REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety
Date: 2021-06-30
Institutions: Directorate-General for Justice and Consumers, European Commission
Subjects: EU alert system, European standard, application of EU law, consumer goods, cross-border cooperation, exchange of information, harmonisation of standards, market supervision, product safety, traceability

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.6.2021  COM(2021) 342 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety      
 
 
Table of Contents 

1

INTRODUCTION ..................................................................................................................................... 1 

1.1

1.2

Scope of the report ....................................................................................................................... 2 

Overview ....................................................................................................................................... 2 

1.2.1

1.2.2

1.2.3

Objectives and scope of the Directive .................................................................................. 2 

Obligations of economic operators and Member State authorities ..................................... 3 

Institutional and enforcement aspects ................................................................................. 3 

2

Application and regulatory developments .......................................................................................... 4 

2.1

2.2

2.3

Safety of consumer products ........................................................................................................ 4 

Traceability .................................................................................................................................... 4 

Functioning of market surveillance ............................................................................................... 5 

2.3.1

2.3.2

2.3.3

2.3.4

2.3.5

Market surveillance cooperation with other public authorities and with customs ............. 5 

Joint action and coordinated activities of market surveillance authorities .......................... 6 

Recalls and other corrective measures ................................................................................. 6 

Injury databases .................................................................................................................... 7 

New regulatory developments related to market surveillance ............................................ 7 

2.4

Safety Gate/RAPEX and cross-border cooperation ....................................................................... 7 

2.4.1

2.4.2

2.4.3

Impact of COVID-19 .............................................................................................................. 8 

RAPEX guidelines ................................................................................................................... 8 

Training ................................................................................................................................. 9 

2.5

Standardisation ............................................................................................................................. 9 

2.5.1

2.5.2

2.5.3

Decisions on safety requirements and standardisation requests......................................... 9 

Decisions on references of standards .................................................................................. 9 

The standardisation process under the Directive and potential improvement ................. 10 

2.6

EU case law on issues related to the General Product Safety Directive ..................................... 10 

2.6.1

Measures based on Article 13 of the Directive ................................................................... 10 

3

CONCLUSIONS ..................................................................................................................................... 11 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  INTRODUCTION 
1

The  General  Product  Safety  Directive  (the  ‘Directive’)  was  adopted  on  3 December 2001,  it 
entered into force on 15 January 2002 and the deadline for its transposition by the Member States 
was 15 January 2004. 

The Directive applies to all non-food consumer products to the extent that there are no specific 
provisions  with  the  same  safety  objective  in  other  EU  legislation,  such  as  EU  harmonisation 
legislation  (hereafter  ‘harmonised  legislation’)  for  specific  products.  The  Directive  also 
establishes the EU Rapid Alert System (Safety Gate1/RAPEX), which enables quick exchange of 
information between EU/EEA Member States and the European Commission on measures taken 
on dangerous non-food products posing a risk to consumers and other users.  

The current health crisis has highlighted the importance of the Directive in providing a safety net 
for consumers, being one of the main pieces of legislation that help remove dangerous products 
(especially products such as face coverings, hand disinfectants and protective gloves). The Safety 
Gate/RAPEX  system  set  up  by  the  Directive  also  enables  authorities  to  take  swift  action  to 
protect the health and safety of consumers in the EU.  

Under  Article  19  of  the  Directive,  the  European  Commission  must  present  a  report  on  the 
implementation  of  the  Directive  to  the  Council  and  Parliament  every  three  years  following 
transposition.  The  first  implementation  report  was  published  in  2009.  The  Commission 
continued to monitor the implementation of the Directive in the Member States and presented its 
findings  in  the  impact  assessment  report  that  accompanied  the  Product  Safety  and  Market 
Surveillance Package in 2013. The impact assessment report, which included the results of data 
collection on implementation issues, was considered equivalent to  an implementation report. In 
view of the process to revise the Directive, the findings of this third implementation report were 
considered in the evaluation and subsequently in the impact assessment of the revised Directive. 

For the purpose of this report the Commission used the findings of the Study for the preparation 
of an implementation report of the General Product Safety Directive2. 

1.1

  Scope of the report 

This report was drawn up pursuant to Article 19(2) of the Directive and includes information on: 
• the safety of consumer products, in particular on improved product traceability; 
• the functioning of market surveillance and RAPEX; 
• standardisation;  
• the measures taken on the basis of Article 13 of the Directive. 

The  geographical  scope  of  this  report  covers  all  EU  Member  States  as  well  as  European 
Economic Area (EEA) countries: Iceland, Liechtenstein and Norway. It covers the period 2013-
2018 and, where available, data from 2019 and 2020 as well. 

1 Safety Gate is used to reflect the planned change of the name of the EU rapid alert system for non-food dangerous products (now RAPEX). 
2 https://ec.europa.eu/info/files/study-preparation-implementation-report-gpsd_en 

2 

 
 
                                                           
 
1.2

  Overview 

1.2.1

  Objectives and scope of the Directive 

The Directive requires all consumer products placed on the EU market to be safe.  It  applies to 
non-food consumer products that are not subject to specific EU legislation governing the safety 
of the products concerned. It is  also applicable to the safety aspects or  risks of products which 
are subject to specific safety requirements imposed by Union law, to the extent that the specific 
EU  harmonised  legislation  makes  no  specific  provisions  with  the  same  safety  objective.  The 
Directive therefore constitutes a safety net that ensures that all products and risks to consumers’ 
health and safety are covered by the safety requirement set by the Directive, even if they are not 
covered by any specific EU legislation.  

The Directive applies to all sales channels, offline and online.  

1.2.2

  Obligations of economic operators and Member State authorities 

The Directive establishes a general obligation on producers to only place on the market products 
that  are  safe,  and  to  provide  information  to  consumers  and  to  Member  State  authorities.  The 
producers  must  set  up  a  minimum  system  of  traceability  and  must  take  appropriate  corrective 
measures  in  the  event  that  dangerous  products  are  found  on  the  market,  such  as  action  to 
withdraw or recall the product. Distributors have a duty of care obligation to ensure compliance 
with the applicable safety requirements. 
Member State authorities must ensure that products  placed on the market  are safe and monitor 
compliance by producers and distributors with the obligations set by the Directive.   
The Directive doesn’t set  any specific direct  obligations on the online marketplaces.  It  may be 
noted that in accordance with Article 14 of Directive 2000/31, hosting service providers are not 
liable  for  the  information  stored  at  the  request  of  a  recipient  of  the  service,  on  condition  that 
upon obtaining actual knowledge or awareness of illegal activity or information, for instance by 
means  of  a  sufficiently  precise  and  adequately  substantiated  notice,  they  act  expeditiously  to 
remove or to disable access to the information. 

Given  the  increasing  role  that  online  marketplaces  play  in  the  current  supply  chain,  the 
Commission  facilitated  the  signature  of  the  Product  Safety  Pledge  (signed  by  11  online 
marketplaces to date), which is a set of voluntary commitments to improve the safety of products 
sold on these online marketplaces by third-party sellers. 

1.2.3

Institutional and enforcement aspects 

The  Directive  establishes  the  Rapid  Alert  System  for  non-food  consumer  products  (Safety 
Gate/RAPEX). This  system  enables the Commission and Member State  authorities to  circulate 
information on measures taken by Member State authorities and economic operators on products 
posing a serious risk to the health and safety of consumers. Information on less than serious risks 
can also be circulated under RAPEX (though this accounts for less than 1% of all notifications). 
The RAPEX system can be opened to non-EU countries on the basis of a specific international 
agreement signed between the EU and the applicant country. Under Article 15 of the Directive, 
the  Commission  implements  this  Directive  with  the  assistance  of  a  committee  composed  of 
representatives from the Member States (the ‘GPSD Committee’). In addition, Article 10 of the 

3 

 
 
 
Directive  sets  up  a  network  of  Member  State  authorities  with  the  aim  of  further  enhancing 
administrative cooperation (the ‘Consumer Safety Network’).  

Given  that  the  Directive  forms  part  of  the  EEA  Agreement,  the  same  rules  and  mechanisms 
apply to EFTA countries that apply the EEA Agreement: Norway, Iceland and Liechtenstein. 

  Application and regulatory developments 
2

2.1

  Safety of consumer products 

With  the  growing  share  of  e-commerce  and  emerging  new  technologies  (such  as  artificial 
intelligence, the internet of things, interconnected products), the definition of safety given in the 
Directive is being challenged in many ways. The Directive gives a definition of a safe product 
that is formulated widely enough to give rise to uncertainties about its interpretations. It does not 
explicitly  cover  risks  related  to  emerging  threats,  such  as  cybersecurity  risks,  software 
malfunction  or  risks  inherent  in  products  with  artificial  intelligence  or  machine  learning 
capabilities.  Consequently,  most  national  authorities  lack  interpretation  and  practice  related  to 
new technology products and have called for the development of guidance at EU level. 

Products  containing  new  technologies  pose  specific  difficulties  for  market  surveillance 
authorities, for instance, the lack of knowledge on possible risks that these products represent, or 
the need to clarify the responsibilities of different authorities/economic operators.  

Concerning  online  sales,  in  most  countries  market  surveillance  activities  are  conducted  mostly 
on  traders  located  in  their  own  country.  The  procedure  can  be  either  similar  to  that  used  for 
products  sold  in  physical  stores,  or  it  specifically  focuses  on  online  checks  of  online 
marketplaces. Authorities that carry out enforcement action on traders selling dangerous products 
and located in non-EU countries reported that they use the mechanism provided by the Product 
Safety Pledge.  

2.2

 Traceability 

Most Member States’ transposition legislation complies with the Directive in that they make it 
mandatory to indicate the name and contact details of the producer and a product reference or, 
where  applicable,  the  batch  number  on  products  or  packaging.  However,  application  of  these 
requirements is not uniform: it may vary according to the characteristics of the products, it may 
extend  the  obligation  beyond  the  producer,  or  require  additional  data,  and  these  differences 
create uncertainties for businesses operating across Europe.  

At  present,  the  Directive’s  provisions  on  traceability  are  not  sufficiently  explicit  to  ensure  the 
collection of complete information on product supply chains and distribution. The data available 
in the Safety Gate/RAPEX demonstrates that product traceability is often insufficient.  In 2019, 
36% of alerts for dangerous products lacked information about the manufacturer; 20% of alerts 
were for products of unknown brand or batch number/barcode; and 12% were for products with 
no type or model information.  

4 

 
 
 
Figure 1, based on alerts registered in the Safety Gate/RAPEX, shows that the only improvement 
in  the  availability  of  information  was  on  the  product  manufacturer  and  on  the  batch 
number/barcode (i.e. fewer alerts lacked this information). There is no clear trend indicating an 
improvement on other aspects of traceability information. 

Figure  1:  Share  of  Safety  Gate/RAPEX  alerts  with  unknown  product  information  (2013-2019)

Source:  Study  for  the  preparation  of  an  implementation  report  of  the  GPSD,  from  Safety 
Gate/RAPEX  data,  retrieved  in  January  2020  (calculation  on  basis  of  full  dataset,  number  of 
alerts concerning consumer products with serious risks 2013-2019). 

The same data also reveal that missing product information is more typical for specific types of 
products such as laser pointers, lighters, jewellery and decorative articles. These products all fall 
within  the  scope  of  the  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 essential to trace them. 

2.3

  Functioning of market surveillance 

The market surveillance system under the Directive appears to be operating under considerable 
resource constraints. In a 2018 evaluation of the product safety-related actions funded under the 
EU  Consumer  Programme3,  authorities  indicated  limited  staff/financial  resources  for  market 
surveillance and enforcement as a factor most frequently undermining the level of achievement. 
Also market surveillance of online markets poses issues, especially related to direct imports from 
outside the EU. 

3  

See  Civic  Consulting  (2018),  ex-post  evaluation  of  the  Consumer  Programme  2007-2013  and  mid-term  evaluation  of  the  Consumer 
Programme 2014-2020, Part 1 – Mid-term evaluation of the Consumer Programme 2014-2020 and European Commission. 

5 

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 
 
 
                                                           
2.3.1

  Market surveillance cooperation with other public authorities and with customs 

There  are  different  institutional  models  for  market  surveillance  at  the  national  level,  often 
characterised  by  a  high  degree  of  fragmentation  of  responsibilities.  Cooperation  between 
authorities – customs and other authorities included – comprises a whole range of activities such 
as information exchanges, regular meetings, informal cooperation and joint training courses. The 
improved  use  of  several  systems  such  as  the  Safety  Gate/RAPEX,  the  ICSMS4  and  the  Wiki 
confluence platform5 is great value added to the authorities’ work.  

Cooperation  between  market  surveillance  authorities  (hereafter  MSAs)  and  customs  is  very 
intense  and  regular  in  several  aspects  of  this  work.  In  most  countries,  customs  authorities 
conduct  checks  on  behalf  of  the  MSAs  without  being  a  market  surveillance  authority  in  their 
own right. Some countries6 take a different approach and designate the customs authorities as a 
MSA in its own right, so customs officials can take samples, have them tested and decide how to 
proceed further.  

  Joint actions and coordinated activities of market surveillance authorities 

2.3.2
The aim of joint actions and coordinated activities7 is to promote and coordinate cooperation for 
the  purpose  of  applying  Directive  2001/95/EC  and  ensuring  a  consistent  approach  to 
implementing  product  safety  legislation  across  the  internal  market.  This  typically  covers: 
coordinated  sampling  and  testing  of  non-food  products  found  on  EU/EEA  markets,  risk 
assessment,  exchange  of  expertise  and  best  practices  and  implementation  of  an  effective 
communication strategy.  

A high number of market surveillance authorities participate regularly in coordinated actions that 
has resulted in identifying a considerable number of dangerous products. To provide assistance 
to  the  Consumer  Safety  Network,  the  Commission  has  co-funded  14    joint  actions  on  market 
surveillance by these authorities during the reporting period. Most joint actions have resulted in 
the  identification  of  a  significant  number  of  dangerous  products,  leading  to  notifications  in 
Safety  Gate/RAPEX  for  13  categories  of  products.  The  ongoing  Coordinated  Activities  on  the 
Safety  of  Products  (CASP)  2020  and  CASP  2021  projects  likewise  follow  the  implementation 
approach  of  joint  sampling,  testing,  risk  assessment  and  best  practice  exchange  to  carry  out 
market surveillance actions in the EU/EEA Member States. 

2.3.3

  Recalls and other corrective measures 

Under Article 5(3) of the Directive, producers and distributors are required to immediately notify 
respective authorities in case  a product that they have placed on the market poses safety risks to 
the consumer.  

4  Information  and  Communication  System  on  Market  Surveillance:  ICSMS  represents  an  IT  platform  which  purpose  is  to  facilitate 

communication between market surveillance authorities in Europe. 

5 Wiki confluence is a web-based corporate collaboration software, widely used by market surveillance authorities. 
6 Finland, France and Latvia. 
7 Between 2008 and 2018, joint actions were funded and implemented by the European Commission’s Consumer Programme, under the category 
of  grant  agreements.  Since  2018,  the  implementation  modality  and  financing  of  joint  actions  was  replaced  by  a  procurement  framework 
funded fully by the European Commission. Currently they are called Coordinated actions on the safety of products. 

6 

 
 
                                                           
When  products  are  found  to  be  dangerous,  Member  States  must  ensure  that  they  are  recalled, 
withdrawn or prohibit their placing on their market, and they must also inform the Commission 
without  delay  via  the  Safety  Gate/RAPEX.  In  the  notification,  Member  States  provide 
information on the product and the measures adopted. Data from RAPEX contains 5 983 recalls 
covering 2013-2019 in  the EU/EEA, showing  an increasing trend. Recalls and other corrective 
measures are organised in practically all countries, both on a voluntary and a mandatory basis.  

Injury databases 

2.3.4
The  EU-funded  project  “European  Injury  Database”8  (IDB)  provided  some  data  on  product-
related injuries and accidents in the EU, but only a minority of Member States collected injury 
data systematically. 

The creation of online databases (comprising data related to statistics on dangerous products and 
injuries,  risk  assessment,  market  surveillance  history,  findings  and  fines)  could  provide  better 
information  for  businesses,  may  have  a  deterrent  effect  on  non-compliant  companies  and  may 
improve consumer warnings for dangerous products. There has also been a suggestion to create a 
system to collect data on product-related injuries, preferably at the EU’s initiative. 

2.3.5

  New regulatory developments related to market surveillance 

On 20 June 2019, Regulation (EU) 2019/1020 of the European Parliament and of the Council on 
market  surveillance  and  compliance  of  products  was  adopted,  amending  Directive  2004/42/EC 
and  Regulations  (EC)  No  765/2008  and  (EU)  No  305/2011.  This  Regulation  brings  in  new 
market surveillance provisions for products subject to EU harmonised rules, while  rules for non-
harmonised products are set by the Directive.  The majority of authorities and other stakeholders 
confirmed  that  having  different  rules  for  harmonised  and  non-harmonised  products  was 
problematic.  It  was  suggested  that  aligning  the  Directive  with  the  obligations  and  enforcement 
powers  detailed  in  the  harmonised  market  surveillance  legislation  would  facilitate  better 
enforcement action. 

The Notice on the market surveillance of products sold online9 sets out good practices for market 
surveillance of products sold online and for communication with businesses and consumers. The 
Notice  concerns  the  application  of  the  Directive  and  of  Regulation  (EC)  No  765/2008  and  it 
aimed to achieve a more uniform and coherent application of the rules governing products sold 
online. 

2.4

  Safety Gate/RAPEX and cross-border cooperation 

The  number  of  alerts  sent  to  the  Rapid  Alert  System  for  non-food  consumer  products  has 
increased  progressively  over  the  years,  remaining  above  2 000  alerts  a  year  since  2012.  The 
system circulated 2 243 alerts in 201910 and 2 253 alerts in 202011 across Europe.   

8 https://ec.europa.eu/health/sites/default/files/indicators_data/docs/idb_flyer_en.pdf 
9 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2017.250.01.0001.01.ENG, OJ C250,  1.8.2017, p. 1–19 
10https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/reports/docs/RAPEX.2019.report

.EN.pdf  

7 

 
 
 
                                                           
The Safety Gate/RAPEX is the key channel for market surveillance authorities to communicate 
and cooperate with their counterpart authorities in the EU/EEA. MSAs cooperate with authorities 
in  other  EU/EEA  countries  once  a  month  or  more  often  using  Safety  Gate/RAPEX  and 
frequently  using  other  tools  (ICSMS,  Wiki  confluence).  However,  there  are  delays  in 
notifications,  often  due  to  complex  market  surveillance  structures,  or  other  factors  such  as  the 
lack  of  testing  facilities  or  insufficient  human  or  financial  resources.  This  often  causes  delays, 
resulting in  a lag in  the notification period of an average of two weeks between detection of a 
dangerous product and notification in the system. Also the lack of sufficient information to trace 
notified products prevents authorities from taking action.  

In  line  with  the  reported  inconsistencies  of  risk  assessments,  additional  action  can  be  taken  to 
harmonise and improve risk assessment approaches of MSAs, building on current guidelines and 
tools12.  

On  the  basis  of  a  Memorandum  of  Understanding  signed  in  2006,  selected  information  on 
products originating from China and notified in RAPEX are shared with Chinese authorities for 
their follow-up. Chinese authorities then report back to the Commission on follow-up action. The 
administrative  arrangement  of  November  2018  also  enables  automated  exchange  of  selected 
information  on  dangerous  non-food  consumer  products  between  the  EU’s  Safety  Gate/RAPEX 
system and Health Canada’s RADAR system.   

2.4.1

Impact of COVID-19 

The  COVID-19  crisis  has  created  high  demand  for  protective  equipment  such  as  face  masks, 
medical  devices  and  hand  sanitisers.  As  regards  products  covered  by  the  Safety  Gate/RAPEX 
alert system,  Member States notified national measures taken against dangerous products linked 
to COVID-19, together with active market surveillance action on personal protective equipment, 
and online sales, particularly of masks. So far, over 200 RAPEX notifications on products related 
to the COVID-19 crisis (face coverings, hand disinfectants, gloves) have been made since March 
202013.  

2.4.2

  RAPEX guidelines  

In  order  to  improve  the  functioning  of  the  RAPEX  system,  under  Annex  II,  point  8  of  the 
Directive, the Commission must regularly update guidelines concerning the joint management of 
the  Rapid  Alert  System  by  the  Commission  and  the  Member  States.  Commission  Decision 
2010/15/EU  was  the  first  update  of  the  guidelines,  followed  and  repealed  by  Commission 
Implementing  Decision  (EU)  2019/41714.The  impact  of  the  revised  guidelines  is  visible  in  the 
following example: as from November 2018 the guidelines specified that if a chemical substance 
in a product is already banned or restricted under EU legislation, the product can be considered 

11 https://ec.europa.eu_safety_consumers_consumers_safety_gate_statisticsAndAnualReports_2020_RAPEX_2020_report_EN.pdf  
12 Study for the preparation of an Implementation Report of the General Product Safety Directive, 2020. 
13 Please note that this data is subject to change. 
14 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). 

8 

 
 
 
                                                                                                                                                                                           
to pose a serious risk without requiring a specific risk assessment. This guidance has facilitated 
the notification procedure on measures taken against dangerous chemical products. 

2.4.3

  Training  

Joint training courses are regularly organised involving multiple market surveillance authorities 
and also other authorities, such as customs. At EU level, training and sharing of best practices of 
market surveillance authorities include the E-enforcement Academy project, which was  carried 
out  between  December  2016  and  December  2019.  To  safeguard,  revise  and  update  all  project 
materials  and  components,  a  second  project  is  being  launched  in  2021.  Similarly,  it  aims  to 
provide, update and maintain high-quality training and learning materials to support the work of 
national consumer protection authorities and the network of authorities responsible for consumer 
product safety (Consumer Safety Network) with a view to create common tools and methods to 
tackle the challenges of online trade and e-enforcement. 

2.5

 Standardisation 

2.5.1

  Decisions on safety requirements and standardisation requests 

Commission  Decisions  EU  (2015)  547  and  EU (2014)  59  adopted  safety  requirements  for  two 
product  types:  alcohol-powered  flue-less  fireplaces  and  laser  products15.    Subsequently,  the 
standardisation  request  was  published  for  both  products  and  the  standardisation  work  is 
ongoing16. 

2.5.2

  Decisions on references of standards 

Over  the  reporting  period,  the  European  Commission  referenced  67  standards  under  the 
Directive for the following product types: 

stationary training equipment 

internal blinds 
lighters 

  gymnastic equipment 
 
  child use and care articles 
  bicycles 
 
 
  children's clothing  
 
  cigarettes (ignition propensity) 
  child protective products 
  audio, video and similar (safety requirements) 
 

floating leisure articles 

information technology equipment (safety - general requirements) 

15 In addition to the standards referenced, a number of standardisation requests under the Directive are active, of which some have already been 
issued before 2013. 
16 Commission Implementing Decisions C(2015) 8011 final and C(2015)557 final. 

9 

 
 
 
                                                           
In  2019,  17  standards  were  withdrawn  and  replaced  by  revised  standards17.  All  remaining 
standards were re-referenced and included in the Implementing decision, to create a complete list 
of references, as specified in recital 26 of the Implementing Decision. 

2.5.3

  The standardisation process under the Directive and potential improvement 

Article 4 of the Directive provides for a standardisation process consisting of four steps: 

1. the Commission issues a decision to set safety requirements to be met by the standard; 
2. the Commission issues a formal request to European standardisation organisation (ESOs) to 
develop standard(s); 
3. the ESOs develop a standard compliant with safety requirements; 
4. the Commission issues a decision on the referencing of the standard in the OJ EU. 

The  length  and  complexity  of  the  standardisation  process  inevitably  builds  delays,  and  is 
reported  as  burdensome  and  in  need  of  simplification.  Step  3  came  in  for  particular  criticism. 
The  procedure  of  drawing  up  a  European  standard  by  the  ESOs  is  subject  to  a  number  of 
requirements, such as the participation of all stakeholders, and the application of the consensus 
principle, which aims to reach unanimous agreement on the draft standard. Another general issue 
is that the procedure does not adapt to technical and scientific progress as fast as it should, while 
being based on a standardisation request (Step 2). Once this request is made, it may be overtaken 
by technical innovation rather quickly and this may become a problem if it takes a long time to 
develop the standard. This may lead to the standard becoming obsolete before being referenced. 
Proposals  from  stakeholders  to  streamline  the  standardisation  process  suggest  that  the  system 
could be made more efficient. Possible improvement could be achieved by dropping some of the 
steps, reducing the number of Commission  decisions involved, or reducing the time it takes to 
adopt a standardisation request (Steps 1 and 2), and to publish a standard and its referencing in 
the Official Journal (Step 4). The involvement of two different Committees with Member States 
representatives is considered by the different groups involved to be inefficient and burdensome. 

2.6

  EU case law on issues related to the General Product Safety Directive  

2.6.1

  Measures based on Article 13 of the Directive 

In some exceptional circumstances, Article 13 of the Directive allows the Commission to adopt 
temporary measures (valid for one year), via a decision, to eliminate a serious risk from certain 
products.  It  can  be  used  in  situations  where  the  Member  States  significantly  differ  on  the 
approach to managing the safety risk, and at the same time the risk must be managed with a high 
degree of urgency and can be eliminated only by adopting appropriate measures at EU level.  

The latest occasion the Commission applied the procedure under Article 13 of the Directive was 
on 9 August 2011, when it adopted a decision on the compliance of standard EN 16156:2010 and 
the assessment of the ignition propensity of cigarettes18.  

17 Commission Implementing Decision (EU) 2019/1698 of 9 October 2019. 
18 Commission Decision 2011/496/EU (OJ L 205, 10.8.2011, p.31-32). 

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  CONCLUSIONS 
3

The Directive has proven to be a powerful tool to ensure a high level of consumer protection. It 
has  helped  trace  and  remove  huge  volumes  of  dangerous  products  from  the  European  market. 
The RAPEX system, set up by the Directive, has complemented the regulatory framework that 
applies to some key consumer products, such as toys, childcare articles and electrical appliances, 
with a well-functioning rapid exchange and alert system.  

However,  the  Directive  was  adopted  at  a  time  when  new  technology  products  and  connected 
devices  were  rare,  which  is  no  longer  the  case.  Such  developments  challenge  the  current 
definition  of  product  safety  and  bring  new  risks  or  change  the  way  existing  risks  could 
materialise  (for  example  cybersecurity  affecting  product  safety),  and  these  risks  must  be 
reflected and duly taken into account. Further challenges stem from the growing scale of online 
sales, with new operators selling products online. The Directive should ensure the same level of 
product safety, irrespective of the channel that they are sold to consumers.  

The purpose of Article 5(1) of the Directive is that, in the event of a safety problem, dangerous 
products present on the market can be traced and swiftly removed if necessary to avoid putting 
consumers at risk. The Directive does not further specify the traceability requirement, and there 
are differences in detail as to how the rules are applied in the Member States. Particularly in the 
context of online sales, the lack of information on how to trace products and producers remains a 
practical  problem  for  enforcement  authorities  and  certain  economic  operators.  An  analysis  of 
RAPEX  data  confirms  that  certain  product  categories  are  over-represented  among  dangerous 
products  in  that  they  lack  at  least  two  of  three  key  information  items  needed  for  traceability 
(brand, type/number of product, batch number/barcode). 

Market surveillance under the Directive has been successful, as indicated by the steady number 
of over 2 000 RAPEX notifications per year.  Nevertheless, in an increasingly global market with 
more  and  more  products  coming  to  the  EU  from  non-EU  countries,  there  is  a  need  for  further 
coordination of market surveillance activities between the Member States, including cooperation 
with customs authorities. Coordination could be stepped up further by improving the exchange of 
information  and  best  practice  between  Member  State  authorities,  and  by  taking  measures  to 
increase  institutional  and  financial  capacity.  Enhancing  the  overall  framework  and  providing 
appropriate tools (especially tools to aid online market surveillance) would considerably increase 
effective enforcement by the authorities. 

The  European  Commission  provides  for  the  development  of  European  standards  to  make  the 
general  safety  requirement  more  operational.  However,  given  the  length  of  the  standardisation 
process  under  the  Directive,  there  is  a  considerable  lag  between  the  start  and  the  end  of  the 
standardisation process. During this period, there is a lack of criteria to assess product safety and 
a resulting uncertainty for economic operators and market surveillance authorities. 

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