COMMISSION STAFF WORKING DOCUMENT STAKEHOLDER CONSULTATION - SYNOPSIS REPORT 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: application of EU law, civil liability, defective product, producer's liability, product quality, technological change

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.5.2018 SWD(2018) 158 final  COMMISSION STAFF WORKING DOCUMENT STAKEHOLDER CONSULTATION - SYNOPSIS REPORT 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) 157 final}  
 
 
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. 

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  States1  replied.  14  position  papers  were  shared  by  consumers  (1),  business 
associations (9) and public authorities/civil society representatives (4).  

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). 

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

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Responses came from 14 Member States.2 

A  Computer-assisted  telephone  (CATI)  survey  (29  May  –  14  June  2017)  covering  11 
Member  States3  was  addressed  to  producers,  importers,  and  suppliers.  457  producers 
responded.4 

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).5 

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 
Directive6 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.  

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. 

2  
3   
4  
5  
6  

BE, BG, DK, EL, ES, FR, IT, LT, LU, MT, NL, SI, FI, UK.  
CZ, DE, ES, FR, IT, LT, NL, AT, PL, SE, UK. 
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: 

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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 the Directive to new technological developments is not straightforward.   

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.  

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. 

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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  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. 

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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 
technological  and  scientific 
exemptions  under 
developments. 

the  Directive  are  adequate 

the 

to 

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. 

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. 

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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. 

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. 

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