COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on 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: 2026-04-23
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, 23.4.2026  COM(2026) 151 final 2023/0226 (COD)  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT  pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  concerning the position of the Council on a Regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (Text with EEA relevance)  
 
2023/0226 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on a Regulation of the European Parliament and of the Council 
on plants obtained by certain new genomic techniques and their food and feed, and 
amending Regulation (EU) 2017/625 

(Text with EEA relevance) 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council (document COM(2023) 411 final – 2023/0226 COD): 

6 July 2023 

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

26 October 2023 

Date of the opinion of the European Committee of the Regions: 

17 April 2024 

Date of the position of the European Parliament, first reading: 

24 April 2024 

Date of transmission of the amended proposal: 

N/A 

Date of adoption of the position of the Council: 

21 April 2026 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

The  Commission  proposal  aims  at  enabling  the  development  and  placing  on  the  market  of 
plants  and products  obtained by  certain new genomic techniques (NGTs) contributing  to  an 
innovative,  resilient,  sustainable  and  competitive  agri-food  sector,  while  maintaining  a  high 
level of protection of human and animal health and of the environment. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

The  position  of  the Council  as  adopted  at  first  reading  fully  reflects  the  political  agreement 
reached  between  the  European  Parliament  and  the  Council  on  3  December  2025.  The 
Commission supports this agreement. The main points of this agreement are the following: 

• 

NGT plants have to fulfil two conditions to obtain category 1  NGT plant  status: 1) 
the  criteria  of  equivalence  of  NGT  plants  to  conventional  plants  (Annex  I  to  the 
Commission proposal), 2) the NGT plant must not include certain traits among the 
traits conveyed by the genetic modification (‘herbicide tolerance’ and ‘production of 
a  substance  with  known  insecticidal  action’)  set  out  in  Annex  II.  If  an  NGT  plant 
does  not  fulfil  those  conditions,  it  will  be  treated  as  category  2.  The  criteria  of 

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equivalence have been amended on several points, while maintaining the essence and 
scientific robustness of the Commission proposal. The exclusion of certain traits was 
not in the Commission proposal, but is acceptable as the number of traits on the list is 
limited and sufficient justification has been provided for the exclusion of such traits. 

The category 1 status verification process includes a requirement for the requester to 
accompany  the  request  with  scientific  evidence  substantiating  the  relation 
between the introduced genetic modifications and the intended trait. 

A recital was added to clarify that the emergency measures in the legislation on food, 
feed  and  other  products  also  apply  to  category  1  NGT  plants  in  case  the  latter  are 
likely to constitute a serious risk to human health, animal health or the environment. 
This  amendment,  and  the  one  above,  are  in  line  with  the  logic  of  the  Commission 
proposal. 

In the context of the Commission’s evaluation of the application of  the Regulation, 
the  Commission  is  required  to  present  a  report  that  is  to  include  producers’  and 
consumers’  perception  of  the  ban  of  NGT  plants  in  organic  production,  and  to 
assess  the  burden  on  organic  operators  resulting  from  the  Regulation.  A  new 
provision  clarifies  that  the  adventitious  or  technically  unavoidable  presence  of 
category 1 NGT plants and their products in organic production should not constitute 
non-compliance  with  Regulation  (EU)  2018/848  on  organic  production.  Those 
amendments are intended to facilitate the coexistence between organic, conventional 
and NGT production chains, in line with the Commission proposal. 

Member  States  are  entitled  to  request  the  exclusion  of  their  territory  from  the 
cultivation of category NGT 2 plants and to take voluntary co-existence measures. 
This is compatible with the logic of the Commission proposal, as it aligns the rules 
for category NGT 2 plants with the existing legislation on GMOs. 

To strengthen sustainability, an article is added to specify the sustainability elements 
of  the  monitoring  programme  and  the  consideration  of  its  outcome  in  the 
implementation reports and evaluation provided for in the Regulation, so as to allow 
the Commission to assess the need for further sustainability measures. Furthermore, a 
new  article  provides  for  controls  by  Member  States  of  compliance  with  the 
Regulation.  Those  modifications  strengthen  the  monitoring  provisions  of  the 
Commission proposal. 

The  empowerment  for  the  Commission  to  adopt  delegated  acts  (instead  of 
implementing  acts)  on  the  technical  requirements  to  demonstrate  that  a  plant  is  a 
NGT  plant  and  for  the  preparation  of  verification  requests  for  NGT  1  plants  is 
acceptable. 

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Several provisions related to patents were added. These concern:  

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a  voluntary  code  of  conduct  to  enhance  patent  transparency,  ensure  fair 
licensing  and  enhance  legal  certainty  for  breeders  and  farmers,  with  the 
Commission  overseeing  its  establishment,  monitoring  it,  evaluating  its 
operation  and  taking  follow-up  actions  (including  of  a  legislative  nature)  if 
necessary; 

declarations  in  the  context  of  the  verification  procedure  to  determine  that  a 
NGT  plant  is  category  1:  the  requester  must  declare  patents  relevant  for  the 
plant  (that  the  requester  or  others  hold)  and  keep  the  information  updated,  to 
the best of their knowledge; the requester may also submit a declaration of the 

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patent  holder  of  whether  they  intend  to  license  NGT  plants  under  fair  and 
reasonable  conditions  within  the  Union.  If  the  requester  is  the  patent  holder, 
they must submit such a declaration and a further declaration indicating if they 
are or intend to become a member of a licensing platform;  

the  Commission  is  required  to  publish  guidance  to  assist  operators  on 
intellectual  property  matters  relevant  for  NGT  plants  as  well  as  on  financial 
resources and programmes to support related research and development;  

the  Commission  is  required  to  conduct  an  assessment  on  the  impact  of  the 
patenting  of  NGT  plants  and  examine  measures  to  follow  up  (if  appropriate, 
submitting  a  legislative  proposal).  It  must  conduct  a  second  assessment  if  no 
follow-up measures are taken after the first study;  

the Commission is to set up an expert group on the effect of patents on NGT 
plants,  which  would  assist  the  Commission  in  surveying  and  exchanging 
information  on  issues  such  as  access  to  genetic  resources,  transparency  on 
patents  and  innovation  in  the  field  of  NGT  plants.  An  expert  from  the 
Community Plant Variety Office should participate in the expert group; 

the  rules  applicable 

recitals  recall  that  patents  on  plants  obtained  by  technical  methods  do  not 
extend  to  plants  that  have  been  produced  by  essentially  biological  processes; 
explain 
the  context  of  possible  unintentional 
infringements  of  patents  by  farmers  due  to  cross-pollination;  recall  the 
Commission’s  evaluation  of  Council  Regulation  (EC)  No  2100/94  on  
Community  plant  variety  rights;  and  encourage  all  Member  States  to  adopt  a 
limited breeders’ exemption. 

in 

While  patent  issues  are  not  the  subject-matter  of  the  Commission  proposal,  those 
modifications  address  concerns  about  the  potential  impacts  of  patents  in  the  area  of  plant 
breeding  without  amending  the  substance  of  Union  patent  law  and  are  acceptable  to  the 
Commission. 

4. 

CONCLUSION 

The Commission supports the results of the inter-institutional negotiations and can therefore 
accept the Council's position at first reading. 

5. 

STATEMENT FROM THE COMMISSION 

The Commission has made a unilateral statement set out in the Appendix. 

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APPENDIX 

Statement from the Commission 

The European Commission reiterates its full commitment to protecting the functioning of the 
internal  market  and  the  plant  breeding  sector,  in  particular  small  and  medium-sized 
enterprises (SMEs).  

To this end, in accordance with the provisions of the compromise agreement, the Commission 
recalls the following measures included in the text to be adopted by the Council as its position 
at first reading: 

1.  The  Commission  will  closely  monitor the  impact  of  the  NGT  regulation  on  SMEs  in  the 
European seed sector, with the objective to avoid that the development of NGT plants, and in 
particular their patenting, leads to negative impacts on the plant breeding market, such as the 
exclusion of SMEs.  

2. The Commission will oversee the drawing up of a code of conduct which will be ready as 
soon as possible and no later than 6 months before entry into application of the regulation.  

3.  The  Commission  will  assess  the  functioning  of  licensing  platforms  and  their  use  by  the 
seed  sector,  to  ensure  transparency  on  patents  and  facilitated  access  to  licences  for  SMEs 
under fair and reasonable conditions.  

4.  The  Commission  will  ensure  that  SMEs  have  access  to  support  and  guidance  on  patent 
matters  relating  to  plants,  in  order  to  balance  the  relations  between  different  players  in  the 
plant breeding market.  

5.  The  Commission  will  fulfil  all  its  reporting  obligations,  which  include  a  report  on  the 
implementation of the regulation every 5 years (Article 32(1)), an assessment of the impact of 
the regulation (Article 32(3)), an assessment of the impact of NGT plant patenting practices 
(Article 31(4)), and a report on the functioning of the code of conduct every 5 years (Article 
30(7)).  

6.  As  part  of  its  assessment  under  Article  31(4),  the  Commission  will  consider  the 
appropriateness  of  updating  or  supplementing  its  interpretative  notice  2016/C  411/03  on 
certain articles of Directive 98/44/EC on the legal protection of biotechnological inventions. 
In particular, the Commission will assess whether it would be appropriate and legally feasible 
to further precise and clarify the patentability criteria for inventions relating to plant genetic 
information, the concept of essentially biological processes and the conditions for compulsory 
cross-licensing  set  out  in  Article  12  of  that  Directive,  without  prejudice  to  the  legal 
framework  provided  for  in  the  Directive  and  in  full  compliance  with  the  international 
commitments of the EU.  

7. In the event that the system is not functioning smoothly, in particular as regards SMEs, the 
Commission will consider, where appropriate, the establishment of mandatory conditions  or 
safeguards as part of the review clause provided for in Article 31(10), in full compliance with 
the international commitments of the EU. 

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