REPORT FROM THE COMMISSION on the experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms for the period 2022 – 2024
Date: 2026-02-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: access to information, application of EU law, clinical trial, environmental risk prevention, exchange of information, genetically modified organism, health control, interpretation of the law, microorganism, waste disposal

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 11.2.2026  COM(2026) 68 final  REPORT FROM THE COMMISSION on the experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms for the period 2022 – 2024     
 
 
Table of Contents 
INTRODUCTION ...................................................................................................................... 2 

PART I: GENERAL IMPLEMENTATION OF THE DIRECTIVE ......................................... 4 

1.  Notification and approval systems (and relevant changes) ............................................ 4 
2.  Waste disposal ................................................................................................................ 5 
Inspection and enforcement issues ................................................................................. 6 
3. 
4.  Accidents ........................................................................................................................ 7 
5.  Public information and consultation .............................................................................. 8 
Interpretation of the Directive ........................................................................................ 8 
6. 
7.  Overview of contained uses ........................................................................................... 9 

PART II: INVESTIGATIONAL MEDICINAL PRODUCTS THAT CONTAIN OR 
CONSIST OF GMMs............................................................................................................... 10 

PART III: CONTAINED USE OF GMOs OTHER THAN GMMs ........................................ 11 

CONCLUSIONS ...................................................................................................................... 12 

 
 
 
 
 
Report on the experience of Member States with Directive 2009/41/EC of the European 
Parliament and of the Council of 6 May 2009 on the contained use of genetically 
modified micro-organisms for the period 2022 – 2024 

The  information  contained  in  this  document  has  been  compiled  by  the  Commission  from 
individual  reports  submitted  by  Member  States  in  accordance  with  Article  17  of  Directive 
2009/41/EC of the European Parliament and of the Council on the contained use of genetically 
modified micro-organisms1 (GMMs). 

INTRODUCTION 

Directive 2009/41/EC ("the Directive") provides that every three years Member States are to 
send to the Commission a summary report on their experience with the Directive2 and that the 
Commission  is  to  publish  a  summary  based  on  these  reports3.  The  Commission  has  so  far 
published  six  reports  pursuant  to  the  Directive  or  to  the  preceding  Council  Directive 
90/219/EEC4, for the periods 1999-2003, 2003-2006, 2006-2009, 2009-2014, 2014-2018 and 
2019-20215. 

The present report covers the period from January 2022 to December 2024 and is based on 27 
Member States’ and two EEA EFTA States’6 individual reports. 

The  national  reports  are  based  on  a  questionnaire  prepared  by  the  Commission  services  on 
Member States’ experience with the general implementation of the Directive, including their 
notification  and  approval  systems,  inspection  and  enforcement  activities,  waste  disposal 
measures,  accidents,  public  consultation  and  an  overview  of  contained  uses  for  GMMs 
authorised in their territories. 

The Directive does not regulate the contained use of genetically modified organisms (GMOs) 
other  than  GMMs,  i.e.  genetically  modified  (GM)  plants  and  animals.  However,  Directive 
2001/18/EC on the deliberate release into the environment of GMOs7 provides that, in some 
cases, the principles of containment set out in Directive 2009/41/EC are also relevant to other 
GMOs. This is the case where GMOs other than GMMs are made available to third parties ‘to 
be used exclusively for activities where appropriate stringent containment measures are used 
to limit their contact with and to provide a high level of safety for the general population and 
the environment’ (Article 2(4), 2nd subparagraph, 2nd indent). In such cases, according to the 
same provision, ‘the measures should be based on the same principles of containment as laid 
down in Directive 90/219/EEC’. If the principles of containment of Directive 2009/41/EC are 
not met, the transfer of the GMO to a third party constitutes ‘placing on the market’ within the 

1 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009  on the contained use of 
genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75). 
2 Article 17(2). 
3 Article 17(3). 
4 Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms 
(OJ L 117, 8.5.1990, p. 1). 
5 The reports are available on this European Commission webpage 
6 Annex XX to the EEA Agreement (which lists, amongst others, the EU GMO legislation applicable under that 
Agreement) provides that ‘[f]or the purposes of this Annex and notwithstanding the provisions of Protocol 1, the 
term "Member State(s)" contained in the acts referred to shall be understood to include, in addition to its meaning 
in the relevant EC acts, Iceland, Liechtenstein, Norway’. Therefore, reference to ‘Member States’ in this document 
also includes the EEA EFTA States who replied to the questionnaire (Iceland and Norway). 
7 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 

 
 
 
meaning  of  Article  2(4)  of  Directive  2001/18/EC  and  is  subject  to  the  requirements  of  that 
Directive. 

In a number of Member States, the relevant national legislation regulates the contained use of 
other  GMOs  as  well.  Therefore,  the  Commission  extended  the  scope  of  its  questionnaire  to 
allow  Member  States  to  share  their  experience  in  regulating  the  contained  use  of  those 
organisms at national level. 

The  report  focuses  on  changes  from  previous  reports  and  highlights  new  issues  and 
implementing challenges raised by Member States and the way they were addressed. 

Disclaimer: The information contained in this report relating to Member States is based on 
Member States’ individual reports. 

Neither the European Commission nor any person acting on its behalf is responsible for the 
content of that information and of any use made of it. 

The individual reports submitted by Member States are not published and are only used as a 
basis for the Commission’s summary report. 

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PART I: GENERAL IMPLEMENTATION OF THE DIRECTIVE 

1.  Notification and approval systems (and relevant changes) 

According to Articles 6 to 9 of the Directive, any person planning to use premises for the first 
time for the contained use of GMMs must notify its intended uses to the national competent 
authorities,  providing  details  on  the  GMMs,  premises,  protective  measures,  and  risk 
assessment. Classes 2, 3 and 4 contained uses require prior consent: class 2 only before the first 
use, while classes 3 and 4 require consent before first and subsequent uses. 

No major changes since the previous reporting period were reported concerning the national 
legislation implementing the Directive. 

However,  a  number  of  Member  States  implemented  several  reforms  aimed  at  improving 
efficiency  or  increasing  digitalisation,  or  restructured  competent  authorities  and 
processes: 

-  France streamlined the rules concerning the uses raising negligible risks and, as of June 
2022, a new competent authority8 oversees notifications for the contained use of GMMs 
in the context of clinical trials of investigational medicinal products using a dedicated 
online platform; 

- 

- 

Iceland replaced the earlier competent authority by the newly established Environment 
and Energy Agency; 

Italy improved its notification system with a digital platform to manage notifications 
and developed a networking tool to train and connect researchers, safety officers and 
institutions and to enhance skills and compliance with the Directive9; 

-  Cyprus developed a new confidential notification system requiring notifications to be 

now submitted through a standardised format and payment of application fees; 

-  Lithuania  changed  the  competent  authority.  As  of  January  2023,  the  Environmental 
Protection  Agency  under  the  Ministry  of  Environment  oversees  notifications  and 
authorisations for the contained use of GMOs and GMMs; 

-  Hungary  restructured  its  competent  authority,  merging  two  institutions10,  and 
introduced a new system with application and risk assessment forms for contained use 
activities and providing guidance to users11;  

-  Norway launched a new web-based portal for GMM notifications in 2024, improving 
user experience and enabling better traceability of applications and facility approvals12; 

-  Slovenia renamed its competent authority and inspectorate, reflecting structural changes 
in  government  departments.  The  Ministry  of  Environment,  Climate  and  Energy  now 
replaced the former Ministry of Environment and Spatial Planning;  

-  Sweden introduced a new system that requires providing notifications for classes 3 and 

4 through secure registered mail. 

8 Agence nationale de sécurité du médicament et des produits de santé (ANSM). 
9 www.biotechsafety.org   
10 The National Institute of Pharmacy and Nutrition (OGYÉI) has been merged with the National Center for 
Public Health and Pharmacy (NNGYK). 
11 Forms and guidance are available at gmo.kormany.hu 
12 https://gmo.helsedirektoratet.no/ 

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Several Member States13 reported challenges such as delays in processing notifications within 
the statutory timeframe due to understaffing and increased workload, administrative burdens, 
limited  digital  infrastructure,  difficulties  handling  notifications  for  mobile  laboratories  and 
increase of applications for biopharmaceutical products involving GMMs.  

2.  Waste disposal 

For  the  contained  use  of  GMMs,  Article  5(1)  of  the  Directive  requires  the  application  of 
appropriate  containment  and  other  protective  measures  listed  in  Annex  IV  to  the  Directive 
corresponding to the class of the contained use, including waste disposal measures.  

In this respect, most Member States did not report significant changes or challenges concerning 
waste disposal management during the reporting period. 

Some Member States reported specific developments: 

-  Belgium reported adoption of new waste legislation. The Brussels Capital Region14 and 
the  Walloon  Region  adopted  a  framework  to  streamline  regulations  and  promote 
circular  economy  goals.  Both  regions  are  testing  alternative  inactivation  methods, 
including  microwave  technology  and  shredding  with  sterilisation.  Incineration  of 
fermentation  residues  was  also  tested  and  flagged  as  costly  and  inefficient,  with 
anaerobic digestion as a sustainable waste disposal being considered for low-risk waste, 
pending on-site validation.  

-  Germany noted no major changes but highlighted technical challenges. These included 
the  need  for  vacuum-enabled  autoclaves,  validating  complex  waste  matrices  and 
bioindicator  use  for  hydrogen  peroxide  fumigation.  One  case  of  GMMs  waste 
mismanagement  prompted  improved  training  and  labelling.  There  are  requests  from 
operators  for  a  publicly  available  list  of  validated  inactivation  alternatives  to 
autoclaving. 

-  Hungary indicated that  its new application forms  for contained use activities include 
dedicated  sections  on  waste  management.  Users  must  describe  the  type  and  form  of 
waste  to  be  generated,  its  treatment,  final  form,  and  destination.  Waste  containing 
GMMs  must  be  treated  as  hazardous,  autoclaved  on-site,  and  transported  to  an 
authorised  disposal  company.  A  copy  of  the  transportation  contract  must  also  be 
submitted to the competent authority. 

-  Austria  reported  ongoing  user  requests  for  the  use  of  microwave  technology  as  an 
alternative  to  autoclaving  for  inactivating  GMMs,  mainly  in  contained  use  activities 
involving negligible or low risks. As this method was deemed unsuitable for higher-risk 
waste, enveloped viruses and virus stock solutions by the Austrian Scientific Committee 
for Working with GMO in Contained Use, the competent authorities advised continuing 
the use of autoclaving and called for guidelines to validate alternatives to it. 

-  Finland reported reduced autoclaving use due to cost and occupational hazard concerns, 
along  with  a  decline  in  the  availability  of  effective  disinfectants  compliant  with  the 
relevant  EU  legislation.  This  has  led  to  increased  waste  incineration.  The  competent 
authority  has  encouraged  users  to  explore  alternative  inactivation  methods  and  is 
providing case-specific advice. 

13 Belgium, Germany, Ireland, France, Croatia, Italy, Hungary, Finland and Sweden. 
14 BRUDALEX 2.0. 

5 

 
 
3.  Inspection and enforcement issues 

According  to  Articles  10  and  16  of  the  Directive,  the  competent  authorities  of  the  Member 
States must organise inspections and other enforcement measures to ensure compliance. 

The  majority  of  Member  States  reported  no  changes  in  their  inspection  and  enforcement 
activities. 

Several  Member  States  provided  information  on  improvements  to  enforcement  and  control 
activities during the reporting period: 

-  Belgium  reported  region-specific  practices,  with  the  Walloon  Region  increasing 

collaboration with scientific experts for more in-depth inspections; 

-  The Czech Republic returned to standard on-site inspections after temporarily relying 

on remote controls during the COVID-19 pandemic; 

- 

Ireland noted a threefold increase in enforcement activities compared to the previous 
period, which had been affected by the COVID-19 pandemic; 

-  France enhanced its capacity by appointing ‘sworn inspectors’ who now conduct regular 

monthly inspections; 

- 

Italy  improved  its  inspection  system  by  validating  procedures  through  simulated 
activities,  appointing  and  training  inspectors,  and  sharing  these  validated  procedures 
within the European Enforcement Project15;  

-  Cyprus  introduced  a  risk-based  inspection  approach  focused  on  higher-risk  facilities 
such  as  universities  and  laboratories,  alongside  improved  reporting  and  follow-up 
activities. 

The issues most frequently encountered during inspections reported by some Member States 
were related to deficiencies in: 

•  Documentation and administrative procedures16 

Member States identified missing or outdated biosafety documentation, incomplete GMM 
records, failure to notify changes (e.g. new premises, biosafety officer), lack of internal 
audits, insufficient or unclear risk assessments. 

• 

Infrastructure and biosafety measures17 

Some physical and procedural shortcomings were noted, such as outdated or inadequately 
maintained  equipment,  improper  use  of  biosafety  cabinets  and  incomplete  waste 
management systems.  

•  Notification and approval18 

15 The European Enforcement Project on GMOs is a network of regulators from inspectorates across the Euro-
pean Union (and beyond) responsible for the inspection of activities involving GMOs. The network was founded 
in 1997. 
16 The Czech Republic, Germany, Ireland, Italy, the Netherlands, Austria, Slovenia, Slovakia and Finland. 
17 Germany, Spain, Italy, the Netherlands, Norway and Austria. 
18 France, Italy, Norway and Austria.  

6 

 
 
Member States reported issues such as starting GMM use without prior notification, using 
facilities not approved for the required containment level or delayed notifications on any 
changes of uses to authorities. 

• 

Inspection and enforcement practices19 

Several Member States reported variations in inspection frequency, especially following 
adjustments  made  during  the  COVID-19  pandemic.  Nonetheless,  most  Member  States 
have  since  reinstated  regular  procedures  and  enhanced  their  inspection  protocols  where 
needed. 

•  Resources, training & personnel oversight20 

In  some  cases,  inspections  revealed  lack  of  training  records  or  programmes,  missing 
certificates  or  unclear  responsibilities  among  staff.  A  few  Member  States21  noted 
challenges in maintaining dedicated biosafety expertise in the competent authorities due to 
limited resources.  

Member  States  reported  enforcement  actions  taken  following  inspections.  When  non-
compliance was identified, measures such as reports, warnings or fines were applied, and users 
usually  implemented  the  corrective  actions  requested  by  the  authorities  within  the  given 
timeframe, which was verified through follow-up inspections. While a range of minor issues 
was  identified  during  inspections,  they  were  not  deemed  critical,  and  they  were  typically 
resolved during or shortly after the inspections to avoid adverse effects on human health or the 
environment. 

The constraints related to the available biosafety expertise in the competent authorities were 
mitigated through training initiatives, inter-agency cooperation and capacity-building efforts. 

4.  Accidents 

According  to  Articles  14  and  15  of  the  Directive,  the  competent  authorities  of  the  Member 
States must take the necessary measures to ensure that, in the event of an accident, the user is 
required  immediately  to  inform  the  competent  authority  and  provide  specific  information 
regarding  the  accident,  the  GMMs  involved,  information  necessary  to  assess  the  effects  on 
health and the environment and the measures taken.  

No accidents (according to the definition of ‘accident’ in Article 2(d) of the Directive22) were 
reported. 

In some Member States23 criteria were provided by the competent authorities to enable users to 
assess whether a release was significant, based on factors such as the nature and quantity of the 
GMMs released, its potential hazard to human health or the environment and their containment 
level. 

Some  Member  States24  reported  incidents  that  did  not  meet  the  threshold  for  a  significant 
release. These included power outages, waste misclassification, minor leaks, equipment failures 

19 The Czech Republic, Ireland and Sweden. 
20 Germany, Ireland, Italy, the Netherlands and Finland. 
21 France and Luxembourg. 
22 ‘Accident’ means any incident involving a significant and unintended release of GMMs in the course of their 
contained use which could present an immediate or delayed hazard to human health or the environment. 
23 The Czech Republic, Germany, Ireland, Italy, the Netherlands and Finland. 
24 Germany, Ireland, France, the Netherlands and Finland. 

7 

 
 
and minor laboratory errors, all of which were judged by the competent authorities not to pose 
significant risks to health or the environment. 

In most cases, national authorities rely on biosafety officers’ case-by-case evaluations to assess 
the significance of GMM releases, rather than apply fixed criteria.  

5.  Public information and consultation 

According  to  Article  12  of  the  Directive,  Member  States  may  consult  the  public  on  certain 
aspects  of  the  proposed  contained  use,  if  they  deem  such  consultation  appropriate,  while 
applying the confidentiality requirements set out in Article 18. 

In this context, most Member States reported no changes in the provision of information to the 
public on contained uses of GMMs since the previous reporting period.  

Belgium reported changes to the publicly available information as regards permits for contained 
use activities, aiming to prevent potential misuse of information for biosecurity reasons, without 
prejudice to the requirements of Article 18 of the Directive. 

The reported public consultations concerned class 3 and class 4 contained uses. Belgium and 
Ireland reported having received input from the public, addressed during the review process. 
Belgium reported concerns raised by the public related to opposition to animal experimentation 
and to perceived biological risks to humans and animals living in the vicinity. Other Member 
States25 that conducted public consultations reported that no comments were received.  

Some  Member  States26  reported  no  public  consultations  during  the  reported  period,  often 
because the notifications concerned lower-risk class activities. 

A number of Member States27 did not provide information on public consultations. 

6.  Interpretation of the Directive 

Nine Member States28  reported that they did  not meet any specific  challenges  regarding the 
interpretation of the Directive.  

By contrast, seven Member States29 identified difficulties interpreting and implementing the 
Directive, particularly due to scientific and technological advancements such as new genomic 
techniques (NGTs), self-cloning and novel delivery systems like viral-like particles and lipid 
nanoparticles. 

Those Member States noted that the receipt of more complex applications has led to challenges 
in  interpreting  the  GMO/GMM  definitions  and  determining  the  legal  status  of  organisms. 
Several competent authorities pointed out that these issues would benefit from discussion at the 
Regulatory  Committee  established  by  the  Directive,  with  consideration  given  to  providing 
guidance supporting a harmonised approach.  

In particular, the following difficulties were raised: 

25 Germany, Iceland, Spain, Hungary, Romania and Slovakia. 
26 Bulgaria, the Czech Republic, Norway, Portugal and Finland.  
27Denmark, Greece, France, Croatia, Cyprus, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Slovenia 
and Sweden.  
28 Estonia, Greece, Cyprus, Latvia, Lithuania, Poland, Portugal, Slovenia and Slovakia. 
29 Belgium, Germany, Denmark, Ireland, Italy, the Netherlands and Finland.  

8 

 
 
-  Denmark reported difficulties in applying the Directive in several cases concerning the 
administration of medicinal products that contain or consist of GMMs in patients' homes 
and  noted  the  importance  of  establishing  common  regulatory  approaches  across 
Member States to avoid cross-border inconsistencies; 

-  Germany reported feedback from some federal states’ competent authorities regarding 
uncertainties about the interpretation of the GMO definition and the applicability of the 
interpretation regarding the mutagenesis exemption in Directive 2001/18/EC made by 
the  Court  of  Justice  in  201830  to  the  Directive,  leading  in  certain  cases  to  varying 
interpretations among federal states;  

-  Croatia and Italy referred to the complexity in distinguishing between contained use and 
deliberate release as regards clinical trials with GMOs/GMMs, and Italy highlighted that 
different interpretations and approaches create difficulties for the competent authorities, 
companies and users; 

-  Sweden reported uncertainty regarding how to apply requirements for GMMs used in 

mobile or temporary laboratories with changing locations. 

To  address  the  above-mentioned  difficulties,  some  Member  States  implemented  various 
solutions,  including  internal  expert  consultations31,  updated  national  guidance  on  NGTs32, 
enhanced scientific input and coordination between competent authorities (Spain).  

To  address  questions  relating  to  the  interpretation  of  the  GMO/GMM  definitions,  the 
Netherlands  established  an  ad-hoc  group  of  national  experts  supported  by  a  Dutch  research 
project that received input from other Member States’ experts. The findings33 were published 
in  November  2024  and  presented  to  the  Regulatory  Committee  established  in  Directive 
2001/18/EC  in  December  202434  and  to  the  Regulatory  Committee  established  in  Directive 
2009/41/EC in September 202535.  

Belgium shared their approach to Do-It-Yourself practices and experience in applying biosafety 
requirements,  e.g.  identifying  and  raising  awareness  of  the  open  science  community  on 
regulatory requirements of GMMs contained use.  

7.  Overview of contained uses   

Several  Member States36  reported  a stable or slightly increasing  number of notifications for 
contained uses of GMMs compared to the previous reporting period.  

However, differences are observed in the number of notifications for classes of contained uses 
among the reporting Member States. In particular: 

-  Belgium confirmed that class 2 accounts for most contained uses (71 % of notifications); 
-  The Netherlands reported a decrease in class 2 and class 3 notifications and suggested 
that the decrease in class 2 activities may be partly due to some viral vector systems 
now being  classified as  class 1 and  possibly  because broad-scope notifications (with 
more  general  descriptions  of  vector  systems  and  donor  sequences)  resulted  in  a 

30 Judgment of 25.7.2018, Case C-528/16, Confédération paysanne and Others (ECLI:EU:C:2018:583). 
31 Germany and the Netherlands. 
32 France and Italy. 
33 Perseus report on Interpretation of the GMO definition in EU Member States 
34 11 December 2024, point A.03. 
35 26 September 2025, point A.07 
36 Bulgaria, Ireland, Cyprus, Norway, Slovakia and Sweden. 

9 

 
 
reduction in the number of amendments of earlier notified Class 2 activities with such 
descriptions;  

-  France mentioned a 39% decrease in class 1 notifications and a similar rise in class 2 

notifications;  

-  Austria observed an increase in class 1 commercial notifications but noted a decrease in 

total number of notifications;  

-  Slovenia noted a shift from class 1 to class 2 notifications and an increase in commercial 

notifications;  

-  Finland observed a slight overall decline in notifications but reported steady commercial 

and research notifications.  

Class 3 notifications are fewer overall but have increased in several Member States, for example 
Spain and France, mostly related to research. Hungary also reported an increase in class 3 uses 
and  the  authorisation  of  one  class  4  activity.  On  the  other  hand,  Italy  reported  a  significant 
decrease in such notifications.  

As regards the type of activities notified, research and development (R&D) continue to prevail 
in contained uses, although commercial activities are increasingly prominent in a few Member 
States.  For  instance,  Belgium  reported  that  51%  of  notifications  were  related  to  R&D,  with 
commercial  activities  comprising  36%,  and  the  use  of  GMMs  in  healthcare  institutions 
accounting  for  13%.  Slovakia  highlighted  growing  commercial  use  focused  on  improving 
health and the environment. 

PART  II:  INVESTIGATIONAL  MEDICINAL  PRODUCTS  THAT 
CONTAIN OR CONSIST OF GMMs 

Clinical  trials involving investigational  medicinal products (IMPs) that contain or consist  of 
GMMs (GMMs-IMPs) fall under both the clinical trials37 and the GMO legislation, particularly 
Directives 2001/18/EC and 2009/41/EC.  

Member States reported no major changes in the manufacturing and administration of GMM-
IMPs for human and veterinary use.  

Several Member States have adapted their procedures to streamline approvals for clinical trials 
with GMMs-IMPs. Belgium has introduced national guidance and simplified assessment and 
approval  procedures.  Austria  has  adapted  its  national  regulations  on  the  use  of  GMOs  for 
medicinal purposes  in  line with  Directive 2001/18/EC and has  simplified the environmental 
risk assessment by accepting common application forms. Spain and Sweden reported applying 
Directive  2001/18/EC  to  such  products,  incorporating  additional  steps  such  as  public 
consultation. Germany highlighted improved coordination between the competent authorities 
responsible for clinical trials and those overseeing GMMs. France noted that in certain cases, 
if there is a doubt on the classification or on the environmental risk, the competent authority 
can seek an opinion of the Committee of contained use of GMOs hosted by the GMO competent 
authority of contained use, namely the Ministry of Research. 

Some Member States38 reported ongoing efforts to further develop their approaches for such 
products,  particularly  in  assessing  specific  cases  such  as  home-based  trials39  and  the  use  of 
biopharmaceutical products involving use of GMMs in clinical trials.  

37 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical 
trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1. 
38 Denmark, Croatia and Finland. 
39 Administration of investigational medicinal products at home during a clinical trial.  

10 

 
 
Germany  and  Italy  emphasised  the  need  for  enhanced  collaboration  between  national 
authorities and their counterparts in other Member States to ensure a harmonised approach in 
conducting clinical trials and to streamline the application of regulatory requirements for users 
across Member States. 

Bulgaria  and  Italy  considered  that  maintaining  digital  records  for  GMMs-related  clinical 
activities would improve traceability at the EU level. 

Finland  reported  operational  challenges,  including  language  barriers  when  using  common 
application  forms,  as  these  sometimes  conflict  with  the  language  requirements  in  national 
legislation,  and  issues  related  to  the  requirements  applicable  to  cross-border  movement  of 
GMM-IMPs manufactured outside the EU.  

PART III: CONTAINED USE OF GMOs OTHER THAN GMMs 

Most Member States40 have national legislation regulating the contained use of GMOs other 
than GMMs, i.e. GM plants and animals. Overall, where national legislation exists, Member 
States have largely aligned their procedures with Directive 2009/41/EC. 

Several  Member  States41  reported  no  challenges  in  applying  the  measures  set  out  in  the 
Directive to the contained use of GMOs other than GMMs.  

Difficulties were reported by some Member States regarding the identification of appropriate 
containment measures, deciding on the GMO status of certain organisms and differentiating 
between deliberate release and contained use in some cases: 

-  Germany  noted  that  while  facilities  working  with  GM  animals  or  plants  rarely  pose 
major  issues,  specific  difficulties  arise  with  containment  for  insects  and  the  safe 
inactivation of large animal carcasses treated with GMMs. These issues were discussed 
among national authorities and referred to the relevant national committee for guidance. 
Additionally,  one  authority  highlighted  legal  uncertainty  concerning  the  containment 
measures to apply to NGT animals. 

-  Spain  reported  that,  in  some  cases,  scientific  discussions  were  needed  to  determine 
whether certain organisms meet the definition of GMO. The national biosafety advisory 
body consults its experts and informs the competent authority.  

-  The  Netherlands  reported  difficulties  in  distinguishing  between  contained  use  and 
deliberate  release  in  cases  such  as  large-scale  animal  trials,  biofuel  production  using 
GMMs or the use of GMMs as biosensors. Questions were also raised about the status 
of GM animals, or of animals exposed to GMMs, after the experiments. 

-  Sweden noted that, unlike for GMMs, it does not rely on predefined containment classes 
for  GMOs,  and  all  facilities  must  be  individually  authorised.  While  not  seen  as  a 
challenge, the Swedish Board of Agriculture is reviewing whether the current system is 
proportionate to the actual risk. 

-  Finland  reported  diverse  applications  of  NGTs  in  animal  research,  often  involving 
modifications without the insertion of foreign DNA or with limited heritability, which 
complicates  the  assessment  of  GMO  status  by  the  competent  authority  and  the 
determination  of  whether  containment  requirements  should  apply.  Additionally, 

40 Belgium, the Czech Republic, Denmark, Germany, Ireland, Iceland, Spain, Latvia, Lithuania, Hungary, 
    the Netherlands, Norway, Austria, Portugal, Slovenia, Slovakia, Finland and Sweden. 
41 The Czech Republic, the Netherlands and Austria. 

11 

 
 
questions have arisen regarding the transport of  gene  edited  fish embryos from  third 
countries,  particularly  whether  regulations  on  the  transport  of  dangerous  goods  are 
applicable.  

Some  Member  States42  reported  that  they  require  consent  from,  or  involve  consultation 
(Portugal)  of,  multiple  authorities  for  the  contained  use  of  GMOs  other  than  GMMs.  Italy 
reported that users may voluntarily ask the competent authority under Directive 2001/18/EC to 
verify the application of containment measures set out in Annex IV to Directive 2009/41/EC to 
GMOs other than GMMs.  

CONCLUSIONS 

As regards the overall implementation of the Directive, the national reports show that Member 
States have adopted the provisions and established the structures and procedures to ensure that 
the necessary measures are taken to avoid adverse effects on human health and the environment 
which  might  arise  from  the  contained  use  of  GMMs,  with  continued  improvements  in 
administrative efficiency, digital transformation and administrative coherence. While no major 
structural  changes  were  reported  in  the  notification  and  approval  systems,  several  Member 
States have reported targeted reforms to modernise, clarify and streamline processes to adapt to 
evolving technological progress.  

However, certain operational challenges have been reported, including staff shortages, digital 
infrastructure limitations, administrative complexity and regulatory uncertainties— particularly 
in emerging areas such as mobile laboratories and novel biopharmaceutical products.  

Waste  disposal  management  remained  largely  unchanged,  though  several  Member  States 
explored alternative methods for GMM inactivation in response to the technical and financial 
constraints  of  traditional  autoclaving.  Member  States  and  the  Commission  have  exchanged 
views  on  practices  on  this  issue  at  the  meeting  of  the  Regulatory  Committee  on  Directive 
2009/41/EC on 20 September 202343 and on 26 September 202544.  

Inspection  and  enforcement  activities  have  continued  as  in  previous  reporting  periods. 
Overall,  competent  authorities  appear  to  maintain  effective  oversight.  Inspections  generally 
revealed only minor administrative or procedural deficiencies that were addressed promptly to 
prevent adverse effects on human health or the environment. While inspection frequency was 
temporarily impacted by the COVID-19 pandemic, routine procedures have since resumed. 

No accidents, as defined in the Directive, were reported during the reporting period, suggesting 
a high level of containment and biosafety oversight.  

Public  information  and  consultation  practices  remained  largely  unchanged  and  generally 
result in low levels of public engagement.  

During  the  reporting  period,  Member  States  have  exchanged  information  on  their  national 
measures  and  best  practices  on  various  other  issues  relating  to  the  application  of  biosafety 
requirements  set  out  in  the  Directive  in  the  context  of  the  meetings  of  the  Regulatory 
Committee. These exchanges concerned national experiences identifying and raising awareness 
within the open science community about regulatory requirements of contained use of GMMs45, 
national guidelines to assess antibiotic resistance marker genes in contained use applications 

42 Slovenia and Slovakia. 
43 20 September 2023, point A.01. 
44 26 September 2025, point A.02  
45 20 September 2023, point A.02. 

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and activities by users for the phasing out of these genes46. In 2025, the Regulatory Committee 
discussed  several  issues  raised  by  the  Member  States  during  the  reporting  period.  These 
included the inspection of high-containment facilities, the transport of GMMs, waste disposal 
management, and the prevention and protection of health and the environment in relation to 
new biotechnological techniques47. 

The interpretation of the Directive continues to pose  certain challenges for some Member 
States, linked e.g. to  the classification of certain  organisms and applications. General  issues 
related to the interpretation of the GMO definition are regularly discussed in the meetings of 
the  Regulatory  Committee  established  in  Directive  2001/18/EC.  Several  issues  specifically 
relating to the interpretation of the GMM definition and the appropriate safety measures under 
the contained use of GMMs (e.g., in the case of bacteriophages) have been discussed at the 
meetings  of  the  Regulatory  Committee  established  in  Directive  2009/41/EC  during  the 
reporting period48 and on 26 September 202549.  

One Member State reported that there is still internal uncertainty regarding the applicability to 
the contained use of GMMs under Directive 2009/41/EC of the Court of Justice ruling in 2018 
regarding the mutagenesis exemption in Directive 2001/18/EC. In that regard, the Commission 
refers to the clarifications provided in its 2014-201850 and 2019-202151 reports.  

The  reported  numbers  of  notifications  of  contained  uses  appear  to  be  stable  or  slightly 
increasing, with class 1 and class 2 activities prevailing. Commercial applications are gaining 
relevance alongside research and education, with notifications increasingly managed through 
digital systems.  

In  the  area  of  GMMs-IMPs,  most  Member  States  reported  no  major  developments.  Some 
Member States highlighted again the complexity of authorisation procedures  under different 
regulatory frameworks for GMMs-IMPs i.e. under the GMO legislation and Regulation (EU) 
No 536/2014 on clinical trials, and differences in Member States’ approaches as regards the 
environmental  risk  assessment  of  clinical  trials  with  GMMs-IMPs.  Several  Member  States 
expressed the need for improved EU-level guidance, enhanced digital tracking of clinical trials 
and clearer rules for cross-border movement of GMMs.  

In this regard, it should be noted that, on 26 April 2023, the Commission adopted proposals for 
a Regulation and a Directive on the revision of the pharmaceutical legislation52, reviewing the 
requirements  for  the  authorisation  and  supervision  of  medicinal  products  for  human  use. 
Amendments to Regulation (EU) No 536/2014 aim to streamline the authorisation process for 
clinical  trials  involving  investigational  medicinal products  that  contain or consist  of GMOs, 
enabling a single authorisation under that Regulation. A new centralised procedure is proposed 
for  conducting  environmental  risk  assessments  as  part  of  these  clinical  trial  authorisations, 
seeking to eliminate fragmented national requirements and improve the clinical trial framework 
for  GMO  medicines  across  the  EU.  The  ordinary  legislative  procedure  on  these  legislative 
proposals is ongoing. 

For  the  contained  use  of  GMOs  other  than  GMMs—i.e.  GM  plants  and  animals—most 
national  frameworks  are  aligned  with  Directive  2009/41/EC.  While  no  major  issues  were 

46 20 September 2023, point A.03.  
47 26 September 2025, points A.03 to A.07  
48 20 September 2023, point A.04. 
49 26 September 2025, point A.05 
50 COM(2021) 266 final 
51 COM(2023) 75 final 
52 COM (2023) 192 final and COM(2023) 193 final.  

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reported  in  most  cases,  some  Member  States  experienced  certain  challenges  including 
identifying appropriate containment measures, managing cross-border transport, and ensuring 
consistent risk assessment.  

14