COMMISSION STAFF WORKING DOCUMENT Evaluation of 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 Accompanying the document Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Application of the Council Directive on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products (85/374/EEC)
Date: 2018-05-07
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: civil liability, defective product, producer's liability, product quality, technological change

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.5.2018  SWD(2018) 157 final  COMMISSION STAFF WORKING DOCUMENT Evaluation of 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 Accompanying the document Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Application of the Council Directive on the approximation of the laws, regulations, and administrative provisions of the Member States concerning liability for defective products (85/374/EEC) {COM(2018) 246 final} - {SWD(2018) 158 final}  
 
 
Table of contents 

1. 

1.1. 

1.2. 

2. 

2.1. 

INTRODUCTION ............................................................................................ 3 

EVALUATION OF PRODUCT LIABILITY DIRECTIVE: PURPOSE AND 
SCOPE .............................................................................................................. 3 

BACKGROUND FOR THE EVALUATION ................................................. 4 

BACKGROUND TO THE INTERVENTION ................................................ 5 

BASELINE AND POINTS OF COMPARISON ............................................. 5 

2.1.1. 

What is the current legal framework? .............................................................. 6 

3. 

3.1. 

3.2. 

3.3. 

4. 

4.1. 

4.2. 

IMPLEMENTATION / STATE OF PLAY ................................................... 10 

DESCRIPTION OF THE IMPLEMENTATION .......................................... 10 

PRODUCTS ABOUT WHICH CLAIMS ARE MADE ................................ 11 

HOW ARE INJURED PARTIES MAKING USE OF THE DIRECTIVE? .. 12 

METHOD ....................................................................................................... 15 

SHORT DESCRIPTION OF METHODOLOGY .......................................... 15 

EXTERNAL STUDY FOR THE EVALUATION ........................................ 16 

4.2.1. 
4.2.2. 

Desk research and literature review .............................................................. 17 
Stakeholders consultation ............................................................................... 18 

4.3. 

4.4. 

5. 

5.1. 

5.1.1. 

5.1.2. 

5.1.3. 
5.1.4. 
5.1.5. 

5.2. 

5.2.1. 
5.2.2. 
5.2.3. 
5.2.4. 

5.3. 

5.3.1. 
5.3.2. 

DATA ANALYSIS ........................................................................................ 19 

LIMITATIONS AND ROBUSTNESS OF FINDINGS ................................ 20 

ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS ..... 21 

EFFECTIVENESS: EVALUATING TO WHAT EXTENT THE PRODUCT 
LIABILITY DIRECTIVE ACHIEVED ITS OBJECTIVES ......................... 21 

Effectiveness towards harmonisation of strict liability rules and an effectively 
operating internal market ............................................................................... 21 
Effectiveness  towards  the  right  for  consumers  to  claim  damages  and 
consumer protection ....................................................................................... 29 
Effectiveness vis-à-vis new technological developments ................................ 32 
Main drivers to the objectives achieved ......................................................... 35 
Conclusion on effectiveness ............................................................................ 36 

EFFICIENCY ................................................................................................. 37 

Analysis of costs ............................................................................................. 37 
Analysis of benefits ......................................................................................... 40 
Balance and distribution between costs and benefits ..................................... 41 
Conclusion on efficiency ................................................................................. 42 

COHERENCE ................................................................................................ 43 

Product safety legislation ............................................................................... 43 
Rules on consumer protection in the area of contractual liability ................. 47 

1 

 
 
5.3.3. 
5.3.4. 

5.4. 

5.4.1. 

5.4.2. 

5.5. 

Rules on applicable law and disputes resolution ........................................... 48 
Conclusion on coherence ............................................................................... 49 

RELEVANCE ................................................................................................ 49 

Relevance  of  the  Directive  to  current  needs,  including  needs  related  to  new 
technological developments ............................................................................ 49 
Relevance of specific provisions of the Directive ........................................... 50 

EU ADDED VALUE ..................................................................................... 57 

5.5.1. 

Conclusion on EU Added value ...................................................................... 60 

6. 

CONCLUSIONS ............................................................................................ 60 

2 

 
1. 

1.1. 

INTRODUCTION 

Evaluation of Product Liability Directive: Purpose and scope 

Directive  85/374/EEC  concerning  the  liability  for  defective  products1  (hereinafter  'the 
Directive)  lays  down  common  rules  for  strict  liability  (i.e.  "liability  without  fault")  of 
producers  for  damage  caused  by  defective  products  at  European  Union  level.  It  allows 
parties that have been injured by defective products to claim financial compensation for 
death, personal injuries or for damage caused to an item of property intended for private 
use  with  a  threshold  of  500  EUR.  The  Directive  provides  the  injured  person  with  an 
extra-contractual  regime  of  liability2.  It  does  not  cover  contractual  liability,  which  is 
imposed on an entity by the terms of a contract. 

The strict liability regime put in place by the Directive implies that liability is imposed 
on the producer regardless of any fault on his part (such as negligence or intention). 

The  purpose  of  this  evaluation  is  to  assess  the  functioning  and  the  performance  of  the 
Directive  for  the  period  2000-2016,  as  it  was  never  evaluated.  It  covers  the  EU-28 
Member States. 

According to the Better Regulation principles, this evaluation assesses the effectiveness, 
efficiency,  coherence,  relevance  and  EU  added  value  of  the  Directive.  In  fact,  the 
evaluation  assesses  retrospectively  the  functioning  and  performance  of  the  Directive. 
However, the evaluation also investigates whether the Directive remains fit-for-purpose 
vis-à-vis  emerging  digital  technologies  such  as  the  Internet  of  Things  and  autonomous 
systems.  For  this  purpose,  the  evaluation  examines  to  what  extent  it  has  been  used  in 
Member  States  when  it  comes  to  damage  caused  by  advanced  robots,  autonomous 
systems,  Internet  of  Things,  defective  apps  or  other  non-embedded  software.  In  this 
context,  this  evaluation  also  assesses  whether  the  objectives  and  requirements  of  the 
Directive are still fit for purpose in light of these technologies. 

The results of this evaluation will inform the Commission’s further approach to product 
liability by clarifying whether the Directive is functioning well, whether guidance on and 
clarification  of  certain  concepts  are  necessary,  or  to  see  whether  certain  adaptations  of 
the Directive may be of value to ensure the Directive’s continued value to the EU legal 
framework. 

1  

2  

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,  as 
modified by Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 
(OJ L 210, 7.8.1985, p.29 and JO L 141 4.6.1999, p. 20) 
Extra-contractual  liability  is  set  outside  of  a  contract,  for  example  directly  in  imposed  pieces  of 
legislation or through common law as types of :   
a)  Liability arising from an offense: The person who committed the offense will be liable in front of 
the injured party or responsible for the damage he/she caused to the party without any contractual 
agreement between them. An offense can be an intentional act or negligence; 
b)  Liability  in  the  absence  of  an  offense:  In  liability  without  an  offense,  a  person  may  be  liable 
notwithstanding that the damage caused was unforeseeable. For example, the occupier of a building 
shall  be  liable  for  any  damage  caused  by  objects  falling  from  it.  Sometimes,  not  only  one  party 
should  be  held  liable.  For  example,  where  two  motor  vehicles  have  a  collision  and  each  of  the 
vehicles shall be deemed to have contributed equally to the accident, the owner of each vehicle shall 
bear half of the total amount of the damage resulting from the accident. 
c) Liability for the action of others: if a person is liable for another person by law he/she is bound to 
compensate the injured party (e.g. a parent is liable under law if his child incurs liability).  

3 

 
 
                                                            
 
 
 
1.2. 

Background for the evaluation  

The  Directive  was  adopted  in  1985  and  since  then  the  European  Commission  has 
regularly  reported  to  the  Council  and  Parliament  on  the  main  issues  related  to  its 
application pursuant to Article 21 of the Directive3. This Article obliges the Commission 
to  report  every  five  years  to  the  European  Parliament  and  to  the  Council  on  the 
application  of  the  Directive  and,  if  necessary,  to  submit  appropriate  proposals.  This 
evaluation accompanies the fifth report4.  

In  the  fourth  report  (covering  the  period  2006-2010),  the  Commission  highlighted  the 
contribution  of  the  Directive  in  maintaining  the  balance  of  interests  between  producers 
and consumers regarding the liability for defective products. The Commission pinpointed 
that national experts and stakeholders had underlined the importance of having balanced 
liability  instruments  governing  the  relationship  between  companies  and  consumers. 
However, the parties concerned had expressed differing opinions on the effectiveness of 
specific  provisions,  notably  about  the  burden  of  proof,  the  defence  of  regulatory 
compliance,  the  development  of  risk  defence  and  the  EUR  500  threshold  for  property 
damage.  

Organisations representing consumers, for instance, claimed to be unfairly disadvantaged 
by  the  burden  of  proof  in  product  liability  claims  and  stressed  the  difficulties  to 
investigate claims properly or to gain access to essential information especially in case of 
technical  products.  Moreover,  consumer  organisations  asked  for  more  protection  at  a 
lower cost, which would imply removing the threshold of EUR 500. On the side of the 
producers  and  insurers,  however,  the  arguments  raised  focused  on  the  risk  that  any 
relaxation of the rules on the burden of proof or on the threshold for property damages 
would lead to more claims for minor damages.    

Facing  the  challenges  of  digital  transformation  and  in  particular  to  facilitate  the 
investment into and the development of the digital economy, questions arose concerning 

3          The Directive does not foresee the presentation to the Commission of national reports.  

4  

To  face  the  lack  of  information  on  the  implementation  of  the  Directive  when  preparing  the 
Commission's  report,  Commission's  services  used  to  submit  a  questionnaire  to  the  national 
authorities  and  to  the  different  categories  of  stakeholders  concerned  by  the  Directive.  The 
questionnaire  raised  points  related  to  its  application  during  the  concerned  period  and  about  the 
problems  encountered.  It  was  addressed  to  the  representatives  of  the  two  experts  groups  of  the 
Commission,  one  composed  of  national  authorities,  the  other  of  stakeholders  (such  as  producers, 
consumers, insurers). It facilitated the task of gathering information and its comparison. 
The  lack  of  information  on  the  application  of  the  Directive  available  to  the  Commission  was  the 
main reason to launch the study for the evaluation. Therefore, the data and information contained in 
this SWD comes mainly from the Study for the evaluation (see footnote 8 for further information).  
Earlier  reports:  First  report  on  the  application  of  the  Council  Directive  on  the  approximation  of 
laws, regulations and administrative provisions of Member States concerning liability for defective 
products, COM (95) 617 final of 13 December 1995;  
Green Paper of the Commission "Liability for defective products". COM(1999) 396 final of 28 July 
1999  
Second report on the application of the Council Directive on the approximation of laws, regulations 
and  administrative  provisions  of  Member  States  concerning  liability  for  defective  products,  COM 
(2000) 893final of 31 January 2001 
Third report on the application of the Council Directive on the approximation of laws, regulations 
and  administrative  provisions  of  Member  States  concerning  liability  for  defective  products,  COM 
(2006) 496final of 14 September 2006 
Fourth report on the application of the Council Directive on the approximation of laws, regulations 
and  administrative  provisions  of  Member  States  concerning  liability  for  defective  products.  COM 
(2011) 547 final of 8 September 2011. 

4 

 
                                                            
 
 
 
 
 
 
the  clarity  of  the  legal  framework,  in  particular  the  scope  of  the  Directive  to  deal  with 
liability issues for  IoT devices and complex autonomous systems. 

In  its  Digitising  Industry  Communication5,  the  Commission  indicated  that  it  would 
examine  in  greater  detail  the  emerging  issues  of  data  ownership,  access  and  re-use  as 
well  as  the  legal  conditions  of  safety  and  liability  related  to  the  specificities  of  the 
Internet  of  Things,  robotics  and  automated  systems  (such  as  robots,  highly  automated 
cars,  distribution  intelligence  as  part  of  the  smart  grids).  The  uptake  of  the  Internet  of 
Things  may  create  challenges  with  respect  to  liability  for  damages  of  the  economic 
players.  In  this  context,  interested  parties  also  raised  questions  about  the  allocation  of 
liability in the Internet of Things6.  

This  evaluation  was  launched  in  June  2016.  It  takes  into  account  the  European 
Parliament's  Resolution  with  recommendations  on  Civil  Law  Rules  on  Robotics  of 
February 20177.  

This evaluation builds on a study carried out by an external contractor8. The final report 
of  the  Study  for  the  evaluation  of  Directive  85/374/EEC  has  been  approved  by  the 
Commission's services in February 2018.   

2. 

2.1. 

BACKGROUND TO THE INTERVENTION  

Baseline and points of comparison  

When the Commission proposed the Directive, it considered that a legal approximation 
of Member States’ laws was necessary to protect consumers against damages caused to 
health  and  property  by  defective  products.  Before  the  Directive,  a  consumer  was 
protected by damages caused by defective products according to the legal conditions of 
the  individual  Member  States.  These  provided  different  degrees  of  protection.  The 
Commission  further  considered  that  an  equal  and  adequate  protection  of  the  consumer 
could  be  achieved  only  through  the  introduction  of  liability  irrespective  of  fault  on  the 
part of the producer of the defective product that caused the damage. Any other type of 
liability  would  have  created  almost  insurmountable  difficulties  of  proof  to  the  injured 
party or might not have covered the most important causes of damage.  

By striking a fair balance of risk between consumers and producers, the Directive aims at 
reconciling  consumers'  interests  with  the  interests  of  producers'  in  line  with  the  Single 
Market policies, notably for the free circulation of goods and a fair competition. It seeks 

5  

6  

7  

8   

Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions - Digitising European Industry 
Reaping the full benefits of a Digital Single Market (COM(2016) 180 final) of 19 April 2016. 
Commission Staff Working Document- Advancing the Internet of Things in Europe, accompanying 
the  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions " Digitising European Industry- 
Reaping the full benefits of a Digital Single Market (SWD(2016) 110/2) of 19 April 2016. 
European Parliament Resolution of 16 February 2017 with recommendations to the Commission on 
Civil Law Rules on Robotics (2015/2103(INL).  
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fTEXT%2bTA%2bP8-
TA-2017-0051%2b0%2bDOC%2bXML%2bV0%2f%2fEN&language=EN 
A  specific contract was signed by the Commission with Technopolis Consulting Group Belgium in 
the  context  of  the  Framework  contract  N°  ENTR/172/PP/2012/F  LOT  4  (evaluations)  on  19 
December 2016. An amendment of the contract related to the duration was agreed on 14 July 2017. 

        The  Final  report  of  the  Study  for  the  evaluation  of  Council  Directive  85/374/EEC  on  the 
approximation  of  laws,  regulations  and  administrative  provisions  of  Member  States  concerning 
liability for defective products was approved by the Commission's services in February 2018. 

5 

 
 
                                                            
 
to ensure that injured persons are compensated for damages suffered due to a defective 
product.  

Therefore,  the  Commission  considered  that  liability  on  the  part  of  the  producer 
irrespective  of  fault  would  ensure  an  appropriate  solution  to  this  problem  in  an  age  of 
increasing  technicality.  The  producer  could  indeed  include  the  expenditure  incurred  to 
cover this liability in production costs when calculating the price of the product. 

2.1.1.  What is the current legal framework?  

The Directive was adopted on the basis of Article 100 of the EEC Treaty (today Article 
114 TFEU).   

The Directive is considered to create an exhaustive harmonisation for the matters that it 
explicitly  covers9.  Several  matters  are  however  left  to  national  law,  as  for  instance  the 
ceilings for damages resulting in death or personal injury by identical items (Article 16 
(1)), the development risk defence (Article 15.1 (b)) or the rules related to non-material 
damages (Article 9). 

The  intervention  logic  of  the  Directive  is  summarised  in  the  figure  below.  Three  main 
needs  or  drivers  led  to  the  definition  of  three  strategic  objectives,  namely  the  free 
movement of goods, the protection of consumer’s health and property, and an undistorted 
competition among market operators in the single market.  

These three strategic objectives are translated into two specific objectives (common rules 
on  strict  liability  for  producers  and  the  right  for  consumers  to  claim  damages), 
representing  the  operational  orientations  of  the  Directive.  These  strategic  and  specific 
objectives  are  achieved  through  a  set  of  rules  that  were  hence  expected  to  produce 
several key results and eventually trigger a set of impacts. To fully understand how the 
interaction among the above factors works and delivers the promised changes over time, 
the  intervention  logic  also  considers  external  factors  which  may  influence  the 
performance of the Directive.  

9  

For  instance,  CJEU  Judgment  of  25  April  2002,  Case  C-52/00.  Commission  of  the  European 
Communities v French Republic 

6 

 
 
                                                            
 
Figure 1: Intervention logic of the Directive 

Source: Study for the evaluation of the Directive   

Since  this  is  the  first  comprehensive  evaluation  of  the  Directive,  this  evaluation  pays 
specific attention to the impacts of some relevant provisions of the Directive, for instance 
the definition of ‘product’ or ‘defectiveness’ or the allocation of the burden of proof on 
the injured person for obtaining compensation. The objective is to assess whether these 
definitions  and  provisions  are  still  fit  for  purpose,  especially  in  the  context  of  the 
technological  developments  (i.e.  software,  Cloud,  Internet  of  Things,  advanced  robots, 
automated and autonomous systems).  

 The fundamental elements of the Directive are the following (more information can be 
found in Annex 6): 

• 

• 

"Strict liability"(Article 1) means that producers are liable for damages caused by 
a defect in their product independently of whether the defect is due to negligence or 
ill-intent. Producers are liable without fault on their part.  

'Product'  (Article  2)  means  any  movable,  even  though  incorporated  into  another 
movable or into an immovable, including electricity.  

The  Court  of  Justice  indicated  that  the  Directive  applies  to  products  used  while 
providing any service (Case C-203/99)10 but that the liability of a service provider 
does  not  fall  within  the  scope  of  the  Directive  (Case  C-495/10.)11  However,  the 
Directive  does  not  prevent  Member  States  from  applying  national  rules  under 
which a service provider using a defective product is liable for damage thus caused.  

10  
11  

CJEU. Judgment of 10 May 2001. Case C-203/99.Henning Veedfald v Århus Amtskommune.  
CJEU, Judgement of 21 December 2011, Case C-495/11, Dutrueux and Caisse primaire d'assurance 
maladie du Jura. 

7 

Strategic ObjectivesHigh degree of protection of EU consumers against damage caused by a defective product Ensure the free movement of goods without distortion of competitionResultsImpactsSame degree of strict liability of producers for damage caused by a defective product and overall consumer protection•Free movement of goods •Protection of consumers’ health and property•Undistorted competition in the single market between market operators•Havingacommonruleonstrictliabilityontheproducerfordamagesduetoadefectiveproduct•RightofconsumerstoclaimdamagessufferedfromadefectiveproductExternal factorsWidespread mass-market production –new technological developments (i.e. software, Cloud, Internet of Things, advanced robots and automated systems) -supply chain fragmentationEstablishment of a level playing field for businesses and of conditions for the free movement of products within the internal marketNeedsSpecific objectivesRules(Provisions of the Directive)•Definitionofdefectiveproduct,damageandofproducer•Liabilityoftheproducerfordefectsinhis/herproducts•Liabilityfordefectiveproductdoesnotexcludecontractualliability•Applicabilitytoallmovables,includingelectricity•500EURthresholdformaterialcompensationfordeviceusedforprivatepurpose•Burdenofproofliesupontheconsumerastodamage,defectandcausalrelationship•Exclusionofliabilityupongivencircumstances•3-yearlimitationperiodforrecoveryofdamages•Limitationperiodforactionsonliabilityfordefectiveproduct10yearsafterthedefectiveproductwasputoncirculation•MemberStatesarefreetosetforthorexcludeliabilityforproductsthatarenotapparentlydefectivewhenputintocirculationaccordingtothestateofscienceandtechnology(developmentrisks)•Acommonruleonstrictliabilityontheproducerfordamagesduetoadefectiveproduct•ClearrulesfortheconsumertoclaimingcompensationincaseofdamagesfordefectiveproductsEnsure the liability of producers for damage caused by a defective product  
 
 
                                                            
 
  
• 

• 

A product is 'defective' (Article 6) when it does not provide the safety a person is 
entitled to expect, taking all circumstances into account, including the presentation 
of the product, the reasonably expected use and the time when the product was put 
into  circulation.12  This  provision  also  points  out  that  a  product  may  not  be 
considered  defective  for  the  sole  reason  that  a  better  product  is  subsequently  put 
into circulation. 

The main concept of the product liability regime is the defectiveness of the product 
which  is,  in  turn,  related  to  the  expected  safety  of  the  product13.  It  is  irrelevant 
whether the product is fit for purpose or fit for use. This question of fitness for use 
belongs  to  the  rules  related  to  the  sale  of  goods,  outside  of  the  scope  of  the 
Directive.  

'Producer' (Article 3) means the manufacturer of a finished product, the producer 
of any raw material or the manufacturer of a component part and any person who, 
by  putting  his  name,  trade  mark  or  other  distinguishing  feature  on  the  product 
presents  himself  as  its  producer,  as  well  as  any  person  who  imports  into  the 
European Union a product for sale, hire, leasing or any form of distribution in the 
course  of  his  business.  The  producer  defined  as  such  shall  be  liable  for  damage 
caused to consumers by a defect in his product.  

The term "producer" is deliberately broad so that an injured person easily can find a 
liable  person.  In  case  of  an  anonymous  product,  the  supplier  will  be  held  liable 
unless he discloses the identity of the producer.     

The  Directive  foresees  that  where  two  or  more  persons  are  liable  for  the  same 
damage,  they  shall  be  liable  jointly  and  severally,  without  prejudice  to  the 
provisions of national law concerning the rights of contribution or recourse (Article 
5). Pursuant to Article 12, the liability of the producer may not, in relation to the 
injured person, be  limited or excluded by a provision of national law limiting  his 
liability or exempting him from liability. 

  Exemptions  of  liability  (Article  7):  the  Directive  establishes  a  catalogue  of 

defences or circumstances that could exclude liability.  

In  particular,  the  producer  shall  not  be  liable  if  he  proves  some  circumstances, 
including:  

a) 
b) 

that he did not put the product into circulation; or  
that,  having  regard  to  circumstances,  it  is  probable  that  the  defect  which 
causes  the  damage  did  not  exist  at  the  time  when  the  product  was  put  into 
circulation by him or that this defect came into being afterwards; or 

12    Distinction  is  to  be  made  between  product  "liability"  and  product  "safety".  Directive  85/374/EEC 
seeks  to  compensate  ex-post  for  damages  suffered  by  consumers  due  to  a  defective  product. 
However,  there  are  other  pieces  of  European  Union  legislation  that  prevent  damages  ex-ante,  by 
ensuring that products placed on the EU market are safe (for instance, the General Product Safety 
Directive or other  sector-specific  legislation such  as  the directives  related  to  machinery,  electrical 
equipment, radio equipment, medical devices, cosmetics, pharmaceutical products or toys). To the 
extent that safety legislation ensures the safety of products on the market, it will reduce the need for 
consumers to seek for compensation under product liability rules. 
However,  this definition does  not always fit with  all product  categories,  for  example  for products 
such as pharmaceuticals, which by their very nature may be considered as high-risk products. For 
those  products  the (unexpected)  harmfulness  becomes  more relevant  than  the defectiveness of  the 
products as such. 

13  

8 

 
 
 
 
                                                            
 
c) 

d) 

e) 

f) 

that  the  product  was  neither  manufactured  by  him  for  sale  or  any  form  of 
distribution for economic purpose nor manufactured or distributed by him in 
the course of his business; or 
that  the  defect  is  due  to  compliance  of  the  product  with  mandatory 
regulations issued by the public authorities; or 
that the state of scientific and technical knowledge at the time when he put 
the  product  into  circulation  was  not  such  as  to  enable  the  existence  of  the 
defect to be discovered (the so-called Development Risk Clause); or 
in the case of a manufacturer of a component, that the defect is attributable 
to the design of the product in which the component has been fitted or to the 
instructions given by the manufacturer of the product. 

Member States are obliged to include in their transposition laws the circumstances 
listed in Article 7 releasing a producer from strict liability. However, according to 
Article 15(1)(b), each Member State may provide that the producer shall be liable 
even  if  he  proves  that  the  state  of  scientific  and  technical  knowledge  at  the  time 
when he put the product into circulation was not such as to enable the existence of 
a defect to be discovered.  

In the context of defect due to compliance with mandatory regulations, it should be 
noted that compliance with voluntary standards would not provide a defence.  

• 

'Burden of proof' (Article 4): the injured person is required to prove the damage, 
the defect and the causal relationship between defect and damage for the purpose of 
compensation. 

The Court of Justice stated, in Case C-621/1514, that this proof could be facilitated 
by accepting national evidentiary rules according to which certain factual evidence 
may  constitute  serious,  specific  and  consistent  evidence,  even  if  there  is  no 
conclusive scientific evidence to the matter.  

• 

'Damage' (Article 9) for the purpose of the Directive means:  

a) 
b) 

any damage caused by death or by personal injuries, and 
any  damage  to,  or  destruction  of,  any  item  of  property  other  than  the 
defective product itself, provided that it was intended and used for private use 
and consumption with a lower threshold of  EUR 500.  

By subjecting the compensation of damages to property to a minimum threshold of 
a  fixed  amount  (EUR  500),  the  Directive  aims  to  avoid  litigation  in  an  excessive 
number of cases. The Directive limits the compensation for damage to property for 
goods  for  private  use  or  consumption  (as  opposed  to  business  property,  for 
instance, damage caused to a company car would be excluded). 

• 

Time-limits (Articles 10, 11 and 16) 

According  to  Article  10,  a  limitation  period  of  three  years  shall  apply  to 
proceedings for the recovery of damages and the rights conferred upon the injured 
person pursuant to this Directive expire after ten years from the date on which the 
producer put the defective product into circulation (Article 11).  

These time-limits aim at creating a balance between the interests of producers and 
those of injured parties. They are there to give legal certainty and reduce financial 
burdens for producers.   

14  

CJEU. Judgment of 21 June 2017. Case C-621/15. N. W and Others v Sanofi Pasteur  

9 

 
 
                                                            
Any  Member  State  may  provide  that  a  producer's  total  liability  for  damage 
resulting from death or personal injury and caused by identical items with the same 
defect  shall be limited  to an amount  which may not  be  less than 70 million EUR 
(Article 16). 

 

Other liabilities: 

The Directive does not affect any rights an injured person may have according to 
the rules of the law of contractual or non-contractual liability or a special liability 
system existing at the moment when this Directive was notified (Article 13).  

While the Court clarified that Member States may not maintain a general system of 
product liability different from that provided for in the Directive (Case C-52/00)15, 
it  does  not  preclude  the  application  of  other  systems  of  contractual  or  non-
contractual liability based on other grounds, such as fault or a warranty in respect 
to latent defects (Case C-183/00 and C-310/13) 16.  

3. 

3.1. 

IMPLEMENTATION / STATE OF PLAY 

Description of the implementation   

According  to  the  analysis  carried  out  by  the  Commission's  services  on  the  national 
measures  transposing  the  Directive,  all  Member  States  transposed  the  Directive, 
including the amendments brought by Directive 1999/34/EC17.    

Five  Member  States  (Finland,  France,  Hungary,  Luxembourg  and  Spain)  adopted  the 
derogation for "Development risk clause" under Article 15(1) (b), thus providing that the 
producer  shall  be  liable  even  if  he  proves  that  the  state  of  scientific  and  technical 
knowledge at the time when he put the product into circulation was not such as to enable 
the  existence  of  a  defect  to  be  discovered.  However,  the  derogation  has  not  been 
transposed uniformly  across  those Member States.  Two Member States  having  adopted 
the  derogation  without  limitations,  thus  applying  to  all  categories  of  producers  and 
products (Luxembourg and Finland)18, while the others only exclude some categories of 
producers  and  products:  in  Hungary  the  derogation  does  not  apply  to  pharmaceutical 
products;  in  Spain  it  does  not  apply  to  medicinal  products,  foodstuffs  or  food  products 

15  

16  

17  

18  

CJEU.  Judgment  of  25  April  2002.  Case  C-52/00.  Commission  of  the  European  Communities  v 
French Republic.  
CJEU- Judgement of 25 April 2002. Case C-183/00 María Victoria González Sánchez v Medicina 
Asturiana SA. and Judgement of 20 November 2014, Case C-310/13, Novo Nordisk Pharma GmbH 
http://eur-
lex.europa.eu/search.html?DB_NATURAL_DIRECTIVE=1985,374&qid=1519146702874&DTS_
DOM=NATIONAL_LAW&type=advanced&lang=en&SUBDOM_INIT=MNE&DTS_SUBDOM=
MNE 
http://eur-
lex.europa.eu/search.html?DB_NATURAL_DIRECTIVE=1999,34&qid=1519146793581&DTS_D
OM=NATIONAL_LAW&type=advanced&lang=en&SUBDOM_INIT=MNE&DTS_SUBDOM=M
NE  
In Luxembourg, the legislator does not make any distinction; therefore the producer can invoke the 
development  risk  clause  for  any  products,  regardless  of  their  nature.  In  Finland,  according  to  the 
Government proposal regarding the enactment of the Product Liability Act and the implementation 
of  the  Directive,  the  extent  of  the  derogation  has  not  been  explicitly  defined  yet,  so  it  should  be 
interpreted to apply to all products according to the Directive. 

10 

 
 
 
                                                            
 
intended  for  human  consumption.  In  France  the  derogation  only  applies  to  products 
derived from the human body19.   

Some  Member  States  have  introduced  provisions  to  elaborate  some  concepts  of  the 
Directive:  

• 

• 

• 

Austria,  Belgium,  Cyprus  and  Czech  Republic  have  introduced  a  criterion  to 
determine when a product is “put into circulation”,  

Spain, Hungary, Italy, Poland, Portugal and Sweden have set the “reasonable time” 
by which the supplier of the product must inform the injured person of the identity 
of  the  producer  or  of  the  person  who  supplied  him  with  the  product  where  the 
producer of the product cannot be identified, so as not to be treated as its producer; 

Some  Member  States  have  added  other  complementary  provisions.  Germany,  for 
instance,  specified  the  nature  of  damages  that  can  be  indemnified,  while  the 
Netherlands  specified  the  term  for  recourse  against  the  producer  held  liable  for  a 
defect.  

The  Commission  monitored  the  transposition  of  Member  States.  In  this  context, 
infringement  proceedings  were  launched  during  the  reporting  period  for  incorrect 
transposition  of  the  Directive.  One  was  based  on  the  grounds  of  a  national  provision 
providing that the supplier were liable under the same conditions than the producer (Case 
C-327/05),  other  on  the  fact  that  the  thresholds  for  material  damages  was  lower  than 
EUR 500 (Case C-52/00). 

In  the  majority  of  Member  States,  the  national  provisions  implementing  the  Directive 
were  generally  applied  alongside  other  regulations  on  contractual,  non-contractual  or 
other  types  of  liability.  The  coexistence  of  different  product  liability  rules,  which  is 
permitted  under  Article  13  of  the  Directive,  makes  consumer  protection  more 
comprehensive as it will explicitly extend to aspects not covered by the Directive.  

3.2. 

Products about which claims are made   

According to the information collected by the Study for the evaluation of the Directive, 
in the reporting period (2000-2016)20, the Directive was more frequently applied to raw 
materials,  pharmaceutical  products  and  vehicles.  52%  of  cases  relate  to  one  of  these 
categories. As it appears in the table below, raw materials represent 21% of products at 
stake, followed by pharmaceutical products (16%), motor vehicles (15%) and machinery 
(12%).  The cases  submitted to  the CJEU concern  pharmaceutical products and medical 
devices  (67%),  followed  by  electrical  machinery  (17%),  food  and  beverages  (8%)  and 
vehicles (8%).   

19  

20  

For further detail, the Hungarian Civil Code states that the producer of any pharmaceutical products 
is liable even if the state of scientific and technical knowledge at the time when the product was put 
into circulation was not such as to enable detection of the existence of the defect. Along the same 
line,  the  Spanish  Royal  Legislative  Decree  1/2007  of  16  November  2007  states  that  producers  of 
medicinal  products,  foods  or  foodstuffs  intended  for  human  consumption  cannot  invoke  the 
exemption  provided  under  Article  15  §1(b)  of  the  Directive.  In  France,  the  Law  n°  98-389  of  19 
May  1998  modifying  Art.  1386-12  of  the  Civil  Code  states  that  the  producer  cannot  invoke  the 
exemption  when  the  damage  has  been  caused  by  an  element  of  the  human  body  or  by  products 
derived from it. 

    Evaluation of Council Directive 85/374/EEC. Final report, p. 19f. 

11 

 
 
                                                            
Each of the other product categories did not exceed 8% of total cases. Also, due to the 
heterogeneity  of  the  raw  materials  and  machinery  categories,  the  products  in  question 
varied substantially.  

Concerning  new  technological  developments,  the  study  could  only  identify  one  case  in 
Bulgaria  invoking  the  Directive  where  the  claimed  damage  concerned  specifically  data 
but no material damage21. The case was about a storage unit, a product in which software 
and apps from different sources can be installed after purchase. The damage claimed was 
the loss of stored information, due to defects in the external hard disk. The claimant, who 
claimed for a compensation of around €800 (1,600 BGN), was not able to prove that the 
information had been stored on the external disk prior to the occurrence of the defect and 
also to prove the damages caused to him by the loss of the information.  

Table 1: Recurrence of product categories subject of claims over 2000-2016 

Product categories 

Raw materials 

Pharmaceutical products 

Vehicles 

Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof 

Miscellaneous manufactured articles 

Chemicals 

Agricultural goods 

Electrical machinery and equipment and others 

Foods & beverages 

Clothing and accessories 

Cosmetics 

Total 

Total  % 

116 

88 

83 

68 

44 

40 

38 

33 

16 

11 

10 

21% 

16% 

15% 

12% 

8% 

7% 

7% 

6% 

3% 

2% 

2% 

547 

100% 

Source: Study for the evaluation of Directive 85/374/EEC 

According to the available information, no recurrent types of defects have been reported 
in the mentioned categories of products. 

3.3. 

How are injured parties making use of the Directive? 

The Directive does not contain specific provisions in respect of access to the courts for 
injured  parties.  Injured  parties  can  settle  claims  for  damages  following  the  procedural 
rules based on private law in the  different legal systems of the Member States, such as 
litigation  in  court  but  also  through  direct  negotiation  or  other  mechanisms  as,  for 
instance, arbitration or mediation. The information collected by the Commission for the 
application reports and for the evaluation shows that, in general, the parties settle product 
liability  related  claims  through  direct  negotiation  in  46%  of  cases,  whereas  32%  are 
resolved in court and 15% through mechanisms for alternative dispute resolution22. Only 
a small share (7%) of claims under the Directive is decided through other means, such as 
settlements with the insurer of the responsible entity.  

According to the desk  research performed by the contractor, the majority of claims  are 
settled: 

21  
22  

Bulgarian case no. 20942/2012 
Directive  2013/11/EU  on  alternative  dispute  resolution  for  consumer  does  not  apply  to  litigation 
under the Product Liability Directive. 

12 

 
 
 
                                                            
 

 

 

By  direct  negotiation  between  interested  parties  in  Cyprus,  Czech  Republic, 
Croatia, Hungary, Italy, Portugal and Sweden, 

Litigation in a national court in Estonia, Finland, France, Poland and Romania, 

Through a dispute resolution mechanism in Bulgaria, Greece and Lithuania. 

Figure 2: Systems used to settle the claims, EU28, average percentage 

Source: Study for the evaluation of Directive 85/374/EEC 

This  desk  research  performed  by  the  contractor  is  confirmed  by  data  gathered  from 
consumers  and  producers  responding  to  the  open  public  consultation  related  to  the 
evaluation  of  the  Directive.  All  categories  of  stakeholders23  indicate  how  extrajudicial 
arrangements represent a common way to settle cases, and that most cases are settled out 
of court. No significant differences appear when firms are broken down by size.  

Most producers have a general insurance contract covering different risks, including the 
cost  of  compensation  in  case  of  defective  products.  Only  a  small  share  has  a  specific 
insurance contract covering the risks related to the Directive.  

According  to  the  findings  of  the  Study  for  the  evaluation  of  the  Directive,  798  claims 
based  on  product  liability  rules  were  brought  to  national  courts  in  the  Member  States 
during the period of 2000 to 201624.  

The graphic below shows that the number of claims brought to court each year has nearly 
doubled over the period: while it was equal to 30 in 2000, in 2016 it reached 59.  

23  

24  

Around  60% of  consumers  providing  a response  to  the  specific questions  in  the OPC  replied  that 
they  were  not involved  in  a  judicial proceeding  to  claim  compensation for  a  damage  caused  by  a 
defective  product,  whilst  the  remaining  40%  were  involved  in  a  judicial  proceeding.  66.7%  of 
producers providing a response answered that they have received claims for compensation regarding 
damages  caused  by  defective  products  and  that  the  claimant  obtained  compensation  though  an 
extrajudicial arrangement. In addition, it was also indicated by the 71,4% of other participants that 
injured parties have been compensated “rarely” or “never” through a judicial decision. 
Information on national case law was gathered by the external contractor through desk research at 
national  level.  The  information  is  likely  not  complete  and  thus  not  entirely  representative  as 
databases and information available varied from Member State to Member State.  

13 

 
 
 
 
 
                                                            
Figure 3: Number of claims per year, adjusted per new Member State entries 

Source: Study for the evaluation of Directive 85/374/EEC 

In the majority of cases, the producer sued was the manufacturer of a finished product. A 
significant role has been played also by suppliers and importers: as shown in the figure 
below, they have been brought to court almost half as many times as the manufacturers 
of finished products. 

Figure 4: Number of times when producers have been brought to court from 2000-2016 

Source: Study for the evaluation of Directive 85/374/EEC 

According to the Study, claimants quite often invoke the national law implementing the 
Directive, but tort or contract law is also used to decide on compensations for defective 
products. The legislation invoked by the injured persons to raise a claim was, on average, 
contract law in 68% of cases, general tort law in 21% of cases, similar legislation to that 
implementing  the  Directive  in  7%  of  cases,  specific  legislation  in  3%  of  cases,  and 
another legislation in 1% of cases25.  

Around  60%  (476  out  of  798)  of  claims  for  defective  products  were  successful  for 
injured parties from 2000 to 2016. The other cases were decided in favour of producers. 
It seems that there is no particular difference in the level of success of injured parties if 
the case is settled in court rather than out of it.  

25  

This  occurred  in  the  14  Member  States  for  which  information  was  available,  but  particularly 
prevalent is in France, Germany and Greece. 

14 

0510152025303520002001200220032004200520062007200820092010201120122013201420152016The manufacturer of a finished productThe producer of any raw materialThe manufacturer of a component partThe person who, by putting his name, trademark, or other distinguishing feature on the product, presents himself as the producerThe importerThe supplier 
 
 
 
 
 
                                                            
4. 

4.1. 

METHOD 

Short description of methodology 

The evaluation was carried out according to the Commission’s evaluation techniques and 
triangulation  methods  to  ensure  robustness  of  the  information  obtained.  As  much  as 
possible, conclusions are based on results of the consultation activities, official statistics 
and studies.  

The  evaluation  followed  several  steps  to  collect  both  qualitative  and  quantitative  data 
from the relevant stakeholders, and national authorities.  

The following criteria and corresponding questions were identified by the Commission. 

Effectiveness: 

  To what extent does the Directive meet its objective of guaranteeing at EU level 
the liability of the producer for damage caused by a defective product and in turn, 
contributes  to  an  effectively  operating  internal  market  for  goods  and  to  the 
protection of the consumer?  

  In this case, which are the main elements that have contributed to meeting these 

objectives? 

  Are there any aspects/provisions/definitions that have rendered certain aspects of 
the Directive more or less effective than others, and if there are, what lessons can 
be drawn? 

  How  many  cases  have  been  brought  to  courts  on  the  applicability  of  the 

Directive?  Which was the issue in question and the ruling?  

  Has  technical  and  technological  progress  and,  in  particular  the  development  of 

connected objects, affected the effectiveness of the Directive?  

  What  are,  if  any,  the  consequences  or  effects  (either  positive  or  negative)  that 

were not originally planned? 

Efficiency: 

  What are the regulatory (including administrative) costs for relevant stakeholders 
stemming from the Directive and how do they compare to the benefits? Are the 
benefits achieved at reasonable costs (with focus on SMEs)? 

  Are  the  benefits  achieved  at  reasonable  cost  for  consumers?  Does  the  Directive 
strike the right balance between the strict liability of the producer and the burden 
of proof placed on consumers? 

  What  factors  influenced  the  efficiency  of  reaching  the  achievements  which  the 

Directive sets out?  

Coherence: 

  To what extent are there complementarities between the Directive and any other 
Union action, in particular initiatives in the context of DSM? To what extent are 
they coherent? 

  To what extent is the Directive coherent with wider EU policy, such as the free 
movement of goods and/or the protection of the consumers, including EU product 
safety legislation? 

15 

 
  To what  extent is the  intervention consistent  and coherent with  the EU rules  on 
consumer  protection  in  the  area  of  contractual  liability  (including  new 
Commission initiatives in the digital context26)? 

Relevance: 

  To what extent do the initial objectives correspond to the current needs, including 

new needs created by innovative products? 

  To  what  extent  is  there  a  need  to  clarify  or  modify  the  concept  of  product, 
producer, defective, damage or the category of exemptions in the Directive? 

  How well is the term "defective" in the Directive adapted to new technological or 
scientific  advances  such  as  apps  and  non-embedded  software,  advanced  robots 
and autonomous/intelligent systems? 

  How well adapted is the intervention to the changing market environment: often 
blurred  distinction  between  private  and  professional  use  of  products  and  the 
servitisation of products when products and services are often sold and consumed 
together? 

  How has the strict liability been allocated in case of damage caused by a product 

which is interconnected with other products or services in the IoT? Why? 

  How  has  the  strict  liability  been  allocated  when  the  damage  comes  from  the 
unintended behaviour of an autonomous system or an advanced robot? Why? 

EU added value: 

  What  is  the  added  value  of  the  Directive  for  stakeholders  (manufacturers, 
including  software  developers  and  economic  operators  in  the  DSM,  and 
consumers)? 

  To  what  extent  does  the  issue  of  strict  liability  addressed  by  the  Directive 

continue to require action at EU level? 

  What would be the most likely consequences of reducing the scope of the existing 

EU intervention? 

The  study  for  the  evaluation  of  Directive  85/374/EEC  was  carried  out  by  an  external 
consultant27.   

4.2. 

External study for the evaluation 

An  external  supportive  study  on  the  Directive  aimed  to  assess  its  functioning  and 
performance and to identify potential shortcomings and whether improvements should be 
envisaged  was  launched.  It  covered  the  time  period  of  2000-2016  and  the  Directive’s 
application in the 28 Member States. A specific focus lay on its application with regards 
to  new  technological  developments,  such  as  the  Internet  of  Things  and  autonomous 
systems.  The  assessment  was  done  according  to  five  criteria:  effectiveness,  efficiency, 
coherence, relevance and EU added value.   

    http://ec.europa.eu/justice/contract/digital-contract-rules/index_en.htm 

26  
27       The initial duration of the contract was of 30 weeks. The deadline was extended to 43 weeks by an 
amendment  to  the  contract,  agreed  by  the  parties  on  14  July  2017.  The  final  list  of  evaluation 
questions considered for that Study, addressing the questions identified by the Commission, can be 
found in Annex 3.  

16 

 
 
 
                                                            
During  the  preparation  of  the  study  and  the  evaluation,  the  consultant  encountered 
difficulties  in  obtaining  all  the  relevant  data  from  the  national  courts  and  from  the 
economic  operators  on  its  implementation.  Despite  the  big  effort  and  the  mitigation 
measures to gather more feedback from stakeholders, the rate of responses remained low 
for  the  Open  Public  Consultation  and  the  online  targeted  survey.  In  particular,  the 
conclusions related to the effectiveness and the efficiency parts, are based on qualitative 
rather than quantitative analysis. This was mitigated by the computer assisted telephone 
interviews,  which  were  addressed  to  457  stakeholders,  and  the  face  or  telephone 
interviews  which  provided  an  additional  feedback  from  stakeholders.  These,  together 
with the desk research including studies or literature, were used to validate the collected 
data and results28. 

The most important tools used the for data collection were:  

4.2.1.  Desk research and literature review 

Desk research was mainly conducted by the consultant focused on29: 

 

 

 

 

Judgements of the Court of Justice  and national case law related to the Directive; 

The national legislation transposing the Directive in the 28 EU Member States; 

European Union legislation most relevant to product liability (in particular, product  
safety and consumer protection legislation);  

Literature relevant to the Directive, its policy context and the main issues related to 
its implementation. Mostly, this comprised academic literature.  

The information gathered in preparation of the reports on the application of the Directive 
also served to identify and compare recurrent issues in in the application of the Directive 
since its entry into force.  

Furthermore,  the  Lowels  report  of  2003  on  the  Directive30  as  well  as  the  reflections 
provided  by  the  Study  on  the  emerging  issues  of  data  ownership,  interoperability,  re- 
usability  and  access  to  data,  and  liability31  were  taken  into  consideration.  The  latter 
specifically contemplates matters related to the liability of the Internet of Things, robots 
and autonomous systems. Based on legal analysis, it highlights possible problems, their 
causes and effects and possible ways of dealing with liability in the near future.  

28    More  information  on  the  difficulties  and  mitigation  measures  can  be  found  in  section  4.4 

29  

30  

31    

Limitations and robustness of findings. 
Please refer to the Bibliography (Annex 10) of the Final report for the Study for the evaluation of 
Directive 85/374/EEC for a complete overview of the sources used during the desk research.  
Among this, the Lowels Report:, Product Liability in the European Union, 2003. A Study carried 
out  on  behalf  the  European  Commission  in  order  to  analyse  and  compare  the  practical  effects  of 
different systems applicable in Member States of the European Union regarding procedural aspects 
of claims for defective products. 
Fondazione Rosselli Report: Analysis of the Economic Impact of the Development Risk Clause as 
provided by Directive 85/374/EEC on Liability for Defective Products, 2004. A Study carried out of 
behalf of the European Commission with a view to analyse the economic impact of the development 
risk clause provided in Article 7 e) of the Directive. 
Study on emerging issues of data ownership, interoperability, (re-)usability and access to data, and 
liability.  https://ec.europa.eu/digital-single-market/en/news/study-emerging-issues-data-ownership-
interoperability-re-usability-and-access-data-and 

17 

 
 
 
                                                            
 
4.2.2. 

Stakeholders consultation32 

The  stakeholders'  consultation  followed  the  consultation  strategy  adopted  for  the 
evaluation33.  The consultant performed the following actions:  

 

 

 

 

An  Open  Public  Consultation  (10  January  2017  to  26  April  2017)  addressed  to 
any  interested  stakeholders.  The  consultation  ran  12  weeks  on  the  Commission 
web-site Your-Voice in Europe and consisted of three different questionnaires for 
producers/insurers; consumers; and national authorities, civil society and academia. 
All  three  questionnaires  were  prepared  by  the  Commission's  services  and  were 
available in all official languages. 

The  Commission  received  113  online  replies  and  14  position  papers  that  were 
analysed by the consultant. 

An  online  targeted  survey  (3  April  2017  to  end  May  2017)  aimed  at  collecting 
stakeholders' specific feedback on the application and performance of the Directive 
by  means  of  five  different  questionnaires  for  producers,  suppliers  and  related 
industry  associations;  consumer  associations;  insurers  and  related  associations; 
public  authorities;  civil  society  and  technical  experts  working  in  judicial  matters. 
More  than  400  stakeholders  were  consulted  but  only  26  complete  replies  were 
submitted.  

A computer-assisted telephone interviewing (CATI) (29 May to 14 June 2017), 
consisting of one questionnaire with closed questions targeted to business aimed at 
collecting  feedback  on  producers’,  importers’  and  suppliers’  experience  with  the 
Directive. 457 stakeholders responded. 

61  telephone  or  face  interviews  (3  May  to  end  July  2017)  with  representatives 
from Industry and  SMEs across all sectors, consumers,  insurers, academia, think-
tanks,  consultants,  public  national  administrations  and  also  EU  officials  from  the 
European Parliament and from the Commission. 

For the purpose of collecting data, the consultant set up a network of correspondents in 
the Member States with the aim to gather information on the Product Liability Directive 
for each Member State.  

The Commission organised a Conference on the Evaluation of the Product Liability 
Directive  that  took  place  on  20  October  2017  in  Brussels  (Belgium).  The  Conference 
was  addressed  to  Member  States  and  different  categories  of  interested  stakeholders,  in 
particular  to  those  that  participated  in  the  public  consultation.  The  purpose  of  the 
Conference was to have an exchange of views on the preliminary results of the external 
Study. 

In  addition  to  the  data  collection  tools  foreseen  in  the  consultation  strategy  for  the 
evaluation  of  the  Product  Liability  Directive,  further  information  was  gathered  through 
the  activities  launched  in  the  context  of  the  Building  a  European  Data  Economy 
Communication34.  They  provided  supplementary  information  from  stakeholders  and 

32  
33  
34 

For more detail, see the Synopsis report of the consultation activities in Annex 2 of this document.  
http://ec.europa.eu/DocsRoom/documents/18843  
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social Committee and the Committee of the Regions. Building the European Data 
Economy. COM(2017) 9 final, 10 January 2017. 
Commission Staff Working Document on the free flow of data and emerging issues of the European 
data economy, accompanying the Communication Building a European data economy. SWD(2017) 
2 final. 

18 

 
  
                                                            
 
Member States on their views on the adequacy of the Directive for the new technological 
developments. Among those: 

 

Liability  part  of  the  Open  public  consultation  "Building  a  European  Data 
Economy" (10 January to 26 April 2016).     

  Workshop  with  the  Member  States  on  the  emerging  issues  of  the  data  economy 
follow-up  to  the  Communication  'Building  a  European  Data  Economy',  31  May 
2017, Brussels, Belgium. 

  Workshop  on  "Liability  in  the  area  of  Autonomous  Systems  and  Advanced 

Robots/Internet of Things-Systems", 13 July 2017, Brussels, Belgium. 

  Meeting of the Internal Market Advisory Committee (IMAC), on 23 October 2017, 
Brussels, Belgium on Data Economy (session Liability). The preliminary results of 
the evaluation study were discussed with member States at this occasion. 

In addition, the Commission's services participated in the following events: 

 

 

Seminar  "Reviewing  the  Product  Liability  Directive"  organised  by  the  British 
Institute  of  International  and  Comparative  Law  of  the  University  of  London 
(Product Liability Forum), 14 June 2017, London, United Kingdom. 

OECD  Conference  on  Artificial  Intelligence-  AI:  Intelligent  Machines,  Smart 
Policies, 26-27 October, Paris, France35. 

4.3. 

Data analysis  

To  assess  the  functioning  and  performance  of  the  Directive  and  to  evaluate  whether  it 
achieves  its  objectives  and  is  able  to  deal  with  new  technological  developments,  a 
number of Evaluation Questions (EQs)36 addressing those identified by the Commission 
have been used to guide the analysis of the contractor: 

• 

• 

• 

• 

• 

35 
36  

Effectiveness:  whether  and  to  what  extent  the  Directive’s  objectives  in  terms  of 
protection of consumers, undistorted competition and free movement of goods have 
been achieved so far at both national and EU levels (EQs 1-3). 

Efficiency: whether the Directive  has  proportionally  delivered its results  in terms 
of resources used, cost and benefits for stakeholders (EQs 4-8). 

Coherence: whether the Directive is consistent with other relevant EU legislation 
and  to  what  extent  the  divergences  (if  any)  prevent  the  achievements  of  its 
objectives (EQs 9-10). 

Relevance:  whether  the  objectives  of  the  Directive  still  correspond  to  current 
problems, needs and challenges. In particular, the study assessed to what extent the 
scope and mechanisms of the Directive allowed addressing the main issues arising 
from new technological developments (EQs 11-15).  

EU Added value: to what extent the results of the EU action are additional to the 
value that would have resulted from action at Member State level (EQs 16-20). 

https://ec.europa.eu/digital-single-market/en/news/synopsis-report-public-consultation-building-
european-data-economy  
http://www.oecd.org/going-digital/ai-intelligent-machines-smart-policies/conference-agenda 
According to the Terms of Reference for the contract, the final report of the Study for the evaluation 
of  Directive  85/374/EEC  answers  to  37  EQs,  11  of  them  are  descriptive  and  related  to  the 
implementation of the Directive.  

19 

 
 
                                                                                                                                                                                 
 
4.4. 

Limitations and robustness of findings 

Several  limitations  were  encountered  for  the  evaluation  of  the  Directive.  First  of  all,  it 
was impossible to compare the current situation with the situation before the entry into 
application of the Directive as the overall economic and legal environment of the EU has 
fundamentally changed since the 1980s and as no data is available from this time.  

It was also difficult to obtain comprehensive data on the use of the Directive in court and 
in out of court settlements in the 28 Member States during the period concerned by the 
evaluation (2000-2016). In particular, the absence of monitoring at national level and the 
special  features  of  each  Member  States  (for  instance,  only  some  of  them  have  public 
databases  or  registers)  rendered  the  research  and  collection  of  information  at  national 
level  very  difficult.  Therefore,  the  collected  data  may  be  incomplete  and  not  fully 
reliable. 

Especially the number of cases resolved in court cited in the study was retrieved from the 
information found by the network of lawyers collecting data for the purposes of the desk 
research conducted in the Study. This number therefore needs to be treated with caution, 
as the information collected depended on specific features of each Member State and of 
the  public  databases  available.  For  instance,  the  French  cases  were  found  through  the 
main  public  legal  databases  that  do  not  list  first  instance  decisions.  Therefore,  the 
analysis for France was limited to the decisions of the courts of appeal and the Supreme 
Court  between  1  January  2000  and  31  December  2016.  For  other  Member  States,  the 
cases were retrieved from commercial and public databases that do not necessarily report 
all  cases.  The  assumption  is  therefore  that  this  number  is  not  fully  representative  and 
underestimates  the  real  dimension  of  claims  based  on  product  liability  rules  in  the 
European Union. 

Out-of-court settlements, including arbitration awards, mediations and direct negotiations 
were either confidential or not listed in official databases. The evaluation therefore bases 
itself  on  the  data  available  for  each  Member  State  which  is  not  likely  to  provide  a 
complete picture of the out-of-court settlements for the reasons mentioned. 

The  consultation  strategy  originally  foresaw  a  balanced  feedback  from  different 
categories  of  stakeholders,  including  a  geographical  balance  and  a  broad  spectrum  of 
products. However, while this has not been possible to achieve across the board and the 
data collected should therefore not be regarded as statistically representative, the targeted 
interviews have mitigated this to the extent possible.  

To complement the data collected, the Commission also participated e.g. in the Product 
Liability Seminar organised by the Product Liability Forum  and organised the  Product 
Liability  Conference  to  discuss  and  verify  the  preliminary  results  of  the  external 
evaluation study.  

Finally, the poor response on the targeted survey hampered the quantification of the costs 
and benefits. These costs and benefits were qualitatively evaluated. The Product Liability 
Directive’s provisions were mapped and discussions developed on whether, compared to 
the  situation  previous  to  its  entry  into  force  (i.e.  in  the  absence  of  it),  these  provisions 
entail a cost rather than a benefit for the relevant stakeholders. All elements provided by 
stakeholders  were  used  for  the  quantification  of  costs  and  benefits,  where  possible. 
Moreover, three cases were analysed to provide quantitative examples of the costs placed 
on producers and consumers due to the Product Liability Directive. However, the limited 
amount  of  information  provided  on  this  aspect  did  not  allow  a  proper  and  reliable 
quantification of costs and benefits to be made.  

20 

 
Despite these shortcomings, a picture of the functioning and performance of the Product 
Liability  Directive  emerged.  For  new  technological  developments  (apps  and  software, 
Internet  of  Things  connected  objects  or  autonomous  systems)  on  the  other  hand,  there 
was limited information available at this stage so that no sufficiently robust conclusions 
can be drawn and further investigation and analysis are needed.  

5. 

ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS 

5.1. 

Effectiveness:  Evaluating  to  what  extent  the  Product  Liability  Directive 
achieved its objectives 

EQ. To what extent does the Directive meet its objective of guaranteeing at EU level the 
liability of the producer for damage caused by a defective product and in turn, contribute 
to  an  effectively  operating  internal  market  for  goods  and  to  the  protection  of  the 
consumer? 

EQ. What are, if any, the consequences or effects (either positive or negative) that were 
not originally planned? 

The  Directive  is  expected  to  ensure  the  right  of  consumers  to  claim  damages  suffered 
from  defective  products,  and  to  create  a  common  and  harmonised  set  of  rules  on  strict 
liability. This should enhance the protection of consumers’ health and property, the free 
movement of goods, and undistorted competition among market operators in the Single 
Market,  thus  producing  a  harmonised  level-playing  field  across  Member  States.  While 
the allocation of the burden of proof foreseen by the Directive appears to have rendered 
claims particularly difficult for consumers, in particular for complex products, no other 
unintended consequences or effects have been identified. 

5.1.1.  Effectiveness  towards  harmonisation  of  strict  liability  rules  and  an  effectively 

operating internal market 

The  analysis  of  national 
the  Directive  carried  out  by 
Commission's  services  shows  that  the  Directive  has  been  uniformly  transposed  in 
Member  States.  Therefore,  compensation  for  damages  caused  by  defective  products  on 
the basis of strict liability is uniformly available to injured parties across the EU.  

transposing 

legislation 

According to the reviewed literature in the Study37, the harmonisation of the rules and the 
judgments  of  the  CJEU  contributed  to  a  harmonised  environment  for  businesses  by 
preventing  distorted  competition  in  the  internal  market.  Stakeholders  have  shared  this 
view. In the context of the consultation activities for the evaluation38, most stakeholders 
deem  the  Directive  effective  in  providing  a  level  playing  field  across  the  European 
Union, by defining the same liability rules in all Member States they export to, which is 
deemed to be a strong advantage. 

37  
38   

    See section 5.1.3 of the Study. 

See Synopsis report on the stakeholders consultation, Annex 2 of this document 

21 

 
 
 
 
 
                                                            
Producers have the same liability rules in all Member States they 
export to  

35

30

25

20

15

10

5

0

Producers
Authorities
Consumers

Strong
advantage
29
20
31

Minor
advantage
7
2
7

Neutral

3
3
9

Minor
disadvantage
1
0
1

Serious
disadvantage
0
0
0

Source: Open public consultation 

The  majority  of  stakeholders  were  aware  of  injured  parties'  right  to  compensation  for 
damage caused by defective products.  

Producers and/or importers into the European Union must 
compensate consumers for damage caused by their defective 
product, regardless of whether producers/importers are at fault or 
negligent.  

40
30
20
10
0

I am aware
I am not aware

Producers
34
6

Authorities
21
4

Consumers
38
10

Source: Open public consultation 

22 

 
 
 
 
 
 
 
 
 
 
 
EQ.  How many cases have been brought to courts on the applicability of the Directive? 

According  to  the  Study,  798  claims  based  on  product  liability  rules  were  brought  to 
national courts in the Member States during the period 2000 to 201639. In the very large 
majority of cases identified, the product at stake had been produced in the same Member 
State where the claim was brought and the defendant was in most cases the manufacturer 
of  a  finished  product  (on  average,  81%  of  claims  for  defective  products);  only  3%  the 
cases  on  average  concerned  products  originating  from  another  Member  State,  with  0% 
involving  products  from  third  countries.  While  the  Directive  is  considered  to  level  the 
playing field in the EU, the study could only identify 21 cross-border cases (i.e. 3% of 
the total). No definite reasons were identified for this in the Study. Lack of knowledge of 
procedural  rules  as  well  as  difficulties  relating  to  possible  language  barriers  were 
identified  as  possible  reasons  that  could  discourage  consumers  from  bringing  a  claim 
against a defendant in the jurisdiction of another Member State. 

5.1.1.1.  Role of specific rules in contributing to the effectiveness of the Directive   

EQ Are there any aspects/provisions/definitions that have rendered certain aspects of the 
Directive more or less effective than others, and if there are, what lessons can be drawn? 

The Directive pursues its objectives through its main provisions. These therefore need to 
be  assessed  in  terms  of  how  and  to  what  extent  they  affect  the  effectiveness  of  the 
Directive.   

According to the analysis of the provisions implementing the Directive, the results of the 
consultation  activities  in  the  context  of  the  evaluation40,  mainly  the  open  public 
consultation,  as  well  as  other  desk  research  carried  out  for  the  Study,  it  appears  the 
following. 

 

Product 

The Directive applies to a broad range of heterogeneous products; from agricultural 
products to highly sophisticated and complex industrial products. This broad notion 
was  considered  to  render  the  Directive  future  proof  by  the  open  public 
consultation’s respondents. As such, the Directive has stood through more than 30 
years of technological evolution. The products that could be found in the European 
market  in  1985  where  the  Directive  was  adopted  may  not  present  the  same 
technical  complexity  or  characteristics  as  they  do  today,  but  they  continue  to  be 
covered  by  the  notion  of  product  set  out  in  the  Directive.  However,  with  the 
increasing  overlap  between  products  and  services,  it  has  been  highlighted  e.g.  by 
the  Study  on  emerging  issues41  that  the  distinction  between  products  and services 

39  

40   
41  

Information on national case law was gathered by the external contractor through desk research at 
national  level.  The  information  is  likely  not  complete  and  thus  not  entirely  representative  as 
databases and information available varied from Member State to Member State. 

See also  Synopsis report of the stakeholders consultation, Annex 2 of this document  
Study on emerging issues of data ownership, interoperability, (re-)usability and access to data, and 
liability.  https://ec.europa.eu/digital-single-market/en/news/study-emerging-issues-data-ownership-
interoperability-re-usability-and-access-data-and 

23 

 
 
 
                                                            
for the purpose of the Directive may become difficult in the future42. A clarification 
of the concept “product”, e.g. with regards to software, may therefore contribute to 
improving effectiveness. This needs further assessment. 

The Directive applies to very heterogeneous products (e.g. to 
damages caused by malfunctioning pacemakers or by defective 
staplers) 

25

20

15

10

5

0

Future-proof
Needs to be adapted
No opinion

Source: Open public consultation 

 

Damages43 

Producers
19
11
10

Authorities
14
8
3

Consumers
21
21
6

The  Directive  applies  to  damages  caused  by  death  or  personal  injuries  and  to 
private property. A threshold of EUR 500 applies. The Directive does not prejudice 
compensation  for  pain  and  suffering  and  other  non-material  damages  under  the 
benefit of national provisions.  

The  CJEU  has  stated  that  a  Member  State  may  not  restrict  the  types  of  material 
damage  for  which  claims  can  be  brought  forward  (Case  C-203/99)  and  this  does 
not seem to be under discussion in Member States. 

Claimants  more  often  seek  compensation  in  court  for  damages  to  physical  well-
being. Even if there is no clear evidence to explain this pattern, one may conclude 
that  damages to  physical well-being have  a  bigger impact on injured persons  and 
such claims are not subject to a financial threshold – and most likely concern larger 
sums anyhow.  

With  regard  to  material  damages  and,  in  particular  to  the  distinction  between 
private and professional use, evidence gathered by the evaluation suggests that the 
claims have been brought at the national level irrespectively of the type of use: the 
number  of  successful  claims  even  if  the  item  was  subject  to  professional  use  is 
higher (150 cases)  44 than the number of claims rejected because the injured party 

See Synopsis Report.  

    See Section 5.1.1.2 of the Study. For more information, see Annex 6. 

42  
43  
44   Member States that did not report claims in which the damages where suffered in the context of a 
professional  activity  were  Czech  Republic,  Estonia,  Ireland,  Latvia,  Malta,  Romania,  Slovak 
Republic, Slovenia, Sweden and United Kingdom. 

24 

 
 
 
                                                            
did  not  use  the  item  of  property  for  his  own  private  use  or  consumption  (23 
cases)45.   

Nevertheless,  concerning  material  damages,  the  effectiveness  of  the  condition  on 
the EUR 500 threshold seems to be questionable: 

Firstly,  there  are  concerns  as  regards  its  national  interpretation.  Some  Member 
States transposed Article 9 of the Directive interpreting the EUR 500 threshold as a 
threshold  which,  when  reached,  would  allow  for  pursuing  compensation  for  the 
entirety of the damage suffered, whereas others (e.g. France, Germany, Netherland 
and  Spain)  transposed  it  as  a  deductible,  i.e.  as  a  sum  to  be  deducted  from  the 
compensation owed without regard to the scale of the damage. This divergence in 
the  interpretation  may  create  a  different  degree  of  protection  of  the  injured  party 
across Member States.  

Secondly,  according  to  the  information  obtained,  in  four  out  of  five  cases  a 
compensation  is  not  claimed  as  the  damage  is  below  the  threshold.  This  could 
explain why this is rarely cited as a reason for rejecting a claim in court and why 
most cases relate to physical well-being.  

Therefore, despite the fact that the Directive seems to be effective and particularly 
for  damages  to  well-being,  the  EUR  500  threshold  represent,  according  to  
consumer representatives, an obstacle for the full effectiveness of the Directive to 
cover claims for compensation in many cases of material damage since claims for 
lower material damages cannot be introduced.  

 

Defect  and burden of proof 

Issues  related  to  the  burden  of  proof  raise  significant  concerns  mostly  among 
consumers46. Claimants find it particularly difficult to prove the defect and the link 
between defect and damage in court.  

The burden of proof is the central component of the Directive that triggers the right 
for compensation.  

According  to  the  Study  for  the  evaluation,  the  most  frequent  reasons  to  reject 
claims relate to the proof of the defect and its link with the damage, which together 
account for 53% of the cases of rejection. Difficulties in applying the definition of 
defective product and subsequently in proving the link between damage and defect 
seem  to  be  particularly  relevant  in  cases  of  complex  products,  such  as 
pharmaceuticals. For those products, the injured party need to gather expertise to be 
able to prove the lack of safety of the product and the link to the damage suffered. 
It  is  therefore  probably  not  surprising  that  all  the  CJEU  preliminary  rulings 
concerned  these  types  of  products  and  many  dealt  with  the  burden  of  proof  in 
recent years. 

According  to  victims  of  medicines  (Stevens-Johnson  Syndrome,  Valproate  or 
Distilben)  the  definition  of  "defect"  is  not  suitable  for  pharmaceutical  products 
because  the  leaflet’s  information  about  the  risk  of  serious  adverse  effects 

45  

Claims rejected because the damaged item of property was subject to professional use occurred in 
the following Member States: -Austria, Belgium, Germany, Hungary, Italy, Lithuania, Luxembourg, 
Netherland and Portugal.  

46   More than half of the consumer representatives responding to the open public consultation for the 
evaluation declared to agree on the fact that it is difficult to prove the defect of a product to obtain 
compensation.  

25 

 
                                                            
exonerates  the  producer  for  these  effects47.  Therefore,  it  is  extremely  difficult  for 
such an injured party to demonstrate the causality and the defect of a medicine in 
connection with the damage. Either the adverse effect of the medicine is unknown 
and it is therefore hard to provide sufficient scientific elements to establish the link 
(causality) and the development risk clause may be invoked, or it is known and was 
therefore published in the leaflet, which means that the medicine was not defective. 
Injured persons potentially find themselves in a Catch-22 situation where they have 
to bear the full cost of damages without access to compensation.  

In  this  respect,  while  the  definition  of  defect,  damage  and  their  link  seem  to  be 
effective for tangible products in general, the distinction between a known risk and 
an unexpected risk – particularly for pharmaceutical products – may be less clear. 

Exceptions of the producer   

According  to  the  Study,  most  respondents  to  the  public  consultation  find  the 
exemptions from liability (such as compliance of a product with mandatory rules or 
the state of scientific and technical knowledge when the product was marketed) too 
advantageous  for  the  producer.  However,  their  effect  in  practice  appears  to  be 
rather limited.  

There  was  little  to  no  evidence  found  by  the  study  on  the  evaluation  that 
compliance of the product with mandatory regulations issued by public authorities 
posed major problems. The development risk clause is much more contested 

Nonetheless,  there  are  arguments  that  the  development  risk  clause  has  played  an 
important  role  in  ensuring  the  balance  between  consumer  expectations  about 
product  safety  and  fostering  innovation  in  Europe,  well  beyond  its  limited  use  in 
courts48.  Furthermore,  the  development  risk  clause  could  represent  a  factor  in 
determining the relative stability of product liability insurance costs for European 
industry  and  keeping  litigation  at  a  reasonable  level.  On  the  other  hand,  the 
evaluation study did not reveal remarkable differences between Member States that 
derogated from this clause and those who did not. 

All  in  all,  despite  some  difficulties  expressed  by  stakeholders,  there  is  no  clear 
evidence on the fact that exceptions represent an obstacle to an effectively internal 
market, neither to consumer protection.  

 

Limitation and expiry period  

During the consultation activities, the three-year period to lodge a claim has been 
challenged by stakeholders: on average, 41% of the businesses and around a third 
of  the  stakeholders  declared  this  limitation  should  be  updated  in  light  of  recent 
technical  developments.  Moreover,  the  majority  of  stakeholders  expressed 
difficulties  in  observing  the  three-year  period  for  making  a  claim  to  recover 
damages in case of complex products, such as pharmaceutical products, that need 
expertise and research to find the defect and the link to the damage.  

As for the 10-year period, the Study for the evaluation has identified issues mainly 
related  to  its  relation  with  the  concept  of  “put  into  circulation”  which  has  been 

47  

48   

The perception of risk and acknowledged risk could be different in case of pharmaceutical products. 
For  pharmaceutical  products,  it  is  a  constituent  element  to  highlight  the  risk  which  are  known  to 
patients 
Study Fondazione Roselli (2004) already mentioned. 

26 

 
                                                            
addressed  in  three  CJEU  judgments49.  Besides  the  clarifications  brought  by  these 
judgments,  some  Member  States  (Austria,  Belgium,  Cyprus  and  Czech  Republic) 
have determined when a product is “put into circulation”. 

The  10-year  period  starts  from  the  moment  a  producer  puts  the  product  into 
circulation.  For  products  that  remain  in  the  distribution  chain  for  a  long  time  or 
deploy their effects over a long time span, the protection of the consumer may be 
reduced in comparison with his or her possible expectations: this is particularly the 
case of pharmaceutical products.  

During  the  Product  Liability  Conference  of  20  October  2017,  representatives  of 
victims  of  medicines  (Stevens-Johnson  Syndrome,  Valproate  or  Distilben)  raised 
the  issue  of  the  unsuitability  of  the  3-  and  10-year  limitation  periods.  The 
asymmetry  of  information  between  patients  and  firms  regarding  adverse  effects 
means  that  victims  may  take  more  than  three  years  after  the  onset  of  a  serious 
adverse effect to prove that the product was defective and that it is related to their 
damage.  Moreover,  victims  of  long-term  adverse  effects  (e.g.  Distilben  affects 
subsequent  generations)  cannot  be  compensated  within  the  10-year  limitation 
period following the entry of the drug onto the market.  

However,  the  number  of  claims  rejected  because  of  the  expiry  of  the  limitation 
period appears to be residual. This suggests that, in general, the limitation periods 
do not hamper the effectiveness of the Directive, except for certain pharmaceutical 
products  for  which  some  doubts  can  be  raised  on  the  basis  of  the  elements 
mentioned above as highlighted in the Product Liability Conference of 20 October 
2017.  

  Most important difficulties to obtain compensation 

According  to  the  information  collected  for  the  previous  Commission's  reports  on 
the application of the Directive, it appeared that the main difficulty for the injured 
party to obtain compensation was the burden of proof, that is, to prove the defect in 
the product and the link between the defect and the damage.  

The  desk  research  undertaken  in  the  context  of  the  Study  showed  that  the  most 
frequent  reasons  for  rejecting  a  claim  for  a  defective  product  are  related  to  the 
burden of proof, and specifically to: i) prove the defect (32% of cases) and ii) prove 
the  link  between  the  defect  and  the  damage  (21%  of  cases).  These  two  concern 
53% of the cases of rejection.  

The causes of rejection connected to liability exemptions for the producer appear to 
be  the  least  frequent  (overall  equal  to  10%  of  cases).  Among  these,  the  most 
recurring liability exemption is the Development Risk Clause of Article 7 (e) (4% 
of cases)50.  

49  

50  

The  CJEU  stated  that  a  medical  device  is  deemed  to  be  “put  into  circulation”  when  it  is  used  to 
provide  the  relevant  medical  service,  and  the  damage  caused  results  from  that  service  (Case  C-
203/99). In a second case concerning vaccines, the Court stated that a product is considered as “put 
into circulation” when it is taken out of the manufacturing process and enters a marketing process 
through  which  it  is  offered  to  the  public  to  be  used  and  consumed  (Case  C-127/2004).  In  a  third 
case, the Court stated that the expiration term of 10 years starts from the moment when the product 
has been put into circulation by the producer and not by the retailer (Case C-45/13). 
The Development Risk Clause (DCR) was used as a cause of rejection of claims more frequently in 
Italy, France, Hungary and Belgium. It should be said that the more cases pass the burden of proof 
test  in  favour  of  victims  the  more  this  exemption  may  become  relevant,  especially  for  complex 
products. 

27 

 
                                                            
Other  reasons  for  rejection  are  the  expiration  of  the  three-year  limitation  period 
(4%),  the  fact  that  the  injured  person  did  not  use  the  product  mainly  for  private 
use/consumption, and that the damage was caused also by the fault of the injured 
person (each equal to  7%). The following figure  shows the total  number of cases 
rejected and the related reasons. 

Figure 5: Reasons for rejection of a claim, EU28 

Source: Study for the evaluation of Directive 85/374/EEC 

This is confirmed by the information collected from the open public consultation, 
which indicates that the main obstacle for consumers to succeed in their claim is 
the burden of proof of the defect of the product and the link with the damage. In 
addition,  many  consumers  find  it  difficult  to  observe  the  three-year  period  for 
making  a  claim  to  recover  damages,  to  exceed  the  threshold  of  EUR  500  for 
property  damages  or  to  distinguish  between  private  and  professional  use  of  a 
product.   

The burden of proof appears to be particularly problematic in the pharmaceutical 
sector as the claimant must use scientific evidence showing that the risk is known 
and because the producer can dismiss liability by indicating the risk in the product 
leaflet.  Accordingly,  the  associations  of  victims  of  medicines  consider  that  the 
three-year and ten years expiry period are too short for a patient to collect all the 
relevant  information  and  documentation  to  prove  the  link  between  product  and 
damage. In addition, the adverse effects of medicines may only become evident a 
long time after consumption.  

The Court of Justice has played an important role in minimising these difficulties 
without  a  reversal  of  the  burden  of  proof  established  by  the  Directive:  Where  a 
product  belongs  to  the  same  group  or  forms  part  of  the  same  production  series 
(such  as  pacemakers  and  implantable  cardioverter  defibrillators)  having  a 
potential defect, they may be classified as defective without any need to establish 
the defect of the individual product. The cost of the operation that is necessary to 
remove  such  a  potentially  defective  product  is  considered  damage  within  the 
meaning of the Directive (Cases C-503/13 and C-504/13).  

Similarly,  the  Court  ruled  that  national  rules  granting  consumers  the  right  to 
require  the  manufacturer  of  a  product  to  provide  them  with  information  on  the 
adverse  effects  of that  product  can be accepted as  they fall outside the scope of 
the Directive (Case C-310/13). Such rules make it easier for the injured person to 
establish  the  liability  of  the  producer.  Also,  the  Court  accepted  national 
evidentiary  rules  whereby  certain  factual  evidence  may  be  considered  by  the 
national court to constitute serious, specific and consistent evidence of a defect of 

28 

110267710021212323144550102030405060708090100110Consumer gave up trying to achieve compensation before the claim was launchedProof of defectProof of the linkProducer did not put the product into circulationThe defect did not exist at the time when the product was marketedThe product was not for sale or for distribution for economic purposesThe defect was due to compliance of the product with mandatory regulationsDRCProducer manufactured only a component, following the instructions of the…The damage was caused also by the fault of the injured personThe injured person did not use the product mainly for private use/consumptionExpiration of the3-year periodExpiration of the 10-year periodOther 
 
 
 
a  product  and  the  causal  link  with  the  damage,  even  if  there  is  no  conclusive 
scientific evidence to the matter. This method should not nevertheless result in a 
reversal  of  the  burden  of  proof  (Case  C-621/15)  but  should  be  recognised  as 
being  an  essential  element,  especially  with  respect  to  adverse  effects  of 
pharmaceutical products, where evidence often is inconclusive, this may facilitate 
matters for injured persons.  

A  further  issue  which  proved  to  be  difficult  to  interpret  relates  to  the  precise 
identification  of  the  time  when  a  product  is  “put  into  circulation”.  This  was  the 
subject  of  three  rulings  of  the  Court  of  Justice  and  appears  to  be  particularly 
relevant for the pharmaceutical sector or for medical devices. In this regard, it is 
relevant  to  recall  that  four  Member  States  (i.e.  Austria,  Belgium,  Cyprus  and 
Czech Republic) have introduced provisions to define when a product is put into 
circulation.   

The  CJEU  stated  that  a  medical  device  is  deemed  to  be  “put  into  circulation” 
when  it  is  used  to  provide  the  relevant  medical  service,  and  the  damage  caused 
results from that service (Case C-203/99). In a second case concerning vaccines, 
the CJEU ruled that a product is considered to be put into circulation when it is 
taken  out  of  the  manufacturing  process  and  enters  a  marketing  process  through 
which it is offered to the public to be used and consumed (Case C-127/2004). In a 
third case, the CJEU clarified that the expiration term of 10 years starts from the 
moment when the product has been put into circulation by the producer and not 
by the retailer (Case C-45/13). 

5.1.2.  Effectiveness towards the right for consumers to claim damages and consumer 

protection 

According  to  the  results  of  the  open  public  consultation,  more  than  85%  of  the 
respondents  consider  that  the  Directive  is  advantageous  for  consumers  and  producers 
because consumers can enjoy the same rights wherever they are in the European Union 
and the product liability rules covered by the Directive are the same in all the Member 
States.  

29 

 
 
 
Consumers can enjoy the same rights in terms of compensation 
wherever they are in the EU  

40

35

30

25

20

15

10

5

0

Producers
Authorities
Consumers

Strong
advantage
32
17
35

Minor
advantage
4
5
10

Neutral

4
3
3

Minor
disadvantage
0
0
0

Serious
disadvantage
0
0
0

Source: Open public consultation 

In addition, 68% of respondents to the open consultation believe that the Directive strikes 
a  fair  balance  between  the  interests  of  producers  and  those  of  the  consumers.  This  last 
view,  relating  to  the  fair  balance  between  the  interests  of  producers  and  those  of  the 
consumers, is also expressly stated in most of the position papers51.  

Do you think that the Directive on liability of defective products 
provides for a fair balance between the interest of producers and 
those of the consumers?  

25

20

15

10

5

0

Producers
Authorities
Consumers

Yes, to a
significant
extent
13
6
18

Yes, to a
moderate extent

No

Not at all

I do not know

20
9
12

2
7
9

0
1
7

5
2
2

51  

See  Brief factual summary on the results of the public consultation on the rules of producer liability 
for damage caused by a defective product. 
http://ec.europa.eu/growth/content/public-consultation-rules-liability-producer-damage-caused-
defective-product-0_en  

30 

 
 
 
                                                            
 
Source: Open public consultation 

However,  when  contrasting  this  information  with  targeted  surveys  and  interviews, 
different  stakeholders  expressed  specific  views  which  painted  a  more  differentiated 
picture.  

With  a  view  to  justify  their  position,  stakeholders  refer  to  different  provisions  of  the 
Directive to support their views. These views are not new; they have been expressed by 
the stakeholders in the context of the preparation of the three last Commission's reports 
on the application of the Directive. Overall, given that the Directive represents a trade-off 
that balances different interests, one can identify opposing views between consumers and 
producers when it comes to the effectiveness of certain concepts.  

For  most  consumer  associations,  the  Directive  is  not  fully  effective,  as  they  consider 
producer's interests to be better protected than those of consumers.52  

Similarly,  consumers  believe  that  the  Directive  is  not  always  effective  in  protecting 
consumers mainly because: 

 

 

 

 

 

claimants  have  to  prove  the  defect,  the  damage  and  their  link,  which  can  be 
burdensome  in  some  fields,  as  for  instance  pharmaceutical  or  complex  products, 
(these  arguments  have  also  been  raised  with  regards  to  new  technological 
developments), 

the  EUR 500 threshold aims to avoiding litigation for small claims,  

compensation of the damage only if the item of property was intended and used for 
private  purpose  and  not  when  the  defective  product  was  used  for  professional 
purposes; 

the  time  limit  of  3  and  10  years  to  obtain  compensation  is  too  short  in  cases  of 
complex products that require more expertise;  

the exceptions to liability in favour of the producers are too advantageous  (such as 
the development risk clause). 

Conversely, producers deem the Directive as effective in protecting consumers because:  

 

 

claimants may request compensation without need to prove the fault or negligence 
of the producer, 

clear identification of the operator(s) to be held liable.  

These  different  views  also  manifest  themselves  in  academic  literature53.  Some  suggest 
that the Directive contributes to consumer protection through the right to claim damages 
suffered  by  defective  products.  Other  scholars,  on  the  other  hand,  consider  the 
Directive’s  protection  less  effective  as  producers  are  rarely  required  to  compensate 
victims -especially in the field of pharmaceuticals54.   

See Synopsis report on the consultation of stakeholders, Annex 2 of this document 

52   
53       See Final report of the Study for the evaluation, in Annex 10 Bibliography. 
54   More specifically, some stakeholders such as the European Federation of Pharmaceutical Industries 
and Associations have indicated that pharmaceuticals should be outside of the scope of the Directive 
and should have a specific liability regime. See section 5.3. 

31 

 
 
 
                                                            
Based on the data available for the Study for the evaluation, it appears that the question 
related  to  the  burden  of  proof  (defect,  damage  and  their  link)  as  well  as  the  EUR  500 
threshold do indeed have an effect in terms of consumer protection, while the impact of 
other  factors  is  less  important.  Courts  have  been  accepting  claims  concerning  products 
that  were  not  intended  for  private  use.  The  ratio  of  liability  claims  per  person  in  those 
Member States that have derogated from the development risk clause is only marginally 
higher than in those Member States that have not. Rejections of claims based on the time 
limitations  appear  to  be  residual,  even  though  clarification  concerning  the  notion  of 
“putting into circulation” may prove useful and avoid conflict. 

In fact, most claims brought to court, appear to be successful for the injured party, while 
in general claims are rather settled out of court. An interpretation of this is that producers 
“fear” the Directive and prefer to settle out of court, rather than facing trial.  

Overall,  there  appears  to  be  agreement  that  the  Directive  is  effective  to  some  extent  in 
contributing  to  consumer  protection  and  a  level  playing  field  across  the  EU.  However, 
certain  provisions  notably  the  burden  of  proof  and  the  EUR  500  threshold  may  create 
difficulties to an effective application of the Directive.  

5.1.3.  Effectiveness vis-à-vis new technological developments 

EQ.    Has  the  technological  progress  and,  in  particular  the  development  of  connected 
objects, affected the effectiveness of the Directive?  

The acceleration of interconnectedness and autonomy of technology raises questions on 
whether the Directive will continue to be effective in a scenario where these technologies 
will become more widespread and advanced.  

In the open public consultation around 50% of producers and consumers stated that the 
Directive  is  adequate  to  cover  their  own  needs  when  dealing  with  innovative 
technological  developments.  This  opinion  was  also  expressed  in  the  context  of  the 
consultation activities launched in the context of the initiative "Building a European Data 
Economy". 55  

55   

See  Synopsis  report  at  https://ec.europa.eu/digital-single-market/en/news/synopsis-report-public-
consultation-building-european-data-economy 

32 

 
 
 
 
 
                                                            
  
 
Do you think that the Directive on liability for defective products 
covers the needs of producers dealing with innovative 
technological developments, such as smart devices, robots or 
automated systems?  

14

12

10

8

6

4

2

0

Producers
Authorities
Consumers

Yes, to a
significant
extent
8
12
5

Yes, to a
moderate extent

No

Not at all

I do not know

13
13
7

8
8
4

0
5
2

11
10
7

Source: Open public consultation 

However,  45%  of  producers,  58%  of  consumers  and  44%  of  the  other  respondents 
(including  public  authorities  and  civil  society)  consider  that  for  some  products  (e.g. 
products  where  software  and  applications  from  different  sources  can  be  installed  after 
purchase, products performing automated tasks based on algorithms, data analytics, self-
learning  algorithms  or  products  purchased  as  a  bundle  with  related  services)  the 
application of the Directive might be problematic or uncertain in particular due to their 
complexity and degree of automation.   

According to your experience, are there products for which the 
application of the Directive on liability of defective products is or might 
become uncertain and/or problematic?  

18
16
14
12
10
8
6
4
2
0

Producers
Authorities
Consumers

Yes, to a
significant
extent
5
5
17

Yes, to a
moderate extent

No

Not at all

I do not know

13
11
11

9
5
8

1
0
4

12
4
8

Source: Open public consultation 

33 

 
 
 
 
 
If the application of the Directive on liability of defective products is or 
might become uncertain and/or problematic, which are those products? 

25
20
15
10
5
0

Products
on which
software
and
application
s from
different
sources can
be…

Products
connected
to the
internet

Products
purchased
as a bundle
with
related
services

Products
that are
used both
in the
private and
professiona
l life

Products
performing
automated
tasks based
on
algorithms
and data
analysis
(e.g. cars…

Products
performing
automated
tasks based
on self-
learning
algorithms
(Artificial
Intellige…

Products
shared with
other users
through
collaborati
ve
platforms

Other

No Answer

Producers

Authorities

Consumers

15

13

22

8

9

18

11

9

19

8

8

11

12

8

17

10

9

17

9

5

14

2

5

7

22

9

20

Source: Open public consultation 

Feedback from stakeholders shows that a large majority, mostly producers and insurers, 
believe  there  is  no  need  to  update  the  Directive  vis-à-vis  new  technological 
developments.  Businesses  consider  contractual  relations  to  be  appropriate  to  deal  with 
business  to  business  liability  questions.    For  business  to  consumer  relations,  they  do 
acknowledge that difficulties may arise in the future, e.g. on 3D Printing or autonomous 
systems56. On the other hand, the majority of consumers believe that the current rules are 
not fit for new technological developments.  

At  the  Conference  on  Product  Liability,  business  associations  reiterated  that  complex 
value  chains  and  automatisation  are  nothing  new  and  that  the  Directive  is  in  fact 
technology-neutral.  Only  completely  autonomous  systems,  such  as  self-driving  cars 
might  eventually  require  regulatory  changes.  They  cautioned  against  premature 
regulation  without  concrete  evidence  of  real  life  problems.  It  was  for  example 
highlighted  that  in  terms  of  liability  effects  there  is  no  difference  between  using  a  3D 
printer  to  produce  product  parts  or  finished  products,  and  using  other  more  traditional 
machinery  or  manufacturing  methods.  Therefore,  businesses  considered  that,  at  this 
stage, the directive is fit for purpose and that any changes would be premature as some 
technologies such as fully autonomous systems are not even marketed yet.  

Representatives of insurers agreed that the directive is suitable, but that research on what 
safety is with regards to emerging digital technologies is needed. Consumer organisations 
were in favour of a revision of the Directive.  

Also, most Member States have expressed caution against precipitated legislative action 
on  several  occasions;  for  instance,  during  the  meeting  of  the  Internal  Market  Advisory 
Committee (IMAC) of 23 October 2017 or at the Workshop with the Member States on 
emerging issues of the data economy of 31 May 2017. Member States indicated that they 

56  

As  regard  autonomous vehicles,  see  GEAR 2030  - High  Level  Group  on  the  Competitiveness  and 
Sustainable  Growth  of 
. 
https://ec.europa.eu/docsroom/documents/26081/   

the  European  Union-Final  report 

the  Automotive  Industry 

in 

34 

 
 
 
                                                            
prefer  collecting  robust  evidence  of  shortcomings  before  amending  the  current  legal 
framework.  

It  appears  that  there  is  a  need  to  ensure  legal  certainty  for consumers  and  producers  to 
support innovative businesses in this area. 

The  Study  on  emerging  issues  identifies  a  set  of  several  main  specificities  of  new 
technologies  that  challenge  the  product  liability  framework.  These  refer  notably  to 
changing complexities over the lifetime of a product that are no longer controlled by the 
producer  (this  can  be  autonomous,  self-learning  behaviour  or  added  software 
applications). These technologies can also become increasingly intangible.  

For the Directive, this raises mostly questions in terms of whether its current concepts are 
still relevant to grapple these types of situations. 

Based on your experience, is there a need to adapt the 
Directive on liability of defective products for the 
products listed in the previous question?  

30

25

20

15

10

5

0

Yes
No
I do not know

Producers
10
11
19

Authorities
10
7
8

Consumers
26
10
12

Source: Open public consultation 

In  summary, due to  the lack of concrete cases and experience  with  damages caused by 
new  technological  developments,  the  Directive’s  effectiveness  remains  a  highly 
contested  subject.  Any  assessment  has  to  be  purely  abstract  and  further  evidence 
gathering  and  reflection  would  be  necessary  to  arrive  at  a  sound  conclusion  on  the 
Directive’s (in)effectiveness in this respect.  

5.1.4.  Main drivers to the objectives achieved 

EQ Which are the elements that have contributed to meeting the Directive's objectives? 

The  main  drivers  to  the  effectiveness  of  the  Directive  are  related  to  the  level  of 
uniformity  in  its  implementation,  its  role  as  “safety  net”  within  a  broader  legislative 

35 

 
 
 
 
 
 
framework to protect consumers, the level of generality of some provisions that allow for 
flexibility and wide coverage, and the high level of awareness of stakeholders. 

Firstly,  the  principle  of  strict  liability  on  the  producer  in  case  of  damages  caused  by  a 
defective  product  is  applied  in  all  Member  States  with  a  reasonable  uniformity  in  its 
implementation.  Also  the  number  of  cases  in  comparison  to  the  population  of  each 
Member State does not vary so much that one might suspect that in some Member States 
there are interpretations materially more favourable to the injured persons than in others  

Secondly, the Directive is fully integrated into the wider EU legislative framework. Even 
if the number of case law examples identified in the European Union from 2000 to 2016 
can be seen as low, these data need to be interpreted in light of the fact that the Directive 
acts as a “safety net” in the framework of European legislation. Indeed, there are several 
layers  of  protection  which  coexist  and  contribute  to  reducing  the  need  to  invoke  the 
Directive:  first,  the  safety  legislation,  both  general  and  sectorial,  guaranteeing  the 
marketing  of  safe  products  in  the  internal  market;  second,  the  system  of  market 
surveillance;  third,  the  contractual  obligations  and  the  guarantee  available  to  the 
consumer.  

In  addition,  the  Directive  does  not  exclude  any  other  compensation  claim  based  on 
contractual or other extra-contractual liability. 

Thirdly, some provisions of the Directive are general enough to cover a wide variety of 
situations:  

 

 

 

 

Stakeholders’ awareness of the right to seek compensation for damage caused by a 
defective product increases the Directive’s effectiveness.  

The  Directive  does  not  provide  indications  on  the  systems  to  settle  claims. 
Consumers  are  free  to  choose  the  most  effective  system  (either  direct  negotiation 
with the person or entity held liable, alternative dispute resolution methods such as 
mediation and arbitration, or litigation in court. This is one of the strengths of the 
Directive,  allowing  for  adaptation  to  national  contexts  (including  their  judicial 
systems) and specific circumstances.  

The concepts of product and defect cover a vast range of sectors and situations. The 
case  law  shows  that  almost  any  kind  of  movable  can  be  the  subject  of  product 
liability. All in all, evidence suggests there are no difficulties in interpreting what a 
product  is,  even  though  this  may  become  less  evident  if  there  are  services  that 
affect  the  functioning  of  the  product  with  resulting  damage.  In  addition,  a 
clarification  of  the  concepts  of  damage,  in  particular  of  economic  damages,  and 
defect may nevertheless render the Directive more effective in practice. 

The methods for compensation are not defined in the Directive; producers are free 
to use the most useful way of covering their liability.  In fact, most producers have 
a  general  insurance  contract  covering  different  risks,  including  the  cost  of 
compensation in case of defective products.  

5.1.5.  Conclusion on effectiveness 

The Product Liability Directive appears overall to have met its objectives of guaranteeing 
the  producer’s  liability  for  damages  caused  by  a  defective  product,  and,  in  turn,  the 
protection  of  consumers,  while  ensuring  an  effectively  operating  internal  market  for 
goods. Overall, the Directive has reached a reasonable uniformity in its implementation 
and the set of its rules makes it effective. 

36 

 
 
However,  certain  concepts  of  the  Directive,  would  benefit  from  clarification  to  ensure 
legal certainty. This relates, as highlighted above, to the concept of product in the context 
of  new  technological  developments  with  regards  to  the  increasing  overlap  between 
products and services as well as with regards to software, the concept of damage or the 
concept of defect in particular in relation to complex products such as pharmaceuticals. 
In addition, with regard to emerging digital technologies further evidence is necessary.  

5.2. 

Efficiency  

EQ.  What  are  the  regulatory  (including  administrative)  costs  for  relevant  stakeholders 
stemming from the Directive and how do they compare to the benefits?  

As  pointed  out,  the  data  collected  for  the  purpose  of  the  evaluation  should  not  be 
regarded  as  complete.  This  section  is  therefore  rather  based  on  qualitative  than 
quantitative analysis57.  

5.2.1.  Analysis of costs  

The relevant stakeholder groups affected by the Directive and its related obligations are 
producers, consumers, and Member States authorities. 

The main costs entailed by the Directive are mapped in table below, explained more in 
detail in the following paragraphs.  

Table 2: Mapping of costs due to the Directive 

Types of cost 

Provision 

Enforcement costs 

(e.g. court fees, lawyers’ and 
experts’ fees) 

Given that the Directive is a private law 
instrument, it leaves to the parties (and 
specifically to consumers) the burden to 
“enforce” its rules, i.e. to raise a claim in 
case of damage caused by a defective 
product.  

Stakeholder 
affected 

Consumers, 
producers. 
Member States 
affected only in 
case of in-court 
settlement  

Substantive compliance 
costs (e.g. the amount of 
compensation to be paid) 

Strict liability of producer (Art. 1) 

Producers 

Burden of proof (Art. 4) 

Consumers 

Joint liability of producers (Art. 5) 

Producers 

EUR 500  threshold (Art. 9) 

Consumers 

three-year limitation period (Art. 10) 

Consumers 

57  

To help to a better comprehension, the Study for the evaluation presents the costs related to three 
cases three cases studies. 

37 

 
 
 
 
 
 
 
                                                            
Types of cost 

Provision 

Stakeholder 
affected 

10-year limitation period (Art. 11) 

Consumers 

Administrative burden58 

Communicate to the Commission the 
derogation to Art. 7(e) (Art. 15(2)) 

Member States 

Indirect costs59 

Not required by any Directive provision 

Producers 

(e.g. specific liability 
insurance, reputational costs) 

Source: Study for the Evaluation of the Directive 85/374/EEC 

Enforcement costs 

The Directive does not provide specific details and procedures on how to settle claims for 
damages  caused  by  defective  products,  and  most  of  the  settlements  occur  out  of  court, 
with  negotiations  between  the  parties.  Therefore,  the  enforcement  costs  related  to  the 
Directive can be of two types, based on whether the claim is settled in court or out-of-
court. 

If  the  claim  is  settled  in  court,  the  enforcement  costs  are  comprised  of,  for  instance, 
lawyers’,  bailiffs’  and  experts’  fees,  court  fees,  taxes,  and  all  costs  related  to  judicial 
proceedings.  These  costs  vary  considerably  across  Member  States,  and  depend,  among 
other  factors,  on  the  type  of  litigation,  the  overall  length  of  the  proceeding,  the 
compensation amount, the court and the final decision. For instance, civil proceeding fees 
can range from less than EUR 200 (e.g. in Belgium, Estonia and Sweden), to over EUR 
1,000 (e.g. in Hungary and Slovakia).60 

By way of example, these costs vary on the basis of the final decision as usually fees are 
reimbursed  (wholly  or  in  part)  if  the  claimant  is  successful.  Enforcement  costs  of  this 
type  primarily  weigh  on  consumers,  on  producers  or  on  the  insurance  company  (if  the 
producer  has  a  specific  insurance),  and  partly  on  national  budgets,  as  courts  are  public 
institutions and not all court costs may be fully covered by court fees. 

In case that the claim is settled out of court, the enforcement costs are related to lawyers’ 
and  experts’  fees,  and  may  also  include  mediation  or  arbitrators’  fees.  This  type  of 
enforcement costs weighs on consumers and producers (or insurance companies). 

A general quantification of enforcement costs is not possible due to data limitations and 
to the fact that they are determined on a case-by-case basis based on specific systems of 

58  

59  

60  

Administrative  burdens  are  costs  borne  by  businesses,  citizens,  civil  society  organisations  and 
public  authorities  as  a  result  of  administrative  activities  performed  to  comply  with  information 
obligations included in legal rules. 
These costs are experienced by consumers, government agencies or other stakeholders that are not 
directly targeted by the Directive.  
For  instance,  in  a  case  between  a  producer  and  a  buyer  involving  EUR  20,000  worth  goods,  the 
majority  of  Member  States  present  fees between  EUR  400  and  EUR  800.  The  calculation  of  fees 
depends  on  several  factors,  and  largely  varies  across  Member  States.  In  Finland,  for  instance, 
proceeding  fees  depend  on  the  stage  of  the  proceedings.  Some  Member  States  (e.g.  France, 
Luxembourg  or  Sweden)  may  not  have  fees  at  the  appeal  stage;  in  some  countries  (e.g.  Czech 
Republic,  Poland  or  Slovak  Republic)  fees  for  the  appeal  are  the  same  as  those  due  for  the  first 
degree proceeding. See Study for the evaluation of the Directive. 

38 

 
 
                                                            
each  Member  State  jurisdiction.  However,  these  costs  (including  procedural,  court, 
experts and lawyers’ fees) mainly are determined by national praxis and judicial systems 
– not the Directive. 

Substantive compliance costs  

The Directive attempts to strike a balance between consumers’ and producers’ interests. 
Its costs are a trade-off: the benefit of one is the other’s cost.  Compliance costs related to 
the Directive are detailed below per category of stakeholder: 

Producers:  

  Strict liability (Article 1): introduces a cost that –if the claim is successful- will be 
equal to the amount of compensation to be paid. This cost is case-dependent.  

Consumers:  

  The  burden  of  proof  (Article  4):  This  provision  is  the  stepping  stone  to 
compensation  for  damage  but  also  appears  to  be  the  most  burdensome  to 
consumers.  The costs related to the burden of proof varies from sector to sector. 
Particular  difficulties  were  highlighted  for  pharmaceuticals.  One  of  the  major 
problems  appears  to  be  related  to  the  demonstration  of  the  link  between  the 
damage and the defect61; 

  The EUR 500 threshold (Article 9) represents a cost for consumers (and a benefit 
for  the  producer)  inasmuch  as  it  prevents  any  claims  (and  related  possible 
compensation) under EUR 500 from being raised, which is often the case.  

  The three-year limitation period (Article 10) for the recovery of damages entails a 
cost for consumers (and a potential benefit for the producer) in terms of missed 
compensation.  

  The 10-year limitation period (Article 11) to make a claim from the date on which 
the producer put into circulation the product which caused the damage potentially 
entails  a  cost  in  terms  of  missed  compensation.  This  provision  is  particularly 
costly  in  the  case  of  damages  caused  by  defective  pharmaceutical  products  that 
are amongst the products most frequently subject of claims.  

Administrative burden 

The  Directive  foresees  an  information  obligation  in  Article  15(2),  requiring  Member 
States  to  inform  the  Commission  in  case  they  derogate  to  the  development  risk  clause 
(i.e.  to  Article  7(e)).  This  cost  is  deemed  to  be  residual.  It  only  requires  a  simple 
transmission of information. 

The  Commission  received  no  comments  on  the  administrative  burden  related  to  the 
implementation of the Directive. Given that the implementation costs of the Directive are 
residual, one can conclude that there is no simplification potential. 

61  

This was recognised by the consumers, public authorities and civil society responding to the open 
public consultation and to the targeted survey. 

39 

 
 
 
 
 
                                                            
Indirect costs 

Indirect costs are not introduced by the Directive, but are its direct consequence. These 
costs  affect  producers  and  mainly  relate  to  the  payment  of  insurance  premiums  related 
specifically to strict liability.  

Responses to the consultation show that these costs are basically unchanged from 2000, 
also considering sectors characterised by new technological developments. The coverage 
offered  by  strict  liability  insurances  varies  from  one  case  to  another.  For  instance,  in 
Denmark and France, product liability insurance usually covers damages resulting from 
the  defective  product,  the  costs  of  the  technical  analyses  made  by  the  expert  and  the 
proceeding costs. Therefore, the producer is fully covered and does not need to bear any 
additional expenses. In Germany, insurance offers seem to be more differentiated and the 
product liability insurance may, for instance, cover damage compensation until a certain 
limit, and cover in addition the extra costs (expert, lawyer, proceeding costs) or cover up 
to a certain limit both damage compensation and proceeding costs. 

Reputational costs  and Research and Development  (R&D) costs are definitely relevant, 
especially  for  those  manufacturers  that  produce  robotic  devices.  Indeed,  investments  in 
research  and  development  could  lead  to  the  creation  of  products  with  a  certain 
technological added value, but also with high liability risk. In these cases, producers tend 
to  delay  the  introduction  of  the  products  to  the  market,  up  to  the  moment  when  the 
technology is considered safer to avoid potential reputational damages.62  

5.2.2.  Analysis of benefits  

The Directive has set the basis for a common rule on strict liability of the producer and 
for consumers’ right to claim compensation for damages due to a defective product.  

As  it  is  the  case  with  the  costs,  the  assessment  of  benefits  is  based  on  a  qualitative 
analysis. A summary of the analysis appears in the table below:  

Table 2: Mapping of benefits 

Types of benefit 

Provision 

Stakeholder affected 

Improved well-being 

Strict liability of producer (Art. 1) 

Consumers  

Joint liability of producers (Art. 5) 

Market efficiency63 

Burden of proof (Art. 4) 

Producers 

Exemptions (Art. 7) 

EUR 500 threshold (Art. 9) 

Three-year limitation period (Art. 10) 

10-year limitation period (Art. 11) 

62  

63  

RoboLaw (2014). Regulating Emerging Robotic Technologies in Europe: Robotics facing Law and 
Ethics  -  Collaborative  project  (CP),  FP7-SiS-Challenge  1-3:  Regulating  emerging  scientific  and 
technological developments. 
This  might  include  improved  allocation  of  resources,  removal  of  regulatory  or  market  failures  or 
cost savings generated by new initiatives/regulation. 

40 

 
 
                                                            
Types of benefit 

Provision 

Stakeholder affected 

Increased 
harmonisation64 

Compliance with the Directive (Art. 
19) and harmonisation through the 
cases of the CJEU 

Consumers; 

Producers, including 
suppliers and importers. 

Source: Study for the evaluation of Directive 85/374/EEC  

Consumer's improved well-being 

The strict liability of producer represents a clear benefit for injured parties. Since 1985, 
consumers  enjoy  the  right  to  obtain  compensation  for  damage  caused  by  a  defective 
product  directly  from  its  producer.  Consumers’  claims  have  been  successful  in  60%  of 
the  cases  examined  in  the  context  of  the  Study  for  the  evaluation.  Therefore,  the 
Directive has increased consumer protection. 

This  has  been  confirmed  by  the  results  of  the  public  consultation,  since  stakeholders 
strongly  agree  that  consumers  can  enjoy  the  same  rights  in  terms  of  compensation 
wherever they are in the European Union. 

Market efficiency 

With  the  aim  to  ensure  an  effective  internal  market,  the  Directive  provisions  entailing 
benefits for producers are those related to the existence of burden of proof, the 500 EUR 
threshold  and  the  three-  and  10-year  limitation  period,  as  these  provisions  limit  the 
possibility  for  consumers  to  claim  for  compensation.  More  in  particular,  the  500  EUR 
threshold limits the number of claims that can be raised against producers.  

In addition, the exemptions provided in Article 7 are beneficial to producers as they limit 
the producer’s liability in certain cases, even if a defective product has caused damage. It 
is up to the producer to demonstrate that he is not liable due to one of these exemptions. 
Five  member  States  have  derogated  from  the  development  risk  clause  thus  potentially 
disadvantaging producers in these countries – even though there was no significant data 
to confirm this argument.   

The  benefits  related  to  these  provisions  translate  into  the  development  of  a  clear  and 
stable  legal  framework,  confirmed  by  the  results  of  the  open  public  consultation.  
Stakeholders  strongly  agree  that  the  level  playing  field  created  by  the  Directive  is  a 
benefit.  

Increased harmonisation 

The  increased  harmonisation  stemming  from  the  Directive  is  a  benefit  that  most 
stakeholders  consulted  perceived.  Indeed,  the  large  majority  of  the  respondents  to  the 
open public consultation believe that the fact that consumers can enjoy the same rights in 

64  

This refers to the creation of a level-playing field for producers and consumers, guaranteeing at EU 
level the liability of the producer in all Member States, and ensuring an increased homogeneity of 
procedures.  

41 

 
 
 
 
 
 
                                                            
terms of compensation is a strong advantage, together with the fact that Member States 
cannot  implement  different  product  liability  rules  than  those  already  covered  by  the 
Directive for national producers and that would lead to different levels of protection.  

5.2.3.  Balance and distribution between costs and benefits 

EQ.  Are  the  benefits  achieved  at  reasonable  cost  for  consumers  and  producers  (with 
focus on SME)? 

The relevant costs for consumers are equal to enforcement costs as well as the costs they 
bear  for  the  financial  threshold,  time  limitations  and  exceptions.  This  includes  i.e.  all 
requirements  weighting  on  consumers  to  prove  the  rightfulness  of  the  claim  and  to  the 
cost relating  to  the  damage  suffered,  which  can  be  high  if  the  claim  is  settled in  court, 
and which can be a substantial obstacle when the claimant must anticipate them.  

The costs for producers are  mainly indirect costs related to insurance, and enforcement 
costs related to  the settlement of claims  (when  consumers are successful).  Overall, few 
producers  choose  to  pay  for  specific  strict  liability  insurance  directly  related  to  the 
Directive,  but  most  of  them  have  an  insurance  policy  covering  product  liability  jointly 
with  other  risks  and,  if  they  do  so,  they  incorporate  this  cost  in  product  prices  and 
transfer  it  on  consumers.  As  for  the  enforcement  costs,  they  are  in  principle  paid  by 
producers in 60% of the cases as they are paid whenever a consumer claim is successful 
The cost-benefit ratio for producers remains reasonable also when SMEs are considered. 
There does not appear to be a specific impact on SMEs.   

Thus benefits appear to be achieved at a reasonable cost for producers but  – depending 
on the product in question  – costs may be very high or sometimes even prohibitive for 
consumers.  

EQ. Does the Directive strike the right balance between the costs borne by the producers 
to  cover  the  strict  liability  and  the  requirements  on  the  injured  party  to  obtain 
compensation? 

EQ.  What  factors  influenced  the  efficiency  of  reaching  the  achievements  which  the 
Directive sets out? 

Some products require a more complicated and costly assessment procedure, in terms of 
complexity of the procedure itself, whereas other products require less onerous systems 
of assessment.  

The  costs  for  producers  are  mainly  the  costs  originating  from  claims  and  costs  of 
insurance. For consumers, however, most of the costs are related to the burden of proof. 
The  benefits  that  were  shown  for  both  parties  were  efficiency  and  legal  certainty  for 
producers,  and  compensation  for  damage  for  consumers.  However,  some  concerns 
remain regarding fairness in this balance for consumers, especially in view of the higher 
cost  of  substantiating  proof  of  a  defect  and  its  link  with  the  damage  in  more  complex 
products such as pharmaceutical.  

Given  that  costs  are  to  a  very  large  extent  related  to  procedures  not  covered  by  the 
Directive,  arguments  have  been  put  forward  that  this  should  be  addressed  outside  the 
scope of the Directive. 

The  positive  or  negative  assessment  on  efficiency  with  respect  to  the  provisions  of  the 
Directive depends on the category of stakeholders concerned, producer or consumer. In 
fact, the provisions which are considered more efficient for producers are they considered 

42 

 
 
more  inefficient  for  consumers,  and  vice  versa.  This  therefore  also  requires  a  political 
assessment in terms of balancing the original objectives of the Directive. 

5.2.4.  Conclusion on efficiency  

According to the qualitative assessment, the Directive in principle has managed to strike 
a balance between the costs and benefits borne  by producers and consumers. However, 
the balance between costs and benefits relating to the Directive appears to be appropriate 
for producers but it is not uniform across Member States and sectors or product types for 
consumers. There are also other factors that could play a significant role in determining 
the  efficiency  of  the  Directive,  such  as  the  costs  and  duration  of  judicial  procedures, 
which vary substantially from one Member State to another and have a more direct effect 
on  consumers.  They  represent  the  most  important  administrative  burden.  However,  as 
these  are  not  due  to  burdens  that the  Directive itself  imposes  no specific  simplification 
potential was identified in this respect. 

5.3. 

Coherence 

EQ  To  what  extent  is  the  intervention  consistent  and  coherent  with  the  EU  rules  on 
consumer protection in the area of contractual liability? 

EQ  To  what  extent  is  the  Directive  coherent  with  wider  EU  policy,  such  as  the  free 
movement of goods and/or the protection of the consumers, including EU product safety 
legislation? 

Several pieces of legislation have been identified and analysed to assess the coherence of 
the Directive with EU policies and rules65:  

1. 

2. 

Safety sectorial legislation and the General Product Safety Directive (the “GPSD”);  

Rules on consumer protection in the area of contractual liability, and, in particular: 

 

 

The Directive on Consumer Rights (the “DCR”);66 
The Sales and Guarantee Directive (the “SGD”);67 

3. 

Rules on applicable law, litigation and Alternative Dispute Regulation: 

 

 

 

The Rome II regulation;68 
The Brussels IA regulation;69 
The Directive on consumer ADR.70 

65  

66  

67  

68  

69  

The Study for the evaluation of the Directive 85/374/EEC  analyses also the proposal for a directive 
on  contracts  for  the  supply of digital  content  and  the  proposal  for  a  directive  on  contracts  for  the 
online and other distance sales of goods (COM(2015) 634 final) 
Directive  2011/83/EU  of  the  European  Parliament  And  Of  The  Council  of  25  October  2011  on 
consumer  rights,  amending  Council  Directive  93/13/EEC  and  Directive  1999/44/EC  of  the 
European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 
97/7/EC of the European Parliament and of the Council. 
Directive  1999/44/EC  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  on  certain 
aspects of the sale of consumer goods and associated guarantees. 
Regulation (EC) no 864/2007 of the European Parliament and of the Council of 11 July 2007 on the 
law applicable to non-contractual obligations. 
Regulation (EU) no 1215/2012 of the European Parliament and of the Council of 12 December 2012 
on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. 

43 

 
 
 
                                                            
5.3.1.  Product safety legislation 

European Union product safety legislation aims at ensuring that only safe products can be 
placed on the internal market. Manufacturers (producers) are responsible for the safety of 
their product. 

All  products placed on the market in the internal market are subject to safety  rules, set 
under either: 

 

 

EU harmonisation safety legislation, which that sets EU wide essential health and 
safety requirements (EHSR) that the products in question need to meet. , The vast 
majority of products marketed in the EU are covered either partly or fully by EU 
harmonisation safety legislation. 

The General Product Safety Directive (GPSD), that establishes a general obligation 
upon manufacturers to ensure that consumer products, which do not fall within the 
scope  of  sectorial  legislation  covering  safety  aspects,  are  manufactured  in 
compliance with the general safety requirements provided therein. The GPSD has a 
safety net role for products and risks not covered by the harmonisation legislation. 

When the product is placed on the market or brought into use for the first time, designers 
and manufacturers must  meet all essential requirements relevant to the specific product 
based on the state of the art.  

Then, within the market surveillance system, relevant national authorities check whether 
products  meet  the  requirements  of  the  applicable  safety  legislation  and  take  necessary 
steps to make sure that products are compliant. Producers and distributors have also legal 
obligations once the product is placed on the market; for instance, according to Articles 
5.3 and 8 of the GPSD, if they become aware that a product that they have placed on the 
market  poses  risks  to  the  consumer,  they  shall  immediately  inform  the  competent 
authorities and take all the necessary measures up to the product recall if needed. 

5.3.1.1.  Sectorial safety legislation 

Specific  rules  exist  for  example  for  the  safety  of  toys,  electrical  and  electronic  goods, 
cosmetics, chemicals, medical devices, food and feed,  and other specific product groups, 
as machines or pharmaceutical products. 

Providing just a few examples, it is important to consider: 

 

70  

71  

Directive 2014/35/EU on low voltage electrical equipment71 (hereinafter also “Low 
Voltage  Directive”  or  “LVD”),  which  ensures  that  electrical  equipment  within 
certain  voltage  limits  provides  a  high  level  of  protection  for  European  citizens. 
Electrical  equipment  under  the  LVD  covers  a  wide  range  of  consumer  and 
professional  products  e.g.  household  appliances,  cables,  power  supply units, laser 
equipment and some components such as fuses 

Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative 
dispute  resolution  for  consumer  disputes  and  amending  Regulation  (EC)  No  2006/2004  and 
Directive 2009/22/EC. 
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the 
harmonisation of the laws of the Member States relating to the making available on the market of 
electrical  equipment  designed  for  use  within  certain  voltage 
limits.  Source:  http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0035&from=EN  

44 

 
 
 
                                                                                                                                                                                 
 

 

 

Directive  2014/53/EU  on  radio  equipment72  (hereinafter  also  “Radio  Equipment 
Directive”  or  “RED”)  which  ensures  a  Single  Market  for  radio  equipment  by 
setting essential requirements for safety and health, electromagnetic compatibility, 
and  the  efficient  use  of  the  radio  spectrum  and  applies  to  all  products  using  the 
radio frequency spectrum, this includes embedded software. 

Regulation (EU) 2017/745 on medical devices and the Regulation (EU) 2017/746 
on  in  vitro  diagnostic  medical  device73s  establish  a  modernised  and  more  robust 
EU  legislative  framework  to  ensure  better  protection  of  public  health  and  patient 
safety. Moreover both the two regulations state that software is considered, under 
the provisions of the regulation, as a product. Further, the Regulations on medical 
devices provide that the liability they set forth is without prejudice to the Product 
Liability Directive. 

Regulation (EC) No 178/2002 on general food law74 (the GFL Regulation) sets outs 
an overarching and coherent framework for the development of food law (including 
feed)  both  at  Union  and  national  levels.  To  this  end,  it  lays  down  general 
principles, requirements and procedures that underpin decision making in relation 
to food and feed, covering all stages of food and feed production and distribution. 
These  principles,  requirements  and  procedures  are  further  incorporated  in  other 
Union  legislative  acts  covering  the  food  chain.  Amongst  others,  the  GFL 
Regulation sets out the primary responsibility of food and feed business operators 
(FBOs): they must (a) ensure compliance with all EU and national food law that is 
relevant  to  their  activities  and  within  the  businesses  under  their  control  and  (b) 
perform their own controls.  Furthermore, food placed on the market must be safe, 
i.e. food must not be potentially injurious to health or unfit for human consumption 
(food safety requirement). Similarly, feed placed on the market must be safe (feed 
safety requirement). Where FBOs consider or suspect that food or feed is not safe, 
they  must  withdraw  or  recall  such  products  and  notify  the  competent  authorities 
under  certain  conditions.  All  FBOs  must  be  able  to  identify  from  whom  and  to 
whom a product has been supplied ('one step back – one step forward' traceability 
for safety purposes) and to have systems and procedures in place that allow for this 
information  to  be  made  available to the competent  authorities upon request. Feed 
and food imported into the Union must comply with all requirements of Union food 
law.  National  competent  authorities  are  responsible  for  enforcing  food  law, 
verifying  that  food  and  feed  placed  on  the  EU  market  are  safe  and  applying 
effective, proportionate and dissuasive measures and penalties where a violation of 
food law is detected. As stated in Article 21 of the GFL Regulation, the application 

72  

73  

74  

Directive  2014/53/EU  of  the  European  Parliament  and  of  the  Council  of  16  April  2014  on  the 
harmonisation of the laws of the Member States relating to the making available on the market of 
radio  equipment  and  repealing  Directive  1999/5/EC.  Source:  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32014L0053&from=EN  
Regulation (EU) 2017/745 on medical devices of the European Parliament  and of the Council  of 5 
April 2017 on medical devices , , amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC 
http://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R0745&from=EN  
Regulation (EU) 2017/746 on of the European Parliament and of the Council of 5 April 2017 on in 
vitro  diagnostic  medical  devices  and  repealing  Directive  98/79/EC  and  Commission  Decision 
2010/227/EU Source: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements of food law, establishing the European Food 
Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety,  Source:  http://eur-
lex.europa.eu/legal-content/EN/TXT/?qid=1518796393897&uri=CELEX:32002R0178. 

45 

 
                                                            
 
 
 

 

of  the  general  principles  and  requirements  underpinning  Union  food  law  are 
without prejudice to the Product Liability Directive.  
Directive  (EC)  2006/4275  on  machinery  covers  a  wide  range  of  machines  and 
equipment  for  consumers  and  commercial  or  industrial  purposes,  it  is  also  the 
relevant safety legislation for robots. This Directive ensures a high level of health 
and safety for consumers, users and other exposed persons as regards the products 
in its scope, placed on the market.  
Directive (EC) 2001/83/EC76 on pharmaceutical products sets standards to ensure 
a  high  level  of  public  health  protection  and  the  quality,  safety  and  efficacy  of 
authorized  medicines.  In  addition,  it  promotes  the  functioning  of  the  internal 
market, with measures to encourage innovation. It is based on the principle that a 
medicinal product requires a marketing authorisation by the competent authorities 
before being placed on the market. 

The mentioned pieces of legislation do not contain specific provisions on the liability of 
the concerned products, but expressly refer in the text to the application of the Product 
Liability Directive in case of damages caused by a defective product. 

However,  as  it  was  noted  already  in  2011,  some  stakeholders,  as  e.g.  the  European 
Federation  of  Pharmaceutical  Industries  and  Associations,  have  indicated  on  several 
occasions that pharmaceuticals products should be outside of the scope of the Directive 
and should have a specific liability regime77. 

5.3.1.2.  General Product Safety Directive (GPSD) 

The GPSD aims to ensure that only safe consumer products are placed on the market. A 
product is safe when under normal or reasonably foreseeable conditions of use, including 
duration  and,  where  applicable,  putting  into  service,  installation  and  maintenance 
requirements,  it  does  not  present  any  risks  or  only  the  minimum  risks  compatible  with 
the product use, considered to be acceptable and consistent with a high level of protection 
for the safety and health of persons, taking into account particular aspects such as the (i) 
characteristics of the product, (ii) the effect on other products, (iii) the presentation of the 
product,  (iv)  the  categories  of  consumers  at  risk  when  using  the  product.  The  GPSD 
applies  in  the  absence  of  other  European  Union  laws  relating  to  product  safety, 
complementing sector specific legislation. The GPSD establishes obligations for both the 
producers and distributors, and Member States authorities.  

Producers must only place products on the market which are safe and inform consumers 
of any risks associated with these products. They also have to make sure any dangerous 
products  presented  on the  market  can  be  traced78  so  they  can  be  removed  to  avoid  any 

75 

76  

77  

78  

relating 

Directive  2006/42/EC  of  the  European  Parliament  and  of  the  Council  of  17  May  2006  on 
machinery,  and  amending  Directive  95/16/EC  (recast.  Source:    http://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:32006L0042  
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community  code 
for  human  use.  Source:  http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02001L0083-
20121116&qid=1472567249742&from=EN  
See, for instance, Fourth report on the application of the Council Directive on the approximation of 
laws, regulations and administrative provisions of Member States concerning liability for defective 
products (already mentioned), . p.8.  
By  establishing  notification  obligations  on  producers  and  distributors  concerning  information  on 
products that do not comply with the general safety requirements to the competent authorities, the 

to  medicinal  products 

46 

 
 
                                                            
risks  to  consumers.  Distributors  are  required  to  act  with  due  care  to  help  ensure 
compliance  with  the  applicable  safety  requirements,  they  shall  participate  in  the 
monitoring of the safety of the products and cooperate with the producers and competent 
authorities.  

The GPSD states that its provisions should not affect victims’ rights within the meaning 
of the Directive (which remains an autonomous legal regime).  

The Directive and the GPSD are therefore coherent.  

The  concept  of  defectiveness  "lack  of  the  safety  which  a  person  is  entitled  to  expect” 
provided by the Directive includes the expectation that the products placed on the market 
do not present risks for the physical safety and health of persons, according to the GPSD.  

At  the  Product  Liability  Conference  held  in  Brussels,  stakeholders'  representatives  of 
producers  and  civil  society  were  of  the  opinion  that  the  Product  Liability  Directive  is 
consistent  with  product  safety  legislation,  and  is  an  integral  part  of  it.  However,  other 
stakeholders,  mostly  consumers  and  victims  of  drugs,  claimed  that  one  of  the 
inconsistencies  is  that  while  pharmaceuticals  are  covered  by  the  Product  Liability 
Directive,  they are  not  covered by the General Product Safety regime (in  particular the 
definition of "safe product") but by a specific safety regime, and this should be adjusted 
by  defining  a  specific  liability  regime  for  pharmaceuticals.  This  would  imply  that 
pharmaceuticals should be removed from the scope of the Directive.  

To clarify, it should be noted that General Product Safety Directive is called works as a 
‘lex generalis’, while more specific regimes, like for example pharmaceuticals, but also 
pesticides,  chemicals,  medical  devices  work  as  ‘lex  specialis’  etc…,  where  the  safety 
assessment is part of a process that is undertaken prior to the product being placed on the 
market  due  to  the  inherent  and  specific  risks  of  the  product.  In  addition,  it  should  be 
considered  that  if  certain  deficiencies  with  regard  to  the  application  of  the  Directive  to 
certain product categories are detected, this may need to be taken into account in future 
revisions of the rules. 

5.3.2.  Rules on consumer protection in the area of contractual liability 
The  Directive  on  Consumer  Rights  (DCR)79  establishes  rules  on  information  to  be 
provided  for  distance  contracts,  off-premises  contracts,  as  well  as  other  types  of 
contracts. It also regulates the right of withdrawal for distance and off-premises contracts 
and harmonises certain provisions dealing with the performance and some other aspects 
of  business-to-consumer  contracts.  Based  on  the  DCR,  both  consumers  and  traders  can 
rely  on  a  single  regulatory  framework  clearly  defining  legal  concepts  that  would  avoid 
disparities  that  create  significant  internal  market  barriers.  The  analysis  identified  some 
minor lexical divergences, for instance the definition of "goods"  – though not affecting 
the overall implementation of the Directive – between the DCR and the Product Liability 
Directive.  In fact, it appears that these lexical divergences are due to the different scopes 

79  

GPSD  aims  at  having  the  risks  notified  as  soon  as  possible  in  order  to  avoid  damages  caused  to 
consumers by dangerous products. 
Directive  2011/83/EU  of  the  European  Parliament  and  of  the  Council  of  25  October  2011  on 
consumer  rights,  amending  Council  Directive  93/13/EEC  and  Directive  1999/44/EC  of  the 
European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 
97/7/EC  of  the  European  Parliament  and  of  the  Council.  Source:  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32011L0083&rid=1 

47 

 
 
                                                                                                                                                                                 
of  the  two  directives  and  there  is  no  evidence  that  they  affect  the  effectiveness  or 
efficiency of the Directive.  
The  Sales  and  Guarantee  Directive  (SGD)80  provides  for  a  common  set  of  minimum 
rules  of  consumer  law,  to  strengthen  consumers’  confidence  and  to  reduce  difficulties 
encountered by consumers in relation to product non-conformity with the contract. The 
Product  Liability  Directive  and  the  SGD  do  not  overlap,  they  concur  to  the  protection  of 
consumers by regulating different fields. 

In the context of the Digital Single Market Strategy, two proposals have been presented 
by the Commission for the adoption by the legislators:  the proposal for a Directive on 
certain aspects concerning contracts for the supply of digital content81 and the amended 
proposal for a Directive on certain aspects concerning contracts for the sales of goods82. 
These  proposals  aim  to  contribute  to  fostering  growth  through  the  creation  of  a  true 
Digital  Single  Market,  to  the  benefit  of  both  consumers  and  businesses,  by  eliminating 
the key contract law-related barriers hindering cross-border trade. 

In  the  light  of  the  above  analysis,  there  are  no  relevant  incoherencies  between  the 
Directive and the EU pieces of legislation considered. The Directive appears as being a 
coherent complementary tool to ensure consumer protection. 

5.3.3.  Rules on applicable law and disputes resolution 
The Rome II Regulation83 sets forth the conflict-of-law rule in matters of product liability 
(Article 5) by means of a cascade system, where the first element to be taken into account 
is  the  law  of  the  country  in  which  the  person  sustaining  the  damage  had  his  or  her 
habitual  residence  when  the  damage  occurred,  if  the  product  was  marketed  in  that 
country; the other elements are triggered if the product was not marketed in that country 
and,  in  essence,  make  the  law  applicable  to  the  claim  depend  on  the  place  where  the 
product was marketed. However, this does not preclude (a) that, where both the person 
claimed to be liable and the person sustaining damage have their habitual residence in the 
same country at the time when the damage occurs, the law of that country shall apply and 
(b) the possibility of a manifestly closer connection to another country.  

The  Directive  and  the  Regulation  appear  synergic  in  allowing  protection  of  consumer 
based  on  the  possibility  for  the  same  consumer  to  predict  the  law  applicable  to  the 
possible damage affecting him (first, the law of his place of residence), while striking a 
balance  with  the  defendant’s  needs  by  taking  into  account  where  the  product  was 
marketed. 

80  

81  

82  

83  

Directive  1999/44/EC  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  on  certain 
aspects  of 
the  sale  of  consumer  goods  and  associated  guarantees.  Source:  http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31999L0044   
Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  certain  aspects 
concerning contracts for the supply of digital content (COM(2015) 634 final).  
Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  on  certain  aspects 
concerning  contracts  for  the  supply  of  digital  content  (Brussels,  9.12.2015  COM(2015)  634  final 
2015/0287 (COD) and . Proposal for a Directive of the European Parliament and of the Council on 
certain  aspects  concerning  contracts  for  the  online  and  other  distance  sales  of  goods.  Source: 
http://ec.europa.eu/justice/contract/files/directive_-digital_content.pdf  
Regulation (EC) no 864/2007 of the European Parliament and of the Council of 11 July 2007 on the 
law 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:199:0040:0049:EN:PDF 

non-contractual 

obligations. 

applicable 

Source: 

to 

48 

 
 
                                                            
The  Brussels  IA  Regulation  84aims  to  set  clear  rules  on  jurisdiction  in  civil  and 
commercial  matters.  The  CJEU  recently  clarified  that  claims  under  the  Directive  were 
subject to Article 5 (3) of Brussels I Regulation (CJEU Case C-45/13), which provided 
that  a  person  domiciled  in  a  Member  State  may,  in  another  Member  State,  be  sued  in 
matters relating to tort, delict or quasi-delict, in the courts for the place where the harmful 
event occurred or  may occur, just like Article 7(2) of the Brussels IA Regulation does. 
Further, the CJEU also stated that, where a manufacturer faces a claim of liability for a 
defective product, the place of the event giving rise to the damage is the place where the 
product in question was manufactured (CJEU Case C-45/13).  
In contrast, the Directive on alternative dispute resolution for consumer disputes (ADR)85 
is  limited  to  the  resolution  of  contractual  disputes  and  does  not  cover  the  disputes  that 
can arise from damages from defective products according to the Directive. Indeed, there 
are currently no EU rules in place for the alternative resolution of claims related to the 
Directive. Given that their scopes are mutually exclusive, the two directives are deemed 
to be coherent. No comments have been received from stakeholders on this.  

5.3.4.  Conclusion on coherence  

The Directive appears fully coherent both with the product safety legislation and with EU 
rules  on  consumer  protection  in  the area  of  product  safety,  with  the  rules  on  consumer 
protection in the area of contractual liability and with those related to the conflict-of-law. 

Overall,  the  analysis  carried  out  confirmed  that  there  does  not  seem  to  be  any 
contradiction  between  the  Product  Liability  Directive  and  the  European  Union  safety 
legislation with the EU consumer protection rules nor with the rules on applicable law in 
cases of disputes.  

However,  the  digitalisation  of  the  economy  will  require  legislative  changes:  safety 
legislation  such  as  the  Machinery  Directive86  has  been  evaluated,  and  for  the  Radio 
Equipment  Directive  possible  action  is  considered.  An  assessment  of  the  continued 
coherence  of  the  Directive  with  these  pieces  of  legislation  will  therefore  remain 
necessary.  

5.4. 

Relevance  

5.4.1.  Relevance  of  the  Directive  to  current  needs,  including  needs  related  to  new 

technological developments 

EQ  To  what  extent  do  the  initial  objectives  correspond  to  the  current  needs,  including 
new needs created by innovative products? 

The Directive was adopted in order to respond to the following needs: 

84  

85  

86  

Regulation (EU) no 1215/2012 of the European Parliament and of the Council of 12 December 2012 
on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters. 
Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:351:0001:0032:en:PDF 
Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative 
dispute  resolution  for  consumer  disputes  and  amending  Regulation  (EC)  No  2006/2004  and 
Directive 
http://eur-
2009/22/EC. 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:165:0063:0079:EN:PDF   

SWD Evaluation of the Machinery Directive (SWD(2018)160). 

49 

 
 
 
                                                            
 
 

 

 

Ensure  a  high  degree  of  consumer  protection  against  damages  to  health  and 
property caused by a defective product; 

Ensure producers’ liability for damages caused by a defective product; 

Enhance the free movement of products without distorting competition by setting a 
common rule on strict liability of the producer. 

The  original  needs  of  to  ensuring  ensure  producers’  liability,  consumer  protection  and 
undistorted  competition  remain  relevant.  The  Directive  was  the  first  EU  instrument  on 
producer liability. The real challenge was to maximise its positive effects for consumers 
by  ensuring  the  best  compensation  of  victims,  while  keeping  costs  reasonable.  As  the 
number of claims across the EU have shown, the Directive continues to be invoked by 
consumers when claiming compensation for damages caused by defective products. The 
numbers have been relatively stable over the evaluation period of 2000-2016. 

But while the needs remain the same, it is important to ask whether the tools provided by 
the Directive continue to be relevant and future-proof. 

 In a similar vein, the European Parliament has noted that it could be necessary to adapt 
the Directive to the challenges brought by the new digital context87. 

In the public consultation, 50% of consumers and producers do not consider the current 
situation  to  be  problematic,  while  numbers  increase  when  it  comes  to  future 
developments.  Then respondents note that there are products for which the application of 
the  Directive  is  or  might  become  uncertain  and/or  problematic.  These  products  mainly 
come  under  the  definition  of  emerging  digital  technologies.  As  a  consequence,  62%  of 
respondents considered the Directive should be adapted.  

Based on the public consultation, it appears that the perception of the new technological 
developments  depends  on  the  category  of  stakeholders.  The  majority  of  producers  and 
insurers  consider  that  the  Directive  is  still  adequate  to  cover  new  technological 
developments,  especially  those  which  are  already  fully  rolled  out  in  the  market. 
Consumers,  on  the  other  hand,  tend  to  prefer  a  revision  of  the  Directive88.  The  same 
opinions  were  manifested  in  the  context  of  the  activities  launched  for  the  "Building  a 
European Data Economy". 

The  Study  for  the  evaluation  states  that  on  the one  hand, the  majority  of  desk-research 
sources  seem  favourable  to  a  revision  of  the  Directive  to  clarify  to  which  extent  the 
Directive is applicable to the different new technological developments and whether the 
strict  liability  rule  applies  to  all  kinds  of  software.  On  the  other  hand,  other  authors 
consider it reasonable to resolve the issue created by new technological developments by 
means  of  interpretation  of  the  courts  only,  waiting  for  the  future  evolution  of  the  new 
technologies.  

Given the lack of evidence for either approach, further analysis and fact finding appear to 
be advisable. 

5.4.2.  Relevance of specific provisions of the Directive 

87  

88  

See European Parliament Resolution of 16 February 2017 on Civil Law Rules on Robotics, already 
mentioned.  
See Synopsis report for the evaluation of the Directive 85/374/EEC, Annex 2 of this document 

50 

 
 
 
                                                            
EQ  How  well  adapted  is  the  intervention  to  the  changing  market  environment:  often 
blurred distinction between private and professional use and the servitisation of products 
where products and services are often sold and consumed together?  

5.4.1.1.  Distinction between products and services 

The Directive does not make any reference to the concept of service nor does it provide 
for the distinction between products and services. It solely provides for the definition of 
product, according to Article 2.  

The notion of product mainly refers to movables even though incorporated into another 
movable or into an immovable. Since 1999, "primary agricultural products" (products of 
the  soil,  of  stock-farming  and  of  fisheries,  excluding  products  which  have  undergone 
initial  processing)  are  under  the  scope  of  the  Directive.  Services  do  not  fall  into  the 
definition of product. 

However, the distinction between product and service is  becoming  increasingly  blurred 
with regards to new technological developments.  
The  Study  reports  that,  overall,  18  Member  States89  do  not  have  any  forms  of  extra-
contractual liability in  place to  protect consumers from damages caused specifically by 
defects  of  either  intangibles  (e.g.  software),  or  services.  On  the  contrary,  nine  Member 
States90 ensure an extra-contractual liability to protect consumers from damages caused 
by  defects  both  of  intangibles  (e.g.  software)  and  services.  A  distinction  can  be  made 
between these Member States. In two Member States91, the rules set forth in the Directive 
are stretched to ensure strict liability for services and intangibles too. 

The  Study  also  notes  that  there  is  no  common  doctrinal  opinion  on  a  number  of  these 
issues, for example on software. For some authors software most often takes the form of 
a movable item and can be considered a ‘product’ from the perspective of consumers and 
business users. For others, software is more similar to a service.  

At  European  Union  level,  the  CJEU  has  for  some  specific  cases  contributed  to  the 
classification of software, which for instance is to be considered a medical device (i.e. a 
product) when intended by the manufacturer to be  used specifically for one or  more of 
the  medical  purposes  set  out  in  the  definition  of  ‘medical  devices’.92  In  addition,  the 
Radio  Equipment  Directive,  the  Regulations  on  medical  devices  and  on  in  vitro 
diagnostic93, may include software.94  

89  

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark,  Spain, Croatia, Hungary, Ireland, 
Italy, Latvia, Luxembourg, Poland, Portugal, Romania, Sweden and United Kingdom.  Information 
not available for FI.  

91  
92  

90    Germany,  Estonia,  Greece,  France,  Lithuania,  Malta,  Netherlands,  Slovenia  and  Slovak  Republic.  
In  some  of  them  (Germany,  Estonia,  Malta,  Netherlands,    Slovenia  and  Slovak  Republic)  the 
protection  of  consumers  from  damages  caused  by  defects  of  either  intangibles  or  services  stems 
from  general  rules,  normally  tort  law:  in  these  cases,  protection  essentially  stems  from  the 
interpretation of general rules to include services or intangibles 
Greece and Lithuania. 
CJEU  Case  C-219/11.  This  requires  a  case-by-case  analysis,  as  demonstrated  also  in  pending 
judgment  (CJEU  Case  C-329/16)  in  which  the  Court  has  to  determine  whether  a  certain  type  of 
software should be considered a medical device where that software has at least one function that 
permits the use of data specific to a patient to help his doctor issue a prescription.  
Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on 
medical  devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation 
(EC)  No  1223/2009  and  repealing  Council  Directives  90/385/EEC  and  93/42/EEC  and  (ii) 

93  

51 

 
 
                                                            
Finally, for products purchased as a bundle with related services, the service part is only 
considered a part of the product in some Member States. This possibly creates different 
levels of consumer protection and of producers’ liability across the internal market95. 

These  views  are  shared  by  stakeholders  participating  in  the  consultation.  They  believe 
that  it  is  sometimes  difficult  to  distinguish  a  product  from  a  service,  since  they  can  be 
bundled  together,  and  that  it  is  even  more  burdensome  to  distinguish  a  product  from  a 
service  when  they  are  bundled  together  in  the  context  of  new  technological 
developments, especially when dealing with cloud technologies and IoT.  

Today,  embedded  software  or  other  specific  technical  features  are  already  an  integral 
component of many products. In terms of EU product safety legislation, the producer is 
responsible for the safety of the final product as a whole. Therefore, for products which 
include  software  at  the  moment  they  were  put  into  circulation  by  the  producer,  the 
Directive could address liability claims for damages caused by defects in this software. 
The more open nature of new products, where the producer is no longer able to control 
software  or  other  technical  features  subsequently  installed  in  or  learned  by  the  product 
may however pose a challenge for establishing claims under the Directive. 

With specific reference to new technological developments, the majority of producers of 
IoT/robotics devices responding to the open public consultation on Building a European 
data economy answered that they have never experienced problems so far in not knowing 
in  which  category  (product/service)  to  classify  the  device  in  order  to  comply  with  a 
specific liability regime.  

During  the  Product  Liability  Conference,  held  in  Brussels,  some  stakeholders  said  that 
the  distinction  between  the  definitions  of  products  and  services  has  become  obsolete. 
They pointed out that it should be clarified whether hardware and software are products 
and  are  cover  under  the  Directive,  as  these  definitions  might  become  problematic  as 
technology  develops.  Some  insurers  nevertheless  insisted  that  marketed  robots  are 
finished products and fall under Product Liability Directive. According to the consumer 
representatives,  it  would  be  necessary  to  revise  the  Directive  with  a  view  to  expressly 
including new risks.  

In conclusion, while there is little evidence of practical problems, the distinction between 
products and services may in the future no longer be pertinent. Hence, there is a need to 
clarify what products and features are covered by the Directive.  

Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on  in 
vitro  diagnostic  medical  devices  and  repealing  Directive  98/79/EC  and  Commission  Decision 
2010/227/EU. 
Recital  19  of  Regulation  (EU)  2017/745  states  that:  “It  is  necessary  to  clarify  that  software  in  its 
own right, when specifically intended by the manufacturer to be used for one or more of the medical 
purposes set out in the definition of a medical device, qualifies as a medical device, while software 
for general purposes, even when used in a healthcare setting, or software intended for life-style and 
well-being purposes is not a medical device. The qualification of software, either as a device or an 
accessory,  is  independent  of  the  software's  location  or  the  type  of  interconnection  between  the 
software and a device.” 
Products  purchased  in  bundle  with  services  are  not  considered  products  in  Greece,  Italy,  Malta, 
Netherlands and United Kingdom.  In Finland and Luxembourg they are considered products.  

94  

95  

52 

 
 
                                                                                                                                                                                 
 
5.4.1.2.  Distinction between private and professional use 

The Directive does not expressly refer to the professional use of products. The distinction 
between professional and private use of products emerges, nonetheless, with regard to the 
definition  of  damage  to  an  item  of  property  other  than  the  defective  product  itself: 
according to article 9(b) such item of property shall be (i) of a type ordinarily intended 
for  private use  or  consumption,  and  (ii)  used  by  the  injured  person  mainly  for  his  own 
private  use  or  consumption.  Hence,  only  in  such  cases  the  damage  is  subject  to 
compensation.   

The majority of participants to the consultation activities for the evaluation agreed that it 
is sometimes difficult to distinguish between private and professional use of a product. 

The Study for the evaluation shows that, in at least 150 cases, the national courts allowed 
the compensation even if the item of property was subject to professional use96. On the 
contrary,  23  claims  were  rejected  because  the  injured  person  did  not  use  the  product 
mainly for his own private use or consumption.  

The Directive must be interpreted as not precluding the interpretation of domestic law or 
the  application  of  settled  domestic  case-law  according  to  which  an  injured  person  can 
seek compensation for damage to an item of property intended for professional use and 
employed for that purpose as shows CJEU (Case C-285/08). 

With  regard  to  damage  caused  by  death  or  by  personal  injuries  (article  9(a)),  the 
Directive does not limit its application to the private activities: this has been interpreted 
as  meaning  that  in  case  of  damage  caused  by  death  or  by  personal  injuries  the 
compensation shall be allowed regardless of whether the injured person was operating in 
his private or professional activity.   

Therefore,  the  distinction  between  private  and  professional  use  of  products  is  relevant 
only  with  regard  to  the  damage  caused  to  another  item  of  property.  Nowadays,  the 
distinction between private and professional use is becoming less evident, especially with 
regard  to  smartphones,  cloud  technologies  and  connected  devices.  The  continued 
relevance of this provision is therefore debatable.  

5.4.1.3.  Relevance  of  some  definitions  (product,  producer,  damage,  and  category  of 

exemptions) to the new technological developments  

EQ. To what extent is there a need to clarify or modify the concept of product, producer, 
damage or the category of exemptions in the Directive? 

Definition of product 

The definition of “product” as per article 2 of the Directive is related to the concept of 
“movable”.  This  has  been  interpreted  as  meaning  that  only  tangible  goods  shall  be 
considered  products:  indeed,  at  the  time  in  which  the  Directive  has  been  adopted,  no 
clear  examples  of  non-tangible  goods  were  widespread  in  the  market.  However,  even 
today, most of these non-tangible goods are integrated into tangible goods in one form or 
another. 

The main question in relation to new technological developments is how to classify the 
devices/  products  resulting  from  these  technologies.  It  appears  that  in  this  context  the 
services relating to tangible products will become more prominent in the near future and 

96  

These cases seem to concentrate in a few countries: Austria,  Denmark and France  

53 

 
 
                                                            
thus the balance between products and services may shift towards services, and products 
will increasingly come with the provision of services.  

Indeed,  the  non-tangible  nature  of  some  new  technological  developments  (software, 
applications,  Internet  of  Things,  Artificial  Intelligence  systems)  makes  it  difficult  to 
classify them as products rather than services. Yet, the majority of producers of Internet 
of  Things  and  robotics  devices  responding  to  the  public  consultation  on  Building  a 
European Data Economy initiative answered that they have never experienced problems 
in  the  qualification  of  the  good  as  a  product  or  as  a  service.97  Other  contributions 
obtained  in  the  context  of  the  consultation  raise  doubts  over  the  adequacy  of  the 
definition  of  product  vis-à-vis  new  technological  developments,  as  cloud  technologies.  
Some stakeholders raised  the need for an interpretation  of the concept of product or  an 
enlargement of the concept of product, including, for instance, some new technological 
developments  such  as  Artificial  intelligence  or  cloud  technologies,  as  well  as 
applications. This is particularly relevant in the context of the Directive where the non-
tangible element is  not  included in  the product put  into circulation by the producer but 
installed subsequently as a stand-alone feature. 

Definition of producer 

The notion of producer provided for in Article 3 reflects the definition of product for the 
purpose of the Directive. 
For robotics, according to the European Parliament’s Report98 ”the concepts of product, 
producer, damage or the category of exemptions as defined in the Directive […] could 
not  be  apt  anymore  when  dealing  with  the  emerging  field  of  robotics:  “[…]  in  the 
scenario  where  a  robot  can  take  autonomous  decisions,  the  traditional  rules  will  not 
suffice to activate a robot’s liability, since they would not make it possible to identify the 
party responsible for providing compensation and to require this party to make good the 
damage it has caused”. 

The new technological developments, as the Internet of Things or a 3D Printer, involve 
different actors in the value chain, which all enable the technology to function (product 
manufacturers,  software  producers,  the  connectivity  service,  sensor  manufacturers, 
owners  of  the  object,  service  providers  etc.).  In  addition,  some  of  these  technological 
developments have a very open ecosystem, (e.g. Internet of Things applications), where 
new features can be added by the user or even third parties to create a new one.  

Thus,  the  question  emerges  of  whether  the  concept  of  ''producer'',  as  defined  in  the 
context of Product Liability Directive fits with the type of responsibilities that may arise 
in systems encompassing software, Artificial Intelligence systems, data services, etc.  

Conversely,  one  would  expect  that  these  technologies  would  have  to  correspond  to 
certain requirements which give consumers expected safety levels and a producer putting 
these  products  into  circulation  ensures  that  they  meet  these  expectations,  -  also  with 
regards to interaction in a connected world. 

In conclusion, the concept of the producer as responsible for his or her products remains 
relevant. There may be, however, a need to assess the impact of changing product (and/or 
product/service) configurations on this concept to see whether it should be clarified.  

 Definition of damage 

97  
98   

See Synopsis report for the evaluation of Directive 85/374/EEC. 
See European Parliament.  Resolution on Civil Law Rules on Robotics, already mentioned.  

54 

 
                                                            
The  notion  of  damage  provided  for  in  the  Directive  concerns  basically  two  kind  of 
damages:  the  physical  injuries,  and  the  damage  to  item  of  properties.  The  physical 
damage  also  covers  economic  losses,  such  as  incapacity  to  work.    However,  financial 
damage  is  limited  to  damages to  items of property mainly  intended  for private use and 
does not cover pure economic losses, meaning a pecuniary loss not consequential upon 
injury or damage. This means that e.g. infringements of privacy are cannot be regarded as 
damages covered by the Directive. The Directive does not foresee the compensation of 
non-material damage. This is without prejudice to national provisions. 

Consumer  representatives  would  like  to  extend  the  definition  of  damage  to  the  non-
material  damage  and  to  economic  losses.  The  Study  concludes  that  a  large  number  of 
consumers  consider  that  the  definition  of  damage  is  not  adequately  defined  in  the 
Directive, because it does not cover all types of possible damages, especially with regard 
to  the  damages  which  can  be  caused  by  some  new  technological  developments. 
Extending  the  concept  of  damage  to  other  types  of  damages  (e.g.  economic  losses, 
privacy infringements or environmental damage) is a political choice that would have to 
be studied in detail.  

Compensation is granted only for property damage above € 500  

25

20

15

10

5

0

Future-proof
Needs to be adapted
No opinion

Source: Open public consultation 

Producers
15
12
13

Authorities
11
8
6

Consumers
15
22
11

Definition of the exemptions from liability 

According  to  the  Study  the  categories  of  exemptions  are  overall  well  accepted  by 
businesses irrespectively of their size. More specifically, the results of the survey shows 
that  on  average,  65%  of  the  respondents  think  that  definitions  and  the  category  of 
exceptions  are  adequate  for  their  business  model  building  upon  the  new  technological 
developments. This positive result is largely due to the support of medium firms, being 
85% of them positively assessing the provisions, 15% of respondents, with a significant 
share of small firms which consider that these provisions are not adequate. 

Similarly,  on  average,  36%  of  businesses  declared  to  be  satisfied  with  the  three-year 
period for the recovery of damage. However, this provision seems to cause more concern 
to small enterprises than to medium and large ones. Indeed 33% of small enterprises are 
dissatisfied while  31%  are  satisfied.  On  the  contrary  the  majority  of  medium  and  large 
firms declare to be satisfied with this prescription period. 

55 

 
 
 
With regard to the thresholds, businesses are overall satisfied with the lower threshold of 
EUR  500  for  damage  compensation.  Nonetheless,  this  provision  is  supported  more 
strongly by medium and large firms. 

On  the  other  hand,  respondents  to  the  consultation  believe  that  particularly  the 
development  risk  clause  and  the  exemption  provided  for  in  Article  7  are  not  adequate.  
This is specifically so when dealing with Artificial Intelligence and robotics due to their 
increasing  rate  of  technological  development  that  can  cause  difficulties  in  the 
interpretation of this clause.  Yet, businesses are divided on removing this clause. 43% of 
large  firms  are  in  favour,  while  38  %  the  medium  firms  think  this  removal  would  be 
disadvantageous. Small firms tend to think that this removal would be neutral (33%) or 
even disadvantageous (31%). Consumers support removing this clause. 

According  to  the  majority  of  the  respondents  to  the  open  public  consultation  related  to 
Building a European Data Economy, there should be a liability cap (i.e. an upper bound 
to  the  compensation  of  damages)  independently  of  whom  is  considered  liable.  In 
particular 20% answered that such cap should exists only for specific products abiding by 
the 
strict 
experimentation/testing phase, 27% answered for all IoT products. The remaining part of 
respondents answered that there should not be a liability cap (47%). 

standards,  6%  answered  only 

specific  products 

safety 

for 

in 

At this stage, due to the lack of concrete data on their effect on new technologies and the 
balance  between  consumers’  and  producers’  interests  it  is  not  possible  to  conclude 
whether the list of exemptions provided for in the Directive continues to be relevant to 
emerging technologies. Their impact needs to be further analysed.  

5.4.1.4.  The concept of defectiveness 

EQ  How  well  is  the  term  ‘defective’  as  defined  in  the  Directive  adapted  to  new 
technological or scientific advances such as apps and non-embedded software, advanced 
robots  and  autonomous/intelligent  systems?  For  example,  could  software  vulnerability 
(for  instance,  a  cyber-attack  or  a  failure  to  update  security  software  or  a  misuse  of 
information) be considered as a defect? 

The defectiveness for the purpose of the Product Liability Directive is strictly connected 
with the concept of product safety. Something caused a damage even though this should 
not have reasonably happened.  

The Directive states that the defectiveness of a product is determined on the basis of the 
legitimate expectations of the public and thus not be based on the subjective expectations 
of a consumer. Apart from the minimum safety requirements listed by safety legislation, 
it may be difficult to determine the specific level of safety that a consumer is entitled to 
expect.  Thus  the  defectiveness  of  a  product  must  be  assessed  on  a  case-by-case  basis. 
The  courts  have  a  wide  range  of  appreciation  and  can  take  into  account  the  dynamic 
aspect of the safety assessment.  

The  term  “defect”  is  therefore  a  relative  concept.  Thus,  in  this  perspective,  despite  the 
maximal harmonisation character of the Directive, there is a risk of divergence between 
Member States on key issues including the core concept of defectiveness. 

Also,  in  the  field  of  robotics,  there  is  a  debate  on  whether  an  unintended  autonomous 
behaviour of an advanced robot is a defect or not. Indeed, robots are meant to perform 
autonomous  behaviours,  they  are  programmed  to  do  so.  Given  their  self-learning 
capacities,  one  could,  in  consequence  argue  that  not  all  unforeseen  autonomous 

56 

 
 
behaviour  is  a  defect.  On  the  other  hand,  these  robots  will  be  employed  to  perform 
certain tasks, which will inevitably be linked to safety expectations. 

As  reflected  in  the  figure  below, the  majority  of  respondents  to  the  survey  launched  in 
the  context  of  the  consultation  for the  evaluation  are rather aligned  on  the  fact  that the 
new technological developments are not adequately covered by the Directive. 

Figure 6: Adequacy of the Directive to cover strict liability caused by defect in any of the 
following new technological developments 

Maintain the exemption of the producer liability under certain 
circumstances (e.g. when he proves that at the time when the product 
was marketed, he was not able to detect the defect due to the state of 
scientific and technical knowledge  

30

25

20

15

10

5

0

Agree
Do not agree
No opinion

Source: Open public consultation 

Producers
28
6
6

Consumers
11
28
9

In this new context, the definition of defect of the Directive may need to be revisited to 
provide certainty regarding new technological developments. As it is closely linked to the 
concept of damage, and an extension of damages covered would also require reassessing 
the notion of defectiveness. 

5.4.1.5.  Conclusion on relevance 

Overall,  as  regards  current  states  of  technological  developments  and  tangible  products, 
the  Directive  and  its  broad  concepts  appear  to  remain  relevant  to  meeting  its  original 
objectives.  However,  the  debate  on  new  technological  developments  shows  that  these 
concepts could be clearer as there currently seems to be a lack of understanding to what 
extent they apply to emerging technologies.  

Due to  the lack of empirical evidence,  it could not  be evaluated how the strict liability 
was allocated in case of damage caused by a product which is interconnected with other 
products  or  services  in  the  IoT,  or  when  the  damage  comes  from  the  unintended 
behaviour of an autonomous system or an advanced robot. 

5.5. 

EU Added value  

EQ  What  is  the  EU  added  value  of  the  Directive  for  stakeholders  (manufacturers, 
including software developers and economic operators in the DSM, and consumers)? 

57 

 
 
 
EQ  To  what  extent  does  the  issue  of  strict  liability,  as  addressed  by  the  Directive 
continue to require action at EU level?  

The EU added value of the Directive is strongly acknowledged in the case of consumer 
protection: the large majority of stakeholders responding to the open public consultation 
related  to  the  evaluation  consider  it  to  be  a  strong  advantage  to  have  a  Directive  on 
liability  for  defective  products,  as  this  allows  consumers  to  enjoy  the  same  rights  for 
compensation wherever they are in the European Union. In their opinion, this could not 
have been achieved with national legislation only.99 This is confirmed in the results of the 
targeted surveys as well as the interviews. Documentary review conducted in the Study 
also points to the EU added value of the Directive as striking the right balance between 
consumer protection and innovation in Europe.100 

As shown by the figure below, stakeholders are generally positive towards extending the 
scope and provisions of the Directive rather than reducing it;  especially regarding (i) the 
reduction  of  the  threshold  of  EUR500  for  damages  caused  to  property,  (ii)  the 
enlargement of the notion of damage as to include the  economic loss and the notion of 
defect as to include fitness for use of the product, (iii) the removal of the burden of proof 
related to the defect, (iv) the extension of the strict liability to other market operators and 
(v) the extension of the scope, covering also services.  

Consistently, stakeholders negatively perceive a change in the Directive which (i) limits 
the  scope  only  to  tangible  product,  (ii)  reduces  the  types  of  damage,  (iii)  raises  the 
threshold of EUR 500 for damages caused to property and (iv) removes the development 
risk clause.  

Figure 7: What would be the effects of the following modifications of the Directive 

Source: Study for the evaluation of the Directive 85/374/EEC 

In  conclusion,  the  EU  added  value  of  the  Directive  seems  largely  recognised  for  the 
protection of consumers and the balance between consumer protection and innovation in 
Europe. There still are, however, some concerns especially among consumers with regard 
to  new  technological  developments,  but  they  do  not  question  the  value  of  EU  level 
responses.  

Summary of open public consultation 

99  
100       See section 4.5 of the Study. 

58 

81556522422724347535761111220%20%40%60%80%100%Extending its scope to servicesLimiting its scope, for instance to cover only tangible productsExpanding the strict liability to other market operatorsEnlarging the concept of "defect" to include the fitness for use of the productRemoving the burden of proof of the defect from the injured partyEnlarging the types of material damages to cover also economic lossReducing the types of damages to which it appliesRaising the threshold of €500 for damages caused to propertyDecreasing the threshold of €500 for damages caused to property Removing the producer's exemption as regards the state of scientific and technological…Reducing the 3-year period for the injured party to start the proceedingsReducing the expiry period of 10 years from when the producer put the product in circulationPositiveNegativeNone 
 
 
 
                                                            
EQ What would be the most likely consequences of reducing the scope of the existing EU 
intervention? 

Support for reducing the scope of the Directive is rare among the stakeholders. However, 
as  already  indicated,  some  producers  of  pharmaceutical  products  and  victims  of 
medicines consider that it would be better to exclude pharmaceutical products from the 
scope of the Directive. 

In  general,  stakeholders  consulted  for  the  evaluation  either  consider  the  Directive  as 
future  proof  or  call  for  a  revision  in  order  to  enlarge  its  scope.  For  them,  reducing  the 
scope  of  the  Directive  may  undermine  consumer  protection,  also  leading  to  negative 
consequences  for  producers  such  as  uncertainty  and  subsequent  difficulty  to  predict 
(potentially higher) costs, decrease of harmonisation, and internal market fragmentation. 

EQ.   What would be the most likely consequences of repealing the Directive? 

Should the Directive be repealed, either tort law, contract law or both would apply with 
heterogeneous rules in terms of protection and liability. 

Due the objective of protection of the consumers, the repeal of the Directive may have a 
negative  impact  both  on  consumer  protection  and  on  the  uniformity  of  EU  legislation. 
The  general  tort  law  usually  requires  that  the  injured  party  demonstrates  at  least  the 
negligence or fault of the producer and that the damage is unlawful.  For general contract 
law, it is needed that the injured party demonstrates the existence of a contract.  

A repeal of the Directive would mean that consumer protection would depend upon the 
courts’  interpretation  of  their  national  law  (contractual  and/or  tort  law),  leading  to 
varying  levels  of  consumer  protection  in  the  different  Member  States,  with  potential 
impacts  on  the  free  movement  of  products  and  distorting  competition.  Therefore,  the 
most likely consequences of repealing the Directive would be a negative impact both on 
consumer protection and the functioning of the single market. 

EQ  According  to  the  case-law  and  the  experience  on  the  application  of  the  Directive, 
could it be considered appropriate to enlarge the scope of the Directive, for instance so 
as to cover the services? 

Nine  Member  States  have  rules  ensuring  an  extra-contractual  liability  to  protect 
consumers  from  damages  caused  by  defects  both  of  intangibles  (e.g.  software)  and 
services.  In  six  of  these  Member  States,  the  protection  of  consumers  from  damages 
caused by defects either of intangibles or of services stems from general rules, normally 
tort  law:  in  these  cases,  protection  essentially  stems  from  the  interpretation  of  general 
rules  to  include  services  or  intangibles.  In  three  other  Member  States,  the  liability  to 
damages caused by intangibles or services is covered by specific legislation. 

Therefore  the  state  of  the  legislation  concurring  with  the  Directive  shows  that,  in 
principle, it could be possible to extend the rules of the Directive so as to cover services 
or  other  intangibles,  like  software.  In  this  sense,  stakeholders  responding  to  the  open 
public consultation considered that providers of software should be held liable according 
to the Directive. 

In  addition,  the  notion  of  damage  could  be  revisited  to  cover  economic  losses  or 
infringements of privacy. 

59 

 
 
 
 
Providers of software, applications and algorithms should potentially be 
held liable  

35

30

25

20

15

10

5

0

Agree
Do not agree
No opinion

Producers
26
4
10

Authorities
19
0
6

Consumers
32
2
14

Source: Open public consultation 

5.5.1.  Conclusion on EU Added value  

In conclusion, the added value of an EU level product liability framework is uncontested. 
If  any,  the  Directive  is  rather  considered  to  provide  too  little  EU  added  value  and  EU 
level legislation of product liability should be extended beyond the current scope of the 
Directive. 

6. 

CONCLUSIONS 

There  is  a  consensus  among  stakeholders  that  overall  the  Product  Liability  Directive 
contributes  to  a  level  playing  field  in  the  single  market  and  contributes  to  consumer 
protection.  This  is  better  achieved  than  could  be  done  at  national  level.  It  matches 
expectations  in  the  sense  that  consumers  are  aware  of  their  right  to  compensation  for 
damage  caused  by  defective  products  and  that  it  provides  a  clear  legal  framework  for 
businesses across the EU. 

A standard cost-benefit analysis was not possible due to the limitations of available data. 
The qualitative analysis of the Directive’s efficiency has nevertheless concluded that, the 
Directive  seems  an  efficient  legislative  instrument,  achieving  its  objectives  at  a 
reasonable  cost  and  ensuring  a  good  cost-benefit  ratio  for  all  sizes  of  companies. 
However,  the  cost-benefit  ratio  is  not  always  fair  and  straightforward  for  consumers, 
mainly due to the cost linked to the burden of proof, which imply costs that an injured 
person has to anticipate to bring a claim in court, including those related to the judicial 
proceedings. The cost of judicial proceedings is outside the scope of the Directive, hence 
there  was  no  simplification  potential  identified  in  this  respect.  Compensation  for 
damages caused by pharmaceutical products sticks out as particularly problematic, where 
adjustments might be needed to provide a real level-playing field.  

60 

 
 
 
 
The  evaluation  shows  that  the  Directive  is  coherent  with  the  existing  product  safety 
legislation  and  is  complementary  with  the  rules  on  consumer  protection  in  the  area  of 
contractual  liability.  Coherence  and  synergies  have  been  confirmed  also  between  the 
Directive and the rules on applicable law in civil and commercial matters. 

There  are,  however,  certain  aspects  of  the  Directive  that  have  an  impact  on  the 
effectiveness of the Directive.  

There are concerns about the continued balance between the interests of consumers and 
producers,  notably  with  regards  to  the  burden  of  proof.  At  present,  it  appears  that 
especially complex products such as pharmaceutical products –but also emerging digital 
technologies  -  pose  a  problem  in  terms  of  e.g.  access  to  and  availability  of  technical 
information that may make it very difficult for consumers to be able to prove the links 
between defects and damages. Furthermore, 500€ threshold can be identified as cost to 
the consumer that may excessively limit the number of claims. 

Furthermore,  the  definition  of  product  appears  to  no  longer  be  as  clear-cut  as  it  may 
have been when the Directive was adopted for example in the light of new technological 
developments where the distinction between products and services becomes blurred or in 
the context of software. Given that the Directive applies to products, a clarification of its 
scope could therefore be envisaged. 

In  a  similar  vein,  as  products  are  more  easily,  altered  adapted  and  combined  with 
services,  the  definition  of  the  producer  may  become  less  clear  particularly  in  the 
context of emerging digital technologies and the circular economy. The definition of the 
producer,  while  continuing  to  be  valuable  as  it  ensure  strict  liability,  may  therefore  no 
longer be fully relevant in its current form. Another question is raised by the limitation 
of  damage  to  physical  and  material  damage  to  the  detriment  of  e.g.  economic  or 
environmental damage. Linked to this is the definition of defect which may require being 
updated  to  new  types  of  problems  such  as  infringements  of  privacy  or  how  to  link  the 
notion of defect with the types of autonomous behaviours leading to damages. Extending 
the scope of the Directive in this direction is, however, a political decision that will have 
to be carefully assessed. 

A detailed assessment of the effects of such changes within the existing framework needs 
to  be  carried  out.  There  may  be  a  need  for  guidance,  clarification  and  if  necessary 
adaptation  of  certain  aspects  in  light  of  technological  developments  to  ensure  that  the 
Directive  continues  to  meet  its  objectives  to  the  extent  possible.  The  roll  out  of  these 
technologies should be closely monitored and observed.  

The evaluation has also highlighted that at present, there is a lack of empirical data that 
would allow for a conclusive statement concerning new technologies. There do not seem 
to have been a significant number of incidents where the Directive was unable to apply. 
Despite  the  on-going  work  on  safety,  over  time  more  evidence  will  become  available. 
Further fact finding is required that should allow for a more detailed assessment than is 
currently possible based on legal analysis to assess whether the Directive remains fit for 
purpose in that evolving context. This and other aspects that may become relevant will be 
assessed in the framework of the report on the application of the Directive. 

61 

 
 
 
 
ANNEX 1: PROCEDURAL INFORMATION 

1. 

LEAD DG, DECIDE PLANNING/CWP REFERENCES 

  Lead  DG:  Directorate  General  Internal  Market,  Industry,  Entrepreneurship  and 

SMEs (DG GROW) 

  Decide/Planning:  2016/GROW/027--  V  report  on  the  application  of  Directive 
85/374/EEC  on  liability  for  defective  products  and  SWD  on  the  evaluation  of 
Directive 85/374/EEC. 

  REFIT (evaluation). 

2.  ORGANISATION AND TIMING 

  An Inter-service Steering Group oversaw the process to ensure coherence and 
comprehensiveness  with  the  Commission’s  overall  responsibilities  and 
activities in related policy areas such as safety and consumer protection.  

The ISG met 10 times: 13 July 2016, 31 August 2016, 11 November 2016, 10 
January 2017, 7 February 2017, 16 May 2017, 5 September 2017, 10 October 
2017, 23 January 2018 and 8 February 2018.  

  Publication  in  EUROPA  of  the  Roadmap  on  the  evaluation,  12  September 

2016 

  Signature of a specific contract for the Study on the evaluation,  19 December 

2016  

  Launch of the Open public consultation, 10 January 2017 ( 12 weeks)  

  Approval of the Final report of the Study for the evaluation, February 2018 

3. 

EXCEPTIONS TO THE BETTER REGULATION GUIDELINES 

NA 

4.  CONSULTATION OF THE RSB (IF APPLICABLE) 

NA 

62 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 

EVIDENCE, SOURCES AND QUALITY 

  First report on the application of the Council Directive on the approximation 
of  laws,  regulations  and  administrative  provisions  of  Member  States 
concerning  liability  for  defective  products,  COM  (95)  617  final  of  13 
December 1995. 

  Green  Paper  of 

the  Commission  "Liability  for  defective  products". 

COM(1999) 396 final of 28 July 1999 . 

  Second  report  on  the  application  of  the  Council  Directive  on  the 
approximation of laws, regulations and administrative provisions of Member 
States concerning liability for defective products, COM (2000) 893final of 31 
January 2001. 

  Third report on the application of the Council Directive on the approximation 
of  laws,  regulations  and  administrative  provisions  of  Member  States 
concerning  liability  for  defective  products,  COM  (2006)  496final  of  14 
September 2006. 

  Fourth  report  on 

the  application  of 

the 
approximation of laws, regulations and administrative provisions of Member 
States concerning liability for defective products. COM (2011) 547 final of 8 
September 2011. 

the  Council  Directive  on 

  Lowels Report: Product Liability in the European Union, 2003.  

  Fondazione Rosselli Report: Analysis of the Economic Impact of the 

Development Risk Clause as provided by Directive 85/374/EEC on Liability 
for Defective Product, 2004.  

  Communication  from  the  Commission  to  the  European  Parliament,  the 
Council, the European Economic and Social  Committee and the Committee 
of the Regions - Digitising European Industry Reaping the full benefits of a 
Digital Single Market (COM(2016) 180 final) of 19 April 2016. 

  Commission  Staff  Working  Document-  Advancing  the  Internet  of  Things  in 
Europe,  accompanying  the  Communication  from  the  Commission  to  the 
European  Parliament,  the  Council,  the  European  Economic  and  Social 
Committee  and  the  Committee  of  the  Regions  "  Digitising  European 
Industry-  Reaping  the  full  benefits  of  a  Digital  Single  Market  (SWD(2016) 
110/2. 

  European Parliament Resolution of 16 February 2017 with recommendations 

to the Commission on Civil Law Rules on Robotics (2015/2103(INL).  

Evaluation  of  Council  Directive  85/374/EEC  on  the  approximation  of  laws, 
regulations and administrative provisions of the Member States concerning liability 
for defective products- Final Report. 2018.  

63 

 
 
  
 
 
 
 
 
 
 
 
ANNEX 2: STAKEHOLDER CONSULTATION : SYNOPSIS REPORT  

1.  INTRODUCTION 

Directive  85/374/EEC  on  the  approximation  of  laws,  regulations  and  administrative 
provisions  of  the  Member  States  concerning  liability  for  defective  products  (the 
“Directive”) aims at guaranteeing the protection of consumers’ health and property, the 
free  movement  of  goods  and  undistorted  competition  among  market  operators  in  the 
Single Market. 

The Commission launched an evaluation to judge if the Directive meets its objectives and 
is fit for purpose vis-à-vis the new technological developments such as Internet of Things 
or autonomous systems. A stakeholder consultation was part of this evaluation. 

The evaluation was launched with a roadmap and a consultation strategy. The roadmap 
contained a description of the purpose, content, scope and evidence base of the 
evaluation. The Commission did not receive any comment from stakeholders on the 
roadmap neither on the consultation strategy as they were published. 

2.  OBJECTIVES OF THE CONSULTATION 

The  consultation  strategy  aimed  at  gathering  information  from  stakeholders  to  feed  the 
assessment of its effectiveness, efficiency, relevance, coherence and EU added value. 

Relevant  stakeholders  include  producers,  importers,  suppliers  and  their  industry 
associations, consumers and consumer organisations, insurers and federations of insurers, 
technical experts, and  public authorities and civil society  (e.g. think-tanks, experts, law 
firms/legal experts).  

This document presents an overview of the consultation activities and their results. 

3.  CONSULTATION METHODS AND TOOLS 

Overall,  657  stakeholders  from  all  Member  States  (except  for  Latvia,  Portugal,  and 
Slovenia)  and  all  target  groups  (except  for  technical  experts)  contributed  to  the 
consultation. 

3.1.  Public Consultation 

An open public consultation was launched (10 January – 26 April 2017) in 23 European 
Union  languages,  consisting  of  three  online  questionnaires  addressed  to  producers; 
consumers; public authorities and civil society representatives. 

113  stakeholders  (40  producers,  48  consumers  and  23  public  authorities/civil  society) 
from  16  Member  States101  replied.  14  position  papers  were  shared  by  consumers  (1), 
business associations (9) and public authorities/civil society representatives (4).  

101   All except DK, EE, EL, HR, CY, LV, LU, HU, PL, PT, SI, SE. 

64 

 
 
 
 
 
 
                                                            
3.2. 

Surveys 

A targeted survey (3 April – 20 May 2017) was carried out through five questionnaires 
in English addressed to: 

  Producers and suppliers and related industry associations (4 responses); 

  Consumer associations (11); 

 

Insurers and related associations (0); 

  Public authorities and civil society representatives (11); 

  Technical experts active in courts (0). 
Responses came from 14 Member States.102 

A Computer-assisted telephone (CATI) survey (29 May – 14 June 2017) covering 11 
Member  States103  was  addressed  to  producers,  importers,  and  suppliers.  457  producers 
responded.104 

61 interviews (3 May – end of July 2017) were held with stakeholders with experience 
with the Directive (17 producers, 11 consumers, 9 insurers, 24 public authorities and civil 
society representatives).105 

The targeted surveys encountered some limitations: 

  Low  level  of  participation  in  the  targeted  survey:  more  than  400  stakeholders 

were contacted, but only 26 replied. 

  No representative from technical experts replied. 

3.3. Conference on the Evaluation of the Product Liability Directive 

The European Commission held a Conference on the evaluation of the Product Liability 
Directive106 in Brussels on 20 October 2017, addressed to Member State's representatives 
and  different  categories  of  stakeholders  and  aimed  at  exchanging  views  on  the 
preliminary results of the external study on the evaluation. 

4.  MAIN RESULTS OF THE CONSULTATION ACTIVITIES 

Several  stakeholders  had  experience  with  the  Directive.  Most  businesses  dealt  with 
claims  brought  by  injured  persons  and  paid  for  insurance;  consumer  associations  were 
familiar with claims by injured persons; insurers provided specific insurance policies and 
paid  compensations;  public  authorities  and  civil  society  representatives  dealt  with  the 
needs of specific stakeholder categories, acted in litigation or carried out research on the 
Directive.  

BE, BG, DK, EL, ES, FR, IT, LT, LU, MT, NL, SI, FI, UK.  

102  
103    CZ, DE, ES, FR, IT, LT, NL, AT, PL, SE, UK. 
104  
105  
106  

From CZ, DE, ES, FR, IT, LT, NL, AT, PL, SE, UK.  
From BE, DK, DE, EE, ES, FR, HR, IT, CY, LU, HU, MT, NL, FI, UK. 
See minutes of the Product Liability Conference at  https://ec.europa.eu/docsroom/documents/26661  

65 

 
 
 
 
                                                            
4.1 

Effectiveness 

The  consultation  aimed  at  understanding  whether  and  to  what  extent  the  Directive’s 
objectives  in  terms  of  protection  of  consumers,  undistorted  competition  and  free 
movement of goods have been achieved so far at both national and EU levels. 

Most  stakeholders  are  aware  of  the  Directive.  For  most  public  authorities  and  civil 
society  representatives,  the  Directive  is  effective  as  consumers  benefit  from  the  strict 
liability  of  producers,  and  consumers’  and  producers’  interests  are  fairly  balanced.  For 
these reasons, they also believe that the system of strict liability must be maintained. 

Most  producers  deem  the  Directive  to  be  effective,  as  it  creates  a  level  playing  field 
across  Europe  by  setting  the  same  liability  rules  in  all  Member  States  and  balances 
consumers’ and producers’ interests, setting clear rules regardless of the product type. 

Finally,  for  insurers  the  Directive  is  effective  overall,  as  it  balances  consumers’  and 
producers’ interests. 

However,  for  most  consumer  associations  the  Directive  is  not  fully  effective,  as  it 
protects producers’ interests more than those of consumers. 

In particular, some provisions of the Directive are seen as more effective than others: 

  Products, not services 

For  some  of  the  stakeholders  (both  producers  and  consumers)  the  distinction  between 
products  and  services  is  not  clear  anymore  and  the  Directive  should  also  cover  the 
damages caused by services; other producers believe that the Directive should not cover 
these damages. 

For  more  than  half  of  the  public  authorities  and  civil  society  representatives  consulted, 
the distinction between products and services is not adequate and the Directive’s scope 
should be extended to services. 

The vast majority of consumers and their associations underline that it may be difficult to 
distinguish a product from a service, as they are often bundled together, and they would 
favour a regime covering both products and services. 

On  the  contrary,  for  more  than  half  of  the  businesses,  the distinction  between  products 
and services is adequate and there is no need to extend the Directive to services. 

  What about new technological developments? 

The  application  of 
straightforward.   

the  Directive 

to  new 

technological  developments 

is  not 

The feedback from stakeholders on new technological developments is quite divergent: 
for some stakeholders (including many producers, some consumers, insurers and public 
authorities/civil society representatives) there is no need to update the Directive vis-à-vis 
new technological developments. Others from all consulted categories find it difficult to 
apply  the  Directive  to  these  items,  given  their  intangible  nature  and  increasing 
complexity. 

More  specifically,  for  almost  half  of  the  public  authorities  and  civil  society 
representatives and almost all consumers, the scope of the Directive should be broadened 
to  new  technological  developments  and  balance  consumers’  safety  and  innovation, 
considering the distinction between products and services and the concept of “defect” as 
not adequate for these developments.  

66 

 
Most  businesses  consider  apps,  non-embedded  software  and  IoT  components  to  be 
“products” pursuant to the Directive, while they have diverging views as to whether the 
liability  is  adequately  allocated  among  the  different  operators.  Furthermore,  for  them 
defect  is  adequately  defined  as  to  damages  caused  by  an  advanced  robot  or  an 
autonomous system.  

For  a  large  majority  of  businesses  the  exemptions  under  the  Directive  are  adequate  for 
new technological developments and the Directive already applies to them; they consider 
the Directive to be fit-for-purpose and neutral to different technologies. 

Similarly,  for  a  large  majority  of  insurer  associations  there  is  no  need  to  adapt  the 
Directive to new technological developments. 

  Burden of proof 

For  a  large  majority  of  public  authorities  and  civil  society  representatives  the  proof  of 
defect and of the link between it and the damage is burdensome to consumers. 

Almost  all  consumer  associations  see  this  burden  as  the  most  frequent  obstacle  to 
obtaining  compensation, especially with  regard to  new technological  developments and 
increasing product complexity. 

However, only a few insurers view the burden of proof as onerous in practice. 

Most businesses think that removing this burden would be disadvantageous: indeed, the 
burden of proof upon the injured person is essential as a basis for the claim; removing it 
would make the Directive unfair. 

  Damages to property 

For  a  slight  majority  of  public  authorities  and  civil  society  representatives,  the  €500 
threshold  should  be  removed  to  allow  compensation  of  smaller  damages.  Also,  the 
majority  of  consumer  associations  would  lower  the  threshold,  as  the  price  of  many 
products has decreased over the years.  

While most businesses do not favour a modification of the threshold, a significant share 
of small firms (24%) favour decreasing the threshold. 

For the majority of stakeholders, except for insurers, it is difficult to apply the condition 
that the item of property is of a type ordinarily intended for private use or consumption 
and was used by the injured person mainly for his own private use or consumption; they 
believe it should be removed. 

For half the public authorities and civil society representatives this provision should be 
removed, as it is increasingly difficult to distinguish when an item of property is intended 
for professional or private use. 

Most  businesses  (63%)  and  more  than  half  of  the  consumer  associations  consider  the 
distinction between private and professional use as not adequate, since products can have 
both uses, and the removal of such distinction would not cause any problems. 

Almost all insurers associations consider the distinction between private and professional 
use of products as clear enough and no change is needed. 

The  Conference  on  Product  Liability  gave  the  opportunity  to  further  elaborate  on  the 
views  obtained  through  the  use  of  other  consultation  tools.  On  effectiveness  of  the 
Directive, the majority of manufacturers and insurers considered that the Directive meets 
its objectives and that it is future-proof for the new technological developments. In their 
opinion,  any  revision  at  this  stage  would  be  premature.  However,  consumers  were  in 

67 

 
favour  of  a  revision  of  the  Directive  with  a  view  to  facilitate  the  compensation  of  the 
injured party. 

4.2  Efficiency 

The  consultation  focused  on  the  balance  between  the  costs  borne  by  the  producers  to 
cover the strict liability and the burdens on the injured party to obtain compensation, as 
well  as  on  aspects  making  it  more  or  less  efficient  in  ensuring  strict  liability  of  the 
producer. 

Data on costs and benefits were expected from the targeted survey: however, the low rate 
of  response  hampered  proper  quantification.  Data  retrieved  from  the  other  consultation 
activities allowed carrying out only a qualitative analysis. 

In particular, for more than half of  the businesses, costs and benefits deriving from the 
Directive are well balanced. 

Yet  more  than  two-thirds  of  consumer  associations  see  costs  as  higher  for  consumers: 
proving  the  defect  and  its  link  to  the  damage  is  burdensome  due  to  increasing  product 
complexity. For almost half of the insurers, the burden of proof can be difficult to fulfil 
in practice. 

As  a  third  point  of  view,  for  two  thirds  of  the  public  authorities  and  civil  society 
representatives,  although  costs  relating  to  the  Directive  are  acceptable  for  traditional 
products,  the  new  technological  developments  could  bring  new  costs  for  producers  to 
comply with it. 

4.3  Coherence 

The  consultation  focused  also  on  questions  relating  to  the  coherence,  complementarity 
and  consistency  between  the  Directive  and  other  Union  actions,  in  particular  product 
safety legislation and consumer protection.  

The  Conference  on  Product  Liability  was  the  occasion  for  the  stakeholders  to  confirm 
that  the  Directive  is  perceived  as  coherent  and  consistent  with  the  EU  product  safety 
legislation and with the rules on consumer protection. It was recalled that products placed 
on the European market must comply with EU safety legislation. In case that they caused 
damages  due  to  a  defect,  consumers  can  bring  legal  action  against  the  producer  in  the 
context of the Directive (extra-contractual liability) but also against the seller according 
to the contractual liability rules. 

4.4  Relevance 

The  consultation  activities  aimed  at  understanding  whether  the  initial  needs  still 
correspond to current needs, including needs created by innovative products. They also 
aimed at investigating whether the definitions of product, producer, defect and damage 
or  the  exemptions  under  the  Directive  are  adequate  to  the  technological  and  scientific 
developments. 

Outcomes  are  quite  fragmented:  for  most  stakeholders  there  is  a  need  to  update  the 
Directive  vis-à-vis  new  technological  developments,  even  though  they  have  not 
experienced any issues in applying the Directive. 

68 

 
 
 
 
Overall,  for  the  majority  of  public  authorities  and  civil  society  representatives  the 
Directive  is  future-proof,  and  the  harmonisation  it  brought  across  the  EU  confirms  its 
current  relevance;  however,  they  suggest  a  revision  of  the  Directive  in  relation  to  new 
technological developments. For the vast majority of businesses the Directive is future-
proof and relevant due to the harmonisation it brought. 

For  the  vast  majority  of  consumer  associations  the  Directive  has  harmonised  product 
liability rules. However, they favour a revision of the Directive to take into account the 
new 
technological  developments,  as  do  public  authorities  and  civil  society 
representatives, because of the lower relevance of the Directive vis-à-vis the new needs 
and  the  limited  applicability  of  the  concepts  of  the  Directive  to  new  technological 
developments. 

4.5  EU added value 

The  consultation  aimed  at  gathering  feedback  on  whether  strict  liability  continues  to 
require action at the EU level. Moreover, the consultation focused on understanding the 
most  likely  consequences  in  case  of  scope  reduction  or  repeal  of  the  Directive  or 
extension of its scope. 

Overall,  all  stakeholders  acknowledge  the  EU  added  value  of  the  Directive  and  no 
stakeholder suggested to repeal it. 

A majority of businesses agree that the level playing field achieved would not be possible 
with individual Member States action. In addition, for almost all consumer associations 
the protection of consumers achieved would not be feasible with only national action. 

The  vast  majority  of  public  authorities  and  civil  society  representatives  deem  that  the 
Directive added value to the EU legal framework and policies. 

The  Conference  on  Product  Liability  confirmed  the  positions  defended  by  the  different 
categories  of  stakeholders.  In  addition,  many  participants  emphasised:  (i)  the  link 
between  product  safety  and  product  liability  rules,  (ii)  the  difficulty  for  victims  of 
undesirable  effects  of  pharmaceutical  products  to  prove  the  defect  and  the  casual  link 
between defect and damage in order to get compensation, (iii) the lack of evidence on the 
application of the Directive to the new technological developments, and (iv) the need to 
maintain a fair balance between the interests of the parties. 

5.   MAIN CONCLUSIONS  

Consultation activities allowed to gather a wide range of views on the Directive in terms 
of  what  has  worked  well  and  what  has  not  worked  so  well  so  far,  as  well  as  on 
expectations for the future.  

Overall the Directive was viewed as being generally effective in achieving its objectives 
by  public  authorities,  civil  society,  businesses  and  insurers  representatives,  though 
consumer  organisations  were  more  critical  especially  on  obstacles  to  obtaining 
compensation, in particular related to the increasing complexity of providing the burden 
of  proof,  a  more  difficult  delineation  of  products  and  services  as  well  as  the  500€ 
threshold for material damages. 

Most stakeholder categories recognised the efficiency of the Directive. In particular, all 
categories,  except  for  consumer  associations,  think  the  costs  and  benefits  due  to  the 
Directive for consumers and producers are balanced. 

69 

 
 
 
The Directive is seen as coherent with the EU legislation protecting consumers, relevant 
and future-proof. Nonetheless, representatives from public authorities, civil society and 
consumer  associations  agree  there  are  issues  not  adequately  covered  by  the  Directive 
with  regard  to  new  technological  developments,  while  businesses  are  more  reluctant  to 
amending the Directive. 

There was a large consensus among stakeholders that the Directive has EU added value. 

The Conference on the Evaluation of the Product Liability Directive gave the opportunity 
to  confirm  the  need  to  pursue  the  reflection  on  the  future  of  the  Directive  in  order  to 
ensure legal certainty, in particular in relation to its application to new technologies, such 
as Artificial Intelligence systems and advanced robots and internet of Things. 

70 

 
ANNEX 3: METHODS AND ANALYTICAL MODELS 

Evaluation questions 

The table below lists all final evaluation questions from the Study on the Evaluation of the Product Liability Directive.  

EFFECTIVENESS 

EQ 1: To what extent the Directive meets its objective of guaranteeing at EU level the liability of the producer for damage caused by a defective 
product and in turn, contributes to an effectively operating internal market for goods and to the protection of the consumer? 

EQ 2/3: Which are the main drivers to the objectives achieved? 

EQ 5/6/13: What is the impact of the new technological developments on the effectiveness of the Directive? 

EQ 8/12: What are the systems used to settle the claims by injured persons from damages caused by defective products? 

EQ 9: Which products have been most frequently at cause for the purpose of recovery of damages? 

EQ 10: Which types of defects have been most frequently detected in those products? 

EQ 11: Which type of damages (personal injuries or property) have been more often the object of recovery? 

EQ 14: How many cases have been brought to the courts on the applicability of the Directive? Which was the issue in question and the ruling? 

EQ 15: In the judicial cases, what have been the most frequent difficulties encountered by consumers when obtaining compensation, in particular 
during the last five years? The identification of the defect? The establishment of the causal link between damage and defect? The threshold of 
€500? The allocation of the liability among the economic players? Other? 

EQ 16: In general, have the claimants been successful in the litigation? Is there a trend to be observed in the last five years?  

EQ 17: Have cases been brought to the national courts relating to the application of the Directive to damages caused by a defect, for instance the 
malfunctioning, in apps or in another non-embedded software? If it is the case, which was the issue at stake and what was the ruling?  

EQ 18: Have there been cases brought to the national courts or solved through an out-of-court settlement relating to the application of the Directive 
to damages caused by a robot, in particular in an advanced robot or an autonomous system? If it is the case, what was the issue at stake and the 

71 

 
ruling?  

EQ 19: Have there been cases in which the damage was caused by a product interconnected with other products or services, for instance in the 
context of IoT and automated systems? How has the liability been allocated in those cases? 

EQ 20: In the context of new technological developments, have there been discrepancies between the judgements made by the courts on similar 
cases? What were the problems at stake? 

EFFICIENCY 

EQ 21: What are the regulatory (including administrative) costs for relevant stakeholders stemming from the Directive? 

EQ 22: What are the main benefits for stakeholders and civil society that derive from the Directive? 

EQ 23: Are the benefits achieved at reasonable cost for consumers and producers (with focus on SMEs)? 

EQ 24: Does the Directive strike the right balance between the costs borne by the producers to cover the strict liability and the requirements on the 
injured party to obtain compensation? 

EQ 25: What aspects of the Directive are most efficient or inefficient to reach the objective of having a system of strict liability on the producer?  

COHERENCE 

EQ 26: To what extent is the intervention consistent and coherent with the EU rules on consumer protection in the area of contractual liability (for 
example, new Commission initiatives in the digital context)? 

EQ 27: To what extent is the Directive coherent with wider EU policy, such as the free movement of goods and/or the protection of the consumers, 
including EU product safety? 

RELEVANCE 

EQ 28: To what extent do the initial objectives correspond to the current needs, including new needs created by innovative products? 

EQ 29: To what extent does the distinction between products and services when dealing with product liability continue to be apt for dealing with 
the new technological developments?  

72 

 
EQ 30: How well adapted is the intervention to the changing market environment: often with a blurred distinction between private and professional 
use of products?  

EQ 31: To what extent the concepts of product, producer, damage or the category of exemptions as defined in the Directive are adequate to 
correspond to the technological and scientific developments? 

EQ 32: How well is the term 'defective' as defined in the Directive adapted to new technological or scientific advances such as apps and non-
embedded software, advanced robots and autonomous/intelligent systems? For example, could software vulnerability (for instance, a cyber-attack 
or a failure to update security software or a misuse of information) be considered as a defect? 

EU ADDED VALUE 

EQ 33: What is the EU added value of the Directive for stakeholders (manufacturers, including software developers and economic operators in the 
DSM, and consumers)? 

EQ 34: To what extent does the issue of strict liability, as addressed by the Directive continue to require action at EU level? 

EQ 35: What would be the most likely consequences of reducing the scope of the existing EU intervention? 

EQ 36: What would be the most likely consequences of repealing the Directive? 

EQ 37: According to the case law and the experience on the application of the Directive, could it be considered appropriate to enlarge the scope of 
the Directive, for instance so as to cover the services? 

73 

 
74 

 
 
– Evaluation grids 

► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

►  JC1 The Directive 

►  Assessment of the extent to which the 

►  1. Level of 

meets its objective in 
guaranteeing at EU 
level the strict 
liability of the 
producer for damage 
caused by a defective 
product 

Directive has led to recognition of liability (in 
and out of courts). The analysis is based on 
stakeholders’ perception and other secondary 
sources. 

satisfaction on the 
effectiveness of the 
Directive in 
guaranteeing the 
liability of 
producers for 
damages caused by 
defective products 

►  JC2 The Directive 

►  Assessment of the extent to which the 

►  1. Level of 

► 

  ► 

  ► 

  ►  x 

contributes to an 
effectively operating 
internal market for 
goods 

Directive has led to a level playing field for 
producers 
The analysis is based on stakeholders’ 
perception and other secondary sources. 

satisfaction on the 
effectiveness of the 
Directive on its 
contribution to a 
level playing field 

n
o
i
t
a
l
-
s
i
g
e
l
S
M

► 
►

w
a
l

e
s
a
c
S
M

w
a
l
-
e
s
a
c
U
E

w
e
i
v
e
r
k
s
e
D

C
P
O

►

P

C

►

►

  ►  x  ►  x  ►  x 
►

►

►

C
I

►

)
3
Q

(
S
T

►

S
C

/

A
P

►

)
6
Q
–
1
Q

(

I

►

T

►

)
1
Q

(

I

►

►

)
3
2
Q

(
S
T

►

)
9
1
Q
A
P

,
0
2
Q
C

(

x

►

►

)
2
1
Q

(
S
T

►

)
2
Q

(
S
T

►

)
2
1
Q

(
S
T

►

)
6
Q

,
7
Q

(
S
T

►

)
6
Q
–

1
Q

(

I

,
)
4
Q

,
3
Q

(
S
T

►

►  Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
►  Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
►  Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 

s
s
e
n
e
v
i
t
c
e
f
f

E

►

s
s
e
n
e
v
i
t
c
e
f
f

E

►

s
s
e
n

e
v
i
t
c
e
f
f

E

►

►  JC3 The Directive 
contributes to the 
protection of the 
consumers 

►  Assessment of the extent to which the 

►  1. Level of 

► 

  ►  x  ►  x  ►  x 

Directive contributes to a more effective 
protection of consumers. Analysis of the 
extent to which consumers have obtained 

satisfaction on the 
effectiveness of the 
Directive for 

,
0
2
Q
C

(

x

)
9
1
Q
A
P

►

S
T

►

I

,
)
1
1
Q

(

,
6
3
Q
Q
–
(
S
1
T
Q
(

►

)
)
4
0
Q
1
Q
–

–
1
Q

(

I

)
6
Q

►

S
T

►

I

,
)
1
1
Q

(

6
Q

-
1
Q

(

)
0
1
Q

-

►

75 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

n
o
i
t
a
l
-
s
i
g
e
l
S
M

►

w
a
l

e
s
a
c
S
M

►

w
a
l
-
e
s
a
c
U
E

►

w
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r
k
s
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►

C
P
O

►

P

C

►

►

C
I

►

S
C

/

A
P

►

T

►

compensation compared to what was 
requested  
The analysis is based on stakeholders’ 
perception, and other secondary sources. 

consumer 
protection 
2. Ratio 
compensation 
requested/ 
compensation 
awarded 

► 

►  JC4 The Directive 
contributes to other 
not originally planned 
consequences and 
effects 

Identification of aspects that go beyond the 
liability of producer for damages from 
defective products, through both desk and 
field research.  

► 

►  x  ►  x  ►  x  ►  x 

)
2
Q

(

I

►

)
2
Q

(

I

►

)
2
Q

(

I

►

►

)
2
Q

(

I

►

)
9
Q

-

4
Q

-

3
Q

-

2
Q

-

1
Q

(

I

)
7
1
Q

,
6
1
Q

(
S
T

►

►

►

►

►

)
3
1
Q

(

I

►

)
4
Q

(

I

►

►  Q2/3. Which are the 

►  JC1 Some provisions 

►  Assessment of the extent to which the 

►  1. Level of 

►  x  ►  x  ►  x  ►  x 

main drivers to the 
objectives achieved? 

have been 
implemented more 
consistently in MS  

following terms have been implemented 
consistently in the MS:  
1. Producer 
2. Defective 
3. Damages 
4. Product (also including new technologies) 
5. Safety 
6. Material thresholds of €500 

uniformity of 
implementation  
2. Number of case 
law references 
evidencing 
extension of the 
Directive by way 
of similarity  
3. Number of case 

76 

level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 

►  Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 

s
s
e
n
e
v
i
t
c
e
f
f

E

►

s
s
e
n
e
v
i
t
c
e
f
f

E

►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

law references 
evidencing 
exclusion of 
liability of the 
producer and/or 
other economic 
operators 
4. Rate of 
recurrence of 
specific factors  

n
o
i
t
a
l
-
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►  Q2/3. Which are the 

main drivers to the 
objectives achieved? 

►  JC2 It is possible to 
identify specific 
aspects in the 
Directive that render 
it more or less 
effective 

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►

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►

►  Q4. Have any gaps, 
uncertainties or 
inadequacies 
occurred in the 
application of the 
Directive, in 
particular during the 
last five years? If 
yes, which ones and 
with which 

►  Assessment of the extent to which specific 

►  Ranking of drivers  ► 

  ► 

  ► 

  ►  x 

► 

► 

characteristics of Directive make it more 
effective: 
- application of the Directive to many 
products 
- strict liability of the producer 
- notion of "defective" 
- proof of defect 
- proof of damage 
- proof of the link between the defect and the 
damage 
- identification of the producer 
- material threshold of €500 
- private use 
- three-year period  
- expiry period of 10 years 

)
7
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►  Please consider that 

►  N/A  

►  N/A 

such question has 
been deleted because 
covered in terms of 
Relevance, below. 

►  N
/
A 

►  N
/
A 

►  N
/
A 

►  N
/
A 

►

A
N

/

►

A
N

/

►

A
N

/

►

A
N

/

►

A
N

/

►

77 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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►

consequence? A 
particular attention 
should be paid to 
any potential 
regulatory lacunas 
relating to the new 
technological 
developments and 
how these were 
filled-in at national 
level? 

►  Q5/6/13. What is 
the impact of the 
new technological 
developments on the 
effectiveness of the 
Directive? 

►  JC1 The Directive 

►  Analysis of the extent to which new 

properly covers new 
technological 
developments new 
technological 
developments 

technological developments are covered or 
not, and why, by the Directive, by looking at  
- how new technological developments new 
technological developments are treated by 
national legislation.  
- there are new contractual arrangements 
covering the risks created by new 
technological developments (notably 
insurance contracts, in general, specific 
professional insurances).  
Analysis of the extent to which the Directive 
has impacts on economic operators in the 
digital economy, through interviews. 

Identification of the main systems used to 
settle claims by injured persons from 
damages caused by defective products 
through the analysis of case law and 
stakeholder consultation.  
The analysis shall focus on how many claims 
are settled in court and out of court with 
possible identification of any kind of trend in 
the use of these systems. 

►  Q8/12. What are the 
systems used to 
settle the claims by 
injured persons 
from damages 
caused by defective 
products? 

►  JC1 There are 

► 

different systems in 
place to settle the 
claims by injured 
persons 

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►

►  x  ►  x  ►  x  ►  x 

►  1. Number of case 
law references 
relating to new 
technological 
developments  
2. Percentage of 
claims relating to 
new technological 
developments  

►  1. Percentage of 
claims settled by 
each system 

► 

  ►  x  ►  x  ► 

)
3
2
Q
A
P

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2
2
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 ►  Q9. Which products 
have been most 

s
s

►  JC1 There are 

products whose defect 

► 

Identification of the products most frequently 
subject to claims through the analysis of case 

►  1. Ranking of 
products 

► 

  ►  x  ►  x  ► 

►

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

frequently at cause 
for the purpose of 
recovery of 
damages? 
►  Q10. Which types 

of defects have been 
most frequently 
detected in those 
products? 

►  Q11 Which type of 
damages (personal 
injuries or property) 
have been more 
often the object of 
recovery? 

►  Q14 How many 
cases have been 
brought to the courts 
on the applicability 
of the Directive? 
Which was the issue 
in question and the 
ruling? 

caused damages 
object of recovery in 
claims from 2000 
onward 

►  JC1 There are defects 
that have been 
frequently detected in 
products from 2000 
onward 
►  JC1 There are 

damages (personal 
injuries or property) 
that are more often 
subject of recovery in 
the cases from 2000 
onward 

law and stakeholder consultation 

► 

Identification of the different types of defects 
most frequently subject to claims through the 
analysis of case law and stakeholder 
consultation 

►  Mapping and distribution of types of 

damages:  
- personal injuries 
- property 
through the analysis of case law and 
stakeholder consultation 

►  JC1 Cases brought to 

► 

courts on the 
applicability of the 
Directive 

Identification of claims brought to court from 
2000 onward, with particular mention and 
details from 2011 onward, analysed by 
subject matter and ruling. Identification and 
mapping of the main issues behind the claim 
and final outcome of the judicial proceedings  

►  Q15 In the judicial 

►  JC1 There are 

► 

specific difficulties 
faced by consumers in 
obtaining 
compensation from 
2000 onward 

cases, what have 
been the most 
frequent difficulties 
encountered by 
consumers when 
obtaining 
compensation, in 
particular during the 
last five years? The 
identification of the 
defect? The 

Identification of difficulties faced by 
consumers in obtaining compensation in 
judicial proceedings through the analysis of 
the reasons for rejecting the claim or reducing 
the compensation in case law from 2000, and 
particular mention and details from 2011 
onward. 

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►

79 

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►

T

►

►  1. Ranking of types 

► 

  ►  x  ►  x  ► 

of defects 

►  1. Distribution of 
types of damages 

► 

  ►  x  ►  x  ► 

► 

  ►  x  ►  x  ► 

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►

►

►

►

►

►

►

►  1. Number of cases 
brought to court 
2. Number of cases 
per type of issue 
3. Number of cases 
per result of the 
ruling and per type 
of issue 

►  1. Number of case 
law references 
where the 
claimants did not 
receive the 
compensation or 
the claim was 
rejected.  

► 

  ► 

  ► 

  ► 

►

►

►

►

►

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►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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establishment of the 
causal link between 
damage and defect? 
The threshold of 
€500? The 
allocation of the 
liability among the 
economic players? 
Other as for instance 
that the product was 
purchased as a 
bundle with a 
related service? 
►  Q15 In the judicial 

cases, what have 
been the most 
frequent difficulties 
encountered by 
consumers when 
obtaining 
compensation, in 
particular during the 
last five years? The 
identification of the 
defect? The 
establishment of the 
causal link between 
damage and defect? 
The threshold of 
€500? The 
allocation of the 
liability among the 
economic players? 
Other? 
 ►  Q16 In general, 

s
s

have the claimants 

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n

►

►  JC2 There are 

specific difficulties 
faced by consumers in 
obtaining 
compensation from 
2000 onward 

►  Analysis of the recurrence of the following 
types of difficulties faced by consumers in 
obtaining compensation:  
- identification of the defect 
- establishment of the casual link between 
damage and defect 
- threshold of €500 
- allocation of liability among economic 
players 
The analysis is based on case law from 2000, 
and particular mention and details from 2011 
onward. 

►  1. Number of cases 

► 

  ►  x  ►  x  ► 

where the injured 
party did not 
receive 
compensation 
2. Ranking of 
difficulties  

►

►

)
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Q

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8
1
Q

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6
1
Q

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►  JC1 Success of 
claimants in the 

► 

Identification of the number of claims for 
damages of defective products that have been 

►  1. Number of 

► 

  ►  x  ►  x  ► 

claims brought to 

►

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T
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►

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►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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been successful in 
the litigation?  

litigation 

won by injured parties from 2000 onward (in 
courts and out of courts) 

► 

Identification and analysis of case law 
showing whether the Directive covers or does 
not cover claims relating to malfunctions in 
apps or in other non-embedded software. 

►  Q17 Have cases 

been brought to the 
national courts 
relating to the 
application of the 
Directive to 
damages caused by 
a defect, for instance 
the malfunctioning, 
in apps or in another 
non-embedded 
software? If it is the 
case, which was the 
issue at stake and 
what was the ruling? 

►  JC1 Existence of 
claims relating to 
damages caused by 
malfunctions in apps 
or in another non-
embedded software 
which have been 
ruled: 
i) based on 
application of the 
Directive; or 
ii) based on 
application of other 
legislation 

►  Q17 Have cases 

►  JC2 Existence of 

► 

problematic questions 
arising out of the 
abovementioned cases 

been brought to the 
national courts 
relating to the 
application of the 
Directive to 
damages caused by 
a defect, for instance 
the malfunctioning, 

Identification of main issues relating to the 
application of the Directive in case of 
damages caused by malfunctions in apps or in 
another non-embedded software, in terms of 
extra-contractual liability of the producer, 
considering the following:  
- definition of product 
- definition of defect 
- allocation of liability 

81 

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court in relation to 
damages for 
defective products 
from 2000 onward 
2. Number of 
judicial cases in 
which the claimant 
has been successful 
in obtaining 
compensation in 
case law from 2000 
onward 

►  1. Number of cases 
brought to court for 
defects of apps or 
another non-
embedded software 
at national level 

► 

  ►  x  ►  x  ►  x 

►  1. Ranking of 
issues 

► 

  ►  x  ►  x  ►  x 

►

►

►

►

►

►

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► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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in apps or in another 
non-embedded 
software? If it is the 
case, which was the 
issue at stake and 
what was the ruling? 

►  Q18 Have there 

been cases brought 
to the national 
courts or solved 
through an out of 
court settlement 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, in particular 
in an advanced 
robot or an 
autonomous 
system? If it is the 
case, what was the 
issue at stake and 
the ruling? 
►  Q18 Have there 

been cases brought 
to the national 
courts or solved 
through an out of 
court settlement 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, in particular 
in an advanced 

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►

►  JC1 There are cases 
of claims relating to 
damages caused by 
robots which have 
been ruled based on 
the application of the 
Directive by way of 
similarity 

► 

Identification and analysis of settlements 
showing whether the Directive covers or does 
not cover claims relating to damages caused 
by a robot/ automated or autonomous system.  

►  1. Number of cases 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, by type of 
settlement system 

► 

  ►  x  ►  x  ►  x 

►

►  JC2 Existence of 

► 

problematic questions 
arising out of the 
abovementioned cases 

Identification of main issues relating to the 
application of the Directive in case of 
damages caused by a robot/ automated or 
autonomous system, considering the 
following:  
- definition of product 
- definition of defect 
- allocation of liability 

►  1. Ranking of 
issues 

► 

  ►  x  ►  x  ►  x 

►

82 

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►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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► 

Identification of cases in which the damage 
was caused by a "defect" of a product 
interconnected with other products or 
services, for instance in the context of IoT 
and automated systems. 

►  1. Number of cases 
on damages caused 
by a product 
interconnected 
with other products 
or services 

►  x  ►  x  ►  x  ►  x 

robot or an 
autonomous 
system? If it is the 
case, what was the 
issue at stake and 
the ruling? 
►  Q19 Have there 

been cases in which 
the damage was 
caused by a product 
interconnected with 
other products or 
services, for 
instance in the 
context of IoT and 
automated systems? 
How has the 
liability been 
allocated in those 
cases? 

►  JC1 There are cases 
of claims relating to 
damages caused by 
interconnected 
products, services (for 
instance IoT items, 
automated and 
autonomous systems 
and other New 
Technological 
Developments).  

s
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Identification of how the liability has been 
allocated in the context of IoT in case of 
damages due to defects of new technological 
developments products. Focus on those 
possible areas already covered and those not 
covered yet by a protection similar to the one 
granted by the Directive. 

►  1. Number of cases 
where the liability 
was allocated to 
stakeholders other 
than the producer 

►  x  ►  x  ►  x  ►  x 

►  Q19 Have there 

►  JC2 Allocation of 

► 

been cases in which 
the damage was 
caused by a product 
interconnected with 
other products or 
services, for 
instance in the 
context of IoT and 
automated systems? 
How has the 
liability been 
allocated in those 
cases? 

strict liability in case 
of damages caused by 
a defect in a product 
interconnected with 
other product or 
service (for instance 
IoT items, automated 
and autonomous 
systems and other 
new technological 
developments).  

 ►  Q20 In the context 

s
s

of new 

►  JC1 There are 
interpretative 

► 

Identification of cases in which the courts of 
each MS might have applied other legislation 

►  1. Number of cases 
in which legislation 

► 

  ►  x  ►  x  ► 

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► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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problems arising out 
of new technological 
developments  

technological 
developments, have 
there been 
discrepancies 
between the 
judgments made by 
the courts on similar 
cases? What were 
the problems at 
stake? 

and/or the principles of the Directive by way 
of similarity to claims relating to new 
technological developments to claims relating 
to new technological developments from 
2000 onward with reference to: 
- apps and other non-embedded software 
- robots/automated/autonomous systems 
- interconnected products  
Analysis of the reasons for discrepancies 
based on stakeholders perception 

►  Q21 What are the 
regulatory 
(including 
administrative) costs 
for relevant 
stakeholders 
stemming from the 
Directive? 

►  Q22 What are the 
main benefits for 
stakeholders and 
civil society that 
derive from the 
Directive? 

y
c
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e
i
c
i
f
f

E

►

y
c
n
e
i
c
i
f
f

E

►

►  JC1 There are 
regulatory and 
administrative costs 
stemming from the 
Directive  

►  Mapping of costs distinguishing between:  

- direct (i.e. administrative) 
- enforcement  
- indirect  
based on the preliminary mapping provided 
in the inception report 
Quantification of costs 

► 

  ► 

  ► 

  ►  x 

)

A
P
8
1
Q

,

P
5
2
Q

,

C
9
1
Q

(

x

►  JC1 It is possible to 

►  Mapping of benefits distinguishing between:  

►  Rating of identified 

► 

  ► 

  ► 

  ►  x 

identify some benefits 
that are deriving from 
the Directive that are 
particularly relevant 
for stakeholders 

- direct (i.e. administrative) 
- enforcement 
- indirect  
based on the preliminary mapping provided 
in the inception report 

benefits 

84 

►

)

A
P
8
1
Q

,

P
5
2
Q

,

C
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1
Q

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x

►

►

►

►

)
9
Q

,
8
Q

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7
Q

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6
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►

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Q

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Q

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Q

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►

other than the 
Directive was 
applied to claims 
on damages caused 
by new 
technological 
products, directly 
or by the way of 
extension of its 
principles by type 
of "new 
technological 
developments" 
2. Number of cases 
in which other 
legislation was 
applied to damages 
caused by defects 
in new 
technological 
developments 

►  1. Costs on total 
production value 
for producers; 
2. Ranking on the 
level of burden for 
consumers; 
2. Costs for 
consumers (where 
available).  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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►

►

C
I

►

►  Q23 Are the 

►  JC1 The ratio 

benefits achieved at 
reasonable cost for 
consumers and 
producers (with 
focus on SMEs)? 

between the benefits 
and the costs is 
perceived as 
reasonable by 
stakeholders 

Quantification of benefits 

►  Analysis of the balance between costs and 
benefits based on the perception of 
consumers, distinguishing between 
"traditional products" and "products relating 
to New Technological Developments", 
overall and by type of stakeholder.  
Information will be gathered through the 
survey to consumers and producers and the 
results of the OPC 

►  Q24 Does the 

►  JC1 The ratio 

►  Analysis of the ratio between insurance 

between the insurance 
costs of the producer 
and the compensation 
received by the 
consumers is 
appropriate 

premiums and compensation costs (loss ratio) 
for damages caused by defective products 
compared to the overall average ratio, where 
possible distinguishing between "traditional 
products" and "products relating to new 
technological developments" 
Analysis of stakeholder perception  

►  1. Level of 

►
► 

►
  ► 

►
  ► 

►
  ►  x 

satisfaction of 
stakeholders on the 
balance between 
costs and benefits, 
by type of product 

►  1. Ratio between 
the specific and 
average loss ratio 
2. Ratio of loss 
ratio for traditional 
products and 
products relating to 
new technological 
developments  

► 

  ► 

  ► 

  ►  x 

►  Analysis of the level of efficiency of specific 

►  Ranking of most 

► 

  ► 

  ► 

  ► 

aspects of the Directive based on 
stakeholders' perception from OPC and 
interviews (specific elements: proof of defect, 
proof of damage, proof of link, attribution of 
liability to specific person/entity, threshold of 
€500, proof of private purposes, three year 
expiry period) 

efficient/inefficient 
aspects 

  ►  Q26 To what extent 

is the intervention 
consistent and 
coherent with the 
EU rules on 

►  Analysis of the extent to which the Directive 

►  1. Level of 

► 

  ► 

  ► 

  ►  x 

interacts with other EU rules on consumer 
protection in the area of contractual liability 
in terms of discrepancies, inconsistencies and 
applications, considering specifically the 

coherence (i.e. 
number of 
discrepancies, 
inconsistencies, 

►

►

►

►

►

85 

y
c
n
e
i
c
i
f
f

E

►

y
c
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i
c
i
f
f

E

►

y
c
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e
i
c
i
f
f

E

►

e
c
n
e
r
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h
o
C

Directive strike the 
right balance 
between the costs 
borne by the 
producers to cover 
the strict liability 
and the 
requirements on the 
injured party to 
obtain 
compensation? 
►  Q25 What aspects 
of the Directive are 
most efficient or 
inefficient to reach 
the objective of 
having a system of 
strict liability on the 
producer? 

►  JC1 There are some 
elements of the 
Directive that are 
more or less efficient 
than others.  

►  JC1 The Directive is 
coherent with EU 
rules on consumer 
protection in the area 
of contractual 

)
6
Q

(

I

►

)
7
Q

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6
Q

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I

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Q

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T

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Q
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5
Q

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3
Q

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8
3
Q

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Q

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►

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Q

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1
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1
Q
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P

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9
Q
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x

►

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2
Q
P

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2
2
Q
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P

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1
2
Q
C

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x

►

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9
1
Q
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0
2
Q
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x

►

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C

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P

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►

►

►

►

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8
Q

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I

►

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3
1
Q

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6
Q

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4
Q

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I

►

►

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9
Q

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►

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1
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►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
n
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► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

liability, in particular 
with regard to the EU 
initiatives in the 
digital content 

consumer protection 
in the area of 
contractual liability 
(for example, new 
Commission 
initiatives in the 
digital context)? 

applications) with 
EU Rules  

following: 
- Proposal for a Directive of the European 
Parliament and of the Council on certain 
aspects concerning contracts for the supply of 
digital content COM(2015) 634 final; 
- Proposal for a Directive of the European 
Parliament and of The Council on certain 
aspects concerning contracts for the online 
and other distance sales of goods COM(2015) 
635 final; 
 - Regulation (EC) No 593/2008 of the 
European Parliament and of the Council of 17 
June 2008 on the law applicable to 
contractual obligations (Rome I); 
- European Consumer Agenda 
Communication from the Commission to the 
European Parliament, the Council, the 
Economic And Social Committee and the 
Committee of the Regions A European 
Consumer Agenda - Boosting confidence and 
growth  

►  Q27 To what extent 
is the Directive 
coherent with wider 
EU policy, such as 
the free movement 
of goods and/or the 
protection of the 
consumers, 
including EU 
product safety? 

►  JC1 The Directive is 
coherent with EU 
policy, in particular 
the one relating to 
principle of free 
movement of goods, 
protection of the 
consumers and EU 
product safety 
policies.  

e
c
n
e
r
e
h
o
C

►

►  Analysis of the extent to which there are 

►  1. Level of 

► 

  ► 

  ► 

  ►  x 

coherence with 
wider EU Policy  

►

►

►

►

►

►

conflicts or gaps between the Directive and 
other EU policy, with regard to safety, free 
movement of goods and protection of the 
consumers, with specific reference to 2001/95 
General Product Safety Directive, or 
Regulation 765/2008 on accreditation and 
market surveillance relating to the marketing 
of products. 

e
c
n
a
v
e
l
e
R

  ►  Q28 To what extent 

do the initial 
objectives 
correspond to the 
current needs, 

►  JC1 There are no 
additional needs 
besides those 
connected to the 
protection of 

►  Mapping of case law relating to new 

►  1. Proportion of 

► 

technological developments to understand to 
which extent the Directive applies. 
Analysis of the approximation of national law 
and case law. 

case law relating to 
new technological 
developments on 
all case law under 

  ►  x  ►  x  ►  x 

,
4
2
Q
C

(

x

►

)
7
2
Q
P

,
1
2
-
0
2
Q
A
P

)
0
2
Q

(

I

►

)
6
1
Q

(

I

►

►

►

)
2
1
Q

(

I

►

►

86 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

including new needs 
created by 
innovative 
products? 

"consumers" and 
liability of 
"producers" for 
defective "products" 

Analysis of stakeholders' perception on needs 
not covered by the Directive. Analysis of 
results from Q29, Q30, Q31, Q32. 

►  Q29 To what extent 
does the distinction 
between products 
and services when 
dealing with product 
liability continue to 
be apt for dealing 
with the new 
technological 
developments? 
►  Q30 How well 
adapted is the 
intervention to the 
changing market 
environment: often 
with a blurred 
distinction between 
private and 
professional use of 
products? 

►  JC1 The distinction 

►  Analysis of any difficulties encountered in 

between products and 
services is still apt for 
new technological 
developments 
products 

distinguishing products from services due to 
new technological developments.  
Analysis of stakeholder perception  

►  JC1 The distinction 
between private and 
professional use is 
still apt to the 
changing market 
environment 

►  Analysis of any difficulties encountered in 

distinguishing private and professional use of 
products, due to new technological 
developments. The analysis shall focus on 
case law and existing national legislation 
relating to damages caused by defects in 
products intended and used in the 
professional activity. 
Analysis of stakeholders' perception on the 
need to extend the Directive to professional 
use.  

relating to the 
Directive; 
2. Level of 
satisfaction of 
stakeholders of the 
relevance of the 
Directive; 

►  1. Number of cases 
ruling on the 
concept of products 
and services in the 
framework of new 
technological 
developments. 

►  Number of claims 
brought by 
consumers and 
professionals for 
damages caused by 
defective products. 

e
c
n
a
v
e
l
e
R

►

e
c
n
a
v
e
l
e
R

►

e
c
n
a
v
e
l
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R

►

►  Q31 To what extent 

►  JC1 Existence of 

cases where claims 
are referred to terms 
different to the ones 
in the question 

are the concept of 
product, producer, 
damage or the 
category of 
exemptions as 
defined in the 
Directive adequate 

►  Analysis of the extent to which the terms 
“product” (Art.2), “producer” (Art.3), 
“damage” (Art.9), “exemption of liability” 
(Art.7) of the Directive are fit for purpose vis-
à-vis the new technological developments.  
Therefore it is important to understand 
whether the Directive is still apt to cover such 
developments. In order to verify it, desk 

►  1. Number of case 
law references 
relating to the 
concepts in the 
question applying 
to new 
technological 
developments; 

►  x  ►  x  ►  x  ►  x 

►

87 

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►  x  ►  x  ►  x  ►  x 

►  x  ►  x  ►  x  ►  x 

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►

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x

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►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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  ►  x  ►  x  ►  x 

►

►

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T

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► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

research and stakeholders’ consultation shall 
be carried out. In particular, the main points 
to take into consideration are: 
1. The importance of the role played by the 
individuals who are involved in trade chain;  
2. Uncertainties with the new technological 
developments;  
3. Existence of different kinds of damage 
caused by new technological developments. 

►  Analysis of cases relating to new 

technological developments where it was 
difficult to apply the term defective. Analysis 
of the perception of stakeholders on the 
difficulties to apply the term “defect” in case 
of specific new technological development. 

2. Level of 
satisfaction of 
stakeholders on the 
adequacy of the 
definitions 

►  1. Number of case 
law references 
relating to defects 
of new 
technological 
developments 
products  
2. Level of 
adequacy  

►  JC1 There are cases 
relating to new 
technological 
developments where 
it was difficult to 
apply the term 
defective 

to correspond to the 
technological and 
scientific 
developments? 

►  Q32 How well is the 

term ‘defective’ as 
defined in the 
Directive adapted to 
new technological 
or scientific 
advances such as 
apps and non-
embedded software, 
advanced robots and 
autonomous/intellig
ent systems? For 
example, could 
software 
vulnerability (for 
instance, a cyber-
attack or a failure to 
update security 
software or a misuse 
of information) be 
considered as a 
defect? 

e
c
n
a
v
e
l
e
R

►

e
u
l
a
V

d
e
d
d
A
U
E

►

►  Q33 What is the EU 

added value of the 
Directive for 
stakeholders 
(manufacturers, 

►  gSnmnrJC1 The 
objectives of the 
Directive could not be 
reached only with 
national legislation 

►  Analysis of the extent to which stakeholders 
consider that the Directive generates an EU 
added value for them, with particular focus 
on the new technological developments. 

►  1. Rating based on 
stakeholders’ 
perception 

► 

  ► 

  ► 

  ► 

,
7
2
Q
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6
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Q

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►

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

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including software 
developers and 
economic operators 
in the DSM, and 
consumers)? 
►  Q34 To what extent 
does the issue of 
strict liability, as 
addressed by the 
Directive continue 
to require action at 
EU level? 

►  JC1 The issue of 
strict liability 
continues to require 
action at EU level 

►  JC1 Effects derive in 
case of reducing the 
scope of the Directive 

►  Q35 What would be 
the most likely 
consequences of 
reducing the scope 
of the existing EU 
intervention? 

e
u
l
a
V
d
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d
A
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►

e
u
l
a
V
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d
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E

►

►  JC1 Effects derive in 
case of repealing the 
Directive 

  ►  Q36 What would be 

the most likely 
consequences of 
repealing the 
Directive? 

e
u
l
a
V
d
e
d
d
A
U
E

►

►  Analysis of the extent to which the rule of 

strict liability on the producer in case of 
damages caused by a defective product is 
harmonised and MS may not adopt legislation 
jeopardising the application of the principle.  
Analysis of the extent to which national 
legislation of different MS interferes, 
overlaps and/or conflicts with the Directive, 
so as to require the intervention of the 
European institutions -i.e. European Court of 
Justice, with specific reference to  
i)contractual law, 
ii) extra-contractual based on fault on the 
producer 

►  Analysis of the extent to which reducing the 
scope of the Directive has impacts on the 
uniformity of legislation of MS, with regard 
to: 
1. the free movement of goods in terms of 
intra EU trade; 
2. different protection of injured persons 
according to national liability rules; 
3. liability of producers for damages caused 
by defective products. 

►  x  ►  x  ►  x  ►  x 

►  1. Number of cases 
for (contractual, 
fault and non-
strict) liability of 
defective products 
2. Level of 
approximation of 
practices among 
MS 

►  1. Level of 

►  x  ► 

  ► 

  ►  x 

harmonisation of 
MS national 
legislation 
2. Rating based on 
stakeholders 
perception  

►  Analysis of the extent to which repealing the 

►  1. Level of 

►  x  ► 

  ► 

  ►  x 

Directive has impacts on the uniformity of 
legislation of MS, with regard to benefits and 
obstacles that would arise in absence of the 
Directive, with regard to: 
1. the free movement of goods in terms of 
intra EU trade; 

uniformity of MS 
national legislation 
on civil liability for 
damages caused by 
defective products 
2. Rating on 

89 

►

►

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►

► 

►  Question 

►  Judgment Criteria 

►  Analytical framework 

► 

Indicators 

2. differentiation of protection of consumers 
and other clients according to national rules 
on liability for damage; 
3. liability of producers for damages caused 
by defective products. 

►  JC1 Opportunity to 
enlarge the scope of 
the Directive so as to 
cover, for instance, 
services 

►  Analysis of the extent to which it would be 
appropriate to enlarge the scope of the 
Directive, in light of the spread of services 
and new technological developments, taking 
into account the EU safety rules. 

possible 
asymmetries across 
MS based on 
stakeholders' 
perception 
►  1. Percentage of 

cases for producers' 
liability relating to 
new technological 
developments 
and/or services that 
are settled without 
application of the 
Directive 
2. Rating based on 
stakeholders' 
perception 

►  Q37 According to 

the case-law and the 
experience on the 
application of the 
Directive, could it 
be considered 
appropriate to 
enlarge the scope of 
the Directive, for 
instance so as to 
cover the services? 

e
u
l
a
V
d
e
d
d
A
U
E

►

n
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►

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►  x  ►  x  ►  x  ►  x 

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7
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90 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX 4: COST-BENEFIT ANALYSIS 

I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Same as for 
citizens/consumers 

Same as for 
citizens/consumers 

Description:  
These costs are 
associated with 
activities linked to 
the implementation 
of initiatives such as 
monitoring, 
enforcement and 
adjudication  
They are recurring 
costs 
Type of cost: 
Claims raised in 
court: clawyers’, 
bailiffs’ and experts’ 
fees, court fees, 
taxes, and all costs 
relating to judicial 
proceedings.  
Claims raised out of 
court: lawyers’ and 
experts’ fees, 
insurance fees 
Expected?  Yes 

Qualitative 

Yes. 
A. in court claim: 
These costs vary 
considerably across 
Member States  and 
depend, among other 
factors, on the type of 
litigation, the overall 
proceeding length, the 
compensation amount, 
the court, and the final 
decision.  
B. out of court claim: 
This type of 
enforcement cost 
weighs on consumers 
and producers (or 
insurance companies).  
Sources: country 
fiches; CATI survey 
However, these costs 
(including procedural, 
court, experts’ and 
lawyers’ fees) do not 

Quantitative / 
monetary 
A 
quantification 
of 
enforcement 
costs is not 
possible due 
to data 
limitations 
and to the fact 
that they are 
determined on 
a case-by-case 
basis 
depending on 
specific 
systems in 
each Member 
State 
jurisdiction 
and the type 
of litigation, 
as well as the 
final decision.  
Considering 

COST 1: 
Enforcement 
costs 

Qualitative 

The 
Directive is a 
private law 
instrument. 
Therefore, 
there is no 
involvement 
of any public 
authorities to 
ensure that 
its rules are 
enforced. As 
a private 
instrument, it 
leaves to the 
parties (i.e. to 
consumers) 
the burden to 
“enforce” its 
rules, i.e. to 
raise a claim 
in case of 
damage 
caused by a 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

N/A 

91 

 
 
 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Quantitative / 
monetary 
cases settled 
in court, 
proceeding 
fees in a civil 
proceeding 
can range 
from less than 
€200 (e.g. in 
BE, EE and 
SE) to over 
€1,000 (e.g. in 
HU and SK). 

N/A 

Qualitative 

seem to have any 
connection to the 
Directive, being that 
they mainly relate to 
national practices and 
judicial systems 

Unexpected? No, 
even though they 
vary from 
jurisdiction to 
jurisdiction, 
depending on 
whether claims are 
raised in court or out 
of court 

Description:  
Substantive 
compliance costs 
encompass those 
investments and 
expenses that are 
faced by businesses 
and citizens to 
comply with 
obligations or 
requirements 
contained in a legal 
rule. 
They are recurring 
costs. 

Yes.  
This cost (and a 
potential benefit for 
producers/businesses) is 
represented by: 
1. The burden of proof, 
which appears to be the 
most burdensome 
element for consumers. 
In particular it is related 
to the difficulties in 
proving the link 
between the defect and 
the damage, attributing 
liability, proving the 

COST 2: 
Substantive 
compliance 
costs 

Qualitative 

Quantitative / 
monetary 

Qualitative 

defective 
product. 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

N/A 

N/A 

N/A 

yes 

N/A 

Yes 
• Strict liability 
costs (Article 1): 
introduces a cost 
that – if the claim is 
successful ̶ will be 
equal to the amount 
of compensation to 
be paid. This cost is 
case-dependent.  
Moreover, the 
actual cost will 
depend on the 
definition of 
“producer” adopted 

92 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative / 
monetary 

Type of cost: 
The amount of 
compensation to be 
paid to the 
counterpart.  
Related provisions: 
Strict liability of 
producer (Art.1); 
Burden of proof 
(Art.4); Joint 
liability of producers 
(Art.5); €500 
threshold (Art.9); 
three-year limitation 
period (Art.10); 10-
year limitation 
period (Art.11) 
Expected?  Yes 

defect of the product, 
discovering where the 
defect occurred and 
proving the damage.  
Time (and related 
burden and therefore 
cost) to prove the right 
to be compensated 
varies across Member 
States, as well as across 
sectors (e.g. they seem 
to be particularly 
relevant in the 
pharmaceutical and 
medical sector). 
2. The The €500 
threshold (Article 9), 
which represents a cost 

Qualitative 

by the Member 
State when 
transposing the 
Directive.   
As a consequence, 
this cost is likely to 
be unequal across 
the EU;  
• Joint liability of 
producers costs 
(Article 5): the 
study identified no 
cases where this 
provision was 
applied. 
Source: interview 
and survey 

93 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

Unexpected? No 

for consumers 
inasmuch as it prevents 
any claims (and related 
possible compensation) 
under €500 from being 
raised, which is often 
the case.  
3. The three-year 
limitation period 
(Article 10) for the 
recovery of damages, 
which entails a cost for 
consumers in terms of 
missed compensation 
after its conclusions.  
However, the this 
elements does not seem 
to represent a major 
cause for rejection of a 
claim (4% of the cases 
mapped at national 
level). 
4. The 10-year 
limitation period 
(Article 11) to make a 
claim from the date on 
which the producer put 
into circulation the 
product which caused 
the damage potentially 
entails a significant cost 
in terms of missed 

94 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

compensation. This 
provision is particularly 
costly in the case of 
damages caused by 
defective 
pharmaceutical 
products (among the 
products most 
frequently subject to 
claims). Moreover, it is 
reasonable to assume 
that damages caused by 
defective 
pharmaceutical 
products are likely to 
have significant 
consequences (and 
costs).  
However, the cost 
related to the burden of 
proof cannot be fully 
attributable to the 
Directive, since this 
element is at the basis 
of the Western legal 
tradition and judicial 
system 
Source: country fiches; 
stakeholders' interviews 
and survey 

95 

 
 
COST 3: 
Administrative 
burden 

Description:  
Administrative 
burdens are costs 
borne by businesses, 
citizens, civil society 
organisations and 
public authorities as 
a result of 
administrative 
activities performed 
to comply with 
information 
obligations included 
in legal rules. 
However, the only 
provision of the 
Directive entailing 
an information 
obligation is Article 
15(2), requiring 
Member States to 
inform the 
Commission in case 
they derogate to the 
development risk 
clause (i.e. to Article 
7(e)). 
Type of cost: 
Communicate to the 
Commission the 
derogation to 
Art.7(e) (Art.15(2)) 

I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

Yes 
This cost is 
deemed to be 
residual, 
given that, 
based on 
findings of 
the desk 
research at 
the national 
level, it 
affected only 
five Member 
States, it is 
one-off, and 
the provision 
per se does 
not require 
anything 
more than a 
simple 
transmission 
of 
information  
Source: 
country fiche 

N/A 

NA 

N/A 

N/A 

N/A 

N/A 

N/A 

96 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

Expected?  Yes 

Unexpected? No 
Description: 
Indirect costs are not 
introduced by the 
Directive, but are its 
direct consequence. 
These costs are 
experienced by 
consumers, 
government agencies 
or other stakeholders 
that are not directly 
targeted by the 
initiative/regulation. 
These costs are 
usually transmitted 
through changes in 
the prices and/or 
availability and /or 
quality of the goods 
or services produced 
in the regulated 
sector 
Type of  cost: 
e.g. specific liability 
insurance, 
reputational costs 

Expected?  Yes 

Unexpected? No 

COST 4: 
Indirect costs 

N/A 

N/A 

Yes. 
These costs mainly 
relate to the 
payment of 
insurance premiums 
related specifically 
to strict liability. 
In particular, 
reputational costs 
and research and 
development costs 
are definitely 
relevant, especially 
for those 
manufacturers that 
produce robotic 
devices.  
Source: 
stakeholders' 
interview, CATI 
survey, OPC 

97 

N/A 

N/A 

N/A 

N/A 

N/A 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

BENEFIT 1: 
Improved well-
being 

Description:  
Such benefits 
include, most 
notably, health, 
safety and 
environmental 
benefits 
Provisions: 
Strict liability of 
producer (Art. 1) 
Joint liability of 
producers (Art. 5) 

Yes 
Both strict and joint 
liability represent a 
clear benefit for 
consumers, which enjoy 
the right to obtain 
compensation for 
damage caused by a 
defective product 
directly from its 
producer. Therefore, at 
least in principle, the 
Directive has increased 
consumer protection 
and reduced the legal 
costs related to claims 
for defective products. 
Stakeholders strongly 
agree that consumers 
can enjoy the same 
rights in terms of 
compensation wherever 
they are in the EU 
Sources: OPC, country 
fiches (number of 
successful claims is 
higher than the number 
of non-successful 
claims in favour of 
consumers) 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

98 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

N/A 

N/A 

N/A 

N/A 

N/A 

Qualitative 

Quantitative / 
monetary 

N/A 

N/A 

BENEFIT 2: 
Market 
efficiency 

Description:  
This might include 
improved allocation 
of resources, 
removal of 
regulatory or market 
failures or cost 
savings generated by 
new 
initiatives/regulation 
Provisions: 
Burden of proof 
(Art. 4) 
Exemptions (Art. 7) 
€500 threshold (Art. 
9) 
three-year limitation 
period (Art. 10) 
10-year limitation 
period (Art. 11) 

Qualitative 

Yes 
The benefits related 
to the provisions of 
the Directive 
translate into the 
development of a 
clear and stable 
legal framework. 
Provisions such as 
the €500 threshold 
and the three- and 
10-year limitation 
period limit the 
possibility for 
consumers to issue 
claims for 
compensation, thus 
reducing the claims 
against producers or 
the likelihood for a 
compensation to be 
paid to consumers 
Source: country 
fiches; desk 
research; 
stakeholders' 
survey, OPC, 
interview 

99 

 
 
I. Overview of costs – benefits identified in the evaluation 

Citizens/Consumers 

Businesses 

Administrations 

Insurers 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative / 
monetary 

Qualitative 

Quantitative 
/ monetary 

Qualitative 

Quantitative 
/ monetary 

yes 
Source: stakeholders'  
interview, OPC 

N/A 

yes 
Source: 
stakeholders'  
interview, OPC 

N/A 

yes 
Source: 
stakeholders'  
interview, 
OPC 

N/A 

yes 
Source: 
stakeholders'  
interview, 
OPC 

N/A 

BENEFIT 3: 
Increased 
harmonisation 

Description: 
This refers to the 
creation of a level 
playing field for 
producers and 
consumers, 
guaranteeing at EU 
level the liability of 
the producer in all 
Member States, and 
ensuring an 
increased 
homogeneity of 
procedures 
Provisions: 
Compliance with the 
Directive (Art. 19) 
and harmonisation 
through the cases of 
the CJEU 

100 

 
 
ANNEX 5: BACKGROUND ON THE DIRECTIVE 

The initial proposal of the Commission implemented the Council Resolution of 14 April 
1975 on the preliminary programme of the European Community with a view of a policy 
of  protection  and  information  of  the  consumer107.  By  this  Resolution,  the  Council 
engaged itself to harmonise the right on the liability for defective products within a short 
period.  

The  adoption  of  the  Directive  took  around  ten  years.  The  initial  proposal  of  the 
Commission  of  1976108  was  amended  according  to  the  opinion  of  the  European 
Parliament  and  the  Economic  and  Social  Committee  and  resubmitted  in  1979109.  The 
Council adopted the Directive in 1985. This long time-span shows the complexity of the 
matter and the time needed to obtain a compromise among  the Member States during a 
period when a unanimous vote in the Council was still necessary. In fact, the agreement 
was reached due to compromises in controversial areas, namely the exclusion of primary 
agricultural  products  and  game  from  the  scope,  the  availability  of  a  defence  for  the 
producer based on the state of scientific/technological knowledge and the imposition of a 
ceiling on liability for death or personal injury caused by identical products. 

At the same time, the Council of Europe was drafting a  Convention on the same topic, 
(European  Convention  on  Products  Liability  in  regard  to  Personal  Injury  and  Death)110 
which was adopted on 27 January 1977. Only three States have ratified the Convention. 
This  text  was  quite  similar  to  the  Commission's  proposal,  but  the  Convention  did  not 
cover material damages. 

In 1990, the Commission tabled a proposal for a directive on the liability of the suppliers 
of  services111  as  a  follow-up  to  its  Three  year  plan  for  consumer  policy  (1990-1992)112. 
The draft provided for the liability of the supplier of services for direct damage caused 
(by his fault in the provision of the service) to the health and physical integrity of persons 
or their property.  It was to apply to any transaction carried out on a commercial basis or 
by a public body and in an  independent manner, whether or not in return for payment, 
which  did  not  have  as  its  direct  and  exclusive  object  the  manufacture  of  goods.  The 
proposal obliged the  injured  party  to provide  proof  of  the  damage  while setting a  
causal  relationship  between  the performance  of  the  service  and the  damage.  Only 
services that compromise private safety, i.e. services which could damage the health or 
physical integrity of private persons or property were concerned. Services causing only 
financial damage were excluded. The proposal was withdrawn in 1994 due to the lack of 
an interinstitutional consensus. 113  
In the aftermath of the "mad cow" crisis, Directive 1999/34/EC114 enlarged the scope of 
the Directive 85/374/EEC to all products, including the primary agricultural products and 
game,  which  in  fact  were  already  mentioned  in  the  proposal  of  1976.  The  objective  of 

107  
108   
109  

110  
111  
112  
113  
114  

JO C 92, 25 April 1975, p.1 
See Doc. COM (76) 372 final of 23 July 1976- (OJ C 241, 14 October 1976, p.9  
See  Doc.  COM  (79)  415  final,  26  September  1979  (OJ  C  271,  26  October  1979,  p.3.  The  initial 
proposal  was  amended  with  a  view  to  excluding  primary  agricultural  products,  artistic  and  craft 
made products from the scope of the Directive. 
https://www.coe.int/en/web/conventions/full-list/-/conventions/rms/0900001680077321 
See Doc. COM(1990) 482 
See Doc. COM(1990) 98 final 
See Doc. COM (1994) 260. 
JO L 141, 4 June 1999, p.20 
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1999:141:0020:0021:en:PDF  

101 

 
 
                                                            
 
this amending Directive was to establish a common rule on strict liability for all kind of 
products  and  to  facilitate  a  legitimate  compensation  for  damage  to  health  caused  by 
defective agricultural products.  

By  Resolution  of  19  December  2002115,  the  Council    suggested  to  the  Commission  to 
evaluate  the  need  to  modify  the  provisions  related  to  the  liability  of  the  supplier, 
particularly Articles 3 and 12 of the Directive, due to problems in several Member States 
with the attribution of liability to suppliers.  However, the Commission considered that if 
this  Resolution  were  given  effect,  this  would  mark  a  departure  from  the  objective  of 
harmonisation of product liability rules under the Directive116. No legislative action was 
taken. 

115    Council Resolution of 19 December 2002 on the modification of the Directive related to the liability 

for defective products (2003/C 26/02). JO C 26, 4 February 2003, p.2 
See Third report concerning liability for defective products. COM (2006) 496 final. 

116   

102 

 
 
 
                                                            
ANNEX  6:  CONCEPTS  OF  THE  PRODUCT  LIABILITY  DIRECTIVE  IN 
DETAIL 

The fundamental elements of the Directive are the following: 

• 

"Strict liability"(Article 1) means that producers are liable for damages caused by 
a defect in their product; independently of whether the defect is due to negligence 
or ill-intent. Producers are liable without fault on their part.  

Indeed,  according  to  the  Preamble  of  the  Directive,  adequate  protection  of 
consumers  necessitates  a  liability  regime  without  fault:  ‘it  is  the  sole  means  of 
adequately  solving  the  problem  of  increasing  technicality’  and  to  have  ‘a  fair 
apportionment of the risks inherent in modern technological production’. 

• 

'Product'  (Article  2)  means  any  movable,  even  though  incorporated  into  another 
movable or into an immovable, including electricity.  

The  Court  of  Justice  indicated  that  the  Directive  applies  to  products  used  while 
providing any service (Case C-203/99)117 but that the liability of a service provider 
does  not  fall  within  the  scope  of  the  Directive  (Case  C-495/10.)118  However,  the 
Directive  does  not  prevent  Member  States  from  applying  national  rules  under 
which a service provider using a defective product is liable for damage thus caused.  

• 

A product is 'defective' (Article 6) when it does not provide the safety a person is 
entitled to expect, taking all circumstances into account, including the presentation 
of the product, the reasonably expected use and the time when the product was put 
into  circulation.119  This  provision  also  points  out  that  a  product  may  not  be 
considered  defective  for  the  sole  reason  that  a  better  product  is  subsequently  put 
into circulation. 

The main concept of the product liability regime is the defectiveness of the product 
which  is,  in  turn,  related  to  the  expected  safety  of  the  product120.  It  is  irrelevant 
whether the product is fit for purpose or fit for use This question of fitness for use 
belongs  to  the  rules  related  to  the  sale  of  goods,  outside  of  the  scope  of  the 
Directive.  

According  to  this  provision  the  defectiveness  must  be  assessed  based  on  the 
average  consumer  expectation  test.  This  text  represents  however  an  objective 
analysis;  thus  the  defectiveness  must  be  assessed  on  the  basis  of  the  legitimate 

117  
118  

CJEU. Judgment of 10 May 2001. Case C-203/99.Henning Veedfald v Århus Amtskommune.  
CJEU, Judgement of 21 December 2011, Case C-495/11, Dutrueux and Caisse primaire d'assurance 
maladie du Jura. 

119    Distinction  is  to  be  made  between  product  "liability"  and  product  "safety".  Directive  85/374/EEC 
seeks  to  compensate  ex-post  for  damages  suffered  by  consumers  due  to  a  defective  product. 
However,  there  are  other  pieces  of  European  Union  legislation  that  prevent  damages  ex-ante,  by 
ensuring that products placed on the EU market are safe (for instance, the General Product Safety 
Directive or other  sector-specific  legislation such  as  the directives  related  to  machinery,  electrical 
equipment, radio equipment, medical devices, cosmetics, pharmaceutical products or toys.  To the 
extent that safety legislation ensures the safety of products on the market, it will reduce the need for 
consumers to seek for compensation under product liability rules. 

120   However,  this definition does  not always fit with  all product  categories,  for  example  for products 
such as pharmaceuticals, which by their very nature may be considered as high-risk products. For 
those  products  the (unexpected)  harmfulness  becomes  more relevant  than  the defectiveness of  the 
products as such. 

103 

 
 
                                                            
  
 
expectation of the public and not on the subjective expectations or predisposition of 
one person.  

The  defectiveness  of  a  product  should  be  assessed  on  a  case-by-case  basis, 
considering  all  the  relevant  circumstances,  on  the  basis  of  objective  criteria, 
including  especially  product  safety  legislation.  This  leaves  a  large  margin  of 
interpretation to the national courts.  

In  2015,  the  CJEU  gave  further  guidance  to  national  courts  on  how  to  assess  the 
safety which the public is entitled to expect. The case concerned pacemakers and 
cardioverter  defibrillators  and  the  Court  ruled  that  where  is  found  that  such 
products belonging to the same group or forming part of the same production series 
have a potential defect, such a product may be classified as defective without there 
being  any  need  to  establish  that  the  individual  product  has  such  a  defect  (Joint 
Cases C-503/13 and 504/13).121  

This ruling reaffirmed the protective function of the Directive, in particular related 
to  specific  products,  such  as  medical  devices,  which  require  a  particularly  high 
level  of  consumer  protection.  In  these  cases,  the  potential  lack  of  safety  is 
considered as being a potential defect due to the high potential for damage that the 
malfunctioning of those products might cause to patients. 

As provided in Article 6, when it comes to assess the legitimate safety expectation 
of the public, all relevant circumstances should be taken into consideration. Three 
elements are listed as examples: 

i)  

the  presentation  of  the  product,  i.e.  how  the  product  has  been  put  into 
circulation  and  how  is  it  presented  to  the  public.  It  includes  marketing, 
packaging,  instructions,  warnings,  etc.  In  case  of  inaccurate  or  missing 
information,  this  may  render  a  product  defective,  especially  in  the  case  of 
products such as medical devices or pharmaceutical products 122. 

Even  though  it  is  impossible  to  warn  the  public  about  all  the  potential 
dangers  of  a  product,  EU  legislation  obliges  the  producer  to  provide  the 
consumer  with  the  relevant  information  to  enable  her  or  him  to  assess  the 
risks during normal use and to take precautions against those risks. 

However, this does not mean that a warning or other form of precautionary 
information  will  automatically  render  an  unsafe  product  safe.  Even  the 
presence  of  an  exhaustive  list  of  warnings  does  not  guarantee  the  safety  of 
the  product;  therefore,  the  judge  will  have  to  determine  if  the  warnings 
correspond to the safety expectations of the public at large. 

Finally,  warnings  and  instructions  about  the  use  of  a  product  will  be  also 
taken into consideration by the court for the assessment.  

ii)  

reasonable expected use includes consumption, but also other activities such 
as  storage.  The  producer  has  also  to  anticipate  that  the  product  could  be 
misused by the consumer by designing the product in a safer way or, if it is 
not enough, by warning the consumer.  

121    CJEU.  Judgment  of  5  March  2015.  Joint  Cases  C-  503/13  and  504/13.Boston  Scientific 

122  

Medizintechnik GmbH v AOK Sachsen-Anhalt.  
The  outcome  of  CJEU  Judgement  of  20  November  2014,  Case  C-310/13,  Novo  Nordisk  Pharma 
GmbH also shows that some aspects, which may be considered as closely related to an exhaustive 
liability scheme, such as the access to relevant information, are not covered by the current scope of 
the Directive. However, those rules may be nowadays seen as essential for a balanced system. 

104 

 
                                                            
iii)  

the  time  when  the  product  was  put  into  circulation;  Later  technical 
developments,  as  well  as  subsequent  circumstances  that  may  affect  the 
product, should not be taken into account. The fact that new rules apply for 
those products is not per se an element to consider the product as unsafe.  

• 

'Producer' (Article 3) means the manufacturer of a finished product, the producer 
of any raw material or the manufacturer of a component part and any person who, 
by  putting  his  name,  trade  mark  or  other  distinguishing  feature  on  the  product 
presents  himself  as  its  producer,  as  well  as  any  person  who  imports  into  the 
European Union a product for sale, hire, leasing or any form of distribution in the 
course  of  his  business.  The  producer  defined  as  such  shall  be  liable  for  damage 
caused to consumers by a defect in his product.  

Where  the  producer  cannot  be  identified,  each  supplier  of  the  product  shall  be 
treated as its producer unless he informs the injured party, within a reasonable time 
of the identity of the producer or of the person who supplied him with the product.  

The  term  "producer"  is  deliberately  broad  so  that  an  injured  person  easily  find  a 
liable  person.  In  case  of  an  anonymous  product,  the  supplier  will  be  held  liable 
unless he discloses the identity of the producer.     

The Directive does not define the term "supplier", but according to the case-law of 
the Court of Justice, the supplier must be regarded as any intermediary involved in 
the marketing or distribution chain of the product.123 

The  Directive  foresees  that  where  two  or  more  persons  are  liable  for  the  same 
damage,  they  shall  be  liable  jointly  and  severally,  without  prejudice  to  the 
provisions of national law concerning the rights of contribution or recourse (Article 
5). Pursuant to Article 12, the liability of the producer may not, in relation to the 
injured person, be  limited or excluded by a provision of national law limiting his 
liability or exempting him from liability. 

  Exemptions  of  liability  (Article  7):  the  Directive  establishes  a  catalogue  of 

defences or circumstances that could exclude liability.  

In  particular,  the  producer  shall  not  be  liable  if  he  proves  some  circumstances, 
including:  

g) 
h) 

i) 

j) 

k) 

that he did not put the product into circulation; or  
that,  having  regard  to  circumstances,  it  is  probable  that  the  defect  which 
causes  the  damage  did  not  exist  at  the  time  when  the  product  was  put  into 
circulation by him or that this defect came into being afterwards; or 
that  the  product  was  neither  manufactured  by  him  for  sale  or  any  form  of 
distribution for economic purpose nor manufactured or distributed by him in 
the course of his business; or 
that  the  defect  is  due  to  compliance  of  the  product  with  mandatory 
regulations issued by the public authorities; or 
that the state of scientific and technical knowledge at the time when he put 
the  product  into  circulation  was  not  such  as  to  enable  the  existence  of  the 
defect to be discovered (the so-called Development Risk Clause); or 

123  

CJEU, Judgement of 21 December 2011, Case C-495/11, Dutrueux and Caisse primaire d'assurance 
maladie du Jura. 

105 

 
 
 
 
                                                            
  
l) 

in the case of a manufacturer of a component, that the defect is attributable 
to the design of the product in which the component has been fifted or to the 
instructions given by the manufacturer of the product. 

Member States are obliged to include in their transposition laws the circumstances 
listed in Article 7 releasing a producer from strict liability. However, according to 
Article 15(1)(b), each Member State may provide that the producer shall be liable 
even  if  he  proves  that  the  state  of  scientific  and  technical  knowledge  at  the  time 
when he put the product into circulation was not such as to enable the existence of 
a defect to be discovered.  

The  Court  of  Justice  noted  in  Case  C-300/95124  that,  in  accordance  with  the 
principle  of  fair  apportionment  of  risks  between  the  injured  person  and  the 
producer, the latter has a defence if he can prove certain facts exonerating him from 
liability.  For  this  purpose,  it  should  be  considered  that  the  relevant  scientific  and 
technological  knowledge must  have  been  accessible  at  the  time when the product 
was  put  into  circulation.  It  follows  that,  in  order  to  have  such  a  defence,  the 
producer of a defective product must prove that the objective state of scientific and 
technological knowledge was not such as to enable the existence of the defect to be 
discovered. 

In Case C-203/99, the exemption from liability based on the fact that the product 
was  neither  manufactured  by  him  for  sale  or  any  form  of  distribution  was 
interpreted as  meaning that  the exemption from liability where  an  activity  has  no 
economic  or  business  purpose  does  not  extend  to  the  case  of  a  defective  product 
which has been manufactured and used in the course of a specific medical service 
which was financed entirely from public funds and  for which  the patient  was not 
required to pay any consideration. 

In the context of defect due to compliance with mandatory regulations, it should be 
noted that compliance with voluntary standards would not provide a defence.  

• 

'Burden of proof' (Article 4): the injured person is required to prove the damage, 
the defect and the causal relationship between defect and damage for the purpose of 
compensation. 

The Court of Justice stated, in Case C-621/15125, that this proof could be facilitated 
by accepting national evidentiary rules according to which certain factual evidence 
may  constitute  serious,  specific  and  consistent  evidence,  even  if  there  is  no 
conclusive scientific evidence to the matter.  

• 

'Damage' (Article 9) for the purpose of the Directive means:  

c) 
d) 

any damage caused by death or by personal injuries, and 
any  damage  to,  or  destruction  of,  any  item  of  property  other  than  the 
defective product itself, provided that it was intended and used for private use 
and consumption with a lower threshold of  EUR 500.  

By subjecting the compensation of damages to property to a minimum threshold of 
a  fixed  amount  (EUR  500),  the  Directive  aims  to  avoid  litigation  in  an  excessive 
number of cases. The Directive limits the compensation for damage to property for 

124    CJEU.  Judgment  of  29  May 1997.  Case  C-  300/95.  Commission  of  the  European  Communities  v 

United Kingdom of Great Britain and Northern Ireland.  
CJEU. Judgment of 21 June 2017. Case C-621/15. N. W and Others v Sanofi Pasteur  

125  

106 

 
 
                                                            
goods  for  private  use  or  consumption  (as  opposed  to  business  property,  for 
instance, damage caused to a company car would be excluded). 

As the Court of Justice ruled in Case C-285/08126, compensation for damage to an 
item  of  property  intended  for  professional  use  and  employed  for  that  use  is  not 
covered by the scope of application of the Directive. However, the Directive does 
not prevent a Member State establishing such a system of liability corresponding to 
the one established by the Directive. 

The Court has also stated that Member States cannot restrict the damages resulting 
from death, personal injury or the types of material damage to or destruction of an 
item of property, which is to be compensated (Case C-203/99).  

Compensation  of  economic  loss  is  only  taken  into  account  in  case  of  personal 
injuries (for instance, incapacity to work due to the injury). 

• 

Time-limits (Articles 10, 11 and 16) 

According  to  Article  10,  a  limitation  period  of  three  years  shall  apply  to 
proceedings for the recovery of damages and the rights conferred upon the injured 
person pursuant to this Directive expire after ten years from the date on which the 
producer put the defective product into circulation (Article 11).  

These time-limits aim at creating a balance between the interests of producers and 
those of injured parties. They are there to give legal certainty and reduce financial 
burdens for producers.   

Any  Member  State  may  provide  that  a  producer's  total  liability  for  damage 
resulting from death or personal injury and caused by identical items with the same 
defect  shall be limited  to an amount  which may not  be less  than 70 million EUR 
(Article 16). 

  Other liabilities: 

The Directive does not affect any rights an injured person may have according to 
the rules of the law of contractual or non-contractual liability or a special liability 
system existing at the moment when this Directive was notified (Article 13).  

While the Court clarified that Member States may not maintain a general system of 
product liability different from that provided for in the Directive ( Case C-52/00)127, 
it  does  not  preclude  the  application  of  other  systems  of  contractual  or  non-
contractual liability based on other grounds, such as fault or a warranty in respect 
to latent defects (Case C-183/00 and C-310/13). 128 

126  
127  

128  

CJEU. Judgment of 4 June 2009. Case C-285/08. Moteurs Leroy Somer v Dalkia France.  
CJEU.  Judgment  of  25  April  2002.  Case  C-52/00.  Commission  of  the  European  Communities  v 
French Republic.  
CJEU- Judgement of 25 April 2002. Case C-183/00 María Victoria González Sánchez v Medicina 
Asturiana SA. and Judgement of 20 November 2014, Case C-310/13, Novo Nordisk Pharma GmbH 

107