
iaa-on-new-genomic-techniques/ 
18 https://www.testbiotech.org/en; https://www.vzbv.de/sites/default/files/2022-11/vzbv-
report_final_final.pdf 
19  https://www.efsa.europa.eu/en/news/faq-criteria-risk-assessment-plants-produced-targeted-mutagenesis-
cisgenesis-and-intragenesis 

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ANNEX 7: APPLICATIONS OF NGTS IN PLANTS AND 
CASE STUDIES ON POTENTIAL IMPACTS 

1.  OVERVIEW OF APPLICATIONS OF NGTS IN PLANTS 

The Commission Joint Research Centre (JRC) analysed in 2021 the current and future 
market applications1 relating to NGTs. 

The JRC report illustrates the wide range of traits and plant species in the focus of NGTs 
(see Table 1 and 2 and Figures 1 and 2). Regarding developed traits, disease resistance is 
targeted to more types of pathogens and pests. Abiotic stress tolerance is widely explored 
and  includes  resistance  to  drought,  salinity  and  heat  stress.  Modified  composition  goes 
beyond  starch  and  oil  content,  where  many  crops  are  in  development  with  improved 
nutrition  properties  (fibres,  vitamins  content)  together  with  the  reduction  of  potentially 
harmful  compounds  (toxins,  allergens,  acrylamide,  etc.)  or  gluten.  Also,  several 
applications  are  dedicated  to  obtaining  higher  and  more  stable  yield  (in  terms  of  plant 
production  and/or  size  of  fruits  and  grains).  Regarding  targeted  plants  species,  these 
cover  a  wider  range  of  plant  groups  from  cereals  to  fruits,  legumes  and  vegetables, 
compared  to  GMOs  from  established  genomic  techniques,  which  mainly  concern  few 
cereal (maize, rice) and oil and fibre crops (soybean, cotton, oilseed rape). 

Tables  1  and  2  and  figures  1,  2  and  3  summarise  the  plants  and  traits  identified  in  the 
JRC market review and reflect the situation in 2020. 

Table 1. Summary of plants identified in the JRC database of NGT products. 

Plant groups 

Plants included (not exhaustive) 

Cereals 

Maize, Wheat, Rice, Barley, Sorghum, Millet 

Forage and grasses 

Alfalfa, Ryegrass, Switchgrass, Setaria viridis 

Fruits 

Legumes 

Apple, Banana, Orange, Groundcherry, Grapefruit, Grapevine, Kiwifruit, 
Melon, Watermelon, Berries, Stone fruits, Avocado 
Beans, Chickpea, Peanut, Pea, Pigeon Pea 

Oil and fibre crops 

Ornamentals 

Sugar crops 

Soybean, Rapeseed, Cotton, Camelina, Flax, Pennycress, Sunflower, 
Mustard, Strawberry 
Chrysanthemum, Dandelion, Orchid, Petunia, Poinsettia, Poppy, Japanese 
morning glory, Wishbone flower, Jasmine tobacco 
Sugar beet, Sugarcane 

Trees 

Poplar, softwood trees 

Tubers and root 
vegetables 
Vegetable crops 

Potato, Sweet potato, Cassava, Beetroot 

Tomato, Broccoli, Cabbage, Cucumber, Eggplant, Lettuce, Pepper, Chicory 

Other plants 

Cacao, Coffee, Tobacco, Salvia 

1 Parisi, C. and Rodriguez Cerezo, E., Current and future 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. 

158 

 
 
                                                           
Figure 1: Distribution of NGT plant entries in the database by plant group and development stage (commercial, pre-
commercial, advanced and early R&D stages)1.  

Table 2. Trait categories in the JRC NGT plant products database. 

Trait category 

Description 

 Biotic Stress Tolerance 

Resistance to biotic stressors like, nematodes, fungi, bacteria, viruses and 
other pests, pathogens, or parasites 

 Abiotic stress tolerance 

Resistance to abiotic stressors like drought, heat, salt, rain or UV 
radiation. 

 Herbicide tolerance 

Tolerance to different types of herbicides 

 Modified colour/flavour  Modified colour or flavour 

 Modified composition 

Modified content of substances like starch, oil, proteins, vitamins, fibres, 
toxic substances, allergens etc. to improve food/feed quality of for a better 
industrial use. It includes seedless fruits as a quality characteristic. 

 Plant yield and architecture 

Yield increase (or yield stability) related to higher number of 
flowers/seeds/fruits, to fruit size/weight and to photosynthetic efficiency. 
It also includes other changes in plant architecture including plant height 
and shape, fruit shape, and growth pattern, among others. 

 Storage performance 

Improvement of characteristics like shelf life and storage conditions (e.g. 
cold storage), including non-browning and reduced black spot. 

 Other traits 

Remaining traits, not classified in the previous categories, including, 
among others, production of molecules of industrial interest, flowering 
time for agronomic purposes and nitrogen use. 

 Breeding tools 

Reproductive/flowering characteristics including, among others, induction 
of sterility, early flowering, and haploid techniques 

159 

 
 
 
 
Figure 2: Distribution of NGT plant entries in the JRC database by trait category and development stage (commercial, 
pre-commercial, advanced and early R&D stages)1. 

Figure 3: Distribution of NGT plant entries in the database by trait category and development stage (commercial, pre-
commercial, advanced R&D), limited to a 2030 horizon. 

An  overview  of  applications  of  NGTs  in  plants  is  also  provided  by  the  database  of 
published literature on the use of genome editing in crop plants maintained by the 
EU-SAGE  network2,  which  contains  information  on  genome-editing  research  and 
provides details on crop plant species and traits addressed and the techniques used and is 
kept  up  to  date.  Genome  editing  applications  are  identified  in  more  than  60  different 
crops with the vast majority in rice, tomato, maize, soybean, wheat and potato. The traits 
introduced  in  the  improved  crops  are  diverse  and  relevant  for  farmers  (e.g.  agronomic 
value)  as  well  as  consumers  (e.g.  nutrition).  Table  3  describes  the  distribution  of  these 
traits for the time-period 1996-2022.  

2 https://www.eu-sage.eu/genome-search  

160 

 
 
 
 
 
 
                                                           
Table 3. Distribution of genome editing applications according to different trait categories in the period 1996–20222. 

 Trait category 

 % 

 Plant yield and growth 

 22.2% (144) 

 Improved food/feed quality 

 21.9% (142) 

 Industrial utilisation 

 14.4% (93) 

 Biotic Stress Tolerance 

 8% (117) 

 Abiotic stress tolerance 

 7.9% (51) 

 Herbicide tolerance 

 7.7% (50) 

 Modified colour/flavour 

 5.9% (38) 

 Storage performance 

 2% (13) 

The  Food  and  Agriculture  Organization  of  the  United  Nations  (FAO)  also  includes 
examples of applications in their recent paper on ‘Gene editing and agrifood systems’3, 
for all of these trait categories (see Table 4).  

Table 4. Applications of genome editing technologies in agrifood systems. 

Species 

Camelina 

Trait 

Research Organisation  

Improved fatty acid 
composition 

Department of Plant Sciences and Plant Pathology, Montana State 
University, Bozeman, MT 59717, USA 

Lettuce 

Increased vitamin C 
content 

Oilseed rape 

Improved fatty acid 
composition 

State Key Laboratory of Plant Cell and Chromosome 
Engineering, Center for Genome Editing, Institute of Genetics 
and Developmental Biology, Chinese Academy of Sciences, 
Beijing, China 

National Key Laboratory of Crop Genetic Improvement, 
Huazhong Agricultural University, Wuhan, China 

Potato 

Soybean 

Tomato 

Reduced acrylamide 
formation 

Improved fatty acid 
composition 

Cellectis plant sciences Inc., New Brighton, MN, USA 

Calyxt, Roseville, MN, USA 

High content of γ-
aminobutyric acid (GABA) 

Sanatech Minato-ku, Tokyo, Japan & University of Tsukuba, 
Ibaraki, Japan 

3 FAO. 2022. Gene editing and agrifood systems. Rome. https://doi.org/10.4060/cc3579en 

161 

 
 
 
                                                           
Wheat 

Low gluten content 

Instituto de Agricultura Sostenible (IAS-CSIC), Córdoba, Spain 

Wild tomato 

De novo domestication – 
High antioxidant content 

Wageningen University, Wageningen, Netherlands 

Several universities from Brazil, Germany and the USA 

Brewer’s 
yeast 

Flavour improvement in 
fermented beverages 

Centre of Microbial and Plant Genetics, Leuven, Belgium 

Alfalfa 

High yield 

National Institute of Agricultural Technology, Argentina 

Banana 

Fungus protection 

Queensland University of Technology, Brisbane, Australia 

Protection against bacterial 
wilt, fusarium wilt and 
banana streak virus 

Protection against bunchy 
top virus 

Protection against fungal 
disease 

Cacao 

International Institute of Tropical Agriculture, Nigeria 

Agricultural Research Council, Pretoria, South Africa 

Pennsylvania State University, USA 

Cassava 

Reduced cyanide levels 

University of California, Berkeley, CA, USA 

Virus resistance 

Cherry 

Virus resistance 

Citrus 

Cucumber 

Protection against citrus 
canker 

Protection against multiple 
viruses 

Department of Horticulture, Plant Biotechnology Resource 
and Outreach Center, Michigan State University, East 
Lansing, MI, USA 

Chinese Academy of Sciences, China 

Department of Plant Pathology and Weed Research, ARO, 
Volcani Center, Bet-Dagan, Israel 

Flax 

Herbicide tolerance 

Cibus, San Diego, CA, USA 

Grapevine 

Drought tolerance 

Stellenbosch University, Stellenbosch, South Africa 

Maize 

Fungus resistance 

DuPont Pioneer, Johnston, IA, USA 

Oilseed rape 

Herbicide tolerance 

Key Laboratory of Plant Functional Genomics of the Ministry of 
Education, Yangzhou University, Yangzhou China 

Potato and 
Sugar beet 

Disease-resistant varieties 

Russian Academy of Sciences, Russian Federation 

Rice 

Salt tolerance 

National Institute for Plant Biotechnology, New Delhi, India 

Fungus protection 

Salt tolerance  

Sorghum 

Increased protein content 

Department of Genetics, Development & Cell Biology, Iowa 
State University, Ames, Iowa, USA 

Key Laboratory of Rice Genetic Breeding of Anhui 
Province,Rice Research Institute, Anhui Academy of Agricultural 
Sciences, Hefei, 230031, China 
University of Queensland, Queensland, Australia 

Soybean 

Tomato 

Striga resistance 

Nematode resistance 

Bacterial resistance 

Provitamin D3 enhanced 

Kenyatta University, Kenya 

Evogene, Rehovot, Israel & TMG, Cambé, Brazil 

Department of Plant and Microbial Biology, University of 
California, Berkeley, USA 
John Innes Centre, Norwich, United Kingdom 

162 

 
Wheat 

Fungus protection 

State Key Laboratory of Plant Cell and Chromosome 
Engineering, Institute of Genetics and Developmental 
Biology, Chinese Academy of Sciences, Beijing, China 

2.  CASE STUDIES  

JRC case studies 

Very  few  NGT  plants  have  been  commercialised  so  far  and  therefore  there  is  limited 
knowledge and assessment of their field performance, environmental effects and benefits 
for consumers.  

For  the  purposes  of  this  impact  assessment,  the  JRC  developed  three  case  studies  to 
showcase  the  potential  impacts,  positive  or  negative,  on  the  social,  environmental  and 
economical  dimensions  of  sustainability.  The  studies  involved  commercially  important 
plants produced via targeted mutagenesis or cisgenesis that are currently in various stages 
of  development  in  the  EU  or  elsewhere  and  which  feature  traits  with  potential  to 
contribute to sustainability objectives:  

  disease resistant apples and potatoes (box 1);  
 
low gluten wheat (box 2);  
  a virus-resistant maize (box 3). 

Box 1: Economic and environmental impacts of disease resistant potatoes and apples developed 
with cisgenesis4 
A key tool in agricultural management are pesticides, as significant shares of harvests are lost to plant 
diseases. To achieve the objectives of the Green Deal, Farm to Fork and the Biodiversity Strategies 
which aim at reducing the use of pesticides, the development of disease resistant varieties is crucial. 
The case study focuses on fungal resistant potato and apple varieties as both plants are difficult to 
breed and because the fungal diseases are severe and can break down resistances. Due to the low 
availability of varieties with durable resistances, potatoes and apples are among the most intensively 
treated crops in terms of pesticide use. For the potential direct economic impacts, the study focused 
on the five EU Member States with the largest average production from 2015 to 2020. For potato 
these are France, the Netherlands, Belgium, Germany, Poland and for apple France, Italy, Germany, 
Poland, Spain.  
The NGT-based potato variety presented here has been developed and extensively tested in multi-
year field trials in the Netherlands. In contrast to the potato variety, the cisgenic apple variety 
analysed is still in the early research and development stage. The project did develop a cisgenic apple 
as proof of concept, however, only based on an introduction of a single resistance gene. In addition, a 
cisgenic construct harbouring three genes against scab was developed and would be readily available. 
Both plants are notoriously challenging to breed, making it time consuming to develop pest resistant 
varieties. Phytophthora infestans and Venturia inaequalis are key pathogens causing late blight 
disease (PLB) in potatoes and scab disease in apple, respectively. In potatoes, the average (maximum) 
number of annual fungicide treatments ranges from 3 (17) in Poland, over 7 (18) in Germany, to 13 
(21) in the Netherlands, and 14 (23 and 25) in France and Belgium. This corresponds to 1.4 kg of 
fungicides per hectare in Poland, 5.2 kg in Germany, 7.1 kg in France, 7.5 kg in the Netherlands, and 
11.2 kg in Belgium. In apples, the average (maximum) number of fungicide treatments is over 20 (30) 
and the applied quantities range from 2.9 kg in Spain, over 8.7 kg in Poland, to 25.6 kg in France, and 
31.7 kg in Germany. 
Varieties with durable resistances to these diseases could allow for sizable reductions of fungicide 
without affecting yields. In potatoes, a 50-80% reduction of fungicides may be feasible under 
commercial conditions. In apples, depending on the region, a reduction of 12-58% is suggested by the 

4 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.  

163 

 
 
 
 
                                                           
literature. The fungicide reductions may generate cost savings for farmers. In PLB resistant potatoes, 
the simulated 90%-confidence-interval of the savings per hectare are EUR350-576 (7.8 to 14.7 % of 
total costs) in France, EUR326-535 (6.3-11.2%) in the Netherlands, EUR292-463 (8.2-13.8%) in 
Belgium, EUR189-323 (5.9-10.9%) in Germany, and EUR49-99 (3.7-7.9%) in Poland. In scab 
resistant apples, the estimates are EUR271-712 (2.7-8.5%) in France, EUR207-556 (2.4-7.3%) in 
Italy, EUR151-516 (1.5-5.6%) in Germany, EUR65-234 (2.3-8.7%) in Poland, and EUR39-242 (0.9-
6.2%) in Spain. 
At country-level, the rate of adoption of the resistant varieties largely determines the total annual cost 
savings. If only the largest farms with more than 20 hectare of potatoes under cultivation were to 
adopt the PLB resistant potatoes, the total annual cost savings are estimated at EUR53 million in 
France, EUR47 million in Germany, EUR47 million in the Netherlands, EUR8 million in Belgium, 
and EUR3 million per year in Poland. If only farms with more than 30 hectare of fruits under 
cultivation were to adopt the scab resistant apples, the total annual cost savings are estimated at 
EUR8.9 million in France, EUR3.2 million in Germany, EUR2.7 million in Poland, EUR2.3 million 
in Italy, and EUR0.9 million in Spain. At EU-level, the PLB resistant potatoes are estimated to 
increase the total potato supply by up to 5%, reduce the producer prices by up to 6%, increase the 
human consumption by up to 0.8%, increase the use for feed by up to 3.5%, decrease the potato 
imports by up to 4.6%, and increase the potato exports by up to 6.2%. 
In terms of environmental impacts, in Germany in 2019, the five most used active ingredients in 
potatoes belong to three Harmonised Risk Indicator (HRI)-1 groups5: group 26 (3 substances), group 
37 (1), and group 48 (1). In the case of apples, the five most used active ingredients belong to group 2 
(4) and group 3 (1). Therefore, the potential reduction in fungicide use in both crops could have 
significant effects on the national risk indicators. The environmental risks of the active ingredients 
currently used in both crops are suggested to be strongly related to their presence in freshwater 
systems. Fruit orchards less than 1 km away from any freshwater system correspond to approximately 
3-15% of the area of production in the different countries. For potato fields in 2018, fields less than 1 
km away from freshwater systems corresponded to approximately 3-11% of the countries’ area of 
production. No effects from the large-scale adoption of PLB resistant potatoes on the total greenhouse 
gas emission related to agricultural activities in the EU were found. 

5 Harmonised Risk Indicator-1 is used to estimate the trends in risk from pesticide use. HRI 1 is calculated 
by multiplying the quantities of active substances placed on the market in plant protection products by a 
weighting factor. 
6 Group 2: Active substances approved or deemed to be approved under Regulation (EC) No 1107/2009, 
and not falling in other categories, and which are listed in Parts A and B of the Annex to Implementing 
Regulation (EU) No 540/2011 
7 Group 3: Active substances approved or deemed to be approved under Article 24 of Regulation (EC) No 
1107/2009, which are candidates for substitution, and which are listed in Part E of the Annex to 
Implementing Regulation (EU) No 540/2011 
8 Group 4: Active substances which are not approved under Regulation (EC) No 1107/2009, and therefore 
which are not listed in the Annex to Implementing Regulation (EU) No 540/2011 

164 

 
 
                                                           
Figure 4: Presentation of the JRC case study on cisgenic potato. 

Figure 5: Presentation of the JRC case study on cisgenic apple. 

165 

 
 
 
 
 
 
Box 2: Socioeconomic impact of low-gluten celiac-safe wheat developed by gene editing9 
1 to 2% of the human population (4.5 million in the EU) suffer from coeliac disease (CD), a life-
long autoimmune disorder, triggered by gluten and similar storage proteins in wheat, rye and barley, 
with severe underdiagnosis, leading to chronic small intestine inflammation. Next to CD, a large 
group of people suffer from non-coeliac wheat sensitivity (NCWS), with overlapping symptoms to 
CD but without elevated level of intestinal damage. Current management is through life-long 
gluten-free diets, which often lead to unbalanced nutrient intake, due to counterbalancing the lack of 
gluten with high salt, fat, and carbohydrates. 
Gluten-free products are 200% more expensive than their normal counterparts. The economic aid 
offered differs among Member States. Patients and their relatives have as a rule little or no financial 
support. Costs for the health care system and productivity are difficult to quantify due to lack of 
data. After diagnosis and following a gluten-free diet, quality of life is reported to improve, and 
post-diagnosis medical costs reduced by 39%.  
It is difficult to generate a low gluten variety via conventional breeding (high copy of genes, 
structural complexity). 
Researchers from the Institute for Sustainable Agriculture of the Spanish National Research Council 
of Córdoba designed a first gene-edited wheat targeting alpha gliadins, which are the most 
immunoreactive, to achieve a variety that is not immunogenic for patients with celiac disease and 
possibly useful also for those with non-celiac wheat sensitivity. These gene-edited wheat lines 
reached a reduction in the alpha-gliadin content from 32% to 82%, while immunoreactivity was 
reduced by 85%. These lines have already been cultivated in greenhouses. 
In addition, a second gene-edited wheat was obtained targeting gamma- and omega-gliadins, and 
achieved a reduction of 70% and 90% in the gamma and omega-gliadins, respectively. These lines 
are not yet being tested in greenhouses. Lastly, cross-breeding between gene-edited lines to combine 
all gliadin mutations in a single soft wheat genotype was carried out. These lines are currently being 
analysed, and the final selection of genotypes containing all mutations is expected to be completed 
by mid-2023. After this, clinical trials are planned using the best line.  
After diagnosis, outpatient costs are estimated to be reduced by 29% (and total medical cost of care 
by 39%) and QALY (quality-adjusted life year) scores are estimated to improve based on adequate 
gluten-free diet. Gene edited low-gluten celiac-safe wheat provides a safe alternative to the gluten-
free products for celiac disease patients and reduces possible nutrient deficiencies and imbalance in 
gut bacteria often associated with wheat avoidance. In addition, while conventional gluten-free 
products are on average 200% more expensive, products based on gene-edited low-gluten non-celiac 
wheat are expected to be only 30% more expensive. More affordable safe gluten-free diets will 
contribute to reducing medical costs post-diagnosis and improving quality of life. 
In addition, the adoption of low-gluten celiac-safe wheat could increase gross margin of farmers per 
ha in average by 30% compared to conventional wheat. Finally, the competitiveness of the EU agri-
food system might be enhanced by increasing export volumes (EUR0.5 to 2.6 billion) and lower 
import volumes (EUR0.1 to 0.5 billion) of this product, if eventually cultivated in the EU. 

9 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.  

166 

 
 
                                                           
Figure 6: Presentation of the JRC case study on targeted mutagenesis wheat. 

Box 3: Biotic resistance in the context of smallholder farming in East Africa: a case on gene 
editing of maize to safeguard food security under the spread of the Maize Lethal Necrosis 
Maize Lethal Necrosis (MLN) is a complex viral disease, spread recently to East Africa from the 
Americas. The disease is highly damaging, putting local food security at risk (majority of calory 
intake in the region comes from maize), as well as inflicting critical economic repercussions. MLN 
causes immense annual losses (~500 K tonnes in Kenya alone) in the production of maize, which is 
a main product on the Sub-Saharan African agricultural market. Maize agriculture provides the 
livelihood of 98% of smallholder farmers. With existing preventive measures and if MLN expands 
to susceptible countries, the impact of MLN could lead to an additional 122,000 additional people 
experiencing severe food insecurity. 
Because small farmers in Africa lack the right management tools to handle MLN, resistance is 
considered the most economically and sustainably effective way in the battle against this disease 
and could save 0.5 Mio people from falling under the poverty line. Given the large variety of 
cultivates used in East Africa highly adapted to regional conditions and the faster development 
compared to conventional breeding, NGTs provide a valuable tool in fighting MLN and reduce yield 
penalty, consequently reducing the number of persons experiencing food insecurity and 
safeguarding smallholder farmers’ livelihoods.  
The gene-edited virus-resistant maize, currently in development, could prevent a deterioration of the 
severe food insecurity in East Africa, as well as deliver economic benefits. 
The references are listed in footnote 10. 

10 Contribution based on a literature review:  
Awata, L. A. O., Beyene, Y., Gowda, M. et al., 2019.  Genetic Analysis of QTL for Resistance to Maize 
Lethal Necrosis in Multiple Mapping Populations. Genes 11, 32. https://doi.org/10.3390/genes11010032 
Awata,  L.  A.  O.,  Ifie,  B.  E., Danquah,  E.et  al., 2021.  Introgression  of  Maize  Lethal  Necrosis  Resistance 
Quantitative Trait Loci Into Susceptible Maize Populations and Validation of the Resistance Under Field 
Conditions in Naivasha, Kenya. Frontiers in Plant Science 12. https://doi.org/10.3389/fpls.2021.649308 
Batchelor,  W.  D.,  Suresh,  L.  M.,  Zhen,  X.  et  al.,  2020.  Simulation  of  Maize  Lethal  Necrosis  (MLN) 
Damage Using the CERES-Maize Model. Agronomy 10, 710. https://doi.org/10.3390/agronomy10050710 
Beyene,  Y.,  Gowda,  M.,  Suresh,  L.  M.  et  al.,  2017.  Genetic  analysis  of  tropical  maize  inbred  lines  for 
resistance to maize lethal necrosis disease. Euphytica 213, 224. https://doi.org/10.1007/s10681-017-2012-3 

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Boddupalli,  P.,  Suresh,  L.  M.,  Mwatuni,  F.  et  al.,  2020.  Maize  lethal  necrosis  (MLN):  Efforts  toward 
containing  the  spread  and  impact  of  a  devastating  transboundary  disease  in  sub-Saharan  Africa.  Virus 
Research 282, 197943. https://doi.org/10.1016/j.virusres.2020.197943 
Das, B., Atlin, G. N., Olsen, M., Burgueño, J. et al., 2019. Identification of donors for low-nitrogen stress 
with maize lethal necrosis (MLN) tolerance for maize breeding in sub-Saharan Africa. Euphytica 215, 80. 
https://doi.org/10.1007/s10681-019-2406-5 
De Groote, H., Oloo, F., Tongruksawattana, S., & Das, B., 2016.  Community-survey based assessment of 
the geographic distribution and impact of maize lethal necrosis (MLN) disease in Kenya. Crop Protection 
82, 30–35. https://doi.org/10.1016/j.cropro.2015.12.003 
Dhugga,  K.  S.,  2022.  Gene  Editing  to  Accelerate  Crop  Breeding.  Frontiers  in  Plant  Science  13. 
https://doi.org/10.3389/fpls.2022.889995 
FAO, IFAD, UNICEF, WFP and WHO. 2022. The State of Food Security and Nutrition in the World 2022. 
Repurposing food and agricultural policies to make healthy diets more affordable. Rome, FAO 
Flachowsky, H., Le Roux, P.-M., Peil, A. et al., 2011. Application of a high-speed breeding technology to 
apple (Malus × domestica) based on transgenic early flowering plants and marker-assisted selection. New 
Phytologist 192, 364–377. https://doi.org/10.1111/j.1469-8137.2011.03813.x 
Garrett,  K.  A.,  Andersen,  K.  F.,  Asche,  F.  et  al.,  2017.  Resistance  Genes  in  Global  Crop  Breeding 
Networks. Phytopathology 107, 1268–1278. https://doi.org/10.1094/PHYTO-03-17-0082-FI 
Isabirye,  B.  E.,  &  Rwomushana,  I.,  2016.  Current  and  future  potential  distribution  of  maize  chlorotic 
mottle  virus  and  risk  of  maize  lethal  necrosis  disease  in  Africa.  Journal  of  Crop  Protection  5,  215–228. 
https://doi.org/10.18869/modares.jcp.5.2.215 
Jafari  Jozani,  H.,  Thiel,  M.,  Abdel-Rahman,  E.  M.  et  al.,  2022.  Investigation  of  Maize  Lethal  Necrosis 
(MLN)  severity  and  cropping  systems  mapping  in  agro-ecological  maize  systems  in  Bomet,  Kenya 
utilizing  RapidEye  and  Landsat-8  Imagery.  Geology,  Ecology,  and  Landscapes  6,  125–140. 
https://doi.org/10.1080/24749508.2020.1761195 
Lee, M., 1998. Genome projects and gene pools: New germplasm for plant breeding? Proceedings of the 
National Academy of Sciences 95, 2001–2004. https://doi.org/10.1073/pnas.95.5.2001 
Mahuku, G., Lockhart, B. E., Wanjala, B. et al., 2015. Maize Lethal Necrosis (MLN), an Emerging Threat 
to  Maize-Based  Food  Security 
in  Sub-Saharan  Africa.  Phytopathology  105,  956–965. 
https://doi.org/10.1094/PHYTO-12-14-0367-FI 
Marenya,  P.  P.,  Erenstein,  O.,  Prasanna,  B.,  Makumbi,  D.  et  al.,  2018.  Maize  lethal  necrosis  disease: 
Evaluating  agronomic  and  genetic  control  strategies  for  Ethiopia  and  Kenya.  Agricultural  Systems  162, 
220–228. https://doi.org/10.1016/j.agsy.2018.01.016 
Murithi, A., Olsen, M. S., Kwemoi, D. B. et al., 2021. Discovery and Validation of a Recessively Inherited 
Major-Effect QTL Conferring Resistance to Maize Lethal Necrosis (MLN) Disease. Frontiers in Genetics 
12. https://doi.org/10.3389/fgene.2021.767883 
Mwatuni, F. M., Nyende, A. B., Njuguna, J. et al., 2020. Occurrence, genetic diversity, and recombination 
of  maize 
in  Kenya.  Virus  Research  286,  198081. 
https://doi.org/10.1016/j.virusres.2020.198081 
Nelson,  R.,  Wiesner-Hanks,  T.,  Wisser,  R.,  &  Balint-Kurti,  P.,  2018.  Navigating  complexity  to  breed 
disease-resistant crops. Nature Reviews Genetics 19, 21–33. https://doi.org/10.1038/nrg.2017.82 
Njeru,  F.,  Mwaura,  S.,  Kusolwa,  P.  M.,  &  Misinzo,  G.,  2022  Maize  production  systems,  farmers’ 
perception and current status of maize lethal necrosis in selected counties in Kenya. All Life 15, 692–705. 
https://doi.org/10.1080/26895293.2022.2085815 
Pratt,  C.  F.,  Constantine,  K.  L.,  &  Murphy,  S.  T.,  2017.  Economic  impacts  of  invasive  alien  species  on 
African smallholder livelihoods. Global Food Security 14, 31–37. https://doi.org/10.1016/j.gfs.2017.01.011 
Redinbaugh,  M.  G.,  &  Stewart,  L.  R.,  2018.  Maize  Lethal  Necrosis:  An  Emerging,  Synergistic  Viral 
Disease.  Annual  Review  of  Virology  5,  301–322.  https://doi.org/10.1146/annurev-virology-092917-
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maize 
303–315. 
in 
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Regassa, B., Abraham, A., Fininsa, C. et al., 2020) Distribution of maize lethal necrosis epidemics and its 
association  with  cropping  systems  and  cultural  practices  in  Ethiopia.  Crop  Protection  134,  105151. 
https://doi.org/10.1016/j.cropro.2020.105151 
Richard, K., Abdel-Rahman, E. M., Subramanian, S. et al., 2021. Estimating maize lethal necrosis (MLN) 
severity 
in  Kenya  using  multispectral  high-resolution  data.  Applied  Geomatics  13,  389–400. 
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from the Wild. Science 277, 1063–1066. https://doi.org/10.1126/science.277.5329.1063 

lethal  necrosis  disease-causing  viruses 

Phytopathology 

Ethiopia. 

necrosis 

Journal 

lethal 

169, 

of 

168 

 
                                                                                                                                                                            
 
Figure 7: Presentation of the JRC case study on targeted mutagenesis maize. 

Tracy, W. F., 2004. Breeding: the backcross method. In R. M. Goodman (Ed.), Encyclopedia of Plant and 
Crop Science. Routledge. https://doi.org/10.1081/E-EPCS 
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Publications, New York. 

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Horizon 2020 projects and other research concerning NGT applications 

A Horizon 2020 project has considered an NGT root chicory for inulin production (box 
4),  and  presented  an  environmental  and  socio-economic  assessment  of  the  whole  value 
chain of the new chicory variants and their derived products. 

Box 4: Root chicory for inulin production (H2020 project)11 
Root chicory (Cichorium intybus) is a specialty crop, nearly exclusively cultivated in Belgium and 
the Netherlands where the growing conditions for this crop species are best, and which experiences 
increased demands as a source of food ingredients. Root chicory is cultivated for the food fibre 
inulin, a chain of fructose molecules – fibre is extracted from the root and included in foods such as 
yoghurts and cereal bars as low-calorie sweetener – and for the production of terpenes, which are 
able to inhibit, like antibiotics, the growth of fungi or bacteria, or are reported to prevent cancer 
cells from growing. The CHIC project12 employed targeted mutagenesis to develop chicory 
varieties that (1) produce more and healthier inulin fibres and (2) produce sufficient amounts of 
medicinal terpenes. 
A socio-economic and environmental impact assessment, using a multi-regional input-output 
(MRIO) analysis and life-cycle assessment (LCA), assumes that the NGT-based root chicory would 
not be regulated as a GMO. Three scenarios are modelled: 

-  A  baseline  scenario  which  uses  the  current  situation  of  chicory  yield,  cultivation 

practices, energy use, and the current levels of inulin and terpene extraction; 
a chicory with a higher inulin content and reduced terpene content; 
a chicory with higher inulin and terpene content. 

- 
- 

According to the project’s conclusions, the two scenarios based on new chicory varieties both show 
positive socio-economic impacts (production and employment effects) compared to the baseline 
scenario. The study found that the higher inulin and terpene content of the NGT chicory varieties 
can lead to more jobs, can generate higher added value, can reduce GHG emissions and can reduce 
primary energy demand. Despite the market value of inulin, chicory is still an underdeveloped crop 
in the EU. NGT varieties of chicory with a higher inulin content and the additional production of 
terpenes can increase the competitive value of chicory in comparison to other crop species. 

Furthermore,  a  new  Horizon  Europe  project  GeneBEcon13,  started  in  September  2022, 
will  examine  the  innovation  potential  of  gene  editing  in  enabling  a  sustainable 
bioeconomy  in  Europe.  Through  the  application  of  this  technology  in  potato  and 
microalgae,  GeneBEcon  intends  to  promote  energy-efficient,  low-input,  and  zero-
pollution  agricultural  production  and  clean  industrial  processing.  First,  the  technical 
potential will be explored by applying gene editing to develop 1) a virus-resistant potato 
with an industrial tuber starch quality, and 2) microalgae-based production of industrially 
relevant  mycosporin-like  amino  acids.  Second,  the  risk-regulatory  aspects,  economic 
incentives, and social perceptions will be investigated. In the latter, comparative analyses 
will  be  enabled  by  two  different  production  systems:  open-field  agricultural  crop  and 
contained-system microalgae. 

Other  national  research  projects  are  also  investigating  the  potential  of  genome  editing 
(e.g. GenEdit in Belgium14). A COST Action (PlantEd, 2019-2023)15, involving over 330 
experts  from  36  European  countries  and  beyond,  is  aimed  at  advancing  the  technology 

11 Hingsamer M., Kulmer V., de Roode M. &Kernitzkyi M. (2022) Environmental and socio-economic 
impacts of new plant breeding technologies: A case study of root chicory for inulin production. Frontiers 
in Genome Editing 4, doi: 10.3389/fgeed.2022.919392 
12 https://cordis.europa.eu/project/id/760891/results  
13https://cordis.europa.eu/project/id/101061015  
14 https://www.sciensano.be/en/projects/development-and-evaluation-approaches-detection-organisms-
modified-new-genome-editing-techniques  
15https://plantgenomeediting.eu/  

170 

 
                                                           
and  assessing  its  impact,  discuss  regulatory  options,  monitor  public  perceptions  and 
develop educational and outreach activities. 

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ANNEX 8: EU LEGAL FRAMEWORK ON GMOS 

The GMO legal framework has as main aims to protect human and animal health and the 
environment  in  accordance  with  the  precautionary  principle  and  to  ensure  the  effective 
functioning  of  the  internal  market.  It  regulates  the  deliberate  release  (including  the 
placing  on  the  market)  of  GMOs  and  of  food  and  feed  produced  from  GMOs,  the 
contained use of GMMs, as well as the export of GMOs to third countries (in application 
of the EU’s obligations under the Cartagena Protocol on Biosafety to the UN Convention 
on  Biological  Diversity1).  The  GMO  acquis  rests  on  five  main  pieces  of  legislation, 
namely: 

-  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 
organisms2 

-  Directive  2009/41/EC  of  the  European  Parliament  and  of  the  Council  of  6  May 

2009 on the contained use of genetically modified micro-organisms3  

-  Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 

22 September 2003 on genetically modified food and feed4 

-  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 organisms5 

-  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 
15 July 2003 on transboundary movements of genetically modified organisms6. 

The  EU  GMO  legislation  applies  to  GMOs  as  defined  in  Article  2(2)  of  Directive 
2001/18/EC, i.e. ‘an organism, with the exception of human beings, in which the genetic 
material  has  been  altered  in  a  way  that  does  not  occur  naturally  by  mating  and/or 
natural  recombination’.  The  definition  is  further  refined  by  a  non-exhaustive  list  of 
genetic  modification  techniques  set  out  in  Part  1  of  Annex  IA  to  the  Directive  and  by 
excluding the techniques listed in Part 2 of that annex, which are not considered to result 
in  genetic  modification  under  certain  conditions.  Furthermore,  Article  3(1)  of  the 
Directive  excludes  from  the  scope  of  the  Directive  GMOs  that  result  from  the 
techniques/methods listed in Annex IB (i.e. mutagenesis and certain types of cell fusion), 
provided  that  they  do  not  involve  the  use  of  recombinant  nucleic  acid  molecules  or 
GMOs.  

In  2018,  the  Court  of  Justice  of  the  EU  clarified  the  interpretation  of  the  scope  of  the 
mutagenesis exemption (judgment of 25.7.2018, Case C-528/16 Confédération paysanne 
and Others7). The Court ruled, firstly, that organisms obtained by means of mutagenesis 

1 Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted on 29 January 2000, concluded 
on behalf of the EU by Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the 
European Community, of the Cartagena Protocol on Biosafety, OJ L 201, 31.7.2002, p. 48. 
2 OJ L 106, 17.4.2001, p. 1 
3 OJ L 125, 21.5.2009, p. 75 
4 OJ L 268, 18.10.2003, p. 1 
5 OJ L 268, 18.10.2003, p. 24 
6 OJ L 287, 5.11.2003, p. 1 
7 See footnote 14. 

172 

 
 
                                                           
techniques/methods  constitute  GMOs  as  they  meet  the  definition  in  Article  2(2)  of 
Directive  2001/18/EC  and  are  not  included  in  the  exhaustive  list  of  techniques  not 
resulting  in  genetic  modification  set  out  in  Part  2  of  Annex  IA  to  that  directive,  and, 
secondly,  that  the  mutagenesis  exemption  in  Annex  IB  to  that  directive  must  be 
interpreted  as  only  covering  organisms  obtained  by  means  of  mutagenesis 
techniques/methods  which  have  conventionally  been  used  in  a  number  of  applications 
and  have  a  long  safety  record,  and  that  new  techniques/methods  that  have  appeared  or 
have been mostly developed since Directive 2001/18/EC was adopted are not exempted. 
Accordingly,  the  Court  concluded  that  organisms  obtained  by  means  of  random 
mutagenesis techniques/methods are excluded from the scope of the Directive, whereas 
organisms  obtained  by  techniques/methods  of  targeted  mutagenesis  are  not  exempted 
(judgment of 25.7.2018, Case C-528/16 Confédération paysanne and Others, paragraphs 
48, 51, 54). In a recent judgment, the Court further clarified that organisms obtained by 
in vitro random mutagenesis techniques/methods are exempted from the GMO legislation 
(judgment of 7 February 2023, Case C-688/21 Confédération paysanne and Others)8. 

Although  the  above-mentioned  2018  judgment  only  concerned  the  mutagenesis 
exemption,  its conclusions apply also  to  organisms  produced by means  of other NGTs, 
such  as  cisgenesis.  Indeed,  organisms  obtained  by  those  techniques  alter  the  genetic 
material in a way that does not occur naturally by mating or natural recombination and, 
therefore, constitute GMOs. Since those techniques are neither listed in Part 2 of Annex 
IA  nor  in  Annex  IB  to  Directive  2001/18/EC,  it  must  be  concluded  that  organisms 
obtained by those techniques are subject to the GMO legislation9. 

The  main  elements  of  the  GMO  acquis  are  described  in  the  next  paragraphs  (see  also 
diagram in the end of the section). 

  Directive  2001/18/EC  on  the  deliberate  release  of  genetically  modified 

organisms 

Directive  2001/18/EC  requires  the  relevant  national  authorities’  prior  consent  for  the 
deliberate  release  of  GMOs  into  the  environment.  In  order  to  obtain  consent,  an 
application  (‘notification’)  has  to  be  submitted  to  the  national  competent  authority, 
accompanied  inter alia  by an environmental risk assessment. The risk assessment must 
comply with the general principles and the methodology set out in the Directive and must 
draw  conclusions  for  each  relevant  area  of  risk.  The  requirements  are  different  for  the 
placing on the market of GMOs as or in products (Part C of the Directive) and for other 
purposes, such as experimental releases (Part B).  

The authorisation procedure for the placing on the market of GMOs other than food and 
feed  is  conducted  by  Member  States.  The  national  competent  authority  to  which  the 
notification  has  been  submitted  must  deliver  an  assessment  report  on  the  submitted 
notification.  In  cases  where  the  Commission  or  another  Member  State  have  expressed 
objections to the assessment report and no agreement has been reached, the Commission 
adopts a decision after obtaining the scientific opinion of EFSA. The national competent 
authority that prepared the report rejects the notification or gives written consent for the 
placing on the market of the GMO and sets out the conditions, as well as labelling and 
monitoring  requirements.  The  consent  can  be  valid  for  a  renewable  period  of  up  to  10 
years. 

8 ECLI:EU:C:2023:75 
9 European Commission (2021c), sections 4.2.2, 4.2.3 and 4.2.4. 

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The Directive allows Member States to ban the cultivation of GMOs in their territory or 
part thereof based on compelling grounds (such as grounds relating to town and country 
planning, land use, etc) other than those concerning the safety of GMOs for health or the 
environment. So far this provision has been  applied as regards the authorisation for the 
cultivation of one GM plant10, from which 18  of the 27 Member States11 excluded all of 
part of their territory.  

  Directive  2009/41/EC  on  the  contained  use  of  genetically  modified  micro-

organisms (GMMs) 

This Directive defines a GMM as ‘a micro-organism in which the genetic material has 
been  altered  in  a  way  that  does  not  occur  naturally  by  mating  and/or  natural 
recombination’  (Article  2(b)).  It  requires  a  notification  to  the  national  competent 
authorities and in some cases their prior consent for the contained use of GMMs. To that 
end,  the  user  has  to  carry  out  an  assessment  of  the  contained  uses  as  regards  risks  to 
human health and the environment.  

Directive  2009/41/EC  only  applies  to  GMMs.  The  contained  use  of  other  GMOs  is 
currently not regulated at EU level, but is subject to national legislation in most Member 
States. 

  Regulation (EC) No 1829/2003 on GM food and feed 

This  Regulation  requires  authorisation  for  the  placing  on  the  market  of  food  and  feed 
consisting  of,  containing  or  produced  from  GMOs  (‘GM  food  and  feed’).  The 
authorisation procedure is centralised, providing for a single application to be submitted 
to  a  national  competent  authority  for  all  the  intended  uses  of  the  GM  food  or  feed  in 
question (including cultivation). It is based on an independent risk assessment carried out 
by  EFSA.  Authorisation  may  be  granted  only  if  the  risk  assessment  demonstrates  that, 
under  its  intended  conditions  of  use,  the  product  has  no  adverse  effects  for  human  and 
animal health and for the environment compared to its conventionl counterparts, does not 
mislead  the  user  or  the  consumer  and  is  not  nutritionally  disadvantageous  compared  to 
the food or feed it is intended to replace.  

Authorisations are granted by the Commission for a renewable period of ten years. They 
may  impose  conditions  or  restrictions,  including  post-market  monitoring  requirements, 
and must set  out  the method  for detecting the transformation  event,  as provided by the 
applicant and validated by the EU Reference Laboratory for GM Food and Feed (EURL), 
as well as the place from which the reference material may be obtained. The Regulation 
also provides for mandatory labelling of authorised GM food and feed, so that final users 
and  consumers  can  make  an  informed  choice,  but  exempts  food  and  feed  containing 
traces  of  GMOs  or  GM  material  in  a  proportion  no  higher  than  0.9%  of  the  food/food 
ingredient/feed/feed component provided that this presence is adventitious or technically 
unavoidable. 

10 Commission Implementing Decision (EU) 2016/321 of 3 March 2016 adjusting the geographical scope 
of the authorisation for cultivation of genetically modified maize (Zea mays L.) MON 810 (MON-ØØ81Ø-
6) (OJ L60, p 90). 
11 AT, BE (Wallonia), BG, CY, DE, DK, EL, FR, HR, HU, IT, LV, LT, LU, MT, NL, PL, SI 

174 

 
                                                           
  Regulation (EC) No 1830/2003 on the traceability and labelling of GMOs and 

the traceability of food and feed products produced from them 

Under  this  Regulation,  operators  placing  GMOs  and  GM  food  and  feed  on  the  market 
must inform the operators receiving the products, in writing, that the products contain or 
consist of GMOs. They must provide an indication of each ingredient/material produced 
from GMOs or, for products without an ingredients list, an indication that the product is 
produced  from  GMOs.  They  must  keep  that  information  for  five  years  and  be  able  to 
identify the operator(s)  by whom and to  whom the products  have been  made available. 
Traceability  requirements  allow for  close monitoring of potential effects  of the product 
on  environment  and  health,  and  where  necessary  for  the  withdrawal  of  products  if  an 
unexpected risk to human health or to the environment is detected.  

Furthermore, the Regulation requires that all products consisting of or containing GMOs 
are labelled as GMOs. 

The  Regulation  exempts  from  the  traceability  and  labelling  requirements  products 
containing  traces  of  GMOs  intended  for  direct  use  as  food,  feed  or  for  processing  and 
food/feed  containing  traces  of  GMOs  or  GM  material  in  a  proportion  not  higher  than 
0.9% provided that these traces are adventitious or technically unavoidable. 

  Regulation (EC) No 1946/2003 on transboundary movements of GMOs 

At  international  level,  the  EU  is  a  party  to  the  Cartagena  Protocol  on  Biosafety.  The 
purpose of the Protocol, in line with the precautionary approach, is to ensure an adequate 
level of protection in the safe transfer, handling and use of GMOs that may have adverse 
effects  on  biodiversity  and  human  health.  To  that  end,  it  sets  out  common  rules  to  be 
followed  in  transboundary  movements  of  GMOs  and  provides  for  a  central  database 
(Biosafety Clearing House) to allow parties to exchange information on GMOs and help 
them  to  comply  with  their  obligations  under  the  Protocol.  The  Protocol’s  procedures 
concerning  exports  of  GMOs  are  implemented  in  the  EU  by  Regulation  (EC) 
No 1946/2003  on  transboundary  movements  of  GMOs.  In  particular,  the  Regulation 
requires  EU  operators  to  notify  the  competent  authorities  of  importing  countries  of 
exports of GMOs intended for deliberate release into the environment and to seek their 
consent prior to the first export. It also requires the Commission and Member States to 
inform the Biosafety Clearing House of relevant legislation and decisions on GMOs. 

.

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176 

 
 
ANNEX 9: PROBLEM TREE 

177 

 
 
 
 
 
ANNEX 10: INTERVENTION LOGIC 

178 

 
 
 
ANNEX 11: PROCEDURE FOR NOTIFICATION (OPTION 4) 

179 

 
 
  
 
 
 
ANNEX 12: SME TEST  

Step 1/4: Identification of affected businesses 

SMEs form an important part of the plant breeding sector, with over 90% in some Member States 
of  plant  breeders  being  SMEs  .  The  majority  of  EU  farmers  are  small  (and  micro)  enterprises. 
Under  the  current  GMO  legislation,  the  SMEs  in  NGTs  and  GMO  plant  breeding  seeking 
authorisation  for  the  release  or  placing  on  the  market  of  products  have,  though,  a  very  limited 
presence. This  signals that  the  current  legislation  affects them  negatively,  with  the  exception  of 
the organic sector. The latter is dominated by micro and small farmers and small organic breeders. 

Key question: To what extent is the initiative relevant for SMEs? (not relevant, relevant, highly 
relevant) 

This  initiative  is  considered  relevant  for  SMEs.  Policy  objectives  of  the  initiative  are  aimed  at 
reducing  regulatory  costs  and  regulatory  uncertainty,  both  of  which  disproportionately  affect 
SMEs.  Moreover,  there  is  an  expectation  that  measures  aimed  at  a  level  playing  field  vis  à  vis 
non-EU  countries  will  benefit  the  internal  market  players,  including  SMEs.  The  initiative  also 
aims  at  facilitating  the  application  of  NGTs  to  wider  range  of  traits  and  of  niche  or  locally 
important  crop  species,  which  often  are  the  focus  of  SMEs,  thereby  opening  the  market  to  a 
greater diversity of players. 

Step 2/4: Consultation of SME Stakeholders 

 SMEs have been explicitly integrated in the  consultation strategy. For the different consultation 
methods,  the  following  numbers  (shares)  of  SMEs  or  associations  representing  SMEs  
participated: 
- 
General  Interviews:  11  business  associations  representing  the  various  value  chain 
segments  which  represent  SMEs  as  well  as  large  companies.  3  interviews  with  farmer 
organisations.  2  interviews  with  organic  business  stakeholders,  mainly  representing  small 
companies  (including  farmers).  Thus  16  out  of  25  (64%)  of  the  general  interviews  concerned 
business organisations that represented SMEs. 
Cost-benefit  analysis  (CBA):  the  CBA  mapped  costs  for  the  biotechnology  industry, 
- 
processors,  farmers,  and  retail.  While  regulatory  costs  are  the  same  for  all  size  classes  of 
companies, SMEs have  – for reasons already mentioned above-  more difficulties to cover them. 
This is covered qualitatively. To understand the situation, out of five interviewed companies for 
the CBA, two were small firms.   
Targeted Survey: 8 out 122 respondents (6%) identified as SMEs 
- 
- 
Public  consultation  (PC):  out  of  179  companies/business  associations  125  (69.8%) 
identified as Small and Medium Sized Enterprises (SMEs), comprised of medium companies (28; 
15.6%), small companies (33; 8.4%), and micro-companies (64; 35.8%). 
- 
Focus Groups: in two focus groups, six sector and farmer representatives joined (out of 14 
participants).  In  particular,  the  small  farmer’s  perspectives  were  taken  into  account  through  the 
inclusion of two farmer/organic farmer organisations. 
Given that neither SMEs nor larger companies have much experience with GMOs and NGTs in 
the EU, most of the quantitative effects are based on expectations and qualitative assessment. 

180 

 
 
 
 
 
 
Step 3/4: Assessment of the impact on SMEs 

Views from the public consultation in response to a question on necessary regulatory measures to facilitate 
the  uptake  of  NGTs  by  SMEs  indicate  that  mainly  a  stable,  reliable,  inexpensive  framework  is  needed. 
Farmers  voice  that  ‘lower  fees  and  easier  and  faster  procedures  will  facilitate  the  uptake  by  SME’  and  it 
would be essential to ‘secure a quick and low-cost administrative process’. The plant breeding/seeds sector 
indicated  that  ‘the  financial  and  bureaucratic  hurdles  should  be  kept  as  low  as  possible  in  order  to  grant 
SMEs the opportunity to use NGT’.  

A potential loss of competitiveness is widely felt among the respondents of the PC in case there is no change 
in the current legislation, e.g.: “if we continue GMO regulation, it would mean that we as a  small/medium-
sized processing company do not in any way have a chance to use NGT” and that would imply a “loss of 
competitiveness with large competitors”. NGTs have the characteristics of a less costly platform technology 
that  could  lead  to  an  opening  up  of  the  plant  breeding  landscape  from  which  a  variety  of  SMEs  could 
benefit. This has been observed in Argentina after its regulatory shift to excluding certain NGTs from the 
GMO definition. 

The current GMO legal framework is not fit-for purpose for certain NGTs and their products (Commission 
NGT study, 2021). Costs for the required evidence and procedures do not differ between large companies 
and SMEs but large companies have different advantages and mitigation measures at hand: SMEs tend to be 
more  vulnerable  to  regulatory  requirements  than  larger  firms,  which  benefit  from  economies  of  scale,  in-
house legal departments, diversification of risks, etc.). Under the current situation, SMEs are more likely to 
reduce  their  NGT-development  effort.  They  are  also  less  likely  to  shift  product  development  to  non-EU 
countries and are particularly sensitive to uncertainty. They have fewer financial reserves and cannot spread 
their risks over a broad portfolio. Any risks that might result in a lack or delayed market authorisation are 
therefore particularly affecting SMEs. 

The  preferred  option  is  by  far  the  most  advantageous  for  SMEs  compared  to  the  current  situation,  as 
administrative  and  compliance  costs  will  nearly  be  eliminated  for  those  NGT  products  to  which  the 
notification procedure is applicable. Furthermore, the clear definition of objective notification criteria would 
reduce uncertainties and render the regulatory process more predictable for SMEs. It also has the strongest 
impact  on  competitiveness  as  a  lower  regulatory  burden  will  enable  investments  in  R&D  and  subsequent 
product development, both from large multinational plant breeders as well as SMEs. Regulatory incentives 
linked  to  the  authorisation  of  NGT  plants  under  the  preferred  option  would  facilitate  access  to  and 
navigation of the regulatory framework, especially for SMEs, supporting their competitiveness. 

The  impact  analysis  shows  that  NGTs  offer  opportunities  for  small  farmers,  depending  on  the  developed 
traits and plants. With (potentially) less land needed to obtain higher yield, less pesticides used to maintain 
healthy crops, less water is needed for irrigation, or crops being more resistant to biotic and abiotic stress, 
farmers expect to have economic gains. The gains will be somewhat offset by expected higher seed prices, 
but overall a positive economic impact is envisaged. In parallel, positive environmental effects (in particular 
on  soil,  water,  air  use  and  quality)  would  allow  farmers  to  transform  current  farming  practices  into  more 
sustainable ones. 

In the preferred option, which is expected to result in the highest number of NGT plants on the EU market 
and  where  notified  NGT  plants  would  not  be  subject  to  labelling  and  traceability  as  GMOs,  the  highest 
negative  impact on SMEs  from the organic and GM-free sectors in the sector is expected, should notified 
NGT plants remain banned in the organic sector.  

While  from  the  legal  point  of  view  the  NGT  initiative  is  independent  from  the  rules  on  the  protection  of 
intellectual property  and does not address matters of  application of the IPR legislation  to NGT plants, the 
Commission has taken note of the concerns brought forward by certain stakeholders on the possible impacts 
on SMEs relating to the application of the IPR legislation, and will carefully consider them. 

181 

 
 
Step 4/4: Minimising negative impacts on SMEs 

The preferred option maximises the positive impacts on SMEs in the breeding sector. The 
notification procedure in the preferred option would minimise costs for breeder as they undergo 
the same process as conventionally bred plant varieties. SME operators developing plants subject 
to the authorisation procedure with adapted risk assessment can benefit from regulatory incentives 
such as the additional regulatory advice and guidance or waiving of detection method validation 
fees and faster procedures. This particularly relevant for SMEs, which as a rule lack a regulatory 
department with dedicated staff. These will help lower barriers to market access and thus support 
SMEs competitiveness in the breeding sector. 

As regards SMEs in the organic and GM-free sectors, in the case of authorised NGT products, the 
current mechanisms of the GMO legislation relied on by organic and GM-free operators will 
remain in place (traceability, labelling, national coexistence measures) and will impose obligations 
on all actors in the supply chain dealing with NGT plants. As regards notified products, a public 
register of NGT plants subject to notification will support the establishment of supply chains free 
from NGT products. As regards negative impacts resulting from, if NGT products subject to 
notification, which could be produced also by conventional breeding, were accepted in organic 
production, this would reduce the burden of establishing NGT free supply chains and the 
consequences of possible accidental admixture. 

182