COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the document Proposal for a Regulation of the European Parliament and of the Council on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council
Date: 2021-06-30
Institutions: Directorate-General for Justice and Consumers, European Commission
Subjects: European standard, consumer goods, harmonisation of standards, market supervision, product safety, safety standard, technical standard, traceability

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.6.2021  SWD(2021) 168 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT  Accompanying the document Proposal for a Regulation of the European Parliament and of the Council    on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council, and repealing Council Directive 87/357/EEC and Directive 2001/95/EC of the European Parliament and of the Council    {COM(2021) 346 final} - {SEC(2021) 280 final} - {SWD(2021) 169 final}  
 
 
Table of contents 

1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ................................................. 4 

PROBLEM DEFINITION ..................................................................................................... 10 

2.1.  What are the problems? .............................................................................................. 10 
Product safety challenges linked to new technologies .......................................... 12 
2.1.1. 

2.1.2. 

Product safety challenges in the online sales channels.......................................... 15 

2.1.3. 

Ineffective product recalls ..................................................................................... 17 

2.1.4.  Market surveillance rules are complex and not fully effective.............................. 19 

2.1.5. 

Inconsistent application of product safety rules for food-imitating products ........ 21 

2.1.6. 

Problems related to the legal form......................................................................... 21 

2.1.7. 

Regulatory burden and costs of the GPSD (REFIT problem) ............................... 22 

2.2.  What are the problem drivers? .................................................................................... 22 
2.3.  How will the problem evolve? .................................................................................... 24 

3.  WHY SHOULD THE EU ACT? ........................................................................................... 25 

3.1.  Legal basis .................................................................................................................. 25 
3.2.  Subsidiarity: Necessity of EU action .......................................................................... 25 
3.3.  Subsidiarity: Added value of EU action ..................................................................... 26 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ................................................................. 27 

4.1.  General objectives ...................................................................................................... 27 
4.2.  Specific objectives ...................................................................................................... 27 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? ....................................................... 29 

5.1.  What is the baseline from which options are assessed? .............................................. 29 
5.2.  Description of the policy options ................................................................................ 32 
5.3.  Options discarded at an early stage ............................................................................. 42 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ............................................. 43 

6.1. 
6.2. 
6.3. 
6.4. 

Impacts of Option 1 .................................................................................................... 44 
Impacts of Option 2 .................................................................................................... 48 
Impacts of Option 3 .................................................................................................... 55 
Impacts of Option 4 .................................................................................................... 61 

7.  HOW DO THE OPTIONS COMPARE? .............................................................................. 64 

8. 

PREFERRED OPTION ......................................................................................................... 76 

8.1.  Preferred option – Option 3 ........................................................................................ 76 
8.2.  REFIT (simplification and improved efficiency) ....................................................... 78 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................... 79 

ANNEX 1: PROCEDURAL INFORMATION ............................................................................. 83 

ANNEX 2: STAKEHOLDER CONSULTATION ........................................................................ 87 

ANNEX 3: WHO IS AFFECTED AND HOW? ............................................................................ 96 

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ANNEX 4: ANALYTICAL METHODS ..................................................................................... 101 

ANNEX 5: EVALUATION REPORT ........................................................................................... 30 

ANNEX  6:  EFFECTS  OF  THE  COVID-19  CRISIS  IN  THE  CONTEXT  OF  THE 

POLICY OPTIONS AND THEIR EXPECTED IMPACTS ............................................... 102 

ANNEX 7: SMES TEST .............................................................................................................. 104 

ANNEX 8: EFFECTIVENESS OF RECALLS OF CONSUMER PRODUCTS ........................ 108 

ANNEX 9: COOPERATION ACTIVITIES UNDER GPSD ...................................................... 125 

ANNEX 10: STANDARDISATION PROCEDURE .................................................................. 128 

ANNEX 11: SUMMARY OF REPLIES TO THE OPEN PUBLIC CONSULTATION ............ 129 

ANNEX  12:  STAKEHOLDERS  OPINIONS  ON  THE  BENEFITS  OF  THE 

DIFFERENT OPTIONS ...................................................................................................... 143 

ANNEX  13:  MINUTES  FROM  THE  EU  WORKSHOPS  ADDRESSING  THE  SALE 

OF ILLEGAL GOODS ONLINE ........................................................................................ 146 

ANNEX  14:  MINUTES  FROM  THE  EU  WORKSHOP  ON  STRATEGIES  TO 

MAXIMISE THE EFFECTIVENESS OF PRODUCT RECALLS .................................... 148 

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Term or acronym 

Meaning or definition 

Glossary 

Artificial Intelligence 

Charter of Fundamental Rights of the European Union 

Consumer Safety Network 

Digital Services Act 

European Economic Area 

European Union 

Council Directive 87/357/EEC concerning the safety of food-
imitating products 

Directive 2001/95/EC on the general safety of products (General 
Product Safety Directive) 

Information and Communication Technology 

Impact Assessment 

Internet of things 

Market surveillance authority 

Open Public Consultation 

Product Safety Pledge 

Regulatory fitness and performance check 

AI 

Charter 

CSN 

DSA 

EEA 

EU 

FIPD 

GPSD 

ICT 

IA 

IoT 

MSA 

OPC 

Pledge 

REFIT 

Safety Gate/RAPEX 

EU Rapid Alert System on dangerous consumer products 

SME 

Subgroup 

GPSD Study 

Small and Medium Enterprise 

Sub-group on AI, connected devices and other challenges for new 
technologies to the Consumer Safety Network 

The study commissioned by the Commission to support the 
evaluation and impact assessment of the GPSD revision and 
conducted by CIVIC consulting 

TFEU 

Treaty on the Functioning of the European Union 

 
 
 
 
 
 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

This  report  aims  at  assessing  the  impacts  of  a  revision  of  the  Directive  2001/95/EC  on 
general product safety1 (GPSD). It analyses also the impacts of a possible integration of 
the Directive 87/357/EEC2 concerning the safety of food-imitating products (FIPD) into 
the GPSD.  

The  objective  of  the  GPSD  is  to  ensure  EU  consumers  are  protected  from  dangerous 
products and to ensure the proper functioning of the Single Market. The GPSD provides 
the  general  EU  legal  framework  for  the  safety  of  non-food  consumer  products  and 
requires that all products placed on the market be safe. The non-food consumer products 
include all products (including in the context of providing a service), which are not food 
stuff  and  are  intended  for  consumers  or  are  likely  to  be  used  by  consumers,  and  are 
supplied or made available to them in the course of a commercial activity, be they new, 
used or reconditioned3. 

As illustrated in the Table 1, the non-food product safety framework is mainly made up 
of two sets of legislative instruments:  

  Union  Harmonisation  (hereinafter  harmonised)  legislation:  Regulation  (EU) 
2019/1020  on  market  surveillance  and  compliance  of  products  together  with  the 
product-specific  safety  legislation,  such  as  the  toys  or  the  machinery  directive  form 
‘harmonised legislation’ (legislation setting common rules across the EU for specific 
sectors) 

  The GPSD: As lex generalis, it applies to non-food consumer products to the extent 
that  there  are  no  specific  provisions  with  the  same  objective  in  rules  of  Union  law 
governing the safety of the products concerned, such as EU harmonised legislation for 
specific categories of products. Therefore it fully applies to non-harmonised consumer 
products  and  also  partially  to  the  consumer  harmonised  products  for  aspects  not 
covered  by  the  harmonised  legislation.  As  such,  it  provides  a  “safety  net”  for 
consumers  and  aims  to  ensure  that  EU  consumers  are  protected  against  any  safety 
risks of consumer products, including future ones.  

1 Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety 
2 Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning 
products which, appearing to be other than they are, endanger the health or safety of consumers 
3 The definition of product in the GPSD excludes second-hand products supplied as antiques or as products to be 
repaired or reconditioned prior to being used. 

4 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
Table 1: General overview of the Product Safety Framework 

Product Safety Framework  

Non-food 

Food 

Non- Harmonised 

Harmonised 

Non-consumer 

Consumer 

Non-consumer 

                           Products  

Areas 

Obligations of economic 
operators 

Sector specific Union 
harmonisation 
legislation 

+ GPSD as safety net  

Regulation (EU) 
2019/1020 

+Ability for market 
surveillance authorities 
to take “more specific 
measures” provided 
for in GPSD  

Sector specific Union 
harmonisation 
legislation 

General Food Law 
Regulation Regulation 
(EC) No 178/2002  

and  

Regulation (EC) 
1935/2004 on food 
contact materials   

Regulation (EU) 
2019/1020 

Market surveillance on the 
internal market 

National  Law 
under the mutual 
recognition 
Regulation 

GPSD 

Safety Gate (RAPEX) 

Customs control for 
products imported to the 
EU 

Regulation (EU) 
2019/1020 and GPSD 

Regulation (EU) 
2019/1020 and GPSD 

Regulation (EU) 2019/1020 

Regulation (EU) 
2017/625 

The  GPSD,  as  a  safety  net,  is  complementary  to  harmonised  legislation  in  two  ways. 
First,  it  applies  in  its  entirety  to  consumer  products  falling  outside  the  scope  of 
harmonised  legislation  (e.g.  furniture,  childcare  articles,  clothes).  Secondly,  it  applies 
partially  to  consumer  products  covered  by  harmonised  legislation  (e.g.  toys  or  cars)  as 
long as aspects of product safety covered by the GPSD are not covered in the harmonised 
legislation  (for  example,  until  very  recently  EU  legislation  for  cars  did  not  include 
provisions on product recalls, that were subject to the GPSD).  

The concept of safety under the GPSD always covers levels of protection for the safety 
and  health  of  persons,  i.e.  the  dangerous  product  under  the  GPSD  poses  a  risk  to  the 
health  and  safety  of  consumers.  These  risks  can  materialise  in  different  ways  but  to  be 
covered  under  the  GPSD  the  risks  always  have  to  relate  to  health  and  safety  of 
consumers. Other types  of safety such as  material  damages  are not  covered unless they 
are linked to the safety and health of consumers. 

Regarding  market surveillance, there are also  two different systems  in place:  one for 
harmonised products (Regulation  (EU) 2019/1020) and another under the GPSD for non-
harmonised products and risks falling under the scope of the GPSD.  

The  GPSD  does  not  cover  pharmaceuticals,  medical  devices  and  food  products.  The 
safety of food products  is regulated separately under the General  Food  Law Regulation 
(EC) No 178/2002. The food products have their own regime, including an alert system 
(RASFF).  However,  the  Regulation  (EC)  No  1935/2004  on  food  contact  materials  can 
interact  with  the  GPSD  when  it  comes  to  products  containing  such  materials  (e.g. 
reusable lunch boxes). Unsafe products containing food-contact materials products might 
be subject to safety alerts in both alert systems, RASFF for food and Safety Gate/RAPEX 
for non-food products. 

The GPSD provides for the obligations of economic operators in the product safety field, 
in  particular  the  general  obligation  for  producers  to  place  only  safe  products  on  the 
market. It contains rules on the power and obligations of Member States and on market 

5 

 
 
 
 
 
 
 
 
surveillance.  The  GPSD  establishes  provisions  on  the  application  of  the  general  safety 
requirement and on the adoption of European safety standards supporting the legislation, 
which  provide  presumption  of  safety  and  therefore  facilitate  the  compliance  with  the 
safety requirement under the GPSD. The GPSD includes obligations for Member States 
and  the  Commission  to  inform  consumers  about  dangerous  products  and  contains  the 
legal  basis  for  the  EU  Rapid  Alert  System  (Safety  Gate/RAPEX),  which  enables  quick 
exchange  of  information  between  EU/EEA  countries  and  the  Commission  on  measures 
taken on unsafe non-food products posing a risk to consumers4. Finally, the GPSD also 
establishes  cooperation  on  product  safety  between  the  Commission  and  Member  States 
authorities competent for product safety in  the context  of the Consumer  Product  Safety 
Network ‘CSN’. 
Directive 87/357/EEC5 (Food-Imitating Products Directive, ‘FIPD’) sets out rules for 
the  safety  of  food-imitating  products,  i.e.  products  which  can  be  confused  with 
foodstuffs, while not being food-stuffs. The FIPD has been originally adopted to address 
divergence in national provisions on products which, appearing to be other than they are, 
endanger  the  safety  or  health  of  consumers6.  The  measures  taken  against  unsafe  food-
imitating products by Member States are also notified in the Safety Gate/RAPEX.  

The scope of this initiative covers therefore all non-harmonised consumer products, food-
imitating products and also partially also harmonised products for aspects not covered by 
the  harmonised  legislation.  However  for  some  aspects  the  analysis  also  includes 
harmonised  products,  where  data  could  not  be  dissociated  between  the  harmonised  and 
non-harmonised products. 

The Commission has adopted guidance to clarify some of the aspects of the GPSD. The 
Commission Notice on the market surveillance of products sold online (2017/C 250/01)7 
provides guidance for the enforcement of EU legislation on the safety and compliance of 
non-food  products  sold  online.  The  Notice  also  sets  out  good  practices  for  the  market 
surveillance  of  products  sold  online  and  for  communication  with  businesses  and 
consumers.  On  9  November  2018,  the  Commission  also  revised  the  guidelines  for  the 
functioning of Safety Gate/RAPEX8 (originally adopted in 2004 and revised for the first 
time in 2010).  

ECJ Jurisprudence does not bring particular element helping interpreting the provisions 
of the GPSD, most of it being linked either to access to documents or to non-applicability 
in the presence of harmonised legislation. 

At international  level,  very different  approaches to  product safety  can be distinguished: 
Few  jurisdictions,  such  as  Canada  and  more  recently  Brazil  (in  2019),  have  adopted  a 
safety regulatory framework which includes a general safety requirement, similar to the 
EU “safety net”. This approach is usually considered in international fora as the best way 

4  Regulation (EC) 765/2008 and the new Regulation (EU) 2019/1020 on market surveillance and compliance extends 
the scope of Safety Gate/RAPEX also to products to be used by professionals  
5 Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning 
products which, appearing to be other than they are, endanger the health or safety of consumers 
6 These pre-existing national provisions were differing in content, scope and field of application and therefore creating 
barriers to the free movement of goods and unequal competitive conditions on the market without ensuring effective 
protection for consumers, especially children. 
7 Commission Notice on the market surveillance of products sold online (2017/C 250/01) of 28 July 2017 
8 Decision 9 November 2018 laying down guidelines for the management of the Community Rapid Information System 
(RAPEX). According to Annex II, point 8 of GPSD, the Commission regularly update such guidelines. The new 
version of the guidelines updates the scope and purpose of safety Gate/RAPEX, integrates certain aspects of Regulation 
(EC) 765/2008 on market surveillance of harmonised products (inclusion of professional products and extension of the 
risks to risks other than those for the health and safety of consumers (e.g. environmental risks), includes a reference to 
new tools developed over the last years for the proper functioning of Safety Gate/RAPEX, clarifies notification criteria 
and enhances traceability, which is essential for follow up by countries in the Safety Gate/RAPEX network. 

6 

 
 
                                                           
to  ensure  that  regulators  have  an  appropriate  legal  basis  to  order  corrective  measures 
against all types of dangerous products, notably when facing emerging safety issues that 
are not subject to any regulation yet9.  

In some jurisdictions such as the United States (US) or New Zealand, liability rules play a 
major  role  to  complement  product  safety  provisions  and  private  enforcement  is  a  key 
aspect  of  such  systems.  The  US  system  also  relies  on  a  sophisticated  injury  data 
collection  scheme  and  deterrent  penalties  incentivising  businesses  to  inform  as  soon  as 
possible  the  consumer  product  safety  agency  about  dangerous  products  they  are 
responsible for. In China, governmental approvals (be it certification, license, registration 
or  individual  approval)  are  required  for  many  products  and  groups  of  products  before 
they can be placed on the market.  

Fora  for  multilateral  product  safety  cooperation,  such  as  the  OECD  and  UNCTAD, 
provide  opportunities  to  learn  about  and  get  inspiration  from  other  jurisdictions’  best 
practices and new regulatory developments.  

Political context 

The Commission announced the revision of the GPSD in its Work Programme 2020 and 
confirmed it in the Adjusted Commission Work Programme 2020 published on 27 May 
2020, as one of its REFIT (Regulatory Fitness and Performance Programme)10 initiatives 
under  the  headline  objective  “A  New  Push  for  European  Democracy”.  This  revision  is 
also one of the legislative proposals mentioned in the Communication of the Commission 
on New Consumer Agenda11, published on 13 November 2020. 

In the field of new technologies (including artificial intelligence ‘AI’), the Commission 
published a Report on safety and liability implications of AI, the Internet of Things and 
Robotics12  accompanying  the  White  Paper  on  AI13  in  February  2020.  The  report 
highlights  the  need  to  include  clear  provisions  in  the  EU  product  safety  legislation, 
including  the  GPSD,  to  explicitly  address  safety  risks  linked  to  products  incorporating 
new technologies (connected products and AI).  

The other EU institutions have also highlighted the importance of product safety policy. 
The  European  Parliament  adopted  a  resolution  on  addressing  product  safety  in  the 
Single  Market  on  25  November  202014  which  also  emphasised  the  need  to  revise  the 
GPSD. 

In  its  Presidency  conclusions  on  The  Charter  of  Fundamental  Rights  in  the  context  of 
Artificial  Intelligence  and  Digital  Change15,  the  Council  stated  that  while  these 
technologies  may  enhance  the  market  surveillance  of  product  safety  on  the  EU  market, 
they may also pose new challenges to consumer protection in the product safety area. The 
Council Conclusions  on Shaping Europe's Digital Future16 of 9 June 2020 mention  that 

9 See for instance the OECD Recommendation on Consumer Product Safety from 17 July 2020, 
https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0459#mainText  
10 REFIT is the European Commission's regulatory fitness and performance programme established in 2012 to ensure 
that EU law is 'fit for purpose'. It is a process under which existing legislation and measures are analysed to make sure 
that the benefits of EU law are reached at least cost for stakeholders, citizens and public administrations and that 
regulatory costs are reduced, without affecting the policy objectives pursued by the initiative in question. 
11 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0696 
12 https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-
robotics_en 
13 https://ec.europa.eu/info/files/white-paper-artificial-intelligence-european-approach-excellence-and-trust_en 
14 https://www.europarl.europa.eu/doceo/document/TA-9-2020-0319_EN.html 
15 https://www.consilium.europa.eu/media/46496/st11481-en20.pdf 
16 https://www.consilium.europa.eu/media/44389/st08711-en20.pdf?utm_source=dsms-
auto&utm_medium=email&utm_campaign=Shaping+Europe%e2%80%99s+digital+future+-
+Council+adopts+conclusions 

7 

 
 
                                                           
digital  economy  is  to  be  characterised  by  a  high  degree  of  trust,  security,  safety  and 
choice for consumers17.  

Finally, the review builds on the results of the Evaluation of the GPSD and the FIPD, 
conducted  back-to-back  to  this  Impact  Assessment  (‘IA’)  in  order  to  assess  the 
performance of GPSD in line with the Commission’s Better Regulation rules (see Annex 
5). The Evaluation showed the necessity to adapt the GPSD to address product challenges 
related  to  e-commerce  as  well  as  the  rapid  development  of  new  technologies,  and  to 
ensure better enforcement and more efficient market surveillance for consumer products, 
including  by  aligning  the  systems  for  harmonised  and  non-harmonised  products. 
Furthermore, the Evaluation also showed the necessity to modify some of the provisions 
of the GPSD to improve its effectiveness. For example, legislative changes are needed to 
improve  the  effectiveness  of  product  recalls,  as  well  as  the  treatment  of  food-imitating 
products. 

The  Commission  already  proposed  to  revise  the  GPSD  with  the  2013  Product  Safety 
and  Market  Surveillance  Package.  This  2013  Package  -  made  up  of  two  proposed 
Regulations,  one  on  product  safety  (COM(2013)078),  the  other  on  market  surveillance 
(COM(2013)075),  aimed  at  enhancing  product  safety  rules  and  creating  a  single  set  of 
market  surveillance  rules  for  harmonised  and  non-harmonised  products.  The  2013 
Package was blocked in the inter-institutional process as the Council did not agree on a 
common  position  because  of  a  proposed  provision  on  the  mandatory  marking  of  the 
origin  of  industrial  products  (the  “Made  in”  provision).  The  proposals  were  finally 
withdrawn by the Commission in September 2020.  

Legal context  

The legal framework relevant for the safety of consumer products has evolved with the 
adoption of several legal acts: 
With  the  adoption  of  Regulation  (EU)  2019/102018  on  market  surveillance  and 
compliance  of  products,  the  legal  framework  for  market  surveillance  of  harmonised 
products has changed and has been adapted in particular to the challenges linked to the 
online sales. The market surveillance of non-harmonised products, also initially included 
in the 2013 Product Safety and Market Surveillance Package, remained unchanged. The 
differences  between  the  two  market  surveillance  frameworks  have  been  therefore 
perpetuated  with  the  adoption  of  Regulation  (EU)  2019/1020,  except  for  the  provisions 
on  products  entering  the  EU  market,  which  apply  to  all  products  covered  by  Union 
harmonisation  law  under  Regulation  (EU)  2019/1020.  This  Regulation  widened  the 
difference between the regime applicable to harmonised and non-harmonised products, in 
particular by envisaging new powers and cooperation instruments for market surveillance 
authorities  (‘MSAs’)  and  introducing  some  new  features  such  as  the  “responsible 
person”, according to  which any economic operators that wants  to  sell its products  into 
the EU market has to be represented by an economic operator in the EU (applicable not to 
all harmonised products but only to some of them). 

17 Council stressed also that some AI applications can entail a number of risks, such as biased and opaque decisions 
affecting citizens’ fundamental rights, such as the rights to safety and security. Concerning software, Council 
underlined the potential of safe, secure, sustainable and trusted hard- and software value chains to enable and establish 
trust in European digital technologies. Council also stressed the need to enhance citizens’ safety and to protect their 
rights in the digital sphere across the Single Market and the need for effective and proportionate action against illegal 
activities and content online, including the distribution of dangerous goods. 
18 Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance 
and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 
305/2011 

8 

 
 
 
                                                           
In  the  standardisation  area,  the  Commission  adopted  Regulation  (EU)  1025/201219  on 
European standardisation, which provides  the general  framework   for the adoption of 
European standards  for  products  and services  (to help  assessing conformity with  Union 
legislation),  identifies  Information  and  Communication  Technology  (‘ICT’)  technical 
specifications, and allow financing for the European standardisation process.  It also sets 
an obligation for European Standardisation Organisations (CEN, CENELEC, ETSI) and 
National Standardisation Bodies on transparency and participation. 
The  adoption  of  the  new  Regulation  (EU)  2019/51520  facilitates  the  application  of  the 
principle of mutual recognition according to which, where no harmonised rules exist at 
European  level,  products  lawfully  marketed  in  one  Member  State  can  be  sold  in  other 
Member States regardless of complying or not with the national technical rules of these 
Member States. 

Links with other legal initiatives 

The GPSD initiative has the following links with other recent and ongoing proposals: 
Digital Services Act (DSA)21: The DSA presented by the Commission on 15 December 
2020  includes  a  new  set  of  horizontal  rules  to  regulate  the  responsibility  of  online 
intermediaries, including online marketplaces22. The DSA proposal aims to establish new 
obligations for online intermediaries inter alia in relation with how they handle all types 
of illegal content hosted on their websites (e.g. unsafe products, counterfeit products, hate 
speech,  etc).  The  DSA  establishes  the  general  horizontal  obligations  for  online 
intermediaries  and  leaves  room  for  legislation  in  relation  with  specific  types  of  illegal 
content (such as product safety) to be more specific. For example, the DSA provides the 
general framework for the notice-and-action system, but without providing the details on 
the timeframe or the procedure, which could then be set up in the revised GPSD (GPSD 
would  provide  a  specific  timeline  and  detailed  procedure  for  such  notices  of  unsafe 
products).  The  GPSD  may  also  regulate  other  product  safety  aspects  of  online  sales 
beyond  the  role  of  online  intermediaries,  such  as  the  role  of  sellers  and  the  powers  of 
market surveillance authorities. 

Artificial Intelligence (AI) horizontal framework: The new legislative proposal for AI 
horizontal  framework  lays  down  harmonised  rules  for  the  placing  on  the  market,  the 
putting  into  service  and  the  use  of  artificial  intelligence  systems  (‘AI  systems’)  in  the 
Union,  consistent  with  a  high  level  of  protection  of  the  public  interests,  in  particular 
health and safety, and fundamental rights and freedoms of persons. It lays down specific 
requirements with which high-risk AI systems must comply and imposes obligations on 
providers and users of such systems (for example, regulating inter alia safety aspects of 
AI applications in products such as machinery or lifts). Consequently, and with respect to 
product safety, it will establish specific requirements for certain AI applications, and the 
GPSD would apply as a safety net for products and safety aspects not covered by the AI 
horizontal legislation, and therefore complement it. The scope of the initiative is such that 
it  is  likely  that  some  AI  applications  would  remain  not  covered  (e.g.  some  consumer 

19 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European 
standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament 
and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European 
Parliament and of the Council 
20 Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual 
recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008.  
21 https://eur-lex.europa.eu/legal-content/en/TXT/?qid=1608117147218&uri=COM%3A2020%3A825%3AFIN 
22 The DSA provides for several due diligence obligations relevant for the product safety area, namely obligations on 
notice & action, know your business customer, cooperation with authorities as well as clear terms and conditions 
including respect for consumer protection rights. 

9 

 
 
                                                           
products such as vacuum cleaners). The revised GPSD would therefore need to provide a 
legal  basis  for  withdrawing  such  products  from  the  market  to  ensure  an  effective 
protection of consumers.  

Delegated acts under the Radio Equipment Directive (RED): the RED establishes the 
possibility for the Commission of adopting delegated acts in relation with several aspects, 
including  protection  of  personal  data  and  fraud  for  specific  categories  of  radio  devices. 
The  Commission  is  working  on  several  delegated  acts  that  might  partially  address  the 
issue of products presenting cybersecurity risks. However, it will not be possible to cover 
all  possible  consumer  products  via  delegated  acts,  for  instance,  devices  connected  by 
cable. Such gaps might be covered by a revised GPSD in its role of safety net.  

Directive  on  Security  of  Network  and  Information  Systems  (NIS):  The  recent 
proposal for a NIS 2 Directive, presented by the Commission on 16 December 2020, lays 
down  obligations  for  all  Member  States  to  adopt  a  national  strategy  on  the  security  of 
network and information systems. However, it does not include minimum cybersecurity 
requirements for consumer products, so it does not provide any legal basis for authorities 
to  take  action  against  products  presenting  such  risks.  The  Cybersecurity  Act 
(Regulation  (EU)  2019/881) 
introduces  an  EU-wide  cybersecurity  certification 
framework  for  ICT  products,  services  and  processes.  However,  it  does  not  include 
minimum  cybersecurity  legal  requirements  for  ICT  products.  The  GPSD  is  therefore 
complementary to these initiatives to fill these gaps.  

Circular  Economy:  According  to  the  new  Circular  Economy  Action  Plan,  products 
placed  on  the  EU  market  should  be  more  sustainable  and  designed  therefore  to  last 
longer, to be easier to repair and upgrade, recycle and reuse. It is essential that repaired, 
upgraded,  recycled  or  reused  products  continue  to  meet  product  safety  requirements. 
According to the Eco-design directive (Directive 2009/125/EC), safety and health have to 
be taken into account  in the choice of  a specific design solution; however safety issues 
related to the end products are not specifically addressed. The Sustainable Product Policy 
Initiative  (which  intends  to  replace  the  Eco-design  directive  and  extend  its  scope)  will 
notably aim at correcting the fact that many products cannot be easily and safely reused, 
repaired  or  recycled.  In  case  some  safety  aspects  related  to  products  in  the  circular 
economy (such as refurbished appliances or clothing made from recycled plastics) are not 
specifically addressed by initiatives from the Circular Economy Action Plan and do not 
fall under harmonised legislation, the safety net function of the GPSD comes into play.  

2.  PROBLEM DEFINITION 

2.1.  What are the problems? 

The Evaluation and the stakeholder views show that the GPSD appears overall to have 
met  its  objectives  of  ensuring  a  high  level  of  safety  of  consumers,  while  ensuring  an 
effectively operating internal market for goods; however, still too many unsafe products 
reach or remain in the hands of consumers.  

On the EU Single Market there should not be obstacles and barriers to the free movement 
of goods, which enables unsafe goods to circulate within the EU. Concerning the trend in 
the safety of products, the evaluation showed that the notifications of dangerous products 
by market surveillance authorities (‘MSAs’) in the Safety Gate/RAPEX increased, from 
2005 to 2010, from around 540 to 2000 notifications/year and then fluctuated between 1 
550  to  2  100  notifications/year  (30%  of  which  concerned    non-harmonised  products). 

10 

 
 
 
Also  the  number  of  follow-up  measures23  reported  in  Safety  Gate/RAPEX  has  steadily 
increased since data started to be gathered in this respect by the European Commission in 
2011.  Some  encouraging  signs,  such  as  improvements  in  product  safety  perceived  by 
consumers  and  a  plurality  of  stakeholders24can  be  observed;  however,  available  data 
show that unsafe products  are still available on the EU market.  The share of dangerous 
products  found  by  MSAs  in  inspections  represents  between  2%  and  16%  of  total 
consumer products inspected, with a median value of 4%25. Unsafe products on the EU 
market  affects  consumers  as  well  as  economic  operators  that  play  by  the  rules  as  they 
suffer from lack of level playing field with “rogue operators” from inside and outside the 
EU not observing EU product safety rules.  

Unsafe  products  represent  an  important  cost  for  consumers  and  society.  The  GPSD 
Study  supporting  the  GPSD  Evaluation  and  IA  (hereinafter  ‘GPSD  Study’)26  estimates 
the consumer detriment due to unsafe products today in the following way: 

-  Consumer detriment linked to product-related injuries and premature death: 

The  total  detriment  to  EU  consumers  and  society  from  product-related  injuries  and 
premature death to be EUR 76.6 billion per year. This is the sum of detriment caused by 
non-fatal  product-related  injuries  and  the  cost  of  premature  death  where  a  consumer 
product  is  involved  (e.g.  accident  with  tools,  strangulation,  electrocution,  or  fire) 
occurring outside of work-related locations27. This figure includes health care utilisation 
costs, productivity losses, loss of quality of life, cost of premature death linked to injuries 
due to consumer products (both harmonised and non-harmonised) in the EU.  

The  analysis  based  on  previous  research  and  interviews  with  product  safety  experts 
concluded that 15% is a reasonable and cautious estimate for the proportion of this total 
detriment  that  was  caused  by  unsafe  consumer  products,  or  could  have  been  prevented 
through better design, instruction or a safety device. These 15% of accidents could have 
been  prevented  if  the  products  were  safe.  On  this  basis,  the  preventable  detriment 
suffered by EU consumers and society due to product-related accidents can be estimated 
at EUR 11.5 billion per year28. 

-  Consumer detriment linked to the loss of value of unsafe products 

In  addition  to  the  above  injury  related  detriment,  the  GPSD  Study  estimates  that  the 
consumers  also  suffered  financial  costs  of  a  total  value  of  EUR  19.3  billion  in  2019 
arising from the fact they have purchased unsafe products  that they would not have 

23 Follow-ups can be defined as the feedback received from Member States participating in the Rapid Alert System on 
actions they have taken following up another country’s alerts on their own market. 
24 Source: European Commission 2016 and 2018 survey of consumers’ attitudes toward cross-border trade and 
consumer protection and the GPSD Implementation report 
25 Source: the GPSD Study. Member States inspections can be targeted so these figures cannot represent the proportion 
of all unsafe products on the EU market.  
26 Study to support the preparation of an evaluation of the General Product Safety Directive as well as of an impact 
assessment on its potential revision, prepared by Civic consulting, December 2020 
https://ec.europa.eu/info/files/study-support-preparation-evaluation-gpsd-well-impact-assessment-its-revision-part-1-
evaluation_en  
https://ec.europa.eu/info/files/study-support-preparation-evaluation-gpsd-well-impact-assessment-its-revision-part-2-
impact-assessment_en 
27 These estimates are based on the best possible approximation of product-related injuries and fatalities. The detriment 
cannot be estimated separately by categories of products and therefore include all consumer products, harmonised and 
non-harmonised products. 
28 15% of EUR 76.6 billion per year. This is the part of the total injury detriment linked to the injuries/deaths caused by 
the unsafe aspect of the products. These accidents could have been prevented if the products were safe. The remaining 
EUR 65.1 billion are injuries/deaths where a product is involved but the accident is not caused by the unsafe aspect of 
the product (e.g. falling from a ladder is a product-related accident but it doesn’t mean that the ladder itself is unsafe). 
This part cannot be prevented. 

11 

 
 
                                                           
purchased  if  they  knew  these  products  were  unsafe  (hereinafter  ‘consumer  detriment 
linked to the value of unsafe products’). The estimation is based on the fact that the value 
of  unsafe  non-harmonised  products  per  year  is  estimated  at  EUR  3.9  billion  for  online 
sales channels,  and EUR 15.4 billion for brick-and-mortar shops  and other offline sales 
channels, for a total of EUR 19.3 billion. This detriment is reduced due to recalls (under 
current  low  recall  effectiveness  scenario)  by  approximately  EUR  0.4  billion  per  year, 
assuming  that  consumers  are  compensated  fully  for  all  non-harmonised  products  they 
returned  to  producers  in  response  to  a  product  recall.  This  detriment  relates  to  non-
harmonised products covered by the GPSD and is based on the assumption that the loss in 
consumer welfare is at least the price to which the product was purchased.29   

The presence of unsafe products on the EU market affects therefore both EU consumers 
(final  users  of  products)  who  bear  the  risk  of  accidents,  injury  or  death  caused  by 
dangerous  products  and  related  costs  and  Member  States  who  bear  increased  health 
expenditure  costs  resulting  from  health  treatment  of  injuries  caused  by  dangerous 
products.  

The  circulation  of  unsafe  products  on  the  EU  market  also  creates  a  problem  for  the 
Single  Market:  it  does  not  only  contravene  the  principle  of  free  circulation  of  goods 
(only safe goods are allowed to circulate in the Single Market), but it also risks to create 
distortions of competition on the EU Single Market. Economic operators compliant with 
EU  product  safety  rules  face  compliance  costs  in  comparison  with  non-complaint 
operators.  At  the  same  time,  the  presence  of  unsafe  products  on  the  EU  market  puts  in 
danger the health and safety of EU consumers, which also undermines consumer’s trust 
and  confidence  in  the  EU  Single  Market.  Trust  is  an  essential  engine  of  consumers’ 
consumption  and  therefore  the  growth  of  the  EU  economy30.  The  Eurobarometer  data 
indicate a decrease between 2016 and 2018 in confidence of consumers in the safety of 
products sold in the EU31. 

Also,  in  the  open  public  consultation  (‘OPC’)  a  large  majority  of  respondents  (71%) 
expressed  that  current  EU  safety  rules  for  non-food  consumer  products  covered  by  the 
GPSD could be improved in specific areas to be more adequate to protect consumers32.  

2.1.1.  Product safety challenges linked to new technologies  

At  the  time  of  the  adoption  of  the  Directive  the  number  of  consumer  products 
incorporating new technologies was scarce. This is not the case anymore. The scenario is 
likely to evolve with the increasing use of AI, impacting the whole EU market. Moreover, 
there were 14.2 billion connected devices in 2019 worldwide, a figure that is estimated to 
go up to 25 billion by 2025, of which 4.9 billion estimated to be in Europe33. 

The application of the GPSD to new technology products, such as connected devices or 
AI-powered  products,  is  not  crystal-clear  and  the  safety  of  these  products  is  not  fully 
covered by other EU legislation. The GPSD does not explicitly address the fact that new 

29 This relates to non-harmonised consumer products covered by the GPSD. This is based on the assumption that 
willingness to pay (WTP) for a product depends on the utility of the product for the purchaser. WTP is equal or higher 
as the price for which a product is purchased by a consumer, as otherwise the transaction would not take place. It is 
very likely that WTP would be close to zero for an unsafe product (nobody wants to buy e.g., a dangerous childcare 
product) – so the loss in consumer welfare is at least the price to which the product was purchased.This calculation 
assumes that the consumers do not get reimbursed for the unsafe product.  
30Consumer consumption represented 52,6% of the GDP of the EU in 2019. Source: 
https://ec.europa.eu/eurostat/statistics-explained/index.php/Household_consumption_by_purpose 
31 See European Commission 2016 and 2018 survey of consumers’ attitudes toward cross-border trade and consumer 
protection. 
32 See Annex 11 on results of the OPC. 
33 Netherlands Entreprise Agency - https://www.cbi.eu/market-information/outsourcing-itobpo/intergrated-internet-
things/market-potential 

12 

 
 
                                                           
technologies,  in  particular  AI  and  goods  with  digital  elements34,  can  impact  product 
safety.  In  the  OPC  almost  half  the  respondents  considered  the  safety  of  products 
involving  new  technologies  not  to  be  adequately  regulated  (47%)35.  The  Evaluation 
showed that this can be problematic, as the development of new technologies mean that 
some of the provisions  of the GPSD are not  well adapted to  respond to  its objective of 
ensuring that all products (including those incorporating new technologies) must be safe 
for consumers.  

As such, new technologies pose challenges to the concepts and definitions used under 
the  GPSD.  New  technology-based  products  also  bring  new  risks  to  consumers’  health 
and safety or change the way the existing risks could materialise. These new risks, such 
as cybersecurity threats, might be possibly present in consumer products and this remains 
not  explicitly  covered  in  EU  legislation  for  the  moment.  Besides,  the  applicability  of 
software updates for product safety is still not regulated under EU legislation either (lack 
of clarify of the responsibilities of economic operators when for example an application is 
downloaded into a product modifying its safety features).  

A typical example is when a product becomes dangerous by not possessing a minimum 
level of cybersecurity, leaving it open to hacking by a malicious party; that was the case 
of a passenger car notified in the Safety Gate/RAPEX36. The radio in the vehicle might 
have  had  certain  software  security  gaps  allowing  unauthorised  third  party  access  to  the 
interconnected  control  systems  in  the  vehicle.  If  these  software  security  gaps  were 
exploited  by  a  third  party  for  malicious  purposes,  a  road  accident  could  have  occurred. 
The Sub-group on AI, connected devices and other challenges for new technologies to the 
Consumer Safety Network (‘the Subgroup’) highlighted that the lack of explicit mention 
in the GPSD of cybersecurity risks affecting safety (‘cybersafety’) posed a challenge for 
the protection of consumers and legal certainty for businesses.  

Another example relates to consumer’s personal security that can be endangered by third 
party  accessing  their  information,  as  illustrated  in  another  notification  in  Safety  Gate 
RAPEX of a smartwatch for children37.  The Icelandic authority argued that this product 
would  not  cause  a  direct  harm  to  the  child  wearing  it,  but  lacking  a  minimum  level  of 
security, it can be easily used as a tool to have access to the location of the child. As one 
of  the  product’s  intended  function  is  to  keep  children  safe  through  localisation,  a 
consumer would expect that it would not pose security threats to children that may affect 
their safety by them potentially being tracked and/or contacted by anyone. As measures 
regarding  this  product  were  notified  to  Safety  Gate/RAPEX,  authorities  in  the  Member 
States  took  follow-up  actions.  However,  the  Evaluation  showed  that  many  of  those 
authorities were unsure whether the GPSD38 was applicable to such risks due to the lack 
of explicit provisions in this respect. The Sub-group also raised the fact that it is unclear 
under which legal or policy instrument such personal security risks should be tackled so 
that consumers are effectively protected against such threats. 

In addition, the Subgroup stated that there is evidence that new technologies can have an 
impact  on  the  mental  health  of  consumers;  e.g.  connected  products  as  a  cause  of 

34 As defined in Directive (EU) 2019/770 on certain aspects concerning contracts for the supply of digital content and 
digital services ‘goods with digital elements’ means any tangible movable items that incorporate, or are inter-connected 
with, digital content or a digital service in such a way that the absence of that digital content or digital service would 
prevent the goods from performing their functions. 
35 See Annex 11 on the results of the OPC 
36 RAPEX notification from Germany published in the EU Safety Gate (A12/1671/15) of a passenger car. 
37  Example RAPEX  notification  from  Iceland  published  in  the  EU  Safety  Gate’s  website  (A12/0157/19)  of  a 
smartwatch for children.  
38 The legal basis of this notification was the GPSD as at the moment there was no delegated acts under the RED which 
could cover this case. 

13 

 
 
                                                           
depression,  loss  of  sleep,  altered  brain  function  and  myopia  or  early  blindness  in 
students39 and children40. It was also noted however that some mental health challenges 
linked  to  products  do  not  originate  from  new  technologies,  they  were  prevalent  before 
digitalisation. The subgroup also expressed that it was unclear if mental health risks are 
covered  under  the  current  definition  of  safety  of  the  Directive,  and  that  mental  health 
harm intrinsically caused by a product itself should be covered.  

Moreover,  it  is  not  clearly  stated  to  what  extent  the  definition  of  “product”  includes 
software, whether it is sold with the product or associated with the product later on. This 
might  impact  the  safety  assessment  of  the  given  product.  New  technologies  also  pose 
challenges  related  to  the  notion  of  placing  a  product  on  the  market41.  For  example, 
products including new technologies can evolve and their safety features may change via 
software updates or machine learning after they have been placed on the market. 

Many  of  the  problems  linked  to  new  technologies  are  crosscutting,  so  the  Commission 
has adopted or is working on a number of proposals in relation to those issues. In some 
cases  specific  risks  linked  to  new  technologies  can  be  tackled  by  EU  harmonised 
legislation.  While  such  proposals  may  partially  address  the  gaps  identified,  there  are 
some aspects that remain or will remain not covered and for which action is still needed 
in the context of this initiative.  

The  Commission  is  currently  developing  a  delegated  act  under  the  Radio  Equipment 
Directive  and  assessing  whether  the  provisions  of  that  Directive  referring  to  the 
combination  of  radio  equipment  and  software  should  apply  to  certain  categories  of 
products  covered  by  that  Directive,  as  well  as  to  standalone  software  uploaded  onto 
connected products that communicate via certain radio modules. The Commission is also 
reviewing the Machinery Directive  to  address  those types  of  risk having an impact  on 
safety,  for  example  protecting  the  machinery  against  malicious  third  parties  or  lack  of 
connectivity. However, despite this, there are still some gaps in addressing safety risks of 
consumer  products  containing  new  technologies  not  already  covered  by  other  EU 
legislation. Home appliances connected to the Internet by cable e.g. will not be covered 
under the delegated acts of the Radio Equipment Directive, so cybersecurity risks of such 
products  will  not  be  covered  by  such  delegated  acts.  In  addition,  in  view  of  the  highly 
innovative  potential  of  the  new  technology  sector,  it  is  difficult  to  foresee  the  safety 
features and risks of these new technology products.  

Finally, the Subgroup also mentioned that one of the common characteristics of AI and 
Internet of things (‘IoT’) products is the presence of software that can change/evolve over 
time. This challenges the traditional meaning of the concept of placing on the market of 
the GPSD. Therefore, the Subgroup recommended that a possible GPSD revision should 
clarify  that  products  should  be  safe  over  their  whole  expected  lifespan,  and  should 
explore the introduction of the concept of ‘substantial modification’ affecting the safety 
of the product after a product was once placed on the market.  

This  problem  affects  all  consumers  purchasing  new  technology  products  and  causes 
particular  difficulties  to  vulnerable  consumers  that  are  not  familiar  with  new 
technologies, in particular small children and the elderly. 

The lack of legal certainty regarding the application of consumer product safety rules to 
new technologies may create regulatory costs to businesses (especially SMEs) developing 

39 K. Demirci, M. Akgönül, A. Akpinar, 2015. Relationship of smartphone use severity with sleep quality, depression, 
and anxiety in university students. Journal of Behavioural Addictions, 4(2): 85–92. 
40 Dresp-Langley B. Children's Health in the Digital Age. Int J Environ Res Public Health. 2020 May 6;17(9):3240. 
doi: 10.3390/ijerph17093240. PMID: 32384728; PMCID: PMC7246471. 
41 The GPSD requires producers to place only safe products on the market (cf Article 3). 

14 

 
 
                                                           
and producing new technology products and undermines their efforts to design innovative 
and cyber-safe products. 

2.1.2.  Product safety challenges in the online sales channels  

While  the  GPSD  applies  to  consumer  products  regardless  if  they  are  sold  offline  or 
online, the increasing use of e-commerce has negatively influenced the relevance and 
effectiveness of the GPSD, creating new challenges for the safety of consumers. Online 
sales  increased  steadily  since  the  GPSD’s  adoption:  in  2002  only  9%  of  Europeans 
purchased online, while over 70% of them shop online today42.  Furthermore, one out of 
five companies in  the  EU nowadays sells online43.This  trend has  been amplified by the 
COVID 19 crisis and related lockdowns: in the EU-27, retail sales via mail order houses 
or the Internet in April 2020 increased by 30% compared to April 2019, while total retail 
sales  decreased  by  17.9%44  (see  Evaluation  Annex  5).  In  addition,  many  of  dangerous 
COVID-19  related  products  (e.g.  dangerous  masks,  hand  sanitisers)  have  been  found 
online  (by  22  October  2020  they  represented  16%  of  all  COVID-19  notifications  in 
Safety Gate/RAPEX from the beginning of the COVID-19 crisis). Furthermore, 39% of 
respondents  in  the  OPC  expressed  that  safety  rules  for  products  covered  by  the  GPSD 
were  not  adapted  to  online  trade  and  among  respondents  who  experienced  a  product 
safety incident within the last 5 years, 70% bought this product online45.  

First,  the  GPSD  does  not  provide  for  sufficiently  effective  instruments  for  online 
market surveillance by MSAs. They lack e.g. powers to acquire product samples under 
covert  identity  or  block  websites  proposing  dangerous  products46.  This  creates 
inefficiencies  in  the  market  surveillance  of  non-harmonised  products  sold  online,  and 
therefore  insufficient  action  against  such  products.  This  affects  the  consumer  trust  in 
online  sales.  While  such  instruments  exist  for  the  harmonised  products  covered  by 
Regulation  (EU)  2019/1020  on  market  surveillance,  the  fact  that  the  latter  is  not 
applicable to non-harmonised products will create an uneven level-playing field between 
these two categories of consumer products in the Single Market once this Regulation will 
apply47.  This  means  that  an  authority  could  be  entitled  to  take  more  effective  actions 
online against a toy bed (a toy being a harmonised product) as opposed to a baby’s crib, 
which falls under the GPSD.  

Second,  new  online  business  models  and  actors,  such  as  online  marketplaces  hosting 
third party sellers, have become prominent and product safety rules for these economic 
operators  are  unclear  under  the  current  GPSD.  Among  European  businesses  selling 
goods  online,  40%  have  been  using  online  marketplaces  to  reach  their  customers  in 
201948.The  GPSD  does  not  establish  clear  legal  obligations  for  product  safety  for 
business  models  that  do  not  fall  under  the  existing  categories  of  producer,  importer  or 
distributor.  The  online  marketplace  does  not  fit  to  these  categories.  This  affects  both 
consumer protection and safety of products sold online and the related consumer’s trust, 
creates  inefficiencies  in  online  market  surveillance  and  creates  an  uneven  level-playing 
field between the economic operators selling offline and those selling online in the EU. 

42 Nestor Duch-Brown, 2015 
43 Eurostat (isoc_ec_eseln2), data for 2019. 
44 OECD -  E-commerce in the time of COVID-19, http://www.oecd.org/coronavirus/policy-responses/e-commerce-in-
the-time-of-covid-19-3a2b78e8/#biblio-d1e705  
45 See Annex 11 on results of the OPC. 
46 On 1st August 2017 the Commission issued a Notice on the market surveillance of products sold online to help 
public authorities with their market surveillance of online sales but this Notice doesn’t create legal tools as such. 
47 The market surveillance provisions under Regulation (EU) 2019/102O will enter into force in July 2021. 
48 ESTAT https://appsso.eurostat.ec.europa.eu/nui/submitViewTableAction.do See also (Eurobarometer - TNS, 2016) 
for more granular data based on a 2016 survey 

15 

 
 
                                                           
This  has  been  addressed  partially  through  voluntary  action:  in  2018  several  online 
marketplaces  signed  voluntary  commitments  to  improve  the  safety  of  products  sold 
online:  the  Product  Safety  Pledge  (hereinafter  ’the  Pledge’).  The  current  eleven 
signatories49  committed,  among  others,  to  react  within  two  days  when  a  government 
informs them about an unsafe product offered on the platform, to cooperate with national 
authorities and to fight against repeat offenders. As the Evaluation has highlighted, while 
these  voluntary  commitments  reflect  some  progress  related  to  the  cooperation  between 
the signatories and authorities, it is challenging to analyse the effectiveness of the Pledge 
due  to  a  suboptimal  reporting  system  from  the  signatories.  The  Pledge  has  positive 
impacts, as it has set the grounds for an increased cooperation framework between online 
marketplaces and market surveillance authorities. However, authorities and stakeholders 
have  signalled  in  the  GPSD  Study  that  as  long  as  the  Pledge  remains  voluntary,  the 
infringement  of  those  commitments  cannot  be  penalised  by  authorities.  It  is  also 
challenging to analyse how effective the Pledge is in appropriately ensuring the safety of 
products sold online, since the Key Performance Indicators (KPIs) are calculated only on 
certain  commitments.  From  this  aspect,  the  Pledge  did  not  help  to  get  information  on 
specific issues  such  as on emerging risks of new technologies or improved recalls. The 
monitoring  reports  also  showed  that  there  has  been  a  divergence  in  the  way  online 
marketplaces  calculated  the  KPIs,  making  it  difficult  to  extract  conclusions  from  those 
numbers  and  properly  monitor  the  effectiveness  of  the  commitments  of  the  Pledge. 
Finally, there are also many players on the market that have not decided to adhere to the 
voluntary  commitments,  creating  an  uneven 
level-playing  field  between  online 
marketplaces targeting EU consumers. Therefore, while the Pledge sets out a very useful 
mean  of  cooperation  between  online  marketplaces  and  national  authorities,  its 
effectiveness  is  limited  by  the  limited  range  of  signatories  and  by  its  voluntary  nature, 
limiting enforcement. 

Finally,  via  online  sales,  EU  consumers  also  purchase  more  frequently  products 
offered directly by operators established outside the EU: the proportion of purchases 
from sellers outside the EU increased from 17% in 2014 to 27% in 201950. Around 150 
million  small  consignments are imported free of VAT into the EU each  year51.  In 2017 
there were 150.000 private consignments coming from China to individual EU consumers 
per day52. This  is problematic:  first,  direct  imports make it more complicated to  control 
the safety  of the product before it enters the  EU  market  since it is  directly  delivered in 
individual  packages  to  the  consumer  without  possibly  being  handled  by  any  economic 
operator  in  the  EU  subject  to  products  safety  obligations  under  the  GPSD53.  Second, 
national authorities have difficulties to engage with the trader in case of safety concerns, 
if  the  trader  is  not  represented  in  the  EU  but  is  based  in  a  third  country.  Article  4  of 
Regulation  (EU)  2019/1020  on  market  surveillance  creates  an  obligation,  in  case  a 
product is sold in the EU, to have an economic operator in the EU for certain tasks linked 
to market surveillance of products’ safety and compliance, but its applicability is limited 
to certain categories of harmonised products. If the product safety is not evenly enforced 
between  EU  and  non-EU  operators,  this  creates  an  uneven  level-playing  field  between 
these  operators.  A  study  provided  by  Eurocommerce  indicates  that  the  cost  difference 
between  products  produced  in  accordance  with  EU  rules  and  standards,  and  produced 

49 AliExpress, Allegro, Amazon, Bol.com, C-discount, Ebay, eMAG, Etsy, Joom, Rakuten France, Wish.com 
50 Eurostat https://ec.europa.eu/eurostat/statistics-explained/index.php?title=E_commerce_statistics_for_individuals#E-
shopping_from_other_EU_countries 
51 European Commission , Memo 2017 - Modernising VAT for e-commerce 
https://ec.europa.eu/commission/presscorner/detail/en/MEMO_16_3746  
52 Eurocommerce – Creating a level-playing field for retail in Europe – August 2019 
53 Pure postal and delivery services are exempted from product safety obligations. 

16 

 
 
                                                           
without  taking  account  of  the  EU  rules  may  be  important  for  some  products54.  While 
these  conclusions  cannot  be  extrapolated  to  the  overall  market  or  to  all  products,  they 
give  an  indication  of  the  possible  detriment  due  to  the  presence  of  rogue  traders  from 
third countries. 

in  brick-and-mortar  shops.  For  example,  data  coming  from 

The  Evaluation  has  also  compiled  evidence  pointing  to  the  fact  that  the  control  of  the 
safety  of  products  sold  online  is  more  problematic  than  the  one  for  unsafe  products 
found 
the  Safety 
Gate/RAPEX  for  the  period  2018-2019  show  that  the  share  of  notifications  of  unsafe 
products  in  which  one  of  the  four  traceability  information  items55  was  missing  was 
between  29,2%  and  57,3%  (depending  on  the  item)  for  products  'sold  online'  and  
considerably  lower  (between  12,6%  and  35,7%)  for  products  sold  offline.  None  of  the 
traceability information was found in 12,8% notifications of products sold online, while it 
was only 0,5% for the unsafe products sold offline. 

These problems affect also economic operators. EU producers face an uneven playing 
field  between them  and  non-EU producers if those do not  comply with  EU safety rules 
and  therefore  do  not  bear  the  compliance  costs  of  the  EU  product  safety  legislation. 
Online marketplaces targeting EU consumers also do not have a level-playing field since 
the signatories of the Pledge bear additional costs and administrative burden compared to 
non-signatories that do not take the steps outlined in the Pledge. 

In the area of online sales, the product safety obligations of online market places are not 
spelled  out  in  any  EU  legislation  and  current  market  surveillance  provisions  relating  to 
products imported from outside the EU are tackled only for certain harmonised products 
under Regulation (EU) 2019/1020.  

Besides, there are also traceability problems with products offered online (the traceability 
of the online chain is often deficient and there is a gap between the product information 
available to the consumer for a product sold online and offline). The DSA aims to partly 
tackle  these  issues  by  introducing  the  “Know-Your-Business-Customer”  principle 
(KYBC) and traceability provisions when it comes to the online sales via certain online 
marketplaces,  leaving  scope  to  the  revised  GPSD  to  tackle  traceability  issues  for  all 
online sales. 

2.1.3.  Ineffective product recalls  

Article 5 of the GPSD requires that when a product already sold to consumers turns out to 
be  dangerous,  it  needs  to  be  recalled  (as  a  measure  of  last  resort)  to  protect  EU 
consumers. But the GPSD does not set any specific rules regarding the modalities of 
recalling  unsafe  products  and  evidence  suggests  that  the  proportion  of  products 
successfully recovered from consumers remains generally low, as recognised by a recent 
OECD report56 (even though it varies considerably depending on factors such as channel 
of  sale57  and  product  type58).  For  instance,  one  Member  State  indicated  that  the  return 
rate  rarely  exceeds  10%,  except  when  products  have  been  purchased  online59.  Another 
national  authority  estimated that around 80% of products  that have relatively low value 
and short lifespan remain in consumers’ hands60. 

54Eurocommerce - Creating a level-playing field for retail in Europe – August 2019. 
55 Indication of: manufacturer, brand, type/model, batch number/barcode 
56 OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 5. 
57 Recalls tend to be more effective if the product was bought online because it’s easier to identify and directly contact 
the buyers. 
58 Recall effectiveness increases with product price and expected lifespan and decreases with product age. 
59 Idem, p. 17. 
60 European Commission, 2021, Behavioural study on strategies to increase the effectiveness of product recalls. 

17 

 
 
                                                           
The EU-wide societal cost of recalled products remaining in consumers’ hands have been 
estimated  at  approximately  €378  million  in  2019  due  to  healthcare  costs,  productivity 
losses  and  losses  of  quality  of  life61.  The  GPSD  Study  also  estimated  that  the  value  of 
recalled products that remain with consumers is today EUR 1.3 billion. 

The  consequences  of  delayed  and  ineffective  recalls  are  also  exemplified  by  the  deaths 
and  injuries  caused  by  recent  examples  of  recalled  products  such  as  faulty  airbags 
(estimated  to  have  caused  35  deaths  and  300  injuries  worldwide62)  and  baby  sleepers 
(associated with 59 baby deaths in the US63).  

The  recall  procedure  is  not  fully  harmonised  in  the  EU,  which  leads  to  different 
practices,  depending  on  national  provisions  and  economic  operators  involved.  As  an 
example, fewer than half of EU/EEA countries have established codes of good practice or 
guidelines  on  recalls,  and  only  few  of  these  documents  set  out  requirements  as  to  the 
content and channels of recall information or remedies for consumers. The evaluation has 
identified this as a significant  shortcoming, suggesting that existing requirements are in 
themselves  currently  not  sufficient  to  ensure  effective  recalls,  leading  to  two  problem 
areas. 

First, many EU consumers are not aware of ongoing recalls of products they own. It is 
often  difficult  to  reach  the  owners  of  the  recalled  product.  Apart  from  motor  vehicles 
(whose  registration  with  public  authorities  is  mandatory),  registration  schemes  are  only 
available  for  few  higher-value  product  categories  like  domestic  electric  appliances  and 
communication devices, and even there no link is typically made between registration and 
safety64. In addition, economic operators are hesitant about using customers’ information 
collected for other purposes (e.g. in the context of online sales or loyalty programmes) in 
the event of a recall because of legal uncertainty about the compliance with the General 
Data Protection Regulation.65 Also, there are no comprehensive public sources of recall 
information  for  consumers.  For  instance,  in  most  EU/EEA  countries,  the  recalling 
company has no obligation to put the recall notice on their website or social media and 
not  all  Member  States’  authorities  publish  recall  information  on  their  websites,  in 
addition to reporting recalls to the Safety Gate/RAPEX66. 

Second,  consumers  may  not  return  a  recalled  product  even  if  they  are  aware  of  the 
recall. According to recent surveys, more than a third of EU consumers continue using a 
recalled  product  despite  seeing  a  recall  notice67.  This  may  be  caused  by  recall  notices 
being unclear and/or minimising consumers’ perception of risk. For instance, the analysis 
of  existing  recall  announcements  showed  that  over  half  of  them  used  terms  and 
expressions,  which  could  downplay  risk,  such  as  ‘voluntary/precautionary  recall’, 
‘potential  concern/problem’,  ‘in  rare  cases/in  specific  conditions’  or  highlighting  that 

61 Idem 
62 https://www.consumerreports.org/car-recalls-defects/takata-airbag-recall-everything-you-need-to-know/ 
63 https://www.washingtonpost.com/gdpr-
consent/?next_url=https%3a%2f%2fwww.washingtonpost.com%2fbusiness%2f2019%2f10%2f17%2fstudy-concludes-
design-rock-n-play-other-infant-sleepers-led-deaths%2f  
64 European Commission, 2021, Behavioural study on strategies to improve the effectiveness of product recalls. 
65 European Commission, Notes from EU Workshop on strategies to maximise the effectiveness of product recalls, 23rd 
October 2019, p. 2. 
66 However, not all recalls need to be notified to Safety Gate/RAPEX. As regards products posing a less than serious 
risk, notification is encouraged but not mandatory in the case of voluntary measures taken against products covered by 
the GPSD and in the case of both voluntary and compulsory measures taken against products subject to EU harmonised 
legislation. In addition, Member States are not required to notify corrective measures in cases where the effects of the 
product risk cannot go beyond the territory of the Member State. 
67 European Commission, 2021, Behavioural study on strategies to improve the effectiveness of product recalls, 
European Commission, 2019, Survey on consumer behaviour and product recalls effectiveness. Final Report 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/ Product.Recall.pdf 

18 

 
 
                                                           
there  have  been  no  reported  injuries.  Also  the  procedure  for  consumers  to  return  the 
recalled product may be complex and burdensome and the remedies offered may not be 
sufficiently attractive and timely. In a recent consumer survey, recall process taking too 
much time and effort was the second-top reason for not responding to a recall (after the 
product being cheap)68. 

The  stakeholders  especially  affected  by  insufficient  recall  effectiveness  are  socially 
disadvantaged, younger and less safety-conscious consumers (who have shown to be less 
responsive  to  product  recalls  and  less  likely  to  register  their  products69)  as  well  as 
consumers living in remote areas (for whom returning the recalled product can be costly). 
Diverging national requirements (e.g. on recall communication and remedies) also result 
in an uneven level-playing field for companies.  

2.1.4.  Market surveillance rules are complex and not fully effective 

Following  the  adoption  of  Regulation  (EU)  2019/1020,  the  market  surveillance  rules 
differ for harmonised and non-harmonised products. This Regulation is applicable to 
the non-harmonised area under GPSD only regarding the provisions for customs controls. 
The  market  surveillance  rules  under  this  Regulation  apply  only  to  harmonised  products 
and  differ  from  those  for  non-harmonised  products  in  several  aspects:  responsible 
operator in the EU for products entering the EU market, online market surveillance tools 
(mystery  shopping,  blocking  websites),  strengthened  market  surveillance  rules  (e.g. 
Single Liaison Office, cross-border mutual assistance). 

The Evaluation has also identified coherence problems resulting from the fact that there 
are two different sets of market surveillance rules, for harmonised and non-harmonised 
products.  One  good  example  is  toys  (e.g.  doll’s  bed)  and  childcare  articles  (e.g.  baby’s 
bed),  that  might  be  conceptually  very  close  and  targeting  the  same  consumers,  but  are 
however  regulated  differently:  a  toy  is  a  harmonised  product  regulated  by  Directive 
2009/48/EC,  a  baby’s  bed  is  a  childcare  article,  which  is  a  non-harmonised  product, 
falling  under  the  scope  of  application  of  the  GPSD.  Therefore,  market  surveillance 
authorities have different powers for these two products: for example they can carry out 
online investigations under covered identity for a doll’s bed, but not for a baby’s bed, as 
explained above.70  
This has also clear implications for the effectiveness and efficiency of the GPSD71 as it 
may  lead  to  market  surveillance  inefficiencies  and  thus  higher  presence  of  unsafe 
products  on  the  EU  market  in  the  non-harmonised  area.  Ensuring  coherence  between 
these rules is important both for market surveillance authorities (they have difficulties to 
apply  different  rules  according  to  the  products,  e.g.  since  they  do  not  have  the  same 
market  surveillance  tools  for  harmonised  and  non-harmonised  products  in  online  sales) 
and for economic operator who might deal, at the same time, with both types of products: 
different rules complicate and make more expensive the business activity.  

The Evaluation identified also several additional problems for market surveillance of 
product safety: 

68 European Commission, 2021, Behavioural study on strategies to improve the effectiveness of product recalls 
69 Idem, European Commission, 2019, Survey on consumer behaviour and product recalls effectiveness. Final Report 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/ Product.Recall.pdf 
70 Regulation 2019(1020) creates e.g. obligation to designate a responsible economic operator in the EU, possibility to 
use specific tools for online market surveillance (mystery shopping, blocking websites), etc. 
71 This leads to asymmetrical obligations for the different actors based on whether they are dealing with harmonised or 
non-harmonised products, leading to administrative burden and complexities for EU businesses. 

19 

 
 
                                                           
- Market  surveillance  and  customs  authorities  lack  appropriate  instruments  to  enforce 
product safety rules for non-harmonised products, in particular in online sales, such as 
blocking websites, mystery shopping.  

- Products are difficult to trace throughout the supply chain. In particular, products such 
as laser pointers, lighters, jewellery, or decorative articles, that fall within the scope of 
GPSD  and  are  not  subject  to  sector-specific  harmonisation  rules,  are  more  likely  to 
lack relevant information items that are essential to trace them in case they are notified 
to Safety Gate/RAPEX.  

- The process for adopting voluntary safety standards for the GPSD products is complex 
and  not  sufficiently  efficient.    It  requires  a  three  step  process  involving  comitology. 
This could be simplified and streamlined. 

- There  are  differences  in  the  GPSD  implementation  across  Member  States.  (e.g.  the 

traceability requirements differ between Member States).  

- There  is  a  lack  of  a  mechanism  at  EU  level  to  solve  divergent  positions  of  Member 
States regarding the risk assessment of a specific product, which causes a difference in 
the  treatment  of  some  consumer  products  inside  the  Single  Market.  The  number  of 
notifications to the Safety Gate/RAPEX that were subject to disputes between Member 
States has been on average 30 per year.  

- The  deterrent  effect  of  the  GPSD  might  not  be  effective  enough.  A  plausible 
explanation for this suggested by several stakeholders might be that the sanctions and 
penalties  for  product  safety  infringements,  that  are  not  harmonised  across  Member 
States, remain low. This creates a problem in the context where all products cannot be 
controlled  by  the  national  authorities,  in  view  of  their  huge  volumes  and  need  to 
facilitate trade and free movement of goods. 

- The  market  surveillance  system  under  the  GPSD  appears  to  be  operating  under 
considerable  resource  constraints72.  Market  surveillance  authorities  have  indicated 
limited  staff/financial  resources  for  market  surveillance  and  enforcement  most 
frequently  as  a  key  factor  influencing  negatively  the  level  of  achievement  of  their 
tasks.  

-  The  difficulty  of  taking  enforcement  actions  against  economic  operators  outside  the 
EU.  This  is  particularly  relevant  as  the  growth  of  online  sales  73  have  resulted  in  an 
increase of direct imports; around 150 million small consignments are imported free of 
VAT into the EU each year74.  

Uneven  and,  in  some  cases,  insufficient  enforcement  actions  can  harm  EU  consumers, 
since  they  are  exposed  to  more  dangerous  products,  but  also  risk  to  distort  competition 
for  EU  businesses  and  create  obstacles  to  free  movement  of  goods.  National  market 
surveillance authorities suffer from higher administrative costs as a consequence of cross-
border inefficiencies and investigation costs if the relevant operator or the product to be 
traced are difficult to find. Discrepancies in the GPSD implementation create an uneven 
playing  field  between  Member  States  and  additional  regulatory  burden  for  businesses 
active across the EU. 

The  fragmentation  of  the  market  surveillance  rules  between  harmonised  and  non-
harmonised products may also create regulatory burden both for national administrations 
and EU businesses. The complexity of the market surveillance legislation creates higher 

72 See Annex 11 on the results of the OPC. When asked about the main challenges for enforcement half of the 
respondents considered as problematic that Member States’ authorities did not have enough resources (49%), followed 
by the difficulty of taking enforcement actions against economic operators outside the EU (46%).  
73 Idem 
74 European Commission , Memo 2017 - Modernising VAT for e-commerce 
https://ec.europa.eu/commission/presscorner/detail/en/MEMO_16_3746  

20 

 
 
                                                           
costs  for  economic  operators  (additional  costs  of  complying  with  different  national 
market  surveillance  and  product  safety  rules  for  businesses  operating  in  more  than  one 
Member  State).  The  current  standardisation  process  for  non-harmonised  products  also 
creates unnecessary administrative burden at EU level and undermines the efficiency of 
the standardisation process under the GPSD. 

2.1.5.  Inconsistent  application  of  product  safety  rules  for  food-imitating 

products 

The legal framework providing rules on safety issues linked to food imitating products is 
set out in Directive 87/357/EEC (FIPD). This Directive was adopted  before the GPSD 
was  created  the  horizontal  legal  framework  for  safety  of  all  non-harmonised  products, 
and  it  aimed  at  harmonising  the  divergent  pre-existing  national  rules  on  food  imitating 
products75.  Such  separation  of  rules  according  to  a  specific  aspect  of  a  product  creates 
regulatory complexity for national administrations and economic operators.  

As reflected in the Evaluation, the number of Safety Gate/RAPEX notifications of food 
imitating products is a small percentage of the total. Between 2005 and  2015, a total of 
258  notifications  (around  17  per  year  on  average)  relate  to  food  imitating  products. 
Moreover, it seems that the product category “Food-imitating products” was only used up 
to 2015; afterwards, the products have been categorised according to their use (cosmetics, 
clothing, etc.): since 2015, 71 notifications mentioning products not complying with the 
FIPD  have  been  submitted  under  other  categories  such  as  cosmetics,  kitchen/cooking 
accessories, stationery, or decorative articles. Despite that, the number of notification for 
food-imitating  products  remain  low.  The  aspects  related  to  the  imitating  nature  of  the 
product  were  incorporated  in  the  risk  assessment  of  the  product  itself,  but  not  in  a 
systematic manner by all Member States. 

Indeed,  the  safety  provisions  of  the  FIPD  are  applied  differently  between  Member 
States,  which  have  diverging  positions  on  substantial  issues,  in  particular  whether  all 
food-imitating  products  should  be  banned  per  se  or  measures  against  these  products 
should be based on a risk assessment under this Directive. Indeed, the FIPD was adopted 
before the GPSD, which sets out the principle of the necessity of risk assessment before 
taking appropriate measures against dangerous products and some Member States started 
to apply to food-imitating products the GPSD logic while others maintained the primary 
interpretation of the FIPD as a ban of these products. 

Such different application of this Directive leads to an uneven treatment of these products 
across  the  EU  and  risks  to  create  distortions  of  competition  in  the  Single  Market.  The 
stakeholders impacted by this problem are businesses producing such products, due to the 
lack  of  clarity  of  rules,  and  also  European  consumers,  who  are  differently  protected 
against  these  products.  National  market  surveillance  authorities  also  suffer  from  higher 
administrative  costs  due  to  complexity  of  the  rules.  The  low  number  of  notifications 
related  to  food-imitating  products  in  the  Safety  Gate/RAPEX  also  raises  a  question 
whether a separate legal regime for these products remains justified.  

2.1.6.  Problems related to the legal form  

The current legal form, a Directive, creates several problems linked especially to the 
implementation  and  national  differences  regarding  the  date  and/or  manner  of 
transposition.  Several problems have been encountered in the application of the GPSD, 
such as the application of provision on the corrective measures to be adopted in case of a 
dangerous  product  found  on  the  market  (Article  8  of  the  GPSD):  the  measures  to  be 

75 The first version of the GPSD was the Council Directive 92/59/EEC of 29 June 1992 on general product safety 

21 

 
 
                                                           
adopted and the type can vary consistently among Member States national transposition 
legislation entailing different treatments in different Member States, bringing eventually 
to fragmentation in the internal market. Even more relevant, in practice, is the different 
transposition of the provision on traceability  (Article 5 of the GPSD):  the requirements 
contained in this article are transposed differently, for example as far as the indication of 
the batch of a product or the way and location of the identity and details of the producer 
are concerned. 

2.1.7.  Regulatory burden and costs of the GPSD (REFIT problem) 

To  summarise,  several  of  the  aspects  of  the  current  GPSD  developed  above  create 
unnecessary regulatory burden for MSAs and companies: discrepancies between market 
surveillance  procedures  for  harmonised  products  and  non-harmonised  products,  market 
surveillance  inefficiencies  between  Member  States  due  to  diverging  assessments  and 
actions  taken  against  products,  lack  of  clarity  inter  alia  about  the  scope  of  GPSD,  sub-
efficient  standardisation  procedures,  different  implementation  of  safety  rules  for  food-
imitating products, differences in GPSD implementation, and lack of resources for MSAs 
to implement the rules.  

2.2.  What are the problem drivers? 

The figure below summarises the main drivers for the general problem and the five 
specific problems identified above: 

Figure 1: GPSD General problem tree 

The underlying drivers (causes) for the identified problems are multifaceted: 

22 

 
 
 
 
 
 
 
Table 2: Nature of problem drivers 

Drivers 
nature 
Market 
failure 

Problem 
area 
General 
problem of 
unsafe 
products 
occurring 
on the 
market 

Asymmetry 
of 
information  

Split markets 

New 
technologies 

Regulatory 
failures 

Online sales 

Regulatory 
failures 

Recalls  

Regulatory 
failures 

Drivers’ action 

Under  classical  economic  rationale,  the  producer’s  objective  is  profit  maximisation  and 
therefore  to  produce  the  given  product  at  the  best  price;  in  the  absence  of  any  safety 
regulation,  it  may  tend  to  sacrifice  the  product  quality  and  safety  by  choosing  cheaper 
components  and  undergoing  less  safety  verifications.  The  market  price  of  a  dangerous 
product does not reflect the real cost for the consumer and for the society, in particular the 
costs  of  injuries  linked  to  a  dangerous  product.  Therefore,  the  market  does  not  take  into 
account the negative externalities of dangerous products in terms of reduced public health 
and increased public health expenses and such market outcome is therefore not optimal for 
the  society.  However  it  also  has  to  be  taken  into  account  that  it  is  important  for  some 
companies to produce products that are  safe  for consumers, as their reputation  is at stake 
and they may lose the consumers’ trust in their brand.  
Information  is  needed  for  markets  to  operate  efficiently.  Buyers  need  to  know  about  the 
quality and safety of the product to assess its value. The consumer does not know exactly in 
which way the product has been produced and its exact components, while the safety of a 
product can be verified including by undergoing a proper laboratory test, which is of course 
impossible for an individual consumer to do in advance. Consequently,  most of the times 
consumers  cannot  verify  the  product  safety  when  buying  a  product  and  take  this  into 
consideration  in  their  choice;  therefore  they  may  make  the  wrong  choice  and  buy  unsafe 
products, which leads to sub-optimal societal outcomes.  
In the markets where actors have different and not aligned objectives and the information is 
imperfect (as explained above), socially desirable actions are not undertaken and regulation 
can then redefine the characteristics of products to be placed on the market, as it is the case 
for product safety legislation.  

The  GPSD  does  not  provide  enough  legal  certainty  about  the  coverage  of  the  specific 
features  of  new  technology  products,  such  as  software  updates  or  the  evolving  nature  of 
some products. Some new types of risks linked to new technologies (such as cybersecurity 
risks  affecting  safety)  are  not  explicitly  covered,  which  leads  to  legal  uncertainty. 
Consequently,  the  current  GPSD  does  not  efficiently  play  its  role  of  safety  net  for  new 
technology products. 
When the GPSD was developed, online sales were still at an early stage and therefore the 
GPSD’s  provisions  do  not  properly  address  the  challenges  of  the  current  online 
environment. The GPSD does not set out specific obligations related to product safety for 
the online marketplaces, while these play today an important role in the online sales. Also, 
the  GPSD  does  not  provide  for  effective  investigation  tools  for  online  sales.  Finally,  E-
commerce  allows  for  an  important  increase  of  direct  imports  from  economic  operators 
located outside the EU. While the GPSD creates product safety obligations for any products 
being  placed  on  the  EU  market,  regardless  of  their  place  of  origin,  it  is  very  difficult  to 
enforce  against  traders  established  outside  the  Union  and  offering  their  products  to  EU 
consumers.  There  are  therefore  enforcement  difficulties  allowing  the  entering  of  non-
harmonised  consumer  products  on  the  EU  market  without  having  an  economic  operator 
responsible for these products in the EU. 
Recall  procedure  as  such  is  not  defined  under  the  GPSD.  In  particular,  there  are  no 
minimum  requirements  on  the  content  and  channels  or  recall  communication  or  remedies 
that consumers are entitled to. In some countries, requirements are more prescriptive than 
in others, leading to varying levels of consumer protection. One major deficiency is the lack 
of legal basis for using existing customers’ data for recall purposes. 

Market 
failures 
(companies 
fail to act 

Companies may fear the negative reputational impact and other costs created by a recall 
and  thus  avoid  communicating  clearly  about  possible  safety  issues  and  delay  recall 
measures and/or underplay the risk  when the  product turns out to be dangerous76. Almost 
half (47%) of industry respondents to a European Commission’s survey indicated that they 

76An analysis of existing product registration schemes indicated that very few companies make a link between 
registration and safety, while a similar analysis of recall announcements showed that over half of them used terms and 
expressions, which could reduce consumers’ perceptions of risk European Commission, 2021, Behavioural study on 
strategies to improve the effectiveness of product recalls. 

23 

 
 
 
 
 
 
                                                           
effectively) 

Behavioural 
biases 
(consumer 
inertia) 

Market 
surveillance 

Regulatory 
failures 

Food-
imitating 
products 

Regulatory 
failures 

did  not  have  a  written  procedure  in  place  in  case  the  product  needs  to  be  recalled  (even 
though  safety-conscious  companies  were  likely  overrepresented  in  the  survey)77.  Also 
marketing literature suggests that most companies engage in a passive recall strategy rather 
than a proactive one78. 
Consumers  do  not  always  act  in  a  rational  way  in  response  to  recalls.  Biases  such  as 
information  overload  and  framing  effects  mean  that  if  recall  notices  are  lengthy  and 
unclear, consumers may ignore them, especially if they are time poor. Over-optimism may 
result in consumers underweighting the risk posed by a recalled product, while inertia and 
endowment effect79 relate to the fact that consumers have an inherent preference for status-
quo, which in the case of recalls means keeping the product. 
At EU level, the market surveillance rules for harmonised and non-harmonised products are 
not only set up in two different legal texts, but also the  applicable rules differ in several 
aspects  for  these  two  categories  of  products,  which  creates  regulatory  complexity  for 
national administrations and businesses. Furthermore, implementation issues stem from the 
fact that the GPSD is a Directive and as such is not directly applicable in the EU and, as the 
Evaluation shows, is transposed differently across EU Member States. The GPSD also does 
not  sufficiently  harmonise  the  provisions  on  the  product  traceability,  which  are  therefore 
defined  at  national  level  and  prove  to  be  insufficient.  The  GPSD  does  not  tackle  the 
disputes on the risk assessment between Member States, and the standardisation procedure 
under the GPSD is not efficient enough. 
At national level, the main driver for enforcement problems is lack of resources dedicated 
to market surveillance by Member States. Also, the current level of penalties and sanctions 
does not create a sufficient deterrent effect for economic operators to prevent the placing of 
unsafe products on the market. 

The  uneven  application  of  product  safety  rules  for  food-imitating  products  stems  from 
the fact that the rules are formulated in such a way that it allows a very different application 
across  EU  Member  States,  some  categorically  banning  all  food  imitating  products,  some 
others  performing  a  risk  assessment  before  deciding  on  the  measure.  The  fact  that  these 
rules  are  set  out  in  another  piece  of  legislation  than  the  rest  of  the  product  safety  rules 
creates unnecessary regulatory complexity for national administrations and businesses and 
leads to incoherent measures on the Single Market. 

2.3.  How will the problem evolve? 

Some of the identified problems will remain and even likely get worse: in particular those 
linked  to  online  sales  and  new  technologies.  There  is  a  clear  increasing  trend  in  online 
sales  in  the  EU.  The  COVID-19  crisis  and  the  repetitive  lockdowns  are  accelerating  e-
commerce, as well as imports of consumer products from outside the EU. There is also an 
increase  of  new  technology  consumer  products  being  available  on  the  EU  market. 
Therefore, the magnitude of problems linked to these new digital challenges is likely to 
increase. 

At the same time, digital developments offer also opportunities for more efficient market 
surveillance  by  using  new  technology  tools,  for  example  to  identify  already  recalled 
products  online.  Online  sales  may  ease  the  identification  of  customers,  which  is 
particularly important in recalls. Also, connected products may be easier to recall and fix 
or switch off remotely.  

77 Idem. 
78 Chen, Yubo & Ganesan, Shankar & Liu, Yong. (2009). Does a Firm's Product-Recall Strategy Affect Its Financial 
Value? An Examination of Strategic Alternatives During Product-Harm Crises. Journal of Marketing American 
Marketing Association ISSN. 73. 214-226. 10.1509/jmkg.73.6.214 
Mukherjee, U., Ball, G., Wowak, K., Natarajan, K. and Miller, J (2021), Hiding in the Herd: The Product Recall 
Clustering Phenomenon, Manufacturing & Service Operations Management, https://doi.org/10.1287/msom.2020.0937 
Kalaignanam, Kartik & Kushwaha, Tarun & Eilert, Meike. (2012). The Impact of Product Recalls on Future Product 
Reliability and Future Accidents: Evidence from the Automobile Industry. Journal of Marketing. 77. 10.2307/23487412 
79 In behavioural economics the endowment effect is he finding that people are more likely to retain an object they own 
than acquire that same object when they do not own it 

24 

 
 
 
 
                                                           
The  new  Regulation  (EU)  2019/1020  will  only  have  a  limited  effect  on  the  market 
surveillance for products and risks covered by GPSD since only its provisions on customs 
(Chapter VII of this Regulation) apply to these products. 

Some other problems will also continue to exist and are likely to remain the same or of 
the  same  magnitude  in  the  absence  of  EU  action,  in  particular  the  fragmentation, 
complexity  and  ineffectiveness  identified  in  the  market  surveillance  rules.  These 
problems are mainly linked to regulatory failures of the legal framework itself and would 
get  worse  only  if  there  is  an  increased  trend  of  non-harmonised  consumer  products 
circulating on the EU market. Problems linked to lack of resources mostly relates to the 
political priorities and resources of the Member States. 

3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

The legal basis for this initiative is Article 114, with due regard to Article 16980, of the 
TFEU. The GPSD has for object ensuring product safety and improving the functioning 
of  the  internal  market.  GPSD  aims  at  ensuring  a  high  level  of  consumer  protection,  by 
contributing to protect the health, safety of European consumers and promoting their right 
to information81.   

The EU has no exclusive competence on product safety, which is a shared competence. 
Therefore, the subsidiarity principle does apply. 

3.2. 

Subsidiarity: Necessity of EU action 

The GPSD harmonises the general product safety requirement in the EU. Ensuring safety 
of products in the Single Market cannot be achieved sufficiently by Member States acting 
alone for the following reasons: 

- Data show unsafe products are spread across the EU: unsafe products can be found in 
all Member States82.  
- Products  circulate  freely  across  the  Single  Market,  including  the  dangerous  ones. 
When  a  dangerous  product  is  identified  in  a  certain  country  it  is  very  likely  that  the 
same  product  could  be  found  in  other  Member  States  too,  not  least  following  the 
exponential growth of online selling. This is demonstrated by the number of follow-up 
actions taken by Member States in their country after the notification of a dangerous 
product  in  the  RAPEX/Safety  Gate;  while  in  2011  there  were  2100  follow-up 
measures,  in  2019  more  than  4400  of  such  measures  were  notified  to  Safety 
Gate/RAPEX.  

- Different  rules  on  product  safety  at  national  level  can  create  uneven  costs  for 
businesses  to  comply  with  product  safety  legislation  and  therefore  can  cause 
distortions of the internal market when /if companies want to operate across borders. 
- According to Article 169 of TFEU, in order to promote the interests of consumers and 
to ensure a high level of consumer protection, the Union shall contribute to protecting 
the  health  and  safety  of  consumers.  If  there  are  different  rules  concerning  product 

80 Article 169 make reference to Article 114 to achieve its objectives. 
81 Also, product safety is part of the high level of consumer protection that Union policies ensure (see Article 38 of the 
Charter of Fundamental Rights of the European Union) and therefore one of the pillars of the EU consumer protection 
policy. 
82 See Safety Gate/RAPEX annual report –
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/reports/d
ocs/RAPEX.2019.Factsheet.EN.pdf 

25 

 
 
 
                                                           
safety  and  its  market  surveillance,  EU  consumers  will  not  be  protected  against 
dangerous products in the same way across the Member States.  

- The  identified  problem  drivers  mostly  do  not  have  any  national  or  sub-national 
specificities  (problems  linked  to  digital  challenges,  recalls  and  food-imitating 
products).  Problem  drivers  for  market  surveillance  have  partly  a  national  dimension 
concerning  the  lack  of  resources,  level  of  penalties  and  availability  of  market 
surveillance tools, which can differ from one Member State to another.  

The  objective  of  products  safety  cannot  be  sufficiently  achieved  by  the  Member  States 
acting  alone,  given  the  need  for  a  very  high  degree  of  cooperation,  interaction  and 
coherent  action  of  all  the  competent  authorities  in  all  Member  States  across  the  Single 
Market  to  ensure  the  same  high  level  of  protection  of  consumers  and  enable  effective 
action  on  the  Single  Market  where  products  circulate  freely.  Member  States  cannot 
ensure cooperation and coordination by acting independently. 

The GPSD establishes the cooperation and coordination between Member States: via the 
EU Safety Gate/RAPEX, Member States inform each other about measures taken against 
dangerous  products.    They  also  take  follow-up  actions  in  their  territory  if  the  product 
alerted  is  present  there.  Moreover,  authorities  consider  the  implementation  of  EU 
coordinated  market  surveillance  activities  on  product  safety  extremely  useful,  as 
economies of scale and the funding provided  by  the Commission have allowed them to 
carry out inspections for some priority categories of products.  

The  measures  under  this  initiative  would  not  affect  the  Member  States'  competences  in 
market  surveillance  or  assessment  of  risks,  neither  would  they  interfere  with  national 
enforcement  or  judicial  systems,  nor  would  they  affect  the  internal  division  of 
competences  among  authorities  at  national  level.  In  the  product  safety  field,  Member 
States  can  act  first  independently  to  notify  the  corrective  measures  taken  against 
dangerous  products,  but  then  follow-up  actions  are  required  from  all  other  Member 
States. 

3.3. 

Subsidiarity: Added value of EU action 

EU  level  action  in  product  safety  for  non-harmonised  products  has  clear  benefits 
demonstrated by the GPSD evaluation: 

-  Common  Union  rules  allow  economy  of  scale  in  market  surveillance,  in  particular 
nowadays with the exponential development of online selling which intensifies sales 
across  the  EU  and  direct  imports  from  outside  the  EU.  Sharing  costs  of  market 
surveillance occurs also by performing joint market surveillance actions among EU 
countries and exchange information. 

-  EU  action  allows  faster  and  more  efficient  circulation  of  information,  in  particular 
via  the  Safety  Gate/Rapex,  thus  ensuring  fast  actions  against  dangerous  products 
across the EU and also level playing field.  

-  Common rules for product safety at EU level have benefits in term of costs savings 
and  lower  administrative  burden  and  complexities  for  businesses  by  avoiding  them 
having  to  comply  with  heterogeneous  sets  of  national  rules.  This  enables  also  free 
circulation  of  goods  in  the  EU  and  allows  for  closer  cooperation  between  Member 
States. 

-  Common  Union  rules  enable  developing  EU  product  safety  standards,  which  by 
giving  EU-wide  presumption  of  safety  facilitate  product  safety  compliance  for 
businesses (and potentially decrease the related costs). 
 At  international  level  the  common  set  of  provisions  established  by  the  GPSD  has 
also  allowed  the  EU  to  be  stronger  in  promoting  high  level  of  safety  with 
international  actors,  thus  tackling  the  increasingly  high  circulation  of  goods  from 
third countries via online selling.  

- 

26 

 
 
The  functioning  of  the  internal  market  will  be  improved  by  EU  level  action  since 
common product safety and market surveillance rules across  the EU will ensure a more 
even  treatment  of  businesses  and  therefore  less  likely  distort  competition  on  the  EU 
Single  Market.  Better  market  surveillance  and  enhanced  coordination  between  Member 
States  will  lead  to  higher  detection  of  unsafe  products,  and  thus  to  higher  consumer 
protection and trust. 

The food-imitating product directive is currently subject to very different interpretations 
between Member States, ranging from a ban of such products to the inclusion of the food-
imitating aspect in the elements taken into account in the risk assessment. This leads to a 
fragmentation of the internal market regarding such products, a more unified approach of 
food-imitating products is therefore needed at the EU level, requiring Union action.    

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

Figure 2: Schematic overview of problems and objectives 

4.1.  General objectives 

The  general  objective  of  the  GPSD  is  to  ensure  EU  consumers  are  protected  from 
dangerous products and to ensure the proper functioning of the Single Market. These two 
main  objectives  of  the  GPSD  are  interlinked:  if  the  same  high  level  of  safety 
requirements applies to all economic operators, it ensures the health and protection of EU 
consumers and also level-playing field for all businesses operating on the EU market. 

4.2. 

Specific objectives 

This  initiative has  five specific objectives  linked to  the five problems identified;  it also 
seeks  to  simplify  legislation  and  reduce  the  administrative  burden  of  the  current  acts 
under consideration (REFIT objective): 

27 

 
 
 
 
 
 
 
 
 
Table 3: Specific objectives 

Specific objectives 

Description 

Ensure that the EU legal 
framework provides for a safety 
net for all consumer products and 
risks, including products and risks 
linked to new technologies 

Address product safety challenges 
in the online sales channels 

Make product recalls more 
effective and efficient to keep 
unsafe products away from 
consumers 

Enhance market surveillance and 
ensure better alignment of rules 
for harmonised and non-
harmonised consumer products 

This initiative aims to make sure that the  GPSD ensures the safety of all non-harmonised 
products  and  addresses  relevant  risks.  In  view  of  the  development  of  new  technologies, 
there  is  a  need  to  ensure  legal  certainty  regarding  the  legal  coverage  of  new  technology 
products such as connected products and AI, and to be able to address new products safety 
risks  for  health  and  safety  of  consumers  related  to  these  new  technologies,  when  not 
already covered by sectoral legislation. The aim is to preserve the role of the GPSD as a 
safety net for consumers. 
The initiative does not aim to regulate all risks related to new technologies in general but 
only when they create risks to health and safety of consumers (e.g. cybersecurity can entail 
risks for privacy or data protection, which are not covered by the GPSD; the GPSD would 
only cover the risks related to health and safety (e.g. physical incident) created by e.g. lack 
of sufficient cybersecurity features) 

There  is  also  a  need  to  adapt  the  GPSD  to  the  new  challenges  of  e-commerce.  Product 
safety must be ensured irrespectively of the modalities of the supply chain: rules for new 
online  business  models  need  to  be  clarified  and  provisions  for  market  surveillance  of 
imported  products  improved  to  enable  appropriate  consumer  protection  and  level-playing 
field  for  businesses.  Also  national  market  surveillance  authorities  need  to  have  efficient 
tools  to  perform  market  surveillance  of  online  sales  and  the  product  traceability  in  the 
online sales needs to be improved. 

Product recalls play an important role to ensure the safety of EU consumers, since they are 
the last resort to keep dangerous products away from them. This initiative aims to increase 
the effectiveness and efficiency of recalls by improving the channels and content of recall 
information,  making  recall  procedure  less  burdensome  for  EU  consumers  and  ensuring 
their  right  to  an  effective  remedy.  The  initiative  takes  into  account  the  identified 
behavioural  biases  to  increase  consumer  response.  The  initiative  also  aims  to  ensure 
effective monitoring of recall actions. 

This initiative aims to ensure better enforcement of product safety rules by contributing to 
more efficient market surveillance. The objective is to improve product traceability so that 
dangerous product can be effectively  eliminated, the deterrent effect of the legislation for 
economic  operators  not  complying  with  the  rules,  and  to  tackle  possible  discrepancies 
about risk assessment between Member States. The aim is also to simplify the procedures 
leading up to referencing  standards in the Official Journal of the  EU for non-harmonised 
products. 
Following the recent adoption of Regulation (EU) 2019/1020, there is a need to align the 
market  surveillance  legislative  framework  for  non-harmonised  products  with  the  one  for 
harmonised products, the definitions of the  GPSD with product harmonisation legislation 
and ensure equal treatment for all products and businesses.  
The  objective 
to  ensure  more  efficient  and  coherent  enforcement  and 
implementation  of  the  product  safety  rules  across  the  EU  and  to  monitor  that  sufficient 
resources are dedicated to market surveillance at national level. 

is  also 

Address safety issues related to 
food-imitating products 

This  initiative  aims  to  ensure  a  consistent  application  of  product  safety  rules  for  food-
imitating products by simplifying and clarifying those rules. 

REFIT Simplification and 
improving the efficiency of the 
existing legislation 

This initiative aims also to simplify and reduce the regulatory burden of the current GPSD. 

Figure 3 presents the intervention logic for this initiative: 

28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3: Intervention logic 

Source: GPSD Study 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

5.1.  What is the baseline from which options are assessed? 

In  the  baseline  scenario,  no  new  legislative  or  non-legislative  actions  specifically 
targeting the safety of consumer products will be developed at EU or national level. This 
scenario includes several EU-level and national policies and measures which are assumed 
to continue being in force or will enter into force in the future:  

At EU level, the Commission has recently adopted a proposal for a Digital Services Act 
which,  if  adopted  by  the  co-legislators  and  once  entered  into  force,  should  set  up  new 
responsibilities  for  online  intermediaries,  including  online  marketplaces.  Also,  the 
Commission  has  recently  announced its  intention to  propose  new legislative initiatives 
linked  to  new  technologies  and  artificial  intelligence,  namely  the  proposal  for  a 
horizontal  instrument  on  AI  and  the  proposal  for  the  revision  of  the  Machinery 
Directive,  which  will  clarify  certain  sectorial  safety  aspects  of  new  technologies.  The 
new customs provisions applicable for GPSD products under the new  Regulation (EU) 
2019/1020 will start to apply in 2021. The Commission will continue, in the frame of the 
allocated EU budget, to finance coordinated market surveillance activities on product 

29 

Needs/ProblemsOutputs/resultsImpactsObjectivesGlobal objectivesTo ensure the safety of non-food consumer products on the EU marketTo contribute to the functioning of the Single Market and ensure a level playing field for businessesInputs/activities•Implementation of changes to the EU legal framework on product safety•Provision of funding and staff at EU level for product safety information exchange, coordination and training measures•Provision of funding and staff at Member State level for controls of imports from third countries, market surveillance and supervision of corrective actions etc•Activities in the fields of:•Safety Gate/RAPEX•Risk assessment, incl. new types of risks linked to new technologies•Training (e.g. E-enforce-ment Academy)•Exchange of information with third countries•Data collection, including on product-safety related injuries•Enforcement of product safety obligations of companies and intermediaries, including relevant new actors•Standardisation activities•Consumer awareness raising regarding product safetyReduced discrepancies in implementation of EU product safety legislation across MSConsumer are better protected online and offline from unsafe consumer products, including from products that pose new types of risks –including those linked linked to new techno-logies –, and risks due to envi-ronmental aspects that are relevant for human health    More effective corrective actions, including recallsEU legal framework modernised to provide a safety net to consumers regarding the safety of non-food productsMore standards prepared in a shorter timeframe for non-harmonised products that are a cause of consumer detrimentMore efficient standardisation procedure of mandating and referencing standards for non-harmonised productsDiscrepancies in implementation of GPSD across MS and divergences in risk assessment between national authorities Product safety challenges, including related to new technologies such as IoT or AI lead to new risks for consumersImproved enforcement of product safety obligations Reduced compliance costs and administrative burdens for EU businessesStandardisation process under GPSD more burdensome than for harmonised productsMore effective RAPEX system, e.g. by reducing the time from identification of an unsafe product to its notification through the system Obligations for business operators regarding safety large-ly independent from whether they are dealing with harmoni-sed or non-harmonised products Lack of level playing field for EU businesses compared to operators in third countriesBetter defined roles and responsibilities of different actors incl. when products are purchased by consumers directly from third countries, for product recalls etcBetter traceability of unsafe consumer productsLevel playing field for EU businesses with respect to product safety obligations, incl. with operators located in third countries and with respect to new supply chain actors Reduction of consumer detriment due to unsafe products, including regarding products purchased online or directly from third countriesMarket surveillance rules under GPSD are complex and not fully effectiveFragmented EU legal framework lead to increased compliance costs and administrative burdens for EU businessesSufficient enforcement powers provided to national authorities in all Member States Specific objectivesEnsure that the EU legal framework provides for general safety rules for all consumer products and risks, including product risks linked to new technologiesAddress product safety challenges in the online sales channelsMake product recalls more effective and efficient to keep unsafe products away from consumersEnhance market surveillance and ensure better alignment of rules for harmonisedand non-harmonisedconsumer products Address safety issues related to food imitating productsConsumers are offered products online that may be unsafe, not sufficiently traceable and covered by market surveillance Increased trust of consumers that products are safe and consequently, in the Single MarketEU legal framework more consistent and less complex/ fragmented, incl. with respect to food imitating productsConsumers better aware of product safety and recallsMore innovative and competitive EU economy that leads on the safety and sustainability of its productsIncrease in e-commerce, incl. direct B2C transactions with non-EU countries, facilitated by new economic operators, such as online marketplacesInsufficient resources for market surveillance in some MS, incl. for online market surveillanceLack of consistentand actionable data on product-related injuries of consumersInconsistent application of product safety rules for food-imitating productsInsufficient effectiveness of recalls of consumer productsBetter data on product-related injuries of consumersConsumers suffer detriment due to unsafe products, and may lose trust in the Single MarketMore uniform risk assessment of  responsible authorities in the EU regarding product safety related risk, including new types of risks linked to new technologies and environmental risks  
 
 
 
safety  (see  Annex  9).  The  Commission  is  expected  to  continue  its  advocacy  policy  on 
product  safety,  in  the  form  of  information  campaigns  and  other  promotion  initiatives 
such as the Product Safety Award83. The Commission will also continue its coordination 
role in product safety as Chair of the Consumer Safety Network (‘CSN’)84. In the area 
of  product  safety  in  the  online  sales,  the  baseline  scenario  takes  into  account  that  the 
Commission  will  continue  the  cooperation  with  and  steering  the  commitments  of  the 
online market places in the context of the Product Safety Pledge. Finally, the Commission 
will  continue  adopting  safety  standards  giving  presumption  of  safety  for  non-
harmonised  products  under  the  current  procedure,  and  also  its  international  cooperation 
activities.  

At  national  level,  it  is  assumed  that  Member  States  will  also  continue  their  measures 
supporting  product  safety  policy,  such  as  information  and  promotion  campaigns,  under 
the constraints of the national budgets, and their current market surveillance activities.  

Several expected socio-economic developments are also relevant for the product safety 
area.  Important  technological  developments  bring  an  increasing  number  of  AI-driven 
consumer  products  and  connected  products  on  the  EU  market.  Also  the  increasing 
digitalisation  of  online  sales,  dramatically  accelerated  during  the  current  COVID-19 
crisis, will increase the number of products sold online and also those imported directly 
from  outside  the  EU.  Demographic  changes  can  also  have  an  impact  on  the  safety  of 
consumers, as for example older people have specific consumption-related needs85.  

The  time  horizon  for  this  baseline  scenario,  which  will  be  used  for  the  assessment  of 
impacts of the different options is a 10 years’ horizon. This takes into account the likely 
lifetime of any individual option and on the need to allow for impacts to be realised.  

The GPSD Study estimated the costs associated with this baseline scenario for businesses 
and Member States as following: 

Table  4:  Estimated  annual  cost  for  businesses  to  comply with  the  GPSD,  by  company  size  class,  in 
million EUR 

Cost by company size 

Total costs 

Company size (employees) 

From 0 to 49 

50 – 249  

250 or more   All size categories 

Total of manufacturing 

Total of wholesale 

Total of retail 

Total  

   79 

   118 

   232 

   428 

   101 

   81 

   44 

   226 

   163 

   122 

   163 

   448 

   343 

   321 

   439 

  1 102 

Source: The survey conducted in the context of the GPSD Study 

The  estimated  costs  for  businesses  to  comply  with  the  GPSD  in  its  current  form 
amount to EUR 1.1 billion per year86.  

Consumer detriment linked to the unsafe products is expected to grow in the mid-term in 
the  baseline  scenario,  due  to  increasing  consumption  and  a  continuing  shift  to  e-
commerce:  the  GPSD  Study  evaluates  that  consumers  suffer  financial  costs  of  EUR 
19.3 billion in 2019 arising from the fact that they have purchased unsafe products that 

83 Since 2019 the Product Safety Award rewards every two years businesses going the extra mile for product safety, 
beyond their legal requirements. 
84 CSN is a network of authorities of the Member States competent for product safety. See Annex 9. 
85 COM(2020) 696 final - New Consumer Agenda - Strengthening consumer resilience for sustainable recovery 
86 Product safety-related costs that companies would incur anyway (i.e. even in absence of product safety legislation, 
e.g. because these costs relate to due diligence) are deducted. 

30 

 
 
 
                                                           
they  would  not  have  purchased  if  they  knew  these  products  are  unsafe.  This  consumer 
detriment in the EU due to unsafe non-harmonised products is estimated on the basis that 
the product value is EUR 3.9 billion for the online sales channels, and EUR 15.4 billion 
for  brick-and-mortar  shops  and  other  offline  sales  channels,  for  a  total  of  EUR  19.3 
billion per year. This estimated baseline consumer detriment in the EU related to unsafe 
non-harmonised products is currently reduced due to recalls by approximately EUR 0.4 
billion per year87. This consumer detriment due to the loss of value of unsafe products is 
expected to reach EUR 20.8 billion by 2025 and almost EUR 22 billion by 2034 in the 
baseline scenario88.  

The cost estimation for Member States takes into account  the different organisational 
approaches  of  Member  States  to  market  surveillance  and  is  based  on  staff  data  for 
surveillance  of  non-harmonised  consumer  products  at  national  level.  The  GPSD  Study 
concluded  that  the  total  EU27  staff-related  costs  for  market  surveillance  of  non-
harmonised consumer product amount to approximately EUR 122.4 million per year89. 
Also,  four  in  ten  MSAs  reported  incurring  costs  other  than  staff  costs  (e.g.  testing  of 
products), estimated at most at 0.34% of total staff costs.  

The GPSD Study identified that (minor to significant) additional costs due to differences 
in  the  safety  requirements  in  Member  States,  caused  by  differences  in  the  national 
implementation  of  the  GPSD  (e.g.  regarding  traceability  requirements)  or  legislative 
fragmentation between harmonised and non-harmonised products, currently affect 42% 
of  surveyed  companies  and  16%  of  MSAs.  These  costs  are  estimated  for  MSAs  to 
amount  to  EUR  0.7  million  annually  (total  for  the  EU27)  and  to  EUR  119  million 
annually for businesses. 

On the benefits side of the baseline, the interviews carried out in the context of the GPSD 
Study  identified  that  authorities  and  businesses  see  moderate  to  significant  benefits 
resulting from the GPSD across the board, and in particular through better information on 
unsafe  products  and  measures  taken  by  authorities  provided  through  the  Safety 
Gate/RAPEX,  a  better  functioning  internal  market  and  increased  consumer  trust.  90% 
respondents  that  expressed  an  opinion  considered  the  costs  due  to  the  product  safety 
requirements  of  the  GPSD  to  be  at  least  “moderately  proportionate”  to  the  resulting 
benefits. Close to 60% of respondents that had an opinion even found these costs to be 
“largely  proportionate”  or  “very  proportionate”,  including  respondents  from  companies 
and business associations. 

For  SMEs,  the  estimated  annual  costs  to  comply  with  the  GPSD  (after  subtraction  of 
business-as-usual costs) are EUR 428 million per year (companies < 50 employees) and 
EUR  226  million  per  year  (companies  50  to  249  employees).  The  median  value  for 
consumer product safety-related costs in proportion of the total annual turnover appears 
to  decrease  with  the  company’s  size/turnover.  This  is  likely  due  to  scale  effects.  This 
general  pattern  is  confirmed  by  SMEs’  replies  to  the  business  stakeholder  survey. 
Accordingly, SMEs account for 59% of the total of GPSD-related compliance costs in the 
EU, in line with their overall share in the market.  

The  GPSD  Study  also  analysed  the  impacts  of  the  COVID  19  crisis  on  the  baseline 
scenario. It shows that while the confinement measures have serious expected impacts on 
GDP,  total  retail  quickly  recovered  after  the  first  crisis  wave,  but  new  measures  in  the 

87 The GPSD Study estimated the total consumer detriment under the baseline scenario with low recall effectiveness to 
be about EUR 1.3 billion per year (calculated as a value of recalled products that remain with consumers). 
88 The GPSD Study could estimate the impact of options on the consumer detriment taking as assumption that the 
detriment incurred by consumers in case of an unsafe product is equivalent to at least its purchase price. 
89 Monetised on basis of population size, number of person hours per year and average wage. 

31 

 
 
                                                           
current second wave are likely to again lead to substantial impacts on retail and therefore 
sales of products. The decline in overall retail sales has been accompanied by a rise of e-
commerce sales that are expected to increase by 16.9% in 2020 in Western Europe90. The 
boost  in  new  spending  is  expected  to  leave  e-commerce  permanently  ahead  of  its 
previous pace.  

In general terms, product safety processes at companies including with respect to related 
supply chain management appear to remain largely unchanged in the COVID-19 context, 
except  with  the  increasing  reliance  on  electronic  communication  instead  of  physical 
meetings  (this  may  pose  issues  to  product  assessments).  Companies  also  confirmed  the 
switch to online sales channels to offer products. 

Moreover  this  crisis  required  increased  market  surveillance  of  COVID-19-related 
products,  in  particular  face-covering  products  (other  than  the  medical  or  personal 
protective equipment devices).Until 1 December 2020, 16 Member States notified in the 
Safety  Gate/RAPEX  174  alerts  (mainly  safety  masks,  some  disinfecting  gels  and  UV 
lamps).  

Finally, there is a strong political commitment for a strong product safety policy at EU 
level. This has been recognised by the recently adopted Consumer Agenda91 and several 
Council conclusions  as explained above. The GPSD evaluation  confirms  the validity of 
the  GPSD,  but  at  the  same  time  considers  the  need  for  its  revision.  The  European 
Parliament  has  also  highlighted  the  need  to  revise  the  GPSD  in  its  resolution  on 
addressing product  safety  in  the Single Market92.  This  also  has been largely recognised 
by the stakeholders in the consultation process. 

5.2.  Description of the policy options  

To address the objectives developed above, the initiative will intervene on the following 
areas: 

Figure 4: Interventions to improve the GPSD’s effectiveness 

90 https://www.emarketer.com/content/western-europe-see-10-83-billion-more-ecommerce-sales-than-expected 
91 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0696 
92 https://www.europarl.europa.eu/doceo/document/TA-9-2020-0319_EN.html 

32 

 
 
                                                           
 
Beyond the baseline scenario (‘Status quo’) not involving any new actions, the identified 
policy options to address the different specific objectives are: 

•  Option 1. Improved implementation and enforcement of the existing legal 

framework, without legal revision of the GPSD (only FIPD revised); 
•  Option 2. Targeted revision of the GPSD (Directive or Regulation); 
•  Option 3. Full revision of the GPSD and recasting as Regulation; 
•  Option 4. Integration of more legal instruments 

The range of options includes non-legislative (Option 1) and legislative actions (Options 
2,  3  and  4)  to  address  the  different  specific  objectives.  All  the  options  defined  in  the 
report  propose  specific  actions  to  address  all  five  problems  identified,  but  differ  in  the 
level of ambition.   

The substantive provisions of the Food-imitating Product Directive were considered 
to be revised under all options 1 to 4 with two possible sub-options: (a) a full ban of 
food-imitating products per se and (b) application of a product safety risk-assessment on 
a case by case basis to this category of products. 

Table 5: Overview of the policy options and addressees of the measures 

Option 
0 
Baseline 

Option 1 

Enhanced 
enforcement 

Option 2 

Targeted legal 
revision 

Option 3 

Full legal revision 

Option 4 

Integration of 
rules 

New 
technologies 

No 
change 

• Guidance for 

economic operators 

• Use of standards 

for new risks 

• Coverage of new risks 
• No clarifications on 

software related rules 

• Coverage of new risks 
• Clarify software related 

rules  

Online sales 

No 
change 

Reform, promotion 
and expansion of the 
Product Safety 
Pledge 

• Making most 

provisions inspired by 
the Product Safety 
Pledge legally binding 

Recall 
effectiveness 

No 
change 

Guidance on product 
recalls 

Market 
surveillance 

No 
change 

Increased funding of 
joint market 
surveillance 
activities 

• Mandatory 

requirements on 
product recalls 
• Legal basis to use 

customers’ data for 
recalls 

• Mandatory elements of 

recall notice 

• Alignment with market 

surveillance and 
traceability rules of 
harmonised products  

• Simplifying 

standardisation 
procedures 

Food-
Imitating 
Products 

No 
change 

Separate revision of 
the FIPD to ensure its 
even interpretation  

2 sub-options for 
treatment of food-
imitating products:  
(a)  full ban per se.  

Integration of the FIP 
provisions into the GPSD 

2 sub-options for 
treatment of food-
imitating products:  
(a)  Maintaining 
dedicated provision on 

Obligations for economic 
operators going beyond 
the Product Safety 
Pledge (e.g. display same 
information online as it is 
with the product offline, 
duty of care as for 
distributors) 

Option 2 

+ Some additional 
mandatory 
requirements  
(e.g. on product 
registration, template for 
recall notice, right to 
remedy and monitoring) 

Option 2  

+ stronger enforcement 
powers to Member 
States (penalties) , 
arbitration mechanism 
and increased 
traceability (delegated 
acts) 

Idem Option 2 

Option 3  

+  

Integration of 
the legal 
instruments on 
market 
surveillance 
(GPSD market 
surveillance 
provisions and 
Regulation 
2019/1020) 

Most relevant 
stakeholders 

Businesses (for 
consumer products 
incorporating new 
technologies) and 
MSAs 

Online 
marketplaces, 
online retailers, 
and MSAs 

Businesses 
(harmonised and 
non-harmonised 
consumer 
products), MSAs  

MSAs and 
businesses (in 
particular 
businesses of non-
harmonised 
consumer 
products) 

Producers of food 
imitating products 
and MSAs 

33 

 
 
 
 
(b)  risk-assessment 
approach 

FIP (recast and 
integration) with a full 
ban per se  
(b)  Abandoning any 
dedicated provision 
(repeal) and reliance on 
general provisions for 
risk-assessment 
approach 

Instrument  Directive 

Directive 

Directive or Regulation 

Regulation 

Regulation 

Businesses and MSAs are the most affected stakeholders by the measures as detailed 
in  the  Table  5.  The  SMEs  and  micro-SMEs  are  not  exempted  from  any  of  the 
obligations  foreseen  under  the  different  options.  EU  product  safety  legislation  does  not 
allow for "lighter" regimes for SMEs since a consumer product must be safe whatever the 
characteristics  of  its  supply  chain  to  meet  the  general  objective  of  product  safety  and 
consumer  protection.  However  provisions  are  foreseen  in  the  EU  legislation  e.g.  to 
facilitate  access  for  SMEs  to  EU  safety  standards  including  those  adopted  under  the 
GPSD (see Article 6 of Regulation (EU) 1025/2012). 

The detailed description of the actions  under the different  options, as well as their time 
horizon,  potential  for  simplification  and  reduction  of  regulatory  burden  and  digital 
the  Table  6.
solutions  envisaged 

increase  efficiency,  are  developed 

in 

to 

34 

 
 
 
 
 
Table 6: Option packages  

Objectives 

Option 0 
Baseline 

Option 1 
Enhanced enforcement 

Option 2 
Targeted legal revision 

Option 3 
Full legal revision 

Option 4 
Integration of market 
surveillance rules 

Ensure the EU legal 
framework provides for 
general safety rules for 
all consumer products 
and risks, including 
products and risks linked 
to new technologies  

No change 

• Guidance for businesses 
that cyber-security threats 
and other risks of new 
technologies affecting 
physical or mental health. 
• Exploring use of European 
Standards for new risks 

• New risks (cyber-security and other risks of new 

technologies affecting physical or mental health) explicitly 
covered through legal revision of product safety definition 

+ Clarify software related rules: Explain how software can 
impact the safety of product and clarify responsibilities to 
ensure  consumer safety  

Option 2 

Address product safety 
challenges in the online 
sales channels  

No change 

• Review, promotion and 

expansion of the Product 
Safety Pledge 

Make product recalls 
more effective and 
efficient to keep unsafe 
products away from 
consumers  

No change 

• Guidance on product 

recalls 

Making most provisions of the Product Safety Pledge 
legally binding for all online marketplaces, such as: 
• to consult information on recalled/dangerous products 
available on Safety Gate/RAPEX and from other sources 
and react quickly;  

• to take appropriate action in respect to recalled/dangerous 

products, when they can be identified 

• to provide single contact points for EU MSAs and to 

cooperate with them 

•  to have an internal mechanism for notice and action 

procedure with specific provisions for unsafe products (e.g. 
timeframes for action) and other requirements 

 Mandatory requirements on product  recalls: 

• Legal basis to use available customer contact details for 

recalls 

• Operators need to disseminate recall announcements on 

their website, social media, newsletters, retail outlets and 
other appropriate channels to ensure the widest possible 
reach.  

• Mandatory key elements for recall notices (product 

description + photo, description of hazard, instructions on 
what to do, description of remedy, contact details for 
queries) 

• Prohibition to use terms decreasing the perception of 

risk in recall notices 

Option 2 + additional requirements for online operators: 
• to display of all safety information online that is also 

required to be provided offline; online marketplaces required 
to make sure that sellers on their platform provide this 
information together with the product offer 

• a duty of care to help ensure compliance with the safety 

requirements for online marketplaces (in the same vein as the 
classical distributors have today: stop supplying unsafe 
products, participate in market monitoring, keeping 
traceability information, cooperation in corrective actions, 
cooperate with MSAs, making efforts to identify dangerous 
product offers already removed from their websites but that 
keep reappearing. That duty of care would be different than 
for distributors as they do not have physical contact with the 
product, so their role will focus on doing their most to ensure 
that their websites do not offer dangerous products, and if they 
do, they cooperate with authorities for corrective actions. This 
duty of care would be complementary to the obligations of 
actual sellers on the online marketplaces) 

Option 2 + Further measures to enhance recall effectiveness, 
for example: 

• 

• 

• 

Obligation for economic operators to notify 
consumers directly whenever possible 
Economic operators who already offer product 
registration systems or loyalty programmes should 
offer consumers the possibility to register their 
contact details specifically to receive safety 
notifications 
Possibility to set further requirements for 
registration of specific categories of products 
through delegated act 

•  Mandatory template for recall notices to be set 

through implementing act 

Option 3  

+  

Integration of the legal 
instruments on market 
surveillance (GPSD market 
surveillance provisions merged 
with Regulation 2019/1020 into 
one Regulation on market 
surveillance 

 
 
 
 
 
Enhance market 
surveillance and ensure 
better alignment of rules 
for harmonised and non-
harmonised consumer 
products  

No change 

• Increased funding of EU 
joint market surveillance 
activities among EU 
Member States 

Address safety issues 
related to food-imitating 
products 

No change 

Separate revision of the 
FIPD,  

 2 sub-options for treatment 
of food-imitating products:  
(a)  full ban per se  
(b) risk-assessment 
approach 

Legal revision of the GPSD to align with market 
surveillance and traceability rules for harmonised 
products: 
• The market surveillance rules aligned with Regulation 

(EU) 2019/1020 

• Additional requirements for businesses in line with 
Regulation (EU) 2019/1020 (notably regarding the 
requirement of an EU representative)  and other 
harmonisation legislation, in particular traceability 
requirements from Decision No 768/2008/EC 

+ Simplifying standardisation procedures (streamlining 
the EU process for elaborating safety requirements and the 
standardisation request, e.g. by combining them in one 
Commission Decision) 

Integration of the FIP the provisions into the GPSD. 
2 sub-options for treatment of food-imitating products:  
(a) Maintaining dedicated provision on FIP (recast and 
integration) with a full ban per se  
(b) Abandoning any dedicated provision (repeal) and 
reliance on general provisions risk-assessment approach 

• 

• 

Consumers’ right to an effective, cost-free and 
timely remedy for the recalled product (repair, 
replacement or refund) 
Less burdensome recall procedure for consumers 
(returning a product should not incur any financial 
costs, non-portable items to be collected by the 
operator)Obligation for businesses to register 
voluntary recalls in an EU public database and to 
monitor recall effectiveness. Power for authorities 
to request monitoring data from operators and decide 
if the case can be closed. 

Option 2 
+  

• More stringent rules on penalties to strengthen their deterrent 

effect beyond Regulation (EU) 2019/1020 

•  Arbitration mechanism in case Member States have 

diverging product safety risk assessments (either a group of 
Member States or the Commission are called to arbitrate) 
• Possibility to set further requirements for traceability 
systems through delegated acts, for example regarding 
chemicals in childcare articles.     

Idem Option 2 

Instrument 

Directive 

Directive 

Directive or Regulation 

Regulation 

Regulation 

Digital solutions in 
respect of 
implementation and 
reduction of 
administrative burdens 

None 

of 

online 

digital 
Development 
IT 
solutions,  such  as  an 
system 
to 
(web-crawler) 
identify  dangerous  products 
already 
sold 
notified 
Safety 
via 
Gate/RAPEX.  It  would  allow 
MSAs  to  carry  out  online 
tasks 
surveillance 
market 
more efficiently 

and 

Beyond  the  digital  IT  systems  of  Option  1,  other  digital 
solutions  can  reduce  the  burden  linked  to  the  additional 
obligations  on  recalls  (use  of  internet  and  social  media  to 
increase  recall  communication).  Aligning  to  the  Regulation 
(EU)  2019/1020  will  also  allow  to  explore  digital  interlinks 
between  existing  market  surveillance  systems  at  EU  and 
national level and will therefore make the market surveillance 
more efficient. 

Idem  Option  2  +    possible  digital  solutions  in  the  field  of 
product traceability 

Idem Option 3 

36 

 
 
 
 
 
Time horizon 

Immediate 

for 

short 

setting 
Rather 
guidance 
documents.  The 
revision  of  FIPD)  requires 
adoption  of  a  new  legislative 
act ( minimum 1 year) 

The obligations under this option would become effective by 
the revision and entry into force of the revised GPSD. 

The  obligations  under  this  option  would  need  to  be  completed 
by the revision and entry into force of the revised GPSD. 

this 
The  obligations  under 
option  would  need 
to  be 
completed  by  the  revision  and 
entry  into  force  of  the  revised 
GPSD  and  the  new  market 
surveillance Regulation. 

37 

 
 
Option 1. Enhanced enforcement: Improved implementation and enforcement of the 
existing legal framework, without revision of the GPSD 

This option does not require a legal revision of the GPSD, and would include:  

a)  Development of guidance on the safety of new technologies and exploring the use 
of  European  standards  to  address  new  risks.  The  general  safety  requirement  of 
the GPSD already encompasses protection against all kinds of risks arising from 
the product to the safety and health of persons. The guidance would clarify how 
this  includes  not  only  mechanical,  chemical,  electrical  risks  etc.  but  also 
cybersecurity and personal security threats that affect the safety of persons93, and 
other  risks  related  to  new  technologies  that  potentially  affect  physical  or  mental 
health94.  The  standardisation  procedure  could  be  used  to  elaborate  European 
standards  addressing  safety  requirements  for  consumer  products  concerning 
certain new risks such as cybersecurity risks of new technologies.  

b)  More  support  and  promotion  of  the  Product  Safety  Pledge.  To  tackle  the  safety 
issues related to online sales (including from third countries), the Pledge would be 
through  awareness  campaigns,  and  other  online 
updated  and  promoted 
marketplaces would be encouraged to sign the Pledge. No legal requirements will 
be introduced for online market places and no person responsible for products in 
the EU will be available for non-harmonised products sold online. 

c)  Development of guidance on product recalls. The guidance would address current 
deficiencies  concerning  the  effectiveness  and  efficiency  of  recall  procedures  by 
economic  operators  and  market  surveillance  authorities,  relying  on  the  current 
legislation.  The  guidance  would  concern  e.g.  the  provision  of  more  transparent 
recall information to consumers, the use of customer data for direct notifications 
and cooperation between different actors in the recall process. 

d)  Increased funding for joint market surveillance activities among Member States, 
so that more coordinated actions of authorities across EU Member States could be 
conducted, including the joint testing of consumer products. No legal changes in 
the market surveillance rules, including on penalties, where a light approach, with 
general  provisions  on  penalties,  as  it  is  currently  the  case  in  the  GPSD,  would 
continue. In this case, the deterrent effect of sanctions depends on the provisions 
adopted by Member States.  

e)  Revision  of  the  Food-imitating  Products  Directive  to  clarify  its  scope.  The 
provisions  on  the  Food-imitating  products  would  be  kept  in  the  FIPD  with  two 
possible sub-options: (a) food-imitating products could be banned throughout the 
Union per se per se and (b) application of a product safety risk-assessment on a 
case by case basis to this category of products.  

Option 2. Targeted revision of the GPSD (Directive or Regulation) 

Option 2 would require a legal revision of the GPSD, which would remain a Directive or 
become  a  Regulation.  In  case  the  new  instrument  is  also  a  Directive,  changes  to  the 
GPSD  would  need  to  be  transposed  by  Member  States  into  national  legislation.  The 
changes to the legal framework would include:  

E.g. a smart watch for children, which does not causes a direct harm to the child wearing it, but lacks a 

93  
minimum level of security, so that it can be easily used as a tool to have access to the child and therefore endanger its 
safety.  
94  

Mental health risks for consumers deriving e.g. from their interaction with humanoid AI systems. 

 
 
                                                           
a)  Making explicit how the scope of the legal framework and its definitions apply to 
risks  posed  by  new  technologies  but  without  applying  it  to  standalone  software. 
The definition of safety in the GPSD would be revised to clarify that the covered 
risks arising from the product to the safety and physical/mental health of persons 
include not only mechanical, chemical, electrical risks etc. but also cybersecurity 
and  personal  security  threats  that  affect  the  safety  of  persons,  and  other  risks 
related to new technologies that potentially affect health (similar to the guidance 
that would be provided under Option  1). The definition of product  in the GPSD 
would  not  be  changed,  so  that  safety  risks  stemming  from  software  are  only 
covered if the software is integrated in a product at the time of its placing on the 
market  (as  is  currently  the  case).  There  will  be  not  specific  provisions  on  or 
references to software updates. 

b)  Adding  requirements  for  online  marketplaces  by  making  most  provisions  of  the 
voluntary Product Safety Pledge legally binding. The Pledges’ commitments e.g. 
to  consult  information  on  recalled/dangerous  products  available  on  RAPEX  and 
also from other sources; to take appropriate action in respect to recalled/dangerous 
products,  when  they  can  be  identified;  to  provide  single  contact  points  for  EU 
Member  State  authorities  and  to  cooperate  with  them;  to  have  an  internal 
mechanism for notice and take-down procedure for dangerous products and other 
requirements would become legally binding for all online marketplaces targeting 
EU consumers95.  

c)  Adding  requirements  for  enhancing  the  effectiveness  of  product  recalls.  Create 
legal basis for economic operators to use any available customer contact details at 
their  disposal  (e.g.  obtained  through  loyalty  schemes  or  online  sales)  to  directly 
notify  the  owners  of  recalled  products  (without  the  need  of  consumer  consent). 
Mandatory key elements would be defined that are to be included in every recall 
notice (product description with a photograph, description of hazard, instructions 
on what to do, description of remedy, contact details for queries). Prohibition to 
use 
(e.g. 
‘voluntary/precautionary  recall’  or  "overheating"  instead  of  fire).  In  case  not  all 
affected  consumers  can  be  contacted  directly,  businesses  would  need  to 
disseminate  recall  announcements  on  their  website,  social  media,  newsletters, 
retail outlets and other appropriate channels to ensure the widest possible reach. 

the  perception  of 

terms  decreasing 

recall  notices 

risk 

in 

d)  Ensuring  alignment  with  harmonised  market  surveillance  rules  while  keeping 
different  legal  instruments  and  simplifying  standardisation  procedures.  The 
market  surveillance  rules  provided  in  the  GPSD  would  be  aligned  with  the 
provisions  in  Regulation  (EU)  2019/1020.  Requirements  for  businesses  would 
reflect  the  current  obligations  under  the  GPSD,  and  include  complementary 
requirements in Regulation (EU) 2019/1020 (notably regarding the requirement of 
an EU responsible economic operator to address the specific issue of direct online 

All commitments under the Pledge could become legally binding under this option, except most probably 

95  
commitment 7 (training to sellers on compliance with EU product safety legislation, etc.) and 12 (exploring new 
technologies and innovation to improve the detection of unsafe products).  

39 

 
 
                                                           
imports from third countries by consumers) and other harmonisation legislation96. 
Traceability  requirements  would  include  the  requirement  to  keep  supply  chain 
records  (to  allow  for  one-up  one-down  traceability,  i.e.  the  identification  of 
suppliers  and  clients,  except  final  consumers).  As  a  result,  general  requirements 
for businesses and responsibilities and powers of market  surveillance authorities 
would  be  largely  uniform  for  harmonised  and  non-harmonised  consumer 
products,  including  on  penalties.  Also,  standardisation  procedures  at  the 
Commission level under the GPSD would be simplified.97  

e)  Integrating  the  provisions  of  the  Food-imitating  Products  Directive  into  the 
GPSD.  The  provisions  of  the  FIPD  would  be  integrated  in  the  GPSD  with  the 
same two substantive sub-options as in the Option 1. 

Option 3. Full revision of the GPSD (Regulation) 

Option  3  would  repeal  the  Directive  and  ensure  even  application  of  its  implementation 
through the choice of a Regulation (i.e. it will be directly applicable in Member States). 
This option would include all elements of Option 2 and, in addition:  

a)  Software related rules would be clarified. The GPSD would explain how software 
can  impact  the  safety  of  product  and  clarify  responsibilities  to  ensure  consumer 
safety in such cases. Under this option the definition of product under the GPSD 
could  be  adapted  to  cover  the  software  updates.  Specific  provisions  and 
conditions could be elaborated for cases of software updates that affect the safety 
of  the  product  after  a  product  is  placed  on  the  market,  e.g.  when  the  software 
operates  a  substantial  modification  of  the  product  impacting  the  risk  it  poses  to 
health  and  safety  of  consumers.  It  should  be  noted  that  under  this  option,  the 
revised GPSD would not regulate cybersecurity aspects in general, as that entails 
different issues such as privacy or data protection; however, it would cover cases 
when a lack of cybersecurity features can lead to a physical incident and hurt the 
consumer, therefore not going beyond the area of consumer protection.  

b)  Making  legally  binding  most  provisions  of  the  voluntary  Product  Safety  Pledge 
for  online  marketplaces  (as  in  Option  2)  and  include  new  provisions  for  actors 
across the online supply chain. These new provisions for actors across the online 
supply  chain  would require them to provide all safety information online that is 
also  required  to  be  provided  with  a  product  in  'brick-and-mortar'  stores.  Online 
marketplaces  would  have  a  duty  of  care  and  they  will  be  required  to  make  sure 
that third party sellers on their platform provide this information together with the 
product  offer  (without  being  required  to  check  the  accuracy  of  the  safety 
information provided).  This duty of care obligations would target online market 
places  and  will  be  complementary  to  the  obligations  of  sellers  on  the  online 
marketplaces  (where  the  obligations  of  manufacturer,  importer  or  distributor 
would apply depending on the specific case), which would be particularly useful 
in cases where the sellers are located outside the EU. 

96  
See also Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a 
common framework for the marketing of products, which provides reference provisions, definitions and general 
obligations for economic operators for harmonised products. 
97  
elaboration of the European Standards by the European Standardisation Organisations would not be affected.     

Changes could concern the involvement of Member States committees at various stages of the process. The 

40 

 
 
                                                           
c)  Establish  further  mandatory  requirements  to  enhance  recall  effectiveness.  In 

addition to all the elements of Option 2, the following would be introduced: 

-  Economic  operators  who  offer  product  registration  systems  and  loyalty 
programmes  for  other  purposes  (e.g.  marketing  or  technical  support) 
should  offer  consumers  the  possibility  to  register  their  contact  details 
specifically  to  receive  possible  safety  notifications  (personal  information 
collected  for  the  purpose  of  product  safety  should  be  limited  to  the 
necessary minimum and must not be used for marketing purposes); 

-  Possibility  to  set  out  further  requirements  for  registration  of  specific 

categories of products through delegated act; 

-  Binding template for recall notices to be set out through implementing act; 
-  Consumers’  right  to  an  effective,  cost-free  and  timely  remedy(repair, 

replacement or refund); 

-  Less  burdensome  recall  procedure  for  consumers  (returning  a  product 
should not incur any financial costs, non-portable items to be collected by 
the  operator);  Binding  requirements  for  businesses  to  register  voluntary 
recalls in an EU public database and to monitor recall effectiveness; MSAs 
would  have  the  possibility  to  request  monitoring  data  from  economic 
operators and decide if the case can be closed. 

d)  Give  stronger  enforcement  powers  to  Member  State  authorities  (for  example  on 
penalties)  and  establish  arbitration  mechanism  in  case  Member  States  have 
diverging  product  safety  risk  assessments.  Building  on  Option  2,  general 
requirements for businesses and responsibilities of market surveillance authorities 
would  be  largely  uniform  for  harmonised  and  non-harmonised  consumer 
products.  However,  under  Option  3  stronger  enforcement  rules  would  be 
incorporated: 

- 

- 

 Penalties: The provisions on penalties would be more clearly defined in a 
way to ensure a sufficient deterrent effect, while increasing the sanctioning 
powers of Member States.  

In  case  Member  States  have  diverging 
 Arbitration  mechanism: 
assessments of the risk posed by a notified product, a mechanism could be 
triggered  where  either  a  group  of  Member  States  or  the  Commission  are 
called to arbitrate.  

-  Traceability:  This  option  would  also  create  a  possibility  to  set  further 
requirements for traceability systems through delegated acts, for example 
regarding chemicals in childcare articles.  

-  Finally,  some  further  improvements  to  the  market  surveillance  could  be 
envisaged based on the feedback from the stakeholders and study results.    

e)  Integrating  the  provisions  of  the  Food-imitating  Products  Directive  into  the 

GPSD with the same two substantive sub-options as in the Option 2. 

Option  4.  New  Regulation  merging  market  surveillance  provisions  of  GPSD  and 
Regulation (EU) 2019/1020 

This  option  would  provide  for  a  new  legal  instrument  including  all  elements  described 
under  Option  3  and  also  merging  the  market  surveillance  provisions  of  the  GPSD  and 

41 

 
 
Regulation (EU) 2019/1020 on the market surveillance and compliance of products into 
one new Regulation on market surveillance, so that one single set of rules would apply to 
harmonised and non-harmonised products.  

5.3.  Options discarded at an early stage 

Even if options 0 and 1 have received little support by stakeholders they have not been 
disregarded and the impacts of all options are assessed.  

Initial  policy  options  presented  in  the  Roadmap/Inception  Impact  Assessment  took  into 
account  the  results  of  the  GPSD  implementation  study,  which  –  based  on  a  broad 
consultation  process  –  had  elaborated  key  shortcomings  of  the  current  legal  framework 
and  stakeholder  suggestions  for  improvements.  In  the  course  of  the  GPSD  study,  the 
completeness  of  the  current  set  of  policy  options  was  validated  and  no  further  policy 
options  for  consideration  were  identified.  Also  the  stakeholders  did  not  raise  any  other 
new real alternatives during the consultation process. 

A potential further policy option, discarded at an early stage, is the  complete repeal of 
the current GPSD. The Evaluation of the GPSD (see Annex 5) concludes that, although 
there  is  a  need  for  specific  improvements  and  simplification,  the  GPSD  is  generally 
relevant, effective, efficient and coherent, and has EU added value. 

This  report builds  also  on the conclusions of the  Impact  assessment report prepared for 
the  previous  proposal  to  revise  the  GPSD  tabled  in  2013.  In  particular,  some  of  the 
disregarded or eliminated options after analysis of impacts in 2013 were disregarded also 
in  the  current  report,  e.g.  centralisation  of  market  surveillance  at  EU  level,  direct 
applicability  of  ad-hoc  safety  requirements,  abolition  of  the  general  product  safety 
requirement. 

Also, the introduction of the “Made in” clause, mandatory country of origin labelling for 
products (as it was proposed in the 2013 Package),  has been disregarded at an early stage 
following the technical study the Commission conducted in September 2014,98 assessing 
the costs and benefits of the proposed mandatory country of origin labelling for a number 
of  product  categories.  The  study  concluded  that  there  is  little  evidence  of  possible 
positive impacts  of this clause on product  traceability and safety for any of the product 
groups. Further reinforced traceability requirements will however be analysed in Option 2 
and 3 beyond the “Made in” clause. 

Some  alternatives  were  considered  to  certain  substantive  measures  presented  in  the 
intervention logic and have been disregarded: 

Concerning  new technologies, it was  considered  whether the sectorial  legislation could 
cover  those  new  challenges,  such  as  for  example  the  product  safety  risks  linked  to 
cybersecurity. While particular actions at sectorial level might still be needed, it appeared 
that gaps would remain unless a full safety net is ensured, as it is provided under GPSD 
in its function of lex generalis.  

Regarding setting the requirements for online marketplaces in the product safety area, 
an alternative option would have been to define the precise obligations in the proposal for 

98 VVA Europe 2015 https://ec.europa.eu/info/sites/info/files/indication_origin_study_2015_en.pdf 

42 

 
 
 
                                                           
the DSA. The adopted proposal for the DSA has retained nevertheless a more horizontal 
approach  proposing  the  general  obligations  for  all  types  of  illegal  content,  leaving  the 
definition  of  specific  product  safety  obligations  of  online  marketplaces  to  the  product 
safety legislation. 

When it comes to the traceability requirements, an alternative option could have been 
to  impose  higher  traceability  requirements  for  all  products.  This  option  has  been 
considered and disregarded because of lack of proportionality. 

An  important  objective  of  this  initiative  is  also  to  create  a  sufficient  deterrent  effect  to 
incentivise  the  economic  operators  to  comply  with  the  product  safety  requirements, 
which is particularly important in a context where all the products cannot be controlled in 
view of their huge volumes. The options 3 and 4 propose to increase the deterrent effect 
of  the  GPSD  by  reinforcing  the  provisions  on  penalties  by  setting  some  harmonised 
criteria  and  a  minimum  threshold  for  the  maximum  amount  of  penalties.  A  stronger 
approach  on  penalties  could  have  been  to  set  up  a  precise  list  of  infringements  and 
corresponding  minimum  and  maximum  amounts  for  penalties.  This  option  has  been 
disregarded since interfering with Member States’ competences. 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

The  relevant  stakeholder  affected  by  the  initiative  are  the  economic  operators 
(manufacturers,  importers,  distributors  and  online  market  places),  market  surveillance 
authorities  (MSAs)  and  EU  consumers.  The  main  costs  entailed  by  complying  with  the 
Directive can be classified by stakeholder group as follows: 

-  Substantive  compliance  costs 

for 
manufacturers to ensure compliance with the product safety requirement (setting up 
product  safety  processes,  testing,  recalls,  etc.)  and  other  economic  operators’ 
obligations under GPSD (e.g. for distributors), and possible purchasing of standards. 
-  Administrative costs for economic operators to comply with obligations to provide 

for  economic  operators:  costs  arising 

safety information to national authorities on request. 

-  Enforcement  costs  for  MSAs:  costs  arising  from  market  surveillance  activities 
(implementation, enforcement and monitoring), withdrawal of unsafe products from 
the  market  and  coordination  -  internally  between  MSAs  within  one  country  and 
externally  within  the  Consumer  Safety  Network  and  via  the  Safety  Gate/RAPEX. 
Enforcement and coordination costs for the Commission. 

-  Direct regulatory costs for EU consumers via possible increase of prices or lower 

choice of non-harmonised products. 

-  Direct  regulatory  benefits:  improved  health  and  safety  of  EU  consumers  and  the 
improved  environment  (decrease  of  products  with  both  safety  and  environmental 
risks,  e.g.  due  to  presence  of  dangerous  chemicals)  leads  to  improved  well-being. 
Market  efficiency  improvements  in  the  form  of  better  quality  of  non-harmonised 
products  and  better  information  about  product  safety  (e.g.  about  recalled  products) 
increase  trust  of  consumers  in  the  market  and  increased  purchasing.  Alignment  of 
market surveillance rules for harmonised and non-harmonised products create a more 
level playing field and have therefore positive effect on competition.  

-  Indirect  benefits:  the  decreased  costs  of  injuries  has  positive  impact  on  national 
health  and consumers’ budgets; positive effects on fundamental rights by improving 
consumer protection, including the protection of vulnerable consumers (children, the 

43 

 
 
 
elderly) and on innovation via increased legal certainty regarding the application of 
consumer product safety rules to new technologies. 

-  Cost  savings  linked  to  the  simplification  of  procedures  (e.g.  standardisation), 
reduction of regulatory costs for businesses and administrative burdens for MSAs by 
alignment of market surveillance rules for harmonised and non-harmonised products, 
integration  of  safety  rules  for  food-imitating  products  with  the  rules  for  non-
harmonised  products  and  choice  of  a  directly  applicable 
instrument 
(Regulation).  

legal 

6.1. 

Impacts of Option 1 

Effectiveness in achieving the specific objectives 
Table 7: Assessment of Option 1 related to the specific objectives99 

Objectives  

Areas 

Assessment 

New 
technologies 

Certainty regarding coverage of new risks 

Option will to some extent contribute to certainty regarding coverage 
of new risks, without being legally binding. Implementation 
differences in Member States may remain. 

Certainty regarding coverage of software 

Option will not providing clarity of GPSD’s application to software. 

Impacts 

neutral 
/ + 

Online sales  

Safety of products sold on online platforms 

It is unlikely that safety risks for EU consumers due to products sold 
on online platforms will be significantly reduced. 

neutral 

Information of consumers on essential 
safety aspects 

No change to the current situation. 

Recall 
effectiveness 

Reaching out to consumers affected by 
recalls 

Information provided in recall notices 

Monitoring of recall effectiveness 

Option will to some extent contribute to certainty regarding recall 
procedures, without, however further regulating and therefore 
addressing the underlying reasons for limited recall effectiveness. 

neutral 

Remedies for consumers affected by recalls  No change to the current situation. 

Market 
surveillance 

Alignment of market surveillance 
framework for harmonised and non-
harmonised consumer products   

Limited increase of EU funding100 may enhance enforcement, but no 
change to the current fragmentation of legal framework for market 
surveillance.  

Deterrence effect 

Diverging risk assessments by MSAs 

Simplification of standardisation 
procedures 

No change to the current situation. 

Food-imitating 
products 

Addressing risks of food-imitating products  Clarify the regime for the food-imitating products  : (a) full ban or (b) 

risk-assessment approach 

99 Note: Magnitude of impact as compared with the baseline scenario:  
 neutral = no significant difference to baseline situation;  
 + = positive impact compared to baseline;  
 ++ = significant positive impact compared to baseline.   
An indication of neutral/+ or +/++ indicates an intermediate assessment, depending on implementation details and/or circumstances. 
Costs are indicated as either neutral (no additional costs compared to baseline), or with an indication of the expected increase in EUR 
terms, again compared to the baseline situation. 
100 Under the current proposal for next Multiannual Financial Framework and the Single Market Programme the yearly 
amounts foreseen for coordinated market surveillance actions are only slightly higher (EUR 2,8 million) than the 
spending on these activities in the previous years (EUR 2,4 millions) 

neutral 

+ 

44 

 
 
 
 
 
                                                           
The  GPSD  Study  showed  that  the  overall  average  assessment  of  the  effectiveness  of 
Option  1  in  addressing  the  five  challenges  mirroring  the  five  specific  policy  objectives 
across all respondents and stakeholder groups was 2.9 on a scale of 1 to 5. 

Administrative simplification 

Guidance  provided  under  Option  1  could  to  some  extent  reduce  regulatory  complexity 
and uncertainty regarding the coverage by the GPSD of risks posed by new technologies, 
as well as regarding applicable procedures for recalls. Also, complementary measures in 
the standardisation field to address safety requirements for consumer products concerning 
certain  new  risks  posed  by  new  technologies  could  have  a  similar  effect.  However,  as 
these  guidelines  and  standards  would  not  be  legally  binding,  this  reduction  can  be 
expected  to  be  minor.  In  addition,  legal  uncertainty  regarding  the  application  of  the 
GPSD  to  software  will  remain.  Therefore  Option  1  will  not  significantly  reduce  the 
regulatory  complexity  and  burdens  for  businesses.  The  simplification  potential  is 
therefore very limited, stemming mainly from the clarifications provided under the non-
legally binding guidance documents and the revised FIPD. 

Responsibilities  and  powers  of  market  surveillance  authorities  will  remain  different  for 
harmonised and non-harmonised consumer products,  and related administrative burdens 
for some authorities will continue. In the survey conducted in the GPSD Study, 16% of 
authorities  reported  they  currently  experience  additional  costs  due  to  these  differences. 
Also, administrative burdens on Member States in the field of standardisation would not 
be reduced. 

Option 1 does not include any additional administrative requirements for specific types of 
operators. Only very low burdens are expected for businesses from getting familiar with 
new guidance documents. 

Economic impacts 

The GPSD Study showed that all stakeholders estimate the benefits of Option 1 on a low 
level  (see  Annex  12):  companies/business  associations  estimated  benefits  ‘moderate’  (3 
in  a  scale  of  5  )  and  MSAs  (2.6  in  a  scale  of  5),  and  other  stakeholders  highlight  even 
lower (‘minor’ benefits, 2 in a scale of 5). Businesses assessed the benefits to be ‘minor’ 
when  it  comes  to  increased  business  revenue.  The  assessment  of  other  stakeholders  is 
particularly  low  with  respect  to  the  reduction  of  legal  complexity  and  improved  supply 
chain  management  due  to  improved  traceability  of  products  (values  of  1.8  and  1.9 
respectively in a scale of 5). 

Concerning  the  costs  incurred  under  Option  1,  the  GPSD  Study  indicates  that 
implementing  this  option  would  not  increase  companies’  recurrent  regulatory 
compliance  costs  (staff  costs)  or  other  additional  recurrent  costs,  neither  for 
manufacturers  or  distributors.  Several  business  respondents  indicated  that  nothing 
substantial  would  change  with  the  implementation  of  Option  1  compared  to  the  status 
quo,  even  if  better  guidance  documents  could  potentially  improve  clarity  and  legal 
certainty and, as a result, create some cost savings.  

Option  1  should  create  minor  additional  one-off  costs  for  businesses  related  to  getting 
familiar  with  new  guidance  provided  at  EU  level.  However,  the  quantitative  estimates 
provided  by  company  respondents  in  the  GPSD  Study  confirm  that  no  significant 
additional one-off cost are expected at the EU aggregate level. In conclusion, the GPSD 

45 

 
 
Study  indicates  that  the  implementation  of  Option  1  should  not  change  one-off  and 
recurrent costs of EU businesses. 

No significant firm-level impacts are to be expected due to the implementation of Option 
1 for specific types of operators, be it SMEs or specific operators such as online traders.  

An  exception  are  businesses  that  are  manufacturing  or  distributing  food-imitating 
products.  Currently,  as  explained  in  the  Evaluation,  the  FIPD  is  applied  differently 
across EU countries, as  some MSAs interpret the FIPD as a per se prohibition of food-
imitating  products  while  others  do  a  case-by-case  risk  assessment  of  the  safety  of 
product.  To  analyse  the  impact  of  the  provisions  on  the  food-imitating  products,  two 
different sub-options have been considered: (a) a full ban of food-imitating products; 
or  (b)  provisions  that  would  include  the  food-imitating  aspect  (and  possibly  child-
appealing  in  general)  as  an  element  for  the  assessment  of  the  risk  of  products  and 
require  a  case-by-case  risk  assessment,  as  for  other  consumer  products.  We  can  expect 
that a targeted revision to better clarify the specific requirements of the FIPD would give 
manufacturers  and  distributors  more  legal  certainty  in  both  sub-options.  As  both 
manufacturers and distributors already have to comply with the current FIPD, we do not 
expect additional costs from a revision that merely aims at providing greater clarity and 
legal  certainty  respectively.  A  greater  level-playing  field  regarding  the  implementation 
and enforcement of the FIPD in the EU could lead to minor cost savings on the side of 
manufacturers  and  distributors  of  food-imitating  products.  The  GPSD  Study  concluded 
that the negative economic impact of a full ban of food-imitating products would likely 
be  minor  in  a  broader  economic  perspective,  since  the  number  of  these  products  is 
limited101.  At  the  same  time  the  alternative  option  (b)  is  more  coherent  with  the 
current  risk  assessment  approach  in  the  GPSD  which  has  already  been  applied  to 
food-imitating  products  by  a  number  of  MSAs:  restriction  of  the  free  circulation  of  a 
given  food-imitating  product  would  be  based  on  the  assessment  of  the  particular 
product’s risks and action would be taken according to this assessment. Applying a risk 
assessment would enable a proportionate corrective measure to be taken.  

No macroeconomic effects with  significant  impacts  of the implementation of Option  1 
on the internal market or trade are expected, since measures under Option 1 are voluntary 
in nature and are largely cost neutral.  Implementation differences in Member States are 
likely to remain at least partially since the additional guidance provided under Option 1 
would  not  be  legally  binding.  The  results  of  the  consultation  conducted  for  the  GPSD 
Study show that stakeholders evaluate the benefits on the internal market and trade minor 
to  moderate102.  Significant  impacts  on  competition  and  innovation  are  also  unlikely,  as 
the benefits of guidance in this respect are limited and all measures are quasi cost-neutral 
for  businesses  (except  in  the  area  of  food-imitating  products,  where  a  slight  benefit  is 
possible  due  to  increased  legal  clarity).  Some  benefits  are  expected  due  to  slightly 
increased funding of joint market surveillance activities among Member States.  

101 The Evaluation shows that the food-imitating products represent only a very small proportion of the notifications in 
the Safety Gate/RAPEX  
102 Businesses and business associations assess the potential benefits from better functioning of the EU internal market 
and more level-playing field among businesses as ‘moderate’. The deterrent effect on rogue traders is considered 
‘minor’ to ‘moderate’, while the benefit of a better access to non-EU/EEA markets is assessed to be ‘minor’. On 
average, MSAs expect lower benefits than businesses. When it comes to other stakeholders, their assessment of Option 
1 is much lower at an average of only 1.7 (i.e. below ‘minor’). 

46 

 
 
                                                           
In terms of impact on consumers, the GPSD Study shows that the benefits for consumers 
are judged by stakeholders generally minor to moderate in terms of reduced occurrence of 
unsafe products, reduced number of accidents and injuries caused by unsafe products and 
increased  consumer  trust.  Also  since  Option  1  would,  overall,  not  result  in  increasing 
product  safety-related  costs  for  economic  operators,  it  is  not  expected  to  create  any 
impact on the prices for consumer products in the EU. Due to the voluntary character of 
measures under Option 1, there should not be any impact on consumer choice.  

Concerning the impact on consumers of the sub-options for the food-imitating products, 
both  sub-options  would  lead  to  the  same  level  of  consumer  protection  against  unsafe 
products.  In  particular,  lifting  the  ban  in  those  Member  States  applying  it  nowadays, 
would  not  lower  the  consumer  protection  if  the  risk-assessment  is  applied.  Indeed,  by 
analogy with the risk assessment methodology under the GPSD, the evaluation of the risk 
of  the  product  would  take  into  account  its  food-imitating  aspect  so  the  risk  for  the 
consumer would be properly assessed and if the product is found to be unsafe, its placing 
on the market would be prohibited. 

The guidance provided under Option 1 and the additional funding of coordinated market 
surveillance activities could slightly improve the enforcement of the GPSD, with related 
benefits  for  consumers.  However,  since  online  market  surveillance  will  not  be 
substantially  improved,  consumers  would  continue  to  incur  detriment,  even  if  the 
voluntary  safety  Pledge  would  be  further  promoted.  With  an  increasing  role  of  online 
platforms in the EU retail sector in the future, amplified by the COVID 19 crisis, costs for 
society  due  to  unsafe  products  entering  the  market  through  online  channels  from  third 
countries could increase, although this will also depend whether other measures are taken 
at  EU  level,  including  in  the  framework  of  the  new  DSA.  Option  1  is  therefore  not 
expected  to  increase  the  level  of  consumer  protection,  including  vulnerable  consumer 
groups such as children and the elderly. 

Impacts on Member States 

Option 1 is not expected to provide significant benefits for MSAs, except a reduction in 
uncertainty  about  GPSD  interpretation  thanks  to  the  provision  of  guidance  and  the 
possible additional funding for joint market surveillance activities. However, it needs 
to be considered that the increase of this funding will be limited, as the budget foreseen 
for  these  activities  in  the  Multiannual  Financial  Framework  and  the  Single  Market 
Programme  will  only  be  around  EUR  21  million,  which  amounts  to  a  very  small 
increase  of  yearly  average  budget  for  these  coordinated  activities  (from  EUR  2.4 
million in 2009-2020 to EUR 2.8 million per year in 2021-2027). 

Based on the MSAs’ survey, the GPSD Study found that recurrent costs for MSAs should 
remain  the  same  under  Option  1,  compared  to  the  baseline  situation,  and  one-off  costs 
would  be  very  low  (costs  resulting  from  the  development  of  new  guidance  documents, 
and,  potentially,  the  set-up  of  technical  capacities  for  carrying  out  market  surveillance 
activities related to new risks). 

The  proposed  measures  would  not  be  expected  to  have  other  effects  on  Member  States 
since no modifications of market surveillance mechanisms are proposed.  

In  case  the  risk-assessment  sub-option  were  chosen  for  the  treatment  of  food-imitating 
products,  potential  effects  could  be  observed  on  Member  States  which  have  been 
applying full ban of these products until now. These Member States would need to make 

47 

 
 
a  risk-assessment  of  these  products,  but  this  change  should  not  represent  specifically 
higher costs for these countries since the number of food-imitating products is very low 
and they already apply the risk-assessment approach for all other products103. 

Social impacts, impacts on fundamental rights, environmental impacts  

Due  to  their  limited  scope  and  voluntary  character,  the  measures  implemented  under 
Option  1  would  not  have  significant  social  or  environmental  impacts,  or  impacts  on 
fundamental  rights.  However,  the  GPSD  Study  concludes  that  if  retained,  a  ban  on 
food-imitating  products  from  the  EU  market  would  have  a  negative  impact  on  the 
freedom  to  conduct  a  business  as  defined  under  Article  52  of  the  Charter  of 
Fundamental  Rights  of  the  European  Union  (‘Charter’),  while  the  GPSD  Study, 
based  on  the  feedback  from  Member  States,  could  not  identify  evidence  to  prove  the 
intended benefits (better protection of children) to confirm its proportionality.  

Indeed, food-imitating products are not intrinsically dangerous. They can be if they are so 
similar to foodstuff that they can be confused with food, and if such confusion could pose 
a risk (notably the risk to choke or to be chemically poisoned) if consumers would ingest 
such products. Banning all food-imitating products would mean banning also those food-
imitating products  that are not  dangerous (for instance, those that imitate but  cannot  be 
confused with foodstuff, or those that do not present any  risk, notably because they are 
not a small part or no small part could be detached from it). Article 52 of the Charter sets 
out that limitations  on  the  exercise  of  the  rights  and  freedoms  recognised  by  the  
Charter    may    be    made    only    if    they    respect  the    principle    of  proportionality,    are 
necessary    and    genuinely    meet    objectives    of  general    interest    recognised    by    the  
Union  or   the  need  to  protect  the  rights  and  freedoms  of  others. A general ban of 
food-imitating  products  would  result  in  banning  some  non-dangerous  products,  which 
would  be  an  unjustified  and  non-proportional  restriction  of  the  freedom  to  conduct  a 
business. 

6.2. 

Impacts of Option 2 

Effectiveness in achieving the specific objectives 

Table 8: Summary assessment of Option 2, compared to baseline situation 

Objectives  

Areas 

Assessment 

New technologies 

Certainty regarding coverage of new 
risks 

Legally binding clarifications will avoid uncertainty. Depending on the 
choice of instrument, implementation differences in Member States may 
remain 

Certainty regarding coverage of 
software 

No change to the current situation 

Online sales  

Safety of products sold on online 
platforms 

Safety risks for EU consumers due to products sold on online platforms 
partly reduced, with the effectiveness also depending on other factors 

Information to consumers on essential 
safety aspects 

No change to the current situation 

Recall effectiveness  Reaching out to consumers affected 

Change can be expected to facilitate the use of available customer data, 

103 We also note that the risk-assessment of the food-imitating products appears to be relatively simple in practice: e.g. 
the food-imitating aspect renders highly probable that the product would be put in mouth by children so if small parts 
of the products can detach easily, the product will likely present a serious risk and prohibited from being placed on the 
market. 

Impact 

+ 

neutral 
/ + 

+ 

48 

 
 
 
                                                           
by recalls 

and avoid data protection concerns 

Information provided in recall notices 

Improvement in the information provided to consumers is expected to be 
achieved  

Monitoring of recall effectiveness 

No change to the current situation 

Remedies for consumers affected by 
recalls 

No change to the current situation 

Market surveillance 

Alignment of market surveillance 
framework for harmonised/ non-
harmonised consumer products   

Largely uniform general requirements for businesses and responsibilities 
and powers of market surveillance authorities for harmonised and non-
harmonised consumer products expected to be achieved 

Deterrence effect 

Largely unchanged situation in terms of deterrence of placing unsafe 
products on the market 

Diverging risk assessments by MSAs 

No change to the current situation 

++ 

Simplification of standardisation 
procedures 

Simplification of standardisation procedures is expected to be achieved 

Food-imitating 
products 

Addressing risks of food-imitating 
products 

Clarify the regime for the food-imitating products: (a) full ban or (b) risk-
assessment approach 

+ 

In the GPSD Study’s survey, all stakeholder groups considered that Option 2 addressed 
all  challenges  at  least  moderately  well.  Overall,  the  average  assessment  across  all 
respondents and stakeholder groups was 3.4 out of 5. 

Administrative simplification 

Option 2 is expected to reduce regulatory complexity and uncertainty, and thereby to 
reduce  administrative  burdens  for  businesses.  Key  clarifications  regarding  the  coverage 
of new risks posed by new technologies will be provided in the new legal instrument. As 
these will be legally binding, the regulatory complexity reduction can be expected to 
be more significant than under Option 1. Also, general requirements for businesses 
and  responsibilities  and  powers  of  market  surveillance  authorities  would  be  largely 
uniform for harmonised and non-harmonised consumer products, which is likely to 
contribute  to  reduce  regulatory  complexity  and  thereby  to  reduce  administrative 
burdens for businesses. 

However, depending on the choice of instrument, implementation and interpretation 
differences  between  Member  States  may  remain  (if  a  directive  were  chosen).  The 
legal  form  chosen  under  this  option  2  matters  for  a  certain  number  of  issues  and  in 
particular  simplification  aspects.  Contrary  to  a  directive,  a  regulation  is  directly 
applicable  across  the  Union;  there  is  therefore  no  need  for  Member  States  to  transpose 
EU legislation into national law, which can lead to some implementation  differences as 
analysed in the problem definition. With a regulation, national differences regarding the 
date  and/or  manner  of  transposition  would  be  eliminated,  which  would  facilitate 
consistent  enforcement  and  level-playing  field  in  the  internal  market.  A  regulation 
ensures  better that legal  requirements are implemented at the same time throughout the 
Union;  it  also  better  achieves  streamlining  of  terminology,  important  for  defining  the 
scope  of  the  legislation,  thereby  reducing  administrative  burdens  and  legal  ambiguities. 
The  choice  of  Regulation  also  allows  to  better  deliver  on  the  objective  to  ensure 
coherence  with  the  market  surveillance  legislative  framework  for  harmonised  products, 
where the applicable legal instrument is also a Regulation (Regulation (EU) 2019/1020). 

49 

 
 
 
 
 
 
In  addition,  as  lack  of  clarity  regarding  the  application  to  software  will  remain, 
uncertainty in this respect will likely not be reduced. At the same time, Option 2 would 
provide  limited  additional  requirements  for  specific  operators,  such  as  requirements 
for  online  marketplaces  resulting  from  making  mandatory  many  provisions  of  the 
Pledge,  and  requirements  regarding  mandatory  key  elements  that  are  to  be  included  in 
recall notices.  

Finally,  ensuring  alignment  with  harmonised  market  surveillance  rules  will  reduce 
administrative burdens on MSAs. Similarly, simplified standardisation procedures at the 
Commission’s level should lead to savings for MSAs and the Commission. 

Consequently,  simplifications  would  be  achieved  under  this  option  by  aligning  market 
surveillance procedures for harmonised and non-harmonised products, by simplifying the 
standardisation procedure and by merging the rules on food imitating-products  with  the 
ones  for  non-harmonised  products  into  one  single  legal  instrument  and  repealing  the 
FIPD. Also the increase of legal certainty regarding the application of consumer product 
safety  rules  to  new  technologies  will  likely  reduce  the  regulatory  costs  for  businesses 
producing  new  technology  products.  If  the  new  act  will  be  a  Regulation  the  regulatory 
burden will decrease even more. 

Economic impacts 

According  to  the  GPSD  Study  survey,  businesses  expect  that  implementing  Option  2 
would increase companies’ recurrent regulatory compliance costs to some extent, as 
well as the additional one-off cost linked to the implementation of measures (see Table 
9).  Total  costs  for  businesses  in  the  EU27  in  the  first  year  of  implementation  are 
estimated at  EUR 36.9 million, equivalent  to  0.004% of turnover of EU companies  for 
manufacturing, wholesale and retail of non-harmonised consumer products. They would 
fall in subsequent years down to EUR 29.6 million. 

Table 9: Changes in EU companies’ costs within and after the first year of implementation of Option 
2, in million EUR 

From 0 to 49 
employees 

50 – 249 
employees 

250 or more 
employees 

Total 

First year of implementation (total of one-off and recurrent costs) 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

Total additional costs 

Subsequent years (recurrent costs only) 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

Total additional costs 

4.8 

2.5 

5.0 

12.2 

4.3 

1.7 

3.4 

9.3 

6.1 

1.7 

0.9 

8.8 

5.5 

1.2 

0.6 

7.3 

9.9 

2.6 

3.5 

15.9 

8.9 

1.8 

2.4 

13.0 

20.7 

6.9 

9.4 

36.9 

18.6 

4.7 

6.4 

29.6 

Source: The survey conducted in the context of the GPSD Study 

50 

 
 
 
Estimated  benefits  for  businesses  linked  to  cost  savings,  that  are  currently  caused  by 
differences in the national implementation of the GPSD and would be partly solved if 
the new instrument is a Regulation under the Option 2, would amount to EUR 59 million 
annually104, of which EUR 34 million would be saved by EU SMEs and 26 million EUR 
saved by EU large businesses respectively, compared to the baseline. 

The  GPSD  Study’s  survey  showed  that  MSAs  expect  considerably  more  benefits  for 
businesses  from  the  implementation  of Option  2 (average assessment  of 3.3 out  of 5, 
above moderate; see Annex 12) than businesses/business associations themselves (2.6) 
and  other  stakeholders  (2.7)105,  both  below  moderate.  All  respondent  groups  in  the 
survey assigned similar values to the benefits resulting from better information on unsafe 
products/measures taken by authorities provided through Safety Gate/RAPEX. 

Concerning impact on SMEs, they generally estimate that a revision of the product safety 
requirements  of  the  GPSD  according  to  Option  2  would  bring  a  variety  of  at  least 
‘minor’ to ‘moderate’ benefits106.  At the same time Option 2 would impose additional 
adjustment  (e.g.  familiarisation  cost)  as  well  as  compliance  costs  on  SMEs107,  in 
particular for manufacturers. Table 9 shows that SMEs would likely face relative higher 
compliance costs than large companies from the implementation of the proposed policy 
measures.  

Even though the relative cost increases are generally higher for SMEs, the net impact on 
SMEs  overall  costs  depends  on  the  benefits  that  can  result  from  a  revised  GPSD 
aligned to the market surveillance rules and traceability requirements in Regulation (EU) 
2019/1020.  We  expect  the  SMEs  would  save  EUR  34  million  of  the  costs  that 
currently  arise  from  inconsistencies  in  the  implementation  and  enforcement  of  the 
GPSD  across  the  EU.  Taking  into  consideration  these  benefits  and  the  fact  that  the 
changes  in  SMEs’  costs  from  Option  2  are  very  small,  we  expect  that  the  overall  net 
effect  from  Option  2  on  SMEs’  costs  is  rather  low  and  therefore  unlikely  to  affect 
SMEs’ operations. 

As  regards  the  impact  on  online  marketplaces,  the  additional  costs  from  Option  2 
making most of the Product Safety Pledge obligations binding, would be minor for those 
companies  that  already  signed  the  Pledge.  By  contrast,  non-signatory  marketplaces 
would likely face additional compliance costs108. In particular, some stakeholders were 

104 The baseline costs linked to the different implementation of the GPSD are estimated to amount to 119 million EUR 
annually (see section 7). As Options 3, 4 and possible 2 foresee to recast the GPSD as a Regulation, implementation 
differences would be avoided (due to the direct applicability of the new regulation in Member States), even if some 
differences in the national interpretation of rules may remain. Accordingly, we assume a 50% reduction of businesses’ 
additional costs in this respect in case of choice of Regulation as legal instrument. 
105 Indeed other stakeholders are mainly consumer organisations, which showed a clear preference for Option 3 and 4. 
106 Significant benefits due to improved quality/lifecycle of products and a deterrent effect on rogue traders, relatively 
strong benefits are increased consumer trust, better supply chain management due to improved traceability of products 
and better access to the market in non-EU/EEA. These areas are seen as benefits that SMEs assess to be ‘moderate’ to 
‘significant’. This is also the case for lower operational risks for businesses and easier compliance with product safety 
requirements. By contrast, SMEs considered several benefits to be less than ‘moderate’, including a more level playing 
field among businesses and greater legal certainty. 
107 This is particularly the case for SMEs that (voluntarily) decide to install and operate customer registration systems. 
Similarly, mandatory elements for product recalls (product description with a photograph, description of risk, 
instructions on what to do, link to a recall website and free phone number or online service for queries) would increase 
the cost of SMEs that have put unsafe consumer products to the market. 
108 Two online platforms provided quantitative estimates for the expected impact on recurrent costs, stating that their 
companies’ overall consumer product safety-related costs would increase by 10%. 

51 

 
 
                                                           
concerned  that  these  compliance  costs  might  specifically  affect  small  companies  and 
create  a  deterrent  effect  on  new  market  entrants,  with  potential  negative  effects  on 
competition  between  marketplaces.  Such  costs  should  however  be  low,  as  many 
obligations  under  the  Pledge  that  would  be  implemented  relate  to  a  ‘notice  and  action’ 
procedure  specifically  tailored  for  product  safety  (i.e.  a  reactive  approach,  where 
marketplaces only monitor the information provided by the MSAs about unsafe products 
but do not need to monitor the safety of products they list by themselves). 

Concerning  the  impact  on  producers  of  food-imitating  products,  the  impacts  are  the 
same  as  in  Option  1.  Concerning  the  macroeconomic  effects,  the  interviewed 
stakeholders find that the implementation of Option 2 would have a minor to moderately 
positive impact on the functioning of the EU’s internal market and international trade109: 
measures  to  clarify  the  coverage  of  new  risks  by  new  technologies  in  a  revised  legal 
instrument, as foreseen under Option 2, can address a part of the uncertainties linked to 
the  implementation  of  some  of  the  key  concepts  in  the  GPSD  and  new  technology 
products, whereby uncertainties would remain with respect to the actual effectiveness of 
such  measures,  but  also  with  respect  to  the  coverage  of  software.  It  is  possible  that 
Member States  could resort to national measures in this respect, which would create an 
obstacle to the free movement of goods or services and lead to an uneven level playing 
field for businesses in the future. Still, benefits can be expected from the clarification of 
safety  risks  stemming  from  new  technologies,  recall  procedures  and  more  coordinated 
actions  by  MSAs.  Reduced  legal  complexity  and  uncertainty  could  reduce  companies’ 
administrative burdens to some extent, which could have a moderate positive impact on 
the functioning of the EU’s internal market and international trade. 

Similar to Option 1, the impacts from Option 2 on EU companies’ competitiveness are 
expected to be relatively small as companies’ additional costs incurred by Option 2 in the 
first year of implementation would represent only 0,004% of their annual turnover, we do 
not expect significant impacts on competition for EU businesses, neither for competition 
within the Single Market nor with regard to non-EU competitors.  

As concerns innovation,  due to  the limited impact  on companies’  compliance  costs   no 
significant impacts on EU companies’ overall innovative capacities are expected, i.e. 
higher  budgets  resulting  from  savings  in  compliance  costs  that  translate  to  expanded 
research  and  business  development  activities.  On  the  other  hand,  new  regulatory 
requirements for online platforms might result in less innovation in some online platform 
business  models  over time, depending on the  extent to  which new requirements lead to 
additional costs, which appear, however, to be limited under Option 2. 

In term of impact on consumers, the alignment with the provisions of Regulation (EU) 
2019/1020 on market surveillance and clarifications provided in the new legal instrument 
could  improve the enforcement of the GPSD, with  related benefits  for consumers. Also 
concerning online sales, making relevant provisions of the Pledge binding should lead to 
better  monitoring  of  unsafe  products  by  marketplaces,  as  there  would  be  a  regular 
exchange with market surveillance authorities. Option 2 would therefore be expected to 
increase  the  level  of  protection  of  EU  consumers  to  some  extent,  by  reducing  the 

109 MSAs are on average the most positive stakeholder group about the benefits that would result from the 
implementation of Option 2 with an average of 3.8 (i.e. seeing close to ‘significant’ benefits). By contrast, the averages 
for both companies/business associations and other stakeholders are slightly lower (3.2 and 3.4 respectively, i.e. 
between ‘moderate’ and ‘significant’ benefits). 

52 

 
 
                                                           
incidence  of  unsafe  products  in  online  sales  channel.  The  GPSD  Study  estimated  that 
consumers would therefore benefit in terms of reduced consumer detriment based on 
the  value  of  unsafe  products110.  This  detriment  reduction  is  expected  to  amount  to 
approximately  EUR  333  million  in  the  first  year  of  implementation,  increasing  to 
approximately EUR 1.03 billion over the next decade. As regards improving the recall 
effectiveness  and  therefore  reducing  number  of  unsafe  products  remaining  in  hands  of 
consumers  would  also  bring  benefits:  the  GPSD  Study  estimates  under  a  scenario  of 
somewhat  improved  recall  effectiveness  as  expected  under  Option  2,  the  consumer 
detriment in the EU to be reduced by EUR 205 million in Option 2 compared to the 
baseline.  This  impact  on  consumers  could  be  also  relevant  for  specific  vulnerable 
consumer  groups  such  as  children,  and  the  elderly,  as  they  are  often  more  affected  by 
unsafe products.  

The  survey  of  the  GPSD  Study  shows  that  the  benefits  for  consumers  are  judged  by 
companies/business  associations  and  MSAs  as  ‘moderate’  (average  values  of  3.1  for 
companies/business  associations  and  3.4  for  MSAs  in  a  scale  of  5).  Benefits  include  a 
reduced occurrence of unsafe products and a reduced number of injuries caused by them, 
as  well  as  a  resulting  increase  in  consumer  trust.  Other  stakeholders  are  less  positive 
(below  ‘moderate’,  average  value  of  2.6  out  of  5).  As  the  implementation  of  Option  2 
would  only  result  in  minor  increases  of  consumer  product  safety-related  costs  for  EU 
companies,  the  impacts  from  Option  2  on  prices  of  consumer  products  in  the  EU  are 
expected  to  be  negligible.  None  of  the  measures  considered  under  Option  2  would  be 
expected to have a significant impact on consumer choice in the EU. 

Concerning the impact on consumers of the sub-options for the food-imitating products, 
we consider that both sub-options lead to the same level of consumer protection against 
unsafe products, as analysed under Option 1. 

Impacts on Member States 

The GPSD Study reports that MSAs stated that Option 2 is expected to be more suitable 
than  Option  1  to  improve  the  current  legal  framework  managing  the  risk  of  unsafe 
products being placed in the EU market, but the exact benefits would depend on its actual 
implementation.  Generally,  a  more  uniform  framework  for  harmonised  and  non-
harmonised  consumer  products,  a  simplification  of  standardisation  procedures  and  a 
clarification of rules regarding product recalls foreseen under Option 2 would, over time, 
lead to a reduction of administrative burdens for MSAs. The GPSD Study estimates that, 
if  a  Regulation  is  chosen  as  legal  instrument,  benefits  for  MSAs  arising  from  the 
alignment  of  the  provisions  for  market  surveillance  of  harmonised  and  non-harmonised 
products  would  lead  to  improvements  in  efficiency  of  market  surveillance,  and  related 
cost savings, which are estimated at EUR 0.7 million per year across the EU111.  

Under  Option  2,  MSAs  could  be  impacted  by  a  broadening  of  market  surveillance 
responsibilities  (e.g.  from  modified  definitions  as  regards  risks  posed  by  new 

110 Consumer detriment linked to the value of unsafe products, calculated on the basis of the purchase price of unsafe 
products. 
111 See baseline description. The proposed measures under Options 2 (if Regulation), 3 and 4 would fully align 
provisions for the market surveillance of harmonised and non-harmonised consumer products so that the cost burden 
estimated in the baseline as EUR 0.7 million will be reduced accordingly. 

53 

 
 
                                                           
technologies). New responsibilities are generally reflected by a greater need for internal 
and external resources respectively.  

The GPSD Study estimates the total  additional recurrent costs for MSAs in EU27 of 
approx. EUR 6.7 million annually112. Concerning one-off costs, the few cost estimates 
that  were  provided  by  MSA  respondents  indicate  that  the  one-off  adaptation  and 
implementation costs are considered to be moderate.  

Option  2  would  align  the  enforcement  powers  of  MSAs  regarding  non-harmonised 
products with their powers for harmonised products. Thereby, specific gaps such as legal 
difficulties to conduct mystery shopping for authorities in some Member States would be 
addressed.  However,  the  deterrence  effect  on  rogue  traders  would  not  be  increased,  as 
enforcement powers would  not  be further strengthened through penalties and sanctions. 
Likewise,  no  arbitration  mechanism  would  be  created  for  cases  of  divergences  in  the 
product safety risk assessment between MSAs, and there would be a continued reliance 
on  informal  approaches  in  case  risk  assessments  of  MSAs  diverge  to  harmonise  the 
treatment of products on the Single Market. 

Social impacts 

The  implementation  of  Option  2  is  expected  to  potentially  have  some  positive  social 
impacts with regard to public health and safety and health systems. The clarification 
of covered risks, mandatory obligations for online platforms (in line with the Pledge) and 
the  alignment  with  the  provisions  of  Regulation  (EU)  2019/1020  will,  to  some  extent, 
improve  market  surveillance  and  enforcement.  To  the  extent  that  the  number  of  unsafe 
products on the market is somewhat reduced by these measures in the mid- to long term, 
this  could  potentially  lead  to  a  lower  number  of  injury  cases  caused  by  consumer 
products  in  need  of  medical  attention  or  hospitalisation,  hence  decreasing  public  health 
expenditure  for  the  treatment  of  product  related  injuries.  However,  due  to  the  limited 
amount of measures taken under Option 2 that could effectively reduce consumer injury-
related  detriment  in  the  EU,  any  impact  on  health  systems  would  be  expected  to  be 
considerably more uncertain and smaller in size than under Option 3.The current cost 
of health care utilisation for product-related injuries in the EU are estimated by the 
GPSD Study to approximately EUR 6.7 billion per year, with hospitalisation accounting 
for the larger part of the total health care costs at about EUR 6.1 billion. A revised GPSD 
may contribute thereby to lowering these health care costs for the society. 

Environmental impacts  

The  GPSD  Study  showed  that,  while  authorities  see  ‘moderate’  benefits  regarding 
improved  lifecycle/quality  of  products  and  a  higher  level  of  the  protection  of  the 
environment  due  to  the  reduction  of  unsafe  products  that  also  have  environmental 
impacts,  companies/business  associations  and  other  stakeholders  only  see  between 
‘minor’  and  ‘moderate’  benefits.  The  implementation  of  Option  2  is  likely  to  have 
positive  environmental  impacts,  to  the  extent  that  it  clarifies  the  application  of  the 
general  safety  requirement  to  products  containing  environmentally  harmful  substances 
that  also  pose  a  risk  to  human  health  and  safety.  Already  today  around  25%  of  the 

112 It should be noted that the actual percentage changes would differ for individual MSAs due to different national 
institutional market surveillance systems and organisational characteristics, e.g. the degree of centralisation, MSAs’ 
product coverage and the actual assignment of new competences and enforcement requirements. 

54 

 
 
                                                           
products  notified  in  Safety  Gate/RAPEX  presented  a  chemical  substance  risk  with 
adverse health  effects  to consumers. The relevant  chemicals  were often also  harmful  to 
the environment (e.g. lead and mercury).  

Impacts on fundamental rights 

Option  2  is  expected  to  improve  consumer  safety  to  some  extent  and  also  to  reduce 
product-related environmental risks (see above). The implementation of a revised GPSD 
according  to  Option  2  shall  hence  have  a  positive  impact  and  ensure  a  somewhat 
higher level of consumer protection and a higher level of environmental protection 
in line with the Charter. However, there would be no right to effective, cost-free remedies 
for consumers that own a recalled product, which would limit the positive impact of this 
option.  

At the same time Option 2 imposes additional requirements for businesses, but these do 
not affect the fundamental freedom to conduct a business as the former are necessary 
to pursue the general European Union interest of increasing consumer protection and are 
proportional to the aim pursued, given that the resulting compliance costs are estimated to 
be very limited compared to the businesses’ turnover. The negative effect of a potential 
ban of food-imitating products would be the same as developed under Option 1. 

6.3. 

 Impacts of Option 3 

Effectiveness in achieving the specific objectives 

Table 10: Summary assessment of Option 3, compared to baseline situation 

Objectives   Areas 

Assessment 

New 
technologies 

Certainty regarding coverage of new 
risks 

Legally binding clarifications will avoid uncertainty. The choice of a 
Regulation will avoid implementation differences in Member States 

Certainty regarding coverage of software  Coverage of software by GPSD clarified   

Online sales  

Safety of products sold on online 
platforms 

Safety risks for EU consumers due to products sold on online platforms 
would be partly reduced (and more so than under Option 2) 

Information of consumers on essential 
safety aspects 

Achievement of objectives can be expected 

Recall 
effectiveness 

Reaching out to consumers affected by 
recalls 

The option can be expected to increase the availability and facilitate the 
use of customer data for recall purposes 

Information provided in recall notices 

Improvement in the information provided to consumers achieved 

Monitoring of recall effectiveness 

Improvement in the monitoring of recalls is expected to be achieved, 
also depending on implementation 

Remedies for consumers affected by 
recalls 

Higher consumer participation in recalls expected  

Market 
surveillance 

Alignment of market surveillance 
framework for harmonised and non-
harmonised consumer products   

Largely uniform general requirements for businesses and 
responsibilities and powers of MSAs for harmonised and non-
harmonised consumer products expected to be achieved 

Impact 

++ 

+ / ++ 

++ 

Deterrence effect 

Deterrence effect likely to be achieved, depending on the maximum 
levels of penalties and sanctions foreseen 

++ 

Diverging risk assessments by MSAs 

Risk assessment are likely to become more harmonised, achieving the 
desired effect  

Simplification of standardisation 

Simplification of standardisation procedures is expected to be achieved 

55 

 
 
 
 
 
procedures 

Food-
imitating 
products 

Addressing risks of food-imitating 
products 

 Clarify the regime for the food-imitating products: (a) full ban or (b) 
risk-assessment approach 

+  

The stakeholder survey in the GPSD Study confirmed that all stakeholder groups 
considered that Option 3 addressed all challenges at least moderately well with the 
overall average assessment across all respondents and stakeholder groups at 3.8 on the 
scale from 1 to 5.  

Administrative simplification 

Option  3  would  provide  several  legally  binding  clarifications,  reducing  regulatory 
uncertainty in this respect. General requirements for businesses and responsibilities and 
powers of market surveillance authorities would be largely uniform for harmonised and 
non-harmonised  consumer  products,  and  implementation  differences  in  Member  States 
would  be  reduced,  which  is  likely  to  contribute  to  reduced  regulatory  complexity  and 
thereby to reduced administrative burdens for businesses. 

On  the  other  hand,  Option  3  would  include  some  additional  administrative 
requirements for specific types of operators (e.g. the requirement to provide essential 
safety  information  online  for  online  traders).  The  most  comprehensive  requirements 
would apply in the context of recalls, which will likely lead to increased administrative 
burdens.  The  GPSD  Study  concluded  that  as  currently  the  effectiveness  of  recalls  is 
considered to be limited, these additional measures and the related administrative burdens 
appear to be proportionate.  

Finally, the simplification of the standardisation process has  the  potential to reduce 
administrative burdens  on Member States and at  EU level  by streamlining the related 
EU  process.  There  is  also  potential  for  decreasing  the  regulatory  burden  for 
companies thanks to the arbitration mechanism on the risk assessment. 

Also, the choice of Regulation instead of Directive under this option will further reduce 
the regulatory burden through a consistent application of product safety rules across the 
EU.  

Economic impacts 
The  survey  conducted  in  the  GPSD  Study  estimates113  that  the  additional  recurrent 
costs  would  increase  under  Option  3  as  well  as  the  additional  one-off  cost  (see  Table 
11).  Total  costs  for  businesses  in  the  EU27  in  the  first  year  of  implementation  are 
estimated at  EUR 196.6 million, equivalent  to  0.02% of turnover of EU companies  for 
manufacturing, wholesale and retail of non-harmonised consumer products. They would 
fall  in  subsequent  years  to  EUR  177.8  million.  The  rise  in  costs  for  businesses  in 
Option  3  is  due  to  the  increased  substantive  provisions  under  this  Option,  requiring 
investments on the side of businesses, in particular regarding the online sales and recalls.  

113 The accuracy of the given estimates depends on the implementation details 

56 

 
 
 
 
 
 
 
                                                           
Table  11:  Changes  in  EU  companies’  costs  within  and  after  the  first  year  of  implementation  of 
Option 3, in million EUR 

First year of implementation (total of one-off and recurrent costs) 

From 0 to 49 
employees 

50 – 249 
employees 

250 or more 
employees 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

Total additional costs 

Subsequent years (recurrent costs only) 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

26.9 

12.3 

24.3 

63.5 

25.7 

10.2 

20.2 

Total additional costs 
Source: The survey conducted in the context of the GPSD Study 

56.1 

34.4 

8.5 

4.6 

47.6 

32.9 

7.1 

3.8 

43.8 

55.7 

12.7 

17.1 

85.6 

53.2 

10.6 

14.2 

78.0 

Total 

17.0 

33.6 

46.0 

196.6 

111.7 

27.9 

38.2 

177.8 

Concerning the stakeholders views, the GPSD Study showed that  companies expect the 
implementation of Option 3 to cause changes in their recurrent costs, e.g. costs related to 
additional  staff  and  additional  resources  for  due  diligence  measures  including  the 
establishment  of  IT  systems  and  external  services,  in  addition  to  one-off  costs,  such  as 
familiarisation costs, adaptation costs to regulatory changes (e.g. for external advice). 

Businesses  expect  that  implementing  Option  3  would  increase  companies’  recurrent 
regulatory  compliance  costs,  generally  more  for  manufacturers  than  wholesalers  and 
retailers, as they might have to adjust different stages of the value-adding process to new 
regulatory requirements.  

Estimated  benefits  for  businesses  linked  to  cost  savings,  that  are  currently  caused  by 
differences in the national implementation of the GPSD are the same under Option 3 
as in Option 2 due to the choice of Regulation, amounting to EUR 59 million annually 
(EUR 34 million saved by EU SMEs and 26 million EUR by EU large businesses). These 
costs savings can be deducted from the costs, i.e. net costs in the first year would be EUR 
138 million in the first year. 

The implementation of Option 3 would be expected to address current gaps in the product 
safety  regime  for  non-harmonised  products  and  thereby  safeguard  the  continued  free 
movement of goods in the Single Market. This would likely contribute to positive spill-
over  effects  on  consumer  trust,  demand,  production  and  employment,  compared  to  the 
baseline scenario, which is beneficial for all undertakings.  

Companies  and  business  associations  saw  less  benefits  (between  ‘minor’  and 
‘moderate’)  than  MSAs  and  other  stakeholders,  who  assessed  benefits  to  be  mostly 
considerably more than ‘moderate’ and close to ‘significant’ (see Annex 12).  

As  concerns  the  benefits  for  SMEs,  the  GPSD  Study  shows  that  small  companies 
generally estimate that Option 3 would bring a variety of at least ‘minor’ to ‘moderate’ 
benefits, especially due to its  deterrent effect on rogue traders and better detection of 
unsafe products. However, Option 3 is considered by small companies as less beneficial 

57 

 
 
 
 
 
when  it  comes  to  reducing  legal  complexity  or  making  compliance  with  product  safety 
requirements easier for SMEs. In the case of medium-sized companies, Option 3 is seen 
as a suitable contribution to an increased level-playing field among businesses and to 
have  a  significant  benefit  linked  to  reducing  the  occurrence  of  unsafe  products  and  for 
contributing to a better functioning of the EU internal market. Finally, moderate benefits 
are expected regarding the potential to increase business revenue or consumer trust. 

Even though the relative cost increases are generally higher for the SMEs, the impact 
on  SMEs  overall  costs  is  still  considered  moderate  when  measured  against  the  benefits 
that would result from a greater level of regulatory harmonisation and reduced regulatory 
complexity  through  the  choice  of  a  Regulation,  savings  being  estimated  at  EUR  34 
million  for  EU  SMEs.  The  changes  in  SMEs  costs  are  estimated  to  be  limited  and 
Option 3 would not be expected to affect operations considerably114.  

Online  marketplaces  interviewed  generally  agree  that  the  measures  under  Option  3 
would  bring  several  benefits115.  In  the  GPSD  Study,  some  businesses  also  stated  that 
obligations  for  online  marketplaces  need  to  go  beyond  the  Pledge’s  provisions  and  be 
aligned  with  those  obligations  that  need  to  be  met  by  offline  importers/distributors, 
including applying ex-ante and ex-post measures and meeting traceability requirements.  

Marketplaces  also  indicated  that  Option  3  would  increase  in  particular  their  recurrent 
costs.  The  additional  costs  would  generally  be  relatively  limited  for  signatories  of  the 
Pledge.  By  contrast,  non-signatory  platforms  would  likely  face  additional  compliance 
costs.  These  compliance  costs  might  specifically  affect  small  platforms  and  create  a 
deterrent  effect  on  new  market  entrants,  with  potential  negative  effects  on  competition 
between  platforms,  depending  on  the  size  of  the  additional  costs.  Due  diligence 
obligations in terms of product safety might require more efforts, but would likely imply 
less efforts than those of brick and mortar distributors for fulfilling their obligations under 
the  current  regime,  thanks  to  the  easier  product  and  customer  traceability  on  the  online 
interface of a given platform.  

Online marketplaces and other online sellers would also be affected by a requirement to 
ensure  that  all  safety  information  is  provided  online  in  the  same  vein  as  it  is  required 
“offline”. We expect these costs to be very limited for both online platforms and online 
sellers, as this information is already available and does not go beyond what is indicated 
on the packaging.  

Concerning  the  impact  on  producers  of  food-imitating  products,  the  impacts  are  the 
same under Option 3 as in Option 1 and 2. 

Concerning  the  macroeconomic  impacts,  the  results  of  the  consultation  conducted  for 
this  study  indicate  that  all  stakeholder  groups  see  important  benefits  of  Option  3  in 

114 This consideration is also true for specific information obligations, such as the obligation for actors across the online 
supply chain to provide all safety information online that is also required to be provided with a product in 'brick and 
mortar' stores, and the related obligation for online platforms to make sure that third-party sellers, such as SMEs, 
provide this information. We expect these costs to be relatively minor for companies selling consumer products on 
these platforms, including SMEs. 
115 According to them option 3 would improve consumer trust, provide better information on unsafe products and 
ensure more effective measures taken by MSAs through Safety Gate/RAPEX, and provide greater legal certainty and 
less complexity. Online platforms respondents also tended to agree that the measures in Option 3 would have a 
deterrent effect on rogue traders and reduce the occurrence of products presenting health and safety risks in the Single 
Market.  

58 

 
 
                                                           
terms of a better functioning EU internal market and a better level-playing field  among 
businesses,  partly  through  the  deterrent  effect  on  rogue  traders.  All  these  potential 
benefits were assessed as being ‘moderate’ to ‘significant’ in the GPSD Study’s survey. 

The  alignment  of  the  market  surveillance  rules  for  all  products  and  a  clearer  legal 
framework under Option 3 should overall significantly reduce the businesses’ compliance 
costs and administrative burdens, which would level the playing field for companies from 
different  countries  within  the  EU  and  may  help  many  European  businesses  to  be  more 
competitive  internationally.  At  the  same  time,  a  more  harmonised  regulatory  level-
playing field within the EU will also induce non-EU companies to market their products 
in  the  EU,  with  positive  impacts  on  intra-EU  competition.  The  additional  gains  in  EU 
companies’  competitiveness  are  expected  to  be  very  moderate  as  companies’  current 
compliance costs with  consumer product  safety legislation are already relatively low116, 
accounting for relatively small shares of total revenues. Moreover, additional regulatory 
requirements would level potential cost reductions. 

Depending on the actual implementation, Option 3 should also create a higher deterrent 
effect on rogue traders and therefore ensure a better level-playing field for companies by 
ensuring  that  all  bear  the  compliance  costs  with  products  safety:  this  was  an  important 
point raised in the different consultation activities. 

Due to the relatively low additional costs for businesses, representing 0.02% of their 
annual turnover in the first year of implementation, that would result from Option 3, 
we  expect  neither  significant  distortions  in  competition  and  international  trade  for  EU 
businesses,  nor  significant  impacts  on  EU  companies’  overall  innovative  capacities117. 
The GPSD Study nevertheless expects positive impacts on competition-driven innovation 
due to a greater degree of harmonisation and greater legal certainty (e.g. development of 
new innovative information and traceability systems). 

Concerning the  impact  on consumers, the implementation  of Option  3  would result in 
greater benefits for consumers due to broader coverage and greater effectiveness of the 
GPSD  in  protecting  consumers  from  unsafe  products,  particularly  with  respect  to  the 
mitigation of risks  from  new technologies and the coverage of products  sold  via online 
channels. Option 3 could therefore be expected to increase consumer safety in the online 
environment and have positive effects on consumer trust, which might translate in higher 
demand for consumer goods that are sold via online channels. The GPSD Study estimated 
that consumers would therefore benefit in terms of reduced consumer detriment based 
on the value of unsafe products118. This is expected to amount to approximately EUR 
1.0  billion  in  the  first  year  of  implementation,  increasing  to  approximately  EUR  5.5 
billion over the next decade. Improving the recall effectiveness and therefore reducing 
the  number  of  unsafe  products  remaining  in  hands  of  consumers  would  also  bring 
benefits:  the  GPSD  Study  estimates  under  a  scenario  of  significantly  improved  recall 
effectiveness (under the assumption that return rates of recalled products are doubled due 
to  legislative  measures  and  more  deterrent  sanctions  and  penalties  as  expected  under 

116 The GPSD Study found that companies already do a lot for safety as usual business. 
117 However, new regulatory requirements for online platforms might result in less competitive dynamism and 
innovation in online platform business models over time, depending on the extent to which new requirements lead to 
additional costs (and their size compared to other cost factors), similarly to Option 2 
118 Consumer detriment linked to the value of unsafe products, calculated on the basis of the purchase price of unsafe 
products as explained above. 

59 

 
 
                                                           
Option  3), the consumer detriment due to ineffective recalls  to be reduced by EUR 
410 million in Option 3.  

The survey in the GPSD Study showed that stakeholders consider that Option 3 provides 
‘moderate’ to ‘significant’ benefits for consumers. These include a reduced occurrence 
of  unsafe  products  and  a  reduced  number  on  injuries  caused  by  them,  as  well  as  a 
resulting increase in consumer trust.  

Some of the additional costs incurred to businesses by Option 3 would be passed on, both 
up-  and  downstream  the  product  value  chain,  and  thereby  impact  consumer  prices. 
However, as most businesses report relatively low additional one-off and recurrent costs, 
the short and medium- to long-term impacts on consumer prices in the EU are expected to 
be  negligible.  Also,  the  GPSD  Study  does  not  expect  a  significant  negative  impact  on 
consumer choice in the EU under Option 3119.  

On  the  other  hand,  a  limited  effect  pertaining  to  the  affordability  of  products  is  also 
possible.  While  the  increase  in  consumer  prices  is  overall  considered  negligible  under 
Option  3,  purchase  prices  for  some  non-harmonised  products  might  be  affected  (e.g. 
products  that  are  most  cheaply  ordered  through  online  platforms  from  non-EU/EEA 
traders),  and  low-income  consumers  with  high  price-elasticity  may  reduce  their 
purchases. 

Concerning the impact on consumers of the sub-options for the food-imitating products, 
we consider that both sub-options lead to the same level of consumer protection against 
unsafe products, as analysed under Option 1. 

Impacts on Member States 

Based on the results from the Study, efficiency gains by MSAs would mostly arise from 
the  alignment  of  the  provisions  for  market  surveillance  of  harmonised  and  non-
harmonised  products.  This  would  lead  to  improvements  in  efficiency  of  market 
surveillance, and related cost savings, estimated at EUR 0.7 million per year across the 
EU under Option 3, similarly to Option 2. Also, streamlined standardisation procedures 
and  an  arbitration  mechanism  that  provides  clarification  regarding  risk  assessments  in 
case of disputes between MSAs could lead to additional cost reductions for MSAs over 
time. 

Concerning the costs, the Study  estimates that  Option 3 would lead to  total additional 
recurrent  costs  of  MSAs  in  EU27  of  approx.  EUR  6.7  million  annually  and  only 
relatively moderate one-off adaptation and implementation costs.  

Generally,  the  efficiency  of  market  surveillance  processes  with  implications  across  the 
EU would be increased under Option 3, mainly via an increased deterrent effect through 
provisions on penalties and arbitration mechanism. 

Social impacts 

The  implementation  of  Option  3  is  expected  to  potentially  have  positive  social  impacts 
with regards to public health and safety and health systems, higher than in Option 2. 

119 This will depend more on other measures taken at EU level (e.g. changes to the VAT regime, the provisions of the 
new DSA), which may impact market access for products sold directly to consumers by non-EU/EEA traders through 
online marketplaces. 

60 

 
 
                                                           
The  introduction  of  additional  requirements  for  traceability  and  product  recalls  are 
expected to improve the effectiveness of recalls of unsafe products from consumers. For 
instance, the cost  savings from  directly informing consumers affected by a recall rather 
than using indirect communication channels have been estimated at €73 million in 2019, 
i.e. a fifth of the overall estimated cost of recall ineffectiveness120. In addition, increased 
enforcement powers for Member States to impose penalties and sanctions are anticipated 
to significantly improve market surveillance and enforcement. Consequently, the current 
cost of health care utilisation for product-related injuries in the EU of approximately EUR 
6.7 billion per year could be further reduced under Option 3. 

Environmental impacts  

On  the  benefits  related  to  environment  of  Option  3,  the  Study  reports  that  while 
authorities see ‘moderate’ to ‘significant’ benefits regarding improved lifecycle/quality of 
products  and  a  higher  level  of  environmental  protection  due  to  the  reduction  of  unsafe 
products  that  also  have  environmental  impacts,  companies/business  associations  and 
other  stakeholders  only  see  benefits  that  are  (close  to)  ‘moderate’.  The  same  analysis 
concerning  the  hazardous  chemicals  applies  here  as  under  Option  2,  but  the  positive 
impact of Option 3 is amplified by the expected better product safety enforcement. 

Impacts on fundamental rights 

Option  3  is  expected  to  improve  consumer  safety  whilst  also  reducing  environmental 
risks  (see  below).  It  would  thus  have  a  positive  impact  and  ensure  a  higher  level  of 
consumers’ life as well as consumer protection and environmental protection in line 
with  the  Charter.  This  positive  impact  should  be  amplified  by  better  product  safety 
enforcement.  

The  additional  requirements  imposed  on  economic  operators  do  not  affect  the 
fundamental  freedom  to  conduct  a  business,  as  they  are  necessary  to  pursue  the 
general  EU  interest  of  increasing  consumer  protection  and  are  proportional  to  the  aim 
pursued, given that the resulting compliance costs are estimated to be comparatively low 
compared  to  the  businesses’  turnover.  The  negative  effect  of  a  potential  ban  of  food-
imitating products would be the same as developed under Option 1. 

6.4. 

Impacts of Option 4 

The  main  significant  difference  between  options  3  and  4  concerns  the  merger  of  legal 
instruments for the market surveillance rules for harmonised and non-harmonised 
products  into  one  single  Regulation.  Therefore  the  assessment  of  impacts  will 
concentrate only on this additional element (the rest of the analysis under Option 3 is also 
valid for Option 4, unless stated otherwise in this section).  

Effectiveness in achieving the policy objectives 

Creating  a  single  set  of  rules  that  would  apply  to  harmonised  and  non-harmonised 
consumer products will simplify the EU legal framework greatly. It can be expected that 
the  objective  to  create  uniform  requirements  for  businesses  and  responsibilities  and 

120 European Commission, 2021, Behavioural study on strategies to improve the effectiveness of product 
recalls. 

61 

 
 
 
                                                           
powers of market surveillance authorities for harmonised and non-harmonised consumer 
products  will  be  fully  achieved.  All  stakeholder  groups  considered  that  Option  4 
addressed  all  challenges  at  least  moderately  well.  The  average  assessment  across  all 
stakeholder groups was 3.8 out of 5 (similar to Option 3). 

Administrative simplification 

In addition to  Option 3, a single set of rules for market surveillance of harmonised and 
non-harmonised  consumer  products  in  the  EU  could,  overall,  result  in  even  less  legal 
complexity.  This  could  translate  into  simplifications  for  businesses  and  MSAs  in 
countries  where  current  national  law  implements  the  GPSD  and  harmonised 
product  legislation  through  different  legal  instruments.  However,  where  all  product 
safety legislation is already transposed into a single national product safety law (which is 
the case in some countries), simplifications through a new EU legal instrument are likely 
to be very limited.    

Economic impacts 

The GPSD Study showed that businesses expected costs from Option to be significantly 
higher compared to Option 3 (see Table 12). Total costs for businesses in EU27 in the 
first year of implementation are estimated at EUR 331.1 million, equivalent to 0.03% of 
turnover  of  EU  companies  for  manufacturing,  wholesale  and  retail  of  non-harmonised 
consumer products. They would fall in subsequent years to EUR 296.3 million.  

Table  12:  Changes  in  EU  companies’  costs  within  and  after  the  first  year  of  implementation  of 
Option 4, in million EUR 

From 0 to 49 
employees 

50 – 249 
employees 

250 or more 
employees 

First year of implementation (total of one-off and recurrent costs) 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

Total additional costs 

Subsequent years (recurrent costs only) 

Total manufacturing sectors 

Total wholesale sectors 

Total retail sectors 

45.0 

21.0 

41.2 

107.2 

42.7 

17.1 

33.6 

Total additional costs 
Source: The survey conducted in the context of the GPSD Study 

93.4 

57.7 

14.5 

7.8 

79.9 

54.8 

11.8 

6.4 

72.9 

93.4 

21.6 

29.0 

144.0 

88.7 

17.6 

23.7 

130.0 

Total 

196.0 

57.0 

78.0 

331.1 

186.2 

46.5 

63.6 

296.3 

Compared  to  Option  3,  Option  4  comes  therefore  to  substantial  additional  costs  for 
businesses even if there is no substantive difference regarding the regulatory obligations 
for  businesses  and  integration  of  legal  instruments  should  overall  reduce  regulatory 
complexity.  

A  possible  explanation  for  this  is  that  businesses  were  generally  uncertain  about  the 
precise implications of Option 4 and tended to provide cautious estimates with regard to 
additional costs from new regulatory obligations that might arise if one single set of rules 
would  apply.  The  data  on  costs  for  businesses  under  different  options  provided  by  the 
support  study  are  based  on  the  cost  estimations  provided  directly  by  the  businesses 
during  the  survey.  When  analysing  the  reasons  why  businesses  were  reporting  higher 
costs  for  Option  4,  it  appeared  that  for  businesses  the  legal  certainty,  clarity  of  their 

62 

 
 
 
obligations,  even  application  across  the  EU  and  predictable  legal  environment  are  very 
important. This was also confirmed by the meetings with businesses associations. If the 
rules  were  set  in  one  legal  instrument,  that  would  provide  simplicity  but  proportionally 
more for Member Sates  authorities (in particular  in  those Member States  where market 
surveillance  authorities  handle  both  harmonised  and  non-harmonised  products  together) 
than for businesses. On the contrary, businesses perceived some regulatory risk in Option 
4 linked to the possible reopening of Regulation (EU) 2019/1020 for which negotiations 
have been recently concluded. Businesses had already to invest into the compliance with 
this new market surveillance Regulation and perceived that merging the rules could lead 
to  reopening  of  market  surveillance  provisions  already  agreed  and  would  create 
uncertainty about their future legal environment. It should be noted, however, that these 
costs reported by businesses might be inflated since they are not based on any specific 
calculation  grounds  but  simple  assumptions.  If  the  new  market  surveillance  framework 
would  integrate  the  provisions  relevant  for  economic  operators  in  Regulation  (EU) 
2019/1020, such a new legal instrument would not entail additional costs for businesses. 
Since  Regulation  (EU)  2019/1020  is    setting  up  rules  for  market  surveillance  for 
harmonised products, any integration of market surveillance rules under one unique legal 
instrument  would  therefore  mainly  impact  Member  States  rather  than  businesses,  in 
particular by creating benefits for those Member States where the same authorities handle 
both categories of products, harmonised and non-harmonised. 

This difference in viewpoints between businesses and national authorities has been also 
confirmed by the general assessment of the benefits of Option 4 in the external survey: 
Businesses have been more sceptical, and saw only slightly less than ‘moderate’ benefits 
on average (2.9 on a scale of 5), while market surveillance authorities assessed the Option 
4 as bringing close to ‘significant’ benefits (value of 3.9).   

Other economic impacts (both micro- and macroeconomic impacts) as well as impact 
on  consumer  and  households  are  expected  to  be  identical  to  the  impacts  under 
Option 3.  

The survey of the GPSD Study shows that MSAs expect on average considerably more 
benefits that would result from an implementation of Option 4 than businesses/business 
associations and other stakeholders121. It is notable that the expected benefits of Option 4 
are considered to be slightly higher by all stakeholders than the benefits of Option 3.   

Impacts on Member States 

MSAs  responding  to  the  Study’s  survey  stated  that  having  the  same  rules  for  all 
harmonised  and  non-harmonised  products  would  induce  benefits  beyond  those  already 
identified under Option 3.  
The Study found that Option 4 would bring an increase in recurrent costs of MSAs of 
5%  of  total  annual  staff-related  costs:  this  would  amount  to  total  additional  costs  of 
MSAs in the EU27 of approx. EUR 3.3 million annually122. The few numbers that were 

121 Overall, MSAs assessed a value of 3.9, or very close to ‘significant’ benefits. MSAs especially expect ‘significant’ 
benefits from greater legal certainty and reduced legal complexity (values of 4.3 and 4.1 respectively). Also other 
stakeholders see this option bringing ‘moderate’ to ‘significant’ benefits (average 3.5). Businesses are more sceptical, 
and see slightly less than ‘moderate’ benefits on average (2.9). 
122 Actual percentage changes would differ for individual MSAs due to different national institutional market 
surveillance systems and organisational characteristics, e.g. the degree of centralisation, MSAs’ product coverage and, 
after all, the actual assignment of new competences and enforcement requirements. 

63 

 
 
                                                           
provided  by  MSA  respondents  indicate  that  the  one-off  adaption  and  implementation 
costs are considered to be relatively minor (e.g. to prepare some national guidance, new 
communication strategy and to strengthen cooperation at the national level). 

Social impacts, environmental impacts and impacts on fundamental rights 

As the measures implemented under Option 4 are identical to the measures implemented 
under  Option  3,  the  two  options  are  expected  to  have  identical  impacts  in  a  social  or 
environmental perspective, as well as on fundamental rights. 

7.  HOW DO THE OPTIONS COMPARE? 

In this section, we compare the results of the impact assessment of the four options, based 
on the elements developed in the section 6 and the results of the GPSD Study. 

Expected achievement of objectives 

Table 13: Comparative assessment of impact on objectives 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

Ensure general safety rules, including for product risks 
linked to new technologies 

Address safety challenges in the online sales channels 

Make product recalls more effective 

Enhance market surveillance and ensure better 
alignment of rules 

Address safety issues related to food imitating products 

Total effectiveness score by stakeholders (scale 1-5) 

neutral / + 

+ 

++ 

++ 

neutral 

neutral 

neutral 

+ 

2,9 

neutral / + 

+ / ++  

+ / ++ 

 + 

++ 

+ 

3,4 

++ 

++ 

+  

3,8 

++ 

++ 

+  

3,8 

Source: The survey conducted in the context of the GPSD Study 

Option 1 would be expected to achieve only one of the five policy objectives, with some 
additional benefits due to reduction of uncertainty (provision of EC guidance). Option 2 
appears more effective in reaching objectives, with some identified gaps being closed and 
uncertainty reduced by legal measures; however some other gaps remain (e.g. regarding 
software, product recalls and online sales  channels). Options 3 and 4 would most likely 
achieve all the defined objectives of the initiative. 

Administrative simplification 

Table 14: Comparative assessment of impact on administrative simplification 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

neutral / + 

Reduction of regulatory 
complexity and uncertainty 
Option  1 is  expected to  bring  slight  reduction of regulatory  complexity  and uncertainty 
(via  guidance).  There  are  no  new  administrative  requirements,  however:  administrative 
burdens  due  to  current  fragmentation  of  legal  regime  continue  (experienced  by  16%  of 
MSAs and 42% of companies responding to the survey in the GPSD Study as explained 
in  the  baseline  section).  Option  2  would  bring  some  additional  reduction  of  regulatory 

neutral / + 

+ / ++ 

+ 

64 

 
 
 
 
 
 
complexity and uncertainty, especially if a Regulation was chosen and involve only very 
limited additional administrative requirements for specific operators. 

Under Options 3 and 4, the reduction of regulatory complexity and uncertainty is the 
most  significant  (all  regulatory  gaps  closed),  with  related  reduction  in  administrative 
burdens  for  businesses.  Some  additional  administrative  requirements  concern  specific 
types of operators, the most comprehensive ones concern recalls, which would be limited 
to  companies  that  have  brought  unsafe  products  on  the  market.  Option  4  will  further 
reduce regulatory complexity and bring simplicity, as one single set of rules would apply 
to harmonised and non-harmonised products. 

Economic impacts 

Table 15: Comparative assessment of micro- and macroeconomic impacts 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

Benefits for businesses 

neutral / + 

neutral / + 
(Benefits of EUR 
59 million/year, if 
Regulation) 

+ 
Benefits of EUR 
59 million/year 

+ 
Benefits of EUR 
59 million/year 

Cost of businesses 
(EU27) 

neutral 

Increase by < EUR 37 
million/year 

Increase by < EUR 
197 million/year 

Increase by < EUR 
332 million/year 

Macroeconomic impacts 
(Internal market, trade, 
competition, innovation) 

neutral 

neutral / + 

+ 

+ 

Estimated  benefits  for  businesses  linked  to  costs  savings,  that  are  currently  caused  by 
differences in the national implementation of the GPSD and would be partly solved if 
the  new  instrument  is  a  Regulation  (Options  2,  3  and  4),  would  amount  to  EUR  59 
million  annually123,  of  which  EUR  34  million  would  be  saved  by  EU  SMEs  and  26 
million EUR saved by EU large businesses respectively, compared to the baseline. 

Other  additional  economic  benefits  for  businesses  are  expected  to  be  minor  under 
Options 1 and 2, mostly related to reduction of uncertainty due to guidance (Option 1) or 
the  coverage  of  certain  gaps  in  a  recast  GPSD  (Option  2).  Benefits  are  expected  to 
increase with Options 3 and 4, as all legislative gaps identified in the problem analysis 
are closed and related uncertainty is avoided. The measures taken regarding online sales 
contribute to safeguarding a level-playing field for businesses and the deterrence of rogue 
traders,  which  are  expected  to  have  concrete  benefits  at  firm  level,  especially  in  those 
areas  where  consumer  trust  and  safety  are  affected  by  unsafe  products  entering  the  EU 
through direct online business to consumer transactions. 

123 The baseline costs linked to the different implementation of the GPSD are estimated to amount to 119 million EUR 
annually (see section 7). As Options 3, 4 and possible 2 foresee to recast the GPSD as a Regulation, implementation 
differences would be avoided (due to the direct applicability of the new regulation in Member States), even if some 
differences in the national interpretation of rules may remain. Accordingly, we assume a 50% reduction of businesses’ 
additional costs in this respect in case of choice of Regulation as legal instrument. 

65 

 
 
 
 
 
 
 
                                                           
Table 16: Changes in EU companies’ costs within and after the first year of implementation of 
Options 1 to 4, EU27, in million EUR 

First year of implementation (total of one-off and recurrent costs) 

Option 1 

Option 2 

Option 3 

Option 4 

Manufacturing sectors 

Wholesale sectors 

Retail sectors 

Total additional costs (EU27) 

Subsequent years (recurrent costs only) 

Manufacturing sectors 

Wholesale sectors 

Retail sectors 

Total additional costs (EU27) 

0 

0 

0 

0 

0 

0 

0 

0 

20.7 

6.9 

9.4 

36.9 

18.6 

4.7 

6.4 

29.6 

17.0 

33.6 

46.0 

196.6 

111.7 

27.9 

38.2 

177.8 

196.0 

57.0 

78.0 

331.1 

186.2 

46.5 

63.6 

296.3 

Equivalent to the share of turnover of EU companies for manufacturing, wholesale and retail of non-harmonised 
consumer products (first year of implementation): 

Share in turnover 

0% 

0.004% 

0.02% 

0.03% 

There  are  no  changes  in  compliance  costs  for  EU  companies  under  Option  1,  and  only 
expected to a minor extent under Option 2. Compliance costs of businesses are expected 
to increase more significantly under Options 3 and 4, however still representing a small 
fraction of companies’ turnover, maximum 0.03% for Option 4. 

Under  options  2  to  4  (see  Tables  9,  11,  12),  the  effects  of  additional  compliance  costs 
will have a larger relative cost impact on SMEs than on large companies. Even though 
the relative cost increases are higher for SMEs, the impact on SMEs overall costs is still 
considered  moderate  when  measured  against  the  benefits  that  would  result  from  a 
greater  level  of  regulatory  harmonisation.  The  changes  in  SMEs  costs  are  small  and 
implementation of any of the options would not be expected to significantly affect SMEs. 

Minor impacts on online platforms are expected under Option 2 for those that are not yet 
signatories of the Pledge. Under Options 3 and 4 impacts on online platforms are higher, 
due  to  due  diligence  obligations  in  terms  of  product  safety.  However  this  would  likely 
imply  less  efforts  than  those  the  classical  distributors  have  today  under  GPSD  and 
therefore proportionate to the general objective. 

With respect to macroeconomic impacts, the impacts are expected to be mostly limited, 
with most (positive) impacts to be expected under Options 3 and 4. Both options would 
be  expected  to  lead  to  a  more  aligned  and  clearer  EU  legislative  framework  as  well  as 
reduced legal complexity, which could overall significantly reduce the part of companies’ 
compliance costs. 

Impacts on consumers and households  

The consumers will benefit from the reduction of the unsafe products on the EU market. 
The expected impact of the different options on the reduction of the consumer detriment 
linked to the value of unsafe products is presented in Table 17124.  

124 Estimation of the impact on the injury related detriment could not be done due to the lack of data.  

66 

 
 
 
 
                                                           
Table 17: Expected reduction in consumer detriment due to unsafe products– EU27, in EUR million 
per year 

Year 

Option 1 

Option 2 

Option 3 

Option 4 

2025 (expected 1st implementation year) 

2026 

2029 

2034 

0 

0 

0 

0 

333 

704 

821 

1 031 

1 038 

2 153 

3 924 

5 491 

As Option 3 

Options  3  and  4  are  likely  to  be  more  effective  than  options  1  and  2  to  address  the 
challenges for product safety posed by online sales channels. The measures taken under 
Options 3 and 4 also contribute to aligning the level of product safety between the online 
and  offline  sales  channels  and  increasing  it,  and  thereby  to  reducing  the  incidence  of 
unsafe products on the market overall. Measures taken under Options 3 and 4 are also 
expected to reduce consumer detriment estimated on the basis of the value of unsafe 
products  by  approximately  EUR  1.0  billion  in  the  first  year  of  implementation, 
increasing to approximately EUR 5.5 billion over the next decade, much higher than 
in  Option  2  and  1.  This  represents  the  decrease  of  financial  costs  for  consumers  since 
they would avoid buying unsafe products. The reason for this increase over time is that 
overall consumer detriment is expected to grow in the mid-term in the baseline scenario, 
due to increasing consumption and a continuing shift to e-commerce.  

Also,  enhancing  recall  effectiveness  would  reduce  the  consumer  detriment  since  less 
unsafe products would remain in hands of consumers and they might get compensated for 
the  recalled  products.  Guidance  measures  under  Option  1  in  the  area  of  product  recalls 
are not expected to lead to a significantly higher recall effectiveness, and therefore are not 
expected to reduce related detriment. In contrast, Options 3 and 4 could be expected to 
substantially  reduce  consumer  detriment  related  to  the  value  of  unsafe  products 
which were not effectively recalled by more than EUR 400 million per year (Option 2 
by half of this amount).125  

Table 18: Expected reduction in consumer detriment due to ineffective recalls – EU27, in EUR 
million per year   

Year 

Option 1 

Option 2 

Option 3 

Option 4 

Reduction of consumer detriment  

0 

205 

410 

410 

The other impacts on consumers and households have been estimated as follows: 

Table 19: Comparative assessment of other impacts on consumers and households 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

Consumer prices 

Consumer choice 

neutral 

neutral 

neutral 

neutral 

neutral 

neutral 

neutral 

neutral 

Consumer safety and vulnerable consumers 
neutral 
No  impacts  on  consumer  prices  and  choice  are  expected,  as  estimated  increases  in 
compliance  costs are small compared to  baseline costs, and companies’ overall product 

++ 

++ 

+ 

125 This estimate is based on a number of scenario assumptions, to provide a reasonable and cautious estimate of 
consumer benefits due to improved recall effectiveness. A key assumption is that the detriment incurred by consumers 
in case of a recall of an unsafe product is equivalent to at least its purchase price (a recalled, unsafe product could also 
cause additional detriment linked to damage to persons, other goods or the environment).   

67 

 
 
                                                           
safety-related costs, including regulatory compliance costs, account for only very limited 
shares of the companies’ turnover. 

Regarding  consumer  safety  and  the  protection  of  vulnerable  consumer  groups,  the  four 
options  differ:  Options  3  and  4  are  expected  to  provide  a  higher  level  of  protection  in 
terms of consumer safety and the protection of vulnerable consumer groups, as existing 
regulatory gaps are closed and the related policy objectives are better achieved.  

Impacts on Member States  

Table 20: Comparative assessment of impact on Member States 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

Benefits for MSAs 

neutral / + 

+ 
Benefits of 
EUR 0.7 million/year 

++ 
Benefits of 
EUR 0.7 million/year 

++ 
Benefits of 
EUR 0.7 million/year 

Costs for MSAs 
(EU27) 

Other effects on 
Member States 

neutral 

mostly neutral (<EUR 
7 million/year) 

mostly neutral  
(<EUR 7 million/year) 

mostly neutral  
(<EUR 4 million/year) 

neutral 

neutral / + 

+ 

+ 

Benefits  for MSAs would mostly arise from  the  alignment of the provisions for market 
surveillance of harmonised and non-harmonised products. This leads to improvements in 
efficiency of market surveillance, and related cost savings, which are estimated at EUR 
0.7 million per year across the EU (for Option 2 if Regulation is chosen and Options 3 
and 4)126. Also, streamlined standardisation procedures and an arbitration mechanism that 
provides clarification regarding risk assessments in case of disputes between MSAs could 
lead to additional cost reductions for MSAs over time. 

Cost for MSAs are not expected to increase significantly under any  of the options. 
With Option 1, no additional costs are to be expected. Under the other options, estimates 
of  additional  costs  are  between  EUR  3.3  million/year  (Option  4)  and  EUR  6.6. 
million/year  (in  Options  2  and  3  respectively),  the  difference  being  related  to  the 
expected  degree  of  legislative  alignment  (the  most  far-reaching  alignment  of  the 
legislative framework is under Option 4, which leads to most efficiency gains). 

Social impacts, impacts on fundamental rights and environmental impacts 

Table 21: Comparative assessment of other impacts 

Area 

Option 1 

Option 2 

Option 3 

Option 4 

Social impacts 

Environmental impacts 

Impacts on fundamental rights 

neutral 

neutral 

neutral 

neutral / + 

neutral / + 

neutral / + 

neutral / + 

neutral / + 

+ 

+ 

+ 

+ 

Option  1  is  not  expected  to  have  significant  social  impacts  and  Option  2  only  to  have 
some  positive  ones,  to  the  extent  that  number  of  unsafe  products  and  product-related 

126 See baseline description. The proposed measures under Options 2 (if Regulation), 3 and 4 would fully align 
provisions for the market surveillance of harmonised and non-harmonised consumer products so that the cost burden 
estimated in the baseline as EUR 0.7 million will be reduced accordingly. Legislative fragmentation between 
harmonised and non-harmonised products currently creates costs for MSAs, estimated to amount to EUR 0.7 million 
annually (total for the EU27). If the new legislation is a Regulation aligning rules for harmonised and non-harmonised 
products, it would create benefits in form of costs savings to MSA which are estimated to fully reach the amount of 
EUR 0.7 million per year since the legal fragmentation would disappear. 

68 

 
 
                                                           
environmental  risks  are  reduced.  Most  positive  social  impacts  are  expected  under 
Options 3 and 4, due to enhanced market surveillance which should reduce the number 
of unsafe products on the market in the mid- to long term, and consequently to a lower 
number of injury cases, hence lowering public health costs.  

Also reduction of product-related environmental risks decreases in particular in Options 3 
and 4, to the extent that the application of safety requirement in this respect is clarified 
and effectiveness of recalls of products posing environmental risks is improved.  

Options 1 and 2 are not likely to have significant impacts on fundamental rights (Option 2 
possibly minor), while Options 3 or 4 are expected to have a positive impact and ensure a 
higher level of the consumer protection and environmental protection. Even if Options 3 
and 4 impose additional requirements for businesses, these do not affect the fundamental 
freedom  to  conduct  a  business  and  appear  to  be  proportional  to  the  general  objective 
pursued.  However,  a  ban  of  food-imitating  products  from  the  EU  market  would  have  a 
negative impact on the freedom to  conduct  a business, and its proportionality regarding 
Art 52 of the Charter would need to be proven. 

Impacts of sub-options for food-imitating products 

A  full  ban  of  food-imitating  products  (sub-option  (a))  and  case  by  case  risk-
assessment of food-imitating products (sub-option (b)) appear to both deliver the same 
level  of  consumer  protection  since  in  both  cases  unsafe  products  would  be  subject  to 
corrective measures. In both options there is a benefit linked to better clarification and 
harmonisation  of the rules which would lead to  higher legal  certainty and level-playing 
field for economic operators in both sub-options. The broad economic negative impacts 
of  a  full  ban  of  food-imitating  products  would  likely  be  minor  since  the  number  of 
these products is limited. But a full ban on food-imitating products from the EU market 
without  risk-assessment  would  have  a  negative  impact  on  the  freedom  to  conduct  a 
business,  while  there  is  no  evidence  to  prove  that  it  protects  better  consumers,  in 
particular children, to confirm its proportionality. At the same time, Option (b) is fully 
coherent  with  the  current  risk-based  assessment  approach  in  the  GPSD  and  more 
proportionate  to  the  possible  economic  impact  of  corrective  measures  on  economic 
operators.  

Impacts of the choice of the legal instrument 

The analysis shows that a regulation is preferable to a directive in terms of choice of 
the legal form. A regulation is directly applicable in all Member States; there is therefore 
no need for Member States to transpose EU legislation into national law and no need to 
provide them with time to do so. Possible national differences regarding the date and/or 
manner  of  transposition  would  be  eliminated  with  a  regulation,  which  would  facilitate 
consistent  enforcement  and  level-playing  field  in  the  internal  market.  A  regulation 
ensures  better that legal  requirements are implemented at the same time throughout the 
Union;  it  also  better  achieves  streamlining  of  terminology,  important  for  defining  the 
scope  of  the  legislation,  thereby  reducing  administrative  burdens  and  legal  ambiguities; 
this is particularly true in light of the fact that one of the purposes of the revised GPSD is 
to  make  it  as  coherent  as  possible  with  Regulation  (EU)  2019/1020,  which  is  indeed  a 
Regulation. 

From  a  subsidiarity  and  proportionality  perspective,  the  choice  of  the  legal  delivery 
instrument  in  the form  of regulation  or a directive does not  differ in  term of impact.  In 

69 

 
 
both  cases,  the  subsidiarity  principle  is  respected  since  the  EU  action  is  necessary  to 
harmonise the general product safety requirement in the EU and ensure therefore safety 
of  products,  consumer  protection  and  level-playing  field  in  the  Single  Market.  Both 
instruments  are  proportional  since  the  requirements  introduced  are  proportionate  to 
achieve  the  level  of  product  safety  needed  to  ensure  consumer  protection  and  the  level 
playing-field for businesses. 

The  choice  of  a  Regulation  instead  of  a  Directive  under  the  Options  3  and  4  (and 
possible  Option  2)  will  further  reduce  the  regulatory  burden  thanks  to  a  more 
consistent application of product safety rules across the EU. 

Table  22  below  presents  the  overview  of  all  the  impacts  analysed  in  this  IA  report.  
Concerning the methodology for the comparison of impacts, the report generally operates 
with the “+/-“ rating system for impacts that were qualitatively assessed. However, one 
composite indicator representing the “expected achievement of objectives” was computed 
based  on  5  qualitative  indicators  measuring  the  degree  the  5  specific  objectives  of  the 
GPSD would be achieved. The scale “1-5” was chosen for it to allow for a more accurate 
overall  score  (2.9,  3.8  etc.)  of  the  aggregate  of  the  5  impacts  assessed  with  the  “+/-“ 
rating (which has only 5 scales: --, -, neutral, +, ++). 

70 

 
 
Table 22: GPSD Overview of the impacts of policy options 

Option 1 
Enhanced enforcement 

Option 2 
Targeted legal revision 

Option 3 
Full legal revision  

Option 4 
Integration of rules 

Expected achievement of objectives (scale 1-5) 

Administrative simplification 

Economic impacts 

Benefits for businesses 
Benefits if Regulation 

Cost for businesses (EU27) Increase by  
Share in turnover 

Macroeconomic impacts (Internal market, trade, competition, innovation) 

Impacts on consumers 

Expected reduction in consumer detriment due to unsafe products – EU27, 
in EUR million per year 

Expected reduction in consumer detriment due to ineffective recalls – 

EU27, in EUR million per year   

Consumer prices 

Consumer choice 

Consumer safety and vulnerable consumers 

2,9 

neutral / + 

neutral / + 
NA 

neutral 
0% 

neutral 

1st year 

10th year 

0 

0 

0 

neutral 

neutral 

neutral 

3,4 

neutral / + 

3,8 

+ 

3,8 

+ / ++ 

neutral / + 
EUR 59 million/year 

+ 
EUR 59 million/year 

+ 
EUR 59 million/year 

< EUR 37 million/year 
0.004% 

< EUR 197 million/year 
0.02% 

< EUR 332 million/year 
0.03% 

neutral / + 

333 

1 031 

205 

neutral 

neutral 

+ 

+ 

1 038 

5 491 

410 

neutral 

neutral 

++ 

+ 

1038 

5491 

410 

neutral 

neutral 

++ 

Impacts on Member States 

Social impacts 

Environmental impacts 

Impacts on fundamental rights 

Benefits for MSAs      

Benefits if Regulation 

neutral / + 
NA 

+ 
EUR 0.7 million/year 

++ 
EUR 0.7 million/year 

++ 
EUR 0.7 million/year 

Costs for MSAs (EU27) 

Other effects on Member States 

neutral 

neutral 

neutral 

neutral 

neutral 

mostly neutral              

<EUR 7 million/year 

mostly neutral  
<EUR 7 million/year 

mostly neutral  
<EUR 4 million/year 

neutral / + 

neutral / + 

neutral / + 

neutral / + 

+ 

+ 

neutral / + 

neutral / + 

+ 

+ 

+ 

+ 

 
 
 
Coherence with other EU policy objectives 

Options 3 and 4 deliver the most on the Digital priorities of the EU. These options have 
the highest impact on the online sales and, in line with the EU’s objectives to Shape EU’s 
digital future, these options contribute to make sure that online platforms treat their users 
fairly  and  take  action  to  limit  the  spread  of  unsafe  products  online.  Also  these  options 
provide higher safety and legal certainty for connected products and cybersecurity risks, 
in  line  with  the  EU’s  actions  in  the  AI  and  cybersecurity  fields.  Options  3  and  4  also 
deliver the most in term of positive environmental impacts and are therefore in line with 
the EU Green deal priority of the Commission. 

Stakeholder views on the options 

Figure 5: In your view, to what extent 
would Option [...] effectively address 
the following challenges for product 
safety? – Average across all 
challenges 

Source: The survey conducted in the 
context of the GPSD Study127 

Authorities and other stakeholders assessed Options 3 and 4 as being most effective, and 
considered them to well address the five objectives of this initiative. In contrast, average 
assessments  by  companies/business  associations  do  not  show  a  considerable  variation 
between  the  options.  They  consider  all  four  options  to  address  the  challenges  slightly 
better than ‘moderately well’. 

Figure  6:  Where  do  you  see  the 
that 
greatest  additional  benefits 
would 
the 
result 
implementation  of  Option  […]?  – 
Average across all benefit categories 

from 

Source: The survey conducted in the 
context of the GPSD Study 

127 In total, 153 survey responses were received, of which 27 responses to the survey of consumer organisations and 
other general stakeholder; 48 responses to the survey of authorities, 37 responses to the survey of business associations 
and 41 responses to the survey of companies. 

72 

12345Option 1Option 2Option 3Option 4Not at allVery wellOther stakeholdersAuthoritiesCompanies/ Business associations12345Option 1Option 2Option 3Option 4No change in                                                                                                                 Very significantbenefits at all                                                                                                  Other stakeholdersAuthoritiesCompanies/ Business associations 
 
 
 
 
 
 
 
 
 
 
 
                                                           
 
 
Businesses  find  the  benefits  of  Options  3  and  4  to  be  ‘moderate’  on  average,  but  still 
clearly  more  beneficial  than  Options  1  and  2.  All  stakeholders  provided  the  following 
ranking  of  benefits  for  Options  3  and  4,  with  average  above  ‘moderate’  in  all  three 
stakeholder groups: (1) Better functioning EU internal market, (2) Reduced occurrence of 
products with health and safety risks, (3) Greater legal certainty, (4) More level-playing 
field  among  businesses,  (5)  Reduced  number  of  accidents/injuries  caused  by  unsafe 
products, (6) Better information on unsafe products, (7) Deterrent effect on rogue traders. 

In  the  OPC,  the  stakeholders  showed  a  clear  support  to  certain  of  the  proposed 
provisions under Option 2, 3 and 4, e.g. to increase the role of online marketplaces as 
regards the safety of products offered on their website, along the principles stated in the 
Pledge128 and to create an obligation to have a responsible economic operator in the 
EU  (supported  by  70%  of  stakeholders)129.  Also,  a  large  majority  of  respondents 
expressed  that  products  which  resemble  foodstuff  should  be  incorporated  into  the 
general  product  safety  legal  instrument  (69%)130.  Stakeholders  expressed  also  their 
support for certain additional provisions foreseen under the Option 3 and 4, e.g. on new 
technologies:  When  asked  whether  the  definition  of  a  product  in  the  GPSD  should 
specifically  encompass  software  incorporated  into  the  product,  the  majority  of 
respondents agreed, even in case the software is downloaded after the product has been 
sold  (56%).  A  clear  majority  of  respondents  favoured  safety  obligations  for 
manufacturers  of  products  incorporating  AI  applications  at  the  design  stage  and  also 
during the lifecycle of the product (75%)131. Also, a large majority of respondents agreed 
that the system of product traceability should be reinforced in the GPSD (82%)132. 

Ranking of options 

All the options defined in the report propose specific actions to address all five problems 
identified.  However,  the  analysis  of  impacts  shows  that  some  options  deliver  better  on 
the defined objectives than others.  

Option 1 has considered how to best respond to the specific objectives without revising 
the GPSD. Several non-legislative measures have been considered, in particular issuing 
guidance documents on the applicability of the GPSD to new technologies and on recalls 
and exploring extension of the voluntary measures under the Product Safety Pledge for 
online sales. However, the different consultations showed that such non-legally binding 
measures  would  not  tackle  the  identified  shortcomings.  Also  additional  funding 
possibilities for market surveillance have been considered. But the agreement on the EU 
budget  for  next  years  showed  that  the  EU  funding  of  the  joint  market  surveillance 
activities  by  the  EU  budget  will  remain  stable;  moreover,  in  view  of  the  budget 

128 See Annex 11 on results of the OPC. When asked about the role that online marketplaces should play regarding the 
safety of products offered on their websites, the most commonly supported notions were that they should remove 
dangerous products listed on their website when notified (77%), that online marketplaces should prevent the 
appearance of dangerous products, including their reappearance once they have been removed (66%) and that they 
should inform sellers of their obligation to comply with EU rules on products (64%). More than half of the respondents 
agreed that online marketplaces should inform consumers when a dangerous product has been removed from the 
marketplace (55%). 
129 See Annex 11 on results of the OPC. A large majority of respondents considered that products covered by the 
GPSD should only be placed on the EU market if there is an economic operator established in the EU responsible for 
product safety purposes (70%). 
130 See Annex 11 on results of the OPC. 
131 Idem 
132 Idem 

73 

 
 
 
                                                           
constraints  in  Member  States,  aggravated  by  the  current  Covid-19  crises,  we  do  not 
expect any increase of resources dedicated to market surveillance activities by Member 
States themselves.  

Under  Option  2  and  3  several  legislative  actions  have  been  considered  to  tackle  the 
specific  objectives:  Option  3  being  more  ambitious,  addresses  also  better  the  identified 
shortcomings  as  data  shows.  Option  4  has  considered  a  full  integration  of  market 
surveillance  instruments,  as  it  was  proposed  in  2013,  to  analyse  whether  this  option 
would still be valid after the recent adoption of Regulation (EU) 2019/1020.  

Regarding the food-imitating products, different options have been looked at, namely: 
1) to maintain a separate Directive on food-imitating products; 2) to merge the provisions 
of  the  current  FIPD  into  the  new  GPSD;  3)  to  abandon  targeted  provisions  on  food-
imitating  products  and  instead  use  the  general  provisions  to  ensure  safety  of  such 
products.  For  the  first  two  options,  the  possibility  of  developing  guidance  has  been 
considered in order to overcome the different interpretation by Member States; however, 
the  consultation  of  Member  States  showed  that  the  divergences  in  interpretation  of  the 
Food-Imitating Products Directive were so important that a legal revision of the rules was 
necessary to ensure its even application.  

Furthermore, the assessment showed that a general ban of food-imitating products would 
result in banning some non-dangerous products, which would be an unjustified and non-
proportional restriction of the freedom to conduct a business. It is therefore essential that 
food-imitating  products  follow  the  same  risk-based  approach  that  prevails  for  the  other 
consumer products. Also keeping a separate regime for food-imitating products has been 
considered  as  not  necessary  in  view  of  the  low  number  of  related  notifications  in  the 
Safety Gate/RAPEX. To assess the safety of these products,  their food-imitating aspect 
can be taken into account in the risk assessment under the GPSD, which appears then to 
be  an  appropriate  legal  instrument  to  cover  the  safety  of  these  products.  Therefore  the 
third option consisting in abandoning targeted provisions on food-imitating products and 
instead using the general provisions and the risk-based approach contained in the GPSD 
to ensure safety of such products appears as the most appropriate. 

Table 23: Ranking of the options 

Assessment 

Option 1  While  Option  1  is  causing  no  costs  for  businesses  and  MSAs,  it  is  unlikely  to  be 
adequate to address the problems identified. While uncertainty will be reduced due to 
Commission  guidance,  and  coverage  of  online  platforms  is  expected  to  increase 
through the promotion of the Product Safety Pledge, safety risks due to products sold 
on online platforms are expected to continue, as will the other gaps identified. 

Option 2  Option  2  is  causing  extremely  limited  costs  (<0.004%  of  turnover  for  business, 
mostly  neutral  for  MSAs),  and  is  likely  to  be  partially  adequate  to  address  the 
identified  problems.  Gaps  will  remain  regarding  the  coverage  of  software,  and 
implementation  differences  in  Member  States  will  likely  remain.  Option  2  would 
only partly reduce the consumer detriment, in comparison to Options 3 and 4. 

Option 3  Option 3 is linked to somewhat higher costs (<0.02% of turnover for business, mostly 
neutral  for  MSAs)  and  is  mostly  adequate  to  address  the  problems  identified.  Gaps 
will be closed, and implementation differences avoided. However, while safety risks 
for EU consumers due to products sold on online platforms could be partly reduced 
(and more than under Option 2, as online platforms would have a duty of care), their 
mitigation will also depend on continued surveillance of platforms and other factors 
(adoption of DSA). Option 3 would considerably reduce the consumer detriment (due 
to  the  loss  of  value  of  unsafe  products)  by  1  billion  EUR  in  the  first  year  of 
implementation and by EUR 5.5 billion over the next decade. 

Ranking 
4 

3 

1 

Option 4  Option 4 leads to higher costs for business (<0.03% of turnover) than Option 3 and is 

2 

74 

 
 
mostly  neutral  for  MSAs.  It  is  also  considered  to  be  mostly  adequate  to  address 
problems,  as  measures  under  Options  3  &  4  are  almost  identical.  Reduction  of  the 
consumer detriment would be the same as under Option 3. 

As  indicated  in  the  Table  23,  Option  3  seems  to  deliver  the  best  results  in  terms  of 
meeting  the  defined  objectives  while  keeping  the  economic  impact  limited,  and  is 
therefore the preferred option. Option 4 could deliver broadly the same results in term 
of  objectives  but  with  higher  costs  for  businesses  and  administrative  burdens  (mainly 
linked to uncertainties in revising the Regulation (EU) 2019/1020 on market surveillance 
which has not entered fully into force yet). 

In  this  IA,  the  ranking  of  the  options  has  been  done  on  the  basis  of  the  general 
comparison  of  the  impacts  and  not  specifically  on  a  Multi-criteria  analysis  (MCA)133. 
Indeed, the comparison table of the impacts of policy options clearly shows that Options 
3  and  4  perform  better  overall.  The  evidence  was  gathered  from  multiple  data  sources 
and the results were triangulated to ensure the robustness of the methodology. Based on 
the  analysis,  policy  Options  3  and  4  would  perform  equally  well  except  under  three 
dimensions:  administrative  simplification,  the  costs  for  businesses  and  the  costs  for 
Member  States.  Under  Option  3,  the  costs  for  business  would  be  lower  by  ~EUR  135 
million/year, while under Option 4 the costs for Member States would be lower by ~EUR 
3  million/year  and  could  further  reduce  regulatory  complexity  and  bring  simplicity. 
Option  3  delivers  the  best  results  while  keeping  the  economic  impact  limited,  and  is 
therefore  the  preferred  option.  For  this  reason,  a  Multi-criteria  analysis  (‘MCA’)  was 
considered  to  bring  more  complexity  compared  to  the  added  value  it  would  have  in 
determining the preferred option. 

Nonetheless,  the MCA was tested on the criteria (impacts) in  the comparison  table and 
the results are highly sensitive to the weights attributed: either Option 3 or Option 4 are 
obtaining  the  highest  overall  score,  depending  on  the  factors  which  are  given  slightly 
more  importance.  The  main  reason  is  that  the  two  options  have  very  similar  scores  (as 
explained  above).  Moreover,  in  the  MCA,  the  monetary  (absolute)  values  are 
standardised:  the  40%  difference  in  costs  for  business  (from  EUR  332  million/year  to 
EUR 197 million/year) is considered the same as the 40% difference in costs for Member 
states  (from  EUR  7  million/year  to  EUR  4  million/year).  This  economic  impact  is 
significant and the MCA would not pick it up accordingly. 

The actual effect of the different options will depend on the concrete implementation and 
enforcement of the initiative at national level and in particular on the level of resources 
attributed  to  the  MSAs  and  the  EU  budgets  allocated  to  market  surveillance.  The 
level  of  allocated  resources  would  however  not  change  the  ranking  of  the  options,  in 
particular  because  some  of  the  actions  foreseen  can  deliver  on  the  objectives  without 
higher budgets, e.g. deterrent effect of penalties foreseen under Option 3 and 4. 

The  level  of  allocated  resources  would  nevertheless  impact  the  overall  effectiveness  of 
the enforcement of the options. Concerns related to the lack of adequate resources in the 
competent authorities of some Member States has been expressed by stakeholders during 
the  consultation  process.  None  of  the  options  envisages  to  set  any  obligation  on  the 

133 The multi-criteria analysis is one of the tools presented in the Better Regulation "Toolbox" (Tool #63) to compare 
the different policy options. It is a non-monetary approach and its main advantage is that it allows to simultaneously 
consider a significant number of objectives, criteria and relations. MCA gives the opportunity to deal with policy issues 
characterised by various conflicting assessments, thus allowing for an integrated assessment. 

75 

 
                                                           
 
amount to be invested on product safety tasks by Member States since it is set at national 
level  for  market  surveillance,  which  remains  within  remit  of  national  powers.  The 
legislative  options  envisage  rather  mechanisms  allowing  economies  of  scale  and  better 
functioning  of  market  surveillance,  such  as  reinforced  cooperation  among  MSAs 
including  in  enforcing  measures  adopted,  more  power  for  MSAs  and  more  effective 
measures at their disposal, the possibility to reclaim from the relevant economic operator 
the totality of the costs of their activities in case of dangerous products, the introduction 
of Union testing facilities which can ease the testing activities for MSAs (some of these 
measures are foreseen already in Regulation (EU) 2019/1020 for harmonised products).  

An  effective  enforcement  of  the  different  options  will  be  ensured  by  monitoring  of 
reported  data  on  enforcement  capacities  of  Member  States  (e.g.  in  the  context  of  the 
Consumer Scoreboard or via possible reporting obligations) and raising awareness about 
market surveillance needs in term of resources and tools. Also under Options 3 and 4 the 
arbitration mechanism will allow more harmonised enforcement of product safety. 

The efficiency of the different options can be also enhanced by improving the operation 
of Safety gate/RAPEX (e.g. by tackling the delays identified in the Evaluation between 
the detection of a dangerous product in a Member State and its notification to the Safety 
Gate/RAPEX) and facilitating international cooperation, in particular in the context of 
the  exchanges  of  information  on  dangerous  products  between  the  Safety  Gate/RAPEX 
and  third  countries.  The  Evaluation  found  that  the  procedure  for  setting  up  such 
arrangements to exchange non-public information from the Safety Gate/RAPEX could be 
clarified  to  cover  the  different  levels  of  exchanges  between  the  EU  system  and  third 
countries (in particular via legal revision under options 2, 3 and 4). Such exchanges can 
enhance the  efficiency of Member State’s market  surveillance actions. Also,  enhancing 
product safety worldwide will have a positive impact on protection of EU consumers by 
limiting the entry of dangerous products to the EU market.  

All  the  options,  and  in  particular  the  legislative  options  2  to  4,  including  the  preferred 
Option 3, conform to the principles of subsidiarity, since the new legal provisions relate 
to  areas  where  EU  action  brings  added  value  to  ensure  level-playing  field  on  the  EU 
market and higher product safety, while fully respecting the national competences (these 
options harmonise the obligations on economic operators and respect powers for MSAs). 
All options also conform to the principle of proportionality given that the size of the 
identified problem is considerable (high presence of unsafe consumer products on the EU 
market and related high consumer detriment) and the costs associated with the different 
options  are  limited.  Also  the  choice  of  Regulation  as  Union  action  is  coherent  with 
satisfactory achievement of the objective to ensure level-playing field and effective and 
even enforcement at national level. 

8.  PREFERRED OPTION 

8.1. 

Preferred option – Option 3 

In  view  of  the  data  and  the  analysis  presented  in  the  previous  sections,  the  preferred 
policy  option  is  Option  3.  This  policy  option  addresses  all  identified  problems  and 
objectives  in  the  most  effective,  efficient  and  proportionate  way,  proposing  a  legal 
revision of the GPSD to make it not only fit for purpose now, but also in the future by 
improving its ‘safety net’ function.  

Concerning the objective related to  food-imitating products, the sub-option (b), risk-
assessment approach, is preferred since it is more coherent and proportionate than sub-
option (a), a full ban per se of these products.  

76 

 
The  operational  objectives  under  Option  3  are  as  follows:  it  would  add  legal  clarity 
concerning the coverage of risks of new technologies (cyber-security and other risks of 
new technologies affecting consumer health) and the role of software for product safety. 
It would make most provisions inspired by the Product Safety Pledge legally binding for 
online marketplaces and add additional requirements to improve transparency and duty of 
care  by  online  marketplaces.  It  would  enhance  recall  effectiveness  by  introducing 
mandatory requirements on product recalls and customer traceability. It would also better 
align  the  GPSD  with  market  surveillance  rules  for  harmonised  products,  enhance 
traceability  and  integrate  and  clarify  the  rules  for  the  food-imitating  products.  It  would 
provide for increased enforcement powers for Member States, an arbitration mechanism 
to solve divergent risk assessments and the possibility to adopt delegated acts to improve 
traceability  systems.  It  proposes  a  burden  reduction  measure  by  simplifying 
standardisation procedures. 

In  particular,  the  preferred  option  will  revise  the  Directive  to  include  inter  alia  the 
following provisions to tackle product safety challenges posed by online sales: 

  New obligations for manufacturers and distributors to include in their online 
offers  the  same  information  like  for  the  physical  offers,  namely  information  on 
the name and contact details of the manufacturer and of the responsible economic 
operator in the EU if applicable, safety information and instructions. The online 
market places should also ensure that this information is displayed with the online 
listings. This information allows better traceability of products needed for market 
surveillance and better safety information in the online sales.  

  Establishment of the figure of a responsible economic operator in the EU, in 
line with Regulation (EU) 2019/1020 on market surveillance, to tackle the issue 
of  direct  imports  from  outside  the  EU.  This  Regulation  applies  this  obligation 
only  for  certain  categories of  harmonised products  and could be  extended to  all 
consumer  products  to  make  sure  that  consumers  and  national  authorities  can 
always address  an operator based in the EU for any consumer product potential 
safety issue.   

  New  enforcement  powers  for  market  surveillance  authorities  to  carry  out 
online investigations, in line with Regulation 2019/1020 on market surveillance. 
For  example,  the  possibility  for  authorities  to  carry  out  inspections  using  a 
covered identify or the power to shut down webpages; 

  New  product  safety  obligations  for  online  marketplaces,  in  line  with  the 
general  principles  set  in  the  DSA.  While  manufacturers  will  remain  the  main 
responsible  economic  operators  for  the  safety  of  a  product,  online  marketplaces 
could  play  an  important  role  and  exercise  a  duty  of  care  in  relation  with  their 
responsibilities,  e.g.  making  efforts  to  identify  dangerous  product  offers  already 
removed from their websites but that keep reappearing. That duty of care would 
be different than for distributors as they do not have a physical contact with the 
product, so their role will focus on doing their most to ensure that their websites 
do not  offer dangerous  products,  and if they  do, they cooperate with  authorities 
for corrective actions.  

With  regards  to  software  updates,  the  preferred  option  aims  to  shift  the  responsibility 
for the safety of a product from the initial producer to the actor in charge of the update in 
case of ‘substantial modification’. If certain criteria are met, in the case of modifications 
such as software updates that alter the safety of the product, the responsibility for safety 
would  shift  to  the  actor  in  charge  of  such  modification.  For  example,  if  an  application 

77 

 
aimed  to  improve  the  efficiency  of  a  battery  is  downloaded  into  a  device  and 
consequently  the  hazards  of  the  device  increase,  the  software  developer  would  become 
the responsible actor. That would ensure that actors in charge of substantial modifications 
take  into  account  the  impact  of  their  changes  on  a  specific  product.  In  any  case,  this 
would not apply for most software updates, such as the download of games that do not 
interfere with the safety of a device. 

Under  Option  3,  the  revised  GPSD  would  be  complementary  to  the  other  ongoing 
policy  initiatives  mentioned  in  part  1.  The  advantage  of  clearly  integrating  aspects  of 
substantive alternative policy areas into product safety legislation is therefore to ensure a 
real safety net for consumers, making possible that that all non-food consumer products 
on the EU market are safe. The revised GPSD under the preferred option will address the 
convergences between product safety and the other policy areas, but it will not go beyond 
those to avoid any overlaps. 

Beyond  the  legal  revision  of  the  GPSD,  the  self-regulatory  instruments  such  as  the 
Product  Safety  Pledge  could  be  strengthened  to  complement  the  legal  framework.  The 
Pledge  could  be  further  used  to  continue  the  operational  cooperation  between  online 
marketplaces and MSAs and to include the commitments that would not become binding, 
as  well  as  potential  new  commitments.  This  way  the  Pledge  would  continue  to  play  a 
complementary role to the legal framework. 

Other voluntary cooperation actions with online marketplaces could be explored, such as 
the actions taken in the beginning of the COVID-19 crisis where the online marketplaces, 
upon  a  call  for  cooperation  from  the  Commission,  acted  against  online  scams  and  new 
dangerous products related to the pandemic. 

8.2.  REFIT (simplification and improved efficiency) 

GPSD  being  part  of  REFIT,  the  report  has  analysed  how  the  current  legal  framework 
could  be  simplified,  improve  the  efficiency  and  decrease  administrative  burden.  The 
following actions under Option 3 should lead to such higher efficiencies: 

Table 24: REFIT Cost savings under the preferred option 

REFIT Cost Savings – Preferred Option – Option 3 

Description 

Amount 

Comments 

Alignment to market surveillance procedures for 
harmonised products  
would simplify the market surveillance rules  

Conversion to a Regulation   
would ensure a common application of product safety rules 
and avoid inefficiencies and regulatory costs/burdens related 
to the inconsistent implementation of the GPSD across the 
EU 

78 

Cost savings for MSAs: around 
EUR 0.7 million per year across 
the EU. 
Cost saving for businesses are 
included in the line below on cost 
savings linked to more uniform 
implementation of market 
surveillance rules. 

Benefits are mainly for 
MSAs and businesses 
active in both 
harmonised and non-
harmonised product 
areas.  

Lower regulatory burden and 
costs  
Cost savings for businesses : 
around EUR 59 million 
annually (around EUR 34 
million saved by EU SMEs and 

Benefits for all 
stakeholders (reduced 
burdens and costs for 
businesses and MSAs 
and better enforcement 
and product safety for 

 
 
 
 
 
Simplifying the standardisation procedure under the 
GPSD would decrease the administrative burden  

Simplify and reduce regulatory 
costs 

26 million EUR saved by EU 
large businesses)  

consumers) 

Reduced regulatory costs  

 Lower regulatory burden and 
costs  

Reduced regulatory burden 

Beneficial to all 
stakeholders since 
standards could be  
referenced faster 

Benefits for businesses 
producing new 
technology products 
and consumers of 
these products because 
of legal clarity and 
better safety. 

Benefits for producers 
of food-imitating 
products, for MSAs 
and consumers 

Benefits for MSAs and 
consumers 

Reduced administrative burdens  Beneficial for MSAs, 

businesses and 
consumers 

Lower regulatory burdens 

For MSAs, customs 
authorities 

Clarification of scope and definitions regarding the 
application of consumer product safety rules to new 
technologies  
would lead to higher legal certainty regarding the application 
of consumer product safety rules to new technologies, which 
will likely reduce the costs relating to businesses’ (especially 
SMEs’) efforts to design innovative, safe and cyber-secured 
products. 

Repealing Directive 87/357/EEC and integrating rules on 
food-imitating products into the revised GPSD would 
simplify the product safety legal framework and increase 
coherence in implementation by Member States 

Arbitration mechanism on diverging risk assessments 
would lower the regulatory burden for MSAs by helping to 
resolve disputes on risk assessments 

future 

improved  digital 
introduction  of 
Potential 
solutions for product traceability through delegated acts   
The  Study  identified  e-labelling  solutions  for  traceability 
information as potential complementary measure to increase 
efficiency of product safety market surveillance.  

Digital interlinks between existing market surveillance 
systems at EU and national level (including customs) 
similarly to Regulation (EU) 2019/1020 will make the 
market surveillance more simple and efficient through 
connecting Safety Gate/RAPEX with the EU Customs 
database 

Beyond  these  simplifications  and  higher  efficiencies,  this  initiative  endeavours  to  keep 
regulatory burdens to the minimum necessary both for businesses and Member States to 
what is strictly needed to ensure consumer protection against unsafe products.  

To avoid any legal uncertainties and related burdens, the revised GPSD would avoid any 
overlaps between lex generalis and lex specialis, by defining its scope. Also the ongoing 
work related to product safety under other initiatives has been and will be duly taken into 
account to avoid overlaps and overregulation.  

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

The Commission will monitor the implementation of the revised GPSD, if adopted along 
the  preferred  option,  with  regards  to  the  achievement  of  policy  objectives  identified  in 
this  Impact  Assessment  in  order  to  be  able  to  assess  its  effectiveness  in  the  future 
evaluation. A commitment to evaluate the impacts of the new legislative act, if proposed, 
will  be  included  in  the  draft  proposal.  The  Commission  will  start  monitoring  the 
implementation  of  the  revised  GPSD  after  the  entry  into  force  of  the  initiative.  The 
indicators  proposed  to  monitor  the  achievement  of  policy  objectives  identified  in  this 
Impact Assessment are presented below. 

79 

 
 
 
 
The  monitoring  will  be  done  mainly  by  the  Commission,  based  on  regular  EU-wide 
consumer  surveys  and  data  provided  by  businesses  and  MSAs.  The  monitoring  and 
evaluation  will  be  done  on  the  basis  of  existing  data  sources  where  possible  to  avoid 
additional burdens on the different stakeholders. The new legislative act, if proposed, will 
set out reporting obligations for Member States. This reporting will be done on the basis 
of enforcement indicators which will be further defined by a study. The Commission has 
already identified some gaps concerning enforcement indicators, and will launch a study 
to establish a new set of enforcement indicators134. 

Tables  25  and  26  below  provide  an  exhaustive  list  of  monitoring  indicators.  A 
methodological  study  for  the  design  of  enforcement  indicators  is  ongoing  to  identify 
which  enforcement  indicators  are  the  most  suitable  to  measure  the  achievement  of  the 
different  objectives  and  on  which  Member  States  could  report  in  practice  so  that  the 
Commission  can  receive  reliable  and  comparable  data  for  the  next  evaluation  of  this 
initiative.  Through  this  study  the  Commission  could  complement  the  list  of  the  most 
suitable indicators for the monitoring system. 

The Commission has already mapped existing sources of injury information and looked 
into the possibility of establishing a EU-level injury database to help the implementation 
of  the  product  safety  legislation135.  It  is  currently  assessing  the  costs  and  benefits  or 
setting up such a EU wide injury database (via coordinated actions with Member States). 

Table 25: Monitoring indicators for the main policy objectives 

Policy objectives 

Monitoring indicator 

Data source 

Product safety 

Number of unsafe products on the 
market 
Consumer detriment 

Proper functioning of 
Single Market 

Consumer trust in product safety 
and experience of product-related 
injury 
Number of unsafe products on the 
market 

Safety Gate/RAPEX 
gives a proxy 
Future study (data for 
past available from the 
GPSD Study) 
Consumer Conditions 
Scoreboard 

Safety Gate/RAPEX 
gives a proxy 

Safety net function, also 
new technologies  

Number of unsafe new technology 
products 

Safety Gate/RAPEX 
gives a proxy 

Consumer concerns about safety of 
IoT products 

Eurostat ICT survey, 
Consumer Markets 
Scoreboard 

Yes 

Yes 

Yes 

Product safety in the 
online sales  
Product recalls more 
effective and efficient  

Number of unsafe products found 
online 
Number of recalls and recalled 
products 

Safety Gate/RAPEX 
gives a proxy 
Safety Gate/RAPEX 

Yes 

Yes 

Data collected 
already? 

Yes 

Actors 
responsible 
for data 
collection 
Commission 

Not in a 
recurrent way 

Commission 
via study 

Commission 
via regular 
surveys 
Commission 

Commission 

Commission 
via regular 
consumer 
surveys 
Commission 

Commission 

134 For the future reporting obligations under the revised GPSD, the Commission will consider the reflections and work 
engaged in the harmonised area on the monitoring and reporting in order to aim for consistency and to avoid any 
duplication or unnecessary burden on national administrations in the collection of relevant data and information. 
135https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/docs/
Final_JRC_Report_Injury_and_acccident.pdf 

80 

 
 
 
 
 
 
 
 
 
 
                                                           
(Coordinated) market 
surveillance activities 

Not in a 
recurrent way  

Member States, 
Commission 

Market practices regarding product 
recalls and product registration 
schemes/loyalty programmes 
Self-declared data on recall 
participation and product 
registration and on exposure to 
recall information 

Hard data on recall participation 

Consumer Conditions 
Scoreboard 

Yes 

Monitoring data to be 
collected by economic 
operators 

No 

Commission  
via regular 
surveys 

Economic 
operators 
(Member 
States will be 
able to request 
this 
information) 
Member States 
based on 
indicators 
defined by the 
study 
Commission 

Enhanced market 
surveillance and ensure 
better alignment with 
harmonised products 

Enforcement indicators as defined 
by the study commissioned by the 
EC mentioned above 

National sources, to be 
defined by the 
commissioned Study 

No or only 
partially 

Safety of food imitating 
products 

Number of unsafe food-imitating 
products 

Safety Gate/RAPEX 
gives a proxy 

Yes 

Number of disputes on risk 
assessment of these products 
between Member States 

Safety Gate/RAPEX 

Yes 

Commission 

Table 26: Monitoring indicators for the operational objectives – Option 3 

Operational objectives 

Monitoring indicator 

Sources of data and/or 
data collection methods  

Data collected 
already? 

Clarify coverage of risk and 
products linked to new 
technologies 
Clarify the application to 
software 

Making most provisions of the 
Pledge legally binding for all 
online marketplaces 

Number of questions raised on 
the applicability of new 
technology products 
Number of notifications related 
to safety issues raised by 
software  
KPIs and qualitative data (idem 
Pledge) 

Providing all safety 
information online that is also 
required to be provided offline 

Number of cases where 
diverging level of information 
offline/online found 

Introducing a duty of care for 
online marketplaces 

Number of cases where duty of 
care not respected 

Introducing mandatory 
requirements for recalls 

Number of cases where new 
recall provisions not fulfilled 

Introducing mandatory 
requirements for customer 
traceability 

Number of cases where new 
recall provisions not fulfilled 

81 

Actors 
responsible 
for data 
collection 
Commission 

RAPEX contact points 
Wiki 

Yes 

Safety Gate/RAPEX 

Yes 

Commission 

Monitoring reports of the 
Pledge 

Yes, to be 
reinforced 

Regular checks in the 
context of (coordinated) 
market surveillance 
activities 
Regular checks in the 
context of (coordinated) 
market surveillance 
activities 
Regular checks in the 
context of (coordinated) 
market surveillance 
activities 
Regular checks in the 
context of (coordinated) 
market surveillance 
activities 

No 

No 

No 

No 

Online 
platforms -
Pledge 
signatories 
Member 
States,  
Commission 

Member 
States, 
Commission 

Member 
States, 
Commission 

Member 
States, 
Commission 

 
 
 
 
 
 
 
 
Member 
States, 
Commission
, online 
marketplaces 
Commission 

Commission 
based on 
Member 
States input 
Commission 
based on 
Member 
States input 
Commission 

Align with market 
surveillance and traceability 
rules for harmonised products 
Requiring an economic 
operator in the EU 

- 

Legal analysis 

- 

Commission 

Number of cases where this 
economic operator is missing 

Regular checks in the 
context of (coordinated)  
market surveillance 
activities 

No, can be 
included in the 
Pledge 
monitoring 

Simplifying the 
standardization procedures 

Average duration of the 
standardisation procedure 

Observed durations 

Yes 

Strengthening the enforcement 
powers of MSAs 

Number of enforcement 
measures adopted at national 
level 

Level of penalties foreseen at 
national level 

Implementation reports 
of Member States 

Yes (for past) 

Legal analysis 

Yes (for past) 

Introducing the arbitration 
mechanism 

Number of disputes on risk 
assessment solved 

Safety Gate/RAPEX 

Yes 

Incorporation of provisions on 
the food-imitating products in 
the new legal act 

Number of disputes on risk 
assessment of these products 
between Member States 

Safety Gate/RAPEX 

Yes 

Commission 

82 

 
 
 
 
 
Annex 1: Procedural information 

10.  LEAD DG, DECIDE PLANNING/CWP REFERENCES 

This  Staff Working Document was prepared by  the Directorate-General  for Justice and 
Consumers (DG JUST). 

The Decide reference of this initiative is PLAN/2019/6283 Review of the general product 
safety directive -Proposal for a regulation on general product safety. 

This includes the Impact Assessment report as well as the GPSD Evaluation Report, in 
annex to this Impact Assessment. 

11.  ORGANISATION AND TIMING 

  An Inter Service Steering Group (ISSG) has been established to support the work 
of DG JUST on the evaluation and impact assessment of this initiative set up. 

  DGs  participating  in  this  ISSG:  SG,  LS,  CNECT,  COMP,  ENV,  GROW,  JRC 

OLAF, SANTE, TAXUD 

  This  GPSD  ISSG  held  5  meetings  times  (one  informal  meeting  on  14/02/2020 
and  four  formal  meetings  on  12/06/2020,  08/10/2020,  18/11/2020  and 
07/12/2020). DG JUST consulted the ISSG on the different steps of this initiative: 
Roadmap/Inception  Impact  Assessment,  Consultation  strategy,  Open  Public 
Consultation  questionnaire,  the  study  underlying  the  evaluation  and  impact 
assessment (ISSG provided comments on all study steps and reports) and finally 
on the draft Impact Assessment report. 

  Publication  in  EUROPA  of  the  Roadmap  on  the  evaluation/Inception  Impact 

Assessment, 30 June 2020  

  Launch  of  the  Open  Public  Consultation  on  the  combined  Roadmap/Inception 

Impact Assessment, 30 June 2020 - 6 October 2020 (14 weeks). 

12.  CONSULTATION OF THE RSB 

The  RS  has  been  consulted  on  the  Impact  assessment  report  and  issues  a  ‘positive 
opinion with reservations’ on it. 

The two tables  below present  the  elements  of the RSB opinion  and how the report has 
been updated to take them into account: 

Main issues raised by the RSB in its opinion and related updates 

(1) The report does not sufficiently explain how the horizontal and sectoral elements of the product 
safety framework interact with each other in a coherent manner. The fall-back function of the 
GPSD as safety net is not sufficiently elaborated. The links to recent safety related sectoral 
initiatives are not sufficiently clear.  

Related updates: 

  The report clarifies the overall structure of the EU Product safety framework in more detail by 

explaining the interlink between the GPSD and the other sectorial and harmonised legislation at 

83 

 
EU level and the role of GPSD as safety complementing the other legislation to ensure the safety 
of EU consumers for any product now and in the future. The report includes more graphical 
presentation of the general products safety framework.  

  The interlink with the recent and ongoing initiatives, in particular those on digital platforms, 
cybersecurity, circular economy and artificial intelligence, has been better explained.  

(2) The available policy choices are not sufficiently clear. The report presents only a limited set of 
options and lacks detail on the content of the measures contained therein. It does not explain 
sufficiently why some options are discarded.   

Related updates: 

  The report better explains the structure of the options and how they address the objectives but in 

a different level of depth.  

  The discarded options has been further developed in the revised IA report. In particular, the 

report explains why some options already analysed and disregarded in the IA in 2013 can still be 
disregarded now (e.g. to have different safety requirements for harmonised and non-harmonised 
products, extending the scope to services, abolition of the general product safety requirement). 
Also the report explains that some options have been considered and disregarded because of lack 
of proportionality, e.g. higher traceability requirements for all products. 

  The report explains that other stakeholders did not have raised any other new real alternatives in 

the consultation process until now.  

(3) The report does not explain in a convincing manner why the estimated costs for business under 
the integration option (option 4) are much higher than those of the full legal revision option, 
although in terms of substance the options seem very similar.   

Related updates: 

  Under Option 4 the businesses reported higher costs to our contractor. The report admits that 
these costs might be inflated and a clear disclaimer has been included at this respect in the 
revised report.  

Specific improvements requested by the RSB 

(1) The report should explain upfront how the 
horizontal and sectoral elements of the product 
safety policy framework fit together and how the 
GPSD general safety net fallback functions. It 
should better explain the coherence with Regulation 
2019/1020 on market surveillance, and the 
relevance of the recent changes to that Regulation 
for the GPSD. It should better describe the links to 
recent initiatives, such as on digital platforms, 
cybersecurity, circular economy and artificial 
intelligence.   

(2) The report should better present the scope of the 
initiative, especially on which consumer products 
are covered. In this sense, it may help to include a 
diagram presenting the product safety regulatory 
framework. The safety concept needs elaboration. It 
is not clear what types of risks and damages it 
covers, ranging from health to cyber issues. The 
report should detail the specific mechanisms it will 
use to identify future product risks to function as a 
safety net. 

How the RSB comments have been addressed in 
the revised IA report 
Cf main issue 1 
Explained the interaction of the GPSD with other 
EU legislation  and initiatives relating to product 
safety 

Cf main issue 1 
Included a diagram presenting the product safety 
legal framework 
Better explained the scope of the GPSD and the 
proposal 
Better explained the concept of risk in particular in 
the context of new technologies (cybersecurity 
risks) and how these risks could be assessed (e.g. 
when substantial modification of the product) 

(3) The report should reinforce the problem analysis 

Gaps and deficiencies better explained in the 
problem definition. 

84 

 
 
 
 
 
 
to better reflect the deficiencies and gaps the 
initiative wants to solve. It should clarify to what 
extent self-regulatory measures under the Product 
Safety Pledge have been effective and what lessons 
can be learned. It should explain to what extent the 
Pledge helped to get information on emerging risks 
of new technologies and improved recalls.  

Achievements and limitations of the Product safety 
Pledge better spelled out as well as lesson learnt. 

(4) The range of options analysed should be better 
linked with the specific objectives and the problems 
the initiative aims to tackle. The report should 
provide more detail on the content and functioning 
of the proposed policy measures under the various 
options. It should explore whether there are 
alternative policy choices to the substantive 
measures presented for each problem area under the 
preferred option. It should expand on how the self-
regulatory elements could be strengthened. It should 
provide more details about discarded options and 
the reasons for their exclusion from the analysis.   

Cf main issue 2 
The option packages presented in more detail, 
beyond the summary table.  
The alternative options, which have been discarded 
have been included in the IA report. But no new 
policy options. 
The further use of self-regulatory instruments such 
as the Product Safety Pledge after the adoption of 
the initiative has been explained. 
Examples of other voluntary cooperation actions 
with platforms, e.g. during COVID crisis, have been 
introduced. 

(5) The full integration option comes with 
substantial additional costs as regards market 
surveillance for business although there seem to be 
no real substantive differences on new regulatory 
obligations, compared to the full legal revision 
option. The report should review the robustness and 
reliability of the costs estimates provided in the 
support study given their importance for the overall 
comparison and ranking of options.   

(6) The report should provide greater clarity on how 
this initiative will tackle safety issues related to 
consumers’ online purchase from third countries as 
well as software updates. It should explain how the 
sanction regime would work under the different 
options and clarify whether alternatives with 
different deterrence effects can be assessed. It 
should better describe how effective enforcement of 
the options will be ensured.  

(7) The REFIT aspect should be clarified, 
explaining how the initiative would endeavour to 
keep regulatory burdens to the minimum necessary. 
More information is needed on how overlaps 
between lex generalis and lex specialis would be 
prevented.  

Some more technical comments have been sent 
directly to the author DG. 

Cf main issue 3 
The report reviewed the underlying cost data under 
Option 4 and provides the necessary disclaimers. 

A detailed presentation of the measures under the 
different options (cf point (4)) includes now these 
clarifications. The report presents specific 
explanation of measures to tackle safety issues 
related to consumers’ online purchase from third 
countries as well as software updates. The sanction 
regimes have been explained under the different 
options and alternatives analysed. 
The report now elaborates on ways how to ensure 
better enforcement: e.g. introduction of the 
arbitration mechanism, collecting data on 
enforcement capacities of Member States in the 
context of the Consumer Scoreboard to raise 
awareness. 
The report contains now a reinforced explanation on 
the simplifications, avoiding overlaps and 
overregulation and how the initiative would keep 
the minimum necessary regulatory burden while 
ensuring the objectives. 

Other technical comments (e.g. providing summary 
table of the costs of different options) have be taken 
into account. 

85 

 
 
 
 
 
 
 
 
 
 
 
 
13.  EVIDENCE, SOURCES AND QUALITY 

Studies commissioned or supported by the European Commission 

  Study to  support the preparation of an  evaluation of the General  Product Safety 
Directive  as  well  as  of  an  impact  assessment  on  its  potential  revision,  Civic 
consulting, March 2021 

  Study  for  the  preparation  of  an  Implementation  Report  of  the  General  Product 

Safety Directive, Civic consulting, July 2020 

  Study on the assessment of the opportunities for increasing the availability of EU 
data  on  consumer  product-related  injuries,  European  Commission’s  Joint 
Research Centre’s, May 2020 

  Behavioural  Study  on  strategies  to  improve  the  effectiveness  of  product  recalls, 

LE Europe, June 2021 

  Survey on consumer behaviour and product recalls effectiveness, April 2019 

 

Implementation  of  the  new  Regulation  on  market  surveillance:  indication  of 
origin, VVA Europe, May 2015 

External Expertise 

  Consumer Safety Network (CSN) 

  Sub-Group  on  Artificial  Intelligence,  connected  products  and  other  new 

challenges in product safety to the Consumer Safety Network 

Selective bibliography 

  Bernstein A. (2013), ‘Voluntary Recalls’, University of Chicago Legal Forum, 1: 
394  ff.,  available  at:  http://chicagounbound.uchicago.edu/uclf/vol2013/iss1/10  
and  Jacoby  J.  (1984),  ‘Perspectives  on  Information  Overload’,  Journal  of 
Consumer Research 

  OECD  (2020)- 

  ‘E-commerce  in  the  time  of  COVID-19’,  available  at 

http://www.oecd.org/coronavirus/policy-responses/e-commerce-in-the-time-of-
covid-19-3a2b78e8/#biblio-d1e705 

  OECD  (2018),  ‘Enhancing  Product  Recall  Effectiveness  Globally’,  available  at 
https://www.oecd-ilibrary.org/science-and-technology/enhancing-product-recall-
effectiveness-globally_ef71935c-en  

Other Sources 

  Eurostat 
  European Injury Database (IDB) 
  Safety Gate/RAPEX 
  WHO CHOICE 

86 

 
 
 
Annex 2: Stakeholder consultation  

1.  Consultation strategy 

The  impact  assessment  (IA)  for  the  revision  of  the  General  Product  Safety  Directive 
2001/95/EC (GPSD) was supported by the following consultation activities:  

-  public consultation  on the Inception IA and roadmap;  
- 
- 
- 

an open public consultation (OPC);  
stakeholder workshops;  
ad-hoc  contributions  and  targeted  consultations  with  Member  States  (MS)  and 
other stakeholders. 

The objective of these consultations was to collect qualitative and quantitative evidence 
on all key elements of the IA, from relevant stakeholder groups and the general public.  

The stakeholder groups identified as relevant are:  

-  Consumers and consumer organisations,  
-  Businesses and business organisations,  
-  Member States market surveillance authorities,  
-  Other product safety experts.  

The  consultations  were  publicised  via  social  media  posts,  emails  to  existing  networks 
(including in the Safety Gate- RAPEX weekly update newsletter on dangerous products), 
regular meetings of the expert groups and networks, as well as in speeches delivered by 
high-level Commission officials.  

2.  Overview of consultations 

a)  Consultation  on  the  combined  evaluation  roadmap  and  inception  impact 

assessment  

The  consultation  on  the  combined  evaluation  roadmap  and  Inception  IA  took  place 
between 23 June and 1st September 2020. 44 answers were received: 20 from business 
associations,  9  from  company/business  organisation,  5  from  consumer  organisations,  2 
from non-governmental organisations (NGOs), 3 from citizens, 2 from public authorities, 
1 from a trade union, 2 other, and additional 3 feedback were not relevant (because the 
questionnaire was empty or contained almost no information).  

Most  of  the  stakeholders  supported  the  GPSD  revision,  almost  half  of  them  being  in 
favour of the full revision (options 3+4). 

Option 0 (status quo) 
1 stakeholder 
Option 1 (better implementation and enforcement)  7 stakeholders 
Option 2 (targeted revision) 

Option 3 (full revision) 
Option 4 (integration of legal instruments) 

10  stakeholders  (some  willing  only  changes 
regarding the online dimensions) 
12 stakeholders 
9 stakeholders (mainly consumer organisations) 

87 

 
 
The feedback on the IIA (summarised in the next section) has included the objectives as 
well as the set of options to be analysed in the IA.  

b)  Open public consultation on a new Consumer agenda 

The open public consultation (OPC) ran between 30 June 2020 and 6 October 2020, in 
order to gather views of the public on the ‘New Consumer Agenda’ as well as on three 
legislative  proposals  in  the  area  of  EU  consumer  policy,  including  the  review  of  the 
GPSD. The public questionnaire available in the 24 official EU-languages was targeting 
a  wide  range  of  stakeholders,  both  the  general  public  and  relevant  organisations  and 
institutions.  

The section on the GPSD in the public consultation included questions related to both the 
evaluation  of  the  GPSD  and  the  IA  for  its  revision.  The  number  of  respondents  that 
answered at least one question in this section is 257. The majority of respondents  were 
business  associations  and  EU  citizens  (each  26%),  followed  by  company/business 
organisations  (15%).  Other  respondents  included  public  authorities  (11%),  consumer 
organisations (8%), non-governmental organisations (7%), academic/research institutions 
(3%), non-EU citizens (1%) and other respondents (3%).  

The  full  report  on  the  results  of  this  OPC  has  been  published  on  the  Have  Your  Say 
page.136  

Annex 13 contains the summary of the replies of the OPC GPSD part. 

c) 

EU Workshop on strategies to maximise the effectiveness of product recalls 

The EC organised on 23 October 2019 a workshop on the effectiveness of recalls in order 
to  take  stock  of  existing  market  practices  and  regulatory  approaches,  and  identify 
possible  new  avenues  to  maximise  recall  effectiveness.  68  participants  took  part  in  the 
workshop,  including  regulators  from  around  the  world,  representatives  of  international 
organisations,  consumer  organisations,  industry  and  academics.  The  workshop  was 
divided into three thematic sessions, focusing on i) strategies to facilitate direct consumer 
contact,  ii)  strategies  to  increase  consumer  response  to  recalls  and  iii)  roles  and 
responsibilities in the recall process.  

d) 

2020 International Product Safety Week (IPSW) 

The  EC  organised  the  International  Product  Safety  Week  on  9-12  November  2020137. 
This event is the largest gathering of product safety experts from all around the world and 
it takes place every two years. More than 500 participants  from  73 countries registered 
for the 2020 online edition, including regulators, businesses, or consumer organisations. 
Two sessions were organised on topics of interest for the revision of the GPSD, namely 

136 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12466-General-Product-Safety-Directive-
review/public-consultation 

137 https://ec.europa.eu/info/events/international-product-safety-week-2020-2020-nov-09_en 

88 

 
                                                           
 
on  traceability  and  recalls.  Input  on  these  two  topics  was  collected  both  from  a  wide 
diversity of panellists and also from the audience via interactive online surveys.  

e) 

European Consumer Summit 2020 

The  EC  organised  the  European  Consumer  Summit  on  “Consumers  in  the  Green  and 
Digital  Transition:  Challenges  and  solutions  for  a  new  consumer  policy”,  which  took 
place  on  30-31  January  2020138.  This  event  gathered  over  500  stakeholders  including 
policymakers,  national  enforcement  authorities,  academia,  consumer  and  business 
organisations, and youth representatives, from all Member States. Sessions were notably 
organised on “safety and consumer protection in online trade” and “Artificial Intelligence 
–a consumer-centric approach”. Input was also gathered from the audience via interactive 
surveys.  

f)  Workshops on online marketplaces and product safety  

The EC held a number of workshop sessions related to online marketplaces and product 
safety on 8, 10, 13 and 17 July 2020. The objective of the workshops was to gather up-to-
date  information  on  the  state  of  play  concerning  the  main  challenges  in  addressing  the 
sale of illegal goods online. It focused in particular on measures and good practices from 
marketplaces  and  the  cooperation  with  authorities  and  relevant  third  parties.  Input 
gathered  through  these  sessions  aimed  at  feeding  into  the  revision  of  the  e-commerce 
Directive  and  of  the  GPSD.  The  workshops  gathered  more  than  60  participants  each, 
covering  a  very  wide  range  of  stakeholders,  such  as  online  marketplaces,  retailers, 
industry associations, consumer organisations and MS authorities. Annex 14 contains the 
minutes from these workshops. 

g) 

Ad hoc contributions and consultations 

Input from a variety of stakeholders (Member States authorities, consumer organisations, 
businesses,  business  organisations…)  has  been  collected,  notably  via  extensive 
consultations,  in  the  framework  of  the  dedicated  study  for  the  evaluation  and  impact 
assessment  of  the  Directive  as  well  as  the  study  supporting  the  preparation  of  the 
implementation report of the Directive.  
Input  has  also  been  received  from  the  following  stakeholders  via  ad  hoc  contributions 
and/or ad hoc consultations: consumer organisations, businesses, business organisations, 
national chamber of commerce, trademark association. Further bilateral discussions were 
also held with Member State authorities.  

Stakeholders’  input  was  also  collected  through  the  expert  group  ‘Consumer  Safety 
Network’  and  the  Sub-Group  on  Artificial  Intelligence  (AI),  connected  products  and 
other new challenges in product safety. 

A  workshop  of  the  Consumer  Safety  Network  expert  group  was  organised  on  19 
November 2020 to discuss the study results supporting the implementation report of the 

138 https://ec.europa.eu/info/events/european-consumer-summit-2020-2020-jan-30_en 

89 

 
                                                           
Directive, the evaluation and the impact assessment, as well as specific topics of interest 
(penalties, operator-based market surveillance and cooperation with customs authorities).   

The consultations for the evaluation and impact assessment of the revision of the General 
Product Safety Directive, which forms part of the wider consultation strategy on the New 
Consumers  Agenda,  have  also  benefitted  from  the  consultations  on  other  ongoing 
initiatives of the European Commission, namely linked to the White Paper on Artificial 
Intelligence and the proposal for a Digital Services Act.   

3.  Summary of the results of the consultations 

In  the  following  summary,  "consumer  representatives"  means  national  and  EU-level 
consumer  organisations,  "business  representatives"  includes  national  and  EU-level 
business organisations,  

"MS  authorities"  includes  national  market  surveillance  authorities  and  government 
authorities in charge of product safety. 

1) 

Preserving the safety net role of the GPSD  

The  overall  feedback  among  all  stakeholder  groups  is  that  the  GPSD  is  a  useful 
legislation  and  its  safety  net  principle  should  be  preserved.  Consumer  representatives 
also  emphasised  the  precautionary  principle  being  a  key  pillar  of  the  product  safety 
legislation.  

However, a large majority of respondents expressed that current EU safety rules for non-
food consumer products covered by the GPSD could be improved in specific areas to be 
more adequate to protect consumers (71% in OPC).  

2) 

Tackling the challenges posed by new technologies 

Stakeholders  acknowledge  that  new  technologies  raise  many  challenges.  Different 
stakeholders  favoured different approaches to tackle these. In the OPC, almost half the 
respondents  considered  the  safety  of  products  involving  new  technologies  not  to  be 
adequately  regulated  (47%).  The  majority  of  respondents  agree  that  the  definition  of  a 
product  in  the  GPSD  should  specifically  encompass  software  incorporated  into  the 
product, even in case the software is downloaded after the product has been sold (56%). 
About  a  quarter  of  respondents  considered  that  only  software  already  installed  into  the 
product when sold should be included.  

Almost all respondents support the introduction of a requirement for products that could 
be  modified  via  software  updates/download  or  machine  learning  to  remain  safe 
throughout  their  lifetime  (very  important  for  72%,  rather  important  for  24%).  A  clear 
majority  of  respondents  also  favoured  safety  obligations  for  manufacturers  of  products 
incorporating  AI  applications  at  the  design  stage  and  also  during  the  lifecycle  of  the 

90 

 
 
product (75%), whereas only 9% of respondents expressed that the obligations should be 
limited to the design stage.  

In the consultations, consumer representatives and several MS authorities expressed their 
support in extending the definition of ‘safety’ to include (cyber)security aspects that have 
an  impact  on  safety.  In  the  consultation  on  the  Roadmap/Inception  IA,  technology-
oriented businesses showed more reluctance regarding the inclusion in the GPSD of new 
technologies  and  new  risks  related  to  them  as  they  point  out  the  possible  overlap  with 
other  pieces  of  legislation.  Their  preference  is  that  the  GPSD  remains  a  technology-
neutral tool, and that risks linked to new technologies are covered in other more specific 
pieces of legislation. 

3) 

Addressing safety issues associated with products sold online 

The issue of products coming directly or via online platforms from outside the EU was a 
recurrent  issue  mentioned  in  the  consultations.  Businesses  and  business  representatives 
stress  the level-playing  field angle and they point  out  that currently, many  EU  retailers 
suffer from unfair competition in relation to operators based in third countries. Consumer 
representatives  call  to  close  loopholes  regarding  international  e-commerce.  Consumer 
representatives  and  other  stakeholders  also  mentioned  the  issue  of  dangerous  products 
reappearing  on  online  marketplaces.  MS  authorities  stress  the  difficulty  to  control 
products coming from third countries and to take enforcement actions against economic 
operators outside the EU.  

In  the  OPC,  the  majority  of  respondents  expressed  that  they  were  aware  of  problems 
associated  with  online marketplaces  having  no direct  legal  obligations for the safety of 
products hosted on their platform by sellers (53%). When asked about the role that online 
marketplaces should play regarding the safety of products offered on their websites, the 
most  commonly  supported  notions  were  that  they  should  remove  dangerous  products 
listed on their website when notified (77%), that online marketplaces should prevent the 
appearance  of  dangerous  products,  including  their  reappearance  once  they  have  been 
removed (66%) and that they should inform sellers of their obligation to comply with EU 
rules  on  products  (64%).  A  lower  number  of  respondents  thought  that  online 
marketplaces  should  do  a  cursory  check  on  all  products  offered  on  their  website  to 
identify products that likely do not comply with safety rules (42%).  

Views  diverge  between  stakeholders  when  it  comes  to  the  obligations  of  online 
marketplaces:  

-  Consumer  representatives  are  in  favour  of  strengthening  their  responsibilities 

across the supply chain.  

-  Businesses’ views are heterogeneous, in particular:  

o  Retailers  argue  that  online  marketplaces  play  a  key  role  in  the  supply 
chain, and therefore they should have a corresponding responsibility.  

91 

 
 
 
o  Online  marketplaces  responding  to  the  OPC  expressed  that  they  would 
also accept some of the Product Safety Pledge’s provisions being binding, 
but not more. 

According to the  participants of the session on the safety of product sold online at the 
EU  Consumer  Summit  2020,  voluntary  commitments  are  not  sufficient  (89%  of 
respondents),enhanced  responsibility  for  online  marketplaces  are  needed,  as  well  as 
better enforcement (for instance regarding website blocking by authorities). 

4) 

Improving market surveillance rules and enforcement 

Stakeholders  from  all  categories  are  in  favour  of  aligning  market  surveillance  rules 
between  harmonised  and  non-harmonised  products.  Some  stakeholders  insisted  on  the 
fact that the GPSD relies too much on ex post market surveillance, and more action on ex 
ante  prevention  should  be  done  at  different  levels.  Member  States’  authorities  lack  of 
resources for market surveillance was also repeatedly mentioned in consultations. Other 
challenges  mentioned  in  the  OPC  included  the  insufficient  number  of  control  checks 
carried  out,  including  by  customs  (29%),  insufficient  cooperation  between  market 
surveillance  authorities  in  the  EU  (27%),  and  divergences  between  authorities  in  the 
assessment of product risks (19%).  

Regarding  the  introduction  of  a  “responsible  person”  in  the  revised  GPSD,  a  large 
majority  of  respondents  in  the  OPC  considered  that  products  covered  by  the  GPSD 
should only be placed on the EU market if there is an economic operator established in 
the  EU  responsible  for  product  safety  purposes  (70% 
in  favour).  Consumer 
representatives support the introduction of such “responsible persons” in the EU, in line 
with Regulation 1020/2019, but stress that their responsibilities should be strengthened.  

Consumer  representatives  also  call  for  increased  international  cooperation  on  market 
surveillance, product safety, customs and enforcement.  

5) 

Revision of the standardisation process  

Stakeholders are mostly in favour of simplifying the standardisation process to develop 
new  standards.  Consumer  organisations  suggested  the  Commission  Decision  on  safety 
requirements to become legally binding. 

6) 

Including food-imitating products in the scope of the revised GPSD 

Most  stakeholders  are  in  favour  of  incorporating  the  food-imitating  legislation  into  the 
GPSD.  In  the  OPC,  a  large  majority  of  respondents  expressed  that  products  which 
resemble  foodstuff  should  be  incorporated  into  the  general  product  safety  legal 
instrument (69%). In the consultation on the inception IA, including this element in the 
product safety risk assessment was the favoured approach. No support was expressed to 
the full ban of food-imitating products. Consumer representatives also suggest including 
risk  assessment  criteria  regarding  the  child-appealing  aspect  of  products  in  the  revised 
GPSD.  

92 

 
7) 

Improving the framework for product recalls 

Stakeholders’ opinions differ regarding the need to tackle recalls in the revised GPSD. In 
the consultation on the inception IA, some stakeholders stressed that this issue is mostly 
linked to consumers’ behaviours or to rogue traders. In the OPC, approximately a fifth of 
respondents regarded as problematic that there were no specific requirements for product 
recalls (22%). However, a consumer representative pointed out that this issue might not 
appear  very  important  precisely  because  consumers  are  not  sufficiently  aware  about 
recalls. Consumer representatives and many MS  authorities are in  favour of addressing 
them in the legislation or through guidance.  

The crucial importance of using direct communication to consumers for recalls has been 
repeatedly stressed in the consultations, whenever it is possible, for instance because the 
product  was  registered,  bought  online,  or  bought  with  the  use  of  loyalty  card.  Direct 
notification was also  judged  as being by far the  most effective channel  to  spread recall 
information  (according  to  92%  of  respondents  in  the  survey  held  during  the  IPSW 
session on product recalls).  

There  was  also  a  general  agreement  among  respondents  that  companies  should  be 
obliged  to  use  customer  data  at  their  disposal  to  contact  affected  consumers  directly  in 
case of recalls (60% ‘strongly agreed’ and 32% ‘tended to agree’, IPSW survey). In this 
regard,  businesses  and  authorities  call  for  more  clarity  on  data  protection  aspects  and 
compliance with the General Data Protection Regulation. Several stakeholders mentioned 
that  consumers  should  be  able  to  choose  to  receive  safety  notifications  only  (when 
registering a product or subscribing to a loyalty scheme).  

Consumer  representatives  and  authorities  also  stressed  that  online  marketplaces  should 
play a facilitating role in recalls, taking advantage of the channels and systems they have 
already put in place to communicate with both consumers and sellers. In the OPC, more 
than  half  of  the  respondents  agreed  that  online  marketplaces  should  inform  consumers 
when a dangerous product has been removed from the marketplace (55%). The potential 
benefits linked to connected products were also stressed: when a connected product itself 
is subject to a recall, this technology can be used to warn consumers or, if they fail to act, 
switch off the product or reduce its performance.  

Participants in the workshop on recall effectiveness and IPSW session on recalls agreed 
that a recall notice should be easy to read, straight to the point and clearly describe the 
risk and action to take. Several stakeholders stressed that some key elements and ground 
rules, applicable to all recall notices, should be standardised and made compulsory.  

8) 

Improving traceability along the supply chain 

A large majority of stakeholders agree that the system of product traceability should be 
reinforced in the GPSD (82% in favour in the OPC). The elements that most respondents 
in the IPSW online survey wanted to see as mandatory is the type, batch or serial number 
or other element allowing the identification of the product (85%). This was followed by 
the  manufacturer’s  name  (81%),  the  importer’s  name  (63%)  and  the  trademark  (59%). 

93 

 
Most respondents also favoured the possibility to have traceability information available 
in an electronic format only, for instance via a QR code (55%). However, the consumer 
representative noted that vulnerable consumers who do not necessarily have the capacity 
to read a QR code should not be left aside.  

Stakeholders  also  appear  to  be  in  favour  of  the  introduction  of  a  “one  up  one  down” 
traceability requirement in the revision of the GPSD, whereby economic operators have 
to keep information about the upstream and downstream economic operator in the supply 
chain (93% in favour in the slido survey conducted at the recall session of the  IPSW). 
Consumer  representative  explained  that  a  differentiation  between  durable  and  non-
durable  goods  would  be  relevant  when  it  comes  to  the  number  of  years  during  which 
such information should be kept. Moreover, the role of online marketplaces in improving 
product  traceability  was  also  stressed,  notably  that  they  should  check  that  traceability 
information is available before listing a product.  

Stakeholders  would  also  welcome  the  possibility  to  set  up  additional  traceability 
requirements  for  the  components  of  the  product  (74%  in  favour,  IPSW  survey). 
Consumer representative stressed that because of the growing importance of the circular 
economy, traceability is increasingly important not only for the product itself but also for 
its components.  

9) 

Better tackling of chemical risks 

Consumer representatives consider that the revised GPSD should play the role of a real 
safety  net  for  chemicals  in  all  products,  by  setting  detailed  chemical  safety  criteria  for 
non-harmonised consumer products through implementing measures.  

10)  Addressing counterfeit products  

Brand  owner  organisations  stressed  that  the  GPSD  should  be  amended  to  tackle 
counterfeit unsafe products.  

4.  Use of the results of the consultations  

The  results  from  the  consultation  activities  have  been  incorporated  throughout  the  IA 
from    the  problem  definition  to  possible  options  and  their  impacts.  The  consultations 
have  confirmed  the  relevance  of  the  five  objectives  identified  in  the  inception  impact 
assessment, as well as the elements and the options proposed to answer these objectives. 
The  results  have  also  been  taken  into  account  in  the  Evaluation  (Annex  5)  for  the 
assessment of the GPSD against the five evaluation criteria, to reflect the different views 
of the stakeholders.  

Moreover, some elements raised in the consultations will be included as accompanying 
implementation  measures  of  this  initiative,  notably  regarding  international  cooperation: 
consumer  representatives  have  called  for  good  examples  of  cooperation  between 
regulators,  such  as  the  EU-Canada    arrangement    on    product    safety    alerts,    to    be  

94 

 
 
replicated    with    other    countries.  This  will  be  included  in  the  larger  implementation 
strategy.   

Regarding the inclusion  of the fight  against unsafe counterfeit products  in the scope of 
the  revision  of  the  GPSD,  this  issue  was  duly  taken  into  consideration,  but  was  not 
included in the scope of the IA. Indeed, counterfeit products are already addressed by EU 
legislation, and unsafe products are covered including by the GPSD, regardless of their 
authenticity. Even though counterfeit products can pose safety risks, the safety of a given 
product has to be analysed based on a risk assessment.  

95 

 
 
Annex 3: Who is affected and how? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

In case the preferred option 3 is retained, the initiative will have practical implications 
on both the economic operators handling products covered by the GPSD (it can be 
producer,  distributor,  importer,  online  marketplaces  or  fulfilment  house)  and  market 
surveillance authorities in the Member States. 

Under  Option  3,  businesses  will  have  additional  requirements:  manufacturers  and 
importers  will  have  additional  traceability  requirements  and  online  traders  (online 
retailers,  distributors  or  marketplaces)  will  have  the  requirement  to  provide  the  same 
information  online,  which  is  available  offline  (traceability  and  other  mandatory  safety 
information). This would imply for businesses setting up internal mechanisms to ensure 
they  comply  with  these  traceability  and  transparency  provisions.  Comprehensive 
additional requirements would apply in the context of recalls for all businesses, but these 
additional requirements  would have practical  implications only to  those companies that 
have  actually  brought  unsafe  products  onto  the  market.  Online  marketplaces  will  also 
have to make sure they set up internal mechanisms to comply with most of the Product 
Safety Pledge’s provisions and the duty of care responsibility, which would also apply to 
them. In addition, companies selling in the Single Market from outside the EU will have 
to  set  up  arrangements  to  ensure  that  the  products  sold  in  the  EU  have  a  responsible 
economic  operator.  Finally,  enhanced  penalties  would  have  an  impact  on  the  non-
complaint businesses.    

A  broadening  of  market  surveillance  responsibilities,  new  competences  and  a  greater 
need for internal and external resources respectively to perform the market surveillance 
(e.g. the new tools for market surveillance online broaden the possibilities of MSAs and 
may  require  additional  resources  and  skills),  will  impact  market  surveillance 
authorities  in  Member  States.  However,  the  provisions  on  MSAs’  powers  are  largely 
aligned to the existing market surveillance provisions applicable to harmonised products 
under Regulation (EU) 2019/1020. Therefore, these provisions are not new to MSs and in 
particular  for  those  MSs  where  MSAs  handle  already  both  categories  of  products, 
harmonised  and  non-harmonised.  The  practical  implications  are  therefore  rather  better 
synergies  and  use  of  existing  structures  and  resources  than  new  additional  needs.  The 
extended coverage of risks from new technologies (e.g. cyber-security risks that have an 
impact  on  safety)  would  be  expected  to  increase  the  need  for  professional  staff  and 
external expertise on the side of MSAs to check the safety of new technology products.  

The practical implications will start operating as  soon as the revised GPSD has entered 
into force.  

96 

 
 
 
2.  SUMMARY OF COSTS AND BENEFITS 

I. Overview of Benefits (total for all provisions) – Preferred Option 
Description 

Amount 

Comments 

Direct benefits 

Increased  safety  of  non-
harmonised  products  and 
reduced  product  safety  risks 
covered  by  GPSD 
(and 
related  reduction  of  number 
on injuries caused by unsafe 
products) 

Higher  return  rates  during 
recalls of unsafe products 

Level  playing  field  and  a 
better 
EU 
functioning 
internal market 

Reduced 
and burdens for businesses 

regulatory  costs 

Main  impact  on  EU  consumers  via  broader 
coverage  and  greater  effectiveness  of  the 
GPSD  in  protecting  consumers  from  unsafe 
products, in particular in online sales and for 
risks of new technologies. 
Impact  also  on  MS  (positive  impact  on 
health care budget) 

in 

injuries 

the  EU 

suffered  by  EU 
-  Preventable  detriment 
consumers  and  society  due  to  product-related 
accidents estimated at EUR 11.5 billion per year. 
-  the  current  cost  of  health  care  utilisation  for 
is 
product-related 
approximately  EUR  6.7  billion  per  year,  with 
hospitalisation  accounting  for  the  larger  part  of 
the  total  health  care  costs  at  about  EUR  6.1 
billion.  
These costs can be reduced under Option 3 
Options  3  also  expected  to  reduce  consumer 
detriment  estimated  on  the  basis  of  the  value  of 
unsafe  products  by  approximately  EUR  1.04 
billion  in  the  first  year  of  implementation, 
increasing  to  approximately  EUR  5.5  billion 
over  the  next  decade,  This  represents  the 
decrease  of  financial  costs  for  consumers  since 
they would avoid buying unsafe products. 

The  GPSD  Study  also  showed  that  stakeholder 
consider  that  Option  3  provides  ‘moderate’  to 
‘significant’ benefits for consumers.  

Reduced number of deaths and injuries caused by 
products  staying  in  hands  of  consumers  due  to 
delayed  and  badly  managed  recalls.  Reduced 
amount of consumer detriment.  
Reduced consumer detriment related to the value 
of  unsafe  products  which  were  not  effectively 
recalled by EUR 410 million per year. 
Examples  from  ineffective  recalls:  faulty  Takata 
airbags  (estimated  to  have  cause  35  deaths  and 
300 injuries worldwide) and Fisher-Price rock ‘n 
play  baby  sleepers  (associated  with  59  baby 
deaths in the US). 

These  potential  benefits  were  assessed  as  being 
‘moderate’ to ‘significant’ in the Study’s survey 

Main  impact  on  EU  consumers  via  lower 
exposure  to  unsafe  products  and  on  MS 
(positive impact on health care budget).  

Mainly  via  alignment  of 
the  market 
surveillance  rules  for  all  products,  a  clearer 
legal  framework  and  deterrent  effect  on 
rogue traders. 
Main impact on EU businesses.  

to 

Cost  reductions  for  all  businesses  and 
in 
particular for the 42% of businesses who reported 
the  diverging 
related 
additional  costs 
implementation of the GPSD.  
Cost  savings  for  businesses  of  around  EUR  59 
million annually (EUR 34  million saved by EU 
SMEs  and  26  million  EUR  saved  by  EU  large 
businesses 
more 
respectively) 
harmonised implementation. 
Study  showed  that  companies  and  business 
associations  estimate 
the  benefits  between 
‘minor’  and  ‘moderate’  and  MSAs  and  other 
stakeholders to be mostly considerably more than 

through 

uncertainty 

instrument  will 
and 

Main impact on businesses via: 
-legally  binding  clarifications  and  choice  of 
reduce 
Regulation  as 
regulatory 
even 
implementation 
-aligning  the  general  market  surveillance 
and  safety  requirements  for  harmonise  and 
non-harmonised 
reduce 
implementation differences and improve the 
traceability of supply chain 

products  will 

97 

 
 
 
Efficiency  gains  in  market 
surveillance 
and 
enforcement 

‘moderate’ and close to ‘significant’. 

Cost reductions for all MSAs and in particular for 
the16% of MSAs who reported related additional 
costs to the  diverging legal frameworks between 
harmonised and non-harmonised products.  
Cost  savings  for  MSAs  estimated  at  EUR  0.7 
million per year across the EU. 

Reduced 
administrative 
burden of the standardisation 
process 

Not quantifiable 

Indirect benefits 

Positive spill-over effects on 
consumer 
trust,  demand, 
production and employment 

Improved 
competitiveness 

companies’ 

Not quantifiable 

Additional  competitiveness  gains  expected  to  be 
very moderate as companies’ current compliance 
costs  with  consumer  product  safety  legislation 
low  and  additional 
are  already 
regulatory  requirements  would  level  potential 
cost reductions. 

relatively 

impacts 

Positive 
competition-driven 
innovation  

on 

Not quantifiable 

Main  impact  on  MSAs  due  to  aligning 
market  surveillance  provisions  between 
harmonised  and  non-harmonised  products, 
more aligned enforcement powers, increased 
deterrent effect and arbitration mechanism. 

Via the simplification of the standardisation 
the  related  EU 
process  will  streamline 
accelerate 
process.  As 
standardisation work, it would increase legal 
certainty  for  companies  on  the  standards  to 
comply with.  
Main impact on MSs and EC 

it  would 

Via  increased  safety  of  products  and  free 
movement  of  goods  in  the  Single  Market. 
Beneficial for all undertakings 

Via  a  more  harmonised  regulatory  level-
playing field within the EU 
Main impact on EU businesses 

Via  a  greater  degree  of  harmonisation  and 
greater  legal  certainty  (e.g.  development  of 
new  innovative  information  and  traceability 
systems). 

II. Overview of costs – Preferred option 

Citizens/Consumers  

Businesses 

Administrations 

One-off 

Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

- 

- 

New 
general 
due 
diligence 
measures 
of 
economic 
operators 
for 
product 
safety  

Direct costs 

Only 
relatively 
moderate 
one-off 
adaptation 
and 
implementat
ion costs. 

total 
additional 
recurrent 
of 
costs 
in 
MSAs 
EU27 
of 
approx.  EUR 
6.7  million 
annually 

Familiarisation 
costs, 
adaptation  costs 
to 
regulatory 
changes 
Total  costs  of 
businesses 
in 
the EU27 in the 
first  year  of 
implementation 
are  estimated  at 
196.6 
EUR 
million 
(one-
off  +  recurrent 
costs in the first 
year), 
to 
equivalent 
0.02% 
of 
turnover of EU 
companies  for 
manufacturing, 
wholesale  and 

Additional 
regulatory 
compliance 
costs,  related  to 
staff 
and 
additional 
resources (more 
for 
manufacturers  
to 
adjust 
different  stages 
the  value-
of 
adding  process 
to 
new 
regulatory 
requirements)  
Recurrent  costs 
amount to EUR 
177.8 million 
(0,02% 
companies’ 
turnover) 

of 

98 

 
 
 
 
retail  of  non-
harmonised 
consumer 
products.  

- 

- 

- 

- 

Indirect costs 

- 

in 

Potential  impact 
on 
consumer 
the 
prices 
EU,  expected  to 
be 
negligible 
(potentially  for 
low-income 
consumers).  No 
significant 
or 
negative  impact 
consumer 
on 
choice 
the 
EU expected 

in 

- 

- 

Costs 
estimation 
included  in  the 
total above 

of 

Duty 
care 
obligation
s 
for 
online 
marketpl
aces 

Direct costs 

- 

- 

in 
for 

for  all 

Additional 
regulatory 
compliance 
costs, 
online 
marketplaces 
and 
particular 
non-signatory 
of  the  Pledge, 
but  likely  less 
efforts 
than 
those  of  brick 
and 
mortar 
distributors  for 
fulfilling 
their 
obligations 
today. 
Costs 
estimation 
included  in  the 
total above 

Indirect costs 

- 

- 

Direct costs 

is 

All  safety 
informati
on 
provided 
online 
in 
the  same 
vein  as  it 
is 
required 
“offline” 

Indirect costs 

- 

Direct costs 

New 
requirem
ents 
recalls 

on 

Reduced 
cost 
recall 
(improved 

of 

- 

- 

- 

- 

- 

- 

- 

- 

- 

and 
sellers 

Costs to be very 
limited  for  both 
online 
platforms 
online 
(information  
already 
and 
available 
does  not  go 
beyond  what  is 
indicated on the 
packaging) 

- 

- 

- 

- 

- 

- 

- 

Higher 
administrative 
burden 
recalls 

for 
and 

99 

 
 
 
 
remedy) 

registration 
systems.  Costs 
limited 
mainly 
situations 
to 
when 
recall 
occurs 
(unsafe 
product  placed 
on  the  market) 
and  in  any  case 
operators 
should  already 
carry 
out 
effective 
recalls.  

Indirect costs 

Direct costs 

- 

- 

- 

- 

- 

- 

Integratio
n  of  food-
imitating 
products 
into 
GPSD 

- 

- 

- 

Minimal  effect 
on  producers  of 
food-imitating 
products, and in 
any  case  not 
exceeding  costs 
supported 
by 
other producers 

- 

Potentially 
some costs for 
MSAs  which 
were  applying 
a  ban  per  se 
of 
these 
products  and 
to 
will  have 
do 
risk 
a 
assessment. 
Considered  as 
minor in  view 
of  the  limited 
amount 
of 
these products 

Indirect costs 

- 

- 

- 

- 

- 

(1) Estimates to be provided with respect to the baseline; (2) costs are provided for each identifiable action/obligation of  the 
preferred option otherwise for all retained options when no preferred option is specified; (3) If relevant and available, please 
present information on costs according to the standard typology of costs (compliance costs, regulatory charges, hassle costs, 
administrative costs, enforcement costs, indirect costs; see section 6 of the attached guidance). 

100 

 
 
 
 
 
 
Annex 4: Analytical methods 

This Annex provides an overview of the following analytical methods and techniques as 
well as the related data sources used for the impact assessment: 

  Estimation  of  the  detriment  due  to  product-related  injuries  and  fatalities  in  the 

EU; 

  Estimation of costs of compliance with the GPSD for EU businesses; 
  Estimation of costs of compliance with the GPSD for Member states; 
  Estimation of the costs of implementing specific policy options for the potential 

revision of the GPSD;  

  Estimation of benefits of measures concerning online sales channels; 
  Estimation of benefits of measures in the field of recalls; and 
  Methods for other supporting estimations. 

They are elaborated in the following sub-section. 

1.  Estimation of the detriment due to product-related injuries and fatalities in 

the EU 

The cost of non-fatal product related injuries in the EU 
For the calculation of the cost of non-fatal product related injuries in the EU139, we use 
the European Injury Database (IDB) as a source of data on product-related injuries. The 
data  are  voluntarily  contributed  by  the  Member  States  participating  in  the  IDB,  which 
were 15 out of 28 Member States in 2016140. Two levels of datasets exist in the IDB: the 
full  dataset  indicated  as  IDB-FDS  and  the  minimum  dataset  referred  to  as  IDB-MDS. 
The  IDB-FDS  provides  more detailed information with  regards to  the circumstances of 
the  injury  and  the  products  involved,  in  comparison  to  the  IDB-MDS,  which  includes 
limited  information  pertaining  to  the  injury,  but  provides  data  that  can  be  used  to 
extrapolate data to the EU level. For the analysis, both datasets have been used.   

The analysis focused on accidental, non-intentional injuries and excluded transport injury 
events and work-related injuries. As IDB data has also been used as an indicator for the 
European  Commission’s  Consumer  Market  Scoreboard,  we  have  selected  the  same 
product groups used by the Consumer Market Scoreboard to define consumer products as 
represented in the IDB141.  

The analysis refers to the European Union of 27 Member States. The monetary values in the 

139  
analysis are expressed in EUR 2017; in cases where 2017 values have not been available, monetary values 
were inflated to 2017 values using Eurostat’s Labor Cost IndexEurostat, Labour cost index by NACE Rev. 
2 activity - nominal value, annual data [lc_lci_r2_a]. NACE_R2: Industry, construction and services 
(except activities of households as employers and extra-territorial organisations and bodies). Extracted 
16/06/2020.  
140  
141  
consumers’, 10th edition, p. 60-61. 

Ibid., p. 26.  
See European Commission (2014), ‘Consumer Markets Scoreboard. Making markets work for 

101 

 
 
                                                           
To estimate the number of injuries related to different product groups we have used the 
number  of  injuries  recorded  in  the  IDB-FDS  between  2013-2017.  On  basis  of  the  data 
provided in the IDB we estimated the total number of injuries in the EU27 on average per 
year between 2013-2017, using Eurostat population data to extrapolate the FDS data. The 
method for extrapolation is elaborated in detail in Annex IIc.  

Health care utilization 

Health  care  utilization  costs  include  the  costs  of  hospitalization/hospital  admission,  the 
costs  of  treatment  in  a  hospital  emergency  department,  as  well  as  the  costs  of  being 
treated in a non-hospital setting e.g. at a doctor’s office or as an outpatient. To calculate 
the  cost  of  health  care  corresponding  to  the  product-related  injuries,  it  is  necessary  to 
retrieve data regarding the consequences of the injuries in terms of the required medical 
attention as well as the unit costs for each type of health care. The data contained in the 
IDB-FDS  enabled  us  to  identify  between  three  different  groups  of  product-related 
injuries in terms of the type of treatment required: Patients with product-related injuries 
that  are  sent  home  after  treatment;  Patients  with  product-related  injuries  that  are  either 
treated and referred to a general practitioner for further treatment or treated and referred 
for  further  treatment  as  an  outpatient;  Patients  with  product-related  injuries  that  are 
treated and admitted to hospital or transferred to another hospital. 

To arrive at the costs of health care utilization we used the approach as described in the 
following box:  

Health care utilisation costs for a given injury type can be estimated by multiplying the average cost of 
treatment by the number of cases, as indicated below: 

𝐻𝑒𝑎𝑡ℎ𝐶𝑎𝑟𝑒𝑈𝑡𝑖𝑙𝐸𝑈 = ∑[𝑁𝑟𝐼𝑛𝑗𝑢𝑟𝑖𝑒𝑠𝐸𝑈,𝐶𝑎𝑡   ×   𝐴𝑣𝑔𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝐶𝑜𝑠𝑡𝐸𝑈,𝐶𝑎𝑡] 

Where: 
     HealthCareUtilEU is the total cost of health care utilisation at the EU level; 
     NrInjuriesEU,Cat is the number of product-related injuries by treatment category; 
     AvgTreatmentCostEU,Cat 
     given MS, by treatment category. 

the  average  cost  of 

treatment 

for 

is 

the  given 

injury 

in  a  

For  assessing  average  treatment  costs,  we  used  unit  cost  values  for  health  service 
delivery from the WHO-CHOICE project, which are provided for different world regions 
in  2010 international  dollars142. After converting the two types of costs into EUR 2010 
using  the  OECD  purchasing  power  parity  (PPP)  exchange  rate143,  we  inflated  them  to 
EUR 2017 using Eurostat’s Labor Cost Index. Based on these conversions we calculated 
the average cost per inpatient bed hospital day and the average cost per outpatient visit. 
We  used  the  calculated  values  to  estimate  respectively  the  cost  of  the  three  groups  of 
treatment (as indicated above). 

142   WHO Economic Analysis and Evaluation Team (2010), ‘WHO-CHOICE estimates of cost for 
inpatient and outpatient health service delivery’, pp. 1-60, available at: https://www.who.int/choice/cost-
effectiveness/inputs/country_inpatient_outpatient_2010.pdf. 
143  
en (accessed on 06 July 2020).  

OECD (2020), Purchasing power parities (PPP) (indicator), available at: doi: 10.1787/1290ee5a-

102 

 
 
                                                           
Productivity losses 

The  cost  of  productivity  losses  is  considered  for  this  assessment  to  correspond  to  the 
value of missed time from work. The cost of productivity losses was calculated first by 
estimating  the  number  of  work  days  lost  as  a  consequence  of  the  injury  related  to  a 
product  and  then  multiplying  this  number  by  the  EU  average  gross  daily  earnings. 
Product related injuries for which the type of treatment is not indicated or recorded are 
not  taken into account  for the assessment  of productivity losses.  The detailed approach 
for determining productivity losses is provided in the following box:  

The cost of productivity losses for a given treatment category are calculated as the cost of missed work. In 
order to account for the fact that a disproportionate number of injuries occur among children, we take into 
consideration the proportion of victims that are of working age. The calculation can be expressed as: 

𝑃𝑟𝑜𝑑𝐿𝑜𝑠𝑠𝐸𝑈 = ∑[𝑁𝑟𝐼𝑛𝑗𝑢𝑟𝑖𝑒𝑠𝐸𝑈,𝐶𝑎𝑡   ×   𝑊𝐴𝑃𝑜𝑝𝐸𝑈   ×   𝐿𝑀𝑃𝐸𝑈   ×   𝑊𝑎𝑔𝑒𝐸𝑈 ×   𝐷𝑎𝑦𝑠𝐿𝑜𝑠𝑡𝐶𝑎𝑡] 

is 

the 

Where: 
     ProdLossEU is the total cost of productivity losses in the EU; 
Cat 
     NrInjuriesEU, 
     treatment category;  
     WAPopEU is the proportion of the injured persons that are of working age; 
     LMPEU is the labour market participation rate in the EU for working age population; 
     WageEU is the average daily wage in the EU; and 
     DaysLostCat 
     category. 

the  average  number  of  days  of  work 

product-related 

number 

injuries 

lost 

of 

is 

in 

a 

given  

for  a  given 

treatment  

Loss of quality of life  

To estimate the impact of the injury in terms of reduced life quality we use the Quality 
Adjusted  Life  Year  (QALY),  a  measure  that  integrates  evaluation  of  the  quality  and 
quantity of life144. For calculating the cost due to reduced quality of life, we have used 
the following approach145. 

Loss of quality of life will be considered for serious injuries, which are considered to be those for which 
hospitalisation was required, according to the following equation. 

𝐿𝑜𝑠𝑠𝑄𝑢𝑎𝑙𝑖𝑡𝑦𝐿𝑖𝑓𝑒𝐸𝑈 = ∑[𝑁𝑟𝐼𝑛𝑗𝑢𝑟𝑖𝑒𝑠𝐸𝑈,𝐻𝑜𝑠𝑝,𝐼𝑛𝑗   ×   𝐿𝑜𝑠𝑠𝑄𝐴𝐿𝑌𝐼𝑛𝑗   × 𝑉𝑎𝑙𝑢𝑒𝑄𝐴𝐿𝑌𝐸𝑈 ] 

is 

the  monetised 

Where: 
     LossQualityLifeEU 
     hospitalised due to product-related injuries in the EU; 
     NrInjuriesEU,Hosp, 
     related to products in the EU;  
     LossQALYInj is the Quality Adjusted Life Year loss for each main type of injury; 
     ValueQALYEU is the monetary value assigned to a Quality Adjusted Life Year. 

the  number  of  hospitalised  cases  for  each  main 

quality 

total 

loss 

of 

of 

Inj 

is 

life 

of 

patients  

type  of 

injury  

For each of the injuries we have identified on basis of IDB data, we used a corresponding 

Adler, Matthew D. "QALY's and Policy Evaluation: A New Perspective." Yale Journal of Health 

144  
Policy, Law, and Ethics 6, (2006), Hammitt, James K. "QALYs Versus WTP." Risk Analysis 22, no. 5 
(2002): 985-1001.  
145  
Injuries. A proposal based on Quality Adjusted Life Years. Cambridge, Antwerp, Portland: Intersentia, 
2014. 

See Karapanou, Vaia. Towards a Better Assessment of Pain and Suffering Damages for Personal 

103 

 
 
                                                           
QALY-weight  that  expresses  the  impact  of  the  injury  in  terms  of  the  quality  of  life  of 
individuals,  using  relevant  specific  estimates.  Another  approach  that  has  been  used  to 
estimate the WTP for a QALY involves taking advantage of the existing literature on the 
Value of Statistical Life (VSL). This approach, the validity of which was also confirmed 
by  an  expert  of  the  European  Chemicals  Agency  (ECHA),  is  also  consistent  with  the 
VSL approach that is used below to calculate the cost of premature death. We followed 
this  approach  to  derive  the  monetary  value  for  one  QALY,  using  the  VSL  range  of 
estimates  between  €3.5  million  (lower  estimate)  and  €5  million  (higher  estimate) 
included  in  the  Commission’s  Better  Regulation  Toolbox146.  After  expressing  them  in 
EUR  2017  using  the  labour  cost  index  we  converted  them  to  VSLY  estimates  by 
applying a discount factor of 4%147 and a remaining life expectancy of 35 years, which is 
commonly  considered  as  the  remaining  life  expectancy  of  an  adult  at  the  time  of 
injury148. Finally, considering that the resulting values based on the VSL are upper bound 
estimates that tend to overestimate the value per QALY by a factor of two on average, we 
divided  the  estimated  amounts  by  two149.  The  resulting  range  of  willingness  to  pay 
estimates per QALY used in this study are listed in the following table.   

Source 

WTP for a QALY estimate 

Civic Consulting based on VSL estimates 
provided in EU Commission’s Better 
Regulation Toolbox 

€101 706 (low estimate)  
€123 500 (medium estimate) 
€145 294 (high estimate) (in EUR 2017) 

The cost of product related premature death in the EU 

In  order  to  arrive  at  the  number  of  fatal  injuries  in  Europe,  we  have  used  the  WHO 
Mortality  Database  (WHO-MDB)  which  contains  data  for  all  countries  participating  in 
WHO150. To enable a selection of fatal injury incidents that are relevant for this analysis 
we  have  filtered  existing  data  by  selecting  injury  incidents  based  on  specific  ICD-10 
codes. Based on the incidence figures extracted from the WHO dataset we calculated the 
cost of premature death related to the selected fatalities. Our approach is detailed in the 
box: 

Cost of premature death is estimated for all non-intentional fatalities caused by mechanisms relevant for 
product safety (such as tools, strangulation, electric current, or fire) outside of work-related locations, on 
basis of the following equation: 

Where: 

𝐿𝑜𝑠𝑠𝐹𝑎𝑡𝑎𝑙𝐸𝑈 = 𝑁𝑟𝐹𝑎𝑡𝑎𝑙𝐸𝑈   × 𝑉𝑆𝐿𝐸𝑈 

Better Regulation Toolbox complementing the better regulation guideline presented in 

146  
SWD(2017) 350, p. 245.  
147  
SWD(2017) 350, p. 503. 
148   To estimate VSLY we use the formula VSLY= r*VSL/(1-(1+r)^-L) where r is the discount rate and L 

Better Regulation Toolbox complementing the better regulation guideline presented in 

is remaining life expectancy, see also Joseph E. Aldy & W. Kip Viscusi, 2008. "Adjusting the Value of 
a Statistical Life for Age and Cohort Effects," The Review of Economics and Statistics, MIT Press, 
vol. 90(3), pages 573-581.  

Daniel Herrera-Araujo, James K. Hammitt & Christoph M. Rheinberger (2020), “Theoretical 

149  
bounds on the value of improved health”, Journal of Health Economics 72, p. 1-15. 
150  

WHO Mortality Database, accessible at: https://www.who.int/healthinfo/mortality_data/en/. 

104 

 
 
                                                           
     LossFatalEU is the monetised total loss due to the relevant fatalities in the EU; 
     NrFatalEU is the number of relevant fatalities in the EU;  

     VSLEU is the monetary value of a statistical life in the EU. 

The monetary value used to quantify the value of a statistical human life is derived from 
individuals’  willingness  to  pay  (WTP)  to  eliminate  a  small  risk  of  dying151.  Numerous 
studies  exist  in  which the  VSL  has  been  empirically  estimated  using  the  hedonic  wage 
method,  the  stated  preference  method  or  other  methods152.  We  have  used  the  estimates 
provided by the European Chemicals Agency (ECHA) to calculate the cost of premature 
death, which are also referred to as reference values in the Better Regulation Toolbox of 
the European Commission153. More specifically we use  the average value of  the higher 
and  lower  estimate  for  the  value  of  a  statistical  life  provided  by  ECHA  (EUR  4.25 
million) as a standard assumption for the cost of a premature death, while retaining the 
low  and  high  estimates  for  later  sensitivity  analysis.  Expressed  in  2017  values  (again 
inflated  by  using  the  labour  cost  index),  we  arrived  at  a  VSL  estimate  of  EUR  4.6 
million. We have used this estimate to arrive at the annual cost of premature death due to 
fatalities caused by mechanisms relevant for product safety. 

2.  Estimation of costs of compliance with the GPSD for EU businesses 

(baseline business costs) 

We first focused on the estimation of the baseline market size, i.e. the total turnover of 
EU businesses from manufacturing and/or selling non-harmonised consumer products in 
the EU154, before analysing company level compliance cost data, and extrapolating it to 
EU  level,  based  on  the  estimated  baseline  market  size.  The  analysis  is  structured 
according to six steps: 

Step 1: Estimation of EU companies’ total annual turnover from the production and/or 
sales of non-harmonised consumer products in the EU 

industry  codes  and  sector  descriptions,  we 

those 
Based  on  NACE 
manufacturing sectors (NACE Rev. 2, B-E), wholesale services sectors and retail sectors 
(NACE  Rev.  2,  G)  in  which  consumer  products  are  produced  and/or  sold,  i.e.  we 
excluded  sectors  that  clearly  focus  on  the  production  and  sales  of  industrial  products. 
Sectors  related  to  motor  vehicles  have  been  excluded,  in  line  with  the  focus  on  non-
harmonised consumer products. While retail sale can be assumed to be largely related to 
consumer  products  (although  retailers  may  also  sell  to  professional  users,  and  may  sell 
services),  the  wholesale  and  manufacturing  in  the  listed  areas  clearly  also  contain 
industrial/professional  products,  an  issue  considered  in  Step  3  below.  To  arrive  at  the 

identified 

151  
It can also be derived by the willingness to accept (WTA) a small probability of death. 
152   The stated preference method tries to elicit the value of non-market goods by directly asking people 
how much they value these goods while the hedonic wage method uses labor market data that reveal 
the trade-offs workers make between job risks and additional pay. The hedonic wage method belongs 
to the group of revealed preference methods which infer WTP / WTA values from observed behaviour. 
See Alessandra Arcuri, 2012, "Risk Regulation” in: Roger J. Van den Bergh & Alessio M. Pacces 
(ed.), Regulation and Economics, chapter 6, Edward Elgar Publishing.  

Better Regulation Toolbox complementing the better regulation guideline presented in SWD 

153  
(2017) 350, p. 245. 
154  

All estimates in this section refer to the EU27 as of 2020.  

105 

 
 
                                                           
share of non-harmonised products produced and/or sold in these sectors, we applied the 
estimate  provided  in  the  2017  EU  impact  assessment  for  the  new  Market  Surveillance 
Regulation, which estimated that about 54% of products circulating within the European 
Single Market are harmonised products and 46% are non-harmonised products155.  

Step 2: Deduction of extra-EU export 

To calculate the net turnover for non-harmonised consumer products that are only sold in 
the  EU,  we  deducted  the  share  of  extra-EU  exports  from  the  total  turnover  of  EU 
companies. The calculation is based on an approximation of sector-specific export shares. 
The extra-EU trade by enterprise characteristics data provided by Eurostat do not exactly 
match the sector classification of turnover data by enterprise size class156. We therefore 
approximated the extra-EU export shares of manufacturing, wholesale and retail sectors 
on the basis of those sectors for which we found full concordance in the two datasets157. 
The  estimated  extra-EU  export  shares  of  manufacturing,  wholesale  and  retail  sectors 
were  subtracted  from  the  annual  turnover  of  EU  companies  with  non-harmonised 
products in the selected sectors.  

Step 3: Deduction of industrial and professional products 

We corrected the EU turnover derived in Step 2 by the percentage shares of turnover that 
can be attributed to the production and/or sales of consumer products in manufacturing, 
wholesale and retail sectors. For this purpose, we drew on a different dataset, namely the 
final  consumption  expenditure  of  households  by  consumption  purpose158.  We  again 
correct  for  the  share  of  harmonised  products,  and  arrived  at  an  estimate  for  total 
household  consumption  of  non-harmonised  products.  For  the  following  analysis  we 
assumed that this consumption of non-harmonised consumer products is equivalent to the 
total  turnover  from  non-harmonised  consumer  products  sold  by  EU  retailers.  The 
estimated  retail  turnover  from  non-harmonised  products  indicated  before  was  adjusted 
accordingly,  and  the  resulting  amount  was  allocated  between  the  three  enterprise  size 
classes.  Due  to  data  limitations,  the  same  methodology  could  not  be  applied  for 
manufacturing  and  wholesale  sectors159.  For  manufacturing  and  wholesale  sectors,  we 
estimated the share of turnover that can be attributed to consumer products on the basis 
of the share of “consumer-oriented” wholesale services in total wholesale services.  It is 
assumed that the same share reflects the portion of consumer products produced and/or 
sold  by manufacturers.  Based on this approach,  we could  calculate the total  annual  EU 
turnover of EU companies from non-harmonised consumer products.  

SWD(2017) 466 final PART 2/4 Commission Staff Working Document Impact Assessment 

These sectors are: “Manufacture of textiles, Manufacture of wood and of products of wood and 

In the Annex, we provided detailed trade volumes of extra-EU exports by NACE Rev. 2 activity 

155  
Accompanying the document COM(2017) 795. 
156  
and enterprise size class. 
157  
cork, except furniture; manufacture of articles of straw and plaiting materials”, “Manufacture of paper and 
paper products”, “Manufacture of computer, electronic and optical products”, “Manufacture of electrical 
equipment”, “Manufacture of furniture”, “Wholesale trade, except of motor vehicles and motorcycles”, and 
“Retail trade, except of motor vehicles and motorcycles”. In the Annex, we provide shares of extra-EU 
exports in key consumer products sectors broken-down by enterprise size class. 
158  
digit) [nama_10_co3_p3]. 
159  
sectors, i.e. final products that are consumed by households. 

Eurostat data do not allow to extract “pure” consumer products for manufacturing and wholesale 

Eurostat, Final consumption expenditure of households by consumption purpose (COICOP 3 

106 

 
                                                           
Step  4:  Derivation  of  empirical  estimates  for  companies’  product  safety-related  costs 
on the basis of survey responses  

In our company cost survey and the complementary interviews conducted with selected 
companies,  businesses  were  asked  to  indicate  staff  time  used  for  managing  product 
safety,  testing  for  product  safety,  recalls  and  other  consumer  product  safety  related 
activities. We asked respondents to consider all costs for ensuring product safety of both 
harmonised and non-harmonised consumer products (excluding pharmaceuticals, medical 
devices or food), as the identification of costs for non-harmonised products only was not 
considered  to  be  feasible.  In  addition  to  staff  requirements,  companies  were  asked  to 
provide  estimates  for  other  costs  to  comply  with  safety  requirements  for  consumer 
products  (e.g.  costs  for  external  legal  advice,  costs  for  external  safety  testing,  costs  for 
certification of safety of products etc.)160. The cost estimates provided by the respondents 
also include business-as-usual costs, which would incur even in absence of product safety 
regulation  (see  Step  6).  These  estimates  were  used  to  estimate  companies’  annual 
regulatory  compliance  costs  in  Euro  terms.  The  calculation  of  Euro-denominated  costs 
for  staff  was  based  on  the  EU’s  (weighted)  average  wage  for  the  business  economy, 
which in 2019 was 27.50 Euro per hour161. To account for overhead costs, a 25% mark-
up  was  added  to  staff-related  costs.  Subsequently,  the  costs  for  each  company  were 
related to the EU turnover for consumer products, i.e. we expressed companies’ annual 
cost  resulting  from  activities  to  comply  with  safety  requirements  for  (harmonised  and 
non-harmonised) consumer products as a share of the related turnover.  

Step  5:  Extrapolation  of  EU  companies’  annual  costs  related  to  the  GPSD  incl. 
business-as-usual costs that occur also in absence of regulation 

For each enterprise size class, we multiplied the empirical median values for companies’ 
relative  product  safety-related  costs,  which  were  derived  in  Step  4,  with  the  annual 
turnover of EU companies that can be attributed to  the production and/or sales of non-
harmonised  consumer  products  in  the  EU  (Step  3).  The  results  of  this  calculation  still 
include business-as-usual costs. 

Step  6:  Deduction  of  business-as-usual  costs  and  extrapolation  of  EU  companies’ 
annual compliance cost related to the GPSD 

In our company survey and interviews, we asked businesses to indicate the share of the 
total  product  safety-related costs that they would incur anyway (i.e. even in  absence of 
product  safety  legislation,  e.g.  because  these  costs  relate  to  due  diligence),  hereafter 
referred  to  as  business-as-usual  costs,  BAU.  These  estimates  reflected  the  self-
assessment of the companies that are part of the sample, and are therefore subjective in 
nature. However, as concerns differences  between manufacturers, on the one hand, and 
wholesalers  and  retailers,  on  the  other,  we  considered  the  estimates  to  be  in  line  with 
expectations  and  a  credible  basis  for  the  final  step  of  the  assessment.  We  applied  the 
empirical  median  values  of  these  shares  to  the  product  safety-related  cost  estimates 
derived  in  Step  5.  Excluding  business-as-usual  costs,  we  obtained  compliance  costs  of 
EU companies that can be attributed to non-harmonised consumer products, i.e. the costs 
for businesses to comply with the GPSD.  

160  
161  
Eurostat. 

Business stakeholders were asked to estimates average costs per month in EUR. 
Labour cost for LCI (compensation of employees plus taxes minus subsidies), provided by 

107 

 
                                                           
3.  Estimation of costs of compliance with the GPSD for Member States 

(baseline costs for Member States) 

The estimation of MSAs’ staff-related costs related to market surveillance activities for 
non-harmonised consumer products in the EU was based on the following three steps: 

Step 1: Identification of MSAs annual FTEs for market surveillance activities related 
to non-harmonised consumer products 

For  our  estimate  we  used  the  number  of  full  time  equivalent  (FTE)  staff  for  market 
surveillance  of  consumer  products  as  provided  in  the  country  research.  Where  the 
available  country  estimates  related  to  the  market  surveillance  of  non-harmonised 
consumer  products,  this  figure  was  directly  used  in  the  calculation.  Where  estimates 
related to the total staff for market surveillance of both harmonised and non-harmonised 
consumer  products,  we  allocated  staff  according 
the  54%/46%  ratio  for 
harmonised/non-harmonised  products  circulating  within  the  European  Single  Market  to 
derive an estimate for related market surveillance activities162. It should be noted that a 
share of 46% in staff time for market surveillance of non-harmonised consumer products 
is  12  percentage  points  higher  than  the  empirical  median  share  indicated  by  MSAs  for 
activities  devoted  to  non-harmonised  products  in  the  stakeholder  survey  (34%), 
potentially  causing  an  estimate  at  the  higher  end  of  MSAs’  actual  costs  that  can  be 
attributed  to  market  surveillance  activities  for  non-harmonised  consumer  products.  For 
seven countries, no information on staff numbers was available at all.  

to 

Step  2:  Approximation  of  annual  FTEs  for  market  surveillance  activities  related  to 
non-harmonised consumer products for countries for which data was not available 

For  the  seven  countries,  for  which  no  staff  data  was  available  (Croatia,  Germany, 
Hungary, Italy Slovenia, Slovakia, and Spain) we estimated the number of FTEs on the 
basis  of  the  data  for  the  remaining  20  Member  States.  To  account  for  institutional 
differences  with  regard  to  the  level  of  centralisation,  we  considered  two  clusters  of 
countries, in line with the characteristics of the respective market surveillance systems as 
described above:  Cluster 1: responsibility for market surveillance is centralised (no sub-
national  administrations  involved);  Cluster  2:  responsibility  for  market  surveillance  is 
(partly)  delegated  to  or  competence  of  sub-national  administrations,  in  line  with  the 
administrative structure of the country. 

As mentioned before, the 2017 EU impact assessment for the new Market Surveillance Regulation 

162  
estimated that about 54% of products circulating within the European Single Market are harmonised 
products and 46% are non-harmonised products. See SWD(2017) 466 final PART 2/4 Commission Staff 
Working Document Impact Assessment Accompanying the document COM(2017) 795. 

108 

 
                                                           
To  derive  estimates  for  the  number  of  FTEs  per  million  population  for  Slovenia  and 
Slovakia  (more  centralised  market  surveillance),  we  applied  the  sample  median  of  3.5 
FTEs  per  million  population.  To  derive  FTE  estimates  for  the  number  of  FTEs  per 
million population for Croatia, Germany, Hungary,  Italy and Spain  (more decentralised 
market surveillance), we applied the sample median of 4.6 FTEs per million population.  

Step  3:  Calculation  of  annual  staff  costs  for  market  surveillance  activities  related  to 
non-harmonised consumer products  

In  the  final  step,  we  calculated  the  EUR  equivalent  of  the  estimated  number  of  staff 
required  for  market  surveillance  of  non-harmonised  consumer  products  by  multiplying 
the number of FTEs per million population by: 

  The size of population for each country (in million); 
  The number of person-hours per year (1 720) 163; and 

  The average wage of 28.00 EUR, which corresponds to the EU27 average wage 
of “administrative and support service activities” (18.70 EUR) and “professional, 
scientific and technical activities” (37.30 EUR) for 2017 (latest figure available in 
Eurostat database).  

4.  Estimation of the costs of implementing specific policy options for the 

potential revision of the GPSD 

Companies  assessed  in  their  responses  to  our  cost  survey  the  change  that  the 
implementation of each option would cause in their recurrent costs, e.g. costs related to 
additional staff and additional resources for due diligence measures such as  IT systems 
and external services, in addition to one-off costs, such as familiarisation costs and costs 
from adapting to regulatory changes (e.g. for external advice). Both types of costs were 
analysed.  

To estimate the impact of the implementation of each option on EU businesses’ recurrent 
costs,  we  applied  the  percentage  change  in  recurrent  (annual)  costs  as  assessed  by 
respondents to the estimated annual product safety-related costs of companies producing 
and/or  selling  consumer  products  in  the  EU  (baseline  estimates).  Applying  the  sample 
median as best estimate for the extent to which recurrent costs would increase under each 
option, we calculated the change in the estimated annual consumer product safety-related 
costs of EU businesses in Euro terms for manufacturers, wholesalers and retailers.  

Our  estimation  of  EU  businesses’  total  one-off  costs  was  based  on  individual 
respondents’ estimates for the total additional staff needed and the total additional non-
staff costs that arise from familiarisation and implementation efforts under each option. 
Based  on  the  respondents  estimates,  we  calculated  staff  costs  in  Euro  terms  and  added 
other (non-staff) one-off costs. The calculation of Euro-denominated costs for staff was 
based  on  the  EU’s  (weighted)  average  wage  for  the  business  economy,  which  in  2019 

163  
year. See, e.g. the H2020 Programme: User's Guide for the Personnel Costs Wizard. 

Following EU Horizon 2020 guidelines, one person year corresponds to 1 720 person-hours per 

109 

 
                                                           
was 27.50 Euro per hour164. To account for overhead costs, a 25% mark-up was added to 
staff-related costs.  

The total one-off costs for each company were divided by the EU turnover for consumer 
products,  i.e.  we  expressed  companies’  total  additional  one-off  costs  resulting  from 
activities to comply with safety requirements for consumer products under Option3 as a 
share  of  the  related  turnover.  Applying  the  sample  median  to  the  estimated  annual 
turnover for manufacture, wholesale and retail of consumer products in the EU resulted 
in estimates for additional one-off cost for manufacturers, wholesalers and retailers. 

The  estimate  of  recurrent  and  one-off  costs  of  MSAs  was  conducted  using  a  similar 
approach, with estimates on how the implementation of each option would change their 
recurrent  costs  derived  from  the  answers  to  our  survey  of  authorities.  Again,  we 
multiplied  the  empirical  median  with  baseline  costs,  to  estimate  recurrent  costs,  and 
separately assessed one-off costs.  

5.  Estimation of benefits of measures concerning online sales channels 

No consistent data is available on the incidence of unsafe products on the EU market. In 
the analysis, we used stakeholder assessments as best available estimate to first analyse 
the potential detriment accruing currently to consumers due to unsafe products on the EU 
market, and then consider the impact that increasing e-commerce and the implementation 
of  different  policy  options  could  be  expected  to  have  on  this  baseline  situation.  A  key 
challenge  in  this  respect  is  the  size  of  the  detriment  to  consumers  posed  by  unsafe 
products. An unsafe product could lead to injuries and fatalities, which cause substantial 
detriment in the EU every year. Due to data limitations, it is not possible to quantify the 
occurrence of product-related injuries and fatalities, or damage to other goods caused by 
unsafe products according to sales channel. We therefore in this analysis use as proxy for 
the detriment caused by an unsafe product its value (as expressed by its purchase price). 
This approach seems to rather underestimate than overestimate detriment, in light of the 
different situations analysed. In our baseline analysis, we have estimated the total EU27 
household  consumption  of  non-harmonised  consumer  products  (excluding  food  and 
medical  products)  at  EUR  428 664  million  per  year.  Combining  this  data  with  the 
estimate  of  the  incidence  of  unsafe  consumer  products,  we  derive  the  value  of  unsafe 
products per year (which is in our approach equivalent to the related consumer detriment) 
at  EUR  3.9  billion  for  the  online  sales  channels,  and  EUR  15.4  billion  for  brick-and-
mortar shops and other offline sales channels, for a total of EUR 19.3 billion. This figure 
is by its nature an approximate estimate, as the data on which it is based has considerable 
limitations, and the result is affected by the underlying assumptions.  

6.  Estimation of benefits of measures in the field of recalls  

A fundamental obligation that derives from the GPSD is the obligation of producers and 
distributors  to  notify  the  authorities  and  take  the  necessary  actions  for  consumer 
protection, once one of the products that they have placed on the market is identified as 
dangerous165. The limited effectiveness  of recalls also  leads  to  consumer detriment,  the 
size of which is estimated in this annex. 

Labour cost for LCI (compensation of employees plus taxes minus subsidies), provided by 

164  
Eurostat. 
165  

GPSD Art 5 (3). 

110 

 
                                                           
For  estimating  consumer  detriment  due  to  ineffective  recalls,  we  follow  the  approach 
explained  above,  namely  to  use  the  value  of  an  unsafe  product  as  a  proxy  for  the 
detriment  it  causes  to  consumers  that  have  bought  it  (a  detailed  justification  of  this 
approach is provided in the same Annex). When using the value of a recalled product to 
analyse consumer detriment, two situations can be differentiated: 

1.  An unsafe product is recalled and returned to a producer. The resulting consumer 

detriment can be approximated as being zero166; 

2.  An  unsafe  product  is  recalled  and  not  returned  to  a  producer.  In  this  case  the 

consumer detriment is the value of the product, as discussed.  

Under a scenario of improved recall effectiveness, consumer detriment in the EU can be 
expected  to  be  reduced  by  more  than  EUR  400  million  per  year.  As  mentioned  above, 
this estimate is based on a number of scenario assumptions, which have been chosen with 
the aim to provide a conservative estimate of consumer benefits due to improved recall 
effectiveness. A key assumption is that the detriment incurred by consumers in case of a 
recall of an unsafe product  is  equivalent  to  its purchase price. This  is  a very restrictive 
assumption, as it does not consider situations in which a recalled, unsafe product caused 
damage to persons, other goods or the environment. Also, the return rates underlying the 
improved  effectiveness  scenario  are  still  relatively  low  and  might  be  further  increased 
through  appropriate  measures  by  producers  and  authorities,  considering  e.g.,  the 
increased availability of  customer data in  online  transactions.  If  return  rates  were to  be 
improved  beyond  our  assumptions,  consumer  detriment  would  accordingly  be  further 
reduced, compared to the estimate provided.   

7.  Methods for other supporting estimations 

Other  supporting  estimations  include  the  analysis  of  costs  of  mandatory  accident 
reporting  and  the  extrapolation  of  the  number  of  parcels  imported  to  the  EU.  In  both 
cases,  baseline  data  was  extrapolated  using  relevant  data  sources  from  international 
organisations or data from non-EU countries in which comparable measures were taken. 
For  more  details  on  the  methodological  approach  taken  in  each  case,  see  the  relevant 
section of the report.  

8.  Validation and quality assurance of results of analyses conducted 

Great  care  was  taken  to  explore  all  possible  data  sources  at  EU  level  and  from 
international databases to use the best  available data, which is  a key element of quality 
assurance.  All  analyses  were  validated  internally  by  different  members  of  the  team,  to 
safeguard internal consistency and accuracy. Finally, in major analyses external expertise 
was  involved,  either  through  advisory  roles  (e.g.  an  expert  of  EuroSafe  supported  the 
data  extraction  process  related  to  the  IDB),  or  through  providing  advice  on  specific 
methodological  issues.  These  included  the  WHO,  which  was  consulted  on  possible 
approaches  to  group  ICD-10  codes,  and  ECHA,  which  provided  advice  on  the  most 
appropriate method to determine VSLY values.  

Sensitivity  analysis  was  used  to  assess  robustness  of  estimates  against  different 
assumptions, where relevant. With respect to the estimation of detriment, we elaborated 

166  
In reality, even in this situation consumers incur a detriment due to the time spent for the 
transaction, e.g., for returning the product by mail or in person to a shop. However, this additional 
detriment is not considered here, provide a conservative, simplified estimate. 

111 

 
                                                           
sensitivity scenarios concerning the cost of premature death and the loss of quality of life. 
The  first  scenario  to  be  tested  against  the  main  scenario  involved  using  the  lower 
estimate of the VSL to recalculate the costs incurred as a result of premature death. The 
second  scenario  involves  the  opposite  recalculation,  namely  using  the  high  estimate  of 
the VSL and the corresponding QALY value to recalculate the costs incurred as a result 
of  premature  death  and  of  lost  quality  of  life.  The  third  and  fourth  scenarios  take  into 
account the fact that the type of the injury as such e.g. injury to muscle, burn etc. does 
not convey the severity of the injury which may significantly influence the magnitude of 
the loss. Therefore, to account for the possibility of a mild and severe occurrence of the 
same  type  of  injury  we  estimated  the  loss  of  quality  of  life  using  both  low  and  high 
QALY losses per each type of injury. The rest of the assumptions (monetary value of a 
VSL, a QALY) remained the same as in the main scenario. The fifth and final sensitivity 
scenario involved taking into account for the calculation of the cost of premature death 
only the fatalities caused by mechanisms relevant for product safety that occur at home 
keeping everything else constant.  

112 

 
 
 
 
 
Annex 5: Evaluation report 

Table of contents 

1. 

INTRODUCTION .............................................................................................................................. 33 

Purpose and scope .................................................................................................... 33 

2. 

BACKGROUND TO THE INTERVENTION ................................................................................... 34 

Description of the intervention and its objectives .................................................... 34 
Baseline and points of comparison ........................................................................... 37 

3. 

IMPLEMENTATION / STATE OF PLAY ........................................................................................ 38 

4.  METHOD............................................................................................................................................ 41 

Short description of methodology ............................................................................ 41 
External studies ........................................................................................................ 42 
Open public consultation (OPC) and stakeholders’ workshops ............................... 42 
Limitations and robustness of findings .................................................................... 43 

5.  ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS .......................................... 44 

5.1 Relevance ........................................................................................................... 44 
General relevance of the Directive ........................................................................ 44 
5.1.1. 

5.1.2. 

Relevance of of the Directive vis-à-vis E-commerce and direct imports .............. 46 

5.1.3. 

Relevance of the Directive vis-à-vis new technologies ......................................... 50 

5.1.4. 

Relevance of definitions of the Directive .............................................................. 52 

5.1.5. 

Relevance of environmental issues, including chemical risks .............................. 53 

5.1.6. 

Conclusion on relevance ....................................................................................... 55 

5.2 Effectiveness ...................................................................................................... 55 
5.2.1. Extent to which the Directive has been effective in contributing to consumer safety. 55 

5.2.2. Extent to which the Directive has been effective in contributing to the functioning of 
the Single Market .................................................................................................................. 60 

5.2.3 Effectiveness of the system of market surveillance under the Directive ...................... 61 

5.2.4 Effectiveness of Safety Gate/RAPEX .......................................................................... 65 

5.2.5 Effectiveness of the standardisation procedure of the Directive .................................. 66 

5.2.6 Effectiveness of provisions on product recalls ............................................................. 67 

5.2.7 Impact of ecommerce in the effectiveness of the Directive ......................................... 70 

5.2.8 Impact of new technologies in the effectiveness of the Directive ................................ 73 

5.2.9 Effectiveness of Food Imitating Products directive ..................................................... 74 

5.2.10 Conclusion of effectiveness ........................................................................................ 75 

5.3 Efficiency ........................................................................................................... 75 
5.3.1. Analysis of costs .......................................................................................................... 75 

5.3.1.1 Costs for businesses................................................................................................... 75 

30 

 
5.3.1.2 Costs for authorities................................................................................................... 76 

5.3.2. Analysis of benefits ..................................................................................................... 77 

5.3.3. Balance and distribution between costs and benefits .................................................. 78 

5.3.4. Conclusion of efficiency ............................................................................................. 79 

5.4 Coherence ........................................................................................................... 80 
5.4.1 Internal coherence of the Directive .............................................................................. 80 

5.4.2 Coherence with product harmonisation legislation and market surveillance ............... 80 

5.4.3 Coherence with standardisation policies ...................................................................... 83 

5.4.4 Coherence with consumer protection and product liability legislation ........................ 83 

5.4.5 Coherence with E-commerce rules ............................................................................... 85 

5.4.6 Coherence with wider EU policy ................................................................................. 86 

5.4.7 Conclusion on coherence .............................................................................................. 86 

5.5. EU added value ................................................................................................. 87 

6. 

CONCLUSIONS AND LESSONS LEARNT .................................................................................... 88 

APPENDIX 1: PROCEDURAL INFORMATION ...................................................................................... 90 

APPENDIX 2: METHODS AND ANALYTICAL MODELS ..................................................................... 92 

APPENDIX 3: EVALUATION QUESTIONS............................................................................................. 97 

APPENDIX 4: IMPLEMENTATION OF THE FOOD IMITATING PRODUCTS DIRECTIVE .............. 99 

31 

 
Glossary 

Term or acronym 

Meaning or definition 

AI 

BAU 

CETA 

CSN 

DGCCRF 

DSA 

EEA 

EFTA 

EU 

EQ 

FIPD 

GPSD 

IA 

IoT 

NLF 

OECD 

OPC 

Artificial Intelligence 

Business as Usual 

EU-Canada Comprehensive and Economic Trade Agreement 

Consumer Safety Network 

Direction générale de la Concurrence, de la Consommation et de la 
Répression des fraudes, France 

Digital Services Act 

European Economic Area 

European Free Trade Association 

European Union 

Evaluation Question 

Council Directive 87/357/EEC concerning the safety of food-
imitating products  

Directive 2001/95/EC on the general safety of products 

Impact Assessment 

Internet of Things 

New Legislative Framework 

Organisation for Economic Cooperation and Development 

Open Public Consultation 

Safety Gate/RAPEX 

The rapid alert system for dangerous non-food products 

Subgroup 

SME 

UCPD 

VAT 

The Subgroup on AI, connected devices and other new challenges 
in product safety to the Consumer Safety Network  

Small and Medium Enterprise 

Unfair Commercial Practices Directive 

Value Added Tax 

32 

 
 
1. 

INTRODUCTION  

1.1 

PURPOSE AND SCOPE 

Over  two  decades,  the  Directive  2001/95/EC  on  the  general  safety  of  products  (‘the 
Directive’) has established a product safety framework to ensure the safety of consumer 
products. 

In  February 2013 the Commission  adopted the Product  Safety and Market Surveillance 
Package167,  whose  aim  was,  among  other  things,  to  revise  the  Directive.  The  proposed 
rules  however  were  not  adopted  by  the  Council  and  the  Parliament,  due  to  the  lack  of 
political consensus on the so called "made-in" clause. Consequently, the proposals were 
withdrawn in September 2020.  

Since the adoption of the Directive in 2001, new developments in products and markets 
have occurred, in particular as concerns products incorporating new technologies and e-
commerce.  In  addition,  the  adoption  of  new  legal  instruments,  such  as  the  recently 
updated Regulation on market surveillance and compliance of products168, has had as a 
consequence that the Directive’s provisions on market  surveillance are not  fully in  line 
with market surveillance rules for harmonised products. 

The  Directive  has  never  been  evaluated  since  its  entry  into  force169.  In  light  of  the 
above-mentioned  developments,  the  Commission  has  carried  out  an  Evaluation  of  the 
Directive  to  assess  its  performance.  This  evaluation  has  been  prepared  back-to-back 
with the Impact Assessment for a proposal to revise the Directive. This was justified as 
at  the  time  of  the  launch  of  this  initiative  the  Commission  had  already  quite  some 
evidence to support the evaluation and the impact assessment. An impact assessment was 
already  carried  out  by  the  Commission  in  2013,  as  well  as  for  the  recently  adopted 
Regulation  (EU)  2019/2010  on  market  surveillance  and  compliance  of  products. 
Moreover, both the Evaluation and the Impact assessment were supported by a number of 
studies and other data gathered through consultation. A  report on the implementation 
of  the  Directive  also  accompanies  the  Impact  Assessment  and  the  Evaluation,  as 
established in Article 19(2) of the Directive.  

The  geographical  scope  of  the  evaluation  covers  31  countries  (EU28,  Iceland, 
Liechtenstein  and  Norway).  It  focuses  on  the  period  from  2004  (i.e.  subsequent  to  the 
deadline for its transposition and application according to Article 22 of the Directive) to 
2020,  seeking  to  understand  trends  over  this  period  wherever  possible.  This  evaluation 

167 COM(2013) 78 final - The Product Safety and Market Surveillance Package  
168 Regulation (EU) 2019/1020 Regulation on market surveillance and compliance of products 
169 The Product Safety and Market Surveillance Package did not include a proper evaluation of the 
Directive 2001/95/EC according to Better Regulation rules.  

33 

 
 
                                                           
also  covers  Council  Directive  87/357/EEC  concerning  the  safety  of  food-imitating 
products (FIPD)170. 

This  evaluation  assesses  the  following  criteria:  relevance  (whether  the  tools  of  the 
Directive  correspond  to  current  needs),  effectiveness  (whether  the  original  objectives 
have  been  achieved),  efficiency  (the  functioning  of  the  Directive  from  a  simplification 
and  burden  reduction  perspective),  coherence  (how  the  Directive  works  together  with 
other legislation in the field of safety of consumer products), and the EU added value of 
the  Directive.  The  evaluation's  findings  have  fed  into  an  Impact  Assessment  of  the 
policy options, which addresses the problems identified, including those related to food-
imitating products.   

2.  BACKGROUND TO THE INTERVENTION  

2.1 

DESCRIPTION OF THE INTERVENTION AND ITS OBJECTIVES 

The Directive has a twofold objective. On the one hand, according to its recital (2), the 
Directive pursues the aim of improving the functioning of the internal market. As recital 
(3)  confirms,  it  has  introduced  a  common  legislative  framework  in  order  to  avoid 
disparities between Member States that could have emerged in the absence of Union law. 
At the same time, the Directive intends to achieve a high level of consumer protection by 
introducing  a  general  product  safety  requirement and other measures (recital  (4)).  Both 
aims are interrelated, it is the safety requirement for consumer products envisaged by the 
Directive,  which  prevents  disparities  that  would  lead  to  creating  barriers  to  trade  and 
distortion of competition within the internal market. 

The Directive establishes a general safety requirement for all consumer products, as it 
obliges the producers to only place safe products on the market. 

The Directive applies to all sales channels, offline and online.  

Safety of services falls outside the scope of the Directive, but in order to secure a high 
level  of  consumer  protection,  its  provisions  also  apply  to  products  that  are  supplied  or 
made  available  to  consumers  in  the  context  of  a  service  used  by  them.  The  safety  of 
equipment used by the service provider, in particular that on which the consumers ride or 
travel,  is  nevertheless  excluded.  However,  products  which  are  actively  operated  by  the 
consumer at the premises of a service provider, such as hairdryers available to guests in 
hotels rooms, are subject to the provisions of the Directive.  

One of the key characteristics of the Directive is its role as a “safety net”, as it applies 
insofar as  there are no  more specific provisions with  the same objective in  EU product 
harmonisation legislation. Therefore, it complements sectorial legislation, as it covers all 
aspects  and risks not  specifically  addressed, thus  ensuring  a high level  of protection of 
consumers.  

170 Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States 
concerning products which appearing, to be other than they are, endanger the health or safety of consumers 

34 

 
                                                           
Standards are very important for the implementation of the Directive. The general safety 
requirement can be difficult to  apply  for businesses and national  authorities because of 
the  lack  of  a  common  benchmark  on  what  constitutes  a  “safe”  product.  Therefore,  the 
Commission  can  make  use  of  European  standards  to  make  this  general  safety 
requirement  more  operational.  European  standards  are  voluntary  and  market-driven171 
and their advantage is not only that they replace the corresponding national standards in 
all  Member  States,  making  the  life  of  businesses,  including  SMEs,  easier,  but  in 
particular that products are presumed safe if they conform to voluntary national standards 
transposing  European  standards,  which  are  referenced  in  the  EU  Official  Journal. 
Standards  therefore  serve  a  double  purpose:  facilitating  market  access  and  ensuring 
product  safety.  The  first  step  in  the  standardisation  process  under  the  Directive  is  a 
Commission  Decision  to  set  the  so-called  "safety  requirements"  to  be  met  by  the 
standards172.  The  second  step  is  the  adoption  of  a  Commission  Decision173  issuing  the 
formal 
the  European  Standardisation 
Organisations to develop standards compliant with the EC-adopted safety requirements. 
The last step takes place after the European standardisation organisation  has developed 
the  standard  in  conformity  with  the  safety  requirements.  At  this  stage,  in  case  the 
Member  States  in  the  Committee  established  in  Article  15  of  the  Directive  vote 
favourably  and  the  Commission  consider  that  the  standard  complies  with  the 
requirements  of  the  GPSD,  the  Commission  adopts  a  Commission  Decision  to  publish 
the reference to this standard in the EU's Official Journal. A more detailed explanation of 
the standardisation procedure is detailed in Annex 10.  

standardisation 

("mandate") 

request 

to 

The  Directive  provides  for  additional  duties  for  economic  operators,  which  can  be 
differentiated between measures to be taken before or after the product is placed on the 
market:  

  Pre-market  obligations:  Besides  the  general  safety  requirement,  the  Directive 
requires producers to inform consumers of any risks associated with the products 
they  supply.  The  aim  is  to  enable  consumers  to  assess  the  risks  inherent  in  a 
product throughout the normal or reasonably foreseeable period of its use, where 
such  risks  are  not  immediately  obvious  without  adequate  warnings,  and  to  take 
precautions against those risks. This obligation must be fulfilled when the product 
is made available on the market. It not only relates to information on the proper 
use of the product (as described in user manuals), but also to risks that come, for 
example, with the age or the long-term use of the product. Producers should also 

171 They are developed by the European Standardisation Organisations (CEN, Cenelec, ETSI), recognised 
by the Regulation on European Standardisation 1025/2012. ANEC, the European association representing 
consumers in standardisation, is funded by the EU budget and participates as an observer in the Consumer 
Safety Network. 
172 It is based on preliminary work undertaken with Member States, industry and consumer associations 
(i.e. involving the Consumer Safety Network) to check the feasibility, the relevance and to reach consensus 
about the contents of the safety requirements. 
173 This is done in compliance with the Standardisation Regulation 1025/2012.   

35 

 
                                                           
make sure that any product present on the market can be traced to swiftly enable 
removal if necessary to avoid putting consumers at risk. 

  Post-market  obligations:  Producers  and  distributors  shall  cooperate  with  the 
competent authorities on actions taken to avoid the risks posed by products which 
they  supply  or  have  supplied.  Producers  and  distributors  are  also  required  to 
immediately  notify  the  respective  authorities  in  EU  Member  States  in  case  they 
know or ought to know, on the basis of the information in their possession and as 
professionals, that a product that they have placed on the market poses risks to the 
consumer that are incompatible with the general safety requirement. Accordingly, 
producers  shall  withdraw  unsafe  products  from  the  market,  publish  warnings  of 
unsafe products or recall products from consumers on a voluntary basis or at the 
request of the competent authorities. Distributors are required to act with due care 
and  within  the  limits  of  their  respective  activities,  they  need  to  participate  in 
monitoring the safety of products placed on the market. 

To  complement  this  and  in  order  to  ensure  appropriate  enforcement  of  the  EU  product 
safety  requirements,  the  Directive  also  sets  out  responsibilities  for  Member  States  to 
establish systematic approaches to perform effective market surveillance. Member States 
establish or nominate national authorities competent to monitor the compliance with the 
product  safety  requirements  and  give  the  necessary  powers  to  these  authorities  to  take 
appropriate measures under the Directive. National market surveillance authorities have a 
responsibility to:  

  check whether products available on the market are safe;  
  ensure product safety legislation and rules are applied by manufacturers and other 

 

actors in the supply chain;  
take appropriate action in case a unsafe product is detected on the market.  
The  Directive  sets  up  the  Rapid  Alert  System  for  non-food  Consumer  Products 
(hereinafter  "Safety  Gate/RAPEX").  This  system  establishes  the  circulation  of 
information  among  the  Commission  and  Member  States'  authorities  on  measures  taken 
by  Member  States'  authorities  and  economic  operators  in  relation  to  products  posing  a 
serious risk to the health and safety of consumers. Information on non-serious risks can 
also  be  circulated  under  Safety  Gate/RAPEX.  The  Commission  publishes  relevant 
information concerning all notifications on the EU Safety Gate website174. Member States 
are required to  follow up the notifications  of products  posing a serious risk and inform 
the Commission of any measures adopted. The system has been expanded by Regulation 
765/2008175 to apply also to measures adopted in relation to professional products and to 
other  public  interests  beyond  safety,  such  as  the  protection  of  the  environment  and 
security. 

174https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/r
ape x/index_en.htm 
175 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surveillance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93 

36 

 
                                                           
In some exceptional circumstances, Article 13 of the Directive allows the Commission to 
adopt temporary measures (valid for 1 year), via a decision, to ensure the safety of certain 
products. It can be used in situations where at the same time Member States significantly 
differ on the approach how to deal with the safety risk; where the risk needs to be dealt 
with  a  high  degree  of  urgency  or  where  the  risk  can  be  eliminated  only  by  adopting 
appropriate measures at EU level.  

This  evaluation  also  covers  Council  Directive  87/357/EEC  (FIPD),  that  applies  to 
products  “which,  although  not  foodstuffs,  possess  a  form,  odour,  colour,  appearance, 
packaging,  volume  or  size,  so  that  is  likely  that  consumers,  especially  children,  will 
confuse them with foodstuffs and in consequence place them in their mouths, or suck or 
ingest  them,  which  might  be  unsafe  and  cause,  for  example,  suffocation,  poisoning,  or 
the perforation or obstruction of the digestive tract.”  

2.2 

BASELINE AND POINTS OF COMPARISON  

An intervention logic was developed for the purposes of this evaluation (see Figure 1). It 
shows  the  logical  sequence  and  causal  relationships  between  the  Directive’s  rationale, 
based  on  identified  needs,  its  objectives,  the  activities  undertaken,  the  intended  results 
(outputs),  outcomes  and  impacts.  The  figure  also  shows  other  external  factors  (beyond 
the Directive’s control) that may influence the impacts and outcomes.  

Figure 1: Intervention logic 

Source: GPSD Study 

This  evaluation  takes also into account  the accompanying  Implementation Report 2019 
as established in Article 19 of the Directive.  

37 

 
3. 

IMPLEMENTATION / STATE OF PLAY  

The  first  general  product  safety  directive  was  adopted  in  1992176.  That  directive  was 
amended (resulting in Directive 2001/95/EC on the general safety of products, subject of 
this evaluation) in order to complete, reinforce or clarify some of its provisions in light of 
experience as well as  relevant developments on consumer product safety, together with 
the  changes  made  to  the  Treaty,  especially  in  articles  concerning  public  health  and 
consumer protection, and in the light of the precautionary principle.  

All  EU  Member  States  notified  transposition  measures  of  the  Directive,  and  this 
evaluation  showed  that  there  have  not  been  any  problems  in  the  transposition  of  the 
Directive  into  national  legislation.  There  are  no  open  infringements  regarding  the 
implementation of the Directive.  

Member  States  are  responsible  for  appointing  competent  authorities  responsible  for  the 
implementation  of  the  Directive  at  national  level  and  for  ensuring  that  the  Directive  is 
effectively enforced  within their territories.  In addition,  Article 10 of the Directive sets 
up  an  informal  network  of  the  Member  States'  authorities  aimed  at  further  enhancing 
administrative cooperation (the "Consumer Safety Network"). Given that the Directive 
forms part of the EEA Agreement, the same rules and mechanisms are also in place in the 
EFTA countries applying the EEA Agreement, i.e. Norway, Iceland and Liechtenstein. 

Most market surveillance authorities in the Member States work on the basis of annual 
inspection programmes which take into account, among others, previous experiences and 
findings,  products  that  are  frequently  found  unsafe  and  consumer  complaints.  If 
necessary,  all  Member  States  carry  out  controls  and  tests  which  are  not  necessarily 
foreseen  in  their  programming,  for  example  in  emergency  situations.  To  provide 
assistance  to  the  European  network  of  Member  States'  product  safety  authorities,  the 
Commission has co-funded more than 50 joint actions on market surveillance among 
these authorities since 2007. 

Regarding  the  implementation  of  the  Safety  Gate/RAPEX,  the  number  of  measures 
reported  in  the  system  has  increased  progressively  over  the  years  and  since  2012  has 
stayed just above 2,000 alerts a year. In 2019, a total of 2,243 measures were circulated 
in the system177.  

176 Council Directive 92/59/EEC of 29 June 1992 
177https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/r
apex/reports/docs/RAPEX.2019.report.EN.pdf 

38 

 
 
 
 
 
 
                                                           
Figure 2: Number of alerts in Safety Gate/RAPEX for the period 2003-2019 

Number of alerts per year 

3000

2500

2000

1500

1000

500

0

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Source: Safety Gate/RAPEX 

According  to  Article  12.4  of  the  Directive,  the  Rapid  Alert  System  remains  open  to 
applicant  countries,  third  countries  or  international  organisations,  within  the 
framework  of  agreements  between  the  EU  and  those  countries  or  international 
organisations,  according  to  arrangements  defined  in  these  agreements.  Based  on  this 
article,  a  specific  module  of  the  system  has  been  created  to  allow  for  swift  flagging  of 
notifications  to  the  Chinese  authorities  concerning  unsafe  products  from  China.  The 
Chinese  authorities  investigate  these  cases  in  order  to  trace  back  the  manufacturers, 
exporters  and  businesses  concerned  and  take  measures,  which  most  often  consist  of 
making companies aware of product safety rules in Europe. In addition, an exchange of 
information on unsafe consumer products started with the Canadian authorities in 2019, 
enabled by the EU-Canada Comprehensive and Economic Trade Agreement (CETA) and 
an  Administrative  Arrangement  between  the  European  Commission’s  Directorate-
General  Justice  and  Consumers  and  the  Department  of  Health  Canada.  The  exchanges 
aim  to  help  EU  Member  States  better  target  their  enforcement  efforts  and  identify 
emerging product safety risks.  

Furthermore,  according  to  Annex  II,  point  8  of  the  Directive,  the  Commission  shall 
regularly update guidelines concerning the joint management of the Rapid Alert System 
by the Commission and the Member States. A first version of the guidelines was adopted 
in  2004178,  followed  by  another  version  in  2010179.  The  most  recent  version  dates  from 
2018180. 

178 Commission Decision 2004/418/EC (OJ L 151, 30.4.2004, p. 84) 
179 Commission Decision 2010/15 (OJ L 22, 26.1.2010, p1-64) 
180 Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for 
the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 
of Directive 2001/95/EC on general product safety and its notification system (notified under document 
C(2018) 7334). OJ L 73, 15.3.2019, p.121–187 

39 

 
 
                                                           
When it comes to standardisation work under the General Product Safety Directive, there 
are currently a total of 67 standards that have been referenced under the Directive by the 
European  Commission.  In  2019,  all  referenced  standards  were  included  in  a  new 
Decision181,  to  "create  a  complete  list  of  references".  These  standards  concern  the 
following product types: 

  Furniture 
  Gymnastic equipment 
  Stationary training equipment 
  Child use and care articles 
  Bicycles 
  Paragliding equipment 
Internal blinds 
 
  Diving accessories 
  Lighters 
  Roller sports equipment 
  Decorative oil lamps 
  Children's clothing  
  Floating leisure articles 
  Cigarettes (ignition propensity) 
  Child protective products 
  Audio, video and similar (safety requirements) 
 

Information technology equipment (safety - general requirements) 

To  date,  the  Commission  applied  the  procedure  provided  for  in  Article  13  of  the 
Directive on five occasions:   

  Firstly, it was used to extend the ban on phthalates in toys182 during the period up 

to the adoption of the permanent ban under Directive 2005/84/EC183 

  The  next  measure  based  on  this  Article  was  the  Decision  of  11  May  2006184 
requiring Member States to ensure that cigarette lighters placed on the EU market 
be  child-resistant  and  to  prohibit  placing  on  the market  lighters  which  resemble 
objects that are particularly attractive to children (so-called "novelty lighters"). In 
the absence of a suitable revised version of the European standard on child safety 
requirements for lighters which could be referenced in the Official Journal of the 
EU as providing a presumption of conformity with the safety requirement of the 
GPSD, it was necessary to extend the period of validity of this Decision ten times 

181 Commission Implementing Decision (EU) 2019/1698 of 9 October 2019 
182  Commission Decisions 2004/178/EC (OJ L 55, 24.2.2004, p. 66), 2004/624/EC (OJ L 280, 31.8.2004, 
p. 34) and 2004/781/EC (OJ L 344, 20.11.2004, p. 35) 
183  Directive 2005/84/EC (OJ L 344, 27.12.2005, p. 40) 
184  Commission Decision 2006/502/EC (OJ L 198, 20.7.2006, p. 41) 

40 

 
                                                           
(extension which was valid until 11 May 2017185). A new version of the above-
mentioned European standard was referenced in the Official Journal of the EU in 
2017.  

  Another  measure  was  taken  by  the  Decision  of  21  April  2008186  requiring 
Member  States  to  ensure  that  magnetic  toys  placed  or  made  available  on  the 
market  display  a  warning  about  the  health  and  safety  risks  they  pose.  Magnets 
used  in  toys  have  become  more  powerful,  but  also  detach  more  easily,  thus 
presenting life-threatening risks if ingested (as they can perforate the stomach or 
intestines).  The  Commission  adopted  this  temporary  measure  which  was  valid 
until 21 April 2009, until a relevant safety standard was adopted and referenced 
by the Commission in the Official Journal of the EU.  

  Another measure was adopted on 19 March 2009187, requiring Member States to 
ensure  that  products  containing  the  biocide  dimethylfumarate  are  not  placed  or 
made available on the market.  

  Finally, on 9 August  2011 a Decision was  adopted regarding the  compliance of 
standard  EN  16156:2010  and  the  assessment  of  the  ignition  propensity  of 
cigarettes188.  

The enforcement  of  the  FIPD has been unequal  across the EU as Member States have 
divergent  opinions  on  its  interpretation,  in  particular  its  relation  with  other  pieces  of 
sectorial legislation, such as the Toys Safety Directive and the Cosmetic, Detergents and 
CLP  Regulations.  The  Commission  proposed  the  withdrawal  of  the  FIPD  and  the 
inclusion  of  its  provisions  within  the  General  Product  Safety  Regulation  in  the  2013 
Package  on  Product  Safety  and  Market  Surveillance.  The  Commission  has  since 
withdrawn this Package and therefore the FIPD remains in force. More information about 
the implementation of the FIPD is provided in Appendix 4.  

4.  METHOD  

2.2. 

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.  The  evaluation 
received input from 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.  

185 In chronological order: Commission Decision 2007/231/EC (3) until 11 May 2008, Commission 
Decision 2008/322/EC (4) until 11 May 2009, Commission Decision 2009/298/EC (5) until 11 May 2010, 
Commission Decision 2010/157/EU (6) until 11 May 2011, Commission Decision 2011/176/EU (7) until 
11 May 2012, Commission Implementing Decision 2012/53/EU (8) until 11 May 2013, Commission 
Implementing Decision 2013/113/EU (1) until 11 May 2014, Commission Implementing Decision 
2014/61/EU (2) until 11 May 2015, Commission Implementing Decision (EU) 2015/249 (3) until 11 May 
2016 and Commission Implementing Decision (EU) 2016/575 until 11 May 2017 
186 Commission Decision 2008/329/EC (OJ L 114, 26.4.2008, p. 90) 
187 Commission Decision 2009/251/EC (OJ L 74/32) 
188 Commission Decision 2011/496/EU (OJ L 205, 10.8.2011, p. 31–32) 

41 

 
                                                           
2.3.  External studies 

This Evaluation is based on two main building blocks: 

1)  An external study on the Directive aimed to assess its functioning and performance and 
to identify potential shortcomings and whether improvements should be envisaged.  

2)  Complementary studies and research. This includes the following: 

a.  A study on product recall effectiveness  
b.  A  study  to  support  the  preparation  of  the  Implementation  report  of  the 

Directive, which ran from August 2019 to March 2020.  

c.  The European Commission’s Joint Research Centre’s study on the assessment of 
the  opportunities  for  increasing  the  availability  of  EU  data  on  consumer 
product- related injuries189.  

Figure 3: External studies supporting the GPSD initiative 

2.4.  Open public consultation (OPC) and stakeholders’ workshops 

The public consultation on the EU's New Consumer Agenda, that included a specific 
section on the Directive, ran between 30 June 2020 and 6 October 2020. The consultation 
was  available  in  24  official  EU-languages  and  respondents  could  reply  in  any  of  these 
languages. 

The  objective  of  this  consultation  was  to  gather  the  views  of  the  public  on  the  new 
European  consumer  policy  for  the  next  period,  the  so-called  ‘New  Consumer  Agenda', 
including  a  questionnaire  on  the  Directive.  These  views  provided  input  into  the 
evaluation and impact assessment of the General Product Safety Directive. The questions 
on  the  review  of  the  Directive  were  tailored  to  two  main  categories  of  stakeholders, 
respectively  the  general  public  and  stakeholders  who  are  familiar  and  have  certain 
experience  with  market  surveillance  and  product  safety  rules.  There  were  257 
respondents  that  answered  at  least  one  question  related  to  the  General  Product  Safety 
Directive. The majority of respondents were business associations and EU citizens (each 
26%),  followed  by  company/business  organisations  (15%).  Other  respondents  included 

189 https://injuryprevention.bmj.com/content/early/2020/09/28/injuryprev-2020-043677.full 

42 

 
 
                                                           
public authorities (11%), consumer organisations (8%), non-governmental organisations 
(NGOs)  (7%),  academic/research  institutions  (3%),  non-EU  citizens  (1%)  and  other 
respondents (3%). 

Moreover,  the  Commission  set  up  a  Sub-group of  the  Consumer  Safety  Network  on 
artificial  intelligence,  connected  products  and  other  new  challenges  on  product 
safety. The Sub-group’s tasks were to assess whether and to what extent existing product 
safety  frameworks  are  adapted  to  emerging  market  realities  (connected  products,  AI, 
software,  etc.)  and,  in  particular,  to  assist  the  Commission  in  developing  an  EU-wide 
assessment  on  the  need  for  the  possible  adaptations  of  the  General  Product  Safety 
Directive in this regard. The Sub-group was established in November 2019.  

The Commission also organised a series of workshops as part of a broader engagement 
with  stakeholders  and  evidence-collection  strategy,  supporting  the  evaluation  of  the  E-
Commerce Directive  and the impact  assessment for the Digital  Services Act  as well as 
the  revision  of  the  General  Product  Safety  Directive.  The  workshops  aimed  to  gather 
information on the role online marketplaces are playing in the current online supply chain 
and views on their role for the future. The main findings of the workshops are detailed in 
Annex 13.  

Finally, the Commission also engaged with different stakeholders from around the world 
in  the  frame  of  the  International  Product  Safety  Week  in  November  2020,  for  the 
discussion of different topics including products recalls and traceability.  

2.5.  Limitations and robustness of findings 

One  important  limitation  of  this  evaluation  is  the  difficulty  to  differentiate  data 
between  harmonised  and  non-harmonised  products.  The  Directive  plays  a 
complementary to the product harmonisation legislation, and consequently it is extremely 
complicated  to  isolate  the  effects  and  impacts  of  the  Directive.  Moreover,  although 
market surveillance rules differ for harmonised and non-harmonised products, in practice 
Member States organise their investigations and enforcement actions in a comprehensive 
manner,  without  distinguishing  its  legal  basis,  rendering  almost  impossible  to  evaluate 
both  frameworks  separately.  As  a  mitigating  measure,  these  aspects  were  addressed  in 
the consultations activities. 

Moreover, it is worthwhile to mention that data coming from the Safety Gate/RAPEX 
should be interpreted cautiously. Measures reported in the system might be affected by 
multiple  factors,  in  particular  inspection  priorities  of  authorities,  perceived  risks,  etc. 
Besides, notifications only reflect injury events if these are communicated to the market 
surveillance authorities, which is not systematically the case and not based on the actual 
frequency  of  injuries.  Notifications  also  refer  to  products,  but  not  the  exact  number  of 
articles or items affected by the measure. This does not in any way limit the value of the 
system,  but  shows  that  its  data  cannot  be  simply  used  as  proxy  for  product  safety 
trends  or  for  analysing  the  preventive  potential  of  enhanced  product  design  or  safety 
features. Consequently, the evaluation has considered data from Safety Gate/RAPEX as 
one indicator among several, and it is complemented by other datasets and sources.  

43 

 
During  the  consultations  activities,  considerable  efforts  were  made  to  reach  out  SMEs. 
Otherwise  explicitly  mentioned,  opinions  of  SMEs  do  not  significantly  differ  from  the 
opinion of other business stakeholders.  

Information  related to  the product  safety  aspects  of  emerging digital technologies, i.e. 
Internet  of  Things  (IoT)  and  Artificial  Intelligence  (AI),  is  scarce  and  often  not 
sufficiently  mature,  since  some  of  these  technologies  are  still  under  evolution.  The 
conclusions  of  the  evaluation  in  this  aspect  are  based  on  information  collected  from 
stakeholders, studies, media sources and forecasts. 

Notwithstanding the specific limitations mentioned above, which could at least partially 
be  compensated  by  the  answers  obtained  during  the  consultation  activities,  the  overall 
availability  and  reliability  of  data  and  the  approach  taken  is  generally  considered 
satisfactory.   

5.  ANALYSIS AND ANSWERS TO THE EVALUATION QUESTIONS  

5.1 Relevance 

5.2.1.  General relevance of the Directive 

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

  Consumer products placed on the EU market for consumers do not cause harm to the 

safety and health of people.  

  Free movement of goods in the Single Market. 

These original needs remain relevant and match the general objectives of the Directive. 
However, it is important to consider whether the specific tools and provisions provided 
by the Directive continue to be relevant and future-proof. 

A large majority of respondents of the OPC expressed that the current EU safety rules for 
non-food  consumer  products  covered  by  the  Directive  could  be  improved  in  specific 
areas  to  be  more  adequate  to  protect  consumers  (see  figure  4).  Nearly  one  in  four 
respondents  held  that  the  current  rules  were  fully  adequate,  whereas  only  a  small 
minority considered them not to be adequate at all. 

44 

 
 
 
 
 
 
 
 
 
 
Figure 4: Replies to the OPC question: “In your view, to what extent are current EU 
safety rules for non-food consumer products covered by the GPSD adequate to protect 
consumers?” 

Fully 
adequate 
23% 

Not 
adequate at 
all 
6% 

Could be 
improved in 
specific 
areas 
71% 

Source: OPC. Total no. of respondents: 214, Single-choice question 

When  asked  about  problems  related  to  the  implementation  of  safety  rules  for  products 
covered  by  the  Directive,  respondents  of  the  OPC  (see  figure  5)  most  commonly 
expressed that rules were not adapted to online trade (39%) and that the rules were not 
appropriately  enforced  (39%).  More  than  a  third  also  considered  the  rules  not  to  be 
adapted  to  new  technologies  (36%)  and  perceived  legal  definitions  as  not  sufficiently 
clear  or  outdated  (35%).  Slightly  less  than  a  third  of  respondents  (30%)  reported  that 
roles and obligations of different economic operators were not appropriately defined and 
that 
to  report  unsafe  products.  Lastly, 
approximately a fifth of respondents regarded as problematic that there were no specific 
requirements for product recalls (22%) or listed other issues (23%). 

there  were  difficulties  for  consumers 

Figure 5: Replies to the OPC question: “Are you aware of any problems related to the 
implementation of EU safety rules for consumer products covered by the GPSD?” 

RULES ARE NOT ADAPTED TO ONLINE TRADE 

PRODUCT SAFETY RULES ARE NOT APPROPRIATELY 
ENFORCED 

RULES ARE NOT ADAPTED TO NEW TECHNOLOGY 
PRODUCTS (E.G. CONNECTED DEVICES) 

LEGAL DEFINITIONS (SUCH AS “PRODUCT”, “SAFE 
PRODUCT” OR “PLACING ON THE MARKET”) ARE NOT … 

THE ROLES AND OBLIGATIONS OF DIFFERENT 
ECONOMIC OPERATORS ARE NOT APPROPRIATELY … 

DIFFICULTIES FOR CONSUMERS TO REPORT UNSAFE 
PRODUCTS 

THERE ARE NO SPECIFIC REQUIREMENTS FOR 
PRODUCT RECALLS 

OTHER 

39% 

39% 

36% 

35% 

30% 

30% 

22% 

23% 

Source: OPC. Total no. of respondents: 205, Multiple-choice question 

45 

 
 
 
 
 
 
 
 
 
 
Moreover, some stakeholders indicated in their comments that the COVID-19 crisis has 
led to emerging needs in relation to product safety. They expressed that consumer safety 
was a cardinal value, as the COVID-19 crisis has accelerated existing trends, such as the 
increased use by consumers of online retail for non-food purchases. 

In  the  sub-sections  below  the  relevance  of  specific  aspects  and  tools  provided  by  the 
Directive are analysed. 

5.2.2.  Relevance of of the Directive vis-à-vis E-commerce and direct 

imports 

While  the  Directive  does  not  establish  specific  provisions  related  to  online  sales,  it 
clearly applies to all sales channels, offline and online. Case law190 has clarified that EU 
product legislation also applies to cases where online sellers based outside the EU target 
consumers  in  the  EU.  The  assessment  to  determine  if  an  online  offer  targets  EU 
consumers  must  be  done  on  a  case-by-case  basis.  The  following  aspects  could  be 
considered:  the  international  nature of the activity, use of a language  and currency (for 
example the euro) of the Member States, a domain name registered in one of the Member 
States, geographical areas to which dispatch is possible.  

At the same time,  the number of consumers buying products online has drastically 
increased  since  the  adoption  of  the  Directive.  In  2007,  less  than  half  of  Internet  users 
bought  or  ordered  goods  or  services  for  private  use  in  the  previous  12  months;  in 
contrast,  in  2019  that  figured  increase  to  71%,  with  five  countries  (UK,  Denmark, 
Netherlands,  Sweden  and  Germany)  exceeding  80%191.  Furthermore,  the  COVID-19 
crisis  has  accelerated  this  trend:  in  the  EU-27,  retail  sales  via  mail  order  houses  or  the 
Internet in April 2020 increased by 30% compared to April 2019, while total retail sales 
diminished by 17.9% (Figure 6)192.  

190 Judgment of the Court of Justice of the European Union of 12 July 2011, Case C-324/09, L'Oréal/eBay, 
paragraph 65 and Judgment of the Court of Justice of the European Union of 7 December 2010 in joined 
Cases C-585/08 and C-144/09 Peter Pammer v Reederei Karl Schlüter GmbH & Co KG, and Hotel 
Alpenhof GesmbH v Oliver Heller. 
191 Eurostat 
192 OECD -  E-commerce in the time of COVID-19, http://www.oecd.org/coronavirus/policy-responses/e-
commerce-in-the-time-of-covid-19-3a2b78e8/#biblio-d1e705  

46 

 
 
 
 
 
 
 
 
 
                                                           
Figure 6 - Retail turnover, year-on-year change, EU-27 (July 2019- July 2020) 

Source: OECD, E-commerce in the time of COVID-19 

Evidence gathered in the context of the evaluation showed that online sales have led to 
problems  in  enforcing  the  Directive  for  mainly  two  reasons:  difficulties  for  the 
enforcement of the control of products sold online and unavailability of responsible 
economic  operators  measures  could  be  effectively  addressed  to  in  case  products  are 
directly imported from outside the EU. 

In the frame of the preparation of the Notice on the market surveillance of products sold 
online193, as well as discussions held within the Coordinated Activities on Product Safety 
2019194,  the  following  challenges  were  identified  for  market  surveillance  authorities  in 
relation with the safety of products sold online: 

  Sampling:  there  is  a  lack  of  clear  competences  for  authorities  to  engage  in 
mystery shopping  at  the level  of the  Directive.  There are also  legal  restrictions 
for  authorities  in  some  Member  States  that  prevent  them  from  hiding  their 
identity when making online inspections, which can make online product safety 
checks ineffective. 

  Testing:  authorities  face  challenges  in  conducting  risk  assessments  or  safety 

tests due to the lack of physical access to products.  

193 C/2017/5200 Commission Notice on the market surveillance of products sold online 
194CASP 2019 Coordinated Activities on the Safety of Products – Online Market Surveillance – Final 
report 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/assets/documents/casp/CAS
P_HA_online_market_final_report.pdf 

47 

 
 
                                                           
  Resources: the lack of financial resources, or even the lack of credit cards that 
authorities can use for online sampling, combined with the lack of competence to 
ask  traders  for  reimbursement  of  the  product  price  makes  online  market 
surveillance  difficult.  In  contrast,  during  offline  market  surveillance  activities, 
authorities can usually seize products free of charge. 

  Identification  of  economic  operators:  authorities  face  difficulties  finding  and 

contacting the trader selling through online marketplaces.  

  Product  identification:  there  is  often  lack  of  sufficient  data  on  products 
available  online  (no  images  of  labels,  bad  quality  pictures,  and  no  technical 
data).  The  Directive  does  not  establish  obligations  to  economic  operators  on 
what specific information needs to be provided in an online offer.  

  Reappearance of unsafe products and repeat infringers: it often happens that 
offers containing unsafe products that were already removed are re-uploaded on 
the same or a different online marketplace.  

  Awareness:  there is  lack of  awareness among  consumers and businesses about 

buying and selling safe and compliant products online. 

In  addition,  e-commerce  allows  consumers  to  purchase  directly  from  operators  located 
outside  the  EU.  This  makes  it  more  difficult  for  authorities  to  check  the  safety  of 
products  entering  the  single  market.  These  direct  imports  have  increased  in  the  latest 
years:  around  150  million  small  consignments  are  imported  free  of  VAT  into  the  EU 
each  year195  and  it  has  been  reported  that  in  2017  there  were  150.000  private 
consignments coming from China to individual consumers per day196. This is a challenge 
for  product  safety  as,  in  the  case  of  non-harmonised  products197,  there  is  often  no 
economic operator within the EU available that market surveillance authorities could turn 
to  for  enforcement  measures  in  the  EU.  As  noted  above,  the  Directive  imposes 
obligations on the producer as well as on distributors. In practice this means: 

  The  manufacturer’s  representative  and  the  importer  might  be  considered  as 

producers according to Article 2(e) of the Directive. 

  Where  the  producer  is  domiciled  in  a  non-EU/EEA  country,  it  is  in  most  cases 
outside the reach of the market  surveillance authorities of the Member States to 
impose  measures  on  them.  Market  surveillance  authorities  may  be  able  to 
cooperate with the authorities of the non-EU/EEA country where the producer is 

195 European Commission , Memo 2017 - Modernising VAT for e-commerce 
https://ec.europa.eu/commission/presscorner/detail/en/MEMO_16_3746  
196 Eurocommerce – Creating a level-playing field for retail in Europe – August 2019 
197 For a certain number of harmonised products, Article 4 Regulation 2019/1020 foresees the figure of the 
responsible economic operator in the EU. 

48 

 
                                                           
domiciled (which is the exception198), but in principle they cannot take measures 
themselves.  

  Moreover,  if  the  producer  sends  non-harmonised  products  directly  to  the 
consumer, there is  no (other) economic operator  with  product  safety obligations 
involved in the EU.  

The only supply chain actor that is often involved before the consumer gets the product is 
an  online  platform.  However,  it  seems  that  online  marketplaces  do  not  fall  under  the 
definition of distributor under the Directive and therefore they are not subject to product 
safety  enforcement  measures  in  a  way  that  is  foreseen  for  producers  and  distributors. 
Moreover,  even  where  Member  States  have  taken  measures  to  recall  unsafe  products, 
evidence  from  different  investigations  carried  out  by  stakeholders  show  that  recalled 
products often continue to be sold or to reappear on the market in online sales channels. 

The  European  Commission  already  identified  these  challenges  and  took  some  non-
legislative measures to try to tackle the issue. First, it adopted a  Notice on the market 
surveillance  of  products  sold  online199  to  assist  Member  State  authorities  in  the 
enforcement of EU legislation on the safety and compliance of non-food products and to 
contribute  to  a  more  uniform  and  coherent  application  of  that  legislation  in  the  online 
environment.  In  addition,  the  European  Commission  facilitated  the  signature  by  nine 
online marketplaces of the Product Safety Pledge200. This initiative, originally signed in 
2018 and the first of its kind in the product safety area, sets out specific voluntary actions 
in  12  different  areas  by  online  marketplaces  to  improve  product  safety  going  beyond 
what  is  already  established  in  EU  legislation.  As  part  of  the  Pledge,  signatory  online 
marketplaces have committed to report to the European Commission every six months on 
the  actions  taken  to  implement  the  Product  Safety  Pledge,  with  the  inclusion  of  key 
performance indicators. 

However,  stakeholders  have  pointed  out  that  these  measures,  although  positive,  do  not 
resolve  the  underlying  problems  related  to  online  sales.  The  Notice  on  the  market 
surveillance  of  products  sold  online  has  proven  to  be  a  useful  guidance  for  authorities, 
but does not solve the issue that in many countries they have legal and practical barriers 
to  carry  out  online  investigations  and  take  appropriate  measures.  The  Product  Safety 
Pledge  has  set  the  grounds  for  an  increased  cooperation  framework  between  online 
marketplaces and market surveillance authorities. However, as pointed by authorities and 
stakeholders, it remains voluntary, so it cannot be enforced in case of infringements, and 
there are still many actors on the market that have not adhered to the initiative.  

198  
Direct cooperation of market surveillance authorities with other relevant authorities in non-
EU/EEA countries is only carried out in a minority of countries. Authorities from only five countries 
(Germany, France, Ireland, Lithuania, United Kingdom) reported cooperating once every three months or 
more often with non-EU/EEA country authorities, see GPSD implementation study, p 105. 
199 C/2017/5200 Commission Notice on the market surveillance of products sold online 
200 Product Safety Pledge, available at: 
https://ec.europa.eu/info/sites/info/files/voluntary_commitment_document_4signatures3-web.pdf  

49 

 
                                                           
In  conclusion,  it  can  be  noted  that  the  Directive  is  not  adapted  to  the  specific 
challenges  posed  by  online  sales,  including  the  increased  level  of  direct  B2C  imports 
towards  the  EU,  facilitated  by  online  marketplaces  and  fulfilment  service  providers201. 
Many  stakeholders  have  noted  that  it  would  be  beneficial  to  adjust  the  Directive  in 
relation  to  these  additional  economic  operators,  to  address  the  newly  emerged  needs 
related to the online environment and to increase the safety of products sold online to EU 
consumers. 

5.2.3.  Relevance of the Directive vis-à-vis new technologies  

At  the  time  of  the  adoption  of  the  Directive  the  number  of  consumer  products 
incorporating  new  technologies  was  scarce.  This  is  not  the  case  anymore.  There  were 
14.2 billion connected devices in 2019 worldwide, a figure that is estimated to go up to 
25 billion by 2025, of which 4.9 billion will be in Europe202.  

Almost half the respondents of the OPC considered the safety of products involving new 
technologies to be not adequately regulated (47%), with only 18 % stating the opposite. 
The other 35% did not know (see figure 7). 

Figure  7:  Replies  to  the  OPC  question:  “Do  you  think  that  the  safety  of  products 
involving new technologies is adequately regulated?” 

Don't know 
35% 

Yes 
18% 

No 
47% 

Source: OPC. Total no. of respondents: 227, Single-choice question 

201 Fulfilment service providers are defined in Regulation 2019/1020 as follows: ‘fulfilment service 
provider’ means any natural or legal person offering, in the course of commercial activity, at least two of 
the following services: warehousing, packaging, addressing and dispatching, without having ownership of 
the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of 
the European Parliament and of the Council ( 31), parcel delivery services as defined in point 2 of Article 2 
of Regulation (EU) 2018/644 of the European Parliament and of the Council ( 32), and any other postal 
services or freight transport services 
202 Netherlands Entreprise Agency - https://www.cbi.eu/market-information/outsourcing-
itobpo/intergrated-internet-things/market-potential 

50 

 
 
                                                           
The  European  Commission  published  in  February  2020  a  report  on  the  safety  and 
liability  of  new  technologies203.  The  report  identified  uncertainties  linked  to  the 
application of the product safety framework with respect to the specific risks posed by AI 
systems  and  other  digital  technologies.  It  concluded  that  the  current  product  safety 
legislation,  including  the  General  Product  Safety  Directive  and  harmonised  product 
legislation  that  follows  the  horizontal  rules  of  the  “New  Legislative  Framework”204, 
already supports an extended concept of safety protecting against all kind of risks arising 
from new technology products. However, there were a number of unclear areas according 
to the report:  

  EU  legislation  does  not  comprehensively  include  explicit  provisions  regarding 
some categories or risks posed by new technologies, such as cybersecurity risks 
that affect safety. Such provisions would provide a better protection of users and 
more legal certainty for businesses. 

  While  the  Union  product  safety  legislation  takes  into  account  the  safety  risks 
stemming from software integrated in a product at the time of its placing on the 
market and, potentially, subsequent updates foreseen by the manufacturer, there is 
a  lack  of  specific  and/or  explicit  requirements  on  standalone  software  (e.g.  an 
'app' that would be downloaded). The product safety framework does not provide 
for additional obligations for manufacturers to ensure that they provide features to 
prevent the upload of software having an impact on safety during the lifetime of 
AI products205. 

  Regarding  the  concept  of  “placing  on  the  market”,  as  far  as  the  future 
“behaviour” of AI products can be determined in advance by the risk assessment 
carried out by the manufacturer before the products are placed on the market, the 
Union product safety framework already sets out obligations for producers to take 
into  account  in  the  risk  assessment  the  “use”  of  the  products  throughout  their 
lifetime. However, there may be also situations in the future where the outcomes 
of the AI systems cannot be fully determined in advance. In such a situation, the 
risk  assessment  performed  before  placing  the  product  on  the  market  may  no 
longer reflect the use, functioning or behaviour of the product. 

Moreover,  the  Subgroup  on  AI,  connected  devices  and  other  new  challenges  in 
product  safety  to  the  Consumer  Safety  Network  reached  the  following  conclusions 
regarding the relevance of the Directive vis-à-vis new technologies: 

  The  legal  definition  of  safe  product  of  the  Directive  can  be  understood  as 
addressing  many  types  of  risks  by  which  a  product  can,  directly  or  indirectly, 
cause  harm  to  consumers.  However,  it  does  not  explicitly  refer  to  some  risks 

203 Report on the safety and liability implications of Artificial Intelligence, the Internet of 
Things and robotics COM/2020/64 final 

204 Regulation (EC) No. 765/2008 and Decision (EC) No. 768/2008  
205 The Radio Equipment Directive envisages the possibility to adopt delegated acts under its Article 3(3)(i) 
that would partially address this issue.  

51 

 
                                                           
posed to new technologies, such as cybersecurity risks that affect safety (“cyber-
safety”).  

  New  technologies  can  also  pose  risks  not  only  because  they  can  have  a  direct 
impact  on  the  health  and  safety  of  the  consumers,  but  also  because  through 
connectivity,  they  can  be  indirectly  used  as  a  tool  to  put  at  risk  their  personal 
security.  Having  said  that,  it  is  unclear  under  which  legal  or  policy  instrument 
such  personal  security  risks  should  be  tackled  so  that  consumers  are  effectively 
protected against such threats. 

  Regarding  mental  health,  while  they  are  not  a  new  phemonenon,  there  is 
evidence  that  new  technologies  can  have  a  psychological  impact  on  users206. 
However, the Sub-group agreed that risks to mental health that are not intrinsic to 
the product, but come from the use of a product in particular ways, should not be 
considered part of the concept of “safety” in the Directive. 

  Despite  that  the  current  version  of  the  Directive  is  in  theory  broad  enough  to 
cover safety risks resulting from software interacting with the product, it does 
not explicitly mention it, creating legal uncertainty in this regard. 

  One  of  the  common  characteristics  of  AI  and  IoT  products  is  the  presence  of 
software  that  can  change/evolve  over  time.  This  challenges  the  traditional 
meaning of the concept of placing on the market of the Directive.  

Finally,  it  was  mentioned  by  one  stakeholder  of  the  OPC  that  3D  printing  could  also 
affect product safety. However, it appears that this technology does not seem to present 
new  safety  challenges.  3D  printers  are  already  covered  by  sectorial  legislation 
(Machinery Directive). For the products created by the 3D printer, if they are placed on 
the market, they need to comply with product safety legislation, as 3D printing is just a 
new  manufacturing  technique.  Furthermore,  there  is  a  similarity  between  products 
“printed”  by  consumers  for  their  own  use  and  traditional  DIY  products  created  by 
consumers.   

5.2.4.  Relevance of definitions of the Directive 

In  the  context  of  the  GPSD  Study,  stakeholders  were  asked  whether  or  not  they 
considered the key concepts of the Directive to be still relevant or whether they saw a 
need  for  it  to  be  adapted  to  changed  circumstances.  Often,  comparable  numbers  of 
stakeholders even of the same group – companies/business associations, authorities and 
other stakeholders – suggested that a concept should be changed or kept as it is. Figure 8 
provides an overview of results, and indicates the number of respondents that considered 
that a specific concept needed to be clarified and updated:  

206 Dresp-Langley B. Children's Health in the Digital Age. Int J Environ Res Public Health. 2020 May 
6;17(9):3240. doi: 10.3390/ijerph17093240. PMID: 32384728; PMCID: PMC7246471. 

52 

 
                                                           
Figure 8: Replies to the question of the GPSD Study “Considering the emergence of new technologies 
and new business models/actors: Is there a need to clarify and update [the following] terms and concepts 
as currently used in the GPSD? – Number of respondents indicating Yes” 

Source: GPSD Study 

It  appears  that  most  of  stakeholders  detected  that  the  current  definitions  for  some 
concepts do not appropriately reflect the needs of the Directive. The reasons highlighted 
related  to  divergences  with  other  pieces  of  EU  legislation  (see  coherence  section),  but 
also to the fact that some of the definitions are now outdated due to the development of 
new technologies and online sales.  

5.2.5.  Relevance of environmental issues, including chemical risks 

The definition of safety in Art. 2(b) of the Directive covers all product-related risks that 
can affect  the safety and health of persons. This definition therefore also  includes risks 
related to environmental pollutants in products that can affect human health (e.g. heavy 
metals  such  as  lead  and  cadmium,  phthalates,  etc.).  A  broader  scope  of  risks  to  be 
considered  in  addition  to  those  related  to  the  health  and  safety  of  consumers,  such  as 
security and environmental risks, was only introduced with Regulation (EC) 765/2008 
setting  out  the  requirements  for  accreditation  and  market  surveillance  relating  to  the 
marketing  of  products.  Since  then,  the  Safety  Gate/RAPEX  applies  to  measures  which 
prevent,  restrict  or  impose  specific  conditions  on  the  marketing  and  use  of  products 

53 

411131722222524303811191720202225272426844161517151616190102030405060708090Other“Recall”“Withdrawal”“Product”“Dangerous product”“Safe product”“Producer”“Serious risk”“Distributor”“Placing on the market”Number of respondents indicating YESCompanies/ Business associationsAuthoritiesOther stakeholders 
 
posing a serious risk to the health and safety of consumers or to measures which prevent, 
restrict  or  impose  specific  conditions  on  the  marketing  and  use  of  products  posing  a 
serious  risk  to  the  health,  safety  or,  for  harmonised  products,  other  relevant  public 
interests, including environmental risks.  

Data  from  the  Safety  Gate/RAPEX  shows  how  the  number  of  notifications  indicating 
“Environmental”  as  the  type  risk  was  slowly  increasing,  and  in  2019  the  number  of 
notifications suddenly more than tripled. This rapid rise can be explained by the revision 
of the guidelines of the Rapid Alert System adopted in 2018 that clarified the cases where 
risk  assessments  related  to  chemical  risks  do  not  need  to  be  performed  in  order  to 
consider  a  product  as  unsafe.  The  revised  guidelines  have  indeed  set  out  that  if  a 
chemical substance in a product is already banned or restricted by Union legislation, the 
product can be considered to pose a serious risk, without the need to perform a specific 
risk assessment. This has simplified the risk assessment process for chemicals, including 
environmental pollutants with health impact.  

Another factor to  take into consideration in  the surge of notifications on environmental 
risks concerns the increased focus on motor vehicles’ emissions in the aftermath of the 
“Dieselgate”,  and  the  subsequent  number  of  alerts  regarding  vehicles  not  satisfying 
emission standards.  

Figure 9: Number of notifications to Safety Gate/RAPEX mentioning “Environment” among the risk 
types 

Source: Safety Gate/RAPEX.   

A  further  analysis  of  the  recent  dataset  of  the  system  shows  that  there  seems  to  be  a 
general tendency to identify the risk as “chemical” if the substance in the product poses a 
direct health risk to the consumer, e.g. acute poisoning. For the years 2013 to 2019, the 
dataset contains 3 606 notifications (approximately 25% of all notifications in the period) 
of products presenting a “Chemical” risk, more than ten times the number of notifications 
that indicate "Environment" as risk type. However, substances presenting a chemical risk 
will  often  also  have  an  adverse  effect  on  the  environment.  In  some  cases,  the  products 
notified  in  the  rapid  alert  system  contain  substances  that  can  be  dangerous  for  human 
health  (e.g.  cadmium,  lead)  but  that  are  contained  in  parts  of  the  product  that  the 
consumer will not be in direct contact with (e.g. solders). The risk will thus materialise 

54 

 
 
during  the  “end  of  life”  phase  of  the  product,  with  a  possible  accumulation  of  these 
dangerous substances in the environment. While the definition of safety in the Directive 
is considered to cover risks related to environmental pollutants in products that can affect 
human health, this coverage is  not  explicitly stated. This  leaves room for interpretation 
regarding products posing long-term risks stemming from the toxicity  of environmental 
pollutants. The extent to which the Directive is well adapted to environmental issues with 
health  impact  therefore  depends  on  the  interpretation  of  the  definition  of  safety  in  the 
Directive and could be clarified. 

As  regards  emerging  chemical  hazards,  the  Directive  has  showed  in  a  number  of 
occasions  its  particular  relevance  in  being  a  safety  net  and  the  role  of  the  rapid  alert 
system as a ”watchdog” for new chemical hazards. Examples are Dimethilfumarate and 
Bisphenol  A,  for  which  restrictions  were  triggered  after  measures  against  products 
containing these chemicals were reported in Safety Gate/RAPEX (see above section 3). 

It  can  therefore  be  concluded  that  the  Directive  remains  relevant  in  relation  with 
environmental  and  chemical  risks.  However,  legal  changes  might  be  needed  to  clarify 
that risks related to the indirect and long-term health effects of environmental pollution 
under the scope of the Directive. 

5.2.6.  Conclusion on relevance  

Overall, the Directive, its objectives and the product safety framework that it establishes 
remain  relevant  for  the  needs  of  avoiding  harm  to  consumers  and  building  trust  on 
consumer  products  as  a  prerequisite  for  the  free  movement  of  goods.  However,  the 
growth of online sales and the development of new technologies show that some of the 
provisions of the Directive are not well adapted to respond to its objectives. In addition, 
some  of  the  definitions  and  provisions  are  now  outdated  and  could  be  subject  to  fine-
tuning.  

5.2 Effectiveness 

5.2.1.  Extent  to  which  the  Directive  has  been  effective  in  contributing  to 

consumer safety 

Several indicators and data sources can be used to assess the extent to which the GPSD 
and  related  market  surveillance  and  notification  procedures  have  been  effective  in 
achieving a high level of consumer protection through the reduction of unsafe products 
on the EU market. These include the following indicators/sources: 

  Trends in the number of Safety Gate/RAPEX notifications; 

  Share of unsafe products found during market surveillance inspections; 

  Data on product-related injuries; 

  Assessment  of  consumers  and  stakeholders  concerning  the  level  of  product 

safety achieved.  

None of these indicators is without limitations, and to obtain an overall picture they have 
to be considered together.  

55 

 
First, the number of alerts to Safety Gate/RAPEX show a progressive increase over the 
years; since 2012 the total number of notifications was just above 2,000 alerts a year. In 
2019, a total of 2,243 alerts were circulated in the system. The three product categories 
with the largest number of notifications (toys, clothing and motor vehicles) account for 
between 1 050 and 1 350 annual notifications with an average of 1 230 notifications per 
year. 

Notifications in the Safety Gate/RAPEX may include information concerning the number 
of items that are being affected by the measures taken, e.g. the number of items that were 
rejected  at  the  EU  border,  or  the  number  of  items  that  were  recalled  from  the  market. 
This information is part of the notification that is only accessible for market surveillance 
authorities. Table 1 shows an extract of this data, covering a twelve month period from 
May  2019  to  April  2020,  and  including  information  for  a  total  of  536  notifications  in 
which more than 1 000 items were affected.  

Table 1: Number of notifications and number of items affected by measures taken per product category 
(May 2019 to April 2020) 

Product category 

Number of 
notifica-tions 

Motor vehicles 

Construction products 

Protective equipment 
Electrical appliances and 
equipment  

Toys  

Other 

Cosmetics 

Lighting equipment 

Lighting chains 
Childcare articles and 
children's equipment 

Chemical products 

Kitchen/cooking accessories 

Hobby/sports equipment 

Jewellery 
Clothing, textiles and 
fashion items 

Machinery 

Decorative articles 

Pyrotechnic articles 

Measuring instruments 

Gas appliances 

Recreational crafts 

Gadgets 

Total 

Number of items affected, with data referring to ... 

Total 

National 
circulation 

EU/EEA 
circulation 

Worldwide 
circulation 

Unknown 
circulation 

27 240 

1 049 811 

9 424 961 

17 462 909 

27 964 921 

4 800 

4 290 000 

4 500 000 

4 500 000 

16 545 

4 311 345 

638 177 

63 278 

1 146 608 

210 719 

2 058 782 

183 800 

539 534 

483 901 

1 207 235 

105 520 

2 160 

5 952 

1 200 

5 031 

11 000 

3 648 

10 700 

56 560 

12 969 

8 111 

13 197 

22 073 

14 400 

3 000 

1 008 

528 594 

208 063 

231 657 

51 600 

539 294 

264 623 

244 626 

157 120 

131 817 

139 928 

75 073 

57 249 

45 734 

51 394 

24 985 

28 556 

5 052 

6 140 

2 953 

77 233 

63 201 

58 931 

52 594 

52 089 

28 556 

16 052 

14 400 

6 648 

6 140 

2 953 

1 008 

272 

1 

11 

30 

126a) 

7 

12 

11 

17 

9 

4b) 

3 

6 

5 

7 

3 

4 

1 

2 

3 

1 

1 

536 

988 528 

6 084 641 

10 571 569 

24 122 941 

41 767 679 

Source: Safety Gate/RAPEX. Bold = Non-harmonised product category.  

56 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As  the  table  shows,  the  listed  notifications  in  this  twelve-month  period  affected  some 
41.8  million  items  in  total  or  79 900  items  per  notification  on  average.  The  largest 
category  is  “Motor  vehicles”  with  the  highest  number  of  notifications  (272)  and  the 
highest  number  of  items  affected  (approximately  28  million  items).  Notifications  that 
concern clearly non-harmonised product categories (marked in bold) account for a total 
of 169 548 items in this five-month period.  

Regarding evidence  from  market surveillance  activities of Member States authorities, 
table  2  presents  data  on  the  total  number  of  consumer  products  inspected  by  market 
surveillance authorities in the EU/EEA member countries, as well as the total number of 
unsafe  consumer  products  found207.  The  share  of  unsafe  products  found  by  market 
surveillance  authorities  in  their  inspections  is  frequently  between  2%  and  16%  of  total 
consumer products inspected (interquartile range), with the median value being 4%208. In 
some  countries  this  share  is  much  higher:  from  five  countries  it  was  reported  that  the 
share of unsafe products of total consumer products inspected is close to 20% or higher. 
However,  the  GPSD  Study  notes  that  the  data  has  been  reported  from  various  sources 
according to different criteria, so that these figures have to be interpreted with care. As 
market surveillance authorities often sample according to risk-based criteria (i.e. focusing 
on risky products,  conducting visual inspections to  choose for testing products  that can 
potentially  be  unsafe),  this  figure  is  not  representative  of  the  incidence  of  unsafe 
consumer products on the market209.   

Table 2: Share of inspected consumer products and share of unsafe products found (last 
available year, mostly 2018 or 2019)  

Country 

Austria 
Belgiuma) 
Bulgariap) 
Croatiaq) 
Cyprusb) 
Czech Republicc) 
Denmarkd) 
Estoniae) 
Finlandr) 

Total number of 
consumer products 
inspected 

Total number of unsafe 
consumer products 
found 

Share of unsafe products 
found (of total products 
inspected) 

: 

710 

4 624 

4 475 

7 105 

17 088 

2 500 

8 317 

85 

: 

283 

120 

47 

301 

156 

520 

46 

31 

: 

40% 

3% 

1% 

4% 

1% 

21% 

1% 

36% 

The interquartile range is the data between the 25th and 75th percentile of a data series. The 

207 The table includes combined figures for harmonised and non-harmonised products, as separate statistics 
are rarely available. 
208  
median is the middle value, or 50th percentile. In other words, the interquartile range comprises the 
quartiles below and above the median. 
209  
which may be influenced by changing priorities concerning which risks are considered by authorities when 
conducting inspections.  

This risk-based approach also affects the type and number of Safety Gate/RAPEX notifications, 

57 

 
                                                           
Frances) 
Germanyf) 
Greeceg) 
Hungary 
Irelandt) 
Italy 
Latviah) 
Lithuaniai) 
Luxembourgj) 
Maltak) 
Netherlands 
Poland l) 
Portugalu) 
Romaniam) 
Slovenian) 
Slovakia 

Spain 

Sweden 

3 980 

27 541 

850 

: 

492 

: 

1 144 

2 000 

867 

1 313 

6 500 

8 671 

: 

15 245 

605 

: 

: 

: 

760 

12 715 

100 

: 

: 

: 

64 

59 

15 

22 

n.a. 

440 

: 

41 

9 

: 

: 

: 

UK 
Source: GPSD Study, from data provided by market surveillance authorities 

: 

: 

19% 

46% 

12% 

: 

 : 

: 

6% 

3% 

2% 

2% 

n.a. 

5% 

: 

0.3% 

1% 

: 

: 

: 

: 

Furthermore,  according  to  the  analysis  presented  in  Annex  4,  it  is  estimated  that 
consumer  detriment  linked  to  injuries  and  premature  deaths  from  unsafe  products  is 
EUR  76.6  billion  per  year.  This  is  the  sum  of  detriment  caused  by  non-fatal  product-
related injuries, and the cost of premature death due to fatalities caused by mechanisms 
relevant for product safety (such as tools, strangulation, electric current, or fire) occurring 
outside  of  work-related  locations210.  The  analysis  based  on  previous  research  and 
interviews with product safety experts concluded that 15% is a reasonable and cautious 
estimate for the proportion of the total detriment that was caused by consumer products, 
or  could  have  been  prevented  through  better  design,  instruction  or  a  safety  device.  On 
this  basis,  the  preventable  detriment  suffered  by  EU  consumers  and  society  due  to 
product-related accidents can be estimated at EUR 11.5 billion per year. 

In addition to this injury related detriment, the GPSD Study estimates that the consumers 
also suffer financial costs  of a  total  value of  EUR 19.3 billion for 2019 arising from 
the fact they have purchased unsafe products  that they  would not  have purchased if 
they knew these products were unsafe211. 

210 These estimates are based on the best possible approximation of product-related injuries and fatalities. 
The detriment cannot be estimated separately by categories of products and therefore include all consumer 
products, harmonised and non-harmonised products. 
211 This relates to non-harmonised consumer products covered by the GPSD. This is based on the 
assumption that willingness to pay (WTP) for a product depends on the utility of the product for the 
purchaser. WTP is equal or higher as the price for which a product is purchased by a consumer, as 
otherwise the transaction would not take place. It is very likely that WTP would be close to zero for an 
unsafe product (nobody wants to buy e.g., a dangerous childcare product) – so the loss in consumer welfare 

58 

 
                                                           
 
Consumer survey data can also provide supporting evidence regarding product safety, at 
least to the extent that consumers perceive product safety to be an issue relevant to them, 
based  on  their  own  experiences,  the  experiences  of  friends  and  media  reports.  EU  data 
exists concerning the consumer perception of the level of product safety in the EU. The 
data derives from the Commission’s regular surveys on consumer attitudes toward cross-
border trade and consumer protection since 2008 (the last relevant survey was conducted 
in 2018).  

Figure 10: Percentage of consumers who agree that essentially all non-food products 
are safe or that a small number of non-food products are unsafe (EU average), 2008-
2018 

Source: Compilation of the GPSD Study based on data from the Commission’s 2016 and 
2018 survey of consumers’ attitudes toward cross-border trade and consumer protection  

Figure 10 indicates that consumer trust in product safety in the EU has shown a slight 
increase  over  time,  with  the  proportion  of  consumers  agreeing  that  essentially  all  non-
food products in their country are safe (or that only a small number are unsafe) increasing 
from  65%  in  2008  to  78%  in  2016,  before  decreasing  again  to  70%;  a  possible 
explanation provided by stakeholders for this late drop is the increase of unsafe products 
found online. The largest increase (9 percentage points) occurred between the 2014 and 
2016 surveys, before returning in 2018 to slightly above the 2014 level.  

During the GPSD study, stakeholders were consulted on their views about to what extent 
the  Directive  has  been  effective  in  reaching  its  objective  of  protecting  consumers  from 
unsafe products. Their overall opinion was positive, while SME provided a slightly more 
negative opinion in this regard than other businesses.  

is at least the price to which the product was purchased.This calculation assumes that the consumers do not 
get reimbursed for the unsafe product.  

59 

0%10%20%30%40%50%60%70%80%90%100%20082009201020112012201420162018 
 
                                                                                                                                                                            
The available data also confirms that large numbers of unsafe products that could affect 
the  safety  of  EU  consumers  are  rejected  at  the  borders,  withdrawn  from  the  market  or 
recalled.  This  implies  that  a  reduction  of  unsafe  products  on  the  market  is  achieved  in 
practice, in line with the objective of the Directive.  

However, there is still a significant number of unsafe products in the EU market, which 
hint to the fact that the deterrent effect of the Directive might not be effective enough. A 
plausible  explanation  for  this,  suggested  by  several  stakeholders,  might  be  that  the 
maximum amounts of sanctions and penalties for product safety infringements, that are 
not  harmonised  across  Member States, remain  significantly low. Sometimes  companies 
organise  product  recalls  and  other  measures  in  jurisdictions  first  where  the  level  of 
penalties is  higher than in some EU Member States. This  damages the effectiveness of 
the Directive and the EU product safety framework as a whole.   

5.2.2. Extent to which the Directive has been effective in contributing to the 

functioning of the Single Market  

According to its recital (2), the Directive pursues the aim of improving the functioning of 
the  internal  market.  As  recital  (3)  confirms,  it  has  introduced  a  common  legislative 
framework in order to avoid disparities between Member States that could have emerged 
in the absence of Union law. 

The Directive plays an essential role in the functioning of the Single Market, in line with 
the legal basis of the legislation, so that producers ensure safety and market surveillance 
authorities can take  actions against  products,  risks and aspects  not  covered by sectorial 
legislation.  There  is  no  indication  that  Member  States  have  tried  to  stop  the  income  of 
products for  from other EU Countries for which no harmonisation legislation exists and 
to  which  the  Directive  therefore  applies  fully  (non-harmonised  products)  for  other 
reasons than their insufficient level of safety. 

However,  stakeholders  emphasise  that  market  surveillance  authorities  of  different 
Member States may come to different conclusions in relation to the risks posed and 
safety  of  a  particular  product,  and  that  this  in  some  cases  affect  their  operations  and 
increases administrative burdens, thus having a negative impact on the functioning of the 
Single  Market  and  the  level-playing  field  for  economic  operators.  Disputes  between 
Member  States  on  risk  assessments  are  discussed  within  the  Safety  Gate/RAPEX 
network.  Over  recent  years,  the  number  of  such  disputes  to  better  align  the  risk 
assessments  by  different  Member  States'  authorities  has  been  relatively  stable,  as 
indicated in table 3. The number of notifications that were subject to disputes has been on 
average less than 30 per year212.     

212 The number of actual disputes was slightly higher, as in some cases more than one Member State 
provided a different risk assessment in a follow-up notification (or "reaction" as it was named previously) 
compared to the risk assessment by the Member State that submitted the original notification. 

60 

 
                                                           
Table 3: Number of disputes on risk assessments that needed to be discussed within the RAPEX network 

Year 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

Total 

Source: Safety Gate/RAPEX.  

Number  of  notifications  that 
were subject to disputes 
19 

39 

33 

19 

24 

26 

30 

190 

Number of follow up disputes 

21 

41 

39 

24 

28 

27 

30 

210 

In this regard, it is important to note that over the  years, the European Commission has 
issued  a  number  of  guidance  documents  that  support  the  uniform  application  of  the 
Directive in the Member States, including the Commission Implementing Decision (EU) 
2019/417  of  8  November  2018  laying  down  guidelines  for  the  management  of  the 
European  Union  Rapid  Information  System  ‘RAPEX’  according  to  Article  12  of 
Directive  2001/95/EC  on  general  product  safety.  Moreover,  there  is  evidence  that  the 
training  programmes  that  the  European  Commission  organised  for  the  national  market 
surveillance  authorities  and  the  EU  financing  of  coordinated  market  surveillance 
activities  of  EU  Member  States  have  contributed  to  a  more  uniform  application  of  the 
Directive in the Member States. 

Nevertheless,  the  lack  of  a  mechanism  at  EU  level  to  solve  divergent  positions  of 
Member States regarding the risk assessment of a specific product remains a challenge 
for the effectiveness of Directive.  

During  the  GPSD  stakeholders  were  consulted  on  their  views  about  to  what  extent  the 
Directive has been effective in reaching its objective of contributing to the functioning of 
the  Single  Market.  Their  overall  opinion  was  positive,  while  SME  provided  a  slightly 
more negative opinion in this regard than other businesses.  

As conclusion, on a general level the Directive has been effective in contributing to the 
free movement of goods within the Single Market. The lack of a mechanism to arbitrate 
disputes on risk assessment contributes negatively to the effectiveness of the Directive.  

5.2.3 Effectiveness of the system of market surveillance under the Directive 

The  Directive  establishes  the  obligation  for  Member  States  to  carry  out  market 
surveillance activities to enforce is provisions. This evaluation detected three key factors 
that  have  negatively  influenced  the  effectiveness  of  the  market  surveillance  provisions: 
traceability  of  unsafe  products  as  a  precondition  for  market  surveillance;  the  lack  of 
resources of authorities; and the coexistence of two different market surveillance systems 
for  harmonised  and  non-harmonised  products.  The  latter  point  is  developed  in  the 
Coherence section; the other two here below. 

61 

 
The  extent  to  which  actions  by  market  surveillance  authorities  against  unsafe  products 
are effective depends on how easily, quickly and precisely products can be identified and 
traced  back  to  specific  producers,  importers,  distributors,  sellers  and  consumers.  An 
adequate  system  of  product  traceability  allows  market  surveillance  authorities  to 
determine if an unsafe  product  is  on their market, to  trace the economic  operators who 
made the product  available, and to  enforce the appropriate corrective actions. From the 
perspective  of  the  economic  operator,  traceability  is  fundamental  for  effectively  and 
efficiently managing product risks; increased traceability enables more targeted and less 
costly  corrective  actions,  e.g.  by  limiting  the  size  of  withdrawals  or  recalls.  Finally, 
traceability  is  also  important  for  consumers  because  if  an  unsafe  product  is  already 
purchased, clear product identification is necessary for consumers to respond to a recall. 

It  appears  that  at  present,  the  Directive’s  provisions  on  traceability  are  not  sufficiently 
explicit to guarantee that complete information on supply chains and distribution of the 
product  is  gathered.  The  Directive  does  not  contain  detailed  traceability  requirements. 
Article  5(1)  contains  a  general  obligation  for  producers  to  provide  the  necessary 
information for tracing a product, without asking for specific or minimum identification 
information.  According  to  article  5(1),  this  information  may  for  example  include  “an 
indication,  by  means  of  the  product  or  its  packaging,  of  the  identity  and  details  of  the 
producer and the product reference or, where applicable, the batch of products to which it 
belongs,  except  where  not  to  give  such  indication  is  justified”.  Apart  from  producers, 
distributors are also required to keep and provide documentation necessary for tracing the 
origin  of  the  products  (article  5(2)).  Furthermore,  the  emergence  of  online  sales  poses 
additional  challenges  to  trace  an  unsafe  product  back  to  where  and  by  whom  it  was 
produced and sold from.  

The extent to which these requirements based on the Directive achieve adequate product 
traceability can be demonstrated through the data available in  the Safety  Gate/RAPEX. 
From  2013  to  2019  a  significant  share  of  the  alerts  that  were  submitted  for  unsafe 
consumer products involved products with unknown product information items. In 2019 
for  instance,  36%  of  alerts  for  unsafe  products  did  not  include  information  about  the 
manufacturer; 20% concerned products of unknown brand or batch number/barcode; and 
a share of 12% regarded products with no type or model information. Figure 11 based on 
alerts registered in the EU Safety Gate shows that only an improvement over time on the 
availability of information on the manufacturer and batch number/barcode of the product 
(i.e. a decrease of the number of alerts that did not provide such information). There is no 
clear trend of improvement over time for the rest of the traceability information. 

62 

 
Figure  11:  Share  of  Safety  Gate/RAPEX  alerts  with  unknown  product  information 
items (2013-2019) 

Source: GPSD Study, from Safety Gate/RAPEX data 

The same data also  reveal that missing product information is more typical for specific 
types of products such as laser pointers, lighters, jewellery, decorative articles, etc. What 
these products have in common is that they all fall within the scope of Directive and are 
not subject to sector-specific harmonisation rules. It follows that product categories under 
the Directive are more likely to lack relevant information items that are essential to trace 
them.  

Secondly,  the  market  surveillance  system  under  the  Directive  (consisting  of  market 
surveillance activities by authorities in the Member States, information exchange through 
Safety  Gate/RAPEX  and  coordination  and  support  measures)  appears  to  be  operating 
under  considerable  resource  constraints.  In  a  2018  evaluation  of  the  product  safety-
related  actions  funded  under  the  EU  Consumer  Programmes213,  authorities  indicated 
limited staff/financial resources for market surveillance and enforcement most frequently 
as  a  factor  influencing  negatively  the  level  of  their  achievement.  A  previous  study 
concluded  that  the  total  budget  available  to  authorities  in  18  EU  Member  States  for 
which  data  was  available  declined  annually  between  2010  and  2013  in  nominal  terms, 
and  the  total  staff  resources  available  to  authorities  (in  full  time  equivalent  units)  also 
showed  a  negative  trend214.  In  a  recent  survey,  both  authorities  and  other  stakeholders 

See Civic Consulting (2018), Ex-post evaluation of the Consumer Programme 2007-2013 and 

213  
mid-term evaluation of the Consumer Programme 2014-2020, Part 1 – Mid-term evaluation of the 
Consumer Programme 2014-2020 and European Commission, 
214  
provisions of Regulation (EC) No 765/2008, Final Report, May 2017, p 35-39. 

European Commission, Ex-post evaluation of the application of the market surveillance 

63 

0%5%10%15%20%25%30%35%40%45%50%2013201420152016201720182019Pecent of all alertsNo batch number/barcodeNo brandNo type/modelNo manufacturerNone of the four 
 
                                                           
agreed that two of the three top problems affecting the functioning of market surveillance 
relate to a lack of resources: limited staff resources of market surveillance authorities in 
general, and in addition, a specific lack of financial resources for product testing215. It is 
widely  acknowledged  by  authorities  and  other  stakeholders  that  the  staff  and  financial 
resources of market surveillance authorities are often insufficient, with the fragmentation 
of responsibilities at national level leading to inefficiencies due to a lack of economies of 
scale  in  some  cases,  and  contradictory  measures  and  approaches  for  risk  assessment 
between  authorities  in  others.  Also,  the  number  of  inspections  can  be  considered  as 
generally low, with a median of roughly 400 inspections of consumer products per year 
and  million  population,  based  on  data  from  those  Member  States  that  provided  such 
information.  

Over  the  last  15  years,  the  European  Commission  has  co-financed  more  than  50 
coordinated  market  surveillance  activities  (the  so-called  Joint  Actions  or,  since  2018, 
Coordinated Activities on the Safety of Products or CASP) carried out by Member State 
authorities,  with  a  total  budget  around  27  million  EUR  since  the  start  of  the  activities. 
These  coordinated  activities  aim  at  promoting  and  coordinating  administrative 
cooperation  for  the  application  of  Directive  and  ultimately  at  ensuring  a  consistent 
approach  towards  the  effective  enforcement  of  product  safety  legislation  across  the 
internal  market.  Most  coordinated  actions  have  resulted  in  the  identification  of  a 
significant number of unsafe products, with non-compliance rates around 20%216, leading 
to consequent notifications in the Safety Gate/RAPEX for 14 categories of products. The 
implementation of these actions have been considered by authorities extremely useful, as 
economies  of  scale  allow  and  the  funding  provided  by  the  Commission  have    helped 
them to carry out inspections for some categories of products that would have been less 
controlled otherwise.   

Finally,  it  was  mentioned  by  several  authorities  that  some  Member  States  complement 
product-based market surveillance with a market surveillance of internal processes set up 
by  economic  operators  to  ensure  product  safety.  In  those  cases,  authorities  reported  an 
increase of the effectiveness of product safety enforcement.  

In  conclusion,  while  the  Directive  sets  an  efficient  system  to  ensure  the  safety  of 
consumer  products  and  contribute  to  better  and  more  coordinated  market  surveillance, 
challenges related to traceability, institutional fragmentation (including regarding market 
surveillance of harmonised and non-harmonised consumer products) as well as resource 
constraints  limit  the  effectiveness  of  the  overall  system.  At  the  same  time,  coordinated 
surveillance  activities  have  proven  to  be  very  efficient,  contributing  to  a  consistent 
enforcement of product safety legislation across the internal market. 

GPSD implementation study, p.90. 

215  
216 Joint Action reports repeatedly indicate that these high rates of non-compliance were not necessarily 
representative for the market, as non-random samples were taken and often samples were tested where a 
visual inspection had suggested possible deficiencies.  

64 

 
                                                           
5.2.4 Effectiveness of the Safety Gate/RAPEX 

The Safety Gate/RAPEX ensures that information about unsafe products withdrawn from 
the  market  and/or  recalled  from  consumers  anywhere  in  Europe  is  circulated  between 
Member States and the European Commission, so that appropriate action can be taken by 
market surveillance authorities in all EU Member States (and the EEA countries Iceland, 
Liechtenstein  and  Norway).  During  the  period  2005  to  2019  a  total  of  25  560 
notifications  were  submitted  (close  to  5  notifications  on  average  per  day),  with  all 
Member States participating in the system on a regular basis. The indispensable character 
of  the  system  is  emphasised  by  the  diversity  of  institutional  approaches  for  market 
surveillance  and  the  high  degree  of  fragmentation  of  market  surveillance  authorities 
according  to  sectoral  and/or  administrative  considerations  in  many  in  Member  States, 
which requires quick and effective information exchange and distribution, for which the 
system is a key channel. 

The  effectiveness  of  the  Safety  Gate/RAPEX  is  also  illustrated  by  the  analysis  of  the 
number of follow-up measures. Follow-ups can be defined as the feedback received from 
Member  States  participating  in  the  Rapid  Alert  System  on  actions  they  have  taken 
following  up  another  country’s  alerts.  As  Figure  12  shows,  the  number  of  follow-up 
measures have steadily increased since data started to be gathered in this respect by the 
European Commission in 2011.  

Figure 12: Number to follow-up measures taken by Member States reported to Safety 
Gate/RAPEX for the period 2011-2019 

Follow-up 

5000

4500

4000

3500

3000

2500

2000

1500

1000

500

0

2011

2012

2013

2014

2015

2016

2017

2018

2019

Source: Safety Gate/RAPEX 

The  GPSD  Study  also  showed  that  authorities  to  a  large  extent  appreciated  the 
functioning of RAPEX, with 65% considering the system to function at least 'moderately 
well' (48% considered it to be 'rather' or 'very well' functioning). Other stakeholders were 
even  more  positive,  with  70%  finding  the  system  at  least  'moderately  well'  functioning 
(46%  considered  it  to  be  'rather'  or  'very  well'  functioning).  Only  a  small  minority 
provided a negative assessment ('rather not' or 'not at all' functioning).   

65 

 
 
Despite  this  general  satisfaction  with  the  rapid  alert  system,  there  are  also  issues  that 
prevent its optimal operation. In the surveys of authorities and general stakeholders for 
the  GPSD  Study,  respondents  were  asked  whether  they  had  encountered  impediments 
when using the system.  Moreover, the recent GPSD implementation study analysed the 
average duration between the detection of an unsafe product and its notification to Safety 
Gate/RAPEX  in  each  Member  State.  The  RAPEX  system  sets  out  guidelines  setting 
indicative timeframes for notifications, but these are not compulsory for Member States. 
In most cases this duration is two weeks or more; in some cases, the duration might be up 
to 6 months.  

Several authorities emphasised that the duration between detection of an unsafe product 
and its notification to the system depended on the type of product, the risk, the required 
testing and the behaviour of the economic operator (objections by the relevant economic 
operator are in some cases reported to lead to significant delays). 

Regarding international cooperation, there is high interest both from third countries and 
from the EU in exchanging information on unsafe products between the Safety Gate/ 
RAPEX, and third countries. This exchange enables more efficient market surveillance 
in  the  EU  and  enhancing  product  safety  worldwide  which  can  also  in  turn  result  in  a 
better  protection  of  EU  consumers.  When  it  comes  to  the  procedure  to  set  up 
arrangements to exchange non-public information from the RAPEX system, the Directive 
does  not  provide  absolute  clarity.  Indeed,  article  12(4)  only  mentions  “access  to 
RAPEX”,  which  must  be  based  on  an  international  agreement.  The  Directive  does  not 
distinguish  between the  different  levels  of exchanges between the EU system and  third 
countries. In practice, there is a major difference between:  

  a third country becoming a full RAPEX member. 
  a third country with which selected non-public RAPEX information is shared. 

The current provisions of the Directive clearly cover the first type of cooperation, which 
consists  in  full  access  to  Safety  Gate/RAPEX  and  must  be  based  on  an  international 
agreement.  However,  there  is  no  clarity  on  the  procedure  for  the  second  type  of 
cooperation. 

It can be concluded that the rapid alert system achieves its objective to provide a platform 
for exchange of information concerning unsafe products. Since its establishment in 2003 
in  accordance  with  Article  12  of  the  Directive,  it  has  become  a  cornerstone  of  the  EU 
market  surveillance  and  product  safety  framework.  Market  surveillance  authorities  and 
other  stakeholders  therefore  consider  the  Safety  Gate/RAPEX  mostly  to  be  well 
functioning  and  effective.  Still,  certain  issues  currently  prevent  its  optimal  operation, 
such  as  delays  between  the  detection  of  an  unsafe  product  in  a  Member  State  and  its 
notification to Safety Gate/RAPEX, as well as the procedure to set up arrangements for 
the exchange of information with third countries.  

5.2.5 Effectiveness of the standardisation procedure of the Directive  

The  standardisation  system  established  under  the  Directive  has  been  effective  in  the 
sense that standardisation requests have been elaborated under the Directive and these led 
in  most  cases  to  standards  which  help  producers  to  comply  with  the  general  products 

66 

 
safety requirement under the Directive by providing presumption of safety of the product. 
The list of referenced standards shows the importance of the Directive in this respect, as 
most of the listed products  have a high potential for consumer harm. The GPSD  Study 
showed  that  referenced  standards  are  widely  used  by  manufacturers,  as  a  conforming 
product  shall  be  presumed  safe.  Even  a  brief  Internet  research  on  a  major  e-commerce 
website indicates that products falling under the Directive (such as gymnastic equipment, 
bicycles,  carry  cots  and  stands  etc.  )  are  regularly  advertised  as  conforming  to  the 
relevant  standards,  thereby  providing  evidence  of  their  application  in  practice.  Market 
surveillance  authorities  also  make  an  extensive  use  of  standards  to  assess  the  safety  of 
products and take measures accordingly.  

Replies from  stakeholders to  the GPSD Study  have shown that  the effectiveness  of the 
standardisation  process  might  be  hampered  by  several  procedural  issues.  In  particular, 
stakeholders have stated that the process is considered to be long and complicated, and 
sometimes  it  reduces  the  possibilities  for  participation  of  authorities,  SMEs,  consumer 
organisations  and  other  organisations,  as  well  as  universities.  However,  it  should  be 
mentioned that the standardisation process must strike a balance between speed and the 
quality of the outcome, thus, of the standard.  

As detailed in Annex 10, the process under the Directive includes one step more than the 
procedure  applied  in  relation  to  harmonised  standards.  The  reason  is  that  the 
harmonisation directives contain essential safety requirements on which standards can be 
based. In contrast, the wide coverage of the Directive requires specification of the safety 
requirements for a specific product, which then serves as a guideline for the work of the 
European  standardisation  bodies217.  The  addition  of  Step  1  of  the  process  under  the 
the  European 
Directive 
standardisation organisations  attempt to  achieve  consensus,  the duration  for elaborating 
the standard by the ESO (Step 3) also seems to be justified by the nature of the process; 
while this takes time, the consensus-principle has always been regarded to be an essential 
element  of  standard  setting  procedures.  Step  4,  the  Commission  decision  to  reference 
standards,  has  been  recently  adapted  following  developments  in  case  law.  However,  a 
possible  merger  of  steps  1  and  2  would  offer  a  potential  area  of  improvement  (in 
particular to enhance its efficiency, see section below). 

justified  and  unavoidable.  As 

therefore  seems 

to  be 

5.2.6 Effectiveness of provisions on product recalls 

Product  recalls  are  one  of  the  most  common  measures  to  mitigate  the  risks  posed  by 
unsafe products in the EU218. Among the over-2000 measures reported each year through 
the EU Rapid alert system219 about half concern recalling the products from consumers. 
The  Directive  does  not  contain  any  specific  provisions  for  recall  procedures  and 

See the GPSD implementation study, at 7.2.1. 

217  
218  The term “recall” refers here to the process aimed at achieving the return of a dangerous product that 

has already been supplied to consumers, initiated directly by the producer or distributor of the 
dangerous product, or ordered by authorities. 

219https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/r

apex/index_en.htm  

67 

 
                                                           
timelines,  communication  or  the  remedies  to  be  offered  to  consumers.  Producers 
undertake  voluntary  action  to  organise  recalls  but  authorities  can  also  order  a  recall  on 
the  basis  of  notifications  of  unsafe  products  from  other  countries  or  the  results  of  their 
own  market  surveillance  activities  or  if  producers’  actions  are  deemed  insufficient.  As 
shown by the Implementation Study, each Member State follows its own approach, with 
some common elements, but also diverging practices. 

While the effectiveness of product recalls varies considerably depending on factors such 
as  channel  of  sale220  and  product  category221,  the  proportion  of  products  successfully 
recovered  from  consumers  remains  generally  low,  as  recognised  by  a  recent  OECD 
report222. For instance, one Member State indicated that the return rate (understood as the 
number  of  products  returned  by  consumers  following  the  release  of  a  product  recall 
notice  and  other  related  communications)  rarely  exceeds  10%,  except  when  products 
have been purchased online, which makes it easier for suppliers to contact and alert their 
customers  about  a  recall223.  Another  national  authority  estimated  that  around  80%  of 
products of low value with a short lifespan remain in consumers’ hands224. 

The consequences of delayed and ineffective recalls are also  exemplified by the deaths 
and  injuries  caused  by  products  such  as  faulty  airbags  (estimated  to  have  caused  35 
deaths and 300 injuries worldwide225) and baby sleepers (associated with 59 baby deaths 
in the US226); see Annex 8.  

In the interviews with authorities held in the frame of the GPSD Study, few of them were 
able to estimate recall effectiveness in terms of the percentage of the recalled consumer 
products that were actually collected. Several authorities also suggested that even though 
they collect related data, it is difficult to determine the effectiveness of product recalls. 
At a recent EU workshop, it was concluded that there is no systematic approach by the 
authorities to monitoring recall effectiveness227.  

The main obstacle to recall effectiveness is the difficulty of identifying and contacting 
the owners of recalled products, which means that many EU consumers are simply not 
aware that they own a recalled product. The Directive does not contain any requirements 

220 Recalls tend to be more effective if the product was bought online because it’s easier to identify and 
directly contact the buyers. 
221 Recall effectiveness increases with product price and expected lifespan and decreases with product age.  
222 OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 5.223 Idem, p. 17. 
223 Idem, p. 17. 
224 European Commission, 2021, Behavioural study on strategies to increase the effectiveness of product 
recalls. 
225 https://www.consumerreports.org/car-recalls-defects/takata-airbag-recall-everything-you-need-to-know/ 
226  
consent/?next_url=https%3a%2f%2fwww.washingtonpost.com%2fbusiness%2f2019%2f10%2f17%2fstud
y-concludes-design-rock-n-play-other-infant-sleepers-led-deaths%2f  
227  
p.11. Annex 14 

EU workshop on strategies to maximize the effectiveness of product recalls, 23 October 2019, 

https://www.washingtonpost.com/gdpr-

68 

 
                                                           
on  consumer  traceability  and  authorities  interviewed  for  the  Implementation  Study 
mentioned that reaching the final consumer is a challenging task.  

For most recalled products, customer data is not available or even if it is available, it is 
not  used  to  inform  affected  consumers.  Apart  from  motor  vehicles  (whose  registration 
with  public  authorities  is  mandatory),  registration  schemes  are  only  available  for  few 
higher-value  product  categories  like  domestic  electric  appliances  and  communication 
devices,  and  even  in  these  sectors  actual  registration  rates  tend  to  be  rather  low228..  In 
addition,  economic  operators  are  hesitant  about  using  customers’  information  collected 
for other purposes (e.g. in the loyalty programmes or online sales) in the event of a recall 
because  of  a  possible  legal  uncertainty  about  the  compliance  with  the  General  Data 
Protection  Regulation229.  Limitations  on  customer  data  were  also  notified  by  online 
platforms  in  a  Study  on  contractual  relations  between  online  platforms  and  their 
professional  users230.  Moreover,  there  are  no  systematic  sources  of  indirect  recall 
information  for  consumers.  For  instance,  only  12  EU/EEA  countries  publish  recall 
information on their websites231.   

A  second  obstacle  to  recall  effectiveness  is  the  consumers’  reluctance  to  return  a 
recalled  product  even  if  they  are  aware  about  the  recall.  An  EU-wide  survey 
commissioned  by  the  European  Commission  showed  that  over  a  third  of  consumers 
(35%)  did  not  react  to  a  recall  that  was  relevant  to  them:  31%  continued  using  the 
product  with  extra  caution,  while  4%  took  no  action  whatsoever232.  The  corresponding 
figures  in  a  most  recent  consumer  survey  in  10  EU  countries  were  24%  and  13%, 
respectively233. 

This  may  be  caused  by  recall  notices  being  unclear  and/or  minimising  consumers’ 
perception  of  risk.  For  instance,  the  analysis  of  existing  recall  announcements  showed 
that  over  half  of  them  used  terms  and  expressions,  which  could  undermine  consumers’ 
perception of risk, such as ‘voluntary/precautionary recall’, ‘potential concern/problem’, 
in  rare  cases’/in  specific  conditions’  or  highlighting  that  there  have  been  no  reported 
injuries234. In addition, the procedure for consumers to return the recalled product may be 
complex and burdensome.  

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

228 European Commission, 2021, Behavioural study on strategies to increase the effectiveness of product 
recalls. 
229 European Commission, Notes from EU Workshop on strategies to maximise the effectiveness of 
product recalls, 23rd October 2019, p. 2. 
230 Study on contractual relationships between online platforms and their professional users, April 2018.  
231  
product recalls. 
232  
20, available at: 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/Product.Reca
ll.pdf.  
233  
product recalls. 
234 Idem. 

European Commission (2019). Survey on consumer behavior and product recalls effectiveness, p. 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

69 

 
                                                           
In addition to the issues mentioned above, behavioural research235 suggests that cognitive 
biases  and  heuristics  may  also  influence  consumers  to  take  suboptimal  decisions 
regarding how to respond to product recalls and may lead them not to take action. Biases 
such as information overload and framing effects mean that if recall notices are lengthy 
and  unclear,  consumers  may  ignore  them,  especially  if  they  lack  time.  Over-optimism 
may  result  in  consumers  underweighting  the  risk  posed  by  a  recalled  product,  while 
inertia and endowment effect (i.e. the emotional bias that causes individuals to value an 
owned  object  higher,  often  irrationally,  than  its  market  value)  relate  to  the  fact  that 
consumers have an inherent preference for status-quo, which in the case of recalls means 
keeping the product236.  

To  sum  up,  the  increase  in  the  number  of  product  recalls  over  time  and  the  fact  that 
recalls  are  currently  for  most  part  organised  on  a  voluntary  basis  can  be  considered  as 
indications  that  the  Directive  has  contributed  to  making  recalls  more  widely  used  as  a 
corrective  measure.  However,  EU-wide  general  requirements  regarding  the  recall 
procedure  or  communication  are  missing.  This  has  been  repeatedly  reported  as  a 
significant  shortcoming,  suggesting  that  existing  requirements  are  in  themselves 
currently not sufficient to ensure effective recalls. The resulting limited effectiveness of 
recalls  may negatively  affect  consumer safety  and the degree to  which there is  a level-
playing field for businesses in the internal market, affecting therefore the extent to which 
the objectives of the Directive are achieved in practice. 

5.2.7 Impact of e-commerce in the effectiveness of the Directive 

The  evaluation  showed  that  e-commerce  poses  additional  challenges  for  the  control  of 
the safety of products sold online, thus questioning the effectiveness of the Directive in 
this  regard.  In  particular,  there  is  evidence  pointing  to  the  fact  that  the  control  of  the 
safety of products sold online is more problematic than the one for unsafe products 
found in brick-and-mortar shops. Data coming  from  the Safety  Gate/RAPEX for the 
period 2018-2019 show that the share of notifications of products 'sold online' in which 
one  of  the  four  traceability  information  items  was  missing  (see  table  4)  was  between 
29,2% and 57,3% (depending on the item); the share for notifications not indicating ‘sold 
online’  in  which  one  of  the  four  traceability  information  items  was  missing  was 
considerably lower (between 12,6% and 35%7).  

235 Bernstein A. (2013), ‘Voluntary Recalls’, University of Chicago Legal Forum, 1: 394 ff., available at: 
http://chicagounbound.uchicago.edu/uclf/vol2013/iss1/10 and Jacoby J. (1984), ‘Perspectives on 
Information Overload’, Journal of Consumer Research, 10(4), pp. 432-435. 
236 See OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 5. 

70 

 
 
 
 
 
                                                           
Table  4:  Number  and  share  of  Safety  Gate/RAPEX  notifications  concerning  unsafe 
consumer products with unknown product information items (by sales channel, 2018-
2019) 

Total 
number of 
notifications  

Number of 
notifications 
regarding 
products not 
indicating 
'online'  

Share : 
Notifications 
not online 
missing 
information / 
Total 
notifications not 
online 

Number of 
notifications 
regarding 
products 
indicating 
'online'  

Share : 
Notifications 
online 
missing 
information / 
Total 
notifications 
online 

Total  number  of 
notifications 
for 
consumer products 
2018-19 

3 864 

3590 

- 

274 

- 

Notifications in which information item is missing 

1437 
800 
531 

- No manufacturer 
- No brand 
- No type/model 
- No batch 
number/barcode 
- None of the four 
  Source: Prepared with Safety Gate/RAPEX data.  

805 

52 

1 280 
700 
451 

667 

17 

35,7% 
19,5% 
12,6% 

18,6% 

0,5% 

157 
100 
80 

138 

35 

57,3% 
36,5% 
29,2% 

50,3% 

12,8% 

Furthermore,  recent  investigations  from  market  surveillance  authorities,  consumer 
organisations and industry associations show worrying levels of unsafe products in some 
categories of products sold online: 

  A campaign carried out in 2018 by DGCCRF237, the French market surveillance 
authority,  showed  that  on  average  42.8%  of  the  inspected  products  online  were 
unsafe. The level of dangerous products reportedly varied a lot depending on the 
product  category:  high  rates  of  unsafe  products  were  found  for  example  in  low 
priced jewellery (74%) and some electrical products (66%), while for cosmetics 
the rate was 16%.  The situation also  varied  greatly  considering the marketplace 
on  which  the  samples  were  taken  (ranging  for  example  from  22%  to  58%  of 
unsafe  products).  The  authority  concluded  that  it  found  a  significantly  higher 
share  of  unsafe  products  on  online  marketplaces  compared  to  products  sampled 
across all distribution channels. 
In  February  2020,  six  consumer  groups  from  the  BEUC  network238  tested  250 
electrical  goods,  toys,  cosmetics  and  other  products  bought  from  a  number  of 
online  marketplaces.  They  selected  the  products  based  on  possible  risks  and 
found that 66% of them failed EU safety laws with possible consequences such as 
electric shock, fire or suffocation. 

 

237 Direction générale de la Concurrence, de la Consommation et de la Répression des fraudes 
238 https://www.beuc.eu/publications/two-thirds-250-products-bought-online-marketplaces-fail-safety-tests-
consumer-groups/html 

71 

 
 
                                                           
  Also in 2020, Toy Industries of Europe239 undertook a project to assess the safety 
and the legal compliance of toys bought from operators who sell on several online 
marketplaces present in the EU. The assessment was conducted on toys bought in 
seven EU markets - Denmark, France, Germany, Italy, the Netherlands, Spain and 
Sweden. The project showed that more than 97% of the 193 toys assessed did not 
comply with strict EU toy safety rules and 76% of 134 that were safety-tested had 
defects that made them unsafe for children. In addition, 83% of the toys bought as 
part of the project did not include necessary traceability information. 

These results support the other evidence provided above. When interpreting the research 
presented in the previous paragraphs, it is important to recall that all quoted studies are 
based on risk-based sampling, i.e. they focused on products with a higher probability for 
non-compliances.  While  this  is  a  standard  approach  used  by  market  surveillance 
authorities, it means that results are not necessarily representative of the market overall, 
but provide insights into specific problem areas. 

As already stated in the section on Relevance, the Commission has taken some actions to 
tackle this problematic. One major action has been the facilitation of the signature of the 
Product  Safety  Pledge  by  9  online  marketplaces.  Most market  surveillance  authorities 
and  the  online  marketplaces  part  of  the  Pledge  see  the  signature  of  the  voluntary 
commitments as positive, as it sets a cooperation framework and defines possible actions 
to be carried out by online platforms as an important player in the supply chain. The 3rd 
Monitoring Report of the Pledge240, published in November 2020, showed some progress: 
there  are  indications  that  signatories  are  taking  actions  to  monitor  Safety  Gate/RAPEX 
notifications and remove product listings when notified by authorities. However, further 
than that it is challenging to analyse the effectiveness of the Pledge to appropriately 
ensure the safety of products sold online. The report also showed that there has been a 
divergence  in  the  way  online  marketplaces  calculated  the  Key  Performance  Indicators 
(KPIs),  making  it  difficult  to  extract  conclusions  from  those  numbers  and  monitor  the 
effectiveness of the commitments of the Pledge. Further negotiations with marketplaces 
to enhance the monitoring and accountability of the Pledge have proved to be complex. 
In  addition,  authorities,  consumer  organisations  and  other  stakeholders  have  signalled 
that  the  Product  Safety  Pledge  remains  voluntary,  so  the  infringement  of  those 
commitments  cannot  be  penalised  by  authorities.  There  are  also  many  players  on  the 
market  that have decided not  to  adhere to  the voluntary  commitments, creating  also  an 
uneven level-playing field between online marketplaces targeting EU consumers. 

In addition, the presence of unsafe products in online channels can have an impact 
on  the  level-playing  field  for  businesses.  A  study  published  by  Eurocommerce241 
showed estimations on how much lower the purchase price would be if the products did 
not  comply  with  EU  Product  Safety  Rules.  The  cost  difference  between  products 

239 https://www.toyindustries.eu/wp-content/uploads/2020/06/Executive-Summary-Online-Marketplaces-6-
1.pdf 
240 https://ec.europa.eu/info/sites/info/files/3rd_progress_report_product_safety_pledge.pdf 
241 Eurocommerce – Creating a level-playing field for retail in Europe – August 2019 

72 

 
                                                           
produced  in  accordance  with  EU  rules  and  standards,  and  produced  without  taking 
account of the EU rules was considered as significant. While such calculations cannot be 
extrapolated  to  a  whole  category  of  products,  they  give  an  indication  of  the  possible 
detriment of the presence of rogue traders.  

The  evidence  described  above  shows  that  e-commerce  allows  for  a  growing  flow  of 
consumer  products  (both  those  falling  under  the  Directive  and  those  falling  under 
harmonised  legislation)  to  enter  the  EU  market  including  unsafe  and  recalled  products, 
with traders and products being often untraceable. While these problems also do occur in 
the ‘offline’ environment, they are more relevant in the online environment which allows 
products to enter the EU market without having a relevant economic operator in the EU. 
It  can  therefore  be  concluded  that  on  balance,  the  emergence  of  e-commerce  has 
negatively affected the effectiveness of the Directive in terms of enforcing the general 
safety  and  traceability  requirements,  but  also  with  respect  to  effective  market 
surveillance by the Member States.  

5.2.8 Impact of new technologies in the effectiveness of the Directive 

The  development  of  new  technologies  is  also  putting  into  question  the  effectiveness  of 
the  Directive  as  a  safety  net  for  products,  aspects  and  risks  not  covered  by  product 
harmonisation legislation. 

As stated in the section on Relevance, the uncertainties regarding the applicability of 
the  Directive  to  new  technologies,  such  as  to  new  risks,  have  also  an  impact  on  its 
effectiveness. A good example can be the follow up of a Safety Gate/RAPEX notification 
from Iceland regarding a smartwatch for children242. The Icelandic authority argues that 
this product would not cause a direct harm to the child wearing it, but lacking a minimum 
level of security, it can be easily used as a tool to have access to the child. As one of the 
product’s  intended  function  is  to  keep  children  safe  through  localisation,  a  consumer 
would  expect  that  it  would  not  pose  security  threats  to  children  that  may  affect  their 
safety by  potentially  being tracked and/or contacted by anyone. As  measures regarding 
this  product  were  notified  to  Safety  Gate/RAPEX,  authorities  in  the  rest  of  Member 
States took follow-up actions. 

However,  as  the  surveys  for  the  GPSD  Study  showed,  many  of  those  authorities  were 
unsure if the Directive applied to such risks due to the lack of explicit provisions in that 
regard. The lack of explicit provisions and/or guidelines with regard to the safety of new 
technologies  has  a  negative  impact  on  the  effectiveness  of  the  Directive.  Furthermore, 
almost half of the interviewed Member States authorities reported that they currently do 
not carry out inspections on products incorporating new technologies, which could also 
be due to such lack of clarity. The report on the safety and liability of new technologies243 

242 Safety Gate/RAPEX notification from Iceland published in the EU Safety Gate’s website 
(A12/0157/19) 
243 Report on the safety and liability implications of Artificial Intelligence, the Internet of Things and 
robotics COM/2020/64 final 

73 

 
                                                           
also concluded that EU product safety legislation would need to be further clarified for 
legal certainty.  

The example of consumer products using new technologies illustrates both the strengths 
and  the  weaknesses  of  the  general  safety  requirement  of  the  Directive.  It  confirms  the 
advantage of  a  general requirement that products need to  be safe independent  from  the 
technology  used,  i.e.  the  safety  requirement  being  technology-neutral.  However,  it  also 
has  shown  its  weakness  in  that  certain  key  definitions,  such  as  “safe  product”  and 
“product”, which are broad and unspecific to apply in a wide range of situations, can be 
ambiguous in the context of new technologies, and therefore create practical difficulties 
for the application of the Directive, which reduce its effectiveness. 

5.2.9 Effectiveness of the Food-Imitating Products directive 

The  number  of  Safety  Gate/RAPEX  notifications  of  food  imitating  products  is  small. 
Between 2013 and 2019, a total of 114 notifications (less than 20 per  year on average) 
that  relate  to  food  imitating  products,  as  table  5  shows.  Moreover,  it  seems  that  the 
product  category  “Food-imitating  products”  was  only  used  up  to  2015;  afterwards,  the 
products  have  been  categorised  according  to  their  use  (cosmetics,  clothing,  etc.),  and 
aspects  related  to  the  imitating  nature  of  the  product  were  incorporated  in  the  risk 
assessment of the product itself  (but not in a systematic manner by all Member States). 

Table 5: Notifications to Safety Gate/RAPEX related to food-imitating products 

Product category 

Year 

Total 

Cosmetics 
Decorative articles 
Food-imitating products 
Other 
Stationery 
Toys 

Total 

Source: Safety Gate/RAPEX 

2013 

2014 

2015 

2016 

2017 

2018 

2019 

1 

3 
1 

12 

8 

1 

13 

8 

4 

1 

1 
26 

27 

28 
4 

4 

36 

1 
17 

2 
2 
3 

33 
23 
46 
2 
2 
8 

25 

114 

To  address  this  issue,  in  2019  the  Commission  circulated  a  questionnaire  to  Member 
States  on  the  implementation  of  the  FIPD.  Its  outcome  showed  that  there  are  very 
different interpretations of the FIPD (and notably whether food-imitating products should 
be banned per se or be subject  to  a risk assessment).  These divergences  rendered the 
FIPD ineffective in practice, as there is not a harmonised approach for this category of 
products in the EU.  

During  a  meeting  of  the  Consumer  Safety  Network  organised  in  November  2019, 
Member  States  agreed  that  the  development  of  guidelines  would  not  enhance  the 
effectiveness  of  the  FIPD  and  legal  changes  might  be  needed  to  address  the  diverging 
interpretations of this directive. 

74 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.2.10 Conclusion on effectiveness 

The Directive appears overall to have met its objectives of ensuring a high level of safety 
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.  

However,  certain  provisions  of  the  Directive  have  proven  to  affect  negatively  its 
effectiveness, resulting in a continuing influx of new unsafe products on the market. This 
relates,  as  highlighted  above,  to  the  lack  of  a  mechanism  to  arbitrate  disputes  on  risk 
assessment, challenges on the traceability of unsafe products, lack of resources of market 
surveillance  authorities,  as  well  as  the  impact  of  e-commerce  and  new  technologies  on 
the effectiveness of the Directive. Furthermore, more clarity could be sought with regards 
to product recalls and other key definitions. The current divergences of interpretation of 
the  FIPD  among  Member  States  has  also  resulted  to  be  inefficient,  so  actions  in  that 
respect should be pursued.  

5.3 Efficiency 

5.3.1. Analysis of costs 

The  current  costs  of  compliance  with  the  Directive  are  directly  accruing  to  businesses 
and market surveillance authorities, and indirectly to  consumers in the form of costs of 
consumer goods and taxes. 

5.3.1.1 Costs for businesses 

The Directive applies fully to consumer products for which no specific EU harmonised 
legislation  exists.  It  does  not  apply  to  industrial/professional  products.  While  the 
Directive is also applicable to harmonised consumer products to the extent that there are 
no specific provisions with the same safety objective in the EU harmonised legislation, 
the significance of this ‘residual effect’ of the Directive depends on several factors, most 
notably  on  the  extent  to  which  EU  harmonised  legislation  reflects  the  same  level  of 
protection.  As  the  residual  effects  on  manufacturing  and  distribution  of  harmonised 
products are in any case expected to be minor compared to the effects in the area of non-
harmonised products, this assessment focuses on the latter. In other words, the following 
assessment only considers the costs of compliance with the Directive for manufacturers 
and distributors of non-harmonised consumer products. 

Following this approach, the estimation of business costs is based on the following steps 
and detailed in Appendix 2: 

  Step 1: Estimation of EU companies’ total annual turnover from the production 
and/or  sales  of  non-harmonised  consumer  products  in  the  EU  -  Based  on  this 
approach,  the  total  EU  turnover  from  non-harmonised  products  in  the  selected 
sectors amounts to EUR 773 billion for EU manufacturers, EUR 750 billion for 
EU wholesalers and EUR 581 billion for EU retailers. 

  Step 2: Deduction of extra-EU export – This results in an estimation of an annual 
EU  turnover  related  to  non-harmonised  products  of  EUR  655  billion  for  EU 

75 

 
manufacturers, EUR 707 billion EUR for EU wholesalers and approx. EUR 485 
billion EUR for EU retailers. 

  Step 3: Deduction of industrial and professional products - As a result, the total 
annual EU turnover of EU companies from non-harmonised consumer products is 
estimated at EUR 1032 billion EUR. 

  Step  4:  Derivation  of  empirical  estimates  for  companies’  product  safety-related 
costs  –  These  estimates  take  into  account  activities  such  as  managing  product 
safety, testing for product safety, and product recalls.  

  Step  5:  Extrapolation  of  EU  companies’  annual  costs  related  to  the  Directive 

including business-as-usual costs that occur also in absence of regulation. 

  Step 6: Deduction of business-as-usual costs and extrapolation of EU companies’ 

annual compliance cost related to the Directive 

As  indicated  in  table  6,  the  estimated  costs  for  EU  businesses  to  comply  with  the 
Directive amount to EUR 1.1 billion per year, of which EUR 343 million accrue to EU 
manufacturers, EUR 321 million to EU wholesalers and EUR 439 million to EU retailers. 

Table  6:  Estimated  annual  cost  for  businesses  to  comply  with  the  GPSD,  by  company  size 
class, in million EUR  

Company size (employees)  From 0 to 49 

50 – 249  

250 or more  

All size categories 

Cost by company size 

Total costs 

Total of manufacturing 

Total of wholesale 

Total of retail 

Total  

79 

118 

232 

428 

101 

81 

44 

226 

163 

122 

163 

448 

Source: GPSD Study, based on company costs survey and Eurostat data.  

343 

321 

439 

1 102 

With  regards  to  SMEs,  companies  with  less  than  50  employees  are  estimated  to  have 
GPSD-related  costs  (after  business-as-usual  costs  such  as  costs  related  to  general  due 
diligence  activities  have  been  subtracted)  of  approx.  428  million  EUR  per  year,  and 
companies with 50 to 249 employees are estimated have GPSD-related costs of approx. 
226 million EUR per year (see Table 6 above). Accordingly, SMEs account for 59% of 
the total of GPSD-related compliance costs in the EU, in line with their overall share in 
the market.  It  should be  noted that due to  the relatively high number of  EU SMEs that 
engage  in  wholesale  and  (particularly  in)  retail  sectors  compared  to  manufacturing 
sectors (and compared to large EU companies which are more engaged in manufacturing 
activities),  GPSD-related  measures  that  impact  on  the  distribution  chains  of  non-
harmonised consumer products can be expected to have a higher aggregate impact on EU 
SMEs than measures that impact on manufacturers. 

5.3.1.2 Costs for authorities 

Assessing  the  costs  for  market  surveillance  authorities  to  comply  with  the  Directive  is 
complicated due to organisational differences across Member States. Market surveillance 
systems  for  consumer  products  differ  in  the  extent  to  which  market  surveillance  is 
conducted by authorities with broader or with narrower sectoral responsibility, as well as 

76 

 
 
to the degree of centralisation of the administration of each country. These organisational 
features  affect  how  market  surveillance  of  non-harmonised  consumer  products  is 
organised, and in some cases the share of staff working on market surveillance of non-
harmonised products is unknown. 

To overcome this limitation, the estimate of market surveillance costs has been based on 
comprehensive  staff  data  for  20  EU  Member  States  obtained  through  interviews  and 
surveys.  Consequently,  the  estimation  for  total  EU27  staff-related  costs  for  market 
surveillance  of  non-harmonised  consumer  product  amount  to  approximately  EUR  122 
million  per  year.  Of  this  amount,  EUR  14  million  accrue  in  countries  where 
responsibility  for  market  surveillance  is  centralised  and  EUR  108  million  in  countries 
where  responsibility  for  market  surveillance  is  (partly)  delegated  to  or  competence  of 
sub-national  administrations  (for  more  info  see  Appendix  2).  Non-staff  related  costs  of 
market  surveillance  activities  for  non-harmonised  consumer  products  in  the  EU  can  be 
considered negligible (EUR 0).  

5.3.2. Analysis of benefits  

The  main  benefit  of  the  Directive  is  the  consumer  protection  and  its  consequential 
reduction of consumer detriment. The GPSD Study provided an analysis of detriment 
due  to  product-related  injuries  and  fatalities  in  the  EU  (see  Annex  4).  The  analysis 
concluded that the preventable detriment suffered by EU  consumers and society due to 
product-related accidents (and related injuries and pre-mature deaths) can be estimated at 
EUR  11.5  billion  per  year.  In  addition  to  this  injury  related  detriment,  the  consumers 
also suffer financial costs of a total value of EUR 19.3 billion for 2019 arising from the 
fact  they  have  purchased  unsafe  products  that  they  would  not  have  purchased  if  they 
knew these products are unsafe While it is not possible to estimate the detriment suffered 
by EU consumers and society that is avoided by EU product safety legislation, including 
the Directive, it is reasonable to assume that in absence of the general safety requirement, 
the standards referenced and other provisions under the Directive, the detriment suffered 
due to product-related accidents and financial costs for consumers would be substantially 
higher,  thereby  outweighing  the  related  costs  for  companies,  market  surveillance 
authorities and consumers.  

Furthermore, the Directive has contributed with additional benefits: 

 

Increased  consumer  trust:  as  reflected  in  Figure  10,  there  has  been  an  increase  of 
consumer trust from 65% in 2008 to 78% in 2016; 
Increased business revenue (e.g. due to increased reputation /brand value); 
Improved quality / lifecycle of products; 

 
 
  Better information on unsafe products/measures taken by authorities provided through 
the  Safety  Gate/RAPEX  (more  than  25,000  notifications  since  the  establishment  of  the 
system); 

  Better supply chain management due to traceability of products; 
  Greater legal certainty; 
  Lower operational risk for businesses; 
  Deterrent effect on rogue traders; 

77 

 
  More level-playing field among businesses; 
  Better functioning of the EU Single market; 
  Higher level of protection of the environment due to reduction of unsafe products that 

also have environmental impacts (e.g. lead in PVC, siloxanes, Nonylphenol); 

  Better access to the market in non-EU/EEA countries. 

2.5.1.  5.3.3. Balance and distribution between costs and benefits  

About  nine  in  ten  respondents  that  had  an  opinion  considered  the  costs  due  to  product 
safety  requirements  of  the  GPSD  to  be  at  least  “moderately  proportionate”  to  the 
resulting benefits. Close to six in ten respondents that had an opinion even found these 
costs to be “largely proportionate” or “very proportionate”. 

This largely positive assessment is consistent with the analysis of compliance costs (see 
table 7). A large part of costs related EU product safety legislation for consumer products 
are  considered  as  business-as-usual  costs  (BAU),  i.e.  costs  that  companies  would  incur 
anyway  (i.e.  even  in  absence  of  product  safety  legislation,  for  example  because  these 
costs  relate  to  their  due  diligence  procedures).  Compliance  costs  due  to  the  safety 
requirements of the Directive that exclude business-as-usual costs are therefore limited, 
compared to  the benefits  the Directive brings, including in terms  of  contributing to  the 
functioning of the internal market. 

78 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 7: Assessment of costs and benefits 

Type 

Costs 

Companies’ 
compliance costs 

States’ 
for  market 

Member 
costs 
surveillance costs 

Benefitsa) 

Better 
information 
on  unsafe  products 
through  Safety  Gate 
/RAPEX  
A  better  functioning 
internal market 

Increased  consumer 
trust  

Reduced  occurrence 
of 
products 
presenting health and 
safety 
risks  & 
reduced  number  of 
accidents/injuries 
caused  by  unsafe 
products 

Assessment of cost/benefits 

Consumer product safety-related compliance costs are estimated at 0.59% of turnover for 
manufacturing  sectors  and  0.14%  for  retail  and  wholesale  services  sectors.  Subtracting 
costs  that  companies  would  incur  anyway  (i.e.  even  in  absence  of  product  safety 
legislation,  e.g.  because  these  costs  relate  to  due  diligence),  the  estimated  costs  for 
businesses to comply with the GPSD amount to EUR 1.1 billion per year, of which EUR 
343 million accrue to EU manufacturers, EUR 321 million to EU wholesalers and EUR 
439 million to EU retailers 
Total  EU27  staff-related  costs  for  market  surveillance  of  non-harmonised  consumer 
product  amount  to  approximately  EUR  122  million  per  year.  Of  this  amount,  EUR  14 
million  accrue  in  (smaller)  countries  where  responsibility  for  market  surveillance  is 
centralised  and  EUR  108  million  in  (often  larger)  countries  where  responsibility  for 
market surveillance is (partly) delegated to or competence of sub-national administrations 

In  the  period  2005  to  2019,  a  total  25  850  publicly  available  notifications  were 
transmitted  through  Safety  Gate/RAPEX,  including  25 051  notifications  concerning 
products  with  serious  risks.  In  a  12  months  period  2019/20,  the  analysed  notifications 
affected some 41.8 million items in total  
The  aim  of  free  movement  of  (non-harmonised)  goods  within  the  internal  market  has 
been achieved. There were only few cases where Member States prohibited or hindered 
the import of products from other Member States that had been certified in line with EU 
product safety law, and these cases all related to specific harmonised legislation but not to 
the GPSD. There is no indication that Member States try to stop imports from other 
Member  States  for  reasons  of  their  insufficient  level  of  safety.  Standardisation  has 
contributed to the uniform application of product safety law in the Member States. So far, 
a total of 80 standards were referenced under the GPSD 
Consumer trust in product safety in the EU has shown a slight increase over time, with 
the  proportion  of  consumers  agreeing  that  essentially  all  non-food  products  in  their 
country are safe (or that only a small number are unsafe) increasing from 65% in 2008 to 
78% in 2016, before decreasing again to 70%. The largest increase (9 percentage points) 
occurred between the 2014 and 2016 surveys, before returning  in 2018 to slightly above 
the 2014 level 
Based  on  data  from  the  European  Injury  Database  (IDB)  an  estimated  11  million 
product-related injuries, in  which consumers visited  a hospital emergency department 
due to the injury, occur in the EU each year. The related detriment is estimated at EUR 
76.6  billion  per  year.  This  is  the  sum  of  detriment  caused  by  non-fatal  product-related 
injuries, and the cost of premature death due to fatalities caused by mechanisms relevant 
for product safety (such as tools, strangulation, electric current, or fire) occurring outside 
of  work-related  locations.  The  preventable  detriment  suffered  by  EU  consumers  and 
society due to product-related accidents can be estimated at EUR 11.5 billion per year. In 
addition, consumers also suffer financial costs of a  total value of EUR 19.3 billion per 
year arising from the fact they have purchased unsafe products  that they would not 
have purchased if they knew these products are unsafe. It is reasonable to assume that in 
absence  of  the  general  safety  requirement  of  the  GPSD,  and  the  standards  referenced 
under  the  Directive,  detriment  suffered  due  to  product-related  accidents  and  financial 
costs would be considerably higher. 

Source: GPSD Study 

5.3.4. Conclusion on efficiency 

This evaluation therefore concludes that the costs of the Directive are proportionate to 
the benefits it brings.  

However, it should be highlighted that several of the factors that affect the effectiveness 
of the Directive may also influence its efficiency: 

79 

 
  Complexity  of  the  legal  framework  for  product  safety,  in  particular  the  co-

existence of two systems of rules on market surveillance; 

  Difficulties  on  enforcement  by  market  surveillance  authorities  the  provisions  of 
the  Directive,  in  particular  due  to  challenges  posed  by  E-commerce  and 
traceability; 

  Lack  of  a  mechanism  to  solve  differences  in  risk  assessment  of  authorities  in 

different Member States; 

  Outdated/unclear  terms  and  concepts  used  in  the  Directive,  in  particular  with 

regards to new technologies; 

  Delays in notification of unsafe products through Safety Gate/RAPEX; 
  Challenges related to the standardisation process; 
  Suboptimal effectiveness of product recalls.   

Consequently, actions aimed to address those issues would contribute to further enhance 
the efficiency of the Directive. 

5.4 Coherence 

5.4.1 Internal coherence of the Directive 

This  evaluation  did  not  identify  discrepancies  or  inconsistencies  between  the 
provisions  of  the  Directive.  This  has  been  backed  by  stakeholders  interviewed  for  the 
preparation of the GPSD Study. However, certain stakeholder have signalled that certain 
provisions of the Directive lack clarity. In particular, Art 5(1) of the Directive, that sets 
obligations  for  producers  to  provide  necessary  information  for  tracing  the  origin  of  a 
product,  is  considered  to  be  very  vague  and  subject  to  multiple  interpretations.  This 
vagueness has led to slight differences in implementation in Member States and a lack of 
certainty for economic operators.  

5.4.2  Coherence  with  product  harmonisation  legislation  and  market 

surveillance  

Article 1.2 of the Directive provides that the provisions of the Directive “shall apply in so 
far as there are no specific provisions with the same objective in rules of Community law 
governing  the  safety  of  the  products  concerned”.  This  definition  of  the  scope  of  the 
Directive as  lex generalis ensures  its coherence  with  product  harmonisation  legislation, 
as  there  are  no  overlaps  between  the  Directive  and  a  specific  instrument.  This  role  of 
“safety  net”  is  considered  by  stakeholders  consulted  for  this  evaluation  as  an 
unquestionable element and cornerstone for the protection of consumers in the EU, as 
well as an essential element for the free movement of goods in the Single Market. The 
interlinks  of the Directive with  sectorial  legislation has also  been acknowledged by the 
Court of Justice of the EU244. 

Nevertheless,  despite  the  full  coherence  of  the  Directive  with  product  harmonisation 
legislation,  some  stakeholders  state  that  there  are  in  practice  some  uncertainties  when 

244 Judgment of the Court (Eighth Chamber) of 30 April 2009. Lidl Magyarország Kereskedelmi bt v 
Nemzeti Hírközlési Hatóság Tanácsa. Case C-132/08 

80 

 
                                                           
determining the applicable legislation to a specific category of products. However, as the 
GPSD  Evaluation  and  IA  shows,  the  reasons  for  these  practical  challenges  are  not 
necessarily linked to the scope of the Directive, that by definition plays a residual role for 
harmonised products, but rather by the sometimes unclear scope of specific pieces of EU 
product harmonisation legislation or by the lack of guidelines or supporting documents to 
provide clarity to businesses.  

An  additional  aspect  that  can  contribute  to  such  uncertainty  is  the  existence  of 
discrepancies between some of the definitions of the Directive and definitions of the 
product  harmonisation  legislation,  in  particular  legislation  following  the  New 
Legislative Framework (NLF) set by Decision 768/2008/EC245 (see Table X). While the 
divergence of those terms is not significant, a lack of alignment has a negative impact on 
the coherence of the EU product safety framework. 

Table 8: Comparison of key concepts in the Directive and Decision No 768/2008/EC 

Concept 

Directive 2001/95/EC (GPSD), Article 2 e-h 

"producer" shall mean: 
(i) the manufacturer of the product, when he is 
established in the Community, and any other person 
presenting himself as the manufacturer by affixing to 
the product his name, trade mark or other distinctive 
mark, or the person who reconditions the product; 
(ii) the manufacturer's representative, when the 
manufacturer is not established in the Community or, 
if there is no representative established in the 
Community, the importer of the product; 
(iii) other professionals in the supply chain, insofar as 
their activities may affect the safety properties of a 
product; 

"distributor"  shall  mean  any  professional  in  the 
supply chain whose activity does not affect the safety 
properties of a product; 

Decision No 768/2008/EC, Annex 
I, Article R1, points 3, 6, 14, 15 
 ‘manufacturer’ shall mean any 
natural or legal person who 
manufactures a product or has a 
product designed or manufactured, 
and markets that product under his 
name or trademark; 

 ‘distributor’ shall mean any 
natural or legal person in the 
supply chain, other than the 
manufacturer or the importer, who 
makes a product available on the 
market; 

Producer 

Distributor 

Recall 

"recall"  shall  mean  any  measure  aimed  at  achieving 
the  return  of  a  dangerous  product  that  has  already 
been supplied or made available to consumers by the 
producer or distributor; 

‘recall’ shall mean any measure 
aimed at achieving the return of a 
product that has already been made 
available to the end user; 

Withdrawal 

"withdrawal"  shall  mean  any  measure  aimed  at 
preventing  the  distribution,  display  and  offer  of  a 
product dangerous to the consumer. 

 ‘withdrawal’ shall mean any 
measure aimed at preventing a 
product in the supply chain from 
being made available on the 
market. 

Source: GPSD Study 

245 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common 
framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA 
relevance OJ L 218, 13.8.2008, p. 82–128 

81 

 
 
 
                                                           
It  also  needs  to  be  signalled  that  Decision  768/2008/EC  is  not  yet  aligned  with 
Regulation 1020/2019 on market surveillance, that has incorporated new definitions such 
as “fulfilment service provider”. The Decision is also currently under evaluation. 

The  respondents  have  pointed  out  that  the  interlink  between  the  Directive  and 
legislation on chemicals, notably Regulation (EC) No 1907/2006 (REACH), sometimes 
lacks clarity. For instance, the term “product” is not used in REACH, as it refers instead 
to “articles”, while it uses “substances” for a chemical element and its compounds. Some 
respondents  suggested  that  this  can  cause  confusion,  when  the  measures  refer  to, 
respectively a “dangerous product” (Article 2(c) and (g), Article 8(1)(e) and (f), Article 
10(2)(a)  and  (d),  Article  13(3)  GPSD)  and  a  “dangerous  substance”  (mainly  Title  VIII 
REACH).  In  particular,  the  question  of  whether  the  presence  of  a  dangerous  substance 
would always  lead to  the finding of a dangerous product  pursuant  to  the Directive  was 
raised. This issue has been tackled in the revision of the guidelines on the operation of 
the Rapid Alert System RAPEX in 2018. The revised guidelines set out that “[t]he risk 
level  of  a  product  may  be  considered  to  be  serious  if  it  contains  a  chemical  substance 
either banned or in a concentration above the limit established by European legislation. 
Therefore,  in  cases  where  measures  are  taken  against  products  containing  a  chemical 
substance  subject  to  a  restriction  contained  in  EU  Legislation,  a  notification  may  be 
submitted without a detailed risk assessment” 246. By presuming the serious nature of the 
risk when a product contains a substance either banned or in a concentration above the 
established  limit,  the  work  of  market  surveillance  authorities  is  facilitated  and  this 
ensures the consistency of measures among Member States.  

Due  to  the  fact  that  chemical  limits  in  sectorial  legislation  often  concern  specific 
categories  of  products,  it  is  important  to  correctly  classify  a  product,  which  can  prove 
difficult for borderline cases. The consistency of chemical limits for products that present 
similarities but fall under different legislations (e.g. toys and childcare articles) can thus 
be  raised,  as  well  as  the  possibility  to  proceed  by  analogy  when  establishing  a  risk 
assessment for the products not covered by such restrictions.  

In  relation  with  food  contact  materials,  the  Evaluation  observed  that  these  products 
generally  fall  under  the  purview  of  food  law247,  however,  some  food  contact  materials 
may  require  an  evaluation  in  line  with  the  General  Product  Safety  Directive.  This  may 
have  implications  that  are  not  comprehensively  addressed  in  the  legal  framework  e.g. 
regarding which authority is responsible for a specific problem and also whether to notify 
the  safety  issue  through  Safety  Gate/RAPEX  or  the  Rapid  Alert  System  for  Food  and 
Feed.  

246 Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for 
the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 
of Directive 2001/95/EC on general product safety and its notification system. 
247 Food Contact Material Framework Regulation (EC) 1935/2004 and the General Food Law Regulation 
(EC) 178/2002 

82 

 
                                                           
Regarding market surveillance, as already stated above, there are two different systems 
established by the EU legislation:  one applicable to  product  harmonisation legislation 
as  established  in  Regulation  2019/1020  on  market  surveillance  and  the  one  set  by  the 
Directive for non-harmonised products. The existence of these two systems exacerbates 
the  risk  of  weakening  the  general  coherence  of  the  product  safety  framework.  The 
majority  of  respondents  of  the  OPC  confirmed  having  experienced  problems  with  the 
divergence  of  rules  between  harmonised  and  non-harmonised  products.  Furthermore, 
some stakeholders stated that the implementation of two different set of rules is not even 
justified;  a  consumer  organisation  provided  the  paradoxical  example  that  there  are 
different market surveillance provisions for a baby doll bed that for an actual baby bed.  

This has also been considered by market surveillance authorities as a major challenge, as 
the  investigation  and  enforcement  powers  granted  to  them  are  different  depending  on 
each  system.  The  maintenance  of  both  systems  also  entails  internal  administrative 
costs and inefficiencies for Member States.  

5.4.3 Coherence with standardisation policies 

The  evaluation  identified  that  there  is  a  divergence  between  the  standardisation 
procedures  set  by  Regulation  (EU)  No  1025/2012248  and  the  Directive,  as  the  latter 
counts with an additional step. However, this divergence is justified and corresponds to 
the fact that the Directive does not contain specific safety requirements in the legal text, 
so it requires an additional step for the setting up of such safety requirements.  

However,  the  inter-links  of  both  instruments  can  result  in  some  inefficiencies.  In  line 
with this Regulation, after the decision on safety requirements by the GPSD Committee, 
the  decision  on  the  standardisation  request  is  adopted  by  a  different  Committee,  the 
Standardisation Committee, which is also the responsible for standardisation procedures 
in  case  of  harmonised  products.  The  involvement  of  two  different  Committees  with 
Member  States  representatives  is  considered  by  the  different  actors  involved  to  be  not 
efficient  and  burdensome.  Consequently,  this  has  an  impact  on  the  coherence  of  the 
standardisation  process  of  the  Directive  with  the  general  framework  provided  by 
Regulation  (EU)  No  1025/2012.  This  is  an  area  that  could  be  subject  to  administrative 
simplification.  

5.4.4 Coherence with consumer protection and product liability legislation 

Some  stakeholders  have  mentioned  the  lack  of  consistency  between  consumer  rights 
under  the  Directive  and  other  EU  consumer  protection  framework  with  respect  to 
redress  options.  For  example,  the  Unfair  Commercial  Practices  Directive  2005/29/EC 

248 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on 
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 
94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 
2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC 
and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance - 
OJ L 316, 14.11.2012, p. 12–33 

83 

 
                                                           
(UCPD)249 could provide remedies for the victims of unfair commercial practices in cases 
involving the purchase of unsafe products, such as a right to compensation. Furthermore 
the Consumer Sales Directive 1999/44/EC250, as well as the newly adopted Sale of Goods 
Directive  2019/771/EU251,  could  provide  remedies  for  victims  of  non-conforming 
products,  such  as  a  right  to  a  termination  of  contract.  The  General  Product  Safety 
Directive  does  not  award  such  rights  to  consumers,  which  may  not  only  limit  the 
involvement of stakeholders in monitoring product safety, but also weaken the coherence 
of  the  consumer  protection  framework  against  unsafe  products.  However,  the  recently 
adopted Directive on representative actions for the protection of the collective interests of 
consumers252, includes Articles 3 and 5 of the General Product Safety Directive in the list 
of  consumer  legislation,  a  breach  of  which  will  entitle  the  qualified  national  entities  to 
bring  forward  a  representative  action  in  case  such  breach  harm  or  may  harm  the 
collective interests of consumers.   

Directive  85/374/EEC  concerning  the  liability  for  defective  products253  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. In order to successfully claim compensation, the injured person has to prove 
the  damage,  the  defect  and  the  causal  relationship  between  defect  and  damage.  The 
evaluation of the Product Liability Directive254, published in May 2018, concluded on its 
persistent  correspondence to  the  general  expectations the public can have from  product 
safety legislation, such as the General Product Safety Directive. The EU product safety 
rules describe the safety levels that products placed on the EU market must meet. In turn, 
they  represent  the  safety  levels  for  these  products  that  an  injured  person  is  entitled  to 

249 As amended by Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 
November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 
2011/83/EU of the European Parliament and of the Council as regards the better enforcement and 
modernisation of Union consumer protection rules, which added a new Article 11a to the UCPD on redress 
rights for consumers. This will be applicable as from 28 May 2022. 
250 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, OJ L 171, 7.7.1999, p. 12–16 
251 Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain 
aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 
2009/22/EC, and repealing Directive 1999/44/EC - PE/27/2019/REV/1 - OJ L 136, 22.5.2019, p. 28–50 
252 Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on 
representative actions for the protection of the collective interests of consumers and repealing Directive 
2009/22/EC, OJ L 409, 4.12.2020, p. 1–27 
253 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) 
254 COMMISSION STAFF WORKING DOCUMENT SWD(2018) 157 final - 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 

84 

 
                                                           
expect  under  the  Product  Liability  Directive.  Moreover,  the  General  Product  Safety 
Directive  states  in  its  recital  (36)  that  its  provisions  should  not  affect  victims’  rights 
within  the  meaning  of  the  Product  Liability  Directive,  which  remains  an  autonomous 
legal  regime.  However,  the  evaluation  of  the  PLD  also  noted  that  as  technological 
changes  will  bring  about  corresponding  changes  in  the  economy,  the  relevance  of  the 
PLD to these new needs will have to be ensured.255     

5.4.5 Coherence with E-commerce rules 

The  E-commerce  Directive256  establishes  the  general  legal  framework  for  electronic 
commerce  in  the  EU.  The  obligations  set  out  apply,  inter  alia,  to  online  sellers  of 
products  and  services  or  online  advertisers,  as  long  as  they  are  providers  of  an 
information society service that fall within the scope of that Directive. 

Under the E-commerce Directive, Member States cannot impose a general obligation on 
online intermediaries to monitor the content or a general obligation to actively seek the 
facts or circumstances indicating illegal activity. 

Intermediary service providers carrying out  hosting activities may benefit under certain 
conditions from an exemption of liability for illegal information provided by third parties 
using their networks or illegal activities initiated by third parties. However, the liability 
exemption  is  subject  to  specific  conditions.  It  only  applies  if  the  intermediary  service 
providers  have  no  actual  knowledge  or  awareness  of  the  illegal  activity  or  information 
hosted or, upon obtaining such knowledge or awareness  (for instance by  a ‘sufficiently 
precise  and  adequately  substantiated’  notice257),  they  act  expeditiously  to  remove  or  to 
disable access to it. If hosting service providers do not fulfil these conditions, they are not 
covered by the liability exemption and thus can be held liable for the content they host. 

While  the  E-commerce  Directive  does  not  define  the  concept  of  illegal  information  or 
activity, based on the General Product Safety Directive as well as product harmonisation 
legislation, this concept can also cover the offer of unsafe products. In that sense, it can 
be established that the E-commerce Directive is coherent with the Directive.  

However,  stakeholders  have  signalled  in  the  different  consultations  that  the  principles 
mentioned above related to the prohibition of general monitoring and the liability system 
make difficult the implementation of the provisions of the Directive. Participants at the 
workshop  on  online  marketplaces  (see  Annex  13)  agreed  that  online  marketplaces  play 
an essential role in the supply chain, and that more responsibilities and cooperation with 
market  surveillance  authorities  would  help  to  effectively  control  the  safety  of  products 
sold through their platforms. This issue has been partially tackled by the recent proposal 

255  Ibidem, page 49 and ff. 
256 Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal 
aspects of information society services, in particular electronic commerce, in the Internal Market (E-
commerce Directive) (OJ L 178, 17.7.2000, p. 1). 
257 In Case C-324/09, L'Oréal vs. eBay, the European Court of Justice clarified that the relevant question 
relating to the conditions for benefiting from a liability exemption was whether eBay was aware of facts 
and circumstances from which the illegal activity was apparent (paragraphs 120 to 123). 

85 

 
                                                           
of  the  Commission  for  a  Digital  Services  Act258,  a  comprehensive  set  of  new  rules, 
which regulate the responsibilities of digital services that act as intermediaries, including 
online  marketplaces.  In  particular,  the  proposal  sets  out  clear  due  diligence  obligations 
for  online  intermediaries  such  as  a  harmonised  notice  and  action  mechanism, 
transparency  obligations,  measures  to  deter  rogue  traders,  cooperation  with  competent 
authorities and an obligation for online marketplaces to gather information on the identity 
of traders using their platforms.  

5.4.6 Coherence with wider EU policy 

The evaluation shows that there are no coherence problems of the Directive with wider 
EU policy and priorities. However, some of the stakeholders in the consultations of the 
GPSD  Study  mentioned  a  few  areas  where  frictions  remain.  Those  issues  cannot  be 
considered as coherence problems of the Directive per se and they cannot be solved by a 
single instrument. However, they are worthy to be mentioned below.   

As explained in the effectiveness section, the Directive is considered to be effective with 
regards to its objective to allow the free movement of goods within the Single Market. 
However,  stakeholders  mentioned  that  there  might  coherence  problems  with  regard  to 
mutual recognition. Stakeholders indicated their uncertainty as  to  whether a particular 
product,  and  its  producers  or  distributors,  could  enjoy  the  free  movement  of  goods,  if 
there  was  an  option  for  the  Member  States  to  adopt  voluntary  national  certification 
systems. According to stakeholders, various Member States have such voluntary national 
certification  systems  in  place  for  various  products.  Whilst  the  presence  of  such 
certification systems does not make the market prohibitive for products from outside this 
Member  State,  as  there  is  no  obligation  to  comply  with  the  potential  additional  safety 
requirements,  it  may  make  the  market  more  difficult  to  succeed  in  without  that 
certification mark, in particular for SMEs.  

With  regard  to  sustainability,  several  stakeholders  highlighted  that  in  their  view  the 
emerging  circular  economy  implied  the  need  for  legal  certainty  with  regard  to  reused, 
refurbished  and  repaired  products,  and  in  particular  in  relation  with  who  within  the 
circular supply chain should bear the responsibility for the safety of the re-sold products. 
In  the  context  of  the  Sub-group  on  new  technologies  and  product  safety,  several 
stakeholders  mentioned  that  for  harmonised  products,  concepts  such  as  ‘substantial 
modification’ already provided clarity in this respect, and such provisions were missing 
for non-harmonised products.  

2.5.2.  5.4.7 Conclusion on coherence 

It  results  from  this  evaluation  that  overall,  the  Directive  shows  a  high  degree  of 
internal coherence, as there are no major contradictions among its provisions, as well as 
external (i.e. with other pieces of EU legislation), playing a key role in the Single Market 
framework. Further coherence however could be sought through more clarity.  

258 COM(2020) 825 final Proposal for a Regulation of the European Parliament and of the Council on a 
Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC 

86 

 
                                                           
As  regards  coherence  with  other  pieces  of  legislation,  this  evaluation  has  detected  a 
major  shortcoming  regarding  the  coherence  of  market  surveillance  provisions. 
While  rules  for  harmonised  and  non-harmonised  are  clear  and  do  not  overlap  between 
each other, in practice the coexistence of two systems has an impact on the coherence of 
the legal framework, and has implications for market surveillance authorities.  

5.5. EU added value 

The GPSD Study shows that both authorities and companies/business associations see on 
average a “significant added value”. While other stakeholders provide a somewhat less 
positive  assessment,  they  consider  the  Directive  to  provide  still  more  than  “moderate 
added value”. A considerable number of respondents across all stakeholder groups found 
the Directive to even have “very significant added value”; namely 42 of 141 stakeholders 
had this opinion. In contrast, only 9 respondents to our surveys found the GPSD to have 
“no”  or  only  “minor”  added  value.  SMEs  were  also  slightly  less  positive  than  other 
business stakeholders.  

The  reasons  for  such  positive  assessment  are  clear.  Action  at  EU  level  is  important  to 
protect consumers and to ensure obligations on the EU businesses evenly. Furthermore, 
the  Directive  ensuring  rapid  circulation  of 
common  rules  established  under 
information among Member States on unsafe products are essential to protect consumer 
and  ensure  a  fair  internal  market.  Products  freely  circulate  across  the  Internal  Market. 
When an unsafe product is identified in a certain Member State it is very likely that the 
same  product  could  be  found  in  other  Member  States  too.  This  shows  the  clear  cross-
border  effect  of  product  safety,  which  cannot  be  sufficiently  achieved  by  the  Member 
States’  individual  actions  because  they  cannot  ensure  cooperation  and  coordination  by 
acting alone.  

Since  the  adoption  of  the  Directive  there  have  been  no  procedures  in  the  EU  courts 
related to national measures in the area of the health and safety of products that fall under 
its scope of application. 

The  Directive  has  also  contributed  to  economies  of  scale  with  regard  to  market 
surveillance.  The  Directive  allows  the  performance  of  joint  market  surveillance  action 
and exchange of sensitive information.  

Furthermore the Safety Gate/RAPEX system established by the Directive allows faster 
and  more  efficient  circulation  of  information  between  Member  States,  ensuring  a  level 
playing field. The circulation of information through the Safety Gate/RAPEX allows to 
spread  information  on  unsafe  products  among  both  Member  States  Authorities  and 
consumers.  

At  international  level,  the  common  set  of  provisions  established  by  the  Directive  has 
also  allowed  the  EU  to  be  stronger  in  promoting  high  level  of  safety  at  a  more  global 
level,  very  important  nowadays  with  the  increasing  circulation  of  goods  via  online 
selling. 

Repealing  the  Directive  would  lead  to  fragmentation  and  differing  levels  of 
consumer protection. The safety of consumer products  is  so intrinsically  linked to  the 

87 

 
internal market that such fragmentation of rules would create a very critical obstacle for 
the internal market and for the European consumer.  

Therefore,  this  evaluation  concludes  that  the  EU  added  value  of  the  Directive  is 
undeniable. Nevertheless, it needs to be recognised that the added value of the Directive 
and  its  harmonious  application  in  the  Member  States  could  be  further  improved  by 
clearer rules and/or guidance documents.  

6.  CONCLUSIONS AND LESSONS LEARNT  

The role of the Directive as a cornerstone of consumer safety and the functioning of the 
Single Market is uncontested. Its objectives remain fully relevant, and its EU added value 
cannot be denied. The role of safety net of the Directive remains essential for consumer 
protection, as it provides a legal basis aimed to ensure that no dangerous products end up 
in  the  consumer’s  hands.  The  establishment  of  the  Rapid  Alert  System  for  dangerous 
non-food  products  under  the  Directive  has  proven  to  be  a  success,  and  consequently 
expanded  via  Regulation  765/2008  first  and  Regulation  2019/1020  afterwards  to  other 
categories of products, such as professional products, and to other risks, such as risks to 
the environment, security and other risks to other interests to the Union.  

However,  this  evaluation  has  exposed  a  number  of  factors  that  put  into  question  the 
extent to which some provisions of the Directive contribute to the proper achievement of 
the goals that it pursues. 

In the first place, the growth of E-commerce has negatively influenced the relevance and 
effectiveness  of  the  Directive.  As  repeatedly  stated  through  this  report,  the  Directive 
applies to all consumer products regardless if they are sold in brick-and-mortar shops or 
online. However, it can be taken as a lesson learnt that the lack of explicit provisions of 
the Directive to address the specificities of online selling, in particular the appearance of 
new  actors  in  the  online  supply  chain,  has  negatively  affected  to  the  safety  of  EU 
consumers  as  well  as  the  level-playing  field  for  compliant  EU  businesses.  New  rules 
regarding E-commerce, in particular the Digital Services Act, are likely to contribute to 
partially address this issue. However, explicit provisions directly related to E-commerce 
and product safety could be envisaged.   

The rapid development of new technologies is also questioning the relevance of some of 
the  key  concepts  of  the  Directive.  The  appearance  of  some  new  risks  linked  to 
connectivity, the applicability of the Directive to software updates and downloads as well 
as  the  evolving  functionalities  of  AI-powered  products  raise  the  question  whether  the 
Directive  is  clear  enough  to  provide  legal  certainty  for  businesses  and  protection  to 
consumers.  While  legislative  measures  should  be  sought  in  product  harmonised 
legislation  to  address  the  particularities  of  these  technologies,  this  evaluation  has  also 
showed  a  need  to  ensure  that  the  Directive  remains  as  the  safety  net  for  all  consumer 
products, including those incorporating new technologies.  

The  evaluation  has  also  identified  the  problems  for  the  coherence  of  the  EU  legal 
framework  and  the  existence  of  two  different  sets  of  rules  on  market  surveillance  for 

88 

 
harmonised  and  non-harmonised  products,  that  have  also  clear  implications  for  the 
effectiveness and efficiency of the Directive. An alignment between both frameworks, as 
well as in the definitions of the Directive with product harmonisation legislation, should 
be sought.  

Finally,  it  is  also  apparent  from  this  evaluation  that  it  would  be  necessary  to  fine-tune 
some  of  the  provisions  to  improve  the  effectiveness  of  the  Directive.  In  particular, 
legislative changes or further actions are needed to improve the effectiveness of product 
recalls.  There  is  a  need  for  mechanism  to  arbitrate  disputes  between  Member  States 
regarding  risk  assessments.  The  traceability  system  under  the  Directive  and  the 
resources  constraints  of  market  surveillance  authorities  are  challenges  that  make  it 
difficult to effectively control the safety of products, and consequently need to be tackled 
to  ensure  a  proper  protection  of  consumers  and  functioning  of  the  Single  Market. 
Provisions  of  the  FIPD  on  food-imitating  products  are  currently  not  enforced  in  a 
harmonised  manner  among  Member  States,  so  a  solution  to  address  this  challenge  is 
needed.  

89 

 
 
 
Appendix 1: Procedural information 

1.  LEAD DG, DeCIDE PLANNING/CWP REFERENCES 

  Lead DG: Directorate General for Justice and Consumers (DG JUST) 
  Decide/Planning:  PLAN/2019/6283  Review  of  the  general  product  safety  directive  -

Proposal for a regulation on general product safety.  

  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.  

  This GPSD ISSG held 5 meetings times (one informal meeting on 14/02/2020 and four 
formal  meetings  on  12/06/2020,  08/10/2020,  18/11/2020  and  07/12/2020).  DG  JUST 
consulted  the  ISSG  on  the  different  steps  of  this  initiative:  Roadmap/Inception  Impact 
Assessment,  Consultation  strategy,  open  public  consultation  questionnaire,  the  study 
underlying the evaluation and impact assessment (ISSG provided comments on all study 
steps and reports) and finally on the draft evaluation.  

  Publication in EUROPA of the Roadmap on the evaluation, 30 June 2020  
  Launch of the Open public consultation, 30 June 2020 - 6 October 2020 (14 weeks)   

3.  EXCEPTIONS TO THE BETTER REGULATION GUIDELINES 

 This Evaluation has been conducted back-to-back to the Impact assessment. 

4.  CONSULTATION OF THE RSB (IF APPLICABLE) 

 This Evaluation report is one of the annexes to the Impact Assessment report, on which the RSB 
has been consulted. 

5.  EVIDENCE, SOURCES AND QUALITY 

Studies commissioned or supported by the European Commission 

  Study to  support the preparation of an  evaluation of the General  Product Safety 
Directive  as  well  as  of  an  impact  assessment  on  its  potential  revision,  Civic 
consulting, December 2020 

  Study  for  the  preparation  of  an  Implementation  Report  of  the  General  Product 

Safety Directive, Civic consulting, July 2020 

  Study on the assessment of the opportunities for increasing the availability of EU 
data  on  consumer  product-  related  injuries,  European  Commission’s  Joint 
Research Centre’s, May 2020 

  Behavioural  Study  on  strategies  to  improve  the  effectiveness  of  product  recalls, 

LE Europe, December 2020 

  Survey on consumer behaviour and product recalls effectiveness, April 2019 

 

Implementation  of  the  new  Regulation  on  market  surveillance:  indication  of 
origin, VVA Europe, May 2015 

90 

 
External Expertise 

  Consumer Safety Network (CSN) 

  Sub-group  on  Artificial  Intelligence,  connected  products  and  other  new 

challenges in product safety to the Consumer Safety Network 

Selective bibliography 

  Bernstein A. (2013), ‘Voluntary Recalls’, University of Chicago Legal Forum, 1: 
394  ff.,  available  at:  http://chicagounbound.uchicago.edu/uclf/vol2013/iss1/10  
and  Jacoby  J.  (1984),  ‘Perspectives  on  Information  Overload’,  Journal  of 
Consumer Research 

  OECD  (2020)- 

  ‘E-commerce  in  the  time  of  COVID-19’,  available  at 

http://www.oecd.org/coronavirus/policy-responses/e-commerce-in-the-time-of-
covid-19-3a2b78e8/#biblio-d1e705 

  OECD  (2018),  ‘Enhancing  Product  Recall  Effectiveness  Globally’,  available  at 
https://www.oecd-ilibrary.org/science-and-technology/enhancing-product-recall-
effectiveness-globally_ef71935c-en  

Other Sources 

  Eurostat 
  European Injury Database (IDB) 
  Safety Gate/RAPEX 
  WHO CHOICE 

91 

 
 
Appendix 2: Analytical methods 

This Appendix shows the analytical methods additionally used for the preparation of the 
Evaluation.  For  more  general  information  about  the  Analytical  methods,  please  see 
Annex 4.  

5.1.  Estimation of costs of  compliance with  the Directive for EU businesses 

(for efficiency criterion) 

Firstly, there is a need to calculate the estimation of the baseline market size, i.e. the total 
turnover of EU businesses from manufacturing and/or selling non-harmonised consumer 
products  in  the  EU259,  before  analysing  company  level  compliance  cost  data,  and 
extrapolating it to EU level, based on the estimated baseline market size. The analysis is 
structured according to six steps: 

Step 1: Estimation of EU companies’ total annual turnover from the production and/or 
sales of non-harmonised consumer products in the EU 

Based  on  NACE  industry  codes  and  sector  descriptions,  those  manufacturing  sectors 
were  identified  (NACE  Rev.  2,  B-E),  wholesale  services  sectors  and  retail  sectors 
(NACE Rev. 2, G) in which consumer products are produced and/or sold, i.e. sectors that 
clearly  focus  on  the  production  and  sales  of  industrial  products  were  excluded.  Sectors 
related to motor vehicles have been excluded, in line with the focus on non-harmonised 
consumer  products.  While  retail  sale  can  be  assumed  to  be  largely  related  to  consumer 
products  (although  retailers  may  also  sell  to  professional  users,  and  may  sell  services), 
the  wholesale  and  manufacturing 
listed  areas  clearly  also  contain 
industrial/professional  products,  an  issue  considered  in  Step  3  below.  To  arrive  at  the 
share of non-harmonised products  produced and/or sold  in  these sectors, it was applied 
the estimate provided in the 2017 EU impact assessment for the new Market Surveillance 
Regulation, which estimated that about 54% of products circulating within the European 
Single Market are harmonised products and 46% are non-harmonised products260.  

the 

in 

Step 2: Deduction of extra-EU export 

To calculate the net turnover for non-harmonised consumer products that are only sold in 
the  EU,  the  share  of  extra-EU  exports  from  the  total  turnover  of  EU  companies  was 
deducted. The calculation is based on an approximation of sector-specific export shares. 
The extra-EU trade by enterprise characteristics data provided by Eurostat do not exactly 
match  the  sector  classification  of  turnover  data  by  enterprise  size  class.  Therefore  the 

All estimates in this section refer to the EU27 as of 2020.  

259  
260  
Accompanying the document COM (2017) 795. 

SWD (2017) 466 final PART 2/4 Commission Staff Working Document Impact Assessment 

92 

 
 
                                                           
extra-EU export shares of manufacturing, wholesale and retail sectors were approximated 
on the basis of those sectors261. The estimated extra-EU export shares of manufacturing, 
wholesale and retail sectors were subtracted from the annual turnover of EU companies 
with non-harmonised products in the selected sectors.  

Step 3: Deduction of industrial and professional products 

The  EU  turnover  derived  in  Step  2  was  corrected  by  the  percentage  shares  of  turnover 
that  can  be  attributed  to  the  production  and/or  sales  of  consumer  products  in 
manufacturing,  wholesale  and  retail  sectors.  For  this  purpose,  a  different  dataset  was 
drawn,  namely  the  final  consumption  expenditure  of  households  by  consumption 
purpose262. There was  a correction for the share of harmonised products, and arrived at 
an  estimate  for  total  household  consumption  of  non-harmonised  products.  For  the 
following  analysis  it  was  assumed  that  this  consumption  of  non-harmonised  consumer 
products is equivalent to the total turnover from non-harmonised consumer products sold 
by  EU  retailers.  The  estimated  retail  turnover  from  non-harmonised  products  indicated 
before  was  adjusted  accordingly,  and  the  resulting  amount  was  allocated  between  the 
three enterprise size classes. Due to data limitations, the same methodology could not be 
applied  for  manufacturing  and  wholesale  sectors263.  For  manufacturing  and  wholesale 
sectors, it was estimated the share of turnover that can be attributed to consumer products 
on  the  basis  of  the  share  of  “consumer-oriented”  wholesale  services  in  total  wholesale 
services.  It  is  assumed  that  the  same  share  reflects  the  portion  of  consumer  products 
produced  and/or  sold  by  manufacturers.  Based  on  this  approach,  the  total  annual  EU 
turnover of EU companies from non-harmonised consumer products was calculated.  

Step 4: Derivation of empirical estimates for companies’ product safety-related costs on 
the basis of survey responses  

In  the  GPSD  study,  businesses  were  asked  to  indicate  staff  time  used  for  managing 
product  safety,  testing  for  product  safety,  recalls  and  other  consumer  product  safety 
related  activities.  Respondents  were  asked  to  consider  all  costs  for  ensuring  product 
safety  of  both  harmonised  and  non-harmonised  consumer  products  (excluding 
pharmaceuticals,  medical  devices  or  food),  as  the  identification  of  costs  for  non-
harmonised  products  only  was  not  considered  to  be  feasible.  In  addition  to  staff 
requirements, companies were asked to provide estimates for other costs to comply with 
safety requirements for consumer products (e.g. costs for external legal advice, costs for 

These sectors are: “Manufacture of textiles, Manufacture of wood and of products of wood and 

261  
cork, except furniture; manufacture of articles of straw and plaiting materials”, “Manufacture of paper and 
paper products”, “Manufacture of computer, electronic and optical products”, “Manufacture of electrical 
equipment”, “Manufacture of furniture”, “Wholesale trade, except of motor vehicles and motorcycles”, and 
“Retail trade, except of motor vehicles and motorcycles”.  
262  
digit) [nama_10_co3_p3]. 
263  
sectors, i.e. final products that are consumed by households. 

Eurostat data do not allow to extract “pure” consumer products for manufacturing and wholesale 

Eurostat, Final consumption expenditure of households by consumption purpose (COICOP 3 

93 

 
                                                           
external  safety  testing,  costs  for  certification  of  safety  of  products  etc.)264.  The  cost 
estimates provided by the respondents also include business-as-usual costs, which would 
incur  even  in  absence  of  product  safety  regulation  (see  Step  6).  These  estimates  were 
used  to  estimate  companies’  annual  regulatory  compliance  costs  in  Euro  terms.  The 
calculation  of  Euro-denominated  costs  for  staff  was  based  on  the  EU’s  (weighted) 
average wage for the business economy, which in 2019 was 27.50 Euro per hour265. To 
account  for  overhead  costs,  a  25%  mark-up  was  added  to  staff-related  costs. 
Subsequently, the costs for each company were related to the EU turnover for consumer 
products,  i.e.  companies’  annual  cost  resulting  from  activities  to  comply  with  safety 
requirements for (all) consumer products as a share of the related turnover.  

Step 5: Extrapolation of EU companies’ annual costs related to the Directive  including 
business-as-usual costs that occur also in absence of regulation 

For  each  enterprise  size  class,  the  empirical  median  values  for  companies’  relative 
product  safety-related  costs  (Step  4)  were  multiplied  by  the  annual  turnover  of  EU 
companies  that  can  be  attributed  to  the  production  and/or  sales  of  non-harmonised 
consumer  products  in  the  EU  (Step  3).  The  results  of  this  calculation  still  include 
business-as-usual costs. 

Step 6: Deduction of business-as-usual costs and extrapolation of EU companies’ annual 
compliance cost related to the Directive 

In  the  GPSD  Study,  businesses  were  asked  to  indicate  the  share  of  the  total  product 
safety-related costs that they would incur anyway (i.e. even in absence of product safety 
legislation,  e.g.  because  these  costs  relate  to  due  diligence),  hereafter  referred  to  as 
business-as-usual  costs,  BAU.  These  estimates  reflected  the  self-assessment  of  the 
companies that are part of the sample, and are therefore subjective in nature. However, as 
concerns  differences  between  manufacturers,  on  the  one  hand,  and  wholesalers  and 
retailers, on the other, it was considered that the estimates to be in line with expectations 
and a credible basis for the final step of the assessment. The empirical median values of 
these shares were applied to the product safety-related cost estimates derived in Step 5. 
Excluding business-as-usual costs, compliance costs of EU companies were obtained that 
can  be  attributed  to  non-harmonised  consumer  products,  i.e.  the  costs  for  businesses  to 
comply with the Directive.  

5.2.  Estimation of costs of compliance with the Directive for Member States 

(for efficiency criterion) 

The  estimation  of  market  surveillance  authorities’  staff-related  costs  related  to  market 
surveillance activities for non-harmonised consumer products in the EU was based on the 
following three steps: 

264  
265  
Eurostat. 

Business stakeholders were asked to estimates average costs per month in EUR. 

Labour cost for LCI (compensation of employees plus taxes minus subsidies), provided by 

94 

 
                                                           
Step  1:  Identification  of  authorities’  annual  FTEs  for  market  surveillance  activities 
related to non-harmonised consumer products 

The  number  of  full  time  equivalent  (FTE)  staff  for  market  surveillance  of  consumer 
products  as  provided  in  the  country  research  was  used.  Where  the  available  country 
estimates related to  the  market  surveillance of non-harmonised consumer products,  this 
figure was directly used in the calculation. Where estimates related to the total staff for 
market  surveillance  of  both  harmonised  and  non-harmonised  consumer  products,  staff 
was allocated according to the 54%/46% ratio for harmonised/non-harmonised products 
circulating  within  the  European  Single  Market  to  derive  an  estimate  for  related  market 
surveillance activities266. It should be noted that a share of 46% in staff time for market 
surveillance  of  non-harmonised  consumer  products  is  12  percentage  points  higher  than 
the  empirical  median  share  indicated  by  authorities  for  activities  devoted  to  non-
harmonised products in the stakeholder survey (34%), potentially causing an estimate at 
the  higher  end  of  authorities’  actual  costs  that  can  be  attributed  to  market  surveillance 
activities for non-harmonised consumer products. For seven countries, no information on 
staff numbers was available at all.  

Step 2: Approximation of annual FTEs for market surveillance activities related to non-
harmonised consumer products for countries for which data was not available 

For  the  seven  countries,  for  which  no  staff  data  was  available  (Croatia,  Germany, 
Hungary,  Italy Slovenia, Slovakia, and Spain) it was estimated the number of  FTEs on 
the  basis  of  the  data  for  the  remaining  20  Member  States.  To  account  for  institutional 
differences with regard to the level of centralisation, it was considered that two clusters 
of countries, in line with the characteristics of the respective market surveillance systems 
as  described  above:  Cluster  1:  responsibility  for  market  surveillance  is  centralised  (no 
sub-national  administrations  involved);  Cluster 2:  responsibility for market  surveillance 
is  (partly)  delegated  to  or  competence  of  sub-national  administrations,  in  line  with  the 
administrative structure of the country. 

To  derive  estimates  for  the  number  of  FTEs  per  million  population  for  Slovenia  and 
Slovakia  (more  centralised  market  surveillance),  the  sample  median  of  3.5  FTEs  per 
million  population  was  applied.  To  derive  FTE  estimates  for  the  number  of  FTEs  per 
million population for Croatia, Germany, Hungary,  Italy and Spain  (more decentralised 
market surveillance), the sample median of 4.6 FTEs per million population was applied.  

As mentioned before, the 2017 EU impact assessment for the new Market Surveillance Regulation 

266  
estimated that about 54% of products circulating within the European Single Market are harmonised 
products and 46% are non-harmonised products. See SWD (2017) 466 final PART 2/4 Commission Staff 
Working Document Impact Assessment Accompanying the document COM(2017) 795. 

95 

 
                                                           
Step 3: Calculation of annual staff costs for market surveillance activities related to non-
harmonised consumer products  

In  the  final  step,  it  was  calculated  that  the  EUR  equivalent  of  the  estimated  number  of 
staff  required  for  market  surveillance  of  non-harmonised  consumer  products  by 
multiplying the number of FTEs per million population by: 

  The size of population for each country (in million); 

  The number of person-hours per year (1 720) 267; and 

  The average wage of 28.00 EUR, which corresponds to the EU27 average wage 
of “administrative and support service activities” (18.70 EUR) and “professional, 
scientific and technical activities” (37.30 EUR) for 2017 (latest figure available in 
Eurostat database).  

5.3.  Methods for other supporting estimations (for effectiveness criterion) 

Other  supporting  estimations  include  the  analysis  of  data  from  the  rapid  alert  system. 
Data from Safety Gate/RAPEX was used for the analysis of the baseline situation and the 
related problem analysis. For this purpose, a full dataset covering the years 2005 to 2019 
was  retrieved.  The  dataset  consisted  of  a  total  of  25  850  notifications  that  are  publicly 
available.  The  dataset  included  25  051  notifications  concerning  products  with  serious 
risks,  738  notifications  of  products  with  other  risk  levels,  and  61  other  types  of  alerts. 
This dataset was merged with a second dataset covering notifications in the period 2011 
to 2019, which included complementary (not publicly available) data. 

267  
year. See, e.g. the H2020 Programme: User's Guide for the Personnel Costs Wizard. 

Following EU Horizon 2020 guidelines, one person year corresponds to 1 720 person-hours per 

96 

 
 
                                                           
Appendix 3: Evaluation questions 

Relevance 

To what extent the initial objectives of the GPSD correspond to the current needs?  

To what extent is there a need to clarify concepts set out in the GPSD, such as 
“product”, “safe product”, “serious risk” and “placing on the market”?  

How well adapted is the GPSD to online sales?  

How well adapted is the GPSD to challenges posed by new technologies, such as 
cybersecurity risks in relation to safety, self-evolving products and stand-alone 
software or emerging safety issues in the post-market phase of the product?  

How well is GPSD adapted to increased level of direct imports towards the EU?  

How well adapted is the GPSD to environmental issues with health impact? In 
particular, how this health impact is considered by taking into account the 
assessment done under REACH related to chemicals?  

Effectiveness 

To what extent does the GPSD meets its objectives of achieving a high level of 
consumer protection through the reduction of unsafe products and contributing to 
the functioning of the Single Market? Which are the main elements that have 
contributed to this? Is there anything missing?  

To what extent has the market surveillance system established by the GPSD (in 
particular the Rapid Alert System for dangerous non-food products) been effective?  

How has the development of e-commerce affected the effectiveness of the GPSD?  

How has the development of new technologies, such as Artificial Intelligence, Internet 
of Things and connected devices, affected the effectiveness of the GPSD?  

How effective has been the development and use of the standards supporting the 
implementation of the GPSD?   

How well is GPSD adapted to ensure efficient corrective actions are taken, in 
particular recalls?  

How well is GPSD adapted to ensure effective market surveillance? 

Are there any aspects/means/actors that render certain aspects of the Directive more 
or less effective than others (including product recalls), and if there are, what lessons 
can be drawn from this? 

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

97 

 
 
 
 
 
Efficiency 

What are the regulatory (including administrative) costs of the GPSD for the 
different actors involved (Member States authorities, businesses, consumers) and for 
the society overall? In particular, what is the economic cost for businesses to comply 
with the GPSD?  

What are the benefits of the GPSD for the different actors involved (Member States 
authorities, businesses, consumers) and for the society overall?  

To what extent are these costs proportionate to the benefits?  

What factors influenced the efficiency of reaching the objectives which the GPSD sets 
out?  

Coherence 

Are there any discrepancies and/or inconsistencies between the provisions of the 
GPSD?  

Are there overlaps and/or complementarities between the GPSD and any other Union 
legislation with similar objectives, in particular regarding market surveillance, 
product harmonisation legislation, including horizontal legislation on chemicals and 
food contact materials legislation, standardisation, consumer protection law and 
product liability, and also other union legislation such as the E-commerce Directive? 

To what extent is the Directive coherent with wider EU policy, such as rules on free 
movement of goods, mutual recognition, customs, competition, industrial policy, 
sustainability (environmental protection) and trade? 

EU added value 

What is the added value of the GPSD compared to what could reasonably have been 
expected from Member States acting at national level?  

What would be the most likely consequences of withdrawing the GPSD? How would 
it affect the functioning of the Single Market and the health and safety of consumers?  

98 

 
 
 
 
 
 
Appendix 4: Implementation of the Food Imitating Products 
Directive (FIPD) 

Council  Directive  87/357/EEC  (the  Food-Imitating  Products  Directive)  was  adopted  to 
address  the  lack  of  harmonisation  amongst  national  measures  trying  to  ensure  product 
safety  of  products  ‘appearing  to  be  other  than  they  are’.  Before  the  adoption  of  the 
Directive,  there  were  legal  provisions  or  regulations  in  force  in  several  Member  States 
concerning  certain  products  which,  appearing  to  be  other  than  they  are,  endanger  the 
safety or health of consumers. However, these provisions differed in content, scope and 
field of application. In particular, these provisions concerned in certain Member States all 
products which resemble foodstuffs while not being such whilst in other Member States 
they  concern  products  likely  to  be  confused  with  foodstuffs,  especially  confectionery. 
This  situation  created  significant  barriers  to  the  free  movement  of  goods  and  unequal 
competitive  conditions  within  the  Community  without  ensuring  effective  protection  for 
consumers, especially children. 

The  products  covered  by  the  FIPD  possess,  pursuant  to  Article  1(2),  a  ‘form,  odour, 
colour,  appearance,  packaging,  labelling,  volume  or  size’  that  consumers,  especially 
children,  could  confuse  with  foodstuffs,  and  endanger  health  of  safety  of  consumers 
(Article  1(1)).  The  fact  that  these  products  imitate  foodstuffs  could  then  lead  to 
consumers putting such products in their mouths, sucking or ingesting them, which could 
be dangerous. This led the European legislator to provide that Member States should take 
all measures necessary to prohibit the marketing and introduction of such products on the 
market268  through  the  above-mentioned  Directive.  The  justification  for  the  adoption  of 
this measure was twofold: to improve consumer protection, especially the protection of 
children,  as  well  as  to  ensure  a  level-playing  field  on  the  Internal  Market  of  such 
products. The latter goal aimed at eliminating barriers to the free movement of goods that 
could  imitate  other  products,  but  which  would  not  create  serious  risks  to  consumer 
protection. 

While most Member States have implemented the Food-Imitating Products Directive into 
national  legislation  as  in  the  Directive,  without  additional  provisions,  there  are 
differences  in  interpretation.  Some  authorities  perceive  products  in  this  category  as 
dangerous per se, whilst others are of the opinion that any serious risks need to be proven 
through  an  appropriate  risk  assessment  procedure.  Indeed,  the  Food-Imitating  Products 
Directive has been adopted before the GPSD, which sets out the principle of the necessity 
of  risk  assessment  of  the  product  safety  before  taking  appropriate  measures  against 
products and some Member States started to apply to food-imitating product the GPSD 
logic  while  others  stayed  at  the  primary  interpretation  of  the  Food-Imitating  Products 
Directive  as  a  ban  of  these  products.  This  had  then  led  to  differences  in  the  national 
assessment  whether  a  particular  food-imitating  product  should  be  prohibited  from  the 
market.  However,  the  number  of  Safety  Gate/RAPEX  notifications  of  food-imitating 

268 Article 2 Food Imitating Directive. 

99 

 
                                                           
products is small. Between 2013 and 2019, a total of 114 notifications that relate to food-
imitating  products269.  The  table  below  shows  the  product  categories  for  these 
notifications  in  the  period  2013  to  2019.  The  number  of  notifications  of  food-imitating 
products  is  fairly  small  –  up  to  36  notifications  out  of  the  approximately  2  000 
notifications annually. The number has varied significantly over the years, from 1 to 36 
notifications annually. 

Table 9: Notifications to Safety Gate/RAPEX related to food-imitating products 

Product category 

Year 

Total 

Cosmetics 
Decorative articles 
Food-imitating products 
Other 
Stationery 
Toys 

Total 

Source: Safety Gate/RAPEX 

2013  2014  2015  2016  2017  2018  2019 

1 

3 
1 

12 

8 

1 

13 

8 

4 

1 

1 
26 

27 

28 
4 

4 

36 

1 
17 

2 
2 
3 

33 
23 
46 
2 
2 
8 

25 

114 

The table shows that the product category “Food-imitating products” was only used up to 
2015. Afterwards, the products have been categorised according to their use (cosmetics, 
clothing,  etc.).  This  seems  to  indicate  that  a  change  of  practice  has  occurred  in  the 
Member  States  to  remove  the  overlap  between  the  category  “food-imitating  products” 
and  other  product  categories.  Most  of  these  notifications  makes  reference  to  the  Food-
Imitating  Products  Directive  in  the  description  of  the  risk  and  include  a  statement  like 
“The product does not comply with the Food-Imitating Products Directive.” Apparently, 
many  authorities  ban  a  food  imitating  product  because  the  Food-Imitating  Products 
Directive directly bans such products  without the need for a risk assessment. However, 
this raises questions regarding the proportionality of such measures.  

The vast majority of the notifications related to food-imitating products (87%) mentions 
or includes choking in the description of the risk associated with the product, presumably 
because  the  product  is  or  contains  small  parts.  The  second-most  common  risk  type  is 
“chemical” (12%). 

There is little evidence available regarding the adverse effect of food-imitating products. 
A 2011 opinion by the  Scientific Committee on Consumer Safety  concluded that “Few 
cases of accidental ingestion of food-resembling or child-appealing products are reported. 
This  may  be  due  to  the  lack  of  sufficient  registered  information  to  discriminate  these 

269 These are identified in different ways, and some cases meet several of the criteria at the same time: The 
parameter “Category” includes “Food imitating products” (46 notifications); The parameter “Product” 
includes the text “imitat” (6 notifications); The parameter “Description” contains the text “imitat” (46 
notifications); The parameter “Risk” contains the text “imitat” (57 notifications). Cases that were identified 
using the filtering term “imitat” have subsequently been reviewed manually to remove cases that did not 
refer to food (e.g. notifications related to “leather imitation”, “imitation of gun”, etc.) 

100 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                           
types  of  products.  Data  from  poison  centres  and  scientific  literature  on  accidental 
ingestion  of  cosmetics  or  liquid  household  products  suggest  that  the  majority  of  such 
ingestions  result  in  mild  gastrointestinal  effects.  […]  The  weight  of  evidence  from 
accidental ingestion of cosmetics suggests that there is a low risk of acute poisoning in 
either children or the elderly. For household products, there is a slight increase of a more 
serious  outcome”.  From  the  opinion,  which  focused  on  chemical  consumer  products 
resembling  food  and/or  having  child-appealing  properties’,  it  appears  that  these  food-
imitating  products  rarely  represent  serious  or  high  risks.  However,  the  opinion  also 
concludes  that  “there  is  a  lack  of  specific  data  on  accidental  ingestion  from  consumer 
products resembling food and/or having child-appealing properties”. 

It can therefore be concluded that while a majority of Member States seems to apply the 
provisions  of  the  Food-Imitating  Products  Directive  only  in  cases  where  the  risks  are 
serious, there are also countries that consider products in this category as dangerous per 
se. In other words, the legal framework for food-imitating products is applied differently 
in different countries. 

101 

 
 
 
Annex  6: Effects  of the COVID-19  crisis  in  the  context of the 
policy options and their expected impacts 

The analysis of the impact of COVID-19 in the Study underlying the GPSD Evaluation 
and  Impact  assessment  is  based  on  macroeconomic  data  and  a  series  of  interviews 
conducted  with  companies  active  in  (also)  non-harmonised  consumer  products.  The 
Study  explored  the  companies’  views  on  the  policy  options  and  potential  effects  of 
COVID-19  in  this  respect,  as  well  as  expectations  concerning  relevant  long  term, 
structural changes.  

In terms of structural changes that would need to be considered for changes in the EU 
legislative framework in general, interviewees expected: 

  A change in  consumer behaviour towards  more  quality products  that are also 

more eco-friendly;  

  Energy  efficiency  will  be  an  important  topic  and  people  will  likely  buy  more 

sustainable and environmentally friendly products;  

  Promoting the reuse, refurbishment and recycling of used products;  

  A stronger focus on hygiene is expected, and the safety of these products will 

have a more prominent role for consumers. 

in 

the  short-term, 

interviewees  expected  practical  difficulties 

Furthermore, 
in 
conducting  market  surveillance  for  authorities  due  to  COVID-19  restrictions.  An 
interviewee  noted  that  COVID-19  had  led  to  a  reduction  in  controls.  Accordingly,  this 
interviewee considered that the need for a clearer GPSD has increased as it would help 
conducting market  surveillance more effectively  in  the ‘new normal’ with less visits  of 
inspectors.  

Interviewees also expected in the medium-term to long-term that reduced public budgets 
(due to potential austerity measures after the pandemic) would mean that the downward 
trend in market surveillance capacities in Member States that they had noted after the 
financial crises would continue. According to their view, this would increase the need for 
a  less  complex  legal  framework  and  a  (resulting)  more  efficient  market  surveillance, 
more efficient recall procedures, and increased support through EU programmes.  

Concerning the impacts of the options for a possible revision of the GPSD, interviewees 
emphasised  the  overall  impact  of  COVID-19  on  the  baseline  situation,  i.e.  the 
increased importance of e-commerce, including with third countries, which was expected 
to put additional demands on authorities in terms of online market surveillance. Safety of 
products sold online is therefore expected by interviewees to  become more important, 
which  would  make  Options  3  and  4  (and  especially  the  suggested  changes  regarding 
online  sales  and  online  marketplaces)  more  relevant.  All  interviewees  stressed  the 
importance of having a common set of rules in the EU, and of reducing administrative 
burdens,  e.g.  to  explore  differences  in  legislation  between  countries.  Interviewees  also 
emphasised that good guidance would help in decision-making of companies. 

The  Study  concludes  that  the  COVID-19  crisis  has  increased  the  need  for  reducing 
existing,  and  avoiding  additional  administrative  burdens,  while  the  growing 

102 

 
 
importance  of  online  sales  channels  has  emphasised  the  need  to  close  related 
legislative and enforcement gaps.  

103 

 
Annex 7: SMEs Test 

The  results  of  the  SMEs  test,  based  on  the  data  from  the  GPSD  Study  and  other 
consultation activities,  are summarised in the following table: 

(1) Preliminary assessment of businesses likely to be affected  

All businesses handling consumer non-harmonised products are likely to be affected, including SMEs. 

For  SMEs,  the  estimated  annual  costs  to  comply  with  the  GPSD  today  (after  subtraction  of 
business-as-usual costs) are EUR 428 million per year (companies < 50 employees) and  EUR 226 
million per year (companies 50 to 249 employees). The median value for consumer product safety-
related  costs  in  proportion  of  the  total  annual  turnover  appears  to  decrease  with  the  company’s 
size/turnover. This is likely due to scale effects. This general pattern is confirmed by SMEs’ replies to 
the business stakeholder survey in the GPSD Study. Accordingly, SMEs account for 59% of the total 
of  GPSD-related  compliance  costs  in  the  EU,  in  line  with  their  overall  share  in  the  market.  (See 
section 5 of the Impact Assessment Report, baseline scenario) 

(2) Consultation with SMEs representatives 

EU SMEs and SMEs associations have been consulted during the preparation of the Evaluation and 
Impact assessment. For the GPSD Study, considerable efforts were made to reach out to businesses, 
including SMEs and their representatives. The survey questionnaires were widely distributed amongst 
SMEs and other business stakeholders as follows: questionnaires were sent to more than 1000 SMEs 
and  other  businesses  and  more  than  300  relevant  business  associations  (including  UEAPME, 
BusinessEurope, Digitaleurope, EMOTA, EuroCommerce, etc) in all EU27 Member States (plus UK). 
Only  relatively  low  number  of  direct  responses  were  received  from  SMEs  in  the  GPSD  Study  (6 
survey  responses  from  SMEs,  2  interviews  with  SMEs,  37  survey  responses  from  business 
associations, which often also represent SMEs (e.g. Toy industry, furniture  
Industry, etc.). However, no response was received from business associations that only or specifically 
represent SMEs. 
Business  associations  representing  SMEs  also  provided  feedback  on  the  GPSD  Roadmap/Inception 
Impact Assessment and replied to the Open Public Consultation (16 replies received from SMEs and 
68 from business associations).  

Consultation results: 
In  the  survey  conducted  for  the  GPSD  Study  SMEs  did  by  large  provide  similar  assessments  to 
companies  in  general.  However,  SMEs  responding  to  the  survey  only  reported  ‘minor’  additional 
costs due to differences in the safety requirements in Member States that are caused by differences in 
the  national  implementation  of  the  GPSD  (e.g.  regarding  traceability  requirements).  In  contrast  to 
larger companies, none of the SME respondents indicated ‘moderate’ or ‘significant’ additional costs 
due  to  differences  in  the  national  implementation  of  the  GPSD.  A  possible  reason  is  that  larger 
companies  are  more  likely  to  operate  in  several  EU  Member  States  than  SMEs,  and  therefore 
experience relevant legislative differences more often.   
Also  notable  is  that  in  the  assessment  of  the  effectiveness  of  options,  as  well  as  concerning  the 
benefits  they  bring,  business  associations  often  provided  considerably  lower  assessments  than 
companies, including SMEs, especially regarding policy options involving legislative change. 

Specific views of SMEs on the impact of COVID 19 crisis include: 

  Regarding the question of how the COVID-19 pandemic has in any way affected how product 
safety in companies is safeguarded and any related supply chain issues, an SME respondent 
mentioned that testing for new devices is taking longer due to delays related to the pandemic. 

104 

 
 
 
 
 
Such delays for example in supply chain functioning can have a particularly detrimental effect 
on business activity of SMEs. 

  A SME respondent also stated that the pandemic is likely to have an impact on long-lasting, 
structural  changes  of  the  'new  normal'  in  behaviour  and  economy  that  are  significant  for 
SMEs.  For  example,  people  are  expected  to  buy  more  sustainable  and  environmentally 
friendly products.  

  Regarding  the  question  of  how  the  COVID-19  crisis  affects  the  policy  options  and  their 
expected  impacts,  one  SME  respondent  stressed  that  it  was  a  bad  time  to  be  bringing  in 
additional  regulations  for  businesses.  The  interviewee  mentioned  that  many  businesses  are 
really  struggling,  and  that  this  is  especially  the  case  for  SMEs.  He  continued  that  these 
challenges, including for SMEs, also arise from changing consumer habits.  

  However,  one  SME  respondent  also  argued  that  better  clarification  of  rules  would  reduce 
costs significantly. Cost reductions would take place on the sales level, i.e. less explanation to 
buyers and insurance companies, and the design and manufacturing level, i.e. less explanation 
of product safety requirements to engineers. But the SME respondent also stated that one-off 
costs  would  generally  increase  for  all  regulatory  options  except  for  Option  1  due  to 
familiarisation costs occurring in the organisation, i.e. explaining the new rules internally and 
externally. And these costs are especially significant for SMEs, according to the interviewee.  

(3) Measurement of the impact on SMEs 

The  Impact  assessment  comes  to  the  following  conclusions  regarding  the  impacts  on  SMEs  of 
the different options (see Section 6 of the Impact assessment Report): 

Option 1: No significant firm-level impacts are to be expected due to the implementation of Option 1 
for  SMEs.  Option  1  does  not  foresee  any  legislative  changes  to  the  GPSD  and  therefore  no  new 
requirements but also no possibilities for more costs efficiencies for SMEs. 

Option 2:  
Total  costs  for  SMEs  in  the  EU27  in  the  first  year  of  implementation  are  estimated  at  EUR  21 
million. They would fall in subsequent years down to EUR 16.6 million. 
Estimated benefits for SMEs linked to cost savings, that are currently caused by differences in the 
national  implementation  of  the  GPSD  and  would  be  partly  solved  if  a  the  new  instrument  is  a 
Regulation under the Option 2, would amount to EUR 34 million annually, compared to the baseline. 
Idem for Options 3 and 4 which already foresee the choice of Regulation as legal instrument replacing 
GPSD. 
SMEs generally estimate that a revision of the product safety requirements of the GPSD according to 
Option  2  would  bring  a  variety  of  at  least  ‘minor’  to  ‘moderate’  benefits270.    At  the  same  time 
Option  2  would  impose  additional  adjustment  (e.g.  familiarisation  cost)  as  well  as  compliance 
costs  on  SMEs271,  in  particular  for  manufacturers.  Data  show  that  SMEs  would  likely  face  relative 
higher  compliance  costs  than  large  companies  from  the  implementation  of  the  proposed  policy 
measures.  
Even  though  the  relative  cost  increases  are  generally  higher  for  SMEs,  the  net  impact  on  SMEs 
overall  costs  depends  on  the  benefits  that  can  result  from  a  revised  GPSD  aligned  to  the  market 

270 Significant benefits due to improved quality/lifecycle of products and a deterrent effect on rogue traders, relatively 
strong benefits are increased consumer trust, better supply chain management due to improved traceability of products 
and better access to the market in non-EU/EEA. These areas are seen as benefits that SMEs assess to be ‘moderate’ to 
‘significant’. This is also the case for lower operational risks for businesses and easier compliance with product safety 
requirements. By contrast, SMEs considered several benefits to be less than ‘moderate’, including a more level playing 
field among businesses and greater legal certainty. 
271 This is particularly the case for SMEs that (voluntarily) decide to install and operate customer registration systems. 
Similarly, mandatory elements for product recalls (product description with a photograph, description of risk, 
instructions on what to do, link to a recall website and free phone number or online service for queries) would increase 
the cost of SMEs that have put unsafe consumer products to the market. 

105 

 
 
 
 
                                                           
surveillance rules and traceability requirements in Regulation (EU) 2019/1020. We expect the SMEs 
could save some of the costs that currently arise from inconsistencies in the implementation and 
enforcement of the GPSD across the EU. Taking into consideration these benefits and the fact that 
the changes in SMEs’ costs from Option 2 are very small, we expect that the overall net effect from 
Option 2  on  SMEs’  costs  is  rather  low and  therefore  unlikely  to affect  SMEs’  operations. This is 
also confirmed by cost data above.  

Option 3:  
Total  costs  for  SMEs  in  the  EU27  in  the  first  year  of  implementation  are  estimated  at  EUR  111 
million. They would fall in subsequent years down to EUR 99.9 million. 
Estimated benefits for SMEs linked to cost savings that are currently caused by differences in the 
national implementation of the GPSD and would be partly solved by the choice of Regulation and 
would amount to EUR 34 million annually, compared to the baseline.  
As concerns the benefits for SMEs, the GPSD Study shows that small companies generally estimate 
that  Option  3  would  bring  a  variety  of  at  least  ‘minor’  to  ‘moderate’  benefits,  especially  due  to  its 
deterrent  effect  on  rogue  traders  and  better  detection  of  unsafe  products.  However,  Option  3  is 
considered  by  small  companies  as  less  beneficial  when  it  comes  to  reducing  legal  complexity  or 
making compliance with product safety requirements easier for SMEs. In the case of  medium-sized 
companies, Option 3 is seen as a suitable contribution to an increased level-playing field among 
businesses and to have a significant benefit linked to reducing the occurrence of unsafe products and 
for  contributing  to  a  better  functioning  of  the  EU  internal  market.  Finally,  moderate  benefits  are 
expected regarding the potential to increase business revenue or consumer trust. 
Even  though  the  relative  cost  increases  are  generally  higher  for  the  SMEs,  the  impact  on  SMEs 
overall costs is still considered moderate when measured against the benefits that would result from a 
greater level of regulatory harmonisation and reduced regulatory complexity through the choice of a 
Regulation.  The  changes  in  SMEs  costs  are  estimated  to  be  limited  and    Option  3  would  not  be 
expected to affect operations considerably272.  

Option 4:  
Total costs for SMEs in the EU27 in the first year of implementation are estimated at  EUR 187.1 
million. They would fall in subsequent years down to EUR 166.3 million. 
Estimated benefits for SMEs linked to cost savings that are currently caused by differences in the 
national implementation of the GPSD and would be partly solved by the choice of Regulation and 
would amount to EUR 34 million annually, compared to the baseline.  

Overall, under options 2 to 4, the effects of additional compliance costs will have a  larger relative 
cost impact on SMEs than on large companies. Even though the relative cost increases are higher for 
SMEs, the impact on SMEs overall costs is still considered moderate when measured against the 
benefits  that  would  result  from  a  greater  level  of  regulatory  harmonisation.  The  changes  in  SMEs 
costs are small and implementation of any of the options would not be expected to significantly affect 
SMEs. 

Figures 1 and 2 below show that SMEs assess Option 3 as addressing the best the challenges for 
product safety and bringing the highest additional benefits among all the options: 

272 This consideration is also true for specific information obligations, such as the obligation for actors across the 
online supply chain to provide all safety information online that is also required to be provided with a product in 'brick 
and mortar' stores, and the related obligation for online platforms to make sure that third-party sellers, such as SMEs, 
provide this information. We expect these costs to be relatively minor for companies selling consumer products on 
these platforms, including SMEs. 

106 

 
 
 
 
 
 
 
 
 
 
                                                           
Figure  1:  In  your  view,  to  what  extent  would  Option  [...]  effectively  address  the  following 
challenges  for  product  safety?  –  Average  across  all  challenges,  by  business  stakeholder  group 
(Source GPSD Study) 

Figure  2:  Where  do  you  see  the  greatest  additional  benefits  that  would  result  from  the 
implementation  of  Option  […]?  –  Average  across  all  benefit  categories,  by  business  stakeholder 
group (Source GPSD Study) 

Options 3 and 4 are seen as providing most benefits by companies overall, as well as SMEs as specific 
sub-group,  which  assessed  these  benefits  on  average  between  ‘moderate’  and  ‘significant’.  While 
SMEs  consider  Option  2  to  also  bring  more  than  ‘moderate’  benefits,  companies  as  a  whole  and 
business associations are more sceptical, with an assessment on average across benefit categories of 
less  than  ‘moderate’  benefits  regarding  Option  2.  In  general,  business  associations  tend  to  see  less 
benefits than companies and SMEs. Note however, that the sample of SMEs responding to the survey 
is very small, so that results have to be interpreted with care.    

4) Assess alternative options and mitigating measures 

The  SMEs  and  micro-SMEs  are  not  exempted  from  any  of  the  obligations  foreseen  under  the 
different options analysed in this Impact Assessment. Indeed, EU product safety legislation does not 
allow  for  "lighter"  regimes  for  SMEs  since  a  consumer  product  must  be  safe  whatever  the 
characteristics  of  its  supply  chain  to  meet  the  general  objective  of  product  safety  and  consumer 
protection. However provisions are foreseen in the EU legislation e.g. to facilitate access for SMEs to 
EU  safety  standards  including  those  adopted  under  the  GPSD  (see  Article  6  of  Regulation  (EU) 
1025/2012). (See Section 5 of the Impact Assessment Report) 

107 

12345Option 1Option 2Option 3Option 4No change in                                                                                                                 Very significantbenefits at all                                                                                                  Business associationsCompaniesSMEs 
 
 
 
 
 
 
 
Annex 8: Effectiveness of recalls of consumer products 

1.  CONTEXT 

1.1. 

Prevalence of recalls in the EU 

Product  recalls  are  one  of  the  most  common  measures  to  mitigate  the  risks  posed  by 
dangerous products in the EU273. Among the over-2000 measures reported each  year to 
the  Safety  Gate/RAPEX274,  about  half  concern  recalling  products  from  consumers.  A 
total of six thousand recalls have been notified in the system from 2013 to 2019, with an 
overall  increase  of  approximately  35%  (see  Figure  1).  These  figures  are  likely  an 
underestimation, as not all recalls in a country are necessarily notified at EU level275.  

Figure 1: Number of recalls registered in the Safety Gate/RAPEX in 2013-2019 

The increasing trend can to a large extent be attributed to the increase in the number of 
recalls  concerning  motor  vehicles,  which  grew  by  a  factor  of  more  than  3  from  159 
recalls  in  2013  to  507  (i.e.  48%)  in  2019.  Apart  from  motor  vehicles,  the  five  most 
frequently recalled product categories according to Safety Gate/RAPEX alerts were toys; 
clothing  and  textiles;  electrical  appliances  and  equipment;  lighting  equipment;  and 
childcare articles and children equipment.  

273  By the term “recall” we refer to the process aimed in particular at achieving the return of a dangerous 

product that has already been supplied to consumers, initiated directly by the producer or distributor of 
the dangerous product, or ordered by authorities. 

274https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/r

apex/index_en.htm  

As regards products posing a less than serious risk, notification is encouraged but not mandatory 

275  
in the case of voluntary measures taken against products covered by the GPSD and in the case of both 
voluntary and compulsory measures taken against products subject to EU harmonised legislation. In 
addition, Member States are not required to notify corrective measures in cases where the effects of the 
product risk cannot go beyond the territory of the Member State. 

108 

0200400600800100012002013201420152016201720182019 
 
                                                           
1.2.  Legal provisions  

Under the GPSD, producers and distributors have to inform immediately the competent 
national  authorities  when  they  become  aware  that  a  product  they  have  placed  on  the 
market is dangerous, giving details of the actions taken to prevent risks to consumers276.  

Producers  have  the  primary  responsibility  for  the  safety  of  products  they  place  on  the 
market. If necessary to avoid risks to the health and safety of consumers, they have the 
obligation to take appropriate action (including withdrawing the dangerous product from 
the  supply  chain,  warning  consumers  or,  as  a  measure  of  last  resort,  recalling  products 
that have already been supplied to consumers)277.  

Distributors have to act “with due care” and must not supply products which they know 
are unsafe. They also have to cooperate in the action taken by producers and competent 
authorities to avoid the risks and pass on information on product risks278.  

Member  States  authorities  have  the  power  to  order  a  recall  or  to  coordinate  or,  if 
appropriate,  to  organise  it  together  with  producers  and  distributors279.  In  general, 
authorities shall encourage and promote voluntary actions by producers and distributors, 
including  where  applicable  by  the  development  of  codes  of  good  practice.  However,  if 
voluntary  action  is  unsatisfactory  or  insufficient,  they  shall  order  the  measures  or 
organise them themselves280. 

There  are  no  specific  rules  at  the  EU  level  on  how  a  recall  should  be  organised.  The 
GPSD  only  states  that  "recall  shall  take  place  as  a  last  resort,  where  other  measures 
would not suffice to prevent the risks involved, in instances where the producers consider 
it  necessary  or  where  they  are  obliged  to  do  so  further  to  a  measure  taken  by  the 
competent authority” and that it “may be effected within the framework of codes of good 
practice on the matter in the Member State concerned, where such codes exist”.  

In fact, few Member States have established such codes of good practice or guidelines on 
recalls  (see  table  1  below).  In  addition,  most  consist  of  a  very  brief  description  of  the 
recall process with little further requirements.  

Table 1: National guidance documents on recalls 

Country 

Website 

Austria 

Belgium 

Denmark 

Finland 
France 
Germany 

https://www.sozialministerium.at/Themen/Konsumentenschutz/Produktsicherheit/Gefaehrliche-
Produkte-und-Rueckrufe.html 
https://economie.fgov.be/fr/themes/qualite-securite/securite-des-produits-et/rappel-dun-produit-
ou-autre 

https://www.sik.dk/erhverv/produkter/vejledninger/generelle-vejledninger-om-
produkter/tilbagetraekning-og-tilbagekaldelse-produkter 
https://tukes.fi/en/products-and-services/dangerous-products 
A guide on product recalls is being developed  
https://www.baua.de/DE/Themen/Anwendungssichere-Chemikalien-und-

276  
277  
278  
279  
280  

GPSD Art 5 (3). 
See GPSD Art 5 (1), (b) of the third subparagraph, and last paragraph. 
GPSD Art 5 (2). 
GPSD Art. 8(1)(f)(ii). 
GPSD Art. 8(2). 

109 

 
 
                                                           
Produkte/Produktsicherheit/Rueckrufmanagement/Handlungsempfehlungen.html 
https://www.baua.de/DE/Themen/Anwendungssichere-Chemikalien-und-
Produkte/Produktsicherheit/Rueckrufmanagement/Rueckrufmanagement_node.html  
https://www.dsb.no/lover/produkter-og-forbrukertjenester/veiledning-til-forskrift/veileder-om-
meldeplikt-ved-farlige-produkter/ 
https://www.konsumentverket.se/for-foretag/produktsakerhet/salt-farlig-vara/ 

Norway 

Sweden 

In the absence of EU-wide rules on recall procedure, communication or remedies, each 
Member  State  follows  its  own  approach,  with  some  common  elements  (e.g.  in  most 
countries, voluntary recalls are more common than mandatory ones), but also diverging 
requirements.  

The increase in the number of product recalls over time and the fact that most recalls take 
place  voluntarily  can  be  considered  as  an  indication  that  the  GPSD  has  contributed  to 
making recalls more widely used as a corrective measure. On the other hand, the lack of 
minimum  EU-wide  requirements  regarding  recall  communication,  remedies  or 
monitoring  has  been  repeatedly  reported  as  a  significant  shortcoming,  with  negative 
impacts on consumer safety and on level-playing field for businesses.  

2.  ASSESSMENT OF RECALL EFFECTIVENESS 

The  effectiveness  of  product  recalls  varies  considerably  depending  on  factors  such  as 
customer traceability and product type. Recalls tend to be considerably more effective, if 
affected consumers can be identified and contacted directly (e.g. because the product was 
registered,  bought  online  or  delivered  to  customer’s  home).  Recall  effectiveness  also 
increases with product price and expected lifespan and decreases with product age. In the 
automotive sector, up to 100% success  rates have been reported, thanks in particular to 
mandatory motor vehicle registration281. Likewise, Samsung’s recall of over 4.6 million 
Galaxy  Note7  phones  resulted  in  90%  return  rate  within  four  months  and  a  further  7% 
within 7 months thanks to the sending of over 23  million  alerts  and  push  notifications  
to  the company’s  customers  and  a  software update  that  reduced  battery  capacity  up 
to  0%282.  

Success rates tend to be much lower for cheaper products and when it is not possible to 
reach  out  to  affected  consumers.  In  general,  the  proportion  of  products  successfully 
recovered from consumers remains low, as recognised by a  recent OECD report283. For 
instance,  one  Member  State  indicated  that  the  return  rates  for  recalled  products  rarely 
exceed  10%,  except  when  products  have  been  purchased  online284.  Another  national 
authority estimated that around 80% of products that have relatively low value and short 
lifespan remain in consumers’ hands285. 

Recall participation also depends on consumers’ characteristics. Socially disadvantaged, 
relatively young and less safety-conscious consumers are less likely to both participate in 
recalls (especially if such participation is time-consuming) and to register their products 

German Federal Motor Transport Authority (KBA) presentation at the Interrnational Product 

281  
Safety Week, 11/10/2010, https://youtu.be/S-RGd4jVhvQ, iTWire (2021). Car manufacturers complete 
99.9% of Takata airbag recall, https://www.itwire.com/automotive/car-manufacturers-complete-99-9-of-
takata-airbag-recall.html.   
282  
283  
284  
285  

OECD (2018), Measuring and maximising the impact of product recalls globally, p. 9. 
OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 5. 
Idem, p. 17. 
European Commission, 2021, Behavioural study on strategies to increase the effectiveness of product recalls. 

110 

 
 
                                                           
(making them more difficult to contact in case of a recall)286.The EU-wide societal cost of 
recalled products  remaining in consumers’ hands have been estimated at  approximately 
€378 million in 2019 due to healthcare costs, productivity losses and losses of quality of 
life.287  

The  consequences  of  delayed  and  badly  managed  recalls  are  also  exemplified  by  the 
deaths and injuries caused by products such as faulty Takata airbags (estimated to have 
cause  35  deaths  and  300  injuries  worldwide288)  and  Fisher-Price  rock  ‘n  play  baby 
sleepers (associated with 59 baby deaths in the US289).  

3.  REASONS FOR LIMITED RECALL EFFECTIVENESS  

3.1.  Many consumers are not aware of product recalls 

The main obstacle to recall effectiveness is the difficulty of reaching out to the owners of 
recalled products, which means that many EU consumers are simply not aware that they 
own a recalled product.  

3.1.1.  Limited direct communication with consumers 

There is a general agreement that direct communication with consumers (e.g. via email, 
telephone,  SMS  or  connected  devices)  is  more  effective  not  only  in  reaching  affected 
consumers  but  also  in  encouraging  consumer  response  compared  to  indirect  methods 
such as press releases or recall announcements published on companies’ and authorities’ 
websites.  In  an  online  experiment  carried  out  by  the  European  Commission  72%  of 
respondents who were presented with a direct recall notification acted on it compared to 
31% of respondents who saw a generic notification with the same description of hazard, 
action to take and remedy. Based on these figures, the EU-wide cost savings from using 
direct recall communication have been estimated at €73 million in 2019, i.e. a fifth of the 
overall estimated cost of recall ineffectiveness290.  

Effectiveness of generic vs direct recall notification 

Idem. 
Idem.288   https://www.consumerreports.org/car-recalls-defects/takata-airbag-recall-everything-you-need-to-

286  
287  
know/ 
288  
289  
consent/?next_url=https%3a%2f%2fwww.washingtonpost.com%2fbusiness%2f2019%2f10%2f17%2fstudy-
concludes-design-rock-n-play-other-infant-sleepers-led-deaths%2f  
290  
product recalls. 

https://www.consumerreports.org/car-recalls-defects/takata-airbag-recall-everything-you-need-to-know/ 
https://www.washingtonpost.com/gdpr-

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

111 

 
                                                           
Source: Online experiment 

Direct  contact  is  also  seen  as  the  most  effective  communication  channel  by  industry 
stakeholders291  and  indicated  as  the  preferred  communication  method  by  all  consumer 
groups292. 

Effectiveness of different communication channels (sum of replies: ‘effective’ and ‘very effective’) 

Source: Online industry survey 

These findings are corroborated by actual recall monitoring data from the US Consumer 
Product  Safety  Commission  (CPSC),  which  found  that  direct  recall  alerts  result  in  an 

Idem. 
European Commission (2019). Survey on consumer behavior and product recalls effectiveness, p. 

291  
292  
20, available at: 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/Product.Reca
ll.pdf. 

112 

 
 
 
                                                           
average return rate of 50% compared to  6% for joint  press  release issued by the CPSC 
and the recalling company293. 

Yes,  authorities  interviewed  for  the  GPSD  Implementation  Study  recognised  that 
identifying  and  directly  reaching  out  to  affected  consumers  is  a  challenging  task.  The 
Directive  does  not  contain  any  requirements  on  consumer  traceability.  As  for  national 
guidance  documents,  Finnish  and  Belgian  ones  require  that  affected  consumers  be 
contacted  directly,  whenever  feasible,  but  in  most  countries  there  are  no  similar 
requirements. 

For most recalled products, customer data is not available and even in situations when it 
is available, it is not always used to reach out to the owners of recalled products because 
of data protection concerns.  

3.1.1.1.Suboptimal use of product registration schemes 

When  a  consumer  registers  a  product,  he  or  she  provides  information  (e.g.  an  email 
address) that personally links them to this product and allows for direct contact in case of 
product  recalls  or  safety  warnings.  Yet,  apart  from  motor  vehicles  (whose  registration 
with  public  authorities  is  mandatory),  registration  schemes  are  only  available  for  few 
higher-value  product  categories like domestic  electronic appliances  and communication 
devices294.  In  addition,  even  in  these  sectors  actual  registration  rates  tend  to  be  rather 
low.  In  a  recent  consumer  survey,  declared  registration  rates  were  37%  for 
communication  devices,  33%  for  domestic  electrical  appliances,  24%  for  childcare 
articles and 8% for toys295.  

The main barriers to product registration include: 

  No  link  between  product  registration  and  safety:  Research  on  existing  EU 
registration schemes indicated that product safety is in general not highlighted in the 
analysed registration schemes and the main benefit of registration is framed in terms 
of  general  customer  support  or  marketing.  Only  4  out  of  the  40  analysed  schemes 
mentioned product safety as a sole or one of the benefits of product registration in the 
invitation to register296. As a consequence, consumers seldom see the safety benefit of 
registering their products. Only 40% of consumers across the EU indicated they are 
aware  of  the  possibility  to  register  their  products  for  safety  purposes297.  In  a  more 
recent  consumer  survey,  the  most  frequently-reported  reasons  for  not  registering  a 
product  were  not  knowing  that  registration  was  possible  (42%)  and  not  seeing  the 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

CPSC (2017), CPSC Defect Recall Data Carol Cave Deputy Director, Office of Compliance and 

293  
Field Operations July 25, 2017, available at: https://www.slideshare.net/USCPSC/cpsc-recall-
effectiveness-workshop-recall-data. (The US CPSC classifies a case as a ‘recall alert’, if the company is 
able to contact 95% of affected consumers using direct notification channel, in which case no press release 
is required). 
294  
product recalls. 
295  
296  
297   

Idem 
Idem 
European Commission, 2019, Survey on consumer behaviour and product recalls 
effectiveness. 
Report 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/reposit
ory/tips/ Product.Recall.pdf  

Final 

113 

 
                                                           
benefit  of  registration  (25%)298.  Likewise,  in  consumer  focus  groups,  participants 
associated product registration with warranty or after-sales support but did not make 
a link between registration and safety299.  

  Data protection  concerns: While the majority  of 40 analysed registration schemes 
did  envisage  the  use  of  registration  data  for  safety  notifications  or  general  product 
support in their privacy/data notices, in all but two cases, the notices also mentioned 
marketing/after-sales  communications  in  addition  to  safety  communications.  In 
addition, only in a minority of cases consumers were given the choice to opt in or out 
from marketing communications300. In the online industry survey, half of respondents 
said  that  they  used  customer  information  received  through  product  registration  to 
send marketing information.    

Use of customer information obtained through product registration (N=23) 

91% 

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

52% 

48% 

To contact customers in
case of safety issues, e.g.
a product recall

To offer after-sale
service and support

To send information
about new products and
special offers

Source: Online industry survey 

At  the  same  time,  concerns  about  how  their  personal  data  will  be  used  is  a  major 
concern  for  consumers.  In  the  EU  focus  groups,  a  key  reason  participants  provided 
for  not  registering  their  products  was  that  they  felt  uncomfortable  about  providing 
personal  data,  which  they  feared  would  be  used  for  targeted  advertising  (profiling) 
and other marketing purposes301. Likewise, in a US survey, 59% of respondents were 
concerned  about  unwanted  communication  from  the  company  after  registering  a 
product  and  79%  said  they  would  be  more  likely  to  register  products  if  companies 
were prohibited from contacting consumers for non-safety-related issues302.  

European Commission (2021), Behavioural study on strategies to improve the effectiveness of 

298  
product recalls. 
299  
Idem  
300  
Idem 
301  
European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 
product recalls. 
 Schoettle, B., Sivak, M. (2015). Consumer Preferences Regarding Product Registration. (Report No. 

UMTRI-2015-26), available at: 

114 

 
 
                                                           
 
The  possibility  to  use  product  registration  data  for  marketing  purposes  has  been 
limited in some third countries. For instance, the US mandatory product registration 
card for childcare products needs to provide clear reassurance to consumers that the 
information  provided  will  only  be  used  in  case  of  safety  alerts  and  recalls303. 
Likewise,  the  UK  code  of  practice  recommends  that  consumers  should  be  asked  to 
consent  to  their  contact  details  being  recorded  exclusively  for  product  safety 
purposes, without having to opt in or out of marketing communication304.  

  Effort  required:  While  most  products  are  registered  (with  the  manufacturer)  after 
the actual purchase, the  point of sale has  been identified as the key moment  during 
which  consumers  can  be  prompted  to  register  their  products305.  In  an  online 
experiment carried out by the European Commission, considerably more respondents 
clicked on an invitation to register a product when they saw it at the check-out (45%) 
than when they saw it after completing the purchase, either as part of the packaging 
(14%) or as a general registration campaign (10%)306. The amount of information that 
needs  to  be  retrieved  and/or  filled  in  can  also  act  as  a  deterrent.  In  the  online 
experiment, when the product information was pre-filled (mimicking for instance QR 
code  scanning),  87%  of  respondents  completed  the  registration  compared  to  63% 
when  they  needed  to  fill  in  the  information  themselves307.  Finally,  time  limits  for 
registration  or  the  requirement  to  provide  a  proof  of  purchase  may  make  it  more 
difficult or even impossible to register many products, in particular those received as 
gifts or bought second-hand308.  

3.1.1.2. Other sources of customer data not routinely used for recalls 

Data  allowing  to  link  customers  to  specific  purchases  is  also  routinely  collected  by 
companies through other sources. While customarily intended for marketing promotion, 
loyalty  programmes  and  other  data  (e.g.  digital  receipts  or  delivery  records)  held  by 
retailers  can  also  enable  identification  of  consumers  in  case  of  product  recalls.  A  third 
source  of  consumer  data  that  could  be  used  for  recall  purposes  is  the  consumer 
information  provided  in  the  context  of  online  purchases.  Purchasing  a  product  directly 
from  the  online  seller  implies  that  customer’s  contact  details  are  is  registered 
automatically and the online seller can hence easily use the information provided in the 
event of a product recall. When the purchase takes place through an online marketplace, 
depending on its business model, the marketplace can either notify consumers directly or 
request the sellers to do so in the event of a recall campaign. Similarly, the data held by 

UK Department for Business, Energy & Industrial Strategy (BEIS), 2018, Supporting better 

http://deepblue.lib.umich.edu/bitstream/handle/2027.42/116020/103219.pdf?sequence=1&isAllowed=y303S
ee:https://www.cpsc.gov/Regulations-Laws--Standards/Rulemaking/Final-and-Proposed-Rules/Consumer-
Registra-tion-of-Durable-Infant-or-Toddler-Products/  
303See:https://www.cpsc.gov/Regulations-Laws--Standards/Rulemaking/Final-and-Proposed-
Rules/Consumer-Registra-tion-of-Durable-Infant-or-Toddler-Products/  
304  
product recalls: Code of practice on consumer product safety related recalls and other corrective actions  
https://www.bsigroup.com/en-GB/pas7100-supporting-better-product-recalls/  
305  
Notes from EU expert workshop on recall effectiveness of 23/10/219, p. 3, U.S. Consumer 
Product Safety Commission (CPSC), 2017, Transcript of Recall Effectiveness Workshop, 25 July 2017, pp. 
21-29. https://www.cpsc.gov/Recall-Effectiveness.  
306  
product recalls. 
307  
308 Idem  

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

Idem 

115 

 
                                                                                                                                                                            
 
payment card providers or insurance companies could also be used to inform consumers 
about relevant recalls.309 

However, economic operators are hesitant about using customers’ information collected 
for  non-safety  purposes  in  the  event  of  a  recall  because  of  a  possible  legal  uncertainty 
about  the  compliance  with  the  General  Data  Protection  Regulation.310  Even  though 
safety-conscious  companies  were  likely  overrepresented  in  the  survey311,  28%  of 
respondents in an online survey carried out by the European Commission indicated that 
they  do  not  use  customer  data  (collected  e.g.  through  loyalty  schemes,  online  sales, 
digital receipts etc.) to contact customers in case there is an issue with their product312. 

Do  you  use  customer  data  collected  for  other  purposes  (e.g.  loyalty  schemes,  online  sales,  digital 
receipts etc.) to contact customers in case there is a safety issue with their product? (N=147) 

At  the  same  time,  consumers  may  provide  “dirty  data”  (e.g.  fake  contact  details  or  an 
email address that they do not regularly check) when signing up for loyalty programmes 
to  avoid  receiving  marketing  information.  A  possibility  for  consumers  to  provide 
separate contact details only for the purpose of safety notifications has been put forward 
as  a  good  practice  to  increase  the  usefulness  of  loyalty  programmes  for  recall 
purposes313. 

3.1.2.  No comprehensive sources of public information to consumers 

In most cases, it will not be possible to directly reach all consumers affected by a recall.  
In such situations, using a multitude of communication channels is recommended as the 
best  approach  to  increase  the  visibility  of  the  recall  message  and  appeal  to  different 

Notes from EU expert workshop on recall effectiveness of 23/10/2019, pp. 2-5. 
Notes from EU expert workshop on recall effectiveness of 23/10/2019, p. 2. 
Mostly companies interested in product safety might have participated, especially that the survey 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

309  
310  
311  
was promoted in the Safety Gate weekly reports. 
312  
product recalls. 
313  

Notes from EU expert workshop on recall effectiveness of 23/10/2019, p. 4. 

116 

 
 
 
 
                                                           
consumer  categories314.  These  channels  may  include  company's  website,  social  media 
and newsletters, paid announcements in newspapers, TV or radio as well as point-of-sale 
information. Social media ads have been identified as particularly cost-effective not only 
in targeting specific audience but also in activating the word of mouth, people being able 
to  share  recall  information  with  their  contacts  who  they  think  may  be  using  a  recalled 
product315.  At  the  same  time,  online  communication  channels  may  be  less  effective  in 
reaching older and less Internet-savvy consumers316.  

At the moment, there are no rules on public sources of recall information to consumers in 
the  GPSD.  Likewise,  in  most  EU/EEA  countries,  the  recalling  company  has  no  legal 
obligation  to  put  the  recall  notice  on  their  website,  social  media,  newsletter  or  retail 
outlet.  In  response  to  the  consultation  on  the  GPSD  Roadmap/Inception  Impact 
assessment, it was highlighted that some countries demand printed advertising as part of 
the recall communication, while in other countries, this is reportedly not the case.  

Even  though  safety-conscious  companies  were  likely  overrepresented  in  the  survey317, 
less  than  one  in  three  respondents  in  an  online  survey  carried  out  by  the  European 
Commission indicated that their recall procedure envisages the use of newspaper articles 
to  encourage  recall  participation  and  slightly  over  a  half  said  the  same  for  company’s 
social media318. 

314   Bond, C., Ferraro, C., Luxton, S., & Sands, S. (2010). Social media advertising: An investigation of 

consumer perceptions, attitudes, and preferences for engagement. In P. Ballantine, & J. Finsterwalder 
(Eds.), Proceedings of the Australian and New Zealand Marketing Academy (ANZMAC) Conference 
2010 -'Doing More with Less' (pp. 1 - 7). University of Canterbury.  

European Commission, 2019, Survey on consumer behaviour and product recalls effectiveness. 

315 U.S. Consumer Product Safety Commission (CPSC), 2017, Transcript of Recall Effectiveness 
Workshop, 25 July 2017, pp. 7-12, 32-4, https://www.cpsc.gov/Recall-Effectiveness.  
316  
Final Report https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/ 
Product.Recall.pdf 
317  
was promoted in the Safety Gate weekly reports. 
318  
product recalls. 

Mostly companies interested in product safety might have participated, especially that the survey 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

117 

 
 
 
                                                           
Does your recall procedure envisage the use of one of the following channels to  encourage customer 
participation in a product recall? (N=21) 

In  addition,  not  all  authorities  engage  in  spreading  recall  information  on  their  website 
and/or  social  media  (in  addition  to  notifying  recalls  to  the  Safety  Gate/RAPEX319). 
Identified national central recall portals are listed in the table below320. 

Table: National central recall portals 

Country 

Austria 
Bulgaria 

Denmark 
Estonia   
Finland 

Website 

https://www.ages.at/produktwarnungen/ (also a related app) 
https://kzp.bg/opasni-stoki-v-bulgaria?f_category=0&f_year=2020&f_search=  (mandatory 
recalls) 
https://kzp.bg/novini/dekatlon-balgariya-eood-predpriema-dobrovolni-merki-vav-vrazka-s-
ustanovena-opasnost-pri-izpolzvane-na-detski-shorti-za-bord-500kid-olaian  (voluntary 
recalls) 
https://www.sik.dk/farlige-produkter 
Estonia: https://www.ttja.ee/et/tarbijale/ohutus 
https://marek.tukes.fi 

319  
However, not all recalls need to be notified to Safety Gate/RAPEX. As regards products posing a 
less than serious risk, notification is encouraged but not mandatory in the case of voluntary measures taken 
against products covered by the GPSD and in the case of both voluntary and compulsory measures taken 
against products subject to EU harmonised legislation. In addition, Member States are not required to 
notify corrective measures in cases where the effects of the product risk cannot go beyond the territory of 
the Member State. 
320 In addition, specialised portals for motor vehicles exist in Finland 
(https://recall.trafi.fi/#vclass=&mark=&model=) and the Netherlands 
(https://terugroepregister.rdw.nl/Pages/Terugroepregister.aspx) 

118 

 
 
 
                                                           
France 
Germany 
Hungary 
Iceland 
Ireland 
Latvia 
Luxembourg 
Malta 
Norway 
Poland 
Romania 
Slovenia 
Sweden 

https://www.economie.gouv.fr/dgccrf/securite/avis-rappels-produits 
www.rueckrufe.de 
https://fogyasztovedelem.kormany.hu/#/veszelyes_termekek_ 
https://www.neytendastofa.is/neytendur/solubonn-innkollun-voru/ 
https://www.ccpc.ie/consumers/product-safety/product-recalls/ 
https://www.ptac.gov.lv/lv/jaunumi?category%5B103%5D=103 
https://portail-qualite.public.lu/fr/alertes.html 
https://mccaa.org.mt/Section/Content?contentId=4407 
https://farligeprodukter.no/ 
http://publikacje.uokik.gov.pl/hermes3_pub/ 
https://anpc.ro/categorie/44/retrageri-voluntare-de-produse 
https://www.gov.si/zbirke/seznami/nevarni-proizvodi/ 
https://www.konsumentverket.se/aktuellt/aterkallelser-av-varor/ 

3.2.  Consumers fail to respond to recalls 

The extent to which a product recall will be successful and prevent harm depends also on 
whether  consumers respond, once they become  aware that a product  they  own is  being 
recalled. 

An EU-wide survey on recall effectiveness by the European Commission found that over 
a  third  of  consumers  (35%)  did  not  react  to  a  recall  that  was  relevant  to  them:  31% 
continued using the product with extra caution, while 4% took no action whatsoever321. 
The  corresponding  figures  in  a  most  recent  consumer  survey  in  10  EU  countries  were 
24% and 13%, respectively322. Lack of consumer responsiveness was also pointed out by 
several MSAs interviewed for the Implementation Study. 

Consumers’  propensity  to  respond  to  recalls  depends  on  several  external  factors. 
Product characteristics, such as product value, expected lifespan, age and type, all play 
a  role.  Low  product  value  typically  decreases  consumers'  motivation  to  participate  in  a 
recall323.  The  US  CPSC  data  show  that  return  rates  increase  with  the  price  of  the 
product324.  Likewise,  in  a  recent  survey  by  the  European  Commission,  self-reported 
recall  participation  rates  ranged  from  73%  for  motor  vehicles  and  63%  for  furniture  to 
39% for clothing and footwear and 31% for children’s toys325. MSAs interviewed for the 
Implementation  Study  also  highlighted  the  importance  of  product  value.    In  particular, 
recalls of low-priced products from Asia, distributed on open-air markets, Asian shops or 
online  marketplaces,  were  reported  to  be  very  ineffective.  On  the  contrary  more 
consumers are inclined to return expensive products such as cars326. Consumers will also 
be  more  motivated  to  respond  to  a  recall,  the  newer  the  product  and  the  longer  they 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

European Commission (2019). Survey on consumer behavior and product recalls effectiveness, p. 

321  
20, available at: 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/Product.Reca
ll.pdf.  
322  
product recalls. 
323  
324  
325  
product recalls. 
326  

OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 17. 
CPSC (25th July 2017), Recall effectiveness workshop meeting minutes, p. 41. 
European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

Implementation Study. 

119 

 
 
                                                           
expect  it  to  last.327  Furthermore,  consumers  tend  to  underestimate  the  risks  associated 
with leisure products (e.g. for sports, recreational vehicles) as they are often linked with 
positive emotions328. In addition to product characteristics, cconsumers’ socio-economic 
status  also  plays  a  role,  disadvantaged  and  younger  consumers  being  less  likely  to 
respond to a recall.329  

However, consumers’ propensity to respond to a recall also depends on the recall internal 
characteristics:  the  clarity  and  persuasiveness  of  recall  communication,  the  ease  of  the 
recall process and the attractiveness of the remedies offered.  

3.2.1.  Unclear recall communication  

The  way  in  which  recall  announcements  are  formulated  and  presented  can  affect 
consumers' understanding, perception of risk and motivation to act.  

3.2.1.1.Content and layout of recall notices not specified in the EU 

lead 

information  overload  and 
Lengthy  and  complex  recall  notices  may 
disengagement,  especially  among  lower-educated  and  time-poor  consumers.  It  is 
therefore important for recall announcements to use plain and concise language, avoiding 
legal terms and jargon. The inclusion of a product picture and further product identifiers 
(as well as a clear visual indication of where to find them on the product) can also help 
consumers immediately determine if they own the recalled product. Finally, the inclusion 
of colour and graphic elements may also help draw consumers’ attention to the recall.330 

to 

A  number  of  jurisdictions  outside  the  EU  defined  the  main  elements  that  need  to  be 
included  in  a  recall  notice,  with  the  aim  of  making  them  clearer  and  more  salient.  A 
standardised  template  for  recall  notices  has  been  set  out  in  Australia  and  the  UK  (see 
below). In the EU, elements that need to be included in a recall notice are specified in the 
Finish  and  Norwegian  guidance  documents  but  in  most  countries  there  are  no 
requirements in this regard. 

Australian and UK template for recall announcements 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

U.S. Consumer Product Safety Commission (CPSC); XL Associates; Heiden Associates, 2003. 
Idem, European Commission (2019). Survey on consumer behavior and product recalls 

327  
product recalls. 
328  
329  
effectiveness, p. 20, available at: 
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/tips/Product.Reca
ll.pdf. 
330  

OECD report, Notes from EU expert workshop on recall effectiveness of 23/10/2019, p.  

120 

 
 
                                                           
In  the  focus  groups  carried  out  by  the  European  Commission,  participants  preferred 
shorter  paragraphs  with  clear  subheadings  over  a  single  body  of  text  with  the  same 
information.  They  also  appreciated  the  inclusion  of  product  picture.  The  red  frame 
received more mixed feedback. While some participants considered it as “eye-catching”, 
others felt that it was exaggerated and made the notice look like spam email. However, 
eye-catching imagery might work better for indirect communication.331 

Moreover, stakeholder interviews suggested that defining key elements to be included in 
all recall notices would be beneficial for the companies too who would have clarity as to 
what information is required and in what format.332 

3.2.1.2.Downplaying perceived risk 

Consumers’  perception  of  the  likelihood  and  severity  of  the  risk  posed  by  a  recalled 
product is another important factor influencing their decision to participate in a recall333. 
It  is  therefore  crucial  that  recall  notices  clearly  explain  the  hazard  associated  with  the 
recalled product, avoiding euphemisms (such as 'overheating' or ‘thermal event’ instead 
of  'fire  hazard')  as  well  as  any  other  terms  that  may  decrease  consumers'  perception  of 
risk (such as 'voluntary' or 'precautionary')334. Some third jurisdictions have banned this 
kind of terms in their guidance documents (Australia, South Africa, UK). 

In  focus  groups  carried  out  by  the  European  Commission,  participants  felt  that  a  good 
recall message needs to show a sense of urgency, underlining the risk to  the consumer. 
The phrase “voluntary product recall” in the heading was viewed as to weak, self-evident 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

331  
product recalls. 
332 Idem 
333  
summary of the literature on consumer motivation and behavior’, p. 17 ff, available at: 
https://www.cpsc.gov/s3fs-public/RecallEffectiveness.pdf.  
334 Idem 

CPSC, XL Associates and Heiden Associates (2003), ‘Recall effectiveness research: a review and 

121 

 
 
 
                                                           
or confusing because participants  were unsure to whom “voluntary” referred or what  it 
meant. 335 

At the same time, the analysis of existing recall announcements showed that  more than 
half  of  them  (35  out  of  55)  used  terms  that  could  downplay  consumers’  perception  of 
risk, for example: 

‘voluntary/precautionary recall’ or ‘voluntary replacement programme’ (27 cases) 
‘in rare cases’/’in specific conditions’ (20 cases) 
highlighting that there have been no reported injuries (2 cases).336 

3.2.2.  Burdensome recall procedure  

If  participating  in  a  recall  is  costly  and  does  not  outweigh  the  compensation  proposed, 
this  will  serve  as  a  disincentive  to  respond  to  a  recall.  The  costs  associated  with  recall 
participation may include financial costs (e.g. of shipping back the product), opportunity 
costs/loss of time, required effort, loss of product use etc.  In a recent consumer survey, 
recall  process  taking  too  much  time  and  effort  was  the  second-top  reason  for  not 
responding to a recall (after the product being cheap)337. 

Some  of  the  best  practices  to  minimise  consumer  effort  identified  through  European 
Commission’s mapping of existing recall campaigns and expert workshop include:  

the company picking up any bulky items  (like washing machines) from  consumer’s 

home or arranging for in-home repair,  

offering a pre-paid postage, if the product needed to be sent back, 
allowing customers to return the product in any shop that supplies the product (rather 
than the one where they purchased the product) or at a neighbourhood collection 
point,  

accepting the return without a proof of purchase (which consumers are unlikely . to 

keep, especially in the case of cheaper purchases).338 

The  setting  up  of  a  free  hotline  or  other  two-way  communication  mechanism  with 
consumers to answer any queries about a recall was also identified as a good practice339. 

Furthermore, it was suggested that in some cases, the recalled products could be disposed 
of  or  repaired  by  consumers  themselves  instead  of  being  returned  to  the  recalling 
company340.   

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

335  
product recalls. 
336  
Idem. 
337  European Commission, 2021, Behavioural study on strategies to improve the effectiveness of product 
recalls. 
338  
Notes from EU expert workshop on recall effectiveness of 23/10/2019, pp. 8-9. 
339   
340  

Idem. 
Notes from EU expert workshop on recall effectiveness of 23/10/2019, pp. 8-9. 

Idem 

122 

 
 
                                                           
 
3.2.3.  Insufficient remedies 

Consumers’ likelihood to respond to a recall will also depend on the attractiveness of the 
compensation  offered.341  Tardy  or  insufficient  remedies  may  reduce  consumers’ 
propensity to act upon a recall.  

At  EU  level,  the  General  Sales  Directive  guarantees  the  right  to  repair,  replacement  or 
refund  in  case  of  product  non-conformity  for  a  minimum  period  of  2  years  after  the 
delivery  of  the  goods.  However,  many  products  are  recalled  after  the  expiry  of  the 
obligatory guarantee period. 

The  European  Commission’s  mapping  of  existing  recall  campaigns  found  that  in  some 
cases  the  description  of  the  remedy  in  the  recall  notice  was  unclear  or  missing.  In 
addition,  sometimes  the  remedy  was  seen  as  inadequate.  This  included  cases  when 
consumers were offered a discount to buy a new product from the same company rather 
than  a  proper  remedy  such  as  a  repair,  replacement  or  refund  (detected  in  two  US 
campaigns)  or  when  the  remedy  involved  providing  consumers  with  free  replacement 
parts for self-repair but the instructions were not very user-friendly and the process itself 
was time-consuming.342  

In  consumer  focus  groups,  some  participants  mentioned  that  they  would  like  a 
compensation for the period during which they cannot use the product.343 

3.2.4.  Behavioural biases 

Behavioural biases may also negatively impact consumers' propensity to return a recalled 
product. The box below includes a comprehensive overview of such biases identified by 
the OECD.  

Consumer behavioural biases applied to product recalls344 

Information  overload:  If  recalls  contain  too  much  information  or 
consumers  feel  overwhelmed  with  information  on  recalls,  they  may 
disengage and not  take action, especially if they  are also  time poor. With 
the growing number of product recalls in countries, consumers may suffer 
from  "recall  information"  fatigue,  and  may  not  pay  attention  to  the  recall 
alerts that are relevant to them.  

Framing  effects:  Consumers  are  influenced  by  how  information  is 
presented. Presenting an option in a certain way may induce consumers to 
evaluate  the  choice  from  a  particular  reference  point.  For  example, 
consumers  are  less  likely  to  respond  to  voluntary  recalls  if  the  potential 
hazards  are  not  clearly  stated.  They  are  also  less  likely  to  follow 
instructions, including the steps they should follow to return the product, if 
such instructions are presented in a complex and lengthy message. 

341  
342  
product recalls. 
343  
product recalls. 
344  

OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 21. 
European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

European Commission, 2021, Behavioural study on strategies to improve the effectiveness of 

OECD (2018), Enhancing Product Recall Effectiveness Globally, p. 34. 

123 

 
 
 
                                                           
Inertia:  With  an  inherent  fear  of  the  unknown,  when  consumers  face 
complex  products  or  a  bewildering  array  of  choices,  they  may  ignore 
possible  choices  or  choose  not  to  choose.  Consumers  may  also  rely  on 
simple  “rules  of  thumb”  to  avoid  change  or  are  guided  by  the  values, 
actions and expectations of a particular society or group. 

Endowment  effect:  Consumers  often  demand  much  more  to  give  up  an 
object than they would be willing to pay to acquire it.  A consumer’s value 
of a product increases when it becomes part of their endowment, so if the 
perceived  inconvenience  associated  with  returning  a  recalled  product 
outweighs 
the  compensation  (i.e.  return,  refund  or  replacement), 
consumers  are  less  likely  to  return  it.  This  is  because  naturally  humans 
tend to be loss averse, even if it is in relation to a recalled product.  

Over-optimism:  Consumers  tend  to  think  that  they  are  more  likely  to 
experience  an  outcome  that  is  better  than  the  average  expected  outcome. 
This  may  cause  them  to  miss  or  ignore  warnings,  or  negative  messages. 
Consumers  may  also  be  more  inclined  to  keep  using  unsafe  products, 
particularly if these products have been used for a long time without injury 
caused to them or to someone they know.   

Time inconsistency: Consumers may make choices that are not consistent 
across  time  periods  due  to  conflicts  between  short-term  urges  and  long-
term interests. 

124 

 
 
Annex 9: Cooperation activities under GPSD 

The  GPSD  is  one  component  of  a  broader  consumer  product  safety  framework.  Apart 
from  legislative  texts  (which  also  include  harmonised  legislation),  it  comprises  non-
legislative  initiatives  aimed  at  advancing  the  safety  of  consumer  products,  via  cross-
border and international cooperation, as well as cooperation with stakeholders.  

1)  Cross-border cooperation  

The Consumer Safety Network and RAPEX contact point network  

The  Consumer  Safety  Network  (CSN)  is  the  expert  group  gathering  product  safety 
authorities of EU/EEA countries to  discuss about ongoing and emerging product  safety 
issues.  

The RAPEX contact point network gathers all national RAPEX contact points to discuss 
questions related to the operation of the rapid alert system Safety Gate- RAPEX.  

These  networks  are  important  fora  for  authorities  to  discuss  about  the  challenges  they 
face  and  exchange  best  practices.  They  also  offer  the  possibility  to  foster  cooperation 
with  stakeholders:  in  December  2018,  a  CSN  workshop  was  organised  on  the 
cooperation  between  national  product  safety  authorities  and  consumer  organisations. 
Similarly, in  November  2019, a CSN workshop took  place on the cooperation between 
authorities and online marketplaces.  

Coordinated activities on the safety of products (CASP) 

The European Commission helps market surveillance authorities (MSAs) responsible for 
the enforcement of non-food consumer product safety across Europe work together, pool 
resources  and  share  best  practices.  It  does  so  by  organising  coordinated  market 
surveillance and coordinated activities on the safety of products (CASP). These projects 
provide  EU/EEA  authorities  with  the  financing  tools  needed  to  jointly  test  products, 
determine  their  risks  and  take  the  necessary  measures  against  any  identified  dangerous 
products in order to keep all European consumers safe.  

CASP  projects  can  focus  on  the  analysis  of  a  single  product  or  a  group  of  products 
(product specific activities) or on the exchange of best practices on market surveillance 
(horizontal activities).  

The MSAs work on resulting recommendations, which are converted into communication 
material  to  be  disseminated  among  economic  operators  and  consumers.  At  the  end  of 
each  project  cycle,  the  CASP  Closing  Event  presents  the  outcomes  of  the  projects  and 
launches  a  European  wide  communication  campaign,  contributing  to  greater  awareness 
about product safety. 

Over the last 15 years, the European Commission has co-financed more than 50 activities 
with  a  total  EU  budget  around  27  million  EUR  since  the  start  of  the  activities.  Most 
coordinated  actions  have  resulted  in  the  identification  of  a  significant  number  of 

125 

 
 
 
 
dangerous  products,  with  non-compliance  rates  around  20%345,  leading  to  consequent 
notifications in the Safety Gate/RAPEX for 14 categories of products. 

2)  International cooperation  

Cooperation with China 

In recent years, about half of the alerts on Safety Gate have given China as the dangerous 
product’s    country    of    origin.    This    is    mainly    due    to    the    volume    of    Chinese  
products  imported  into  Europe.  Since 2006, the European Commission has had formal 
cooperation  on  product  safety  with  the  Chinese  authorities,  which  follow  up  on 
dangerous  products  from  China  notified  in  the  rapid  alert  system  and  report  to  the 
Commission  about  the  follow-up  measures  they  take.  Cooperation  with  this  major 
producer  country  helps  improve  product  safety  “at  source”,  so  that  fewer  dangerous 
products reach European markets.  

Information exchange with Canada 

Given  the  increasingly  global  nature  of  supply  chains,  cooperation  is  also  key  with 
countries  that  have  the  same  or  similar  products  on  their  market.  This  allows  for  more 
timely identification of emerging product safety issues and enables EU Member States to 
better detect dangerous products. Exchanges  of  information  on  dangerous  consumer  
products    started    with    the    Canadian    authorities    in    2019    under    the    EU-Canada  
Comprehensive  and  Economic  Trade  Agreement   (CETA).  The  exchanges   aim at    
helping        EU      Member  States  better  target  their  enforcement  efforts  and  identify 
emerging product safety risks.  

Multilateral cooperation  

Given  the  global  nature  of  most  product  safety  challenges  (e.g.  the  safety  of  products 
sold online, the safety of artificial intelligence and connected products), it is paramount 
that  the  EU  position  is  voiced  in  international  discussions  on  these  subjects  to  better 
protect  its  consumers.  The  Commission  is  actively  participating  in  the  OECD  and 
UNCTAD  Working  Groups  on  Consumer  Product  Safety.  The  European  Commission 
has  also  become  an  ex-officio  board  member  of  the  International  Consumer  Product 
Health  and  Safety  Organisation  (ICPHSO)  board.  ICPHSO  is  an  international,  not  for 
profit and neutral forum for product safety stakeholders, which offers regular occasions 
for product safety stakeholders to meet, discuss about major global challenges and share 
good practices in this field.  

3)  Cooperation  with  businesses  to  go  above  and  beyond  minimum  legal 

requirements  

Product Safety Pledge  

In June 2018, four online marketplaces (AliExpress, Amazon, eBay and Rakuten France), 
signed  a  Product  Safety  Pledge.  They  were  later  joined  by  Allegro,  CDiscount, 
Wish.com, Bol.com and eMAG. 

345 Joint Action reports repeatedly indicate that these high rates of non-compliance were not necessarily 
representative for the market, as non-random samples were taken and often samples were tested where a 
visual inspection had suggested possible deficiencies.  

126 

 
 
 
 
 
 
 
                                                           
The  conclusion  of  this  Pledge  was  facilitated  by  the  European  Commission  with  the 
objective  of  increasing  the  safety  of  products  sold  online  by  third-party  sellers  through 
online marketplaces. This initiative, which is the first one of its kind in the product safety 
area, sets out specific voluntary actions in 12 different areas by online marketplaces that 
go beyond what is already established in EU legislation.  As part of the Pledge, signatory 
online  marketplaces  have  committed  to  report  to  the  European  Commission  every  six 
months on the actions taken to implement the Product Safety Pledge, with the inclusion 
of key performance indicators. 

EU Product Safety Award 

In  2019,  the  European  Commission  launched  the  first  EU  Product  Safety  Award, 
rewarding businesses that go the extra mile to protect consumers, beyond the minimum 
requirements laid down in EU law.  

127 

 
 
Annex 10: Standardisation procedure 

The GPSD requires producers to put only safe products on the market. This requirement 
may  be  difficult  to  apply  because  of  the  lack  of  a  common  benchmark  on  what 
constitutes a safe product. Standards can respond to this need and they play an important 
role  in  EU  product  safety  law.  In  the  framework  of  the  GPSD,  they  facilitate  market 
access and ensure the safety of products. 

The  European  Commission  can  request  the  European  Standardisation  Organisations 
(ESOs)  to  develop  standards  to  support  product  safety  legislation.  In  the  case  of  the 
GPSD,  the  Commission  first  needs  to  issue  a  Commission  decision  on  safety 
requirements to be met by the standard and then issue a standardisation request (mandate) 
to  the  ESOs  to  develop  the  standard.  When  the  requested  standard  is  developed,  the 
Commission checks the compliance of the standard with the safety requirements.  If the 
outcome is positive, the reference of the standard is published in the Official Journal of 
the European Union. Products compliant with the standards referenced in the OJ EU are 
presumed to be safe. This helps businesses to know what to comply with and the market 
surveillance  authorities  by  providing  a  benchmark  to  assess  safety  of  a  product. 
Ultimately they contribute to safer products on the market for the benefit of consumers. 
The procedure is represented in the following scheme:  

The  overall  process  can  be  quite  long  and  burdensome.  However,  the  standardisation 
process must strike a balance between speed and the quality of the outcome, thus, of the 
standard. 

The  process  under  the  GPSD  includes  one  step  more  than  the  procedure  applied  in 
relation to harmonised standards. The reason is that the harmonisation directives contain 
essential safety requirements on which standards can be based. In the case of the GPSD, 
its wide coverage calls for specification of the safety requirements for a specific product, 
which  then  serves  as  a  guideline  for  the  work  of  the  European  standardisation  bodies. 
There is room for improvement especially as regards Step 2. The GPSD Study found that 
there seems to be room to streamline the process that currently requires the involvement 
of two different committees. This appears to duplicate work, and leads to inefficiencies, 
as the members of the two committees are not necessarily the same.  

128 

STEP 1. Commission issues a Decision to set safety requirements•Preliminary work to plan Decision•With input from Member States (involving the Consumer Safety Network), industry, ESOs and consumer organisations•Vote by MS in GPSD Committee•Commission adopts DecisionSTEP 2.Commission issues a formal mandate to ESOs to develop standard•Commission issues a standardisation request (‚man-date‘) to ESOs•Formal consultation of stakeholders (including ESOs)•Vote by MS in Standardisation Committee •Adoption & notifi-cation of request•ESO accepts/rejectsSTEP 3. Development of standard by ESO compliant with safety requirements•Programming of the standardi-sation process•Drafting of standard •Public enquiry•Refining the draft standard•Ratification and publication of the standard•Submission of references to CommissionSTEP 4. Commission issues a Decision about the referencing of the standard•Verification that standard is in line with safety requirements and vote by MS in GPSD Committee•Commission adopts Decision recognising standard / reference to stan-dard published in the Official Journal of the EULack of common EU benchmark on what constitutes „safe“ for a specific  product, for which certain risks have been establishedCommon EU benchmark (EN Standard) established and applied by producers 
 
Annex 11: Summary of replies to the open public consultation 

Q1 In your view, to what extent are current EU safety rules for non-food consumer 
products covered by the GPSD adequate to protect consumers? 

A  large  majority  of  respondents  expressed  that  current  EU  safety  rules  for  non-food 
consumer products covered by the GPSD could be improved in specific areas to be more 
adequate  to  protect  consumers  (71%).  Nearly  one  in  four  respondents  held  that  the 
current rules were fully adequate, whereas only a small minority considered them not to 
be adequate at all (6%), see the following figure. 

Fully 
adequate 
23% 

Not adequate 
at all 
6% 

Could be 
improved in 
specific areas 
71% 

Total no. of respondents: 214, Single-choice question 

Q2 Are you aware of any problems related to the implementation of EU safety rules 
for consumer products covered by the GPSD? 

When  asked  about  problems  related  to  the  implementation  of  safety  rules  for  products 
covered by the GPSD, respondents most commonly expressed that rules were not adapted 
to  online  trade  (39%)  and  that  the  rules  were  not  appropriately  enforced  (39%).  More 
than a third also  considered the rules not  to  be adapted to  new technologies (36%) and 
perceived legal definitions as not sufficiently clear or outdated (35%). Slightly less than a 
third  of  respondents  (30%)  reported  that  roles  and  obligations  of  different  economic 
operators were not appropriately defined and that there were difficulties for consumers to 
report  unsafe  products.  Lastly,  approximately  a  fifth  of  respondents  regarded  as 
problematic that there were no specific requirements  for product  recalls (22%) or listed 
other issues (23%) (see the following figure). 

 
 
 
 
RULES ARE NOT ADAPTED TO ONLINE TRADE 

PRODUCT SAFETY RULES ARE NOT APPROPRIATELY 
ENFORCED 

RULES ARE NOT ADAPTED TO NEW TECHNOLOGY 
PRODUCTS (E.G. CONNECTED DEVICES) 

LEGAL DEFINITIONS (SUCH AS “PRODUCT”, “SAFE 
PRODUCT” OR “PLACING ON THE MARKET”) ARE … 

THE ROLES AND OBLIGATIONS OF DIFFERENT 
ECONOMIC OPERATORS ARE NOT APPROPRIATELY … 

DIFFICULTIES FOR CONSUMERS TO REPORT UNSAFE 
PRODUCTS 

THERE ARE NO SPECIFIC REQUIREMENTS FOR 
PRODUCT RECALLS 

OTHER 

Total no. of respondents: 205, Multiple-choice question 

39% 

39% 

36% 

35% 

30% 

30% 

22% 

23% 

In  their  comments,  respondents  detailed  their  views  regarding  problems  with  the 
implementation  of  the  GPSD.  In  line  with  ‘online  trade’  being  a  major  concern  to  the 
safety of products, many respondents referred to problems in this area, often specifically 
referring  to  online  trade  with  third  countries.  In  this  context,  the  “current  lack  of 
responsibility and acknowledgment of online marketplaces' role in the supply chain” was 
mentioned  by  a  large  number  of  respondents.  A  related  issue  that  was  frequently 
indicated  concerned  customs  controls  of  consignments  from  non-EU  countries  to 
consumers.  Often,  comments  were  framed  as  suggestions  for  improvement,  i.e.  it  was 
suggested to ensure better customs controls of these consignments. 

Many stakeholders considered that the GPSD was not properly enforced or implemented 
effectively, with a typical example being a statement that the “current framework is not 
implemented effectively (over 500 MSAs in Europe with no minimum standard for recall 
or  takedown  notices)”.  Respondents  referred  to  differences  in  risk  assessment,  and 
considered  resources  of  market  surveillance  authorities  to  be  insufficient,  including 
regarding testing. Finally, a number of respondents raised specific issues, such as: 

  The lack of data on injuries and accidents, and the need that accident and incident 

alert systems must be adjusted to work in practice; 

  Limitations  in  scope  of  the  directive,  such  as  the  lack  of  services  covered 
(including  financial  services  and  online  gambling  services  with  a  high  addictive 
potential), and counterfeiting; 

  Limitations of the concept of “safe product”, which was considered to not always 

meaning that the product is safe for specific vulnerable groups; 

  The absence of specific rules on the safety of child appealing products; 

  Lack  of  adaptation  to  new  technologies,  including  the  lack  of  coverage  of 

software as “product” (see also next question). 

130 

 
 
 
 
Q3 Do you think that the safety of products involving new technologies is adequately 
regulated? 

Almost half the respondents considered the safety of products involving new technologies 
to be not adequately regulated (47%), with only 18 % stating the opposite. The other 35% 
did not know (see the following figure). 

Don't know 
35% 

Yes 
18% 

No 
47% 

Total no. of respondents: 227, Single-choice question 

Q4 When incorporated into a physical product, software can malfunction and cause 
a safety issue. When considering whether a product is safe, should the definition of a 
product in the GPSD specifically encompass also the software incorporated into it? 

When  asked  whether  the  definition  of  a  product  in  the  GPSD  should  specifically 
encompass  software  incorporated  into  the  product,  the  majority  of  respondents  agreed, 
even in case the software is downloaded after the product has been sold (56%).  

About  a  quarter  of  respondents  considered  that  only  software  already  installed  into  the 
product when sold should be included. Only a small minority answered that the definition 
should  not  encompass  software  (6%)  or  preferred  an  “other”  option  (12%),  see  figure 
below. 

131 

 
 
 
 
 
Yes, also when software is downloaded into the
device after it has been sold

56% 

Yes, but only when software is already installed
into the product when sold

26% 

No

6% 

Other

12% 

Total no. of respondents: 211 

Respondents  could  provide  comments,  and  again  explained  their  positions.  Those  that 
argued  that  all  software  should  be  covered  (even  if  downloaded  after  the  purchase  of  a 
product) typically provided one or more of the following arguments: 

  Safe  software  is  as  essential  as  safe  hardware.  One  cannot  function  without  the 

other; 

  Software can change the properties and hence the safety of a device. The GPSD 

must have a safety net function here; 

  Modern goods are made from software and hardware, and both of them can cause 

safety issue. It is important that both are covered; 

  Encompassing software into the product definition would eliminate ambiguities. 

In contrast, there were also several respondents that did not see any need for changes to 
the GPSD in this respect, arguing: 

  Physical product can cause harm and should be designed to be safe, not software; 

  The definition of products currently used in the GPSD is up to date and broad and 

flexible enough to reflect new developments and challenges; 

  A risk-based approach should be taken with new technologies. If there are gaps, 

targeted legislation is the most effective way to address risks. 

Finally,  comments  considered  how  responsibility  should  be  allocated  in  case  software 
would cause a product to be unsafe. There was no consensus in this respect. Rather, the 
answers reflected the different  perspectives  of the respondents: Those that saw a strong 
role  of  the  manufacturer  argued  that  the  safety  of  the  product  must  take  into  account 
software designed to operate the product, even if the software is installed afterwards, and 
that a product should have safety functions that minimise the risk of malfunction of added 
software.  In  contrast,  others  suggested  that  the  duties  of  the  manufacturer  of  a  device 
should not cover safety risks posed by a standalone software installed later, over which 
the  manufacturer  has  no  control.  Some  respondents  also  argued  that  if  users  installed 
software, manufacturers or distributors should not be responsible for its safety unless they 
had instructed or authorised this. 

132 

 
 
 
 
Q5  How  important  do  you  think  it  is  that  products  that  could  be  modified  via 
software  updates/downloads  or  machine  learning  are  required  to  remain  safe 
throughout their lifetime? 

Almost all respondents considered a requirement for products that could be modified via 
software  updates/download  or  machine  learning  to  remain  safe  to  be  very  important 
(72%)  or  rather  important  (24%).  A  mere  3%  regarded  the  requirement  as  rather 
unimportant, while none of the respondents considered it not to be important at all  (see 
the following figure). 

72% 

24% 

3% 

0% 

Very important

Rather
important

Rather
unimportant

Not at all
important

Total no. of respondents: 217, Single-choice question 

Q6 Products  incorporating  AI  applications  can  evolve  via  machine  learning  and 
other  techniques,  even  after  they  have  been  acquired  by  consumers,  potentially 
posing safety risks. In your opinion, at which moment of the lifecycle of the product 
should manufacturers have safety obligations? 

A clear majority of respondents favoured safety obligations for manufacturers of products 
incorporating  AI  applications  at  the  design  stage  and  also  during  the  lifecycle  of  the 
product (75%), whereas only 9% of respondents expressed that the obligations should be 
limited to the design stage. 16% preferred an “other” solution (see the following figure). 

75% 

9% 

OBLIGATIONS AT THE DESIGN STAGE 
AND ALSO DURING THE LIFECYCLE OF 
THE PRODUCT 

OBLIGATIONS ONLY AT THE DESIGN 
STAGE 

Total no. of respondents: 213, Single-choice question 

16% 

OTHER 

133 

 
 
 
 
 
 
 
 
In their comments, respondents mostly reiterated their views without providing additional 
details.  Some  respondents  that  agreed  to  safety  obligations  of  manufacturers  during  the 
lifecycle  of  the  product,  elaborated  on  limitations  to  this  principle.  According  to  their 
view the level of safety during the lifecycle should be compared to the level of risk with 
human control (not “zero risk”), should exclude “substantial modifications” or be limited 
to the “foreseeable period of use of the product”. Finally, there were also respondents that 
saw a need for regulating AI horizontally, and not in the GPSD.          

Q7 Have you experienced any product safety incident within the last 5 years? 

A clear majority of respondents did not experience any product safety incident within the 
last  5  years  (65%),  with  the  share  of  affirmative  answers  being  35%,  see  the  following 
figure). 

Yes 
35% 

No 
65% 

Total no. of respondents: 175, Single-choice question 

If yes, how did you buy the product? 

Among  the  62  respondents  that  answered  yes  to  Q7  the  largest  group  had  bought  the 
product  online  from  a  seller  based  in  the  EU  (27%),  followed  by  each  24%  of 
respondents  that  had  acquired  the  product  from  a  physical  shop  or  online  from  a  seller 
based  outside  the  EU.  About  one  fifth  of  respondents  stated  that  they  had  obtained  the 
product online but were unsure where the seller was based and 5% gave no answer  (see 
the following figure). 

Online from a seller based in the EU

From a physical shop

Online from a seller based outside the EU

Online but I am not sure where the seller was
based

No answer

5% 

Multiple-choice question 

27% 

24% 

24% 

19% 

134 

 
 
 
 
 
 
 
Q8 Have  you  experienced  any  lack  of  information  linked  to  safety  when  buying 
products online? 

A  small  majority  of  the  respondents  reported  that  they  had  experienced  a  lack  of 
information linked to safety when buying products online (51%), while the other half did 
not share this experience (49%), see the figure below. 

Yes 
51% 

No 
49% 

Total no. of respondents: 185, Single-choice question 

If yes, what was this lack of information linked to? 

Of those 94 respondents that answered yes to Q8 a clear majority considered the lack of 
information to be linked to missing contact of the producer of a product bought online to 
report a safety incident to (65%) and/or to not receiving enough warnings or instructions 
concerning  the  product  sold  online  (63%).  Slightly  less  than  half  of  the  respondents 
perceived  that  there  was  no  place  to  report  a  product  safety  incident  on  the  website  as 
problematic  in  this  respect  (44%),  while  a  quarter  of  the  respondents  considered  other 
factors to be relevant. Another 1% gave no answer (see the following figure). 

No information available to contact the producer of
the product bought online to report a safety incident

Not enough warnings or instructions concerning the
product sold online

No place to report a product safety incident on the
website

65% 

63% 

44% 

Other

26% 

No answer

1% 

Multiple-choice question 

Q9 Online marketplaces enable companies to sell to EU consumers but, according to 
EU rules, they do not have direct legal obligations for the safety of products hosted 

135 

 
 
 
 
 
 
on their platform by sellers. Are you aware of any problems this regime would bring 
about? 

The majority of respondents expressed that they were aware of problems associated with 
online marketplaces having no direct  legal  obligations for the safety of products  hosted 
on their platform by sellers (53%). However, almost half of the respondents indicated the 
opposite (47%) (see the following figure). 

Yes 
53% 

No 
47% 

Total no. of respondents: 209, Single-choice question 

Q10  What  should  be  the  role  of  online  marketplaces  as  regards  the  safety  of 
products offered on their website? 

When asked about the role that online marketplaces should play regarding the safety of 
products offered on their websites, the most commonly supported notions were that they 
should  remove  dangerous  products  listed  on  their  website  when  notified  (77%),  that 
online marketplaces should prevent the appearance of dangerous products, including their 
reappearance once they have been removed (66%) and that they should inform sellers of 
their  obligation  to  comply  with  EU  rules  on  products  (64%).  More  than  half  of  the 
respondents agreed that online marketplaces should inform consumers when a dangerous 
product  has  been  removed  from  the  marketplace  (55%).  A  slightly  lower  number  of 
respondents thought that online marketplaces should do a cursory check on all products 
offered on their website to identify products that likely do not comply with safety rules 
(42%). Several respondents also indicated the option “other” (14%), see the figure below. 

136 

 
 
 
 
Online marketplaces should remove dangerous products listed on
their websites when notified to them

Online marketplaces should prevent the appearance of dangerous
products, including the reappearance of dangerous products'
listings once they have been removed

Online marketplaces should inform sellers of their obligation to
comply with EU rules on products

Online marketplaces should inform consumers when a dangerous
product has been removed from the marketplace

Online marketplaces should do a cursory check on all products
offered on their website to identify products that likely do not
comply with safety rules

77% 

66% 

64% 

55% 

42% 

Other

14% 

Total no. of respondents: 221, Multiple-choice question 

Nearly  all  detailed  comments  provided  by  respondents  concerned  suggestions  for 
additional  obligations  for  online  marketplaces.  In  many  cases,  respondents  considered 
that  due  to  the  active  role  of  the  marketplaces  in  facilitating  transactions,  platforms 
should  have  the  same  responsibilities  as  other  importers/distributors/traders  (selling 
online or in  brick-and-mortar shops). Respondents suggested  a large variety of possible 
additional obligations for online marketplaces, including: 

  Taking  reasonable  efforts/work  more  proactively  to  prevent  appearance  of 

dangerous products; 

  Using technology (such as AI) to swiftly identify and delist unsafe products; 

  Checking  all  products  offered  in  order  to  identify  non-compliant/recalled 

products; 

  Verifying  the  presence  of  the  CE  mark  and  the  absence  of  obvious  safety 

concerns; 

 

Implementing  testing  requirements,  especially  for  products  falling  under  the 
WEEE, Battery and Packaging Directives; 

  Keeping a notification form available for suspected cases of unsafe products; 

 

Informing  market  surveillance  authorities  immediately  of  unsafe  products 
identified;  

  Cooperating with enforcement authorities; 

 

Informing consumers who have previously bought a product that was later taken 
down following a valid request for takedown; 

137 

 
 
 
  Not sending unsafe products to consumers when they have already been ordered 

but are not sent yet;  

  Recalling unsafe products from consumers and destroying the stored products; 

 

Identifying  repeat  offenders  which  would  prevent  them  to  re-list  dangerous 
products on the marketplace; 

  Being liable for products they sell. 

A  minority  of  respondents  suggested,  however,  that  responsibilities  and  obligations 
imposed on online marketplaces should be proportionate (or  effective  and feasible) and 
take into account the size and scope of the provider in question. They also considered that 
obligations  should  not  handicap  SMEs  competing  against  bigger  and  more  established 
companies who are better placed to overcome related regulatory burdens. 

Finally,  several  respondents  suggested  that  the  scope  of  checks  to  be  conducted  by 
marketplaces  should  include  not  only  unsafe  products,  but  also  counterfeit  products  in 
general, and life animals/pets sold on platforms, to safeguard that only registered animals 
are offered by traceable sellers (with a specific reference to illegal puppy trade). 

Q11 What are the main challenges for enforcement? 

When  asked  about  the  main  challenges  for  enforcement  half  of  the  respondents 
considered as problematic that Member States’ authorities did not have enough resources 
(49%),  followed  by  the  difficulty  of  taking  enforcement  actions  against  economic 
operators  outside  the  EU  (46%).  Other  challenges  included  that  not  enough  control 
checks are carried out, including by customs (29%), that there is not enough cooperation 
between market surveillance authorities in the EU (27%), and that these authorities assess 
product risk differently (19%). All other answer items were indicated by 18% or less of 
respondents. 

138 

 
 
 
 
Member States’ authorities do not have enough 
resources 

Enforcement actions against economic operators outside
the EU are difficult

Not enough control checks carried out, including by
customs

Not enough cooperation among market surveillance
authorities in the EU

Member States’ authorities assess product risks 
differently 

Member States’ authorities lack specific powers: they 
cannot impose efficient sanctions on economic … 

Member States’ authorities cannot take effective actions 
online ( e.g. mystery shopping, restrict access to the … 

49% 

46% 

29% 

27% 

19% 

18% 

18% 

Fragmentation of the market surveillance legislation
between harmonised and non-harmonised products

14% 

Dangerous products are difficult to trace

12% 

Other

18% 

Total no. of respondents: 207, Multiple-choice question with maximum 3 choices 

In  their  comments,  respondents  referred  to  the  above  listed  challenges  in  detail.  It  was 
suggested that the listed enforcement issues would need to be addressed through GPSD 
reform  and  through  making  available  more  resources  at  national  level  for  enforcement 
and  better  controls,  including  customs  controls.  Several  stakeholders  referred  to 
Regulation  (EU)  2019/1020  on  market  surveillance  (which  is  applicable  in  the 
harmonised product  sectors), indicating that it provided relevant  means of enforcement. 
Other suggestions included that: 

  National authorities needed more resources or information on products coming 

from outside the EU to ensure effective checks; 

  The GPSD should be converted into a regulation in order to rule out national 

differences in implementation; 

  Powers should be specified and harmonised, and enforcement be improved 

through joint action by several Member States. 

Q12 Do you think that products covered by the GPSD should only be placed on the 
EU market if there is an economic operator established in the EU who is responsible 
for product safety purposes? 

A  large  majority  of  respondents  considered  that  products  covered  by  the  GPSD  should 
only be placed on the EU market if there is an economic operator established in the EU 

139 

 
 
 
 
 
responsible for product safety purposes (70%), with the other 30% expressed the opposite 
view (see the following figure). 

No 
30% 

Yes 
70% 

Total no. of respondents: 186, Single-choice question 

Q13  Are  you  aware  of  any  issue  where  additional  competences  of  the  European 
Commission for the enforcement of product safety rules could improve the safety of 
consumers? 

Close  to  two  thirds  of  respondents  indicated  that  they  were  not  aware  of  issues  where 
additional  enforcement  competences  of  the  European  Commission  could  improve  the 
safety of consumers (64%). However, more than a third of the respondents suggested the 
opposite (36%), see the figure below. 

Yes 
36% 

No 
64% 

Total no. of respondents: 170, Single-choice question 

Q14  Should  the  system  of  product  traceability  be  reinforced  in  the  GPSD  so  that 
products can be better traced if there is a safety issue? 

A large majority of respondents agreed that the system of product traceability should be 
reinforced  in  the  GPSD  (82%),  while  only  18%  of  respondents  did  not  regard  this  as 
necessary (see the following figure). 

140 

 
 
 
 
 
 
 
No 
18% 

Yes 
82% 

Total no. of respondents: 171, Single-choice question 

Q15 Do you experience problems with the divergence of rules between harmonised 
and non-harmonised products? 

Almost  one  in  three  respondents  reported  having  experienced  problems  with  the 
divergence of rules between harmonised and non-harmonised products (30%), while 23% 
stated  the  opposite.  Almost  half  of  the  respondents  expressed  that  they  did  not  know 
(47%) (see the following figure). 

Don't know 
47% 

Yes 
30% 

No 
23% 

Total no. of respondents: 178, Single-choice question 

Q16  Products  which  resemble  foodstuff,  while  not  being  such,  have  a  separate 
regime  (Council  Directive  87/357/EEC).  This  has  given  rise  to  different 
interpretations  on  whether  such  products  are  dangerous  in  itself  or  not.  Should 
these products keep having a separated regime or be incorporated into the general 
product safety legal instrument? 

A large majority of respondents expressed that products which resemble foodstuff should 
be incorporated into the general product safety legal instrument (69%), whereas the other 
31% felt that the regime should remain separate. 

141 

 
 
 
 
 
 
No, it should 
remain 
separate 
31% 

Yes, it should 
be 
incorporated 
69% 

Total no. of respondents: 155, Single-choice question 

142 

 
 
 
 
 
Annex 12: Stakeholders opinions on the benefits of the 
different options 

The  survey  conducted  in  the  context  of  the  GPSD  Study  shows  the  following 
stakeholders’ views on the additional benefits for businesses resulting from the different 
options: 

Additional benefits for businesses resulting from the implementation of Option 1 

Additional benefits for businesses resulting from the implementation of Option 2 

143 

 
 
 
Additional benefits for businesses resulting from the implementation of Option 3 

Additional benefits for businesses resulting from the implementation of Option 4 

144 

 
 
 
 
 
145 

12345Increased business revenue (e.g. due to increasedreputation/brand value)Lower operational risk for businessesEasier compliance with product safety requirements forSMEsBetter supply chain management due to improvedtraceability of productsReduced legal complexityBetter information on unsafe products/ measures takenby authorities provided through Safety Gate /RAPEXGreater legal certaintyNo change inVery significantbenefits at alladditionalbenefitsOther stakeholdersAuthoritiesCompanies/ Business associations 
 
 
 
Annex 13: Minutes from the EU workshops addressing the sale 
of illegal goods online 

The workshops were co-organised by DG CNECT and DG JUST, 8, 10, 13 and 17 July 
2020, as part of a broader engagement with stakeholders and evidence collection strategy 
for the Digital Services Act package as well as the revision of the General Product Safety 
Directive.  

The objective of the workshops was to gather up-to-date information on the state of play 
concerning the main challenges in addressing the sale of illegal goods online. It focused 
in particular at measures and good practices from marketplaces and the cooperation with 
authorities  and  responsible  third  parties.  Panellists  and  participants  –  which  included 
online  marketplaces,  retail  associations,  consumer  organisations,  national  market 
surveillance authorities as well as representatives from the European Commission - were 
invited to share their experiences and engage in a discussion on potential new policy and 
regulatory measures. 

The event was made of four separate online sessions: 

Session 1: Sellers and products identification mechanisms, 8 July 2020 - The first session 
was  focused  on  the  information  online  marketplaces  are  currently  gathering  on  their 
sellers. Online marketplaces started with a short overview of practices in identifying their 
business  sellers  and  product  listings  on  their  platforms.  Most  online  marketplaces 
specified  that  business  sellers  are  required  to  submit  background  information  (e.g. 
company name, VAT number, address, etc.) before being admitted to sell.  

Overall,  all  participants  agreed  on  the  importance  of  having  transparency  as  regard 
business traders. Some participants highlighted that more should be done in this context, 
especially when it comes to sellers established outside the EU and therefore not always 
covered  by  EU  rules.  Some  stakeholders  considered  that  more  cooperation  with 
authorities in Member States could also help identifying rogue sellers.  

Session 2:  How to tackle dangerous goods and product safety issues online: notice and 
action procedures and the role of the Safety Gate/RAPEX -  The first part of this session 
concerned  best  practices  on  notice  and  action  procedures  to  tackle  dangerous  goods, 
including  notices  from  authorities,  consumer  associations,  consumers  and  other  actors. 
Generally,  all  participants  agreed  that  a  harmonised  notice  and  action  procedure  would 
facilitate the fight against dangerous products online. Some participants highlighted that 
often  notices  are  not  accurate  enough  and  online  marketplaces  have  difficulties  in 
identifying the dangerous products notified. In this regard, many participants called for a 
minimum information requirement for notices. Online marketplaces also stated that filters 
are  not  entirely  reliable  and  that  such  tools  should  always  be  accompanied  by  human 
review and notice and action mechanisms.  

The second part of the session concerned Safety Gate/RAPEX. In this regard, a number 
of  investigations  carried  out  by  consumer  organisations,  retail  associations  and  market 
surveillance  authorities  were  also  presented,  with  results  on  the  number  of  dangerous 
products  available  online  raising  clear  concerns.  Marketplaces  are  taking  some  action, 
such  as  periodically  checking  Safety  Gate/RAPEX  (as  they  have  committed  in  the 
Product Safety Pledge). Some participants pointed out, the information in the Safety Gate 

146 

 
 
only  shows  only  part  of  the  issue  and  more  needs  to  be  done  in  this  regard.  Some 
remedies  were  proposed  by  national  authorities,  such  as  establishing  an  obligation  to 
cooperation  with  market  surveillance  and  custom  authorities.  Some  participants  also 
suggested to have an API interface to Safety Gate/RAPEX which would then be linked to 
online  marketplaces  and  allow  them  and  consumers  to  have  real-time  information  on 
product safety.  

Session  3:   What  other  measures  and  challenges  for  keeping  consumers  safe  from 
dangerous  goods  online?  –  The  session  focused  on  other  preventive  measures  that 
marketplaces can take to ensure that no dangerous product is placed on the market. Three 
main aspects were mentioned by participants. First, the importance of data, that in many 
cases  is  not  provided  by  the  seller,  making  enforcement  very  difficult.  Second,  online 
sales  and  product  safety  are  global  issues,  therefore  international  cooperation  is  key  to 
address  these  challenges.  Thirdly,  many  participants  mentioned  the  issue  around 
traceability, and how it needs to  be enhanced so dangerous products  sold  online can be 
correctly  identified  and  corrective  measures  can  be  enforced  by  both  platforms  and 
authorities.  The  challenge  of  reappearance  of  dangerous  products  already  removed  was 
also  addressed,  although  not  specific  measures  or  solutions  were  mentioned  by 
participants.  

Session 4: Consumer law and online marketplaces, 17 July 2020 -The main focus of this 
session  was  to  address  content  that  is  illegal  because  it  constitutes  a  violation  of 
applicable EU consumer law.  

The session started with a short presentation held by DG JUST on the relevance of EU 
consumer law for a) online marketplaces regarding their own activities and content; b) the 
business  users  of  online  marketplaces;  and  c)  online  marketplaces  in  their  capacity  as 
hosts of their business users.  

The  discussion  then  zoomed  in  on  third-party  content  and  the  measures  that  online 
marketplaces  are  taking  to  prevent  activities  that  violate  applicable  EU  consumer  law. 
Online marketplaces specified that their objective is to create trust on the platform, both 
for  consumers  and  sellers.  They  further  stated  that  sellers  are  in  charge  of  their  own 
compliance,  but  that  they  are  responsible  to  give  them  the  means  to  be  able  to  be 
compliant with EU law. 

Some  participants  flagged  that  the  main  problem  with  EU  consumer  law  is  the  lack  of 
resources and enforcement.  

Cooperation  was  also  mentioned  by  many  participants  as  being  the  key  to  ensure  a 
coherent enforcement of EU consumer law. According to many participants, all the actors 
in the supply chain should work together to raise awareness around consumer rules. 

147 

 
 
 
Annex 14: Minutes from the EU Workshop on strategies to 
maximise the effectiveness of product recalls  

On  23  October  2019,  a  workshop  has  been  organised  by  the  European  Commission  to 
discuss the strategies to maximise the effectiveness of product recalls. The participants of 
the workshop included regulators from around the world, representatives of international 
organisations (OECD, UNCTAD), consumer organisations, industry and academics. 

The  aim  of  the  workshop  was  to  take  stock  of  existing  market  practices  and  regulatory 
approaches,  and  identify  possible  new  avenues  to  maximise  recall  effectiveness.  As  a 
next-step, the most promising ideas could be tested through an EU behavioural study, the 
results of which should also be of relevance for other stakeholders and jurisdictions. 

The  workshop  was  divided  into  three  thematic  sessions,  focusing  on  i)  Strategies  to 
facilitate direct consumer contact, ii) Strategies to increase consumer response to recalls 
and iii) Roles and responsibilities in the recall process. The last part of the workshop was 
limited to regulators in order to discuss possible next steps.  

1.  Session 1: Strategies to facilitate direct consumer contact 

The objective of this session was to: 

  get  a  comparative  overview  of  strengths  and  weaknesses  of  various  methods  of 

identifying the owners of recalled products, and 

  brainstorm  on  best  ways  to  address  the  barriers  that  prevent  consumers  from 

sharing their contact details for safety notification purposes. 

PRESENTATIONS  

UK  Electrical  Safety  First  talked  about  strategies  to  improve  product  registration. 
According to Electrical Safety First research, only 1 in 3 people register electric products, 
because  they  1)  fear  unwanted  marketing  communications  2)  think  it  takes  too  much 
effort  and  time  3)  do  not  see  the  benefit.  The  charity  has  launched  several  awareness-
raising  campaigns  to  encourage  registration  of  electrical  devices  and  domestic 
appliances346.  Further  avenues  to  encourage  product  registration  include  1)  separating 
marketing  from  safety  notifications,  2)  standardising  and  simplifying  registration 
material, 3) point-of-sale registration and 4) technological solutions (barcodes/QR/RFID, 
connected devices). 

Decathlon explained that the company uses different strategies to communicate recalls to 
its customers – from general displays in stores and on the website to personalised letters 
and  e-mails.  Phone  calls  and  SMS  are  also  used  in  case  of  small-scale  recalls.  The 
experience shows that direct communication is the most effective strategy. 

The main source of consumer data is a voluntary loyalty programme, which varies across 
different  countries,  and  allows  Decathlon  to  contact  affected  consumers  directly.  The 

346 Among others: https://www.electricalsafetyfirst.org.uk/product-recalls/product-registration/, 
https://www.electricalsafetyfirst.org.uk/what-we-do/campaigns/nan-knows-best/, 
http://www.whitegoodsafety.com/ 

148 

 
 
                                                           
company  also  offers  voluntary  registration  at  the  moment  of  purchase,  but  for  the  time 
being this possibility is limited to bicycles, which are the highest-risk product.  

The company noted that even if they do not post recall announcements on social media, 
consumers  may  do  it  themselves  and  even  share  incomplete  and  incorrect  information. 
Therefore,  the  best  option  is  to  share  recall  information  directly,  or  through  sports 
community groups, which additionally encourages word-of-mouth.  

The Finnish Safety and Chemicals Agency (Tukes) focused on how economic operators 
should  use  loyalty  cards  data  for  recalls  in  the  light  of  the  EU  personal  data  protection 
rules. 

They  started  by  recalling  an  incident  of  toxic  olives  causing  botulism  that  occurred  in 
Finland in 2011. In addition to vast media attention, most of the affected consumers were 
contacted directly due to accessibility to personal data in customer loyalty registers.  

Nowadays Tukes's guidance on product recalls explicitly recommends that if a company 
has  a  comprehensive  customer  register  available,  contacting  people  directly  is  the  most 
effective  way  to  notify  them  about  a  product  recall.  Also,  according  to  the  European 
Commission's survey, consumers would prefer direct personal communication regarding 
recalls. 

However,  following  the  entry  into  force  of  the  EU  General  Data  Protection  Regulation 
(GDPR) in May 2018, economic operators have become much more cautious about using 
loyalty  programmes  data  to  reach  out  to  consumers  in  case  of  a  recall.  In  an  ideal 
scenario,  recalls  should  be  defined  as  the  initial  purpose  of  personal  data  processing  in 
customer  registers.  This  way,  when  consumers  sign  up  for  a  loyalty  scheme  or  make  a 
purchase  online,  they  would  explicitly  agree  to  be  contacted  in  case  of  safety  issues. 
However,  even  in  the  absence  of  such  explicit  consent,  the  use  of  customers'  personal 
data  can  be  justified.  To  make  sure  that  companies  do  not  to  delay  safety  measures 
because of the GDPR concerns, Tukes, the  Office of Data Protection Ombudsman, and 
the Finnish Commerce Federation are currently preparing a memorandum on the issue.  

However, some practical questions still remain. This is especially important as GDPR is 
part of the European legislation, and interpretations need to be harmonised throughout the 
EU.  

The  representatives  of  the  Commission  mentioned  that  the  Commission  is  looking  into 
developing  a  hands-on  guidance  on  how  personal  data  should  be  handled  in  the  recall 
process. She confirmed that the recommended default approach, in line with the General 
Data  Protection  Regulation,  is  for  businesses  to  include  in  their  privacy  policy  the 
possibility to contact customers to inform them about safety notifications.  

GROUP DISCUSSIONS  

GROUP 1: Increasing product registration rates 

There  was  a  general  consensus  that  the  best  way  to  reach  out  to  consumers  with  recall 
information  is  to  contact  them  directly  and  that  increasing  product  registration  rates 
should therefore be encouraged.  

The  participants  explored  major  barriers  to  registration  both  from  a  consumer  and  a 
business perspective, and suggested possible solutions. 

149 

 
 
 
Most consumers simply do not understand the interest of registering their products, and 
do not make the link between registration and safety. This is especially the case for lower 
value products (Australian representative mentioned the cut-off threshold of 50 AU$). It 
is therefore important to clearly communicate about the benefits of product registration. 

There  is  also  a  widespread  lack  of  trust  that  the  data  will  not  be  used  for  marketing 
communication.  The  US  product  registration  card  for  childcare  articles  provides  a 
statement  that  the  information  will  only  be  used  in  case  of  safety  alerts  and  recalls. 
However, it was mentioned that even that could be further strengthened (e.g. by adding 
that any other use would be subject to liability).  

At  the  same  time,  consumers  are  not  a  heterogeneous  group;  they  have  different  risk 
perceptions  and  attitudes.  The  more  risk-averse  are  also  more  likely  to  register  their 
products. The challenge is to reach out to the rest. Engaging more vulnerable consumer 
groups  is  a  particular  challenge.  Local  messengers  can  be  helpful  in  this  regard  (for 
instance churches in New Zealand). 

The  participants  agreed  that  the  registration  process  should  become  as  seamless  as 
possible. One option to explore is  standardising  and simplifying  registration  material  to 
only  capture  the  minimum  necessary  information.  Technological  solutions  -  such  as 
mobile QR code scanning (already very popular in China and Southeast Asia) or even a 
dedicated  product  registration  app  –  would  also  minimise  the  effort  required  from  the 
consumer. 

The  timing  of  registration  matters  too.  It  was  noted  that  the  key  moment  during  which 
consumers can be prompted to  register their products  is  at  the point-of-sale. The CPSC 
evaluation  has  shown  that  unless  the  registration  card  is  filled  out  (and  assisted) 
immediately after the purchase, there is little chance that it will ever be. While point-of-
sale registration may be difficult in physical stores with high customer flow, this is quite 
straightforward in the case of online purchases. The idea of encouraging registration upon 
the receipt of the product was also put forward. The UK mentioned their pilot project in 
cooperation with Whirlpool, testing registration at delivery. 

As for the business side, it was noted that economic operators may be reticent to highlight 
the  link  between  registration  and  safety  so  as  to  not  to  suggest  even  the  slightest 
possibility  of  their  product  not  being  safe.  It  may  be  therefore  more  appropriate  and 
effective for the message to come from the government agency.  

It was also mentioned that if economic operators were obliged to offer the possibility of 
product  registration  to  consumers,  especially  at  the  point/moment  of  sale,  this  would 
greatly increase registration rates. The role of retailers in the process should be carefully 
analysed:  while  they  are  not  the  responsible  party,  they  could  greatly  facilitate 
communication.  

Beyond  product  registration,  it  was  noted  that  customers'  data  is  generated  also  during 
other touch points of the consumer journey: most products are paid by card; big items are 
usually delivered and complex items installed. Yet, this data is not being used for safety 
purposes because of concerns about personal data protection. 

Finally,  it  was  mentioned  that  being  able  to  reach  the  affected  consumers  directly  does 
not guarantee that he or she will react.  In the case of New Zealand Takata recall, even 
very  intense  direct  contact  (up  to  6 letters)  did  not  guarantee  a  100%  response  (despite 
free  repair  and  very  serious  risk).  New  Zealand  is  therefore  shifting  from  the  carrot  to 

150 

 
 
stick  approach  (“if  you  fail  to  respond  to  the  recall,  your  vehicle  will  be  not  pass  the 
compulsory periodic inspection"). 

GROUP 2: Other methods of identifying affected consumers 

To start with, participants were asked about their personal experiences when subscribing 
to loyalty programs (to which programmes and why they were more likely to subscribe 
to) and how familiar they were with the concept of "dirty data" (which can be for instance 
fake contact details or an email address that is not checked by the user).  

There  was  a  general  agreement  that  this  depends  on  the  trust  towards  the  brand  or 
website. Some said  they prefer to  create specific email  addresses  for this very purpose, 
fearing to be overwhelmed with marketing emails. This is in line with different surveys 
showing  that  consumers  all  over  Europe  tend  to  provide  “dirty  data”  for  loyalty 
programme registration: almost a third of people tend to give an email address that they 
do not regularly check.  

The  benefits  of  providing  accurate  data  when  signing  up  to  such  programmes  are  not 
really  obvious  to  consumers  (the  main  motivation  being  financial),  while  they  see  the 
immediate  adverse  effects  of  appearing  on  more  marketing  listings  and  receiving  more 
advertising.  This  issue  is  important,  as  it  might  undermine  the  effectiveness  of  direct 
safety notifications.  

A  good  practice  could  be  for  consumers  enrolling  in  a  loyalty  programme  to  have  the 
possibility  to  provide  a  specific  email  address/phone  number  to  receive  safety 
notifications only (similarly to what is suggested for product registration).  

The need for the consumer to  be  “pulled” rather than “pushed” was also stressed when 
discussing  how  best  to  encourage  consumers  to  share  their  personal  data  for  safety 
purposes. Most consumers do not see the benefit of giving out their data. Communicating 
on  these  issues  appears  essential.  Participants  stressed  that  even  though  loyalty 
programmes can be helpful, they should not be the only means of generating customers' 
data for safety purposes. 

The  potential  role  of  financial  institutions  in  contacting  affected  consumers  was  also 
discussed.  In  some  cases,  it  is  indeed  possible  for  bank  service  providers  to  identify 
consumers who have purchased a recalled product when the payment has been done with 
a  credit/debit  card.  Some  participants  shared  experiences  with  such  use  of  financial 
institutions in recalls:  

-  An extra benefit of banks directly communicating recall information to consumers 

is that consumers tend to have more trust in these messages.  

-  Handling of personal data is one of consumers' major concerns when third parties 

are involved in the recall process.  

-  The  emergence  of  “FinTech”  (financial  technology  companies)  should  also  be 
considered when looking at ways to facilitate consumer identification, taking into 
account that customers can have virtual credit cards for purchases online, or can 
have multiple credit cards per account.   

Participants  also  discussed  how  online  marketplaces  can  play  a  facilitating  role,  taking 
advantage  of  the  channels  and  systems  they  have  already  put  in  place  to  communicate 
with  both  consumers  and  sellers.  Two  different  models  exist:  some  platforms  ask  the 

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sellers of recalled products to notify affected consumers, others send the recall message 
themselves.  

The benefits linked to connected products were also stressed. When a connected product 
itself is subject to a recall, this technology can be used to warn consumers or, if they fail 
to act, switch off the product or reduce its performance. Connected products may also be 
able  to  “monitor”  other  products.  For  instance,  some  smartphones  can  identify  the 
charger that is plugged to them and could alert consumers in case this charger is recalled. 
In the food sector, a connected fridge could identify recalled items placed into it.  

It  was  also  emphasised  that  consumers  may  sometimes  not  react  to  a  recall  alert,  even 
when properly informed. In such situations, different solutions could be explored:  

- 

- 

- 

the role of voice assistants to remind consumers of the need to act;  

the possibility to remotely switch off the unsafe product;  

asking consumers who failed to react to a recall whether they have stopped using 
the product or have disposed of it (such information could be asked e.g. in recall 
notifications sent by online marketplaces). 

Finally, the issue of products that are no longer in the hands of the initial buyer (e.g. gifts, 
second-hand  products)  was  discussed.  A  good  practice  could  for  recall  notification  to 
include  into  the  instruction  “If  you  have  given  or  sold  this  product  to  another  person, 
please forward them this message for their safety”.  

2.  Session 2: Strategies to increase consumers' response to recalls 

The aim of this session was to explore how recall communication and procedure can be 
improved to enhance consumer response.  

PRESENTATIONS  

UK  Office  for  Product  Safety  and  Standards  presented  the  interim  results  of  the  UK 
government research into consumer attitudes towards product safety. The study revealed 
that  only  17%  of  consumers  consider  product  safety  a  priority  when  purchasing  a 
product,  and 23% had registered a product  they  recently purchased. Overall, the results 
highlight  that  consumers  assume  products  are  regulated  and  safe,  and  are  therefore  not 
motivated  to  register  their  products.  The  study  has  also  identified  different  consumer 
profiles,  indicating  that  the  communication  should  be  adapted  to  reach  each  segment: 
"aware",  "busy  families",  "second-hand  shoppers",  "less  connected",  "quick  to  repair", 
"buy to last", "latest quality". 

Based on the research results and recent Whirlpool tumble dryer recall, some of the most 
important  elements  to  include  in  a  recall  notice  include  word  "safety"  in  the  title, 
photograph of the product, clear description of the hazard and instructions on what to do 
as  well  as  highlighting  the  incentive  (e.g.  free  replacement).  Finally,  methods  for 
communicating to hard-to-reach consumers should be considered.  

In March 2018, the UK government adopted a Guidance on Recalls (PAS 7100), which 
instructs  manufacturers,  importers  and  distributors  on  how  to  effectively  plan,  manage 
and  monitor  product  recalls.  The  second  part  aims  at  regulators  and  their  role  in 
monitoring  incidents  and  supporting  businesses.  The  guidance  will  be  reviewed  and 
updated, based on learnings from different product recalls. 

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The  Australian  Competition  and  Consumer  Commission  presented  the  findings  from 
Australian  research  into  the  Takata  airbag  recall.  The  Takata  recall  is  the  biggest 
compulsory recall in Australia's history, where 1 in 4 vehicles was affected by defective 
airbag  which  had  caused  26  deaths  worldwide.  A  communication  campaign  “A  faulty 
airbag can kill  you” was launched to alert consumers of the hazard. The research based 
on this recall case study focused on identifying the link between recall effectiveness and 
1)  different  communication  and  engagement  strategies,  2)  consumers'  socio-economic 
characteristics  and  3)  behavioural  biases.  The  findings  indicate  the  importance  of 
generating  initial  recall  awareness  through  mass  media,  and  following  up  with  direct 
notifications methods (with priority given to two-way channels). It is also crucial to reach 
out to the local areas where affected consumers live and communicating in the language 
they  speak.  Trusted  messengers,  such  as  community  organisations,  are  important  to  get 
the message across.  

The  French  General  directorate  for  competition,  consumer  policy  and  fraud  control 
(DGCCRF)  presented  the  actions  taken  by  the  French  government  to  improve  recall 
effectiveness  after  the  2018  Lactalis  infant  milk  formula  crisis.  In  this  particular  case, 
voluntary measures were not enough, so the Minister of Economy and Finance ordered a 
mandatory recall. The recall faced several effectiveness issues, both on the producer level 
(failure to correctly identify affected batches, to take effective measure and to withdraw 
all recalled products  from  the supply  chain) and on retail level  (some recalled products 
still on sale). As a follow-up to the Lactalis crisis, new legal remedies were adopted both 
in the food law (October 2018) and in the economic law (May 2019): 1) self-test reports 
showing  environmental  contamination  to  be  immediately  forwarded  to  authorities  2) 
increased  accountability  of  producers  and  retailers  during  withdrawals  and  recalls  3) 
centralised public recalls website. The latter will cover food and feed as well as non-food 
consumer products (except for pharmaceuticals and medical devices). The website will be 
linked  to  a  mobile  application  –  “Signal  Conso”  –  that  allows  consumers  to  report  any 
concerns (safety as well as economic and commercial).  

GROUP DISCUSSIONS  

GROUP 1: Content and format of a recall notice 

The  group  reflected  on  how  to  improve  the  content  and  visual  presentation  of  recall 
notices to make them more eye-catching and persuasive. 

The experts agreed that the message should be short, straight to the point and attention-
grabbing. Some argued that terms like 'important safety notice/warning' may actually be 
preferable to 'recall' in the headline. The risk needs to be communicated in a transparent 
and  understandable  way,  avoiding  "sugar-coating"  and  jargon.  If  relevant,  the  message 
should  be  translated  into  different  languages  so  that  it  reaches  consumers  in  their  own 
language. Since "a picture is worth a thousand words", product identification information 
should be accompanied by high-quality visual material. The idea of using a recognisable 
recall symbol was also mentioned. 

It  was  noted  that  standardising  the  content  and  layout  of  recall  announcements  has  the 
potential  to  make  them  simpler  and  more  easily  recognisable.  EBay  mentioned  their 
positive  experience  with  recall  messages  harmonisation.  However,  there  may  also  be 
downsides to standardisation: if recall notices become too similar, they may also be less 

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eye-catching and some products have a very specific target audience). It was agreed that 
some  key  elements  and  ground  rules,  applicable  to  all  recall  notices,  should  be 
standardised and compulsory. 

Moreover,  recall  messages  could  include  certain  behaviourally-informed  'nudges'  and 
persuasion  techniques,  such  as  social  proof,  loss  aversion,  reciprocity,  personalisation. 
For  instance,  appealing  to  social  norms  (i.e.  highlighting  that  the  majority  of  people 
engage in and/or approve of certain behaviour) has proved effective in other policy areas. 
If  using  statistics,  the  numbers  need  to  be  real,  yet  somehow  surprising  to  the  public 
(typically higher than expected). In cases when recall response rates are low, mentioning 
dynamic statistics (“increasingly many”) could be an option. Personalisation (e.g. adding 
a person's name to the message) has also been shown to encourage action but it is only an 
option when the consumer can be contacted directly. In addition, opportunity cost (i.e. the 
costs of not having corrective measures in place) could be highlighted in communication 
to help enhance consumers trust in the whole product safety system.  

There was  a broad  agreement that setting  up a centralised  government  recall portal  can 
provide a useful single access point for consumers. However, this should not remove the 
responsibility from businesses to spread the message through all possible channels.  

GROUP 2:  Communication channels 

The group agreed that the most appropriate communication channels to reach out to the 
affected consumers will depend on a number of factors. 

The age of the target audience is of crucial importance. While Facebook and Instagram 
are  key  to  reach  younger  consumer  groups,  traditional  media  such  as  TV  and  radio 
remain the preferred communication channels for older consumers.  

Language,  ethnicity  and  culture  were  identified  as  other  important  aspects  when 
elaborating  a  recall  campaign.  In  addition,  some  groups  may  require  very  targeted 
communication  approach,  e.g.  through  religious  communities.  Cultural  differences  also 
play  a  role.  As  an  example,  a  recall  carried  out  at  the  same  time  and  with  the  same 
communication material in a European country and in an Asian country resulted in very 
different response times.  

In addition, geography and how easy it is for consumers to return a recalled product also 
needs  to  be  taken  into  account.  An  example  of  a  producer  sending  help  to  remote 
communities to repair the product was mentioned. Such approach would also be helpful if 
the  product  is  too  heavy  to  be  brought/sent  back.  Another  solution  would  be  to  ask 
consumers  to  destroy  the  product  themselves  and  send  only  a  proof  of  destruction  to 
receive a remedy. 

Regardless of the specificities of the case and characteristics of the target audience, direct 
communication  with  individual  consumers  is  always  more  effective  than  blanket 
communication campaigns. According the US CPSC research, direct contact results in an 
average 50% return rate, compared to 6% in case of generic press releases. 

It was also highlighted that the channels should not be separated from the message itself. 
A recall notice should be formulated in a way that is attractive and understandable for the 
target  audience.  Otherwise,  it  will  not  motivate  action.  Consumers  should  get  clear 
information  on  the  risk  at  hand  and  instructions  on  what  to  do  with  the  product.    If 

154 

 
 
information is presented in a clear and transparent way, it may actually boost consumers' 
trust in the recalling company. 

Examples  of  communications  to  catch  consumers'  attention  and  motivate  response 
include  using  animals  or  icons  as  recall  ambassadors  (e.g.  the  US  campaign  with  a  cat 
riding a unicorn).  

Finally,  it  was  mentioned  that  the  communication  capacities  will  depend  on  the  size  of 
the company and its place in the supply chain. Bigger companies are usually more aware 
of the importance of recalls and have dedicated departments to deal with them. SMEs and 
start-ups face more challenges.  

GROUP 3: Recall procedure and remedies 

The main topic was how to increase consumer response to recalls, focusing on the recall 
procedure  itself.  While  acknowledging  that  the  “one-size-fits-all”  approach  is  not 
possible, participants recognised that all steps of the recall process should be as simple as 
possible  and  the  remedies  offered  should  be  sufficient  from  a  consumers'  perspective. 
Often, consumer inaction is due to the procedure to follow being too complex or difficult 
to understand, while the recall should be as easy as buying the product.  

To start with, a recall notice should be attractive and easy to understand for the consumer, 
providing  clear  information  that  a  product  he/she  bought  is  affected,  what  steps  to  take 
and where to get more information. It is crucial to adopt the consumers’ language in the 
recall  communication.  For  instance,  a  recent  IKEA  recall  in  Sweden  was  published  in 
Swedish, English and Arabic to reach also immigrant families. Effective communication 
also means using pictures in addition to text. 

Participants  emphasised  that  there  is  still  no  means  of  identification  for  many  recalled 
products,  and  suggested  that  some  identification  requirements  should  be  mandatory.  At 
the  same  time,  it  was  noted  that  multiple  model  names  and  codes  in  the  same  recall 
notification  may  be  confusing.  The  use  of  online  tools  would  be  one  solution  to  allow 
consumers to easily ascertain if their product is affected by a recall.  

The  setting  up  of  a  hotline  to  answer  to  consumers’  questions  on  a  recall  was  also 
identified as a good practice, even though it might not be possible for SMEs due to the 
costs involved.  

Participants  agreed  that  guidance  would  be  a  good  idea  to  help  businesses  navigate  the 
recall procedure, especially those that do not perform recalls on a regular basis. Having a 
timeframe for different  steps in  the recall procedure, following the UK example, would 
help  (even though, again,  the need for  a case-by-case approach should be stressed);  the 
same goes for standard responses. Overall, economic operators expressed their preference 
for a coordinated approach to recalls at the EU level. 

As for deadlines, the earlier a recall is published the better. However, this does not mean 
that the information about previous recalls should be removed. To increase recall’s speed, 
IKEA uses "risk  communicators", who send targeted messages early in  the stage of the 
recall process. They also keep a communication channel for consumers for any queries.  

Typically, businesses face a response peak (highest  number of returns) in  Month-2 (i.e. 
after 8 weeks), then they start “re-launching” the recall.  

When defining the remedies, it is important to adopt a holistic approach, taking account 
of both safety and environmental considerations. The type of product and the risk at stake 

155 

 
 
will also have an impact. Having large numbers of consumers bringing or sending back a 
product may not always be the most efficient and sustainable solution. It was noted that 
for  large  items  it  may  be  preferable  for  the  economic  operator  to  pick  up  the  recalled 
product  themselves  (even  though  for  SMEs  this  may  be  a  challenge).  For  low-value 
products, providing the information "danger: dispose of it" may be the best approach. In 
some cases self-repairs by consumers (under instruction) may be feasible, and could also 
help minimise consumers' fear of losing the product (which is a major barrier to product 
returns). The question is what burden can be placed on the consumer to return the product 
and under which circumstances and what type of products can be left in the consumers' 
hands  (for self-repair or disposal).  

Another  issue  is  how  to  take  account  of  reactions  other  than  returns.  It  would  be  very 
helpful to  introduce a  feedback mechanism, whereby the consumer could indicate  what 
they did in response to a recall (e.g. "I disposed of the product, I repaired it myself, I had 
it repaired by the manufacturer, I sent//brought it back to the manufacturer/retailer, I no 
longer own the product"). 

It was suggested that public authorities should play a more active role in communicating 
recall information to consumers as "trusted messengers". Official letters by the authorities 
with  a  reference  to  the  recalling  company  can  help  boost  consumers'  trust  and  increase 
response  rates.  Authorities  should  also  provide  support  to  businesses  in  designing  the 
most  efficient  recall  remedies  (businesses  often  go  for  the  least  expensive  solution).  In 
addition,  in  case  the  measures  taken  by  economic  operators  are  not  sufficient,  the 
authorities  should  step  in  and  support  businesses  in  designing  a  better  second  recall 
solution  to  avoid  "recall  fatigue".  Finally,  participants  pointed  to  the  need  for 
strengthened cooperation between authorities from different jurisdictions.  

Among  the  challenges  on  the  consumer  side,  participants  mentioned  specific  socio-
demographic  characteristics  (e.g.  consumers  with  disabilities  or  living  in  remote  areas) 
and  different  risk  perceptions.  For  instance,  informed  consumers  may  feel  less  risk-
averse. Some people may also try to repair a dangerous product on their own, the fear of 
loss  being  an  important  barrier  to  recalls.  Therefore,  it  is  important  to  adopt  a  flexible 
approach both to the communication and to the remedies.  

It  was  also  highlighted  that  recalls  can  be  particularly  difficult  if  other  people  can  be 
harmed by the unsafe product and not necessarily the buyer himself (e.g. cases where the 
product generates environmental pollution or poses a risk of fire). Incentivising people to 
take action in such cases may be particularly challenging. 

Financial incentives were considered useful, but  not  appropriate for  all products,  which 
again calls for a case-by case approach. The US CPSC recommends a “bounty” (refund 
of the product's initial price plus a little extra) in well-justified cases. Financial incentives 
and  fines  should  be  used  in  particularly  high-risk  cases  when  the  product  needs  to  be 
removed  from  homes  (e.g.  strollers)  or  when  other  means  do  not  work.  Financial 
incentives  should  be  used  intelligently  and  not  too  often  so  that  consumers  do  not  get 
used  to  "picking  the  best  offer".  The  case  of  a  recall  where  the  financial  incentive 
increased during the second wave was brought up; the risk could be that in future recalls, 
consumers would wait to act until the incentive has increased, which would be counter-
productive.    

Another  way  to  increase  consumers'  propensity  to  reply  to  a  recall  is  to  minimise  the 
effort  required  from  them.  This  could  include  product’s  collection  by  the  businesses 

156 

 
 
themselves,  repair  outside  of  business  hours,  or  “proposed  default  dates”  for 
repair/collection.  

Hasbro  mentioned  that  in  the  framework  of  their  programme  to  return  old  toys  for 
recycling,  consumers  have  two  possibilities,  i.e.  to  print  a  free-shipping  document  or 
leave the toys at a collect point at neighbourhood collection points (retailers). The latter 
solution,  which  is  similar  to  systems  used  to  recycle  medicines  and  batteries,  has  been 
found to be more effective. It was, however, noted that this solution may not be feasible 
for products bought online, if the retailer has no physical shop.  

3.  Session 3: Roles and responsibilities in the recall process 

The  objective  of  this  session  was  to  discuss  the  roles  and  responsibilities  of  different 
actors  involved  in  a  recall  process  and  how  to  improve  their  cooperation  to  optimise 
recall effectiveness. 

PRESENTATIONS 

US Consumer Product and Safety Commission (CPSC) and Health Canada gave a joint 
presentation on the benefits of regulators' proactive involvement in recall communication 
and recall coordination across jurisdictions. The CPSC shared their extensive experience 
of  collaborating  with  the  recalling  firm  on  defining  the  corrective  action  plan  before 
recall  announcement.  In  particular,  the  authority  and  the  recalling  firm  negotiate  the 
language  of  a  joint  press  release  and  other  recall  communications.  The  CPSC  is  also 
closely involved in monitoring the effectiveness of the recall (e.g. on the basis of monthly 
progress reports from the recalling firm). Moreover, product safety authorities in the US, 
Canada  and  Mexico  have  a  long-lasting  structured  cooperation,  which  includes 
coordinating important voluntary recalls across jurisdictions. Around a third of the 250-
300 recalls taking place in Canada each year are done jointly with the US. The benefits 
include  increase  in  consumer  participation,  leverage  from  other  regulators,  information 
sharing,  strengthening  cross-border  protection  of  consumers,  consistent  messaging  and 
reducing the burden on the industry. Health Canada explained their criteria for classifying 
recalls depending on the level of hazard and corresponding timelines for communicating 
recall  information.  Health  Canada's  Recalls  and  Safety  Alert  website  provides  single 
access point to all recall information. It also contains guidance for businesses on how to 
complete an effective voluntary recall. 

Goodbaby  International  explained  the  company's  internal  product  incident  management 
procedure  and  its  24/24/24  commitment  to  product  safety.  A  product  recall  may  be 
triggered  by  1)  critical  incidents,  2)  injury  reports  and/or  3)  test  failures.  The  analysis 
stage includes full understanding of the risk, possible solutions as well as implications in 
terms  of  logistics  and  project  management.  Depending  on  the  severity  of  the  case,  a 
decision is made to either continue safety campaign and prepare a product recall or close 
the campaign and transfer the case to 8D/quality management. The implementation phase 
consists in determining and developing the most effective overall procedure to "go live" 
with  the  recall,  The  legal  authority  is  also  updated  at  this  stage.  The  activation  phase 
includes  recall  communication,  administering  the  solution  to  all  products  in  the  market 
and storage as well as monitoring and reporting on the response rates. In the final stage, 

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the  safety  campaign  is  completed,  authorities  notified  of  the  outcome  and  lessons 
gathered for future incidents.   

Amazon  described  company's  product  recall  programme.  In  line  with  the  voluntary 
commitments made in the Product Safety Pledge (June 2018), authorities' recall websites 
and the EU Safety Gate are monitored on a daily basis and dangerous product listing are 
removed within 2 working days. The same deadline is applied to responding to authority 
contacts. Advanced search options are used to identify all affected products (e.g. in case a 
batch number is missing, image search may be used). Confirmed listings are immediately 
removed  from  sale  and  multilingual  key-word  based  filters  are  implemented  to  identify 
and  prevent  re-listing.  Tailored  messages  are  sent  to  suppliers  and,  if  required  by  the 
recall  type  and  scope,  to  individual  customers.  Physical  inventory  is  removed  from  the 
supply chain by returning the products to the supplier or destroying them. 

SGS  Digital  Trust  Services  talked  on  behalf  of  the  TIC  Council  about  the  impact  of 
cybersecurity  risks  linked  to  Internet  of  Things  (IoT)  devices  and  the  implications  for 
consumers,  manufacturers  and  regulators.  IoT  vulnerabilities  usually  affect  all  Member 
States  (as  compared  e.g.  to  food)  and  may  pose  a  wide  range  of  risks  to  consumers 
(including  fatal  safety  risks),  businesses  and  the  society  as  a  whole.  The  vulnerabilities 
may not be transparent for the manufacturers and the users or there may be technical or 
other challenges to fixing and patching them. The actions to be taken by consumers and 
manufacturers were discussed, including the possibility of reducing or switching off the 
devices  capacity  to  prevent  incidents.  The  implications  for  the  regulation,  surveillance 
and enforcement work were also examined. 

GROUP DISCUSSIONS 

GROUP 1: Roles and responsibilities of authorities  

The  Commission  announced  that  a  coordinated  activity  (CASP)  on  recalls  will  be 
organised next year and there are still some places available for EU market surveillance 
authorities to join.  

Different  authorities  shared  their  experiences  and  practices  regarding  product  recalls. 
From  the  discussions  held,  it  can  be  concluded  that  there  is  no  systematic  approach  to 
market  surveillance  authorities’  involvement  in  the  recall  process,  either  before  it  is 
launched  (e.g.  economic  operators  checking  with  the  authorities  whether  and  how  the 
recall should be carried out) or in monitoring the effectiveness of measures taken by the 
businesses.  

In some jurisdictions, such as the Australia, New Zealand, the UK and the US, specific 
rules  and  guidance  documents  have  been  issued  to  support  economic  operators 
(particularly smaller ones) in carrying out a successful recall.  

The jurisdictions that are more actively engaged in supporting the businesses in the recall 
process  emphasised  that  this  has  a  positive  impact  on  the  timeliness  and  effectiveness. 
This is confirmed by the comparative research carried out by the OECD Secretariat.  

The role of consumer associations was touched upon as well. Recalls may be triggered by 
test  reports  from  consumer  associations,  even  though  different  level  of  requirements  of 
tests  performed  by  authorities,  economic  operators  or  consumer  associations  may 
complicate  the  process.  Consumer  associations  tend  to  look  at  levels  of  safety  that  go 

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beyond legal regulations, so the authorities may not be able to use them as a direct basis 
for corrective measures.  

The possibility of joint recalls was also mentioned, based on the example of Canada and 
the US that have put in place a well-running system of bilateral and even trilateral (with 
Mexico) recalls. The benefits include greater consistency in the timing of the recall and 
the  remedies  offered  to  consumers.  These  joint  recalls  are  performed  on  a  voluntary 
basis: the company performing the recall must agree to this.  

The  discussion  concluded  with  the  suggestion  that  whenever  economic  operators  are  in 
doubt about how to conduct a recall, they should always contact the authorities.  

GROUP 2: Roles and responsibilities of businesses 

This  Group  discussed  what  businesses  could  do  to  make  product  recalls  easier  for 
consumers and increase their effectiveness.  

It  was  noted  that  bigger  manufacturers  tend  to  have  more  control  of  their  distribution 
channels and may thus be in a better position to manage recalls on their own. Distributors 
usually  do  cooperate  (depending  on  supply  chain  and  market  conditions).  Several 
participants agreed that there is a continuous flow of information between manufacturer 
(technical knowledge) and distributor (local market knowledge) to agree on the best way 
to  perform  recalls.  It  was  mentioned  that  manufacturers  may  prefer  to  take  over  the 
consumers’ mailing list, but distributors may be reluctant to make these available because 
of  data  protection  concerns  and  because  such  lists  are  an  important  marketing  tool. 
Participants  noted  that  traceability  can  be  an  issue  if  the  supply  chain  is  long  and 
complex.  

It was mentioned that authorities may need to step in, in particular in small countries or in 
case  of  SMEs  that  are  not  able  to  control  their  distribution  channels.  For  small 
companies,  a  recall  can  be  extremely  challenging-  not  just  because  of  the  reputational 
damage but also because of its financial impact. It was suggested that a possible solution 
could be to have insurances or emergency funds. 

Participants  representing  online  marketplaces  noted  that  they  are  a  different  actor  than 
“retailers” or “distributors”, as they do not have access to physical products. It was also 
mentioned that online marketplaces take different approaches to recalls, some companies 
taking  control  of the process  and approaching the buyers directly  and others requesting 
the sellers to reach out to their customers. An issue is that some sellers are not limiting 
their sales to one marketplace, and that they have no obligation to report back about recall 
results.  

Regarding communication, participants noted that guidelines would be beneficial for both 
businesses and consumers. However, such guidelines should remain general because each 
and every recall is different, and there is a need for flexibility.  

The  importance  of  monitoring  the  effectiveness  of  each  recall  action  was  clearly 
recognised.  IKEA  mentioned  their  internal  monitoring  system  per  country  (small  EU 
countries tend to be very fast to return while e.g. Japan is very slow). Businesses should 
create return statistics, as well as Q&A for internal use (not all the information gathered 
is needed by consumers). 

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