REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of 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
Date: 2013-02-13
Institutions: European Commission
Subjects: Community certification, application of EU law, customs inspection, exchange of information, intergovernmental cooperation (EU), market supervision, marketing standard, product safety, quality control of industrial products, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
COM(2013) 77 final 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

on the implementation of 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 

(Text with EEA relevance) 

{SWD(2013) 35 final} 
{SWD(2013) 36 final} 

EN 

   EN 

 
 
 
 
  
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

on the implementation of 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 

(Text with EEA relevance) 

1. 

INTRODUCTION 

This  report  gives  an  overview  of  the  implementation  of  Regulation  (EC)  No 
765/2008  (also  'the  Regulation')  setting  out  the  requirements  for  accreditation  and 
market  surveillance  relating  to  the  marketing  of  products  and  repealing  Regulation 
(EEC) No 339/93. This Regulation applies from 1 January 2010. Its main objective is 
to ensure that products on the Single Market covered by Union legislation fulfil the 
applicable requirements, which provide a high level of protection of health and safety 
and other public interests. To this purpose the Regulation establishes a framework for 
accreditation and market surveillance.  

The report was prepared in cooperation with the Member States through the 'SOGS', 
i.e.  the  Senior  Officials  Group  for  Standardisation  and  Conformity  Assessment 
Policy  and  the  ad  hoc  market  surveillance  group  called  ‘SOGS-MSG’.  This  report 
also evaluates the relevance of the conformity assessment, accreditation and market 
surveillance activities that receive Union financing in the light of the requirements of 
EU policies and legislation. 

2. 

ACCREDITATION 

2.1. 

National accreditation bodies 

Regulation  (EC)  No  765/2008  introduces  for  the  first  time  a  legal  framework  for 
accreditation. It applies in both the voluntary and regulated sectors. The purpose is to 
strengthen  accreditation  as  the  last  level  of  control  in  the  conformity  assessment 
system and to enhance trust in conformity assessment results while responding to the 
needs of markets and public authorities alike. 

The  Regulation  introduces  a  number  of  general  principles  and  requirements  for 
national  accreditation  bodies1.  These  requirements  are  in  line  with  the  globally 
accepted  requirements  laid  down  in  the  relevant  ISO/IEC  international  standards, 
although some of them can be perceived as being more rigorous, going beyond the 
requirements set out in the applicable standards. This is the case of the requirements 
according  to  which  there  is  only  one  accreditation  body  per  Member  State, 

1 

See Articles 4, 6 and 8 of the Regulation. 

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accreditation is performed as a public authority activity, accreditation is operated on 
a non-commercial and non- profit basis and accreditation bodies do not compete with 
conformity assessment bodies or amongst each other. 

In order to meet the requirements of the Regulation Member States had to introduce 
changes to their national accreditation systems to a varying degree. While for some 
Member States only some or minor changes were needed, others had to substantially 
overhaul  their  national  accreditation  system.  In  some  cases,  it  was  necessary  to 
merge  a  number  of  accreditation  bodies.  All  Member  States  as  well  as  EFTA 
countries and Turkey have set up national accreditation bodies2. 

The  process  of  restructuring  and  adaptation  to  the  Regulation  is  now  largely 
completed,  while  consolidation  is  still  on-going,  and  in  some  cases  national 
accreditation bodies still need to be strengthened within their national context.  

2.2. 

Cross-border accreditation 

The Regulation foresees that conformity assessment bodies should seek accreditation 
in the Member State where they are established. However, there are three scenarios 
in which a conformity assessment body may seek accreditation elsewhere:  

(1)  The  first  is  that  the  Member  State  in  question  has  not  set  up  a  national 

accreditation body.  

(2)  The  second  scenario  is  that  the  national  accreditation  body  does  not  perform 

accreditation for the activity for which accreditation is sought.  

(3)  The  third  scenario  is  that  the  relevant  national  accreditation  body  has  not 

successfully undergone peer evaluation.  

So  far  the  first  scenario  did  not  materialise  as  all  member  States  have  set  up  a 
national accreditation body. The second and third scenarios are more frequent as not 
all national accreditation bodies perform the full scope of activities.  

While these provisions on cross-border accreditation proved to be relatively straight 
forward,  an  issue  that  has  become  increasingly  important  in  recent  years  is  that  of 
multi-site  international  conformity  assessment  bodies  and  subcontracting.  The 
Commission has, in consensus with the Member States, adopted a policy document 
that explains how accreditation bodies should proceed in such cases with the aim to 
avoid multiple accreditations3. The European Cooperation for Accreditation, EA (see 
section on accreditation infrastructure), has then provided guidelines on how to put 
into practice these policy principles. Some fine-tuning of the implementation of these 
policy  principles  may  still  be  required  after  better  experience  with  these  guidelines 
has been gathered. 

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Their  contact  details  are  available  on 
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=ab.main  
CERTIF 2009-06 Rev. 6.0 Cross Border Accreditation Activities (See accompanying Commission staff 
working document). 

the  Commission  website  at 

the  following  address: 

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2.3. 

Peer evaluation 

Peer  evaluation  is  possibly  the  most  essential  tool  in  ensuring  that  the  European 
accreditation  system  meets  expectations  of  ensuring  the  quality  of  the  European 
conformity  assessment  system.  A  successful  peer  evaluation  is  the  prerequisite  for 
the mutual recognition of accreditation certificates.  

Therefore  a  rigorous  peer  evaluation  mechanism  between  national  accreditation 
bodies  is  central  to  the  good  implementation  of  the  Regulation.  It  ensures  a 
continuous  control  of  the  quality  of  the  work  of  the  national  accreditation  bodies, 
while also providing a learning process not only of those who are assessed but also of 
those who are doing the assessment. It is the peer evaluation that distinguishes and 
singles accreditation out in comparison to other means of assessing the competence 
and  performance  of  conformity  assessment  bodies.  The  next  objective  is  to  further 
strengthen  the  peer  evaluation  process,  to  enhance  the  availability  of  trained  and 
experienced peer evaluators and to further harmonise approaches particularly in the 
regulated sector. 

2.4. 

European accreditation infrastructure 

As set out in the Regulation, the Commission recognised the European Cooperation 
for  Accreditation  (EA)  as  the  European  accreditation  infrastructure4.  It  then 
concluded  an  agreement  that  specifies  the  detailed  tasks  of  EA,  funding  provisions 
and provisions for its supervision.  

In  April  2009,  the  Commission,  EFTA,  Member  States  and  EA  signed  general 
cooperation  guidelines  that  emphasise  their  political  commitment  to  work  closely 
together  on  a  successful  implementation  of  the  accreditation  chapter  of  the 
Regulation5.  They  express  a  common  understanding  of  the  importance  of 
accreditation  for  the  European  economy  as  well  as  its  supporting  role  for  several 
European  policies  and  corresponding  legislation.  The  guidelines  lay  down  the 
specific policy objectives for accreditation so that it may fulfil its goals expressed in 
the Regulation. 

In June 2010, the Commission and EA signed a framework partnership agreement for 
the  period  of  2010-2014.  This  framework  partnership  agreement  allows  financial 
support for EA in fulfilling its tasks as foreseen by the Regulation and meeting the 
objectives  detailed  in  the  guidelines.  The  EA  activities  eligible  for  EU  funding 
include technical work linked to the peer evaluation system, information of interested 
parties  and  participation  in  the  international  organisations  in  the  field  of 
accreditation,  drawing  up  and  updating  of  contributions  to  guidelines  related  to 
accreditation,  notification  of  conformity  assessment  bodies,  conformity  assessment 
and market surveillance, activities of assistance to third countries6. 

4 
5 

6 

See Article 14 of the Regulation. 
General  guidelines  for  the  cooperation  between  the  European  Cooperation  for  Accreditation  and  the 
European Commission, the European Free Trade Association and the competent national authorities. OJ 
http://eur-
2009/C 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2009:116:0006:0011:EN:PDF 
See Article 32 of the Regulation. 

116/04: 

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The  framework  partnership  agreement  stipulates  the  possibility  of  an  annual 
operational  grant  for  the  on-going  work  of  EA  and  its  secretariat.  At  the  time  of 
writing  this  report,  two  annual  operational  grants  amounting  to  375,000€  and 
approximately 40% of the overall EA budget have been disbursed.  

The grant has supported work related to the operation and management of the peer 
evaluation system which in 2010 and 2011 included 32 evaluations - including pre-
evaluations,  initial  evaluations,  re-evaluations  and  extraordinary  evaluations  of 
national  accreditation  bodies  -  and  8  trainings  of  evaluators.  The  activities  in  this 
area also include the launch of an overall  process  of enhancing the peer evaluation 
system that has produced a number of proposals currently under discussion.  

Furthermore the EA's horizontal harmonisation committee as well as the laboratory, 
certification and inspection committees have been working on furthering a common 
understanding on how to perform accreditation and also on supporting accreditation 
in  the  relevant  regulated  sectors.  This  has  resulted  in  a  number  of  guidance 
documents7. 

EA has also been very active in fulfilling its tasks of providing technical expertise to 
different  Commission  services  for  the  inclusion  of  accreditation  in  legislative 
projects or in terms of implementing existing sectoral legislation8.  

In  addition,  EA  has  been  working  with  interested  stakeholders  through  its  EA 
Advisory  Board  and  has  fulfilled  its  obligations  to  participate  in  the  international 
accreditation  organisations  ILAC/IAF  by  participating  in  their  peer  evaluation 
process and in their different working groups. It has also consolidated relations with 
third  countries  by  accepting  national  accreditation  bodies  of  EFTA  and  candidate 
countries  as  full  members  and  by  signing  association  agreements  with  national 
accreditation bodies of countries participating in the European neighbourhood policy. 
EA currently counts 35 full members and 13 associate members9.  

Besides the annual operational grant, the framework partnership agreement with EA 
also stipulates the possibility of action grants for specific projects. So far, no use has 
been made of this possibility.  

Cooperation with EA has been very fruitful on the whole. Considerable efforts have 
been  made  to  meet  the  changed  circumstances  for  accreditation  with  the  entry  into 
force  of  the  Regulation  and  EA's  new  role  as  the  European  accreditation 
infrastructure  within  this  context.  The  progress  made  so  far  should  be  further 
consolidated to continue enhancing accreditation's role as the last level of control in 
the  European  conformity  assessment  system.  As  accreditation  is  increasingly  being 

7 
8 

9 

http://www.european-accreditation.org/content/publications/pub.htm. 
Activities have not been limited to the services of the Directorate-General "Enterprise and Industry" but 
have  spanned  to  other  Directorates-General  (amongst  others  DG  SANCO,  DG  AGRI,  DG  ENV,  DG 
MOVE, DG CLIMA). A prime example would be cooperation on the new European Emission Trading 
(ETS)  Accreditation  and  Verification  Regulation,  where  EA  cooperated  closely  with  DG  ENTR  and 
DG CLIMA in order to come up with a solution that meets the needs of this legislation. (Commission 
Regulation (EU) No 600/2012 of 21 June 2012 on the verification of greenhouse gas emission reports 
and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC of the 
European Parliament and of the Council Text with EEA relevance). 
http://www.european-accreditation.org/content/ea/members.htm 

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used for the purposes of EU legislation, this may also entail a review of the resources 
and financial support available to EA. 

2.5. 

Accreditation in support of notification 

The  Regulation  is  very  clear  in  its  preference  of  accreditation  as  the  means  for 
demonstrating  the  technical  competence  of  a  conformity  assessment  body  for  the 
purposes of 'notification' under specific legislation, i.e. ultimately to acknowledge the 
body's  ability  to  assess  product  compliance  with  the  requirements  of  a  given 
regulation or directive.  

Accreditation  has  the  benefit  of  being  a  transparent,  standard-based  activity,  while 
the peer evaluation process is in place to ensure that comparable levels of quality are 
maintained. This is not the case for notifications that are not based on accreditation. 
The  Commission  has  therefore,  in  consensus  with  the  Member  States,  issued  a 
guidance  document  on  the  kind  of  information  that  a  non-accredited  notification 
should  carry10.  As  unaccredited  notifications  are  not  always  accompanied  by  the 
appropriate  documentation  and  Member  States  and  the  Commission  have  a  longer 
time  frame  to  raise  objections,  the  notification  process  can  in  these  cases  become 
rather drawn-out and cumbersome. 

The use of accreditation for notification purposes differs across Member States and 
across sectors. While some Member States have made accreditation for notification 
purposes  compulsory,  this  is  not  the  case  in  others  that  apply  a  rather  mixed 
approach.  It  is  a  fact  that  at  the  end  of  2009,  before  the  entry  into  force  of  the 
Regulation, out of 2249 notifications 1089 were not accredited and 1118 accredited, 
while until June 2012 there were 3106 notifications of which 861 were not accredited 
and  2196  were  accredited.  Accreditation  is  thus  successfully  taking  on  its  role  in 
support of notification. A closer communication between national authorities and the 
accreditation body is therefore warranted.  

2.6. 

Guidance documents 

The  Commission  has,  in  consensus  with  the  Member  States,  issued  guidance 
documents  which  are  set  out  in  the  accompanying  Commission  staff  working 
document.  

2.7. 

Challenges 

While  the  Regulation  has  set  a  solid  legal  framework  for  accreditation,  the  major 
challenges  in  the  implementation  of  the  accreditation  chapter  of  the  Regulation  for 
the coming years will be to consolidate and strengthen the system as well as raising 
awareness  and  a  better  understanding  of  accreditation's  benefits.  Apart  from  a 
number  of  legal  questions  surrounding  accreditation,  this  will  require  a  further 
strengthening of the peer evaluation system as the main tool for ensuring a continued 
quality of certificates throughout the EU. Furthermore accreditation for notification 
purposes will need to be given greater prominence and it will have to be used more 
systematically in EU legislation where the latter provides for conformity assessment 
and the designation of conformity assessment bodies. This may also require that the 

10 

CERTIF  2010-08  Rev.1  Notification  without  Accreditation  (Art.  5(2)  of  Regulation  (EC)  No 
765/2008). 

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Commission  and  EA  develop  sectoral  accreditation  schemes  to  ensure  that 
conformity  assessment  bodies  meet  the  level  of  competence  required  by  Union 
harmonisation legislation in fields with specific requirements11. 

3. 

UNION MARKET SURVEILLANCE FRAMEWORK FOR PRODUCTS 

This  section  summarises  the  state  of  play  of  the  implementation  of  the  main 
provisions  of  Regulation  (EC)  No  765/2008  concerning  the  establishment  of  a 
market surveillance framework for all harmonised products in the single market. This 
chapter  complements 
impact  assessment 
information  contained 
accompanying  the  Commission's  proposals  for  a  Consumer  Products  Safety 
Regulation and for a Market Surveillance Regulation. 

the 

the 

in 

3.1. 

Requirements for the organisation of market surveillance by Member States 

The  Regulation  establishes  specific  requirements  for  the  organisation  of  market 
surveillance by Member States since 2010. Most of them have then fine-tuned their 
administrative structures and put in place specific solutions to ensure the fulfilment 
of  those  requirements.  The  replies  of  the  Member  States  to  a  questionnaire  on  the 
implementation of the Regulation can be summarized12 as follows:  

• 

• 

• 

• 

• 

Responsibility  and  identity  of  authorities:  in  most  Member  States,  the 
Regulation  only  required  some  small  adjustments  to  pre-existing  market 
surveillance  activities  (e.g.  establishing  a  programme  for  the  enhancement  of 
market  surveillance)  as  Member  States  have  had  already  set  up  market 
surveillance procedures by relevant national legislation. 

The communication and coordination mechanism between market surveillance 
authorities  varies  amongst  Member  States:  communication  channels  are 
sometimes based on an informal agreement, or communication takes place via 
a  coordination  body  for  market  surveillance,  through  a  Working  Group 
responsible  for  implementation  of  New  Legislative  Framework  or  through  a 
Market Surveillance Committee. 

Procedure to follow up complaints: before the Regulation, most Member States 
had already set up systems for complaints. Although these systems are updated 
on  a  regular  basis,  the  majority  of  Member  States  indicate  that  they  can  be 
improved further. 

Procedure  to  monitor  accidents  and  harm  to  health:  some  Member  States 
believe that an improved system for accident data is needed and could be based 
on the current EU Injuries Database. 

Strengthen  market  surveillance  authorities'  powers:  there  were  some  minor 
adjustments  in  Member  States  as  the  enforcement  powers  have  been  mostly 
compatible  to  those  required  by  the  Regulation.  Some  Member  States  had  to 
amend existing national legislation to comply with the Regulation (EC). 

11 
12 

See Article 13(3) of the Regulation.  
A full overview of the replies can be found in the accompanying Commission staff working document.  

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• 

• 

Strengthen market surveillance authorities' financial and human resources: the 
financial  and  human  resources  for  market  surveillance  were  reduced  due  to 
budgetary constraints in the majority of Member States, while in a minority of 
Member States no major adjustments were considered necessary until now.  

Penalties  for  economic  operators:  penalties  for  non-compliant  economic 
operators  existed  already  before  the  Regulation  came  into  force,  but  were 
slightly  amended  in  certain  Member  States  as  a  consequence  of  the  new 
competences for market surveillance authorities. 

At  the  beginning  of  2010  all  Member  States,  Iceland  and  Turkey,  informed  the 
Commission of their market surveillance authorities and their areas of competence as 
specifically  requested  by  the  Regulation13.  These  communications  provide  a  good 
overview  of  the  distribution  of  tasks  and  responsibilities  in  the  area  of  market 
surveillance  for  harmonised  goods,  including  relevant  contact  details.  They  were 
published  on  the  website  of  the  Commission14  and  certainly  contribute  to 
transparency on national market surveillance authorities in the EU. 

3.2. 

The national market surveillance programmes 

According to the Regulation15 Member States must establish, implement and update 
their market surveillance programmes. They must also communicate the programmes 
to  other  Member  States  and  to  the  Commission  and  make  them  accessible  to  the 
public via internet. The purpose of these programmes is to allow the other countries' 
authorities,  as  well  as  citizens  in  general,  to  understand  how,  when,  where  and  in 
which  areas  market  surveillance  is  carried  out.  National  programmes  then  contain 
information on the general organisation of market surveillance at national level (e.g. 
mechanisms  of  coordination  between  different  authorities,  resources  attributed  to 
them,  working  methods,  etc.)  and  on  specific  areas  of  intervention  (e.g.  product 
categories, risk categories, types of users, etc.).  

The  majority  of  Member  States  communicated  their  national  (general  or  sectoral) 
programmes and any necessary revision to the Commission in 2010, 2011 and 2012 
(see Table 1). In 2012, the Commission published on its website a non-confidential 
original  and  translated  version  of  the  latest  national  programmes  received  from 
Member States, Iceland and Turkey16. 

The  assessment  of  the  efforts  made  by  Member  States  is  overall  very  positive, 
despite  the  fact  that  some  countries  have  put  more  emphasis  on  information 
concerning the general organisation of market surveillance, while others have chosen 
to  privilege  information  on  sector  activities,  so  the  information  is  not  always  fully 
comparable.  The  clarity  on  how  Member  States  have  organised  cooperation  and 
coordination among different authorities and with customs could be improved. 

13 
14 

15 
16 

See Article 17. 
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-
products/market-surveillance-authorities/index_en.htm. 
See Article 18(5). 
http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-
products/national-market-surveillance-programmes/index_en.htm. 

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The  Commission  helped  Member  States'  implementation  of  these  provisions  of  the 
Regulation  in  particular  by  proposing  a  common  template  to  lay  out  their  sector 
programmes. This now greatly facilitates the comparability of national information in 
specific  product  or  legislation  areas  and  makes  it  possible  for  market  surveillance 
authorities to plan cross-border cooperation in areas of common interest. 

Table 1: National Market Surveillance Programmes (NMSP) – state of play 2010-2012  

Type of programme17 

2010 

2011 

2012 

Country 

Austria 

Belgium 

Bulgaria 

Cyprus 

General and Sectoral 

General * 

General * 

General and Sectoral 

Czech Republic 

Sectoral 

Denmark 

General and Sectoral 

Estonia 

Finland 

France 

General and Sectoral 

Sectoral 

General and Sectoral 

Germany 

General * 

Greece 

Hungary 

Ireland 

Italy 

Latvia 

General 

Sectoral 

General * 

General 

General and sectoral 

Lithuania 

Sectoral 

Luxembourg 

General and Sectoral 

Malta 

Sectoral 

Netherlands 

Sectoral 

Poland 

Portugal 

Romania 

Slovakia 

General and Sectoral 

General and Sectoral 

General and Sectoral 

General and Sectoral 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

17 

The situation reflects in particular the approach followed for year 2012. 

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Type of programme17 

2010 

2011 

2012 

Country 

Slovenia 

Spain 

Sweden 

General and Sectoral 

Sectoral 

General and Sectoral 

United Kingdom 

General and Sectoral 

Iceland 

Turkey 

General 

General 

x 

-- 

x 

x 

x 

x 

x 

x18 

x 

x 

x 

x 

x 

x 

x 

x 

x 

x 

* The programme covers also some information on specific sectors, although this is not detailed 

3.3. 

Products presenting a serious risk  

The Regulation establishes a general obligation for Member States to ensure that the 
goods liable to compromise the health or safety of users (consumers and workers) or 
in  any  case  non-compliant  with  product  requirements  set  out  in  the  EU 
harmonisation  legislation  are  withdrawn,  prohibited  or  their  supply  restricted19. 
Moreover,  it  sets  out  that  when  products  –  on  the  basis  of  an  appropriate  risk 
assessment  –  are  considered  to  present  a  serious  risk,  Member  States  must  also 
inform  the  Commission  without  delay  of  the  measures  taken  by  using  the  rapid 
information system "RAPEX"20. 

The  inclusion  in  the  Regulation  of  a  reference  to  the  RAPEX  system  has 
acknowledged  the  importance  of  this  exchange  information  mechanism  for  market 
surveillance in the Single Market and the link of this mechanism to product-specific 
regulations. The reference to the RAPEX system has also had the effect of extending 
the obligation to send RAPEX notifications to all goods falling within the scope of 
EU  harmonisation  legislation,  including  products  for  use  in  a  professional  context 
(e.g. industrial machinery) and products which may harm public interests other than 
health  and  safety  (e.g.  environment,  security,  fairness  of  commercial  transactions, 
etc.).  

This  extension  has  contributed  particularly  to  the  protection  of  workers21  and  the 
protection of the environment22, although the total number of new notifications has 
been  rather  limited  during  the  first  two  years  of  implementation  of  the  Regulation. 
Besides the RAPEX notifications pursuant to the General Products Safety Directive, 
the  Commission  received,  in  2010,  20  notifications  under  Regulation  (EC)  No 
765/2008  (7  of  them  presenting  a  serious  risk);  in  2011  it  received  25  such 

18 
19 
20 
21 

22 

Only for a limited number of products. 
See Article 16. 
See Articles 20 and 22. RAPEX is an alert system already established under Article 12 of the GPSD. 
Examples are the notification of a feed mixer used in agriculture that was found not to comply with the 
Machinery  Directive  2006/42/EC  after  having  caused  a  fatal accident  in  the  notifying  country  and  of 
various dangerous professional tools found not to comply with the Low Voltage Directive 2006/95/EC. 
Examples  are  the  notifications  on  various  consumer  protective  equipment  and  packages  of  toys 
containing  a  quantity  of  cadmium  exceeding  the  limit  allowed  in  the  REACH  Regulation  (EC) 
1907/2006 and the notifications of fireworks containing persistent organic pollutants. 

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notifications  (17  of  them  presenting  a  serious  risk)23.  Overall,  9  Member  States 
transmitted notifications on professional goods and products which may harm public 
interests other than health and safety. 

More recent patterns show an increase in the number of communications received as 
in  2012  the  Commission  validated  altogether  37  new  notifications,  31  of  which 
presented  a  serious  risk.  In  the  same  period  an  additional  Member  State  started  to 
notify.  These  figures  are  expected  to  definitely  go  up  overtime  as  Member  States 
become  more  proactive  in  the  area  of  professional  products  and  fully  adjust  their 
practice to the broader scope of RAPEX. 

On  the  side  of  the  Commission  the  implementation  of  the  Regulation  has  required 
some efforts to coordinate the expertise necessary to assess the new notifications and 
to adjust the operational procedures to the system's wider scope. The completion of 
the new IT platform for RAPEX notifications, called GRAS-RAPEX24, was a major 
step forward for the handling of new notifications. 

3.4. 

An appropriate risk assessment methodology 

As part of implementation of the Regulation carried out through the 'SOGS' groups, 
the Commission set up in 2011 a Risk Assessment Task Force composed of Member 
States' experts. The mission of the task force was to advice on appropriate means of 
carrying out risk assessment for all non-food products and all risks falling within the 
harmonisation legislation. The existing RAPEX Guidelines25 already provide for the 
risk  assessment  methodology  for  consumer  goods,  which  certainly  constitute  an 
important reference for Member States. The task force was then asked to assess: (i) 
whether the existing methodology, whose main focus is on non-harmonised products, 
could suitably take into account the legal requirements of harmonised goods; (ii) how 
to  address  the  need  to  assess  risks  to  public  interests  other  than  health  and  safety, 
which are not taken on board by this methodology.  

At  the  end  of  the  project  the  Risk  Assessment  Task  Force  concluded  that  the 
methodology referred to by the RAPEX Guidelines represents a good basis, however 
its  suitability  to  the  harmonised  area  should  be  improved  by  including  explicit 
references  to  the  product  essential  requirements  and  to  the  relevant  harmonised 
standards.  Furthermore,  the  language  of  the  methodology  should  be  adjusted  to  a 
broader set of public interests by focusing on the concept of 'harm' instead of that of 
'injury'26. 

23 

24 

25 

26 

the  RAPEX  Annual  Reports 

More details on these notifications (notifying Member States, product categories, etc.) can be found in 
chapter  2.3  of 
at: 
http://ec.europa.eu/consumers/safety/rapex/key_docs_en.htm.  
GRAS-RAPEX  has  replaced  the  RAPEX-REIS  application  on  29  May  2012.  The  new  IT  platform 
contains  more  advanced  functionalities  among  which  drop  down  menus  allowing  RAPEX  Contact 
Points to upload information on professional products and other risks than health and safety. 
Adopted  by  Commission  Decision  2010/15/EU  of  16  December  2009,  OJ  L  22,  26.1.2010,  p.  1, 
http://ec.europa.eu/consumers/safety/rapex/docs/rapex_guid_26012010_en.pdf 
Document SOGS-MSG N031Rev1 or CERTIF 2012-01 Rev1. 

and  2011 

for  2010 

available 

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10 

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3.5. 

General information support system - ICSMS 

According to the Regulation, the Commission must develop and maintain a general 
archiving  and  exchange  of  information  system,  on  issues  relating  to  market 
surveillance activities27.  

Commission  experts  examined  possible  alternatives  (acquire  an  existing  tool, 
develop  a  new  tool  etc.)  and  came  to  the  conclusion  that  the  most  appropriate 
solution was to acquire the “ICSMS” tool (Information and Communication System 
for Market Surveillance), which is the only information system of its nature currently 
already  operating.  At  that  moment,  ICSMS  was  used  by  12  EU/EFTA  Member 
States  (Austria,  Belgium,  Cyprus,  Estonia,  Germany,  Luxemburg,  Malta  The 
Netherlands,  Slovenia,  Sweden,  Switzerland  and  UK)  as  communication  means  for 
market surveillance authorities to exchange information on investigations of specific 
products and related activities.  

In  November  2011,  the  Commission  agreed  with  ICSMS-AISBL  (the  body 
regrouping market surveillance authorities in the EU/EFTA Member States that are 
ICSMS  users)  and  LUBW  (Agency  for  environmental  measurements  depending  on 
the  Ministry  of  Environment  and  Transport  of  Baden-Wuerttemberg  that  hosts 
physically ICSMS) to purchase ICSMS for €1,940,940. Under the contract, ICSMS-
AISBL and LUBW undertook to: 

– 

– 

– 

– 

– 

transfer the IPRs of the ICSMS tool to the Commission; 

integrate Member States not yet ICSMS members and provide training to users 
of  the  new  ICSMS  member  countries.  The  first  trainings  have  taken  place  in 
May-June 2012; 

provide  technical  support  and  assistance  to  all  ICSMS  users  (including  help 
desk); 

manage ICSMS on a daily basis and ensure quality of service; 

transfer the know-how of ICSMS to the Commission. 

Supported by the internet, ICSMS enables a comprehensive exchange of information 
between  all  the  market  surveillance  bodies.  The  system  allows  to  quickly  and 
efficiently  share  between  its  users  test  results,  product  identification  data, 
photographs, economic operator information, risk assessments including hazard data, 
accident information, and measures taken by surveillance authorities.  

ICSMS consists of an internal and a public area. The internal area is for the use of 
market  surveillance  authorities.  It  can  also  be  used  by  customs  authorities  and  EU 
officials.  It  contains  all  information  available  (product  description,  test  results, 
measures  taken  etc.).  The  public  area  is  for  the  use  of  consumers  and  economic 
operators.  The  information  which  is  visible  to  the  public  provides  only  the  data, 
which references the product and its non-compliance and not any internal documents 
(i.e. between authority and manufacturer/importer etc.).  

27 

See Article 23 of the Regulation. 

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11 

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ICSMS already gathers test results on more than 47,500 products and lists more than 
650 authorities in all EEA countries for more than 45 directives. The number of user 
accounts is 3,600. ICSMS enables all internal and public users to carry out a specific 
search.  A  search  can  be  made,  for  example,  according  to  individual  products,  and 
according  to  test  results  for  entire  product  groups.  Test  results  can  be  obtained  for 
products  from  specific  countries.  Information  can  be  obtained  for  products  coming 
under  certain  directives,  safeguard  clause  notifications,  information  about  RAPEX 
notifications,  for  manufacturers,  importers  and  dealers.  Confidentiality  aspects  are 
protected by a system of access authorisations.  

Each market surveillance authority can input data about investigated products, which 
are  not  yet  in  the  database  and  add  comments  to  an  already  existing  product 
information file, i.e. feedback about the activities of market surveillance authorities 
with  regard  to  investigated  products.  Furthermore  the  possibility  to  transfer  the 
responsibility for a product from one authority to another (so called “baton passing”) 
exists and is extensively used. 

An  evaluation  of  the  ICSMS  contract  is  premature  as  it  was  signed  in  November 
2011  and  as  the  roll-out  of  the  system  to  EU  countries  which  were  not  already 
members has just started. However, in view of the potential of ICSMS, the contract 
offers  good  “value  for  money”  for  the  Commission  and  all  concerned  stakeholders 
(national  authorities,  manufacturers,  citizens).  The  general  information  support 
system established under the Regulation is meant to be a policy tool that facilitates 
market  surveillance  across  the  European  Union,  in  particular  by  increasing  the 
effectiveness and coherence of investigations carried out at national level.  

According to the experts who use ICSMS, the exchange of information on test results 
and investigations offers advantages for market surveillance authorities such as: 

– 

– 

– 

– 

– 

Prompt  intervention:  information  on  unsafe  products  can  be  announced 
immediately and immediate measures may be taken; 

Deterrence:  “black  sheep”  among  manufacturers  will  be  detected  earlier  and 
punished more effectively; 

Avoiding  duplication  of  work:  Test  results  by  one  surveillance  authority  will 
be immediately made available to all other Member States; 

Possibility to generate statistics by sector, product, etc.; 

Coverage of all issues concerning non-compliance of products. 

In  addition,  ICSMS  provides  a  valuable  platform  for  the  implementation  of  the 
European market surveillance policy by creating the basis for:  

– 

– 

the  coordination  of  wide-scale  market  interventions  against  suspicious 
products;  

the  elaboration  of  best  practices,  the  exchange  of  general  knowledge  and 
experience; 

EN 

12 

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– 

– 

– 

the  adoption  of  a  common  approach  to  market  surveillance  in  different 
countries (thus avoiding distortion to competition); 

the availability of an encyclopaedia of EU market surveillance intelligence; 

the  information  of  citizens  about  non-compliant  products  and  the  contact 
details of the competent authorities28. 

3.6. 

Support to administrative cooperation 

Regulation  (EC)  No  765/2008  gives  the  Commission  the  legal  basis  to  assist  with 
financial aid and support to the Member States in relation to ADCO (Administrative 
Co-operation on Market Surveillance) groups' activities29. 

The  main  objective  of  the  Administrative  Co-operation  groups  on  Market 
Surveillance  is  to  guarantee  proper,  uniform  application  of  the  technical  provisions 
of  the  directives  (certification  procedures)  and  thus  limit  the  use  by  the  Member 
States  of  restrictions  on  the  placing  on  the  market  of  products  certified  to  be  in 
conformity. 

There are currently twenty ADCO groups. They hold, in general, about 40 meetings 
a  year  covering  areas  such  as  construction,  safety  of  toys,  noise  emissions, 
pyrotechnics,  radio  and  telecommunication  terminal  equipment,  electromagnetic 
compatibility,  low  voltage  equipment,  medical  devices,  equipment  and  protective 
systems  intended  for  use  in  explosive  atmospheres,  pressure  and  transportable 
pressure equipment, machinery, lifts, cableways, personal protective equipment, eco-
design,  energy  labelling,  measuring  and  non-automatic  weighing  instruments  or 
recreational  crafts.  The  participants  are  officials  of  national  market  surveillance 
authorities  who  also  ensure  the  chairmanship  of  the  meetings.  The  Commission  is 
also represented in the groups. 

However, different levels of attendance to ADCO groups meetings, from one sector 
to  another,  have  been  noticed.  The  main  reason  of  the  weak  attendance  of  several 
groups seems to be the lack of financial resources for travel and accommodation of 
the  representatives.  On  the other  hand, some  market  surveillance  authorities  do  not 
apply  for  the  chairmanship  of  the  group  because  of  the  same  financial  problem  in 
organising meetings.  

4. 

CONTROLS OF PRODUCTS ENTERING THE EU MARKET 

In  addition,  Regulation  (EC)  No  765/2008  sets  out  a  regulatory  framework  for 
external border controls30. The overall objective of these provisions is to ensure that 
Member States have appropriate control mechanisms in place in order to verify that 
products  originating  from  third  countries  and  entering  the  EU  market  comply  with 
the requirements set out in Union legislation. To this end the Regulation establishes 
basic principles on the operation of external border controls, on the authorisation or 
not  of  the  release  of  the  goods  for  free  circulation  and  on  the  cooperation  of  all 

28 
29 
30 

See Article 19(2). 
See Article 32(1)(e). 
See Articles 27, 28 and 29. 

EN 

13 

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authorities  involved  in  relation  to  both  tasks.  These  provisions  build  on  Council 
Regulation (EEC) No 339/9331, which was repealed by the Regulation. 

4.1. 

Implementation by Member States 

Therefore the Member States implemented specific provisions on border controls by: 

•  establishing  a  single  point  of  contact  in  order  to  develop  effective  and  efficient 

border controls; 

•  making available funding for border controls; 
•  developing policy on how border controls should be carried out; 
•  broadening border controls in order to cover more points of entry; 
•  ensuring  that  border  controls  are  properly  targeted  and  that  trade  facilitation  is 

not adversely affected; 

•  establishing  written  agreements  between  customs  and  market  surveillance 

• 

authorities to strengthen cooperation in the area of border controls; 
improving cooperation between customs and market surveillance authorities (e.g. 
improving information sharing, intensifying cooperation with market surveillance 
authorities of third countries); 

•  providing assistance to custom officers who perform custom controls; 
•  carrying or assisting in risk analyses; 
•  harmonizing customs actions; 
• 
training customs officers. 

4.2. 

Guidance by the Commission 

In  order  to  facilitate  the  implementation  of  Regulation  (EC)  No  765/2008  the 
Commission,  together  with  the  Member  States,  has  drafted  the  Guidelines  for 
imports controls in the area of product safety and compliance32. The Guidelines are 
intended  as  an  instrument  to  assist  customs  and  market  surveillance  authorities  in 
improving cooperation methods and good administrative practice. At the same time, 
the  Guidelines  focus  on  the  practical  questions  customs  are  faced  with  when 
performing controls related to product safety and compliance. 

The Guidelines consist of a Generic and a Specific Part. The generic part is essential 
to  understand  the  overall  relevant  applicable  EU  legislation  and  in  particular  the 
obligations  on  safety  and  compliance  controls  and  the  cooperation  between  the 
relevant national authorities. The specific part of the Guidelines consists of practical 
tools  for  customs  officers,  i.e.  information  sheets  and  check  lists  for  individual 
product groups intended to facilitate controls.  

The Commission is coordinating Member States' efforts to disseminate and use the 
Guidelines at national level. It is also engaged in an extensive programme of country 
visits  to  provide  as  wide  as  possible  guidance  to  national  officials  and  to  address 
specific questions they may have.  

31 

32 

Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on 
product safety in the case of products imported from third countries (OJ L 40, 17.2.1993, p.1). 
http://ec.europa.eu/taxation_customs/resources/documents/common/publications/info_docs/ 
customs/product_safety/guidelines_en.pdf. 

EN 

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All these initiatives have been financed through the Customs 2013 programme33. 

5. 

CE MARKING AND CONFORMITY ASSESSMENT 

The  Commission  has  in  the  past  detected  a  lack  of  understanding  of  what  CE 
marking  means  amongst  economic  operators,  in  particular  SMEs.  For  this  reasons, 
Regulation  (EC)  No  765/2008  lays  down  the  general  principles  underlying  the  CE 
marking. In this respect, upon request by the European Parliament and as part of the 
Regulation  implementation,  the  Commission  committed  itself  to  carry  out  an 
information campaign on CE marking addressed in particular to economic operators 
(with focus on SMEs) but also to public authorities and consumers.  

5.1. 

The CE Marking information campaign 

The  CE  Marking  information  campaign  was  intended  to  raise  the  stakeholders' 
knowledge  regarding  CE  marking.  It  was  financed  by  the  Entrepreneurship  and 
Innovation  Programme  in  2009  and  cost  in  total  2  million  EUR.  The  campaign 
started in the 1st quarter of 2010 and lasted until March 2012. 

The outputs of the campaign include: 

– 

– 

– 

the creation of a dedicated website in all EU/EFTA languages that serves as a 
one-stop-shop 
marking 
information 
(http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/)  

CE 

for 

on 

the  development  of  a  stand  for  presence  at  commercial  fairs34;  educational 
seminars  in  all  EU/EFTA  Member  States  (for  Switzerland  and  Lichtenstein 
there was one joint seminar); 

the  production  of  leaflets  and  brochures  in  all  EU/EFTA  languages  for 
professionals  and  consumers;  the  production  of  two  videos  and  promotional 
material;  the  production  of  factsheets  describing  the  situation  regarding  CE 
Marking  in  various  sectors  in  all  EU/EFTA  languages  and  various  articles  in 
the specialised press.  

The  campaign  appears  to  have  fulfilled  its  goals.  The  feed-back  from  the  seminars 
and  the  fairs  (the  high  number  of  participants35  and  their  positive  written 
evaluations), the high demand for informational material36 and the strong interest of 
print and on-line media37 show the success of the campaign.  

33 

34 

35 

36 
37 

Decision No 624/2007/EC of the European Parliament and of the Council of 23 May 2007 establishing 
an action programme for customs in the Community.  
Presence  at  the  following  fairs:  Hannover Messe  2010 (April  2010), Paris  Hopital  Expo (May  2010), 
London CEDIA EXPO (June 2010), Berlin IFA (September 2010), Madrid Orto Pro Care (September-
October  2010),  Krakow  Eurotool  (October  2010),  Nuernberg  International  Toy  fair  (February  2011), 
Milano fair (January 2011), Hannover Cebit (March 2011), Brno (Czech Republic) Amper fair (March-
April 2011), Hannover Messe (April 2011).  
Almost two thousand stakeholders have followed the seminars. At some fairs, more than two thousand 
people  visited  the  campaign  stand,  while  more  than  two  hundred  visitors  participated  in  deeper 
discussions with the stand personnel. 
Sixty thousand copies of leaflets and brochures already distributed. 
Over one hundred and forty press clippings/publications in magazines, newsletters and on specialised 
websites.  

EN 

15 

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Furthermore  the  majority  of  the  questions  being  asked  by  stakeholders  on  the  CE 
Marking demonstrate that the stakeholders are now more familiar with the meaning 
of the CE Marking and are more aware of their rights and obligations. The number of 
the written questions from the stakeholders to the Commission has increased over the 
period  of  the  campaign.  The  questions  themselves  became  more  complex  and 
refined, demonstrating a much better knowledge of the CE Marking than before. In 
addition the guidance provided by the website reduces the risk of possible mistakes 
and misunderstandings.  

5.2. 

Guidance to sectoral legislator and other stakeholders 

The correct use of the CE marking presupposes a good understanding of conformity 
assessment  procedures  applicable  to  different  products.  In  order  to  help  legislators, 
national authorities, Accreditation Bodies, Conformity Assessment Bodies, operators 
and other stakeholders to select the correct assessment procedures, the Commission 
provided specific guidance through policy documents: 

• 

• 

• 

SOGS-N593  EN  or  CERTIF  2009-03  "Orientations  for  selecting  and 
implementing the modules of Decision 768/2008 and SMEs specificities in the 
area  of  conformity  assessment"  provides  guidance  to  the  sectoral  legislator 
how to select conformity assessment modules from the “menu” of the Decision 
No  768/2008/EC.  Furthermore  it  provides  guidance  to  Notified  Bodies 
performing conformity assessment. In line with the better regulation objectives, 
the legislator must take into account the complexity of the product, the size of 
the undertakings operating in the sector addressed (e.g. SMEs) the technology 
in  question,  the  risk  for  the  public  interest,  the  mass  or  serial  nature  of  the 
production process. Notified bodies must, in a similar way, avoid unnecessary 
burden  for  the  economic  operators,  maintaining  however  the  required  high 
level of protection of the public interest. 

SOGS-N594 EN or CERTIF 2009-04  "Introduction to conformity assessment 
of  the  New  Legislative  Framework  as  laid  down  in  Decision  768/2008"  is 
addressed  to  newcomers  (legislator,  Notified  Bodies,  manufacturers)  into 
conformity  assessment.  It  explains  what  conformity  assessment  is  and 
describes  its  mechanisms  and  its  role  in  the  supply  chain  of  a  product. 
Furthermore  it  explains  the  role  of  the  stakeholders  involved  and  provides  a 
detailed  analysis  of  the  conformity  assessment  procedures  as  defined  in 
Decision 768/2008. 

SOGS N612 EN or CERTIF 2009–08 "Using Harmonised Standards to assess 
the  competence  of  Conformity  Assessment  Bodies  in  the  context  of  the  New 
Legislative  Framework"  is  addressed  mainly  to  Accreditation  Bodies  and 
describes  for  every  conformity  assessment  module  which  of  the  Harmonised 
Standards  published  in  the  Official  Journal  of  the  EU  reflect  the  criteria 
Conformity  Assessment  Bodies  must  fulfil  in  order  to  be  notified  for  the 
module in question. 

The documents are available on the Commission's website38. 

38 

http://ec.europa.eu/enterprise/policies/single-market-goods/documents/certif_doc_en.htm. 

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