Proposal for a Regulation of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products {SEC(2007) 173} {SEC(2007) 174}
Date: 2007-02-14
Institutions: European Commission
Subjects: EC conformity marking, consumer protection, free movement of goods, harmonisation of standards, market supervision, marketing, product safety

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.2.2007 
COM(2007) 37 final 

2007/0029 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

SETTING OUT THE REQUIREMENTS FOR ACCREDITATION AND MARKET 
SURVEILLANCE RELATING TO THE MARKETING OF PRODUCTS  

{SEC(2007) 173} 
{SEC(2007) 174} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  Grounds for and objectives of the proposal 

Free  movement  of  goods,  a  central  pillar  of  the  Single  Market,  is  a  major  driver  for 
competitiveness and economic growth in the EU. Moreover, Community technical legislation 
ensuring the free circulation of products has contributed considerably to the completion and 
operation of the Single Market. It provides for high levels of protection to be respected and 
generally also provides economic operators with the means to demonstrate conformity, thus 
ensuring free circulation through trust in the products..  

Experience in the implementation of all this legislation has shown, however: 

–  a certain risk of distortion to competition because of differing practices in the designation 
of conformity assessment bodies by national authorities and unequal treatment in the case 
of  non  complying  or  dangerous  products  on  the  market,  through  very  different  national 
market surveillance infrastructures, rules and means. 

–  a certain lack of trust in conformity marking. 

–  a certain lack of coherence in its implementation and enforcement. 

The proposals, following the Council's Resolution of 10 November 2003, have the objective 
to  provide  a  common  framework  for  the  existing  infrastructures  for  accreditation  for  the 
control of conformity assessment bodies, and market surveillance for the control of products 
and economic operators, by reinforcing and extending what exists and not weakening existing 
instruments  such  as  the  General  Product  Safety  Directive  which  is  very  successful  and 
effective.  Secondly  they  set  out  agreed  references  for  the  organisation  of  the  revision  of 
existing  product  related  Community  harmonisation  legislation,  where  necessary  and  for  the 
development of future product related legislation. 

•  General context 

The present proposals are very much within the framework of the overall Commission policy 
to promote simplification and better regulation as widely as possible. Originally the Council, 
in  its  Resolution  of  10  November  2003,  invited  the  Commission  to  review  only  the  “new 
approach”  directives.  However  faced  with  the  possibility  of  bringing  together  harmonised 
instruments  that  could  apply  regardless  of  the  legislative  technique  used  (old/new  approach 
legislation) the option followed has been to put forward proposals that can apply in as many 
sectors as possible within a coherent and transparent, harmonised manner, with standardised 
instruments. This covers in particular such issues as definitions such as placing on the market 
etc, the obligations for economic operators, the evaluation of the competence of conformity 
assessment  bodies,  conformity  assessment  procedures,  control  of  products  from  third 
countries or conformity marking issues.  

It  also  covers  the  issues  relating  to  market  surveillance  in  general.  It  is  possible  to  put  into 
place an overall policy and infrastructures throughout the Community without having to do so 
sector by sector and especially by building on the experience of the General Product Directive 

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for consumer products, whose principles and mechanisms can be extended to the surveillance 
of all products, whether consumer products or products for professional use. 

•  Existing provisions in the area of the proposal 

The Council Resolution of 7 May 1985 relating the new approach to technical harmonisation 
and standardisation is the founding document in this area, whilst Council Decision 93/465 of 
22 July 1993 sets out the basic rules for CE marking and for the application of the harmonised 
conformity  assessment  procedures.  These  texts  have  been  complemented  by  different 
resolutions  on  standardization  as  well  as  by  Directive  98/34  recognising  the  role  of  the 
European  standardization  organizations  and  the  priority  for  European  standards,  not  to 
mention the 25 “new approach directives relating to different product sectors. 

Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  on  general  product 
safety provides a market surveillance infrastructure and information exchange system for the 
non harmonised areas and sets obligations for economic operators and national authorities in 
relation to consumer products. 

•  Consistency with the other policies and objectives of the Union 

These  proposals  are  central  to  the  completion  of  the  Single  market  for  products,  and 
contribute to other policies such as in particular, protection of the consumer, of workers and 
of  the  environment.  They  are  integral  to  the  overall  policies  of  the  Commission  within  the 
Lisbon agenda on the chapters better regulation, simplification and market surveillance. 

•  Consistency with the other policies and objectives of the Union 

These  proposals  are  central  to  the  completion  of  the  Single  market  for  products,  and 
contribute to other policies such as in particular, protection of the consumer, of workers and 
of  the  environment.  They  are  integral  to  the  overall  policies  of  the  Commission  within  the 
Lisbon agenda on the chapters’ better regulation, simplification and market surveillance. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents 

The content of the proposals was put together following 20 working documents which were 
widely circulated to all the major stakeholders. This brought some 250 contributions. 

In  2006  an  internet  consultation  via  Your  Voice  in  Europe  (IPM)  provoked  280  answers 
which mainly confirmed the results of the first consultations. 

The  Commission  drew  up  4  fact  finding  questionnaires  dedicated  to  different  stakeholder 
groups. The questionnaire for companies was used by the Euro Info Centre network to carry 
out a business panel operation (i.e. face to face interviews with 800 SMEs). 

Summary of responses and how they have been taken into account 

The contributions received confirm that the proposals should build on what exists as opposed 

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to  creating  a  new  system.  Thus  the  existing  accreditation  system  requires  a  legal  base  as 
opposed  to  being  replaced  by  another  system.  They  reaffirm  it  as  a  public  authority  activity 
and that, as such, should be free of commercial competition. The conformity assessment body 
system requires stricter selection criteria and harmonised national selection processes. Support 
was given to the harmonised definitions and the obligations set out for the economic operators. 
It was confirmed that a systematic requirement for authorised representatives did not solve the 
problem  of  traceability.  Practically  all  contributions  supported  a  Community  market 
surveillance system with information and cooperation system between national authorities in 
extension  to  the  mechanisms  of  the  GPSD  and  without  creating  new  tools.  The  option  of 
abandoning the CE marking was contested and clarifying its meaning and protecting it legally 
were supported..  

An  open  consultation  was  conducted  over  the  internet  from  01/06/2006  to  26/07/2006.  The 
Commission 
on 
http://ec.europa.eu/enterprise/newapproach/review_en.htm. 

responses. 

available 

received 

results 

The 

280 

are 

•  Collection and use of expertise 

Scientific/expertise domains concerned 

Professionals  in  the  fields  of  Conformity  assessment,  accreditation,  market  surveillance, 
standardisation  and  technical  harmonisation  were  involved  as  well  as  experts  from  trade, 
consumer protection and other associations. 

Methodology used 

The experts were consulted on the working documents, participated in meetings and were the 
addressees of the questionnaires. 

Main organisations/experts consulted 

The national experts responsible for standardization and horizontal issues have been consulted 
as have been those responsible for the implementation of Community legislation. The experts 
in  the  field  of  accreditation  and  conformity  assessment  have  also  been  consulted  as  have 
professional trade and consumer associations. 

Summary of advice received and used 

The  vast  majority  of  experts  have  expressed  agreement  with  the  contents  of  the  proposals 
which were drawn up on the basis of their contributions. 

Means used to make the expert advice publicly available 

The option of placing their contributions on the new approach website with the results of the 
consultations is being examined. 

•  Impact assessment 

Basically there are three general options:  

(1) 

The first option consists in keeping the current situation unchanged. Products covered 
by  Community  harmonisation  legislation  would  be  marketed  under  the  conditions 

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created by the existing legal framework and the non-legislative measures currently in 
place. 

(2) 

The second option comprises non-regulatory measures which could be taken without a 
need  to  change  the  existing  or  introducing  new  legislation.  There  are  however  two 
limitations to the potential scope of this option:  

(a) 

(b) 

Problems  originating  in  the  existing  legal  provisions  can  only  be  eliminated 
through a change in the legislation. 

The Commission has made extensive use of non-regulatory instruments. In the 
area  of  market  surveillance  and  evaluation/monitoring  of  notified  bodies  they 
have so far been insufficient to address effectively the problems related to the 
uneven level of enforcement by national authorities.  

(3) 

The  third  option  comprises  measures  requiring  the  intervention  of  the  Community 
legislator accompanied by the reinforcement of non regulated instruments.  

The only option which answers the feedback from all the stakeholders and which provides the 
solutions to the problems exposed is option 3. 

The  Commission  carried  out  an  impact  assessment  listed  in  the  Work  Programme,  whose 
report is accessible on http://ec.europa.eu/enterprise/newapproach/review_en.htm. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  Summary of the proposed action 

The proposals complete the different existing legislative tools by putting forward reinforced 
Community policies on market surveillance and accreditation; to bring coherence to existing 
sectoral  instruments  and  to  examine  how  these  horizontal  instruments  can  be  applied  to  all 
sectors regardless of whether they are "old" or "new" approach. 

The proposals consist in: a regulation for the introduction of accreditation and reinforcement 
market surveillance, and a sui generis decision to set the framework for future legislation. 

The regulation should: 

–  organise  accreditation  at  the  national  and  European  levels;  irrespective  of  the  different 
sectors  of  activity  in  which  accreditation  is  used.  The  proposal  insists  on  the  public 
authority  nature  of  accreditation  in  order  for  it  to  be  the  last  level  of  public  authority 
control, and sets the framework for the recognition of the existing organisation European 
co-operation  for  Accreditation  (EA)  so  as  to  ensure  the  proper  functioning  of  a  rigorous 
peer evaluation. 

–  ensure,  when  not  foreseen  in  other  applicable  Community  legislation,  that  national 
authorities  are  given  equivalent  means  of  intervention  and  the  necessary  authority  to 
intervene in the market to be able to restrict or withdraw non compliant or unsafe products. 
It  ensures  cooperation  as  between  the  internal  authorities  and  the  customs  authorities 
controlling  products  entering  the  market  from  third  countries  and  sets  the  framework  for 

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the exchange of information between national authorities and cooperation between them in 
the case of products on the markets of more than one Member State. 

The decision should: 

–  set the general framework for future sectoral legislation and give guidance on how to use 
the common elements to ensure as much coherence in future sectoral legislation as can be 
politically and technically possible. 

–  set out harmonised definitions, common obligations for the economic operators, criteria for 
the  selection  of  the  conformity  assessment  bodies,  criteria  for  the  national  notifying 
authorities  and  rules  for  the  notification  process.  These  elements  are  supported  by  the 
provisions  on  accreditation.  It  also  sets  out  the  rules  for  the  selection  of  conformity 
assessment procedures as well as the harmonised range of procedures. 

–  provide  a  single  definition  for  the  CE  marking  and  rules  of  responsibility  for  those  who 
affix it and provide for its protection as a Community collective mark, for those directives 
which already provide for it. 

–  put into place a proper information and market surveillance procedure as a prolongation of 
the GPSD system, for the effective enforcement of Community harmonisation legislation 
and to make the link with the safeguard clauses of such legislation. 

–  provide  harmonised  provisions  for  the  future  safeguard  mechanisms  as  a  complement  to 

those for market surveillance. 

•  Legal basis 

The proposals are based on Article 95 of the Treaty. The Regulation is also based on Article 
133 for the control of products from 3rd countries. 

•  Subsidiarity principle 

For over 20 years, in spite of Community policy initiatives for cooperation and development 
of  common  tools,  the  national  instruments  continue  to  vary  and  create  problems  for  an 
equivalent level of protection throughout the Community. Experience in the implementation 
of Community legislation has shown that national non harmonised initiatives have the effect 
of creating discrepancies which counteract the advantages of harmonisation and the internal 
market. 

Most of the contents of the proposal are geared to completing and bringing coherence to the 
legislative  instruments  used  by  the  Community  institutions  to  harmonise  the  national 
legislations which have created barriers to trade in the past or could create them in the future. 
They  are  not  designed  to  create  a  new  European  superstructure  but  to  set  a  framework  for 
better coordination and operation of infrastructures at the national level. 

The  objective  of  Community  legislation  is  to  create  a  sufficient  level  of  trust  as  between 
national authorities and as between operators throughout the Union. This can only be done if 
the  criteria  for  the  operation  of  legislative  requirements  are  fixed  in  common  and  that  the 
national systems put in place for their implementation can show that that they follow similar 
rules, processes and give equivalent results. 

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If  these  activities  are  not  harmonised  the  legislation  misses  its  major  objective  which  is  to 
contribute to the protection of the citizen and to the operation of the Internal Market.  

•  Proportionality principle 

The  present  proposals  are  in  most  cases  built  on  existing  practices,  procedures  and 
infrastructures and constitute more their consolidation and extension than the creation of new 
measures and infrastructures. In the field of accreditation the proposals confirm the existing 
system giving it a Community legal basis and framework. In the field of market surveillance, 
the  objective  of  the  proposals  is  to  coordinate  the  effective  functioning  of  subsidiarity 
activities and responsibilities by the national authorities. The information tools will be geared 
to extending existing tools (such as RAPEX) as opposed to creating new ones. The contents 
of  the  sui  generis  decision,  by  definition,  do  not  create  in  themselves  any  measures  which 
impound  on  national  powers  and  responsibilities.  The  implementation  of  these  measures  in 
future sectoral EU legislation will also be based on the techniques used today in the field of 
the elimination of technical barriers to trade, i.e. based very much on national implementation 
and  intervention  as  opposed  to  Commission  action.  Community  intervention  is  reduced  to 
coordination, cooperation and information in most cases. Where the Community intervenes is 
in cases of safeguard clauses where only the Community can take decisions. The objective of 
these proposals is to reinforce the operation of Community legislation in the field and to avoid 
as much as possible the need for further Community intervention. 

•  Choice of instruments 

The Commission has taken the option of splitting its proposal into two separate legal texts in 
order to take on board the consequences in legal terms of the contents of the proposals: the 
regulation sets the overall framework that completes all the existing legislation in relation to 
accreditation  and  market  surveillance.  This  Regulation  does  not  modify  existing  EU 
legislation  but  complements  it  and  helps  make  the  notification  of  conformity  assessment 
bodies and the operation of safeguard clauses more operational The Decision sets guidelines 
for the future legislator. For this purpose a sui generis decision is proposed, as was done in 
1993 in this same area, in order to set out the common elements for the future, accompanied 
by  guidelines  for  their  implementation.  Future  sectoral  legislation,  new  or  revisions  of 
existing  legislation,  should  use  these  elements  wherever  possible  to  ensure  coherence, 
simplification and to follow rules of better regulation. 

4. 

BUDGETARY IMPLICATION 

The Community financial contribution is extremely reduced in overall terms. In the field of 
accreditation  a  financial  contribution  of  some  15%  of  the  operational  costs  of  EA  which 
correspond  to  75.000  €,  is  foreseen  for  the  purpose  of  ensuring  the  proper  operation  of  the 
European peer evaluation system and therefore remains very modest. Moreover, it is foreseen 
to  provide  a  budget  intervention  of  one  million  €  for  inter  comparison  testing  which 
represents 10% of possible costs if all safeguard clause cases were to lead to inter comparison 
testing. In the field of market surveillance a 1.2 million € contribution for the cooperation of 
all  national  market  surveillance as  well  as  the  exchange  of  information  procedures  between 
them  covering  the  full  range  of  industrial  products  and  covering  controls  of  products 
manufactured in the Community and imported from third countries is minute compared to the 
present non coordinated costs of national market surveillance 

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5. 

ADDITIONAL INFORMATION 

•  Simplification 

The  proposal  provides  for  simplification  of  legislation,  simplification  of  administrative 
procedures for public authorities (EU or national), simplification of administrative procedures 
for private parties. 

The simplification will concern the contents of legislation and the manner in which it is drawn 
up  with  consolidated  ranges  of  solutions  which  have  already  been  tested  and  have  proven 
their effectiveness, meaning that the legislator will be faced with a catalogue of best practices. 

The proposals set standard rules and processes to operate across all sectors, in the form of best 
practices. By consolidating the rules and procedures into a set range, life should be simpler for 
the  national  public  authorities,  for  economic  operators  and  the  consequence  should  be  a 
clearer legislative and administrative image of the Community and greater legal stability. 

Standardised rules across all legislative sectors which apply to the same economic operators 
will lead to greater clarity, greater legal stability more coherence in the measures applicable to 
them  and  eventually  a  reduction  of  some  of  the  burdens  in  conformity  assessment  when  a 
harmonised  market  surveillance  policy  can  take  some  of  the  weight  off  the  pre  marketing 
requirements. 

The  proposal  is  included  in  the  Commission's  Work  and  Legislative  Programme  under  the 
reference CWLP 2006/ENTR 001. 

•  Repeal of existing legislation 

The adoption of the proposal will lead to the repeal of Council regulation 93/339 EEC. 

•  European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the  European 
Economic Area. 

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2007/0029 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

SETTING OUT THE REQUIREMENTS FOR ACCREDITATION AND MARKET 
SURVEILLANCE RELATING TO THE MARKETING OF PRODUCTS  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Articles 
95 and 133 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Having regard to the opinion of the Committee of the Regions3, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas:  

(1) 

(2) 

(3) 

1 
2 
3 
4 
5 

For the purpose of strengthening the overall framework ensuring that products respect 
a high level of protection of public interests, such as health and safety, it is necessary 
to  establish  certain  rules  and  principles  in  relation  to  accreditation  and  market 
surveillance, which are important aspects of that framework.  

This Regulation is to be seen as part of an overall framework ensuring a high level of 
safety of products as provided for in Decision ……. of the European Parliament and of 
the Council of ……. setting up a framework for the marketing of products. 

Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  the  Council  of  28 
January  2002  laying  down  the  general  principles  and  requirements  of  food  law, 
establishing  the  European  Food  Safety  Authority  and  laying  down  procedures  in 
matters of food safety5 and Regulation (EC) No 882/2004 of the European Parliament 
and  of  the  Council  of  29  April  2004  on  official  controls  performed  to  ensure  the 
verification of compliance with feed and food law, animal health and animal welfare 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ 
L 100, 8.4.2006, p. 3). 

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rules6  already  lay  down  a  common  and  uniform  regime  on  matters  covered  by  this 
Regulation.  In  cases  governed  by  food  law  and  feed  law  the  rules  laid  down  in  this 
Regulation  should  not  therefore  apply.  However,  given  the  specific  nature  of  the 
accreditation  obligations  contained  in  Council  Regulation  (EC)  No  509/2006  of  20 
March  2006  on  agricultural  products  and  foodstuffs  as  traditional  specialities 
guaranteed7,  Council  Regulation  (EC)  No  510/2006  of  20  March  2006  on  the 
protection  of  geographical  indications  and  designations  of  origin  for  agricultural 
products  and  foodstuffs8  and  [Council  Regulation  (EC)  No  […/…]  of  …  on  organic 
production and labelling of organic products9], it is appropriate that the provisions of 
this Regulation should apply for the purposes of those accreditation obligations.  

Due  to  their  specific  nature,  tobacco  products  under  Directive  2001/37/EC  of  the 
European Parliament and of the Council of 5 June 2001 on the approximation of laws, 
regulations  and  administrative  provisions  of 
the  Member  States  concerning 
manufacture, presentation and sale of tobacco products10 should be excluded from this 
Regulation. 

Directive  2002/98/EC  of  the  European  Parliament  and  of  the  Council  of  27  January 
2003  setting  standards  of  quality  and  safety  for  the  collection,  testing,  processing, 
storage  and  distribution  of  human  blood  and  blood  components  and  amending 
Directive 2001/83/EC11, and Directive 2004/23/EC of the European Parliament and of 
the  Council  of  31  March  2004  on  setting  standards  of  quality  and  safety  for  the 
donation,  procurement,  testing,  processing,  preservation,  storage  and  distribution  of 
human  tissues  and  cells12,  lay  down  a  common  regime  for  the  products  covered 
therein, which should not therefore be subject to this Regulation.  

Accreditation is part of an overall system including conformity assessment and market 
surveillance  to  assess  and  ensure  the  conformity  of  products  with  the  applicable 
requirements. 

The  particular  value  of  accreditation  lies  in  the  fact  that  it  provides  an  authoritative 
statement of the technical competence of bodies whose task is ensuring that products 
are in conformity with the requirements applicable to them.  

Accreditation,  though so far not regulated at the Community level, is operated in  all 
Member  States.  The  lack  of  common  rules  for  that  activity  has  resulted  in  different 
approaches and differing systems throughout the Community, with the result that the 
degree  of  rigour  applied  in  the  performance  of  accreditation  has  varied  between 
Member  States.  It  is  therefore  necessary  to  develop  a  comprehensive  framework  for 
accreditation and to lay down at Community level the principles for its operation and 
organisation. 

OJ L 165, 30.4.2004; corrected version in OJ L 191, 28.5.2004, p. 1. 
OJ L 93, 31.3.2006, p. 1 
OJ  L  93,  31.3.2006,  p.  12.  Regulation  as  amended  by  Regulation  (EC)  No  1791/2006  (OJ  L  363, 
20.12.2006, p. 1). 
Proposal COM (2005) 671 final. 
OJ L 194, 18.7.2001, p. 26. 
OJ L 033, 8.2.2003, p. 30.. 
OJ L 102, 7.4.2004, p. 48. 

(4) 

(5) 

(6) 

(7) 

(8) 

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(9) 

A system of accreditation which functions by reference to binding rules contributes to 
strengthening  mutual  confidence  between  Member  States  in  the  competence  of 
conformity  assessment  bodies  and  consequently  in  the  certificates  and  test  reports 
issued by them. It thereby enhances the principle of mutual recognition and therefore 
the  provisions  on  accreditation  in  this  Regulation  should  apply  in  relation  to  bodies 
carrying  out  conformity  assessments  in  both  the  regulated  and  non-regulated  areas. 
The issue at stake is the quality of certificates and test reports irrespective of whether 
they fall under the regulated or non-regulated area and no distinction should therefore 
be made between those areas.  

(10)  Regulation  (EC)  No  761/2001  of  the  European  Parliament  and  of  the  Council  of  19 
March  2001  allowing  voluntary  participation  by  organisations  in  a  Community  eco-
management  and  audit  schemes  (EMAS)13  established  a  system  for  the  accreditation 
of independent environmental verifiers and for the supervision of their activities. Since 
the  rules  covering  that  system  differ  from  the  provisions  of  this  Regulation,  cases 
governed by Regulation (EC) No 761/2001 should be excluded from the scope of this 
Regulation. 

(11)  Since  the  purpose  of  accreditation  is  to  provide  an  authoritative  statement  of  the 
competence of a body to perform conformity assessment activities, it is necessary to 
provide that Member States should not maintain more than one national accreditation 
body  and  should  ensure  that  it  is  organised  in  such  a  way  as  to  safeguard  the 
objectivity and impartiality of its activities. Such national accreditation bodies should 
operate independently of commercial conformity assessment activities. It is therefore 
appropriate  to  provide  that  Member  States  ensure  that  in  the  performance  of  their 
tasks,  national  accreditation  bodies  are  deemed  to  exercise  public  authority, 
irrespective of their legal status. 

(12)  For  the  assessment  and  continued  monitoring  of  the  competence  of  a  conformity 
assessment  body,  it  is  essential  to  determine  its  technological  knowledge  and 
experience and its capability to carry out assessment. It is therefore necessary that the 
national accreditation body possesses the pertinent knowledge, competence and means 
for the proper performance of its tasks. 

(13)  Accreditation  should  in  principle  be  operated  as  a  self-supporting  activity.  Member 

States should ensure that financial support exists for the fulfilment of special tasks. 

(14) 

(15) 

In  those  cases  where  it  is  not  economically  meaningful  or  sustainable  for  a  Member 
State  to  establish  a  national  accreditation  body,  that  Member  State  should  have  the 
possibility  of  having  recourse  to  the  national  accreditation  body  of  another  Member 
State. 

In  order  to  avoid  duplication  of  accreditation  and  to  enhance  acceptance  and 
recognition of accreditation certificates as well as to perform effective monitoring of 
accredited conformity assessment bodies, the conformity assessment bodies should in 
principle request accreditation by the national accreditation body of the Member State 
in which they are established. Nevertheless, it is necessary to ensure that a conformity 

13 

OJ L 114, 24.2.2001, p. 1). Regulation as last amended by Commission Regulation (EC) No 196/2006 
(OJ L 32, 4.2.2006, p. 4). 

EN 

11 

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assessment body has the possibility to request accreditation in another Member State 
in  cases  where  in  its  Member  State  there  is  no  national  accreditation  body  or  where 
such  body  is  not  competent  to  provide  the  requested  accreditation  services.  In  these 
cases,  appropriate  co-operation  and  exchange  of  information  between  national 
accreditation bodies should be established. 

(16) 

(17) 

In  order  to  ensure  that  national  accreditation  bodies  fulfil  the  requirements  and 
obligations  under  this  Regulation,  it  is  important  that  Member  States  support  the 
proper  functioning  of  the  accreditation  system,  perform  regular  monitoring  of  their 
national  accreditation  bodies  and  take  appropriate  corrective  measures  where 
necessary. 

In  order  to  ensure  the  equivalence  of  the  level  of  competence  of  conformity 
assessment  bodies  and  to  facilitate  mutual  recognition  and  promote  the  overall 
acceptance  of  accreditation  certificates  and  conformity  assessment  results  issued  by 
accredited bodies, it is necessary that national accreditation bodies operate a rigorous 
and transparent peer evaluation system and regularly undergo such evaluation.  

(18)  The main mission of the European co-operation for Accreditation (EA) is to further a 
transparent  and  quality  led  system  to  evaluate  the  competence  of  conformity 
assessment bodies throughout Europe. The EA is managing a peer evaluation system 
among  national  accreditation  bodies  from  the  Member  States  and  other  European 
countries.  That  system  has  proved  to  be  efficient  and  to  provide  mutual  confidence. 
Therefore, Member States should ensure that their national accreditation bodies  seek 
or maintain membership in the EA. 

(19)  Effective co-operation among national accreditation bodies is essential for the proper 
implementation  of  peer  evaluation  and  with  regard  to  cross-frontier  accreditation.  In 
the interests of transparency, it is, therefore, necessary to provide for an obligation for 
national accreditation bodies to exchange information among themselves as well as to 
provide  the  relevant  information  to  the  national  authorities  and  the  Commission. 
Updated  and  accurate  information  about  the  availability  of  accreditation  activities 
operated  by  national  accreditation  bodies  should  also  be  made  public  and,  therefore, 
accessible in particular to conformity assessment bodies. 

(20)  The  sectoral  accreditation  schemes  should  cover  the  fields  of  activity  where  general 
requirements  for  competence  of  conformity  assessment  bodies  are  not  sufficient  to 
ensure the necessary level of protection where specific detailed technology or health 
and  safety  related  requirements  are  imposed.  Given  the  fact  that  the  EA  has  at  its 
disposal a broad range of technical expertise, it should be requested to develop such 
schemes, especially for areas covered by Community legislation. 

(21)  For the purposes of ensuring an equivalent and consistent enforcement of Community 
harmonisation 
introduces  a  Community  market 
this  Regulation 
surveillance framework, defining both minimum requirements against the background 
of the objectives to be achieved by Member States, and a framework for administrative 
cooperation including the exchange of information among Member States.  

legislation, 

(22) 

In certain sectors Community requirements already exist in order to ensure that market 
surveillance  activities  are  carried  out  on  the  basis  of  common  rules.  To  avoid  any 
overlaps,  those  sectors  should  not  be  not  subject  to  this  Regulation.  Hence,  the 

EN 

12 

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following instruments should be excluded from the provisions on market surveillance 
but  come  under  the  scope  of  the  provisions  for  control  of  products  from  third 
countries: Council Directive 70/156/EEC of 6 February 1970 on the approximation of 
the laws of the Member States relating to the type-approval of motor vehicles and their 
trailers14, Council Directive 76/768/EEC of 27 July 1976 on the approximation of the 
laws  of  the  Member  States  relating  to  cosmetic  products15,  Council  Directive 
90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating  to  active  implantable  medical  devices16,  Council  Directive  93/42/EEC  of  14 
June  1993  concerning  medical  devices17,  Directive  97/68/EC  of  the  European 
Parliament and of the Council of 16 December 1997 on the approximation of the laws 
of  the  Member  States  relating  to  measures  against  the  emission  of  gaseous  and 
particulate polluants from the internal combustion engines to be installed in non-road 
mobile  machinery18,  Directive  98/79/EC  of  the  European  Parliament  and  of  the 
Council  of  27  October  1998  on  in  vitro  diagnostic  medical  devices19,  Directive 
2001/82/EC of the European  Parliament and  of  the  Council  of  6  November  2001  on 
to  veterinary  medicinal  products20,  Directive 
the  Community  code  relating 
2001/83/EC of the European  Parliament and  of  the  Council  of  6  November  2001  on 
the  Community  code  relating  to  medicinal  products  for  human  use21,  Directive 
2002/88/EC  of  the  European  Parliament  and  of  the  Council  of  9  December  2002 
amending Directive 97/68/EC on the approximation of the laws of the Member States 
relating  to  measures  against  the  emission  of  gaseous  and  particulate  pollutants  from 
internal combustion engines to be installed in non-road mobile machinery22, Directive 
2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating 
to  the  type-approval  of  two  or  three-wheel  motor  vehicles  and  repealing  Council 
Directive  92/61/EEC23,  Regulation  (EC)  No  1592/2002  of  the  European  Parliament 
and of the Council of 15 July 2002 on common rules in the field of civil aviation and 
establishing  a  European  Aviation  Safety  Agency24,  Directive  2003/37/EC  of  the 
European  Parliament  and  of  the  Council  of  26 May  2003  on  type-approval  of 
agricultural  or  forestry  tractors,  their  trailers  and  interchangeable  towed  machinery, 
together  with  their  systems,  components  and  separate  technical  units  and  repealing 
Directive 74/150/EEC25, Directive 2004/26/EC of the European Parliament and of the 
Council of 21 April 2004 amending Directive 97/68/EC on the approximation of the 
laws  of  the  Member  States  relating  to  measures against the emission of gaseous and 
particulate  pollutants  from  internal  combustion  engines  to  be  installed  in  non-road 
mobile machinery26, Regulation (EC) No 273/2004 of the European Parliament and of 

OJ L 42, 23.2.1970, p. 1. 

OJ L 262, 27.9.1976, p. 169. 
OJ L 189, 20.7.1990, p. 17. 

OJ L 169, 12.7.1993, p. 1. 

OJ  L  59,  27.2.1998,  p.  1.  Directive  as  last  amended  by  Council  Directive  2006/105/EC  (OJ  L  363, 
20.12.2006, p. 368). 
OJ L 331, 7.12.1998, p. 1. 

OJ L 311, 28.11.2001, p. 1. 

OJ L 311, 28.11.2001, p. 67. 

OJ L 35, 11.2.2003, p. 28. 
OJ L 124, 9.5.2002, p. 1. 
OJ L 240, 7.9.2002, p. 1. 
OJ L 171, 9.7.2003, p. 1. 

OJ L 146, 30.4.2004, p. 1. 

14 
15 
16 

17 

18 

19 

20 

21 

22 
23 
24 

25 

26 

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13 

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the Council of 11 February 2004 on drug precursors27, Regulation (EC) No 726/2004 
of  the  European  Parliament  and  of  the  Council  of  31 March  2004  laying  down 
Community procedures for the authorisation and supervision of medicinal products for 
human and veterinary use and establishing a European Medicines Agency28. 

(23)  Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  on  general 
product  safety29  has  set  up  a  market  surveillance  and  administrative  cooperation 
framework  in  respect  of  consumer  products.  The  provisions  of  this  Regulation  on 
market surveillance should not apply in relation to products, as defined in Article 2(a) 
of Directive 2001/95/EC, in so far as the health and safety of consumers is concerned. 

(24)  Cooperation  of  competent  authorities  at  the  national  level  and  across  borders  in 
exchanging information, investigating infringements and taking action to bring about 
their  cessation  is  essential  to  the  protection  of  health  and  safety  and  to  guaranteeing 
the smooth functioning of the internal market. 

(25)  Situations  of  serious  risk  posed  by  a  product  require  rapid  intervention,  which  may 
entail  the  product  being  withdrawn  from  the  market  or  recalled  or  prohibited  being 
made  available  on  the  market.  In  those  situations  it  is  necessary  to  have  access  to  a 
system of rapid exchange of information between Member States and the Commission. 
The  system  provided  by  Article  12  of  Directive  2001/95/EC  has  proved  its 
effectiveness  and  efficiency  in  the  area of  consumer  products.  To  avoid  unnecessary 
duplication, that system should be used for the purpose of this Regulation. Moreover, 
ensuring  coherent  market  surveillance  throughout  the  Community  requires  a 
comprehensive  exchange  of  information  on  national  activities  in  this  context,  going 
beyond this system. 

(26) 

Information exchanged between competent authorities should be subject to the strictest 
guarantees  of  confidentiality  and  professional  secrecy  in  order  to  ensure  that 
investigations  are  not  compromised  and  the  reputation  of  economic  operators  is  not 
unfairly harmed. Directive 95/46/EC of the European Parliament and of the Council of 
24  October  1995  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal  data  and  on  the  free  movement  of  such  data30  and  Regulation  (EC)  No 
45/2001 of the European Parliament and of the Council of 18 December 2000 on the 
protection  of  individuals  with  regard  to  the  processing  of  personal  data  by  the 
Community institutions and bodies and on the free movement of such data31 apply in 
the context of this Regulation. 

(27)  Community  legislation  harmonising  the  conditions  for  the  marketing  of  products 
provides  for  specific  procedures  establishing  whether  a  national  measure  restricting 
the free movement of a product is justified or not (safeguard clause procedures). Those 
procedures  apply  subsequently  to  a  rapid  exchange  of  information  on  products 
presenting a serious risk. 

27 

28 

29 
30 

31 

OJ L 47, 18.2.2004, p. 1. 
OJ L 136, 30.4.2004, p. 1. 
OJ L 11, 15.1.2002, p. 4. 
OJ  L  281,  23.11.1995,  p.  31.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  (OJ  L  284, 
31.10.2003, p. 1). 
OJ L 8, 12.1.2001, p. 1. 

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14 

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(28)  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 countries32 
lays  down  rules  regarding  the  suspension  of  the  release  of  products  by  customs 
authorities and provides for further proceedings including the involvement of market 
surveillance authorities. It is therefore appropriate that those provisions, including the 
involvement of market surveillance authorities, be integrated into this Regulation and 
have the same scope.  

(29)  Points of entry at the external borders are well placed to detect unsafe products even 
before they are placed on the market. An obligation for customs authorities to execute 
checks on an adequate scale can therefore contribute to a safer market place. 

(30)  Experience has shown that products which are not released are often re-exported and 
subsequently enter the Community market at other points of entry, thus negating the 
customs authorities’ efforts. Market surveillance authorities should therefore be given 
the means to proceed with the destruction of products if they deem it appropriate. 

(31)  The Member States should lay down rules on penalties applicable to infringements of 
the  provisions  of  this  Regulation  and  ensure  that  they  are  implemented.  Those 
penalties must be effective, proportionate and dissuasive. 

(32) 

In order to achieve the objectives of this Regulation, it is necessary for the Community 
to  contribute  to  the  financing  of  activities  required  to  implement  the  policies  in  the 
field of accreditation and market surveillance. Financing should be provided either in 
the form of grants without a call for proposals to the EA, or in the form of grants with 
a call for proposals or by awarding contracts to the EA or to other bodies, depending 
on the nature of the activity to be financed and in accordance with Council Regulation 
(EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable 
to  the  general  budget  of  the  European  Communities33,  hereinafter  “the  Financial 
Regulation”. 

(33)  For  some  specialised  tasks,  such  as  the  production  and  revision  of  sectoral 
accreditation  schemes,  and  for  other  tasks  related  to  verification  of  the  technical 
competence and facilities of laboratories and certification or inspection bodies the EA 
should  be  eligible  for  Community  financing,  since  it  is  well  adapted  to  provide  the 
necessary technical expertise in this respect. 

(34)  Given  the  function  of  the  EA  in  the  peer  evaluation  of  accreditation  bodies  and  its 
ability to assist the Member States with the management of such peer evaluation, the 
Commission  should  be  in  a  position  to  provide  grants  for  the  functioning  of  the  EA 
secretariat  which  should  provide  ongoing  support  for  accreditation  activities  at 
Community level. 

(35)  A  partnership  agreement  should  be  signed,  in  accordance  with  the  provisions  of  the 
Financial  Regulation,  between  the  Commission  and  the  EA  in  order  to  fix  the 
administrative and financial rules on financing accreditation activities. 

32 

33 

OJ  L  40,  17.2.1993,  p.  1.  Regulation  as  amended  by  Regulation  (EC)  No  806/2003  (OJ  L  122, 
16.5.2003, p. 1). 
OJ  L  248,  16.9.2002,  p.  1.  Regulation  as  last  amended  by  Council  Regulation  (EC, 
Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1). 

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(36) 

In  addition,  financing  should  also  be  available  to  other  bodies  besides  the  EA  as 
regards other activities in the field of conformity assessment, metrology, accreditation 
and  market  surveillance,  such  as  drawing  up  and  updating  of  guidelines,  inter-
comparison  activities  linked  to  the  operation  of  safeguard  clauses,  preliminary  or 
ancillary activities in connection with the implementation of Community legislation in 
the  said  areas  and  programmes  of  technical  assistance  and  co-operation  with  non-
member  countries  as  well  as  enhancement  of  the  policies  in  the  said  areas  at 
Community and international level.  

(37)  This Regulation respects the fundamental rights and observes the principles reflected 

in the Charter of Fundamental Rights of the European Union. 

(38)  Since  the  objective  of  the  Regulation,  namely  to  ensure  that  products  on  the  market 
covered by Community legislation respect a high level of health and safety and other 
public  interests,  whilst  guaranteeing  the  functioning  of  the  internal  market,  by 
providing  a  framework  for  accreditation  and  market  surveillance,  cannot  be 
sufficiently  achieved  by  the  Member  States  and  can  therefore,  by  reason  of  its  scale 
and  effects,  be  better  achieved  at  Community  level,  the  Community  may  adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty. In accordance with the principle of proportionality, as set out in that Article, 
this  Regulation  does  not  go  beyond  what  is  necessary  in  order  to  achieve  this 
objective, 

HAVE ADOPTED THIS REGULATION: 

CHAPTER I 
GENERAL PROVISIONS 

Subject matter and scope 

Article 1 

1. 

This Regulation lays down rules on the organisation and operation of accreditation of 
conformity  assessment  bodies  performing  assessment  of  any  substance,  preparation 
or  other  product,  whether  or  not  such  substance,  preparation  or  product  has 
undergone transformation, to be placed on the Community market. 

It also provides a framework for market surveillance and the control of products from 
third  countries  to  ensure  that  substances,  preparations  and  transformed  products 
subject  to  Community  legislation  harmonising  the  conditions  for  the  marketing  of 
products, hereinafter “Community harmonisation legislation” respect a high level of 
protection of public interests such as health and safety in general, of health and safety 
at the workplace, protection of consumers, of the environment, and of security.  

2. 

This Regulation shall not apply in cases governed by: 

(a) 

food law as defined in Article 3 of Regulation (EC) N° 178/2002 with 
the exception, as regards Chapter II, of Regulation (EC) N° 509/2006, 

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510/2006 and […/…] [on organic production and labelling of organic 
products];  

(b) 

feed law as defined in Article 3 of Regulation (EC) N° 882/2004; 

(c) 

Directive 2001/37/EC; 

(d) 

Directive 2002/98/EC; 

(e) 

Directive 2004/23/EC. 

Article 2 

Definitions 

For the purposes of this Regulation the following definitions shall apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

“making  available  on  the  market”  means  any  supply  of  a  product  for 
distribution, consumption or use on the Community market in the course of a 
commercial activity, whether in return for payment or free of charge; 

“placing on the market” means the first making available of a product on the 
Community market;  

“manufacturer” means a natural or legal person who designs or manufactures 
a  product  or  who  has  such  a  product  designed  or  manufactured,  under  his 
name or trademark;  

“authorised  representative”  means  any  natural  or  legal  person  established 
within  the  Community  who  has  received  a  written  mandate  from  the 
manufacturer to act on his behalf for specified tasks with regard to the latter’s 
obligations under the relevant Community legislation; 

“distributor”  means  any  natural  or  legal  person  in  the  supply  chain,  who 
makes a product available on the market; 

“importer”  means  any  natural  or  legal  person  established  within  the 
Community,  who  places  a  product  from  a  third  country  on  the  Community 
market; 

“economic  operators”  means  the  manufacturer,  the  importer,  distributor  and 
the authorised representative; 

“technical specification” has the meaning assigned to it by point 3 of Article 1 
of Directive 98/34/EC; 

“harmonised  standard”  means  a  standard  adopted  by  one  of  the  European 
standardisation bodies listed in Annex I to Directive 98/34/EC in accordance 
with Article 6 of Directive 98/34/EC; 

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(10) 

(11) 

(12) 

(13) 

“accreditation”  means  a  third-party  attestation,  related  to  a  conformity 
assessment body, conveying formal demonstration of its competence to carry 
out specific conformity assessment tasks;  

“national accreditation body” means the sole authoritative body in a Member 
State that performs accreditation with authority derived from government; 

“recall”  means  any  measure  aimed  at  achieving  the  return  of  a  product  that 
has already been made available to the end user. 

“withdrawal”  shall  mean  any  measure  aimed  at  preventing  the  making 
available on the market of a product in the supply chain. 

CHAPTER II 
ACCREDITATION 

Article 3 

Scope 

1. 

Where  accreditation  is  used  on  a  compulsory  or  voluntary  basis  to  assess  the 
competence of conformity assessment bodies to carry out conformity assessment of 
any  substance,  preparation  or  other  product,  whether  or  not  such  substance, 
preparation  or  product  has  undergone  transformation,  this  Chapter  shall  apply, 
irrespective of the legal status of the body performing the accreditation. 

2. 

This  Chapter  shall  apply  to  accreditation  referred  to  in  Regulations  (EC)  Nos 
509/2006 and 510/2006 and […/…] [on organic production and labelling of organic 
products]. 

3. 

This chapter shall not apply in cases governed by Regulation (EC) No 761/2001. 

General principles 

Article 4 

1. 

2. 

3. 

Accreditation  shall  be  operated  in  each  Member  State  by  a  single  national 
accreditation body. 

Where  a  Member  State  considers  it  not  economically  meaningful  or  sustainable  to 
have a national accreditation body or to provide certain accreditation services, it may 
have recourse to a national accreditation body of another Member State.  

A Member State shall inform the Commission and the other Member States where a 
national  accreditation  body  is  established  and  for  which  conformity  assessment 
activities it performs accreditation, including any changes thereto.  

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It  shall  inform  the  Commission  and  the  other  Member  States  where,  in  accordance 
with paragraph 2, recourse is had to a national accreditation body of another Member 
State. 

The national accreditation body shall be deemed to exercise public authority.  

The  responsibilities  and  tasks  of  the  national  accreditation  body  shall  be  clearly 
distinguished from those of other national authorities. 

The national accreditation body shall operate on a non profit basis. It may not offer 
or provide any activities or services that conformity assessment bodies provide, nor 
may it provide consultancy services. 

Member States shall ensure that their national accreditation body has the appropriate 
resources, both financial and personnel, for the proper performance of its tasks. 

The national accreditation body shall seek membership of European co-operation for 
Accreditation (EA).  

4. 

5. 

6. 

7. 

8. 

Operation of accreditation 

Article 5 

1. 

2. 

3. 

4. 

National  accreditation  bodies  shall,  when  requested  by  a  conformity  assessment 
body, evaluate whether the conformity assessment body is competent to carry out a 
specific  conformity  assessment  activity  and,  where  that  is  the  case,  issue  an 
accreditation certificate to that effect. 

The  national  accreditation  body  shall  monitor  any  conformity  assessment  body  to 
which it has issued an accreditation certificate. 

Where the national accreditation body ascertains that a conformity assessment body 
which has received an accreditation certificate is no longer competent to carry out a 
specific  conformity  assessment  activity  or  commits  a  serious  breach  of  its 
obligations,  the  national  accreditation  body  shall  take  all  appropriate  measures  to 
restrict, suspend or withdraw its accreditation certificate.  

Member  States  shall  establish  procedures  for  the  resolution  of  appeals  and 
complaints made against accreditation decisions, or the absence thereof.  

Cross-frontier accreditation 

Article 6 

1. 

Where  a  conformity  assessment  body  requests accreditation,  it  shall  do  so  with  the 
national accreditation body of the Member State in which it is established or with the 
national accreditation body to which that Member State has had recourse pursuant to 
Article 4(2). 

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However,  a  conformity  assessment  body  may  request  accreditation  by  a  national 
accreditation body other than those referred to in the first subparagraph in any one of 
the following situations: 

(a) 

(b) 

(c) 

where the Member State in which it is established has decided not to 
establish  a  national  accreditation  body  and  has  not  had  recourse  to  a 
national  accreditation  body  of  another  Member  State  pursuant  to 
Article 4(2); 

where  the  national  accreditation  bodies  referred  to  in  the  first 
subparagraph  do  not  perform  accreditation 
the 
in  respect  of 
conformity assessment activities for which accreditation is sought; 

where  the  national  accreditation  bodies  referred  to  in  the  first 
subparagraph  have  not  yet,  or  have  not  successfully,  undergone  the 
peer  evaluation  under  Article  9  in  respect  of  the  conformity 
assessment activities for which accreditation is sought. 

2. 

3. 

Where a national accreditation body receives a request under paragraph 1 (b) or (c), 
it  shall  inform  the  national  accreditation  body  of  the  Member  State  in  which  the 
requesting  conformity  assessment  body  is  established.  In  such  cases,  the  national 
accreditation  body  of  the  Member  State  in  which  the  requesting  conformity 
assessment body is established may require to participate as an observer. 

A  national  accreditation  body  may  request  another  national  accreditation  body  to 
carry out a part of the assessment activity. In such a case, the accreditation certificate 
shall be issued by the requesting body. 

Article 7 

Requirements for national accreditation bodies 

A national accreditation body shall fulfil the following requirements: 

(1) 

(2) 

(3) 

(4) 

(5) 

it  shall  be  organised  in  such  a  manner  as  to  make  it  independent  from  the 
conformity  assessment  bodies  which  it  assesses  and  from  commercial 
pressures  and  to  ensure  that  no  conflicts  of  interest  occur  with  conformity 
assessment bodies; 

it shall document the duties, responsibilities and authorities of personnel who 
could affect the quality of the assessment and attestation of competence; 

it  shall  be  organised  and  operated  so  as  to  safeguard  the  objectivity  and 
impartiality of its activities; 

it shall ensure that each decision relating to the attestation of competence is 
taken  by  competent  persons  different  from  those  who  carried  out  the 
assessment; 

it  shall  have  adequate  arrangements  to  safeguard  the  confidentiality  of  the 
information obtained; 

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(6) 

(7) 

(8) 

(9) 

it shall identify the conformity assessment activities for which it is competent 
to perform accreditation, referring, where appropriate, to relevant Community 
or national legislation and standards; 

it  shall  set  up  the  necessary  procedures  to  ensure  efficient  management  and 
appropriate internal controls; 

it  shall  have  a  sufficient  number  of  competent  personnel  for  the  proper 
performance of its tasks; 

it  shall  establish,  implement  and  maintain  procedures  for  monitoring  the 
performance and competence of the personnel involved. 

Compliance with requirements 

Article 8 

1. 

2. 

Member States shall monitor their national accreditation bodies at regular intervals in 
order to ensure that they fulfil the requirements laid down in Article 7. 

Member  States  may  choose  to  accept  successful  peer  evaluation  under  Article  9  as 
fulfilling the needs of the monitoring provided for in the first paragraph. 

Where a national accreditation body does not meet the requirements, or fails to fulfil 
the  obligations,  under  this  Regulation,  the  Member  State  concerned  shall  take  the 
appropriate corrective action or shall ensure that such corrective action is taken, and 
shall inform the Commission thereof. 

Peer evaluation 

Article 9  

1. 

2. 

3. 

4. 

5. 

6. 

National accreditation bodies shall operate a peer evaluation system and participate 
in it. 

Member States shall ensure that their national accreditation bodies regularly undergo 
peer evaluation. 

The  peer  evaluation  shall  be  operated  on  the  basis  of  sound  and  transparent 
evaluation criteria and procedures. Appropriate appeals procedures against decisions 
taken as a result of the evaluation shall be provided for.  

The peer evaluation shall ascertain whether the national accreditation bodies meet the 
requirements laid down in Article 7.  

The results of the peer evaluation shall be communicated to all Member States and 
the Commission. 

The  Commission  shall  oversee  the  rules  and  the  proper  functioning  of  the  peer 
evaluation system. 

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21 

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Presumption of conformity 

Article 10 

National  accreditation  bodies  that  comply  with  the  criteria  laid  down  in  the  relevant 
harmonised standard, the reference of which has been published in the Official Journal of the 
European Union, shall be presumed to fulfil the requirements set out in Article 7. 

Information obligation 

Article 11 

1. 

2. 

3. 

A national accreditation body shall inform the other national accreditation bodies of 
the conformity assessment activities in respect of which it operates accreditation and 
of any changes and extensions thereto.  

A national accreditation body shall inform the competent national authorities and the 
Commission  of  all  conformity  assessment  activities  in  respect  of  which  it  operates 
accreditation in support of Community legislation and of any changes thereto.  

A  national  accreditation  body  shall  make  publicly  available  information  about  the 
results of its peer evaluation, the conformity assessment activities in respect of which 
it operates accreditation and about any changes thereto. 

Requests to EA 

Article 12 

The  Commission,  following  consultation  of  the  Committee  set  up  by  Article  5  of  Directive 
98/34/EC,  may  request  the  EA  to  contribute  to  the  development,  maintenance  and 
implementation of accreditation in the Community. 

The Commission may also, following the procedure laid down the first paragraph, request the 
EA to develop sectoral accreditation schemes. 

Such schemes shall identify the sectoral technical specifications necessary to ensure the level 
of  competence  required  by  Community  harmonisation  legislation  in  fields  with  specific 
technology or health and safety related requirements. 

EN 

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CHAPTER III 
COMMUNITY MARKET SURVEILLANCE FRAMEWORK 
AND CONTROLS OF PRODUCTS ENTERING THE 
COMMUNITY MARKET 

SECTION 1 

GENERAL PROVISIONS 

Article 13 

Scope 

1. 

2. 

3. 

This  Chapter 
products,hereinafter “products”, covered by Community harmonisation legislation. 

substances,  preparations  and 

shall  apply 

transformed 

to 

Articles 14 to 23 shall not apply to products as defined in Article 2(a) of Directive 
2001/95/EC in so far as the health or safety of consumers is concerned.  

Articles  14  to  23  shall  not  apply  in  cases  governed  by  the  following  Community 
harmonisation legislation: 

(a) 

Directive 70/156/EEC;  

(b) 

Directive 76/768/EEC; 

(c) 

Directive 90/385/EEC;  

(d) 

Directive 93/42/EEC; 

(e) 

Directive 97/68/EC; 

(f) 

Directive 98/79/EC; 

(g) 

Directive 2001/82/EC; 

(h) 

Directive 2001/83/EC; 

(i) 

(j) 

Directive 2002/24/EC; 

Directive 2002/88/EC; 

(k) 

Regulation (EC) N° 1592/2002; 

(l) 

Directive 2003/37/EC; 

(m)  Directive 2004/26/EC; 

(n) 

Regulation (EC) N° 273/2004; 

EN 

23 

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(o) 

Regulation (EC) N° 726/2004; 

4. 

Articles 24 to 26 shall apply only in so far as other Community legislation does not 
contain specific provisions relating to the organisation of border controls on specific 
products. 

General requirements  

Article 14 

Member States shall organise and perform surveillance in order to ensure that products on the 
Community market, or entering that market, which are covered by Community harmonisation 
legislation,  satisfy  the  provisions  of  the  relevant  Community  harmonisation  legislation  and 
that  they  do  not,  under  the  condition  that  they  are  properly  installed,  maintained  and  used, 
compromise health or safety or other issues of public interest protection set out in the relevant 
Community harmonisation legislation.  

SECTION 2 

COMMUNITY MARKET SURVEILLANCE FRAMEWORK 

Information obligations 

Article 15 

Each  Member  State  shall  inform  the  Commission  and  the  other  Member  States  of  the 
authorities competent to perform market surveillance on its territory, hereinafter "the market 
surveillance authorities".  

Obligations of the Member States as regards organisation 

Article 16 

1. 

2. 

3. 

4. 

5. 

Member  States  shall  ensure  communication  and  co-ordination  between  all  the 
different market surveillance authorities.  

Member States shall establish adequate procedures in order to follow-up complaints 
or reports on issues related to risks arising from products falling under Community 
harmonisation  legislation,  monitor  accidents  and  damage  to  health  which  are 
suspected to have been caused by those products and follow up and update scientific 
and technical knowledge concerning safety issues. 

Member  States  shall  ensure  that  their  market  surveillance  authorities  have  the 
necessary powers and resources in order to properly perform their tasks. 

Member  States  shall  establish, 
surveillance programmes.  

implement  and  periodically  update  market 

Member  States  shall  periodically  review  and  assess  the  functioning  of  their 
surveillance activities.  

EN 

24 

   EN 

 
Market surveillance measures 

Article 17 

1. 

The  market  surveillance  authorities  shall  perform  appropriate  checks  on  the 
characteristics  of  products  on  an  adequate  scale,  through  documentary,  and,  where 
appropriate, physical and laboratory checks on the basis of representative samples. 

The authorities shall be entitled to require economic operators to make available such 
documentation and information as appear to them to be necessary for the purposes of 
Article 14. 

They shall also be entitled to enter the premises of the economic operators concerned 
where it appears to them to be necessary for the purposes of Article 14. 

2. 

3. 

The market surveillance authorities shall take appropriate measures in order to alert 
the users in their territory about any product they have identified as presenting a risk. 

They  shall  co-operate  with  economic  operators  on  actions  which  could  prevent  or 
reduce risks caused by products made available by them.  

The  market  surveillance  authorities  shall  carry  out 
independence and observe confidentiality and professional secrecy. 

their  duties  with  due 

Products presenting a serious risk 

Article 18 

Member States shall ensure that products which present a serious risk, including a serious risk 
the  effects  of  which  are  not  immediate,  requiring  a  rapid  intervention  are  recalled  or 
withdrawn or that they are prohibited from being made available on the market and that the 
Commission is without delay informed in accordance with Article 20. 

Restrictive measures  

Article 19 

1. 

2. 

3. 

Member  States  shall  ensure  that  any  measure  taken,  pursuant  to  the  relevant 
Community harmonisation legislation, to prohibit or restrict the making available of 
a  product,  to  withdraw  it  from  the  market  or  recall  it,  states  the  exact  grounds  on 
which it is based.  

Such  measures  shall  be  communicated  without  delay  to  the  economic  operator 
concerned, who shall at the same time be informed of the remedies available under 
the  national  law  in  force  in  the  Member  State  concerned  and  of  the  time  limits  to 
which such remedies are subject. 

Prior  to  the  adoption  of  a  measure  as  referred  to  in  paragraph  1,  the  economic 
operator  concerned,  shall  be  given  the  opportunity  to  put  forward  his  viewpoint, 
unless such consultation is not possible because of the urgency of the measure to be 

EN 

25 

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taken, as justified by health or safety requirements or other public interests covered 
by the relevant Community harmonisation legislation. 

Exchange of information – Community Rapid Information System 

Article 20 

1. 

2. 

3. 

4. 

Where  a  Member  State  takes  measures  under  Article  18  and  considers  that  the 
reasons which prompted the measures or the effects of the measures taken go beyond 
its  territory,  it  shall,  immediately,  notify  the  Commission,  in  accordance  with 
paragraph 4, of the measures taken or those it intends to take. It shall also inform the 
Commission without delay of modification or withdrawal of any such measure. 

Member States shall also notify to the Commission any voluntary measures taken by 
an economic operator in the case of a serious risk presented by a product which he 
has made available on the market. 

The  notification  under  paragraphs  1  and  2  shall  provide  all  available  details,  in 
particular  as  regards  the  necessary  data  for  the  identification  of  the  product,  the 
origin  and  the  supply  chain  of  the  product,  the  related  risk,  the  nature  and  the 
duration  of  the  national  measure  taken  and  any  voluntary  measures  taken  by 
economic operators. 

For the purposes of paragraphs 1, 2 and 3 of this Article the market surveillance and 
information  exchange  system  provided  for  in  Article  12  of  Directive  2001/95/EC 
shall  be  used.  Paragraphs  2,  3  and  4  of  Article  12  of  Directive  2001/95/EC  shall 
apply mutatis mutandis. 

Information support system  

Article 21 

1. 

2. 

The  Commission  shall  develop  and  maintain  a  general  archiving  and  exchange  of 
information system on issues relating to market surveillance activities. 

For the purposes of paragraph 1, Member States and the Commission shall provide 
information  at  their  disposal  on  products  presenting  a  risk,  in  particular, 
identification of risks, results of testing carried out, provisional restrictive measures 
taken, contacts with the economic operators concerned, and justification for action or 
lack thereof. 

The  safeguard  of  confidentiality  and  professional  secrecy  with  regard  to  the 
information content shall be ensured. The protection of professional secrecy shall not 
prevent  the  dissemination  to  the  market  surveillance  authorities  of  information 
relevant for ensuring the effectiveness of market surveillance activities.  

EN 

26 

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Article 22 

Principles of cooperation between the Member States and the Commission 

1. 

2. 

Member States shall ensure efficient co-operation and exchange of information on all 
issues  relating  to  products  presenting  a  risk  between  their  market  surveillance 
authorities and those of the other Member States and between their own authorities 
and the Commission and the relevant Community Agencies.  

For the purposes of paragraph 1, the market surveillance authorities of one Member 
State shall provide, on request, assistance to market surveillance authorities of other 
Member  States  by  supplying  information  or  documentation,  by  carrying  out 
appropriate  investigations  or  any  other  appropriate  measure  or  by  participating  in 
investigations initiated in other Member States. 

Sharing resources 

Article 23 

1. 

2. 

The  Commission  shall  draw-up  and  coordinate  market  surveillance  initiatives  for 
which expertise and cooperation of two or more Member States are required in order 
to share resources and expertise. 

For  the  purposes  of  paragraph  1,  the  Commission,  in  cooperation  with  Member 
States shall: 

(a) 

(b) 

develop  and  organise  training  programmes  and  exchange  of  national 
officials; 

set  up  appropriate  programmes  for  the  exchange  of  experience, 
information  and  best  practice,  programmes  and  actions  for  common 
projects,  information  campaigns,  joint  visit  programmes  and  the 
sharing of resources. 

3. 

Member States shall ensure that their national authorities participate in the activities 
referred to in paragraph 2, where appropriate. 

CONTROLS OF PRODUCTS ENTERING THE COMMUNITY MARKET 

SECTION 3 

Controls of products entering the Community market 

Article 24 

1. 

Member States shall ensure that their customs authorities perform or have performed 
appropriate checks on the characteristics of a product on an adequate scale before it 
is released for free circulation. 

EN 

27 

   EN 

 
2. 

The customs authorities shall suspend release of a product for free circulation when, 
in  carrying  out  the  checks  referred  to  in  paragraph  1,  they  make  either  of  the 
following findings: 

(a) 

(b) 

the  product  displays  characteristics  which  give  cause  to  believe  that 
the  product,  under  the  condition  that  it  is  properly  installed, 
maintained  and  used,  presents  a  serious  risk  to  health  or  safety  or  to 
any  other  issue  of  public  interest  protection  as  referred  to  in  the 
second subparagraph of Article 1 paragraph 1; 

the product is not accompanied by the documentation required by the 
relevant  Community  harmonisation  legislation  or  is  not  marked  in 
accordance with such legislation.  

3. 

4. 

The customs authorities shall immediately notify the market surveillance authorities 
of any such suspension. 

In  the  case  of  perishable  products,  the  market  surveillance  authorities  and  the 
customs authorities shall, as far as possible, seek to ensure that any requirements they 
may impose with regard to the storage of the products or the parking of the vehicles 
used for transport are not incompatible with the preservation of those products. 

For  the  purposes  of  this  section,  Article  22  shall  apply  in  respect  of  customs 
authorities,  without  prejudice  to  the  application  of  Community  law  providing  for 
more specific systems of cooperation between those authorities. 

Release of products 

Article 25 

1. 

2. 

A  product  the  release  of  which  has  been  suspended  by  the  customs  authorities 
pursuant  to  Article  24  shall  be  released  if,  within  three  working  days  of  the 
suspension  of  release,  the  customs  authorities  have  not  been  notified  of  any  action 
taken  by  the  market  surveillance  authorities  and  provided  that  all  the  other 
requirements and formalities pertaining to such release have been met. 

Where the market surveillance authorities find that the product in question does not 
present a serious risk to health and safety or cannot be regarded as being in breach of 
Community  harmonisation  legislation,  the  product  in  question  shall  be  released 
provided  that  all  the  other  requirements  and  formalities  pertaining  to  such  release 
have been met.  

National measures 

Article 26 

1. 

Where  the  market  surveillance  authorities  responsible  find  that  the  product 
concerned  presents  a  serious  risk,  they  shall  take  measures  to  prohibit  the  product 
from  being  placed  on  the  market  and  ask  the  customs  authorities  to  include  the 

EN 

28 

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following endorsement on the commercial invoice accompanying the product and on 
any other relevant accompanying document:  

'Dangerous product - release for free circulation not authorized - Regulation (EC) No 
…/..'. 

Where  the  market  surveillance  authorities  find  that  the  product  concerned  does  not 
comply  with  the  Community  harmonisation  legislation,  they  shall  take  appropriate 
action which may, if necessary, include prohibiting the product from being placed on 
the market. 

In  cases  where  placing  on  the  market  is  prohibited,  they  shall  ask  the  customs 
authorities  to  include  the  following  endorsement  on  the  commercial  invoice 
accompanying the product and on any other relevant accompanying document:  

'Product not in conformity - release for free circulation not authorized - Regulation 
(EC) No …/..',  

Where the product concerned is subsequently declared for a customs procedure other 
than  release  and  provided  the  market  surveillance  authorities  do  not  object,  the 
endorsements  listed  in  paragraphs  1  and  2  shall  also  be  included,  under  the  same 
conditions, on the documents used in connection with that procedure. 

Market surveillance authorities may destroy products presenting a serious risk where 
they deem it necessary and proportionate. 

2. 

3. 

4. 

CHAPTER IV 
COMMUNITY FINANCING 

Body pursuing an aim of general European interest 

Article 27 

European co-operation for Accreditation (EA) shall be considered to be a body pursuing an 
aim  of  general  European  interest  according  to  Article  162  of  Commission  Regulation  (EC, 
Euratom)  No  2342/2002  of  23  December  2002  laying  down  detailed  rules  for  the 
implementation of Regulation (EC, Euratom) N° 1605/200234. 

Activities eligible for Community financing 

Article 28 

1. 

The  Community  may  finance  the  following  activities  in  connection  with  the 
application of this Regulation: 

34 

OJ L 357, 31.12.2002, p. 1. 

EN 

29 

   EN 

 
                                                 
(a) 

(b) 

(c) 

the production and revision of sectoral accreditation schemes referred 
to in the third paragraph of Article 12;  

the activities of the central secretariat of EA, such as the coordination 
of  accreditation  activities,  the  processing  of  technical  work  linked  to 
the  operation  of  the  peer  evaluation  system,  the  provision  of 
information  to  interested  parties  and  EA’s  participation  in  the 
activities of international organisations in the field of accreditation; 

the  drawing  up  and  updating  of  contributions  for  guidelines  in  the 
fields  of  accreditation,  notification  to  the  Commission  of  conformity 
assessment bodies, conformity assessment and market surveillance; 

(d) 

intercomparison activities linked to the operation of safeguard clauses; 

(e) 

(f) 

(g) 

the  putting  at  the  disposal  of  the  Commission  technical  expertise  for 
the  purposes  of  assisting  it  in  its  implementation  of  market 
surveillance administrative cooperation, market surveillance decisions 
and safeguard clause cases; 

implementation  of 

the  performance  of  preliminary  or  ancillary  work  in  connection  with 
the  conformity  assessment,  metrology, 
the 
to 
accreditation  and  market  surveillance  activities 
the 
studies, 
implementation  of  Community 
programmes,  evaluations,  guidelines,  comparative  analyses,  mutual 
joint visits, research work, databases (development and maintenance), 
training  activities, 
inter-
laboratory tests and conformity assessment work; 

laboratory  work,  proficiency 

linked 
such  as 

legislation, 

testing, 

activities  seeking  to  carry  out  programmes  of  technical  assistance, 
cooperation  with  non-member  countries  and  the  promotion  and 
enhancement  of 
the  European  conformity  assessment,  market 
surveillance  and  accreditation  policies  and  systems  among  interested 
parties in the Community and at international level. 

2. 

The activities referred to in paragraph 1(a) shall be eligible for Community financing 
only if the Committee set up by Article 5 of Directive 98/34/EC has been consulted 
on the requests to be submitted to EA. 

Bodies eligible for Community financing 

Article 29 

Community financing may be granted to EA for the implementation of the activities listed in 
Article 28. 

However, Community financing may also be granted to other bodies for the carrying out of 
the activities set out in Article 28 except those set out in paragraph 1 (a) and (b). 

EN 

30 

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Financing 

Article 30 

The appropriations allocated to the activities referred to in this Regulation shall be determined 
each year by the budgetary authority within the limits of the current financial framework. 

Article 31 

Financing arrangements 

1. 

Community financing shall be provided: 

(a) 

(b) 

without a call for proposals, to EA to carry out those activities referred 
to  in  Article  28(1)  (a)  to  (g)  for  which  grants  can  be  awarded  in 
accordance with the Financial Regulation;  

in  the  form  of  grants  after  a  call  for  proposals,  or  by  public 
procurement procedures, to other bodies to carry out the work referred 
to in Article 28(1) (c) to (g). 

2. 

3. 

4. 

The activities of the central secretariat of EA, referred to in Article 28(1)(b), may be 
financed  on  the  basis  of  operating  grants.  In  the  event  of  renewal,  the  operating 
grants shall not be decreased automatically. 

Grant agreements may authorize flat-rate cover of the beneficiary's overheads up to a 
maximum of 10% of total eligible direct costs for actions, except where indirect costs 
of  the  beneficiary  are  covered  through  an  operating  grant  financed  from  the 
Community budget. 

The common cooperation objectives and the administrative and financial conditions 
relating  to  the  grants  awarded  to  EA  may  be  defined  in  a  framework  partnership 
agreement  signed  by  the  Commission  and  EA,  in  accordance  with  the  Financial 
Regulation and Regulation (EC, Euratom) No 2342/2002. The European Parliament 
and the Council shall be informed of the conclusion of such agreement. 

Management and monitoring 

Article 32 

1. 

The  appropriations  determined  by  the  budgetary  authority  for  the  financing  of 
conformity  assessment,  accreditation  and  market  surveillance  activities  may  also 
cover  the  administrative  expenses  relating  to  actions  involving  preparation, 
monitoring,  inspection,  auditing  and  evaluation  which  are  directly  necessary  for 
achieving  the  objectives  of  this  Regulation,  and  particularly  studies,  meetings, 
information and publication activities, expenses relating to informatics networks for 
the  exchange  of  information  and  any  other  expenditure  on  administrative  and 
technical assistance which the Commission may use for conformity assessment and 
accreditation activities. 

EN 

31 

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2. 

The  Commission  shall  evaluate  the  relevance  of  the  conformity  assessment, 
accreditation  and  market  surveillance  activities  receiving  Community  financing  in 
the light of  the  requirements of  Community policies and  legislation and  inform the 
European  Parliament  and  the  Council  about  the  outcome  of  such  activities  at  least 
every five years. 

Protection of the Community’s financial interests 

Article 33 

1. 

2. 

3. 

The Commission shall ensure that, when the activities financed under this Regulation 
are  implemented,  the  Community’s  financial  interests  are  protected  by  the 
application  of  preventive  measures  against  fraud,  corruption  and  other  illegal 
activities,  by  effective  checks  and  by  the  recovery  of  amounts  unduly  paid  and,  if 
irregularities  are  detected,  by  effective,  proportionate  and  dissuasive  penalties,  in 
accordance  with  Council  Regulation  (EC,  Euratom)  N°  2988/95  of  18  December 
1995  on  the  protection  of  the  European  Communities  financial  interests35,  Council 
Regulation (Euratom, EC) N° 2185/96 of 11 November 1996 concerning on-the-spot 
checks  and  inspections  carried  out  by  the  Commission  in  order  to  protect  the 
European Communities’ financial interest against fraud and other irregularities36 and 
Regulation (EC) N° 1073/1999 of the European Parliament and of the Council of 25 
May  1999  concerning  investigations  conducted  by  the  European  Anti-Fraud  Office 
(OLAF)37. 

For  the  Community  activities  financed  under  this  Regulation,  the  notion  of 
irregularity referred to in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall 
mean  any  infringement  of  a  provision  of  Community  law  or  any  breach  of  a 
contractual  obligation  resulting  from  an  act  or  omission  by  an  economic  operator 
which  has,  or  would  have,  the  effect  of  prejudicing  the  general  budget  of  the 
European  Communities  or  budgets  managed  by  them  by  an  unjustified  item  of 
expenditure. 

Any  agreements  and  contracts  resulting  from  this  Regulation  shall  provide  for 
monitoring  and  financial  control  by  the  Commission  or  any  representative  which  it 
authorizes  and  for  audits  by  the  Court  of  Auditors,  which  if  necessary  may  be 
conducted on the spot. 

35 
36 
37 

OJ L 312, 23.12.1995, p. 1. 
OJ L 292, 15.11.1996, p. 2. 
OJ L 136, 31.5.1999, p. 1. 

EN 

32 

   EN 

 
                                                 
FINAL PROVISIONS  

Article 34 

Technical Guidelines 

In  order  to  facilitate  the  implementation  of  this  Regulation,  the  Commission  shall  draw  up 
guidelines. 

Transitional provisions 

Article 35 

1. 

2. 

Accreditation  certificates  issued  before  the  entry  into  force  of  this  Regulation  shall 
remain valid until the date of their expiry. This Regulation shall, however, apply in 
the case of their extension or renewal. 

Where  in  a  Member  State  accreditation  is  not  operated  by  a  single  national 
accreditation  body  and  that  Member  State  intends  to  continue  to  operate 
accreditation, it shall make the necessary structural adaptations in order to establish a 
single national accreditation body by 1 January 2010 at the latest. 

Penalties 

Article 36 

The  Member  States  shall  lay  down  the  rules  on  penalties,  which  may  include  criminal 
sanctions,  for  serious  infringements,  applicable  to  infringements  of  the  provisions  of  this 
Regulation  and  shall  take  all  measures  necessary  to  ensure  that  they  are  implemented.  The 
penalties  provided  for  must  be  effective,  proportionate  and  dissuasive.  The  Member  States 
shall notify those provisions to the Commission by […] at the latest and shall notify it without 
delay of any subsequent amendment affecting them. 

Repeal 

Article 37 

Regulation (EEC) No 339/93 is repealed with effect from two years after the date of entry into 
force of this Regulation. 

Any references to the repealed Regulation shall be construed as references to this Regulation. 

This Regulation shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union. 

Article 38 

EN 

33 

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Chapter  III  shall  apply  with  effect  from  two  years  after  the  date  of  entry  into  force  of  this 
Regulation. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, […] 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…]

EN 

34 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

NAME OF THE PROPOSAL: 

Proposal for a Regulation of the European Parliament and of the Council setting out 
the requirements for accreditation and market surveillance relating to the conditions 
for the marketing of products. 

2. 

ABM / ABB FRAMEWORK 

Policy Area(s) concerned and associated Activity/Activities: ABB2 – Internal Market 
for Goods and Sectoral Policies. 

3. 

BUDGET LINES 

3.1. 

Budget  lines  (operational  lines  and  related  technical  and  administrative 
assistance lines (ex- B..A lines)) including headings: 

02.03.01 

3.2. 

Duration of the action and of the financial impact: 

Continuous 

3.3. 

Budgetary characteristics: 

Budget 
line 

Type of expenditure 

New 

EFTA 
contribution 

Contributions 
from applicant 
countries 

Heading in 
financial 
perspective 

02.03.01  Non-
comp 

Diff 

NO 

YES 

NO 

1a 

EN 

35 

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4. 

SUMMARY OF RESOURCES 

4.1. 

Financial Resources 

4.1.1. 

Summary of commitment appropriations (CA) and payment appropriations (PA) 

Expenditure type 

Section 
no. 

Operational expenditure38 

Commitment Appropriations 
(CA) 

8.1. 

Payment 
(PA) 

Appropriations 

a 

b 

EUR million (to 3 decimal places) 

2009  2010  2011  2012  2013  2014 

and 
later 

Total 

1,175  1,175 

1,175 

1,175 

1,175 

1,175 

0,352  1,175 

1,175 

1,175 

1,175 

1,175 

Administrative expenditure within reference amount39 

Technical  &  administrative 
assistance (NDA) 

8.2.4. 

c 

TOTAL REFERENCE AMOUNT 

1,1 

1,1 

1,1 

1,1 

1,1 

1,1 

Commitment 
Appropriations 

2,275  2,275 

2,275 

2,275 

2,275 

2,275 

a+c 

Payment Appropriations 

b+c 

1,452  2,275 

2,275 

2,275 

2,275 

2,275 

Administrative expenditure not included in reference amount40 

0 

0 

0 

0 

0 

0 

0 

Human 
associated 
(NDA) 

resources 

and 
expenditure 

8.2.5. 

d 

Administrative  costs,  other 
than  human  resources  and 
not 
associated 
included 
reference 
in 
amount (NDA) 

costs, 

8.2.6. 

e 

Total indicative financial cost of intervention 

TOTAL CA including cost 
of Human Resources 

TOTAL  PA  including  cost 
of Human Resources 

a+c
+d+
e 

b+c
+d+
e 

2,275  2,275 

2,275 

2,275 

2,275 

2,275 

1,452  2,275 

2,275 

2,275 

2,275 

2,275 

38 
39 
40 

Expenditure that does not fall under Chapter xx 01 of the Title xx concerned. 
Expenditure within article xx 01 04 of Title xx. 
Expenditure within chapter xx 01 other than articles xx 01 04 or xx 01 05. 

EN 

36 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Co-financing details: 

No co-financing  

4.1.2.  Compatibility with Financial Programming 

The proposal is compatible with existing financial programming. 

4.1.3.  Financial impact on Revenue 

The proposal has no financial implications on revenue 

4.2. 

Human Resources FTE (including officials, temporary and external staff) – see 
detail under point 8.2.1. 

Annual requirements 

2009 

2010  2011 

2012 

2013 

2014 
and 
later 

Total  number  of  new  human 
resources 

4* 

* supplementary staff should be foreseen over the entire period 

5. 

CHARACTERISTICS AND OBJECTIVES 

5.1. 

Need to be met in the short or long term 

The  proposal  provides  for 
the  reinforcement  of  European  cooperation  for 
Accreditation  as  the  means  of  ensuring  that  accreditation  can  play  the  role  of  the 
final level of control in the proper functioning of EU legislation which has recourse 
to  professional  conformity  assessment  bodies.  This  in  turn  requires  that  certain 
activities  be  carried  out  for  the  purpose  of  Community  legislation  and  in  particular 
the  proper  and  rigorous  operation  of  a  peer  evaluation  system  of  control  of  the 
national  accreditation  bodies  at  the  European  level  answering  the  needs  of  public 
authorities. 

Effective  European  participation  and  input  to  international  activities  at  the 
international  level  are  indispensable  in  order  to  promote  and  defend  European 
interests in this area of activity. 

In  order  to  be  able  to  manage  complaints  and  disputes  as  well  as  safeguard  clause 
cases  under  EU  legislation,  the  Commission  needs  to  be  able  to  dispose  of  the 
technical means and resources. The provision of a Community budgetary programme 
would  enable  the  Commission  to  meet  these  needs  which  it  does  not  dispose  of 
naturally within its services. 

More  generally  in  the  field  of  market  surveillance,  it  is  necessary  to  provide  for  a 
number  of  coordinating  activities  at  the  European  level  in  particular  for:  the 
establishment  and  coordination  of  ad  hoc  market  surveillance  projects  in  order  to 
share  resources  and  expertise:  develop  and  organise  training  programmes  and 
exchange  of  national  officials  including  customs  authorities;  promote  the  exchange 

EN 

37 

   EN 

 
 
 
 
 
 
 
 
of  experience  and  share  resources  on  risk  analysis  activities;  set  up  appropriate 
programmes for the exchange of information and best practices, through programmes 
for common projects, information campaigns, joint visit programmes, etc  

The general objectives of the proposal are set out in the explanatory memorandum. 

5.2. 

Value-added  of  Community  involvement  and  coherence  of  the  proposal  with 
other financial instruments and possible synergy 

The creation of the internal market for goods is one of the objectives of the European 
Community.  Pursuant  to  Article  14(2)  of  the  EC  Treaty,  the  internal  market  shall 
comprise  an  area  without  internal  frontiers  in  which  the  free  movement  of  goods, 
persons,  services  and  capital  is  ensured  in  accordance  with  the  provisions  of  the 
Treaty.  The  Community  harmonisation  of  legislative  requirements  for  the  safety  of 
products has contributed considerably to the achievement of the Treaty’s objectives.  

The  objective  of  this  proposal  is  to  put  into  place  the  means  to  ensure  the  proper 
level of credibility of EU legislation and trust that public authorities can place in its 
implementation and in particular in the CE marking regime. 

Ensuring the proper coherence and coordination of the technical tools to implement 
the  political  levels  of  protection  set  out  in  the  legislation  is  a  sine  qua  non  for 
success. 

The  capacity  of  the  Commission  to  intervene  quickly  and  on  the  basis  of  sound 
technical infrastructures and decisions can also contribute considerably to the overall 
objective of creating trust in the EU system. 

A  comparison  of  the  options  set  out  in  the  impact  assessment  points  clearly  to  a 
regulatory approach on the basis of Article 95(1) EC Treaty to give a legal basis to 
these  activities  and  to  reinforce  their  Community  nature.  Moreover  in  the  face  of 
differing national legislation, Community legislation is the only feasible option. 

5.3. 

Objectives, expected results and related indicators of the proposal in the context 
of the ABM framework 

In  the  context  of  the  enlarged  single  market,  action  at  EU  level  carries  an  evident 
added value, providing European businesses with a large, single market and allowing 
economies of scale. At the same time, the smooth functioning of this market requires 
for  its  very  supra-national  nature  an  EU-level  intervention,  while  limiting  the  EC 
intervention to what is strictly necessary.  

The main  objective  of the proposal  is to ensure the free movement of goods in the 
harmonised  area.  It  should  impose  the  minimum  economic  burden  consistent  with 
achieving this objective, and it should be applied effectively and easily. The impact 
assessment comprises a more detailed and technical description of the objectives and 
the expected results. 

A proper functioning of EU legislation through the implementation of this proposal 
should lead to reduction in diverging national measures in relation to products on the 
market  and 
reports  and 
certification/inspection certificates. 

to  a  greater  acceptance  of  and 

trust 

test 

in 

EN 

38 

   EN 

 
This  should  in  turn  lead  economic  operators  to  have  less  need  of  recourse  to 
unnecessary  multiple  certification  and  marking  and  to  fewer  interventions  of  the 
Commission under the safeguard clauses. 

5.4.  Method of Implementation (indicative) 

Direct centralised management by the Commission 

6. 

MONITORING AND EVALUATION 

6.1.  Monitoring system 

The  monitoring  shall  be  carried  out  by  the  Commission  itself,  assisted  both  by  the 
Committee set up under Directive 98/34 laying down a procedure for the provision of 
information  in  the  field  of  technical  standards  and  regulations,  as  well  as  by  the 
Group of Experts called the Group of Government Officials in the field of standards 
and conformity assessment. 

6.2. 

Evaluation 

6.2.1.  Ex-ante evaluation 

A real ex ante evaluation is not a simple affair when introducing a new Community 
policy, however past experience in the operation of harmonisation legislation (mutual 
joint  visit  programme),  experience of the operation of the present infrastructures in 
the  field  of  accreditation  and  an  extrapolation  of  the  experiences  of  the  European 
standardisation programme show that a small Community budgetary contribution can 
be  effective  and  ensure  proper  and  effective  public  authority  protection  f  public 
interests. (See ex ante evaluation in annex). 

6.2.2.  Measures taken following an intermediate/ex-post evaluation (lessons  learned from 

similar experiences in the past) 

Not applicable. 

6.2.3.  Terms and frequency of future evaluation 

The  terms  and  the  frequency  of  future  evaluation  activities  will  be  determined  in 
accordance with the applicable rules. 

7. 

ANTI-FRAUD MEASURES  

Full application of internal control standards No 14, 15, 16, 17, 18, 19, 20, 21. 

The  Commission  shall  ensure  that,  when  actions  financed  under  the  present 
programme are implemented, the financial interests of the Community are protected 
by  the  application  of  preventive  measures  against  fraud,  corruption  and  any  other 
illegal activities, by effective checks and by the recovery of the amounts unduly paid 
and, if irregularities are detected, by effective, proportional and dissuasive penalties, 
in accordance with Council Regulation (EC, Euratom) No 2988/95 of 18 December 

EN 

39 

   EN 

 
1995  on  the  protection  of  the  European  Communities  financial  interests,  and  with 
Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 
May  1999  concerning  investigations  conducted  by  the  European  Anti-Fraud  Office 
(OLAF). 

EN 

40 

   EN 

 
8. 

DETAILS OF RESOURCES 

8.1. 

Objectives of the proposal in terms of their financial cost 

Commitment appropriations in EUR million (to 3 decimal places) 

2009 

2010 

2011 

2012 

2013 

2014 and later 

TOTAL 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

No. 
outputs 

Total 
cost 

1 report 

0,075 

1 report 

0,075 

1 report 

0,075 

1 report 

0,075 

1 report 

0,070 

1 report 

0,075 

Type of output 

Av. 
cost 

Service 
contract 

of 

(Headings 
Objectives, 
and 
actions 
outputs should be 
provided) 

Contribution to the 
the 
operation  of 
peer 
evaluation 
system, 
Contribution to the 
participation 
in 
international  work 
and 
general 
secretariat support 

Inter-comparisons 
programmes 

Service 
contract 

Service 
contract 

and 

Market 
surveillance 
accreditation 
guidelines 

50 
prelim 
reports 

3-4 
guidelin
es 

1,000 

50 
reports 

1,000 

50 
reports 

1,000 

50 
reports 

1,000 

1,000 

1,000 

0,100  

3-4 
guidelin
es 

0,100  

3-4 
guidelin
es 

0,100  

3-4 
guidelin
es 

0,100  

3-4 
guidelin
es 

0,100 

3-4 
guidelin
es 

0,100 

TOTAL COST 

1,175 

1,175 

0 

1,175 

1,175 

0 

1,175 

0 

1,175 

0 

EN 

41 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2. 

Administrative Expenditure 

8.2.1.  Number and type of human resources 

Types of post 

Staff to be assigned to management of the actions using supplementary 
resources (number of posts/FTEs) 

2009 

2010 

2011 

2012 

2013 

2014 

Officials or 
temporary 
staff41 (XX 01 
01) 

A*/AD 

2AD* 

B*, 
C*/AST 

2AST* 

Staff  financed42  by  art. 
XX 01 02 

Other  staff43  financed by 
art. XX 01 04/05 

TOTAL 

0 

0 

4* 

0 

0 

0 

0 

0 

0 

0 

0 

0 

0 

* supplementary staff should be foreseen over the entire period 

8.2.2.  Description of tasks deriving from the action 

Besides the follow-up of the proposal and the  assessment of the implementation of 
the legislative texts at the national level, the task will consist of managing: 

- the political and contractual relations with European co-operation for Accreditation 

- the financial relations with EA 

- the cooperation of the national market surveillance authorities in general and more 
particularly under the safeguard cases 

- management of the inter comparisons programmes both from the technical and the 
financial points of view 

-  management  of  the  mutual  joint  visits  programme,  co-operation  and  training 
programmes and information tools. 

8.2.3. 

Sources of human resources (statutory) 

Posts to be redeployed using existing resources within the managing service (internal 
redeployment) 

41 
42 
43 

Cost of which is NOT covered by the reference amount 
Cost of which is NOT covered by the reference amount 
Cost of which is included within the reference amount 

EN 

42 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
8.2.4.  Other  Administrative  expenditure  included  in  reference  amount  (XX  01  04/05  – 

Expenditure on administrative management) 

Budget line 

(number and heading) 

2009 

2010 

2011 

2012 

2013 

2014 
and 
later 

TOTAL 

EUR million (to 3 decimal places) 

Technical 

and 
1 
assistance (including related staff costs) 

administrative 

Executive agencies 

0 

0 

0 

0 

0 

0 

0 

Other 

technical 

and 

administrative 

assistance: 

Administrative 

cooperation, 

studies, 
training  programmes,  exchange  of 
national experts, mutual joint visits etc 

0,500 

0,500 

0,500 

0,500 

0,500 

0,500 

- intra muros 

0,200 

0,200 

0,200 

0,200 

0,200 

Extension of Rapex web tool 

- extra muros 

Development of ICSMS information tool 

0,200 

0,400 

0,400 

0,400 

0,400 

0,400 

0,400 

Total  Technical  and  administrative 
assistance 

1.1  

1.1  

1.1  

1.1  

1.1  

1.1  

8.2.5.  Financial cost of human resources and associated costs not included in the reference 

amount 

EUR million (to 3 decimal places) 

Type of human resources 

2009 

2010 

2011 

2012 

2013 

Officials  and  temporary  staff 
(XX 01 01) 

Staff  financed  by  Art  XX  01 
02  (auxiliary,  END,  contract 
staff, etc.) 

0 

0 

(specify budget line) 

0 

0 

0 

0 

0 

0 

0 

0 

2 

0 

0 

cost 

of  Human 
Total 
Resources  and  associated 
costs 
in  reference 
amount) 

(NOT 

0 

0 

0 

0 

0 

0 

EN 

43 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.2.6. Other administrative expenditure not included in reference amount 

EUR million (to 3 decimal places)

2009 

2010 

2011 

2012 

2013 

2014
and 
later 

TOTAL 

XX 01 02 11 01 – Missions 

XX 01 02 11 02 – Meetings & Conferences 

XX 01 02 11 03 – Committees44  

XX 01 02 11 04 – Studies & consultations 

XX 01 02 11 05 - Information systems 

2 

Total 

Other  Management 

Expenditure (XX 01 02 11) 

3  Other 

expenditure 

administrative 
including reference to budget line) 

nature 

of 

an 
(specify 

expenditure, 
than  human  resources  and 
in 

Total  Administrative 
other 
associated  costs  (NOT 
reference amount) 

included 

44 

Specify the type of committee and the group to which it belongs. 

EN 

44 

   EN