Report from the Commission to the European Parliament AND to 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: 2009-01-14
Institutions: European Commission
Subjects: European standard, consumer protection, marketing, product safety, report

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.1.2009 
COM(2008) 905 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
TO 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  

(presented by the Commission) 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

2. 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

3.6. 

4. 

4.1. 

4.2. 

4.3. 

4.4. 

4.5. 

4.6. 

4.7. 

Introduction ................................................................................................................ 3 

Scope of the Report...................................................................................................... 3 

Overview ...................................................................................................................... 3 

Transposition .............................................................................................................. 5 

Application and Regulatory Developments ............................................................. 5 

Functioning of Market Surveillance............................................................................. 5 

Functioning of RAPEX ................................................................................................ 6 

Traceability of Products ............................................................................................... 8 

Community Measures based on Article 13 of the Directive ........................................ 9 

Standardisation........................................................................................................... 10 

Safety of Services....................................................................................................... 12 

Conclusions ............................................................................................................... 12 

General ....................................................................................................................... 12 

Transposition.............................................................................................................. 13 

Functioning of Market Surveillance........................................................................... 13 

Functioning of RAPEX .............................................................................................. 13 

Traceability of Products ............................................................................................. 13 

Community Measures based on Article 13 of the Directive ...................................... 14 

Standardisation........................................................................................................... 14 

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1. 

INTRODUCTION 

The General Product Safety Directive (the "Directive")1 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.  It  replaced  an  earlier  General  Product  Safety  Directive  dating 
from 19922.  

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; 

•  functioning of market surveillance and RAPEX; 

•  standardisation ; 

•  measures taken on the basis of Article 13 of the Directive. 

Although the Directive does not apply to the safety of services, some of its provisions focus on 
this area to ensure "the attainment of the protection objectives" of the Directive. This Report will 
therefore also present the main developments towards safer services in Europe.  

In 2007, further to massive recalls of consumer products worldwide, a Commission internal 
review3 of the EU product safety framework concluded that the Community system, including 
this Directive, is capable of providing to European citizens a high level of protection against 
unsafe consumer products4, as long as the rules of the system are properly applied. The review 
nevertheless  identified  some  areas  for  improvement  and  the  adoption  of  the  Commission 
Decision on magnets in toys5 was a direct follow up to this review. Furthermore, the proposal 
for revising the current European Directive on the safety on toys6, and the "New Legislative 
Framework"7 for the marketing of goods will raise the existing level of protection. This report 
also identifies further scope for perfecting the system created by this Directive. 

1.2. 

Overview  

1.2.1.  Objectives and Scope  

The purpose of the Directive is to ensure that only safe consumer products are placed 
on  the  Community  market.  The  Directive  applies  to  non-food  consumer  products. 
Where  such  products  are  subject  to  specific  safety  requirements  imposed  by  other 

1 

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3 
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5 
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Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  of  3  December  2001  on  general 
product safety, OJ L 11, 15.1.2002, p. 4. 

OJ L 228, 11.8.1992, p. 24. 

http://ec.europa.eu/consumers/safety/news/stocktaking_%20execsum_en.pdf 

http://ec.europa.eu/consumers/strategy/docs/eurobar_298_summary_en.pdf 

See Section 3.4 

COM (2008) 9 and: http://ec.europa.eu/enterprise/toys/2008_108_directive.htm  

See Section 3.1.2 and: http://ec.europa.eu/enterprise/newapproach/index_en.htm 

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Community  legislation,  the  Directive  applies  only  to  those  aspects  and  risks,  or 
categories of risks that are not covered by those specific requirements8.  

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 for use 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 or sun beds in solariums, are subject to 
the provisions of the Directive9.  

1.2.2.  Obligations of Economic Operators and Member States' Authorities 

The Directive establishes a general obligation on economic operators to place only safe 
products on the market, and to provide information to consumers and the Member States' 
authorities. This information shall refer to products' traceability, and the application of 
measures, such as product withdrawal or recall. 10 

Member States' authorities must ensure that products placed on the market are safe and 
they  must  fulfil  this  obligation  by  monitoring  compliance  by  producers  and 
distributors with the obligations that the Directive places upon them.  

1.2.3. 

Institutional and Enforcement Framework 

The  Directive  provides  for  the  Rapid  Alert  System  for  non-food  Consumer 
Products ("RAPEX"). This system establishes the circulation of information among 
the Commission and Member States' authorities of information 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 RAPEX (less than 1% of all notifications). The RAPEX 
system  remains  open  to  third  countries  on  the  basis  of  a  specific  agreement  signed 
between  the  Community  and  the  applicant  country.  So  far  only  one  non-EU  state 
(China) has received a partial and indirect access to RAPEX data. 

Pursuant  to  Article  15  of  the  Directive,  the  Commission  is  assisted  in  its 
implementation tasks by a Committee composed of representatives from the Member 
States  (the  "GPSD  Committee").  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"). 

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For a guide clarifying the application of the Directive and the directives covering the safety of sector 
specific products see http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm 

See the Opinion of the Scientific Committee on Consumer Products (SCCP) at: 
http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.htm#3  

Guidelines for economic operators, Commission Decision 2004/905 (OJ L 381, 28.12.2004, p. 63) 

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Given that the Directive forms part of the EEA Agreement11, the same rules and 
mechanisms are also in place in the EFTA countries applying the EEA Agreement, 
i.e. Norway, Iceland and Liechtenstein. 

2. 

TRANSPOSITION  

Transposition  measures  have  been  notified  by  all  27  EU  Member  States.12 
However,  the  method  of  implementation  has  not  been  the  same  in  all  Member 
States13. Bilateral discussions between the Commission and the Member States are 
still ongoing to clarify certain aspects. 

In  particular,  the  safety  assessment  aspects  differ  in  some  transposition  acts  from 
the  rules  laid  down  in  Article  3  of  the  Directive.  Some  Member  States  have  not 
transposed  all  the  criteria  listed  in  Article  3,  while  other  Member  States  have 
modified such criteria or developed their own ones.  

As far as traceability is concerned, some Member States have made it obligatory to 
indicate  on  the  product  or  packaging,  the  identity  and  details  of  the  producer  (or 
importer) , while other Member States have left it optional. Consequently, producers' 
obligations can differ in practice from one Member State to another.  

In  some  Member  States,  notification  by  producers  is  required  only  in  the  case  of  a 
known risk, and there is no obligation to notify when the producer "ought to know" 
the risk based on available information.  

Finally,  although  the  Member  States  are  obliged  to  lay  down  provisions  to  comply 
with measures that the Commission can adopt under Article 13, some Member States 
have  not  laid  down  dedicated  national  provisions  designed  to  implement  such 
measures.  

3. 

APPLICATION AND REGULATORY DEVELOPMENTS 

3.1. 

Functioning of Market Surveillance  

Most  market  surveillance  authorities  in  the  Member  States  work  on  the  basis  of  annual 
inspection programmes which take into account previous experiences and findings, 
products  that  are  frequently  notified  through  the  RAPEX  system  and  consumer 
complaints. If necessary, all Member States carry out controls and tests which are not 
necessarily covered by their programming, for example in emergency situations. 

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Decision 9/2003 (OJ No L 94, 10.4.2003, p.59)  

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:72001L0095:EN:NOT 

A comparative transposition inventory can be found at: 
http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm 

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3.1.1. 

Joint Actions 

To  promote  a  European  network  of  Member  States'  product  safety  authorities14,  the 
Commission has co-funded several joint cross-border surveillance and enforcement 
actions  between  these  authorities15  during  the  past  five  years.  These  joint  actions 
have  covered  suffocation  accidents  involving  children,  safety  of  playground 
equipment, cigarette lighters, lighting chains and cord extension sets. Two actions 
address  cross-border  cooperation:  one 
is  on  collaboration  with  customs 
authorities  in  the  Baltic  Sea  Region  and  the  other  one,  known  as  the  "EMARS" 
project, is aimed at enhancing market surveillance through best practice. This last 
project  involved  15  Member  States  and  resulted  in  the development of a knowledge 
base, a rapid advice system, a best practice handbook and a strategy document on the 
future of market surveillance16.  

3.1.2.  New Legislative Framework  

On 9 July 2008 a new legislative framework for the marketing of products consisting 
of Regulation (EC) No. 765/200817 and Decision 768/2008/EC18 were adopted. One 
of  the  objectives  of  these  measures  is  to  establish  a  reinforced  market  surveillance 
framework  for  products  covered  by  Community  harmonisation  legislation  and 
traceability of products. Furthermore, the Regulation lays down the obligation for the 
competent  authorities  of  the  Member  States  to  carry  out  appropriate  checks  on  the 
characteristics of products on an adequate scale on the EU market and before those 
products  are  released  for  free  circulation.  The  Commission  is  currently  preparing 
guidelines  to  clarify  the  relationship  between  the  market  surveillance  framework 
under the Regulation and the Directive.  

Besides,  Article  42  of  the  Regulation  (EC)  No.  765/2008  modified  the  wording  of 
Article  8(3)  of  the  Directive  to  render  these  provisions  more  stringent  for  the 
Member  States  and  align  the  wording  of  the  Directive  with  the  provisions  of  the 
Regulation. 

3.2. 

Functioning of RAPEX 

3.2.1.  Circulating Alerts on Dangerous Products 

The RAPEX system is designed to ensure efficient dissemination of information to all 
Member States to allow rapid action to be taken against consumer products that are 
detected  on  the  market,  which  present  serious  risks  to  the  health  and  safety  of 
consumers.  To  deal  with  so-called  "emergency  situations",  mechanisms  in  place 
ensure that the alert information is immediately circulated to all Member States for 
follow-up.  

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Article 10 of the Directive; and, for budgetary aspects, see Decision 1926/2006 (OJ L 404, 30.12.2006, 
p. 39) 
http://ec.europa.eu/consumers/safety/projects/index_en.htm#ongoing_projects 

http://www.emars.eu/ 

OJ L 218, 13.8.2008, p. 30 

Ibid., p. 82 

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The Commission services publish relevant information concerning all RAPEX notifications 
weekly on the Internet19. 

3.2.2.  RAPEX Guidelines  

In  2004  the  Commission  adopted  specific  guidance  ("the  RAPEX  Guidelines")  to 
ensure the efficient operation of RAPEX20. The RAPEX Guidelines define the scope of 
the Member States' duty of  notification  by  describing  the  criteria  which  apply  to  the 
definition of "serious risk", and by providing guidance on the types of measures and 
products  to  be  notified.  They  also  contain  risk-assessment  guidelines.  In  2008,  the 
Commission started the revision of the RAPEX Guidelines, which is necessary in the 
light of the due to various developments which have taken place since 2004.  

3.2.3. 

Statistical Trends 2004-2008 

The number of notifications validated by the Commission has risen steeply in recent 
years.  In  2007,  the  Commission  validated  1605  notifications,  compared  to 1051  in 
2006, 847 in 2005 and 468 in 2004. The number of measures notified in which a serious 
risk was involved has more than tripled, up from 388 in 2004 to 1.355 in 2007. This 
upward trend has continued in 2008. The increase in the number of notifications can 
be attributed to the more effective enforcement of product safety by the Member States 
authorities,  increased  awareness  of  their  responsibilities  on  the  part  of  business,  the 
successive  enlargements  of  the  EU  in  2004  and  2007,  as  well  as  the  network 
building measures coordinated by the Commission21. Moreover, the gap between the 
countries  with  the  highest  and  lowest  number  of  notifications  is  becoming  ever 
narrowed.  

As  regards  the  categories  of  products  which  are  subject  to  corrective  measures 
owing  to  the  seriousness  of  the  risks  involved,  articles  intended  for  children  (toys 
and  children's  equipment)  and  electrical  products  (e.g.  domestic  appliances,  lighting 
equipment) are the product groups for which the highest number of notifications have been 
issued;  collectively,  these  product  groups  account  for  over  50%  of  all  RAPEX 
notifications.  

The  most  common  risks  observed  have  been  injury,  choking  and  electric  shock, 
followed by burns, fire, suffocation and chemical risks. Long-term risks, such as those 
arising  from  exposure  to  certain  chemicals,  are  more  difficult  to  detect  and  assess 
because the hazardous effects are not immediately evident22. 

The number of notifications of voluntary corrective measures taken by businesses has 
increased over the years: in 2007, it reached 50% of the total number of notifications of 
products posing a serious risk  

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21 
22 

http://ec.europa.eu/consumers/safety/rapex/index_en.htm  The  importance  of  this  information  portal  is 
shown by the average of 35.200 monthly visits it had in 2007. 

Commission Decision 2004/418/EC (OJ L 151, 30.4.2004, p. 84) 

http://ec.europa.eu/consumers/safety/rapex/stats_reports_en.htm 

The  Commission  has  developed  an  on-line  exposure  assessment  toolbox  to  improve  coherence  in  risk 
assessment:http://www.jrc.ec.europa.eu/eis%2D chemrisks/) . 

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3.2.4.  Training 

The  Commission  has  organised  training  sessions  for  Member  States'  authorities  in 
charge  of  product  safety,  aimed  at  strengthening  their  capacity  to  participate  in  the 
RAPEX  network.  In  2006-2008,  a  total  of  22  Member  States  benefited  from  these 
seminars.  The  Commission  also  hosts  meetings  of  RAPEX  contact  points  in 
Brussels. In addition, customs and market surveillance authorities from all Member 
States  agreed  on  the  need  of  enhanced  cooperation,  improvement  of  risk 
management and better sharing of knowledge and best practices23. 

3.2.5.  RAPEX-China 

Given the very high proportion of RAPEX notifications relating to products of Chinese 
origin (as high as 56% between January and September 2008, 52% in 2007,  49%  in 
2006,  49%  in  2005  and  38%  in  2004),  relations  with  the  Chinese  authorities  on 
product  safety  have  been  intensified.  In  January  2006,  the  Commission's  Directorate-
General  for  Health  and  Consumers  and  the  Administration  for  Quality  Supervision, 
Inspection and Quarantine of the People’s Republic of China ("AQSIQ") signed a 
Memorandum  of  Understanding  ("MoU").  The  MoU  was  updated  in  November 
2008 to reflect the strengthened cooperation.  

AQSIQ has access via a dedicated IT-system to notifications of dangerous products of 
Chinese  origin  registered  under  RAPEX  ("RAPEX-China").  The  Chinese  authorities 
report to the Commission quarterly on the follow-up actions taken on the basis of the 
RAPEX data. So far, AQSIQ has submitted seven reports to the Commission. Between 
September 2006 and May 2008, AQSIQ has investigated and, where necessary, taken 
measures in relation to 599 RAPEX notifications. In 51% of the cases, investigations 
resulted  in  the  adoption  of  preventive  or  restrictive  measures  either  by  AQSIQ  or 
voluntarily  by  the  Chinese  manufacturer  (or  exporter):  these  included  corrective 
measures, export bans, strengthened supervision of the Chinese companies concerned 
and the suspension or withdrawal of export licences. In 49% of the cases investigated, 
no measures were taken, mainly owing to the lack of available information about the 
Chinese manufacturer or exporter.  

3.3. 

Traceability of Products 

Traceability  serves  to  identify  economic  operators  involved  in  the  production  and 
distribution  process.  With  this  information,  corrective  measures  can  be  put  in  place 
effectively.  High-profile  alerts  on  non-food  consumer  goods  worldwide  have  recently 
highlighted  the  need  for  effective  recall  procedures  which  are  not  excessively  costly 
for economic operators.  

Article 5(1) of the Directive contains general obligations for producers to provide 
consumers  with  the  necessary  information  for  tracing  the  origin  of  a  product  or  to 
display the identity of the producer or details of the production batch on the packaging of 
the product. Nevertheless, it is up to the Member States to adopt concrete measures to 
implement  such  obligations.  The  number  of  notifications  in  which  the  product  was 
untraceable has decreased in comparison with previous years. However, as products that 

23 

Conclusions  of  the  Seminar  "Preventing  Imports  of  Dangerous  Products",  April  2008,  funded  by  the 
Customs 2013 Programme.  

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pose  a  serious  risk  and  whose  country  of  origin  is  unknown  account  for  10%  of 
notifications24, there is still room for improvement.  

Further  improvements  can  be  expected  as  a  result  of  the  recently  adopted  Decision 
768/2008/EC,  which  requires  the  indication  of  the  name  and  the  address  of  the 
manufacturer and, for imported products, both the importer and the manufacturer, as a 
general principle for Community harmonisation legislation.25  

3.4. 

Community Measures based on Article 13 of the Directive 

To  date,  the  Commission  has  applied  the  procedure  provided  for  in  Article  13  of 
the  Directive  on  three  occasions.  Firstly,  it  was  used  to  extend  the  ban  on 
phthalates in toys26 during the period up to the adoption of the permanent ban under 
Directive 2005/84/EC.27 

The next measure based on this Article was the Decision of 11 May 200628 requiring 
Member  States  to  ensure  that  cigarette  lighters  placed  on  the  EU  market  are  child-
resistant and to prohibit the placing on the market of lighters which resemble objects 
that  are  particularly  attractive  to  children  (so-called  "novelty  lighters").  Lighters 
fulfilling  certain  technical  criteria  are  excluded  from  the  scope  of  the  Decision. 
Member States were required to comply with the Decision by 11 March 2007 at the latest. 
The  Decision  was  prolonged  until  11  May  2008  by  a  Decision  of  12  April  200729, 
which  also  prohibited  the  supply  to  consumers  of  non  child-resistant  and  novelty 
lighters as of 11 March 2008. A further prolongation, until 11 May 2009, was adopted 
on 18 April 200830  

The  most  recent  measure  based  on  Article  13  was  the  Decision  of  21  April  200831 
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 the intestines. In the 
absence  of  dedicated  provisions  in  the  current  legislation  and  in  the  relevant  safety 
standard  (both  undergoing  revision),  the  Commission  adopted  this  temporary  measure 
which is valid until 21 April 2009.  

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27 
28 
29 
30 

31 

Situation 
http://ec.europa.eu/consumers/safety/rapex/stats_reports_en.htm 

in  September  2008, 

source:  RAPEX 

statistics 

January  –  September  2008. 

Decision 768/2008/EC, Annex I, Articles R2(6) and R4(3) 

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)  

Directive 2005/84/EC (OJ L 344, 27.12.2005, p. 40) 

Commission Decision 2006/502/EC (OJ L 198, 20.7.2006, p. 41) 

Commission Decision 2007/231/EC (OJ L 99, 14.4.2007, p. 16) 

Commission Decision 2008/322/EC (OJ L 109, 19.4.2008, p. 40). A working group of experts from the 
customs and the market surveillance authorities of the Member States has been set up to improve the 
coordination of control activities. 

Commission Decision 2008/329/EC (OJ L 114, 26.4.2008, p. 90)  

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The  application  of  measures  under  Article  13  of  the  Directive  has  shown  that  the 
temporary nature of these measures is a cause of concern. On the one hand the limited 
validity of these measures and their repeated renewals cause uncertainty for economic 
operators.  On  the  other  hand,  because  these  measures  are  temporary,  they  cannot 
eliminate the root-cause of the safety problem concerned. 

3.5. 

Standardisation  

3.5.1.  Procedure and Relevant Actors 

The  Directive  lays  down  criteria  for  assessing  product  safety,  in  the  absence  of 
Community  legislation  referring  to  national  legislation  and  to  European  standards 
developed  by  the  European  standardisation  organisations  ("ESOs")32.  According  to 
Article 3(2), a product is presumed to be safe when it conforms to voluntary national 
standards transposing European standards whose references have been published in the 
Official Journal of the European Union ("OJEU"). 

Under  the  terms  of  Article  4,  the  Commission  adopts,  by  comitology  procedure, 
Decisions specifying the safety requirements which the future standards should reflect. 
Subsequently, based on the above-mentioned Decision, the Commission issues mandates 
to the relevant ESO, to develop standards which satisfy the specific safety requirements. 

Once  a  standard  is  drawn  up  and  adopted  by  an  ESO,  the  Commission  takes  a 
Decision -under the comitology procedure- confirming that the standard was drafted in 
compliance  with  the  procedure  referred  to  above  and  it  publishes  the  reference  of  the 
standard  in  the  OJEU.  This  publication  confers  on  the  products  manufactured 
according  to  that  standard  (or  its  equivalent  national versions) the presumption of 
conformity with the general safety requirement of the Directive under Article 3(2).  

The  initial  Decision  determining  the  specific  safety  requirements  does  not  create,  as 
such, either a presumption of safety for products complying with the said requirements, 
or  an  immediately  applicable  set  of  obligations  and  rights  for  third  parties. 
Nevertheless,  these  Decisions  can  be  used  as  an  additional  tool  to  assess  whether a 
product  is  in  conformity  with  the  general  safety  requirement  under  Article  3(3)  of  the 
Directive.  

the 

interests  represented 

Regarding 
in  standard-making,  access  and  effective 
participation  of  societal  interests  in  the  standardisation  process  can  be  hampered  by 
many  factors  such  as  lack  of  resources,  insufficient  expertise  and  ineffective 
coordination.  This  is  why  the  Commission  grants  financial  support  to  consumer  and 
environmental organisations, as well as to trade unions and SMEs. As far as consumer 
representation is concerned, the Commission contributes financially to the functioning of 
the 
European  consumer  organisations  which  represent  consumer 
development of standards for products and services at Community level33.  

interests 

in 

32 

33 

CEN (European Committee for Standardisation), CENELEC (European Committee for Electro-technical 
Standardisation), and ETSI (European Telecommunications Standards Institute). See also: 
http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/stdbody.html 

For more information: http://ec.europa.eu/consumers/tenders/information/grants/support_en.htm 

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3.5.2.  Decisions on Safety Requirements and Mandates 

During  the  period  covered  by  this  report,  three  Decisions  laying  down  safety 
requirements were taken, and corresponding standardisation mandates were issued 
pursuant to points (a) and (b) of Article 4(1).  

On  21  April  2005,  the  Commission  adopted  Decision  2005/323/EC  on  the  safety 
requirements to be met by the European standards for floating leisure articles for use 
on  or  in  the  water34.  On  the  basis  of  that  Decision,  the  Commission  issued  mandate 
M/372 to CEN. Seven standards is being developed under this mandate35.  

On 25 March 2008, the Commission adopted Decision 2008/264/EC on the fire safety 
requirements  to  be  met  by  European  standards  for  cigarettes36.  On  the  basis  of  that 
Decision,  the  Commission  sent  mandate  M/425  to  CEN  to  develop  a  standard  to 
reduce the ignition propensity of cigarettes. 

On  23  April  2008,  the  Commission  adopted  Decision  2008/357/EC  on  specific  child 
safety requirements for lighters37. This resulted in mandate M/427 to revise the existing 
standard EN 13869 on child resistance for lighters.  

3.5.3.  Publication of References of Standards  

During the reporting period, the Commission adopted three decisions on the compliance 
of  certain  standards  with  the  general  safety  requirement  of  the  Directive38.  These 
decisions were adopted in accordance with second and fourth subparagraph of Article 
4(2)  of  the  Directive.  Each  publication  replaced  the  previous  one  of  its  kind; 
therefore the updated list of standards referenced under the Directive is the one annexed 
to the most recent publication in 200639. 

3.5.4.  Preparation of Future Standardisation Mandates 

The Commission plans to improve the safety of childcare articles, intended for babies 
and  very  young  children  (generally  from  birth  to  4-5  years)  to  accompany  their 
sleep,  feeding,  bathing  and  transportation.  Numerous  accidents,  sometimes  fatal, 
involving  these  products  take  place  every  year  in  Europe40.  Under  the  Directive, 
several safety standards for childcare articles have  been published.  However, there 
are many products for which there are still no safety standards, while in the case of 
other products the existing standards do not cover all the risks. A study commissioned in 
2006  has  enabled  the  identification  and  ranking  of  a  list  of  products  for  which 
standardisation should be launched as a priority. The study includes a preliminary risk 

34 
35 
36 
37 
38 

39 
40 

OJ L 104, 23.4.2005, p. 39 

See www.cen.eu 

OJ L 83, 26.3.2008, p. 35 

OJ L 120, 7.5.2008, p. 11 

Decision of 23 April 2004, C(2004)1493 (not published), Decision 2005/718/EC (OJ L 271, 15.10.2005, 
p. 51), and Decision 2006/514/EC ( OJ L 200, 22.7.2006, p. 35) 

Commission communication 2006/C 171/04, (OJ C 171, 22.7.2006, p. 23) 

Injuries of children (0-14 years), data 2002-2004. See https://webgate.ec.europa.eu/idb  

EN 

11 

   EN 

 
                                                 
assessment,  and  draft  safety  requirements.  The  Decisions  laying  down  the  safety 
requirements are due to be adopted in the course of 2009.  

In the area of accidents and injuries due to fires and flames, the Commission continues to 
develop  its  strategy  to  improve  the  fire  safety  of  residential  environments.  The 
Commission  is  looking  at  ways  of  improving  the  safety  of  flammable  surfaces  and 
materials used in homes, such as furniture, furnishings, clothing and TV sets. There 
are a number of European voluntary standards in this area, but discussions with the 
Member  States  have  made  it  clear  that  the  solutions  offered  by  these  standards  are 
not fully satisfactory, especially as far as the use of flame retardants is concerned. A 
key preliminary step is therefore to acquire comprehensive knowledge of the chemicals 
used  as  flame  retardants,  with  a  view  to  creating  a  satisfactory  trade-off  between 
fire  safety  and  health  and  environment  protection  to  be  reflected  in  safety 
standards. 

3.6. 

Safety of Services 

With  respect  to  the  safety  of  consumer  services,  the  Commission  notes  the  lack  of 
consensus among Member States regarding the appropriate level of Community action. 
At the same time, public opinion and political pressure from the European Parliament 
suggest  that  action  is  required,  at  European  level,  to  address  general  risks  and 
accidents, such as fire safety in hotels. 

The  need  to  improve  the  existing  European  system  for  monitoring  accidents  and 
injuries,  including  those  related  to  services,  has  been  recognized  in  a  number  of 
Commission's proposals aimed at preventing injuries and promoting safety41.  

In  2007,  the  Commission  adopted  a  proposal  for  a  draft  framework  Regulation 
concerning Community statistics on public health and health and safety at work42. The 
lack of comparable data has not, however, prevented the Commission from pursuing 
new  initiatives,  where  the  focus  is  on  awareness  raising,  and  encouraging 
stakeholders to address priority areas for Community action, such as hotel safety. 

In  response  to  the  Commission  mandate  M/371  in  the  area  of  services,  CEN  carried 
out  a  study  to  determine  the  feasibility  of a  standardisation  program  of  requirements 
for delivery of services, including its safety aspects43. 

4. 

CONCLUSIONS 

4.1. 

General  

The  Directive  has  proven  to  be  a  powerful  tool  for  ensuring  a  high  level  of 
consumer  protection.  It  has  helped  to  track  down  and  eliminate  a  vast  number  of 
unsafe  products  from  the  European  market.  The  RAPEX  system,  set  up  by  the 
Directive,  has  complemented  the  existing  regulatory  framework  applying  to  some 

41 
42 
43 

EN 

COM (2006) 328 and 329 

COM(2007) 46  

See http://www.cen.eu/cenorm/sectors/nbo/value/chesss/index.asp 

12 

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key  consumers'  products  –such  as  toys,  cosmetics,  electrical  appliances  and 
luminaries,  personal  protective  equipments,  vehicles  with  a  dedicated  rapid 
exchange and alert system. 

4.2. 

Transposition  

While transposition of the Directive by the Member States is overall adequate, there 
are  still  certain  inconsistencies.  The  Commission  services  are  cooperating  with  the 
Member  States  to  ascertain  whether  further  measures  by  certain  Member  States  are 
needed,  but  the  Commission  reserves  the  right  to  initiate  infringement  proceedings, 
where  necessary.  This  concerns  in  particular  the  observation  of  time  limits  for  the 
enforcement of measures under Article 13 of the Directive 

4.3. 

Functioning of Market Surveillance  

The major increase in RAPEX notifications over the last four years is a clear indication 
that  market  surveillance  under  the  Directive  has  been  successful.  Nevertheless,  in  an 
increasingly global market with more and more products coming to the EU from third 
countries,  there  is  a  need  for  further  co-ordination  of  market  surveillance  activities 
between the Member States, including cooperation with customs authorities.  

Such coordination would benefit from the implementation of commonly-agreed best 
practices (such as those resulting from the EMARS project), increased exchange of 
information  between  Member  States  authorities  within  the  existing  IT  tools,  proper 
implementation  of  the  framework  set  out  in  the  New  Legislative  Framework  and  a 
stronger role for the Commission in joint priority setting for market surveillance.  

4.4. 

Functioning of RAPEX 

Many  countries  regard  the  Directive,  and  the  RAPEX  system  in  particular,  as  a 
benchmark,  and  several  national,  regional  and  international  organisations  have 
expressed an interest in participating in the system or in receiving assistance to set up 
similar systems. 

While the increase in the number of notifications has placed the system under some 
strain,  it  is  nevertheless  a  clear  indicator  of  improved  consumer  protection  at 
European  level.  The  increase  in  reported  measures  adopted  directly  by  economic 
operators to contain the risks posed by consumer products also shows that responsible 
businesses take product safety seriously and respect the obligations placed on them by 
the Directive. 

4.5. 

Traceability of Products 

The  identification  of  the  producer  on  the  product  or  its  packaging  is  an  important 
element  for  ensuring  traceability44.  However,  this  requirement  is  not  mandatory  in  all 
Member  States'  legislations  and  this  leads  to  unsatisfactory  results.  If  the  market 
surveillance authority cannot trace the manufacturer or importer of a product that is 
found to be dangerous, it is not in a position to take fully effective measures. Further 
improvements  could  be  achieved  if  the  mandatory  nature  of  this  identification 

44 

Article 5(1), fourth subparagraph point (a) of the Directive 

EN 

13 

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requirement  were  clarified  and  if  all  products  carried  this  information  about  the 
economic operator responsible for the product's safety. This would also bring it more 
closely in line with the provisions of the New Legislative Framework Decision which 
makes it obligatory for the name, registered trade name or registered trademark of the 
manufacturer or importer as well as their address to be indicated on the product.45 

4.6. 

Community Measures based on Article 13 of the Directive 

While temporary measures are indeed necessary in certain circumstances, the Directive 
contains no specific provisions explicitly permitting a permanent ban on non-harmonised 
products, once they have been unambiguously proved to be dangerous46. 

4.7. 

Standardisation 

The  standardisation  provisions  should  be  simplified  to  allow  greater  flexibility.  It 
should be possible to lay down safety requirements for a specific category of products 
(e.g.  childcare  articles,  furniture,  clothing)  and,  on  the  basis  of  those,  issue 
"framework"  or  "standing" mandates to the ESOs. This would streamline the lengthy 
procedure for issuing the safety requirements for each individual product. Moreover, 
technological improvements and new risks could be addressed swiftly.  

The Commission should also be able to publish the reference of a standard adopted by 
an ESO without a corresponding mandate, if the product covered by the standard falls 
within pre-identified categories of products for which the Commission has set relevant 
safety  requirements,  and  provided  that  such  standard  satisfies  them.  In  this  way,  the 
resulting presumption of conformity with the general safety requirement would encourage 
business compliance and lead to better protection of consumers.  

Decision 768/2008/EC, Annex I, Articles R2(6) and R4(3). 

45 
46 
http://ec.europa.eu/consumers/safety/rapex/docs/rapex_annualreport2008_en.pdf 
http://ec.europa.eu/consumers/strategy/docs/fl224%20_eurobar_cbs_analrep.pdf 

See RAPEX Annual Report 2007 and Eurobarometer report October 2008: 

EN 

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