COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT Executive Summary of the impact assessment report Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMNET 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

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   EUROPEAN COMMISSION  Brussels, 5.7.2023  SWD(2023) 413 final  COMMISSION STAFF WORKING DOCUMENT  EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT REPORT  Executive Summary of the impact assessment report Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMNET 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) 412 final}  
 
 
INTRODUCTION 

New genomic techniques (NGTs) provide new opportunities to alter the genetic material of an 
organism  allowing  the  development  of  plant  varieties  with  specific  traits.  The  Commission 
study of April 2021 concluded that the current legislation is in need of adaptation to scientific 
and technological progress for some NGTs and their products. The study also concluded that 
plants obtained with NGTs have the potential to contribute to the objectives of the European 
Green Deal and its Farm to Fork Strategy.  

The scope of this initiative are plants produced by targeted mutagenesis and cisgenesis and their 
food and feed. There is considerable evidence available about the safety of plants obtained by 
targeted mutagenesis and cisgenesis. The European Food Safety Authority (EFSA) concluded 
that there are no new hazards specifically linked to these techniques and that, on a case-by-case 
basis,  a  lesser  amount  of  data  might  be  needed  for  their  risk  assessment  compared  to 
transgenesis. Furthermore, targeted mutagenesis and cisgenesis can produce alterations that in 
some cases can also be obtained naturally or by conventional breeding.  

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 the environment.  

PROBLEM DEFINITION 

The initiative aims to tackle three problems: 

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

  The  current  GMO  legislation  raises  implementation  and  enforcement  challenges  for 
certain plants produced by targeted mutagenesis or cisgenesis, in particular NGT plants 
for which a specific detection method cannot be provided. 

  The current GMO legislation applied to NGTs is not conducive to developing innovative 

beneficial products. 

The drivers for these problems include the fact that the current framework lags behind scientific 
developments and is not designed to developing innovative NGT products and to placing them 
on the market. 

WHY SHOULD THE EU ACT? 

EU action is essential to achieve a harmonised, high level of protection of human and animal 
health and the environment in relation to NGT plants and their food and feed so that they may 
circulate freely within a smooth-functioning internal market. There is also an urgent need to 
ensure  availability  of  plant  varieties  that  can  contribute  to  challenges  such  as  food  security, 
climate change and biodiversity reduction, further aggravated by the present geopolitical and 
energy crisis in Europe. The Farm to Fork Strategy recognises the role that biotechnology can 
play in meeting those challenges, which need an EU-wide response. 

OBJECTIVES 

The general objectives of this initiative are to maintain a high level of protection of human and 
animal health and of the environment, in accordance with the precautionary principle, to enable 

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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 and to ensure the effective functioning of the internal market  and 
enhance the competitiveness of the EU agri-food sector at the EU and global level, providing a 
level-playing field for its operators. The specific objectives to meet these general objectives 
are: 

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

2.   Deliberate  release  and  placing  on  the  market  of  NGT  plants  and  derived  food/feed 
products that feature a wide range of plant species and traits by various developers. 
3.   NGT  plants  released  or  placed  on  the  market  feature  traits  that  can  contribute  to  a 

sustainable agri-food system.  

WHAT ARE THE AVAILABLE POLICY OPTIONS? 

After screening the potential measures, they were grouped into five policy options: 

1.  Baseline: plants obtained by targeted mutagenesis and cisgenesis would continue to be 
regulated  under  the  current  GMO  legislation  and  its  risk  assessment,  authorisation, 
traceability and labelling requirements. 

2.  Option 1: the legislation would be adapted to cater for the diverse risk profiles of plants 
obtained by targeted mutagenesis and cisgenesis and to address detection challenges, 
with traceability and labelling as in the baseline. 

3.  Option 2: the legislation would be adapted to cater for the diverse risk profiles of plants 
obtained by targeted mutagenesis and cisgenesis, to address detection challenges and to 
incentivise  the  development  and  placing  on  the  market  of  plant  products  that  can 
contribute  to  a  sustainable  agri-food  system  through  regulatory  incentives  and,  as 
labelling  alternatives:  a  GM  label  accompanied  by  a  sustainability  label  or  a  factual 
statement on the trait introduced, or no GMO label if the NGT trait has the potential to 
contribute to sustainability .  

4.  Option 3: the legislation would be adapted to cater for the diverse risk profiles of plants 
obtained by targeted mutagenesis and cisgenesis and to address detection challenges. In 
addition, applicants for authorisation would be required to show that the introduced trait 
is not detrimental to sustainability. 

5.  Option  4:  notification  procedure1  for  plants  obtained  by  targeted  mutagenesis  or 
cisgenesis  that  could  also  occur  naturally  or  be  produced  by  conventional  breeding, 
which would be treated similarly to conventional plants; a transparency register would 
be established for these plants. For other plants, options 1, 2 or 3 would apply. 

THE PREFERRED POLICY OPTION 

The  preferred  option  is  a  combination  of  option  4  (for  NGT  plants  that  could  also  occur 
naturally or be produced by conventional breeding) and of option 2 (for other NGT plants). In 
the  latter,  the  labelling  would  consist  in  a  label  identifying  the  product  as  obtained  by 
biotechnology and providing a factual statement on the purpose of the introduced trait.  

IMPACTS OF THE PREFERRED POLICY OPTION 

The combination of option 4 for products that could also occur naturally or be produced by 

1 In the legislative proposal, the term finally used is ‘verification procedure’. 

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conventional  breeding  and  of  option  2  for  all  other  products  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. 

Making NGT plants that could also occur naturally or be produced by conventional breeding 
subject  to  a  notification  procedure  achieves  safety  while  ensuring  that  requirements  are 
proportionate to the risk of such NGT plants. It has by far the strongest positive impact on the 
development and placing on the market of NGT products, as it results in a higher degree of 
simplification and reduction of administrative burden for applicants and authorities. This option 
also shows the highest potential to facilitate the contribution of NGTs to sustainability of the 
agri-food system, in the light of the development pipeline and in synergy with EU policies and 
regulatory developments. It is by far the most advantageous for SMEs, as administrative and 
compliance costs will substantially decrease, and it has the strongest impact on competitiveness. 

An authorisation with adapted risk assessment for NGT plants not covered by the notification 
procedure ensures safety, as well as proportionality by adapting the data requirements for risk 
assessment  to  the  diverse  risk  profiles  of  NGT  plants  that  could  not  occur  naturally  or  be 
produced by conventional breeding. It would bring an additional, although on certain aspects 
moderate, improvement concerning attractiveness to develop such NGT plants in the EU. Cost 
reductions  for  applicants  compared  to  the  baseline  range  from  low  to  very  substantial. 
Regulatory incentives would bring moderate positive impacts in terms of steering towards traits 
with  sustainability  potential  and  would  facilitate  access  to  and  navigation  of  the  regulatory 
framework, especially for SMEs, supporting their competitiveness.  

NGT  plants  subject  to  authorisation  would  also  remain  subject  to  traceability  and  labelling. 
Labelling would be complemented with information on the purpose of the genetic modification 
to allow operators and consumers to make informed choices and is expected to drive market 
demand for products with beneficial traits.  

For  NGT  plants  subject  to  authorisation,  current  tools  (traceability,  labelling,  national 
coexistence  measures)  would  remain  available  to  supply  chains  that  do  not  use  GMOs.  For 
NGT plants subject to notification, transparency measures would allow choice at the beginning 
of the supply chain for operators to be able to decide to use or avoid NGTs. A public register 
would  inform  operators  and  consumers  of  NGT  plants  that  have  met  the  criteria  of  the 
notification procedure.  

The preferred option creates an enabling framework that meets the demand for new varieties 
with  traits  beneficial  to  the  environment,  supporting  sustainable  farming  practices  and 
delivering benefits to consumers. It is comparable to the approach followed in an increasing 
number  of  third  countries  and  would  be  the  least  disruptive  of  trade.  It  would  ensure  close 
monitoring of the uptake of the NGT products and the accompanying economic, environmental 
and social impacts. 

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