REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms
Date: 2024-04-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, animal feedingstuffs, delegated legislation, environmental protection, food inspection, foodstuff, genetically modified organism, powers of the institutions (EU), traceability, transfer of competence

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.4.2024  COM(2024) 170 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 

THE COUNCIL 

on the exercise of the power to adopt delegated acts conferred on the Commission 
pursuant to Directive 2001/18/EC on the deliberate release into the environment of 
genetically modified organisms and Regulation (EC) No 1830/2003 concerning the 
traceability and labelling of genetically modified organisms and the traceability of food 
and feed products produced from genetically modified organisms 

1.  INTRODUCTION 

into 

Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  on  the  deliberate 
the  environment  of  genetically  modified  organisms1 
release 
(GMOs)  and 
Regulation (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council,  concerning 
the  traceability  and  labelling  of  GMOs  and  the  traceability  of  food  and  feed  products 
produced from GMOs2 are two of  the several  building  blocks of the EU’s legal  framework 
for GMOs.  

The  objective  of  Directive  2001/18/EC  is  to  approximate  the  laws,  regulations  and 
administrative  provisions  of  the  Member  States  and  to  protect  human  health  and  the 
environment when carrying out the deliberate release into the environment of GMOs for any 
other  purposes  than  placing  on  the  market  within  the  EU  and  when  placing  on  the  market 
GMOs as or in products within the EU. 

Regulation  (EC)  No  1830/2003  provides  a  framework  for  the  traceability  of  products 
consisting  of  or  containing  GMOs,  and  food  and  feed  produced  from  GMOs,  with  the 
objectives  of  facilitating  accurate  labelling,  monitoring  the  effects  on  the  environment  and, 
where  appropriate,  on  health,  and  the  implementation  of  the  appropriate  risk  management 
measures.  

2.  LEGAL BASIS  

Directive  2001/18/EC  empowers  the  Commission  to  adopt  delegated  acts,  as  referred  to  in 
Article 29a(2), with a view to the following: 

•  establishing derogatory criteria and information  requirements for the notification for the 

placing on the market of certain types of GMOs, as provided for in Article 16(2), 

•  establishing minimum thresholds below which products where adventitious or technically 
unavoidable traces of authorised GMOs cannot be excluded do not have to be labelled as 
GMOs, as provided for in Article 21(2), 

1  Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the  deliberate 
release  into  the  environment of  genetically  modified  organisms  and  repealing  Council  Directive  90/220/EEC, 
OJ L 106, 17.4.2001, p. 1. 
2  Regulation  (EC)  No  1830/2003  of  the  European  Parliament  and  of  the  Council  of  22  September  2003 
concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed 
products  produced  from  genetically  modified  organisms  and  amending  Directive  2001/18/EC,  OJ  L  268, 
18.10.2003, p. 24. 

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•  establishing lower thresholds than 0,9 %, below which the labelling requirements set out 
in  the  Directive  do  not  apply  to  traces  of  GMOs  in  products  intended  for  direct 
processing, as provided for in Article 21(3), 

•  establishing specific labelling requirements for GMOs that are not placed on the market 

within the meaning of that Directive, as provided for in Article 26(2), 
•  adapting the Annexes to technical progress, as provided for in Article 27. 

Regulation  (EC)  No  1830/2003  empowers  the  Commission  to  adopt  a  delegated  act,  as 
referred  to  in  Article  9a(2),  to  supplement  that  Regulation  by  establishing  and  adapting  a 
system for the development and assignment of unique identifiers to GMOs, as provided for in 
Article 8. 

Pursuant  to  Article  29a(2)  of  Directive  2001/18/EC  and  Article  9a(2)  of  Regulation  (EC) 
No 1830/2003,  the  power  to  adopt  delegated  acts  concerning  the  matters  listed  therein  is 
conferred on the Commission for a period of five years from 26 July 2019. The present report 
in respect of the exercise of the delegations of power during this five-year period is submitted 
by  the  Commission  to  the  European  Parliament  and  the  Council,  as  required  in  both  cases. 
The delegations of power are to be tacitly extended for periods of identical duration, unless 
the European Parliament or the Council opposes such extension not later than three months 
before the end of each period. 

3.  EXERCISE OF THE DELEGATIONS 

3.1. EMPOWERMENTS USED DURING THE REPORTING PERIOD 

During the reporting period, the Commission used one empowerment, as described below. 

•  Article 27 of Directive 2001/18/EC 

Article 27 of Directive 2001/18/EC empowers the Commission to amend certain Annexes 
to  that  Directive  (Sections  C  and  D  of  Annex  II,  Annexes  III  to  VI,  and  Section  C  of 
Annex  VII)  in  order  to  adapt  them  to  technical  progress.  On  8  March  2018,  the 
Commission  adopted  Commission  Directive  (EU)  2018/350  amending  Directive 
2001/18/EC  as  regards  the  environmental  risk  assessment  of  GMOs3.  This  Directive 
amended Annexes  II,  III, and IV to  Directive 2001/18/EC  in order to  adapt  them to  the 
technical  progress,  in  particular  incorporating  the  essential  elements  of  the  revised 
guidance  of  the  European  Food  Safety  Authority  (EFSA)  on  the  environmental  risk 
assessment of GM plants4.  

3.2. EMPOWERMENTS NOT USED DURING THE REPORTING PERIOD 

Certain  empowerments  have  not  been  used  during  the  reporting  period  for  the  reasons 
explained below.  

3  Commission  Directive  (EU)  2018/350  of  8  March  2018  amending  Directive  2001/18/EC  of  the  European 
Parliament and of the Council as regards the environmental risk assessment of genetically modified organisms, 
OJ L 67, 9.3.2018, p. 30. 
4 EFSA Panel on GMO, Guidance on the environmental risk assessment of genetically modified plants.  EFSA 
Journal 2010;8(11):1879.doi:10.2903/j.efsa.2010.1879. www.efsa.europa.eu/efsajournal.htm 

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•  Article 16(2) of Directive 2001/18/EC 

Article  16  of  Directive  2001/18/EC  allows  a  Member  State  competent  authority,  or  the 
Commission  on  its  own  initiative,  to  make  a  proposal  on  criteria  and  information 
requirements to be met for the notification for the placing on the market of certain types 
of GMOs, which would replace the standard requirements set out under Article 13(2) of 
the  Directive.  The  adoption  of  the  delegated  act  establishing  the  specific  criteria  and 
information requirements would, in addition to complying with the requirements set out 
in Article 29a of the Directive, require the consultation of EFSA and a comment period 
for  the  public.  No  Member  State  competent  authority  or  the  Commission  have  made  a 
proposal  under  this  Article.  In  particular,  in  the  reporting  period,  based  on  the  limited 
number  of  notifications  received  under  that  Directive  for  the  placing  on  the  market  of 
GMOs  as  or  in  products,  the  Commission  considered  the  standard  requirements  set  out 
under Article 13(2) of the Directive to be appropriate. The Commission has therefore not 
yet made use of this delegated power. 

•  Article 21(2) of Directive 2001/18/EC 

Article  21(2)  of  Directive  2001/18/EC  empowers  the  Commission  to  supplement  that 
Directive by establishing minimum thresholds below which products where adventitious 
or technically unavoidable traces of authorised GMOs cannot be excluded do not have to 
be  labelled  as  GMOs.  Threshold  levels  are  to  be  established  according  to  the  product 
concerned. For products intended for direct processing, for food and for feed, thresholds 
for  the  adventitious  or  technically  unavoidable  presence  of  authorised  GM  material  are 
already established by Article 21(3) of Directive 2001/18/EC and Articles 12(2) and 24(2) 
of  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the  Council5, 
respectively.  

The Commission has not yet made use of this delegated power. In the reporting period, 
work  focused  on  ensuring  an  even  application  of  the  ‘zero  tolerance’,  applicable  in 
absence of a threshold, regarding seeds.6 

•  Article 21(3) of Directive 2001/18/EC 

For products intended for direct processing, Article 21(3), first subparagraph, of Directive 
2001/18/EC  establishes  a  threshold  of  0,9 %,  below  which  the  GMO  labelling 
requirements do not apply to adventitious or technically unavoidable traces of authorised 
GMOs.  Article  21(3),  second  subparagraph,  of  Directive  2001/18/EC  empowers  the 
Commission  to  supplement  that  Directive  by  establishing  lower  thresholds  for  these 
products. In the reporting period, the Commission considered the threshold of 0,9 % to be 
appropriate  and  effective.  The  Commission  has  therefore  not  yet  made  use  of  the 
delegated power to establish lower thresholds for these products.  

5  Regulation  (EC)  No  1829/2003  of  the  European  Parliament  and  of  the  Council  of  22  September  2003  on 
genetically modified food and feed, OJ L 268, 18.10.2003, p. 1.  
6 Seed testing convergence, endorsed during the meeting of the Regulatory Committee of Directive 2001/18/EC 
held 
https://food.ec.europa.eu/system/files/2020-07/reg-com_2001-18-
ec_20200604_result_seed-testing-convergence.pdf 

2020. 

June 

on 

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•  Article 26(2) of Directive 2001/18/EC 

Article 26 of Directive 2001/18/EC concerns the labelling of GMOs to be made available 
for  operations  that  are  not  regarded  as  placing  on  the  market,  referred  to  under 
Article 2(4), second subparagraph (making available GMOs for contained use activities or 
deliberate  releases  complying  with  the  requirements  laid  down  in  Part  B  of  Directive 
2001/18/EC). Article 26(1) in conjunction with Annex IV sets out labelling requirements 
for  these  GMOs.  Article  26(2)  empowers  the  Commission  to  amend  Annex IV  by 
establishing specific labelling requirements for these GMOs. In the reporting period, the 
Commission considered the labelling requirements in the relevant sections of Annex IV to 
be appropriate for these GMOs. The Commission has therefore not yet made use of this 
delegated power.  

•  Article 8 of Regulation (EC) No 1830/2003 

Article  8  of  Regulation  (EC)  No  1830/2003  empowers  the  Commission  to  supplement 
that  Regulation  by  establishing  and  adapting  a  system  for  the  development  and 
assignment  of  unique  identifiers  to  GMOs  taking  account  of  developments  in 
international  fora.  Commission  Regulation  (EC)  No  65/2004  of  14  January  2004 
establishing  a  system  for  the  development  and  assignment  of  unique  identifiers  for 
GMOs7 entered into force on 16 January 2004. This act was adopted based on Article 8 of 
Regulation (EC) No 1830/2003 in its version applicable until 26 July 2019. In line with 
the  delegated  power,  it  may  be  revised  in  the  future  to  adapt  the  system  for  the 
development and assignment of unique identifiers if needed.  

4.  CONCLUSION 

The Commission sees the need for a tacit extension of the delegations of power  concerning 
the  matters  listed  in  Article  29a(2)  of  Directive  2001/18/EC  and  Article  9a(2)  of 
Regulation (EC) No 1830/2003 for a period of five years as from 26 July 2024, in accordance 
with  those  Articles.  The  rationale  for  the  delegations  of  power  has  not  changed.  They  are 
important  to  maintain  the  necessary  flexibility  in  the  legal  framework,  to  adjust  it  to 
scientific,  technological  and  other  developments  and  to  experience  gained  with  the 
application of the framework, and to  allow the Commission to act in the areas where it did 
not act to this moment, but may need to do so in the future. Thereby, the powers granted are 
important  for  achieving  the  objectives  of  Directive  2001/18/EC  and  Regulation  (EC) 
No 1830/2003. 

With  this  report,  the  Commission  complies  with  the  reporting  requirements  established  in 
Article 29a(2) of Directive 2001/18/EC and Article 9a(2) of Regulation (EC) No 1830/2003. 

The Commission invites the European Parliament and the Council to take note of this report. 

7 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and 
assignment of unique identifiers for genetically modified organisms, OJ L 10, 16.1.2004, p. 5. 

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