COMMISSION STAFF WORKING DOCUMENT AI Subsidiarity Grid Accompanying the document 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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 28.9.2022  SWD(2022) 318 final  COMMISSION STAFF WORKING DOCUMENT AI Subsidiarity Grid  Accompanying the document 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) {COM(2022) 496 final} - {SEC(2022) 344 final} - {SWD(2022) 319 final} - {SWD(2022) 320 final}  
 
 
Subsidiarity Grid 

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy initiative? 

The (proposal for a) Directive on adapting non-contractual civil liability rules to artificial intelligence is 
based on Article 114 of the Treaty on the Functioning of the European Union (TFEU), which regulates 
the approximation of the provisions laid down by law, regulation or administrative action in Member 
States having as their object the establishment and functioning of the internal market. The Directive 
harmonises  targeted  aspects  of  the  Member  States’  existing  civil  liability  rules  applicable  to  AI-
systems, in order to improve the conditions for the functioning of the internal market in AI-enabled 
products  and  services.  The  choice  of  Article  114  TFEU  as  a  legal  basis  is  also  supported  by  the  EP 
which has called twice upon the Commission to use this legal basis for a legislative proposal.1 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or supporting in 
nature? 

In the case of  civil liability rules  applicable to AI-systems, aiming  to improve the  conditions for the 
functioning  of  the  internal  market  in  AI-enabled  products  and  services,  the  Union’s  competence  is 
shared  –  according  to  Article  4(2)(a)  TFEU,  internal  market  as  a  policy  area  is  subject  to  a  shared 
competence between the Union and its Member States.  

Subsidiarity does not apply for policy areas where the Union has exclusive competence as defined in 
Article 3 TFEU2. It is the specific legal basis which determines whether the proposal falls under the 
subsidiarity control mechanism. Article 4 TFEU3 sets out the areas where competence is shared 
between the Union and the Member States. Article 6 TFEU4 sets out the areas for which the Unions 
has competence only to support the actions of the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1 Does the proposal fulfil the procedural requirements of Protocol No. 25: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

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 a public 
and several targeted consultations.  
An online  public  consultation was open from 18 October 2021 to 10 January  2022 to gather views 
from  a  wide  variety  of  stakeholders,  including  consumers,  civil  society  organisations,  industry 
associations,  businesses,  including  SMEs,  and  public  authorities.  After  analysing  all  the  responses 

1  Resolution  of  16  February  2017  on  Civil  Law  Rules  on  Robotics  (2015/2103(INL));  legislative  own-initiative 
Resolution of 20 October 2020 on a civil liability regime for AI (2020/2014(INL)). 
2 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
3 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
4 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
5 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

1 

 
 
 
                                                           
received,  the  Commission  published  a  summary  outcome  and  the  individual  responses  on  its 
website.6 
In  addition,  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 
20197 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 study8, a behavioural economics study9 and an economic study10. 

The  explanatory memorandum  (section  2)  and  the  impact  assessment  (chapter  3) explain  how  the 
principle of subsidiarity has been taken into account by this legislative proposal – for further details 
see answer to question 2.2 below.  

2.2 Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with the 
principle of subsidiarity? 

internal  market  barriers.  Further, 

The  explanatory  memorandum  clarifies  that  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-border 
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-border  trade, 
entailing  significant 
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. 

6 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  
7 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 
8 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. 
9  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. 
10 Deloitte, Study to support the Commission’s Impact Assessment on liability for artificial intelligence, 2021. 

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The arguments above are substantiated in more detail in chapter 3 of the impact assessment.  

2.3 Based on the answers to the questions below, can the objectives of the proposed action be 

achieved sufficiently by the Member States acting alone (necessity for EU action)? 

Given the existing differences between tort liability regimes across Member States and the likelihood 
that those differences would only increase if measures were adopted at national level to adapt such 
liability regimes to AI risks, the objectives of the proposed action (such as ensuring legal certainty on 
a cross-border basis and consistently preventing compensation gaps in cases where AI systems are 
involved) cannot be sufficiently achieved by Member States acting alone. In absence of EU action, the 
identified obstacles to a well-functioning internal market for safe AI-enabled products and services 
would still persist.  

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

In  the  area  covered  by  this  proposal,  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-border 
trade, entailing significant internal market barriers.  
For  the  quantification  of  the  cross-border  activities  in  this  sector,  see  also  section  6.2.6  of  the 
economic study. 

(b)  Would national action or the absence of the EU level action conflict with core objectives of 

the Treaty11 or significantly damage the interests of other Member States? 

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, which is against the core objective of 
the Treaty to establish a well-functioning internal market. At the same time, the fact that victims of 
harm  caused  by  AI  systems  would  not  benefit  of  the  same  level  of  protection  as  victims  of  harm 
caused by other technologies is against the principle of equal access to justice, hampering the trust in 
AI and ultimately the uptake of AI-enabled products/services across the EU Member States. 

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

There is concrete evidence showing that a number of Member States may take unilateral legislative 
measures  to  address  the  specific  challenges  posed  by  AI  with  respect  to  liability.  For  example,  AI 
strategies adopted in Czechia, Italy, Malta, Poland and Portugal mention initiatives to clarify liability 
(see  also  section  3.1  of  the  IA).  However,  given  the  already  existing  large  divergence  between 
Member  States’  existing  civil  liability  rules,  it  is  likely  that  any  national  AI-specific  measures  on 
liability would follow existing different national approaches and therefore increase fragmentation in 
the  EU.  Thus  relying  on  separate  measures  at  the  level  of  each  Member  State  cannot  address  the 
main concerns identified by the present initiative.    

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

11 https://europa.eu/european-union/about-eu/eu-in-brief_en  

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across the national, regional and local levels of the EU? 

Some Member States envisage already the adoption of measures on liability for AI-enabled products 
and  services,  while  other  Member  States  have  not  put  forward  such  initiatives.  This  divergence  of 
approaches will increase the already existing fragmentation of tort liability regimes among Member 
States. As a  consequence, some victims would be  left  to bear the burden of damage caused by AI, 
affecting victims disproportionately and allowing for an externalisation of costs linked to the roll-out 
of AI. At the same time, companies active cross-border would face a multiplicity of liability regimes, 
hampering  their  development  and  innovation  potential.  These  elements  would  undermine  the 
functioning  of  the  internal  market  for  safe  AI-enabled  products  and  services.  This  matter  is  less 
relevant  for  local  and  regional  levels  within  Member  States,  given  that  tort  liability  is  in  general 
regulated at national level in Europe.  

(e)  Is the problem widespread across the EU or limited to a few Member States? 

So far, businesses that want to produce, disseminate and operate AI-enabled products and services 
across  borders  are  uncertain  whether  and  how  existing  liability  regimes  in  Member  States  would 
apply  to  damage  caused  by  AI.  This  uncertainty  concerns  not  only  their  own  Member  State  but 
particularly other Member States where they will export to or operate their products and services. 
Some  Member  States  may  take  unilateral  legislative  measures  to  address  the  specific  challenges 
posed  by  AI  with  respect  to  liability  (see  Member  States  mentioned  under  2.3(c)  above).  It  is  very 
likely that any national AI-specific measures on liability would follow existing different national tort 
law  approaches,  thus  increasing  the  barriers  to  the  roll-out  of  AI-enabled  products  and  services 
across the internal market in general, and not only on some national markets. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

No, the measure is proposed to support Member States in ensuring legal certainty and consistently 
preventing compensation gaps in cases where AI systems are involved.  

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

Tort  law  traditions  differ  significantly  across  Member  States  and  their  adaptation  to  deal  with  AI-
liability  cases  is  likely  to  increase  such  differences.  The  latter  concern  for  instance  the  standard  of 
proof  for  causation,  procedural  alleviations  of  the  burden  of  proof,  administrative  law  measures 
assisting those charged with the burden of proof, the basis for liability, different approaches to causal 
uncertainty etc. In addition, while fault-based liabilities are the liability regimes by default in Europe 
and are framed very differently across Member States, some Member States also have strict liability 
regimes in place. 

2.4 Based on the answer to the questions below, can the objectives of the proposed action be 

better achieved at Union level by reason of scale or effects of that action (EU added value)? 

The  objectives  of  the  proposed  action,  to  ensure  legal  certainty  and  consistently  prevent 
compensation  gaps  in  cases  where  AI  systems  are  involved,  thus  creating  the  conditions  for  the 
deployment  of  AI-technologies  in  the  internal  market,  can  be  better  achieved  at  Union  level,  by 
ensuring  a  minimum  level  of  harmonisation.  This  will  increase  public  trust  and  the  uptake  of  AI-
enabled products and services, enabling companies (in particular SMEs, which are among the most 
active  in  the  AI  sector)  to  expand  their  activities  across  borders.  On  the  contrary,  relying  only  on 
possible measures at national level would increase legal fragmentation across the EU and will create 
obstacles to cross-border activities (as explained under question 2.3 above).  

4 

 
 
(a)  Are there clear benefits from EU level action?  

increasing 

improved  by  preventing  fragmentation  and 

The  conditions  for  the  roll-out  and  development  of  AI-technologies  in  the  internal  market  can  be 
significantly 
legal  certainty  through 
harmonised  measures  at  EU  level,  compared  to  possible  adaptations  of  liability  rules  at  national 
level.  The  economic  study  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. 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. 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level (larger 

benefits per unit cost)? Will the functioning of the internal market be improved? 

It  is  only  through  EU  action  that  the  desired  effect  of  promoting  consumer  trust  in  AI-enabled 
products  and services  by preventing  liability  gaps  linked  to  the  specific  characteristics of  AI can  be 
achieved  consistently  across  the  internal  market.  Harmonised  adaptations  of  existing  liability  rules 
are  needed,  ensuring  a  consistent  (minimum)  level  of  protection  for  all  victims  (citizens  and 
companies) and consistent incentives to prevent harm and ensure accountability. The Directive will 
create the  conditions  for businesses  to  use  cross-border  opportunities  and  expand  their  AI-related 
activities  in  the  internal  market.  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  (see  page  49  of  the  Impact 
Assessment).  

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

Harmonising at EU level the relevant liability rules to respond to the risks posed by AI systems would 
significantly  improve  the  conditions  for  the  roll-out  and  development  of  AI-technologies  in  the 
internal market. Such more homogenous approach is needed to prevent legal fragmentation (which 
may result  from possible adaptations of liability rules at national level)  and increase  legal certainty 
for  consumers  and  businesses,  while  preventing  liability  gaps  and  ensuring  that  victims  of  harm 
caused by AI systems are duly compensated, including in cases with cross-border dimensions.  

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member States 
and the local and regional authorities (beyond the costs and benefits of acting at national, 
regional and local levels)? 

The Directive follows a minimum harmonisation approach, focusing on disclosure of information and 
alleviation of the  burden of  proof  through  establishment  of  causality  presumption  subject  to  strict 
conditions. This approach, based on a minimum intervention at EU level, allows victims of damage 
caused  by  AI  systems  to  invoke  more  favourable  rules  of  national  law.  Thus,  national  laws  could 
maintain, for example, reversals of the  burden of proof under fault-based regimes, or national no-
fault liability regimes of which there are already a large variety in national laws, possibly applying to 
damage  caused  by  AI  systems.  The  benefits  of  EU  action,  described  under  points  2.4(a)-(c)  above, 
outweigh the minimum loss of competence of Member States in this area.  

(e)  Will there be improved legal clarity for those having to implement the legislation? 

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The  risks  stemming  from  AI  systems  pose  challenges  for  the  current  tort  liability  regimes  across 
Member  States.  To  tackle  those  risks,  the  Directive  will  bring  legal  clarity on the  right  to  access  to 
information and the correspondent disclosure obligations, as well as alleviate the burden of proof of 
claimants  by  establishing  rebuttable  presumptions  of  causality  between  non-compliance  with  legal 
duties of care and the output of the AI system that caused the damage. These rules will significantly 
increase legal certainty for claimants and defendants, for legal practitioners and national courts, as 
well  as  for  relevant  public  authorities.  At  the  same  time,  consumers  and  businesses  will  benefit  of 
this  enhanced  legal  clarity,  which  will  increase  their  trust  in  the  internal  market  for  AI-enabled 
products  and  services.  The  assessment  of  relevant  liability  risks  will  be  facilitated,  as  well  as  their 
insurability.  

3.  Proportionality: How the EU should act 

3.1  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality of the 
proposal and a statement allowing appraisal of the compliance of the proposal with the 
principle of proportionality? 

The explanatory memorandum clarifies that 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 more extensive measures.  
The first stage is limited to the burden-of-proof measures strictly necessary to address the AI-specific 
problems identified. It builds on the  substantive  conditions of liability currently existing in national 
rules,  such  as  fault  or  causality,  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 proof, 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. However, 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  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, including situations where no-fault 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.  
The elements above are substantiated in more detail in the impact assessment (see especially section 
4 of annex 10 to the IA, on the comparison of the policy options in terms of proportionality). 

3.2 Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

Yes,  this  Directive,  focusing  on  the  alleviation  of  the  burden  of  proof,  reflects  the  Commission’s 
targeted  approach  of  ensuring  that  victims  are  not  less,  but  also  not  more  protected  due  to  the 
involvement  of  AI.  Any  shifts  in  the  risk  and  cost  distribution  between  affected  stakeholders  that 
would go beyond counter-balancing the specific proof-related challenges of AI are thus avoided, and 
Member States’ well-established liability systems are respected to the maximum extent possible. In a 
second  stage,  under  the  review  clause,  it  will  be  assessed  whether  a  higher  level  of  regulatory 
intervention  is  needed  (such  as  non-fault  liability  or  mandatory  insurance),  subject  also  to  the 

6 

 
 
evolution and deployment of AI-technologies on the market and the emergence of possible incidents 
linked to AI systems.  

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily on 

their own, and where the Union can do better? 

The  Directive  is  limited  to  the  measures  strictly  necessary  to  address  the  AI-specific  problems 
identified.  In  particular,  it would  not  touch  upon the  substantive  conditions of liability  like  fault  or 
causality (which remain in the remit of national law), but focus on targeted proof-related measures 
(disclosure of information and alleviation of the burden of proof through rebuttable presumptions) 
ensuring that victims have the same level of protection as in cases not involving AI. Under the review 
clause,  the  Directive  provides  for  re-assessing  the  need  for  more  stringent  or  more  extensive 
measures at a later stage, without committing to specific outcomes of such review.  

(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 

coherent with the satisfactory achievement of, and ensuring compliance with the objectives 
pursued (e.g. choice between regulation, (framework) directive, recommendation, or 
alternative regulatory methods such as co-legislation, etc.)? 

A  mandatory  instrument  is  able  to  prevent  protection  gaps  stemming  from  partial  or  no 
implementation. While a non-binding instrument presents a less intrusive approach, it is unlikely to 
address the identified problems in an effective manner. Among the binding instruments, a directive is 
the  most  suitable  instrument,  as  it  provides  the  desired  harmonisation  effect  and  legal  certainty, 
while  also being the adequate instrument to enable MS in a flexible manner to fit the harmonised 
measures  without  friction  into  their  national  liability  regimes.  On  the  contrary,  a  regulation  would 
not have allowed for such flexibility in the politically sensitive field of civil law. On these grounds, the 
choice has been made to submit this proposal in the form of a directive.   

(c)  Does the Union action leave as much scope for national decision as possible while achieving 
satisfactorily the objectives set? (e.g. is it possible to limit the European action to minimum 
standards or use a less stringent policy instrument or approach?) 

The Directive achieves the set objectives with a minimally invasive approach. It is focused on burden-
of-proof measures  strictly necessary to address the AI-specific problems identified. It builds on the 
substantive  conditions  of  liability  currently  existing  in  national  rules,  such  as  fault  or  causality,  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  proof,  this  proposal  has  chosen  to  use  rebuttable  presumptions  as  the  least 
interventionist  tool.  However,  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.  Given  that  this 
Directive  follows  a  minimum  harmonisation  approach,  Member  States  remain  free  to  use  in  their 
national law more invasive tools if they deem it appropriate, such as reversals of the burden of proof, 
irrebuttable presumptions, strict liability etc.  

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these costs 
commensurate with the objective to be achieved? 

The Directive will not have implications for the budget of the European Union or its Member States, 
at national, regional or local level. It also does not  impose  specific costs on economic operators or 
citizens.  By  reducing  fragmentation  and  increasing  legal  certainty  regarding  stakeholders’  liability 
internal  risk 
exposure,  the  Directive 

information/representation, 

lowers  stakeholders’ 

legal 

7 

 
 
management  and  compliance  costs,  facilitating  financial  planning  as  well  as  risk  estimates  for 
insurance purposes.  

(e)  While respecting the Union law, have special circumstances applying in individual Member 

States been taken into account? 

By  proposing  a  minimum  harmonisation  approach,  this  Directive  takes  into  account  the  different 
levels of regulatory intervention of Member States as regards the tort liability for damages caused by 
AI  systems.  The  Impact  Assessment  and  the  Comparative  Legal  Study  underpinning  this  proposal 
have assessed the various civil law traditions on tort liability present in different Member States. The 
directive as a legal instrument gives the Member States the needed flexibility when integrating the 
harmonised measures into their national liability regimes.  

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