Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs
Date: 2025-12-16
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: environmental monitoring, environmental protection, genetically modified organism, market access, medicine, microorganism, organ transplantation, product quality, product safety, public health

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   EUROPEAN COMMISSION  Strasbourg, 16.12.2025  COM(2025) 1031 final 2025/0405 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

This  proposal  accompanies  the  Regulation  (EU)  …/…  [European  Biotech  Act],  which 
establishes  a  legislative  framework  to  strengthen  the  competitiveness  of  the  health 
biotechnology sector. That Regulation creates and reinforces favourable conditions for health 
biotechnology, from research and development to the timely placing on the Union market and 
production of biotechnology innovations and products, while safeguarding high standards of 
protection of human health, patient safety and animal health, the environment, ethics, quality 
of products, food and feed safety, and biosecurity. For the purposes of that Regulation, health 
biotechnology  means  the  application  of  biotechnology  for  the  promotion,  protection,  or 
restoration of human health and biotechnological applications relevant to animal health, plant 
health, veterinary public health, and food safety, insofar as these areas contribute directly or 
indirectly  to  the  protection  of  human  health  and  align  with  the  Union’s  public-health 
objectives,  as  set  out  under  Article  168  of  the  Treaty  on  the  Functioning  of  the  European 
Union. The overall context, rationale and objectives of that horizontal initiative are set out in 
detail  in  its  accompanying  Explanatory  Memorandum.  In  order  for  the  new  framework  to 
operate effectively within the existing acquis, targeted updates are required in two pieces of 
sectoral legislation. 

Directive  2001/18/EC  on  the  deliberate  release  into  the  environment  of  genetically 
modified organisms1 

Genetically modified micro-organisms (GMMs) play a decisive role in biotechnology, both as 
a  tool  for  manufacturing  but  also  as  products  themselves.  Micro-organisms  reproduce  and 
grow rapidly and  can be easily engineered. Their applications are broad and diverse and go 
well beyond the health sector. Products explored for agri-food use include novel biofertilisers 
and biopesticides, biological food preservatives, and biosensors registering the contamination 
of food products. In the industrial sector GMMs can be used to remove harmful chemicals and 
gases, including CO2, from effluents and emissions or to recover valuable metals like gold or 
lithium from electronics and battery waste. Similar GMMs can also be used in environmental 
applications  to  restore  soil  health  and  water  quality.  Also,  applications  to  modulate  the  gut 
microbiome of cattle to reduce methane emissions are explored. A number of these products 
are  already  commercialised  or  in  later  stages  of  development  in  third  countries,  notably  the 
USA and China. Together, these products could have a substantial impact on the EU economy 
and  competitiveness,  and  contribute  to,  for  example,  the  reduction  of  greenhouse  gas 
emissions,  the  use  of  more  sustainable  tools  in  agriculture,  the  reduction  of  food  waste,  the 
removal  of  residues  of  pesticide  and  medicines  use  from  the  environment  or  the  combat  of 
antimicrobial resistance. 

The development  time and costs for a GMM are much lower compared to  other genetically 
modified  (GM)  organisms  such  as  GM  plants.  Hence,  the  regulatory  framework  needs  to 
ensure  that  GMMs  and  their  derived  products  reach  the  Union  market  before  becoming 
obsolete.  

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, ELI: http://data.europa.eu/eli/dir/2001/18/oj). 

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To unlock the innovation potential of GMMs and to render the EU market more attractive for 
their development, production and marketing, it is necessary to make the applicable rules on 
GMMs fit for purpose. Directive 2001/18/EC on the deliberate release into the environment of 
genetically  modified  organisms  (GMOs)  was  primarily  designed  to  regulate  GM  plants, 
making it less suitable for GMMs, which differ significantly from plants in terms of biological 
properties and capabilities as well as potential applications. 

Directive  2010/53/EU  on  quality  and  safety  of  human  organs 
transplantation2 

intended  for 

The area of solid organ transplantation, which forms part of the broader domain of Substances 
of  Human  Origin  (SoHO),  is  subject  to  continuous  innovation,  in  particular  through 
technologies  aimed  at  expanding  the  ex-vivo  time  window  between  procurement  from  the 
donor  and  transplantation  into  the  recipient.  The  extension  of  this  time  window  creates 
opportunities for applying different types of processing operations to maintain or improve the 
functional  status  of  organs  prior  to  transplantation.  To  achieve  legal  certainty,  this  Act 
introduces  provisions  clarifying  how  these  processing  activities  can  be  organised  under  the 
oversight  of  the  transplant  authorities.  Where  such  processing  involves  medicinal  products, 
medical devices or SoHO preparations, transplant authorities shall collaborate closely with the 
corresponding  competent  authorities  with  the  relevant  expertise  in  those  areas,  ensuring 
coherent oversight and coordinated regulatory implementation. 

• 

Consistency with existing policy provisions in the policy area 

The targeted amendments to Directive 2001/18/EC are consistent with the overall objectives 
of  that  Directive,  namely,  to  ensure  a  high  level  of  protection  of  human  health  and  the 
environment in the deliberate release and placing on the market of GMOs and to ensure the 
effective functioning of the internal market. The adjustments proposed here have the aim of 
creating  a  tailored,  more  efficient  and  streamlined  regulatory  framework  for  GMMs.  They 
relate  to  the  risk  assessment,  to  the  validity  of  the  consent  granted  for  their  placing  on  the 
market, and to detection methods applicable to all GMMs, as well as to the introduction of the 
concept  of  low-risk  GMMs,  including  scientific  criteria  confirming  this  status,  and  set  a 
framework  for  a  streamlined  authorisation  procedure  for  eligible  low-risk  GMMs.  These 
measures to be introduced reflect recent scientific assessments and are in line with scientific 
and technical progress after the adoption of the Directive. 

The  amendments  to  Directive  2010/53/EU  are  likewise  consistent  with  its  objective  of 
ensuring  high  standards  of  quality  and  safety  of  human  organs  intended  for  transplantation. 
Clarifying the regulatory treatment of organ processing activities and strengthening oversight 
mechanisms  aligns  the  Directive  with  current  clinical  practice  and  supports  coordinated 
implementation across Member States. 

Together,  these  targeted  amendments  preserve  the  protection  objectives  of  the  existing 
legislation while contributing to the objectives of the Biotechnology Act. 

2 

Directive  2010/53/EU  of  the European  Parliament  and  of  the  Council of  7  July  2010  on  standards of 
quality  and  safety  of  human  organs  intended  for  transplantation  (OJ  L  207,  6.8.2010,  p.  14,  ELI: 
http://data.europa.eu/eli/dir/2010/53/oj). 

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• 

Consistency with other Union policies 

The proposal supports the wider objectives of the European Biotechnology Act, which forms 
part of the Union’s strategic efforts to strengthen competitiveness, innovation capacity and the 
safe  development  of  biotechnology  across  sectors.  The  proposal  contributes  to  a  more 
consistent, inclusive and predictable regulatory environment for biotechnology applications in 
the Union. 

The  amendments  to  Directive  2001/18/EC  are  coherent  with  Union  policies  promoting 
science-based risk assessment and proportionate regulatory requirements, including the work 
of the European Food Safety Authority (EFSA) in the area of GMMs. They also complement 
Union initiatives aimed at supporting research, innovation and the safe use of biotechnology 
in industrial, environmental and health-related applications. 

The  amendments  to  Directive  2010/53/EU  are  consistent  with  broader  Union  policies  on 
public health, quality and safety of medical treatments, and the effective functioning of cross-
border  healthcare  systems.  By  clarifying  the  regulatory  treatment  of  organ  processing 
technologies,  the  proposal  supports  coordinated  implementation  across  Member  States  and 
complements  Union  actions  in  adjacent  areas,  such  as  medicinal  products,  medical  devices 
and substances of human origin. 

2. 

• 

– 

– 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

Article 114 of the Treaty on the Functioning of the European Union (‘TFEU’) which 
provides the basis to take measures for the approximation of laws which have as their 
object  the establishment and functioning  of the internal  market.  In accordance with 
Article 114(3) TFEU, the proposal seeks to achieve the objective of a high level of 
health and safety protection; 

Article  168(4)  TFEU,  concerning  the  achievement  of  a  high  level  of  human  health 
protection  through  the  adoption,  in  order  to  meet  common  safety  concerns,  of 
measures  setting  high  standards  of  quality  and  safety  of  organs  and  substances  of 
human origin, blood and blood derivatives; in the veterinary and phytosanitary fields 
which  have  as  their  direct  objective  the  protection  of  public  health;  and  measures 
setting  high  standards  of  quality  and  safety  for  medicinal  products  and  devices  for 
medical use. 

• 

Subsidiarity (for non-exclusive competence)  

In accordance with the principle of subsidiarity, in areas which do not fall within its exclusive 
competence, the Union shall act only if and in so far as the objectives of the proposed action 
cannot be sufficiently achieved by the Member States.  

The  requirements  for  the  placing  on  the  market  of  GMMs  as  or  in  products  are  already 
harmonised at  Union level  under the existing  legal  framework applicable to  GMOs.  For the 
reasons explained above, the regulatory framework needs to be adapted to the specificities of 
GMMs.  To  this  end,  action  needs  to  be  taken  by  the  Union  by  amending  Directive 
2001/18/EC.  

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To  achieve  the  goals  outlined  above,  an  amendment  to  Directive  2010/53/EU  is  necessary, 
which can only be done at Union level. 

• 

Proportionality 

The  proposal  does  not  go  beyond  what  is  necessary  to  ensure  the  main  objectives  of 
Regulation (EU) …/… [European Biotech Act] and the existing sectoral legislation are met, 
namely  safeguarding  high  standards  for  the  protection  of  human  health,  animal  health, 
patients and consumers, and the environment, while strengthening the competitiveness of the 
biotechnology sector.  

Moreover,  as  regards  the  amendment  of  Directive  2001/18/EC,  the  proposal  ensures 
proportionality by providing for the adaptation of risk assessment and other requirements to 
reflect  the specificity of  GMMs and creating  tailored provisions for low-risk GMMs. These 
adaptations are intended to ensure that the applicable requirements do not go beyond what is 
necessary  to  ensure  the  legislation’s  objectives,  and  in  particular  a  high  level  of  safety  for 
human health and the environment. 

• 

Choice of the instrument 

Since the proposal amends existing directives, a Directive is the appropriate instrument. This 
ensures  that  the  necessary  adjustments  are  made  directly  to  Directives  2001/18/EC  and 
2010/53/EU while preserving their legal structure and transposition mechanisms. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

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STAKEHOLDER 

Ex-post evaluations/fitness checks  

The Commission published in 2021 a study on new genomic techniques (‘NGTs’) applied to 
plants, animals and micro-organisms3, which concluded that data was still too limited to take 
any  policy  actions  in  this  area.  The  study  identified  limitations  to  the  capacity  of  the  GMO 
legislation  to  keep  pace  with  scientific  developments  that  cause  implementation  challenges 
and  legal  uncertainties.  It  concluded  there  were  indications  that  the  applicable  legislation 
needed to be adapted to scientific and technological progress. As follow-up to the study, the 
Commission  adopted  a  legal  proposal  on  plants  obtained  by  certain  NGTs4.  However,  for 
other  NGTs  and  for  applications  in  other  organisms,  including  micro-organisms,  the  study 
concluded that the necessary scientific knowledge was still limited or lacking, especially on 
safety aspects.  

To address these knowledge gaps, the Commission requested EFSA and the European Union 
Reference  Laboratory  for  genetically  modified  food  and  feed  and  the  European  Network  of 
GMO laboratories (ENGL) to deliver reports on micro-organisms.  

On  19  June  2024,  EFSA  adopted  an  opinion  on  the  application  of  new  developments  in 
biotechnology  to  micro-organisms,  in  which  it  concluded  that  possible  hazards  relate  to  the 
changes  introduced,  regardless  of  the  method  used,  and  that  the  risk  assessment  should  be 
based on the characteristics of the product containing or consisting of micro-organisms. It also 

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Study  on  the  status  of  new  genomic  techniques  under  Union  law  and  in  light  of  the  Court  of  Justice 
ruling in Case C-528/16, SWD(2021) 92 final. 
COM(2023) 410 final. 

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concluded  that  for  certain  GMMs  fewer  requirements  for  risk  assessment  would  be  needed 
compared  to  those  applicable  to  GMOs  in  general5  and  provided  some  criteria  to  identify 
those GMMs6. 

The  EURL-ENGL  delivered  its  report  on  the  detection  of  micro-organisms  obtained  with 
NGTs7 in 2025, pointing to certain challenges due to technical difficulties and to the fact that 
in  some  instances  similar  modifications  to  those  obtained  with  NGTs  may  also  occur 
naturally.  

This opinion and report provide relevant scientific evidence for this proposal. EFSA’s wider 
work on micro-organisms has also been taken into account8. 

For organ transplantation, implementation experience with Directive 2010/53/EU has shown 
the emergence of increasingly sophisticated organ preservation and processing technologies, 
which are not fully covered by the existing provisions but have clear implications for quality, 
safety and oversight. 

In  addition, 
the  Commission  has  drawn  on  contacts  with  competent  authorities, 
transplantation  centres,  industry  and  research  organisations,  which  have  stressed  both  the 
innovation  potential  of  organ  processing  and  the  need  for  legal  clarity  and  proportionate, 
science-based requirements. 

• 

Stakeholder consultations 

Concerning  Directive  2001/18/EU,  an  external  study  commissioned  by  the  European 
Commission 
is  being  carried  out  (‘Analysis  of  the  Regulatory  Framework  for 
Biotechnology  and  Biomanufacturing  in  the  EU’)9.  The  study  provides  an  extensive 
mapping  of  the  main  EU  and  national  legislations  that  apply  to  biotechnology  and 
biomanufacturing  products  and  processes  –  whether  they  are  horizontal  or  sector-specific  – 
and  identifies,  through  surveys,  interviews  and  workshops,  the  challenges,  their  causes  and 
consequences for stakeholders. The study also assesses the impacts of policy options related 
to the EU regulatory framework. Evidence on the impacts of options on genetically modified 
micro-organisms has been collected through 25 interviews (by November 2025). 

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EFSA  GMO  Panel  (EFSA  Panel  on  Genetically  Modified  Organisms),  Mullins,  E.,  Bresson,  J.-L., 
Dewhurst,  I. C., Epstein, M.  M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., 
Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. 
S.,  Glandorf,  D.,  Herman,  L.,  Dalmay,  T.  (2024).  New  developments  in  biotechnology  applied  to 
microorganisms. EFSA Journal, 22(7), e8895; point 4: https://doi.org/10.2903/j.efsa.192024.8895  
EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, 
T.,  Crépet,  A.,  Halldorsson,  T.  I.,  Hoogenboom,  R.,  Jokelainen,  P.,  Knutsen,  H.  K.,  Lambré,  C., 
Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). 
Guidance on the characterisation of microorganisms in support of the risk assessment of products used 
in the food chain. EFSA Journal, 23(11), e9705. https://doi.org/10.2903/j.efsa.2025.9705  
Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., Detection of microorganisms, 
obtained by new genomic techniques, in food and feed products, Publications Office  of the European 
Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/1846532, JRC143597 
EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, 
T.,  Crépet,  A.,  Halldorsson,  T.  I.,  Hoogenboom,  R.,  Jokelainen,  P.,  Knutsen,  H.  K.,  Lambré,  C., 
Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). 
Guidance on the characterisation of microorganisms in support of the risk assessment of products used 
in the food chain. EFSA Journal, 23(11), e9705. https://doi.org/10.2903/j.efsa.2025.9705. 
Impact  assessment  supporting  study  –  Analysis  of  the  regulatory  framework  for  biotechnology  and 
biomanufacturing in the EU; request for service No 1005/PP/GRO/IMA/24/2129/14500 

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Furthermore, stakeholders’ views on GMMs expressed in the calls for evidence related to the 
Biotech  Act10  and  the  Food  and  Feed  Safety  Simplification  Omnibus11  stressing  the  recent 
innovations regarding GMMs and underlining the necessity to adapt the GMO framework to 
these developments have been taken into account.  

Finally,  targeted  consultation  activities  are  also  being  conducted  in  the  context  of  the 
supporting study for the evaluation of the European Food Safety Agency12. 

• 

Impact assessment 

Considering  the  political  urgent  need  to  address  the  policy  challenges  identified  in  the 
European  Biotech  Act  (Regulation  (EU)  …/…),  an  impact  assessment  could  not  have  been 
delivered  in  the  timeframe  available  before  the  proposal’s  adoption.  Instead,  an  analytical 
Staff  Working  Document  (SWD)  will  be  prepared.  The  analytical  SWD  will  explain  the 
proposal  and  will  present  the  underlying  evidence  and  impact  analysis,  including  a  cost–
benefit assessment. 

The provisions of the proposal concern simplification measures which typically  do not offer 
viable alternatives and do not modify the objectives of the amended legislation. Nevertheless, 
the underlying policy rationale, options considered and supporting evidence were developed 
through  stakeholder  consultations  and  analyses  conducted  during  the  preparation  of  the 
European Biotech Act.  

• 

Regulatory fitness and simplification 

The proposal is part of the European Biotechnology Act having the main policy objectives of, 
inter alia, modernising and simplifying the regulatory framework, removing duplications and 
unnecessary  administrative  steps.  The  proposal  is  therefore  aiming  at  improving  the 
regulatory landscape of the biotechnology sector and reducing unnecessary burdens and costs 
for  businesses  and  authorities,  without  undermining  the  protection  of  human  health  and  the 
environment.  

• 

Fundamental rights 

The  proposal  respects  the  rights  and  principles  enshrined  in  the  Charter  of  Fundamental 
Rights  of  the  European  Union  and  does  not  undermine  the  level  of  protection  of  human 
health,  animal  welfare  or  the  environment  guaranteed  under  the  existing  legislative 
framework. 

4. 

BUDGETARY IMPLICATIONS 

The proposal has no direct implications for the Union budget. 

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12 

European  Commission  Have  Your  Say  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14627-Biotech-Act_en. 
European  Commission  Have  Your  Say  website:  https://ec.europa.eu/info/law/better-regulation/have-
your-say/initiatives/14824-Food-and-feed-safety-simplification-omnibus_en 
Performance 
https://food.ec.europa.eu/horizontal-topics/general-food-law/performance-evaluation-european-food-
safety-authority_en 

Safety  Authority 

Evaluation 

European 

Food 

Food 

Safety: 

of 

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5. 

• 

OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

Amendments to Directive 2001/18/EC (genetically modified micro-organisms) 

This Directive introduces specific provisions in Part C of Directive 2001/18/EC on the placing 
on the market of GMMs as or in products other than food and feed with the aim of creating a 
tailored, more efficient and streamlined regulatory framework for GMMs while maintaining a 
high safety level for human health and the environment.  

The provisions proposed relate to  the risk assessment, to  the validity of the consent  granted 
for their placing on the market, and to detection methods applicable to all GMMs. In relation 
to a tailored risk assessment, provision is made for the information requirements in Annex III 
of  Directive  2001/18/EC  to  be  amended  by  delegated  act  in  order  to  adapt  them  to  the 
specificities  of  GMMs,  respecting  the  general  principles  for  the  environmental  risk 
assessment  of  Annex  II  of  Directive  2001/18/EC.  The  validity  of  consent  granted  by  the 
competent authorities would last for an unlimited period of time for GMMs. The modalities to 
comply  with  detection  method  requirements  in  cases  where  it  is  not  feasible  to  provide  a 
method that detects, identifies and quantifies are also adapted in the proposal. 

Further,  the  proposal  would  also  introduce  the  concept  of  low-risk  GMMs,  including 
scientific criteria confirming this status, and set a framework for a streamlined authorisation 
procedure  for  eligible  low-risk  GMMs.  It  is  proposed  that,  by  way  of  delegated  acts,  the 
Commission  supplements  the  low-risk  criteria  and  amends  the  Directive  to  adapt  the  risk 
assessment  information  requirements  in  Annex  III  and  certain  procedural  elements.  The 
requirement for post-market environmental monitoring of low-risk GMMs is equally adapted 
in the proposal, providing the possibility to a notifier, based on certain conditions, to propose 
to omit post-market environmental monitoring. 

Amendments to Directive 2010/53/EU (organ processing) 

Scope  

The  scope  of  Directive  2010/53/EU  is  amended  to  expressly  include  processing  alongside 
donation,  testing,  characterisation,  procurement,  transport  and  transplantation,  and  to  clarify 
that where organs  are used for research purposes, the Directive  applies only  where they  are 
intended for transplantation into the human body. 

Definitions  

The definition of “transplantation” is adjusted to reflect a process intended to restore certain 
functions of the human body by transferring an organ to a recipient. 

A  new  definition  of  “processing”  is  added,  covering  operations  involving  the  handling  of 
organs,  including  but  not  limited  to  preservation,  application  of  chemotherapy  and  surgery, 
performed  to  maintain  or  improve  organ  function  prior  to  transplantation.  The  definition 
excludes: 

• 

• 

preparatory handling during the surgical transplantation intervention; 

the repurposing of organs into tissues or cells; 

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the  use  of  substances  with  a  pharmacological,  immunological  or  metabolic  action 
where  the  primary  aim  is  to  treat  or  prevent  a  disease  in  the  recipient  and  not  to 
process the organ. 

Organ processing regime (new Article 6a)  
A new Article 6a: 

• 

• 

• 

• 

• 

• 

requires  transplantation  centres  to  obtain  prior  authorisation  from  the  competent 
authority  before  applying  a  processed  organ  to  a  recipient,  with  an  exception  for 
clinical outcome monitoring plans forming part of a processed organ authorisation; 

obliges  transplantation  centres  to  perform  a  benefit–risk  assessment  of  the 
processing, including the intended clinical indication; 

provides  that  where  evidence  is  limited  or  risks  are  significant,  the  benefit–risk 
assessment and  a clinical  outcome monitoring plan must be submitted for approval 
by the competent authority; 

requires  competent  authorities,  where  processing  involves  a  medicinal  product, 
medical device or SoHO preparation, to verify that this product or preparation used is 
authorised or certified under the relevant Union framework (Directive 2001/83/EC of 
the European Parliament and of the Council13, Regulation (EC) No 726/2004 of the 
European  Parliament  and  of  the  Council14,  Regulation  (EU)  2017/745  of  the 
European  Parliament  and  of  the  Council15  and  Regulation  (EU)  2024/1938  of  the 
European  Parliament  and  of  the  Council16,  and  to  cooperate  with  the  authorities 
designated under those frameworks, including on clinical outcome data; 

requires the Commission to publish a list of authorised organ processing operations, 
including where relevant associated products; 

empowers the Commission to adopt implementing acts specifying detailed rules for 
organ  processing  authorisation,  in  accordance  with  the  comitology  procedure 
referred to in Article 30(2) of Directive 2010/53/EU. 

Annex Part B  

Information required to characterise an organ and a donor is laid down in Annex to Directive 
2010/53/EU including a Part A (minimum data) and Part B (complementary data). Part B  is 
amended  to  add  “Processing”  as  a  step  applied  to  the  organ  with  the  aim  of  improving  its 

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Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community  code  relating  to  medicinal  products  for  human  use,  OJ  L  311,  28.11.2001,  p.  67,  ELI: 
http://data.europa.eu/eli/dir/2001/83/2025-01-01  
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and  veterinary  use  and  establishing  a  European  Medicines  Agency,  OJ  L  136,  30.4.2004,  p.  1,  ELI: 
http://data.europa.eu/eli/reg/2004/726/oj .  
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009  and  repealing  Council  Directives  90/385/EEC  and  93/42/EEC,  OJ  L  117,  5.5.2017,  p.  1, 
ELI: http://data.europa.eu/eli/reg/2017/745/oj .  
Regulation  (EU)  2024/1938  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  on 
standards  of  quality  and  safety  for  substances  of  human  origin  intended  for  human  application  and 
repealing  Directives  2002/98/EC  and  2004/23/EC,  OJ  L,  2024/1938,  17.7.2024,  ELI: 
http://data.europa.eu/eli/reg/2024/1938/oj.  

EN 

8 

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functional  status  and  potentially  affecting  its  quality  and  safety,  with  examples  such  as 
preservation, application of chemotherapy and surgery. 

EN 

9 

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2025/0405 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market 
of genetically modified micro-organisms and the processing of organs 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 and Article 168(4) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
Having regard to the opinion of the European Economic and Social Committee1,  
Having regard to the opinion of the Committee of the Regions2,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

1 
2 
3 

4 

Regulation (EU) …/… [European Biotech Act] establishes a framework to strengthen 
the competitiveness of the health biotechnology sector in the Union, from research and 
development  to  the  timely  placing  on  the  Union  market  and  production  of 
biotechnology  innovations  and  products,  while  safeguarding  high  standards  of 
protection of human health, patient safety and animal health, the environment, ethics, 
quality  of  products,  food  and  feed  safety  and  biosecurity.  For  the  purposes  of  that 
Regulation,  health  biotechnology  means  the  application  of  biotechnology  for  the 
promotion,  protection,  or  restoration  of  human  health  and  biotechnological 
applications relevant to animal health, plant health, veterinary public health, and food 
safety,  insofar  as  these  areas  contribute  directly  or  indirectly  to  the  protection  of 
human  health  and  align  with  the  Union’s  public-health  objectives,  as  set  out  under 
Article 168 of the Treaty on the Functioning of the European Union.  

 Given that the objectives of Directive 2001/18/EC of the European Parliament and of 
the  Council3  and  Directive  2010/53/EU  of  the  European  Parliament  and  of  the 
Council4 are closely linked to those of Regulation (EU) …/… [European Biotech Act], 
and  considering  that,  since  the  adoption  of  those  Directives,  significant  progress  in 
biotechnology  has  taken  place,  it  is  appropriate  to  adapt  them  in  order  to  align  with 
new  technological  realities  and  with  the  objectives  and  provisions  laid  down  in 

OJ C , , p. . 
OJ C , , p. . 
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, ELI: http://data.europa.eu/eli/dir/2001/18/oj ) 
Directive  2010/53/EU  of  the European  Parliament  and  of  the  Council of  7  July  2010  on  standards of 
quality  and  safety  of  human  organs  intended  for  transplantation  (OJ  L  207,  6.8.2010,    p.  14,  ELI: 
http://data.europa.eu/eli/dir/2010/53/oj)). 

EN 

10 

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(3) 

(4) 

(5) 

(6) 

Regulation  (EU)  …/…  [European  Biotech  Act].  Those  adaptations  are  intended  to 
improve consistency, legal clarity and the smooth functioning of the Union legislative 
framework  for  biotechnology,  and  eventually  to  ensure  the  availability  of  safe  and 
high-quality therapies and other products for Union citizens. 

Genetically  modified  micro-organisms  (GMMs),  such  as  bacteria,  algae,  fungi  and 
viruses,  as  or  in  products  for  uses  other  than  food  and  feed  are  subject  to  the 
requirements of Directive 2001/18/EC. Since the adoption of that Directive, significant 
progress in biotechnology has taken place, and GMMs can now be used for example 
as  or  in  fertilisers,  biocontrol,  bioremediation,  wastewater  treatment,  biomining  and 
bioleaching,  offering  benefits  in  the  wider  agri-food,  industrial  and  environmental 
sectors. 

Following  a  Commission  mandate,  on  19  June  2024,  the  European  Food  Safety 
Authority  (‘the  Authority’)  adopted  an  opinion  on 
the  application  of  new 
developments  in  biotechnology  to  micro-organisms5.  It  concluded  that  possible 
hazards relate to the changes introduced, regardless of the method used, and that the 
risk  assessment  should  be  based  on  the  characteristics  of  the  product  containing  or 
consisting  of  micro-organisms.  It  also  concluded  that  for  certain  GMMs,  fewer 
requirements  for  risk  assessment  would  be  needed  compared  to  those  applicable  to 
GMOs in general. Finally, the Authority considered that, for certain GMMs, the need 
for  post-market  environmental  monitoring  (PMEM)  may  be  waived  based  on  the 
environmental risk assessment. 

Considering that Directive 2001/18/EC was primarily designed to regulate genetically 
modified  plants  obtained  by  certain  established  genomic  techniques,  in  particular 
techniques that introduce into an organism genetic material from non-crossable species 
(transgenesis) and taking into account the Authority’s conclusions on GMMs, as well 
as  the  biological  properties,  capabilities  and  potential  applications  of  GMMs,  which 
differ  significantly  from  those  of  plants,  Directive  2001/18/EC  should  be  adapted  to 
the  specificities  of  GMMs  to  enable  innovative  products  to  reach  the  market  before 
they  become  obsolete  and  without  disproportionate  authorisation  costs,  while 
maintaining a high level of safety. 

For  that  reason,  Directive  2001/18/EC  should  be  amended  to  introduce  specific 
provisions applicable to the placing on the market of GMMs with the aim of creating a 
tailored,  more  efficient  and  streamlined  legislative  framework,  while  maintaining  a 
high level of safety for human health and the environment. Considering that possible 
hazards  relate  to  the  changes  introduced  into  the  genome  of  a  micro-organism 
regardless of the method used, and that micro-organisms are often modified through a 
combination  of  different  techniques,  including  both  established  and  new  genomic 
techniques6, those provisions should cover GMMs in general without focus on specific 
techniques. 

5 

6 

EFSA  GMO  Panel  (EFSA  Panel  on  Genetically  Modified  Organisms),  Mullins,  E.,  Bresson,  J.-L., 
Dewhurst,  I. C., Epstein, M.  M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F.  J., Naegeli, H., 
Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. 
S.,  Glandorf,  D.,  Herman,  L.,  Dalmay,  T.  (2024).  New  developments  in  biotechnology  applied  to 
microorganisms. EFSA Journal, 22(7), e8895; point 4: https://doi.org/10.2903/j.efsa.192024.8895  
Parisi,  C.,  Rodríguez-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. 

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(7) 

(8) 

(9) 

For  the  purpose  of  Directive  2001/18/EC,  the  definitions  of  ‘micro-organism’  and 
‘GMM’ should be based on those of Directive 2009/41/EC of the European Parliament 
and of the Council7 with the exclusion of animal and plant cells in culture. In order to 
ensure that the overall applicable framework on GMOs remains consistent, animal and 
plant  cells  should  be  subject  to  the  same  rules,  regardless  of  whether  they  are  in 
culture, not in culture or embedded in the complete organisms. The specific provisions 
should  therefore  cover  only  micro-organisms  in  the  biological  sense,  including  the 
taxonomic  groups  Archaea  and  Bacteria,  the  unicellular  species  and  life  stages  of 
Protozoa,  Chromista  and  Fungi,  as  well  as  filamentous  fungi  and  viruses,  while 
excluding animal and plant cells in culture. 

To reflect the specific properties of GMMs, the information requirements as set down 
in  Annex III  to  Directive  2001/18/EC  to  be  used  in  the  risk  assessment  should  be 
adapted based on the available information and evidence in relation to GMMs, while 
respecting the principles for the environmental risk assessment of GMOs laid down in 
Annex II to that Directive. In order to carry out those adaptations, the power to adopt 
delegated acts in accordance with Article 290 of the Treaty on the Functioning of the 
European  Union  should  be  delegated  to  the  Commission  in  respect  of  amending  the 
information requirements laid down in Annex III to the Directive.  

Considering  that  the  product  cycles  of  GMMs  are  very  short  and  new  generation 
GMMs  are  developed  in  short  timeframes,  with  new  products  building  on  the 
experience  gained  with  previous  ones,  including  as  regards  the  risk  assessment,  the 
limitation of the period of validity of the consent laid down in Directive 2001/18/EC 
implies  a  burden  for  operators  and  national  competent  authorities  while  bringing 
limited value to the safety of such products given the short life-time of those products. 
Directive  2001/18/EC  already  lays  down  measures  to  ensure  that  any  new  relevant 
information  is  provided  by  the  notifier,  as  well  as  safeguard  measures  in  case  new 
risks  are  identified.  Therefore,  Directive 2001/18/EC  should  provide  that  consents 
granted  for  the  placing  on  the  market  of  GMMs  should  be  valid  for  an  unlimited 
period of time. Any measures necessary to protect human health and the environment 
should continue to be adopted anytime where such consents granted do no longer meet 
the safety conditions set out in that Directive, taking into account new information that 
has become available as well as scientific and technical progress.  

(10)  On  2 October  2025,  the  European  Network  of  GMO  Laboratories  (ENGL)  Working 
Group  on  New  Mutagenesis  Techniques  published  a  report  on  the  analytical 
possibilities and challenges related to the detection of micro-organisms modified using 
new genomic techniques, concluding that analytical testing is not feasible for certain 
GMMs  obtained  through  those  techniques,  especially  in  the  context  of  routine 
laboratory control8. Therefore, in cases where it is not feasible to provide an analytical 
method  that  detects,  identifies  and  quantifies,  if  duly  justified  by  the  notifier,  the 
modalities  to  comply  with  analytical  method  performance  requirements  should  be 
adapted by means of implementing acts. 

7 

8 

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,  ELI: 
http://data.europa.eu/eli/dir/2009/41/oj ). 
Sowa, S., Broothaerts, W., Burns, M., De Loose, M., Debode, F. et al., Detection of microorganisms, 
obtained by new genomic techniques,  in food and feed products, Publications Office  of the European 
Union, Luxembourg, 2025, https://data.europa.eu/doi/10.2760/1846532, JRC143597.  

EN 

12 

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(11)  Furthermore, for certain GMMs, the Authority concluded that fewer data requirements 
for  risk  assessment  would  be  needed9  and  provided  some  criteria  to  identify  those 
GMMs10.  Thus,  Directive  2001/18/EC  should  establish  specific  requirements  for 
GMMs  with  an  inherently  low  risk  profile  to  ensure  that  the  risk  assessment  and 
procedures are proportionate to the risks the GMMs raise. Such adaptation should lead 
to  a  reduction  of  time  to  market  for  low-risk  GMMs,  enabling  innovation  without 
lowering the safety standards.   

(12)  Specifically,  it  is  necessary  to  lay  down  the  criteria  defining  low-risk  GMMs  on  the 
basis of general safety standards as expressed in the Authority’s concept of Qualified 
Presumption of Safety (hereinafter referred to as “QPS”)11 and an absence of genes of 
concern not naturally present in the parental organism as described in the glossary of 
the  Authority’s  guidance  on  the  characterisation  of  micro-organisms12,  including 
acquired  antimicrobial  resistance  genes,  virulence  factors  and  genes  known  to 
contribute to the production of toxins or harmful metabolites.  

(13)  While the basic criteria to be fulfilled for a GMM to be considered a low-risk GMM 
the  Commission  should  be 
should  be  established 
in  Directive  2001/18/EC, 
empowered,  in  accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the 
European  Union,  to  supplement  Directive  2001/18/EC  by  further  specifying  these 
criteria and adding further criteria if necessary. Moreover, the Commission should be 
empowered,  in  accordance  with  Article  290  of  the  Treaty  on  the  Functioning  of  the 
European  Union,  to  amend  Directive  2001/18/EC  by  adapting  the  risk  assessment 
requirements and the authorisation procedure to provide for the demonstration of low-
risk status, to streamline certain procedural elements and to expedite the timelines to 
reflect the adapted risk assessment requirements. 
In  line  with  the  recommendations  of  the  Authority13,  and  in  order  to  not  impose 
disproportionate  administrative  burden,  low-risk  GMMs  should  not  be  subject  to  the 
obligation to establish a post-market environmental monitoring plan if the GMM does 
not  give  rise  to  concerns  that  warrant  monitoring,  such  as  indirect,  delayed  or 
unanticipated effects on human health or on the environment. 

(14) 

9 

10 

11 
12 

13 

EFSA  GMO  Panel  (EFSA  Panel  on  Genetically  Modified  Organisms),  Mullins,  E.,  Bresson,  J.-L., 
Dewhurst,  I. C., Epstein, M.  M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F. J., Naegeli, H., 
Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. 
S.,  Glandorf,  D.,  Herman,  L.,  Dalmay,  T.  (2024).  New  developments  in  biotechnology  applied  to 
microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 
EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, 
T.,  Crépet,  A.,  Halldorsson,  T.  I.,  Hoogenboom,  R.,  Jokelainen,  P.,  Knutsen,  H.  K.,  Lambré,  C., 
Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., … Glandorf, B. (2025). 
Guidance on the characterisation of microorganisms in support of the risk assessment of products used 
in the food chain. EFSA Journal, 23(11), e9705. https://doi.org/10.2903/j.efsa.2025.9705  
https://doi.org/10.5281/zenodo.1146566 
EFSA Scientific Committee, Bennekou, S. H., Allende, A., Bearth, A., Casacuberta, J., Castle, L., Coja, 
T.,  Crépet,  A.,  Halldorsson,  T.  I.,  Hoogenboom,  R.,  Jokelainen,  P.,  Knutsen,  H.  K.,  Lambré,  C., 
Nielsen, S. S., Turck, D., Civera, A. V., Villa, R. E., Zorn, H., Gómez, M. A., …  Glandorf, B. (2025). 
Guidance on the characterisation of microorganisms in support of the risk assessment of products used 
in the food chain. EFSA Journal, 23(11), e9705; page 22: https://doi.org/10.2903/j.efsa.2025.9705.  
EFSA  GMO  Panel  (EFSA  Panel  on  Genetically  Modified  Organisms),  Mullins,  E.,  Bresson,  J.-L., 
Dewhurst,  I. C., Epstein, M.  M., Firbank, L. G., Guerche, P., Hejatko, J., Moreno, F.  J., Naegeli, H., 
Nogué, F., Rostoks, N., Sánchez Serrano, J. J., Savoini, G., Veromann, E., Veronesi, F., Cocconcelli, P. 
S.,  Glandorf,  D.,  Herman,  L.,  Dalmay,  T.  (2024).  New  developments  in  biotechnology  applied  to 
microorganisms. EFSA Journal, 22(7), e8895; point 3.3.2.9.: https://doi.org/10.2903/j.efsa.2024.8895 

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(15)  Processing,  including  preservation,  of  human  organs  is  increasingly  frequent  and 
allows  the  ex-vivo  time  window  between  procurement  from  the  donor  and 
transplantation into the recipient to be extended.  

(16)  The uptake of those preservation and processing technologies not only allows for more 
efficient  organisational  set-up,  but  also  for  improving  human  organs  during  the 
extended  ex-vivo  time  window,  increasing  treatment  options  for  patients  on  waiting 
lists.  Such  activities  need  to  be  subject  to  oversight  by  the  competent  authorities  in 
order  to  ensure  their  quality,  optimise  the  effectiveness  of  transplants  and  protect 
recipients’ health. 

(17)  To ensure a consistent and comprehensive legislative framework by providing clarity 
for  all  actors  involved,  Directive  2010/53/EU  should  cover  processing  of  organs, 
beyond  preservation  of  such  organs.  In  order  to  ensure  coherence  and  efficient 
coordination   among  authorities  operating  under  different  Union 
legislative 
frameworks in the health area, provisions should be laid down to clarify which of the 
technologies  used  fall  under  Union  legislative  frameworks  other  than  Directive 
2010/53/EU, in particular the frameworks established in Directive 2001/83/EC of the 
European  Parliament  and  of  the  Council14,  Regulation  (EC)  No  726/2004  of  the 
European Parliament and of the Council15, Regulation (EU) 2017/745 of the European 
Parliament  and  of  the  Council16  and  Regulation  (EU)  2024/1938  of  the  European 
Parliament and of the Council17. Such provisions should aim to at ensuring coherence 
and  efficient  coordination  among  authorities  operating  under  those  frameworks. 
Directive 2010/53/EU should therefore be amended accordingly. 

(18)  To ensure uniform conditions for the implementation of this Directive, implementing 
powers  should  be  conferred  on  the  Commission.  Those  powers  should  cover,  in 
particular, the adapted modalities to comply with analytical method requirements and 
the supporting information to be submitted to demonstrate the fulfilment of the criteria 
for  being  considered  a  low-risk  GMM  concerning  Directive  2001/18/EC,  as  well  as 
the  establishment  of  detailed  rules  for  the  authorisation  of  organ  processing, 
concerning  Directive  2010/53/EU.  Those  implementing  acts  should  be  adopted  in 
accordance with Regulation (EU) No 182/2011 of the European Parliament and of the 
Council18. 

14 

15 

16 

17 

18  

Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community  code  relating  to  medicinal  products  for  human  use  (OJ  L  311,  28.11.2001,  p.  67,  ELI: 
http://data.europa.eu/eli/dir/2001/83/oj). 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and  veterinary  use  and  establishing  a  European  Medicines  Agency  (OJ  L  136,  30.4.2004,  p.  1,  ELI: 
http://data.europa.eu/eli/reg/2004/726/oj).  
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009  and  repealing  Council  Directives  90/385/EEC  and  93/42/EEC  (OJ  L  117,  5.5.2017,  p.  1, 
ELI: http://data.europa.eu/eli/reg/2017/745/oj).  
Regulation  (EU)  2024/1938  of  the  European  Parliament  and  of  the  Council  of  13  June  2024  on 
standards  of  quality  and  safety  for  substances  of  human  origin  intended  for  human  application  and 
(OJ  L,  2024/1938,  17.7.2024,  ELI: 
repealing  Directives  2002/98/EC  and  2004/23/EC 
http://data.europa.eu/eli/reg/2024/1938/oj).  
Regulation  (EU)  No  182/2011  of  the  European  Parliament  and  of  the  Council  of  16  February  2011 
laying down the rules and general principles concerning mechanisms for control by Member States of 
implementing  powers  (OJ  L  55,  28.2.2011,  p.  13,  ELI: 
the  Commission’s  exercise  of 
http://data.europa.eu/eli/reg/2011/182/oj).  

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(19)  Since the objectives of this Directive, including to ensure legal clarity across Member 
States cannot be sufficiently achieved by the Member States but can rather,  by reason 
of  their  scale  and  effects,  be  better  achieved  at  Union  level,  the  Union  may  adopt 
measures in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality as set 
out  in  that  Article,  this  Directive  does  not  go  beyond  what  is  necessary  in  order  to 
achieve those objectives. 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Amendments to Directive 2001/18/EC 

Directive 2001/18/EC is amended as follows: 

(1) 

in Article 2, the following points (9), (10) and (11) are added: 

‘(9)  ‘micro-organism’ means a micro-organism as defined in Article 2, point (a), of 
Directive 2009/41/EC of the European Parliament and of the Council*, with the 
exception of animal and plant cells in culture; 

(10)  ‘genetically  modified  micro-organism’  or  ‘GMM’  means  a  genetically 
modified  micro-organism  as  defined  in  Article  2,  point  (b),  of  Directive 
2009/41/EC, with the exception of genetically modified animal and plant cells 
in culture; 

(11)  ‘Status of Qualified Presumption of Safety’ means the safety status assigned by 
the  Authority  to  selected  groups  of  micro-organisms  on  the  basis  of  an 
assessment showing no safety concerns;’ 

* 

(2) 

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,  ELI: 
http://data.europa.eu/eli/dir/2009/41/oj ).’; 

In Part C, after the heading ‘PLACING ON THE MARKET OF GMOs AS OR IN 
PRODUCTS’ the following title is inserted: 

‘TITLE I 

GENERAL PROVISIONS APPLICABLE TO GMOs AS OR IN PRODUCTS’ 

(3) 

after Article 24, the following title and Articles 24a to 24g are inserted: 

SPECIFIC PROVISIONS APPLICABLE TO GENETICALLY MODIFIED MICRO-
ORGANISMS (GMMs) AS OR IN PRODUCTS 

‘TITLE II  

Article 24a  

Subject matter and status of GMMs 

1. 

This Title lays down specific rules for the placing on the market of genetically 
modified micro-organisms (GMMs) as or in products. 

2.  Articles  24e and 24f shall apply  only  to  the placing  on the market  of GMMs 

with a low-risk profile as or in products. 

EN 

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3.  Unless  otherwise  provided  for  in  this  Title,  the  rules  of  this  Directive 

applicable to GMOs as or in products shall apply to GMMs as or in products. 

Article 24b  

Adaptation of information requirements 

The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance  with  Article 
29a to amend Annex III in order to provide for specific information requirements in 
notifications concerning the placing on the market of GMMs, so as to adapt them to 
scientific and technical progress. 

Article 24c  

Validity of the consent 

Without prejudice to Article 20(2) and (3) and Article 23, the consent granted under 
Part C shall be valid for an unlimited period of time and Article 17 shall not apply. 

Article 24d  

Detection methods 

1. 

2. 

In  cases  where  it  is  not  feasible  to  provide  a  method  for  detection, 
identification and quantification of the transformation event as detailed in point 
7 of Section A of Annex IV, to which Article 13(2), point (a), refers, and where 
this  is  duly  justified  by  the  notifier,  the  modalities  to  comply  with  analytical 
method  performance  requirements  shall  be  adapted  as  specified  in  the 
implementing act adopted in accordance with Article 24g(1), point (a). 

The competent authority shall assess whether the information on the analytical 
method provided by the notifier justifies the application of adapted modalities 
to comply with detection method requirements in accordance with paragraph 1. 

Article 24e  

Low-risk GMMs 

1.  A  GMM  shall  be  considered  a  ‘low-risk  GMM’  where  it  fulfils  all  of  the 

following criteria: 

(a) 

(b) 

(c) 

it is taxonomically and molecularly well characterised; 

it belongs to a taxonomic unit having the Status of Qualified Presumption 
of Safety; 

it does not contain genes of concern which are not naturally present in the 
parental organism, in particular acquired antimicrobial resistance genes. 

The Commission may supplement those criteria by establishing further criteria, 
as provided for in paragraph 3, point (b), based on available scientific evidence 
concerning the safety of GMMs and on experience gained from the release of 
comparable micro-organisms. 

2. 

The  risk  assessment  of  low-risk  GMMs  and  the  specific  information 
requirements  in  notifications  concerning  their  placing  on  the  market  shall  be 
adapted to their characteristics. 

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The procedural requirements laid down in Title I shall be adapted as provided 
for  in  paragraph  3,  point  (d),  to  provide  for  the  demonstration  of  low-risk 
status, to streamline certain procedural elements and to expedite the timelines. 
Such  adaptations  shall  ensure  a  high  level  of  protection  of  human  health  and 
the environment as well as the necessary consultations of competent authorities 
and the public. 

3. 

The  Commission  is  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 29a to: 

(a) 

(b) 

(c) 

supplement  this  Directive  by  further  specifying  the  low-risk  criteria  of 
GMMs  as  referred  to  in  paragraph  1,  first  subparagraph,  points  (a),  (b) 
and (c); 

supplement  this  Directive  by  establishing,  where  necessary,  additional 
low-risk criteria of GMMs as referred to in paragraph 1; 

amend this Directive by providing for specific information requirements 
in Annex III in notifications concerning the placing on the market of low-
risk GMMs; 

(d) 

amend this Directive by setting out procedural requirements for the risk 
assessment of low-risk GMMs adapted to their characteristics. 

Article 24f  

Monitoring and reporting of low-risk GMMs 

1. 

If, on the basis of the results of any release notified in accordance with Article 
6,  of  the  findings  of  the  environmental  risk  assessment  carried  out  in 
accordance with Article 13(2), point (b), of the characteristics of the GMM, of 
the characteristics and scale of its expected use, and of the characteristics of the 
receiving environment, the notifier considers that a monitoring plan referred to 
in Article 13(2), point (e), is not needed, the notifier may propose not to submit 
a monitoring plan. 

2. 

The written consent referred to in Article 19 shall either specify the monitoring 
requirements, as provided in Article 19(3), point (f), or state that monitoring is 
not required. 

Article 24g  

Implementing acts 

1. 

The Commission shall adopt implementing acts concerning: 

(a) 

(b) 

adapted  modalities  to  comply  with  analytical  method  requirements 
referred to in Article 24d(1); 

the supporting information to be submitted in the notification referred to 
in  Article  13(2)  to  demonstrate  fulfilment  of  the  criteria  referred  to  in 
Article 24e(1) for being considered a low-risk GMM. 

2. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  procedure 
referred to in Article 30(2).’; 

(4) 

Article 29a is replaced by the following: 

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‘Article 29a 

Exercise of the delegation 

1. 

2. 

3. 

The power to adopt delegated acts is conferred on the Commission subject to 
the conditions laid down in this Article. 

The  power  to  adopt  delegated  acts  referred  to  in  Article  16(2),  Article  21(2) 
and  (3),  Article  24b,  Article  24e(3),  Article  26(2)  and  Article  27  shall  be 
conferred on the Commission for a period of five years from [the date of entry 
into force of this Directive]. The Commission shall draw up a report in respect 
of  the  delegation  of  power  not  later  than  nine  months  before  the  end  of  the 
five-year period. The delegation of power shall be tacitly extended for periods 
of an identical duration, unless the European Parliament or the Council opposes 
such extension not later than three months before the end of each period. 

The  delegations  of  power  referred  to  in  Article  16(2),  Article  21(2)  and  (3), 
Article 24b, Article 24e(3), Article 26(2) and Article 27 may be revoked at any 
time by the European Parliament or by the Council. A decision to revoke shall 
put an end to the delegation of the power specified in that decision. It shall take 
effect the day following the publication of the decision in the Official Journal 
of the European Union or at a later date specified therein. It shall not affect the 
validity of any delegated acts already in force. 

4. 

Before  adopting  a  delegated  act,  the  Commission  shall  consult  experts 
designated by each Member State in accordance with the principles laid down 
in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making**. 

5.  As  soon  as  it  adopts  a  delegated  act,  the  Commission  shall  notify  it 

simultaneously to the European Parliament and to the Council. 

6.  A delegated act adopted pursuant to Article 16(2), Article 21(2) and (3), Article 
24b, Article 24e(3), Article 26(2) and Article 27 shall enter into force only if 
no  objection  has  been  expressed  either  by  the  European  Parliament  or  by  the 
Council  within  a  period  of  two  months  of  notification  of  that  act  to  the 
European Parliament and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that 
they  will  not  object.  That  period  shall  be  extended  by  two  months  at  the 
initiative of the European Parliament or of the Council.’ 

** 

OJ L 123, 12.5.2016, p. 1.’. 

Article 2 

Amendments to Directive 2010/53/EU 

Directive 2010/53/EU is amended as follows: 

(1) 

in Article 2, paragraph 1 is replaced by the following: 

‘1.  This  Directive  applies  to  the  donation,  testing,  characterisation,  procurement, 
for 

transplantation  of  organs 

transport 

intended 

and 

processing, 
transplantation.’ 

(2) 

Article 3 is amended as follows: 

(a) 

point (q) is replaced by the following: 

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‘(q) “transplantation” means a process intended to restore certain functions of 

the human body by transferring an organ to a recipient;’ 

(b) 

the following point (ka) is inserted: 

‘(ka)  “processing”  means  any  operation  involving  the  handling  of  organs, 
including  but  not  limited  to  preservation,  application  of  chemotherapy 
and surgery, performed to maintain or improve the functional status of an 
organ  prior  to  transplantation,  with  the  exception  of  the  preparatory 
handling  of  the  organ  during  the  surgical  transplantation  intervention, 
and excluding the following: 

(i) 

the repurposing of organs into tissues or cells; 

(ii) 

the  use  of  a  substance  with  a  pharmacological,  immunological  or 
metabolic  action  with  the  aim  to  treat  or  prevent  a  disease  in  the 
patient  to  whom  the  organ  will  be  transplanted,  where  such  use 
does not constitute processing of the organ.’ 

(3) 

the following Article 6a is inserted: 

‘Article 6a 

Organ processing 

1. 

2. 

3. 

Transplantation centres shall not apply a processed organ to a recipient without 
prior authorisation by the competent authority, other than in the context of  an 
approved  clinical-outcome  monitoring  plan  referred  to  in  paragraph  3  of  this 
Article, as part of an organ processing authorisation. 

The  transplantation  centre  shall  conduct  a  benefit-risk  assessment  of  the 
processing  of  the  organ,  considering  with  the  intended  clinical  indication  for 
which the organ processing authorisation is requested. 

The  transplantation  centre  shall  submit  the  benefit-risk  assessment  to  the 
competent authority for revision. 

In cases where the scientific evidence and clinical data available to perform the 
benefit-risk assessment are not sufficient, or where the assessment identifies a 
significant risk, the transplantation centre shall submit a proposal for a clinical-
outcome monitoring plan for approval by the competent authority. 

4.  Where  the  processing  of  an  organ  entails  the  use  of  a  medicinal  product,  the 
competent authority shall verify that the medicinal product has been authorised 
by a competent authority of a Member State or by the European Commission in 
accordance with Directive 2001/83/EC of the European Parliament and of the 
Council* or Regulation (EC) No 726/2004 of the European Parliament and of 
the Council**. 

5. 

Competent  authorities  shall,  after  consulting  the  authorities  designated  under 
Directive  2001/83/EC,  publish  guidelines  setting  out 
the  necessary 
requirements for the benefit-risk assessment and the management of the organ 
after the administration of the medicinal product. 

6.  Where  the  processing  of  an  organ  entails  the  use  of  a  medical  device,  the 
competent authority shall verify that the medical device has been certified by a 
notified  body  in  accordance  with  Regulation  (EU)  2017/745  of  the  European 
Parliament and of the Council***. 

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7.  Where  the  processing  of  an  organ  entails  the  use  of  a  SoHO  preparation,  the 
competent authority shall verify that the SoHO preparation has been authorised 
by the competent authority in accordance with Regulation (EU) 2024/1938 of 
the European Parliament and of the Council****. 

8.  Where  applicable,  competent  authorities  under  this  Directive  and  the 
competent  authorities  under  Directive  2001/83/EC,  Regulation  (EC)  No 
726/2004,  Regulation  (EU)  2017/745  and  Regulation  (EU)  2024/1938  shall 
collaborate  in  order  to  exchange  clinical  outcome  data  under  such  Union 
legislative  frameworks  including  the  clinical  outcome  monitoring  plan  under 
this Directive.  

9. 

Transplant centres shall not make any significant change regarding the steps of 
the  processing  applied,  without  prior  written  agreement  of  the  competent 
authority. 

10.  Competent authorities may suspend the authorisation where there is reasonable 
ground  to  suspect  that  the  performed  processing  activities  are  not  in 
compliance with the authorisation. 

11.  The Commission shall publish a list of operations that have been authorised as 
organ processing or have received approval for a clinical outcome monitoring 
plan, including, where relevant, the use of medicinal products, medical devices 
or SoHO preparations.  

12.  The Commission shall adopt implementing acts laying down detailed rules for 
the  application  and  authorisation  of  organ  processing  in  accordance  with  the 
procedure referred to in Article 30(2). 

* Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, 
ELI: http://data.europa.eu/eli/dir/2001/83/oj). 

** Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 
laying  down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal 
products for human and veterinary use and establishing a European Medicines Agency (OJ L 
136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). 

***  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on 
medical  devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
(OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj). 

**** Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on 
standards of quality and safety for substances of human origin intended for human application 
and  repealing  Directives  2002/98/EC  and  2004/23/EC  (OJ  L,  2024/1938,  17.07.2024,  ELI: 
http://data.europa.eu/eli/reg/2024/1938/oj).’; 

(4) 

in Part B of the Annex, the following entry is added: 

‘Processing 

Processing steps applied to the organ with the aim of improving its functional status 
and with a potential impact on its quality and safety, including in particular, but not 
limited to, preservation, application of chemotherapy and surgery.’ 

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Article 3 

Transposition 

1. 

2. 

3. 

Member  States  shall  adopt  and  publish  the  laws,  regulations  and  administrative 
provisions necessary to  comply with  this Directive by  [24  months  from  the date of 
entry into force] at the latest. They shall forthwith communicate to the Commission 
the text of those provisions. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  shall  be  accompanied  by  such  a  reference  on  the  occasion  of  their 
official  publication.  Member  States  shall  determine  how  such  reference  is  to  be 
made.  

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

Article 4 

Entry into Force 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 5 

Addressees 

This Directive is addressed to the Member States. 

Done at Strasbourg, 

For the European Parliament 
The President 

For the Council 
The President 

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