Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on adapting non-contractual civil liability rules to artificial intelligence (AI Liability Directive)
Date: 2022-09-28
Institutions: Directorate-General for Justice and Consumers, European Commission
Subjects: artificial intelligence, civil liability, civil liability proceedings, damage, digital technology, disclosure of information, evidence, information technology applications, new technology, proof

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   EUROPEAN COMMISSION  Brussels, 28.9.2022  COM(2022) 496 final 2022/0303 (COD)  Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on adapting non-contractual civil liability rules to artificial intelligence  (AI Liability Directive) (Text with EEA relevance) {SEC(2022) 344 final} - {SWD(2022) 318 final} - {SWD(2022) 319 final} - {SWD(2022) 320 final}  
 
EXPLANATORY MEMORANDUM 

1. 

 

CONTEXT OF THE PROPOSAL  

Reasons for and objectives of the proposal 

This  explanatory  memorandum  accompanies  the  proposal  for  a  Directive  on  adapting  non-
contractual  civil  liability  rules  to  artificial  intelligence  (AI).  In  a  representative  survey  of 
20201, liability ranked amongst the top three barriers to the use of AI by European companies. 
It was cited as the most relevant external obstacle (43%) for companies that are planning to, 
but have not yet adopted AI. 

In  her  Political  Guidelines,  Commission  President  Ursula  von  der  Leyen  laid  out  a 
coordinated European approach on AI2. In its White Paper on AI of 19 February 20203, the 
Commission undertook to promote the uptake of AI and to address the risks associated with 
some  of  its  uses  by  fostering  excellence  and  trust.  In  the  Report  on  AI  Liability 4 
accompanying the White Paper, the Commission identified the specific challenges posed by 
AI to  existing liability  rules.  In its conclusions on shaping Europe’s digital  future of 9 June 
2020, the Council welcomed the consultation on the policy proposals in the White Paper on 
AI and called on the Commission to put forward concrete proposals. On 20 October 2020, the 
European Parliament adopted a legislative own-initiative resolution under Article 225 TFEU 
requesting  the  Commission  to  adopt  a  proposal  for  a  civil  liability  regime  for  AI  based  on 
Article 114 of the Treaty on the Functioning of the EU (TFEU).5 

Current national liability rules, in particular based on fault, are not suited to handling liability 
claims  for  damage  caused  by  AI-enabled  products  and  services.  Under  such  rules,  victims 
need to prove a wrongful action or omission by a person who caused the damage. The specific 
characteristics of AI, including complexity, autonomy and opacity (the so-called “black box” 
effect),  may  make  it  difficult  or  prohibitively  expensive  for  victims  to  identify  the  liable 
person  and  prove  the  requirements  for  a  successful  liability  claim.  In  particular,  when 
claiming  compensation,  victims  could  incur  very  high  up-front  costs  and  face  significantly 
longer  legal  proceedings,  compared  to  cases  not  involving  AI.  Victims  may  therefore  be 
deterred from claiming compensation altogether. These concerns have also been retained by 
the  European  Parliament  (EP)  in  its  resolution  of  3  May  2022  on  artificial  intelligence  in  a 
digital age. 6 

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4 

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6 

European  enterprise  survey  on  the  use  of  technologies  based  on  AI,  Ipsos  2020,  Final  report  p.  58 
(https://op.europa.eu/en/publication-detail/-/publication/f089bbae-f0b0-11ea-991b-01aa75ed71a1) 
 https://ec.europa.eu/commission/sites/beta-political/files/political-guidelines-next-commission_en.pdf 
White  Paper  On  Artificial  Intelligence  –  A  European  approach  to  excellence  and  trust,  19.2.2020, 
COM(2020) 65 final 
Report  from  the  Commission  to  the  European  Parliament,  the  Council  and  the  Economic  and  Social 
Committee  on  the  safety  and  liability  implications  of  artificial  intelligence,  the  internet  of  things  and 
robotics, 19.2.2020, COM(2020) 64 final 
European  Parliament  resolution  of  20 October  2020  with  recommendations  to  the  Commission  on  a 
civil liability regime for artificial intelligence (2020/2014(INL)) 
European  Parliament  resolution  of  3  May  2022  on  artificial  intelligence  in  a  digital  age 
(2020/2266(INI))  

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If a victim brings a claim, national courts, faced with the specific characteristics of AI, may 
adapt the way in which they apply existing rules on an ad hoc basis to come to a just result for 
the victim. This will cause legal uncertainty. Businesses will have difficulties to predict how 
the  existing  liability  rules  will  be  applied,  and  thus  to  assess  and  insure  their  liability 
exposure.  The  effect  will  be  magnified  for  businesses  trading  across  borders,  as  the 
uncertainty  will  cover  different  jurisdictions.  It  will  particularly  affect  small  and  medium-
sized enterprises (SMEs), which cannot rely on in-house legal expertise or capital reserves. 

National  AI  strategies  show  that  several  Member  States  are  considering,  or  even  concretely 
planning, legislative action on civil  liability for  AI. Therefore, it is  expected that, if the EU 
does not  act,  Member States will adapt  their national  liability rules to  the challenges of  AI. 
This will result in further fragmentation and increased costs for businesses active throughout 
the EU. 

The  open  public  consultation  informing  the  Impact  Assessment  of  this  proposal,  confirmed 
the problems explained above. In the opinion of the public, the ‘black box’ effect can make it 
difficult for the victim to prove fault and causality and there may be uncertainty as to how the 
courts  will  interpret  and  apply  existing  national  liability  rules  in  cases  involving  AI. 
Furthermore,  it  showed  a  public  concern  as  to  how  legislative  action  on  adapting  liability 
rules initiated by individual Member States, and the ensuing fragmentation, would affect the 
costs for companies, especially SMEs, preventing the uptake of AI Union wide. 

Thus, the objective of this proposal is to promote the rollout of trustworthy AI to harvest its 
full benefits for the internal market. It does so by ensuring victims of damage caused by AI 
obtain  equivalent  protection  to  victims  of  damage  caused  by  products  in  general.  It  also 
reduces  legal  uncertainty  of  businesses  developing  or  using  AI  regarding  their  possible 
exposure  to  liability  and  prevents  the  emergence  of  fragmented  AI-specific  adaptations  of 
national civil liability rules.  

 

Consistency with existing policy provisions in the policy area 

This  proposal  is  part  of  a  package  of  measures  to  support  the  roll-out  of  AI  in  Europe  by 
fostering excellence and trust. This package comprises three complementary work streams: 

– 

– 

– 

a  legislative  proposal  laying  down  horizontal  rules  on  artificial  intelligence 
systems (AI Act);7  

a revision of sectoral and horizontal product safety rules; 

EU rules to address liability issues related to AI systems. 

In the AI Act proposal, the Commission has proposed rules that seek to reduce risks for safety 
and protect fundamental rights. Safety and liability are two sides of the same coin: they apply 
at  different  moments  and  reinforce  each  other.  While  rules  to  ensure  safety  and  protect 
fundamental rights will reduce risks, they do not eliminate those risks entirely.8 Where such a 
risk materialises, damage may still occur. In such instances, the liability rules of this proposal 
will apply.  

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8 

Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules 
on artificial intelligence (Artificial Intelligence Act) (COM(2021 206 final). 
Only a small number of AI use-cases are expressly prohibited by the AI Act. 

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Effective liability rules also  provide an  economic incentive to  comply  with  safety  rules and 
therefore  contribute  to  preventing  the  occurrence  of  damage. 9  In  addition,  this  proposal 
contributes to the enforcement of the requirements for high-risk AI systems imposed by the 
AI  Act,  because  the  failure  to  comply  with  those  requirements  constitutes  an  important 
element  triggering  the  alleviations  of  the  burden  of  proof.  This  proposal  is  also  consistent 
with  the  general 10  and  sectoral  product  safety  proposed  rules  applicable  to  AI-enabled 
machinery products11 and radio equipment.12 

The  Commission  takes  a  holistic  approach  in  its  AI  policy  to  liability  by  proposing 
adaptations  to  the  producer’s  liability  for  defective  products  under  the  Product  Liability 
Directive  as  well  as  the  targeted  harmonisation  under  this  proposal.  These  two  policy 
initiatives are closely linked and form a package, as claims falling within their scope deal with 
different types of liability. The Product Liability Directive covers producer’s no-fault liability 
for defective products, leading to compensation for certain types of damages, mainly suffered 
by individuals. This proposal covers national liability claims mainly based on the fault of any 
person  with  a  view  of  compensating  any  type  of  damage  and  any  type  of  victim.  They 
complement one another to form an overall effective civil liability system. 

Together these rules will promote trust in AI (and other digital technologies) by ensuring that 
victims are effectively compensated if damage occurs despite the preventive requirements of 
the AI Act and other safety rules.  

 

Consistency with other Union policies 

The  proposal  is  coherent  with  the  Union’s  overall  digital  strategy  as  it  contributes  to 
promoting  technology  that  works  for  people,  one  of  the  three  main  pillars  of  the  policy 
orientation  and  objectives  announced  in  the  Communication  ‘Shaping  Europe's  digital 
future’13.   

In this context, this proposal aims to build trust in the AI and to increase its uptake. This will 
achieve synergies and is complementary with the [Cyber Resilience Act]14, which also aims to 
increase trust in products with digital elements by reducing cyber vulnerabilities and to better 
protect business and consumer users. 

This proposal does not affect the rules set by [the Digital Services Act (DSA)], which provide 
for  a  comprehensive  and  fully  harmonised  framework  for  due  diligence  obligations  for 
algorithmic  decision  making  by  online  platforms,  including  its  exemption  of  liability  for 
providers of intermediary services. 

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14 

Commission  SWD(2021) 84 final,  Impact  assessment  accompanying  the  Artificial  Intelligence  Act, 
p. 88.  
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  general  product  safety 
(COM/2021/346 final). 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  machinery  products 
(COM(2021) 202 final). 
Commission Delegated Regulation (EU) 2022/30 supplementing Directive 2014/53/EU of the European 
Parliament and of the Council with regard to the application of the essential requirements referred to in 
Article 3(3), points (d), (e) and (f), of that Directive (OJ L 7, 12.1.2022, p. 6). 
Communication from the Commission, Shaping Europe's Digital Future, COM/2020/67 final. 
Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  horizontal  cybersecurity 
requirements for products with digital elements - COM(2022) 454 final 

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In addition, by promoting the roll-out of AI, this proposal is linked to the initiatives under the 
EU  strategy  for  data15.  It  also  strengthens  the  Union’s  role  to  help  shape  global  norms  and 
standards and promote trustworthy AI that is consistent with Union values and interests. 

The  proposal  also  has  indirect  links  with  the  European  Green  Deal16.  In  particular,  digital 
technologies,  including  AI,  are  a  critical  enabler  for  attaining  the  sustainability  goals  of  the 
Green  Deal  in  many  different  sectors  (including  healthcare,  transport,  environment  and 
farming).   

 

Main economic, social and environmental impacts 

The  Directive  will  contribute  to  the  rollout  of  AI.  The  conditions  for  the  roll-out  and 
development  of  AI-technologies  in  the  internal  market  can  be  significantly  improved  by 
preventing fragmentation and increasing legal certainty through harmonised measures at EU 
level,  compared  to  possible  adaptations  of  liability  rules  at  national  level.  The  economic 
study17 underpinning  the  Impact  Assessment  of  this  proposal  concluded  –  as  a  conservative 
estimate – that targeted harmonisation measures on civil liability for AI would have a positive 
impact of 5 to 7 % on the production value of relevant cross-border trade as compared to the 
baseline  scenario.  This  added  value  would  be  generated  notably  through  reduced 
fragmentation  and  increased  legal  certainty  regarding  stakeholders’  liability  exposure.  This 
would  lower  stakeholders’  legal  information/representation,  internal  risk  management  and 
compliance costs, facilitate financial planning as well as risk estimates for insurance purposes, 
and enable companies – in particular SMEs – to explore new markets across borders. Based 
on the overall value of the EU AI market affected by the liability-related problems addressed 
by  this  Directive,  it  is  estimated  that  the  latter  will  generate  an  additional  market  value 
between ca. EUR 500mln and ca. EUR 1.1bln. 

In  terms  of  social  impacts,  the  Directive  will  increase  societal  trust  in  AI-technologies  and 
access  to  an  effective  justice  system.  It  will  contribute  to  an  efficient  civil  liability  regime, 
adapted  to  the  specificities  of  AI,  where  justified  claims  for  compensation  of  damage  are 
successful.  Increasing  societal  trust  would  also  benefit  all  companies  in  the  AI-value  chain, 
because strengthening citizens’ confidence will contribute to a faster uptake of AI. Due to the 
incentivising effect of liability rules, preventing liability gaps would also indirectly benefit all 
citizens through an increased level of protection of health and safety (Article 114(3) TFEU) 
and the obviation of sources of health risks (Article 168(1) TFEU). 

As  regards  environmental  impacts,  the  Directive  is  also  expected  to  contribute  to  achieving 
the related Sustainable Development Goals (SDGs) and targets. The uptake of AI applications 
is beneficial for the environment. For instance, AI systems used in process optimisation make 
processes  less  wasteful  (e.g.  by  reducing  the  amount  of  fertilizers  and  pesticides  needed, 
decreasing  the  water  consumption  at  equal  output,  etc.).  The  Directive  would  also  impact 
positively  on  SDGs  because  effective  legislation  on  transparency,  accountability  and 
fundamental  rights  will  direct  AI’s  potential  to  benefit  individuals  and  society  towards 
achieving the SDGs.  

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16 

17 

Commission Communication, A European strategy for data COM/2020/66 final. 
Communication from the Commission to the European Parliament, the European Council, the Council, 
the European economic and social committee and the Committee of the Regions, the European Green 
Deal (COM(2019) 640 final). 
Deloitte, Study to support the Commission’s IA on liability for artificial intelligence, 2021 (‘economic 
study’). 

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2. 

 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The  legal  basis  for  the  proposal  is  Article  114  TFEU,  which  provides  for  the  adoption  of 
measures to ensure the establishment and functioning of the internal market. 

The  problems  this  proposal  aims  to  address,  in  particular  legal  uncertainty  and  legal 
fragmentation, hinder the development of the internal market and thus amount to significant 
obstacles to cross-border trade in AI-enabled products and services.  

The proposal addresses obstacles stemming from the fact that businesses that want to produce, 
disseminate  and  operate  AI-enabled  products  and  services  across  borders  are  uncertain 
whether  and how existing liability  regimes apply to  damage caused by AI. This  uncertainty 
concerns particularly Member States where businesses will export to or operate their products 
and services. In a cross-border context, the law applicable to a non-contractual liability arising 
out  of  a  tort  or  delict  is by  default  the  law  of  the  country  in  which  the  damage  occurs.  For 
these  businesses,  it  is  essential  to  know  the  relevant  liability  risks  and  to  be  able  to  insure 
themselves against them. 

In addition, there are concrete signs that a number of Member States are considering unilateral 
legislative measures to  address  the specific challenges posed by AI with  respect  to  liability. 
For  example,  AI  strategies  adopted  in  Czechia18,  Italy19,  Malta20,  Poland21 and  Portugal22 
mention  initiatives  to  clarify  liability.  Given  the  large  divergence  between  Member  States’ 
existing  civil  liability  rules,  it  is  likely  that  any  national  AI-specific  measure  on  liability 
would follow existing different national approaches and therefore increase fragmentation.  

Therefore,  adaptations  of  liability  rules  taken  on  a  purely  national  basis  would  increase  the 
barriers  to  the  rollout  of  AI-enabled  products  and  services  across  the  internal  market  and 
contribute further to fragmentation.  

 

Subsidiarity  

The  objectives  of  this  proposal  cannot  be  adequately  achieved  at  national  level  because 
emerging  divergent  national  rules  would  increase  legal  uncertainty  and  fragmentation, 
creating  obstacles  to  the  rollout  of  AI-enabled  products  and  services  across  the  internal 
market.  Legal  uncertainty  would  particularly  affect  companies  active  cross-borders  by 
imposing the need for additional legal information/representation, risk management costs and 
foregone  revenue.  At  the  same  time,  differing  national  rules  on  compensation  claims  for 
damage  caused  by  AI  would  increase  transaction  costs  for  businesses,  especially  for  cross-

18 

19 

20 
21 

22 

of 

the 

Czech 

report: 

Strategy 

Strategia 

Artificial 

Republic, 

Intelligence 

National 
2019: 
https://www.mpo.cz/assets/en/guidepost/for-the-media/press-releases/2019/5/NAIS_eng_web.pdf;  AI 
Watch, ‘National strategies on Artificial Intelligence – A European perspective’, 2021 edition – a JRC-
OECD 
https://op.europa.eu/en/publication-detail/-/publication/619fd0b5-d3ca-11eb-895a-
01aa75ed71a1, p. 41. 
2025 
https://assets.innovazione.gov.it/1610546390-midbook2025.pdf;. 
Deloitte, Study to support the Commission’s IA on liability for artificial intelligence, 2021, p. 96. 
See Polityka Rozwoju Sztucznej. Inteligencji w Polsce na lata 2019 – 2027 (Policy for the Development 
of Artificial Intelligence in Poland for 2019-2027) (www.gov.pl/attachment/0aa51cd5-b934-4bcb-8660-
bfecb20ea2a9), 102-3. 
AI  Portugal  2030:  https://www.incode2030.gov.pt/sites/default/files/julho_incode_brochura.pdf;  AI 
Watch, op. cit., p. 113. 

digitalizzazione 

l’innovazione 

tecnologica 

Paese: 

per 

del 

la 

e 

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border  trade,  entailing  significant  internal  market  barriers.  Further,  legal  uncertainty  and 
fragmentation  disproportionately  affect  start-ups  and  SMEs,  which  account  for  most 
companies and the major share of investments in the relevant markets. 

In  the  absence  of  EU  harmonised  rules  for  compensating  damage  caused  by  AI  systems, 
providers, operators and users of AI systems on the one hand and injured persons on the other 
hand  would  be  faced  with  27  different  liability  regimes,  leading  to  different  levels  of 
protection and distorted competition among businesses from different Member States. 

Harmonised measures at EU level would significantly improve conditions for the rollout and 
development  of  AI-technologies  in  the  internal  market  by  preventing  fragmentation  and 
increasing  legal  certainty.  This  added  value  would  be  generated  notably  through  reduced 
fragmentation  and  increased  legal  certainty  regarding  stakeholders’  liability  exposure. 
Moreover, only EU action can consistently achieve the desired effect of promoting consumer 
trust  in  AI-enabled  products  and  services  by  preventing  liability  gaps  linked  to  the  specific 
characteristics  of  AI  across  the  internal  market.  This  would  ensure  a  consistent  (minimum) 
level  of  protection  for  all  victims  (individuals  and  companies)  and  consistent  incentives  to 
prevent damage and ensure accountability. 

 

Proportionality 

The proposal is based on a staged approach. In the first stage, the objectives are achieved with 
a  minimally  invasive  approach;  the  second  stage  involves  re-assessing  the  need  for  more 
stringent or extensive measures.  

The first stage is limited to the burden-of-proof measures to address the AI-specific problems 
identified.  It  builds  on  the  substantive  conditions  of  liability  currently  existing  in  national 
rules, such as causality or fault, but focuses on targeted proof-related measures, ensuring that 
victims  have  the  same  level  of  protection  as  in  cases  not  involving  AI  systems.  Moreover, 
from the various tools available in national law for easing the burden of proof23, this proposal 
has chosen to use rebuttable presumptions as the least interventionist tool. Such presumptions 
are commonly found in national liability systems, and they balance the interests of claimants 
and defendants. At the same time they are designed to  incentivise compliance with  existing 
duties of care set at Union or national level. The proposal does not lead to a reversal of the 
burden  of  proof,  to  avoid  exposing  providers,  operators  and  users  of  AI  systems  to  higher 
liability  risks,  which  may  hamper  innovation  and  reduce  the  uptake  of  AI-enabled  products 
and services. 

The second stage included in the proposal ensures that, when assessing the effect of the first 
stage  in  terms  of  victim  protection  and  uptake  of  AI,  future  technological,  regulatory  and 
jurisprudential  developments  will  be  taken  into  account  when  re-assessing  the  need  to 
harmonise  other  elements  of  the  claims  for  compensation  or  other  tools  related  to  liability 
claims, including for situations where strict liability would be more appropriate, as requested 
by  the  European  Parliament.  Such  assessment  would  also  likely  consider  whether  such  a 
harmonisation would need to be coupled with mandatory insurance to ensure effectiveness.     

 

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EN 

Choice of instrument 

Primarily  strict  liability,  reversal  of  the  burden  of  proof  or  alleviations  of  the  burden  of  proof  in  the 
form of irrebuttable or rebuttable presumptions.  

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A  directive  is  the  most  suitable  instrument  for  this  proposal,  as  it  provides  the  desired 
harmonisation effect and legal certainty, while also providing the flexibility to enable Member 
States to embed the harmonised measures without friction into their national liability regimes.  

A  mandatory  instrument  would  prevent  protection  gaps  stemming  from  partial  or  no 
implementation.  While  a  non-binding  instrument  would  be  less  intrusive,  it  is  unlikely  to 
address  the  identified  problems  in  an  effective  manner.  The  implementation  rate  of  non-
binding  instruments  is  difficult  to  predict  and  there  is  insufficient  indication  that  the 
persuasive  effect  of  a  recommendation  would  be  strong  enough  to  produce  consistent 
adaptation of national laws.  

This  effect  is  even  more  unlikely  for  measures  concerning  private  law,  of  which  non 
contractual  liability  rules  form  part.  This  area  is  characterised  by  long-standing  legal 
traditions, which makes Member States reluctant to pursue coordinated reform unless driven 
by the clear prospect of internal market benefits under a binding EU instrument or the need to 
adapt to new technologies in the digital economy.  

The existing significant divergences between Member States’ liability frameworks are another 
reason why a recommendation is unlikely to be implemented in a consistent manner.  

1. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

 

Stakeholder consultations 

An  extensive  consultation  strategy  was  implemented  to  ensure  a  wide  participation  of 
stakeholders throughout the policy cycle of this proposal. The consultation strategy was based 
on  both  public  and  several  targeted  consultations  (webinars,  bilateral  discussions  with 
companies and various organisations).  

After the initial questions on liability which were part of the public consultation on the White 
Paper  on  AI  and  the  Commission  report  on  safety  and  liability,  a  dedicated  online  public 
consultation was open from 18 October 2021 to 10 January 2022 to gather views from a wide 
variety  of  stakeholders, 
industry 
associations,  businesses,  including  SMEs,  and  public  authorities.  After  analysing  all  the 
responses  received,  the  Commission  published  a  summary  outcome  and  the  individual 
responses on its website24. 

including  consumers,  civil  society  organisations, 

In  total,  233  responses  were  received  from  respondents  from  21  Member  States,  as  well  as 
from  third  countries.  Overall,  the  majority  of  stakeholders  confirmed  the  problems  with 
burden of proof, legal uncertainty and fragmentation and supported action at EU level.  

EU citizens, consumer organizations and academic institutions overwhelmingly confirmed the 
need  for  EU  action  to  ease  victims’  problems  with  the  burden  of  proof.  Businesses,  while 
recognising  the  negative  effects  of  the  uncertainty  around  the  application  of  liability  rules, 
were more cautious and asked for targeted measures to avoid limiting innovation. 

24 

To  be  found  at  <https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12979-Civil-
liability-adapting-liability-rules-to-the-digital-age-and-artificial-intelligence/public-consultation_en> 

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A similar picture appeared regarding the policy options. EU citizens, consumer organizations 
and  academic  institutions  strongly  supported  measures  on  the  burden  of  proof  and 
harmonising  no-fault  liability  (referred  to  as  ‘strict  liability’)  coupled  with  mandatory 
insurance. Businesses were more divided on the policy options, with differences depending in 
part on their size. Strict liability was considered disproportionate by the majority of business 
respondents.  Harmonisation  of  the  easing  of  the  burden  of  proof  gained  more  support, 
particularly  among  SMEs.  However,  businesses  cautioned  against  a  complete  shift  of  the 
burden of proof.  

Therefore, the preferred policy option was developed and refined in light of feedback received 
from stakeholders throughout the impact assessment process to strike a balance between the 
needs expressed and concerns raised by all relevant stakeholder groups. 

 

Collection and use of expertise 

The proposal builds on 4 years of analysis and close involvement of stakeholders, including 
academics,  businesses,  consumer  associations,  Member  States  and  citizens.  The  preparatory 
work  started  in  2018  with  the  setting  up  of  the  Expert  Group  on  Liability  and  New 
Technologies  (New  Technologies  Formation).  The  Expert  Group  produced  a  Report  in 
November 201925 that assessed the challenges some characteristics of AI pose to national civil 
liability rules. 

The  input  from  the  Expert  Group  report  was  complemented  by  three  additional  external 
studies: 

– 

– 

– 

a comparative law study based on a comparative legal analysis of European tort 
laws focused on key AI-related issues26; 

a  behavioural  economics  study  on  the  impacts  of  targeted  adaptations  of  the 
liability  regime  on  consumers’  decision  making,  in  particular  their  trust  and 
willingness to take up AI-enabled products and services27; 
an  economic  study 28 covering  a  number  of  issues:  the  challenges  faced  by 
victims of AI applications compared to victims of non-AI devices when trying 
to  obtain  compensation  for  their  loss;  whether  and  to  what  extent  businesses 
are uncertain about the application of current liability rules to their operations 
involving  AI,  and  whether  the  impact  of  legal  uncertainty  can  hamper 
investment  in  AI;  whether  further  fragmentation  of  national  liability  laws 
would reduce the  effectiveness  of the internal market  for  AI  applications and 
services,  and  whether  and  to  what  extent  harmonising  certain  aspects  of 
national  civil  liability  via  EU  legislation  would  reduce  these  problems  and 
facilitate the overall uptake of AI technology by EU companies. 

25 

26 

27 

28 

Liability  for  artificial  intelligence  and  other  emerging  digital  technologies,  November  2019, 
https://op.europa.eu/en/publication-detail/-/publication/1c5e30be-1197-11ea-8c1f-
01aa75ed71a1/language-en  
Karner/Koch/Geistfeld,  Comparative  Law  Study  on  Civil  Liability  for  Artificial  Intelligence,  2021, 
https://op.europa.eu/en/publication-detail/-/publication/8a32ccc3-0f83-11ec-9151-
01aa75ed71a1/language-en. 
Kantar, Behavioural Study on the link between challenges of Artificial Intelligence for Member States’ 
civil  liability  rules  and  consumer  attitudes  towards  AI-enabled  products  and  services,  Final  Report 
2021. 
Deloitte,  Study to support the Commission’s Impact Assessment on liability  for artificial intelligence, 
2021. 

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 

Impact assessment 

In line with its “Better Regulation” policy, the Commission conducted an impact assessment 
for this proposal examined by the Commission's Regulatory Scrutiny Board. The meeting of 
the Regulatory Scrutiny Board on 6 April 2022 led to a positive opinion with comments. 

Three policy options were assessed: 

Policy option 1: three measures to ease the burden of proof for victims trying to prove their 
liability claim. 

Policy  option  2: the measures under option 1 +  harmonising strict liability rules for AI use 
cases with a particular risk profile, coupled with a mandatory insurance. 

Policy option 3: a staged approach consisting of: 

– 

– 

a first stage: the measures under option 1; 

a  second  stage:  a  review  mechanism  to  re-assess,  in  particular,  the  need  for 
harmonising  strict  liability  for  AI  use  cases  with  a  particular  risk  profile 
(possibly coupled with a mandatory insurance). 

The  policy  options  were  compared  by  way  of  a  multi-criteria  analysis  taking  into  account 
their effectiveness, efficiency, coherence and proportionality. The results of the multi-criteria 
and sensitivity analysis show that policy option 3, easing the burden of proof for AI-related 
claims + targeted review regarding strict liability, possibly coupled with mandatory insurance, 
ranks highest and is therefore the preferred policy choice for this proposal. 

The  preferred  policy  option  would  ensure  that  victims  of  AI-enabled  products  and  services 
(natural persons, businesses and any other public or private entities) are no less protected than 
victims of traditional technologies. It would increase the level of trust in AI and promote its 
uptake. 

Furthermore,  it  would  reduce  legal  uncertainty  and  prevent  fragmentation,  thus  helping 
companies,  and  most  of  all  SMEs,  that  want  to  realise  the  full  potential  of  the  EU  single 
market  by  rolling  out  AI-enabled  products  and  services  cross-border.  The  preferred  policy 
option  also  creates  better  conditions  for  insurers  to  offer  coverage  of  AI-related  activities, 
which is crucial for businesses, especially SMEs to manage their risks. It is namely estimated 
that  the  preferred  policy  option  would  generate  an  increased  AI  market  value  in  the  EU-27 
between ca. EUR 500mln and ca. EUR 1.1bln in 2025. 

 

Fundamental rights 

One of the most important functions of civil liability rules is to ensure that victims of damage 
can  claim  compensation.  By  guaranteeing  effective  compensation,  these  rules  contribute  to 
the protection of the right to an effective remedy and a fair trial (Article 47 of the EU Charter 
of Fundamental Rights, referred to below as 'the Charter') while also giving potentially liable 
persons an incentive to prevent damage, in order to avoid liability. 

With this proposal, the Commission aims to ensure that victims of damage caused by AI have 
an  equivalent  level  of  protection  under  civil  liability  rules  as  victims  of  damage  caused 
without  the  involvement  of  AI.  The  proposal  will  enable  effective  private  enforcement  of 
fundamental rights and preserve the right to an effective remedy where AI-specific risks have 
materialised. In particular, the proposal will help protect fundamental rights, such as the right 

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to life (Article 2 of the Charter), the right to the physical and mental integrity (Article 3), and 
the  right  to  property  (Article 17).  In  addition,  depending  on  each  Member  State’s  civil  law 
system  and traditions, victims will be able to  claim compensation for damage to other legal 
interests, such as violations of personal dignity (Articles 1 and 4 of the Charter), respect for 
private  and  family  life  (Article 7),  the  right  to  equality  (Article 20)  and  non-discrimination 
(Article 21). 

In addition, this proposal complements other strands in the Commission’s AI policy based on 
preventive  regulatory  and  supervisory  requirements  aimed  directly  at  avoiding  fundamental 
rights  breaches  (such  as  discrimination).  These  are  the  AI  Act,  the  General  Data  Protection 
Regulation, the Digital Services Act and EU law on non-discrimination and equal treatment. 
At the same time, this proposal does not create or harmonise the duties of care or the liability 
of various entities whose activity is regulated under those legal acts and, therefore, does not 
create new liability claims or affect the exemptions from liability under those other legal acts. 
This  proposal  only introduces alleviations  of the burden of proof for the victims of damage 
caused by AI systems in claims that can be based on national law or on these other EU laws. 
By  complementing  these  other  strands,  this  proposal  protects  the  victim's  right  to 
compensation under private law, including compensation for fundamental rights breaches.  

4. 

BUDGETARY IMPLICATIONS 

This proposal will not have implications for the budget of the European Union. 

5. 

 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation, monitoring programme and 
targeted review  

This proposal puts forward a staged approach. To ensure that sufficient evidence is available 
for the targeted review in the second stage, the Commission will draw up a monitoring plan, 
detailing how and how often data and other necessary evidence will be collected. 

The monitoring mechanism could cover the following types of data and evidence: 

– 

– 

– 

– 

– 

reporting  and  information  sharing  by  Member  States  regarding  application  of 
measure  to  ease  the  burden  of  proof  in  national  judicial  or  out-of-court 
settlement procedures; 

information  collected  by  the  Commission  or  market  surveillance  authorities 
under the AI Act (in particular Article 62) or other relevant instruments; 

information  and  analyses  supporting  the  evaluation  of  the  AI  Act  and  the 
reports to be prepared by the Commission on implementation of that Act; 

information  and  analyses  supporting  the  assessment  of  relevant  future  policy 
measures  under  the  ‘old  approach’  safety  legislation  to  ensure  that  products 
placed  on  the  Union  market  meet  high  health,  safety  and  environmental 
requirements; 

information  and  analyses  supporting 
the 
application of the Motor Insurance Directive to technological developments (in 
particular  autonomous  and  semi-autonomous  vehicles)  pursuant 
its 
Article 28c(2)(a). 

the  Commission’s  report  on 

to 

 

Detailed explanation of the specific provisions in the proposal 

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1. 

  SUBJECT MATTER AND SCOPE (ARTICLE 1) 

The purpose of this Directive is to improve the functioning of the internal market by laying 
down  uniform  requirements  for  certain  aspects  of  non-contractual  civil  liability  for  damage 
caused  with  the  involvement  of  AI  systems.  It  follows  up  on  the  European  Parliament’s 
Resolution 2020/2014(INL) and adapts private law to the needs of the transition to the digital 
economy. 

The choice of suitable legal tools is limited, given the nature of the burden-of-proof issue and 
the specific characteristics of AI that pose a problem for existing liability rules. In this respect, 
this Directive eases the burden of proof in a very targeted and proportionate manner through 
the  use  of  disclosure  and  rebuttable  presumptions.  It  establishes  for  those  seeking 
compensation  for  damage  a  possibility  to  obtain  information  on  high-risk  AI  systems  to  be 
recorded/documented pursuant to the AI Act. In addition to this, the rebuttable presumptions 
will  give  those  seeking  compensation  for  damage  caused  by  AI  systems  a  more  reasonable 
burden of proof and a chance to succeed with justified liability claims.  

Such  tools  are  not  new;  they  can  be  found  in  national  legislative  systems.  Hence,  these 
national tools constitute helpful reference points on how to address the issues raised by AI for 
existing liability rules in a way which interferes as little as possible with the different national 
legal regimes. 

In addition, when asked about more far-reaching changes such as a reversal of the burden of 
proof or an irrebuttable presumption, businesses provided negative feedback in consultations. 
Targeted  measures  to  ease  the  burden  of  proof  in  form  of  rebuttable  presumptions  were 
chosen as pragmatic and appropriate ways to help victims meet their burden of proof in the 
most targeted and proportionate manner possible. 

Article 1 indicates the subject matter and scope of this Directive: it applies to non-contractual 
civil law claims for damages caused by an AI system, where such claims are brought under 
fault-based  liability  regimes.  This  means  namely  regimes  that  provide  for  a  statutory 
responsibility  to  compensate  for  damage  caused  intentionally  or  by  a  negligent  act  or 
omission.  The  measures  provided  in  this  Directive  can  fit  without  friction  in  existing  civil 
liability  systems,  since  they  reflect  an  approach  that  does  not  touch  on  the  definition  of 
fundamental  concepts  like  ‘fault’  or  ‘damage’,  given  that  the  meaning  of  those  concepts 
varies considerably across the Member States. Thus, beyond the presumptions it establishes, 
this Directive does not  affect  Union or national  rules determining, for instance, which party 
has the burden of proof, what degree of certainty is required as regards the standard of proof, 
or how fault is defined. 

In addition, this Directive does not affect existing rules regulating the conditions of liability in 
the transport sector and those set by the Digital Services Act. 

While  this  Directive  does  not  apply  with  respect  to  criminal  liability,  it  may  be  applicable 
with respect to state liability. State authorities are also covered by the provisions of the AI Act 
as subjects of the obligations prescribed therein. 

This Directive does not apply retroactively, but only to claims for compensation of damages 
that occur as from the date of its transposition. 

The proposal for this Directive has been adopted together with the proposal for a revision of 
the Product Liability Directive 85/374/EEC, in a package aiming to adapt liability rules to the 
digital age and AI, ensuring the necessary alignment between these two complementary legal 
instruments. 

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2. 

DEFINITIONS (ARTICLE 2) 

The definitions in Article 2 follow those of the AI Act to ensure consistency.  

Article 2(6)(b) provides that claims for damages can be brought not only by the injured person 
but also by persons that have succeeded in or have been subrogated into the injured person’s 
rights.  Subrogation  is  the  assumption  by  a  third  party  (such  as  an  insurance  company)  of 
another party’s legal right to collect a debt or damages. Thus one person is entitled to enforce 
the rights of another for their own benefit. Subrogation would also cover heirs of a deceased 
victim. 

In  addition,  Article  2(6)(c)  provides  that  an  action  for  damages  can  also  be  brought  by 
someone acting on behalf of one or more injured parties, in accordance with Union or national 
law. This provision aims to give more possibilities to persons injured by an AI system to have 
their claims assessed by a court, even in cases where individual actions may seem too costly 
or too  cumbersome to  bring, or where joint  actions may  entail  a benefit of scale.  To enable 
victims  of damage caused by  AI  systems  to  enforce their rights  in  relation to  this Directive 
through representative actions, Article 6 amends Annex I to Directive (EU) 2020/1828. 

3. 

DISCLOSURE OF EVIDENCE (ARTICLE 3) 

This Directive aims to provide persons seeking compensation for damage caused by high-risk 
AI systems with effective means to identify potentially liable persons and relevant  evidence 
for  a  claim.  At  the  same  time,  such  means  serve  to  exclude  falsely  identified  potential 
defendants,  saving  time  and  costs  for  the  parties  involved  and  reducing  the  case  load  for 
courts. 

In this respect, Article 3(1) of the Directive provides that a court may order the disclosure of 
relevant  evidence  about  specific  high-risk  AI  systems  that  are  suspected  of  having  caused 
damage. Requests for evidence are addressed to the provider of an AI system, a person who is 
subject to the provider’s obligations laid down by Article 24 or Article 28 (1) of the AI Act or 
a  user  pursuant  to  the  AI  Act.  The  requests  should  be  supported  by  facts  and  evidence 
sufficient  to  establish  the  plausibility  of  the  contemplated  claim  for  damages  and  the 
requested  evidence  should  be  at  the  addressees’  disposal.  Requests  cannot  be  addressed  to 
parties that bear no obligations under the AI Act and therefore have no access to the evidence.  

According to Article 3(2) the claimant can request the disclosure of evidence from providers 
or  users  that  are  not  defendants  only  in  case  all  proportionate  attempts  were  unsuccessfully 
made to gather the evidence from the defendant. 

In  order  for  the  judicial  means  to  be  effective,  Article  3(3)  of  the  Directive  provides  that  a 
court may also order the preservation of such evidence. 

As provided in Article 3(4), first subparagraph,  the court may order such disclosure, only to 
the extent necessary to sustain the claim, given that the information could be critical evidence 
to the injured person’s claim in the case of damage that involve AI systems. 

By  limiting  the  obligation  to  disclose  or  preserve  to  necessary  and  proportionate  evidence, 
Article 3 (4), first subparagraph, aims to ensure proportionality in disclosing evidence, i.e. to 
limit the disclosure to the necessary minimum and prevent blanket requests. 

The second and third subparagraphs of Article 3(4) further aim to strike a balance between the 
claimant’s rights and the need to ensure that such disclosure would be subject to safeguards to 
protect  the  legitimate  interests  of  all  parties  concerned,  such  as  trade  secrets  or  confidential 
information. 

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In  the  same  context,  the  fourth  subparagraph  of  Article  3(4)  aims  to  ensure  that  procedural 
remedies  against  the  order  of  disclosure  or  preservation  are  at  the  disposal  of  the  person 
subject to it. 

Article  3(5)  introduces  a  presumption  of  non-compliance  with  a  duty  of  care.  This  is  a 
procedural tool, relevant only in cases where it is the actual defendant in a claim for damages 
who bears the consequences of not complying with a request to disclose or preserve evidence. 
The  defendant  will  have  the  right  to  rebut  that  presumption.  The  measure  set  out  in  this 
paragraph aims to promote disclosure but also to expedite court proceedings. 

4. 

PRESUMPTION OF CAUSAL LINK IN THE CASE OF FAULT (ARTICLE 4) 

With  respect  to  damage  caused  by  AI  systems,  this  Directive  aims  to  provide  an  effective 
basis  for  claiming  compensation  in  connection  with  the  fault  consisting  in  the  lack  of 
compliance with a duty of care under Union or national law. 

It  can  be  challenging  for  claimants  to  establish  a  causal  link  between  such  non-compliance 
and the output produced by the AI system or the failure of the AI system to produce an output 
that  gave  rise  to  the  relevant  damage.  Therefore,  a  targeted  rebuttable  presumption  of 
causality has been laid down in Article 4 (1) regarding this causal link. Such presumption is 
the least burdensome measure to address the need for fair compensation of the victim. 

The fault of the defendant has to be proven by the claimant according to the applicable Union 
or national rules. Such fault can be established, for example, for non-compliance with a duty 
of  care  pursuant  to  the  AI  Act  or  pursuant  to  other  rules  set  at  Union  level,  such  as  those 
regulating the use of automated monitoring and decision-making for platform work or those 
regulating the operation of unmanned aircraft. Such fault can also be presumed by the court 
on the basis of a non-compliance with a court order for disclosure or preservation of evidence 
under Article 3(5). Still, it is only appropriate to introduce a presumption of causality when it 
can be considered likely that the given fault has influenced the relevant AI system output or 
lack thereof, which can be assessed on the basis of the overall circumstances of the case. At 
the same time, the claimant still has to prove that the AI system (i.e. its output or failure to 
produce one) gave rise to the damage.  

Paragraphs  (2)  and  (3)  differentiate  between,  on  the  one  hand,  claims  brought  against  the 
provider  of  a  high-risk  AI  system  or  against  a  person  subject  to  the  provider’s  obligations 
under the AI Act and, on the other hand, claims brought against the user of such systems. In 
this respect, it follows the respective provisions and relevant conditions of the AI Act. In the 
case of claims based on Article 4(2), the defendants’ compliance with the obligations listed in 
that  paragraph  have  to  be  assessed  also  in  the  light  of  the  risk  management  system  and  its 
results, i.e. risk management measures, under the AI Act. 

In case of high-risk AI systems as defined by the AI Act, Article 4(4) establishes an exception 
from the presumption of causality, where the defendant demonstrates that sufficient evidence 
and  expertise  is  reasonably  accessible  for  the  claimant  to  prove  the  causal  link.  This 
possibility  can  incentivise  defendants  to  comply  with  their  disclosure  obligations,  with 
measures  set  by  the  AI  Act  to  ensure  a  high  level  of  transparency  of  the  AI  or  with 
documenting and recording requirements.  

In  the  case  of  non-high  risk  AI  systems,  Article  4(5)  establishes  a  condition  for  the 
applicability  of  the  presumption  of  causality,  whereby  the  latter  is  subject  to  the  court 
determining  that  it  is  excessively  difficult  for  the  claimant  to  prove  the  causal  link.  Such 
difficulties  are  to  be  assessed  in  light  of  the  characteristics  of  certain  AI  systems,  such  as 
autonomy and opacity, which render the explanation of the inner functioning of the AI system 

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very difficult in  practice, negatively affecting the ability of the claimant to  prove the causal 
link between the fault of the defendant and the AI output. 

In cases where the defendant uses the AI system in the course of a personal non-professional 
activity,  Article  4(6)  provides  that  the  presumption  of  causality  should  only  apply  if  the 
defendant has materially interfered with the conditions of the operation of the AI system or if 
the defendant was required and able to determine the conditions of operation of the AI system 
and failed to do so. This condition is justified by the need to balance the interests of injured 
persons and non-professional users, by exempting from the application of the presumption of 
causality the cases in which non-professional users do not add risk through their behaviour.  

Finally,  Article  4(7)  provides  that  the  defendant  has  the  right  to  rebut  the  causality 
presumption based on Article 4(1).  

Such  effective  civil  liability  rules  have  the  additional  advantage  that  they  give  all  those 
involved in activities related to AI systems an additional incentive to respect their obligations 
regarding their expected conduct. 

5. 

EVALUATION AND TARGETED REVIEW (ARTICLE 5) 

Various national legal systems provide for different strict liability regimes. Elements for such 
a regime at Union level were also suggested by the European Parliament in its own-initiative 
resolution  of  20 October  2020,  consisting  of  a  limited  strict  liability  regime  for  certain  AI-
enabled  technologies  and  a  facilitated  burden  of  proof  under  fault-based  liability  rules.  The 
public  consultations  also  highlighted  a  preference  for  such  a  regime  among  respondents 
(except for non-SMEs businesses), whether or not coupled with mandatory insurance. 

However, the proposal takes into account the differences between national legal traditions and 
the fact that the kind of products and services equipped with AI systems that could affect the 
public  at  large  and  put  at  risk  important  legal  rights,  such  as  the  right  to  life,  health  and 
property,  and  therefore  could  be  subject  to  a  strict  liability  regime,  are  not  yet  widely 
available on the market. 

A  monitoring  programme  is  put  in  place  to  provide  the  Commission  with  information  on 
incidents involving AI systems. The targeted review will assess whether additional measures 
would be needed, such as introducing a strict liability regime and/or mandatory insurance. 

6. 

TRANSPOSITION (ARTICLE 7) 

When  notifying  the  Commission  of  national  transposition  measures  to  comply  with  this 
Directive, Member States should also provide explanatory documents which give sufficiently 
clear  and  precise  information  and  state,  for  each  provision  of  this  Directive,  the  national 
provision(s) ensuring its transposition. This is necessary to enable the Commission to identify, 
for  each  provision  of  the  Directive  requiring  transposition,  the  relevant  part  of  national 
transposition measures creating the corresponding legal obligation in the national legal order, 
whatever the form chosen by the Member States. 

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2022/0303 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on adapting non-contractual civil liability rules to artificial intelligence 
 (AI Liability Directive) 

(Text with EEA relevance) 

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 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 Committee29,  
Having regard to the opinion of the Committee of the Regions30,  

Acting in accordance with the ordinary legislative procedure,  

Whereas: 

(1) 

(2) 

29 
30 
31 

32 

33 

34 

Artificial Intelligence (‘AI’) is a set of enabling technologies which can contribute to a 
wide array of benefits across the entire spectrum of the economy and society. It has a 
large  potential  for  technological  progress  and  allows  new  business  models  in  many 
sectors of the digital economy. 

At the same time, depending on the circumstances of its specific application and use, 
AI  can  generate  risks  and  harm  interests  and  rights  that  are  protected  by  Union  or 
national law. For instance, the use of AI can adversely affect a number of fundamental 
rights, including life, physical integrity and in respect to non-discrimination and equal 
treatment. Regulation (EU) …/… of the European Parliament and of the Council [the 
AI Act]31 provides for requirements intended to reduce risks to safety and fundamental 
rights,  while  other  Union  law  instruments  regulate  general 32  and  sectoral  product 
safety rules applicable also to AI-enabled machinery products33 and radio equipment.34 

OJ C , , p. . 
OJ C , , p. . 
[Proposal  for  a  Regulation  laying  down  harmonised  rules  on  artificial  intelligence  (Artificial 
Intelligence Act) - COM(2021) 206 final] 
[Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  general  product  safety 
(COM(2021) 346 final)] 
[Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  machinery  products 
(COM(2021) 202 final)] 
Commission Delegated Regulation (EU) 2022/30 supplementing Directive 2014/53/EU of the European 
Parliament and of the Council with regard to the application of the essential requirements referred to in 
Article 3(3), points (d), (e) and (f), of that Directive (OJ L 7, 12.1.2022, p. 6) 

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While such requirements intended to reduce risks to safety and fundamental rights are 
meant  to  prevent,  monitor  and address  risks and thus  address  societal  concerns, they 
do  not  provide  individual  relief  to  those  that  have  suffered  damage  caused  by  AI. 
Existing requirements provide in particular for authorisations, checks, monitoring and 
administrative sanctions in relation to AI systems in order to prevent damage. They do 
not provide for compensation of the injured person for damage caused by an output or 
the failure to produce an output by an AI system. 

(3)  When  an  injured  person  seeks  compensation  for  damage  suffered,  Member  States’ 
general  fault-based  liability  rules  usually  require  that  person  to  prove  a  negligent  or 
intentionally damaging act or omission (‘fault’) by the person potentially liable for that 
damage, as well as a causal link between that fault and the relevant damage. However, 
when  AI  is  interposed  between  the  act  or  omission  of  a  person  and  the  damage,  the 
specific characteristics of certain AI systems, such as opacity, autonomous behaviour 
and  complexity,  may  make  it  excessively  difficult,  if  not  impossible,  for  the  injured 
person  to  meet  this  burden  of  proof.  In  particular,  it  may  be  excessively  difficult  to 
prove  that  a  specific  input  for  which  the  potentially  liable  person  is  responsible  had 
caused a specific AI system output that led to the damage at stake. 

(4) 

(5) 

(6) 

(7) 

In  such  cases,  the  level  of  redress  afforded  by  national  civil  liability  rules  may  be 
lower than in cases where technologies other than AI are involved in causing damage. 
Such compensation gaps may contribute to a lower level of societal acceptance of AI 
and trust in AI-enabled products and services.  

To  reap  the  economic  and  societal  benefits  of  AI  and  promote  the  transition  to  the 
digital  economy,  it  is  necessary  to  adapt  in  a  targeted  manner  certain  national  civil 
liability rules to those specific characteristics of certain AI systems. Such adaptations 
should  contribute  to  societal  and  consumer  trust  and  thereby  promote  the  roll-out  of 
AI. Such adaptations should also maintain trust in the judicial system, by ensuring that 
victims  of  damage  caused  with  the  involvement  of  AI  have  the  same  effective 
compensation as victims of damage caused by other technologies. 

Interested stakeholders – injured persons suffering damage, potentially liable persons, 
insurers – face legal uncertainty as to how national courts, when confronted with the 
specific challenges of AI, might apply the existing liability rules in individual cases in 
order  to  achieve  just  results.  In  the  absence  of  Union  action,  at  least  some  Member 
States  are  likely  to  adapt  their  civil  liability  rules  to  address  compensation  gaps  and 
legal  uncertainty  linked  to  the  specific  characteristics  of  certain  AI  systems.  This 
would  create  legal  fragmentation  and  internal  market  barriers  for  businesses  that 
develop  or  provide  innovative  AI-enabled  products  or  services.  Small  and  medium-
sized enterprises would be particularly affected. 

The purpose of this Directive is to contribute to the proper functioning of the internal 
market  by  harmonising  certain  national  non-contractual  fault-based  liability  rules,  so 
as to ensure that persons claiming compensation for damage caused to them by an AI 
system  enjoy  a  level  of  protection  equivalent  to  that  enjoyed  by  persons  claiming 
compensation  for  damage  caused  without  the  involvement  of  an  AI  system.  This 
objective  cannot  be sufficiently  achieved by the  Member States because  the relevant 
internal market obstacles are linked to the risk of unilateral and fragmented regulatory 
measures at national level. Given the digital nature of the products and services falling 
within the scope of this Directive,  the latter is  particularly  relevant  in  a  cross-border 
context.  

EN 

16 

  EN 

(8) 

(9) 

The  objective  of  ensuring  legal  certainty  and  preventing  compensation  gaps  in  cases 
where AI systems are involved can thus be better achieved at Union level. Therefore, 
the Union may adopt measures in accordance with the principle of subsidiarity as set 
out in Article 5 TEU. 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 
that objective. 

It  is  therefore  necessary  to  harmonise  in  a  targeted  manner  specific  aspects  of  fault-
based liability rules at Union level. Such harmonisation should increase legal certainty 
and create a level playing field for AI systems, thereby improving the functioning of 
the  internal  market  as  regards  the  production  and  dissemination  of  AI-enabled 
products and services. 

(10)  To  ensure  proportionality,  it  is  appropriate  to  harmonise  in  a  targeted  manner  only 
those fault-based  liability  rules  that  govern the burden of  proof for persons claiming 
compensation for damage caused by AI systems. This Directive should not harmonise 
general aspects of civil liability which are regulated in different ways by national civil 
liability rules, such as the definition of fault or causality, the different types of damage 
that  give  rise  to  claims  for  damages,  the  distribution  of  liability  over  multiple 
tortfeasors, contributory conduct, the calculation of damages or limitation periods. 

(11)  The  laws  of  the  Member  States  concerning  the  liability  of  producers  for  damage 
caused by the defectiveness of their products are already harmonised at Union level by 
Council Directive 85/374/EEC35. Those laws do not, however, affect Member States’ 
rules  of  contractual  or  non-contractual  liability,  such  as  warranty,  fault  or  strict 
liability, based on other grounds than the defect of the product. While at the same time 
the revision of Council Directive 85/374/EEC seeks to clarify and ensure that injured 
person can claim compensation for damages caused by defective AI-enabled products, 
it  should therefore be clarified that the provisions of this Directive do not  affect  any 
rights which an injured person may have under national rules implementing Directive 
85/374/EEC. In addition, in the field of transport, Union law regulating the liability of 
transport operators should remain unaffected by this Directive.  
[The Digital Services Act (DSA)36] fully harmonises the rules applicable to providers 
of  intermediary  services  in  the  internal  market,  covering  the  societal  risks  stemming 
from the services offered by those providers, including as regards the AI systems they 
use. This Directive does not affect the provisions of [the Digital Services Act (DSA)] 
that  provide  a  comprehensive  and  fully  harmonised  framework  for  due  diligence 
obligations  for  algorithmic  decision-making  by  hosting  service  providers,  including 
the  exemption  from  liability  for  the  dissemination  of  illegal  content  uploaded  by 
recipients of their services where the conditions of that Regulation are met. 

(12) 

(13)  Other  than  in  respect  of  the  presumptions  it  lays  down,  this  Directive  does  not 
harmonise  national  laws  regarding  which  party  has  the  burden  of  proof  or  which 
degree of certainty is required as regards the standard of proof.  

(14)  This  Directive should follow a minimum  harmonisation  approach. Such an approach 
allows claimants in cases of damage caused by AI systems to invoke more favourable 

35 

36 

Council  Directive  85/374/EEC  of  25  July  1985  on  the  approximation  of  the  laws,  regulations  and 
administrative provisions of the Member States concerning liability for defective products (OJ L 210, 
7.8.1985, p. 29). 
[Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  a  Single  Market  For 
Digital Services (Digital Services Act) - COM(2020) 825 final] 

EN 

17 

  EN 

                                                 
rules of national law. Thus, national laws could, for example, maintain reversals of the 
burden  of  proof  under  national  fault-based  regimes,  or  national  no-fault  liability 
(referred  to  as  ‘strict  liability’)  regimes  of  which  there  are  already  a  large  variety  in 
national laws, possibly applying to damage caused by AI systems.  

(15)  Consistency  with  [the AI  Act] should also  be  ensured.  It is  therefore appropriate  for 
this Directive to use the same definitions in respect of AI systems, providers and users. 
In addition, this Directive should only cover claims for damages when the damage is 
caused by an output or the failure to produce an output by an AI system through the 
fault of a person, for example the provider or the user under [the AI Act]. There is no 
need  to  cover  liability  claims  when  the  damage  is  caused  by  a  human  assessment 
followed by a human act or omission, while the AI system only provided information 
or advice which was taken into account by the relevant human actor. In the latter case, 
it is possible to trace back the damage to a human act or omission, as the AI system 
output  is  not  interposed  between  the  human  act  or  omission  and  the  damage,  and 
thereby  establishing  causality  is  not  more  difficult  than  in  situations  where  an  AI 
system is not involved. 

(16)  Access to information about specific high-risk AI systems that are suspected of having 
caused damage is an important factor to ascertain whether to claim compensation and 
to substantiate claims for compensation. Moreover, for high risk AI systems, [the AI 
Act] provides for  specific documentation, information and logging requirements,  but 
does not provide a right to the injured person to access that information. It is therefore 
appropriate to lay down rules on the disclosure of relevant evidence by those that have 
it at their disposal, for the purposes of establishing liability. This should also provide 
an additional incentive to comply with the relevant requirements laid down in [the AI 
Act] to document or record the relevant information. 

(17)  The large number of people usually involved in the design, development, deployment 
and operation of high-risk AI systems, makes it difficult for injured persons to identify 
the person potentially liable for damage caused and to prove the conditions for a claim 
for  damages.  To  allow  injured  persons  to  ascertain  whether  a  claim  for  damages  is 
well-founded, it is appropriate to grant potential claimants a right to request a court to 
order the disclosure of relevant evidence before submitting a claim for damages. Such 
disclosure  should  only  be  ordered  where  the  potential  claimant  presents  facts  and 
information  sufficient  to  support  the  plausibility  of  a  claim  for  damages  and  it  has 
made a prior request to the provider, the person subject to the obligations of a provider 
or  the  user  to  disclose  such  evidence  at  their  disposal  about  specific  high-risk  AI 
systems that are suspected of having caused damage which has been refused. Ordering 
disclosure should lead to a reduction of unnecessary litigation and avoid costs for the 
possible litigants caused by claims which are unjustified or likely to be unsuccessful. 
The refusal of the provider, the person subject to the obligations of a provider or the 
user  prior  to  the  request  to  the  court  to  disclose  evidence  should  not  trigger  the 
presumption of non-compliance with relevant duties of care by the person who refuses 
such disclosure. 

(18)  The limitation of disclosure of evidence as regards high-risk AI systems is consistent 
with [the AI Act], which provides certain specific documentation, record keeping and 
information  obligations  for  operators  involved  in  the  design,  development  and 
deployment  of  high-risk  AI  systems.  Such  consistency  also  ensures  the  necessary 
proportionality by avoiding that operators of AI systems posing lower or no risk would 
be expected to document information to a level similar to that required for high-risk AI 
systems under [the AI Act].  

EN 

18 

  EN 

(19)  National  courts  should  be  able,  in  the  course  of  civil  proceedings,  to  order  the 
disclosure or preservation of relevant evidence related to the damage caused by high-
risk  AI  systems  from  persons  who  are  already  under  an  obligation  to  document  or 
record information pursuant to [the AI Act], be they providers, persons under the same 
obligations as providers, or users of an AI system, either as defendants or third parties 
to the claim. There could be situations where the evidence relevant for the case is held 
by entities that would not be parties to the claim for damages but which are under an 
obligation  to  document  or  record  such  evidence  pursuant  to  [the  AI  Act].  It  is  thus 
necessary to provide for the conditions under which such third parties to the claim can 
be ordered to disclose the relevant evidence.  

(20)  To maintain the balance between the interests of the parties involved in the claim for 
damages  and  of  third  parties  concerned,  the  courts  should  order  the  disclosure  of 
evidence  only  where  this  is  necessary  and  proportionate  for  supporting  the  claim  or 
potential claim for damages. In this respect, disclosure should only concern evidence 
that is necessary for a decision on the respective claim for damages, for example only 
the parts of the relevant records or data sets required to prove non-compliance with a 
requirement  laid  down  by  [the  AI  Act].  To  ensure  the  proportionality  of  such 
disclosure  or  preservation  measures,  national  courts  should  have  effective  means  to 
safeguard the legitimate interests of all parties involved, for instance the protection of 
trade  secrets  within  the  meaning  of  Directive  (EU)  2016/943  of  the  European 
Parliament and of the Council37 and  of confidential  information, such as information 
related to public or national security. In respect of trade secrets or alleged trade secrets 
which  the  court  has  identified  as  confidential  within  the  meaning  of  Directive  (EU) 
2016/943,  national  courts  should  be  empowered  to  take  specific  measures  to  ensure 
the confidentiality of trade secrets during and after the proceedings, while achieving a 
fair and proportionate balance between the trade-secret holder's interest in maintaining 
secrecy and the interest of the injured person. This should include measures to restrict 
access to documents containing trade secrets and access to hearings or documents and 
transcripts  thereof  to  a  limited  number  of  people.  When  deciding  on  such  measures, 
national  courts  should  take  into  account  the  need  to  ensure  the  right  to  an  effective 
remedy and to a fair trial, the legitimate interests of the parties and, where appropriate, 
of third parties, and any potential harm to either party or, where appropriate, to third 
parties, resulting from the granting or rejection of such measures. Moreover, to ensure 
a proportionate application of a disclosure measure towards third parties in claims for 
damages,  the  national  courts  should  order  disclosure  from  third  parties  only  if  the 
evidence cannot be obtained from the defendant. 

(21)  While national courts have the means of enforcing their orders for disclosure through 
various measures, any such enforcement measures could delay claims for damages and 
thus potentially create additional expenses for the litigants. For injured persons, such 
delays  and  additional  expenses  may  make  their  recourse  to  an  effective  judicial 
remedy  more  difficult.  Therefore,  where  a  defendant  in  a  claim  for  damages  fails  to 
disclose  evidence  at  its  disposal  ordered  by  a  court,  it  is  appropriate  to  lay  down  a 
presumption  of  non-compliance  with  those  duties  of  care  which  that  evidence  was 
intended  to  prove.  This  rebuttable  presumption  will  reduce  the  duration  of  litigation 

37 

Directive  (EU)  2016/943  of  the  European  Parliament  and  of  the  Council  of  8  June  2016  on  the 
protection  of  undisclosed  know-how  and  business  information  (trade  secrets)  against  their  unlawful 
acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1). 

EN 

19 

  EN 

                                                 
(22) 

and facilitate more efficient court proceedings. The defendant should be able to rebut 
that presumption by submitting evidence to the contrary.  

In  order  to  address  the  difficulties  to  prove  that  a  specific  input  for  which  the 
potentially liable person is responsible had caused a specific AI system output that led 
to  the  damage  at  stake,  it  is  appropriate  to  provide,  under  certain  conditions,  for  a 
presumption  of  causality.  While  in  a  fault-based  claim  the  claimant  usually  has  to 
prove the damage, the human act or omission constituting fault of the defendant and 
the  causality  link  between  the  two,  this  Directive  does  not  harmonise  the  conditions 
under  which  national  courts  establish  fault.  They  remain  governed  by  the  applicable 
national  law  and,  where  harmonised,  by  applicable  Union  law.  Similarly,  this 
Directive does not harmonise the conditions related to the damage, for instance what 
damages are compensable, which are also regulated by applicable national and Union 
law.  For  the  presumption  of  causality  under  this  Directive  to  apply,  the  fault  of  the 
defendant  should  be  established  as  a  human  act  or  omission  which  does  not  meet  a 
duty of care under Union law or national law that is directly intended to protect against 
the damage that occurred. Thus, this presumption can apply, for example, in a claim 
for damages for physical injury when the court establishes the fault of the defendant 
for  non-complying  with  the  instructions  of  use  which  are  meant  to  prevent  harm  to 
natural persons. Non-compliance with duties of care that were not directly intended to 
protect  against  the  damage  that  occurred  do  not  lead  to  the  application  of  the 
presumption,  for  example  a  provider’s  failure  to  file  required  documentation  with 
competent authorities  would not lead to the application of the presumption in claims 
for damages due to physical injury. It should also be necessary to establish that it can 
be considered reasonably likely, based on the circumstances of the case, that the fault 
has influenced the output produced by the AI system or the failure of the AI system to 
produce  an  output.  Finally,  the  claimant  should  still  be  required  to  prove  that  the 
output or failure to produce an output gave rise to the damage.  

(23)  Such a fault can be established in respect of non-compliance with Union rules which 
specifically regulate high-risk AI systems like the requirements introduced for certain 
high-risk AI systems by [the AI Act], requirements which may be introduced by future 
sectoral legislation for other high-risk AI systems according to [Article 2(2) of the AI 
Act], or duties of care which are linked to certain activities and which are applicable 
irrespective  whether  AI  is  used  for  that  activity.  At  the  same  time,  this  Directive 
neither  creates  nor  harmonises  the  requirements  or  the  liability  of  entities  whose 
activity is regulated under those legal acts, and therefore does not create new liability 
claims. Establishing a breach of such a requirement that amounts to fault will be done 
according  to  the  provisions  of  those  applicable  rules  of  Union  Law,  since  this 
Directive  neither  introduces  new  requirements  nor  affects  existing  requirements.  For 
example, the exemption of liability for providers of intermediary services and the due 
diligence obligations to which they are subject pursuant to [the Digital Services Act] 
are  not  affected  by  this  Directive.  Similarly,  the  compliance  with  requirements 
imposed  on  online  platforms  to  avoid  unauthorised  communication  to  the  public  of 
copyright  protected  works  is  to  be  established  under  Directive  (EU)  2019/790  on 
copyright  and  related  rights  in  the  Digital  Single  Market  and  other  relevant  Union 
copyright law.    

(24) 

In  areas  not  harmonised  by  Union  law,  national  law  continues  to  apply  and  fault  is 
established under the applicable national law. All national liability regimes have duties 
of  care,  taking  as  a  standard  of  conduct  different  expressions  of  the  principle  how  a 
reasonable  person  should  act,  which  also  ensure  the  safe  operation  of  AI  systems  in 

EN 

20 

  EN 

order  to  prevent  damage  to  recognised  legal  interests.  Such  duties  of  care  could  for 
instance require users of AI systems to choose for certain tasks a particular AI system 
with concrete characteristics or to exclude certain segments of a population from being 
exposed to a particular AI system. National law can also introduce specific obligations 
meant to prevent risks for certain activities, which are applicable irrespective whether 
AI  is  used  for  that  activity,  for  example  traffic  rules  or  obligations  specifically 
designed  for  AI  systems,  such  as  additional  national  requirements  for  users  of  high-
risk  AI  systems  pursuant  to  Article  29  (2)  of  [the  AI  Act].  This  Directive  neither 
introduces such requirements nor affects the conditions for establishing fault in case of 
breach of such requirements.  

(25)  Even when fault consisting of a non-compliance with a duty of care directly intended 
to protect against the damage that occurred is established, not every fault should lead 
to the application of the rebuttable presumption linking it to the output of the AI. Such 
a presumption should only apply when it can be considered reasonably likely, from the 
circumstances in which the damage occurred, that such fault has influenced the output 
produced by the AI system or the failure of the  AI system to produce an output that 
gave  rise  to  the  damage.  It  can  be  for  example  considered  reasonably  likely  that  the 
fault has influenced the output or failure to produce an output, when that fault consists 
in breaching a duty of care in respect of limiting the perimeter of operation of the AI 
system and the damage occurred outside the perimeter of operation. On the contrary, a 
breach of a requirement to file certain documents or to register with a given authority, 
even  though  this  might  be  foreseen  for  that  particular  activity  or  even  be  applicable 
expressly  to  the  operation  of  an  AI  system,  could  not  be  considered  as  reasonably 
likely to have influenced the output produced by the AI system or the failure of the AI 
system to produce an output.  

(26)  This  Directive  covers  the  fault  constituting  non-compliance  with  certain  listed 
requirements laid down in Chapters 2 and 3 of [the AI Act] for providers and users of 
high-risk  AI  systems,  the  non-compliance  with  which  can  lead,  under  certain 
conditions, to a presumption of causality. The AI Act provides for full harmonisation 
of  requirements  for  AI  systems,  unless  otherwise  explicitly  laid  down  therein.  It 
harmonises  the  specific  requirements  for  high-risk  AI  systems.  Hence,  for  the 
purposes of claims for damages in which a presumption of causality according to this 
Directive  is  applied,  the  potential  fault  of  providers  or  persons  subject  to  the 
obligations of a provider pursuant  to [the AI Act]  is established only through a  non-
compliance with such requirements. Given that in practice it may be difficult for the 
claimant  to  prove  such  non-compliance  when  the  defendant  is  a  provider  of  the  AI 
system,  and  in  full  consistency  with  the  logic  of  [the  AI  Act],  this  Directive  should 
also  provide  that  the  steps  undertaken  by  the  provider  within  the  risk  management 
system and the results of the risk management system, i.e. the decision to adopt or not 
to  adopt  certain  risk  management  measures,  should  be  taken  into  account  in  the 
determination  of  whether  the  provider  has  complied  with  the  relevant  requirements 
under  the  AI  Act  referred  to  in  this  Directive.  The  risk  management  system  put  in 
place  by  the  provider  pursuant  to  [the  AI  Act]  is  a  continuous  iterative  process  run 
throughout  the  lifecycle  of  the  high-risk  AI  system,  whereby  the  provider  ensures 
compliance  with  mandatory  requirements  meant  to  mitigate  risks  and  can,  therefore, 
be  a  useful  element  for  the  purpose  of  the  assessment  of  this  compliance.  This 
Directive  also  covers  the  cases  of  users’  fault,  when  this  fault  consists  in  non-
compliance  with  certain  specific  requirements  set  by  [the  AI  Act].  In  addition,  the 
fault  of  users  of  high-risk  AI  systems  may  be  established  following  non-compliance 

EN 

21 

  EN 

with other duties of care laid down in Union or national law, in light of Article 29 (2) 
of [the AI Act]. 

(27)  While  the  specific  characteristics  of  certain  AI  systems,  like  autonomy  and  opacity, 
could make it excessively difficult for the claimant to meet the burden of proof, there 
could  be  situations  where  such  difficulties  do  not  exist  because  there  could  be 
sufficient evidence and expertise available to the complainant to prove the causal link. 
This  could  be  the  case,  for  example,  in  respect  of  high-risk  AI  systems  where  the 
claimant  could  reasonably  access  sufficient  evidence  and  expertise 
through 
documentation and logging requirements pursuant to [the AI Act]. In such situations, 
the court should not apply the presumption. 

(28)  The presumption of causality could also apply to AI systems that are not high-risk AI 
systems  because  there  could  be  excessive  difficulties  of  proof  for  the  claimant.  For 
example, such difficulties could be assessed in light of the characteristics of certain AI 
systems,  such  as  autonomy  and  opacity,  which  render  the  explanation  of  the  inner 
functioning of the AI system very difficult in practice, negatively affecting the ability 
of the claimant to prove the causal link between the fault of the defendant and the AI 
output.  A  national  court  should  apply  the  presumption  where  the  claimant  is  in  an 
excessively difficult position to prove causation, since it is required to explain how the 
AI system was led by the human act or omission that constitutes fault to produce the 
output or the failure to produce an output which gave rise to the damage. However, the 
claimant  should  neither  be  required  to  explain  the  characteristics  of  the  AI  system 
concerned nor how these characteristics make it harder to establish the causal link. 

(29)  The  application  of  the  presumption  of  causality  is  meant  to  ensure  for  the  injured 
person  a  similar  level  of  protection  as  for  situations  where  AI  is  not  involved  and 
where causality may therefore be easier to prove. Nevertheless, alleviating the burden 
of  proving  causation  is  not  always  appropriate  under  this  Directive  where  the 
defendant  is  not  a  professional  user  but  rather  a  person  using  the  AI  system  for  its 
private  activities.  In  such  circumstances,  in  order  to  balance  interests  between  the 
injured person and the non-professional user, it needs to be taken into account whether 
such  non-professional  users  can  add  to  the  risk  of  an  AI  system  causing  damage 
through  their  behaviour.  If  the  provider  of  an  AI  system  has  complied  with  all  its 
obligations and, in consequence, that system was deemed sufficiently safe to be put on 
the market for a given use by non-professional users and it is then used for that task, a 
presumption  of  causality  should  not  apply  for  the  simple  launch  of  the  operation  of 
such a system by such non-professional users. A non-professional user that buys an AI 
system and simply launches it according to its purpose, without interfering materially 
with the conditions of operations, should not be covered by the causality presumption 
laid  down  by  this  Directive.  However,  if  a  national  court  determines  that  a  non-
professional  user  materially  interfered  with  the  conditions  of  operation  of  an  AI 
system  or  was  required  and  able  to  determine  the  conditions  of  operation  of  the  AI 
system and failed to do so, then the presumption of causality should apply, where all 
the other conditions are fulfilled. This could be the case, for example, when the non-
professional user does not comply with the instructions of use or with other applicable 
duties  of  care  when  choosing  the  area  of  operation  or  when  setting  performance 
conditions  of  the  AI  system.  This  is  without  prejudice  to  the  fact  that  the  provider 
should determine the intended purpose of an AI system, including the specific context 
and  conditions  of  use,  and  eliminate  or  minimise  the  risks  of  that  system  as 
appropriate  at  the  time  of  the  design  and  development,  taking  into  account  the 
knowledge and expertise of the intended user. 

EN 

22 

  EN 

(30)  Since this Directive introduces a rebuttable presumption, the defendant should be able 

to rebut it, in particular by showing that its fault could not have caused the damage. 

(31) 

It is necessary to provide for a review of this Directive [five years] after the end of the 
transposition period. In particular, that review should examine whether there is a need 
to create no-fault liability rules for claims against the operator, as long as not already 
covered  by  other  Union  liability  rules  in  particular  Directive  85/374/EEC,  combined 
with  a mandatory insurance for the operation of certain  AI systems,  as suggested  by 
the  European  Parliament.38 In  accordance  with  the  principle  of  proportionality,  it  is 
appropriate to assess such a need in the light of relevant technological and regulatory 
developments  in  the  coming  years,  taking  into  account  the  effect  and  impact  on  the 
roll-out  and  uptake  of  AI  systems,  especially  for  SMEs.  Such  a  review  should 
consider,  among  others,  risks  involving  damage  to  important  legal  values  like  life, 
health  and  property  of  unwitting  third  parties  through  the  operation  of  AI-enabled 
products or services. That review should also analyse the effectiveness of the measures 
provided for in this Directive in dealing with such risks, as well as the development of 
appropriate  solutions  by  the  insurance  market.  To  ensure  the  availability  of  the 
information  necessary  to  conduct  such  a  review,  it  is  necessary  to  collect  data  and 
other necessary evidence covering the relevant matters. 

(32)  Given the need to make adaptations to national  civil liability and procedural rules to 
foster  the  rolling-out  of  AI-enabled  products  and  services  under  beneficial  internal 
market  conditions,  societal  acceptance  and  consumer  trust  in  AI  technology  and  the 
justice system, it is appropriate to set a deadline of not later than [two years after the 
entry  into  force]  of  this  Directive  for  Member  States  to  adopt  the  necessary 
transposition measures. 

(33) 

In accordance with  the Joint Political  Declaration of 28 September 2011 of Member 
States  and  the  Commission  on  explanatory  documents 39 ,  Member  States  have 
undertaken  to  accompany,  in  justified  cases,  the  notification  of  their  transposition 
measures  with  one  or  more  documents  explaining  the  relationship  between  the 
components  of  a  directive  and  the  corresponding  parts  of  national  transposition 
instruments. With regard to this Directive, the legislator considers the transmission of 
such documents to be justified, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Subject matter and scope 

1. 

This Directive lays down common rules on: 

(a) 

the  disclosure  of  evidence  on  high-risk  artificial  intelligence  (AI)  systems  to 
enable a claimant to substantiate a non-contractual fault-based civil law claim 
for damages; 

(b) 

the burden of proof in the case of non-contractual fault-based civil law claims 
brought before national courts for damages caused by an AI system. 

38 

39 

European  Parliament  resolution  of  20  October  2020  with  recommendations  to  the  Commission  on  a 
civil liability regime for artificial intelligence (2020/2014(INL)) - OJ C 404, 6.10.2021, p. 107. 
OJ C 369, 17.12.2011, p. 14. 

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2. 

This Directive applies to non-contractual fault-based civil law claims for damages, in 
cases  where  the  damage  caused  by  an  AI  system  occurs  after  [the  end  of  the 
transposition period].   

This Directive does not apply to criminal liability. 

3. 

This Directive shall not affect: 

(a) 

(b) 

(c) 

rules of Union law regulating conditions of liability in the field of transport; 

any  rights  which  an 
implementing Directive 85/374/EEC; 

injured  person  may  have  under  national  rules 

the exemptions from liability and the due diligence obligations as laid down in 
[the Digital Services Act] and  

(d)  national rules determining which party has the burden of proof, which degree 
of certainty is required as regards the standard of proof, or how fault is defined, 
other than in respect of what is provided for in Articles 3 and 4. 

4. 

Member  States  may  adopt  or  maintain  national  rules  that  are  more  favourable  for 
claimants to substantiate a non-contractual civil law claim for damages caused by an 
AI system, provided such rules are compatible with Union law. 

Article 2 

Definitions 

For the purposes of this Directive, the following definitions shall apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

‘AI system’ means an AI system as defined in [Article 3 (1) of the AI Act]; 

‘high-risk AI system’ means an AI system referred to in [Article 6 of the AI Act];  

‘provider’ means a provider as defined in [Article 3 (2) of the AI Act]; 

‘user’ means a user as defined in [Article 3 (4) of the AI Act]; 

‘claim  for  damages’  means  a  non-contractual  fault-based  civil  law  claim  for 
compensation of the damage caused by an output  of an AI system or the failure of 
such  a  system  to  produce  an  output  where  such  an  output  should  have  been 
produced;  

(6) 

‘claimant’ means a person bringing a claim for damages that: 

(a) 

(b) 

(c) 

has  been  injured  by  an  output  of  an  AI  system  or  by  the  failure  of  such  a 
system to produce an output where such an output should have been produced;  

 has succeeded to or has been subrogated to the right of an injured person by 
virtue of law or contract; or 

is acting on behalf of one or more injured persons, in accordance with Union or 
national law. 

(7)  

‘potential claimant’ means a natural or legal person who is considering but has not yet 
brought a claim for damages; 

(8)  

‘defendant’ means the person against whom a claim for damages is brought; 

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(9) 

‘duty of care’ means a required standard of conduct, set by national or Union law, in 
order  to  avoid  damage  to  legal  interests  recognised  at  national  or  Union  law  level, 
including life, physical integrity, property and the protection of fundamental rights. 

Disclosure of evidence and rebuttable presumption of non-compliance 

Article 3 

1. 

2. 

3. 

4. 

Member  States  shall  ensure  that  national  courts  are  empowered,  either  upon  the 
request of a potential claimant who has previously asked a provider, a person subject 
to the obligations of a provider pursuant to [Article 24 or Article 28(1) of the AI Act] 
or  a  user  to  disclose  relevant  evidence  at  its  disposal  about  a  specific  high-risk  AI 
system that is suspected of having caused damage, but was refused, or a claimant, to 
order the disclosure of such evidence from those persons. 

In  support  of  that  request,  the  potential  claimant  must  present  facts  and  evidence 
sufficient to support the plausibility of a claim for damages 

In  the  context  of  a  claim  for  damages,  the  national  court  shall  only  order  the 
disclosure of the evidence by one of the persons listed in paragraph 1, if the claimant 
has undertaken all proportionate attempts at gathering the relevant evidence from the 
defendant. 

Member States shall ensure that national courts, upon the request of a claimant, are 
empowered  to  order  specific  measures  to  preserve  the  evidence  mentioned  in 
paragraph 1.  

National courts shall limit the disclosure of evidence to that which is necessary and 
proportionate  to  support  a  potential  claim  or  a  claim  for  damages  and  the 
preservation to that which is necessary and proportionate to support such a claim for 
damages.  

In  determining  whether  an  order  for  the  disclosure  or  preservation  of  evidence  is 
proportionate,  national  courts  shall  consider  the  legitimate  interests  of  all  parties, 
including third parties  concerned, in  particular in relation  to  the protection of trade 
secrets  within  the  meaning  of  Article  2(1)  of  Directive  (EU)  2016/943  and  of 
confidential information, such as information related to public or national security. 

Member  States  shall  ensure  that,  where  the  disclosure  of  a  trade  secret  or  alleged 
trade  secret  which  the  court  has  identified  as  confidential  within  the  meaning  of 
Article 9(1) of Directive (EU) 2016/943 is ordered, national courts are empowered, 
upon  a  duly  reasoned  request  of  a  party  or  on  their  own  initiative,  to  take  specific 
measures necessary to preserve confidentiality when that evidence is used or referred 
to in legal proceedings.  

Member States shall also ensure that the person ordered to disclose or to preserve the 
evidence  mentioned  in  paragraphs  1  or  2  has  appropriate  procedural  remedies  in 
response to such orders. 

5. 

Where a defendant  fails  to  comply with  an order by  a national  court in  a claim  for 
damages to disclose or to preserve evidence at its disposal pursuant to paragraphs 1 
or 2, a national court shall presume the defendant’s non-compliance with a relevant 
duty of care, in particular in the circumstances referred to in Article 4(2) or (3), that 

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1. 

(a) 

(b) 

(c) 

2. 

the evidence requested was intended to prove for the purposes of the relevant claim 
for damages.  

The defendant shall have the right to rebut that presumption. 

Article 4 

Rebuttable presumption of a causal link in the case of fault 

Subject to the requirements laid down in this Article, national courts shall presume, 
for  the  purposes  of  applying  liability  rules  to  a  claim  for  damages,  the  causal  link 
between the fault of the defendant and the output produced by the AI system or the 
failure of the AI system to produce an output, where all of the following conditions 
are met: 

 the  claimant  has  demonstrated  or  the  court  has  presumed  pursuant  to  Article  3(5), 
the  fault  of  the  defendant,  or  of  a  person  for  whose  behaviour  the  defendant  is 
responsible, consisting in the non-compliance with a duty of care laid down in Union 
or national law directly intended to protect against the damage that occurred; 

it can be considered reasonably likely, based on the circumstances of the case, that 
the fault has influenced the output produced by the AI system or the failure of the AI 
system to produce an output;   

the  claimant  has  demonstrated  that  the  output  produced  by  the  AI  system  or  the 
failure of the AI system to produce an output gave rise to the damage. 

In the case of a claim for damages against a provider of a high-risk AI system subject 
to  the  requirements  laid  down  in  chapters  2  and  3  of  Title  III  of  [the  AI  Act]  or  a 
person subject to the provider’s obligations pursuant to [Article 24 or Article 28(1) of 
the  AI  Act],  the  condition  of  paragraph  1  letter  (a)  shall  be  met  only  where  the 
complainant has demonstrated that the provider or, where relevant, the person subject 
to the provider’s obligations, failed to comply with any of the following requirements 
laid  down  in  those  chapters,  taking  into  account  the  steps  undertaken  in  and  the 
results of the risk management system pursuant to [Article 9 and Article 16 point (a) 
of the AI Act]: 

(a) 

(b) 

(c) 

(d) 

 the  AI  system  is  a  system  which  makes  use  of  techniques  involving  the 
training  of      models  with  data  and  which  was  not  developed  on  the  basis  of 
training, validation and testing data sets that meet the quality criteria referred to 
in [Article 10(2) to (4) of the AI Act];  

 the  AI  system  was  not  designed  and  developed  in  a  way  that  meets  the   
transparency requirements laid down in [Article 13 of the AI Act]; 

the  AI  system  was  not  designed  and  developed  in  a  way  that  allows  for  an 
effective oversight by natural persons during the period in which the AI system 
is in use pursuant to [Article 14 of the AI Act]; 

the AI system was not designed and developed so as to achieve, in the light of 
its  intended  purpose,  an  appropriate  level  of  accuracy,  robustness  and 
cybersecurity pursuant to [Article 15 and Article 16, point (a), of the AI Act]; 
or 

(e) 

the  necessary  corrective  actions  were  not  immediately  taken  to  bring  the  AI 
system in conformity with the obligations laid down in [Title III, Chapter 2 of 

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3. 

4. 

5. 

6. 

the  AI  Act]  or  to  withdraw  or  recall  the  system,  as  appropriate,  pursuant  to 
[Article 16, point (g), and Article 21 of the AI Act]. 

In the case of a claim for damages against a user of a high-risk AI system subject to 
the  requirements  laid  down  in  chapters  2  and  3  of  Title  III  of  [the  AI  Act],  the 
condition  of  paragraph  1  letter  (a)  shall  be  met  where  the  claimant  proves  that  the 
user: 

(a) 

did  not  comply  with  its  obligations  to  use  or  monitor  the  AI  system  in 
accordance  with  the  accompanying  instructions  of  use  or,  where  appropriate, 
suspend or interrupt its use pursuant to [Article 29 of the AI Act]; or 

(b) 

exposed the AI system to input data under its control which is not relevant in 
view of the system’s intended purpose pursuant to [Article 29(3) of the Act]. 

In the case of a claim for damages concerning a high-risk AI system, a national court 
shall  not  apply  the  presumption  laid  down  in  paragraph  1  where  the  defendant 
demonstrates  that  sufficient  evidence  and  expertise  is  reasonably  accessible  for  the 
claimant to prove the causal link mentioned in paragraph 1.  

In the case of a claim for damages concerning an AI system that is not a high-risk AI 
system,  the  presumption  laid  down  in  paragraph  1  shall  only  apply  where  the 
national  court  considers  it excessively difficult  for the claimant to  prove the causal 
link mentioned in paragraph 1. 

In the case of a claim for damages against a defendant who used the AI system in the 
course  of  a  personal,  non-professional  activity,  the  presumption  laid  down  in 
paragraph  1  shall  apply  only  where  the  defendant  materially  interfered  with  the 
conditions of the operation of the AI system or if the defendant was required and able 
to determine the conditions of operation of the AI system and failed to do so. 

7. 

The defendant shall have the right to rebut the presumption laid down in paragraph 1. 

Article 5 

Evaluation and targeted review 

1. 

2. 

3. 

By [DATE five years after the end of the transposition period], the Commission shall 
review  the  application  of  this  Directive  and  present  a  report  to  the  European 
Parliament,  to  the  Council  and  to  the  European  Economic  and  Social  Committee, 
accompanied, where appropriate, by a legislative proposal. 

The report shall examine the effects of Articles 3 and 4 on achieving the objectives 
pursued by this Directive. In particular, it should evaluate the appropriateness of no-
fault liability rules for claims against the operators of certain AI systems, as long as 
not  already  covered  by  other  Union  liability  rules,  and  the  need  for  insurance 
coverage, while taking into account the effect and impact on the roll-out and uptake 
of AI systems, especially for SMEs. 

The  Commission  shall  establish  a  monitoring  programme  for  preparing  the  report 
pursuant  to  paragraphs  1  and  2,  setting  out  how  and  at  what  intervals  the  data  and 
other necessary evidence will be collected. The programme shall specify the action to 
be taken by the Commission and by the Member States in collecting and analysing 
the  data  and  other  evidence.  For  the  purposes  of  that  programme,  Member  States 
communicate the relevant data and evidence to the Commission, by [31 December of 

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the second full year following the end of the transposition period] and by the end of 
each subsequent year.  

Article 6 

Amendment to Directive (EU) 2020/1828 

In Annex I to Directive (EU) 2020/182840, the following point (67) is added:  

"(67) Directive (EU) …/… of the European Parliament and of the Council of … on adapting 
non contractual civil liability rules to artificial intelligence (AI Liability Directive) (OJ L …, 
…, p. …).". 

Article 7 

Transposition 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions necessary to comply with this Directive by [two years after the 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  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

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 8 

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 9 

Addressees 

This Directive is addressed to the Member States. 

Done at Brussels, 

For the European Parliament 
The President  

For the Council 
The President  

40 

Directive  (EU)  2020/1828  of  the  European  Parliament  and  of  the  Council  of  25  November  2020  on 
representative actions for the protection of the collective interests of consumers and repealing Directive 
2009/22/EC (OJ L 409, 4.12.2020, p. 1). 

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